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/Restriction
The response filed on 1/8/26 to the restriction requirement of 10/8/25 has been received. Without traverse, Applicant has elected Group I and “an antagonist of SMAGP” as the elected species identified by “one or a distinct combination of reagents contacted with a cell” in a method encompassed by claims of Group 1.
Claims 1, 5, 8-15, 19-22, 29-32, and 39 are pending.
Claims 8-12, 21, 22, 29-32, and 39 are withdrawn from further consideration by the examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 1, 5, 13-15, 19, and 20 are currently under consideration.
Due to an overlap in search, the following species has been rejoined: an inhibitor of SMAGP.
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.
Claims 1, 5, 13-15, 19, and 20 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. In the instant case, the claims are inclusive of a genus of “antagonists” of SMAGP. The written description in this case sets forth inhibitors of SMAGP, such as siRNA specific for SMAGP. The written description in this case sets, and the prior art, do not adequately describe “antagonists” of SMAGP.
The prior art of Jia et al (OncoTargets and Therapy, 2018, 11: 6925-6935) teaches SMAGP plays a critical role in cell proliferation and tumorigenesis (Abstract, in particular) and infers that SMAGP interactions with protein 4.1, MAGUK, P35, and/or CASK may be responsible for SMAGP activity (paragraph spanning pages 6933-6934, in particular). Without identifying any antagonist of SMAGP or any antagonist of such interactions, Jia et al concludes that further studies are required to verify regulatory mechanisms that mediate interactions between SMAGP and molecules involved in cancer cell proliferation, migration, and invasion (left column on page 6934, in particular).
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or by describing structural features common to that genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.”
The inventions at issue in Lilly were DNA constructs per se, the holdings of that case is also applicable to claims such as those at issue here. Further, disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product. See Ariad, 598 F.3d at 1354-55 (“Regardless whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods... the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-kB activity so as to ‘satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.’”) (internal citation omitted); see also Univ. of Rochester v. G.D. Searle& Co., Inc., 358 F.3d916,918 (Fed.Cir.2004) (applying the same analysis to assess written description for claims to a “method for selectively inhibiting” a particular enzyme by administering a functionally defined compound, i.e., a “non-steroidal compound that selectively inhibits activity” of the gene product for that enzyme).
In regards to claims to a product defined by function, without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 at1568 USPQ2d at 1406 (“definition by function…does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The instant specification fails to provide sufficient descriptive information, such as definitive structural features that are common to the genus. That is, the specification provides neither a representative number of antagonists that encompass the genus nor does it provide a description of structural features that are common to the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus. “[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species.
The functional requirements of the claimed antagonists is the sort of wish list of properties which fails to satisfy the written description requirement because antagonists with those properties have not been adequately described. The “claims merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim’s functional boundaries— leaving it to the pharmaceutical industry to complete an unfinished invention.”Ariad Pharmaceuticals, Inc. v. EliLilly and Co.,598 F.3d 1336, 1353 (Fed. Cir. 2010).
Since the disclosure fails to describe common attributes or characteristics that adequately identify members of the genus, and because the genus is highly variant, the disclosure is insufficient to describe the genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, even though Applicant may propose methods of screening for possible members of the genus, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolation. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. See Ariad, 94 USPQ2d at 1161; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5, 13-15, 19, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jia et al (OncoTargets and Therapy, 2018, 11: 6925-6935).
Jia et al teaches a method of treating cervical cancer comprising contacting CaSki cervical cancer cells with lentivirus shSMAGP to knock-down SMAGP in the cells and administering the cells to a subject, which reduces tumor cell metastasis as compared to metastasis in a subject with shNC cells expressing SMAGP (Figure 4, in particular).
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.
Claims 1, 5, 13-15, 19, and 20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Rio et al (US 2005/0032101 A1; 2/10/05) in view of Jia et al (OncoTargets and Therapy, 2018, 11: 6925-6935).
Rio et al teaches elevated SMAGP expression correlates with elevated metastatic potential of cancer cells (Figure 1, in particular). Rio et al further demonstrates elevating SMAGP expression in pancreatic cancer cells increases metastasis formation (Example 13, in particular). Rio et al further teaches a method for inhibiting proliferation and/or invasive potential of tumor cells in a patient suffering from cancer which comprises treating said patient with an antagonist of SMAGP or an inhibitor of SMAGP expression (claim 4, in particular).
Rio et al does not specifically demonstrate contacting cells with an antagonist of SMAGP or inhibitor of SMAGP expression. However, these deficiencies are made up in the teachings of Jia et al.
Jia et al teaches SMAGP is over-expressed in cervical cancer tissues and cells (Figure 2, in particular). Jia et al further teaches inhibiting SMAGP in cervical cancer cells inhibits cervical cancer cell growth, inhibits cervical cancer cell migration and invasion, and inhibits cervical cancer cell metastasis in vivo (Figures 3-4, in particular). Jia et al further infers that SMAGP interactions with protein 4.1, MAGUK, P35, and/or CASK may be responsible for SMAGP activity (paragraph spanning pages 6933-6934, in particular). Without identifying any particular antagonist of SMAGP or any antagonist of such interactions, Jia et al suggests performing further studies to verify regulatory mechanisms that mediate interactions between SMAGP and molecules involved in cancer cell proliferation, migration, and invasion (left column on page 6934, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to treat a subject with cancer, such as cervical cancer (of Jia et al) or pancreatic cancer (of Rio et al) by administering inhibitors and/or antagonists of SMAGP to the subjects in order to (i) permit the inhibitors (such as lentivirus shSMAGP of Rio et al) to contact the cancer cells and inhibit SMAGP expression and/or (ii) permit the antagonists of SMAGP to antagonize SMAGP activities of SMAGP (such as SMAGP interactions with protein 4.1, MAGUK, P35, and/or CASK of Jia et al) because both Rio et al and Jia et al demonstrate elevated SMAGP correlates with cancer metastasis, Jia et al teaches such metastasis can be inhibited using inhibitors of SMAGP, and Rio et al suggests inhibiting proliferation and/or invasive potential of tumor cells in a patient suffering from cancer which by treating said patient with an antagonist of SMAGP or an inhibitor of SMAGP expression (claim 4, in particular). This is an example of some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
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, 5, 13-15, 19, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 8, and 10-12 of copending Application No. 19/109191 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the copending claims are directed to treating subjects with the same diseases or disorders (such as the same solid cancers or the same autoimmune disorders) by administering the same reagents (inhibitors and/or antagonists of SMAGP). The copending claims are directed to species of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642