DETAILED ACTION
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 Application, Amendments and/or Claims
The amendment and Applicant’s arguments, filed 26 January 2026, have been entered in full. Claims 1-4 and 8 are canceled. Claims 5, 7 and 9 are amended.
Claims 5-7 and 9 are under examination.
Withdrawn Objections And/Or Rejections
The rejection to claims 7 and 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as set forth at pages 3-4 of the previous Office Action (26 September 2025), is withdrawn in view of the amendment (26 January 2026).
The rejection to claims 1-3 under 35 U.S.C. 102(a1) as being anticipated by Jackson et al. (Reference submitted by Applicant; European Respiratory Journal; ABSTRACT 52 Suppl 62:1-2, published 2018), as evidenced by Schally et al. (Reference submitted by Applicant; US 2015/0166617; published 18 June 2015), as set forth at pages 4-5 of the previous Office Action (26 September 2025), is withdrawn in view of the amendment (26 January 2026).
The rejection to claims 1-3 and 9 under 35 U.S.C. 102(a1) and 35 U.S.C. 102(a2) as being anticipated by Schally et al. (Reference submitted by Applicant; US
2013/0261055; published 03 October 2013), as set forth at pages 5-6 of the previous Office Action (26 September 2025), is withdrawn in view of the amendment (26 January 2026).
The rejection to claims 1-6 and 9 under 35 U.S.C. 102(a1) and 35 U.S.C. 102(a2) as being anticipated by Schally et al. (Reference submitted by Applicant; US
2010/0092539; published 15 April 2010), as set forth at pages 6-7 of the previous Office Action (26 September 2025), is withdrawn in view of the amendment (26 January 2026).
The rejection to claims 1-5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Schally et al. (US 2013/0261055; published 03 October 2013) in view of Salwiczek et al. (Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171; 2012), as set forth at pages 7-9 of the previous Office Action (26 September 2025), is withdrawn in view of the amendment (26 January 2026).
The rejection to claims 1-5 and 9 under 35 U.S.C. 103 as being unpatentable over Schally et al. (US 2010/0092539; published 15 April 2010) in view of Rosenkranz et al. (Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273; 1983), as set forth at pages 9-11 of the previous Office Action (26 September 2025), is withdrawn in view of the amendment (26 January 2026).
The rejection to claims 1-3, 5, 7-9 on the ground of nonstatutory double
patenting as being unpatentable over claims 1-16 of U.S. Patent No. US 12,377,135
in view of Salwiczek et al. (Chem Soc Rev, 41: 2135-2171; 2012) and Rosenkranz et
al. (The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273;
1983), as set forth at pages 11-15 of the previous Office Action (26 September 2025), is withdrawn in view of the submitted Terminal Disclaimer. The terminal disclaimer, filed on 26 January 2026, has been reviewed and is accepted. The terminal disclaimer has been recorded.
The rejection to claims 1-3 on the ground of nonstatutory double patenting
as being unpatentable over claims 1-4 of U.S. Patent No. US 11,993,640, as set forth at pages 15-16 of the previous Office Action (26 September 2025), is withdrawn in view of the submitted Terminal Disclaimer. The terminal disclaimer, filed on 26 January 2026, has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
1. Claims 5, 6 and 9 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 36 of copending Application No. 17/396,304 in view of Schally et al. (US 2010/0092539; published 15 April 2010). This is a provisional nonstatutory double patenting rejection.
The basis for this rejection is set forth at pages 16-17 of the previous Office Action (26 September 2025).
Applicant argues that because this rejection is provisional, no response is made at this time. Applicant request that it be held in abeyance until a patent is granted on the ‘304 application.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
Applicant’s attention is respectfully directed to M.P.E.P. § 804(I)(B)(1), which states:
“A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional”
“As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03. Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner. See MPEP § 804.02, subsection VI, for filing terminal disclaimers required to overcome nonstatutory double patenting rejections in applications filed on or after June 8, 1995”.
Accordingly, the rejection is maintained for reasons of record and is expressly not held in abeyance.
2. Claims 5, 6 and 9 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 5 of copending Application No. 18/639,779 in view of and Rosenkranz et al. (The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273; 1983). This is a provisional nonstatutory double patenting rejection.
The basis for this rejection is set forth at pages 17-20 of the previous Office Action (26 September 2025).
Applicant argues that because this rejection is provisional, no response is made at this time. Applicant request that it be held in abeyance until a patent is granted on the ‘779 application.
Applicant’s arguments have been fully considered but are not found persuasive for the reasons stated above from the M.P.E.P. § 804(I)(B)(1).
Accordingly, the rejection is maintained for reasons of record and is expressly not held in abeyance.
NEW CLAIM REJECTIONS/OBJECTIONS
Claim Rejections-35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), First paragraph, Written description, New Matter
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 5-7 and 9 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter Rejection.
The specification as originally filed does not provide support for the invention as now claimed:
“..a method of treating granulomatous lung disease..".
Applicant’s amendment, filed 26 January 2026, asserts that no new matter has been added. However, the Examiner cannot locate the teachings as recited in the instant claims..
The Examiner has found the following teaching in the specification:
[0019] FIG. 1 shows a representative Western blot image of GHRHR expression in an ex vivo granuloma model developed from PBMC of a sarcoidosis patient.
[0035] Any decrease in sarcoidosis or symptoms of sarcoidosis (e.g., inflammation, granuloma formation, or granuloma size), or increase in quality of life, constitutes a beneficial biological effect in a subject.
[0036] Alternatively or in addition, treatment as described herein optionally improves the stage of the disorder or reduces the severity within a stage. Commonly used stages for sarcoidosis includes: stage I, granulomas located mainly in lymph nodes; stage II, granulomas located in lungs and lymph nodes; stage III, granulomas located mainly in lungs with shrinking lymph nodes; stage IV, pulmonary fibrosis.
[0037] Sarcoidosis disease progression is determined using any of a variety of clinical techniques, such as biopsy of the affected organ(s) to identify granulomas, blood test, bronchoscopy, X-ray, neurological tests (e.g., electromyography, evoked potentials, spinal taps, or nerve conduction tests), high-resolution computed tomography (CT) scans, magnetic resonance imaging (MRI), positron electron tomography (PET) scans, pulmonary function tests, and ultrasound.
[0066] In summary, disclosed herein are the therapeutic effects of AVR in a model of lung sarcoidosis granuloma. These results support for the first time that new class of Growth Hormone Releasing Hormone Receptor Antagonist (AVR) is a new therapeutic agent for inflammatory diseases, such as sarcoidosis.
The Examiner cannot find a teaching for treating granulomatous lung disease. The specification as filed does not provide a written description or set forth the metes and bounds of this "limitations".
The Examiner directs Applicant’s attention to Ohshimo et al. (cited herein with, Ohshimo et al. Differential diagnosis of granulomatous lung disease: clues and pitfalls. Eur Respir Rev 2017; 26:pages 1-16; May 2017).
Ohshimo et al. teach that granulomatous lung disease is a heterogenous group of disorders that have a wide spectrum of pathologies with variable clinical manifestation and outcomes (abstract).
Ohshimo et al. teach that the term granulomatous lung disease does not refer to a specific disease entity, but to a wide spectrum of pathologies with variable clinical manifestations and outcomes (page 2).
Ohshimo et al. teach granulomatous lung disease includes Infectious lung diseases such as Mycobacteria (e.g. tuberculosis and nontuberculous mycobacteriosis); Fungal infection (e.g. cryptococcus, coccidioides, histoplasma, blastomyces and aspergillus) and Aspiration pneumonia (page 2, Table 1).
Ohshimo et al. teach granulomatous lung disease includes Noninfectious lung diseases such as Inflammatory (e.g. sarcoidosis, necrotizing sarcoid granulomatosis, bronchocentric granulomatosis), Exposure/toxins (e.g. hypersensitivity pneumonitis, drugs {methotrexate, interferon, Bacillus Calmette-Guérin, infliximab, etanercept, leflunomide, mesalamine and sirolimus}, hot tub lung, berylliosis, talc, metals {aluminium and zirconium}, foreign body reaction, Vasculitis (e.g. granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis) Autoimmune diseases (e.g. rheumatoid nodule) and Malignancy (e.g. sarcoid-like lesions, lymphomatoid granulomatosis) (page 2, Table 1).
The instant specification does not have written support for the breadth of lung diseases/conditions that fall under the term “granulomatous lung disease”. The claims recite New Matter because they now recite a genus (i.e., granulomatous lung disease), wherein said genus encompasses various lung diseases/disorders. The limitation “granulomatous lung disease” renders the claims broader than the original disclosure.
By amending the claims to specifically recite, “a method of treating granulomatous lung disease in a subject”, the instant claims now recite limitations which were not disclosed in the specification as filed, and now changes the scope of the instant disclosure as-filed.
Applicant is required to cancel the new matter in the response to this Office action. Alternatively, Applicant is invited to provide specific written support for the “limitations” indicated above or rely upon the limitations set forth in the specification as filed.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M DEBERRY whose telephone number is (571)272-0882. The examiner can normally be reached M-F 9:00-6:30 pm (alt Fri).
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/R.M.D/Examiner, Art Unit 1647 3/10/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647