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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/09/2026 has been entered.
Status of claims
The amendment filed on 06/09/2026 is acknowledged. Claims 3-5, 10, 11, 13, 14, and 16 have been canceled and claims 17-20 have been withdrawn. Claims 1, 2, 6-9, 12, and 15 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 06/09/2026 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 Any rejection and/or objection not specifically addressed below is herein withdrawn.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.
Rejections maintained
The following rejections of the claims are maintained for reasons of record and the following. The rejections are modified based on the amendments and for clarity (newly underlined).
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.
Claims 1, 2, 12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hernandez et al. (US 2007/0243271 A1).
Hernandez et al. meet all of the limitations of claims 1, 2, 12, and 15. Hernandez et al. disclose topical composition for skin around the eyes (abstract and paragraph 21), and exemplified a cream (the instant claim 15) comprising, by weight,
87.57% water, 5.00% lecithin, 0.01% sodium hyaluronate, 0.20% polysorbate-20, and 0.25% soy phospholipids (paragraph 31), i.e., 0% by weight of propylene glycol and 0% by weight of glycerol (paragraph 31).
With regard to the purified water (the instant claims 1 and 12), mere purity of a product, by itself, does not render the product unobvious. In the instant case water taught by Fuchs et al. is used as a carrier in a topical composition while the claimed purified water is also used in a topical composition and thus have the same utility. Please refer to MPEP 2144.04 VII:
pure materials are novel vis-à-vis less pure or impure materials because there is a difference between pure and impure materials. Therefore, the issue is whether claims to a pure material are unobvious over the prior art. In re Bergstrom, 427 F.2d 1394, 166 USPQ 256 (CCPA 1970). Purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product unobvious.
Factors to be considered in determining whether a purified form of an old product is obvious over the prior art include whether the claimed chemical compound or composition has the same utility as closely related materials in the prior art, and whether the prior art suggests the particular form or structure of the claimed material or suitable methods of obtaining that form or structure.
Hernandez et al. do not specify the claimed osmolality, pH, and exhibiting ≥60% cell survival relative to control in an engineered human tissue irritation test in the instant claim 1. Osmolality, pH, and exhibiting ≥60% cell survival relative to control in an engineered human tissue irritation test of a composition are the result of the components in the composition. With the composition taught by Hernandez et al. being the same as the claimed composition, the composition disclosed by Hernandez et al. would have the same claimed properties as the claimed composition. MPEP 2112.III:
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.”
Response to Applicants’ arguments:
Applicants argue that examiner does not provide evidence of the comparison disclosed by Hernandez et al. possessing the claimed properties.
However, this argument is not deemed persuasive. The claimed properties are inherent of the claimed composition while osmolality is calculated based on known knowledge. Thus, as a result of the composition having the same components as claimed, the composition would necessarily have the claimed properties, whether expressly recognized by Hernandez et al. or not which is supported by the calculated 112.5 mOsm/kg osmolality of the composition based known knowledge in the office action dated 02/12/2026 page 5. Please refer to MPEP 2112.01.II, MPEP 2112.I, MPEP 2112 II:
“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant’s own disclosure and known knowledge support the suitability of the prior art composition as the inventive composition components, the burden is properly shifted to applicant to show otherwise.
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 1, 2, 6-9, 12, and 15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Trumbore et al. (US 2014/0017182 A1).
Trumbore et al. teach a topical composition in form of liquid (the instant claim 15) and claimed a composition, in claim 10, comprising
about 85.85% by weight of water (the instant claim 12),
about 3% by weight of glycerin (glycerol) and about 3% by weight of propanediol (propylene glycol) (the instant claim 1),
about 2% by weight of sodium hyaluronate,
about 1% by weight of lecithin (phosphatidylcholine, the instant claim 2) (claim 1).
Trumbore et al. also teach the composition further comprising about 0.5-1.5% by weight of an antioxidant such as ascorbic acid (vitamin C), tocopherols (vitamin E), etc. (the instant claim 6) (paragraph 45 and claim 5), and skin active agents having desirable topical effect including retinoic acid (vitamin A) and a composition comprising about 4-12% skin conditioning agent or emollient and a composition comprising about 3-9% emollient (paragraph 49 and 61 and claims 5 and 8), i.e., about 1-3% by weight of skin conditioning agent (4-3=1 and 12-9=3). Thus, a person of ordinary skill in the art can readily envisage a composition comprising about 0.5-1.5% by weight of ascorbic acid, about 0.5-1.5% by weight of tocopherols, and 1-3% by weight of skin active agents such as retinoic acid (the instant claim 7).
Trumbore et al. also teach a composition comprising about 0.8% by weight of phenoxyethanol (the instant claims 8 and 9) (claim 7).
Trumbore et al. also teach a composition comprising about 2.5-7.5% by weight of a surfactant including polysorbate 20 (the instant claim 1) (claim 5 and paragraph 36).
Trumbore et al. also teach a composition comprising an anti-irritant (the instant claim 1) (claim 8).
With respect to the art rejection above, it is noted that the reference does not teach that the composition can be used in the manner instantly claimed, [skin moisturizing]; however, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
With regard to the purified water, mere purity of a product, by itself, does not render the product unobvious. In the instant case water taught by Trumbore et al. is used as a carrier in a topical composition while the claimed purified water is also used in a topical composition and thus have the same utility. Please refer to MPEP 2144.04 VII.
Trumbore et al. do not teach polysorbate 20 in the composition of claim 10, a dependent claim of claim 1.
The deficiency is cured by Trumbore et al.’s teachings of a composition in claim 5, dependent claim of claim 1, which comprises about 2.5-7.5% by weight of a surfactant and surfactants including polysorbate 20 and lecithin in paragraph 36.
It would have been prima facie obvious at the time of the invention to a person of ordinary skill in the art to combine the teachings in claim 5 and 10, and paragraph 36 to add polysorbate 20 to the composition in claim 10 as an additional surfactant. It is generally considered to be prima facie obvious to combine compounds each of which is taught by the prior art to be useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for combining them, i.e., adding polysorbate 20 to the composition in claim 10 comprising lecithin, flows from their having been used individually in the prior art, and from them being recognized in the prior art as useful for the same purpose. Furthermore, nonionic surfactants including polysorbate 20 was not previous claimed in claim 1. Please refer to MPEP 2141 I.:
“[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”
Trumbore et al. do not teach the same claimed amount of sodium hyaluronate (about 2% by weight of vs the claimed 0.005-0.01% in the instant claim 1).
A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties.
The claimed range of sodium hyaluronate is 0.005-0.01% w/w and the range of sodium hyaluronate taught in the prior art is about 2% by weight and therefor, close enough to the claimed range. Furthermore, 0.005-10% by weight of polymeric moisturizer including sodium hyaluronate is disclosed as suitable in the instant speciation and previously claimed in claim 5 dated 02/12/2024 and thus the criticality of 0.005-0.01% w/w of sodium hyaluronate over about 2% by weight of sodium hyaluronate taught by Trumbore et al. is not established.
Trumbore et al. do not specify the claimed osmolality, pH, and exhibiting ≥60% cell survival relative to control in an engineered human tissue irritation test in the instant claim 1. Osmolality, pH, and exhibiting ≥60% cell survival relative to control in an engineered human tissue irritation test of a composition are the result of the components in the composition. With the composition taught by Trumbore et al. being obvious to the claimed composition and being the same as the disclosed composition, the composition taught by Trumbore et al. would have the same claimed properties as the disclosed composition. MPEP 2112.III.
Response to Applicants’ arguments:
Applicants argue that Trumbore et al. d not teach polysorbate 20 in the operative combination and it is improper hindsight reasoning to pick polysorbate 20.
However, this argument is not deemed persuasive. It is well-established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the submitted knowledge in the art, to a person of ordinary skill in the art. Please refer to MPEP 2123.I:
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments.
With regard to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. Please refer to MPEP 2145.X.A.
Furthermore, polysorbate 20 was not claimed in claim 1 and was recited as a further component in claims 10 and 11 dated 02/12/2024, i.e., not a must have component while the instant specification also discloses polysorbate 20 being optional (paragraph 7 and 38). Thus, the criticality of inclusion of polysorbate 20 is not established.
Correspondence
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.
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, 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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