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 .
Priority
This application is a CON of 17/535,106 (11/24/2021 ABN)
17/535,106 has PRO 63/118,368 (11/25/2020).
Status
Claims 1, 2, 10, 13-14, 20-22, 35-36, 38, 40, 44, 65, 105-107 are pending.
Drawings
The drawings filed 3/20/24 are objected to for including illegible text, for example in Figs. 1-3. See MPEP 608.02. In addition, a Fig. 3B exists, but not Fig. 3A.
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, 13-14, 20-22, 35-36, 38, 40, 44, 65, 105-107 are rejected under 35 U.S.C. 103 as being unpatentable over Shenoy et.al. (Rheumatology 2010, 49, 2420–2428) in view of Adake et al. (J. Adv. Pharm. Technol. Res., 2015, v. 6, iss. 2, p. 81-85).
Shenoy teaches treating secondary Raynaud’s syndrome in patients with scleroderma by a combination of tadalafil (20 mg) and calcium channel blocker [nifedipine (20–60 mg)/amlodipine (2.5–10 mg)] (Abstract, Table 1). Shenoy teaches that the combination of tadalafil and calcium channel blocker can reduce both the frequency and the duration of the Raynaud’s syndrome (Table 2, Table 3). Shenoy teaches that the combination of tadalafil and calcium channel blocker can and heal digital ulcers in patients with both Raynaud’s syndrome and digital ulcers (Fig. 2). Shenoy teaches that the combination of tadalafil and calcium channel blocker can reduce Raynaud’s syndrome pain (Table 4).
Regarding claim 1, Shenoy does not teach the specific calcium channel blocker is cilnidipine or the specific dose.
Adake teaches cilnidipine and amplodipine are effective calcium channel blockers (CCB) with cilnidipine at 20 mg/day dose and being N-type and L-type that has lower incidence of edema side effects (Abstract, p. 84).
One of ordinary skill in the art following the teaching of Shenoy would have considered Shenoy’s teaching of the utility of the class of pharmaceuticals known as CCBs and substituted known CCB for the same purpose. As per MPEP 2144.06: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As recognized by Adake, cilnidipine and amplodipine were known as calcium channel blockers which Shenoy identified as being useful in the treatment of Raynaud’s syndrome. One of ordinary skill in the art would have considered substituting amplodipine with cilnidipine in Shenoy’s therapy for the same purpose and have a reasonable expectation of success based on the successful demonstration with the same class of pharmaceutical. Thus, the claim is prima facie obvious.
Regarding claim 2, Shenoy teaches treating secondary Raynaud’s syndrome in patients with scleroderma (Abstract, Table 1).
Regarding claims 13-14, Shenoy teaches the treatment was associated with improvement in Raynaud’s syndrome digital ulcerations (Abstract, Table 1, p. 2426: “The healing of the DUs and prevention of appearance of new ulcers in the present study were encouraging”).
Regarding claims 20-22, Shenoy teaches reducing frequency, severity, and duration of symptoms (p. 2426: “patients when receiving tadalafil had significant improvement in the frequency, duration and severity of RP”).
Regarding claim 35, as with claim 1, Shenoy in view of Adake would lead one of ordinary skill in the art to the administration of cilnidipine and tadalafil to treat Raynaud’s disease. Shenoy also teaches that the disease is triggered by cold and results in pain (p. 2420: “RP is an exaggerated physiological phenomenon defined as episodic cold or emotional stress-triggered ischaemic vasospasms” and “patients develop severe RP attacks with intense pain and ischaemic ulcers”) such that one of ordinary skill in the art would have considered utilizing the same therapy to reduce Raynaud’s disease-associated pain and arrive at the claimed invention with a reasonable expectation of success.
Regarding claims 36, and 38, Shenoy teaches that the pain is cold-triggered in the hand (p. 2420: “episodic cold or emotional stress-triggered ischaemic vasospasms of the digital arteries”) and one of ordinary skill in the art would reasonably consider 10C to be cold relative to ambient.
Regarding claim 40, as with claim 35, one of ordinary skill in the art following the combined teaching of Shenoy and Adake would consider the same therapy to reduce susceptibility to triggers.
Regarding claim 41, Shenoy teaches the patients have scleroderma (Abstract).
Regarding claim 44, Shenoy teaches that Raynaud’s disease is caused by vasoconstriction and providing a therapy to treat the disease would be expected to reduce the cause.
Regarding claim 65, Shenoy notes that triggering include exposure to cold in morning hours (p. 2426). Thus, one of ordinary skill in the art would consider administration of therapy when triggering events are likely.
Regarding claim 105, Shenoy teaches primary Raynaud’s syndrome is responsive to vasodilators such as calcium channel blockers (p. 2420) such that one of ordinary skill in the art would have considered the same therapy to be effective for the primary condition.
Regarding claim 106, Shenoy teaches the patients have scleroderma (Abstract).
Regarding claim 107, Shenoy teaches that therapy significantly reduced symptoms (Abstract; p. 2425-2427) which one of ordinary skill in the art would expect to reduce symptoms by at least 25% and arrive at the claimed invention.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Shenoy et.al. (Rheumatology 2010, 49, 2420–2428) in view of Adake et al. (J. Adv. Pharm. Technol. Res., 2015, v. 6, iss. 2, p. 81-85) as applied to 1 above and further in view of Henness et al. (Current Opinion in Rheumatology 2007, 19:611–618).
Regarding claim 10, Shenoy does not teach interstitial lung disease.
Henness teaches “Scleroderma and secondary Raynaud’s phenomenon are frequently associated with increased morbidity” including interstitial lung disease (ILD) (Abstract, p. 611, 614).
One of ordinary skill in the art following the combined teaching of Shenoy and Adake would have known that ILD was a condition associated with Raynaud’s that would be ameliorated by treating the underlying condition.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
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, 13-14, 20-22, 35-36, 38, 40, 44, 65, 105-107 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 7-8, 23, 42-45, 59-60, 64, 71, 73, 75-79 of copending Application No. 18609984 (reference application) in view of Shenoy and Adake as per the 35 USC 103 rejection supra. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims the treatment of the same patient population with the same therapy combination such that it anticipates or renders obvious the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 13-14, 20-22, 35-36, 38, 40, 44, 65, 105-107 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-12, 132-141, 145-147 of copending Application No. 17802727 (reference application) in view of Shenoy and Adake as per the 35 USC 103 rejection supra. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims the treatment of the same patient population with the same therapy combination such that it anticipates or renders obvious the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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, Kortney Klinkel can be reached at (571) 270-5293. 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.
/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
Prosecution Insights