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 .
Restriction/Election of Species
Applicant’s election without traverse of Group I, claims 1-6, set forth in the Reply filed 14 July 2026, is acknowledged.
Status of the Claims
Claims 1-15 are currently pending. Claims 7-15 are withdrawn. Claims 1-6 are the subject of this Office Action. This is the first Office Action on the merits of the claims.
IDS
The references cited on the information disclosure statement(s) were considered and have been made of record.
Notably, one or more of the disclosure statements filed to date lists the following documents: Search Reports, PCT Written Opinion.
The listing of the document(s) noted above is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the document(s) noted above have not been considered.
Furthermore, the listing of references in the specification or claims is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the document(s) noted above are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Claim Interpretations
Instantly claimed SEQ ID NO: 19 comprises instant SEQ ID NO: 7, 4, 6, and 18 (feline thrombin signal peptide, GLP-1 analog, glycine-serine linker, and Fc fragment respectively).
Priority
The effective filing date of the claims is deemed the filing date of the provisional application (i.e., 63/682,091), namely August 12, 2024.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson1 in view of Lancaster 20202, Prabakaran3, and Shibata-Koyama4 as evidenced by Ehrenmann5, and Bellahcene6.
Wilson discloses: GLP-1-linker-Fc fusion proteins adapted for use in feline subjects to treat metabolic diseases (see Wilson, e.g., claims, Fig. 1A, 2, and 8A). In particular, Wilson discloses the fusion protein comprising SEQ ID NO: 14, which comprises the instantly claimed feline thrombin signal peptide, GLP-1 analog, and glycine-serine linker set forth in instant SEQ ID NO: 19 (see Fig.1 below for sequence alignment between instant SEQ ID NO: 19 and SEQ ID NO: 14 of Wilson; compare sequence id. with instant SEQ ID NO: 7, 4, and 6; reads on instant claims 1 and 3).
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Figure 1: Sequence alignment between instant SEQ ID NO: 14 (Qy) and SEQ ID NO: 14 of Wilson (Db). Instantly claimed feline thrombin signal peptide, GLP-1 analog, and glycine-serine linker, set forth in instant SEQ ID NO: 7, 4, and 6, are also annotated above.
Example 2 (Figure 2) of Wilson discloses the expression of "feline Dulaglutide" (Seq ID No:14, Figure SA), a construct in which the lgG Fc portion of dulaglutide is replaced with a feline lgG Fc sequence in combination with a feline thrombin leader (fcTrb). Wilson further discloses that dulaglutide is a homodimer (reads on instant claim 2).
The prior art of Wilson differs from the instantly claimed invention as follows: Wilson does not expressly disclose the particular Fc fragment set forth in instant SEQ ID NO: 19, as required by the instant claims.
Lancaster 2020 discloses insulin-Fc fusion proteins for therapy of obesity in cats (see Lancaster 2020, e.g., at abstract and claims). Lancaster 2020 further points out that since the feline lgG1b isotypes interact with their respective species-specific Fc(gamma) receptors, there may be a risk of unwanted immunogenicity after repeated injections, and that one method for reducing the Fc(gamma) interaction involves deglycosylating or preventing the glycosylation of the Fc fragment during synthesis in the host cell (see Lancaster 2020, e.g., at para. [0116]). Lancaster 2020 indicates that cNg site mutations were made to the Fc fragment in order to reduce the binding affinity of the Fc fragment for Fc(gamma) receptors in vivo (see Lancaster 2020, e.g., at para. [0209]), and further discloses the feline lgG1 b Fc fragment encoded by Seq ID No:20 which shares 99.6% sequence id. with instant SEQ ID NO: 18, the Fc fragment set forth in the instantly claimed fusion protein (see Lancaster 2020, e.g., at claim 12, SEQ ID NO: 12; see also Fig. 2 below for sequence alignment between instant SEQ ID NO: 18 and SEQ ID NO: 20 of Lancaster 2020).
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Figure 2: Sequence alignment between instant SEQ ID NO: 18 (Qy) and SEQ ID NO: 20 of Lancaster 2020 (Db). The one mismatch is highlighted above.
Lancaster 2020 further discloses compositions comprising: the fusion protein and a pharmaceutically acceptable carrier, homodimers of said fusion protein, and greater than or equal to 85% homodimers of said fusion protein (see Lancaster 2020, e.g., at claims 22-23 and 30; para. [141]-[142]; reads on instant claims 4-6).
Prabakaran teaches the N-linked glycosylation at Asn297 is conserved in mammalian IgGs (see Prabakaran, e.g., at abstract and introduction; the particular mutation site is the conserved N-linked glycosylation site, Asn297, as evidenced by Ehrenmann and Bellahcene).
Shibata-Koyama teaches altering asparagine of N-linked glycosylation sites into glutamine to delete the glycosylation (see Shibata-Koyama, e.g., at Fig. 1 description).
Obviousness Analysis:
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than: simple substitution of one known element for another, e.g., the Fc fragment of Wilson for the Fc fragment of Lancaster 2020, to obtain predictable results, e.g., production of a, Fc fusion protein (see MPEP 2143(I)(B); renders obvious the sequence set forth in instant claims 1 and 3); and applying a known technique to a known Fc fragment, e.g., the Fc fragment of Lancaster 2020, ready for improvement to yield predictable results; namely deglycosylating the Fc fragment to reduce immunogenicity. The particular site of mutation, is a known N-linked glycosylation site that is conserved across mammalian species, and specifically replacing the arginine with glutamine at said site is known in the art to delete glycosylation (see MPEP 2143(I)(D), (G); renders obvious the sequence set forth in instant claims 1 and 3); and combining the prior art elements of the cited references according to known methods to yield predictable results e.g., incorporating the disclosures of Lancaster 2020 into the known fusion proteins of Wilson, as GLP-1-linker-Fc fusion proteins, the individual components that make up said fusion proteins (i.e., the instantly claimed feline thrombin signal peptide, GLP-1 analog, glycine-serine linker, and Fc fragment sequences as well as Fc mutations), as well as compositions comprising said proteins and homodimers of said proteins are known in the art, including for medical uses in feline subjects. (see MPEP 2143(I)(A),(G); renders obvious instant claims 1-6).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the methods of the instant invention, as the prior art references cited above provides support and motivation for doing so, as discussed above.
Accordingly, claims 1-6 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.
Patent No.: 10,851,147
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of Patent No. 10,851,147 (reference patent) in view of Wilson, Prabakaran, and Shibata-Koyama as evidenced by Ehrenmann and Bellahcene (supra).
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1-6, the reference patent claims insulin-Fc fusion proteins, compositions comprising said fusion protein and homodimers (see reference claims 1-21). The reference patent specifically claims insulin-Fc fusion proteins comprising the Fc fragment set forth in SEQ ID NO: 23, which shares 99.6% sequence identity with instantly claimed SEQ ID NO:19, and discloses deglycosylating the Fc fragment via cNg-S mutation (see reference specification7, at col. 28).
Although the reference claims do not recite the particular GLP-1 fusion protein, GLP-1-linker-Fc fusion proteins, the individual components that make up said fusion proteins (i.e., the instantly claimed feline thrombin signal peptide, GLP-1 analog, glycine-serine linker, and Fc fragment sequences as well as Fc mutations), as well as compositions comprising said proteins and homodimers of said proteins are known in the art, including for medical uses in feline subjects. Furthermore, these deficiencies in the reference patent are remedied by the prior art teachings/disclosures set forth in references, Wilson, Prabakaran, and Shibata-Koyama, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combining the prior art elements of the cited references according to known methods to yield predictable results, and simply substituting one known deglycosylating Fc fragment mutation for another, e.g., cNg-S for cNg-Q, to yield predictable results (see MPEP 2143(I)(A), (B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the products of the instant invention, as the reference patent and prior art references cited above provides support and motivation for doing so, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims.
Patent No.: 10,870,686
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of Patent No. 10,870,686 (reference patent) in view of Wilson, Prabakaran, and Shibata-Koyama as evidenced by Ehrenmann and Bellahcene (supra).
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1-6, the reference patent claims insulin-Fc fusion proteins, compositions comprising said fusion protein and homodimers (see reference claims 1-21). The reference patent discloses insulin-Fc fusion proteins comprising the Fc fragment set forth in SEQ ID NO: 20, which shares 99.6% sequence identity with instantly claimed SEQ ID NO:19, and discloses deglycosylating the Fc fragment via cNg-S mutation (see reference specification, at col. 28).
Although the reference claims do not recite the particular GLP-1 fusion protein, GLP-1-linker-Fc fusion proteins, the individual components that make up said fusion proteins (i.e., the instantly claimed feline thrombin signal peptide, GLP-1 analog, glycine-serine linker, and Fc fragment sequences as well as Fc mutations), as well as compositions comprising said proteins and homodimers of said proteins are known in the art, including for medical uses in feline subjects. Furthermore, these deficiencies in the reference patent are remedied by the prior art teachings/disclosures set forth in references, Wilson, Prabakaran, and Shibata-Koyama, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combining the prior art elements of the cited references according to known methods to yield predictable results, and simply substituting one known deglycosylating Fc fragment mutation for another, e.g., cNg-S for cNg-Q, to yield predictable results (see MPEP 2143(I)(A), (B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the products of the instant invention, as the reference patent and prior art references cited above provides support and motivation for doing so, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims.
Patent No.: 10,947,292
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of Patent No. 10,947,292 (reference patent) in view of Wilson, Prabakaran, and Shibata-Koyama as evidenced by Ehrenmann and Bellahcene (supra).
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1-6, the reference patent claims insulin-Fc fusion proteins, compositions comprising said fusion protein and homodimers (see reference claims 1-21). The reference patent specifically claims insulin-Fc fusion proteins comprising the Fc fragment set forth in SEQ ID NO: 20, which shares 99.6% sequence identity with instantly claimed SEQ ID NO:19, and discloses deglycosylating the Fc fragment via cNg-S mutation (see reference specification, at col. 28).
Although the reference claims do not recite the particular GLP-1 fusion protein, GLP-1-linker-Fc fusion proteins, the individual components that make up said fusion proteins (i.e., the instantly claimed feline thrombin signal peptide, GLP-1 analog, glycine-serine linker, and Fc fragment sequences as well as Fc mutations), as well as compositions comprising said proteins and homodimers of said proteins are known in the art, including for medical uses in feline subjects. Furthermore, these deficiencies in the reference patent are remedied by the prior art teachings/disclosures set forth in references, Wilson, Prabakaran, and Shibata-Koyama, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combining the prior art elements of the cited references according to known methods to yield predictable results, and simply substituting one known deglycosylating Fc fragment mutation for another, e.g., cNg-S for cNg-Q, to yield predictable results (see MPEP 2143(I)(A), (B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the products of the instant invention, as the reference patent and prior art references cited above provides support and motivation for doing so, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims.
Patent No.: 10,961,294
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of Patent No. 10,961,294 (reference patent) in view of Wilson, Prabakaran, and Shibata-Koyama as evidenced by Ehrenmann and Bellahcene (supra).
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1-6, the reference patent claims insulin-Fc fusion proteins, compositions comprising said fusion protein and homodimers (see reference claims 1-22). The reference patent discloses insulin-Fc fusion proteins comprising the Fc fragment set forth in SEQ ID NO: 20, which shares 99.6% sequence identity with instantly claimed SEQ ID NO:19, and discloses deglycosylating the Fc fragment via cNg-S mutation (see reference specification, at col. 28).
Although the reference claims do not recite the particular GLP-1 fusion protein, GLP-1-linker-Fc fusion proteins, the individual components that make up said fusion proteins (i.e., the instantly claimed feline thrombin signal peptide, GLP-1 analog, glycine-serine linker, and Fc fragment sequences as well as Fc mutations), as well as compositions comprising said proteins and homodimers of said proteins are known in the art, including for medical uses in feline subjects. Furthermore, these deficiencies in the reference patent are remedied by the prior art teachings/disclosures set forth in references, Wilson, Prabakaran, and Shibata-Koyama, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combining the prior art elements of the cited references according to known methods to yield predictable results, and simply substituting one known deglycosylating Fc fragment mutation for another, e.g., cNg-S for cNg-Q, to yield predictable results (see MPEP 2143(I)(A), (B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the products of the instant invention, as the reference patent and prior art references cited above provides support and motivation for doing so, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims.
Patent No.: 11,261,229
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of Patent No. 11,261,229 (reference patent) in view of Wilson, Prabakaran, and Shibata-Koyama as evidenced by Ehrenmann and Bellahcene (supra).
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1-6, the reference patent claims recombinant cells encoding for insulin-Fc fusion proteins (see reference claims 1-22). The reference patent discloses compositions comprising said fusion protein and homodimers as well as insulin-Fc fusion proteins comprising the Fc fragment set forth in SEQ ID NO: 20, which shares 99.6% sequence identity with instantly claimed SEQ ID NO:19, and discloses deglycosylating the Fc fragment via cNg-S mutation (see reference specification, at Figures, Description, and col. 5 and 28 in particular).
Although the reference claims do not recite the particular GLP-1 fusion protein, GLP-1-linker-Fc fusion proteins, the individual components that make up said fusion proteins (i.e., the instantly claimed feline thrombin signal peptide, GLP-1 analog, glycine-serine linker, and Fc fragment sequences as well as Fc mutations), as well as compositions comprising said proteins and homodimers of said proteins are known in the art, including for medical uses in feline subjects. Furthermore, these deficiencies in the reference patent are remedied by the prior art teachings/disclosures set forth in references, Wilson, Prabakaran, and Shibata-Koyama, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combining the prior art elements of the cited references according to known methods to yield predictable results, and simply substituting one known deglycosylating Fc fragment mutation for another, e.g., cNg-S for cNg-Q, to yield predictable results (see MPEP 2143(I)(A), (B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the products of the instant invention, as the reference patent and prior art references cited above provides support and motivation for doing so, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims.
Patent No.: 11,267,862
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of Patent No. 11,267,862 (reference patent) in view of Wilson, Prabakaran, and Shibata-Koyama as evidenced by Ehrenmann and Bellahcene (supra).
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1-6, the reference patent claims recombinant cells encoding for insulin-Fc fusion proteins (see reference claims 1-14). The reference patent specifically claims insulin-Fc fusion proteins comprising the Fc fragment set forth in SEQ ID NO: 23, which shares 99.6% sequence identity with instantly claimed SEQ ID NO:19, and discloses deglycosylating the Fc fragment via cNg-S mutation, as well as related compositions comprising said fusion protein and homodimers (see reference specification, at col. 5 and 28).
Although the reference claims do not recite the particular GLP-1 fusion protein, GLP-1-linker-Fc fusion proteins, the individual components that make up said fusion proteins (i.e., the instantly claimed feline thrombin signal peptide, GLP-1 analog, glycine-serine linker, and Fc fragment sequences as well as Fc mutations), as well as compositions comprising said proteins and homodimers of said proteins are known in the art, including for medical uses in feline subjects. Furthermore, these deficiencies in the reference patent are remedied by the prior art teachings/disclosures set forth in references, Wilson, Prabakaran, and Shibata-Koyama, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combining the prior art elements of the cited references according to known methods to yield predictable results, and simply substituting one known deglycosylating Fc fragment mutation for another, e.g., cNg-S for cNg-Q, to yield predictable results (see MPEP 2143(I)(A), (B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the products of the instant invention, as the reference patent and prior art references cited above provides support and motivation for doing so, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims.
Patent No.: 11,673,934
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of Patent No. 11,673,934 (reference patent) in view of Wilson, Prabakaran, and Shibata-Koyama as evidenced by Ehrenmann and Bellahcene (supra).
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1-6, the reference patent claims insulin-Fc fusion proteins, compositions comprising said fusion protein and homodimers (see reference claims 1-20). The reference patent specifically claims insulin-Fc fusion proteins comprising the Fc fragment set forth in SEQ ID NO: 23, which shares 99.6% sequence identity with instantly claimed SEQ ID NO:19, and discloses deglycosylating the Fc fragment via cNg-S mutation (see reference specification, at col. 28).
Although the reference claims do not recite the particular GLP-1 fusion protein, GLP-1-linker-Fc fusion proteins, the individual components that make up said fusion proteins (i.e., the instantly claimed feline thrombin signal peptide, GLP-1 analog, glycine-serine linker, and Fc fragment sequences as well as Fc mutations), as well as compositions comprising said proteins and homodimers of said proteins are known in the art, including for medical uses in feline subjects. Furthermore, these deficiencies in the reference patent are remedied by the prior art teachings/disclosures set forth in references, Wilson, Prabakaran, and Shibata-Koyama, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combining the prior art elements of the cited references according to known methods to yield predictable results, and simply substituting one known deglycosylating Fc fragment mutation for another, e.g., cNg-S for cNg-Q, to yield predictable results (see MPEP 2143(I)(A), (B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the products of the instant invention, as the reference patent and prior art references cited above provides support and motivation for doing so, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims.
Patent No.: 11,773,151
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of Patent No. 11,773,151 (reference patent) in view of Wilson, Prabakaran, and Shibata-Koyama as evidenced by Ehrenmann and Bellahcene (supra).
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1-6, the reference patent claims insulin-Fc fusion proteins, compositions comprising said fusion protein and homodimers (see reference claims 1-15). The reference patent discloses insulin-Fc fusion proteins comprising the Fc fragment set forth in SEQ ID NO: 20, which shares 99.6% sequence identity with instantly claimed SEQ ID NO:19, and discloses deglycosylating the Fc fragment via cNg-S mutation (see reference specification, at col. 28).
Although the reference claims do not recite the particular GLP-1 fusion protein, GLP-1-linker-Fc fusion proteins, the individual components that make up said fusion proteins (i.e., the instantly claimed feline thrombin signal peptide, GLP-1 analog, glycine-serine linker, and Fc fragment sequences as well as Fc mutations), as well as compositions comprising said proteins and homodimers of said proteins are known in the art, including for medical uses in feline subjects. Furthermore, these deficiencies in the reference patent are remedied by the prior art teachings/disclosures set forth in references, Wilson, Prabakaran, and Shibata-Koyama, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combining the prior art elements of the cited references according to known methods to yield predictable results, and simply substituting one known deglycosylating Fc fragment mutation for another, e.g., cNg-S for cNg-Q, to yield predictable results (see MPEP 2143(I)(A), (B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the products of the instant invention, as the reference patent and prior art references cited above provides support and motivation for doing so, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims.
Conclusion
Claims 1-6 are rejected.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 WO2022046809A1; cited on the IDS
2 WO2020006529A1; cited on the IDS
3 Prabakaran, Ponraj, et al. "Structure of an isolated unglycosylated antibody CH2 domain." Biological Crystallography 64.10 (2008): 1062-1067.
4 Mami Shibata-Koyama et al, The N-linked oligosaccharide at FcγRIIIa Asn-45: an inhibitory element for high FcγRIIIa binding affinity to IgG glycoforms lacking core fucosylation, Glycobiology, Volume 19, Issue 2, February 2009, Pages 126–134, https://doi.org/10.1093/glycob/cwn110
5 Ehrenmann, F., Lefranc, M.-P. Cold Spring Harbor Protoc., 6:737-749 (2011). PMID:21632775 (https://pubmed.ncbi.nlm.nih.gov/21632775). Accessed https://www.imgt.org/3Dstructure-DB/cgi/DomainGapAlign.cgi on 04 August 2026.
6 Bellahcene, Fatena and Ginestoux, Chantal. Correspondence between the IMGT unique numbering for C-DOMAIN, the IMGT exon numbering, the Eu and Kabat numberings: Human IGKC. IMGT Scientific chart. IMGT®, the international ImMunoGenetics information system® http://www.imgt.org. Created: 21/12/2010. Accessed https://www.imgt.org/IMGTScientificChart/Numbering/Hu_IGKCnber.html on 04 August 2026.
7 Per MPEP § 804(II)(B)(1), it is permissible to rely on the Specification for obvious variants (see, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”).
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