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 .
Status of claims
Claims 1-20 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 5/2/25. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating gingivitis in a subject, does not reasonably provide enablement for preventing gingivitis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
The instant specification fails to provide guidance that would allow the skilled artisan to practice the instant invention without resorting to undue experimentation, as discussed in the subsections set forth infra.
The nature of the invention. The invention discloses preventing gigivitis
The Claims require a method of preventing gingivitis. However, the phrase "preventing a disorder", given its broadest reasonable interpretation in light of the teachings in the specification, requires that absolutely no cell, nor tissue, or individual would present any symptom of a disorder after treatment with the claimed composition. The specification presents the results of experiments demonstrating that treatment and not prevention.
The Predictability or Lack Thereof in the Art. Prevention is not practical with oral diseases due to the unpredictability of the condition. According to the American Dental Association (http://www.ada.org/public/topics/bad_breath.asp), oral diseases can be caused by health problems (such as diabetes) or lack of getting the oral cavity professionally cleaned. Periodontal disease begins with plaque that is not removed during daily cleaning. When plaque is not removed it turns into calculus. It is impossible to remove all calculus with daily brushing (http://www.perio.org/consumer/faq_general.htm, pages 1-4). The calculus, if untreated, causes gingivitis, the first stage of periodontal disease. Therefore, it is likely a small amount of gingivitis is present in between dental visits. In the case of the instant invention, gingivitis can be caused by different factors, such as bacterial buildup, gum inflammation , smoking , diabetes etc. therefore it is nearly impossible to protect against them all by using the instant claimed. In order to prevent a disease: one would need to precisely identify those subjects likely to acquire such a disease, administer Applicant's claimed invention, and demonstrate that the patient did not develop the disease as a result of the administration of the claimed invention. The examples present in the specification are a representation of the effect of composition comprising in preventing gingivitis. There is a lack of examples showing the effect of the composition on the development of gingivitis disease over a long period of time or how long the effects of the compositions last before gingivitis is forms.
Suggested language. Since the term “treatment” is a broad term, it will inherently cover therapies in which some protective function may also be present. Accordingly, the examiner recommends simply reciting method for “treatment” of periodontal diseases.
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.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diaz De Rienzo Mayri et al (WO 2015/091294) in view of Gandhi et al (US 2007/0207930) and Wenk et al. (WO2018/145966) and further in view of Waldmann-Laue et al. (WO 2020229006)
Diaz De Rienzo Mayri et al teach an oral care composition such as toothpaste and mouthwash (see pg 5, lines 13+) comprising a mixture of rhamnolipid from 1 wt % to 95 wt% (see pg 4, lines 22+), wherein the composition comprise both mono and di rhamnolipid C10-C10, (see pg 2 lines 1-5; pg 3, line 5+), wherein mono-rhamnolipid is about is at least 50%, although the reference did not teach that the mono is from 5-38, it specifically teach that The ratio of mono- rhamnolipid and di-rhamnolipid may be controlled by the production method (see pg 2, lines 6+). Therefore, it is within the purview of the skilled artisan to determine the production method since the reference makes it obvious to do so (as required by instant claim 1). With regards to instant claim 2, the composition comprises C10-, C8-C10; C10-C12 (see pg 2, lines 15+, as required by instant claims 3-6). Again, the amounts per-se are not taught nonetheless the amounts are based on the production method and the species used for producing.
Gandhi et al teach an oral (see 0047) composition comprising rhamnolipid (see tittle, abstract) in the amount of rhamnolipid is from 0.01-0.20 (see examples 3-7h), wherein the rhamnolipid is selected from a mono-rhamnolipid, a di-rhamnolipid and combinations thereof (see claim 6) and at least one orally acceptable carrier (i.e, colorant see col. 11, lines, as required by instant claim 7) and water (see claim 7, as required by instant 8).
Wenk et al. teach an oral care composition such as such as toothpastes, mouth rinses, gels, (see abstract) comprising a mixture of di and mono rhamnolipid wherein the weight ratio of di-rhamnolipids to mono-rhamnolipids in the mixture is greater than 51 :49, preferably greater than 75:25 (see pg 4, lines 23-26), specifically, the diRL-C10C10 and monoRL-C10C10 contents mentioned above, comprises 0.1 % by weight to 5% by weight, preferably 0.5% by weight to 3% by weight and further teaches he diRL-C10C10 and monoRL-C10C10 contents mentioned above, comprises 0.5% by weight to 15% by weight, preferably 3% by weight to 12% by weight, particularly preferably 5% by weight to 10% by weight, of diRL-C10C12: 1 (as required by instant claim2-3 (see pg 4, lines 35+), wherein the additives present in the oral care can be flavorants pigments, colorants, antibacterial agents, anticaries agents, (see pg 6, lines 28+, as required by instant claim 7), wherein the flavorant is peppermint oil, spearmint oil (see pg 9, lines 30+, as required by instant claim 19).
Waldmann-Laue teaches mono and di rhamnolipid in the treatment of gum disease. Although it is silent of the recitation of gingivitis. The generic is taught and one of ordinary skill in the art would have been motivated to use the teaching to treat gingivitis as gingivitis is a gum disease as such treatment of a gum disease in generality involves treating gingivitis.
With regards to instant claims 9-17 while both references does not explicitly teach these limitation , the claimed limitation appears to be a result or property of the of the oral care composition. As such, the claimed limitations appears to be met by the prior art. Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed method. In the absence of evidence to the contrary, the burden is on the applicant to prove that the function of the product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/ Primary Examiner, Art Unit 1615 9/29/26
