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 .
Priority
The instant application is a CON of 17/497,301 filed 10/08/2021.
Information Disclosure Statement
The information disclosure statement filed 10/31/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. The foreign patent literature document No 1. Does not include a copy.
Claim Objections
Claim 3 is objected to because of the following informalities: “Seaweed” should not be capitalized. Appropriate correction is required. The term seaweed is capitalized.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lindsay (US Patent Application Publication 20210236403A1) in view of Arnold (US Patent Application Publication 20150004560A1).
Lindsay teaches a spray applicator (Lindsay at figures) and the use an applicator comprising foam, cotton, a textile, etc., direct use of fingers, use of a wipe or tissue (Lindsay at [0086]). Lindsay teaches the use of hydroxyapatite (Lindsay at [0047]). Lindsay teaches the use of xylitol (Lindsay at [0250-0255]). Lindsay teaches the use of xylitol in a range of about 1.5% (Lindsay at [0250]). Lindsay teaches the use of coconut oil (Lindsay at [0051-0052]). Lindsay teaches the pH of the biofilm attack solution when diluted according to instructions may be from 2 to 10 (Lindsay at [0089]). Lindsay teaches the use of glycerin in a range of 0.3% to 25% (Lindsay at [0048]). Lindsay teaches the use of less than 10% of lipids like coconut oil ([0051-0052]).
The teachings of Lindsay differ from the instant claims insofar as they do not specifically teach the particle size of the hydroxyapatite. The teachings of Arnold cure this deficit.
Arnold teaches the use of nano medical hydroxyapatite by Sangi Company Ltd. which has a particle size range of between 10-100 nm and is used in an amount of 0.001% to 20% by weight of the composition (Arnold at [0073]). Arnold further discloses that the pH of the composition is used to keep the saliva at a basic pH meaning that the composition is alkaline. Arnold further discloses that the pH of the composition is used to keep the saliva at a basic pH meaning that the composition is alkaline (Arnold at [0072]). Arnold does not require the use of glycerin or fluoride.
The teachings of Arnold differ from the instant claims insofar as they do not specifically teach the use of coconut oil. The teachings of Lindsay cure this deficit.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Lindsay disclose wherein the oral care composition comprises hydroxyapatite, but does not disclose a particle size. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the hydroxyapatite particles of Lindsay to have a size of 10-100 nm since that size is a known and effective size for hydroxyapatite used in oral care compositions as taught by Arnold. There is a reasonable expectation of success because both Arnold and Lindsay teach sprayable dental compositions comprising xylitol and hydroxyapatite.
It would have been prima facie obvious to have combined the hydroxyapatite of Arnold with the hydroxyapatite of Lindsay for the predictable result of an oral care composition comprising xylitol and hydroxyapatite. See MPEP 2144.06(I).
Regarding instant claim 1, Lindsay teaches a spray applicator (Lindsay at figures) and the use an applicator comprising foam, cotton, a textile, etc., direct use of fingers, use of a wipe or tissue (Lindsay at [0086]). Lindsay teaches the use of hydroxyapatite (Lindsay at [0047]). Lindsay teaches the use of xylitol (Lindsay at [0250-0255]). Lindsay teaches the use of coconut oil (Lindsay at [0051-0052]). Arnold teaches the use of nano medical hydroxyapatite by Sangi Company Ltd. which has a particle size range of between 10-100 nm, which overlaps the instantly claimed range of about 10nm to 50nm, and is used in an amount of 0.001% to 20% by weight of the composition (Arnold at [0073]), which overlaps the instantly claimed ranges of about 0.1wt% to about 50wt%. 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). Arnold further discloses that the pH of the composition is used to keep the saliva at a basic pH meaning that the composition is alkaline (Arnold at [0072]). Arnold does not require the use of glycerin or fluoride. Arnold teaches the use of a spray applicator (Arnold at figures).
Regarding instant claim 2, Lindsay teaches a spray applicator (Lindsay at figures) and the use an applicator comprising foam, cotton, a textile, etc., direct use of fingers, use of a wipe or tissue (Lindsay at [0086]).
Regarding instant claim 3, Lindsay teaches a spray applicator (Lindsay at figures) and the use an applicator comprising foam, cotton, a textile, etc., direct use of fingers, use of a wipe or tissue (Lindsay at [0086]).
Regarding instant claim 4, Arnold teaches the use of sodium bicarbonate (Arnold at [0064]).
Regarding instant claim 5, Arnold teaches the use of xylitol (Arnold at [0064]).
Regarding instant claim 6, Arnold teaches the use of xylitol (Arnold at [0064]).
Regarding instant claim 7, Lindsay teaches the use of coconut oil (Lindsay at [0051-0052]).
Regarding instant claim 8, Arnold does not require the use of surfactant.
Regarding instant claim 9, Arnold teaches the use of flavorings (Arnold [0043]).
Regarding instant claim 10-11, Lindsay teaches a spray applicator (Lindsay at figures) and the use an applicator comprising foam, cotton, a textile, etc., direct use of fingers, use of a wipe or tissue (Lindsay at [0086]). Lindsay teaches the use of hydroxyapatite (Lindsay at [0047]). Lindsay teaches the use of xylitol (Lindsay at [0250-0255]). Lindsay teaches the use of coconut oil (Lindsay at [0051-0052]). Lindsay teaches the use of glycerin in a range of 0.3% to 25% (Lindsay at [0048]), which overlaps with the instantly claimed range of 1-3wt%. Lindsay teaches the use of less than 10% of lipids like coconut oil ([0051-0052]), which overlaps the instantly claimed range of less than 0.1%. Arnold teaches the use of nano medical hydroxyapatite by Sangi Company Ltd. which has a particle size range of between 10-100 nm, which overlaps the instantly claimed range of about 10nm to 50nm, and is used in an amount of 0.001% to 20% by weight of the composition (Arnold at [0073]), which overlaps the instantly claimed ranges of less than 10wt%. 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). Arnold further discloses that the pH of the composition is used to keep the saliva at a basic pH meaning that the composition is alkaline (Arnold at [0072]). Arnold does not require the use of glycerin or fluoride.
Regarding instant claim 12, Lindsay teaches a spray applicator (Lindsay at figures) and the use an applicator comprising foam, cotton, a textile, etc., direct use of fingers, use of a wipe or tissue (Lindsay at [0086]).
Regarding instant claim 13, Lindsay teaches the use of xylitol in a range of about 1.5% (Lindsay at [0250]).
Regarding instant claim 14, Arnold teaches the use of xylitol (Arnold at [0064]).
Regarding instant claim 15, Lindsay teaches the use of coconut oil (Lindsay at [0051-0052]).
Regarding instant claim 16, Arnold teaches a pH of above 8, which overlaps the instantly claimed range of about 10 (Arnold at [0071]). 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).
Regarding instant claim 17, Arnold teaches flavoring used in an amount of 0.5% (Arnold at [0089]).
Regarding instant claim 18, Arnold does not require the use of preservatives.
Regarding instant claim 19, Arnold teaches that the composition is stable for over one year (Arnold at [0089]), which overlaps the instantly claimed range of at least 3 years. 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).
Regarding instant claim 20, Lindsay teaches a spray applicator (Lindsay at figures) and the use an applicator comprising foam, cotton, a textile, etc., direct use of fingers, use of a wipe or tissue (Lindsay at [0086]). Lindsay teaches the use of hydroxyapatite (Lindsay at [0047]). Lindsay teaches the use of xylitol (Lindsay at [0250-0255]). Lindsay teaches the use of coconut oil (Lindsay at [0051-0052]). Lindsay teaches the use of glycerin in a range of 0.3% to 25% (Lindsay at [0048]), which overlaps the instantly claimed range of 1-3wt%. Lindsay teaches the use of less than 10% of lipids like coconut oil ([0051-0052]), which overlaps the instantly claimed range of less than 0.1%.Arnold teaches the use of nano medical hydroxyapatite by Sangi Company Ltd. which has a particle size range of between 10-100 nm, which overlaps the instantly claimed range of about 10nm to 50nm, and is used in an amount of 0.001% to 20% by weight of the composition (Arnold at [0073]), which overlaps the instantly claimed ranges of less than 10wt%. 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). Arnold further discloses that the pH of the composition is used to keep the saliva at a basic pH meaning that the composition is alkaline (Arnold at [0072]). Arnold does not require the use of glycerin or fluoride.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,857,654 B2 in view of Lindsay (US Patent Application Publication 20210236403A1) in view of Arnold (US Patent Application Publication 20150004560A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application requires an article which is not required by the reference patent.
The reference patent recites dental product comprising a composition, wherein 1 oz. of the composition comprises: about 9 tsp of a sweetener selected from xylitol, erythritol and/or Stevia, about 2 tsp of sodium bicarbonate, about 1.05 tsp of a nanohydroxyapatite (NHAP) suspension stock having the NHAP in a range of 16.66% w/v and having a particle size in a range of about 10 nm to 50 nm, and peppermint oil and coconut oil, wherein the composition does not contain glycerin, surfactant, preservative and fluoride, wherein the composition is alkaline (654 at claim 1). The reference patent recites wherein the composition further comprises a flavoring agent (654 at claim 2). The reference patent recites wherein the composition further comprises a peroxide compound (654 at claim 3). The reference patent recites wherein the peroxide compound comprises hydrogen peroxide and organic peroxide (654 at claim 4). The reference patent recites wherein the dental product comprises a toothpaste having a shelf life of about 3 years (654 at claim 5). The reference patent recites wherein 1 oz. of the composition contains less than 12 ppm of lead (654 at claim 6). The reference patent recites wherein the composition further comprises KCl (654 at claim 7). The reference patent recites dental product, wherein 1 oz. of the product consists of: about 9 tsp of a sweetener selected from xylitol, erythritol and/or Stevia; about 2 tsp of sodium bicarbonate; about 1.05 tsp of a nanohydroxyapatite (NHAP) suspension stock having the NHAP in a range of 16.66% w/v and having a particle size in a range of about 10 nm to 50 nm; peppermint oil; and coconut oil, wherein the composition is alkaline (654 at claim 8).
The teachings of the reference patent differ from the instant application insofar as it does not specifically teach the use of an applicator. The teachings of Lindsay and Arnold cure this deficit.
The teachings of Lindsay and Arnold are discussed above.
It would have been prima facie obvious to have used the composition of the reference patent with the applicator of Lindsay and Arnold for its intended purpose of delivering an oral care composition. See MPEP 2144.07. One would have a reasonable expectation of success because the dental compositions all contain hydroxyapatite, xylitol, and flavoring.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
Conclusion
No claims were presently allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/FREDERICK F KRASS/Supervisory Patent Examiner, Art Unit 1612