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
Priority and Status of Claims
1. This application is a 371 of PCT/EP2022/054758 02/25/2022, which claims benefit of the foreign application EPO EP2130522.1 with a filing date 02/25/2021.
2. Claims 16-35 are pending in the application.
Claim Rejections - 35 USC § 112
3. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 16-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C.
112, first paragraph (pre-AIA ), because the specification does not reasonably provide
enablement of the instant “phospholipid” without limitation (i.e., no named
compound). The specification does not enable any person skilled in the art to which it
pertains, or with which it is most nearly connected, to make the invention commensurate
in scope with these claims.
ln In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining
whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first
paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or Iack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case:
The nature of the invention
The nature of the invention is a method of use using “phospholipid” without limitation (i.e., no named compound), see claim 16.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Friedman et al. US 5,744,155, it discloses a
a number phospholipid selected from phosphatidylserine or phosphatidylinositol, see
Claim 16 in column 21.
The amount of direction or guidance present and the presence or absence
of working examples
The only direction or guidance present in the instant specification is the description of a number of “phospholipids” on page 3 of the specification. There is no data present in the instant specification for the “phospholipid” without limitation (i.e., no named compound).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “phospholipid” is without limitation (i.e., no named compound).
The quantity or experimentation needed and the Ievel of skill in the art
While the level of the skill in the chemical arts is high, it would require
undue experimentation of one of ordinary skill in the art to resolve any “phospholipid” without limitation. There is no guidance or working examples present for constitutional any “phospholipid” without limitation for the instant invention. Incorporation of the limitation of “phospholipid” (i.e., claim 19) supported by specification into claims 16 and 27 respectively would overcome this rejection.
4. 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 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.
Claim Rejections - 35 USC § 103
5. The following is a quotation of 35 U.S.C. 103(a) 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 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 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 16 and 27 are rejected under 35 U.S.C. 103(a) as being obvious over
Friedman et al. US 5,744,155, and Chen’s US 2005/0287180 A1.
Applicant claim a method of method for the treatment and/or prevention of a skin disease in a subject in need thereof, comprising a step of administering to said subject a therapeutically effective amount of an emulsion; wherein said emulsion comprises at least one oil, at least one phospholipid, and at least one polymeric surfactant; wherein said emulsion is an oil-in-water emulsion; wherein said phospholipid does not comprise phosphatidylcholine (PC); and wherein said emulsion does not comprise vitamin D3, or a derivative or precursor thereof, see claim 16.
Applicants claim an emulsion comprising at least one oil comprising a mixture of triglycerides and fatty acids, at least one phospholipid, and at least one polymeric surfactant selected from an alkyl aryl polyether alcohol, a block copolymer of ethylene oxide and propylene oxide, a polyvinyl alcohol, a polyoxyethylene fatty acid ester and a mixture thereof; wherein said emulsion is an oil-in-water emulsion; wherein said phospholipid does not comprise phosphatidylcholine (PC); and wherein said emulsion does not comprise vitamin D3, or a derivative or precursor thereof, see claim 27.
Determination of the scope and content of the prior art (MPEP §2141.01)
Friedman et al. ‘155 discloses an emulsion composition comprising phospholipid selected from phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol, phosphatidylglycerol, triglyceride, fatty alcohol, see columns 20-21.
Chen’s ‘180 discloses a composition comprising phospholipid selected from phosphatidylcholine or lecithin, triglyceride, alcohol selected from polyvinyl alcohol, see column 12. Chen’s ‘180 compositions are used for treating a number skin disease or disorders selected from skin injuries, wounds, surgeries, bites, cuts, or accidents, acne, or skin cancer, see claim 15 in column 12.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Friedman et al. ‘155 and Chen’s ‘180 is that the instant claims are embraced within the scope of Friedman et al. ‘155 and Chen’s ‘180. Friedman et al. ‘155 and Chen’s ‘180 read on the instant methods of use of claim 16 and compositions of claim 27.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 16 and 27 prima facie obvious because one would be motivated and employ compositions and methods of use of Friedman et al. ‘155 and Chen’s ‘180 to obtain instant invention.
It is prima facie obvious to combine teachings from Friedman et al. ‘155
and Chen’s ‘180 which provide methods of use using a composition comprising
phospholipid, each of which is taught by the prior art to be useful for the same
purpose, i.e., for treating skin disorders or disease. Therefore idea of combining
them flows logically from theirs having been individually taught in the prior art." In
re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), see
MPEP 2144.06.
The motivation to make the claimed methods of use and compositions derived from the known compositions and methods of use of Friedman et al. ‘155 and Chen’s ‘180 would possess similar activity to that which is claimed in the reference.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
November 20, 2025