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 claims
Claims 1 and 12-15 are original. Claims 2-11, 19, and 21-24 are currently amended. Claims 16-18 and 20 are cancelled. Claims 11-15, 19, and 21-24 are withdrawn due to a restriction. Claims 1-10 are pending and under examination.
Priority
This application claims the priority benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 63/512,891, filed July 10, 2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/27/2025 and 07/24/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election of Group I (i.e., claims 1-10) in the response filed on 07/24/2026 is acknowledged. Claims 11-15, 19, and 21-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, here being no allowable generic or linking claim. The election is treated as without traverse as applicant did not traverse the requirement in the response.
Claim Objections
Claim 2, 3 and 10 is objected to because of the following informalities:
Claim 2 and 3 recite “DMSO”, which is an abbreviation to the expanded phrase “dimethyl sulfoxide”. The expanded phrase must be stated in claim 2 prior to the abbreviation.
Claim 10 recites Actron, Ketoflam, Orudis, and Oruvail, all of which are trade names for Ketoprofen, rendering the list to have repeating elements.
Claim 10 recites Aleve, Anaprox, and Naprelan, all of which are trade names for naproxen sodium, rendering the list to have repeating elements.
Claim 10 recites Ansaid, Froben, Flurwood, and Urbifen, all of which are trade names for flurbiprofen, rendering the list to have repeating elements.
Claim 10 recites Brufen, Medipren, Motrin, Nuprin, and Nurofen, all of which are trade names for ibuprofen, rendering the list to have repeating elements.
Claim 10 recites Daypro, Daryrun, and Duraprox, all of which are trade names for oxaprozin, rendering the list to have repeating elements.
Claim 10 recites Ceeoxx, Ceoxx and Vioxx, both of which are trade names for rofecoxib, rendering the list to have repeating elements.
Claim 10 recites Clotam and Tufnil, both of which are trade names for tolfenamic acid, rendering the list to have repeating elements.
Claim 10 recites Mono-Gesic, Salflex, Disalcid, and Salsitab, all of which are trade names for salsalate, rendering the list to have repeating elements.
Claim 10 recites Melox, Mobic, Movalis, and Recoxa, all of which are trade names for meloxicam, rendering the list to have repeating elements.
Claim 10 recites Mesulid, Nimolax, and Sulide, all of which are trade names for nimesulide, rendering the list to have repeating elements.
Claim 10, line 13 has the term “disaclid”, which is both misspelled and a repeat. Proper spelling is disalcid, which is already stated in line 4 of the same claim.
Claim 10 lists “ketrolac”, which is misspelled. Proper spelling is “ketorolac”.
Claim 10 lists ”trilisate disaclid”. It is missing a comma between “trilisate” and “disaclid”.
Claim 10 lists “aspirin acetylsalicylic acid”, which is missing commas between “aspirin” and “acetylsalicylic acid”.
Claim 10 lists “voltaren xefo”, which is missing a comma between “voltaren” and “xefo”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 are rejected under 35 U.S.C. 101 because they pertain to products of nature and amount to nothing significantly more than that. Claim 1 is directed to nonsteroidal anti-inflammatories (NSAID), opioids, and penetration enhancers––iodine (NSAID) is a naturally occurring element (also consider natural products- ginger, turmeric and omega-3 fatty acids), morphine is a naturally occurring opioid found in poppy plant, menthol is a naturally occurring skin penetration enhancer found in oils of certain plants in the mint family. Many terpenes are naturally occurring compounds found in plants. Regarding claim 2 and 5-6, ginkgolides are biologically active terpene lactones present in Ginkgo biloba trees. Regarding Claim 3, dimethyl sulfoxide naturally occurs in oceans as a metabolite of marine algae. Regarding claim 4, protamine naturally occurs in mammalian sperm cells. Claims 7 and 8 merely recite concentrations of such naturally occurring products. Regarding claim 9, morphine (an opioid) is a naturally occurring opioid derived from poppy plants, and mammals also have natural opioids like endorphins and endomorphins. Regarding claim 10, iodine is a naturally occurring element. Additionally, no data has been provided to demonstrate that all such products or combinations thereof in any concentrations produce any characteristics that are markedly different or provide significantly more to the other components than their naturally-occurring counterparts with their individually contributed activities.
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.
Claims 3 and 10 are 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.
Claim 3 is dependent to claim 2 and recites that “the composition comprises 20- 80% DMSO by volume”. It is unclear whether the “20- 80% DMSO by volume” is in addition to the “one or more transdermal delivery agents [that] comprises DMSO” already present in claim 2, or if it is merely limits the “one or more transdermal delivery agents” in claim 2 to be “20- 80% DMSO by volume”. If it is the former, a suggested amendment is to alter the claim language to “Wherein the composition further comprises an additional 20- 80% DMSO by volume”. If it is the latter, a suggested amendment is to alter the claim language to “wherein the one or more transdermal delivery agents comprises 20- 80% DMSO by volume”.
Claim 3 recites “20- 80% DMSO by volume”. It is unclear what the percent of volume is relative to (e.g., relative to the total volume of all solvents, relative to the total volume of the composition, etc.). A suggested amendment is to alter the claim language to “20-80% v/v of DMSO, relative to the total volume of the composition”.
Claim 10 contains the trademarks/trade names Actron, Aleve, Anaprox, Ansaid, Brufen, Butazolidin, Cataflam, Celebrex, Ceoxx, Clinoril, Clotam, Daypro, Dayrun, Disalcid, Dolobid, Duraprox, Dynastat, Feldene, Froben, Flurwood, Keral, Ketoflam, Lodine, Loxonin, Loxomac, Meclomen, Medipren, Melox, Mesulid, Midol, Mobic, Mobiflex, Mono-Gesic, Motrin, Movalis, Naprelan, Naprosyn, Nimalox, Nuprin, Nurofen, Orudis, Oruvail, Oxeno, Ponstel, Previcox, Prexige, Recoxa, Relafen, Salflex, Sprix, Sulide, Toradol, Tolectin, Trilisate, Tufinl, Urbifen, Vioxx, Voltaren, Xefo, Salsitab, and Ceeoxx. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademarks or trade names cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademarks/trade names are used to identify/describe: ketoprofen, naproxen sodium, naproxen sodium, flurbiprofen, ibuprofen, phenylbutazone, diclofenac potassium, celecoxib, rofecoxib, sulindac, tolfenamic acid, oxaprozin, oxaprozin, salsalate, diflunisal, oxaprozin, parecoxib, piroxicam, flurbiprofen, flurbiprofen, dexketoprofen, Ketoprofen, etodolac, loxoprofen sodium, loxoprofen, meclofenamate sodium, ibuprofen, meloxicam, nimesulide, acetaminophen/caffeine/pyrilamine maleate (combination), meloxicam, tenoxicam, salsalate, ibuprofen, meloxicam, naproxen sodium, naproxen, Nimesulide, ibuprofen, ibuprofen, ketoprofen, ketoprofen, loxoprofen, mefenamic acid, firocoxib, lumiracoxib, meloxicam, nabumetone, salsalate, ketorolac tromethamine, Nimesulide, ketorolac, tolmetin, choline magnesium trisalicylate, tolfenamic acid, flurbiprofen, rofecoxib, diclofenac, lornoxicam, salsalate, and rofecoxib, respectively. Accordingly, the identification/description is indefinite.
Claim 10 lists “rapid” in line 11. It is unclear what this term is referring to, as no NSAID with this name exists, which renders this claim indefinite.
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 1-3, 8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh et al. (US20080319092A1).
Singh et al. discloses a transdermal formulation for the delivery of at least one active agent [¶abstract]. In a single embodiment (Table 3, example 2), Singh et al. discloses formulations containing dimethyl sulfoxide (“DMSO”, a transdermal delivery agent) at concentrations of 30% and 45% w/v and diclofenac sodium (an NSAID) at concentrations of 1.5% w/v.
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.
Claims 1-4 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US20080319092A1).
Singh et al. discloses a transdermal formulation for the delivery of at least one active agent [¶abstract].
Regarding Claims 1-3, 8, and 10: In a single embodiment (Table 3, example 2), Singh et al. discloses formulations containing dimethyl sulfoxide (“DMSO”, a transdermal delivery agent) at concentrations of 30% and 45% w/v and diclofenac sodium (an NSAID) at concentrations of 1.5% w/v.
Regarding Claim 4: Singh et al. teaches that protamine sulfate can be used in the formulation as an antidote [¶38].
Regarding Claim 9: Singh et al. teaches that oxycodone, oxymorphone, hydromorphone, fentanyl citrate, etc., can be used as an analgesic [¶33].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate Singh et al.’s disclosed diclofenac sodium or opioid analgesic with DMSO and protamine sulfate. This is because Singh et al. expressly teaches that its disclosed active agents may be incorporated into the same transdermal formulation, either alone or in combination, thereby motivating selection of these known components to provide their respective aforementioned therapeutic effects in a single topical delivery system. The resulting composition would comprise an NSAID and/or opioid, DMSO within the claimed concentration range, protamine sulfate, and the claimed active agent concentration. A person of ordinary skill in the art would have had a reasonable expectation of success in combining these elements because Singh et al. identifies each component as suitable for inclusion in its transdermal formulation.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US20080319092A1) in view of Waugh et al. (US20190105261A1).
Singh et al. teaches all required elements of claims 1-4 and 8-10.
However, Singh et al. fails to teach the required limitations of claims 5 and 7.
Waugh et al. discloses compositions for topical delivery of an active agent and methods for using such compositions [¶abstract], and further teaches that the composition may be applied to the skin’s surface [¶18].
Regarding Claim 5: Waugh et al. teaches that the composition may include penetration enhancers such as DMSO In addition to terpenes and terpenoids including menthol, nerol, and camphor [¶164].
Regarding Claim 7: Waugh et al. teaches that topical compositions may contain about 0.1-25% w/w active ingredient, and states that the disclosed percentages may also be in w/v [¶114], and specifically lists ibuprofen as an NSAID active ingredient. Waugh et al. further teaches that permeation enhancers (e.g., DMSO) can be present in concentrations of up to 30% w/w (¶165). Thus, 0.1% w/v of NSAID and 30% w/w DMSO (density at 25°C is 1.095 g/mL) corresponds to approximately 3.65 µg of NSAID/1 µL of DMSO, which squarely falls within the claimed range of 0.001-10 µg/µL.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Singh et al.’s topical NSAID composition by including terpene permeation enhancers and the active agent concentrations taught by Waugh et al. This is because Waugh et al. expressly teaches that terpenes and terpenoids, including menthols, nerol, and camphor, are suitable penetration enhancers for topical/transdermal delivery of active agents and further teaches active-agents and enhancers encompassing the claimed ratio. A person of ordinary skill in the art would have been motivated to incorporate Waugh et al.’s teachings into Singh et al.’s composition to improve or facilitate transdermal delivery of the active agent while maintaining an effective therapeutic concentration. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because both Singh et al. and Waugh et al. are directed towards topical pharmaceutical compositions employing conventional penetration enhancers to deliver active agents through the skin, and Waugh et al. expressly teaches that the recited components and concentrations are suitable for such formulations.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US20080319092A1) in view of Sand et al. (US20090053290A1).
Singh et al. teaches all required elements of claims 1-4 and 8-10.
However, Singh et al. fails to teach the required limitations of claims 5 and 6.
Sand et al. discloses transdermal delivery compositions and topical compositions for application to the skin [¶abstract].
Regarding Claims 5 and 6: Sand et al. teaches ginkgolide A, ginkgolide B, and ginkgolide C as compounds suitable for inclusion in the composition as antioxidants [¶187].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Singh et al.’s topical pharmaceutical composition to include or more of the ginkgolides taught by Sand et al. This is because Sand et al. expressly teaches that ginkgolide A/B/C are suitable for inclusion in topical transdermal compositions. A person of ordinary skill in the art would have thus been motivated to incorporate Sand et al.’s disclosed ginkgolides into Singh et al.’s topical composition to obtain the known antioxidant and skin-protective properties associated with those compounds while maintaining transdermal delivery of active agent. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because both Singh et al. and Sand et al. are directed to topical pharmaceutical compositions for application to the skin, and Sand et al. expressly teaches incorporating the recited Ginkgolides into such topical formulations.
Conclusions
No claim is found allowable.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/Primary Examiner, Art Unit 1613
Prosecution Insights