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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed 12/21/2023 has been considered and the references therein are of record.
Claim Rejections - 35 USC § 112 (b)
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 17-20, 24, 30, and 35 are 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.
Claims 1-3, 17-20, 24, 30, and 35 are rejected for recitation of intended result/effect without conferring some structural or material difference on the scope of the claim. The claims recite, or are dependent upon, the functional language of a Pin1 inhibitor without specifying any specific structures required to perform the functions. The mechanism steps and requisite structure are merely implied by the functional language and thus the scope of the claim is undefined. Absent additional structure, it is unclear how these claims further limit the scope of the parent claim. MPEP 2173.05(g) states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim' and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” The claims are rejected since they fail to meet all (3) criteria set forth in MPEP 2173.05(g).
Claim Rejections - 35 USC § 112 (a)
Written Description
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 1-3, 24, 30, and 35 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 claims contain 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 making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. Claims recite, or are dependent upon, the genus of a Pin1 inhibitor capable of treating a disease or disorder that’s mediated by dysregulated Pin1 activity, which encompasses a genus of agents. These claims do not require that the genus of the claims possess any particular structure or other distinguishing feature that is characteristic of the genus as a whole. Therefore the claims are drawn to a genus of Pin1 inhibitors for which there is inadequate written description.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see MPEP 2163(II)(3)(a)(i)(A), reduction to drawings MPEP 2163(II)(3)(a)(i)(B), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus MPEP 2163(II)(3)(a)(i)(C).
From the specification, it is clear that Applicant is in possession of species of a method of treating a cancer that is mediated by dysregulated Pin1 activity by co-administering a therapeutically effective amount of ATRA and/or ATO along with gemcitabine. The claims, however are not limited to those species but also includes an immense number of potential Pin1 inhibitors, diseases, and disorders and the specification fails to provide a representative number of species within the recited genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics of the genus as a whole, or representative number of species within the genus, the specification does not provide adequate written description of the claimed genus.
Enablement
Claims 1-3, 17-20, 24, 30, and 35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for ATRA and ATO, does not reasonably provide enablement for the genus of Pin1 inhibitors. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
In AMGEN INC. ET AL. v. SANOFI ET AL. (No. 21-757, decided May 18, 2023), the Supreme Court held that Amgen was not enabled for “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors]” (872 F. 3d 1367, 1372) even though Amgen identified the amino acid sequences of 26 antibodies that perform these two functions.
The case law applies to the instant claims which require any agent capable of inhibiting Pin1, yet the inventors have only disclosed use of ATRA and ATO.
In Amgen, the Supreme Court has stated:
“An antibody' s structure does much to dictate its function—its ability to bind to an antigen and, in some instances, to block other molecules in the body from doing the same. ‘For an antibody to bind to an antigen, the two surfaces have to fit together and contact each other at multiple points.' Id., at 11. But just because an antibody can bind to an antigen does not mean that it can also block. To bind and block, the antibody must establish a sufficiently broad, strong, and stable bond to the antigen. See ibid. Different antibodies have different binding and blocking capacities based on the amino acids that compose them and their three-dimensional shapes. See id., at 11–12.
Despite recent advances, aspects of antibody science remain unpredictable. For example, scientists understand that changing even one amino acid in the sequence can alter an antibody' s structure and function. See id., at 14. But scientists cannot always accurately predict exactly how trading one amino acid for another will affect an antibody' s structure and function. Ibid.”
A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. In the decision of Genentec, Inc., V. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997), the court held that: "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" and that "[t]ossing out the mere germ of an idea does not constitute enabling disclosure". The court further stated that "when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all of the disclosure related to the process is within the skill of the art","[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement". The instant specification is not enabling for the full scope of the claimed invention because one cannot follow the guidance presented therein and practice the claimed method without first making a substantial inventive contribution.
Given that structure is essential to function; and given the unpredictability within the art with respect to creating inhibitors, a person having ordinary skill in the art would have to perform further experimentation in order to make the genus of Pin1 inhibitors encompassed by the claims and use them in the method claimed, commensurate in scope with the breadth of the claims. Given the nature of the invention, a skilled artisan would have to make an immense number of Pin1 inhibitors, then use those in the method claimed of treating a disease, disorder, or cancer that’s mediated by dysregulated Pin1 activity in order to demonstrate making and using with a reasonable expectation of success. This amount of experimentation goes beyond what is considered “a reasonable degree of experimentation” and constitutes undue further experimentation in order to enable the method for the breadth of what is claimed.
Thus, claims 1-3, 17-20, 24, 30, and 35 lack enablement.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
(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 1-5, 7, 9, 17-21, 24-25, and 28-35 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Lu et al., 2018 (US20180153934A1) (see PTO-892).
The instant claims are drawn to a method of treating a cancer that’s mediated by dysregulated Pin1 activity, comprising co-administering Pin1 inhibitors, such as ATRA and ATO, along with chemotherapy, such as gemcitabine. The instant claims are drawn to the pre-treatment with one or more Pin1 inhibitors prior to the co-administration of Pin1 inhibitors and chemotherapy. The instant claims are drawn to the cancer being a solid tumor cancer such as pancreatic ductal adenocarcinoma, breast cancer, colorectal cancer or acute promyelocytic leukemia. The instant claims are drawn to the ATRA in a slow-release formulation.
Lu teaches a method of treating solid tumors such as PDAC by administration of compositions comprising ATRA, ATO, or a combination thereof (Claims 1-159; Fig. 13 – FigS. 22) and that can further comprise gemcitabine (para[0170]). Lu teaches that the therapeutic agents can be administered together or sequentially, or a combination thereof (para[0011, 0075-0077, 0178-0179]). Lu teaches the compositions can be in the form of a liquid, capsule, and/or a slow-release formula (para[0179-0180]; example 8, 12-13).
Therefore, Lu anticipates instant claims 1-5, 7, 9, 17-21, 24-25, and 28-35.
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 1-4, 7, 17-21, 24-25, 28-31, 33, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 12 and 15 of patent No. US10265288B2 (see IDS). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are recited above.
The patented claims recite a method of treating breast cancer, said method comprising: (a) performing an assay to identify the subject as having an elevated level of Pin1 in the cells of the cancer relative to non-cancerous cells of the same tissue type: and (b) administering to said subject a pharmaceutical composition comprising: (i) an effective amount of ATRA and(ii) an additional therapeutic agent, gemcitabine.
Therefore, the patented claims anticipate the instant claims, which also recite, or are dependent upon, a method of treating breast cancer where the cancer is mediated by dysregulated Pin1 activity by administering ATRA and gemcitabine.
The instant claims are rejected as being unpatentable over patent No. US10265288B2.
Claim 1-4, 17, 24-25, 28-31, and 35 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 10, and 14 patent No. US9439884B2 (see PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are recited above.
The patented claims recite a method of reducing elevated Pin1 activity in a subject having elevated levels of a Pin1 marker, comprising the step of co-administering a therapeutically effective amount of ATRA and the immunotherapy, a non-steroidal immunophilin-dependent immunosuppressant, and wherein said subject suffers from an immune disorder characterized by dysregulation of Toll-like receptor and/or type 1 interferon.
Therefore, the patented claims anticipate the instant claims, which also recite, or are dependent upon, a method of treating a disease or disorder mediated by dysregulated Pin1 activity, in a subject in need thereof, comprising administration of a therapeutically effective amount of the Pin1 inhibitor, ATRA, and an immunotherapy.
The instant claims are rejected as being unpatentable over patent No. US9439884B2.
Conclusion
No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH CESARE whose telephone number is (571)272-6908. The examiner can normally be reached Monday - Friday 10am-4pm.
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/JOSEPH D. CESARE/ Examiner, Art Unit 1675
/JEFFREY STUCKER/ Supervisory Patent Examiner, Art Unit 1675
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