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 .
Claim Status
Claims 66-76 are currently pending and subject to examination.
Claim Rejections – 35 USC § 103 – Previously Presented
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.
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.
The rejection of claim(s) 66-76 under 35 U.S.C. 103 as being unpatentable over Lawrence et al. (WO 2017/220446 A1) in view of Chiang & Honore (WO2008057930A2), Hernandez-Pedro et al. (Prevention Research, Volume 68, Issue 9 Supplement, May 1, 2008), and Avery et al. (WO2020061636A1, priority date 28 Sept. 2018) is maintained.
Response to Arguments
Overall, the Applicant’s arguments are directed towards what each reference fails to disclose individually. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Lawrence is relied upon for the compounds and their administration to peripheral neuropathy patients while Chiang, Hernandez-Pedro and Avery are relied upon for the art recognized relationship between RAR agonism and neuropathic pain for the etiologies encompassed by the claims.
Applicant also conflates reasonable expectation of success with guarantee of success. “However, obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g.,In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988).” (MPEP § 2144.08). Applicant repeatedly demands completed efficacy data, subtype attribution studies, and condition-by-condition proof, a standard which exceeds that required to establish a prima facie case of obviousness.
The Applicant argues that Lawrence does not teach or suggest the treatment of neuropathic pain (Remarks, p. 3). These arguments were fully considered but are not persuasive. Lawrence explicitly defines “treatment” to include alleviation of the symptoms of the condition (Lawrence, Spec., p. 57, quoted OA at p. 4). Avery establishes that neuropathic pain is a characteristic symptom of peripheral neuropathy, including entrapment neuropathies such as carpel tunnel syndrome and lumbar radiculopathy (Avery, Spec., p. 14-16, quoted OA at p. 5). Lawrence’s own definition of treatment therefore reaches alleviation of the pain symptom of the condition Lawrence teaches is treatable with the compounds of the instant invention.
Moreover, Applicant’s assertion that pain relief and regeneration are dissociable from the claimed method is unsupported. Hernandez Pedro supplies affirmative evidence that RAR agonists can both reverse pain/ temperature sensitization changes and promote nerve regeneration in the same animal models.
The Applicant argues that Chiang does not supply the missing reasonable expectation of success (Remarks, p. 4-5). These arguments were fully considered but are not persuasive. While Chiang includes prophetic examples, a prior art publication is presumed enabled and operable for everything that it teaches, proof of efficacy is not required, and the burden is on the Applicant to rebut the presumption with evidence, which the Applicant has not attempted (see MPEP § 2121). Regardless, the rejection does not rest on Chiang alone for efficacy because Hernandez-Pedro shows that RAR agonists work in vivo.
The Applicant further attempts to argue that Chiang would not have directed a person of ordinary skill toward Lawrence’s RARβ selective compounds. This argument again treats the reference in isolation. Lawrence specifically teaches these compounds for the treatment of peripheral neuropathies, including alleviation of symptoms, and pain is a well-known symptom of peripheral neuropathies, as shown by Avery. Moreover, Chiang teaches method of treating neuropathic pain by administering an RAR agonist compound (Chiang, Spec., p. 12) of which RARβ is a species within that genus. Chiang’s identification of R667 and tazarotene as representative candidates does not limit Chiang’s broader disclosure. Nonetheless, Applicant concedes that tazarotene is active at RARβ (Remarks, p. 5). Chiang’s representative compounds therefore implicate RARβ, and Hernandez-Pedro independently identifies RARβ as the upregulated receptor accompanying reversal of pain sensation (“Retinoic Acid is able to revert the changes in pain and temperature sensation induced by chemotherapy. As well as to promote nerve regeneration by an increased expression of NGF levels and retinoic acid receptor beta in sciatic nerve” (Hernandez-Pedro, Abstract (emphasis added))). The prior art as a whole therefore points to RARβ, not away from it
The Applicant argues that Hernandez-Pedro does not render the claimed methods obvious because they use a non-selective retinoic acid receptor agonist (Remarks, p. 5-6). These arguments were fully considered but are not persuasive. Applicant’s assertion that Hernandez-Pedro only provides a pan-RAR result with no subtype guidance is not supported by the evidence. Hernandez-Pedro reports that retinoic acid reverted the changes in pain and temperature sensation induced by chemotherapy, and further reports increased expression of retinoic acid receptor beta (RARβ) in sciatic nerve in the retinoic acid treated groups. Of the three RAR subtypes, RARβ is the subtype that Hernandez-Pedro identifies in connection with the observed effects. A person of ordinary skill therefore would have been directed towards RARβ and would have had reason to select Lawrence’s RARβ-selective agonist rather than an arbitrary retinoid, particularly given Lawrence’s teachings that these compounds also treat neuropathies and nerve injuries. Applicant argues the observation is “merely correlative” and that Hernandez-Pedro does not establish causation, but this assertion is not accompanied by evidence. Obviousness does not require that the mechanism be absolutely proven or even correctly understood; only a reasonable expectation of success is required, which is established by the cited references.
Applicant argues that the chemotherapy induced neuropathy is mechanistically distinct from the recited conditions. Avery, however, establishes that chemotherapy induced neuropathy, hypothyroidism associated neuropathy, entrapment neuropathies, radiculopathy, back pain, RA, and trigeminal neuralgia are all recognized in the art as neuropathic pain conditions treatable in a common manner, and that spinal nerve ligation serves as a shared model (Avery, Spec. p. 15-16, 20, cited at OA p. 5). Applicant identifies no art recognized reason why an agent effective in a validated neuropathic pain model would fail across conditions the art itself groups together.
The Applicant argues that Hernandez-Pedro teaches away from the claimed invention is unsupported by evidence. Applicant’s assertion that promoting nerve growth would “worsen constriction and so exacerbate pain” is unsupported by the evidence of the prior art as a whole. Hernandez-Pedro reports the opposite outcome empirically. Notably, nothing in Lawrence, Chiang, or Avery suggests any exacerbation.
The Applicant argues that Avery does not cure the deficiencies (Remarks, p. 6-7). These arguments were fully considered but are not persuasive. Avery is not relied upon for RARβ agonism, and therefore the Applicant’s argument that Avery is directed towards the Nrf2 pathway is not responsive to the rejection. Avery is cited for (i) the art-recognized definition and etiologies of neuropathic pain, expressly including chemotherapy induced neuropathy, hypothyroidism, carpel tunnel syndrome, lumbar radiculopathy, back pain, rheumatoid arthritis, trigeminal neuralgia, and nerve compression; and (ii) the use of a spinal nerve ligation as an accepted model for these painful neuropathies. This is precisely the evidentiary bridge between Hernadez-Pedro’s model and the conditions recited in claim 66.
The Applicant argues that the proposed combination requires impermissible hindsight (Remarks, p. 7). These arguments were fully considered but are not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Each element of the rationale is drawn from the cited references, not from the Applicant’s specification. Lawrence supplies the compound, its mechanism as an RARβ agonist, and its administration to peripheral neuropathy patients. Chiang supplies the express teaching that RAR agonists treat neuropathic pain. Hernandez-Pedro supplies in vivo confirmation together with the finding that implicates RARβ signaling in pain alleviation. Avery supplies the scope of neuropathic pain etiologies. Applicant identifies no element of the rationale that is absent from the cited art.
Reiterated Rejection
Claim(s) 66-76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lawrence et al. (WO 2017/220446 A1) in view of Chiang & Honore (WO2008057930A2), Hernandez-Pedro et al. (Prevention Research, Volume 68, Issue 9 Supplement, May 1, 2008), and Avery et al. (WO2020061636A1, priority date 28 Sept. 2018).
Claim 66 recites:
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Lawrence teaches crystalline BOBA-001 for the treatment of peripheral neuropathy:
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Lawrence, Specification, p. 6;
Another aspect of the present invention pertains to a method of treatment comprising administering to a subject in need of treatment a therapeutically effective amount of a crystalline form of BHBA-001 (e.g., Form 4), or BHBA-001 as obtained from a crystalline form of BHBA-001 (e.g., Form 4), as described herein, preferably in the form of a pharmaceutical composition….
In one embodiment, the treatment is treatment of, for example… peripheral neuropathy.
Lawrence, Specification, p. 8;
The term "treatment," as used herein in the context of treating a condition, pertains generally to treatment and therapy, whether of a human or an animal (e.g., in veterinary applications), in which some desired therapeutic effect is achieved, for example, the inhibition of the progress of the condition, and includes a reduction in the rate of progress, a halt in the rate of progress, alleviation of symptoms of the condition, amelioration of the condition, and cure of the condition. Treatment as a prophylactic measure (i.e., prophylaxis) is also included. For example, use with patients who have not yet developed the condition, but who are at risk of developing the condition, is encompassed by the term "treatment" (that is, treatment of condition encompasses reducing the risk of that condition)
Lawrence, Specification, p. 57.
Lawrence teaches that the compound BOBA-001 (BHBA-001) is a “a (selective) retinoic acid receptor beta (RARβ) (e.g., RARβ2) agonist” which can be used “to (selectively) activate RARβ (e.g., RARβ2), to cause or promote neurite development, neurite outgrowth, and/or neurite regeneration, and in the treatment of diseases and conditions that are mediated by RARβ (e.g., RARβ2), that are ameliorated by the activation of RAR3 (e.g., RARβ2), etc., including, e.g., neurological injuries such as spinal cord injuries.” (Lawrence, Specification, p. 1).
While Lawrence does not specifically teach that the symptom of neuropathy is neuropathic pain, one of ordinary skill in the art would have a reasonable expectation of success to ameliorate neuropathic pain by administering BOBA-001 to a patient in need thereof because retinoic acid receptor (RAR) agonists are known in the art to alleviate neuropathic pain.
For example, Chiang teaches “methods for treating neuropathic pain in mammals by administering a therapeutically effective amount of an RAR agonist compound.” (Chiang, Specification, p. 12). Hernandez-Pedro demonstrates this effect in a mouse model of chemotherapy induced neuropathic pain and finds that the retinoic acid receptor agonist all-trans retinoic acid reversed hyperalgesia as well as promoted nerve regeneration:
Peripheral neuropathy is a common side effect of several anticancer drugs, the effectiveness of these compounds are limited due to the toxic side effects related with the therapy. There are several chemotherapy agents used to treat cancer that are well known by their neurotoxic effects such as cisplatin and paclitaxel. Experimental animal models of chemotherapy-induced peripheral neuropathy have been developed for cisplatin, vincristine and paclitaxel, showing a decreased threshold for pain and temperature. The Neural Growth Factor (NGF) has been investigated as a potential treatment in several neurological diseases, previous reports have shown that retinoic acid (RA) induces differentiation in diverse neuronal cell lines in vivo and in vitro, stimulating the production of NGF and of its receptor. Methods: A total of 60 male wistar rats were randomly divided into 6 groups. Group A (control), B and C were treated with paclitaxel (5mg/kg daily during 6 days) and groups D and E received cisplatin (3mg/kg two times a week every 7 days, during 30 days), group F received all-trans retinoic acid exclusively. Additional all-trans retinoic acid (20mg/kg) p.o. was administered to groups B and D. Two conduct tests were used to asses temperature perception changes hot plate and pain threshold with monolfilaments of nylon, von Frey. The reverse transcriptase and Real time PCR (Applied Biosystem) was used to determine retinoic acid beta receptor expression in nerve biopsy. Levels of NGF in serum were obtained though ELISA analysis. Results: The test for temperature and pain sensation were not affected in the groups treated with RA, however, RA reverted pain and temperature sensation changes in animals treated with chemotherapy. The NGF was decreased in the group of cisplatin and paclitaxel in nerve biopsy when compared with groups A(Control), D (Cisplatin + AR) and B (paclitaxel +AR). Retinoic Acid showed an increased expression of the retinoic acid receptor beta in groups D and B, that were treated with retinoic acid. Conclusion: Retinoic Acid is able to revert the changes in pain and temperature sensation induced by chemotherapy. As well as to promote nerve regeneration by an increased expression of NGF levels and retinoic acid receptor beta in sciatic nerve.
Hernandez-Pedro, Abstract (emphasis added).
Chiang teaches that the retinoic acid receptor is specifically implicated from animal models of neuropathic pain including spinal nerve ligation (Chiang, Specification, p. 13). One of ordinary skill in the art would reasonably expect to achieve similar results across neuropathic pain associated with trigeminal neuralgia, neuropathic pain associated with occipital neuralgia; neuropathic pain associated with painful radiculopathy; neuropathic pain associated with rheumatoid arthritis; neuropathic pain associated with a thyroid hormone disorder; neuropathic pain associated with lower back pain; or neuropathic pain associated with carpal tunnel syndrome because all of these conditions are associated with nerve damage and nerve impingement and can be treated in a similar way.
For example, Avery teaches that “neuropathic (nerve) pain is caused by damage, injury or dysfunction of nerves due to trauma, surgery, disease or chemotherapy. It is often described as burning, painful, cold or akin to electric shocks and may manifest with tingling, pins and needles, numbness or itching. Neuropathic pain can be the primary symptom of a particular condition or disease state, such as cancer, complex regional pain syndrome or post herpetic neuralgia.” (Avery, Specification, p. 14-15) and includes peripheral neuropathic pain caused by chemotherapy, hypothyroidism, entrapment neuropathies such as carpel tunnel syndrome, sciatic pain (lumbar radiculopathy), neuropathic pain associated with back pain, rheumatoid arthritis, trigeminal neuralgia and neuropathic pain associated with nerve compression (Avery, Specification, p. 15-16). Avery demonstrates that spinal nerve ligation is a model for these types of painful neuropathies (Avery, Specification, p. 20).
Therefore, claim 66 was prima facie obvious at the time of filing.
Claims 67-76 merely recites types of neuropathic pain associated with a thyroid hormone disorder, rheumatoid arthritis or nerve compression and are therefore prima facie obvious for the reasons given in the rejection of claim 66.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Nonstatutory Double Patenting – Previously Presented
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.
The rejection of claims 66-76 on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,752,616 B2 (herein ‘616) in view of Lawrence et al. (WO 2017/220446 A1) , Chiang & Honore (WO2008057930A2), Hernandez-Pedro et al. (Prevention Research, Volume 68, Issue 9 Supplement, May 1, 2008), and Avery et al. (WO2020061636A1, priority date 28 Sept. 2019) is maintained.
The rejection of claims 66-76 on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 10,385,044 B2 (herein ‘044) in view of Lawrence et al. (WO 2017/220446 A1), Chiang & Honore (WO2008057930A2), Hernandez-Pedro et al. (Prevention Research, Volume 68, Issue 9 Supplement, May 1, 2008), and Avery et al. (WO2020061636A1, priority date 28 Sept. 2019) is maintained.
The rejection of claims 66-76 on the ground of nonstatutory double patenting as being unpatentable over claims25-26 of U.S. Patent No. 11,401,265 B2 (herein ‘265) in view of Chiang & Honore (WO2008057930A2), Hernandez-Pedro et al. (Prevention Research, Volume 68, Issue 9 Supplement, May 1, 2008), and Avery et al. (WO2020061636A1, priority date 28 Sept. 2019) is maintained.
Response to Arguments
Applicant’s request that the OTDP rejections be held in abeyance is not a complete or proper reply. Applicant’s arguments regarding the § 103 rejection are addressed above and are not persuasive for the same reasons. The rejections are maintained.
Reiterated Rejection
Claims 66-76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,752,616 B2 (herein ‘616) in view of Lawrence et al. (WO 2017/220446 A1) , Chiang & Honore (WO2008057930A2), Hernandez-Pedro et al. (Prevention Research, Volume 68, Issue 9 Supplement, May 1, 2008), and Avery et al. (WO2020061636A1, priority date 28 Sept. 2019).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed towards a method of treating neuropathic pain with BOBA-001 and the claims of ‘616 are directed towards the treatment of neuropathy BOBA-001. One of ordinary skill in the art would have a reasonable expectation of success to apply BOBA-001 to the treatment of neuropathic pain because it is known in the art that BOBA-001 is an RAR agonist and RAR agonists are known in the art for the treatment of neuropathic pain. The rejection of claims 66-67 as obvious over Lawrence in view of Chiang, Hernandez-Pedro and Avery is incorporated herein by reference.
Claims 66-76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 10,385,044 B2 (herein ‘044) in view of Lawrence et al. (WO 2017/220446 A1), Chiang & Honore (WO2008057930A2), Hernandez-Pedro et al. (Prevention Research, Volume 68, Issue 9 Supplement, May 1, 2008), and Avery et al. (WO2020061636A1, priority date 28 Sept. 2019).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed towards a method of treating neuropathic pain with BOBA-001 and the claims of ‘044 are directed towards the treatment of nerve injury with BOBA-001. One of ordinary skill in the art would have a reasonable expectation of success to apply BOBA-001 to the treatment of neuropathic pain because it is known in the art that BOBA-001 is an RAR agonist and RAR agonists are known in the art for the treatment of neuropathic pain. The rejection of claims 66-67 as obvious over Lawrence in view of Chiang, Hernandez-Pedro and Avery is incorporated herein by reference.
Claims 66-76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims25-26 of U.S. Patent No. 11,401,265 B2 (herein ‘265) in view of Chiang & Honore (WO2008057930A2), Hernandez-Pedro et al. (Prevention Research, Volume 68, Issue 9 Supplement, May 1, 2008), and Avery et al. (WO2020061636A1, priority date 28 Sept. 2019).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed towards a method of treating neuropathic pain BOBA-001 and the claims of ‘265 are directed towards the treatment of a condition or disorder mediated by activation RARβ wherein the condition is caused by a neurological injury or neuropathy with compounds with BOBA-001. One of ordinary skill in the art would have a reasonable expectation of success to apply BOBA-001 to the treatment of neuropathic pain because RAR agonists are known in the art for the treatment of neuropathic pain. The rejection of claims 66-67 as obvious over Lawrence in view of Chiang, Hernandez-Pedro and Avery is incorporated herein by reference.
Conclusion
No claim is found to be allowable.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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