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 .
Claims
Claim Rejections - 35 USC § 102 - Anticipation
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 7-10 and 26-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farmer et al. (US 2020/0345610).
Farmer et al. disclose oral health compositions comprising biosurfactants. the biosurfactants comprise glycolipids such as, for example, rhamnolipids (RLP), sophorolipids (SLP), trehalose lipids or mannosylerythritol lipids (MEL). The SLP is in a lactonic or acidic form. In some embodiments, use of acidic form SLP enhances the foaming and cleansing capabilities of the composition when used as, for example, a toothpaste. Preferably, the composition comprises sophorolipids (SLP) and/or their derivatives. For example, a natural mixture of any of the following forms can be used: unacetylated lactonic, unacetylated acidic, monoacetylated lactonic, monoacetylated acidic, diacetylated lactonic, diacetylated acidic; as well as derivatives. The surfactants can be present in a toothpaste composition in an amount from about 0.05% to about 5.0% (paragraph 0152) (instant claims 7 and 26-27). Other components in a toothpaste includes fluoride sources, flavoring, humectants and binding agents (paragraphs 0147 to 0156) (meeting instant claim 8). The composition may also comprise surfactin. One embodiment comprises one or more glycolipids with one or more lipopeptides, for example, SLP derivatives with surfactin and/or surfactin derivatives. The composition can be formulated into a suspension, an emulsion, a hydrogel, a paste, a multiphase solution, a vesicular dispersion, a liquid, a gel, or a powder, for use in, a toothpaste, a mouthwash, a mouth and/or throat spray, a lozenge, a breath mint, a pen or tube with a brush, sponge, or nozzle applicator, a dissolvable strip, an adhesive tape for the teeth, a toothpick, a chewing gum, a tongue scraper, a lip balm, a syringe, a nasal aspirator, a dental floss and/or any other oral care product known in the art (meeting instant claims 9-10).
Farmer et al. disclose that the preferred biosurfactants composition may comprise sophorolipids that may be used in mixtures of lactonic and acidic derivatives. The composition is incorporated into an oral care composition which comprises a carrier. Therefore, Farmer et al. anticipate the instant claims.
In regards to claims 26-27, the surfactants may be used in mixtures and comprise 0.05 to 5%. Therefore, lactonic SLP and acidic SLP would be present at greater than 0.0% and 5% because 5% is the upper limit for total surfactant and both surfactants are required in a mixture.
Claim Rejections - 35 USC § 103 - Obviousness
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 1-2, 6-10 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Farmer et al. (US 2020/0345610).
Farmer et al. disclose oral health compositions comprising biosurfactants. the biosurfactants comprise glycolipids such as, for example, rhamnolipids (RLP), sophorolipids (SLP), trehalose lipids or mannosylerythritol lipids (MEL). The SLP is in a lactonic or acidic form. In some embodiments, use of acidic form SLP enhances the foaming and cleansing capabilities of the composition when used as, for example, a toothpaste. Preferably, the composition comprises sophorolipids (SLP) and/or their derivatives. For example, a natural mixture of any of the following forms can be used: unacetylated lactonic, unacetylated acidic, monoacetylated lactonic, monoacetylated acidic, diacetylated lactonic, diacetylated acidic; as well as derivatives. The surfactants can be present in a toothpaste composition in an amount from about 0.05% to about 5.0% (paragraph 0152). Other components in a toothpaste includes fluoride sources, flavoring, humectants and binding agents (paragraphs 0147 to 0156) (meeting instant claim 8). The composition may also comprise surfactin (meeting instant claims 2 and 6). One embodiment comprises one or more glycolipids with one or more lipopeptides, for example, SLP derivatives with surfactin and/or surfactin derivatives. The composition can be formulated into a suspension, an emulsion, a hydrogel, a paste, a multiphase solution, a vesicular dispersion, a liquid, a gel, or a powder, for use in, a toothpaste, a mouthwash, a mouth and/or throat spray, a lozenge, a breath mint, a pen or tube with a brush, sponge, or nozzle applicator, a dissolvable strip, an adhesive tape for the teeth, a toothpick, a chewing gum, a tongue scraper, a lip balm, a syringe, a nasal aspirator, a dental floss and/or any other oral care product known in the art (meeting instant claims 9-10).
Farmer et al. disclose that the preferred biosurfactants comprise sophorolipids that may be used in mixtures of lactonic and acidic derivatives. This combination may be incorporated into toothpaste compositions in an amount ranging from 0.05% to 5%. The sophorolipids may also be combined with surfactin. Therefore, it would have been obvious to one of ordinary skill prior to filing the instant application to have added mixtures of acidic and lactonic SLP into an oral care composition which comprise a carrier because this is suggested by Farmer et al.
In regards to each amount of lactonic SLP and acidic SLP, acidic SLP enhances the foaming function making it is a result effective variable. Therefore, it would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amount of acidic SLP to obtained the desired foaming. Further, the surfactants may be used in mixtures and comprise 0.05 to 5%. Therefore, lactonic SLP and acidic SLP would be present at greater than 0.0% and 5% because 5% is the upper limit for total surfactant and both surfactants are required in a mixture.
Obvious-Type 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.
1) Claim 1-2, 6-10 and 26-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/643489 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as both sets of claims recite a composition for oral health comprising acidic sophorolipids. The instant claims differ from the copending claims insofar as they recite a mixture of acidic sophorolipids and lactonic sophorolipids. However, the copending application do not exclude lactonic sophorolipids. Therefore the instant claims are obvious over the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2) Claim 1-2, 6-10 and 26-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-11 of copending Application No. 18/252,394 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as both sets of claims recite a composition for oral health comprising acidic sophorolipids. The instant claims differ from the copending claims insofar as they recite a mixture of acidic sophorolipids and lactonic sophorolipids, whereas the copending claims recite a modified sophorolipids compound. However, the copending application includes compounds encompassing both lactonic and acidic sophorolipids. Therefore the instant claims are obvious over the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 6-10 and 26-27 are rejected.
Claims 11-25 are withdrawn.
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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, Sahana Kaup can be reached at 571-272-6897. 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.
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612