DETAILED ACTION
Claims 1-10 are currently pending in the instant application. Claims 1-10 are rejected in this Office 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 .
I. Priority
The instant application is a DIV of 17/018,811, filed on September 11, 2020 PAT 11,865,114 which claims benefit of Foreign Application INDIA 201941036639, filed on September 12, 2019.
II. Information Disclosure Statement
No information disclosure statement (IDS) has been filed in the instant application.
III. Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless -
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5 and 6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sasmal, et al. (WO 2019/207538 A1). The instant invention claims
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The Sasmal, et al. reference teaches pyridazine compounds such as
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(See compound 1, page 128, example 1) which is the same as compound 1 in instant claim 3. The prior art also teaches “a method of preventing the proliferation of unwanted proliferating cells such as in cancer in a subject comprising administering a therapeutically effective amount of a compound of the disclosure” (see page 5). According to the prior art’s definition of cancer, prostate cancer is included as treatable using these compounds. This species of compound anticipates the genus compound of the instant invention, wherein the genus structure and its definitions are stated above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. § 103(a) that forms the basis for all
obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Graham v. John Deere Co. set forth the factual inquiries necessary to determine obviousness under 35 U.S.C. §103(a). See Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Specifically, the analysis must employ the following factual inquiries:
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.
Claim 4 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Sasmal, et al. (WO 2019/207538 A1). Applicants claim
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The Scope and Content of the Prior Art (MPEP §2141.01)
Sasmal, et al. teaches pyridazine derivatives as SMARCA2/4 degraders. The invention is represented by the general formula:
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(see pages 3-5). The prior art also teaches that the SMARCA2/4 degraders can be used to treat diseases or conditions or disorders that are dependent upon SMARCA2/4 and have altered SMARCA2/4 including mutations and overexpression. Such diseases or conditions wherein degradation of SMARCA2/4 proteins provides a benefit is cancer (see page 5, lines 15-30). Examples of cancers dependent on SMARCA2/4 are breast cancer, prostate cancer, etc. (see pages 37-38). The prior art teaches various species such as
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(page 128). The prior art also teaches that the methods include preventing the proliferation of unwanted proliferating cells, such as in cancer and further teaches that the compounds reduce the proliferation of unwanted cells by inducing apoptosis in those cells (see page 5).
The Difference Between the Prior Art and the Claims (MPEP §2141.02)
The difference between the prior art of Sasmal, et al. and the instant invention is that the prior art does not teach that the prostate cancer cells comprise a castration-resistant prostate cancer.
Prima Facie Obviousness-The Rational and Motivation (MPEP §2142-2413)
The prior art teaches that the claimed compound
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can be used to treat various SMARCA2/4 dependent cancers such as prostate cancer but does not teach specifically a castration-resistant prostate cancer. The prior art teaches broadly prostate cancer which would encompass a castration-resistant prostate cancer as well. Therefore, it is within one of ordinary skill in the art when attempting to treat a prostate cancer to be able to treat specific types of prostate cancer. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to be able to treat a castration-resistant prostate cancer based on the teachings of the preferred embodiments in the prior art. For example, a skilled artisan would be motivated to use the compound
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for inhibiting proliferation of prostate cancer cells that comprise a castration-resistant prostate cancer and then use since the prior art broadly teaches prostate cancer which embraces the above type prostate cancer. A prima facie case of obviousness has been established.
Claim Rejections - 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-6 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of issued patent US 12371426 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other because:
Applicants’ elected subject matter is
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Determining the Scope and Content of the Issued Patent
Claim 1 of the issued patent claims
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The issued patent also claims numerous species such as
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compound 43 in claim 14.
Ascertaining the Differences Between the Instant Application and the Issued Patent
The difference between the instant claimed invention and the issued patent’s claimed invention is that the instant claims are drawn to a method of inhibiting proliferation of prostate cancer cells using at least one SMARCA2/4 degrader (i.e., compound of formula I) whereas the issued patent’s claims are drawn to the compound of formula I.
Finding Prima Facie Obviousness
With respect to the conflicting claims being directed to a different statutory class of invention (compositions rather than instantly claimed methods of use), the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent.
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)). Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
Section 804 IIb of the M.P.E.P. states
...those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
In the instant case, the specification of the ‘426 patent identifies the utility for treating prostate cancer and preventing the proliferation of unwanted proliferating cells, such as in cancer or to reduce the proliferation of unwanted cells by inducing apoptosis in those cells. Since the conflicting patent discloses a utility for the compositions claimed therein which is the same as the method recited in the instant claims, the patented claims anticipate the instantly claimed invention.
Claim Rejections - 35 USC § 112(a) (Written Description)
The following is a quotation 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 and 4-10 are rejected under 35 U.S.C. 112(a) 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, at the time the application was filed, had possession of the claimed invention.
The claims are drawn to
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for which the specification does not provide an adequate written description to convey that the inventors were in possession of the full scope of the claimed compounds.
MPEP § 2163 states the following:
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 applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). []
[D]escribing a composition by its function alone typically will not suffice to sufficiently describe the composition. See Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406 (Holding that description of a gene’s function will not enable claims to the gene "because it is only an indication of what the gene does, rather than what it is."); see also Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed.[]
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.)
Factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163.
Disclosed Examples of SMARCA2/4
The specification discloses that in certain embodiments the SMARCA2/4 degrader can be a compound of formula (I)
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(see page 19 of the specification). These compounds are the only examples of SMARCA2/4 degraders present in the specification.
Physical/Chemical Properties and Functional Characteristics
SMARCA2/4 degraders block the growth of prostate cancer cells harboring tumor specific alterations among dependence of androgen receptor, mutation in PTEN, presence of TMPRSS2-ERG gene fusions due either to inactivating mutations in respective genes or loss of expression of respective genes through alternative mechanism other than inactivating mutations. Ring A can be any heterocyclic ring; L is a linker that connects ring A to the targeting ligand.
Method of Using the Claimed Invention
It is unclear what structure is required to be able to inhibit proliferation of prostate cancer cells since Applicants have only provided data and description for the compounds of formula I as the “at least one SMARCA2/4 degrader” in the instant specification.
Written Description Conclusion
A reasonable structure-function correlation has not been established in the prior art for the claimed SMARCA2/4 degraders, which possess structural variation. A person of ordinary skill in the art cannot reasonably predict whether a particular compound would be able to treat a prostate disease due to the lack of structure-function correlation. The specification does not provide a description of the structures required for the claimed function aside from the compounds of formula I depicted above. However, this structure is not of sufficient variety to represent the vast structural diversity of compound embraced by the limitation a “SMARCA2/4 degrader” found in claim 1. Therefore, the specification does not provide written description for compounds that fall outside of the scope of the compounds of formula I
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To overcome the rejection, Applicants are suggested to amend claim 1 to incorporate the limitation of dependent claim 2 which specifically defines the SMARCA2/4 degrader as a compound of formula (I) and delete claim 2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 6:30 AM-3:00PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam C Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626