Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Applicant’s response filed 08/19/2026 has been entered. Claims 1, 4-6, 8-9, 14-19 are amended. Claims 7 and 12 are cancelled. New claim 21 is added. Therefore, claims 1-6, 8-11 and 13-21 are pending are examined.
Withdrawn Objections and Rejections
The 112(d) rejection to claims 7, 9 (not claim 10) and 12 is withdrawn in view of Applicant’s amendment to the claims.
All previous objections and rejections not set forth below have been withdrawn in view of Applicant’s amendment and/or upon further consideration.
This office action is made Non-final not necessitated by Applicant’s amendment. Claims 4-5 and 7 (now cancelled and included all its limitations in claim 1) should have been included in the 112(b) and NSDP rejections. Any inconvenience this may have caused Applicant is regretted.
Claim Rejections - 35 USC § 112
Claims 1-6, 8-11 and 13-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is amended to recite multiple formulas for multiple limitations to determine number of microorganisms to be mutagenized (Np) which render the claim indefinite for the following reasons: 1) the claim requires the Np is “at least 5000”, 2) the claim requires Np “is in the range of 0.7*ONp to 1.3*ONp (assuming “ONp” stands for optimal number of microorganisms to be mutagenized). 3) The claim recites a formula for the “ONp” that includes the limitation “OLS”, Optimal Library Size. 4) The claim also requires a formula for the “OLS”. The formula “OLS = (log(1-PS/100))/(log(1-(1-(1-(Mf x n)) does not correctly define the relationship between the mutation frequency “Mf” and n (number of mutations screened). In addition, the outcome or the numerical values of the formulas for the “Np” (except the at least 5000), “ONp”, and “OLS” are unknown. Therefore, the metes and bounds of the formula for the “OLS”, especially the denominator part, are unclear. 5) It is unclear if the initial target number of microorganisms to be mutagenized is the “at least 5000”, the “Np in the range of 0.7*ONp to 1.3*ONp”, the “ONp”, or the “OLS”; and if the final target number of microorganisms to be mutagenized is the “at least 5000”, the “Np in the range of 0.7*ONp to 1.3*ONp”, the “ONp”, or the “OLS”.
Claim 1 is also indefinite in the recitation of a “mutagenesis frequency of Mf” in part (ii). Claim 1, part (i), defines “Mf” as the mutation frequency.
Clarification is required to more clearly define the metes and bounds of the claims. Dependent claims 2-6 and 8-20 do not obviate the rejection.
Claim 4 is indefinite because parent claim 1 recites “OLS” rather than LS. In addition, since the formula for the OLS in claim 1 is also indefinite, one cannot determine the LS “in the range of 0.5*OLS to 5*OLS”. The numerical value of “OLS” cannot be determined. Clarification is required to more clearly define the metes and bounds of the claim.
Claim 5 is indefinite because step (ii) of claim 1 generates a “pool of microorganisms” rather than “sub-pool of microorganisms”. In addition, the outcome and the numerical values and the optimal size of the sub-pools cannot be determined. Clarification is required to more clearly define the metes and bounds of the claim.
Claims 10-11 are indefinite because “the rate of mutagenesis” lacks antecedent basis in claim 1.
Double Patenting
Claims 1-6, 8-11, and 13-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11, 13 and 15-20 of U.S. Patent No. 12, 428, 678 B2; or over claims 1-5, 8-9, 12-14, 17-18 and 21-22 of U.S. Patent No. 11, 884, 972. This rejection is repeated for the reasons of record as set forth in the last Office action of 05/20/2026. Applicant’s arguments filed 08/19/2026 have been considered but are not deemed persuasive.
Applicant argues that since claim 7 was not included in the NSDP rejection, the amendment to claim 1 to recite the limitations of claim 7 should obviate the rejection. This is not found persuasive because amended claim 1 is indefinite for the recitation of multiple formulas and because the outcome of the formulas and the numerical values for the Np (other than the at least 5000), ONp, and OLS are unknown. Claims 4-5 are also included in the rejection because the metes and bounds of the formulas recited in the claims are unclear. In addition, the outcome and the numerical values of the “LS” of claim 4 and the optimal size of the sub-pools of claim 5 cannot be determined (see the 112(b) rejection above).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the application and each of the issued patent are drawn to a method of identifying unicellular microorganisms or prokaryotes including yeast or fungi species of a predefined species carrying one or more predetermined mutations in one or more nucleotides of interest (NOIs) in a target sequence, wherein the predetermined mutation is a deletion or substitution of one or more NOIs, said method comprising the steps of: subjecting the unicellular or prokaryote species, to random mutagenesis, thereby providing a pool of organisms from said species, representing a plurality of genotypes; dividing said pool into one or more sub-pools of unicellular organisms; preparing genomic DNA (gDNA) samples, each sample comprising gDNA from each genotype within a sub-pool, while maintaining the potential for multiplication of organisms of each genotype within said sub-pool; performing a plurality of PCR amplifications, each comprising (i) the gDNA sample from one sub-pool, (ii) one or more sets of primers, each set flanking one or more target sequences in the gDNA sample, and (iii) PCR reagents; thereby amplifying the one or more target sequences, wherein each PCR amplification comprises a plurality of compartmentalized PCR amplifications, each compartmentalized PCR amplification comprising part of said gDNA sample; detecting one or more PCR amplification products from the one or more amplification products comprising one or more target sequences comprising the one or more predetermined mutations in the one or more NOIs, thereby identifying one or more sub-pools that comprise said one or more predetermined mutations; dividing the prokaryotic species of the one or more identified sub-pools; preparing gDNA samples, each comprising gDNA from each genotype within a sub-pool, while maintaining the potential for multiplication of microorganisms of each genotype within said sub-pool; performing a plurality of PCR amplifications, each comprising (i) the gDNA sample from one secondary sub-pool, (ii) one or more sets of primers, each set flanking one or more target sequences in the gDNA sample, and (iii) PCR reagents, thereby amplifying the one or more target sequences; detecting PCR amplification products from (h) that comprise one or more target sequences comprising the one or more predetermined mutations in the one or more NOIs, thereby identifying one or more secondary sub-pools that comprise said one or more mutations; and identifying microorganism species within one or more secondary sub-pools that carries said one or more predetermined mutations.
The claims of application and the claims of each of the issued patent overlap with respect to the targeted unicellular or prokaryotic microorganisms including yeast and fungi, the steps of inducing mutations, random mutations, and the pool-split approaches, pools of unicellular microorganisms or prokaryotes of different genotypes, sub-pools thereof, wherein the microorganisms or prokaryotes with the determined nucleotide mutations are identified. The claims of both the application and issued patents require steps of preparing DNA samples from sub-pools, performing PCR amplifications, and detecting PCR products comprising the target sequences having mutations in the NOI(s).
Therefore, for all the reasons discussed above and in the last Office action, the claims of the instant application are obvious over the claims of each of the issued patent.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662
