Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 1-33 are pending and under examination in this office action
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 4/3/24. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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 1-33 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.
It is unclear what the foam composition is. Is the foam in an emulsion? Is the emulsion soaked in the foam or is the foam formed from the emulsion. Clarification is required.
Instant claim 2 recites the phrase “oil-in water type emulsion” clarification is required.
Claim 6 recites the term hydrated lecithin, Clarification is required.
The term preferably is indefinite in instant claim 10.
Claim 13 recites the term “enzyme preparation” it is unclear what that means.
Claim 14 recites the phrase “substantially emulsifier-free emulsion” It is not clear as it contradictory to instant claim 1.
Instant claim 16 recites the term bioidentical fats, what does this mean?
Claim18 recites liquid wax ester… it is not clear.
Claim 28 recites “membrane-forming” not clear as well..
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-4, 7-8, 11-17 and 20-25 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Friedman et al.(2005/0244342)
With regards to instant claim 1 Friedman teaches a foam composition (see abstract) comprising an emulsion (see 0033) which comprises an oil phase (see 00891) and water phase (see 0040, see 0059 o/w emulsion), triglyceride (ie., a membrane forming substance, as required by instant claims 1, 3-4, see 0040), a thickener (see 0005, as required by instant claim 7) wherein the thickening agent is hydroxy propylmethyl cellulose (see 0045, as required by instant claim 7), comprises a stabilizer (see 0059, as required by instant claim 8), a lubricating agent (see 0077, as required by instant claim 11), a pharmaceutically active agent (as required by instant claims 12-13, and 25 see 0077), wherein the foam is in the form of a cream (see 0083-0085, as required by instant claim 17), and comprises a water insoluble membrane foaming substance (see 0054, as required by instant claim 20) with a HLB value greater than 8(see 0059, as required by instant claim 21), as a skin care agent (see 0076, as required by instant claim 22) as a masking agent (thus a cleansing agent (as required by instant claim 23, see claim 7), wherein the formulation acts like a sunscreen (see 0102, as required by instant claim 24).
Claim(s) 1-27 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Popp et al. (US 2006/0029657).
Popp teaches with regards to instant claim 1, a foam dosage form (see 0110) comprising oil-in-water emulsion (see 0048, as required by instant claim 2) one membrane forming substance forming a lamellar membrane (see 0008) and comprises a lipid (i.e., a triglyceride, a phospholipid as required by instant claims 3-5, see abstract, 0162) , lecithin (as required by instant claim 6 and 19, (see 0160), xanthan gum (as required by instant claim 6, see 0171), pentylene glycol (see 0169, as required by instant claims 8-9), squalane (see abstract, as required by instant claim 10) as a lubricate (thus comprises a lubricant oil, see 0129), pharmaceutically active agent (as required by instant claims 12-13, see 0178-0179) and emulsifier -free i.e., free of cholesterol (see abstract as required by instant claim 14-15) in the form of a cream (0144, as required by instant claim 17) as a skin care agent, cleansing agent ( see abstract, 0174, as required by instant claims 22-23) as a sunscreen (see 0179, as required by instant claim 24) and a cosmetic agent (see 0118).
With regards to instant claim 26-27, Popp teaches producing an emulsion (see 0048-0050) and package under pressure in a suitable container to generate foam (see 0119).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-33 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Popp et al. (US 2006/0029657) in view of Friedman et al.(2005/0244342) and Simonnet et al. (US 6,342238).
Popp is applied here as above. Claims 28 and 30 would have been obvious to one of ordinary skill in the art as the foam formulation comprises oil, water phase, membrane forming substance, thickening agent homogenized at a temperature of 60 degrees (see 0227, as required in part by claims 28-30), through the use of ultrasonic waves , ie., high energy input (as required by instant claim 31, see 0208) at a pressure from 5,000-25,000 psig. Although the units diver, the concept is taught and therefore it is within the purview of the skilled artisan to make and use the claimed invention. Without showing the criticality of the pressure it would have been obvious to use the the pressure taught to result in the claimed invention. However Popp fails to teach the foam comprises liquid wax ester, nonetheless teaches a avocado wax which is a wax ester (see 0156).. Additionally, Popp fails to teach the propellant weight in the aerosol. Because the idea is taught is a result-effective variable, i.e., a variable that achieves a recognized result and, therefore, the determination of the optimum or workable dosage range would have been well within the practice of routine experimentation by the skilled artisan, absent factual evidence to the contrary, and, further, absent any evidence demonstrating a patentable difference between the compositions used and the criticality of the amount(s).
Friedman is applied here as above. However fails to teach the foam comprises liquid wax ester, nonetheless teaches a bees wax which is a wax ester and teaches that the bees wax including a mixture of alcohols, a majority of which has at least 20 carbon atoms in their carbon chain, are especially well suited as foam adjuvant agents. Thus one of ordinary skill in the art would have been motivated to include with the phospholipid a liquid wax ester with a reasonable expectation of success.
Simonnet teaches hydrogenated lecithin containing emulsion composition for skin care. The emulsion formulations contain glycerol and a glycol such as propylene glycol or pentylene glycol. According to Simonnet, the combination of glycerol and the glycol allows the long- term stability of the emulsion. The emulsion composition is prepared by high speed homogenization (Abstract, col. 3, line 45 through col. 4, line 60, col. 6, line 58 through col. 7, line 4, col. 8, line 18 through col. 9, line 3, Examples and claims).
It would have been obvious to one of ordinary skill in the art to use to have combined the cited art in producing long term stability of the emulsion as taught by Simonnet. Additionally, one would have been motivated to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concerns about. MPEP 2141.01(a).
No Claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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, Robert A. Wax can be reached at 571-272-0623. 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.
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 12/16/25