DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 02/21/2025, are acknowledged. Claims 2-49 are pending in this action. Claim 1 has been cancelled. New claims 2-49 have been added. Claims 2-49 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 continuation of U.S. Patent Application No. of 18/513,181, filed November 17, 2023 and now issued as U.S. Patent No. 12,213,961, which is a continuation of U.S. Patent Application No. 17/680,654, filed February 25, 2022 and now issued as U.S. Patent No. 11,819,494, which claims benefit of foreign priority to GB2201723, filed February 10, 2022. For the record, the certified copy of the GB2201723 application was filed in U.S. Patent Application 17/680,654.
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 (40 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 comprises references on publications (e.g., Para. 0034, 0059, 0066, 0072, 0122, 0163, 0170, 0197-0198). The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The disclosure contains an embedded hyperlink and/or other form of browser-executable code (Para. 0023, 0096). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. MPEP 608.01.
The use of the trademarks/trade names has been noted in this application (e.g., Para. 0062, 0096, 0109, 0126, 0168, 0175, 0182, 0183/Table 2). It should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
The data provided in the specification are unclear, given that the data are shown with units of measurements that are not clearly delineated, e.g., “% l.c.” (Para. 0181, Table 1). Appropriate correction is required.
Information Disclosure Statement
The information disclosure statements (19 pages), filed 12/23/2024, 12/15/2025, 03/27/2026, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Applicant has submitted an oversized information disclosure statement 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”. Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
The information disclosure statement, filed 12/23/2024, fails to comply with 37 CFR 1.98(b)(5), which requires that each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication. MPEP 609.05(a). In the present case, examiner has considered all references filed by the applicant to expedite the prosecution. However, the applicant is informed that the references filed in an improper format (i.e., lined through) should be resubmitted in a proper format to be printed in the patent. MPEP 1302.12. Regarding electronic document(s) retrieved from an online source, it is noted that the format for the citation of an electronic document should be similar to the format used for paper documents of the same type, with the addition of the information in the locations (internet, database, etc.) indicated. MPEP 707.05(e).
For the record, the legible copies of cited non-literature documents have been submitted in parent applications 17/680,654, 18/513,181.
Claim Objections
Claims 2, 6, 11-12, 17, 23-24, 29-32, 35-36, 39-42, 45-49 are objected to because of the following informalities:
Claim 2 recites the limitation “in a patient in need thereof which comprises” that needs to be corrected to “in a patient in need thereof, the method comprising” for clarity.
Claims 6 recites the limitation “stabilizing results in one or more of the group: improved breathing, improved lung ventilation,” that needs to be corrected to “stabilizing results in one or more of the group consisting of improved breathing, improved lung ventilation,” for clarity. Similar is applied to claims 11-12, 17, 23-24, 29-32, 35-36, 39-42, 45-49.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(1)
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 3-4, 9-16, 23-34, 39-46, 48-49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Claim 3 discloses ”the treating of idiopathic pulmonary fibrosis is in a patient having probable usual interstitial pneumonitis as determined by a pattern on an image of the patient's lungs and/or a biopsy” whereas claim 4 discloses “wherein the image is a computed tomography image, which computed tomography image is optionally high resolution” that do not have support in the original specification. To this point, it is noted that the instant specification specifically teaches that a definite diagnosis is usually made by high-resolution computed tomography. No information is provided in the instant specification regarding other images that can be used in the claimed method. Therefore, said limitations in claim 3 and/or 4 constitute a new matter. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. Applicant is required to cancel the new matter in the reply to this Office Action. Claim 9-16, 23-34, 39-46, 48-49 are rejected as being dependent on claim 3 and/or 4.
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 3-49 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 3 discloses a method of treating idiopathic pulmonary fibrosis in “a patient having probable usual interstitial pneumonitis as determined by a pattern on an image of the patient's lungs and/or a biopsy” that is not reasonably clear. To this point, it is noted that neither the claims nor the instant specification provides a clear definition for the term “probable usual interstitial pneumonitis” and/or for a standard for ascertaining the requisite degree (i.e., pattern on an image, biopsy). Therefore, the metes and bounds of the claim are not reasonably clear. Similar is applied to claim 4 regarding the limitation “high resolution”; to claims 6, 11-12, 17, 23-24, 29-32, 35-36, 39-42, 45-49 regarding the limitation “effective to stabilize lung function”; to claims 7, 13-14, 18, 20, 25, 29-30, 33-35, 37-40, 43-48 regarding the limitation “serious adverse events”, to claims 8, 15-16, 19, 21-22, 27-28, 31-34, 36-38, 41-49 regarding the limitation “homogeneously distributed”. Clarification is required.
Claim 3 recites the limitation “in a patient having probable usual interstitial pneumonitis as determined by a pattern on an image of the patient's lungs” that is not reasonably clear, because it is not clearly stated what image should be used. In the present case, it is noted that patients are diagnosed with probable usual interstitial pneumonitis when a radiological pattern on high-resolution computed tomography of the lungs suggests the usual interstitial pneumonia pattern seen in idiopathic pulmonary fibrosis or other fibrotic interstitial lung diseases, but without the full certainty of a typical usual interstitial pneumonia pattern. Similar is applied to claim 4 (dependent on claim 3). Clarification is required.
Claim 5 recites the limitation "perorally administering is carried out: (i) as a stand-alone treatment, in the absence of co-therapy with antifibrotic drugs; (ii) as a 1st line treatment; or (iii) prior to and/or following receiving a prescribed dose of an antifibrotic drug” that is not reasonably clear. First, it is unclear if recited steps (i) and (ii) disclose a sequence of steps in a treatment, or alternative methods of treatment. Second, it is noted that the term "a stand-alone treatment" is understood as "the most intensive treatment" (see olapvex.com as an example). Therefore, it is unclear with what other treatments said method should be compared. If the applicant implies that the limitation "stand alone treatment" implies "the only treatment to be used in the claimed method" than it is noted that claim 5 also recites the limitation "as a 1st line treatment”, or “prior to and/or after a dose of an antifibrotic drug”. Therefore, it is unclear with what other treatments said method can be combined. Similar is applied to claims 9-10, 23-28, 39-44, 48. Clarification is required.
Claim 8 recites the limitation “a dosage form comprising a tablet or a capsule” that is not reasonably clear. Does this limitation imply the use of a dosage form that may include additional compounds even in large amounts (i.e., comprising)? Similar is applied to claims 15-16, 19, 21-22, 27-28, 31-34, 36-38, 41-49. Clarification is required.
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 2-49 are rejected under 35 U.S.C. 103 as being obvious over Dahlof et al., US 2018/0078529 (cited in IDS; pub. date 03/22/2018; hereinafter referred to as Dahlof) in view of Camber et al., WO 2021/214487 (cited in IDS; pub. date 10/28/2021; hereinafter referred to as Camber).
Dahlof teaches therapeutic treatment of idiopathic pulmonary fibrosis by administering to a patient in need thereof a therapeutically effective amount of N-butyloxycarbonyl-3-(4-imidazol-1-ylmethylphenyl)-5-iso-butylthiophene-2-sulfonamide (i.e., Compound 21) or pharmaceutically acceptable salt thereof orally (Claims 5-7, 9; Abstract; Para. 0011-0014, 0053, 0054 as applied to claim 2). Dahlof also teaches that a definite diagnosis of interstitial lung diseases is usually made by lung biopsy, pulmonology, radiology and pathology (Para. 0003 as applied to claims 3, 4).
Dahlof teaches that said active agent can be used either alone or in combination with other active compounds (Para. 0032, 0055 as applied to claims 5, 9-10, 23-28, 39-44, 48-49).
Dahlof teaches that said active agent can be provided in dosage forms such as tablets, capsules for oral administration (Para. 0055 as applied to claims 8, 15-16, 19, 21-22, 27-28, 31-34, 36-38, 41-49) and also teaches that effective doses of said active agent depend upon the patient to be treated and the route of administration and are in the range of 0.1-1000 mg per patient (Claim 10; Para. 0074, 0075).
Dahlof does not specifically teach the use of sodium salt of said active agent (claim 2); and/or the use of dosage forms comprising a powder mixture, wherein said active agent is homogeneously distributed, and also comprising an enteric coating (Claims 8, 15-16, 19, 21-22, 27-28, 31-34, 36-38, 41-49).
Camber teaches the use of dosage forms comprising pharmaceutical compositions comprising Compound 21 or a pharmaceutically-acceptable salt thereof as an active agent (e.g., sodium salt of Compound 21), wherein said dosage forms are suitable for peroral administration and can be used for the treatment of idiopathic pulmonary fibrosis, e.g., interstitial lung diseases such as pneumonitis (Abstract; Pages 1, 6, 11, 27, 30; Example 1).
Camber specifically teaches the use of dosage forms comprising a powder mixture, wherein said active agent is homogeneously distributed (Pages 8, 12), and said active agent is provided in a form of particles having a weight and/or volume-based mean diameter of no more than 50 µm (Abstract; Pages 7, 12), and wherein said pharmaceutical compositions/dosage forms further include a carrier/mannitol in a form of particles having a weight based mean diameter of less than 100 µm (Pages 7-8, 15-16). Further, Camber teaches the use of dosage forms that are protected by an enteric coating comprising polyvinyl acetate phthalate or methacrylic acid copolymers (Abstract; Pages 6, 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the approach taught by Camber preparing the dosage forms comprising sodium salt of Compound 21 to be used for the treatment of idiopathic pulmonary fibrosis as taught by Dahlof. One would do so with expectation of beneficial results, because Camber teaches that said approach allows improving physical and chemical stability of said active agent during and after manufacturing, under storage conditions, and during the use.
Regarding the claimed a treatment schedule/fasting and/or properties/effects/tests of the disclosed treatment, one of ordinary skill in the art would have understood that the result-effective adjustment of conventional working parameters (e.g., determining concentrations of active compound and/or time period for administration of active compound) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Further, it is noted that the cited prior art teaches the use of pharmaceutical formulations (e.g., tablets, capsules) comprising the active agent as instantly claimed, i.e., a sodium salt of Compound 21 to be used for the same purpose, i.e., for the treatment of idiopathic pulmonary fibrosis. Given that the prior art teaches formulations comprising the same components, it is expected that the same beneficial properties and effects would also be provided. Further, it is noted that Federal Circuit has noted that the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer (see, e.g., Atlas Powder Co. v. Ireco, Inc. (190 F.3d 1342, 1347, 51 U.S.P.Q.2d 1943, 1947; Fed. Cir.1999). An inherent feature needs not be recognized by one of ordinary skill in the art at the time of the invention. Schering Corp. v. Geneva Pharmaceuticals, Inc. (339 F.3d 1373, 1377, 67 U.S.P.Q.2d 1664, 1668) (Fed. Cir. 2003). Applicant is advised to clarify the claimed language/scope, the claimed treatment and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Claims 3-4, 9-16, 23-34, 39-46, 48-49, disclosing a treatment of a patient having probable usual interstitial pneumonitis, are rejected as being dependent on rejected independent claim 2.
Further, it is noted that the applied reference by Camber has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. MPEP § 717.02.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
WO 2021/214488 (cited in IDS; has a common assignee with the instant application) - teaches pharmaceutical dosage forms that are suitable for peroral administration for treatment of idiopathic pulmonary fibrosis, and wherein said dosage forms comprise a particulate mixture comprising homogeneously distributed solid particles of Compound 21 or a pharmaceutically-acceptable salt thereof, e.g., sodium salt, admixed with a blend of carrier particles (Abstract; Pages 6, 8-11, 13, 17-25).
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1-19 of U.S. Patent No. 11,819,494; (2) claims 1-27 of U.S. Patent No. 12,213,961; (3) claims 1-25 of U.S. Patent No. 12,128,029.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because prior patents also claim: A method of treatment of idiopathic pulmonary fibrosis by peroral administration to a patient in need thereof a pharmaceutical dosage form comprising N-butyloxycarbonyl-3-(4-imidazol-1-ylmethylphenyl)-5-iso-butylthiophene-2-sulfonamide (i.e., Compound 21) or a pharmaceutically-acceptable/sodium salt thereof in the form of a powder. In the present case, the conflicting claims are not patentably distinct from each other, because claims of prior patent 11,819,494 are merely broader than the instant independent claim that includes additional limitation (i.e., after 2 hours fasting) and therefore is more specific, whereas the instant independent claim is merely broader than prior patents 12,213,961, 12,128,02 claims that include additional limitation (i.e., after 2 hours of fasting and fasting is continued for at least one hour after said perorally administering) and therefore are more specific. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said prior patents.
Claims 2-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1, 14, 17, 18, 20-22 of U.S. Patent No. 11,654,115; (2) claims 1, 15-16, 19 of U.S. Patent No. 11,844,868; (3) claims 1, 8-10, 13-14 of U.S. Patent No. 12,121,614.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because prior patents also claim: A method of treatment of idiopathic pulmonary fibrosis by peroral administration to a patient in need thereof a pharmaceutical dosage form comprising N-butyloxycarbonyl-3-(4-imidazol-1-ylmethylphenyl)-5-iso-butylthiophene-2-sulfonamide (i.e., Compound 21) or a pharmaceutically-acceptable/sodium salt thereof in the form of a powder. In the present case, (i) claims of prior patent 11,654,115 are merely broader than instant independent claim that includes additional limitations (e.g., after 2 hours fasting) and therefore is more specific; whereas (ii) the instant independent claim is are merely broader than claims of prior patents 11,844,868, 12,121614 that include additional limitation (i.e., carrier particles, particle density) and therefore are more specific. Therefore, it is the examiner’s position that the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in the prior patents.
Claims 2-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 20-21, 32 of copending Application No. 17/920,558
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application since the referenced copending application and the instant application are claiming common subject matter, as follows: A method of treatment of idiopathic pulmonary fibrosis by peroral administration to a patient in need thereof a pharmaceutical dosage form comprising Compound 21 or a pharmaceutically acceptable salt thereof. In the present case, the claims of said copending application are merely broader than the instant independent claim that includes additional limitation (e.g., sodium salt of Compound 21) and therefore is more specific. Therefore, it is the examiner position that the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said copending application. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
Claims 2-4, 9-16, 23-34, 39-46. 48-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-28 of copending application 19/389,587.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application since the referenced copending application and the instant application are claiming common subject matter, as follows: A method of treatment of idiopathic pulmonary fibrosis in a patient having probable usual interstitial by peroral administration to a patient in need thereof a pharmaceutical dosage form comprising sodium salt of Compound 21. In the present case, the claims of copending application are merely broader than instant independent claim that includes additional limitation (i.e., 2 hours of fasting) and therefore is more specific. Therefore, it is the examiner position that the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said copending application. This is a provisional obviousness-type double patenting rejection, because the conflicting claims 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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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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