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 of 11 specific amino acid site modifications (claim 14) and SEQ ID NO: 1 in the reply filed on November 20, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Upon searching the elected species, was discovered that the examiner’s search could be reasonably extended to all species. As such, the election of species is withdrawn.
Claims 1 – 20 are pending and have been considered on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 4, 2023; September 1, 2023; July 3, 2024; October 25, 2024; and January 16, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 15 recites a method for preparing a polyethylene glycol-modified urate oxidase, wherein the urate oxidase has one of SEQ ID NOs: 1 – 7 in which “one or more amino acids are substituted, deleted and/or added.” This claim is considered a genus claim that encompasses a wide array of sequences. The specification fails to set forth a representative number of examples in order to reasonably verify possession of such a potentially enormous number of variants.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all variants that might result from a single substitution, deletion or addition within any one of SEQ ID NOs: 1 – 7 as well as any combination thereof. The instant disclosure fails to identify a single substitution or deletion or addition or any combination of substitutions, deletions or additions of any of the claimed SEQ ID NOs. The possible variations in any of these sequences are limitless with potentially millions of types of modifications.
The purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by them. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." The specification lacks sufficient variety of species of variants to reflect this variance in the genus since the specification does not provide any examples of such a genus of a SEQ ID with “one or more amino acids are substituted, deleted and/or added.” Accordingly, the specification fails to provide adequate written description for the genus of a SEQ ID with “one or more amino acids” that are “substituted, deleted and/or added” and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention. Therefore, the specification does not describe the claimed modifications in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these oxidase variants at the time of filing of the present application. Thus, the written description requirement has not been satisfied.
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 18 – 19 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.
In claim 18, the recitations of “more preferably” render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 19 is drawn to a method however is rendered indefinite for referring to “Table 8” because where possible, claims are to be complete in themselves. 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 than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (MPEP 2173.05(s)).
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 – 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7 – 8, 12, 18 – 20 of copending Application No. 17/521 898 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
The reference application claims a polyethylene glycol (PEG) modified urate oxidase (claim 1). Turning to the specification, the modified urate oxidase is prepared in the manner as claimed in the instant application to include providing 200 mmol/L 5KD PEG-SPA (N-hydroxysuccinimidyl propionate) in 2 mmol/L hydrochloric acid solution at a molar ratio ranging from 1:55 to 1:95 (urate oxidase: 5K-PEG-SPA); adding to a carbonate buffer, pH 10; allowing the coupling reaction to occur at 5 to 30° C. for 60 minutes (example 2). The urate oxidase is pegylated at the same amino acid sites (claim 1) of the same SEQ ID (claim 1) and have the same peptide fragments (claim 7), therefore must also share the same peptide map.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 – 22 of copending Application No. 18/312 292 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
The reference application claims a composition comprising a polyethylene glycol (PEG) modified urate oxidase (claims 1, 18). Turning to the specification, the modified urate oxidase is prepared in the manner as claimed in the instant application to include providing 200 mmol/L 5KD PEG-SPA (N-hydroxysuccinimidyl propionate) in 2 mmol/L hydrochloric acid solution at a molar ratio ranging from 1:55 to 1:95 (urate oxidase: 5K-PEG-SPA); adding to a carbonate buffer, pH 10; allowing the coupling reaction to occur at 5 to 30° C. for 60 minutes (example 2). The urate oxidase is pegylated at the same amino acid sites (claims 1, 18) of the same SEQ ID (claim 1) and therefore must share the same peptide fragments and peptide map.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Prior Art Not Relied Upon
Zhang et al. (US 9193967) teaches methods for preparing PEG modified urate oxidase (abstract) wherein powdered 5KD PEG-SPA is added to urate oxidase in the presence of carbonate buffer (example 1). Zhang teaches urate oxidase having 95% identity to claimed SEQ ID NO: 1 (SEQ ID NO: 3, per search result #15). However, Zhang fails to teach providing the PEG-SPA in acid solution.
Hartman et al. (US 2019/0316097) teaches methods for preparing PEG modified urate oxidase (abstract) wherein PEG is added to a uricase solution and incubated (example 5). Hartman teaches a urate oxidase having 100% identity to claimed SEQ ID NO: 1 (SEQ ID NO: 8, per search result #1). However, Hartman fails to teach providing the PEG-SPA in acid solution.
Moreover, it is well known in the art to conjugate PEG to urate oxidase in order to obtain pegylated uricase, however the prior art does not teach or suggest providing PEG in an acidic solution as claimed.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699