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
The amendments to the claims filed January 12, 2026 are acknowledged and entered. Claims 1-2, 5, 8-10, 12-15, 17-19, 22, 28-29, 33 and 35-37 are pending.
Priority
This application is a 371 of PCT/US2023/019121, filed April 19, 2023 which claims priority of SE2250473-2, filed April 19, 2022.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on December 19, 2025 and January 12, 2026. All references have been considered except where marked with a strikethrough.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Claim Objections
Claim 1 is objected to because it recites “or pharmaceutically acceptable salts, polymorphs, stereoisomers, and tautomers”. A “Markush” claim should recite a list of alternatively useable members (see MPEP 2117). It is suggested that the claim be amended to recite alternative members in singular and alternative form (e.g. or a pharmaceutically acceptable salt… or tautomer thereof). Claims 2, 5, 8-10, 12-15, 17-19, 22, 28-29 and 37 recite “and tautomer” and should recite “or tautomer”
Claim 33 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112a
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 1-2, 5, 8-10, 12-15, 17-19, 22, 28-29 and 37 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 a compound of formula (I) or a pharmaceutically acceptable salt, stereoisomer or tautomer thereof does not reasonably provide enablement for a polymorph of formula (I).
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.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation. (United States v. Teletronics Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is needed is not based on a single factor, but rather a conclusion reached by weighing many factors (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). These factors include the following:
1) The nature of the invention and predictability in the art. The invention is directed toward a polymorph of formula (I). The specification does not define “polymorph”. Encyclopedia Britannica defines polymorphism as the condition in which a solid chemical compound exists in more than one crystalline form. A polymorph of the claims would thus be regarded as a solid form of formula (I) that exists in more than one crystalline form.
Regarding predictability in the art, chemistry is generally regarded as unpredictable (see MPEP 2164.03). In the present case, predicting which chemical compounds form crystalline polymorphs cannot be made based on chemical structure alone.
2) Amount of guidance provided by applicant. There is no direction provided regarding how one skilled in the art would make the claimed invention. The specification fails to teach any polymorphs of the claimed invention. There is no compound of formula (I) disclosed that exists in different crystalline forms. Furthermore, no disclosure is provided to teach how one would prepare or obtain otherwise a polymorph of formula (I) as is claimed.
3) Number of working examples. As noted above, applicant has provided no working examples that illustrate the clamed invention or the preparation of the claimed polymorph.
4) Scope of the claims. The scope of the claims involves all of the thousands of possible polymorphs of a compound of formula (I). Thus, the scope of the claims is very broad.
5) Level of skill in the art. The artisan using applicant' s invention would be a chemist with a Ph.D. degree and having several years of bench experience.
6) Undue experimentation. MPEP §2164.01 (a) states, "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)."
The conclusion is clearly justified here that Applicant is not enabled for the full scope of the claims.
Claim 35 is 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 a method of treating systemic or tissue inflammation, which includes inflammatory responses, and a method of treating autoimmune and allergic processes, viral infections, and fibrosis,
does not reasonably provide enablement for
A method of treating cancer generally, treating metabolism, treating cellular activation and proliferation, or preventing viral infections.
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.
Applicant teaches that a compound of formula (I) is a bromodomain inhibitor (page 3; pages 146-147). However, bromodomains are not known to be associated with all diseases of the instant claims. Applicant’s disclosure is only enabling for the treatment of conditions which Applicant has demonstrated may be treated by the instant compound, and of conditions which the prior art is already aware may be treated by a compound with the disclosed activity and for which Applicant has written support. Case law is clear on this point. In an unpredictable art, such as drug therapy to treat disease, models may be used for enablement only if there is a reasonable correlation between the activity in question and the asserted utility. Given the guidance provided by Applicant, one skilled in the art would not be able to practice the full scope of the invention without undue experimentation.
In evaluating the enablement question, several factors are to be considered. Note In re Wands, 8 USPQ2d 1400 and Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed. The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations.
The nature of the invention & breadth of claims:
Claim 1 is drawn to a compound of formula (I).
Claim 35 depends from claim 1 and recites a method of treating an individual suffering from a disease or condition comprising administering to the individual suffering from the disease a compound of claim 1, wherein the disease or condition is selected from the group consisting of systemic or tissue inflammation, inflammatory responses to infection or products of infectious organisms or hypoxia, autoimmune and allergic processes, cellular activation and proliferation, cancer, metabolism, fibrosis, and in the prevention and treatment of viral infections.
Prevention is not defined in the specification. Merriam-Webster dictionary defines prevention as to keep from happening or existing. In view of this definition, prevention of disease as claimed would be understood to mean the disease is kept from occurring or existing.
The specification does not provide a complete definition of cancers embraced by the claims.
No definition of diseases embraced by “metabolism” or “cellular activation and proliferation” is provided.
The nature of the invention is a method of treating disease comprising administration of a bromodomain inhibitor (formula (I)). Because no definition of diseases embraced by the claims is provided, the scope of the claim is very broad including at least a general method of treating all cancers known in the art and any condition embraced by “metabolism” and “cellular activation and proliferation”.
The state of the prior art
State of the prior art reference Zaware et al. (Nature Structural & Molecular Biology, 2019, vol 26, 870-879) teaches bromodomain (BrD) inhibition offers an effective means to target Myc oncogenic activity and was shown to block cell growth in a wide variety of cancers, including acute myeloid leukemia, Burkitt’s lymphoma, multiple myeloma, lung adenocarcinoma, neuroblastoma, a genetically diverse glioblastoma, castration-resistant prostate cancer, and basal-like breast cancer. BET inhibitors have also been used to study HIV latency, autoimmune disorders and Th17 pathology118, and the role of transcriptional pause release in heart failure, among many other viral, autoimmune and inflammatory diseases (page 876, col 2, paragraph 1). Zaware further teaches BrD inhibitors are being investigated for diabetes, coronary artery disease, atherosclerosis, dyslipidemia and cardiovascular diseases (page 876, col 2, paragraph 2).
While the state of the prior art recognizes an association of BrD inhibitors with some forms of disease, the state of the prior art is not aware that such a compound prevents viral infection or generally treats a disorder embraced by metabolism or cellular activation and proliferation
As per the broad treatment of cancer, no compound has ever been found to treat cancers of all types generally as is presently claimed. 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 any pharmaceutical agents that are useful in the treatment of cancer generally. 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” (see the enclosed article, page 1004). 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. Indeed, the existence of such a "silver bullet" is contrary to our present understanding in oncology. 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 environment 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 Cortright, 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 applicants’ 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 (Journal of Hematology & Oncology 2022 (15) 143) 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 (Abstract). Wu teaches that there are 21 different approved drugs for treating lung cancers, some of which have different cellular targets (Table 1, page 5). Similarly, breast cancer (see Table 2, page 10) has 22 different drugs that have varied cellular targets and are indicated for different types of breast cancer. More still, Table 4 (page 17) indicates that there are 17 different drugs available to treat different forms of gastrointestinal cancers. See also Table 6 (page 25), drugs approved for urologic cancers, Table 7 (page 28), drugs approved for skin cancers, and Table 8 (page 33), drugs approved for thyroid cancer. Wu further provides an illustration summarizing the protein structure of some cellular targets and the binding site of their respective drugs (Fig 12, page 38). Taken as a whole, Wu teaches that no single therapeutic has ever been identified as a treatment for all forms of cancer; and closer examination of Fig 12 provides a logical explanation: As highlighted in Fig 12, molecular protein targets implicated in different cancers (e.g. EGFR for lung cancer (see Table 1), VEGFR2 for gastric cancer (see 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 the 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 molecular targets of cancer, all of which all 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.
The state of the prior art and current state of the art thus are not aware of any “silver bullet” drug therapy to treat all forms of cancers as is claimed presently, at least for the reason that persons skilled in the art recognize that different forms of cancer have different treatment requirements and therefore require different drug therapies.
The Level of One of Ordinary Skill
The level of skill in the art is high. The artisan using the claimed invention would be a person with medical training such as a medical doctor or physician with an MD degree or the equivalent.
Predictability in the art
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. Pharmacological activity in general is a very unpredictable area. 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).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Amount of guidance/working examples
Applicant provides in vitro data to show that a compound of formula (I) inhibits bromodomains (pages 3 and 146-147) thus suggesting that the claimed invention may have use in the treatment of systemic or tissue inflammation, autoimmune and allergic processes, viral infections and fibrosis.
However, no experimental or other data is provided to show the instant compounds may have use in the treatment of the full scope of diseases claimed, and least of all those conditions for which there is no known association with bromodomains. The specification does not provide any guidance to one of ordinary skill in the art to extrapolate the in vitro data provided by Applicant to the treatment of the many different forms of disease included in the scope of the method.
As per “prevention”, it is presumed “prevention” of the claimed disease would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted. Nothing in the specification teaches how one skilled in the art identifies a subject who’s disease will be prevented.
The quantity of experimentation needed:
MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on theevidence 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)."
That conclusion is clearly justified here and one skilled in the art could not practice the full scope of the claimed invention without undue experimentation.
Claim Rejections - 35 USC § 112b
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 35-36 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. The claims are indefinite for the reasons that follow:
Claim 35 recites the limitations “cellular activation and proliferation” and “metabolism”. These limitations render the scope of the claim indefinite because the specification does not provide any definition of diseases embraced by these terms. Cellular activation, proliferation, and metabolism are all normal physiological processes and so it is not clear what Applicant intends by a disease that is “cellular activation and proliferation” or “metabolism”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 35 recites the broad recitation “systemic or tissue inflammation” and the claim also recites “inflammatory response to infection…hypoxia” which are the narrower statement of the range/limitation for the reason that “inflammatory responses” are embraced by “system or tissue inflammation”.
Claim 36 recites the broad recitation “dermatitis” and the claim also recites “eczema” and “atopic dermatitis” which are the narrower statement of the range/limitation. “Dermatitis” embraces both “eczema” and “atopic dermatitis”. Claim 36 additionally recites the broad recitations “lung fibrosis”, “gout”, “leukemia”, “kidney cancer”, “skin cancer”, “lung cancer”, “brain cancer”, “intestinal cancer” and the claim also recites “idiopathic pulmonary fibrosis”, “acute gout”, “acute lymphoblastic leukemia…chronic lymphocytic leukemia, chronic myelogenous leukemia”, “renal tumours...renal cell carcinoma“, “melanoma”, “small cell lung cancer, non-small cell lung cancer”, “neurological tumors…glioblastoma multiforme, glioma”, “colon carcinomas …colorectal cancer…small intestine cancer”, which are the narrower statement of the broader limitation, respectively. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 present in the application indicating obviousness or nonobviousness.
Claims 1-2, 5, 9, 12-13, 17 and 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teuber et al (WO 2016016316, cited by Applicant in IDS filed December 19, 2025) (hereinafter “Teuber”)
Teuber teaches a generic group of compounds of formula (I) which embraces applicants’ claimed compounds (See claim 1, formula (I); pictured below for convenience) for use as pharmaceuticals and compositions (claim 39) for the treatment of inflammation including psoriasis (claims 40-41). Teuber teaches 3-(dimethylaminomethyl)-N-(2-hydroxy-4-methyl-6-quinolyl)-5-pyrrolidin-1-yl-1H-indole-6-carboxamide (Compound-85, page 183; pictured below for convenience) which corresponds to a tautomer of instant formula (I) wherein R1 and R2 are each hydrogen; Y is -C(R7)- wherein R7 is hydrogen; A is a 5 membered heteroalicyclic ring (pyrrolidinyl); and ring
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corresponds to a substituted 5 membered heteroaryl.
The only difference between Teuber and the instant claims is that the claims require wherein ring
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is cycloalkyl (X is -C(R4R5)-) or heteroalicyclic (X is -S-, -O-, or -N(R6)-). However, Teuber discloses that the ring
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can be cycloalkyl or heteroalicyclic as required by the claims (see claim 1, formula (I), R10a, R10b, R11a and R11b are taken together to form substituted or unsubstituted C3-8 cycloalkyl or substituted or unsubstituted C2-9 heteroalicyclyl). Teuber thus teaches that ring
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of the instant claims may alternatively be 5 membered heteroaryl, cycloalkyl and heteroalicyclic.
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It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Teuber into the claimed invention by exchanging the 5-membered heteroaryl ring of Compound-85 corresponding to
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for a cycloalkyl or heteroalicyclic as required by the claims because Teuber disclosed that the ring corresponding to
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could alternatively be 5 membered heteroaryl, cycloalkyl or heteroalicyclic.
One would have been motivated as a matter of practicing the invention of Teuber to prepare additional compounds of formula (I) for use in treating inflammatory disease. One would have been especially motivated to make the modification because Teuber specifically taught that the claimed compounds where embraced by formula (I).
One would have had a reasonable expectation of success because Teuber disclosed that the ring corresponding to
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could alternatively be 5 membered heteroaryl, cycloalkyl or heteroalicyclic. One wishing to practice the invention of Teuber could have been reasonably expected to select modifications embraced by the invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5, 9, 12-13, 17 and 35-36 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-37 of U.S. Patent No. 10,752,640. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the patent claims.
Patent claim 1 is drawn to a compound of formula (I)
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.
Patent claim 33 depends from claim 1 and recites wherein the compound is 3-(dimethylaminomethyl)-N-(2-hydroxy-4-methyl-6-quinolyl)-5-pyrrolidin-1-yl-1H-indole-6-carboxamide which corresponds to Compound-85 in the above rejection over Teuber.
Patent claims 35-36 depend from claim 1 and recite a method of treating inflammatory diseases including dermatitis.
The only difference between the patent claims and the instant claims is that the instant claims require wherein ring
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is cycloalkyl (X is -C(R4R5)-) or heteroalicyclic (X is -S-, -O-, or -N(R6)-). However, patent claim 1 permits that the ring corresponding to
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can be cycloalkyl or heteroalicyclic as required by the instant claims (see claim 1, col 564, R10a, R10b, R11a and R11b are taken together to form substituted or unsubstituted C3-8 cycloalkyl or substituted or unsubstituted C2-9 heteroalicyclyl).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the patented compounds into the claimed invention because the patent claims embraced wherein the ring corresponding to
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of instant formula (I) could be cycloalkyl or heteroalicyclic as required by the claimed invention.
One would have been motivated as a matter of practicing the patented invention to prepare additional compounds for use in treating inflammatory disease.
One would have had a reasonable expectation of success because formula (I) of the patent claims embraced the compounds of the instant claims. It would have been reasonable to expect that one wishing to practice the patented invention would select modifications that were embraced by the patented invention.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The closest reference to the invention set forth in instant claim 33 is Teuber et al (WO 2016016316) which was discussed in the rejection herein. The claimed compounds have two or more differences from the compounds disclosed in Teuber. There is no teaching which would have motivated one of ordinary skill in the art before the effective filing date of the instant application to modify Teuber into the specific compounds claimed with any reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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, Jeffrey Murray can be reached on (571) 272-9023. 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.
July 30, 2026
/KEVIN S MARTIN/Examiner, Art Unit 1624
Prosecution Insights