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 .
Status of Claims
Claims 1-16 are pending in this application. 1-3, 5, 7-8 and 11 are amended.
Claims 14-16 are withdrawn as being drawn to a non-elected invention or species, there being no linking or generic claim.
Claims 1-13 are examined on their merits.
Information Disclosure Statement
The IDS filed 12/5/2025 has been reviewed.
Previous Rejections
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Objections/Rejections Withdrawn
Claim Objection
In light of the amendments to the claims the objection to claim 1 is withdrawn.
Claim Rejections - 35 USC §112(b)
In light of the amendments the rejection of claims 1-13 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn.
Claim Rejections - 35 USC §102(a)(1)
In light of the amendments the rejection of claims 1-3, 8 and 10 under 35 U.S.C. 102(a)(1) as being anticipated by Rebman WO 2010/150051 (12/29/2010)(6/2/2023 IDS) as evidenced by the instant specification is withdrawn.
Claim Rejections - 35 USC § 103
In light of the amendments to the claims the rejection of claims 1-13 under 35 U.S.C. 103 as being unpatentable over Rebman WO 2010/150051 (12/29/2010)(6/2/2023 IDS) in view of Winter et al. EP 2210589 (5/6/2015), as evidenced by the instant specification is withdrawn.
New Objections/Rejections
Objection to the Specification
The disclosure is objected to because of the following informalities: Specification recites “1,5 cm” at line 6 of page 14. This appears to be a typographical error. It is suggested that the comma be replaced with a period.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-9 and 1-13 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
The response filed 12/16/2025 added amendments to claim 1 with limitations that introduce NEW MATTER into the claims. The limitation “wherein the solid form has a shape with a diameter of at least 2 cm” does not have clear support in the specification and claims as originally filed.
There is no disclosure of “wherein the solid form has a shape with a diameter of at least 2 cm” in the specification or originally filed claims. The reply filed 12/16/2025 points to page 14, lines 2-14 to support this limitation. While page 14, lines 2-14 does disclose the diameter of a sphere, there is no requirement, discussion or mention of a solid form shape in general having a diameter of at least 2 cm. Thus, while this portion of the specification discloses a sphere as the solid dosage form having the recited dimensions, there is no support for the broader concept of a “shape” having the claimed diameter size. The specification discloses a tablet, a sphere, a cube and a lozenge as the types of dosage forms, but the sphere is the only solid form disclosed with the claimed diameter size.
The meaning of the term shape is not disclosed or defined in the specification. Applicant has not pointed to any disclosure that provides either explicit or implicit support for the phrase ‘wherein the solid form has a shape with a diameter of at least 2 cm’. Thus, one skilled in the art would not understand that applicant was not in possession of the currently claimed invention.
Obviousness is not the standard for the addition new limitations to the disclosure as filed. It is noted that entitlement to a filing date does not extend to subject matter, which is not disclosed, but would be obvious over what is expressly disclosed. Lockwood v. American Airlines Inc., 41 USPQ2d 1961 (Fed. Cir. 1977).
Claim 1 recites limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in claim 1, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in present claim 1 in the specification or claims, as-filed, or remove these limitations from the claim in response to this Office Action.
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 of this title, 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 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Rebman WO 2010/150051 (12/29/2010)(6/2/2023 IDS) in view of Winter et al. EP 2210589 (5/6/2015) and Orthoefer US 6312703 (11/6/2001) as evidenced by the instant specification.
Rebman teaches compositions of plant extracts, carbohydrates and phospholipids for cosmetic applications. (See Abstract). The compositions can be in the form of tablets or granules with plant extract, maltodextrin and lecithin, and the composition are generally skin cosmetics. (See Rebman paragraph immediately preceding Example 1). A tablet is called for in instant claim 10.
Rebman teaches that its compositions with a good proportion of vegetable extract or active ingredients, has high stability during transport and storage and can be processed easily and gently in formulation. (See page 3, second paragraph). During redispersion, stable liposomal preparations can be made. (See second paragraph before Examples).
Rebman teaches a carrier in the form of a carbohydrate that is present in an amount of from 10% to 90%. (See page 3, last paragraph). This overlaps with the 40-90% called for in instant claim 1. Rebman teaches that its cosmetic composition can be a cream moisturizer as called for in instant claim 11. (See page 9, 3rd paragraph).
Rebman teaches maltodextrin and maltodextrin is called for in instant claim 6. (See Rebman claim 1 and page 8, second paragraph). Rebman also teaches a disaccharide which is an oligosaccharide as evidenced in [0049] of the instant specification as called for in instant claim 6. (See claim 5). The maltodextrin is a preferred carbohydrate and can be present in an amount of about 10-90% which overlaps the 20-45% called for in instant claim 1. (See Rebman claim 1 and page 8, second paragraph). The oligosaccharide can also be present in an amount of about 10-90% which overlaps the 20-45% called for in instant claim 1. (See [0201]).
Rebman teaches a phospholipid which is an emulsifying agent as called for in instant claim 9. (See [0303]). Rebman also teaches aloe vera extract which is called for in instant claim 5. (See Rebman claim 11). Rebman also teaches lecithin, which is a dispersant. (See Example 11). Rebman teaches that lecithin is suitable for use in its compositions. Lecithin is a dispersant as called for in instant claim 1.
In Example 6 Rebman exemplifies a solid powder that comprises 15 wt% citric acid, 10 wt% tartaric acid (weak acid, water-soluble preservative), 5 wt% lactic acid, 62 wt% maltodextrin (agglomerating agent) and 3 wt% Lipoid P45. (See Example 6).
Lactic acid is a water soluble pH modifying agent as evidenced by the specification at [0052] as called for in instant claim 1 and 5 wt% falls within the 0.1—10 wt% called for in instant claim 1. It is also a weak acid as called for in instant claim 8.
The lactic acid is a water-soluble and dispersible cosmetic active agent and 5 wt% falls within the 1-20% called for in instant claim 1. Lactic acid is also an active agent for skin care as called for in instant claim 2. Lactic acid is an acid that can keep the skin acidic which is desirable as evidenced by the specification at [0053].
Rebman teaches evening primrose oil extract which is an essential oil as called for in instant claim 9. (See page 5, middle of page).
Rebman teaches that the dried composition is stable to transport and can be easily incorporated into cosmetic formulations and that during redispersion, stable liposomal preparations can be prepared. (See two paragraphs preceding the Examples). This corresponds to the amount of the preservative, pH modifying agent , cosmetic actives in the solid form being the amount required for obtaining an active fluid cosmetic product as called for in instant claim 3. In light of this teaching, it would be no more than routine experimentation to experiment to arrive at the amount of solid composition and volume of water with which to reconstitute it as called for in instant claim 4.
Lactic acid is also a preservative or biocidal which is present in an amount of 5% and which falls within the 1-10% preservative called for in claim 1. (See Example 6).
Rebman does not teach sodium benzoate and does not teach that its solid compositions can come in a kit with a vial head suitable for dispensing the cosmetic. (See [0866]). Rebman also does not teach a solid form having a diameter of at least 2 cm. These deficiencies are made up for with the teachings of Winter et al. and Orthoefer.
Winter et al. (Winter) teaches a composition for sustained release of a pharmaceutically active compound wherein the composition comprises a vesicular phospholipid gel. (See Abstract). Winter teaches that its vesicular phospholipid gel can be used for the production of cosmetic or pharmaceutical compositions.
Winter teaches that its composition can include an additive such as sodium benzoate that assists in producing or stabilizing its phospholipid gel. (See [0121]). Sodium benzoate is called for in instant claim 7.
Winter teaches a kit in which is found a container that allows mixing at least two proteinaceous substance solution with the phospholipid. (See [0135]). Winter also teaches a kit that contains a syringe for administering the composition once it is reconstituted. (See [0162]). Syringe reads on the empty vial for holding and dispensing the cosmetic as called for in instant claim 12. The syringe will have a head suitable for dispensing the cosmetic composition because Winter teaches that the syringe will be suitable for administering the composition as called for in instant claim 13.
Orthoefer teaches solid composition containing lecithin. (See Abstract). Orthoefer teaches the compression of lecithin into solid forms for cosmetic use. (See Abstract, throughout and Example 1). Orthoefer teaches that the solid compositions can be solid formulations of between 0.25 inches and 1.25 inches. (See col. 9, lines 22-30). 1.25 inches is about 3.2 centimeters, which is at least 2 cm as called for in instant claim 1.
It would be prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Rebman solid tablet composition with 5% aloe vera extract, 10% to 90% disaccharide, 10% to 90% disaccharide, 5% lactic acid, 3% phospholipid and evening primrose oil to add sodium benzoate as an additive that can assist with reconstitution and to package the tablet in a kit with an empty syringe to assist with the administration of the reconstituted cosmetic as taught by Winter.
It would be prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Rebman solid tablet composition with 5% aloe vera extract, 10% to 90% disaccharide, 10% to 90% disaccharide, 5% lactic acid, 3% lecithin and evening primrose oil to make the solid tablet composition have a size of about 3.2 centimeters in light of Orthoefer’s teaching that this is an ideal size for a solid formulation containing lecithin and a cosmetic ingredient.
Response to Arguments
Applicants’ arguments of December 16, 2025 have been fully considered and are found to be mostly persuasive in view of the amendments to the claims.
Applicants note the amendments to the claims and request that the claim objections and indefiniteness rejections be withdrawn. The claims amendments address the indefiniteness issues and the rejections are withdrawn above.
Applicants argue that all of the currently claimed elements are not taught in the applied prior art, so there is no anticipation of the claims. Applicants note that none of the examples or embodiments disclose making a solid form having a diameter of at least 2 cm as required by amended claim 1.
This argument is found to be persuasive in light of the amendments and the anticipation rejection is withdrawn above.
Applicants also argue that all of the currently claimed elements are not taught in the applied prior art, so the claims are not obvious. Applicants note that none of the examples or embodiments disclose making a solid form having a diameter of at least 2 cm as required by amended claim 1. Applicants note that Rebman mentions tablets only once in its description. Applicants argue that Rebman does not disclose a solid format for dispersion in fluid prior to use and also does not teach that the use of a dispersing agent for solid forms which are larger than granules of a powder.
Applicants argue that Winder also does not teach a solid shape having a diameter of at least 2 cm comprising an aggregating agent and a dispersing agent. Applicants also note that neither Rebman nor Winter disclose or suggest a kit which contains a vial and a solid form having a diameter of at least 2 cm.
Applicants’ arguments have been fully reviewed and in light of the amendments to the claims are found to be sufficiently persuasive and the rejections have been withdrawn above. The remainder of the arguments are moot in view of the new rejections applied above.
As seen in the new rejection applied above, it would be prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Rebman solid tablet composition with 5% aloe vera extract, 10% to 90% disaccharide, 10% to 90% disaccharide, 5% lactic acid, 3% lecithin and evening primrose oil to make the solid tablet composition have a size of about 3.2 centimeters in light of Orthoefer’s teaching that this is an ideal size for a solid formulation containing lecithin and a cosmetic ingredient.
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 SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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