DETAILED ACTION
The present application is a domestic application, filed 24 May 2023, and claims priority to US Provisional Application No. 63/375,769, filed 15 September 2022 and US Provisional Application No. 63/345,353, filed 24 May 2022.
The preliminary amendment filed 18 January 2024 is acknowledged. Claims 1-18 are pending in the current application. Claims 11-16 and 18 are withdrawn as being drawn to a non-elected invention, see below. Claims 7-10 and 19 are withdrawn as being drawn to a non-elected species, see below. Claims 1-6 and 17 are examined on the merits herein.
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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-10, 17 and 19 in the reply filed on 11 March 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 11-16 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election of chemotherapy-induced neuropathic pain as a species of pain in the reply filed on 11 March 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
To expedite prosecution of the present application, the species has been expanded to include neuropathic pain.
Claims 7-10 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The recitation “wherein the hyaluronic acid is injected into a body cavity” in present claim 17, renders the claim herein indefinite. Claim 17 depends from claim 1, which recites “by the topical administration…of a therapeutically effective amount of hyaluronic acid” in claim 1. Thus, claim 1 already requires a specific topical mode of administration. Thus, it is unclear if claim 17 is an additional step. The claim could be amended to recite “further comprising” and additional language to make it clear the claim is directed towards another separate step of administering hyaluronic acid.
Because of the high level of uncertainty as to what the claim refers to and what is required of the invention as claimed, claim 17 is not further examined on the merits herein.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Birbara et al. (US Patent No. 10,583,100, cited in PTO-892).
Birbara et al. disclose a composition comprising capsaicinoid, low molecular weight hyaluronic acid (LMWHA), high molecular weight hyaluronic acid (HMWHA), surfactant, and lidocaine (claim 1). The composition further comprises a penetration enhancer (claim 26). The formulation typically comprises HA having a MW of 11 kDa, and HA having a MW of about 1,000 kDa (col. 21:33-54; Table 3). The LMWHA typically ranges less than 200 kDa, while the HMWHA is typically greater than 800 kDa (col.15:39-52). The penetration enhancer can include dimethyl sulfoxide (DMSO), (col. 10:28-32). Birbara et al. disclose topically administering the composition to treat pain, wherein the pain includes neuropathic pain (col. 9:56-67). The hyaluronic acid has many functions in the composition: viscosity enhancer and moisturizing agent (example 16). In example 2, it was noted the addition of 1% hyaluronic acid “dramatically reduced the burning sensation and skin irritation induced by a 0.25% capsaicin aqueous formulation”. Birbara et al. teach LMWHA can penetrate the epidermal layer of the skin, where it supplements water loss and helps restore the natural cell regenerative qualities in skin (col.16:30-39). HMWHA works at the epidermal level and offers a protective effect, hydrating and healing the protective barrier on the skin. Combining both reduces the burning and stinging effects of capsaicinoids.
Thus, Birbara et al. disclose topically administering a composition comprising HA, having a MW of at least 120 kDa and 150 kDa to treat pain, including neuropathic pain.
Thus, the disclosure of Birbara et al. anticipates claims 1-6 of the present application.
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.
Claim(s) 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Birbara et al. (cited above) in view of Binder et al. (Dtsch Arztebl Int, 2016, vol. 113, pp. 616-26, cited in PTO-892).
Birbara et al. teach as discussed above.
Birbara et al. do not expressly disclose treating chemotherapy-induced neuropathic pain (CINP), (elected species).
Binder et al. teach neuropathic pain has many causes, including post-chemotherapeutic (CINP), (Box 1). Binder et al. teach “drugs are now chosen to treat neuropathic pain independently of the cause and symptoms of the pain. Topical agents are used only to treat peripheral neuropathy.” (Summary: Conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer hyaluronic acid to treat CINP.
In the same field of endeavor of treating pain, one having ordinary skill in the art would have known from Binder et al. that neuropathic pain, including CINP, is treated with known topical pain relievers, regardless of the cause. One having ordinary skill in the art would have been motivated to administer hyaluronic acid to treat CINP, because it has been taught by Birbara et al. as part of a topical composition for the treatment of neuropathic pain. The skilled artisan would have had a reasonable expectation of success, because Binder et al. teach selecting drugs to treat neuropathic pain independently of the cause and pain symptoms.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAHAR A CRAIGO whose telephone number is (571)270-1326. The examiner can normally be reached M-F: Noon-8pm ET.
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, Fereydoun Sajjadi can be reached at 571-272-3311. 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.
/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
Prosecution Insights