DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ response to the Election of Species Requirement, filed 19 August 2026, in the matter of Application N° 18/865,801. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No additions, amendments, or cancellations have been made to the previously considered claims. No new matter has been added.
Applicants’ elections of the following species, with traverse, are acknowledged:
Photosensitizer: riboflavin 5’-phosphate sodium;
Viscosity Modifier: glycerol;
Biofilm inhibitor: xylitol; and
Penetration enhancer: ethanol.
Claims 1, 2, 5, 7, 10, 11, 15, 16, and 18 encompass the elected invention.
Applicants traverse the election of species requirement on the grounds that the instant Examples demonstrate that “balanced interaction of the various ingredients in differing concentrations produces surprising results” and that the aforementioned Examples combine each of the species in each of the foregoing categories to achieve inhibition of biofilms.
The Examiner, in response, maintains the election and submits that the amended scope of the claims is not commensurate with Applicants’ remarks. Therein, the scope of the Preliminary Amendment allows for a composition with each of the respective components singularly defined with no showing of criticality to support their position.
Applicants’ election is made FINAL. The claims representing the non-elected species: 3, 4, 6, 8, 9, 12-14, 17, 19, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim. Applicants timely traversed the restriction requirement between the compositions.
Thus, claims 1, 2, 5, 7, 10, 11, 15, 16, and 18 are presented and represent all claims currently under consideration.
Information Disclosure Statement
Two Information Disclosure Statements (IDS) filed 14 November 2024, and 4 December 2024 are acknowledged and have been considered.
Specification
Applicants are reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it appears to randomly refer to Fig. 3. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP §608.01(b).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Applicants are 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, 5, 7, 10, 11, 15, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (WO 2011/079075 A1; IDS/ISR reference of record).
The limitations of the claimed invention are directed to a solution comprising:
0.2-0.6 wt% of riboflavin 5’-phosphate sodium;
1.0-5.0 wt% of glycerol;
7.0-25.0 wt% of xylitol; and
water
Patel discloses a liquid solution that is suitable for irrigating and rinsing (e.g., a mouthrinse) that reduces the production of biofilm, comprising a photosensitizing dye, such as riboflavin 5’monophosphate sodium salt, in an amount ranging from about 0.001% to about 1.0 wt% (see e.g., Abstract; claims 1, 2, 10, 11, and 13).
The foregoing is considered to additionally read on an encompass the photosensitizer amounts recited by claim 2 (0.25-0.45 wt%) and claim 15 (0.3 wt%).
Paragraph [0086] discloses that the composition may further comprise at least one humectant and that any orally acceptable humectant may be used including, without limitation, polyhydric alcohols such as glycerin and xylitol. It is additionally disclosed that most humectants may also function as sweeteners. The one or more humectants are disclosed as being present in an amount ranging from 1% to 70%, for example from 2% to 25% by weight of the composition.
Such is considered to teach the combined presence of glycerol and xylitol in claim 1 (i.e., 7-30 wt%), claim 5 (i.e., 9-28 wt%), claim 7 (i.e., 16-30 wt%), claim 16 (i.e., 9.5-27.5 wt%), and claim 18 (i.e., 16-20 wt%).
Paragraph [0078] further defines the diluent as preferably comprising water thereby teaching the instantly claimed water base limitation. The passage additionally teaches that the diluent may be accompanied by an alcohol such as ethanol. The weight ratio of water to alcohol in a mouthwash formulation is further defined as ranging from 1:1 to 20:1.
MPEP §2144.05(I) states that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In the instant case, the Examiner has provided disclosures in the reference demonstrating that each component of the instant invention is taught and that each range falls squarely within the recited range or ranges.
With respect to the amount of ethanol disclosed by the reference, the Examiner submits that it would have been well within the purview of the ordinarily skilled artisan to produce the claimed composition with a water/ethanol diluent (water/penetration enhancer) component that reads on the combination as instantly claimed. The Examiner submits that given the breadth of the “water-base” set forth in the claims and the amount of ethanol recited (e.g., 12-17 wt%), the artisan in possession of Patel would have been adept at including ethanol in an amount that satisfies the practiced ratio of Patel and reads on the instantly claimed amount of ethanol, again, since no specific limitation for the amount of water is set forth in the claims.
Based on the combined teachings of the reference, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
Prosecution Insights