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 without traverse of Group I (claims 1-4, 7-13, and 21) and variable amino acids for SEQ ID NO: 1: X1 is S, X2 is C and X3; and variable amino acids for SEQ ID NO: 2, in the first Fc segment, X4 is C; X5 is C; X6 is K; X7 is E; X8 is N; X9 is Q; X10 is W; X11 is L, X12 is N and X13 is Y, and the second Fc segment, X4 C; X5 is C; X6 is E; X7 is K; X8 is Q; X9 is Q; X10 is S; X11 is A, X12 is Q and X13 is V in the reply filed on 11/14/2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 1-4 and 7-23 are pending.
Claims 14-20 and 22-23 are withdrawn for being drawn to non-elected inventions (i.e., Groups II-III).
Claims 1-4, 7-13, and 21 are under examination.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 3/6/2023, 3/23/2023, 6/17/2024 and 9/11/2025 have been considered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities:
The specification discloses amino acid sequences throughout the specification which recites variants as X1, X2, X3 for SEQ ID NO: 1 (see page 12, paragraph [0046]) and variants X4, X5…..X12 and X 13 for SEQ ID NO: 2 (see page15, paragraph [0059]), however, the sequence listing for SEQ ID NO: 1 do not list X1, X2,X3 and for SEQ ID NO: 2 do not list X4, X5, X6.. or X13. The sequence listing has variants at all position listed as X and therefore, the sequences do not match. Applicants must change the sequence listing to match with the sequences in the specification.
Claim Objections
Sequence Non-compliance
It is noted to applicants that the amino acid sequences recited in claims 1, 4 and 10 to are not consistent. Claim 1 recites a sequence of for linker as GXaa1PXaa2, wherein Xaa1 and Xaa2 are variants within the sequence. The sequence presented in claim 1 is not in the sequence compliance as per 37 CFR 1.821-1.825. It should be noted, though, that when a sequence is presented in the specification, regardless of the format or the manner of presentation of that sequence in the specification, the sequence must still be included in the Sequence Listing and the sequence identifier (“SEQ ID NO:X”) must be used.
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.
Claims 4 and 10 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.
Regarding claim 4, the phrase "X1, X2 and X3 of SEQ ID NO: 1" renders the claim indefinite because the amino acid sequence of SEQ ID NO: 1 recites variants as “X” and therefore, it is unclear and confusing to perform a proper sequence search.
Regarding claim 10, the phrase "X4, X5,…… and X13 of SEQ ID NO: 2" renders the claim indefinite because the amino acid sequence of SEQ ID NO: 2 recites variants as “X” and therefore, it is unclear and confusing for sequence searching department to perform a proper search.
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.
Claim(s) 1-3, 7-9 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (IDS, CN 108794634) in view of Zhang et al. (US Pat. No. 11,453,711).
Xu et al teach a fusion protein comprising human growth hormone immunoglobulin Fc having two units Y1 and Y2 attached with disulfide bond (abstract). They teach that the human GH and an Fc are attached by a linker, wherein the linker can be (GGGGS)n (paragraph [0020]) and they are represented as formula X-L-(Y1-Y2) (abstract). The N-terminal of human GH is not a methionine (see amino acid sequence [0117]) They teach making the fusion protein by expressing in a recombinant expression vector in E. coli (see paragraph [0080]). Xu et al. do not teach that the linker is GXaa1PXaa2, wherein Xaa1 is A and Xaa2 is Q.
Zhang et al teach making a fusion protein of GLP-1 and GDF15 and a pharmaceutical composition comprising the same. They teach that using a linker to make the fusion protein. They teach a linker comprising amino acid sequence that comprises 3 repeats of the amino acid sequence GAQP (SEQ ID NO: 218).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a linker having amino acid sequence (GAQP)3 as taught by Zhang et al make a fusion between human growth hormone and an Fc of the (Fc)2 as taught by Xu et al. Additionally, one would have been motivated to do so because Zhang et al teach fusion of two protein using the linker (GAQP)3. Further, one would have a reasonable expectation of success in using (GAQP)3 to link human GH with an Fc as taught by Zhang et al and that use of a linker is routine in the art. In general use of a specific linker does not rise to a level of patentability and the specification does disclose any surprising result using this linker.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (IDS, CN 108794634) in view of Zhang et al. (US Pat. No. 11,453,711) as applied to claims 1-3, 7-9 and 21 above, and further in view of Bussell (WO 2004007687).
The teachings of Xu et al. and Zhang et al. are set forth supra. Neither Xu et al. nor Zhang et al. teach a human growth amino acid sequence of SEQ ID NO: 1, wherein X1 is S, X2 and X3 are C.
Bussell (WO 2004007687) teaches an amino acid sequence of SEQ ID NO: 66 which is 100% identical to the instantly claimed human growth sequence of SEQ ID NO: 1, wherein X1 is S and X2 and X3 are C (see the sequence alignment below).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a human growth hormone having amino acid sequence of SEQ ID NO:6 as taught by Bussell having 100% sequence identity with the instantly claimed human growth hormone to make a fusion between human growth hormone and an Fc of the (Fc)2 as taught by Xu et al in view of Zhang et al. Additionally, one would have been motivated to do so because Bussell teaches that the amino acid sequence of SEQ ID NO: 66 is a human growth hormone. Further, one would have a reasonable expectation of success in using the amino acid sequence of SEQ ID NO: 66 as taught by Bussell as the human GH with an Fc as taught by Zhang et al in view of Zhang et al.
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723
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Claim(s) 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (IDS, CN 108794634) in view of Zhang et al. (US Pat. No. 11,453,711) as applied to claims 1-3, 7-9 and 21 above, and further in view of Harris et al. (US Pat. No.11,186,639).
Xu et al teach making variants of an Fc and using them for human growth hormone. However, neither Xu nor Zhang et al teach making variants of amino acid sequence of SEQ ID NO: 2, wherein X4 is R, K, D, E OR C; X5 is R, K, D, E or C; X is R, K, D, E or deletion; X7 is A, R, K, D, E or deletion; X8 is D,E,G,Q or N; X9 is D, E, G, Q OR N; X10 is G, S or W; X11 is A, G, P or L; X12 is D, E,G, Q or N; and X13 I, P, V or Y.
Harris et al teach mutations to constant region of an Fc wherein X4 is C, X5 is C, X6 is E, X7 is K, X8 is N,X9 is N and many others (see the sequence alignment). The prior art in the field of making various mutations to an Fc to reduce glycosylation or reduce cytotoxicity are well known.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use an Fc variant as taught by Harris et al or make further mutations as per need known in the prior art to make a fusion between human growth hormone and an Fc of the (Fc)2 as taught by Xu et al in view of Zhang et al. Additionally, one would have been motivated to do so because Harris et al. teach making mutations to an Fc. Further, one would have a reasonable expectation of success in using an Fc which has only a couple of differences in the Fc region as taught by Harris et al. from the instantly claimed amino acid sequence of SEQ ID NO: 2 and make a fusion with human growth hormone as taught by Zhang et al in view of Zhang et al. Additionally, the instant specification does not disclose any surprising result when using a first Fc and a second Fc having one or two amino acid differences. Therefore, the instantly claimed invention would have been obvious to one ordinary skill in the art over the combined teachings of the references.
RESULT 1
US-17-308-946-55
(NOTE: this sequence has 4 duplicates in the database searched)
Sequence 55, US/17308946
Patent No. 11186639
GENERAL INFORMATION
APPLICANT: TENEOBIO, INC.
TITLE OF INVENTION: MULTISPECIFIC HEAVY CHAIN ANTIBODIES WITH MODIFIED HEAVY CHAIN
TITLE OF INVENTION: CONSTANT REGIONS
FILE REFERENCE: TNO-0018-C1-US
CURRENT APPLICATION NUMBER: US/17/308,946
CURRENT FILING DATE: 2021-05-05
PRIOR APPLICATION NUMBER: 63/108,796
PRIOR FILING DATE: 2020-11-02
PRIOR APPLICATION NUMBER: 63/017,589
PRIOR FILING DATE: 2020-04-29
NUMBER OF SEQ ID NOS: 92
SEQ ID NO 55
LENGTH: 229
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Description of Artificial Sequence: Synthetic
Polypeptide
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Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674