DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/29/2026 has been entered.
Claim Status
Claims 1-14 are pending (claim set as filed on 01/29/2026). Claims 3-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. As previously acknowledged, Applicant elected without traverse, Group I, claims 1 and 2, drawn to a variant of an inner membrane protein YjeH, and elected substitution of an amino acid in position 351 with leucine as substitution species, and O-acetylhomoserine as the target product species, in the reply filed on 02/20/2025. Based on the claim interpretation as discussed below under Claim Rejections - 35 USC § 112 (b), the Examiner rejoined the following substitution species: substitution of an amino acid in position 92 with asparagine, and substitution of amino acids in positions 92 and 351 with asparagine and leucine, respectively.
Claims 1-2 are currently under examination and were examined on their merits.
Withdrawn Rejections
The rejection of claims 1-2 under 35 U.S.C. 103 set forth in the previous Office action is withdrawn in light of Applicant’s arguments and declaration under 37 CFR 1.132, filed on 01/29/2026 and 02/10/2026, respectively. The results presented in the declaration provide evidence that a microbial strain comprising a YjeH variant having a leucine substitution in position 351 produces increased amounts of O-acetyl-L-homoserine and homoserine versus a strain comprising wildtype YjeH. The declaration further provides results showing that a microbial strain comprising a YjeH variant having an asparagine substitution in position 92 produces increased amounts of O-acetyl-L-homoserine and homoserine versus a strain comprising wildtype YjeH.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of copending Application No. 18/851,660 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘660 claims SEQ ID NO: 10 which comprises the claimed substitution of an amino acid corresponding to the 351st position in the amino acid sequence of instant SEQ ID NO: 1, wherein SEQ ID NO: 10 has a homology of 99.8% with instant SEQ ID NO: 1 (see alignment of SEQ ID NO: 10 of ‘660 with instant SEQ ID NO: 1 below).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
GenCore version 6.5.2
Copyright (c) 1993 - 2026 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: August 18, 2026, 21:09:45 ; Search time 1 Seconds
(without alignments)
0.175 Million cell updates/sec
Title: US-18-851-660-10
Perfect score: 2157
Sequence: 1 MSGLKQELGLAQGIGLLSTS..........LAGLWLLLPKRKTPENGITT 418
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 418 residues
Total number of hits satisfying chosen parameters: 1
Minimum DB seq length: 0
Maximum DB seq length: inf
Post-processing: Minimum Match 0%
Maximum Match 100%
Listing first 50 summaries
Database : US-17-787-263A-1.fasta:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 2153 99.8 418 1 US-17-787-263A-1 A modified inner m
ALIGNMENTS
RESULT 1
US-17-787-263A-1
Query Match 99.8%; Score 2153; DB 1; Length 418;
Best Local Similarity 99.8%;
Matches 417; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MSGLKQELGLAQGIGLLSTSLLGTGVFAVPALAALVAGNNSLWAWPVLIILVFPIAIVFA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSGLKQELGLAQGIGLLSTSLLGTGVFAVPALAALVAGNNSLWAWPVLIILVFPIAIVFA 60
Qy 61 ILGRHYPSAGGVAHFVGMAFGSRLERVTGWLFLSVIPVGLPAALQIAAGFGQAMFGWHSW 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ILGRHYPSAGGVAHFVGMAFGSRLERVTGWLFLSVIPVGLPAALQIAAGFGQAMFGWHSW 120
Qy 121 QLLLAELGTLALVWYIGTRGASSSANLQTVIAGLIVALIVAIWWAGDIKPANIPFPAPGN 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 QLLLAELGTLALVWYIGTRGASSSANLQTVIAGLIVALIVAIWWAGDIKPANIPFPAPGN 180
Qy 181 IELTGLFAALSVMFWCFVGLEAFAHLASEFKNPERDFPRALMIGLLLAGLVYWGCTVVVL 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 IELTGLFAALSVMFWCFVGLEAFAHLASEFKNPERDFPRALMIGLLLAGLVYWGCTVVVL 240
Qy 241 HFDAYGEKMAAAASLPKIVVQLFGVGALWIACVIGYLACFASLNIYIQSFARLVWSQAQH 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 HFDAYGEKMAAAASLPKIVVQLFGVGALWIACVIGYLACFASLNIYIQSFARLVWSQAQH 300
Qy 301 NPDHYLARLSSRHIPNNALNAVLGCCVVSTLVIHALEINLDALIIYANGILIMIYLLCML 360
|||||||||||||||||||||||||||||||||||||||||||||||||| |||||||||
Db 301 NPDHYLARLSSRHIPNNALNAVLGCCVVSTLVIHALEINLDALIIYANGIFIMIYLLCML 360
Qy 361 AGCKLLQGRYRLLAVVGGLLCVLLLAMVGWKSLYALIMLAGLWLLLPKRKTPENGITT 418
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 AGCKLLQGRYRLLAVVGGLLCVLLLAMVGWKSLYALIMLAGLWLLLPKRKTPENGITT 418
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of copending Application No. 18/851,666 (allowed). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘666 claims SEQ ID NO: 10 which comprises the claimed substitution of an amino acid corresponding to the 351st position in the amino acid sequence of instant SEQ ID NO: 1, wherein SEQ ID NO: 10 has a homology of 99.8% with instant SEQ ID NO: 1 (see alignment of SEQ ID NO: 10 of ‘666 with instant SEQ ID NO: 1 below).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
GenCore version 6.5.2
Copyright (c) 1993 - 2026 Biocceleration Ltd.
OM protein - protein search, using sw model
Run on: August 18, 2026, 21:08:36 ; Search time 1 Seconds
(without alignments)
0.175 Million cell updates/sec
Title: US-18-851-666-10
Perfect score: 2157
Sequence: 1 MSGLKQELGLAQGIGLLSTS..........LAGLWLLLPKRKTPENGITT 418
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 418 residues
Total number of hits satisfying chosen parameters: 1
Minimum DB seq length: 0
Maximum DB seq length: inf
Post-processing: Minimum Match 0%
Maximum Match 100%
Listing first 50 summaries
Database : US-17-787-263A-1.fasta:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 2153 99.8 418 1 US-17-787-263A-1 A modified inner m
ALIGNMENTS
RESULT 1
US-17-787-263A-1
Query Match 99.8%; Score 2153; DB 1; Length 418;
Best Local Similarity 99.8%;
Matches 417; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MSGLKQELGLAQGIGLLSTSLLGTGVFAVPALAALVAGNNSLWAWPVLIILVFPIAIVFA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSGLKQELGLAQGIGLLSTSLLGTGVFAVPALAALVAGNNSLWAWPVLIILVFPIAIVFA 60
Qy 61 ILGRHYPSAGGVAHFVGMAFGSRLERVTGWLFLSVIPVGLPAALQIAAGFGQAMFGWHSW 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ILGRHYPSAGGVAHFVGMAFGSRLERVTGWLFLSVIPVGLPAALQIAAGFGQAMFGWHSW 120
Qy 121 QLLLAELGTLALVWYIGTRGASSSANLQTVIAGLIVALIVAIWWAGDIKPANIPFPAPGN 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 QLLLAELGTLALVWYIGTRGASSSANLQTVIAGLIVALIVAIWWAGDIKPANIPFPAPGN 180
Qy 181 IELTGLFAALSVMFWCFVGLEAFAHLASEFKNPERDFPRALMIGLLLAGLVYWGCTVVVL 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 IELTGLFAALSVMFWCFVGLEAFAHLASEFKNPERDFPRALMIGLLLAGLVYWGCTVVVL 240
Qy 241 HFDAYGEKMAAAASLPKIVVQLFGVGALWIACVIGYLACFASLNIYIQSFARLVWSQAQH 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 HFDAYGEKMAAAASLPKIVVQLFGVGALWIACVIGYLACFASLNIYIQSFARLVWSQAQH 300
Qy 301 NPDHYLARLSSRHIPNNALNAVLGCCVVSTLVIHALEINLDALIIYANGILIMIYLLCML 360
|||||||||||||||||||||||||||||||||||||||||||||||||| |||||||||
Db 301 NPDHYLARLSSRHIPNNALNAVLGCCVVSTLVIHALEINLDALIIYANGIFIMIYLLCML 360
Qy 361 AGCKLLQGRYRLLAVVGGLLCVLLLAMVGWKSLYALIMLAGLWLLLPKRKTPENGITT 418
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 AGCKLLQGRYRLLAVVGGLLCVLLLAMVGWKSLYALIMLAGLWLLLPKRKTPENGITT 418
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2 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 recites “[a] variant of an inner membrane protein YjeH comprising i) substitution of an amino acid corresponding to the 92nd position with asparagine, ii) substitution of an amino acid corresponding to the 351st position with leucine, or iii) substitution of both i) and ii), in an amino acid sequence of SEQ ID NO: 1, and having a homology of 95% or more and less than 100% with SEQ ID NO: 1”, which renders the claim indefinite since the claim can be interpreted in two different ways: In the first interpretation, only embodiment iii) refers to an amino acid sequence of SEQ ID NO: 1, and to having a homology of 95% or more and less than 100% with SEQ ID NO: 1. In a second interpretation, all embodiments i-iii refer to an amino acid sequence of SEQ ID NO: 1, and to having a homology of 95% or more and less than 100% with SEQ ID NO: 1.
One of ordinary skill in the art would not be able to determine the metes and bounds of the claim, and thus, could not clearly determine how to avoid infringement of claim 1. Claim 2 is rejected since it does not clarify the indefinite language of claim 1.
In the interest of compact prosecution, since Applicant’s specification, declaration and remarks appear to support that YjeH variants having the substitutions according to embodiments i and ii refer to an amino acid sequence of SEQ ID NO: 1, and to having a homology of 95% or more and less than 100% with SEQ ID NO: 1, claim 1 is interpreted as follows:
“A variant of an inner membrane protein YjeH comprising
substitution of an amino acid corresponding to the 92nd position with asparagine in an amino acid sequence of SEQ ID NO: 1, and having a homology of 95% or more and less than 100% with SEQ ID NO: 1,
substitution of an amino acid corresponding to the 351st position with leucine in an amino acid sequence of SEQ ID NO: 1, and having a homology of 95% or more and less than 100% with SEQ ID NO: 1, or
substitution of an amino acid corresponding to the 92nd position with asparagine and of an amino acid corresponding to the 351st position with leucine in an amino acid sequence of SEQ ID NO: 1, and having a homology of 95% or more and less than 100% with SEQ ID NO: 1.”
Examination is limited to the above claim interpretation which is consistent with the specification and Applicant’s declaration and remarks. Amending claim 1 as proposed by the Examiner will lead to allowable subject matter.
Closest prior art
Regarding claims 1-2, please note the indefinite language and the Examiner’s claim interpretation as discussed above under Claim Rejections - 35 USC § 112 (b).
The closest prior art to the claimed invention is provided by the teachings of Bae et al. (US 2017/0137853 A1, published on 05/18/2017), hereinafter ‘Bae’.
Bae discloses an inner membrane protein YjeH and its corresponding amino acid sequence SEQ ID NO: 1 (paragraphs [0010], [0013]; see SEQ ID NO: 1 on pages 10-11). Bae’s SEQ ID NO: 1 is identical to the claimed SEQ ID NO: 1. Bae teaches “YjeH may be a protein having […] a homology of 70% or higher, specifically 80% or higher, or more specifically 90% or higher, to the amino acid sequence of SEQ ID NO: 1” (paragraph [0013]), and further discloses that “that any amino acid sequence which has the same amino acid sequence as that of SEQ ID NO: 1,…, can belong to the scope of the present disclosure, although the sequence may have a partial deletion, modification, substitution, or addition therein” (paragraph [0013]).
Bae does not teach a YjeH variant comprising the claimed substitution(s) and having the claimed homology of 95% or more and less than 100% with SEQ ID NO: 1.
Response to Arguments
Applicant has traversed the previous rejections of claims 1-2 under 35 U.S.C. 103 in the reply filed on 01/29/2026. As discussed above under Withdrawn Rejections, the rejection of claims 1-2 under 35 U.S.C. 103 set forth in the previous Office action is withdrawn in light of Applicant’s arguments and Declaration under 37 CFR 1.132, filed on 01/29/2026 and 02/10/2026, respectively.
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA ZINGARELLI whose telephone number is (703)756-1799. The examiner can normally be reached M-F 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANDRA ZINGARELLI/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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