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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The priority date is August 12, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 07, 2024 is being considered by the examiner. The signed IDS forms are attached with the instant office action.
Claims 1-15 are cancelled.
Claims 16-29 are currently under examination.
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 28 and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim recites a use without any method steps.
"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid."
Claim Rejections - 35 USC § 112
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 18, 28, and 29 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.
Claim18, the phrase “at least 95% USDA bio-based”, is unclear. It is unclear in terms of what is bio-based? The claims and specification do not define the scope of bio-based. The disclosure refers to a USDA biobased product, it is unclear if that is the intended composition, a biobased product. Clarification is required.
Claims 28 and 29 attempts to claim a process without setting forth any steps involved in the process, this generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
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.
Claims 16 and 19-29 are rejected under 35 U.S.C. 103 as being unpatentable over Gomez Carlos Natalio et. al. (EP 0392806-A1), Steinberg IIene (WO-2013056044-A1; 2/07/2024 IDS, FOR Doc. # 2), and Schwartz, Ben-Zion Yehuda (WO-2010134060-A1) .
In the instant claim 16 recites, composition for use in treatment of infection by lice, comprising, beeswax, hemisqualane, an emulsifier, and at least one vegetable oil, wherein said composition is devoid of silicones. Gomez et. al. ‘806 teaches “Pediculicidally active compositions comprise as active ingredient a normally solid lipid compound or synthetic equivalent together with an inert additive. The active ingredient is preferably a natural or semisynthetic glyceride or synthetic ester of a higher fatty acid. The compositions are especially suitable for combating lice infestations on the human body.’ (abstract [para-0001]). Furthermore, reference also teaches “semisynthetic glycerides obtained by hydrogenation of animal or vegetable oils (as in instant claim 16, step D), “As examples of natural glycerides …vegetable oils such as…, sunflower (as in instant claim 22); (iii) synthetic esters, for example (a) esters of glycerol and fatty acids, (as recited in instant claim 16 as emulsifiers), (Description [para 0007-0008]). Reference also teaches, “formulations can be prepared by using instead of hydrogenated vegetable oil…other diluents/dispersants such as paraffin, cetostearyl alcohol, lanolin, beeswax, carnauba wax and silicone oils, (Example 2[para-0002]), the use of beeswax as recited in instant claim 16A.
Although Gomez does not teach the exact composition for treatment of lice, however, Steinberg ‘044, teaches “A system and method for treating live head lice is provided. An embodiment of the method comprises the steps of: (a) blending a treatment mixture; (b) applying said treatment mixture to a scalp or hair; and (c) applying a first shampoo to said scalp or said hair (Description [para 0005]). Furthermore, “The treatment mixture used in this method may comprise olive oil and dimethicone. The ratio of olive oil to dimethicone may be approximately 1 to 1. In another embodiment, an effective amount of beeswax may be added to the treatment mixture”, as stated in instant claim 16 and claim 23 and 24 (Olive oil and sorbitan esters are used in the art as surfactant emulsifiers.
Regarding claim 19 and 27, the beeswax in an amount of 0.2 to 4.0 %, Steinberg ‘044 teaches, “The ratio of olive oil to dimethicone may be approximately 1. In yet another embodiment the treatment mixture may include approximately 30-80% olive oil, approximately 30-80% Dimethicone, approximately 0-2% rosemary oils and approximately 0.5-10% beeswax (Description [para 00011])”.
Gomez Carlos Natalio et. al. (EP 0392806-A1) and Steinberg ‘044 do not teach a composition comprising hemisqualane. However, Schwartz ‘060 teaches a composition for removing lice comprising hemisqualane.
Regarding claims 16, item B, 20-21 and 25-27, Schwartz ‘060 teaches “a non-irritating pediculicidal composition for removing lice and/or nits from the hair and/or scalp of an infected person comprising (a) a platform component comprising sugar beet soap, (Summary of Invention [para 0002]).” Although, reference does not recite “hemisqualane”, sugar beet is known in the art as hemisqualane. The reference does not teach the exact % of hemisqualane in the composition, however, reference does teach the amount of hemisqualane as part of preparation of the composition, it would have been obvious variant for one of ordinary skilled in the art to have extracted the plant materials thereby. The final eluted product with what the reference teaches would not be different than the instant claim.
It would have been obvious to a person having ordinary skill in the art at the time of the instant applications effective filing date to have provided treatment for lice in a composition form, because Gomez et. al., Steinberg, and Schwartz teach providing the compositions for treatment of lice thereof.
"It is prima facie obvious to combine the compositions each of which are taught by the prior art to be useful for the same purpose, in order to form another composition to be used for the very same purpose.... [T]he idea of combining the teachings from the references, flows logically from there having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine). One would have had a reasonable expectation of success to achieve the composition to treat lice, because the cited references teach providing the composition in a similar manner for treatment of lice, and because, success merely requires preparing the composition thereof, especially in the absence of the criticality of some undisclosed features, or unexpected results.
While Gomez et. al., Steinberg, and Swartz do not disclose the amounts of the composition, the adjustments of particular conventional working conditions (e.g., determining one or more suitable product, application to the area of the head, and amounts, proportions and ranges thereof in which to perform and providing of a compositions for the treatment of lice), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effectively filled. As evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alpa Amin whose telephone number is (571)272-0562. The examiner can normally be reached 8:30 - 6:00.
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, Anand Desai can be reached at 571-272-0947. 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.
/ALPA NILESH AMIN/ Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655