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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/16/2026 has been entered.
Status of claims
The amendment filed on 01/16/2026 is acknowledged. Claims 2-4, 10, and 12 have been canceled and new claims 24 and 25 have been added. Claims 1, 5-9, 11, and 13-25 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments, arguments, and affidavit filed on 01/16/2026 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 Any rejection and/or objection not specifically addressed below is herein withdrawn.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. In addition, new claim is hereby included in the rejections and the rejections are modified based on the amendments and clarity.
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, 5-9, 11, 13-23, and 25 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hillman (US 2009/0048167 A1) in view of Arshed (US 2013/0195925 A1).
Hillman teaches topical composition (paragraph 50) for the treatment of disease including skin wrinkles (the claimed anti-aging in the instant claims 1, 9, 14, and 20), etc., in human (paragraph 51, 56, 182, 220, and 332) comprising
about 2 ng/mL to about 10 µg/mL (paragraph 49) of one or more human defensins as antimicrobial peptide (AMP) or analog thereof including
α-defensins 1-6 according to Mol Immunol. 2003 November; 40(7):463-7 (human defensin, the instant claims 5 and 22) and human β-defensins 1-6 (the instant claims 13, 14, and 16) (paragraph 44, 48, 49, 51, 52, and 307-313)
(encompassing an α-defensin as the 1st defensin in instant claim 1 and a mixture of an α-defensin and a β-defensin as the 1st and 2nd defensins recited the instant claims 13-21;
encompassing the claimed 4-50 ng/mL in the instant claim 1 and also ≤ 1 µg/mL being sub-antimicrobial effective concentration according to the instant specification paragraph 25 and 1 pg/mL to 100 mg/mL was previously claimed in claim 6 dated 07/07/2025; thus encompassing the claimed sub-antimicrobial concentration effective to improve a visual appearance of skin, substantially reducing wrinkle depth, etc., effective to recruit LGR6+ cells to an interfollicular space in a non-injured skin in the instant claims 1, 9, 14, 15, and 20, and
encompasses the claimed 4-30 ng/mL, 4-25 ng/mL, about 22 ng/mL, and 8-44 ng/mL in the instant claims 6-8, 17-19, and 25), and
physiologically suitable carrier comprising excipients such as gelatin (the claimed cosmetically acceptable carrier in the instant claim 1 and the instant claim 11) and vegetable oil (including fraction of caprylic/capric triglycerides, the instant claim 23) (paragraph 231, 234, and 239).
Though Hillman does not specify the properties of sub-antimicrobial concentration defensin being effective to improve a visual appearance of skin in instant claim 1 and recruit LGR6+ stem cells to an interfollicular space in non-injured skin in instant claim 15, as a result of the method taught by Hillman using the same compound defensin on the same population to treat the same condition as claimed with overlapping concentration range of defensin, the compound would necessarily have the claimed properties, whether expressly recognized by Hillman or not.
Hillman does not teach the topical excipients including phenoxyethanol in the instant claim 1.
This deficiency is cured by Arshed who teaches a topical anti-aging composition comprising anti-inflammatory agents and phenoxyethanol preservative (paragraph 166).
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 Hillman and Arshed to specify the topical excipients in the composition taught by Hillman including phenoxyethanol preservative. Cosmetic antiaging composition comprising phenoxyethanol preservative 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.
Hillman does not teach the same concentration of defensin in the instant claims 1, 6-8, 17-19, and 25 (about 2 ng/mL to about 10 µg/mL vs the claimed 4-50 ng/mL, 4-30 ng/mL, 4-25 ng/mL, about 22 ng/mL, and 8-44 ng/mL).
A prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection.
The claimed ranges of concentration of defensin are 4-50 ng/mL, 4-30 ng/mL, 4-25 ng/mL, about 22 ng/mL, and 8-44 ng/mL and the range of concentration of defensin taught in the prior art is about 2 ng/mL to about 10 µg/mL and therefor, includes the claimed range. Furthermore, 1 pg/mL to 100 mg/mL is claimed in the claims 6 and 17 dated 07/07/2025; thus, the criticality of the claimed 4-50 ng/mL, 4-30 ng/mL, 4-25 ng/mL, about 22 ng/mL, and 8-44 ng/mL over about 2 ng to about 10 µg/mL taught in the prior art is not established.
Response to Applicants’ arguments:
Applicants’ arguments based on the unexpected results in the affidavit are addressed in the Response to applicants’ 37 CFR 1.132 declaration below.
Applicants’ argument with regard to Hillman’s teaching α-defensins with direct influence on tumor proliferation and converting an acute inflammation to a chronic inflammation paragraph 327 and 332 is basically the same as the previous response dated 07/07/2025 is basically the same as the previous response dated, thus the response discussed previously (07/18/2025) applies here as well and is not persuasive for reason discussed.
Applicants argue that Hillman teaches β-defensin 2 worsening skin psoriatic in paragraph 489 (example 7) and thus Hillman teaches away from using β-defensins.
However, this argument is not deemed persuasive. Hillman teaches human defensins including β-defensins 1-6 while Hillman teaches away from β-defensin 2 in example 7, i.e., Hillman does not teach the defensins must include β-defensin 2 and example 7 taught by Hillman can serve as a guidance for person of ordinary skill in the art before the effective filing date of the claimed invention to exclude β-defensin 2.
Applicants argue that Hillman teaches higher concentration in topical formulation due to “limited bioavailability and stability when delivered by other routs” in paragraph 224, 0.8 µg/mL and 0.4 µg/mL in oral formulation in paragraph 90-91, and 10 µg/mL for topical lesion treatment in paragraph 487; thus, Hillman does not teach the claimed 4-50 ng/mL.
However, this argument is not deemed persuasive. As stated in the rejection above, Hillman teaches about 2 ng/mL to about 10 µg/mL of one or more human defensins for the treatment of disease including skin wrinkles. Thus, the claimed defensins are already known for the treatment of disease including skin wrinkles in the art, the claimed concentration represents no more than a determination of the workable concentration range for achieving the known effect. Determining optimum dosages is routine in the pharmaceutical arts. Furthermore, 1 pg/mL to 100 mg/mL was claimed in the claims 6 and 17 dated 07/07/2025; thus, the criticality of the claimed 4-50 ng/mL over about 2 ng to about 10 µg/mL taught in the prior art is not established. MPEP 2144.05.II and MPEP 2144.05.II.A:
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”
Although Hillman teaches higher concentration in topical formulation in paragraph 487, 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. MPEP 2123 II.:
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.
With regard to paragraph 224 of Hillman, the “other routs” in “limited bioavailability and stability when delivered by other routs” paragraph 224 taught by Hillman is gastro intestinal tract, not topical.
Response to applicants’ 37 CFR 1.132 declaration:
The affidavit under 37 CFR 1.132 filed 01/16/2026 is insufficient to overcome the rejection of pending claims as set forth in the last Office action because:
First, with regard to Taub et al. publication, there is no true side-by-side closest to prior art comparison. In the prior art the formulation comprising about 2 ng/mL to about 10 µg/mL antimicrobial peptide (AMP) or analog thereof including human defensins α-defensins 1-6 and human β-defensins 1-6; in the experiment the comparative formulation is placebo. Thus, the results from the experiment are not convincing. Please refer to MPEP 716.02(b).III:
Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims.
Second, with regard to the experimental results of 4.375 ng/mL of α-defensin and 4.375 ng/mL of β-defensin formulation (#51-5-3) and 21.875 ng/mL of α-defensin and 21.875 ng/mL of β-defensin formulation (#H-148-1) not being irritating to skin in exhibit B, there is no experimental results of defensin concentration higher than the claimed 4-50 ng/mL being irritating to skin; thus, the criticality of the now claimed 4-50 ng/mL over about 2 ng to about 10 µg/mL taught in the prior art is not established while 1 pg/mL to 100 mg/mL was claimed in the claims 6 and 17 dated 07/07/2025. Please refer to MPEP 2144.05.II.A:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 2, 5-9, 11, and 13-25 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of US 11,806,384 B2 in view of Arshed (US 2013/0195925 A1). Although the patent and instant claims are not identical, they are not patentably distinct from each other because: the instant claims 1, 2, 5-11, and 13-25 recite a topical anti-aging formulation, comprising a cosmetically acceptable carrier, a 1st defensin, and phenoxyethanol.
The 11,806,384 B2 claims 1-12 recite a kit for treating an extant melasma lesion comprising a cream comprising a cosmetically acceptable carrier in combinations with a 1st defensin in a sub-antimicrobial concentration of the 1st defensin (the newly claimed concentration effective to improve a visual appearance of skin in the instant claim 1 according to the instant specification) that is effective to reduce pigmentation of the extant melasma lesion on application to the extant melasma lesion as a cream formulation; and a serum comprising a cosmetically acceptable carrier in combination with a 1st defensin in a sub-antimicrobial concentration of the 1st defensin that is effective to reduce pigmentation of the extant melasma lesion on application to the extant melasma lesion as a serum formulation.
With respect to the art rejection above, it is noted that the 11,806,384 B2 claims 1-12 do not claim that the composition can be used in the manner instantly claimed; 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.
The 11,806,384 B2 claims 1-12 do not recite the cosmetically acceptable carrier including phenoxyethanol (the instant claim 1).
This deficiency is cured by Arshed whose teachings are discussed above and applied in the same manner.
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 recitations in 11,806,384 B2 claims 1-12 and the teachings in Arshed to specify the topical carrier in the composition recited in 11,806,384 B2 claims 1-126 comprising phenoxyethanol preservative. Cosmetic composition comprising phenoxyethanol preservative 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.
Although the patent and instant claims are not identical, they are not patentably distinct from each other because claims in both applications are drawn to the same composition.
Response to Applicants’ arguments:
Applicants’ argument with regard to US 11,806,384 B2 claiming kit, not topical cosmetic is basically the same as the previous response dated 07/07/2025 is basically the same as the previous response dated, thus the response discussed previously (07/18/2025) applies here as well and is not persuasive for reason discussed.
New ground of rejections necessitated by Applicant’s amendment
New claim 24 necessitates the following new ground of rejection.
Claims 1, 2, 5-9, 11, and 13-25 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hillman (US 2009/0048167 A1) in view of Arshed (US 2013/0195925 A1) and Scarbrough et al. (US 2012/0283332 A1).
The teachings of Hillman and Arshed are discussed above and applied in the same manner. Hillman teaches physiologically suitable carrier comprising excipients such as polyethylene glycol (PEG) (paragraph 234).
Hillman does not specify the physiologically suitable excipients including human albumin in the instant claim 24.
This deficiency is cured by Scarbrough et al. who teach pharmaceutically acceptable carriers in transdermal system including human serum albumin, PEG, etc., (abstract and paragraph 23).
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 Hillman and Scarbrough et al. to replace PEG in the composition taught by Hillman with human serum albumin. Both human serum albumin and PEG being suitable pharmaceutically acceptable carriers in transdermal system 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 PEG in the composition taught by Hillman with human serum albumin 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.
Response to Applicants’ arguments:
Applicant’s arguments, filed on 01/16/2026, have been fully considered but they are moot in view of new ground of rejections.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HONG YU/
Primary Examiner, Art Unit 1614