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 .
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.
DETAILED ACTION
Status of claims
The amendment filed on 04/24/2026 is acknowledged. Claims 1 and 2 have been canceled and new claims 5-14 have been added. Claims 3-14 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 04/24/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New ground of rejection necessitated by Applicant’s amendment
The amendments necessitate the following new ground of rejection.
Claim Rejections - 35 USC § 112
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 9-14 are rejected under 35 U.S.C. 11(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 9-14 introduce new matter as the claim recites the limitation "an amount of intake of the plasmalogen of an adult per day …”. Claims 9-14 depend from claim 3 which recites application of plasmalogen to a human scalp while "an amount of intake of the plasmalogen of an adult per day” is disclosed for oral administration of plasmalogen in the specification as filed (paragraph 30); thus, there is no support in the specification for the limitation "an amount of intake of the plasmalogen of an adult per day …” by human scalp administration, and person skilled in the art would not recognize in the applicant’s disclosure a description of the invention as presently claimed. There is no guidance in the specification to select application of plasmalogen to a human scalp with "an amount of intake of the plasmalogen of an adult per day …” and from MPEP 2163.06: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments. Therefore, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of filing of the instant application.
Rejections maintained
The following rejections of the claims are remained for reasons of record and the following. New claims are hereby included in the rejections and the rejections are modified based on the amendments.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim 3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pierard (US 6,482,826 B1).
Pierard meets all of the limitations of claim 3. Pierard discloses a method of treating individuals with alopecia for reversing alopecia (the claimed hair growth and/or hair restoration) (column 4, line 52-56) by administering to the scalp of said individuals an effective amount of ketoconazole as active ingredient (abstract) with the active ingredient being formulated in liposome-containing compositions; wherein the liposomes are formed with plasmalogens (column 3, line 36-44). The recitation of plasmalogens being an active ingredient is semantic.
Claims 3-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seigfried (US 2011/0059117 A1).
Seigfried meets all of the limitations of claims 3-8. Seigfried discloses a method of treating hair loss comprising topical application, to the skin of a warm-blooded mammal in need thereof of, a liquid composition comprising
4-15% by weight of a phospholipid foaming agent and at least one solvent; and a pharmaceutically acceptable active agent (claims 10 and 54), i.e., >4-15% by weight of a phospholipid foaming agent relative to dry mass (the instant claims 5-8);
wherein the skin includes scalp (paragraph 70); and wherein the phospholipid foaming agents include choline plasmalogen of animal origin (the claimed animal tissue in the instant claim 4) (paragraph 33 and 34). The recitation of plasmalogens being an active ingredient is semantic.
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.
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(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 nonobviousness.
Claims 3-8 are rejected under 35 U.S.C. 103(a) as being unpatentable over Pierard (US6,482,826 B1) in view of Mawatari et al. (US 2013/0172293 A1).
The teachings of Pierard are discussed above and applied in the same manner. Pierard also teaches liposomes being formed with plasmalogens or phosphatidyl choline and exemplifies in example 4 a liposome composition comprising 68.56% by weight of phosphatidyl choline relative to dry mass (20/29.17=0.6856).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in abstract and column 3, line 36-44 and column 4, line 52-56 and example 4 to replace phosphatidyl choline in example 4 with plasmalogens, i.e., 68.56% by weight of plasmalogens relative to dry mass (the instant claims 5-8). Both plasmalogen and phosphatidyl choline suitable for forming liposomes was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for replacing phosphatidyl choline in example 4 with plasmalogens flows from both having been used in the prior art, and from both being recognized in the prior art as useful for the same purpose.
Pierard does not specify the source of plasmalogen in the instant claim 4.
This deficiency is cured by Mawatari et al. who teach plasmalogen extracted from avian tissue (the claimed animal tissue in the instant claim 4) (abstract).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Pierard and Mawatari et al. to specify plasmalogen taught by Pierard being avian tissue extraction. Plasmalogen being avian tissue extraction tissue was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Applicant’s arguments based on the amendments are addressed in the modified rejection above (newly underlined).
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 extension fee 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 HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614
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