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 .
Status of Claims
Claims 38-53 are pending in the instant application.
Claims 1-37 have been canceled.
Withdrawn Objections/Rejections
Applicant’s cancellation of Claims 18-31 renders the rejection thereof under 35 U.S.C. 112(a) moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claims 18-33 renders the rejection thereof under 35 U.S.C. 112(b) moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claims 18-32 renders the rejection thereof under 35 U.S.C. 102(a)(1) moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claims 18-33 renders the rejection thereof on the ground of nonstatutory double patenting moot. This rejection is hereby withdrawn.
Election/Restriction
As noted in the non-final rejection mailed December 30th, 2025, Applicant elected in a reply received November 30th, 2025 in response to a restriction requirement mailed October 24th, 2025. In this reply, Applicant elected without traverse Group I, drawn to Claims 18-33 and a species election of a single species of a compound of formula I as:
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As Applicant has canceled Claims 18-37, to which the restriction requirement was initially drawn, Applicant’s election is applied to the newly presented Claims 38-53. Pursuant to the restriction requirement, Claims 50-53 are withdrawn as claims directed to a non-elected invention.
The following rejections are necessitated by amendment:
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 38-49 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 a tumor of lung cancer, renal carcinoma, breast cancer, colon cancer, pancreatic cancer, liver cancer, or brain tumor, does not reasonably provide enablement for prevention of a tumor or treatment for any tumor with low or no expression of the NNMT gene. 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.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Applicant traversed the rejection of canceled Claims 18-31 under 35 U.S.C. 112(a) on the basis that the instant invention is based on unexpected findings of specific tumors that are highly sensitive to the compound of formula I. Applicant states, beginning at Page 19, last paragraph, of the remarks filed March 23rd, 2026, “The inventive aspect of the present application lies in in the inventor’s innovative discovery that the compounds of formula I exhibit a superior inhibitory effect on tumors exhibiting specific molecular biological characteristics”. Further, Applicant states at Page 30 of the remarks filed March 23rd, 2026 that “the definition of the tumors in the new claims does define new tumor subtypes.”
The examiner does not find the Applicant’s arguments persuasive. While it is clear based on the instant disclosure that the claims are directed to prevention and/or treatment of tumors exhibiting specific biomarkers, Applicant has not provided enabling disclosure for the prevention of tumors exhibiting these biomarkers or for treatment of tumors in tissues apart from those resulting from the specific cancers enumerated above. To this end, for clarity of the record, the Wands factors for the newly presented claims are revisited below.
Nature of the invention:
The invention is drawn to a method for preventing and/or treating a tumor wherein the tumor comprises a tumor with low or no expression of the NMT gene, comprising administration of a compound of Formula I as recited at instant Claim 38.
Breadth of the invention:
The scope of the claim is broad. While Claim 38 recites limitations regarding the expression levels of the NNMT gene, DNA methylase, and/or UHRF1, the tumor thereof could be associated with a myriad of distinct cancers with mutually exclusive etiologies. This could also cover an array of cancers known presently that have yet to be characterized with respect to the levels of expression of the NNMT gene, DNA methylase, and/or UHRF1, or tumors that have yet to be discovered that are classified with low or no expression of the NNMT gene, high expression of DNA methylase, and/or high expression of UHRFG1. Can an Applicant simply “reach through” and obtain patent protection for the treatment of tumors that are later discovered and/or later classified as having low or no expression of NNMT gene, high expression of DNA methylase, and/or high expression of UHRF1. Further, the method of treatment is drawn to administration of a compound of Formula I:
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allowing for compounds resulting from myriad combinations of the variables as defined, for example, at instant Claim 38.
State of the prior art and predictability in the art:
No compound has ever been found to treat cancers of all types generally. Since this assertion is contrary to what is known in medicine, proof must be provided that this revolutionary assertion has merits. The existence of such a “silver bullet” is contrary to our present understanding of oncology. The state of the art is not indicative of any pharmaceutical agents that are useful in the treatment of cancer generally. At Page 1004, Cecil Textbook of Medicine states that “each specific type has unique biologic and clinical features that must be appreciated for proper diagnosis, treatment and study”. Different types of cancers affect different organs and have different methods of growth and harm to the body. Also see In re Buting, 163 USPQ 689 (CCPA 1969), wherein ‘evidence involving a single compound and two types of cancer, was held insufficient to establish the utility of the claims directed to disparate types of cancers’. Thus, it is beyond the skill of oncologists today to get an agent to be effective against cancers generally.
A similar statement appears at In re Application of Hozumi et. al., 226 USPQ 353: “In spite of the vast expenditure of human and capital resources in recent years, no one drug has been found which is effective in treating all types of cancer. Cancer is not a simple disease, nor is it even a single disease, but a complex of a multitude of different entities, each behaving in a different way”. There are compounds that treat a modest range of cancers, but no one has ever been able to figure out how to get a compound to be effective against cancer generally, or even a majority of cancers.
The attempts to find compounds to treat the various cancers arguably constitute the single most massive enterprise in all of pharmacology. This has not resulted in finding any treatment for tumors generally. This is because it is now understood that there is no “master switch” for cancers generally; cancers arise from a bewildering variety of differing mechanisms. Even the most broadly effective antitumor agents are only effective against a small fraction of the vast number of different cancers known. This is true in part because cancers arise from a wide variety of sources, primarily a wide variety of failures of the body’s cell growth regulatory mechanisms, but also such external factors such as viruses (an estimated at least 20% are of viral origin e.g. Human papillomavirus, EBV, Hepatitis B and C, HHV-8, HTLV-1 and other retroviruses, and quite possibly Merkel cell polyomavirus, and there is some evidence that CMV is a causative agent in glioblastoma), exposure to chemicals such as tobacco tars, excess alcohol consumption (which causes hepatic cirrhosis, an important cause of HCC), ionizing radiation, and unknown environmental factors.
Similarly, In re Novak, 134 USPQ 335, 337-338 says “unless one with ordinary skill in the art would accept those allegations as obviously valid and correct, it is proper for the examiner to ask for evidence which substantiates them.” There is no such evidence in this case for a compound that treats all types of cancer. Likewise, In re Cartright, 49 USPQ2d 1464, states: “Moreover, we have not been shown that one of ordinary skill would necessarily conclude from the information expressly disclosed by the written description that the active ingredient” does what the specification surmises that it does. That is exactly the case here. Moreover, even if Applicant’s assertion that cancer in general could be treated with these compounds were plausible -- which it is not --, that “plausible” would not suffice, as was stated in Rasmusson v. SmithKline Beecham Corp., 75 USPQ2d 1297, 1301: “If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success.
Recently, Wu et. al. (“Small-molecule inhibitors, immune checkpoint inhibitors, and more: FDA- approved novel therapeutic drugs for solid tumors from 1991 to 2021; Journal of Hematology & Oncology, 15, 143, 2022; hereinafter referred to as Wu), at the Abstract, discloses that between 1991 and 2021 there have been 228 new cancer drugs approved by the U.S. Food and Drug Administration of which 120 of these are drawn to the treatment of solid tumors alone. At Page 5, Table 1 Wu teaches that there are 21 different approved drugs for treating lung cancers, some of which have cellular targets. At Page 10, Table 2, Wu teaches breast cancer has 22 different drugs that have varied cellular targets and are indicated for different types of breast cancer. At Page 17, Table 4, Wu teaches there are 17 different drugs available to treat different forms of gastrointestinal cancers. At Page 38, Figure 12, Wu summarizes the protein structure of some cellular targets and the binding site of their respective drugs. Taken together, Wu teaches that no single therapeutic has ever been identified as a treatment for all forms of cancer; and closer examination of Figure 12 provides a logical explanation. As highlighted in Figure 12, molecular protein targets implicated in different cancers (e.g. EGFR for lung cancer in Table 1, VEGFR2 for gastric cancer in Table 4) have different three-dimensional protein structures, different active sites, and therefore require different drugs with the right shape and chemical groups in order to bind the target active site and have an effect in treating cancer. In other words, there is no one size fits all approach to treating cancer simply for the reason that no single molecule will have the shape and chemical functional groups necessary to bind and modulate all modular targets of cancer, all of which have varied shapes. It is commonly known in the pharmaceutical arts that shape dictates function wherein drugs which have a shape complimentary to the protein target will bind and have an effect (this is often referred to simplistically as a “Lock and Key” model). Given the varied shape of protein targets in cancer (e.g. EGFR and VEGFR2), it is pure fantasy to speculate that a single drug with a single three dimensional shape will bind all protein targets implicated in cancer therapy and have an effect in treating all forms of the disease. As such, at present the “silver bullet” drug therapy to treat all forms of cancer is elusive and such a therapy is not recognized in the art where the reality is that different forms of cancer require different drug therapies.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
Beginning at Page 43 of the instant specification, Examples 1-4 sufficiently disclose the synthesis of the compounds of Formula I.
Beginning at Page 45, Example 5 sufficiently discloses the efficacy of the administration of compounds of Formula I in inhibiting various tumor cell lines. Included in Example 5 are demonstrations of efficacy against the NCI-H82 cell line, a lung carcinoma cell line, the G-401 cell line, a renal rhabdoid tumor cell line, the MDA-MB-453 cell line, a breast cancer cell line, the SW48 cell line, a colorectal cancer cell line, the CFPAC-1 cell line, a liver cancer cell ine, the 768-O cell line, an adenocarcinoma cell line, a brain cancer cell line, and the SF126 cell line, a human glioblastoma cell line. Example 9 discloses additional data for additional brain tumor cell lines.
These examples are sufficient in demonstrating the efficacy of the claimed compounds in treating a tumor associated with lung cancer, renal carcinoma, breast cancer, colon cancer, pancreatic cancer, liver cancer, or brain tumor. These examples, however, are insufficient to provide enabling disclosure for the prevention of tumors or treatment of tumors in cancers beyond those mentioned above.
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation. As referenced above, a person having ordinary skill in the art would need to identify and/or develop metrics to evaluate the efficacy of compounds in treating tumors beyond those associated with the cancers mentioned above.
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 invention without undue experimentation.
The specification fails to provide enough support for the broadly claimed method of preventing and/or treating a tumor with low or no expression of NNMT gene, high levels of DNA methylase, and/or high levels of UHRF1.
Genentech Inc. V. Novo Nordisk A/S (CAFC) 42 USPQW2d 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 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 having ordinary skill in the art would have to engage in undue experimentation to determine the efficacy of compounds of Formula I in preventing tumors or treating tumors beyond those associated with the cancers previously mentioned.
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.
Claim 41 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 41 recites the following limitations:
“A is O or S” and “W is O or S” for compounds of formula I-4, I-5, and I-6.
There is insufficient antecedent basis for this limitation in the claim, as the claim is drawn to compounds of formula I. As recited in instant Claim 38, from which Claim 41 depends, a compound of formula I requires R2 and R3 to form
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. Therefore, insufficient antecedent basis exists for A or W to be defined as S as recited at instant Claim 41.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 38-48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tin-Wa (US 2007/0298132 A1; cited in non-final office action mailed December 30th, 2025; hereinafter referred to as Tin-Wa) as evidenced by CAS Registry File (2086-83-1; entered into STN November 16th, 1984, obtained from the internet December 11th, 2025; cited in non-final office action mailed December 30th, 2025; hereinafter referred to as CAS Registry File).
Applicant traversed the rejection of Claims 18-32 under 35 U.S.C. 102(a)(1) on the basis that rather than being directed to treatment of tumors defined by traditional tissue-organs, the instant invention is drawn to the treatment of new tumor subtypes. At Page 41 of the remarks filed March 23rd, 2026, Applicant states, “the skilled in the art understand that the precision treatment of tumors differs from traditional anti-cancer therapies. Compared to conventional anti-cancer methods, precision tumor treatment offers significant advantages, including superior treatment efficacy, lower drug dosages, and minimal side effects, which enhance the precision of tumor treatment, reduce adverse effects, and improve patient compliance.”
The examiner does not find this persuasive, as no discernible difference in the methodologies between that taught by Tin-Wa and the instant invention are disclosed. While the instant application enumerates specific biomarkers present, Tin-Wa teaches administration of the same compound (berberine) to the same tissue types. Therefore, though the prior art may have been unaware of the efficacy of berberine’s administration in treating tumors with the specific biomarkers present, practicing the method taught by Tin-Wa would result in the treatment of these tumors because the same compound is being administered under the same conditions. For clarity of the record, the facts outlined in the non-final rejection mailed December 30th, 2025 are detailed below in relation to the newly presented claims.
CAS Registry File teaches the elected species goes by the common name “berberine”.
At the abstract, Tin-Wa teaches berberine is an active compound for selectively inhibiting lung cancer.
At Page 2, Paragraph 0015, Tin-Wa teaches berberine has demonstrated cytotoxicity against various human cancer cell lines, and at Paragraph 0028 teaches that berberine has a selective cytotoxic profile against human lung cancer in a subject panel of human cancer cell lines and that the pure compound berberine can be used to prevent or inhibit tumor growth.
At Table 5 in Figure 7, Tin-Wa teaches an inhibitory effect of berberine against human lung cancer, human colon cancer, epidermoid carcinoma of the nasopharynx, and hormone dependent human prostate cancer.
At Page 7, Claim 11, Tin-Wa teaches a method for inhibiting growth of human lung cancer cells comprising administering an effective amount of a composition comprising berberine.
Taken together, Tin-Wa establishes a method for treating a tumor comprising administration of berberine.
Tin-Wa is silent regarding the expression levels of NNMT gene, expression of DNA methylase, expression of UHRF1, methylation level of nucleotide site of NNMT gene, and methylation level of DNA CpG site of NNMT gene in the tumor being treated, by practicing the method taught by Tin-Wa: inhibiting the growth of lung cancer cells by administering berberine, one will be treating tumors meeting the limitations of the expression levels of NNMT gene, expression of DNA methylase, expression of UHRF1, methylation level of nucleotide site of NNMT gene, and methylation level of DNA CpG site of NNMT gene, even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage in treating tumors with the recited expression levels of NNMT gene, expression of DNA methylase, expression of UHRF1, methylation level of nucleotide site of NNMT gene, and methylation level of DNA CpG site of NNMT gene of the method taught by Tin-Wa: inhibiting lung cancer cell growth by administering berberine.
MPEP 2112, I. states, “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation fort he prior art’s functioning, does not render the old composition patentably new to the discover.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562, F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Further, with respect to Applicant’s assertion that the identification of novel biomarkers in the treated tumors qualify the instantly claimed method as a “precision tumor treatment”, MPEP 2112.01, II., “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” In the instant case, the instant method is not differentiated from the method taught by Tin-Wa, as both methods are drawn to administering berberine to tissues from the same cancer types.
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 38-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-16 and 18-27 of copending Application No. 18/845,613 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they re drawn to treating a tumor wherein the tumor has low or no expression of NMT gene, and/or high expression of DNA methylase, and/or high expression of UHRF1, and/or high methylation level of nucleotide site of NNMT gene, and/or high methylation level of DNA CpG site of NMT gene comprising administering an overlapping set of compounds.
Acknowledgement is made of Applicant’s filing of a terminal disclaimer disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration dates of any patent granted over U.S. Application No. 18/845,613. This terminal disclaimer, however, was disapproved for the following reasons:
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The instantly elected species is berberine:
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This compound reads on a compound of formula I as recited at Claim 13 of the reference application when the variables are defined as follows:
R1, R2, R3, and R4 are each hydrogen.
R5 is hydrogen.
R6 is -O-R15, wherein R15 is methyl.
R7 is unsubstituted C1-alkoxy.
R8 is hydrogen.
R9 is hydrogen.
R10 is hydrogen.
R11 and R14 are each hydrogen.
R12 and R13 are connected to form an unsubstituted 5-membered heterocycloalkane.
Similarly, several of the compounds recited at claim 19 of the reference application read on a compound of Formula I as recited at Claim 38 of the instant application.
For example, the following compound is recited at Claim 19 of the reference application:
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This compound reads on a compound of formula I as recited at Claim 38 of the instant application when the variables are defined as follows:
R1 and R4 are each hydrogen.
R2 and R3, together, form a 5-membered heterocycloalkane ring.
R10 and R11 are each unsubstituted C1-alkoxy.
R12 and R13 are each hydrogen.
R9 is ethyl.
R14 is hydrogen.
Taken together, the instant claims and the reference claims are drawn to treating a common set of tumors by administering the instantly elected species, shown above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 38-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-34 of copending Application No. 18/862,584 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a method of treating a tumor comprising an overlapping set of compounds.
Applicant did not address the previously raised nonstatutory double patenting rejection over claims 25-34 of copending Application No. 18/862,584. Therefore, the rejection is applied to the newly presented claims.
Claim 25 of the reference application is drawn to a method for preventing and/or treating a tumor comprising administering a compound of formula I, wherein formula I is:
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.
Compounds of Formula I of the instant application overlap with the compounds of the reference application when the variables of Formula I of the instant application are defined as follows:
R9 is substituted or unsubstituted 3-12 membered heterocycloalkyl.
R2 and R3, together with the carbon atoms to which they are connected, form substituted or unsubstituted 3-13 membered heterocycloalkane ring.
R1, R4, R5, R6, R7, R8, R10, R11, R12, R13, and R14 are each hydrogen.
Therefore, claims 25-34 of the reference application are drawn to treating an overlapping set of tumors as instantly claimed comprising administering an overlapping set of compounds to what is instantly claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 38-49 are rejected.
Claims 50-53 stand withdrawn.
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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