DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Current Status
This action is responsive to the amended claims of 03/06/2024. Claims 1, 3-7, 11-12, 21, 23-26, 29-38, 46, and 52-53 are pending. Claims 5-6, 38, 46, and 52-53 have been withdrawn. Claims 1, 3-4, 7, 11-12, 21, 23-26, and 29-37 have been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 3-7, 11-12, 21, 23-26, and 29-37), the AR condensate modulator Compound 60, and the species: prostate cancer, LNCaP, AR-V7, and aberrant splicing of AR gene, in the reply filed on 05/25/2026 is acknowledged.
A search for the compound 60
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did not retrieve any prior art. The search was extended to the other compounds disclosed in the application: compounds 2, 6, and 61-62 (Pg. 36-37 ¶185 of the specification). This search did not retrieve any prior art (see SEARCH 6 of the attached search notes).
Thus, the Markush search for AR condensate modulator was extended to the following species:
RK33
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and
A109
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.
Since these species retrieved art, per Markush search practice, the search will not be extended unnecessarily to additional species in this Office Action
These extended species RK33 and A109, and the elected species prostate cancer, LNCaP, AR-V7, and aberrant splicing of AR gene read on claims 1, 3, 7, 11-12, 21, 23-26, and 29-37. RK33 is found in the context of treating an AR variant mutation – this reads on claim 4.
Claims 38, 46, and 52-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/25/2026.
Claims 5-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/25/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 02/10/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/09/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 21, 23-24, and 30-31 are objected to because of the following informalities. Appropriate correction is required.
Claim 21: please replace “decrease” with “decreases”.
Claims 23 and 24: please add a comma between each option in the recited lists; between all IC50s in claim 23 and between each of the cell types in claim 24.
Claim 30: in line 2 please add “in” after the word “characterized”. Dependent claim 31 is similarly objected to since it does not rectify the issue.
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, 3-4, 7, 11-12, 21, 23-26, and 29-37 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.
MPEP 2163(I) states “The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant [inventor] has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee [inventor] was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005).”
Factors considered in making the determination as to whether the artisan would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include: (a) Actual reduction to practice; (b) Disclosure of drawings or structural chemical formulas; (c) Sufficient relevant identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties or (iv) Functional characteristics when coupled with a known or disclosed correlation between function and structure; (d) Method of making the claimed invention; (e) Level of skill and knowledge in the art and (f) Predictability in the art.
The Instant Disclosure:
Claim 1 is broadly drawn to any possible “AR condensate modulator” which is not limited to a defined chemical structure or genus formula. The dependent claims 3-4, 7, 11-12, 21, 23-24, 26, and 29-37 do not provide any structural limitations to the “AR condensate modulator”. Claim 25 recites compounds 2, 6, and 60-62:
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; (see specification Pg. 35-37 ¶179-185 for structures); however, these compounds are all structurally similar and cannot represent the full breadth of “AR condensate modulator”. Further claim 25 recites: a) prodrugs and metabolites thereof, b) compounds which compete with 2, 6, and 60-62, and c)-d) compounds with comparable or higher activity to 2, 6, and 60-62. The claims do not provide any structural limitations for these categories of compound in claim 25. This lack of structural definition does not allow the artisan to envisage the compounds which are part of the invention (see Factors (b) and (c)).
The specification discloses compounds 2, 6, and 60-62 (Pg. 35-37 ¶179-185) as representative species of the “AR condensate modulator.” The specification does provide one example of a comparable AR modulator compound: compound AA (Pg. 78 ¶372; Pg. 98 ¶465 Table). Moreover, the synthetic schemes provided are only for the small group of compounds 2, 6, 60-62, and AA (Pg. 72 ¶341) which are all relatively similar in structure. Further, a “prodrug” is defined as a compound metabolized under physiological conditions or solvolysis to yield the desired active compound – the definition is non-limiting (Pg. 42-43 ¶204). A “metabolite” is defined as a derivative resulting from metabolic process in the body and overlaps with prodrug (Pg. 43 ¶205).
No species of “AR condensate modulator” are provided in the disclosure beyond compounds 2, 6, 60-62, and AA. Applicant does not provide any exemplary prodrugs or metabolites thereof, nor does Applicant provide any examples of compounds, other than AA, which would fall into the categories a)-d) of instant claim 25. Thus, Factors (a) and (d) are not met.
MPEP 2163(II)(A)(2) states “The disclosure of an element may be critical where those of ordinary skill in the art would require it to understand that inventor was in possession of the invention… Amgen, Inc. v. Chugai Pharm.Co., Ltd., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) ("it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it").”
After review of the specification and claims, the Examiner finds that Applicants have not defined the scope of “AR condensate modulator” beyond compounds 2, 6, and 60-62 in a way that distinguishes it from other materials and Applicants have not described how to obtain the full scope of such compounds. Thus, it has not been demonstrated that the Applicant was in possession of the invention that is claimed. Moreover, “AR condensate modulator” and the categories a)-d) of claim 25 would encompass compounds which have not yet been discovered and those with uncharacterized metabolic pathways.
Level of Skill and Knowledge in the Art:
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a synthetic chemist and/or health practitioner with several years of professional experience. However, this factor is outweighed by the unpredictable nature of the pharmaceutical art. It is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which compounds exhibit the desired pharmacological activity.
Regarding condensate modulators, WANG (Wang, W. et al., British Journal of Pharmacology, 2020, 177, 5008-5030) reviews recent findings on phase separation of cancer-related proteins, i.e., condensates (Pg. 5008 Abstract & Right col. ¶1). Since phase separation (condensate formation) is a highly complex and refined biological process, various types of molecules could regulate this process (Pg. 5023 last ¶). However, the design and development of condensate related drugs are still in their infancy with many technological challenges facing the identification of such drugs (Pg. 5024 sect. 5.3 ¶2).
Moreover, the instant compounds 2, 6, and 60-62 are not found in the prior art. So, it would be unclear to the artisan what compounds would “compete with,” induce changes in AR “comparable” to, and/or have “activity comparable to or higher” than the compounds 2, 6, and 60-62 (see instant claim 25).
Thus, the scope of “AR condensate modulator” beyond compounds 2, 6, and 60-62 which is embraced by the instant disclosure is unclear, even in view of the prior art.
Regarding prodrugs, HAN (Han, H., AAPS PharmsciTech., 2000, 2, 1-11) describes that some prodrug forms are not chemically or structurally related to their active form, for example, both glucose
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and hypoxanthine
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are prodrug forms of hydrogen peroxide
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(Pg. 5 Table 1). In view of HAN and the open-ended nature of “prodrug” as defined by the instant disclosure, the artisan would not have sufficient guidance on chemical structures encompassed by “prodrug” of compounds 2, 6, and 60-62.
Regarding metabolites, ZHANG (Zhang & Tang, Acta Pharmaceutica Sinica B, 2018, 8(5), 721-732) discloses, in majority of cases, sites of metabolism are unpredictable and metabolites could have no pharmacological activity (Pg. 725 Right col. ¶2). Thus, the structure and efficacy of a “metabolite” of compounds 2, 6, and 60-62 would be unpredictable to the artisan.
Since compounds 2, 6, and 60-62 did not return any prior art, there is no teaching in the prior art of prodrugs or metabolites of the instantly disclosed compounds.
Without guidance as to what structures correspond to viable AR condensate modulators and/or prodrugs/metabolites of the compounds 2, 6, and 60-62, Factors (e) and (f) are not met.
Conclusions:
Due to the breadth of “AR condensate modulator” and the categories a)-d) of claim 25, the lack of direction given in the claims/specification regarding embodiments of such which show the desired activity, and the challenges in the art, the artisan would not be able to immediately envisage the breadth of “AR condensate modulator” beyond compounds 2, 6, and 60-62 and related compound AA. Accordingly, the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to the artisan that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Thus, claims 1, 3-4, 7, 11-12, 21, 23-26, and 29-37 are rejected as lacking written description for the scope of “AR condensate modulator”. To overcome this rejection, Applicants are encouraged to narrow the scope of “AR condensate modulator” to the disclosed compounds 2, 6, and 60-62 and to strike prodrug and metabolite from the claims.
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 21 and 25 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.
Claim 21 recites the limitation "the at least one (or at least two, three, or four) AR-regulated gene" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. This is the first instance of “the” AR-regulated gene in claim 25 and parent claims 1 and 12 do not recite “an” AR-regulated gene. Thus, “the” AR-regulated gene lacks antecedent basis. The metes and bounds of the claim are undefined rendering the claim indefinite.
Claims 21 and 25 recite “at least one (or at least two, three, or four)”. The use of parentheses around the second set of limitations makes it unclear if “at least two, three, or four” is a required part of the claim or if it is merely exemplary of at least one. Thus, the metes and bounds of the claims are undefined rendering the claim indefinite.
To overcome: Applicant could strike the phrase “(or at least two, three, or four)”.
The term “comparable” and phrase “competes with” in claim 25 are relative terms which render the claim indefinite. The term and phrase are 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. The standard for comparison to the instant compounds 2, 6, and 60-62 is unclear – what constitutes competition and what constitutes comparable activity. Thus, the scope of compounds encompassed by parts b)-d) of claim 25 is unclear. Thus, the metes and bounds of the claims are undefined rendering the claim indefinite.
Claim 25 recites “Compound 60, Compound 61, Compound 62, Compound 6, Compound 2”. These compounds are given no chemical names or chemical structures in the claim text. The identifiers 2, 6, and 60-62 are references to figures in the specification. MPEP 2173.05(s) states “where possible, claims are to be complete in themselves” and incorporation by reference is permitted only in exceptional circumstances where there is no practical way to define the invention in words. Here, the compounds should be defined by chemical name or structure in the claim. As presently drafted, the chemical identity of the compounds is unclear. Thus, the metes and bounds of the claims are undefined rendering the claim indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 recites “the” AR-regulated gene; however, neither of parent claims 1 or 12 recite “an” AR-regulated gene. Thus, claim 21 recites a limitation outside of the scope of the parent claims and does not properly further limit the parent claims. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 3-4, 7, 11-12, 23-25, 29-34, and 36-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by VELKY (Velky, J.E. et al., PNAS, pub. 10 Nov. 2020, 117(45), 28092-28101; provided 12/29/2025) evidenced by: BOIJA (Boija, A. et al., Cancer Cell, pub. 8 Feb. 2021, 39, 174-192; provided 12/29/2025) and CAI (Cai, C. et al., Cancer Research, 2011, 71(20), 6503-6513).
Regarding claims 1, 30, 33-34, and 36-37, VELKY discloses castration-resistant prostate cancer (CRPC) which is resistant to androgen deprivation therapies (Pg. 28092 Background ¶1); in such cells the protein DDX3 binds to AR mRNA and forms stress granules limiting AR protein expression (Pg. 28096 Fig. 3). Administration of the DDX3 inhibitor RK33 to a CRPC-xenograft mouse subject restores AR protein expression and sensitivity of the cancer towards AR therapies (Pg. 28098 Fig. 5). BOIJA is a review article concerning condensates which cites to VELKY and refers to the stress-granules of AR-DDX3 as condensates and the mechanism of AR-therapeutic resistance as an example of “condensate-associated mechanisms of drug resistance” (Pg. 185 Right Col. ¶3).
Regarding claims 11-12, VELKY teaches by inhibiting DDX3 pharmacologically, the condensates are resolved (Pg. 28099 Right col. ¶2), i.e., the RK33 is an AR condensate inhibitor that modulates formation/stability/activity of condensates.
Regarding claim 23, VELKY teaches the dose of RK33 is 2 uM (Pg. 28093 Left col. ¶5) and when administered as a co-treatment with bicalutamide results in a ~50% decrease in cell proliferation (Pg. 28099 Table 1). This is equivalent to a ~2 uM IC50.
Regarding claim 24, VELKY teaches the AR-expressing cell line is C42 (Pg. 28099 Table 1) which is a sub-species of parent cell line LNCaP (Pg. 28093 Right col. ¶2).
Regarding claim 25, since RK33 has a 2 uM IC50, the activity of RK33 is “comparable to” that of compounds 2, 6, and 60-62 in inhibiting proliferation of AR-expressing cancer cells. The instant specification discloses the instant IC50s are ~1-10 uM (Pg. 96 Table 3).
Regarding claim 29, VELKY teaches the C42 cells have increased AR mRNA expression (Pg. 28094 Fig. 1(G)) – i.e., elevated AR activity.
Regarding claims 3-4, 7, and 31-32, CAI discloses C42 harbors a T877A AR mutation (Pg. 6509 Left col. ¶2). This AR mutation is an AR variant. Since the lack of the LBD is optional, this limitation of claims 7 & 32 does not need to be met.
Further, since VELKY teaches resistance to androgen deprivation therapies (Pg. 28092 Background ¶1), claim 3 is met.
Claims 1, 3, 7, 11-12, 21, 23-26, and 29-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ZHOU (WO 2020/081999) evidenced by CHEN (Chen, X. et al., Precision Oncology, 2020, 4(31), 1-7).
Regarding claims 1 and 33-37, ZHOU teaches a method for treating cancer comprising administering the compound
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to a subject, wherein the cancer is metastatic and castration resistant prostate cancer (Pg. 339-340 claims 23-27). Further, the prostate cancer expresses truncated androgen receptor (AR) splice variant (Pg. 340 claim 26). The compound is compound A109 (Pg. 100 Table); A109 was tested in LNCaP cells expressing AR-V7 (Pg. 241 ¶1162) and showed an IC50 of 0.44 uM against cell proliferation as measured by a cell proliferation assay (Pg. 244-245 Table 1D).
CHEN discloses super-enhancers (SE) are highly enriched condensates (Pg. 1 Right col. ¶2) and prostate cancer cells LNCaP express SE comprising AR (Pg. 2 Left col. ¶3). Thus, the LNCaP cells of ZHOU are known to comprise AR condensates.
MPEP 2112.02.I states:
“Under the principles of inherency, if a prior art device (e.g., compound), in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device (e.g., compound). When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.”
The instant specification describes compound A109 of ZHOU (as compound AA) has a micromolar IC50 against AR phase separation into condensates (Pg. 98 ¶465 Table). By the logic of MPEP 2112.02.I, the compound A109 will inherently perform the claimed process of modulating AR condensates when administered in its normal and usual operation to treat prostate cancer.
Further, MPEP 2112.02.II states:
“The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978)”
Here, the use of modulating AR condensates is a result of the administration of the compound A109 and a property of the chemical structure thereof; and the method step of administering the AR condensate modulator to treat the same disease is taught by ZHOU. Thus, the claim is anticipated.
Regarding claims 11-12, by the same logic of MPEP 2112.02.I-II, the compound A109 modulates the formation, stability, or activity of the AR condensate and is an AR condensate inhibitor – i.e., it inhibits formation, stability, or activity. Further, ZHOU teaches the compound A109 inhibits the AR intrinsic disorder domain (Pg. 119 ¶841), further supporting the compound’s role as an inhibitor of AR activity.
Regarding claim 21, ZHOU teaches an IC50 of 535 nM against prostate-specific antigen (PSA) (Pg. 244 Table 1B) and PSA is an AR-regulated gene (Pg. 2 ¶5). The IC50 is equivalent to 50% inhibition or a decrease of expression by 50%; thus, if the IC50 is 535 nM, the compound A109 is expected to decrease expression of PSA by at least 50% when administered at a higher concentration of 5 uM.
Regarding claims 23-24, ZHOU teaches an IC50 of 0.44 uM against LNCaP cell proliferation as measured by a cell proliferation assay (Pg. 244-245 Table 1D).
Regarding claim 25, since the phrase “comparable” is undefined, compound A109’s IC50 of 0.44uM against LNCaP cell proliferation is understood as comparable to the IC50 of ~0.5-1 uM of instant compounds 2 & 6 (Pg. 97 Table 3 of instant specification) – this meets category d) iii) of claim 25.
Regarding claim 26, ZHOU teaches the compound is selective to the AR N-terminal domain (NTD) (Pg. 241 ¶1163). The NTD is intrinsically disordered (Pg. 4 ¶10); thus, it is the intrinsic disorder domain (IDD) of AR. Thus, the compound is understood to bind the IDD of AR.
Regarding claims 3, 7, and 29-32, ZHOU teaches AR-V7 is truncated at the LBD (i.e., aberrant splicing) and expression of AR-V7 is associated with resistance to hormone therapies, i.e., androgen deprivation, (Pg. 5 ¶11). Further, castration-resistant prostate cancer driven by AR is characterized by rising serum PSA (Pg. 2 ¶5). The AR driven rise in serum PSA is understood as elevated AR activity (i.e., instant claim 29).
Claim Rejections - 35 USC § 103
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 12, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over ZHOU (WO 2020/081999) evidenced by CHEN (Chen, X. et al., Precision Oncology, 2020, 4(31), 1-7), as applied to claims 1 and 12 above.
Determining the Scope and Contents of the Prior Art:
ZHOU, as evidenced by CHEN, teaches the method of claims 1 and 12 (above). ZHOU teaches an IC50 of 535 nM against prostate-specific antigen (PSA) (Pg. 244 Table 1B) and PSA is an AR-regulated gene (Pg. 2 ¶5).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
ZHOU does not explicitly state a concentration of 5 uM of A109 results in at least 50% decrease of PSA.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a method useful for reducing PSA expression and possesses the technical knowledge necessary to make adjustments to drug concentrations to optimize/enhance the reduction of PSA. Said artisan has also reviewed the problems in the art regarding reducing PSA and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the reference ZHOU as evidenced by CHEN.
The artisan would be motivated to modulate the concentration of compound A109 to optimize the reduction of PSA expression.
MPEP 2144.05(II)(A) provides guidance about the routine optimization of prior art conditions: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").”
Furthermore, MPEP 2144.05(I) provides, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”
Here, ZHOU teaches, at concentration 535 nM, compound A109 reduces PSA by 50% (Pg. 244 Table 1B). This concentration and resulting % decrease in PSA overlaps/approaches the instant 5 uM concentration and resulting 50% decrease. The concentration of compound A109 is analogous to the concentration recited in the MPEP and is understood to be a results effective variable – i.e., the concentration achieves a recognized result of PSA decrease. Thus, the concentration (and resulting % decrease) may be optimized by routine experimentation. Absent any evidence demonstrating the contrary, the determination of the optimum or workable concentrations of compound A109 would have been well within the practice of the artisan given the guidance of the prior art.
Conclusion
Claims 1, 3-4, 7, 11-12, 21, 23-26, and 29-37 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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