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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/10/25 has been entered.
Claims status
Claims 18 and 19 are new.
Claim 8 is cancelled.
Claims 1-7 and 9-19 are pending.
Claims 12-17 are withdrawn.
Claims 1-7, 9-11, 18 and 19 are under examination.
Withdrawn rejections
Applicant's arguments filed 12/10/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claims 1-11 and 18 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, 9, 11, 12, 15-19 and 21 of copending Application No. 15771246. Application 15771246 went abandoned on 10/23/25 after the Board of Appeals affirmed the Examiner on 8/7/25. Claims 1-11 and 18 were rejected under 35 U.S.C. 103 as being unpatentable over Kilpatrick-Liverman et al. (WO2017074964). This rejection is withdrawn in favor of the rejection below.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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.
Claims 1-7, 9-11, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kilpatrick-Liverman et al. (WO2017074964) and O’Connell et al. (US20100196287).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of an oral care research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from oral care formulations and components, oral pharmaceutical techniques, and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 7, 9, 10 and 18-19, Kilpatrick-Liverman et al. teach in claim 1:
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Kilpatrick-Liverman et al. claim promoting remineralization of dental enamel (Abstract; claims 12-13) because they found that partially hydrolyzed plant proteins are effective in promoting dental remineralization [0006]. Kilpatrick-Liverman et al. show in Table 1 that a composition with 0.2 wt% wheat hydrolysate [0071] had 6.5% remineralization [0078] (15%-8.5% control = 6.5%); 0.5% hydrolyzed wheat protein provides a mean remineralization of 14.58% (Page 22) and 2% hydrolyzed wheat protein provides 18.37% (Table 4; page 24), which the Examiner has portrayed as:
% wheat hydrolysate % remineralization
0.2 6.5
0.5 14.58
2 18.37.
Thus, the amount of hydrolyzed wheat protein is a result effective variable and increasing amounts of hydrolyzed wheat protein provide greater remineralization.
Regarding claim 2, Kilpatrick-Liverman et al. teach that the partially hydrolyzed proteins are from grains of the family Poaceae [0006, 0008, 0010 and 0012].
Regarding claim 3, Kilpatrick-Liverman et al. teach partially hydrolyzed wheat and rice protein (Claim 2).
Regarding claim 4, Kilpatrick-Liverman et al. teach partially hydrolyzed proteins from wheat, rice, almond, potato, soya, pea or combinations thereof [0006, 0010].
Regarding claim 5, Kilpatrick-Liverman et al. teach an effective amount of fluoride (Claim 3).
Regarding claim 6, Kilpatrick-Liverman et al. teach composition without any fluoride source (Table 5, [0056]).
Regarding claims 10-11, Kilpatrick-Liverman et al. teach wherein the composition is in a form selected from a mouth rinse, a toothpaste, a tooth gel, a tooth powder, a non-abrasive gel, a mousse, a foam, a mouth spray, chewing gum, and a tablet, for example dentifrice, e.g., a toothpaste or mouth rinse [0008, 0012, 0028].
Regarding claims 1, 7, 9, 18 and 19, O’Connell et al. teach washing and cleaning compositions (Claim 5) such as a mouth wash that includes additional active ingredients [0130-0134, 0147] such as an active for remineralization [0135] and protein hydrolyzates [0126] such as hydrolyzed wheat protein Gluadin® W40 (Page 11, [0167]). O’Connell et al. teach compositions with 2-28 wt% washing and cleaning active polymers (Claim 8). In the oral and dental care cleaning agent embodiment, in addition to the enzymes (0.1 to 5.0 wt% [0011]), there is 15-35 wt% water and 35-55 wt% of at least one polyhydric alcohol [0147]. The Examiner calculates the low end amount of 0.1 + 15 + 35 = 50.1 wt%, which leaves 49.9 wt% other ingredients, such as remineralization agents/protein hydrolyzates/active polymers to be added.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Kilpatrick-Liverman et al. is that Kilpatrick-Liverman et al. do not expressly teach wherein the partially hydrolyzed plant protein is present in the composition in an amount of from 3.05 weight% to 10.5 weight% or from 3.5-10.5 wt% or from 3.05-30.5 wt% or from 3.5-4.5 wt% or from 3.5-5.5 weight % by total weight of the composition. This deficiency in Kilpatrick-Liverman et al. is cured by the teachings of O’Connell et al.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make the oral care composition of Kilpatrick-Liverman et al. wherein the partially hydrolyzed plant protein is present in the composition in an amount of from 3.05 weight% to 10.5 weight% or from 3.5-10.5 wt% or from 3.05-30.5 wt% or from 3.5-4.5 wt% or from 3.5-5.5 wt% by total weight of the composition, as suggested by O’Connell et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because of the following rationale. The test for obviousness is "what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 4I3, 425 (CCPA I98I) (MPEP 2145(III)). In the present case, the combined references render obvious the claimed amounts of hydrolyzed plant protein with a reasonable expectation of success. (See MPEP 2143.02: The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).) Not only is the ordinary artisan aware that partially hydrolyzed plant protein is an active polymer in mouthwash compositions as taught by Kilpatrick-Liverman but also the ordinary artisan is cognizant that oral care compositions such as mouth washes can comprise from at least 2-28% active polymers from the teachings of O’Connell et al., thus overlapping the claimed ranges. See MPEP 2144.05(I): 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).
Furthermore, the upper value of 3 wt% taught by Kilpatrick-Liverman is nearly the same as the claimed 3.05 wt% and very close to 3.5 wt% such that the ordinary artisan would expect the same properties. See MPEP 2144.05(I): “Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).” Thus, the claimed ranges are obvious over the prior art range in the absence of any criticality. Secondly, there is: “The normal desire of scientists or artisans to improve upon what is already generally known” In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003). It is already known in the art to have 3 wt% of the partially hydrolyzed plant protein and adding more, as suggested by O’Connell et al., would appear to be obvious absent any criticality or unexpected results. The ordinary artisan is motivated to do so in order to enhance the effectiveness in repairing or mitigating the effects of dental erosion, promoting dental remineralization, and enhancing the anti-cavity effects of fluoride as suggested by Kilpatrick-Liverman et al. [0006-0007], by adding more of the partially hydrolyzed plant proteins with a reasonable expectation of success. Especially when it is known through the teachings of Kilpatrick-Liverman et al. that the amount of partially hydrolyzed plant protein is a result-effective variable and O’Connell et al. teach and suggest an overlapping range of active polymer in the composition.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
On pages 5-6 of remarks, Applicant asserts that: “There is no disclosure in Kilpatrick-Liverman that increasing the amount of hydrolyzed wheat protein would result in increasing remineralization beyond the 3 wt. % value recited in Kilpatrick-Liverman.” Respectfully, the Examiner does not agree because the Examiner has shown above that Kilpatrick-Liverman et al. have established a trend of increasing the amount of hydrolyzed wheat protein results in increasing remineralization. The ordinary artisan readily extrapolates this trend beyond the 3 wt% value recited by Kilpatrick-Liverman et al. On page 6, Applicant asserts that: “the Examiner provides no evidence for the assumption that there is a "point at which no further increase is observed."” As asserted in the Advisory Action filed 8/5/25, the burden to demonstrate unexpected results is Applicant’s; not the Examiner’s.
On pages 7-8 of remarks, Applicant provides a Table with relative remineralization values. However, a showing that increasing the wt% of the hydrolyzed protein above 5% results in lower relative remineralization is not an unexpected result at all. It is a simple concentration-response curve. Finding the range of maximum therapeutic benefit is called routine optimization and realized through a simple concentration-response curve. At best Applicant asserts that oral care formulations with concentrations above 3 wt% hydrolyzed plant proteins can be both safe and efficacious [0004]. However, it was already known that 3 wt% is efficacious through the teachings of Kilpatrick-Liverman et al. and the safety concerns appear unknown as admitted by Applicant [0004]. Consequently, Applicant has not added anything to advance the state of the art. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 298, 127 S.Ct. at 1732 (2007)("Granting patent protection to advances that would occur in the ordinary course without real innovation retards progress. . . .")”. Applicant’s findings cannot be considered a significant improvement over the prior art. Accordingly, Applicant has failed to produce any unexpected results.
On page 10 of remarks, Applicant argues with more force claims 9 and 19 directed to 3.5-4.5 wt% and 3.5 to 5.5 wt% partially hydrolyzed plant protein. However, no significant or substantial improvements over the prior art disclosures has been presented by Applicant. Applicant merely used routine research methods to determine that the therapeutic benefit tapers off with increasing concentration by simply performing a routine concentration-response curve. That is just the mechanical skill of the ordinary artisan exercising normal pharmaceutical competence; not inventive ingenuity. Applicant’s arguments are not persuasive.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613