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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 23, 2026 has been entered.
Status of Application
Receipt of Applicant’s remarks and amended claims filed on March 23, 2026 is acknowledged.
Claims 1 and 4-28 are pending in this application.
Claims 2-3 have been cancelled.
Claims 1 and 7-9 have been amended.
Claims 25-28 are new.
All pending claims are under examination in this application.
Withdrawn Rejections
Claim Rejections - 35 USC § 102
The rejection of claims 1 and 3-22 under 35 U.S.C. 102(a)(1) as being anticipated by Cloonan (US 2012/0328537) has been withdrawn in view of the amendments to claim 1 to recite acemannan.
Claim Rejections - 35 USC § 103
The rejection of claims 1 and 3-24 under 35 U.S.C. 103 as being unpatentable over Cloonan (US 2012/0328537) has been withdrawn in view of the amendments to claim 1 to recite acemannan.
New Objection/Rejections
Claim Objections
Claims 26 and 28 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art is that of Cloonan, which is described above. The recitation of unexpected results however is commensurate in scope to the above recited claims.
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, 4-6, 10-25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Cloonan (US 2012/0328537) in view of Maurer (AU 2006208104).
Cloonan discloses a topical wound therapeutic treatment in gel form. The gel is discloses for intra-oral and extra-oral use (abstract).
Table 1 discloses a topical wound treatment gel comprising:
1 liter water;
1.3 gram xylitol (a polyol);
30 grams carboxymethylcellulose
100 mg menthol (an essential oil)
1.5 gram sodium bicarbonate (a bicarbonate).
The gel comprises a pH-adjusting compound necessary to set a pH of approximately 7.0 (paragraph 0020).
The final volume of the disclosed formulation is 1L (1000g) of water.
Regarding claim 4, as noted above, the bicarbonate is sodium bicarbonate.
Regarding claims 5-6, the sodium bicarbonate can be present in the amount of 1 gram to 5 grams per liter of water (paragraph 0020), which is 0.1-0.5%.
Regarding claim 10, as noted above, Table 1 discloses xylitol.
Regarding claim 11, xylitol can be present in the amount of 1-3 g per liter of water (paragraph 0018), which is 0.1-0.3%.
Regarding claim 12, sorbitol (a polyol) can be added to the formulation in the amount of 2.5-7.5 mL per liter of water (paragraph 0019), which is 0.25-0.75%.
Regarding claim 13, peppermint oil (an essential oil) is additionally disclosed (paragraph 0072).
Regarding claim 14, peppermint oil is can be present in the amount of 0.4-3 mL per liter of water (paragraph 0019), which is 0.04-0.3%.
Regarding claims 15-16, Table 1 discloses a gel with approximately 96.6% water, however, the general teachings of Cloonan allow for varying ranges of the components as outlined in the rejection above, which would result in formulations comprising water in the ranges recited in instant claims.
Regarding claims 17-18, the claims recite properties of the gel, since Cloonan discloses the same gel as recited in the instant claims, Applicant’s attention is directed to MPEP 2112.01 which recites "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claims 20-22, the composition is discloses to provide an oral and extra-oral topical wound treatment (paragraph 0018).
Regarding claims 23-24, Cloonan does not disclose pH ranges above approximately 7.0. However, Applicant’s attention is directed to MPEP 2144.05 which discloses a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). It is further noted that instant claims recite the term “about” which is not defined within the instant specification, it is the position of the Examiner that “about 7.5” recited in the instant claims reads on “about 7.0” recited by Cloonan. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have optimized and adjusted the pH range of the hydrogel of Cloonan. Applicant is reminded that where the general conditions of the claims are met, burden is shifted to applicant to provide a patentable distinction. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454 105 USPQ 233,235 (CCPA 1955).
Regarding claims 25 and 27, as noted above, Cloonan discloses xylitol and sodium bicarbonate.
Cloonan does not disclose the use of acemannan.
Maurer discloses a method of treating and preventing periodontal disease by administration of acemannan (abstract).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have included acemannan into the formulation of Cloonan because Maurere discloses acemannan is a complex carbohydrate extract from aloe vera plants, and is considered a primary active component of aloe vera’s healing properties by increasing the amount of tumor necrosis factor, gamma interferon and interleukin 1, all of which assist in the body’s ability to defend and substantially eliminate viruses, bacteria, and tumor cells. As a cell nutrient, acemannan has curative properties (paragraph 0016).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Cloonan (US 2012/0328537) in view of Maurer (AU 2006208104) as applied to claim1, 4-5, 10-25, and 27 above, and further in view of Giniger et al. (US 2007/0122362).
The teachings of Cloonan and Maurer are discussed above.
The combination does not disclose the use of pectin or guar gum.
Giniger discloses hydrogel sheets to be used in the oral cavity (abstract). The hydrogel comprises base ingredients including guar gum, pectin, and carboxymethyl cellulose (paragraph 0055), for example, and mixtures thereof.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have utilized any art recognized base materials in the preparation of the hydrogels of the instant claims.
Applicant is reminded that where the general conditions of the claims are met, burden is shifted to applicant to provide a patentable distinction. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454 105 USPQ 233,235 (CCPA 1955).
Response to Arguments
Applicant has argued the working examples 2-5 and 7-8 demonstrate the claimed hydrogel unexpectedly exhibits:
substantially greater physical stability as demonstrated by its ability to resist changes or decline/reduction in viscosity, and to resist phase separation, over time,
substantially greater chemical stability as demonstrated by resistance to changes in pH over time, and
substantially improved resistance to microbial contamination, relative to comparable hydrogels such as Orasoothe® See, e.g., paragraphs [0037]-[0039], Examples 3-4 (paragraphs [0079]-[0083]), Examples 7-9 (paragraphs [0088]-[0093]), and Figs. 7-9 of the specification.
However, the cited unexpected results are not commensurate in scope with the rejected claims. The examples disclose specific percentages of the specific components at pH of 7.5-8.5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/
Primary Examiner, Art Unit 1615
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