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 .
Election/Restrictions
Applicant's election with traverse of the invention of Group I, claims 1-2, 5, and 7-9, and the species of SEQ ID NO.: 8 in the reply filed on 05/20/2026 is acknowledged. The traversal is on the ground(s) that Jiang does not teach the limitations of amended claim 1 of 05/20/2026. This argument has been fully considered but is not found persuasive because Jiang does teach a protein that falls within the scope of instant claim 1, as discussed below under Claim Rejections – 35 USC 103.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
The amendment of 05/20/2026 has been entered. Claims 1-2, 5, 7-14, 16-18, 21-23, 25, 27-28, and 31-39 are pending in this US patent application. Claims 10-14, 16-18, 21-23, 25, 27-28, and 31-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/20/2026.
Claims 1-2, 5, and 7-9 are currently under examination and were examined on their merits.
Upon further search and consideration, the Examiner has rejoined the species of “a uricase that is at least about 50% identical to SEQ ID NO: 1 with a cysteine at amino acid position 290” with the elected species of SEQ ID NO: 8.
Information Disclosure Statement
The information disclosure statement filed in this application on 01/21/2025 has been received and considered.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over US patent application publication 2018/0282707 filed by Jiang et al., published 10/04/2018.
Jiang teaches a uricase of SEQ ID NO: 1 that has 95.39% sequence identity to instantly recited SEQ ID NO: 1 (see entire document, including Jiang SEQ ID NO: 1; cf. instant claim 1). The uricase contains a recombinantly introduced cysteine residue in an inactive portion of the uricase at a position plus or minus 1 of amino acid 291 (paragraphs 0008-0018 and 0025; cf. claims 1-2 and 5). In a preferred embodiment, the uricase is in a tetramer form (paragraph 0048; cf. claim 8). The uricase may be formulated into a pharmaceutical composition with a pharmaceutically acceptable excipient (paragraphs 0119-0121; cf. claim 9).
However, Jiang does not expressly teach substituting amino acid 290 with cysteine as instantly recited.
While Jiang does not expressly teach substituting amino acid 290 with cysteine as instantly recited, it would have been obvious to one of ordinary skill in the art to do so because Jiang teaches that at least one amino acid in positions 290-292 may be substituted with cysteine. One of ordinary skill in the art would have a reasonable expectation that substituting amino acid 290 of Jiang’s uricase with cysteine as suggested by Jiang would successfully result in the production of a uricase that retains significant activity and is capable of PEGylation, as discussed by Jiang.
Therefore, claims 1-2, 5, and 8-9 are rendered obvious by Jiang and are rejected under 35 U.S.C. 103.
Claims 1-2, 5, and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over US patent application publication 2011/0268713 filed by Gaucher, published 11/03/2011, in view of US patent application publication 2018/0282707 filed by Jiang et al., published 10/04/2018.
Gaucher teaches ancestral forms of mammalian uricases (see entire document, including paragraph 0002). SEQ ID NO: 2 of Gaucher is identical to instant SEQ ID NO: 1 (cf. claim 1). The uricase is a tetramer (paragraph 0046; cf. claim 8). The uricase may be formulated with a suitable pharmaceutical excipient (paragraphs 0131-0132; cf. claim 9). The uricase may be recombinant and have uricolytic activity (paragraphs 0160 and 0164; cf. claim 2). In addition, Gaucher’s teachings incorporate mutants in which any amino acid of the uricase is substituted with any naturally occurring amino acid (paragraph 0037).
However, Gaucher does not teach mutating M25 and N287 of SEQ ID NO: 1 to cysteine, thereby satisfying the limitations of instant claim 5 and resulting in the sequence of instant SEQ ID NO: 8 as recited in instant claim 7.
Jiang teaches the recombinant introduction of cysteine residues into uricase to enable the PEGylation of the uricase to improve the in vivo half life and immunogenicity of the protein (see entire document, including paragraphs 0004-0008).
While Gaucher does not teach mutating M25 and N287 of SEQ ID NO: 1 to cysteine, it would have been obvious to one of ordinary skill in the art to do so because Jiang teaches that the recombinant introduction of cysteine residues into uricase allows for the PEGylation of the uricase, which improves the in vivo half life and immunogenicity of the uricase. One of ordinary skill in the art would have a reasonable expectation that mutating M25 and N287 of Gaucher’s SEQ ID NO: 1 to C would successfully result in the production of a uricase to which PEG could be conjugated.
Therefore, claims 1-2, 5, and 7-9 are rendered obvious by Gaucher in view of Jiang and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
Claims 1-2, 5, and 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4 of U.S. Patent No. 8940861 in view of US patent application publication 2018/0282707 filed by Jiang et al., published 10/04/2018. The claims of ‘861 recite the uricase of instant SEQ ID NO: 1 in a tetramer form along with a pharmaceutically acceptable excipient but do not recite the mutations recited in instant claims 1, 5, and 7. However, these mutations would be obvious in view of Jiang for the reasons cited above under Claim Rejections – 35 USC 103. As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘861 in view of Jiang and are rejected on the ground of nonstatutory double patenting.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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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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/Erin M. Bowers/Primary Examiner, Art Unit 1653 07/21/2026
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