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Claim 13 is withdrawn.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.
Response to Amendment
The amendment filed 01/14/2026 has been entered.
Claims 3 and 17-18 were canceled. Claim 19 was added. Claims 1-2, 4-11, and 16 were amended. No new material was added.
The previous objections and rejections under 35 U.S.C. 103 of claims 3 and 17 are moot because the claims are canceled.
Applicant’s amendments have overcome the previous objections to the claims and specification, the rejections under 35 U.S.C. 112(b) of claims 1, 5-6, 8-11, and 16, and the rejection of claim 16 on the ground of nonstatutory double patenting.
The rejection under 35 U.S.C. 112(b) of claim 12 has been modified to address the amendments and maintained.
The rejections of claims 1-2, 4-12, 14-15 on the ground of nonstatutory double patenting have been modified to address the amendments and maintained.
The rejections of claims 1-2, 4-12, and 14-16 under 35 U.S.C. 103 have been modified to address the amendments and maintained.
The new claim 19 is also rejected under 35 U.S.C. 103 and 35 U.S.C. 112(b), and on the ground of nonstatutory double patenting.
Response to Arguments
Applicant’s arguments, see Remarks (page 9), filed 01/14/2026, with respect to the rejection(s) of claim(s) 1-6, 8, 11, and 14-15 under 35 U.S.C. 103 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 Therefore, the rejection has been withdrawn.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 and Principe.
Applicant did not provide arguments for the double patenting rejections. However, the rejection over US 11,904,041 has been withdrawn due to the amendment of the claims.
Applicant's arguments (Remarks, page 9) filed 01/14/2026, with respect to the rejection of claim 12 under 35 U.S.C. 112(b) have been fully considered but they are not persuasive. In the amendment, Applicant changed the previous parentheses to brackets, and Applicant states that this fully addresses the rejection. This does not address the previous rejection, because both the parenthetical and bracketed recitations of “SEQ ID NO:3” are unclear due to the sequence that was submitted for SEQ ID NO:3 being inconsistent with the listed peptide. The current sequence shows a different 15 amino acid sequence that does not correspond to Pal-KTTKS. The Examiner suggests amending SEQ ID NO:3 to match the peptide sequence Pal-KTTKS in order to fully address the rejection of claim 12 and the rejection of the new claim 19.
Applicant's arguments (Remarks, page 9) filed 01/14/2026, with respect to Principe regarding claim 16 and Delgado regarding claim 1 have been fully considered but they are not persuasive. Applicant states that Principe does not teach all of the features of the amended claim 16. This argument is not persuasive, because Principe teaches the composition of claim 16 as stated in the rejection below. Applicant states that Delgado does not teach all of the features of the amended claim 1. This argument is not persuasive, because Delgado teaches the composition of claim 1 as stated in the rejection below.
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 1-13 and 15-18 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 retinoid selected from a group comprising a retinyl ester 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 claim 8, the copending application teaches all the elements of the current invention as applied to claim 1. The copending application teaches an amino acid (copending application, claim 13).
Regarding claim 9, the copending application teaches all the elements of the current invention as applied to claim 1. The copending application teaches an amino acid comprising Pal-KTTKS (i.e., a peptide; copending application, claim 13).
Regarding claim 10, the copending application teaches all the elements of the current invention as applied to claim 9. The copending application teaches an amino acid comprising Pal-KTTKS (i.e., comprising lysine, threonine, and serine; copending application, claim 13).
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 and the amino acid comprises Pal-KTTKS (copending application, claim 13).
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 retinoid selected from a group comprising a retinol 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 a metal ion source, vitamin, allantoin, or combinations thereof (copending application, claim 2), and an amino acid comprising Pal-KTTKS (i.e., comprising lysine, threonine, and serine; copending application, claim 13).
Claims 1-2, 4-5, and 7-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, 14, 16-17, and 19 of Biesbrock (U.S. Patent No. 12,582,593). Although the claims at issue are not identical, they are not patentably distinct from each other. The reference was cited previously by the Examiner as Application No. 17/890,498.
Regarding claim 1, Biesbrock teaches a leave-on oral care composition comprising a retinoid compound (Biesbrock, claim 1) which can be a retinyl ester (Biesbrock, claim 8) and teaches the composition comprises a mucoadhesive polymer (Biesbrock, claim 17), and 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 (reference, claim 16). Biesbrock does not teach an abrasive, and therefore reads on the composition as claimed.
Regarding claim 2, Biesbrock teaches all the elements of the current invention as applied to claim 1. Biesbrock teaches the composition further comprises a metal ion source (Biesbrock, claim 19).
Regarding claim 4, Biesbrock teaches all the elements of the current invention as applied to claim 1. Biesbrock does not teach any excluded compound from the claimed list, and therefore reads on the composition as claimed.
Regarding claim 5, Biesbrock teaches all the elements of the current invention as applied to claim 1. Biesbrock teaches the composition further comprises a metal ion source, and the metal ion source comprises tin, zinc, copper, or combinations thereof (Biesbrock, claim 19).
Regarding claim 7, Biesbrock teaches all the elements of the current invention as applied to claim 1. Biesbrock teaches the retinoid compound comprises a retinyl ester (Biesbrock, claim 8), comprising retinyl palmitate, retinyl acetate, retinyl propionate, or combinations thereof (Biesbrock, claim 9).
Regarding claim 8, Biesbrock teaches all the elements of the current invention as applied to claim 1. Biesbrock teaches a peptide (i.e., comprising amino acids; Biesbrock, claim 1).
Regarding claim 9, Biesbrock teaches all the elements of the current invention as applied to claim 1. Biesbrock teaches a peptide (Biesbrock, claim 1).
Regarding claim 10, Biesbrock teaches all the elements of the current invention as applied to claim 1. Biesbrock teaches a pentapeptide which has a sequence of lysine-threonine-threonine-lysine-serine (i.e., amino acids from the claimed list; Biesbrock, claim 14).
Regarding claim 11, Biesbrock teaches all the elements of the current invention as applied to claim 1. Biesbrock teaches the composition comprises a fluoride source (Biesbrock, claim 1).
Modified/Maintained 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.
Claim 12 is 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 12, the recitation of “SEQ ID NO:3” renders the claim indefinite because it is unclear whether the limitations in brackets are part of the claimed invention or describing an example or preference. See MPEP § 2173.05(d). It is the Examiner’s interpretation that SEQ ID NO:3 is meant to correspond to the peptide sequence “Pal-KTTKS”, but SEQ ID NO:3 appears to be incorrectly entered in the Sequence Listing, mailed 06/09/2025, as a different 15 amino acid sequence.
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.
Claim 19 is 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 19, the recitation of “SEQ ID NO:3” renders the claim indefinite because it is unclear whether the limitations in brackets are part of the claimed invention or describing an example or preference. See MPEP § 2173.05(d). It is the Examiner’s interpretation that SEQ ID NO:3 is meant to correspond to the peptide sequence “Pal-KTTKS”, but SEQ ID NO:3 appears to be incorrectly entered in the Sequence Listing, mailed 06/09/2025, as a 15 different amino acid sequence.
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Prencipe (US 20170100312 A1; IDS reference, 03/23/2023). The reference was cited previously by the Examiner.
Regarding claim 16, Prencipe teaches a dentifrice composition (i.e., an oral care composition from the claimed list) comprising a source of zinc oxide (Prencipe, page 8, table 1), defines zinc oxide is an antiplaque agent (i.e., a gum health compound; Prencipe, page 1, paragraph 0009). Prencipe further teaches the composition may include a polymeric adherent material for retention of the metal oxide particles during exposure to food and beverages (i.e., a mucoadhesive polymer; Prencipe, page 4, paragraph 0067) such as polyvinyl pyrrolidine (Prencipe, page 5, paragraph 0071), which is a preferred mucoadhesive polymer as defined by the instant specification (page 21, line 15). Prencipe 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.
Prencipe is considered to be analogous to the claimed invention, because both Prencipe 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 Prencipe under the meaning of 35 U.S.C. 103.
Claims 1-2, 4, 6-10, and 12 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) 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 and gum health compound as defined by the instant specification, page 10, line 3; 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 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 and other supports (i.e., an abrasive as defined by the instant specification, page 26, line 3). 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 1. 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 claim 8, Delgado teaches all the elements of the current invention as applied to claim 1. Delgado teaches the composition can comprise amino acids such as serine, proline, alanine, glutamate, or arginine (Delgado, page 16, lines 7-8).
Regarding claim 9, Delgado teaches all the elements of the current invention as applied to claim 1. Delgado teaches the composition can comprise palmitoyl peptapeptide-3 (i.e., a peptide; Delgado, page 17, line 32).
Regarding claim 10, Delgado teaches all the elements of the current invention as applied to claim 9. 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 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).
New Claim Rejections - 35 USC § 103
Claim 19 is 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) 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.
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.
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 1. 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHASITY P JANOSKO whose telephone number is (703)756-5307. The examiner can normally be reached 7:30-3:30 ET.
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, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613