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 the Claims
Claims 1, 16, 18-19, 26, 63, 78, 86, 134-135, 144, 154-155, 160, 167, 176, 180, 192, 204, and 222 are pending. Claims 1, 16, 18-19, 26, 63, 78, 86, 134-135, 144, 154-155, 160, 167, 176, 180, 192, 204, and 222 are rejected.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 11/14/2024 was considered by the Examiner.
Priority Data
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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.
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.
Claim(s) 1, 16, 18-19, 26, 63, 78, 86, 134-135, 144, 154-155, 160, 167, 176, 180, 192, 204, and 222 is/are rejected under 35 U.S.C. 103 as being unpatentable over Birbara (US 2015/0133561) and Campbell (WO2017/127628) [both references disclosed on 11/14/2024 IDS].
Birbara teaches a 74 year old male with painful osteoarthritis of the knee joint received a capsaicin injection while the knee was continuously cooled with ice. This male additionally was treated with 10 ml of a 1% (10 mL of 0.01 grams/ml = 0.1g) lidocaine injection into the knee. Fourteen minutes after injection of the capsaicin, subject experienced complete relief of his osteoarthritic pain symptoms and treatment, including cooling, was terminated (see para. [0202] and Table X).
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Birbara discloses capsaicin injections ranging from 0.001 mg to 1.0 mg and they can provide pain relief for greater than 6 months (see para [0116] and [0118]). Additionally, “[c]ooling the joint or administration site via external cooling means such as a gel pack or ice pack or cooling device also reduces the painful effects from capsaicinoid administration. In one embodiment, the cooling or gel pack produces a temperature above freezing, e.g. 38-50 degrees F” (see para. [0115]). (38-50 degrees F is approximately 3 – 10 degrees C.) The formulations of their invention are useful in relieving pain at an intra-articular site by intra-articular administration injection to the knee (see para [0103] and [0104]).
While Birbara teaches capsaicin administration to an osteoarthritic knee in conjunction with cooling the site, they do not teach sequential dosing of the capsaicin. They also do not teach cooling the site for at least 30 minutes pre and post treatment or reduction in pain specifically using the Numeric Pain Rating Scale (NPRS).
Campbell teaches injecting sequential dosing of capsaicin to treat pain to due to an intermetatarsal neuroma. The methods provide pain relief for up to a year (see para [0006]). The methods generally involve at least two doses of capsaicin to the patient, wherein the second dose is administered no sooner than 3 months after administration of the first dose (see para [0006] and [0007]). The first and second doses of capsaicin are in an amount ranging from about 100 ug to about 1,000 ug (see para [0008]).
Campbell additionally teaches cooling tissue adjacent to the capsaicin injection site by using a cold article having a temperature of about 5 degrees C to about 10 degrees C for approximately 15 minutes. Then, administering a local anesthetic agent including 4 mL of a 1% lidocaine solution (0.04 grams), without epinephrine, to surrounding tissue approximately 30 minutes prior to capsaicin administration. After the capsaicin injection, cooling agent is then put back on the treatment surface for about 30 to 60 minutes (see para [0062]). There is an additional embodiment where cooling is placed back on for 30 minutes between lidocaine and capsaicin injections (see para [0112]).
Campbell’s method is characterized by the following:
a) Achieving a reduction in pain on the NPRS by at least 1 for a duration of at least 8 months or at least 12 months (claims 89 and 93).
Achieving a reduction in pain on the NPRS by at least 2 for a duration of at least 8 months or at least 12 months (claims 99 and 103).
c)Achieving a reduction in pain on the NPRS by no greater than 1 for a duration of at least 8 months or at least 12 months (claims 109 and 113).
d)Achieving a reduction in pain on the NPRS by no greater than 2 for a duration of at least 8 months or at least 12 months (see para [0073]).
Regarding claims 1, 16, 18-19, 26, 63, 78, 86, 134-135, 144, 154-155, 160, 167, 176, 180, 192, 204, and 222, Birbara’s single capsaicin dose providing relief for greater than 6 months (para [0118]) reads on the amelioration of pain of at least 8 and 12 months. Birbara’s cooling temperature of 3 - 10 degrees C (see para [0115]) reads on the temperature range of about 1 to 15 degrees C. Wherein Campbell’s second capsaicin dose is administered no sooner than 3 months after administration of the first dose (see para [0006] and [0007]), this reads on the second dose being administered no sooner than or about 3, 4, 5, 6, 5-7 months post first capsaicin injection. A person of skill would have been motivated to test known administration protocols for capsaicin to determine which would provide optimum results for a given condition.
Regarding claim 26c, a cooling agent with a similar external temperature would be expected to create an analogously similar internal tissue temperature. Applicant has not demonstrated that these conditions impart any unexpected or novel aspect to the reaction. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05.
A PHOSITA would have been motivated to try Campbell’s second capsaicin dosing following Birbara’s single capsaicin injection because it was effective for one condition and osteoarthritic joint pain is difficult to treat. It would have been obvious to optimize a regimen to include further doses of capsaicin to prolong the period of pain relief and arrive at the claimed invention.
Regarding claims 176, 180, 192, and 204, Campbell teaches the same pain reduction assessments. As these are standard pain reduction parameters, it would have been obvious to a PHOSITA to assess these markers following the two dose capsaicin treatment for osteoarthritic knee pain treatment instead of a similar regimen for intermetatarsal neuroma treatment. This renders the claimed invention non-obvious.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
(1 of 3) Claims 1, 16, 18-19, 26, 63, 78, 86, 134-135, 144, 154-155, 160, 167, 176, 180, 192, 204, and 222 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,026,903 in view of Birbara (US 2015/0133561) and Campbell (WO2017/127628).
The claims of the patent are generic to the subject matter of claims 1, 16, 18-19, 26, 63, 78, 86, 134-135, 144, 154-155, 160, 167, 176, 180, 192, 204, and 222 discussed under 35 USC 103 and found to be obvious. The claims of the patent disclose ameliorating joint pain by applying a cooling article, administering a local anesthetic and then administering an injection of capsaicin. The discussion and rationale under 35 USC 103 are incorporated by reference. The generic claim of the patent is deemed to render obvious the instant claims since it embraces subject that would have been obvious to a person of ordinary skill in the art and that is embraced by the instant claims.
(2 of 3) Claims 1, 16, 18-19, 26, 63, 78, 86, 134-135, 144, 154-155, 160, 167, 176, 180, 192, 204, and 222 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12201594 in view of Birbara (US 2015/0133561) and Campbell (WO2017/127628).
The claims of the patent are generic to the subject matter of claims 1, 16, 18-19, 26, 63, 78, 86, 134-135, 144, 154-155, 160, 167, 176, 180, 192, 204, and 222 discussed under 35 USC 103 and found to be obvious. The claims of the patent disclose ameliorating joint pain by applying a cooling article, administering a local anesthetic and then administering an injection of capsaicin. The discussion and rationale under 35 USC 103 are incorporated by reference. The generic claim of the patent is deemed to render obvious the instant claims since it embraces subject that would have been obvious to a person of ordinary skill in the art and that is embraced by the instant claims.
(3 of 3) Claims 1, 16, 18-19, 26, 63, 78, 86, 134-135, 144, 154-155, 160, 167, 176, 180, 192, 204, and 222 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18984070 in view of Birbara (US 2015/0133561) and Campbell (WO2017/127628).
The claims of the copending case are generic to the subject matter of claims 1, 16, 18-19, 26, 63, 78, 86, 134-135, 144, 154-155, 160, 167, 176, 180, 192, 204, and 222 discussed under 35 USC 103 and found to be obvious. The claims of the copending case disclose ameliorating joint pain by applying a cooling article, administering a local anesthetic and then administering an injection of capsaicin. The discussion and rationale under 35 USC 103 are incorporated by reference. The generic claim of the copending case is deemed to render obvious the instant claims since it embraces subject that would have been obvious to a person of ordinary skill in the art and that is embraced by the instant claims.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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