Prosecution Insights
Last updated: August 06, 2026
Application No. 18/284,523

HEAD LICE TREATMENT

Final Rejection §103
Filed
Sep 27, 2023
Priority
Feb 14, 2022 — GB 2201942.6 +1 more
Examiner
CHAO, ALLEN
Art Unit
1622
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Nitoff Limited
OA Round
2 (Final)
67%
Grant Probability
Favorable
3-4
OA Rounds
2m
Est. Remaining
67%
With Interview

Examiner Intelligence

Grants 67% — above average
67%
Career Allowance Rate
4 granted / 6 resolved
+6.7% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
57 currently pending
Career history
40
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
42.2%
+2.2% vs TC avg
§102
24.1%
-15.9% vs TC avg
§112
25.3%
-14.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 6 resolved cases

Office Action

§103
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 . DETAILED ACTION This office action is in reply to the Applicant’s Arguments/Remarks filed 10 June 2026 for application 18/284,523 filed 27 September 2023. Claims 1 and 12 are amended. Currently, claims 1-14 are pending. REJECTIONS – MAINTAINED & NEW Claim Rejections - 35 USC § 103 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. (Maintained) Claims 1-2 and 4-14 are rejected under 35 U.S.C. 103 as being unpatentable over Momentive Performance Materials (Silsoft CLX-E Conditioning Agent Marketing Bulletin, pg. 1-12, copyright 2015-2017, share.google/XhWA1dPBUNDq14X53; entered in IDS on 27 September 2023) in view of B. Rossel (Formable composition for killing arthropods and uses thereof, US PG-PUB 2010/0015064 A1, 2010; entered in IDS on 27 January 2023). Momentive Performance Materials (MPM) discloses the commercially available (circa 2015) product Silsoft CLX-E as a conditioning agent that forms a durable, crosslinked network on hair with results that are described as hair with improved manageability along with a soft, radiant appearance without weighing down hair or leaving behind residue. The chemistry of Silsoft CLX-E is described as a poly-unit polymer containing subdomains including an amine- based linker connected to a siloxane subdomain, another amine-based linker substituted by a subdomain containing siloxy-moieties, another subdomain consisting of multi-unit monomers of ethoxylate and then propoxylate bonded sequentially, and lastly another amine-based linker that is substituted to another poly-unit polymer and an undefined organic substituent, as compared to claim 1 (pg. 2). Regarding the limitation amended to in claims 1 and 12, of the copolymer forming non-greasy in-situ crosslinks when dried on hair, is met as MPM teaches that the amount residue or build-up, that is often greasy, left behind by Silsoft CLX-E condition agent when compared to a traditional silicone conditioner is reduced and actually appears to decrease with more wash cycles (pg. 8 - fig. 12, section 6: build-up study in rinse-off formulation). Consequentially, Silsoft should result in a non-greasy crosslinked network of polymers after use, relative to other conditioning agents. MPM teaches that linear structures are favored for their sensory benefits, that the silicone aligns to the hair shaft to provide a specific "silky" feel to hair, that the polyether provides better water dispersibility and ease of formulation as well as improved adhesion to damaged hair, that the non-reactive amine is substantive to keratinaceous substrates (pg. 2), compared to claim 2, such as hair, to form a soft, flexible film, and lastly that the reaction portions cross- link and provide prolonged effects that can endure through washes while the polyether balances hydrophilic/hydrophobic properties leading to self-limiting deposition. In one formulation, MPM teaches a deep conditioning hair mask which utilizes the ingredients of DI water, hydroxyethylcellulose, glycerin, as compared to claim 6, cetearyl alcohol (1% by weight) (cetearyl alcohol is a mixture of cetyl and stearyl alcohols), as compared to claims 7- 11, glycerol stearate and PEG-100 stearate, Silsoft CLX-E conditioning agent (5% by weight), as compared to claim 4 (pg. 9), and preservatives and fragrances. In another formulation, MPM teaches a cationic conditioner utilizing the ingredients of water, lactic acid, behenamidopropyl diethylamine, cetearyl alcohol (4.4% by weight), Silsoft CLX-E conditioning agent (6% by weight), and preservatives (pg. 9). It is noted that cetyl alcohol is a C₁₆ fatty alcohol and stearyl alcohol is a C₁₈ fatty alcohol. In another formulation, MPM teaches a rinse-off conditioner which utilizes the ingredients of DI water, ceteareth-20, cetearyl alcohol (3% by weight), as compared to claim 11, coconut oil, and Silsoft CLX-E conditioning agent representing a silicone active ingredient (1% by weight), as compared to claim 5 (pg. 5), and a preservative. MPM also teaches a treatment protocol for damaged hair repair wherein the protocol includes the steps of 1) after shampooing, applying repairing cream to damp hair, massaging into the hair with a focus on damaged ends, 2) allow the hair to dry with the product, and 3) briefly rinse hair and style, as compared to claims 12-14 (pg. 4). However, MPM does not disclose a composition for the use in controlling lice or their ova on an animal subject utilizing the Silsoft CLX-E product. Rossel rectifies this deficiency by teaching an active ingredient combination of hydrocarbons and siloxanes as an effective means of killing arthropods and their eggs, including lice and nits (pg. 2). In particular, the hydrocarbons are defined as "low molecular weight" with a specification of 10 to 22 carbon atoms, and siloxanes are defined as "high molecular weight" with a specification of 5 to 900 silicon atoms, as illustrated by Formulas I and Il (pgs. 5-6). In particular, the embodiment of formula Il utilizes a similar amine or quaternary ammonium linker to incorporate other functional moieties. In the preferred form, the invention is specified to be a foamable composition, as to be applied to dried hair. As such, it would have been prima facie obvious, for a person of ordinary skill in the art, to use Silsoft CLX-E, in an appropriate formulation, in the killing and prevention of lice and their ova utilizing the teachings of Rossel, as the illustrated chemical structures of the preferred polymers include several of the sub-domain monomers as described in Silsoft CLX-E. It would therefore be reasonable to predict that Silsoft CLX-E would have the same lice and ova killing/prevention properties while imparting the hair conditioning, non-toxic properties as described by MPM. (Maintained) Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Momentive Performance Materials and Rossel as applied to claims 1-2 and 4-14 above, and further in view of Okada et al. (Fluorine-modified silicone, process for preparing the same, and cosmetics containing the same, EP0657486A2, 1995). Momentive Performance Materials and Rossel disclose a composition, described by hair Silsoft CLX-E in various formulations including a low molecular cationic conditioning agent and low molecular weight glycol, that can be applied to hair as a means to control lice and ova on an animal subject or human. They do not, however, disclose a composition that includes a fluorinated silicone polymer. Okada rectifies this by teaching the use of a fluorine-modified silicone, process for preparing and the cosmetics using including shampoos, hair dressing preparations, and hair tonics. Okada teaches that the application of fluorine-modified silicone for the purpose of protecting hair and skin from water and oil and that incorporate properties such as emulsion stability, can withstand mechanical contact and controlled viscosity. The invention includes where R could be an aliphatic chain or siloxane (pg. 2). As such, it would be prima facie obvious, to a person of ordinary skill in the art, to see that this fluorinated siloxane could be either chemically incorporated into the Silsoft CLX-E polymer backbone or as an organic substituent from the amine linker, or to use this polymer separately in the composition as a means to impart the properties of hydro and lipophobicity to the hair product as a means of conditioning in addition to the previously taught lice and ova preventing and treating properties. Response to Arguments The office kindly thanks the Applicant for their consideration and arguments to the previous office action. Responses are detailed below. Applicant's arguments filed 10 June 2026 have been fully considered but they are not persuasive. On pgs. 9-10, Remarks, the Applicant argues: …In sharp contrast to Rossell, the claimed method, which uses the inventive composition of Claims 1-11, treats the hair prior to infestation, as now explicitly recited in amended independent claim 12, as a preventative treatment…different from Rossell, which applies treatment only after the lice infestation is present… the product in Rossell will, however, leave the hair greasy, weighed down….Rossell teaches a lice treatment that acts via suffocation of the lice….the live lice “reject” the location because of the hydrophobic matrix and leave the host…. In response to Applicant’s arguments, Applicant is correct that Rossell does not teach the use of their invention before the occurrence of an infestation rather than during the discovery of an infestation. However, this misunderstands the purpose of the 103 rejections as Rossell teaches properties and uses that may be inherent to the Silsoft CLX-E conditioning agent because it shares chemical properties to Rossell’s invention including hydrocarbon and siloxane polymers. As the Silsoft CLX-E conditioner as described shares a preponderance of similarity to the chemical structure of the claimed invention as described in claims 1 and 12, it is reasonable to presume that Silsoft CLX-E conditioner may also inherently have the same lice preventing properties if used in such a fashion. Even if the instant invention is not identical to Silsoft CLX-E conditioning agent, it would have nonetheless been obvious to a person of ordinary skill in the art at the time of Applicant’s earliest effective filing date to follow the teachings of Rossell to consider their use in the treatment of lice seeing as the underlying chemical structures share significant similarities. As Silsoft CLX-E conditioning agent appears to be purposed for daily or near daily use for improving and maintaining the quality of hair, use before and during a potential lice infection, seems to the Examiner, to be obvious or inevitable for the end user experiencing both use of the Silsoft CLX-E conditioning agent and a future lice event. While these conclusions are subject by the Examiner, the USPTO does not have the laboratory facilities to evaluate the prior art formulas nor the formulas of the instant application to demonstrate that the prior art Silsoft CLX-E conditioning agent does not possess the properties and use that the instant invention is claiming; therefore, the burden is properly shifted to Applicant to provide evidence should Applicant believe that the formulas of the instant claims will result in a composition with a non-obvious characteristic to a person of ordinary skill in the art in light of the prior art. Additionally, the Examiner notes that with respect to rejected claims 1-11, these are composition claims. The patentability of a composition or product claim does not hinge on its intended use, but on the features of the claimed composition/product. Here, the prior art is suggestive of the claimed compositions. Therefore, whether Applicant intends the claimed composition to be used on hair before the infestation by lice is not dispositive regarding the patentability of the claimed composition. The rejection is maintained. Conclusion No claims are 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 Allen Chao whose telephone number is (571)272-7001. The examiner can normally be reached Monday - Friday 0700-1300. 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, James H Alstrum-Acevedo can be reached at 571-272-5548. 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. /ALLEN CHAO/Examiner, Art Unit 1622 /JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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Prosecution Timeline

Sep 27, 2023
Application Filed
Jan 09, 2026
Non-Final Rejection mailed — §103
Jun 10, 2026
Response Filed
Jul 20, 2026
Final Rejection mailed — §103 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12649751
INHIBITORS OF HPK1 AND METHODS OF USE THEREOF
2y 11m to grant Granted Jun 09, 2026
Study what changed to get past this examiner. Based on 1 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
67%
Grant Probability
67%
With Interview (+0.0%)
3y 0m (~2m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 6 resolved cases by this examiner. Grant probability derived from career allowance rate.

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