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 .
Claim Status
Claims 1-10 are pending and under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The earliest date of priority is based on EP20306254.2 filed 10/21/2020.
Information Disclosure Statement
The information disclosure statement filed 04/21/2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because several of the references are improperly cited for failing to include the dates. See 37 CFR 1.98(b)5. (Each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication.) Those references which do not comply were lined through and not considered. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of 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 statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The listing of references in the specification 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.
Drawings/Brief Description of Drawings
The drawings or the specification (page 26, line 9) are objected to because Figure 2D recites an amino acid sequence without a respective SEQ ID NO. Applicants can correct this by amending the brief description of the drawing or incorporating the SEQ ID directly into the drawing. If correcting the drawing, applicants are reminded that any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 5 is objected to because of the following informalities: Claim 5 sets forth alternative structural inhibitors and includes “a peptide” or “a polypeptide”. However, it is unclear what differentiates a peptide from a polypeptide. It is assumed that these structures are the same. And, if they are the same, applicant should cancel one or the other. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “classical” in claim 9 is a relative term which renders the claim indefinite. The term “classical” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, the specification teaches [0062- pgpub] that the term “classical treatment” refers to any compound, natural or synthetic, used for the treatment of cancer. However, this definition is indefinite because it’s unclear how all compounds used for the treatment of cancer would be considered “classical”.
Claim 5 is rejected for reciting “small molecule” as the metes and bounds of the encompassed molecules cannot be determined. Further, the specification does not explicitly define what is considered “small” for a molecule. There is no upper or lower limit set forth in the specification nor are there any examples of what constitutes a small molecule. Thus, one of ordinary skill in the art would not know if they were a potential infringer of Claim 5.
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.
Claims 1-10 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. This is a written description rejection.
The claims are broadly drawn to a method for treating cancer in a subject comprising administering a therapeutically effective amount of an “inhibitor” of a SPARC fragment. Claims 5-6 narrow the structures of potential inhibitors of SPARC fragments to antibodies, peptides, polypeptides, small molecules, or aptamers. No other claims define what is included or excluded by the genus of potential inhibitors that can exist as inhibitors of SPARC fragments.
The specification teaches [0022-0023- pgpub] that an “inhibitor of SPARC fragment” refers to a natural or synthetic compound able to inhibit the activity of the SPARC fragment and selectively blocks or inactivates SPARC fragment. As used herein, the term “selectively blocks or inactivates” refers to a compound that preferentially binds to and blocks or inactivates SPARC fragment with a greater affinity and potency, respectively, than its interaction with Cath-D.
The specification further teaches that the “inhibitor of SPARC fragment” refers to compounds that block the cleavage of SPARC by Cath-D producing said SPARC fragment. In other words, the “inhibitor of SPARC fragment” includes any compound that blocks the proteolysis of SPARC by Cath-D.
However, the specification does not specifically teach any peptide, polypeptide, small molecule or aptamer that would be considered an “inhibitor of a SPARC fragment”. The genus of potential inhibitors is large and diverse. For example, the state of the art directed to an “inhibitor of a SPARC fragment” appears to include anti-Cathepsin D antibodies. For example, Liaudet-Coopman et al. (US 2018/0127510, published May 10, 2018) teach [0194, 0197-0198] the administration of specific anti-Cath-D antibodies to subjects bearing cancer wherein the antibodies inhibited tumor growth and improved survival of the subjects. The authors further teach [0006] that the invention includes administering isolated human monoclonal antibodies or fragments thereof that inhibit Cath-D catalytic activity. Such inhibition would inherently block the proteolysis of the SPARC substrate by Cath-D. The generic recitation of “inhibitors” such as peptides, antibodies, polypeptides, small molecules, and aptamers represents an extremely large genus of compounds whose sole activity is to prevent the generation of SPARC fragments in cancer patients. Another example includes small interfering RNA that targets the SPARC gene. For example, Al-Murrani et al. (US 2005/0176669, published August 11, 2005) teach [0118] methods of inhibiting the growth of tumor cells with a combination of a chemotherapeutic agent and an inhibitor of the SPARC cellular gene. The inhibitor of the SPARC cellular gene is siRNA.
A description of a genus of may be achieved by means of a recitation of a representative number of species, defined by structure, falling within the scope of the genus. However, the instant specification fails to provide sufficient descriptive information, such as definitive structural or functional features of the claimed genus of “inhibitors” that would distinguish the claimed generic compounds from other molecules that do not have the claimed biological properties. The disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, the disclosure of any natural or synthetic compound able to inhibit the activity of the SPARC fragment is insufficient to describe the large genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe and enable the genus as broadly claimed.
Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) 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, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of inhibitor molecules, 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 isolating it. The compound itself is required.
As set forth above, the written description and state of prior art in this case only sets forth anti-Cath-D antibodies [0057-pgpub] or specific siRNAs as inhibitors of SPARC fragment formation. The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed. An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. Even disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not, without more, provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional. See Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378, 124 USPQ2d 1354, 1361 (Fed. Cir. 2017)("knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies"); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877 (Fed. Cir. 2011)(patent disclosed the antigen the claimed antibody was supposed to bind, but did not disclose any antibodies with the specific claimed properties).
At present, the disclosure fails to describe the common attributes or characteristics that identify members of the genus. Thus, because the genus is highly variant, the contemplation of a world of “inhibitors of SPARC fragment” is insufficient to describe the genus and 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.
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.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liaudet-Coopman et al. (US 2018/0127510, published May 10, 2018).
The claims are broadly drawn to a method of treating any and all cancers in a subject in need thereof comprising administering to the subject a therapeutically effective amount of an “inhibitor of a SPARC fragment”. The specification teaches (page 6, lines 15+) that the “inhibitor of a SPARC fragment” is any natural or synthetic compound that prevents the generation of SPARC fragments. This includes the administration of anti-Cath-D antibodies; “as used herein the terms “administering” or “administration” refer to the act of injecting or otherwise physically delivering a substance as it exists outside the body (e.g., an anti-cath-D antibody) into the subject, such as by mucosal, intradermal, intravenous, subcutaneous, intramuscular delivery and/or any other method of physical delivery described herein or known in the art.” (page 17, line 20).
As to claims 1, 5-8, and 10, Liaudet-Coopman et al. teach [0194, 0197-0198] the administration of anti-Cath-D antibodies to subjects bearing cancer wherein the antibodies inhibited tumor growth and improved survival of the subjects. The authors further teach [0148] that in a particular embodiment, the cancer to be treated is triple-negative breast cancer. The authors further teach [0006] that the invention includes administering isolated human monoclonal antibodies or fragments thereof that inhibit Cath-D catalytic activity. Thus, based on the teachings of the specification as set forth above in line 9, the administration of antibodies that bind to Cath-D are “inhibitors” of a SPARC fragment.
As to claim 9, the reference teaches [0152] that in certain embodiments, an anti-Cath-D antibody or antibody-drug conjugate is used in combination with a second agent for treatment of a disease or disorder. When used for treating cancer, an anti-Cath-D antibody or antibody-drug conjugate of the invention may be used in combination with conventional (classical) cancer therapies such as surgery, radiotherapy, chemotherapy, or combinations thereof.
As to claims 2-4, such claims encompass specific peptide fragments that are naturally generated from the cleavage/proteolysis activity of Cath-D. Since the specification specifically exemplifies anti-Cath-D antibodies as inhibitors of SPARC fragments, the prior art of administering said antibodies in-vivo would inherently prevent the generation of encompassed and claimed SPARC fragments. Further, as set forth in paragraph 10 above, the anti-Cath-D antibodies contemplated for administration by the prior art include those that inhibit the Cath-D catalytic activity. Table 3, page 16 of the prior art exemplifies inhibition of Cath-D proteolytic activity by anti-Cath-D antibodies. Thus, the prior art teaches that administration of such anti-Cath-D antibodies would inherently prevent the generation of SPARC fragments.
Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Claims 1-5, and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Al-Murrani et al. (US 2005/0176669, published August 11, 2005).
Al-Murrani et al. teach/claim methods of inhibiting the growth of tumor cells (treating cancer) with a combination of a classical treatment of cancer (a chemotherapeutic agent) and an inhibitor of the SPARC cellular gene. The inhibitor of the SPARC cellular gene is siRNA.
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In the absence of a definition for what is included or excluded by small molecules (see paragraph 11 above), it is assumed for examination purposes that siRNA encompasses the definition of a small molecule. The reference further teaches [0107] that siRNA molecules according to the invention can comprise a delivery vehicle, including inter alia liposomes, for administration to a subject, carriers and diluents and their salts, and can be present in pharmaceutical compositions.
As to claims 2-4, such claims encompass specific peptide fragments naturally formed by enzymatic proteolysis. However, since the siRNA targets the SPARC gene message, the translated product (SPARC protein and/or fragments thereof) would not be produced. Thus, inherently, any and all potential SPARC fragments would be inhibited.
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 15-16 of U.S. Patent No. 10,526,415. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are broadly drawn to treating breast cancer with an inhibitor of a SPARC fragment. The inhibitor broadly encompasses anti-Cath-D antibodies (see page 17, line 20 of the current specification). Likewise, the patented claims are drawn to a method for treating breast cancer comprising administering a particular species (patented claim 1) of an anti-Cath-D monoclonal antibody or antigen binding fragment thereof. Thus, the entire scope of the reference or patented claim falls within the scope of the examined claim.
As to claims 2-4, such claims encompass specific peptide fragments that are naturally generated from the cleavage/proteolysis activity of Cath-D. Since the specification specifically exemplifies anti-Cath-D antibodies as inhibitors of SPARC fragments, the administration of anti-Cath-D monoclonal antibodies of patented claims 15 and 1 would inherently prevent the generation of encompassed and claimed SPARC fragments.
As to claim 8, in order to properly construe the comprising language of patented claim 16, the referenced patent teaches [column 20, line 18] that such breast cancers include a triple-negative breast cancer. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.
As to claim 9, in order to properly construe the comprising language of patented claim 16, the patent teaches [column 21, line 5] when used treating cancer, an anti-Cath-D antibody or antibody-drug conjugate of the invention may be used in combination with conventional cancer therapies such as surgery, radiotherapy, chemotherapy, or combinations thereof. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-23, and 1-12 of copending Application No. 19/484,600 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the examined/pending claims are broadly drawn to treating any cancer (Claim 1), breast cancer (Claim 7) or triple negative breast cancer (Claim 8) with an inhibitor of a SPARC fragment. The specification of the current claims teaches that the inhibitor encompasses anti-Cath-D antibodies (see page 17, line 20 of the current specification). Likewise, the copending claims are drawn to a method for treating a variety of cancers including breast cancer (Claims 18-19) and triple-negative breast cancer (Claim 20) comprising administering a particular species (copending claim 1) of an anti-Cath-D monoclonal antibody. Thus, the entire scope of the reference or copending claims falls within the scope of the examined claim.
As to copending claims 21-23, and 11; which includes the combination of conventional anti-cancer agents wherein the chemotherapeutic agent is paclitaxel or enzalutamide, current claim 9 includes methods of treating a variety of cancers in combination with a classical treatment of cancer. In order to properly construe the comprising language of current claim 1 (as it relates to cancer) and current claim 9 (as it relates to conventional or classic combinations), the current specification teaches [0049 of pgpub] that the cancer that may treated include, but are not limited to cancer cells from the bladder, blood, bone, bone marrow, brain, breast, colon, esophagus, gastrointestinal, gum, head, kidney, liver, lung, nasopharynx, neck, ovary, prostate, skin, stomach, testis, tongue, or uterus, among others. The specification further teaches [0059-0063 of pgpub] that inhibitors of SPARC fragments for use according to the invention can be administered in combination with a classical treatment of cancer such as radiation therapy, immunotherapy or chemotherapy. Examples of common chemotherapeutics taught by the current specification [0065-pgpub] include “paclitaxel” and anti-androgens such as flutamide, nilutamide, bicalutamide, leuprolide, and goserelin. It would have been obvious to one of ordinary skill in the art (e.g. an oncologist) to also include the well-known anti-androgen enzalutamide as it is widely prescribed for certain types of prostate cancer. As to antibodies conjugated to cytotoxic drugs; such antibody drug conjugates were well known and would have been obvious to include so as to enhance the therapeutic efficacy.
As to co-pending claims 1-4, and 12; said claims are drawn to a specific monoclonal anti-Cathespin-D antibody or fragments thereof which cross-compete for binding to cathepsin-D; all of which are anticipated by the broadly claimed genus of pending claim 1 drawn to administration of a “inhibitor” of a SPARC fragment. Thus, the entire scope of the reference or copending claims drawn to an anti-Cathepsin-D antibody or competing fragments thereof falls within the scope of the examined claim.
Similarly, copending claim 5 is drawn to antibody fragments such as Fab, F(ab’)2, Fab’, dsFv and copending claim 9 is drawn to a human antibody. Such antibody fragments and types of antibodies are well known to those of ordinary skill in the art and their construction represents no more than an obvious variation which would yield predictable results.
Copending claim 6 is drawn to mutations in the FC region of the anti-Cathepsin-D. Mutations such as S239D and I332E were well known to those of ordinary skill prior to the earliest date of priority of both applications to enhance antibody-dependent cell-mediated cytotoxicity (ADCC). See for example Table 1 of Lazar et al. (PNAS, vol 103, No. 11, March 2006).
Copending claim 8 is drawn to another well-known FC mutation; wherein said antibody comprises at least 3 mutations selected from L234A, L235A, and P392G. The first two are well known as the double LALA mutation to enable “effector-silent” FC. The addition of P392G in combination with LALA (P329G-LALA) would have been obvious to one of ordinary skill in the art as such a variant was well known and shown to the most silent according to Schlothauer et al. (Protein Eng. Des. & Sel., vol 29, no 10, 2016).
Copending claims 7, and 10 are drawn to in-vivo effects and would inherently occur in vivo which is similar to the inherent generation of SPARC peptide fragments when Cathepsin-D cleavage activity is prevented (compare to current claims 2-4).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643