CTNF 18/722,189 CTNF 99723 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 12-151 AIA 26-51 12-51 Status of Claims Claims 1-14 are pending in the instant application. Claims 2-14 are amended via the amendment filed June 20 th , 2024. Priority This is a 35 U.S.C. 371 National Stage filing of International Application No. PCT/EP2022/086965 filed December 20 th , 2022, which claims priority under 35 U.S.C. 119(a-d) to EP21216872.8, filed December 22 nd , 2022. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) Information Disclosure Statement The Information Disclosure Statement (IDS) filed December 5 th , 2024 was considered by the Examiner. 07-30-03-h AIA Claim Interpretation The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. For the purposes of examination, claim 13 is being interpreted as a method of treatment and/or prevention of respiratory disorder, sleep-related respiratory disorders, obstructive sleep apnea, central sleep apnea and snoring in human and animals, said method comprising administering to humans and animals in need thereof the medicament as defined in claim 11. Claim Rejections - 35 USC § 112(b) 07-30-02 AIA 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. 07-34-01 Claims 9, 11 and 13-14 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 14 is indefinite as being a use claim . The claim lacks the requisite method steps. See MPEP 2173.05(q): Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101 . In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid." Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim. Similarly, claim 9 is directed toward “A use of the combination as denied in claim 1 for production of a medicament for the treatment and/or prevention of respiratory disorders, sleep related disorders, sleep-related respiratory disorders, obstructive sleep apnea, central sleep apnea and snoring” As written, the claim is unclear as there are no steps to perform for a method within the text of the claim. Refer to MPEP 2173.05(q). Claim 11 recites the limitation "the medicament" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is recommended that Applicant amend claim 11 to depend from claim 10 to overcome the rejection. 07-34-05 AIA Claim 13 recites the limitation " the method " in line 1 . There is insufficient antecedent basis for this limitation in the claim. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim (s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delbeck et al (WO 2021/089683 A1, published May 14 th , 2021, as cited on the IDS) . Determining the scope and contents of the prior art. (See MPEP § 2141.01) Delbeck teaches the following compound (page 129): PNG media_image1.png 120 368 media_image1.png Greyscale . This compound is embraced by instant formula (I), wherein R 6 is PNG media_image2.png 99 133 media_image2.png Greyscale , wherein R 7 is hydrogen and alkyl, m is 1, X is S, Z is CR 4 , wherein R 4 is hydrogen, Y is N, R 3 is H, n is 1, R 2 is hydrogen and R 1 is a 6-memebered heteroaryl, substituted with 2 halogens. Delbeck further teaches that the compound above can be used alone, or in combination with one or more other pharmacologically active substances (page 58, paragraph 8). Delbeck teaches that the other pharmacologically active substance is a noradrenaline reuptake inhibitor, with preference, atomoxetine and reboxetine (page 59, paragraph 6). Further, Delbeck teaches a method for the treatment and/or prevention of breathing difficulties including sleep-induced breathing difficulties such as central and obstructive sleep apnea, snoring (primary and obstructive snoring), dysphagia, peripheral and cardiac vascular disorders including diabetic microangiopathies and disorders of the peripheral and central nervous system including neurodegenerative and neuroinflammatory disorders in humans and animals by administration of an effective amount of at least one compound, such as the one found above (claim 16). Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02) The prior art does not explicitly teach a combination of a compound of instant formula (I) with a noradrenaline reuptake inhibitor. Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143) While Delbeck does not explicitly teach a combination of the above compound and atomoxetine, Delbeck does teach combinations of pharmaceutically active substances in which the aforementioned combination is included. A person having ordinary skill in the art would have been motivated to screen the example compounds in combinations of the prior art to determine which would provide optimum treatment outcome. As such, one of ordinary skill in the art would have used the general teachings of Delbeck to arrive at the instant combination of claim 1 . Regarding claim 2 , as seen in the compound above, X, Y and Z, are selected to form PNG media_image3.png 86 110 media_image3.png Greyscale , R 1 is pyridinyl, substituted with fluorine, R 2 is hydrogen, R 3 is hydrogen, R 4 is hydrogen, R 5 is hydrogen and R 6 is of formula a), wherein R 7 is alkyl and R 7 ’ is hydrogen, n is 1 and m is 1. Regarding claim 3 , as seen in the compound above, X, Y and Z form 1,3-thiazolyl, R 1 is pyridinyl, R 2 is hydrogen, R 3 is hydrogen, R 4 is hydrogen, R 5 is hydrogen and R 6 is of formula a), wherein R 7 is methyl and R 7 ’ is hydrogen, n is 1 and m is 1. Also, the noradrenaline reuptake inhibitor is atomoxetine. Regarding claims 4-7 , the compound above is N-[(3,5 -Difluoropyridin-2-yl)methyl]-2-[(3R)-3 -methyl[1,4'-bipiperidin] -1'-yl] -1,3 -thiazole-5-carboxamide and the noradrenaline reuptake inhibitor is atomoxetine. Regarding claims 8 , the claim recites “for use in a method of treatment and/or prevention…” which is intended use and the claim limitation is met by the compound mixture of claim 1. Claim 14 further places limitations on the diseases of claim 8, which again, is an intended use. Regarding claim 9 , “a use of the combination” is also considered intended use and the claim limitation is met by the combination of claim 1. Regarding claim 10 , Delbeck teaches medicaments with the combination above and one or more inert, non-toxic, pharmaceutically suitable excipients (pages 66-67). Regarding claim 12 , the claim recites “for use in a method of treatment and/or prevention…” which is intended use and the claim limitation is met by the medicament of claim 10. Regarding claim 11 , Delbeck teaches that serotonin reuptake inhibitors may also be used in the combination (Page 59). Regarding claim 13 , as seen above, Delbeck teaches a method for the treatment and/or prevention of breathing difficulties including sleep-induced breathing difficulties such as central and obstructive sleep apnea, snoring (primary and obstructive snoring), dysphagia, peripheral and cardiac vascular disorders including diabetic microangiopathies and disorders of the peripheral and central nervous system including neurodegenerative and neuroinflammatory disorders in humans and animals by administration of an effective amount of at least one compound, such as the one found above (claim 16). Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5. 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, Clinton A Brooks can be reached at (571)270-7682. 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. /A.G.K./Examiner, Art Unit 1626 /FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699 Application/Control Number: 18/722,189 Page 2 Art Unit: 1626 Application/Control Number: 18/722,189 Page 3 Art Unit: 1626 Application/Control Number: 18/722,189 Page 4 Art Unit: 1626 Application/Control Number: 18/722,189 Page 5 Art Unit: 1626 Application/Control Number: 18/722,189 Page 6 Art Unit: 1626 Application/Control Number: 18/722,189 Page 7 Art Unit: 1626 Application/Control Number: 18/722,189 Page 8 Art Unit: 1626 Application/Control Number: 18/722,189 Page 9 Art Unit: 1626
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