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 October 17, 2022 are acknowledged and entered. Claims 1-4, 6, 8-14, 16-19 and 23-26 are pending.
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.
Priority
This application is a 371 of PCT/CN2021/087262, filed April 14,2021, which claims priority of CN 202010304917.6, filed April 17, 2020, and CN 202011594757.X, filed December 29, 2020.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on October 17, 2022; August 25, 2023; November 6, 2023; and July 3, 2024. All references have been considered except where lined through.
The information disclosure statements filed August 25, 2023 and November 6, 2023 fail to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Election/Restriction
Applicant's election with traverse of Group 1 (claims 1-4, 6, 8-11 and 23) in the reply filed on August 14, 2025 is acknowledged.
After careful consideration of Applicant’s arguments, the restriction requirement between Groups 1-4 has been withdrawn. Claims 1-4, 6, 8-14, 16-19 and 23-26 are presently under examination.
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.
Claim 25-26 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 insomnia does not reasonably provide enablement for
A method for broadly treating an orexin-associated disease including chronic obstructive pulmonary disease, obstructive sleep apnea, somnolence, anxiety, obsessive-compulsive disorder, panic, nicotine dependence or eating disorder.
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’s disclosure is only enabling for the treatment of conditions which Applicant has demonstrated may be treated by the instant compound, and of specific conditions which the art is aware can be treated by administration of an orexin receptor antagonist 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 well-established correlation between the assay and clinical efficacy. Applicants have not demonstrated nor have they alleged there is any correlation between the disclosed biological activity of Formula (I) and clinical efficacy against all diseases included in the scope of the claims. Given the direction provided by Applicant, one could not practice the full scope of the invention without undue and unreasonable experimentation.
As a general rule, enablement must be commensurate with the scope of claim language.MPEP 2164.08 states, "The Federal Circuit has repeatedly held that "the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation." In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)" (emphasis added). The "make and use the full scope of the invention without undue experimentation" language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: "A lack of enablement for the full scope of a claim, however, is a legitimate rejection." The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int'l, Inc. v. BMWofN. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
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 composition comprising formula (I). The specification teaches formula (I) is an orexin receptor antagonist (page 1, Technical Field).
Claim 25 depends from claim 1 and recites a method for treating an orexin-associated disease, comprising administering the solid pharmaceutical formulation according to claim l. Claim 26 depends from claim 25 and recites wherein the orexin- associated disease include insomnia, chronic obstructive pulmonary disease, obstructive sleep apnea, somnolence, anxiety, obsessive-compulsive disorder, panic, nicotine dependence or eating disorder.
The specification does not provide a closed definition of a “orexin-associated disease”. However, the specification teaches conditions include (see pages 1-2):
depression; anxiety; addiction; obsessive-compulsive disorder; affective neurosis; depressive neurosis; anxiety neurosis; psychotic depression disorder; behavior disorder; mood disorder; sexual dysfunction; psychosexual disorder; gender disorder; schizophrenia; manic depression; insanity; dementia; severe mental retardation and dyskinesia, such as Huntington's disease and Tourette syndrome; eating disorder such as anorexia, bulimia, cachexia, and obesity; addictive eating behavior; binge eating behavior; cardiovascular disease; diabetes; appetite/taste disorder; emesis, vomiting, nausea; asthma; cancer; Parkinson's disease; Cushing's syndrome/disease; basophilic adenomas; prolactinomas; hyperprolactinemia; pituitary gland tumor/adenomas; hypothalamic disorder; inflammatory bowel disease; stomach dysfunction; stomach ulcer; adiposogenital dystrophy; anterior pituitary disorder;
pituitary disorder; anterior pituitary hypofunction; anterior pituitary hyperfunction; hypothalamic hypogonadism; Kallmann Syndrome (anosmia, hyposmia); functional or psychogenic amenorrhea; hypopituitarism; hypothalamic hypothyroidism; hypothal amusadrenal dysfunction; sudden hyperprolactinemia; hypothalamic growth hormone deficiency; sudden growth deficiency; dwarfism; gigantism; acromegaly; disturbed biological and circadian rhythms; sleep disturbances associated with disorders such as insanity, neuropathic pain, and restless legs syndrome; heart and lung disease, acute and congestive heart failure; hypotension; hypertension; urine retention; osteoporosis; angina pectoris; acute myocardial infarction; ischemic or hemorrhagic stroke; arachnoid hemorrhage; ulcers; allergy; benign prostatic hypertrophy; chronic renal failure; kidney disease; impaired glucose tolerance; migraine; hyperalgesia; pain; increased or exaggerated sensitivity to pain, such as hyperalgesia, burning pain and allodynia; acute pain; burning pain; atypical facial pain; neuropathic pain; back pain; complex regional
pain syndromes I and II; arthritis pain; sport trauma pain; pain associated with infections such as HIV, post-chemotherapy pain; post-stroke pain; postoperative pain; neuralgia; emesis, nausea, vomiting; conditions associated with visceral pain, such as irritable bowel syndrome and angina; migraine; bladder incontinence, such as urge incontinence; tolerance to narcotic or withdrawal from narcotic; sleep disorder; sleep apnea; narcolepsy; insomnia; parasomnia; jet lag syndrome; and neurodegenerative disorder, including disease classification entities such as disinhibition-dementia-Parkinson's disease muscular
dystrophy syndrome; epilepsy; seizure disorder and other diseases associated with common dysfunction of the orexin system
The nature of the invention is thus a method of treatment with an orexin receptor antagonist. The scope of diseases treated by the method is unclear; however, at least includes the massive number of distinct conditions mentioned above including all forms of cancer and all forms of neurodegenerative disease.
The state of the prior art
The state of the prior art is not aware of any single agent or single method which treats all a orexin-associated diseases generally. Moreover, the only diseases that a person skilled in the art would recognize as treatable by instant formula (I) would be those diseases for which there is an established correlation between administration of an orexin receptor antagonist and treatment of the disease.
He et al. (US 10,100,047 B2) provides that a compound of instant formula (I) may be useful for treating a variety of diseases, including some of those claimed (see compound 5-3; col 1) ; however, He does not provide any evidence that administration of an orexin receptor antagonist has the result of treating any particular condition. He only reports in vitro data to show the compounds are orexin receptor antagonists (see Table 1); but, as noted above, in vitro assays may be used for enablement only if there is a well-established correlation between the assay and clinical efficacy. The disclosure of He does not appear to provide any evidence of clinical efficacy.
Abad et al. (Drugs & Aging 2018, 35:791-817) teaches orexin receptor antagonists have use in the treatment of insomnia (See page 798, 4.1 Orexin Receptor Antagonists). A person skilled in the art would therefore anticipate a composition comprising an orexin receptor antagonist, as is presently claimed, would likely be useful for treating insomnia.
The state of the prior art otherwise does not appear to be aware that an orexin receptor antagonist is a general treatment for the massive number of distinct conditions embraced by the instant claims.
The Level of One of Ordinary Skill
The level of skill in the art is high.
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 states the claimed invention has use in the treatment of an orexin-associated disease (page 1, Technical Field) which at least includes all of the conditions (e.g. all of cancer) discussed above.
However, no experimental or other data is provided to show the instant compounds treat any condition within the scope of the claims. The specification does not provide any guidance to one of ordinary skill in the art to extrapolate the reported biological activity of formula (I) as a orexin receptor antagonist to the treatment of all types of diseases claimed, and least of all to the many different forms of cancer included in the scope of the method. As the Supreme Court said in Brenner v. Manson, 148 USPQ at 696: “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” As U.S. Court of Customs and Patent Appeals stated In re Diedrich 138 USPQ at 130, quoting with approval from the decision of the board: “We do not believe that it was the intention of the statutes to require the Patent Office, the courts, or the public to play the sort of guessing game that might be involved if an applicant could satisfy the requirements of the statutes by indicating the usefulness of a claimed compound in terms of possible use so general as to be meaningless and then, after his research or that of his competitors has definitely ascertained an actual use for the compound, adducing evidence intended to show that a particular specific use would have been obvious to men skilled in the particular art to which this use relates.
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 and unreasonable experimentation.
This rejection could be overcome by amending the claims to recite a method of treating insomnia. Applicant is also encouraged to submit evidence which shows a composition comprising formula (I) may have efficacy in treating additional conditions of the instant claims.
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 1-4, 6, 8-11, 23 and 25-26 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:
In claim 1, “an effective amount” of the active ingredient would be required to be present for the pharmaceutical formulation to be effective. Insertion of the phrase “an effective amount” following “comprises” is suggested to indicate that what is intended. Claims 2-4, 6, 8-11, 23 and 25-26 depend from claim 1, do not cure the above mentioned deficiency, and therefore are also indefinite.
Claim 25 recites an “orexin-associated disease” which is indefinite because the scope of such a disease has not been defined by the specification (see pages 1-2, orexin receptor associated with disorders such as anorexia…cancer…heart and lung disease…). An “orexin-associated disease” thus appears to encompass a massive number of distinct conditions and based on the specification one skilled in the art could not say which diseases/conditions are included in the scope of the claim. Examiner suggests amending the claim to recite specific orexin-associated diseases for which Applicant has written support.
Claim 25 recites a method of treating disease; however, does not recite “a subject”. Examiner suggests amending the claim to recite treatment in a subject in order to clarify what Applicant intends. Claim 26 depends from claim 25, fails to cure this deficiency, and is therefore also indefinite.
Claim 26 is indefinite for reciting improper Markush language. The claim recites “orexin-associated disease include”. The term “include” is synonymous with “comprise” and therefore the scope of the claim is open ended. See MPEP 2111.03. The term “include” should be amended to recite “consisting of” as in, for example, “disease is selected from the group consisting of…”
The relevant portion of MPEP 2173.05 (h) is pasted below:
A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022) (each independent claim recites "a selection from the group comprising a person, an animal, an animated character, a creature, an alien, a toy, a structure, a vegetable, and a fruit." … (emphasis added). "Given the breadth of variation among the specified alternatives and the use of the open-ended word ' comprising' to define the scope of the list, we affirm the Board's conclusion that the pending claims recite improper Markush language and are indefinite under § 112(b)."). If a claim is intended to encompass combinations or mixtures of the alternatives set forth in the Markush grouping, the claim may include qualifying language preceding the recited alternatives (such as "at least one member" selected from the group), or within the list of alternatives (such as "or mixtures thereof"). Id. at 1281. See also MPEP § 2111.03
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, 8 and 25-26 is/are rejected under 35 U.S.C. 103 as being obvious over He et al. (US 10,100,047 B2; published October 16, 2018) (hereinafter “He”) in view of Healthline (Tablets vs. Capsules, published February 2020) (hereinafter “Healthline”) and Tran (Size Does Matter, Harbor Compound Pharmacy, October 2019) (hereinafter “Tran”).
He teaches a generic group of compounds which embraces applicants’ claimed compounds (See col 3; claims 1-9) for use as pharmaceuticals and compositions for the treatment of orexin associated diseases (see col 1). The claims differ from the reference by reciting specific species and a more limited genus than the reference. However, it would have been obvious to one having ordinary skill in the art at the time of the invention to select any of the species of the genus taught by the reference, including those instantly claimed, because the skilled chemist would have the reasonable expectation that any of the species of the genus would have similar properties and, thus, the same use as taught for the genus as a whole. One of ordinary skill in the art would have been motivated to select the claimed compounds from the genus in the reference since such compounds would have been suggested by the reference as a whole. It has been held that a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. In re Susi, 440 F.2d 442, 169 USPQ 423, 425 (CCPA 1971), followed by the Federal Circuit in Merck & Co. v. Biocraft Laboratories, 847 F.2d 804, 10 USPQ 2d 1843, 1846 (Fed. Cir. 1989).”
In particular, He teaches compound 5-3 and composition comprising compound 5-3 (col 33, lines 1-20; claim 8; claim 9) which corresponds to instant Formula (I) wherein Z is N, n is 1 and Ra is fluorine. He teaches compound 5-3 is an inhibitor of orexin (Table 1) and that orexin receptors are found in the brain of many warm-blooded animals and are involved in many diseases including insomnia (col 1, Background of Invention). He thus teaches instant Formula (I) may have an effect in treating disease.
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He is silent regarding wherein the form of the composition is a solid formulation; however, Healthline (Tablets vs. Capsules, published February 2020) teaches tablets are the most common types of pill. They are inexpensive, safe and an effective way to deliver oral medication. Taken together, He and Healthline are silent regarding particle size; however, Tran teaches micronized drug particles improve drug bioavailability because the smaller the particle the greater the solubility of the drug (page 1, Size Does Matter: The Importance of Micronized Drugs; pages 1-2 Small Drug Particle Sizes Improve Bioavailability). Tran teaches the particle size of a micronized drug is less than 50 micron (page 3, paragraph 1). Tran teaches highest quality products are those wherein 95% of the drug particles are below 50 micron (page 4). Tran therefore teaches wherein 90% of drug particles are size ≤ 50 µm as recited in claim 1.
The difference between the prior art and the instant claims is that the instant claims recite wherein the composition is a solid formulation wherein particle size of Formula (I) is D90≤ 50 µm; however, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the composition comprising Formula (I) of He into a tablet (solid formulation) wherein particle size of Formula (I) is D90≤ 50 µm because tablets where an effective way to deliver oral medication and it was known particle sizes less than 50 µm improved bioavailability.
One would have been motivated as a matter of trying to develop a method for treating an orexin related disease and because tablets were safe, inexpensive and effective. One would have chosen the claimed particle size because good bioavailability typically improves drug efficacy.
One would have had a reasonable expectation of success because a composition comprising the claimed compound was already known and it was further known that compounds could be administered as tablets.
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, 8 and 25-26 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,100,047 B2 in view of Healthline (Tablets vs. Capsules, published February 2020) (hereinafter “Healthline”) and Tran (Size Does Matter, Harbor Compound Pharmacy, October 2019) (hereinafter “Tran”).
Ppatent claim 1 recites a compound of formula (I). Patent claim 8 depends from claim 1 and is drawn to instant Formula (I) (pictured below for convenience)
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Patent claim 9 recites a pharmaceutical composition. Patent claim 10 recites a method of treatment.
The patent claims are silent regarding wherein the composition is a solid formation and wherein the particle size of Formula (I) is D90≤ 50 µm; however, these limitations are taught by Healthline and Tran as discussed in the above rejection. The teachings of Healthline and Tran are incorporated herein by reference.
The difference between the patent claims and the instant claims is that the instant claims recite wherein the composition is a solid formulation wherein particle size of Formula (I) is D90≤ 50 µm; however, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the patented composition into a tablet (solid formulation) wherein particle size of Formula (I) is D90≤ 50 µm for the reasons provided above and which are incorporated herein by reference.
Allowable Subject Matter
Claims 12-14, 16-19 and 24 are allowable.
Claims 3-4, 6, 9-11 and 23 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest reference to the instant claims is He et al. (US 10,100,047 B2) (hereinafter “He”) which was discussed in the rejections herein. He teaches a composition comprising instant formula (I); however, He is silent regarding wherein the composition requires specific amounts of Formula (I) and additional agents (e.g. a binder, a lubricant, a filler…). Further, He does not teach any method of preparing a tablet as is claimed. There is no teaching which would have motivated a person of ordinary skill in the art, before the effective filing date of the instant application, to modify He into claimed invention with any reasonable expectation of success.
Conclusion
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September 1, 2025
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624