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 .
Claim Status
Claims 1-20 are pending and currently under examination.
Priority
Acknowledgement is made for the following priority:
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Information Disclosure Statement (IDS)
The IDS (1) filed on 14 October 2024 has been considered by the examiner. A signed copy is enclosed.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section.”
Claim Interpretation
Claim 1 is drawn to “[a] topical composition for reducing skin inflammation” comprising an octapeptide and a high molecular weight hyaluronic acid or hyaluronic acid derivative with a molecular weight of at least 0.5 MDa.
The examiner notes that applicant’s language concerning the manner in which the composition is to be used, or the effects of the composition when used impart minimal substantive limitations on the compositions being claimed.
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”). See MPEP 2111.02(II).
As such, the examiner will consider the broadest reasonable interpretation of claim 1 to include topical compositions comprising an octapeptide and a high molecular weight hyaluronic acid or hyaluronic acid derivative with a molecular weight of at least 0.5 MDa.
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings. The amino acid sequence appearing in Fig. 25 of the drawings is not identified by a sequence identifier.
Required response – Applicant must provide:
Amended Figure 25 in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifier (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter..
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.
The factual inquiries 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, 4, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Galderisi (WO 2013/188774 A2, published 19 December 2013) in further view of Rayahin (“High and low molecular weight hyaluronic acid differentially influence macrophage activation,” published 15 June 2015).
Galderisi discloses skin care formulations including octapeptide complexes (abstract).
Regarding claim 1 –
Galderisi discloses a skin care formulation for topical application to human skin that comprises an effective amount of acetyl octapeptide-3 and glycosaminoglycans (p. 2, lines 11-16). Hyaluronic acid (HA) is a member of the glycosaminoglycan genus.
Regarding claim 15 –
Galderisi discloses embodiments of the skin care formulation that is aqueous (p. 3, lines 19-29).
Regarding claims 16 and 17 –
Galderisi discloses the skin care formulation is clinically effective for the treatment of fine lines and deep wrinkles among other visible signs of poor skin health and aging by application to the entire facial area (p. 1, lines 30-32; p. 2 lines 1-3). Galderisi identifies octapeptide SNAP-8® as an anti-wrinkling agent (p. 3, lines 19-29). Since applicant fails to define the parameters of ‘treating or restoring aging skin’ in the specification, examiner contends that fine lines and deep wrinkles are symptoms of aging skin and therefore, Galderisi discloses these limitations.
Galderisi therefore teaches a topical skin composition comprising an octapeptide and recognizes the desirability of including a glycosaminoglycan component to provide anti-inflammatory activity. Galderisi differs from the rejected claims in that while Galderisi discloses the glycosaminoglycan genus, it does not expressly disclose high molecular weight HA with a molecular weight of at least 0.5 MDa. However, this limitation is made obvious by the teachings of Rayahin.
Rayahin teaches various molecular weights of HA can modify different macrophage phenotypes and that this modification is independent of initial activation state of the macrophage (p. 490). Furthermore, Rayahin teaches low molecular weight HA caused up-regulation of pro-inflammatory genes such as tnf and nos2 while high molecular weight HA promoted up-regulation of pro-resolving gene transcription including arj1, il10, and mrc1, and enhanced arginase activity (abstract). Pro-resolving gene transcription in macrophages is a key mechanism for reducing inflammation.
Regarding claims 1, 4, and 16 –
Rayahin discloses HA with high molecular weights of greater than 800 kDa produced the most significant effects, whereby 3000 kDa HA significantly up-regulated arginase expression in macrophages (p. 485).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to use high molecular weight HA, having a molecular weight of at least 0.5 MDa, and the anti-inflammatory glycosaminoglycan in the topical octapeptide composition of Galderisi. One would be motivated to make this selection because: 1) Galderisi expressly provides a topical composition having anti-inflammatory activity and expressly includes an anti-inflammatory glycosaminoglycan component; 2) HA was known in the art to be a glycosaminoglycan used in topical skin care compositions; 3) Rayahin expressly teaches high molecular weight HA provides the desired anti-inflammatory response; and 4) Rayahin expressly teaches lower molecular weight HA produces the opposite, pro-inflammatory effect.
Thus, where Galderisi seeks to reduce inflammation, Rayahin would have guided the skilled artisan toward selecting high molecular weight HA. Selecting a high molecular weight HA having a molecular weight of at least 0.5 MDa overlaps with the range taught by Rayahin as greater than 0.8 MDa (800 kDa).
Accordingly, the combined references render obvious both the recited composition and its suitability for the stated use as recited in instant claims 1, 4, and 15-17.
Claims 5-6 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Galderisi (WO 2013/188774 A2, published 19 December 2013) in further view of Rayahin (“High and low molecular weight hyaluronic acid differentially influence macrophage activation,” published 15 June 2015) as applied to claims 1, 4, and 15-17 above, and further in view of Widgerow (WO 2020/227526 A1, published 12 November 2020).
Galderisi and Rayahin are discussed above, specifically as it pertains to a topical skin composition containing an octapeptide and a high molecular weight HA, methods of use, and anti-inflammatory properties of such. However, neither Galderisi or Rayahin expressly disclose the limitations of instant claims 5-6 and 8-14.
Widgerow discloses compositions and methods for improving bruising, stimulating elastin and/or collagen production, stimulating intrinsic hyaluronic acid production, stimulating adipogenesis, reducing inflammation, or combinations thereof (abstract). These compositions contain a combination of a tripeptide and a hexapeptide ([0005]). In addition, Widgerow contemplated an octa-peptide for use in the invention (Fig. 2, [00233]).
Regarding claim 5 –
Widgerow discloses embodiments of a topical skin composition containing a sodium hyaluronate crosspolymer, which is a high molecular weight synthetic hyaluronic acid with high water-binding capacity and moisturizing abilities ([00123]).
Regarding claim 6 –
Widgerow discloses embodiments of a topical skin composition containing tripeptide-1, a synthetic signal peptide that mimics a fragment of type I collagen and results in elastin and/or collagen stimulation, extracellular matrix recycling, anti-inflammatory effects, or combinations thereof ([0080]).
Regarding claims 8 and 9 –
Widgerow discloses embodiments of a topical skin composition containing hexapeptide-11 or hexapeptide-12, which improve macrophage function ([0081]).
Regarding claim 10 –
Widgerow discloses embodiments of a topical skin composition containing lactoferrin, which has wound healing attributes, promotes proliferation of fibroblasts, and increases HA secretion ([00110]). Widgerow also has antimicrobial activity ([00111]).
Regarding claim 11 –
Widgerow discloses embodiments of a topical skin composition containing phosphatidylserine, which can induce phagocytosis of red blood cells to promote bruise healing ([0099]).
Regarding claim 12 –
Widgerow discloses embodiments of a topical skin composition containing: lactoferrin, hexapeptide-11, and/or phosphatidylserine encapsulated in a liposome ([0005]).
Regarding claim 13 –
Widgerow discloses embodiments of a topical skin composition containing Tremella fuciformis extract, which provide moisture and antioxidant properties ([00120]).
Regarding claim 14 –
Widgerow discloses an exemplary composition containing tripeptide-1 and hexapeptide-12 ([00229]).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the topical octapeptide composition of Galderisi to include additional active ingredients taught by Widgerow. One would be motivated to do so because Widgerow concerns topical, multi-active compositions for improving bruise healing, wound repair, moisturization, HA production, and skin rejuvenation, which are the same general skin-care purposes addressed by Galderisi. Widgerow expressly teaches that its disclosed peptides and additional active ingredients can be combined. The skilled artisan therefore would have reason to incorporate Widgerow’s known skin-active ingredients into the modified composition of Galderisi to provide their disclosed complementary benefits; and with a reasonable expectation of success because the references teach the ingredients in compatible topical compositions.
Accordingly, the combined references render obvious both the recited composition and its suitability for the stated use as recited in instant claims 5-6 and 8-14.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Galderisi (WO 2013/188774 A2, published 19 December 2013) in further view of Rayahin (“High and low molecular weight hyaluronic acid differentially influence macrophage activation,” published 15 June 2015) and Widgerow (WO 2020/227526 A1, published 12 November 2020) as applied to claims 1, 4-6, and 8-17 above, and further in view of Carle (WO 2020/131477 A2, published 25 June 2020).
Galderisi, Rayahin, and Widgerow are discussed above, specifically as it pertains to a topical skin composition containing: an octapeptide, a high molecular weight HA, and a synthetic tripeptide; methods of use; and anti-inflammatory properties of such. However, the above references do not expressly disclose the limitations of instant claim 7.
Carle discloses compositions and methods for use in cosmetic applications whereby an effective amount of the composition can be applied on skin to inhibit production of TNF-α production, tyrosinase, and/or elastase in skin; inhibit the Matrix Metalloproteinase Enzyme activity in the skin, and/or promote the production of fibronectin, collagen, elastin, laminin, and/or fibronectin in the skin (abstract). Carle identifies a composition to counteract the intrinsic and extrinsic factors the change the appearance and/or condition of skin and eventually lead to skin aging ([0008]).
Regarding claim 7 –
Carle discloses this composition includes tetradecyl aminobutyroylvalylaminobutyric urea trifluoroacetate (TAUT) ([0008]) to inhibit TNF-α production ([0010]) while increasing the production of collagen and hyaluronic acid ([0090]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute TAUT for a synthetic tripeptide in the topical skin composition of Widgerow. Carle teaches that TAUT is suitable for incorporation into topical skin compositions and is effectively inhibits the production of pro-inflammatory cytokine TNF-α. A person of ordinary skill seeking to enhance the anti-inflammatory, moisturizing, and skin rejuvenation properties of the Galderisi/Rayahin/Widgerow composition would have been motivated to add TAUT to obtain its known and complementary benefits disclosed by Carle. The skilled artisan would have a reasonable expectation of success because Carle expressly formulated TAUT for topical administration to skin and demonstrates its effects in human dermal fibroblasts. Furthermore, Galderisi, Carle, and Widgerow each combine multiple cosmetically acceptable active ingredients – a technique that is widely used in the art – to address complementary aspects of skin aging, inflammation, hydration, and extracellular matrix repair. The substitution would have amounted to the predictable use of a known active peptide in topical skin compositions according to its established function.
Accordingly, the combined references render obvious the recited composition and its suitability for the stated use as recited in instant claim 7.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over MDSUN (Wrinkle Smoothener, captured 05 December 2021 via Wayback Machine) in further view of Carle (WO 2020/131477 A2, published 25 June 2020).
MDSUN discloses a topical cosmetic composition comprising numerous peptides and alpha lipoic acids to reduce the formation of lines and wrinkles (p. 1).
Regarding claim 20 –
The composition of MDSUN contains acetyl octapeptide-3 (SNAP-8) (p. 1).
While MDSUN does not expressly teach the composition is used in a method to increase hyaluronic acid synthase expression or promote hyaluronic acid synthesis, this feature is made obvious over Carle, whose teachings are discussed above.
Specifically, the composition of MDSUN contains TAUT (p. 2). Carle expressly identifies compounds containing TAUT possess the ability to promote or increase the production of hyaluronic acid in the skin ([0039]).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to administer the composition disclosed by MDSUN with an effective amount of its expressly disclosed TAUT ingredient with a reasonable expectation of promoting hyaluronic acid synthesis because Carle teaches that TAUT-containing topical compositions are effective in promoting the production of hyaluronic acid in the skin. One would have been motivated to use this HA-promoting amount of TAUT to improve skin hydration, firmness, and appearance of aging skin, which are objectives consistent with MDSUN’s topical anti-aging serum. The skilled artisan would have a reasonable expectation of success because Carle provides experimental evidence that TAUT-containing compositions increase HA production in human dermal fibroblasts and expressly recommends its topical application for that purpose.
The resulting method comprises administering to the skin a topical composition containing an octapeptide and promoting hyaluronic acid synthesis, thereby meeting every limitation of instant claim 20.
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.
Copending Application No. 18/297,422
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7-14, and 17-20 of copending Application No. 18/297,422 (‘422) in view of Galderisi (cited previously), Rayahin (cited previously), and Widgerow (cited previously).
Although the claims at issue are not identical, they are not patentably distinct from one another because both applications are drawn to a topical composition containing an octapeptide and a method of using said composition.
Claim 1 of ‘422 reads on claims 1 and 4-5 of the instant application. Specifically, the claims both read on a topical composition comprising an octapeptide. The addition of a high MW hyaluronic acid of at least 0.5 MDa is made obvious by Galderisi and Rayahin, who collectively teach high MW hyaluronic acid is suitable for skin care compositions because of its anti-inflammatory properties as discussed above. Widgerow further teaches sodium hyaluronate as a suitable substitution for hyaluronic acid.
Claim 1 of ‘422 reads on claims 2 and 3 of the instant application. Specifically, SEQ ID NO: 5 of ‘422 is identical to the instantly claimed SEQ ID NO: 5.
The rest of the claims are mapped below:
Instant Application
Claim No.
‘422
Claim No.
6
2
7
3
8 and 9
1
10 and 11
8
12
7
13
8
14
1 + made obvious by the combination of Galderisi, Rayahin, and Widgerow
15
1 + made obvious by the combination of Galderisi, Rayahin, and Widgerow
16
11
17
18
18
11
19
11
20
11
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Copending Application No. 18/913,581
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/913,581 (‘581).
Although the claims at issue are not identical, they are not patentably distinct from one another because both applications are drawn to a topical composition containing a high molecular weight hyaluronic acid and octapeptide, and a method of using said composition.
Claims 1 and 3 of ‘581 read on claim 1 of the instant application. Specifically, the claims both read on a topical composition comprising a high molecular weight HA of at least 0.5 MDa and an octapeptide.
Claims 1 and 2 of ‘581 read on claims 2 and 3 of the instant application. Specifically, SEQ ID NOs: 2, 3, 4, 5, 1, 6, and 7 of ‘581 are identical to the instantly claimed SEQ ID NOs: 1-7, respectively.
The rest of the claims are mapped below:
Instant Application
Claim No.
‘581
Claim No.
4
4
5
5
6
6
7
7
8 and 9
8
10
10
11
11
12
12
13
13
14
1
15
15
16
16
17
17
18 and 19
20
20
16
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Copending Application No. 19/064,198
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/064,198 (‘198) in view of Galderisi (cited previously), Rayahin (cited previously), and Widgerow (cited previously).
Although the claims at issue are not identical, they are not patentably distinct from one another because both applications are drawn to a topical composition containing an octapeptide and a method of using said composition.
Claim 2 of ‘198 reads on claims 1 and 4-5 of the instant application. Specifically, the claims both read on a composition comprising an octapeptide. The addition of a high MW hyaluronic acid of at least 0.5 MDa is made obvious by Galderisi and Rayahin, who collectively teach high MW hyaluronic acid is suitable for skin care compositions because of its anti-inflammatory properties as discussed above. Widgerow further teaches sodium hyaluronate as a suitable substitution for hyaluronic acid.
Claim 2 of ‘198 reads on claims 2 and 3 of the instant application. Specifically, SEQ ID NO: 5 of ‘198 is identical to the instantly claimed SEQ ID NO: 5.
The rest of the claims are mapped below:
Instant Application
Claim No.
‘198
Claim No.
6
10
7
2 + made obvious by the combination of Galderisi, Rayahin, and Widgerow
8 and 9
5 and 8
10-13
2 + made obvious by the combination of Galderisi, Rayahin, and Widgerow
14
6 and 10
15
2 + made obvious by the combination of Galderisi, Rayahin, and Widgerow
16
12
17
19
18 and 19
12
20
12
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Copending Application No. 19/744,537
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 19/744,537 (‘537) in view of Galderisi (cited previously), Rayahin (cited previously), and MDSUN (cited previously).
Although the claims at issue are not identical, they are not patentably distinct from one another because both applications are drawn to a topical composition containing an octapeptide and a method of using said composition.
Claim 1 of ‘537 reads on claims 1 and 4 of the instant application. Specifically, the claims both read on a composition comprising an octapeptide. The addition of a high MW hyaluronic acid of at least 0.5 MDa is made obvious by Galderisi and Rayahin, who collectively teach high MW hyaluronic acid is suitable for skin care compositions because of its anti-inflammatory properties as discussed above.
Claim 1 of ‘537 reads on claims 2 and 3 of the instant application. Specifically, SEQ ID NO: 5 of ‘537 is identical to the instantly claimed SEQ ID NO: 5.
The rest of the claims are mapped below:
Instant Application
Claim No.
‘198
Claim No.
5
7
6
1
7
1 + made obvious by the combination of Galderisi, Rayahin, and MDSUN
8
1
9
1 + made obvious by the combination of Galderisi, Rayahin, and MDSUN
10
3
11
5
12
4
13
10
14
1
15
9
16
11 + made obvious by the combination of Galderisi, Rayahin, and MDSUN
17
15
18 and 19
11
20
11
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Conclusion
Claims 1-20 are rejected. No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A. Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
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, Robert A. Wax can be reached at (571)272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights