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 .
DETAILED ACTION
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-2 and 5-23 have an effective filing date of 22 NOV 2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/27/2023 & 11/07/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
In the response filed on 11/07/2025, Applicant elected:
Species
Endometrial epithelial cancer (EEC) as the species of cancer being treated;
An anti-DKK1 antibody having a heavy chain variable region (HCVR) defined by SEQ ID NO: 12 and a light chain variable region (LCVR) defined by SEQ ID NO: 11 as the species of a DKK1 inhibitor;
(i) Paclitaxel as the species of a second therapeutic agent, and (ii) Cisplatin as the species of an additional therapeutic agent; and
N345D as the species of an activating mutation.
Status of Claims
Claims 1-2 and 5-23 are currently pending and presented for examination on the merits.
Claims 6-7, 18, and 20 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to a non-elected species.
Claims 3-4 are canceled.
Claims 1-2, 5-6, 8, 12-13, and 19-23 are amended.
Claims 1-2, 5, 8-11, 12-17, 19, and 21-23 are under review.
Claims Objections
Claims 21-22 are objected to for reciting tables and figures. MPEP 2173.05(s) states:
“Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table ‘is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.’ Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).”
In this case, the antibody sequences that the tables refer to could easily be incorporated into the claims to define the invention. Appropriate correction is required.
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 1-2, 5, 12-17, 19, and 21-23 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the instant case, the claims are inclusive of a genus of a DKK1 inhibitor. However, the written description in this case only sets forth DKK1 antibodies comprising 1) light chain CDRs SEQ ID NOs: 1,2,3 and heavy chain CDRs SEQ ID NOs: 4,5,6 or 2) light chain CDRs SEQ ID NOs: 7,8,9 and heavy chain CDRs SEQ ID NOs: 10,11,12. The specification does not disclose, and the art does not teach, the genus of a DKK1 inhibitor as broadly encompassed in the claims.
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).
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 DKK1 inhibitors that encompass the genus of DKK1 inhibitors 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. Further, in view of Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) and the Office’s February 2018 memo clarifying written description guidance for claims drawn to antibodies, the 2008 Written Description Training Materials are outdated and should not be relied upon as reflecting the current state of law regarding 35 U.S.C. 112. Further, a “newly characterized antigen” test flouts basic legal principles of the written description requirement (Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017)). Adequate written description of a newly characterized antigen alone is not considered adequate written description of a claimed antibody to that newly characterized antigen. Where an antibody binds to an antigen tells one nothing about the structure of any other antibody. Also, see the Board’s recent decision in Appeal 2017-010877 (claims to “A monoclonal antibody that binds a conformational epitope formed by amino acids 42-66 of SEQ ID NO:1”).
The functional requirements of the claimed antibodies is the sort of wish list of properties which fails to satisfy the written description requirement because “antibodies with those properties have not been adequately described.” Centocor, 636 F.3d at 1352.
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 of the DKK1 antibody, or antigen binding-fragment thereof comprising 1) light chain CDRs SEQ ID NOs: 1,2,3 and heavy chain CDRs SEQ ID NOs: 4,5,6 or 2) light chain CDRs SEQ ID NOs: 7,8,9 and heavy chain CDRs SEQ ID NOs: 10,11,12 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).
Claims 1-2, 5, 8-17, and 21-23 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the instant case, the claims are inclusive of a genus of an activating mutation. However, the written description in this case only sets forth Table 1. The specification does not disclose, and the art does not teach, the genus of an activating mutation as broadly encompassed in the claims.
The specification discloses "an activating mutation of PIK3CA protein" refers to a mutation of the genetic sequence encoding PIK3CA protein that changes the amino acid sequence of PIK3CA in a manner that results in a gain of function (e.g., an elevated cellular level of the protein functionally capable of transducing a signal, when compared to a wild type protein, or the protein that is functionally active in the absence of an upstream activating signal, or the protein that is incapable of being functionally attenuated). However, the written description only reasonably conveys the Table 1 of activating mutations. 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 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 an activating mutation that encompass the genus of activating mutations 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.
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 of the activating mutation 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 § 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.
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 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.
Claims 1-2, 5, 12-17, 19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Castel et al (WO 2017015152 A1), and further in view of Taciak et al (WNT SIGNALING PATHWAY IN DEVELOPMENT AND CANCER, JOURNAL OF PHYSIOLOGY AND PHARMACOLOGY, July 2018, 69, 2, 185-196).
In regards to claims 1-2, Castel et al teaches a method of treating cancer [Abstract]. Castel et al further teaches the cancer is HCC1954 cancer cell [Fig. 1A]. Castel et al further teaches HCC1954 cancer cells are PIK3CA mutant [Lines 6-10, pg. 33]. Castel et al further teaches treating cancer with a gain-of-function mutation is an activation in PIK3CA [Lines 28-32, pg. 4]. Castel et al further teaches treating cancer cells with an activating mutation with a DKK-1 inhibitor [Lines 33-1, pgs. 13-14]. Castel et al further teaches obtaining samples of a cancer from subjects [Lines 7-11, pg. 60].
Castel et al does not specifically teach different cancers. However, this deficiency is made up in the teachings of Taciak et al.
Taciak et al teaches a method of treating relapsed or refractory endometrioid endometrial or endometrioid ovarian cancer comprising administering DKN-01 (DKK-1 inhibitor) as a monotherapy or with paclitaxel [DKN-01, pg. 192].
One of ordinary skill in the art, before the effective filing date, would have been motivated to use Castel’s method of treating cancer cells with an activating mutation with a DKK1 inhibitor, to first determine the sample had a PIK3CA activating mutation before treating, with Taciak’s method of treating endometrial and ovarian cancer comprising administering the DKK-1 inhibitor DKN-01. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to use Castel’s methods for a method of treating a subject suffering from cancer, comprising the steps of: 1) obtaining a sample of cancer cell, 2) determining the subject has an activation mutation of PI3KCA, & 3) administering a DKK1 inhibitor, wherein the cancer is endometrial or ovarian cancer, because the resultant method would be useful in cancer treatment.
In regards to claim 5, Taciak et al teaches DKN-01 [DKN-01, pg. 192].
In regards to claim 12, Castel et al teaches the subject is human [Line 29, pg. 15].
In regards to claims 13-16, Taciak et al teaches administering DKN-01 as a monotherapy or with paclitaxel [DKN-01, pg. 192].
In regards to claim 17, Castel et al teaches administering in combination with an additional therapeutic agent [Line 26, pg. 20, & Line 26-30, pg. 22].
In regards to claim 19, 21, and 22, Castel et al teaches the activating mutations H1047R and E545K, and teaches the mutation can be at amino acid 345 [Lines 30-34, pg. 24].
In regards to claim 23, Taciak et al teaches treating refractory patients [DKN-01, pg. 192].
Claims 1-2, 5, 8-17, 19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Castel et al (WO 2017015152 A1), Taciak et al (WNT SIGNALING PATHWAY IN DEVELOPMENT AND CANCER, JOURNAL OF PHYSIOLOGY AND PHARMACOLOGY, July 2018, 69, 2, 185-196) as applied to claims 1-2, 5, 12-17, 19, and 23 above, and further in view of Chedid et al (WO 2010117980 A1, IDS 9/27/2023 US PAT 8148498).
The teachings of Castel and Taciak et al are discussed above.
Castel et al does not specifically teach SEQ ID NOs for a DKK1 antibody. However, this deficiency is made up in the teachings of Chedid et al.
In regards to claims 8 and 9, Chedid et al teaches DKK-1 antibodies [Abstract]. Chedid et al further teaches treating cancer with DKK1 antibodies [Line 18, pg. 1]. Chedid et al teaches a DKK1 antibody comprising SEQ ID NO: 14. A comparison of instant SEQ ID NOs: 11 and SEQ ID NO: 14 of Chedid et al is shown below.
Instant claim SEQ ID NO: 11 and SEQ ID NO: 14 of Chedid et al.
Query Match 100.0%; Score 562; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPATLSLSPGERATLSCHASDSISNSLHWYQQKPGQAPRLLIYYARQSIQGIPA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPATLSLSPGERATLSCHASDSISNSLHWYQQKPGQAPRLLIYYARQSIQGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQSESWPLHFGGGTKVEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQSESWPLHFGGGTKVEIK 107
Chedid et al further teaches a DKK1 antibody comprising SEQ ID NO: 12. A comparison of instant SEQ ID NO: 12 and SEQ ID NO: 12 of Chedid et al is shown below.
Instant SEQ ID NO: 12 and SEQ ID NO: 12 of Chedid et al.
Query Match 100.0%; Score 635; Length 119;
Best Local Similarity 100.0%;
Matches 119; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSSYTMSWVRQAPGKGLEWVATISGGGFGTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSSYTMSWVRQAPGKGLEWVATISGGGFGTYY 60
Qy 61 PDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCARPGYNNYYFDIWGQGTTVTVSS 119
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCARPGYNNYYFDIWGQGTTVTVSS 119
Additionally SEQ ID NO(s): 18 and 20 of Chedid et al shares 100% sequence homology with the instant SEQ ID NO(s): 17 and 18, respectively.
One of Ordinary skill in the art, before the effective filing date, would have been motivated to use Castel’s method of treating cancer cells with an activating mutation with a DKK1 inhibitor, to first determine the sample had a PIK3CA activating mutation before treating, with Taciak’s method of treating endometrial and ovarian cancer comprising administering the DKK-1 inhibitor DKN-01, with Chedid’s method of treating cancer comprising DKK1 antibodies comprising SEQ ID NOs: 14&12. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to use Castel’s methods for a method of treating a subject suffering from cancer, comprising the steps of: 1) obtaining a sample of cancer cell, 2) determining the subject has an activation mutation of PI3KCA, & 3) administering a DKK1 inhibiting antibody comprising SEQ ID NOs: 14 & 12, wherein the cancer is endometrial or ovarian cancer.
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 1-2, 5, 8-9, 12-17, 19, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16-17, 20, 21-23, and 26 of copending Application No. 17/761,946 ('946) in view of Castel et al (WO 2017015152 A1), Taciak et al (WNT SIGNALING PATHWAY IN DEVELOPMENT AND CANCER, JOURNAL OF PHYSIOLOGY AND PHARMACOLOGY, July 2018, 69, 2, 185-196), and Chedid et al (WO 2010117980 A1, IDS 9/27/2023 US PAT 8148498).
The teachings of Castel et al, Taciak et al, and Chedid et al are discussed above.
Claims 1-2 and 5 are directed to an invention that is not patentably distinct from claims 1 and 5. Specifically, a method of treating cancer in a subject in need thereof, comprising a DKK1 antibody, Furthermore, the cancer is epithelial endometrial cancer or epithelial ovarian cancer (claim 5). The primary difference is between the claims is that the instant claims recite determining is the subject has a PIK3CA activating mutation.
Based on the teachings of Castel et al, one of ordinary skill in the art would have been motivated to modify the conflicting claims to recite determining is the subject has a PIK3CA activating mutation. The invention of the conflicting claims and Castel et al meet the limitation of claims 1-2, and 5.
In regards to claims 8-9, are directed to claims not patentably distinct from claims 16-17 of ‘946. Chedid et al teaches DKK-1 antibodies [Abstract]. Chedid et al further teaches treating cancer with DKK1 antibodies [Line 18, pg. 1]. Chedid et al teaches a DKK1 antibody comprising SEQ ID NO: 14. A comparison of instant SEQ ID NOs: 11 and SEQ ID NO: 14 of Chedid et al is shown below.
Instant claim SEQ ID NO: 11 and SEQ ID NO: 14 of Chedid et al.
Query Match 100.0%; Score 562; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPATLSLSPGERATLSCHASDSISNSLHWYQQKPGQAPRLLIYYARQSIQGIPA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPATLSLSPGERATLSCHASDSISNSLHWYQQKPGQAPRLLIYYARQSIQGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQSESWPLHFGGGTKVEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQSESWPLHFGGGTKVEIK 107
Chedid et al further teaches a DKK1 antibody comprising SEQ ID NO: 12. A comparison of instant SEQ ID NO: 12 and SEQ ID NO: 12 of Chedid et al is shown below.
Instant SEQ ID NO: 12 and SEQ ID NO: 12 of Chedid et al.
Query Match 100.0%; Score 635; Length 119;
Best Local Similarity 100.0%;
Matches 119; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSSYTMSWVRQAPGKGLEWVATISGGGFGTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSSYTMSWVRQAPGKGLEWVATISGGGFGTYY 60
Qy 61 PDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCARPGYNNYYFDIWGQGTTVTVSS 119
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCARPGYNNYYFDIWGQGTTVTVSS 119
Additionally SEQ ID NO(s): 18 and 20 of Chedid et al shares 100% sequence homology with the instant SEQ ID NO(s): 17 and 18, respectively.
In regards to claim 12, is directed to claims not patentably distinct from claims 20 of ‘946. Castel et al teaches the subject is human [Line 29, pg. 15].
In regards to claims 13-16, are direct to claims not patentably distinct from claims 21-23 of ‘946. Taciak et al teaches administering DKN-01 as a monotherapy or with paclitaxel [DKN-01, pg. 192].
In regards to claim 17, is directed to claims not patentably distinct from claim 26 of ‘946. Castel et al teaches administering in combination with an additional therapeutic agent [Line 26, pg. 20, & Line 26-30, pg. 22].
In regards to claim 19-21, Castel et al teaches the activating mutations H1047R and E545K, and teaches the mutation can be at amino acid 345 [Lines 30-34, pg. 24].
In regards to claim 23, Taciak et al teaches treating refractory patients [DKN-01, pg. 192].
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642