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 .
Status of the Application
Claims 1-2, 13-21, 24-25, and 29-37 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 04/27/2026 are acknowledged. Claims 19, 24-25 and 29-30 remain withdrawn in addition to claims 36-37, as being drawn to an unelected invention or specie. Claims under consideration in the instant office action are claims 1-2, 13-18, 20-21, and 31-35.
Applicants' arguments, filed 04/27/2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Election/Restrictions
Newly submitted claims 36-37 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claims 36-37 recite methods of treating a disease or inhibiting microbial activity comprising application of a composition comprising a linear alkanediol, which lack unity of invention with the claimed compositions and are thus distinct inventions.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 36-37 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 14-17, 21, 31-32, and 35 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Trunet (EP 2,842,607, as disclosed in IDS).
Trunet teaches a mixture comprising resorcinol derivatives, bisabolol, and alkandiols
(see abstract). Trunet teaches 1,2-pentandiol, 1,2-nonandiol, and 1,2-decandiol as preferred alkandiols (paragraph 0013). Trunet teaches such compositions further comprising agents against ageing of the skin, anti-acne agents, and surfactants (paragraph 0020). Trunet teaches such compositions in the form of a liquid solution (paragraph 0068). Trunet teaches additional antimicrobial agents such as thyme oil (paragraph 0055).
Therefore, the reference is deemed to anticipate the instant claims above.
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 13, 18, 20, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Trunet (EP 2,842,607, as disclosed in IDS) as applied to claims 1-2, 14-17, 21, 31-32, and 35 above.
The teachings of Trunet are presented above. Trunet further teaches bisabolol present in an amount of about 1 to about 20% and alkandiols present in an amount of 0 to about 60% (claim 5).
Trunet does not teach wherein the mixture comprising at least one first linear alkanediol and one or more second linear alkanediols comprises the first linear alkanediol and the second alkanediol in a ratio in a range of 50 : 50 to 99.9 : 0.1; wherein the at least one linear alkanediol or the mixture comprising at least one first linear alkanediol and one or more second linear alkanediols in an amount of 0.001 to 15.0%; wherein the at least one antimicrobial component in an amount of 0.001 to 15.0%.
Even though the range for concentrations as taught by Trunet is not the same as the claimed concentrations, Trunet does teach an overlapping range of concentrations, and it has been held 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05(I). Furthermore, the determination of concentrations is well within the purview of those skilled in the art through routine experimentation, and it has been held that “it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05(II). It would have been obvious to one of ordinary skill in the art to optimize the concentrations in order to increase the synergy of the components.
The amounts of active agents to be used, the pharmaceutical forms, e.g., tablets, etc; mode of administration, flavors, surfactant are all deemed obvious since they are all within the knowledge of the skilled pharmacologist and represent conventional formulations and modes of administration.
Furthermore, no unobviousness is seen in the ratio claimed because once the usefulness of a compound is known to treat a condition, it is within the skill of the artisan to determine the optimum ratio.
Response to Arguments
Applicant argues that “Trunet does not teach or suggest a combination of a mixture of a 1,2-alkanediol plus a 2,3-alkanediol and an antimicrobial substance, or a mixture of a 1,2-alkanediol plus a different 1,2-alkanediol and an antimicrobial substance, or a combination of a 2,3-alkanediol and an
antimicrobial substance, as recited in claim 2 and presently pending.” The Examiner respectfully disagrees since Trunet teaches a mixture comprising resorcinol derivatives, bisabolol, and alkandiols
(see abstract). Trunet teaches 1,2-pentandiol, 1,2-nonandiol, and 1,2-decandiol as preferred alkandiols (paragraph 0013). Trunet teaches such compositions in the form of a solution (paragraph 0068). Trunet teaches additional antimicrobial agents such as thyme oil (paragraph 0055). Trunet thus reads on the recited components, including the combinations recited in claim 2, and anticipates the claimed composition.
Applicant also argues that “The synergistic activity is an unexpected and superior property of the claimed invention relative to the prior art that allows for better antimicrobial effect at the same concentration of the antimicrobial component, or allows for comparable antimicrobial effect at a lower concentration. Moreover, the claimed invention demonstrates additional superior properties such as substantially decreased unappealing smell of the products incorporating the compositions of the invention. These unexpected and superior properties could not have been predicted from Trunet.” The Examiner respectfully disagrees since although Applicant has demonstrated unexpected synergy in antimicrobial activity against Staphylococcus aureus (Table 3), such results are not commensurate in scope with the claims. The claimed invention does not recite the specific combinations of Components A and B, or the concentrations of such components that were tested in Table 3.
Conclusion
Claims 1-2, 13-18, 20-21, and 29-35 are rejected.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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