DETAILED ACTION
Status of Application
Claims 1-20, filed 10/29/2024, are pending in this action. Claims 1-20 are currently under consideration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application is a 371 of PCT/US2023/020001, filed April 26, 2023, which claims benefit of provisional U.S. Application No. 63/363,883, filed April 29, 2022.
Inventorship
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.
Specification
The lengthy specification (38 pages, exclusive of claims) 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 errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
The specification teaches that the content of compound I in the disclosed compositions can be, e.g., “up to about 150 mg (w/w)” (Page 5) that is unclear. In the present case, it is not clear how the term “w/w” clarifies the concentration/amount of the disclosed compound. Similar is applied to expressions “2,500 mg wt%” (Page 6), “√kPa” (Page 22). Clarification is required.
The specification comprises multiple acronyms, e.g., PAH (Page 10), RH (Page 13), BGJ (Page 17), FDKP (Pages 20, 33), ALK-4, ALK-5, ALK-7 (Page 23), GnF2, HK1 (Page 24), CDK, MAPP (Page 25), “g*” (Page 29) without proper definitions. The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
The data provided in the specification are unclear, given that the data are shown without units of measurements, e.g., 60%, 20%, 40%, 50% (Pages 13, 15-18, 27-28). Appropriate correction is required.
Information Disclosure Statement
The information disclosure statements, filed 10/29/2024, 04/21/2025, 02/09/2026, 06/10/2026, are acknowledged and have been considered. In the present case, it is noted that the applicant has submitted oversized information disclosure statements (26 pages) without specifically pointing out where relevant material can be found in each of the references. As a result, the examiner has considered said information disclosure statements to the extent permitted by the allotted time for such consideration and consistent with the MPEP. Please see the attached initialed PTO-1449.
Claim Rejections - 35 USC § 112(b)
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 1-20 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 pre-AIA the applicant regards as the invention.
Claim 1 discloses “compositions comprising a dry powder”, whereas claims 5, 6 (both dependent on claim 1) disclose the dry powder compositions. In the present case, the structure of the claimed product is not clearly delineated. Similar is applied to claims 7, 8. Clarification is required.
Claim 2 (dependent on claim 1) recites the limitation “effective dose is in an amount of up to 50 mg and one or more pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier and/or excipients” that is unclear. In the present case, it is unclear what is defined as “a dose”. Is it 50 mg of the composition disclosed in claim 1 in combination with additional constituents (i.e., salt, excipients, carriers)? Clarification is required.
Claim 3 (dependent on claim 1) recites the limitation “carrier and/or excipient is a surfactant, an amino acid, or a phospholipid” that is unclear. To this point, it is noted that “surfactant” is a chemical compound that decreases the surface tension or interfacial tension between two liquids, a liquid and a gas, or a liquid and a solid (see Wikipedia), i.e., between different phases. Therefore, it is unclear what is understood as a surfactant in the claimed dry power composition. Clarification is required.
Claim 5 recites the term "about" that is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claims 10, 11. Clarification is required.
Claim 7 (dependent on claim 1) recites the limitation “the dry powder comprises one or more pharmaceutically acceptable carrier and/or excipients”. To this point, it is noted that independent claim 1 discloses compositions comprising a pharmaceutically acceptable carrier (i.e., singular) and/or excipient (i.e., singular). Therefore, it is unclear how claim 7 narrows the scope of the claim upon which it depends. Similar is applied to claim 8, as well as to claims 12, 15-17. Clarification is required.
Claim 10 recites the limitation “particles have a specific surface area ranging from about 25 m2/g to about 63 m2/g” that is unclear and indefinite. To this point, it is noted that where a claimed value (i.e., specific surface area) varies with its method of measurement and several alternative methods of measurement are available (see Wikipedia), the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. See Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). Therefore, the values of said parameter are incomplete insofar as said claim does not specify the frame of reference used to measure it. Therefore, the metes and bounds of the claimed subject matter are not reasonably clear. Similar is applied to claim 11. Clarification is required.
Claim 16 recites the limitation “carrier and/or excipient are sodium citrate, sodium chloride, leucine or isoleucine, or trehalose” that is not reasonably clear. Does this limitation define a carrier/excipient as a mixture of recited compounds? Clarification is required.
Claim 17 discloses “The method of treating pulmonary arterial hypertension of claim 11” that is unclear, because claim 11 discloses the pharmaceutical dry powder composition. Therefore, it is unclear how claim 17 narrows the scope of the claim upon which it depends. Similar is applied to claim 18. Clarification is required.
Claims 4, 9, 13, 14 are rejected as being dependent on rejected independent claims 1 and 12 and failing to cure the defect.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fabio et al., US 2018/0221280 A1 (cited in IDS; hereinafter referred to as Fabio), in view of Bullough et al., WO 2022/235621A1 (cited in IDS; hereinafter referred to as Bullough), and Barrett et al., US 2015/0175624 (cited in IDS; hereinafter referred to as Barrett).
Fabio teaches dry powder compositions suitable for inhalation, wherein said dry compositions can be an amorphous powder (Abstract; Para. 0002, 0009, 0021 as applied to claims 1, 6), and wherein said compositions may include:
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(i) diketopiperazines, e.g., fumaryl dikepiperazine, i.e., bis-3,6-(N-fumaryl-4-aminobutyl)-2,5-diketo-diketopiperazine (shown on the right) particles in a crystalline microparticle form (Para. 0010, 0060-0062 as applied to claims 1, 4, 12, 17);
(ii) polysorbate 80 (i.e., surfactants/carriers/excipients; Para. 0010 as applied to claim 3, 7, 9, 15);
(iii) amino acids, e.g., leucine, isoleucine, trileucine, methionine (i.e., carriers/excipients; Para. 0011 as applied to claims 3, 7, 8, 15, 16);
(iv) zinc citrate, mono-sodium tartrate, sodium citrate, trisodium citrate, zinc chloride (i.e., carriers/excipients; Para. 0011-0013 as applied to claim 7, 8, 15, 16);
(v) polyvinylpyrrolidone (i.e., carriers/excipients; Para. 0038, 0041 as applied to claims 7, 15).
Fabio teaches that said compositions can be used for oral inhalation (Para. 0100 as applied to claim 12), and also teaches that said compositions can be delivered by using a dry powder inhalation system comprising an inhaler that can be used with a unit dose cartridge or capsule for multiple use, a single use inhaler with an integrally built-in container for single use, or a multidose inhaler provided with a plurality of doses integrally configured with the inhaler (Para. 0009, 0050, 0051 as applied to claims 13, 14).
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Though Fabio teaches that said compositions may also include a large variety of drugs to be delivered to lungs (Para. 0049, 0050, 0058, 0068), Fabio does not teach that said compositions also include the drug having a chemical structure as recited in claims 1 and/or 12 (shown on the right) to be used for the treatment of idiopathic pulmonary fibrosis (claims 1-20).
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Bullough teaches the use of dry powder and metered-dose formulations for therapeutic inhaled delivery of ALK5 (TGF-βR1) inhibitor for oral treatment of idiopathic pulmonary fibrosis (Title; Abstract; Para. 001, 006-010, 025, 029-031, 086). To this point, Bullough teaches the use of dry powder formulations comprising the active compound having structure as instant claimed (shown on the right; Para. 019). Bullough teaches that said dry powder formulations may include: (i) amino acids, e.g. glycine, methionine, leucine, isoleucine (Para. 0176, 0242-0246); (ii) sodium chloride, sodium citrate, zinc salts, polyvinylpyrrolidone (Para. 0176, 0224 0242-0245); (iii) lactose, mannitol, trehalose (Para. 0199, 0212-0214), (iv) phospholipids (Para. 0220); and also may include (v) diketopiperazines (Para. 0236).
Barrett teaches the use of 2-(4-methyl-1-(6-methylpyridin-2-yl)-1H-pyrazol-5-yl)thieno[3,2-c]pyridine (Para. 0038), i.e., the compound as instantly claimed and/or structural analogs thereof (Examples) for treatment of pulmonary fibrosis (Claims 25, 27; Para. 0038, 0039, 0096). Barret teaches that said active compound can be included into dry powder compositions (Para. 0081, 0083, 0084) comprising amino acids, e.g., glycine (Para. 0074, 0076), lactose (Para. 0083), and can be administered via inhalation (Para. 0088, 0097).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use/try/include 2-(4-methyl-1-(6-methylpyridin-2-yl)-1H-pyrazol-5-yl)thieno[3,2-c]pyridine as taught by Bullough and Barret into the dry powder composition as taught by Fabio. One would do so with expectation of beneficial results, because Fabio teaches dry powder compositions comprising active agents that are suitable for pulmonary delivery by oral inhalation, and wherein said compositions are highly stable at increased temperatures and relatively high humid environments, and are intended for storage at room temperature with an improved shelf-life. Claims 10, 11, 19-20 are rejected as being dependent on rejected independent claims. With regard to the concentrations as instantly claimed, it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of copending Application No. 19/210,846.
In the present case, it is noted that claims 1-20 of the instant application are duplicates of claims 1-20 of copending Application No. 19/210,846. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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