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 the Application
The claims of 24 March 2024 are entered.
Claims 1-20 are pending and are being examined on the merits.
Claim Interpretation
Claim 1 recites within the preamble the statement that the topical composition is “for improving pigmentation”. This is interpreted as an intended use. Per MPEP 2111.02, if the body of claim fully and intrinsically sets forth all of the limitations of the claim and the preamble statement merely recites an intended use, that intended use is not considered a limitation and is of no significance to claim construction. In this instance, the body sets for all limitations: presence of hexapeptide-11, hexapeptide-12, and one or more dipeptides.
Claim Objections
Claim 18 is objected to because of the following informalities: phenoxyethanol is repeated twice in the lists of further ingredients. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected 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.
Claim 1 recites the terms “hexapeptide-11” and “hexapeptide-12”. These terms are not defined by the specification.
No discussion is made of the sequence of hexapeptide-11. PubChem indicates that this is a peptide FVAPFP (see Compound CID 24998056), but no such sequence is found in the specification or sequence listing. Accordingly, one of ordinary skill in the art cannot ascertain what is being claimed for hexapeptide-11.
The specification discusses palmitoyl hexapeptide-12 as being Pal-VGVAPG, but PubChem indicates that hexapeptide-12 is APGVGV (see Compound CID 10097423). The sequence disclosure includes SEQ ID NO: 25 of sequence VGVAPG. Given this contradiction and lack of definition, one of ordinary skill in the art cannot determine what sequence is being claimed for hexapeptide-12.
For the purposes of prior art the Examiner interprets hexapeptide-11 as FVAPFP in accordance with PubChem, and hexapeptide-12 as VGVAPG in accordance with SEQ ID NO: 25 and the Pal-VGVAPG sequence disclosed in the specification.
The dependent claims do not remedy this deficiency.
Claims 2-4 recite a “photosome”. The specification does not define a photosome, and there is no apparent definition in the art that leads one of ordinary skill in the art to understand the metes and bounds associated with such terminology.
In claim 5, the claim recites “dipeptide-51” and “dipeptide-12”. Neither term is defined by the specification, and the art does not offer a known definition for either term. The metes and bounds are unclear.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 8-10, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Golz-Berner K and Zastrow L (WO 2008/090226 A2, published 31 July 2008, hereafter referred to as ‘226).
The ‘226 application discloses an anti-wrinkle cosmetic comprising VGVAPG, FVAPFP, YA dipeptide, hyaluronic acid, antioxidant, pigment, carriers, and excipients (see e.g. claim 1). This anticipates claim 1, as a cosmetic is by necessity a topical composition.
With respect to claim 8, ‘226 suggests that VGVAPG is present at 0.01-5% by weight, overlapping with the 50-150 ppm range as claimed (see e.g. [0022]).
With respect to claim 9, ‘226 suggests lactoferrin as an antioxidant at 0.01-5% by weight (see e.g. [0013] and [0019]).
With respect to claim 10, as noted above ‘226 suggests production of liposomes.
With respect to claim 16, the examples of ‘226 indicate inclusion of water, which renders the creams as aqueous topical compositions.
With respect to claim 17, ‘226 suggest inclusion of gallic acid (see e.g. [0017]).
With respect to claim 18, at least Example 1 of ‘226 includes glycerin.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1. Claims 1, 6, 11, and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 9, and 10 of U.S. Patent No. 12,053,547 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘547 patent claims an overlapping composition.
The ‘547 patent claims a topical composition comprising hexapeptide-11 encapsulated in a liposome at 0.001 wt% to 0.05 wt%, hexapeptide-12, tripeptide-1, and tetrapeptide-2 (see e.g. claim 1). The composition can further comprise a dipeptide, overlapping with instant claim 1 (see e.g. claim 5).
With respect to claim 6, as noted above the wt% ranges of ‘547 for hexapeptide-11 overlap with the ranges as claimed.
With respect to claim 11, ‘547 claims phosphatidylserine present at 0.025 wt% to 0.1 wt% (see e.g. claims 7 and 9).
With respect to claim 16, ‘547 claims as additional ingredients water, which by necessity would make the composition aqueous (see e.g. claim 10).
With respect to claim 17, ‘547 claims as additional ingredients squalene and Dunaliella salina extract (see e.g. claim 10).
With respect to claim 18, ‘547 claims as additional ingredients phenoxyethanol, ethylhexylglycerin, caprylyl glycol, carprylhydroxamic acid, glycerin, lecithin, tocopherol, betaine, and propanediol (see e.g. claim 10).
2. Claims 1-3, 5-14, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7, 10-12, 14, and 15 of U.S. Patent No. 12,485,079 B2 in view of Incospharm (Catalog Number ICP2006, MelaTrepein) as evidenced by Incospharm History (https://incospharm.com/default/en/01/03.php).
The ‘079 patent claims a method to improve skin pigmentation by administering a composition comprising a first liposome comprising a photolyase, a second liposome, 0.004 wt% to 0.100 wt% of hexapeptide-11, and 0.001 wt% to 0.025 wt% of hexapeptide-12 (see e.g. claim 1).
The difference between ‘079 and the claimed invention is that ‘079 does not claim a dipeptide as part of the formulation.
The Incospharm MelaTrepein art indicates that it contains dipeptide-12 and dipeptide-51, and works to improve skin pigmentation. The Incospharm art does not explicitly disclose a publication date, but the Incospharm History indicates that MelaTrepein was disclosed in 2017.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the ‘079 patent formulation with the Incospharm MelaTrepein to prepare a third composition useful for treating skin pigmentation. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). There would have been a reasonable expectation of success because the ‘079 and MelaTrepein formulations are directed to the same purpose. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claim 2, the first liposome comprising photolyase can reasonably be considered a photosome (see e.g. claims 1 and 7).
With respect to claim 3, as noted above liposomes are present.
With respect to claim 5, as noted above MelaTrepein contains both dipeptide-51 and dipeptide-12.
With respect to claim 6, as noted above ‘079 claims a range of hexapeptide-11 within the range instantly claimed.
With respect to claim 7, ‘079 claims inclusion of hexapeptide-11 and hexapeptide-12 in a liposome (see e.g. claims 1 and 5).
With respect to claim 8, as noted above ‘079 claims a range of hexapeptide-12 within the range instantly claimed.
With respect to claim 9, ’079 claims inclusion of up to 0.25 wt% of lactoferrin (see e.g. claim 3).
With respect to claim 10, ‘079 claims inclusion of the lactoferrin within a liposome (see e.g. claim 5).
With respect to claim 11, ‘079 claims phosphatidylserine at no more than 0.075 wt% (see e.g. claim 4).
With respect to claim 12, ‘079 claims inclusion of silymarin at 0.1 wt% to 1.0 wt% (see e.g. claim 10).
With respect to claim 13, ‘079 claims sesamol at 0.002 wt% to 0.050 wt% (see e.g. claim 11).
With respect to claim 14, ‘079 claims tranexamic acid at 1 wt% to 10 wt% (see e.g. claim 12).
With respect to claim 18, ‘079 claims lecithin and propanediol (see e.g. claim 14).
With respect to claims 19 and 20, as noted above ‘079 claims a method of improving pigmentation from a pigmentation disorder or disease, including hyperpigmentation (see e.g. claims 1 and 15).
3. Claims 1-3, 5-14, and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-29, 31-34, and 37-39 of copending Application No. 19/405,063 in view of Incospharm (Catalog Number ICP2006, MelaTrepein) as evidenced by Incospharm History (https://incospharm.com/default/en/01/03.php).
The ‘063 application claims a topical composition to improve skin pigmentation comprising a first liposome comprising a photolyase, a second liposome, 0.004 wt% to 0.100 wt% of hexapeptide-11, and 0.001 wt% to 0.025 wt% of hexapeptide-12 (see e.g. claim 21). ‘063 also claims that the composition can comprise hexacarboxymethyl dipeptide, overlapping with claim 1 (see e.g. claim 38).
The difference between ‘063 and the claimed invention is that ‘063 does not claim a dipeptide as part of the formulation across all formulations.
The Incospharm MelaTrepein art indicates that it contains dipeptide-12 and dipeptide-51, and works to improve skin pigmentation. The Incospharm art does not explicitly disclose a publication date, but the Incospharm History indicates that MelaTrepein was disclosed in 2017.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the ‘063 patent formulation with the Incospharm MelaTrepein to prepare a third composition useful for treating skin pigmentation. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). There would have been a reasonable expectation of success because the ‘063 and MelaTrepein formulations are directed to the same purpose. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claim 2, the first liposome comprising photolyase can reasonably be considered a photosome (see e.g. claim 21 and 28).
With respect to claim 3, as noted above liposomes are present.
With respect to claim 5, as noted above MelaTrepein contains both dipeptide-51 and dipeptide-12.
With respect to claim 6, as noted above ‘063 claims a range of hexapeptide-11 within the range instantly claimed.
With respect to claim 7, ‘063 claims inclusion of hexapeptide-11 and hexapeptide-12 in a liposome (see e.g. claims 21 and 26).
With respect to claim 8, as noted above ‘063 claims a range of hexapeptide-12 within the range instantly claimed.
With respect to claim 9, ’063 claims inclusion of up to 0.5 wt% of lactoferrin (see e.g. claims 22 and 23).
With respect to claim 10, ‘063 claims inclusion of the lactoferrin within a liposome (see e.g. claim 26).
With respect to claim 11, ‘063 claims phosphatidylserine at no more than 0.25 wt% (see e.g. claims 24 and 25).
With respect to claim 12, ‘063 claims inclusion of silymarin at 0.2 wt% to 3.0 wt% (see e.g. claim 31-32).
With respect to claim 13, ‘063 claims sesamol at 0.002 wt% to 0.050 wt% (see e.g. claim 33).
With respect to claim 14, ‘063 claims tranexamic acid at 0.2 wt% to 10 wt% (see e.g. claim 34).
With respect to claim 17, ‘063 claims Withania extract, gallic acid, hesperidin, Pancratium maritimum, and Tremella fuciformis (see e.g. claim 38).
With respect to claim 18, ‘063 claims lecithin and propanediol (see e.g. claim 37).
With respect to claim 19, ‘063 claims improving pigmentation resulting from a pigmentation disorder or disease (see e.g. claim 21, 27, and 39). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilize the topical composition in a method of improving pigmentation. The rationale comes from the intended use claim of ‘063, which would have provided motivation to claim a method of treatment. There would have been a reasonable expectation of success because of the intended use claiming. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at (571) 270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658
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