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 .
DETAILED ACTION
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 23 Jun 2026 has been entered.
Claims 1 and 5-11 remain pending in the application.
Claims 1 and 5 are amended.
Claims 2-4 are cancelled.
Claim 6 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1, 5, and 7-11 are under examination.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections of claims pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 24 Mar 2026 are hereby partially withdrawn in light of applicant’s amendment and cancellation of the claims.
Rejections 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 5 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.
Claim 5 is indefinite in reciting the percentages without units (e.g., vol/vol, wgt/vol, wgt/wgt) and one skilled in the art, therefore, would not be reasonably apprised of the metes and bounds of the claims.
Response to Arguments
Applicant's arguments filed 23 Jun 2026 have been fully considered but they are not persuasive. Applicant states that the claim has been amended and the rejection is moot. The examiner notes that claim 5 has not been amended to include the necessary units.
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, 5, 7, 8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Maddahi et al. (US 2018/0344625, 06 Dec 2018).
Maddahi teaches oral care products containing naturally derived ingredients ([0003]). Maddahi teaches coconut oil is present in mouthwashes at a concentration preferably from about 0.15% to about 0.6% ([0103]) and that xylitol is present in mouthwashes at a concentration of from about 5% to about 30% ([0106]). These amounts for coconut oil and xylitol render obvious the claimed amounts for the components. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Maddahi does not expressly teach selecting 5-30% xylitol and 0.15-0.6% coconut oil in a mouthwash with sufficient specificity to rise to the level of anticipation.
However, 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 formed a mouthwash composition comprising 5-30% xylitol and 0.15-0.6% coconut oil. One of ordinary skill in the art would have been motivated to do so as oral care products containing naturally derived ingredients are taught by Maddahi and xylitol and coconut oil in the amounts above are specifically taught as suitable for mouthwashes. One of ordinary skill in the art would have a reasonable expectation of successfully forming a mouthwash with xylitol and coconut oil as taught by Maddahi since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Maddahi.
Response to Arguments
Applicant's arguments filed 23 Jun 2026 have been fully considered but they are not persuasive. Applicant states that Maddahi teaches away from the claimed 5-15% xylitol as Maddahi teaches various ranges of xylitol with preferable ranges above the claimed 5% of xylitol (page 4 of remarks). Applicant argues that Maddahi teaches compositions with sea salt, cayenne pepper oil, and grapeseed oil in addition to the xylitol and coconut oil whereas their invention uses only coconut oil and xylitol as the active ingredients (page 4 of remarks). Applicant argues that xylitol is an optional ingredient in Maddahi and argues that a motivation to select the particular combination of 0.2-3% coconut oil together with 5-15% xylitol in a mouthwash where these components serve as the active ingredients has not been provided (page 5 of remarks).
The examiner does not find this persuasive and notes that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Even though Maddahi may teach preferred ranges for components above the lower amounts of the claimed ranges, this does not teach away from the other teaching of Maddahi where the ranges encompass the claimed amounts. Merely reciting a preferred embodiment alternative to the instantly claimed compound does teach not away from using the other forms as additionally taught. Furthermore, "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). Regarding the argument that the inventive composition only requires xylitol and coconut oil as active ingredients, the examiner notes that the claims are open to additional components, including active components, due to the comprising language. Regarding the argument concerning motivation to select coconut oil together with xytlitol, the examiner notes that Maddahi teaches these components as suitable for the compositions in the amounts described above and it is obvious to include components taught by Maddahi as suitable for the compositions. The examiner notes that the rejection was made under 35 U.S.C. 103 which requires that “a patent for a claimed invention may not be obtained… if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been prima facie 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.” “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At, 82 USPQ2d at 1396. Thus, a specific embodiment of the claimed invention is not required to be taught by the art for the claims to be obvious, and the examiner maintains that the claims are obvious for the reasons provided above.
Applicant argues for unexpected results as a composition with 5% xylitol and 0.5% coconut oil decreased targeted bacteria below the threshold level and these values are at the low end of the range that Maddahi taught (page 5 of remarks). The examiner does not find this persuasive. The tested composition with 0.5% coconut oil and 5% xylitol is not commensurate in scope with the claimed 0.2-3% coconut oil and the 5-15% xylitol. Further, it is not clear from the information in the specification that the results are truly unexpected. Only a single composition was tested and there is nothing to indicate that the claimed amounts of xylitol and coconut oil are truly unexpected in the claimed ranged rather than just an optimization of mouthwash components. Overall, the claimed composition is obvious over the teachings of Maddahi and the results presented are insufficient to overcome the prima facie case of obviousness.
New Grounds of Rejections
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 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amendment filed 23 Jun 2026 has introduced new matter into the claims. Claim 10 recites that the “xylitol and the cocounut oil are the only active ingredients for antibacterial action.” The response did not point out where support for newly added limitation could be found in the originally filed disclosure. Support for the limitation that xylitol and coconut oil are the only active ingredients for antibacterial action was not found. Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”). Instant claim 10 now recites limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in claim 10, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in present claim 10 in the specification or claims, as-filed, or remove these limitations from the claims in response to this Office Action.
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Maddahi et al. (US 2018/0344625, 06 Dec 2018) as applied to claims 1, 5, 7, 8, and 11 above and further in view of Vilaboa (US 2008/0241080, published 02 Oct 2008).
The teachings of Maddahi are described supra. The examiner notes that Maddahi further teaches that the compositions treat xerostomia ([0113], [0014]).
Maddahi does not teach the inclusion of one of the components of claim 9 in the mouthwash compositions. This deficiency is made up for in the teachings of Vilaboa.
Vilaboa teaches a composition comprising olive oil, trimethyl glycine and xylitol for treating xerostomia (abstract) and teaches the composition as a mouthwash ([0077]) and teaches water is a solvent for liquid preparations ([0074]) and teaches including water, PEG-40 hydrogenated castor oil, aroma, and sodium benzoate in the mouthwash compositions ([0085]-[0086]).
Therefore, 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 included components of water, PEG-40 hydrogenated castor oil, aroma, and sodium benzoate in the mouthwash compositions of Maddahi. Mouthwash compositions for treating xerostomia and comprising xylitol are known from both Maddahi and Vilaboa. It is further known from Vilaboa that water, PEG-40 hydrogenated castor oil, aroma, and sodium benzoate are suitable components for such mouthwash compositions. Thus, it would have been obvious to one of ordinary skill in the art to include these components as they are known to be suitable for xerostomia mouthwash compositions and their inclusion merely represents the use of known prior art elements in a composition that they are known to be suitable for.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 7-11 is rejected under 35 U.S.C. 103 as being unpatentable over Vilaboa (US 20080241080, published 02 Oct 2008) in view of Maddahi et al. (US 2018/0344625, 06 Dec 2018).
Vilaboa teaches a composition comprising olive oil, trimethyl glycine and xylitol for treating xerostomia (abstract) and teaches the composition as a mouthwash ([0077]). Vilaboa teaches that the xylitol is from 5-30% by weight ([0053]), rendering obvious the claimed amount of xylitol. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Vilaboa teaches water is a solvent for liquid preparations ([0074]) and teaches including water, PEG-40 hydrogenated castor oil, aroma, and sodium benzoate in the mouthwash compositions ([0085]-[0086]).
Vilaboa does not teach the inclusion of coconut oil. This deficiency is made up for in the teachings of Maddahi.
Maddahi teaches oral care products containing naturally derived ingredients ([0003]). Maddahi teaches coconut oil is present in mouthwashes at a concentration preferably from about 0.15% to about 0.6% ([0103]) and the inclusion of xylitol from about 5% to about 30% ([0106]). Maddahi teaches that the compositions treat xerostomia ([0113], [0014]).
Therefore, 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 included 0.15-0.6% coconut oil in the mouthwash compositions of Vilaboa. Mouthwash compositions for treating xerostomia and comprising xylitol are known from both Maddahi and Vilaboa and 0.15-0.6 coconut oil is a suitable component for such mouthwash compositions. Thus, it would have been obvious to one of ordinary skill in the art to include coconut oil as it is a known component suitable for xerostomia mouthwash compositions and the inclusion of coconut oil merely represents the use of a known prior art element in a similar type of composition for a similar purpose, namely treating xerostomia. Regarding claim 10 and the limitation that xylitol and coconut oil are the “only active ingredients for antibacterial action” the examiner notes that the claims remain open to other components due to the “comprising” language and the other components in the composition of Vilaboa are not taught as “for antibacterial action.”
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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, David Blanchard can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.C.M./Examiner, Art Unit 1619 /ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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