M2100

Question 1

Where a rejection not based on priorart is proper (lack of adequate written description,enablement, or utility, etc.)

Answer 1

Such rejection should be stated with a full development of the reasons rather than by a mere conclusion

Question 2

Patent Examination Process

Answer 2

I. DETERMINE WHAT INVENTION IS SOUGHTTO BE PATENTED
II. CONDUCT A THOROUGH SEARCH OF THE PRIOR ART
III. DETERMINE WHETHER THE CLAIMEDINVENTION COMPLIES WITH 35 U.S.C. 101
IV. EVALUATE APPLICATION FORCOMPLIANCE WITH 35 U.S.C. 112
V. DETERMINE WHETHER THE CLAIMEDINVENTION COMPLIES WITH 35 U.S.C. 102 AND103
VI. CLEARLY COMMUNICATE FINDINGS,CONCLUSIONS AND THEIR BASES

Question 3

I. DETERMINE WHAT INVENTION IS SOUGHTTO BE PATENTED

Answer 3

A. Identify and Understand Any Utility for the Invention
* Applicant should contain some indication of the practical application
* Practical application in the utility eligibility vs in the subject matter eligibility => DIFFERENT!
* More than one practical utility possible but ONLY ONE is necessary
* Alternatively, may rely on the CONTEMPORANEOUS ART

B. Review the Detailed Disclosure and Specific Embodiments of the Invention To Understand What theApplicant Has Invented
(A) Determe the function of invention
(B) Determe the features for at least one practical appliction

C. Review the Claims
1. Determine the scope of a claim
2. Correlate each claim limitation to all portions for all cases
3. BRI (2111) will reduce the possibility that the claim will be interpreted more broadly than justified

• Plain meaning of claim language (2111.01)
• Claim language limiting effect (2111.02 ~ 2111.05)
• Disclusure may be EXPRESS, IMPLICIT, or INHERENT
• A positive limitation from the specification cannot be read into a claim that does not itself impose thatlimitation (2111.01, Subsection II)
• When evaluating the scope of a claim, EVERY limitation in the claim must be considered as a whole (Don’t dissect the invention to discrete components)

Question 4

II. CONDUCT A THOROUGH SEARCH OF THEPRIOR ART

Answer 4

MPEP 904

Question 5

III. DETERMINE WHETHER THE CLAIMEDINVENTION COMPLIES WITH 35 U.S.C. 101

Answer 5

A. Consider the Breadth of 35 U.S.C. 101 UnderControlling Law
(i) only one patent may be obtainedfor an invention
(ii) the inventor(s) must be identified in an application filed on or after September 16, 2012 or must be the applicant in applications filed before September 16, 2012
(iii) the claimed invention must be eligible for patenting
(iv) the claimed invention must be useful (have utility)

• Examiners should avoid focusing on only issues of patent-eligibility under 35 U.S.C. 101 and
• Examiners should avoid treating an application solely on the basis of patent-eligibility under 35 U.S.C. 101 except in the most extreme cases

Question 6

IV. EVALUATE APPLICATION FOR COMPLIANCE WITH 35 U.S.C. 112

Answer 6

A. Determine Whether the Claimed InventionComplies with 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C.112, Second Paragraph Requirements
(A) Set forth the subject matter the inventor or a joint inventor regards as the invention
(B) Particularly point out and distinctly claim the invention
* When the claims do not set out and define the invention with a reasonable degree of precision and particularity
* The definiteness of the language must beanalyzed
* 112(f) (2186 ~ 2173)

B. Determine Whether the Claimed InventionComplies with 35 U.S.C. 112(a) or 35 U.S.C. 112, FirstParagraph Requirements
1. Adequate Written Description (2163)
2. Enabling Disclosure (2164)
* Undue experiment
* Complex will not make it undue if a person of skill in the art routinely engages in such experimentation
3. Best Mode 2165 (Two-prong inquiry)
(1) at the time the application was filed, did theinventor possess a best mode for practicing theinvention
(2) if the inventor did possess a best mode, does the written description disclose the best mode in such a manner that a person of ordinary skill in the art could practice the best mode
* The best mode are not usually encountered during examination of an application because evidence to support such a deficiency is seldom in the record

Question 7

V. DETERMINE WHETHER THE CLAIMEDINVENTION COMPLIES WITH 35 U.S.C. 102 AND103

Answer 7

If no differences are found between the claimed invention and the prior art, thenthe claimed invention lacks novelty and is to be rejected by USPTO personnel under 35 U.S.C. 102

One must determine whether the invention would have been obvious to one of ordinary skill in the art. If not, the claimed invention satisfies 35 U.S.C. 103.

Question 8

VI. CLEARLY COMMUNICATE FINDINGS,CONCLUSIONS AND THEIR BASES

Answer 8

Examiners should review all the proposed rejections and their bases to confirm that a prima facie case of unpatentability exists. Only then should any rejection be imposed in an Office action.

Question 9

Utility rejection (101, 112(a))

Answer 9

• The 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph, rejectionimposed in conjunction with a 35 U.S.C. 101rejection should incorporate by reference the groundsof the corresponding 35 U.S.C. 101 rejection.
• If documentary evidence is not available, theexaminer should specifically explain the scientificbasis for his or her factual conclusions
• A rejection based on lack of utilityshould not be maintained if an asserted utility forthe claimed invention would be considered specific,substantial, and credible by a person of ordinary skillin the art in view of all evidence of record
• Office personnel must accept an opinionfrom a qualified expert
• 1. This can occur when anapplicant fails to identify any specific and substantialutility for the invention or fails to disclose enoughinformation about the invention to make itsusefulness immediately apparent to those familiarwith the technological field of the invention 2. The second typeof deficiency arises in the rare instance where anassertion of specific and substantial utility for theinvention made by an applicant is not credible
• If an invention is only partiallysuccessful in achieving a useful result, a rejection of the claimed invention as a whole based on a lack of utility is not appropriate
• Office personnel should not label an asserted utility “incredible,” “speculative” or otherwise unless it is clear that a rejection based on “lack of utility” is proper
• Courts have repeatedly found that the mere identification of a pharmacological activity of a compound that is relevant to an asserted pharmacological use provides an “immediate benefit to the public” and thus satisfies the utility requirement
• Courts have found utility for therapeutic inventions despite the fact that an applicant is at a very early stage in the development of a pharmaceutical product or therapeutic regimen basedon a claimed pharmacological or bioactive compound or composition
• FDA approval, however, is not a prerequisitefor finding a compound useful within themeaning of the patent laws
• If the asserted utility is credible,there is no basis to challenge such a claim on the basis that it lacks utility under 35 U.S.C. 101
• A deficiency under the utility prong of 35 U.S.C.101 also creates a deficiency under 35 U.S.C. 112(a)or pre-AIA 35 U.S.C. 112, first paragraph
• an applicant need only make one credible assertion of specificutility for the claimed invention to satisfy 35 U.S.C.101 and 35 U.S.C. 112
• An applicant who omits a description of the specific and substantial utility of the invention,or who incompletely describes that utility, may encounter problems with respect to the best moderequirement of 35 U.S.C. 112(a)
• When the operativeness of any process would be deemed unlikely by one of ordinary skill in the art, it is not improper for the examiner to call for evidence of operativeness
• Requests for additional evidence should be imposed rarely, and only if necessary to support the scientific credibility of the asserted utility
• As a general matter, evidence of pharmacologicalor other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity inquestion and the asserted utility. STRUCTURAL SIMILARITY TO COMPOUNDSWITH ESTABLISHED UTILITY

Question 10

Inventorship

Question 11

BRI

Answer 11

• Patented claims are not given the broadest reasonable interpretation during court proceedings involving infringement and validity, and can be interpreted based on a fully developed prosecution record.
• The broadest reasonable interpretation does not mean the broadest possible interpretation

Question 12

Plain Meaning

Answer 12

• THE WORDS OF A CLAIM MUST BE GIVEN THEIR “PLAIN MEANING” UNLESS SUCH MEANING IS INCONSISTENT WITH THE SPECIFICATION
• IT IS IMPROPER TO IMPORT CLAIMLIMITATIONS FROM THE SPECIFICATION
• a particular embodiment appearing in thewritten description may not be read into a claim when the claim language is broader than the embodiment
• “PLAIN MEANING” REFERS TO THEORDINARY AND CUSTOMARY MEANING GIVENTO THE TERM BY THOSE OF ORDINARY SKILLIN THE ART
• The ordinary and customary meaning of a term maybe evidenced by a variety of sources, including thewords of the claims themselves, the specification,drawings, and prior art. However, the best sourcefor determining the meaning of a claim term is the specification
• APPLICANT MAY BE OWN LEXICOGRAPHER AND/OR MAY DISAVOW CLAIM SCOPE
• SUMMARY OF DETERMINING THE MEANING OF A CLAIM TERM THAT DOES NOT INVOKE 35 U.S.C. 112(f)
• If no reasonably clear meaning can be ascribedto the claim term after considering the specificationand prior art, the examiner should apply the broadest reasonable interpretation to the claim term as it can be best understood. Also, the claim should be rejected under 35 U.S.C. 112(b) and the specification objected to under 37 CFR 1.75(d).

Question 13

Effect of preamble

Answer 13

• “If the claim preamble, when read in the context of the entire claim, recites limitations of theclaim, or, if the claim preamble is ‘necessary to give life, meaning, and vitality’ to the claim, then theclaim preamble should be construed as if in the balance of the claim.”
• statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference

Question 14

Transitional Phrases

Answer 14

1. Comprising: Synonymous with “including,” “containing,” or“characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps
2. Consisting of: Excludes any element, step, or ingredient not specified in the claim. (Markush grouping -> Consisting of)
3. Consisting essentially of: limits the scope of a claim to the specified materials or steps
   * For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103,absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.”
4. Having: must beinterpreted in light of the specification to determine whether open or closed claim language is intended
5. Composed of: either “consisting of” or “consisting essentially of,”

Question 15

“Adapted to,” “Adapted for,”“Wherein,” “Whereby,”

Answer 15

• that may raise a question as to the limiting effect of the language in a claim

Question 16

Contingent Clauses

Answer 16

The system claim interpretation differs from amethod claim interpretation because the claimedstructure must be present in the system regardlessof whether the condition is met and the function isactually performed

Question 17

Functional and NonfunctionalDescriptive Material

Answer 17

I. DETERMINING WHETHER A FUNCTIONAL RELATIONSHIP EXISTS BETWEEN PRINTED MATTER AND ASSOCIATED SUBSTRATE

II. FUNCTIONAL RELATIONSHIP BETWEEN PRINTED MATTER AND ASSOCIATED SUBSTRATE MUST BE NEW AND NONOBVIOUS

III. MACHINE-READABLE MEDIA
* Where the programming performs some function with respect to the computer with which it is associated, a functional relationship will be found
* Merely serves as a support for information or data, no functional relationship exists

Question 18

Requirements of Rejection Based on Inherency

Answer 18

I. SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERYOF A NEW PROPERTY
* Thus the claiming of a new use, new functionor unknown property which is inherently present in the prior art does not necessarily make the claim patentable

II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION

III. A REJECTION UNDER 35 U.S.C. 102 AND 103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC

IV. EXAMINER MUST PROVIDE RATIONALE OR EVIDENCE TO SHOW INHERENCY

V. ONCE A REFERENCE TEACHING PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS MADE THE BASIS OF A REJECTION, AND THE EXAMINER PRESENTS EVIDENCE OR REASONING TO SHOW INHERENCY, THE BURDEN OF PRODUCTION SHIFTS TO THE APPLICANT

• PRODUCT AND APPARATUS CLAIMS —WHEN THE STRUCTURE RECITED IN THE REFERENCE IS SUBSTANTIALLY IDENTICAL TO THAT OF THE CLAIMS, CLAIMED PROPERTIES OR FUNCTIONS ARE PRESUMEDTO BE INHERENT
• COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES
• PRODUCT CLAIMS – NONFUNCTIONAL PRINTED MATTER DOES NOT DISTINGUISH CLAIMED PRODUCT FROM OTHERWISE IDENTICAL PRIOR ART PRODUCT
• PROCESS CLAIMS — PRIOR ART DEVICE ANTICIPATES A CLAIMED PROCESS IF THE DEVICE CARRIES OUT THE PROCESS DURING NORMAL OPERATION
• PROCESS OF USE CLAIMS — NEW AND NONOBVIOUS USES OF OLD STRUCTURES AND COMPOSITIONS MAY BE PATENTABLE

Question 19

Product-by-Process Claims

Answer 19

• “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself
• The patentability of a product does not depend on its method of production
• ONCE A PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS FOUND AND A PRIOR ART REJECTION IS MADE

Question 20

Apparatus and Article Claims - Functional Language

Answer 20

I. INHERENCY AND FUNCTIONAL LIMITATIONS IN APPARATUS CLAIMS

II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART

III. A PRIOR ART DEVICE CAN PERFORM ALL THE FUNCTIONS OF THE APPARATUS CLAIM AND STILL NOT ANTICIPATE THE CLAIM

IV. DETERMINING WHETHER A COMPUTER-IMPLEMENTED FUNCTIONAL CLAIM LIMITATION IS PATENTABLE OVER THE PRIOR ART UNDER 35 U.S.C. 102 AND 103
* Computer-implemented functional claim limitations may also be broad because the term “computer” is commonly understood by one of ordinary skill in the art to describe a variety of devices with varying degrees of complexity and capabilities

Question 21

Material or Article Worked Upon by Apparatus

Answer 21

• MATERIAL OR ARTICLE WORKED UPON DOES NOT LIMIT APPARATUS CLAIMS
• Novel, Nonobvious Starting Materialor End Product
• A process yielding a novel and nonobvious product may nonetheless be obvious; conversely, a process yielding a well-known product may yet be nonobvious

Question 22

Markush Claims

Answer 22

• A Markush grouping is proper if the members of agroup share a single structural similarity and acommon use
• Improper: (1) the members of the Markush group do not share a “single structural similarity” or (2) the members do not share a common use
• “Single Structural Similarity” - Members of aPhysical, Chemical, or Art-Recognized Class
• Common Use Flows From Substantial Structural Feature

Question 23

Rejection on Prior Art

Answer 23

• “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, orotherwise discourage the solution claimed
• IN SOME CIRCUMSTANCES A FACTUAL REFERENCE NEED NOT ANTEDATE THE FILING DATE
• However, it is impermissible to use a later factual reference showing the state of the art existing after the effective filing date of the application to determine whether the application is enabled or described as required under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph
• Scope of Reference’s Disclosure Which Can Be Used to Reject Claims When the Reference Is a “Patent” but Not a“Publication”
• OFTEN UNCLAIMED DETAILS FOUND IN THEPATENT SPECIFICATION CAN BE RELIED ONEVEN IF PATENT IS SECRET
• Abandoned Applications Disclosed to the Public CanBe Used as Prior Art
• A 35 U.S.C. 102(a)(2) or Pre-AIA 35 U.S.C. 102(e) Rejection Cannot Rely on Matter Which Was Canceled from the Application and Thus Did Not Get Published in the Issued Patent or Application Publication
• A 35 U.S.C. 102(a)(1) or Pre-AIA 35 U.S.C. 102(b) Rejection Over a Published Application May Rely on Information that Was Canceled Prior to Publication
• ADMISSIONS BY APPLICANT CONSTITUTE PRIOR ART
• Where the specification identifies work done by another as “prior art,” the subject matter so identified is treated as admitted prior art
• Applicant explained that the Jepson format was used to avoid a double patenting rejection in a co-pending application and the examiner cited no art showing the subject matter of the preamble
• “The filing of an information disclosure statement shall not be construed to be an admission that the information cited in the statement is, or is considered to be, material to patentability as defined in §1.56(b).”

Question 24

Anticipation (102)

Answer 24

• A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single priorart reference
• The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required
• Normally, only one reference should be used inmaking a rejection under 35 U.S.C. 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:
  (A) Prove the primary reference contains an“enabled disclosure;”
  (B) Explain the meaning of a term used in the primary reference; -
  (C) Show that a characteristic not disclosed in the reference is inherent
• Extra References and Extrinsic Evidence Can Be Used
• Evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based
• “Arguments that the alleged anticipatory prior art is ‘nonanalogous art’ or ‘teaches away from the invention’ or is not recognized as solving the problem solved by the claimed invention, [are] not ‘germane’ to a rejection under section 102.”

Question 25

Genus-Species Situations

Answer 25

I. A SPECIES WILL ANTICIPATE A CLAIM TO A GENUS
* “A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus.”

II. A REFERENCE THAT CLEARLY NAMES THE CLAIMED SPECIES ANTICIPATES THE CLAIM NO MATTER HOW MANY OTHER SPECIES ARE NAMED

III. A GENERIC DISCLOSURE WILL ANTICIPATE A CLAIMED SPECIES COVERED BY THAT DISCLOSURE WHEN THE SPECIES CAN BE “AT ONCE ENVISAGED” FROM THE DISCLOSURE

Question 26

Anticipation of Ranges

Answer 26

I. A SPECIFIC EXAMPLE IN THE PRIOR ART WHICH IS WITHIN A CLAIMED RANGE ANTICIPATES THE RANGE

II. PRIOR ART WHICH TEACHES A RANGE OVERLAPPING OR TOUCHING THE CLAIMED RANGE ANTICIPATES IF THE PRIOR ART RANGE DISCLOSES THE CLAIMED RANGE WITH “SUFFICIENT SPECIFICITY”

III. PRIOR ART WHICH TEACHES A VALUE OR RANGE THAT IS VERY CLOSE TO, BUT DOES NOT OVERLAP OR TOUCH, THE CLAIMED RANGE DOES NOT ANTICIPATE THE CLAIMED RANGE

Question 27

102(a)

Answer 27

• Overcome: arguing that the claims are patentably distinguishable from the prior art, or by amending the claims to patentably distinguish over the prior art
• Filing an affidavit or declaration under37 CFR 1.131(a) showing prior invention, if the reference is not a U.S. patent or a U.S. patent application publication claiming interfering subject matter
• When the claims of the reference U.S. patent or U.S. patent application publication and the application are directed to the same invention or are obvious variants, an affidavit or declaration under 37 CFR1.131(a) is not appropriate to overcome the rejection
• Filing an affidavit or declaration under37 CFR 1.132 showing that the reference inventionis not by “another,” i.e., showing a reference’s disclosure was derived from the inventor’s or at least one joint inventor’s own work
• When the reference is not a statutory bar under pre-AIA 35 U.S.C. 102(b), (c), or (d), applicant can overcome the rejection by swearing back of the reference through the submission of an affidavit under 37 CFR 1.131

Question 28

102(b)

Answer 28

• THE 1-YEAR TIME BAR IS MEASURED FROM THE U.S. FILING DATE
• 1년 지나면 1.131로 극복못함 (A PRE-AIA 35 U.S.C. 102(b) REJECTION CREATES A STATUTORY BAR TO PATENTABILITY OF THE REJECTED CLAIMS)
• Overcome
  (A) Persuasively arguing that the claims are patentably distinguishable from the prior art;
  (B) Amending the claims to patentably distinguish over the prior art;
  (C) Submitting and perfecting a benefit claimunder 35 U.S.C. 120, within the time period set in37 CFR 1.78 (or by filing a grantable petition to accept an unintentionally delayed claim under 37CFR 1.78 as explained in MPEP § 211.04)
• for applications filed on or afterSeptember 16, 2012, by filing a corrected application data sheet under 37 CFR 1.76
• for applications filed prior toSeptember 16, 2012, by amending the specification of the application to contain a specific reference toa prior application or by filing a corrected application data sheet under 37 CFR 1.76
  (D) Submitting and perfecting a benefit claim under 35 U.S.C. 119(e) by complying with the requirements of 37 CFR 1.78 or filing a grantable petition to accept an unintentionally delayed claimunder 37 CFR 1.78

Question 29

Public use

Answer 29

• There Is No Public Use If Inventor Restricted Use to Locations Where There Was a Reasonable Expectation of Privacy and the Use Was for His or Her Own Enjoyment
• The Presence or Absence of a Confidentiality Agreement is Not Dispositive of the Public Use Issue
• An Invention Is in Public Use If the Inventor Allows Another To Use the Invention Without Restriction or Obligation of Secrecy
• Use by an Independent Third Party Is Public Use If It Sufficiently “Informs” the Public of the Invention or a Competitor Could Reasonably Ascertain the Invention
• Even if public use activity by one other than anapplicant is not sufficiently “informing,” there may be adequate grounds upon which to base a rejection under pre-AIA 35 U.S.C. 102(f) and pre-AIA 35U.S.C. 102(g)

Question 30

Sale

Answer 30

• A sale or offer for sale must take place between separate entities
• Delivery of the Offered Item Is Not Required
• Seller Need Not Have the Goods “On Hand” When the Offer for Sale Is Made
• Material Terms of an Offer for Sale Must be Present
• Sale Activity Need Not Be Public
• Inventor’s Consent to the Sale Is Not a Prerequisite To Finding an On Sale Bar: even if the inventor did not consent to the sale or have knowledge that the invention was embodied in the sold article
• Nonprior Art Publications Can Be Used as Evidence of Sale Before the Critical Date
• Abstracts identifying a product’s vendor containing information useful to potential buyers such as whom to contact, price terms, documentation, warranties, training and maintenance along with the date of product release or installation before the inventor’s critical date may provide sufficient evidence of prior sale by a third party to support a rejection based onpre-AIA 35 U.S.C. 102(b) or 103

Question 31

The Invention

Answer 31

• THE INVENTION MUST BE “READY FOR PATENTING”
• INVENTOR HAS SUBMITTED A 37 CFR 1.131 AFFIDAVIT OR DECLARATION
• Affidavits or declarations submitted under 37 CFR1.131 to swear behind a reference may constitute, among other things, an admission that an invention was “complete” more than 1 year before the filing of an application
• Know-how sale: such a transaction is not a‘sale’ of the invention within the meaning of[pre-AIA] §102(b) because the process has not been carried out or performed as a result of the transaction.

Question 32

Experimental Use

Answer 32

• Experimentation must be the primary purpose and any commercial exploitation must be incidental in order for the sale to be a permitted activity that does not create a bar under pre-AIA 35U.S.C. 102(b)
• The experimental use exception…does not include market testing where the inventor is attempting to gauge consumer demand for his claimed invention.The purpose of such activities is commercial exploitation and not experimentation
• if a prototype is considered “complete” by an inventor and all experimentation on the underlying invention has ceased, unrestricted disposal of the prototype constitutes a bar under pre-AIA 35 U.S.C. 102(b).
• Factors: (1) the necessity for public testing, (2) the amount of control over the experiment retained by the inventor, (3) the nature of the invention, (4) the length of the test period, (5) whether payment was made, (6) whether there was a secrecy obligation,(7) whether records of the experiment were kept, (8)who conducted the experiment, … (9) the degree of commercial exploitation during testing[,] … (10)whether the invention reasonably requires evaluation under actual conditions of use, (11) whether testing was systematically performed, (12) whether the inventor continually monitored the invention during testing, and (13) the nature of contacts made with potential customers

Question 33

102(c)

Answer 33

• UNDER 35 U.S.C. 102(c), AN ABANDONMENT MUST BE INTENTIONAL
• Where there is no evidence of expressed intent or conduct by inventor to abandon the invention, delay in reapplying for patent after abandonment of a previous application does not constitute abandonment under pre-AIA 35 U.S.C. 102(c).
• Any inference of abandonment (i.e., intent to dedicate to the public) of subject matter disclosed but not claimed in a previously issued patent is rebuttable by an application filed at any time beforea statutory bar arises

Question 34

102(d)

Answer 34

• Statutory Bar
  (A) The foreign application must be filed more than 12 months before the effective filing date ofthe claimed invention in the United States
  (B) The foreign and United States applications must have been filed by the same applicant or by the same applicant’s legal representatives or assigns
  (C) The foreign application must have actually issued as a patent or inventor’s certificate
• To Be “Patented” an Exclusionary Right Must Be Awarded to the Applicant
• A Published Application Is Not a “Patent”
• An Allowed Application Can Be a “Patent”
• Grant Occurs When Patent Becomes Enforceable
• Pre-AIA 35 U.S.C. 102(d) Applies as of Grant Date Even If There Is a Period of Secrecy After Patent Grant
  (D) The same invention must be involved

Question 35

102(e)

Answer 35

• a published SIR will be treated the same as a U.S.patent
• Note that,where there are joint inventors, only one inventor needs to be different for the inventive entities to be different; put another way, a rejection under pre-AIA35 U.S.C. 102(e) is applicable even if there are some inventors in common between the application and the cited reference
• Overcome
  (C) Filing an affidavit or declaration under 37CFR 1.132 showing that the reference invention isnot by “another.”
  (D) Filing an affidavit or declaration under 37CFR 1.131(a) showing prior invention, if the reference is not a U.S. patent or a U.S. patent application publication claiming interfering subject matter

Question 36

102(f)

Answer 36

• Where it can be shown that an inventor or at least one joint inventor “derived” an invention from another, a rejection under pre-AIA 35 U.S.C. 102(f) is proper

Question 37

102(g)

Answer 37

• Pre-AIA 35 U.S.C. 102(g) issues such as conception,reduction to practice and diligence, while more commonly applied to interference matters, also arise in other contexts
• Pre-AIA 35 U.S.C. 102(g) may form the basis for an ex parte rejection if: (1) the subject matter at issue has been actually reduced to practice by another before the applicant’s invention; and (2) there has been no abandonment, suppression orconcealment
• To qualify as prior art under pre-AIA 35 U.S.C. 102(g), however,there must be evidence that the subject matter was actually reduced to practice, in that conception alone is not sufficient

Question 38

Interference practice

Answer 38

• PRE-AIA 35 U.S.C. 102(g) IS THE BASIS OF INTERFERENCE PRACTICE
• 37 CFR 1.131 DOES NOT APPLY ININTERFERENCE PROCEEDINGS

Question 39

Conception

Answer 39

• Conception has been defined as “the complete performance of the mental part of the inventive act”and it is “the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention as it is thereafter to be applied in practice
• CONCEPTION MUST BE DONE IN THE MIND OF THE INVENTOR
• CONCEPTION REQUIRES CONTEMPORANEOUS RECOGNITION AND APPRECIATION OF THE INVENTION
• A PREVIOUSLY ABANDONED APPLICATION WHICH WAS NOT COPENDING WITH A SUBSEQUENT APPLICATION IS EVIDENCEONLY OF CONCEPTION

Question 40

Reduction to practise

Answer 40

• CONSTRUCTIVE REDUCTION TO PRACTICEREQUIRES COMPLIANCE WITH 35 U.S.C. 112(a)or PRE-AIA 35 U.S.C. 112, FIRST PARAGRAPH

(1) the party constructed an embodiment or performed a process that met every element of the interference count, and (2) the embodiment or process operated for its intended purpose

• TESTING REQUIRED TO ESTABLISH AN ACTUAL REDUCTION TO PRACTICE
• REDUCTION TO PRACTICE REQUIRES RECOGNITION AND APPRECIATION OF THE INVENTION
• Inurement involves a claim by an inventor that, as a matter of law, the acts of another person should accrue to the benefit of the inventor
• IN AN INTERFERENCE PROCEEDING, ALL LIMITATIONS OF A COUNT MUST BE REDUCED TO PRACTICE
• CLAIMED INVENTION IS NOT ACTUALLY REDUCED TO PRACTICE UNLESS THERE IS A KNOWN UTILITY
• A PROBABLE UTILITY MAY NOT BE SUFFICIENT TO ESTABLISH UTILITY

Question 41

Reasonable Diligence

Answer 41

• THE ENTIRE PERIOD DURING WHICH DILIGENCE IS REQUIRED MUST BE ACCOUNTED FOR BY EITHER AFFIRMATIVE ACTS OR ACCEPTABLE EXCUSES
• DILIGENCE REQUIRED IN PREPARING AND FILING PATENT APPLICATION
• END OF DILIGENCE PERIOD IS MARKED BYEITHER ACTUAL OR CONSTRUCTIVE REDUCTION TO PRACTICE

Question 42

102 Rejection

Answer 42

1. First, the examiner should consider whether the reference qualifies as prior art under pre-AIA 35U.S.C. 102(b)
2. If the publication or issue date of the reference is too recent for pre-AIA 35 U.S.C. 102(b) to apply, then the examiner should consider pre-AIA 35U.S.C. 102(e)
3. Even if the reference is prior art under pre-AIA 35U.S.C. 102(e), the examiner should still considerpre-AIA 35 U.S.C. 102(a) for two reasons
   * PCT may be the earliest prior art date under pre-AIA 35 U.S.C.102(a) for the disclosure
   * to being disqualifiedunder pre-AIA 35 U.S.C. 103(c)

Question 43

103

Answer 43

• Rejections will continue to be based upon the substantive law, and it is these rejections that are appealable. Consequently, any failure by Office personnel to follow the guidelines is neither appealable nor petitionable

(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor mayprompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivationin the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention

• Rebuttal evidence may include evidence of “secondary considerations,” such as “commercial success, long felt but unsolved needs, [and] failure of others”
  (A) one of ordinary skill in the art could not have combined the claimed elements by known methods (e.g., due to technological difficulties);
  (B) the elements in combination do not merely perform the function that each element performsseparately; or
  (C) the results of the claimed combination were unexpected.

Question 44

Resolving the Level of Ordinary Skill in the Art

Answer 44

(1) “type ofproblems encountered in the art;”
(2) “prior art solutions to those problems;”
(3) “rapidity with which innovations are made;”
(4) “sophistication of the technology; and”
(5) “educational level of active workers in the field.”

Question 45

Analoguous art

Answer 45

a reference is analogous art to the claimed invention if:
(1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention)

• Any argument by the applicant that the examiner has misconstrued the problem to be solved, and as a result has improperly relied on nonanalogous art, should be fully considered in light of the specification

Question 46

Obvious to try

Answer 46

(1) a finding that at the time of the invention,there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.

Question 47

TSM

Answer 47

• PRIOR ART SUGGESTION OF THE CLAIMED INVENTION NOT NECESSARILY NEGATED BY DESIRABLE ALTERNATIVES
• WHERE THE TEACHINGS OF THE PRIORART CONFLICT, THE EXAMINER MUST WEIGH THE SUGGESTIVE POWER OF EACH REFERENCE
• FACT THAT REFERENCES CAN BE COMBINED OR MODIFIED MAY NOT BE SUFFICIENT TO ESTABLISH PRIMA FACIE OBVIOUSNESS
• If a proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, then there is no suggestion or motivation to make the proposed modification
• If the proposed modification or combination of the prior art would change the principle of operation of the prior art invention being modified, then the teachings of the references are not sufficient to render the claims prima facie obvious

Question 48

Reasonable Expectation of Success

Answer 48

• Obviousness does not require absolute predictability, however, at least some degree of predictability is required
• PREDICTABILITY IS DETERMINED AT THE TIME THE INVENTION WAS MADE

Question 49

All Claim Limitations Must Be Considered

Answer 49

• A claim limitation which is considered indefinite cannot be disregarded
• LIMITATIONS WHICH DO NOT FIND SUPPORT IN THE ORIGINAL SPECIFICATION MUST BE CONSIDERED

Question 50

103 Rejection

Answer 50

I. RATIONALE MAY BE IN A REFERENCE, OR REASONED FROM COMMON KNOWLEDGE IN THE ART, SCIENTIFIC PRINCIPLES, ART-RECOGNIZED EQUIVALENTS, OR LEGALPRECEDENT

II. THE EXPECTATION OF SOME ADVANTAGE IS THE STRONGEST RATIONALE FOR COMBINING REFERENCES

III. LEGAL PRECEDENT CAN PROVIDE THE RATIONALE SUPPORTING OBVIOUSNESS ONLY IF THE FACTS IN THE CASE ARE SUFFICIENTLY SIMILAR TO THOSE IN THE APPLICATION

IV. RATIONALE DIFFERENT FROM APPLICANT’S IS PERMISSIBLE
* It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant

• the inferences which one skilled in the art would reasonably be expected to draw therefrom
• when an examiner relies on a scientific theory, evidentiary support for the existence and meaning of that theory must be provided
• Reliance on Common Knowledge in the Art or “Well Known” Prior Art
• If Official Notice Is Taken of a Fact, Unsupportedby Documentary Evidence, the Technical Line of Reasoning Underlying a Decision To Take Such Notice Must Be Clear and Unmistakable
• If Applicant Traverses a Factual Assertion as Not Properly Officially Noticed or Not Properly Based Upon Common Knowledge, the Examiner Must Support theFinding With Adequate Evidence
• If applicant does not traverse the examiner’s assertion of official notice or applicant’s traverse isnot adequate, the examiner should clearly indicate in the next Office action that the common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner’s assertion of official notice or that the traverse was inadequate

Question 51

Legal Precedent as Source ofSupporting Rationale

Answer 51

I. AESTHETIC DESIGN CHANGES
II. ELIMINATION OF A STEP OR AN ELEMENT AND ITS FUNCTION
III. AUTOMATING A MANUAL ACTIVITY
IV. CHANGES IN SIZE, SHAPE, OR SEQUENCEOF ADDING INGREDIENTS
V. MAKING PORTABLE, INTEGRAL, SEPARABLE, ADJUSTABLE, OR CONTINUOUS
VI. REVERSAL, DUPLICATION, OR REARRANGEMENT OF PARTS
VII. PURIFYING AN OLD PRODUCT
* Purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product nonobvious

Question 52

Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions

Answer 52

• “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped
• a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close
• The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties
• Rebuttal
• Showing That the Range Is Critical
• Showing That the Prior Art Teaches Away
• Showing That the Claimed Parameter Was Not Recognized as “Result-Effective”
• Showing That a Claimed Parameter is Disclosed ina Very Broad Range in Prior Art

Question 53

Art Recognized Equivalence for the Same Purpose

Answer 53

• It is prima facie obvious to combine twocompositions each of which is taught by the priorart to be useful for the same purpose, in order toform a third composition to be used for the verysame purpose

Question 54

Obviousness of Species When Prior Art Teaches Genus

Answer 54

• DETERMINE WHETHER THE CLAIMED SPECIES OR SUBGENUS WOULD HAVE BEEN OBVIOUS TO ONE OF ORDINARY SKILL IN THE PERTINENT ART AT THE TIME THE INVENTIONWAS MADE

(a) Consider the Size of the Genus
(b) Consider the Express Teachings
(c) Consider the Teachings of Structural Similarity
* Consider any teachings of a “typical,” “preferred,” or “optimum” species or subgenus within the disclosed genus
(d) Consider the Teachings of Similar Properties or Uses
(e) Consider the Predictability of the Technology
(f) Consider Any Other Teaching To Support the Selection of the Species or Subgenus

Question 55

Close Structural Similarity Between Chemical Compounds (Homologs, Analogues,Isomers)

Answer 55

I. REJECTION BASED ON CLOSE STRUCTURAL SIMILARITY IS FOUNDED ON THE EXPECTATION THAT COMPOUNDS SIMILARIN STRUCTURE WILL HAVE SIMILAR PROPERTIES

II. HOMOLOGY AND ISOMERISM ARE FACTS WHICH MUST BE CONSIDERED WITH ALL OTHER RELEVANT FACTS IN DETERMINING OBVIOUSNESS

III. PRESENCE OF A TRUE HOMOLOGOUS OR ISOMERIC RELATIONSHIP IS NOT CONTROLLING

IV. PRESENCE OR ABSENCE OF PRIOR ART SUGGESTION OF METHOD OF MAKING A CLAIMED COMPOUND MAY BE RELEVANT INDETERMINING PRIMA FACIE OBVIOUSNESS

V. PRESUMPTION OF OBVIOUSNESS BASED ON STRUCTURAL SIMILARITY IS OVERCOME WHERE THERE IS NO REASONABLE EXPECTATION OF SIMILAR PROPERTIES

VI. IF PRIOR ART COMPOUNDS HAVE NO UTILITY, OR UTILITY ONLY AS INTERMEDIATES, CLAIMED STRUCTURALLY SIMILAR COMPOUNDS MAY NOT BE PRIMA FACIE OBVIOUS OVER THE PRIOR ART

VII. PRIMA FACIE CASE REBUTTABLE BY EVIDENCE OF UNEXPECTED RESULTS

Question 56

Applicant’s rebuttal argument

Answer 56

I. ARGUMENT DOES NOT REPLACE EVIDENCE WHERE EVIDENCE IS NECESSARY
* Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection

II. ARGUING ADDITIONAL ADVANTAGES OR LATENT PROPERTIES
* Prima Facie Obviousness Is Not Rebutted by Merely Recognizing Additional Advantages or Latent Properties Present But Not Recognized in the Prior Art

III. ARGUING THAT PRIOR ART DEVICES ARE NOT PHYSICALLY COMBINABLE
* Reliance on a large number of references in are jection does not, without more, weigh against the obviousness of the claimed invention

VI. ARGUING LIMITATIONS WHICH ARE NOTCLAIMED

VII. ARGUING ECONOMIC INFEASIBILITY
* The fact that a “combination would not be made by businessmen for economic reasons” does not mean that a person of ordinary skill in the art would not make the combination because of some technological incompatibility

VIII. ARGUING ABOUT THE AGE OFREFERENCES

IX. ARGUING THAT PRIOR ART IS NONANALOGOUS
A. Impermissible Hindsight
B. Obvious To Try Rationale
C. Lack of Suggestion To Combine References
D. References Teach Away from the Invention or Render Prior Art Unsatisfactory for Intended Purpose

Question 57

AIA-102/103

Answer 57

• it isimportant to note that although prior art is applied on a claim-by-claim basis, the determination of whether pre-AIA 35 U.S.C. 102 and 35 U.S.C. 103 or AIA 35 U.S.C. 102 and 103 apply is made on anapplication-by-application basis

Question 58

102

Answer 58

• There is, however,no requirement that a prior art document meet the“how to use” requirement of 35 U.S.C. 112(a) inorder to qualify as prior art
• pointing out that actually reducing the invention to practice is not necessary
• proof of efficacy is not required for a prior art reference
• To provide support for a claim under 35 U.S.C. 112(a), it is necessary that the specification describe and enable the entire scope of the claimed invention.
• under AIA 35 U.S.C. 102(a)(1)or (a)(2), the prior art document need only describe and enable one skilled in the art to make a single species or embodiment of the claimed invention

Question 59

Provisional Rejections Under 35U.S.C. 102(a)(2)

Answer 59

I. COPENDING U.S. APPLICATIONS HAVING AT LEAST ONE COMMON INVENTOR OR COMMON APPLICANT OR ARE COMMONLY ASSIGNED

II. COPENDING APPLICATIONS HAVING NO COMMON INVENTOR, APPLICANT, OR ASSIGNEE -> the confidential status of applications under 35 U.S.C.122(a) must be maintained

• The provisions of 37 CFR 1.130 are not available ifit would result in the Office issuing or confirming two patents containing patentably indistinct claims to two different parties. In this situation, an applicant orpatent owner may file a petition for a derivationproceeding pursuant to 37 CFR 42.401

Question 60

Transition application

Answer 60

• Additionally, adding claims after March 16, 2013 in an application filed before March 16, 2013 via an amendment which contains new matter does not make the changes to 35 U.S.C. 102 and 35 U.S.C. 103 in the AIA applicable to the application because 35 U.S.C.132(a) prohibits the introduction of new matter into the disclosure. If new matter is added via amendment, claims directed to the new matter will be rejected under pre-AIA 35 U.S.C. 112, first paragraph.
• If there is ever even a single claim to a claimed invention in the application having an effective filing date on or after March 16, 2013, AIA35 U.S.C. 102 and 103 apply in determining the patentability of every claimed invention in the application. This is the situation even if the remaining claimed inventions all have an effective filing date before March 16, 2013, and even if the claim to a claimed invention having an effective filing date on or after March 16, 2013, is canceled.
• If an application filed on or after March 16, 2013, that did not previously contain any claim to a claimed invention having an effective filing date on or after March 16, 2013, (a pre-AIA application) is amended to contain a claim to a claimed invention having an effective filing date on or after March 16,2013, the application becomes an AIA application (AIA 35 U.S.C. 102 and 103 apply to the application), provided that the newly added claimed invention has support under 35 U.S.C. 112(a) in the application filed on or after March 16, 2013. The application also becomes subject to AIA 35 U.S.C.102 and 103 even if the claim to a claimed invention having an effective filing date on or after March 16,2013, is subsequently canceled.
• If an amendment after an Office action causes the application to change from being governed by pre-AIA 35 U.S.C.102 and 103 (from being a pre-AIA application) to being governed by AIA 35 U.S.C. 102 and 103 (to being a AIA application), any new ground of rejection necessitated by the change in applicable law would be considered a new ground of rejection necessitated by an amendment for purposes of determining whether the next Office action may be made final

-

Question 61

Computer Programming, Computer Implemented Inventions, and 35 U.S.C.112(a)

Answer 61

[Written Description]
- the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed

• express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure

[Best mode]
* First, there must be a subjective determination as to whether the inventor knew of a best mode of practicing the invention at the time the application was filed
* Second, if the inventor had a best mode of practicing the invention in mind, there must be an objective determination as to whether that best mode was disclosed in sufficient detail to allow one skilled in the art to practice it

• [F]low charts or source code listings are not a requirement for adequately disclosing the functions of software

[Enablement]
- without “undue experimentation”
* the factors to consider (All should be considered)
(1) the breadth of the claims;
(2) the nature of the invention;
(3) the state of the prior art;
(4) the level of one of ordinary skill;
(5) the level of predictability in the art;
(6) the amount of direction provided by the inventor;
(7) the existence of working examples; and
(8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.

• When a claim is not limited to any particular structure for performing a recited function and does not invoke 35 U.S.C. 112(f), any claim language reciting the ability to perform a function per se would typically be construed broadly to cover any and all embodiments that perform the recited function
• The specification need not teach what is well known in the art. However, applicant cannot rely on the knowledge of one skilled in the art to supply information that is required to enable the novel aspect of the claimed invention when the enabling knowledge is in fact not known in the art.
• Not everything necessary to practice the invention need be disclosed. This is not to say that the specification must expressly spell out every possible iteration of everyclaim. A specification need not disclose what is well known in the art
• A rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for lack of enablement must be made when the specification does not enable the full scope of the claim

Question 62

Written Description

Answer 62

• An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize thathe or she invented what is claimed.”

i) For Each Claim Drawn to a Single Embodiment or Species
(A) Determine whether the application describes an actual reduction to practice of the claimed invention
(B) If the application does not describe an actual reduction to practice, determine whether the invention is complete as evidenced by a reduction to drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole
(C) If the application does not describe an actual reduction to practice or reduction to drawings or structural chemical formula as discussed above, determine whether the invention has been set forthin terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that applicant was in possession of the claimed invention

• New Claims, Amended Claims, or Claims Asserting Entitlement to the Benefit of an Earlier Priority Date or Filing Date under 35 U.S.C. 119, 120,365, or 386
• when filing an amendment an applicant should show support in the original disclosure for new or amended claim
• Issue Arises
  I. AMENDMENT AFFECTING A CLAIM
  II. RELIANCE ON FILING DATE OF PARENT APPLICATION UNDER 35 U.S.C. 120
  III. RELIANCE ON PRIORITY UNDER 35 U.S.C.119
  IV. SUPPORT FOR A CLAIM CORRESPONDING TO A COUNT IN AN INTERFERENCE
  V. ORIGINAL CLAIM NOT SUFFICIENTLY DESCRIBED
  VI. INDEFINITENESS REJECTION OF A MEANS-(OR STEP-) PLUS-FUNCTION LIMITATION
• “unpredictability in the art” is not a sufficient reason to support a rejection for lack of adequate written description

Question 63

TREATMENT OF NEW MATTER

Answer 63

If new subject matter is added to the disclosure, whether it be in the abstract, the specification, or the drawings, the examiner should object to the introduction of new matter under 35 U.S.C. 132 or 251 as appropriate, and require applicant to cancel the new matter
* If new matter is added to the claims, the examiner should reject the claims under 35U.S.C. 112(a)
* When the claims have not been amended, per se, but the specification has been amended to add new matter, a rejection of the claims under 35 U.S.C.112(a)

• If both the claims and specification contain new matter either directly or indirectly, and there has been both a rejection and objection by the examiner, the issue becomes appealable and should not bedecided by petition.
• a patent application necessarily discloses that function, theory or advantage, even though it saysnothing explicit concerning it
• Replacing the identified material incorporated by reference with the actual text is not new matter

Question 64

The Enablement requirement

Answer 64

• The purpose of the requirement that the specification describe the invention in such terms that one skilled in the art can make and use the claimed invention isto ensure that the invention is communicated to the interested public in a meaningful way
• Naturally, for unstable and transitory chemical intermediates, the “how to make” requirement does not require that the applicant teach how to make the claimed product in stable, permanent or isolatable form
• In the biotechnical area, this is often true when the product or process requires a particular strain of microorganism and when the microorganism is available only after extensive screening
• The applicant need not demonstrate that the invention is completely safe
• An applicant need not have actually reduced the invention to practice prior to filing
• The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation
• lack of working examples or lack of evidence that the claimed invention works as described should never be the sole reason for rejecting the claimed invention on the grounds of lack of enablement
• if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate
• Applicant may submit factual affidavits under 37 CFR 1.132 or cite references to show what one skilled in the art knew at the time of filing the application
• Affidavit practice at the outset usually involves analyzing the skill level and/or qualifications of the affiant, which should be of the person of ordinary skill in the art. When an affiant’s skill level is higher than that required by the person of ordinary skill in the art for a particular application, an examiner may challenge the affidavit as insufficient should the affiant not submit evidence demonstrating the amount of experimentation required by a person of ordinary skill in the art to implement the invention
• In general, the examiner should not use post-filing date references to demonstrate that a patent is not enabled
• The commercial availability of an identified prior art computer system is very pertinent to the issue of enablement. But in some cases, this approach may not be sufficient to meet the applicant’s burden
• It must be emphasized that arguments of counsel alone cannot take the place of evidence in the record once an examiner has advanced a reasonable basis for questioning the disclosure
• Any rejection under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph, based on grounds other than “lack of utility” should be imposed separately from any rejection imposed due to “lack of utility”under 35 U.S.C. 101
• If a claim fails to meet the utility requirement of 35 U.S.C. 101 because it is shown to be nonuseful or inoperative, then it necessarily fails to meet the how-to-use aspect of the enablement requirement of35 U.S.C. 112(a)

Question 65

Enablement Rejection Cases

Answer 65

• A single means claim, i.e., where a means recitation does not appear in combination with another recited element of means
• The presence of inoperative embodiments within the scope of a claim does not necessarily render a claim nonenabled
• prophetic examples do not make the disclosure nonenabling
• A feature which is taught as critical in a specification and is not recited in the claims should result in a rejection of such claim under the enablement provision section of 35 U.S.C. 112

Question 66

The Best Mode Requirement

Answer 66

• Two-prong inquiry
• at the time the application was filed, the inventor possessed a best mode for practicing the invention
• whether the written description disclosed the best mode such that a person skilled in the art could practice it
• Where an inventor knows of a specific material or method that will make possible the successful reproduction of the claimed invention, but does not disclose it, the best mode requirement has not been satisfied
• The absence of a specific working example is not necessarily evidence that the best mode has not been disclosed, nor is the presence of one evidence that it has
• Best mode may be represented by a preferred range of conditions or group of reactants
• There is no requirement in the statute that applicants point out which of their embodiments they consider to be their best
• There is no requirement to update in the context of a foreign priority application
• If the best mode contemplated by the inventor at the time of filing the application is not disclosed, such a defect cannot be cured by submitting anamendment

Question 67

112(b)

Answer 67

• If a rejection is based on 35 U.S.C. 112(b) or pre-AIA 35 U.S.C.112, second paragraph, the examiner should further explain whether the rejection is based on indefiniteness or on the failure to claim what the inventor or a joint invention regards as the invention
• If a claim fails to interrelate essential elements of the invention as defined by applicant(s) in the specification, the claim may be rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as indefinite
• Open Lines of Communication with the Applicant– When Indefiniteness Is the Only Issue, Attempt Resolution through an Interview before Resorting to a Rejection
• a claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear

Question 68

New Terminology

Answer 68

I. THE MEANING OF EVERY TERM SHOULD BE APPARENT
II. THE REQUIREMENT FOR CLARITY AND PRECISION MUST BE BALANCED WITH THE LIMITATIONS OF THE LANGUAGE
III. TERMS USED CONTRARY TO THEIR ORDINARY MEANING MUST BE CLEARLY REDEFINED IN THE WRITTEN DESCRIPTION

Question 69

Relative Terminology

Answer 69

• Claim language employing terms of degree has long been found definite where it provided enough certainty to one of skill in the art when read in the context of the invention
• “relatively shallow,” “of the orderof,” “the order of about 5mm,” and “substantialportion” were held to be indefinite
• A claim may be rendered indefinite by reference to an object that is variable
• Approximation
  A. “About”
  “exceeding about 10% per second” is definite
  “at least about” were invalid for indefiniteness
  B. “Essentially”
  The phrase “a silicon dioxide source that is essentially free of alkali metal” was held to be definite because the specification contained guidelines and examples that were considered sufficient to enable
  C. “Similar”: similar apparatus” was held to be indefinite
  D. “Substantially”: definite
  E. “Type”: Indefinite

Question 70

Numerical Ranges and Amounts Limitations

Answer 70

• Use of a narrow numerical range that falls within a broader range in the same claim may render the claim indefinite when the boundaries of the claim are not discernible
• greater than 100% (i.e., 20-80% of A, 20-80% of B and 1-25% of C) was not indefinite

Question 71

Exemplary Claim Language - indefinite

Answer 71

(A) “R is halogen, for example, chlorine”;
(B) “material such as rock wool or asbestos”
(C) “lighter hydrocarbons, such, for example, as the vapors or gas produced”
(D) “normal operating conditions such as while in the container of a proportioner”
(E) “coke, brick, or like material”

Question 72

Lack of Antecedent Basis

Answer 72

• The mere fact that a term or phrase used in the claim has no antecedent basis in the specification disclosure does not mean, necessarily, that the term or phrase is indefinite.
• The mere fact that the body of a claim recites additional elements which do not appear in the claim’s preamble does not render the claim indefinite

Question 73

Reference to Limitations inAnother Claim

Answer 73

• A claim which makes reference to a preceding claim to define a limitation is an acceptable claim construction which should not necessarily be rejected as improper or confusing under 35 U.S.C. 112(b)

Question 74

Functional Limitations

Answer 74

• Functional language does not, in and of itself, render a claim improper. Id. In fact, 35 U.S.C. 112(f) and pre-AIA 35 U.S.C.112, sixth paragraph, expressly authorize a form of functional claiming
• A functional limitation is often used in association with an element, ingredient, or step of a process to define a particular capability or purpose that is served by the recited element, ingredient or step.
• Examiner’s consideration
  (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim;
  (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and
  (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.
• Applicant’s resolution
  (1) “the ambiguity might be resolved by using a quantitative metric (e.g., numeric limitation as to a physical property) rather than a qualitative functional feature”
  (2) applicant could demonstrate that the “specification provide[s] a formula for calculating a property along with examples that meet the claim limitation and examples that do not”
  (3) applicant could demonstrate that the specification provides a general guideline and examples sufficient to teach a person skilled in the art when the claim limitation was satisfied
  (4) applicant could amend the claims to recite the particular structure that accomplishes the function.

Question 75

Alternative Limitations

Answer 75

I. MARKUSH GROUPS
* A claim which recites a list of alternatives to define a limitation is an acceptable claim construction

• The use of Markush claims of diminishing scope should not, in itself, be considered a sufficient basis for objection to or rejection of claims. However, if such a practice renders the claims indefinite or if it results in undue multiplicity, an appropriate rejection should be made
• the double inclusion of an element by members of a Markush group is not, in itself,sufficient basis for objection to or rejection of claims

II. “OPTIONALLY”: “containing A, B, and optionally C” was considered acceptable alternative language because there was no ambiguity

Question 76

Should not be rejected

Answer 76

• Old combination
• Aggregation
• Double inclustion: There is no per se rule
• Reference to Figures or Tables: Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference
• Chemical Formula: A claim to a chemical compound is not indefinite merely because a structure is not presented or because a partial structure is presented
• Trademarks or Trade Names in a Claim: per se definite
• If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112 (b)
• Mere Function of Machine: Process or method claims are not subject to rejection

Question 77

Should be rejected

Answer 77

• Prolix: Examiners should reject claims as prolix only when they contain such long recitations or unimportant details
• Multiplicity: Where, in view of the nature and scope of applicant’s invention, applicant presents an unreasonable number of claims which are repetitious and multiplied, the net result of which is to confuse rather than to clarify, a rejection on undue multiplicity based on 35 U.S.C. 112(b)
• Omnibus claim: A device substantially as shown and described

Question 78

Claim Directed to Product-By-Process or Product and Process

Answer 78

• A product-by-process claim, which is a product claim that defines the claimed product in terms of the process by which it is made, is proper
• A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b)

Question 79

Use Claim

Answer 79

• Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness
• it merely recites a use without any active, positive steps delimiting how this use is actually practiced
• “Use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101
• “USE” CLAIM MAY BE REJECTED UNDER 35 U.S.C 101 AND/OR 112
• a claim which clearly recited the step of “utilizing” was not indefinite under 35 U.S.C. 112

Question 80

112(f)

Answer 80

• A claim limitation is presumed to invoke 35 U.S.C.112(f) when it explicitly uses the term “means” or or “step” and includes functional language
• The presumption that 35 U.S.C. 112(f) applies is overcome when the limitation further includes the structure, material or acts necessary to perform there cited function.
• 3 prong questions
  (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonceterm or a non-structural term having no specific structural meaning) for performing the claimed function
  (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”;
  (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function
• generic placeholders: “mechanism for,” “module for,” “device for,” “unit for,” “component for,” “element for,” “member for,” “apparatus for,” “machine for,” or “system for.”

Question 81

Computer-Implemented Means-Plus-Function Limitations

Answer 81

For a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b)