Notice of Pre-AIA or AIA Status
The instant application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 30-53 are pending in the instant application file.
Priority
The following continuity data is acknowledged in the instant application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed December 19, 2024, July 23, 2025 and June 1, 2026 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
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 30-31 and 40-53 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 treating MTAP-null cancer, does not reasonably provide enablement for treating all cancer types and subtypes. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
As stated in the MPEP 2164.01 (a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
the nature of the invention,
the state of the prior art,
the predictability or lack thereof in the art,
the amount of direction or guidance instant,
the presence or absence of working examples,
the breadth of the claims,
the quantity of experimentation needed, and
the level of the skill in the art.
In the instant case,
The nature of the invention
The nature of invention of claim 30 is the method of treating cancer comprising administering a PRMT5 inhibitor in an amount ranging from 40 mg to 2000 mg. Paragraphs 55-57 of the instant specification provide where the methods can be used for the treatment of a wide range of various types of cancer, including but not limited to basal cell carcinoma, ‘childhood cancers’, ewing sarcoma, ‘unusual cancers of childhood’, and ‘viral-induced cancer’, for which no enablement is provided.
The state of the prior art and The predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific diseases and by what mechanism).
There is no absolute predictability even in view of the seemingly high level of skill in the art.
The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
The instant claimed invention is highly unpredictable as discussed below:
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
Applicant is claiming the treatment of various cancers.
The state of the prior art is that cancer therapy and prevention remain highly unpredictable. The various types of cancers have different causative agents, involve different cellular mechanisms, and consequently, differ in treatment protocol. It is known that the challenge of cancer treatment has been to target specific therapies to pathogenetically distinct tumor types, that cancer classification has been based primarily on morphological appearance of the tumor and that tumors with similar histopathological appearance can follow significantly different clinical courses and show different responses to therapy (see Golub et al. page 531).
Furthermore, it is known that chemotherapy is most effective against tumors with rapidly dividing cells and that cells of solid tumors divide relatively slowly and chemotherapy is often less effective against them. Additionally, it is known that 75-80% of cancer types (in the US) are due to environmental factors and, in theory, cannot be prevented (Rothman et. al., see page C2, col. 1, Lines 8-23).
Hence, in the absence of a showing of correlation between all the diseases claimed as capable of treatment and prevention by the administration of the compounds of the claims, one of skill in the art is unable to fully predict possible results from the administration of the compound of the claims due to the unpredictability. It is known that the challenge of cancer treatment has been to target specific therapies to pathogenetically distinct tumor types, that cancer classification has been based primarily on morphological appearance of the tumor and that tumors with similar histopathological appearance can follow significantly different clinical courses and show different responses to therapy.
The amount of direction or guidance instant and The presence or absence of working examples
The only direction or guidance instant in the instant specification is the listing of diseases applicant considers as treatable paragraphs 53-57. Additionally, in vitro data for the treatment of various MTAP-null cancers via the claimed PRMT5 inhibitor is found on pages 22-40.
Moreover, the disclosure does not provide how the in vitro data correlates to the treatment of the assorted cancers as claimed. The uses covered by the claims are not enabled based solely on the assay testing reported in the specification. Various studies are required to enable compounds in clinical development; for example, development routinely relies on animal models in addition to iterative assays, not assay testing as done herein. Note Hoffman V. Klaus 9 USPQ2d 1657 (1988) regarding the standard of testing that is necessary to establish the likelihood of in vivo use. Also see Ex parte Powers 220 USPQ 924 (1982) regarding the absence of animal studies and the absence of correlation between the studies conducted in vitro and the diseases to be treated. In the absence sufficient testing of animal models, assays for treating cancer outside of MTAP-null cancer, the claims are not enabled for a skilled artisan.
Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The breadth of the claims
The breadth of the claims is the treatment of cancer comprising administration of a PRMT5 inhibitor having the structure of Compound (G) in an amount ranging from 40-2000 mg to the patient. Paragraph 38 of the instant specification provides:
A "therapeutically effective amount" of a PRMT5 inhibitor means an amount effective to treat or to prevent development of, or to alleviate the existing symptoms of, the patient being treated.
Paragraph 61 provides the following regarding the determination of an effective treatment:
The efficacy of a given treatment for cancer can be determined by the skilled clinician. However, a treatment is considered "effective treatment," as the term is used herein, if any one or all of the signs or symptoms of e.g., a tumor are altered in a beneficial manner or other clinically accepted symptoms are improved, or even ameliorated, e.g., by at least 10% following treatment with an agent as described herein. Efficacy can also be measured by a failure of an individual to worsen as assessed by hospitalization or need for medical
Furthermore, the instant claims cover ‘cancer’, which is taken to encompass all forms of cancer, for which there is no enablement provided.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what cancers out of the multitude claimed would be benefited by the administration of the combination of compounds of the claims.
The level of the skill in the art
The level of skill in the art is high, that of an MD or PHD capable of performing and analyzing a high throughput screen.
However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
Thus, the specification fails to provide sufficient support of the broad use of the compound of the instant claims for the treatment and prevention of the various claimed cancers as a result, necessitating one of skill to perform an exhaustive search for which cancers can be treated or prevented by what compounds of the instant claims in order to practice the claimed invention.
Factors such as “sufficient working examples”, “the level of skill in the art” and “predictability”, etc. have been demonstrated to be sufficiently lacking in the instantly claimed methods. In view of the breadth of the claim, the chemical nature of the invention, and the lack of working examples regarding the activity of the claimed compounds, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent 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”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which hyper-proliferative can be treated or prevented by the composition encompassed in the instant claim, with no assurance of success.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 instant 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 30-36 and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/132914 (Booker et al.; International Filing Date: 2021/12/15; containing an additional inventive entity), in view of WO 2020/033288 A1 (Machacek et al.; Date Published: 2020/02/13).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Booker discloses a method of treating cancer, and further where the cancer is MTAP-null, comprising administration of a PRMT5 inhibitor of the following general structure (see paragraphs 21, 69, 82 for disclosed methods):
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As a particular example, Booker provides the following specific embodiment Compound 481 on page 146:
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Compound 481 of Booker corresponds to Compound (G) of the instant application.
Booker discloses where the method for the treatment of cancer comprises administration of an effective amount of the PRMT5 inhibitor (see paragraphs 21, 23, 59 and 61; also claim 22), and further provides:
In some embodiments, the pharmaceutical composition is formulated for oral administration once a day or QD, and in some such formulations is a tablet where the effective amount of the active ingredient ranges from 1 mg to 1000 mg
See instant claims 30-31.
Booker discloses where PRMT5 inhibitor compounds of the invention are suitable for the treatment of various cancers, including but not limited to lung cancer, non-small cell lung cancer (NSCLC), pancreatic cancer, adenocarcinoma, esophageal cancer, adenocarcinoma of the esophagus (see paragraphs 21-23 and 66-81 as well as claims 22-23; see instant claims 33-36 and 38-39).
Booker discloses anticancer activity of PRTM5 inhibitors against MTAP-null cancer, also indicating inhibition of PRMT5, in Table 12, specifically page 185 for compound 481.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Booker does not disclose administering Compound (G) in an amount ranging from 40 mg to 2000 mg, or further in an amount ranging from 40 mg to 800 mg.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05.
There would be a reasonable expectation of success towards a method of treating cancer in a patient given the disclosure of Booker of a tablet where the effective amount of the active ingredient, comprising Compound (G), ranges from 1 mg to 1000 mg, which overlaps with the required amounts in the instant claims, 40 mg to 2000 mg, and further 40 mg to 800 mg of instant claim 31.
Further still, it would be obvious for one of ordinary skill in the art to adjust the dosage of Compound (G) administered to the patient having cancer during routine optimization to find the therapeutically effective amount.
"[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). See MPEP 2144.05,II.A.
As such, the methods of claims 30-36 and 38-39 are prima facie obvious in view of Booker and are properly rejected.
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claims 40-53 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/132914 (Booker et al.; International Filing Date: 2021/12/15; containing an additional inventive entity), in view of WO 2020/033288 A1 (Machacek et al.; Date Published: 2020/02/13).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Booker discloses a method of treating cancer, and further where the cancer is MTAP-null, comprising administration of a PRMT5 inhibitor of the following general structure (see paragraphs 21, 69, 82 for disclosed methods):
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As a particular example, Booker provides the following specific embodiment Compound 481 on page 146:
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Compound 481 of Booker corresponds to Compound (G) of the instant application.
Booker discloses where the method for the treatment of cancer comprises administration of an effective amount of the PRMT5 inhibitor (see paragraphs 21, 23, 59 and 61; also claim 22), and further provides:
In some embodiments, the pharmaceutical composition is formulated for oral administration once a day or QD, and in some such formulations is a tablet where the effective amount of the active ingredient ranges from 1 mg to 1000 mg
See instant claims 30-31.
Booker discloses where PRMT5 inhibitor compounds of the invention are suitable for the treatment of various cancers, including but not limited to lung cancer, non-small cell lung cancer (NSCLC), pancreatic cancer, adenocarcinoma, esophageal cancer, adenocarcinoma of the esophagus (see paragraphs 21-23 and 66-81 as well as claims 22-23; see instant claims 33-36 and 38-39).
Booker discloses anticancer activity of PRTM5 inhibitors against MTAP-null cancer, also indicating inhibition of PRMT5, in Table 12, specifically page 185 for compound 481.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Booker does not disclose a method of treating cancer in a patient in need thereof, further comprising administering a standard of care therapy for the treatment of cancer, wherein the standard of care therapy comprises chemotherapy, wherein the chemotherapy comprises administering paclitaxel, carboplatin, gemcitabine, irinotecan, 5-fluoracil or pemetrexed or a combination thereof. See instant claims 40-52.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Machacek discloses compounds of the following general formula as PRTM5 inhibitors as well as methods of using these compounds to treat cancer, sickle cell, and hereditary persistence of foetal hemoglobin (HPFH) mutations:
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See abstract, and pages 4, 20-21, and 24.
Machacek discloses a composition for treating cancer comprising the PRMT5 inhibitor and several other therapeutic agents, including but not limited to, paclitaxel, carboplatin, gemcitabine, irinotecan, 5-fluoracil or pemetrexed (see pages 37-40).
Machacek provides the following guidance regarding dosing on pages 49-50:
The dosage regimen utilizing the compounds is selected in accordance with a variety' of factors including type, species, age, weight, sex and medical condition of the patient; the severity of the condition to be treated; the route of administration; the renal and hepatic function of the patient; and the particular compound or salt thereof employed. An ordinarily skilled physician or veterinarian can readily determine and prescribe the effective amount of the drug required to prevent, counter, or arrest the progress of the condition.
[…]
Oral dosages of the compounds, when used for the indicated effects, will range between about 0.01 mg per kg of body weight per day (mg/kg/day) to about 30 mg/kg/day, preferably 0.025-7.5 mg/kg/day, more preferably 0.1-2, 5 mg/kg/day, and most preferably 0.1-0.5 mg/kg/day (unless specified otherwise, amounts of active ingredients are on free base basis).
[…]
Intravenously, the patient would receive the active ingredient in quantities sufficient to deliver about 0.01 mg per kg of body weight per day (mg/kg/day) to about 30 mg/kg/day, preferably 0.025-7.5 mg/kg/day, more preferably 0.1-2.5 mg/kg/day, and even more preferably 0.1-0.5 mg/kg/day.
Machacek discloses PRTM5 inhibition activity for compounds of the disclosure in Table 26, see pages 255-258.
The rationale for the 35 USC § 103 rejection of the method of instant claim 30 in view of Booker as discussed above is incorporated herein by reference.
It would be obvious to one of ordinary skill in the art to combine the teachings of Booker and Machacek as they both are in the field of treating cancer with PRMT5 inhibitors. Booker discloses a method of treating cancer in a patient in need thereof comprising administration of an PRMT5 inhibitor having the structure of instant compound (G). Machacek provides a method of treating cancer in a patient in need thereof comprising administration of a PRMT5 inhibitor and further discloses wherein additional chemotherapy agents, provided in combination with a PRMT5 inhibitor, are also suitable for treating cancer.
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
It would be obvious to one of ordinary skill in the art to combine the PRTM5 inhibitor disclosed by Booker with additional agents disclosed by Machacek in a method of treating cancer. Each component has been shown to be suitable for treating cancer in the prior art. There would be a reasonable expectation of success towards the treatment of cancer based on the anticancer utility disclosed and Machacek disclosure of the composition comprising the PRTM5 inhibitor and additional therapeutic agents as suitable for the treatment of cancer.
Regarding instant claims 43, 45, 47, 49, 51 and 53, which are directed to specific amounts of the chemotherapy agents, Booker and Machacek provide dosage guidance for the composition comprising a PRMT5 inhibitor, and in the disclosure of Machacek further comprising additional chemotherapeutic agents, in the method of treating cancer.
"[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). See MPEP 2144.05,II.A.
Nonetheless, it would have been prima facie obvious to one of ordinary skill in the art to adjust the dosage of paclitaxel, carboplatin, gemcitabine, irinotecan, 5-fluoracil or pemetrexed, during routine optimization to the therapeutically effective dosage.
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
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 30-36 and 38-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 39, 51-53 and 56 of copending Application No. 18/502,780 (reference application), in view of WO 2022/132914 (Booker et al.; International Filing Date: 2021/12/15; containing an additional inventive entity) and WO 2020/033288 A1 (Machacek et al.; Date Published: 2020/02/13).
Claim 39 of the ‘780 application discloses a method of treating a MTAP-null cancer in a subject in need of treatment, the method comprising administering to the subject a therapeutically effective amount of a compound including
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which corresponds to instant compound (G) (see page 15, fifth compound from the bottom). See instant claims 30 and 32.
Claim 51 of the ‘780 application discloses the method of claim 1 of the ‘780 application, wherein the MTAP-null cancer is lung cancer, esophageal cancer, or pancreatic cancer. See instant claims 33-34, 36 and 38.
Claims 52-53 of the ‘780 application recite the following:
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See instant claim 35.
Claim 56 of the ‘780 application further discloses the following:
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The claims of the ‘780 application do not disclose where Compound (G) is administered in an amount ranging from 40-2000 mg, or further 40-800 mg.
The claims of the ‘780 application do not disclose a method of treating cancer in a patient in need thereof, further comprising administering a standard of care therapy for the treatment of cancer, wherein the standard of care therapy comprises chemotherapy, wherein the chemotherapy comprises administering paclitaxel, carboplatin, gemcitabine, irinotecan, 5-fluoracil or pemetrexed or a combination thereof. See instant claims 40-52.
As the ‘780 application discloses a method of treating cancer, and further a MTAP-null cancer, in a subject in need thereof, comprising administration of a compound corresponding to instant compound (G), one of ordinary skill in the art would have been motivated to arrive at the methods of the instant invention in view of the combination of Booker and Machacek as referenced in the 35 USC § 103 rejections above. The rationale from the 35 USC § 103 rejection over claims 30-36 and 38-39 in view of Booker as well as the 35 USC § 103 rejection over claims 40-52 in view of Booker and Machacek is incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claims 30-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1 and 7-9 of copending Application No. 19/132,928 (reference application), in view of WO 2022/132914 (Booker et al.; International Filing Date: 2021/12/15; containing an additional inventive entity) and WO 2020/033288 A1 (Machacek et al.; Date Published: 2020/02/13).
Claim 1 of the ‘928 of the application discloses A method of treating a MTAP-null cancer in a patient in need thereof comprising administering a combination therapy of a therapeutically effective amount of Compound A or pharmaceutically acceptable salt thereof and a therapeutically effective amount of Compound B or pharmaceutically acceptable salt thereof to the patient.
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. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. Also see MPEP 804(II.B.1.).
The specification of the ‘928 of the application discloses the following regarding Compound A:
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Compound A of the ‘928 application corresponds to instant compound (G).
Claims 7-9 of the ‘928 application discloses wherein the MTAP-null cancer is pancreatic cancer, lung cancer and non-squamous cell lung cancer (NSCLC). Claim 12 of the ‘928 application discloses wherein the MTAP-null cancer is pancreatic adenocarcinoma. See instant claims 32-38.
The claims of the ‘928 application do not disclose where Compound (G) is administered in an amount ranging from 40-2000 mg, or further 40-800 mg.
The claims of the ‘928 application do not disclose a method of treating cancer in a patient in need thereof, further comprising administering a standard of care therapy for the treatment of cancer, wherein the standard of care therapy comprises chemotherapy, wherein the chemotherapy comprises administering paclitaxel, carboplatin, gemcitabine, irinotecan, 5-fluoracil or pemetrexed or a combination thereof. See instant claims 40-52.
As the ‘928 application discloses a method of treating cancer, and further a MTAP-null cancer, in a subject in need thereof, comprising administration of a compound corresponding to instant compound (G), one of ordinary skill in the art would have been motivated to arrive at the methods of the instant invention in view of the combination of Booker and Machacek as referenced in the 35 USC § 103 rejections above. The rationale from the 35 USC § 103 rejection over claims 30-36 and 38-39 in view of Booker as well as the 35 USC § 103 rejection over claims 40-52 in view of Booker and Machacek is incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 30-53 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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