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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/17/2025 has been entered.
Status of Claims
Claims 1, 3, 5, 7, and 13-20 are pending. Claims 14-20 are withdrawn.
Priority
Instant application 18/161,402, filed 01/30/2023 claims priority as follows:
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Response to Amendment
The amendment filed 12/17/2025 has been entered. Claims 1 and 7 are amended.
Claims 1, 3, 5, 7, and 13 were previously rejected under 35 U.S.C. 112(b) as indefinite. In view of the amendments filed 12/17/2025, applicant has overcome the rejection. Therefore, the rejection is withdrawn.
Claims 1, 3, and 5 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by M2B Pharma (cited previously). In view of the amendments filed 12/17/2025, applicant has overcome the rejection. Therefore, the rejection is withdrawn.
Claims 7 and 13 were previously rejected under 35 U.S.C. 103 as being unpatentable over LaRosa et al. (cited previously) in view of Emrick (cited previously). In view of the amendments filed 12/17/2025, applicant has overcome the rejection. Therefore, the rejection is withdrawn. However, a new rejection of claims 7 and 13 under section 103 over LaRosa in view of an alternative reference (SDM Magnetics) is presented below.
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.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over LaRosa et al. (US 20210015836 A1; published 2021).
Instant claim 1 is drawn to a composition for numbing the scalp comprising benzocaine, lidocaine, and any combination of pramoxine, dibucaine, tetracaine, benzyl alcohol, vitamin E acetate, and water; wherein the compound further comprises carbopol.
LaRosa et al. teaches topical analgesic compositions to be administered to a skin surface of a subject (title, abstract). LaRosa teaches that the topical formulation includes any formulations that can be applied to a skin surface, such as gels, creams, aerosol sprays, liquids, etc. (see para. [0047]). Further, LaRosa teaches that the topical compositions include one or more external analgesic agents, and teaches lidocaine, benzocaine, pramoxine, tetracaine, dibucaine, and benzyl alcohol as topical analgesics (see para [0020] and Production Example 74 starting at page 23). LaRosa also teaches the use of an “anti-oxidant” in the composition, and particularly teaches vitamin E or vitamin E acetate (see e.g. para. [0037] and [0195]). Additionally, LaRosa teaches compositions comprising water (see e.g. para. [0121] and [0122]), particularly United States Pharmacopeia (USP) water (see e.g. para. [0251]). The water taught by LaRosa is being interpreted as reading on “a purified water base” recited in the claims. LaRosa further teaches the use of a polymeric binder to affect the thickness or viscosity of the composition, and teaches, in particular, carbopol (see e.g. para. [0023], para. [0183], para. [0184]).
Finding of prima facie obviousness
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (A), it would have been prima facie obvious to combine benzocaine, lidocaine, carbopol, and any combination of pramoxine, dibucaine, tetracaine, benzyl alcohol, vitamin E acetate, and purified water. A person having ordinary skill in the art would have reasonably predicted that each of these agents could be combined in order to arrive at a topical analgesic composition in view of LaRosa’s teachings. Each ingredient had a known use and was known in the prior art for use in a topical analgesic composition.
It has been held that “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385, 1395-96 (U.S. 2007), citing Sakraida v. AG Pro, Inc., 425 U.S. 273, 282 (1976) (stating “‘when a patent simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.”). See MPEP 2144.06.
For claim 3, LaRosa teaches a dose of 20% benzocaine (see e.g. page 23, Table B).
For claim 5, LaRosa teaches a dose of 4 % lidocaine (see e.g. page 23, Table B).
Therefore, claims 1, 3, and 5 are prima facie obvious over LaRosa.
Claims 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over LaRosa et al. (US 20210015836 A1; published 2021) in view of SDM Magnetics (https://www.magnet-sdm.com/magnetic-perfume-cap/. January 30, 2018).
The teachings of LaRosa are disclosed above and at least those teachings are incorporated herein by reference and applied to instant claims 7 and 13.
Instant claim 7 is drawn to a scalp numbing system comprising 20% benzocaine, 4% lidocaine, pramoxine, dibucaine, tetracaine, benzyl alcohol, carbopol, lecithin, propylene glycol, vitamin E acetate, and water; and a container comprising a body, lid magnetically attachable to the body, nozzle, and trigger.
As set forth above, LaRosa teaches topical analgesics and teaches 20% benzocaine, 4% lidocaine, and any combination of pramoxine, dibucaine, tetracaine, benzyl alcohol, carbopol, vitamin E acetate, and a purified water base. LaRosa additionally teaches propylene glycol as a solvent (see e.g. para. [0121], para. [0177]) and lecithin as an emulsifier (see e.g. para. [0177]-[0182], para. [0220]).
Applying KSR example rationale (A), it would have been prima facie obvious to combine benzocaine, lidocaine, carbopol, and any combination of pramoxine, dibucaine, tetracaine, benzyl alcohol, vitamin E acetate, lecithin, propylene glycol, and purified water. A person having ordinary skill in the art would have reasonably predicted that each of these agents could be combined in order to arrive at a topical analgesic composition in view of LaRosa’s teachings. Each ingredient had a known use and was known in the prior art for use in a topical analgesic composition.
LaRosa contemplates sprays, pump sprays, and aerosol sprays (e.g. para. [0047]) but does not disclose a container comprising a body, a lid magnetically attachable to the body, a nozzle, and a trigger.
However, containers comprising a body, a lid magnetically attachable to the body, nozzle, and trigger were known in the prior art. For example, SDM Magnetics teaches spray containers for delivering fluids having a body, a lid magnetically attachable to the body, nozzle, and trigger (see, e.g., page 2, bottom figure):
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Applying KSR example rationale (G), it would have been prima facie obvious to modify the analgesic spray composition taught by LaRosa to include a container comprising a body, lid, nozzle, and trigger such as the container taught by SDM Magnetics. A skilled artisan would have been motivated to include the container taught by Emrick in order to be able to deliver a liquid composition as a spray.
For claim 13, LaRosa teaches that the topical formulation includes any formulations that can be applied to a skin surface, such as gels, creams, aerosol sprays, liquids, etc. (see para. [0047]).
Therefore, 7 and 13 are prima facie obvious over LaRosa in view of SDM Magnetics.
Response to Arguments
In the remarks filed 12/17/2025, applicant argues that LaRosa “merely mentions water as a solvent” and that the water in LaRosa is not “purified water” (Remarks, pages 7-9). Applicant additionally argues that LaRosa “does not appear to teach or suggest carbopol as part of the compound, as now required”.
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive. LaRosa teaches United States Pharmacopeia (USP) water and “Purified Water USP” (see e.g. para. [0251], para. [0296], para. [0300]), which is purified water for pharmaceutical use. Additionally, LaRosa teaches the use of a polymeric binder to affect the thickness or viscosity of the composition, and teaches, in particular, carbopol (see e.g. para. [0023], para. [0183], para. [0184]).
Conclusion
Claims 1, 3, 5, 7, and 13 are rejected. Claims 14-20 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621