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 .
Priority
The instant application claims benefit to US Provisional Application 62/696,052 which is drawn to administering anti-RGMa antibodies to treat diabetic neuropathies. The instant claims are drawn to treating a broader class of peripheral neuropathies and therefore claims 15, 18, 19, 20, 24, 30, 31, and 32 will receive benefit of PCT/JP2019/027370 filed 10 July 2019 while claims 22, 23, 26 and 27 will received benefit of US Provisional Application 62/696,052 filed 10 July 2018.
Status of the Claims
Applicant’s amendment filed 23 April 2026 is acknowledged. Claims 15, 24, and 27 have been amended. Claims 15, 18-20, 22-24, 26, 27, and 30-32 are currently pending and under consideration.
Withdraw Rejections
In view of Applicant amending claims 15 and 24 to remove carpal tunnel syndrome and cubital ulnar neuropathy the 35 USC 102 rejection over 2004/0102376 A1 (referred to herein as Max-Planck) as evidenced by Stanford Medicine is hereby withdrawn.
In view of Applicant amending claims 15 and 24 to remove carpal tunnel syndrome and cubital ulnar neuropathy the following 35 USC 103 rejections, non-statutory double patenting rejections, and 35 USC 112(b) rejections:
claims 15, 18, 24, and 30 over Max-Planck as evidenced by Yoon,
claims 19, 20, 31, and 32 over Max-Planck in further view of Hashimoto (see WO2016/175236, as cited on the IDS dated 01/07/2016) as evidenced by either Stanford Medicine or Yoon,
claims 22, 23, 26, and 27 over Max-Planck and in further view of and Rota and Morelli (see Rota and Morelli (2016) Entrapment neuropathies in diabetes mellitus. World Journal of Diabetes; 7(17): 342-253) as evidenced by Stanford Medicine and Yoon,
claims 15, 18-20, 24, and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. ‘388 (as cited on the PTO-892 dated 04/05/2024) and Max-Planck as evidenced by Stanford Medicine
claims 15, 18-20, 22-24, 26, 27, and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. ‘388 (as cited on the PTO-892 dated 04/05/2024), Max-Planck, and Rota and Morelli as evidenced by Stanford Medicine, and
claim 27 is rejected under 35 U.S.C. 112(b)
are hereby withdrawn.
Claim Interpretation
Claim 24 is drawn to treating pain symptoms associated with a disease having a peripheral neuropathy wherein the disease having a peripheral neuropathy is selected from a group identical to the group recited in claim 15. The specification discloses,
“In the present invention, diseases having peripheral neuropathies or astrocytic damages which cause pain symptoms are synonyms of the diseases having peripheral neuropathies or astrocytic damages” (see specification pgs. 36-37 para [0077]).
Therefore, claim 24 is interpreted as treating pain symptoms associated with a disease having a peripheral neuropathy as treating pain symptoms associated with those listed in the Markush group. For example treating pain symptoms associated with peroneal nerve palsy is within the scope of the claim 24, while treating carcinomatous neuropathy of the central nervous system is not within the scope of claim 24.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 15, 18, 22-24, 26-27, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2017/210278 A1 (referred to herein as Mueller2, as cited on the IDS dated 7 January 2021, last foreign patent document).
Applicant's arguments filed 23 April 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues Mueller2 mentions diabetic neuropathy and postherpetic neuralgia in a single line and no experimental data are provided for these conditions (see Remarks pg. 16 middle para).
First, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005; see MPEP § 2123 (I)). Mueller2 teaches administering anti-RGMa antibodies to treat pain, including diabetic neuropathy and postherpetic neuralgia (see Mueller2 pg. 41 para [00141], pg. 59 claims 6, 7, and 11).
Second, in so far as Applicant is arguing Mueller2 is not enabled for treating diabetic neuropathy and postherpetic neuralgia (see Remarks pg. 16, last para) given the working example in Mueller2 is directed to spinal cord injury is not persuasive. When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980) (see MPEP § 2121(I)). In addition, a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; “proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.” Impax Labs. Inc. v. Aventis Pharm.Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (see MPEP § 2121(III)).
Third, in so far as Applicant is arguing the ordinary artisan would not have been motivated to treat peripheral diabetic neuropathy given the success of Mueller2’s working example in the spinal cord is not persuasive (see Remarks pg. 18 starting at C). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971) (see MPEP § 2123(II)). Furthermore, reasonable expectation of success and obviousness are not factors in a 35 USC 102 rejection.
Therefore, the 35 USC 102 rejection of claims 15, 18, 22-24, 26-27, and 30 is hereby maintained.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 19, 20, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over WO2017/210278 A1 (referred to herein as Mueller2, as cited on the IDS dated 7 January 2021, last foreign patent document) in further view of Hashimoto (see WO2016/175236, as cited on the IDS dated 01/07/2016). It is noted, US Patent Publication 2018/0100012 A1 (as cited on the IDS dated 01/07/2021) will be used as an English translation given Hashimoto and US Patent Publication 2018/0100012 A1 have the same underlying PCT and therefore the same disclosure.
Applicant's arguments filed 23 April 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant appears to argue Mueller2 does not render the instant claim obvious nor provide reasonable expectation of success (see Remarks pg. 18 starting at C-pg. 21).
First, Muller2 anticipates treating diabetic neuropathy and postherpetic neuralgia (see Mueller2 pg. 41 para [00141], pg. 59 claims 6, 7, and 11). Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019; see MPEP § 2143.02(I)). Mueller2 explicitly teaches treating pain in diabetic neuropathy and postherpetic neuralgia (see Mueller2 pg. 41 para [00141], pg. 59 claims 6, 7, and 11) therefore Mueller2 provides the reasonable expectation of success.
Second, as stated above while Muller2’s working example demonstrates efficacy in spinal cord injury the disclosed example and preferred embodiment do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971) (see MPEP § 2123(II)).
Therefore, the ordinary artisan would have substituted the anti-RGMa antibodies in a method of treating diabetic neuropathy as taught by Mueller2 with the anti-RGMa antibodies taught by Hashimoto given these are art recognized equivalents (i.e., anti-RGMa antibodies) for the same purpose.
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 15, 18-22, 24, 26, and 30-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 11, and 18-21 of copending Application No. 17/792,673 (referred to herein as ‘673 application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Applicant's arguments filed 23 April 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues Examiner has not articulated a sufficient rationale to support the assertion of the obviousness type double patenting (see Remarks pg. 22 last para).
The instant claims are drawn to treating a peripheral neuropathy. The specification defines “peripheral neuropathy” as a pathological condition in which normal conduction of peripheral nerves is impaired (see specification pg. 1 last para). In addition, the discloses peripheral neuropathies “lead to dysfunctions of motor nerves, sensory serves, and autonomic nerves” (see specification pg. 2, 1st para). The specification also discloses diabetic neuropathies include polyneuropathies which include neuropathies of peripheral, sensory, motor, and autonomic nerves (see specification pg. 2, 1st para). Therefore, instant claim 1 is drawn to a diabetic neuropathy of the peripheral nervous system. The ‘673 application claims treating a diabetic autonomic neuropathy which causes kidney dysfunction (see ‘673 claim 10). Diabetic autonomic neuropathy (DAN) is known in the art as a “subtype of the peripheral polyneuropathies that accompany diabetes” as evidenced by Vinik (see Vinik et al. (2003) Diabetic autonomic neuropathy. Diabetes Care 2003;26(5):1553–1579, in particular pg. 1553, 2nd col. last para). Therefore, pursuant to MPEP § 21.31.02(I) a species will anticipate a claim to a genus. In the instant case the ‘673 claims treating diabetic autonomic neuropathy that causes kidney dysfunction (i.e., species) of the instantly claimed genus of peripheral neuropathies selected from the genus of diabetic neuropathies. Furthermore, the ‘673 application claims particular anti-RGMa antibodies to administer identical to those instantly claimed.
Therefore, the non-statutory double patenting rejection over the ‘673 application is hereby maintained.
Claims 15, 18-20, 24, and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 10, 11, and 13 of U.S. Patent No. ‘346 (as cited on the PTO-892 dated 04/05/2024) and Mazan (as cited on the PTO-892 mailed 16 December 2024). Although the claims at issue are not identical, they are not patentably distinct from each other.
Applicant's arguments filed 23 April 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues Examiner has not articulated a sufficient rationale to support the assertion of the obviousness type double patenting (see Remarks pg. 23 last para).
The instant claims are drawn to treating a peripheral neuropathy. The specification defines “peripheral neuropathy” as a pathological condition in which normal conduction of peripheral nerves is impaired (see specification pg. 1 last para). In addition, the discloses peripheral neuropathies “lead to dysfunctions of motor nerves, sensory serves, and autonomic nerves” (see specification pg. 2, 1st para). The ‘346 patent claims treating Sjogren’s syndrome (i.e., autoimmune connective tissue disease; see claim 15 line 8; as evidenced by Mazan as cited on the PTO-892 mailed 12/16/2024, in particular abstract) with the instantly claimed anti-RGMa antibodies. It was known at the time of filing that 8.5-71% of Sjogren’s syndrome patients exhibit neurological symptoms with the most common being peripheral neuropathy (see Mazan abstract) and specifically chronic inflammatory demyelinating polyneuropathy (CIDP) as evidenced by Mazan (see Mazan pg. 100, 2nd col. last para; see instant claim 15 line 7). Therefore, the ‘346 patent claims treating a known connective tissue disease (i.e., Sjogren’s syndrome) wherein 8.5-70% of patients were known to exhibit neurological symptoms the most common being peripheral neuropathy, such as CIDP, with the claimed anti-RGMa antibodies. Therefore, the ordinary artisan would treat those subjects exhibiting a peripheral neuropathy given more than half of Sjogren’s syndrome patients have a peripheral neuropathy.
Therefore, the non-statutory double patenting rejection of claims 15, 18-20, 24, and 30-32 is hereby maintained.
Claims 15, 18-20, 24, and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 10, 11, and 13 of U.S. Patent No. ‘346 (as cited on the PTO-892 dated 04/05/2024) and Rota and Morelli (as cited on the PTO-892 mailed 10/23/2025).
Applicant's arguments filed 23 April 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues Examiner has not articulated a sufficient rationale to support the assertion of the obviousness type double patenting (see Remarks pg. 24, 5th para).
The ‘346 patent claims treating type I (insulin dependent diabetes mellitus (see ‘346 patent claims 10, 11, and 13) with the instantly claimed anti-RGMa antibodies. Rota and Morelli disclose diabetic neuropathy is
“the most common form of neuropathy in Western countries, with a wide prevalence in literature, ranging from 5%-90%”,
“entrapment neuropathies (EN) are remarkably common in DM at any stage and may be asymptomatic” (see Rota and Morelli pg. 343, 1st col. 1st para, 2nd col. 3rd-5th para, emphasis added), and
specifically names peroneal neuropathy as a common compression injury (see Rota and Morelli pg. 343, 2nd col. last full para; see instant claim 15 line 6).
Therefore, a person of ordinary skill in the art would substitute a type I diabetic mellitus subject for a type I diabetic mellitus subject with diabetic neuropathy specifically painful diabetic neuropathy given the teachings of Rota and Morelli; thereby arriving at the instantly claimed method.
The non-statutory double patenting rejection of claims 15, 18-20, 24, and 30-32 is hereby maintained.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 27 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant's arguments filed 23 April 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues “painful diabetic neuropathies” (see claim 27) is narrower than “treating pain symptoms associated with a disease having a peripheral neuropathy... wherein the disease having a peripheral neuropathy is selected from the group consisting of a diabetic neuropathy” (see claim 24 lines 1-2 and 5). Applicant specifically discloses painful diabetic neuropathies are a subset of peripheral neuropathies and points to pg. 38 para [0081] (see Remarks para spanning pgs. 14-15).
However, the specification discloses “Sensory neuropathies include painful neuropathies with marked paralgesia” (see specification pg. 38 para [0081]). The specification does not disclose all painful diabetic neuropathies are a subset of diabetic sensory neuropathies. Applicant discloses there is pain associated with both motor neuron and autonomic neuropathies (see Remarks para spanning pgs. 14-15). Thus, a painful diabetic neuropathy is a genus of diabetic neuropathies that include motor neuron, autonomic and sensory neuropathies. Therefore, treating a painful diabetic neuropathy does not further limit treating pain symptoms associated with diabetic neuropathy.
The 35 USC 112(d) rejection of claim 27 is hereby maintained.
Conclusion
No claim 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 HILARY ANN PETRASH whose telephone number is (703)756-4630. The examiner can normally be reached Monday-Friday 8:30-4:30 EST.
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/H.A.P./Examiner, Art Unit 1644 /AMY E JUEDES/Primary Examiner, Art Unit 1644
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