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 .
Status of the Claims
Claims 1-14 are pending in the application.
Priority
This application is a PCT national Stage application of PCT/CN2021/078740, filed 03/21/2021, is acknowledged and claims foreign priority to CN202110078514.9 with a priority filing date of 01/21/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/25/2023 was filed prior to the mailing of the instant first Office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. A copy of Form PTO/SB/08 is attached to the instant Office action.
Claim Objections
Claim 11 cites the term “reductive amination reactant”. The examiner requests changing the language to “reductive amination product”.
Claim Rejections - 35 USC § 112
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.
Claim 6 contains the trademark/trade name pET (and other trademark) vectors. Where a 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 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a DNA plasmid and, accordingly, the identification/description is indefinite.
Claim 13 recites the limitation "amino donor" in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim. Claims 10 and 11 do not mention the use of an “amino donor” or any of the listed amino donors mentioned in claim 13.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Suyama, et. al., PAL2NAL: robust conversion of protein sequence alignments into the corresponding codon alignments, Nucleic Acids Research, Volume 34, Issue suppl_2, 1 July 2006, Pages W609–W612 (examiner cited) and Thermo Fisher Scientific highcap brochure (examiner cited) and Addgene protocol (examiner cited).
Claims 4-6 are drawn to a DNA molecule encoding the amino acid dehydrogenase mutant of claim 1, and a recombinant plasmid containing the DNA molecule.
Regarding claims 4-6, it would have been obvious to one of ordinary skill in the art to reverse transcribe the protein in claim 1 to obtain a DNA molecule utilizing the tools outlined by Suvama (page W609, Abstract), to produce an RNA transcript, and utilize a reverse transcriptase in order to produce DNA for insertion into a recombinant plasmid (Thermo Fisher, highcap brochure, page 7).
Claims 7-9 are drawn to a host cell comprising the recombinant plasmid according to claim 6, wherein the host cell comprises a prokaryotic cell or a eukaryotic cell wherein the prokaryotic cell is Escherichia coli BL21 cell or Escherichia coli DH5-alpha competent cell, and the eukaryotic cell is yeast.
Regarding claims 7-9, commercially available kits or standard laboratory techniques can be utilized to transform a host cell with a recombinant plasmid, the host cell being Escherichia coli DH5-alpha (Addgene, pages 1-2).
At the time of the applicant’s invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Suvama and Thermo Fisher to reverse translate the protein in claim 1 to generate a recombinant DNA molecule that could be put into a host cell. One would also have been motivated to apply these techniques to generate the protein as outlined in claim 1. One would have had a reasonable expectation of success because reverse translation of protein to DNA sequences is known in the art, as well as the methods of incorporation of recombinant DNA into host cells. Therefore, the method of claims 4-9 would have been obvious to one of ordinary skill in the art at the time of invention.
For the reasons outlined above, claims 4-9 are rejected.
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.
Instant claims are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, 18 of copending Application No. 18725671 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 2, 10, and 18 of the ‘671 application recite an immobilized enzyme wherein the enzyme comprises an amine dehydrogenase and/or a formate dehydrogenase. The dependent claims further recite an amine dehydrogenase shown in SEQ ID NO: 1. It is noted that SEQ ID NO: 1 of the '671 application is nearly identical to SEQ ID NO: 1 (Query Match 99.1%; Best Local Similarity 99.5%) and comprises the mutation K144G as claimed in instant claim 1-2 (sequencing results shown in Figure 1).
PNG
media_image1.png
686
1430
media_image1.png
Greyscale
Figure 1
Furthermore, the K144G+L294I mutation listed in instant claim 2 is also present in SEQ ID NO: 1 of the ‘671 application. As such, claims 1-2 of the instant application cannot be considered to be patentably distinct over claims 2, 10, 18 of the ‘671 application when there is a specifically recited mutation present in the SEQ ID’s being claimed in both applications. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Status of the claims:
Claims 1-14 are pending.
Claims 1-2, 4-9, and 13 are rejected.
Claim 11 is objected to.
Claims 3, 10-12, and 14 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTHONY STAPON whose telephone number is (571)272-6169. The examiner can normally be reached Monday - Friday 8:00am est - 4pm est.
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, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.S./Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656