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Claim 13 is withdrawn.
Claims 1-2, 4-12, 14-16, and 19 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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, see Remarks (page 6), filed 07/27/2026, with respect to the rejection(s) of claim(s) 16 under 35 U.S.C. 103 over Prencipe have been fully considered and are persuasive due to the amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Delgado, further in view of Prencipe.
Applicant's arguments, see Remarks (pages 6-9), filed 07/27/2026, with respect to the rejection(s) of claim(s) 1-2, 4-12, 14-15, and 19 under 35 U.S.C. 103 over Delgado and Principe have been fully considered but they are not persuasive.
Applicant argues that the specific viscosity and Mucoadhesion index is important for leave-on gum application, while Delgado teaches skin-care creams which lack the properties needed to survive a wet, mucosal environment. Applicant further states that conventional demopharmaceutical or skincare compositions are not suitable for use in the oral cavity due to toxicity (Remarks, pages 7-8). This argument is not persuasive, because 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 which can be a leave-on formulation (Delgado, page 13, line 25), suggesting that the composition would have the properties needed to survive on the gums. Delgado also defines a dermopharmaceutically effective amount as a non-toxic quantity (Delgado, page 11, lines 11-12), further suggesting it would be suitable for use in the oral cavity.
Applicant argues that Table 1 of the specification demonstrates the combination of a retinol/retinyl ester and the peptide Pal-KTTKS exhibits a highly unexpected, synergistic effect on the upregulation of collagen genes COL1A1 and COL1A2 (Remarks, page 8). This argument is not persuasive, because objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support. See MPEP 716.02(d). In the instant case, the data provided in Table 1 compares the application of only retinol, only Pal-KTTKS, or a combination of the two compounds (instant specification, page 40), rather than a leave-on oral care composition comprising these compounds or a retinyl ester, in combination with a mucoadhesive polymer as claimed. Therefore, the data does not provide evidence that the composition as claimed results in an unexpected, synergistic effect. The additional data provided in Tables 4-6 also does not support an unexpected, synergistic effect for the claimed composition. For instance, Example 2, which includes retinol, but not a Pal-KKTKS peptide (instant specification, table 4), is shown to upregulate collagen synthesis by 87.5% vs the baseline control (instant specification, table 5), which is much higher than the 63.7% provided by the formulation of Example 10 comprising retinol and Pal-KTTKS (instant specification, table 7) as claimed.
Applicant argues that there is no motivation for a person of ordinary skill in the art to combine the skin-care cream of Delgado with the leave on oral gel of Prencipe (Remarks, page 9). 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 with 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 those known in the art.
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 1-2, 4-12, 14-15, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 11-12 and 15-16 of copending Application No. 17/892,353 (reference application). The reference was 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 a retinol, a peptide comprising Pal-KTTKS, and a mucoadhesive polymer (copending application, claim 1), 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, preferably wherein the oral care composition has a Mucoadhesion index of no less than 0.3 fluorescent intensity percentage (copending application, claim 11). The copending application further teaches the oral care composition is free of abrasive (copending application, claim 4).
Regarding claim 2, the copending application teaches 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, or combinations thereof (copending application, claim 2).
Regarding claim 4, the copending application teaches 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 3).
Regarding claim 5, the copending application teaches 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 teaches 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 teaches all the elements of the current invention as applied to claim 6. The copending application teaches a retinyl ester from the same claimed list (copending application, claim 7).
Regarding claims 8-9, the copending application teaches all the elements of the current invention as applied to claim 1. As discussed below, the claims do not further limit the invention of claim 1.
Regarding claim 10, the copending application teaches all the elements of the current invention as applied to claim 8. The copending application teaches a peptide comprising Pal-KTTKS (i.e., amino acids comprising lysine, threonine, and serine; copending application, claim 1).
Regarding claim 11, the copending application teaches all the elements of the current invention as applied to claim 1. The copending application teaches the composition comprises fluoride (copending application, claim 12).
Regarding claim 12, the copending application teaches all the elements of the current invention as applied to claim 1. The copending application teaches the gum health compound comprises retinol (copending application, claim 1).
Regarding claim 14, the copending application teaches 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 15).
Regarding claim 15, the copending application teaches all the elements of the current invention as applied to claim 14. The copending application teaches the delivery carrier from the same claimed list (copending application, claim 16).
Regarding claim 19, the copending application teaches a leave-on oral care composition comprising a gum health compound comprising a retinol, Pal-KTTKS, and a mucoadhesive polymer (copending application, claim 1), 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, preferably wherein the oral care composition has a Mucoadhesion index of no less than 0.3 fluorescent intensity percentage (copending application, claim 11). The copending application teaches the gum health compound comprises an allantoin (copending application, claim 2).
Claim Objections
Claim 1 objected to because of the following informalities. Appropriate correction is required.
Regarding claim 1, “(Pal-KTTKS);and (b)” should read (Pal-KTTKS); and (c)”.
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 1-2, 4-12, and 14-15 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 claims 1 and 16, the parenthetical recitation of “(Pal-KTTKS)” renders the claims 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, 4-12, and 14-15, each claim is dependent on the rejected claim 1 and does not cure its deficiencies, and therefore is deficient for the same reasons as above.
Regarding claims 8-9, each claim recites the limitation “further comprising” at the end of the claim, and it is unclear what was intended to be included in each claim.
Claim 10 is dependent on the rejected claim 8 and does not cure its deficiencies, and therefore is deficient for the same reason as above.
Regarding claim 10, the claim recites the limitation "the amino acid". There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8-9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claims 8-9, each claim fails to further limit the subject matter of claim 1, because each claim appears to be incomplete.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-2, 4, 6-10, 12, and 19 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 retinyl palmitate (i.e., a retinyl ester as defined by the instant claim 7; 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 teaches the composition can comprise vitamins, humectants, or mixtures thereof (Delgado, claim 28), and teaches humectants include xanthan gum (Delgado, claim 33), which is a preferred mucoadhesive polymer as defined by the instant specification (page 20, line 15).
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. Delgado also does not specifically mention the composition is free of abrasives. However, 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.
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. As above, 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 4, 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 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 6. Delgado teaches the composition can comprise retinyl palmitate (i.e., a retinyl ester from the claimed list; Delgado, page 18, line 13).
Regarding claims 8-9, Delgado teaches all the elements of the current invention as applied to claim 1. As discussed above, the claims do not further limit the invention of claim 1.
Regarding claim 10, Delgado teaches all the elements of the current invention as applied to claim 8. As above, Delgado teaches the composition can comprise Matrixyl® (INCI: palmitoyl peptapeptide-3 (i.e., a preferred commercially available pentapeptide with the sequence Pal-KTTKS as defined by the instant specification, page 18, lines 22-24, which contains lysine, threonine, and serine from the claimed list; Delgado, page 17, line 32).
Regarding claim 12, Delgado teaches all the elements of the current invention as applied to claim 1. Delgado teaches the composition can comprise retinol (Delgado, page 18, line 13).
Regarding claim 19, 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 which can be a leave-on formulation (Delgado, page 13, line 25). Delgado teaches the composition can comprise retinol (Delgado, page 18, line 13). Delgado teaches the composition can comprise vitamins, humectants, or mixtures thereof (Delgado, claim 28), and teaches humectants include xanthan gum (Delgado, claim 33), which is a preferred mucoadhesive polymer as defined by the instant specification (page 20, line 15). Delgado teaches the composition can comprise Matrixyl® (INCI: palmitoyl peptapeptide-3 (i.e., 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 retinol (Delgado, page 18, line 13), and agents such as allantoin (i.e., a gum health agent from the claimed list; Delgado, page 20, line 6).
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.
Claims 5, 11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Delgado (WO 2013139965 A2) as applied to claims 1-2, 4, 6-10, 12, and 19, 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 2. Delgado teaches the composition (Delgado, abstract) 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) 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 11, 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 14, 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 15, Delgado and Prencipe together teach all the elements of the current invention as applied to claim 14. 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.
New Claim Rejections - 35 USC § 103
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Delgado (WO 2013139965 A2) as applied to claims 1-2, 4, 6-10, 12, and 19, further in view of Prencipe (US 20170100312 A1; IDS reference, 03/23/2023). The references were cited previously by the Examiner.
Regarding claim 16, 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 which can be a leave-on formulation (Delgado, page 13, line 25). Delgado teaches the composition can comprise retinyl palmitate (i.e., a retinyl ester as defined by the instant claim 7; 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 teaches the composition can comprise vitamins, humectants, or mixtures thereof (Delgado, claim 28), and teaches humectants include xanthan gum (Delgado, claim 33), which is a preferred mucoadhesive polymer as defined by the instant specification (page 20, line 15).
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. Delgado also does not specifically mention the composition is free of abrasives. However, 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. Delgado teaches a dermopharmaceutical composition (Delgado, abstract), but does not specifically teach an oral care composition from the claimed list. Prencipe teaches an oral care composition which is a dentifrice composition (Delgado, page 1, paragraph 0002).
As above, 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 be a dentifrice composition as taught by Prencipe, because both references teach a composition for oral care, and Prencipe teaches that dentifrice compositions provide enhanced prevention or reduction of tooth sensitivity (Principe, page 1, paragraph 0008).
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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