DETAILED ACTION
Applicant’s response to the Restriction/Election Requirement received on 11/21/05 has been entered. Claims 1-8, 11-18, 20, 24-26, 32-33, 68, 71-72, 74, and 79-83 are pending in this application. Applicant’s election without traverse of Group I, and the following species: an Fc domain as the species of serum half-life enhancer, a mammalian sialidase as the species of sialidase, and a single sialidase mutation which is a substitution of a proline residue at a position corresponding to position 62 of wild-type human Neu2 (P62), is acknowledged.
Claims 11-12, 14-15, and 74 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/21/25. Please note that the election of species requirement in regards to sialidase mutations required applicant to pick a single mutation or combination of mutations. As applicant selected a single mutation which corresponds to human Neu2 P62, combinations of mutations comprising the P62 mutation have not been elected for initial examination, and as such, claims 11-12, and 14-15 does not correspond to the elected species of sialidase.
Claims 1-8, 13, 16-18, 20, 24-26, 32-33, 68, 71-72, and 79-83 are therefore currently under examination based on the elected species of a sialidase which is a mammalian sialidase, and which has a single mutation which is a substitution of a proline residue at a position corresponding to position 62 of wild-type human Neu2 (P62), and the species of serum half-life enhancer which is an Fc.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . An action on the merits follows.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8, 13, 16-18, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Application Publication 2025/0049846 (2025), hereafter referred to as Alkhateeb et al., with an effective filing date of 1/3/19.
Alkhateeb et al. teaches a fusion protein consisting of a sialidase and an Fc domain of an immunoglobulin, an antibody conjugate comprising a sialidase, an Fc domain, and an antibody recognition domain (Alkhateeb et al., paragraph 37, 87, 103). In particular, Alkhateeb et al. teaches that the sialidase is human sialidase, preferably human neuraminidase 2 (Neu2), and where the sialidase has a single substitution, including a substitution of a proline residue at a position corresponding to position 62 of wild-type human Neu2 (P62) (Alkhateeb et al., paragraphs 10, 57, and 75-76). Alkhateeb et al. also teaches that the sialidase has at least 50% of the enzymatic activity of a full-length sialidase (Alkhateeb et al., paragraph 56). Alkhateeb et al. also teaches that the sialidase may be chemically conjugated instead of fused to the Fc domain (Alkhateeb et al., paragraphs 91 and 101). Finally, Alkhateeb et teaches a pharmaceutical composition comprising the sialidase-Fc fusion protein, where the pharmaceutical composition can be administered intratumorally (Alkhateeb et al., paragraph 214). Thus, by teaching all of the limitations of the claims as written, Alkhateeb et al. anticipates the instant invention as claimed.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
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.
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 1-8, 13, 16-18, 20, 24-26, 32-33, 68, 71-72, and 79-83 are rejected under 35 U.S.C. 103 as being obvious over U.S. Patent Application Publication 2025/0049846 (2025), hereafter referred to as Alkhateeb et al., with an effective filing date of 1/3/19, in view of US Patent Application Publication 2020/00339968 (2020), hereafter referred to as Peng et al., with an effective filing date of 1/3/18, Petrick et al. (1994) Clin. Exp. Metastasis, Vol. 12, 108-116, and Johansson et al. (2003) J. Biochem., Vol. 134, 345-352.
Alkhateeb et al. teaches a fusion protein consisting of a sialidase and an Fc domain of an immunoglobulin, an antibody conjugate comprising a sialidase, an Fc domain, and an antibody recognition domain (Alkhateeb et al., paragraph 37, 87, 103). In particular, Alkhateeb et al. teaches that the sialidase is human sialidase, preferably human neuraminidase 2 (Neu2), and where the sialidase has a single substitution, including a substitution of a proline residue at a position corresponding to position 62 of wild-type human Neu2 (P62) (Alkhateeb et al., paragraphs 10, 57, and 75-76). Alkhateeb et al. also teaches that the sialidase has at least 50% of the enzymatic activity of a full-length sialidase (Alkhateeb et al., paragraph 56). Alkhateeb et al. also teaches that the sialidase may be chemically conjugated instead of fused to the Fc domain (Alkhateeb et al., paragraphs 91 and 101). Alkhateeb et al. also teaches that where the sialidase is conjugated to an antibody, the antibody recognizes CD20, or more specifically is derived from the anti-CD20 antibody rituximab et al. (Alkhateeb et al., paragraph 98 and 100). Finally, Alkhateeb et teaches a pharmaceutical composition comprising the sialidase-Fc fusion protein, where the pharmaceutical composition can be administered intratumorally (Alkhateeb et al., paragraph 214).
While Alkhateeb et al. teaches to administer a pharmaceutical composition comprising a sialidase-Fc fusion protein intratumorally, Alkhateeb et al. does not specifically teach all of the effects of the fusion protein in vivo such as activation of dendritic cells, enhancement of macrophage phagocytosis, and treatment of the tumor itself. Alkhateeb et al. also does not teach to include a stabilizer such as a Ca+ ion in the pharmaceutical composition.
Peng et al. supplements Alkhateeb et al. by teaching that the administration of a pharmaceutical composition comprising a substituted sialidase-Fc fusion protein or antibody conjugate comprising an FC domain and a substituted sialidase, where the substituted sialidase is human Neu2, where the antibody conjugate comprising an antibody binding domain that binds to CD20, or is more specifically derived from the anti-CD20 antibody rituximab, and where the pharmaceutical composition is administered to a subject to treat cancer (Peng et al., paragraphs 10, 16, 22, 118-110, 126, and 128, and claims 84-87). Peng et al. further teaches that administration of the sialidase-Fc fusion protein or antibody conjugate activates dendritic cells by reducing tumor cell mediated inhibition of dendritic cell activation (Peng et al., paragraph 52, 294, and 298). In addition, Peng et al. teaches to include a stabilizer in the pharmaceutical composition comprising the sialidase-Fc fusion protein (Peng et al., paragraph 201). Petrick et al. further supplements Alkhateeb et al. by teaching that desialylation of metastatic human colorectal cancer cells facilitates their binding and phagocytosis by Kupffer cells which are liver macrophages (Petrick et al., pages 108-109).
Therefore, based on the teachings of Alkhateeb et al. to intratumorally administer a pharmaceutical composition comprising a sialidase-Fc fusion where the sialidase has a P62 substitution, the teaching and motivation provided by Peng et al. for delivering substituted sialidase-Fc fusion protein to treat cancer and activate dendritic cells in subjects with a tumor, and the teachings of Petrick that desialylation of tumor cells can increase their phagocytosis by macrophages, it would have been prima facie obvious to the skilled artisan at the time of filing to administer the pharmaceutical composition comprising a sialidase-Fc fusion or antibody conjugate comprising sialidase and an Fc domain where the sialidase has a P62 substitution taught by Alkhateeb to a subject with a tumor in order to treat the tumor, activate dendritic cells, and enhance macrophage phagocytosis of tumor cells with a reasonable expectation of success. It is further noted that as the antibody conjugate may comprise an anti-CD20 antibody, that the administration of the antibody conjugate comprising sialidase and the Fc domain inherently results in simultaneous administration of the antibody and the sialidase-Fc fusion protein.
Further in regards to the inclusion of a stabilizer in the pharmaceutical composition, Peng et al., as noted above, teaches to include a stabilizer in the pharmaceutical composition. However, Peng et al., does not teach that the stabilizer is a Ca+ ion.
Johansson et al. supplements Alkhateeb et al. and Peng et al. by teaching that the presence of either Ca2+ or Mg2+ ions restored antigenicity of dialyzed neuraminidase, i.e. stabilized the structure of the neuraminidase, and increased enzymatic activity of the enzyme (Johansson et al., pages 345 and 349). Therefore, in view of the motivation provided by Peng et al. to include a stabilizer in a pharmaceutical composition of a sialidase-Fc conjugate, and the motivation provided by Johansson et al. to add Ca2+ or Mg2+ ions to stabilize the structure and enhance the activity of a neuraminidase, it would have been prima facie obvious to the skilled artisan at the time of filing to add Ca2+ or Mg2+ ions to a pharmaceutical composition comprising a sialidase-Fc fusion or antibody conjugate comprising sialidase and an Fc domain where the sialidase has a P62 substitution with a reasonable expectation of success.
The applied reference(s) has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Double Patenting
Claims 1-8, 13, 16-18, 20, 24-26, 32-33, 68, 71-72, and 79-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 1) claims 1-4, 8, 12-14, 16, 21, 25, 27, 29-33, 44-45, 47, 55-57, 59, 61, and 63-67 of copending Application No.17/624,118, hereafter referred to as the ‘118 application, OR 2) claims 1-3, 5-14, 18, 21-22, 24-29, 38-39, 46-50, and 55 of copending Application 17/624,121, hereafter referred to as the ‘121 application, OR 3) claims 1-4, 7, 11, 15-20, 24, 27-28, 30, 32-36, 45-46, and 53-57 of copending Application 18/003,234, hereafter referred to as the ‘234 application. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The ‘118 application claims recite a sialidase with a single substitution which is a substitution of a proline residue at a position corresponding to position 62 of wild type human Neu2 (P62) which is conjugated to an antibody and an Fc domain, and/or is a fusion protein comprising the sialidase and the Fc domain, a pharmaceutical composition comprising the sialidase-antibody-Fc conjugate, and a method of treating cancer in a subject by administering the sialidase-antibody-Fc conjugate to the subject (See in particular ‘118 claims 1-4, 8, 25, 27, 32-33, and 66-67). The ‘121 application claims and the ‘234 application claims each recite a sialidase with a single substitution which is a substitution of a proline residue at a position corresponding to position 62 of wild type human Neu2 (P62) which is a fusion protein further comprising an Fc domain, and which may further be conjugated to or comprise an antibody (see in particular ‘121 claims 1, 5, 21-22, 29, 38, and 49-50, OR see in particular ‘234 claims 1, 7, 11, 27, 36, and 56-57). The ‘118 application claims, the ‘121 application claims, and the ‘234 application claims also teach where the antibody is an anti-CD20 antibody, and more specifically rituximab, which as part of the conjugate/fusion protein is inherently administered simultaneously with the sialidase and Fc domain (‘118 claims 1, 30, and 61, OR ‘121 claim 28, OR ‘234 claim 34). In regards to certain limitations present in the instant dependent claims not specifically recited in the instant claims, such as where the administration of the conjugate to a subject for the treatment of cancer further activates dendritic cells or enhances phagocytosis, or where the conjugate comprises a stabilizing agent which is a calcium cation, the ‘118 application claims, the ‘121 application claims, and the ‘234 application claims encompass these limitations, which are also specifically disclosed as variants of the conjugate and methods in the ‘118 specification and the ‘121 specification. The MPEP 804(II)(2)(a) sets forth instances where it is acceptable to utilize the disclosure of a U.S. patent document in conjunction with its claims for obvious-type double patenting rejections. In particular, the MPEP notes that the portion of the specification that supports the patent claims may be considered. See In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). In particular, those portions of the specification which provide support for the reference claims may 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 (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The MPEP gives the example that if the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined. Because that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim. Based on those portions of the ‘118 application disclosure or the ‘121 application disclosure or the ‘234 application disclosure that specifically discloses embodiments of the claimed products and methods, it is clear that the dependent limitations not specifically recited in the ‘118 claims or the ‘121 application claims or the ‘234 application claims are obvious variants of the broader ‘118 application claims or ‘121 application claims or the ‘234 application claims respectively. Thus, the ‘118 claims OR the ‘121 claims or the ‘234 claims render obvious the instant claims
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-8, 13, 16-18, 20, 24-26, 32-33, 68, and 71-72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 9, 11, 15, 17, 19, 21-23, 25-26, 35-37, 48-52, 60, 65-66, and 68 of copending Application No.18,260,383, hereafter referred to as the ‘383 application. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The ‘383 application claims recite a sialidase with a single substitution which is a substitution of a proline residue at a position corresponding to position 62 of wild type human Neu2 (P62) which is part of a fusion protein with an anti-Her2 antibody and an Fc domain, a pharmaceutical composition comprising the sialidase-antibody-Fc fusion protein, and a method of treating cancer in a subject by administering the sialidase-antibody-Fc fusion protein to the subject (See in particular ‘383 claims 1, 3, 5, 17, 19, 26, 35, 51, 52, and 60). In regards to certain limitations present in the instant dependent claims not specifically recited in the instant claims, such as where the administration of the fusion protein to a subject for the treatment of cancer further activates dendritic cells or enhances phagocytosis, or where the conjugate comprises a stabilizing agent which is a calcium cation, the ‘383 application claims encompass these limitations, which are also specifically disclosed as variants of the conjugate and methods in the ‘383 specification. The MPEP 804(II)(2)(a) sets forth instances where it is acceptable to utilize the disclosure of a U.S. patent document in conjunction with its claims for obvious-type double patenting rejections. In particular, the MPEP notes that the portion of the specification that supports the patent claims may be considered. See In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). In particular, those portions of the specification which provide support for the reference claims may 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 (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The MPEP gives the example that if the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined. Because that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim. Based on those portions of the ‘383 application disclosure that specifically discloses embodiments of the claimed products and methods, it is clear that the dependent limitations not specifically recited in the ‘383 claims are obvious variants of the broader ‘383 application claims. Thus, the ‘383 claims render obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-8, 13, 16-18, 20, 24-26, 32-33, 68, and 71-72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 1) claims 1-4, 8, 12-14, 16, 21, 25, 27, 29-33, 35, 44-46, and 60-64 of copending Application No.17/624,116, hereafter referred to as the ‘116 application, OR 2) claims 1-6, 10-13, 15-18, 21, 25, 27, 29, 31, 33-34, 43-45, and 54-58 of copending Application No. 18/260,364, hereafter referred to as the ‘364 application, OR 3) claims 1, 3-6, 9, 13, 15, 17, 19-21, 23-24, 33-35, and 44-48 of copending Application No. 18/260,378, hereafter referred to as the ‘378 application. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The ‘116 application claims OR the ‘364 application claims OR the ‘378 application claims recite a sialidase with a single substitution which is a substitution of a proline residue at a position corresponding to position 62 of wild type human Neu2 (P62) which is part of a fusion protein with an anti-PDL1 antibody and an Fc domain, a pharmaceutical composition comprising the sialidase-antibody-Fc fusion protein, and a method of treating cancer in a subject by administering the sialidase-antibody-Fc fusion protein to the subject (See in particular ‘116 claims 1-4, 8, 25, and 63-64, OR ‘364 application claims 1, 13, 15-17, 27, 43, and 57-58 OR ‘378 application claims 1, 3-4, 15, 24, 33, and 47-48). In regards to certain limitations present in the instant dependent claims not specifically recited in the instant claims, such as where the administration of the fusion protein to a subject for the treatment of cancer further activates dendritic cells or enhances phagocytosis, or where the conjugate comprises a stabilizing agent which is a calcium cation, the ‘116 application claims or the ‘364 application claims or the ‘378 application claims encompass these limitations, which are also specifically disclosed as variants of the conjugate and methods in the ‘118 specification or the ‘364 application or the ‘378 application. The MPEP 804(II)(2)(a) sets forth instances where it is acceptable to utilize the disclosure of a U.S. patent document in conjunction with its claims for obvious-type double patenting rejections. In particular, the MPEP notes that the portion of the specification that supports the patent claims may be considered. See In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). In particular, those portions of the specification which provide support for the reference claims may 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 (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The MPEP gives the example that if the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined. Because that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim. Based on those portions of the ‘116 application disclosure or the ‘364 application disclosure or the ‘378 application disclosure that specifically discloses embodiments of the claimed products and methods, it is clear that the dependent limitations not specifically recited in the ‘116 claims or the ‘364 claims or the ‘378 claims are obvious variants of the broader ‘116 application claims or the ‘364 application claims or the ‘378 application claims respectively. Thus, the ‘116 claims OR the ‘364 claims OR the ‘378 claims render obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
It is noted that nonstatutory double patenting has not been raised at this time in regards to U.S. Patent 11,965,188, hereafter referred to as the ‘188 patent. The claims of the ‘188 patent, while reciting similar products and methods comprising a fusion protein comprising a sialidase with a substitution and an Fc domain, recite that the substitution is the substitution of a cysteine residue at position 332 of SEQ ID NO:1. This substitution does not correspond to the elected species of substitution in the instant application which the single substitution of a proline at position 62.
Prior Art
The following prior art is made of record and not relied upon in view of applicant’s elected species of sialidase. U.S. Patent Application Publication 2022/0105179 (2022), hereafter referred to as Anthony et al., with an effective filing date of 2/21/19, teaches each of the four mammalian neuraminidase, N1-N4, as a fusion protein comprising IgE Fc (Anthony et al., paragraph 124), and U.S. Patent Application Publication 2019/0248919 (2019), hereafter referred to as Woods et al., with an effective filing date of 7/1/16, teaches sialidase-antibody conjugates which comprise an Fc domain, and where the sialidase is human Neu2 (Woods et al., paragraphs 16, 56, and 174). Note that Anthony et al., and Woods et al. would apply as prior art under 35 U.S.C. 102(a)(2) to the generic claim 1. Applicant is reminded that should the elected species be found allowable, applicant will only be entitled to addition species if the generic claim if held to be allowable.
No claims are allowed.
Any inquiry concerning this communication from the examiner should be directed to Anne Marie S. Wehbé, Ph.D., whose telephone number is (571) 272-0737. If the examiner is not available, the examiner’s supervisor, Maria Leavitt, can be reached at (571) 272-1085. For all official communications, the technology center fax number is (571) 273-8300. Please note that all official communications and responses sent by fax must be directed to the technology center fax number. For informal, non-official communications only, the examiner’s direct fax number is (571) 273-0737. For any inquiry of a general nature, please call (571) 272-0547.
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Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634