DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 14 is withdrawn.
Claims 1-7, 11-12, 15-16, and 20 are pending and represent all claims currently under consideration.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/27/2026 has been entered.
Response to Arguments
Applicant's arguments filed 07/27/2026 have been fully considered but they are not persuasive.
Applicant argues that Delgado contains exhaustive, generic “laundry lists” of hundreds of optional excipients, adjuvants, and cosmetic actives, and does not disclose, highlight, or suggest a specific combination of retinol, pal-KTTKS, and hyaluronic acid (Remarks, page 5). This argument is not persuasive, because Delgado teaches a dermopharmaceutical composition wherein the excipient, adjuvant, and/or ingredient is selected from a group which includes humectants, agents stimulating the synthesis of dermal macromolecules, and mixtures thereof (Delgado, claim 28), and teaches humectants to include hyaluronic acid (i.e., “c”; Delgado, page 16, lines 3-15). Delgado specifies that hyaluronic acid is commonly used in the cosmetic and dermopharmaceutical industry due to its elastic and viscous properties and its ability to absorb water, helping to maintain hydrated skin (Delgado, page 2, lines 21-32). Delgado further lists a finite number of about 75 agents stimulating the synthesis of dermal macromolecules, which includes both retinol (Delgado, page 18, line 13) and Matrixyl® INCI: palmitoyl peptapeptide-3 (i.e., “b”, a preferred commercially available pentapeptide with the sequence Pal-KTTKS as defined by the instant specification, page 18, lines 22-24; Delgado, page 17, line 32) (Delgado, pages 17-18). Therefore, because Delgado specifies the usefulness of hyaluronic acid as a humectant, teaches a mixture of humectants and agents, and teaches a finite list of agents, it would have been prima facie obvious to one of ordinary skill in the art to try the claimed combination. As for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art.
Applicant argues that Delgado’s disclosure is built around a Vibrio sp. Exopolysaccharide, which is completely absent from the claimed composition (Remarks, page 5). This argument is not persuasive, because the claims recites the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements, such as in this case, a Vibrio sp. Exopolysaccharide. See MPEP 2111.03(I).
Applicant argues that Table 7 of the specification demonstrates unexpected results of a synergistic relationship between retinol and Pal-KTTKS, and that Table 9 demonstrates an additional benefit to the upregulation of collagen synthesis from the addition of hyaluronic acid, specifically by controlling the diffusion rate of the highly active retinol, reducing the irritating and toxic cellular effects of the retinoid while boosting its regenerative efficacy (Remarks, pages 5-6). This argument is not persuasive, because the additional data provided in Tables 4-6 does not support this assertion. The data provided in the cited Table 7 corresponds to Example Formulations 8-10 of Table 4 (instant specification, table 4). Example 8, which comprises hyaluronate (i.e., a salt of hyaluronic acid) and retinol, differs from Example 2 by only the amount of retinol present. Example 2 is shown to upregulate collagen synthesis by 87.5% vs the baseline control (instant specification, table 5), which is much higher than the asserted additional benefit of 63.7% provided by the formulation of Example 10 comprising hyaluronate, retinol, and Pal-KTTKS (instant specification, table 7). Additionally, Example 5 and Example 9, which each comprise hyaluronate and Pal-KTTKS, differ only in the amount of Pal-KTTKS, and result in very different collagen synthesis levels of 32.3% (instant specification, table 6) and 7.8% (instant specification, table 7). Regarding the cited additional benefit from the addition of hyaluronic acid from Table 9, each of the cited examples comprise hyaluronate (instant specification, tables 8-9), and result in collagen synthesis levels which are lower than the results provided by Examples 2 and 3, which do not contain the Pak-KTTKS peptide (instant specification, tables 4-5).
Applicant argues that there is no motivation for a person of ordinary skill in the art to combine the skin-care exopolysaccharide formulation of Delgado with the zinc oxide dentifrice of Prencipe (Remarks, page 7). This argument is not persuasive, because Delgado, Principe, and the instant invention are in the same field of leave on oral care compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Delgado to include an antiplaque agent as taught by Prencipe, because both references teach a composition for oral care, and Delgado teaches the use of dermopharmaceutical acceptable excipients (Delgado, page 14, line 13), while Prencipe teaches that it is known in the art to use zinc oxide in such compositions (Delgado, page 1, paragraph 0009).
New 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 1-7, 11-12, 15-16, and 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.
Regarding claim 1, the parenthetical recitation of “(Pal-KTTKS)” renders the claim indefinite because it is unclear whether the limitations in parentheses are part of the claimed invention or describing an example or preference as the claimed recites “peptide comprising…” thus it’s unclear if the claim is limited specifically to PAL-KTTKS or to any peptide having in its sequence palmitoyl-lys-thr-thr-lys-ser. See MPEP § 2173.05(d).
Regarding claims 2-7, 11-12, 15-16, and 20, each claim is dependent on the rejected claim 1 and does not cure its deficiencies.
Regarding claim 7, the claim recites the limitation "the retinyl ester". There is insufficient antecedent basis for this limitation in the claim.
Modified/Maintained 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.
Claims 1-7, 11-12, 15-16, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-7, 11, and 14-15 of copending Application No. 17/892,387 (reference application), further in view of Delgado (WO 2013139965 A2). The references were cited previously by the Examiner.
Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, the copending application teaches a leave-on oral care composition comprising a gum health compound comprising retinol, a peptide comprising Pal-KTTKS, and a mucoadhesive polymer (copending application, claim 1). The copending application does not specify the mucoadhesive polymer comprises hyaluronic acid or a salt thereof. Delgado, however, teaches a dermopharmaceutical composition (Delgado, abstract) which can be used to treat gingivitis (i.e., an oral care composition for gum health; Delgado, page 7, lines 31-32) and which can be a leave-on formulation (Delgado, page 13, line 25). Delgado teaches the composition can comprise retinol (Delgado, page 18, line 13), Matrixyl® INCI: palmitoyl peptapeptide-3 (i.e., “b”, a preferred commercially available pentapeptide with the sequence Pal-KTTKS as defined by the instant specification, page 18, lines 22-24; Delgado, page 17, line 32), and vitamins, humectants, or mixtures thereof (Delgado, claim 28). Delgado further teaches humectants include hyaluronic acid (i.e., “c”; Delgado, page 16, lines 3-15).
The copending application and Delgado are both considered to be analogous to the claimed invention, because Delgado, the copending application, and the instant invention are in the same field of oral care compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the claimed invention to include hyaluronic acid as the mucoadhesive polymer, because the copending application does not specify which polymer should be used, while Delgado teaches hyaluronic acid acts as a humectant that retains moisture (Delgado, page 16, lines 3-15) and that promotes processes during wound healing (Delgado, page 4, lines 19-23), suggesting improved wound healing.
Regarding claim 2, the copending application and Delgado together teach all the elements of the current invention as applied to claim 1. The copending application teaches the gum health compound comprises a metal ion source, vitamin, allantoin, gum strengthening polyol (i.e., a compound), or combinations thereof (copending application, claim 2).
Regarding claim 3, the copending application and Delgado together teach all the elements of the current invention as applied to claim 1. The copending application teaches the gum health compound is free of jasmonic acid compound, gibberellic acid, zeatin compound, or combination thereof (copending application, claim 4).
Regarding claim 4, the copending application and Delgado together teach all the elements of the current invention as applied to claim 1. The copending application teaches the oral care composition is free of abrasive (copending application, claim 1).
Regarding claim 5, the copending application and Delgado together teach all the elements of the current invention as applied to claim 2. The copending application teaches the metal ion source from the same claimed list (copending application, claim 5).
Regarding claim 6, the copending application and Delgado together teach all the elements of the current invention as applied to claim 2. The copending application teaches a vitamin from the same claimed list (copending application, claim 6).
Regarding claim 7, the copending application and Delgado together teach all the elements of the current invention as applied to claim 1. The copending application teaches a retinyl ester from the same claimed list (copending application, claim 7).
Regarding claim 11, the copending application and Delgado together teach all the elements of the current invention as applied to claim 1. The copending application teaches the composition comprises a mucoadhesive polymer and teaches the composition has a viscosity consistency coefficient K of from 20 Pas to 500 Pas as measured at 22°C at a shear rate of 0.1-10s-1 (copending application, claim 1).
Regarding claim 12, the copending application and Delgado together teach all the elements of the current invention as applied to claim 1. The copending application teaches the composition comprises a fluoride (copending application, claim 11).
Regarding claim 15, the copending application and Delgado together teach all the elements of the current invention as applied to claim 1. The copending application teaches a kit comprising the leave-on oral care composition and a delivery carrier (copending application, claim 14).
Regarding claim 16, the copending application and Delgado together teach all the elements of the current invention as applied to claim 1. The copending application teaches the delivery carrier from the same claimed list (copending application, claim 15).
Regarding claim 20, the copending application and Delgado together teach all the elements of the current invention as applied to claim 1. As above, the copending application does not specify the mucoadhesive polymer comprises hyaluronic acid. Delgado, however, teaches the composition can comprise vitamins, humectants, or mixtures thereof (Delgado, claim 28), and teaches humectants include hyaluronic acid (i.e., “c”; Delgado, page 16, lines 3-15). Delgado further teaches hyaluronic acid has a molecular weight generally greater than 1000 KDa (i.e., 1,000,000 Da; Delgado, page 1, lines 18-24), which overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the claimed invention to include hyaluronic acid as the mucoadhesive polymer, because the copending application does not specify which polymer should be used, while Delgado teaches hyaluronic acid acts as a humectant that retains moisture (Delgado, page 16, lines 3-15) and that promotes processes during wound healing (Delgado, page 4, lines 19-23), suggesting improved wound healing.
Modified/Maintained 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.
Claims 1-4, 6-7, 11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Delgado (WO 2013139965 A2). The reference was cited previously by the Examiner.
Regarding claim 1, Delgado teaches a dermopharmaceutical composition (Delgado, abstract) which can be used to treat gingivitis (i.e., an oral care composition for gum health; Delgado, page 7, lines 31-32), which can be a leave-on formulation (Delgado, page 13, line 25), and which comprises an excipient, adjuvant, and/or ingredient is selected from a group which includes humectants, agents stimulating the synthesis of dermal macromolecules, and mixtures thereof (Delgado, claim 28). Delgado teaches the agents stimulating the synthesis of dermal macromolecules can comprise retinol (Delgado, page 18, line 13) and Matrixyl® INCI: palmitoyl peptapeptide-3 (i.e., “b”, a preferred commercially available pentapeptide with the sequence Pal-KTTKS as defined by the instant specification, page 18, lines 22-24; Delgado, page 17, line 32), and further teaches humectants include hyaluronic acid (i.e., “c”; Delgado, page 16, lines 3-15).
Delgado is considered to be analogous to the claimed invention, because both Delgado and the instant invention are in the same field of oral care compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the claimed invention based on the teachings of Delgado under the meaning of 35 U.S.C. 103.
Regarding claim 2, Delgado teaches all the elements of the current invention as applied to claim 1. Delgado teaches a dermopharmaceutical composition (Delgado, abstract) which can be used to treat gingivitis (i.e., an oral care composition for gum health; Delgado, page 7, lines 31-32) and teaches the composition can comprise vitamins (i.e., gum health compounds from the claimed list; Delgado, page 15, line 10).
Regarding claim 3, Delgado teaches all the elements of the current invention as applied to claim 1. Delgado does not teach a jasmonic acid compound, gibberellic acid, or a zeatin compound, and therefore reads on the composition as claimed which is free of these ingredients.
Regarding claim 4, Delgado teaches all the elements of the current invention as applied to claim 1. Delgado does not teach the use of an abrasive and teaches compositions comprising a support from a list comprising silica (i.e., an abrasive as defined by the instant specification, page 26, line 3) and other supports (Delgado, claim 24). Therefore, the abrasive is an optional embodiment in the composition of Delgado, and reads on the composition as claimed which is free of an abrasive.
Regarding claim 6, Delgado teaches all the elements of the current invention as applied to claim 2. Delgado teaches the composition can comprise vitamin A (i.e., a vitamin from the claimed list; Delgado, page 17, line 11).
Regarding claim 7, Delgado teaches all the elements of the current invention as applied to claim 1. Delgado teaches the composition can comprise retinyl palmitate (i.e., a retinyl ester from the claimed list; Delgado, page 18, line 13).
Regarding claim 11, Delgado teaches all the elements of the current invention as applied to claim 1. Delgado does not measure a viscosity consistency coefficient or Mucoadhesion index. 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 supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Regarding claim 20, Delgado teaches all the elements of the current invention as applied to claim 1. Delgado teaches the composition can comprise vitamins, humectants, or mixtures thereof (Delgado, claim 28), and teaches humectants include hyaluronic acid (i.e., “c”; Delgado, page 16, lines 3-15). Delgado further teaches hyaluronic acid has a molecular weight generally greater than 1000 KDa (i.e., 1,000,000 Da; Delgado, page 1, lines 18-24), which overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Claims 5, 12, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Delgado (WO 2013139965 A2) as applied to claims 1-4, 6-7, 11, and 20, further in view of Prencipe (US 20170100312 A1; IDS reference, 03/23/2023). The references were cited previously by the Examiner.
Regarding claim 5, Delgado teaches all the elements of the current invention as applied to claim 1. Delgado teaches the composition can be used to treat gingivitis (Delgado, page 7, lines 31-32), but does not specifically teach a gum health compound which is a metal ion source. Prencipe teaches a dentifrice composition (i.e., an oral care composition; Prencipe, abstract) comprising a source of zinc oxide (Prencipe, page 8, table 1) as an antiplaque agent (Prencipe, page 1, paragraph 0009), and teaches a 10 minute treatment with the composition (i.e., a leave-on composition; Prencipe, page 8, paragraph 0106).
Delgado and Principe are both considered to be analogous to the claimed invention, because Delgado, Principe, and the instant invention are in the same field of leave on oral care compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Delgado to include an antiplaque agent as taught by Prencipe, because both references teach a composition for oral care, and Delgado teaches the use of dermopharmaceutical acceptable excipients (Delgado, page 14, line 13), while Prencipe teaches that it is known in the art to use zinc oxide in such compositions (Delgado, page 1, paragraph 0009).
Regarding claim 12, Delgado teaches all the elements of the current invention as applied to claim 1. Delgado teaches the use of dermopharmaceutical acceptable excipients (Delgado, page 14, line 13), but does not specifically teach a fluoride. Prencipe, however, teaches a dentifrice composition comprising sodium fluoride (i.e., a fluoride; Prencipe, page 8, table 1). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Delgado to include an antiplaque agent as taught by Prencipe, because both references teach a composition for oral care, and Delgado teaches the use of dermopharmaceutical acceptable excipients (Delgado, page 14, line 13), while Prencipe teaches that fluoride ion sources are useful in such compositions as an anti-caries agent (Delgado, page 6, paragraph 0088).
Regarding claim 15, Delgado teaches all the elements of the current invention as applied to claim 1. Delgado teaches the composition can be incorporated into cosmetic or dermopharmaceutical delivery systems with an acceptable carrier (Delgado, page 11, lines 18-22), and teaches such delivery systems are known in the art (Delgado, page 13, lines 1-2). Prencipe further teaches the composition can be formulated into a delivery form (i.e., a kit as claimed) and can be applied by film or strip (i.e., delivery carriers; Prencipe, page 8, paragraph 0101). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Delgado to include a delivery system as taught by Prencipe, because both references teach a composition for oral care, and Delgado teaches delivery systems are known in the art (Delgado, page 13, lines 1-2), while Prencipe teaches the delivery system as claimed.
Regarding claim 16, Delgado and Prencipe together teach all the elements of the current invention as applied to claim 15. As above, Prencipe teaches the composition can be applied by film or strip (i.e., delivery carriers from the claimed list; Prencipe, page 8, paragraph 0101). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Delgado to include a delivery system as taught by Prencipe, because both references teach a composition for oral care, and Delgado teaches delivery systems are known in the art (Delgado, page 13, lines 1-2), while Prencipe teaches the delivery system as claimed.
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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