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 .
Response to Arguments
Applicant’s amendments, see pg 6, filed 8/11/2026, with respect to abstract have been fully considered. The objection of 05/12/2026 has been withdrawn.
Applicant’s amendments, see pg 6, filed 8/11/2026, with respect to claim 1 have been fully considered. The objection of 05/12/2026 has been withdrawn.
Applicant’s amendments, see pg 6, filed 8/11/2026, with respect to claim 1 have been fully considered. The 112(b) rejection of 05/12/2026 has been found not persuasive and modified with regards to the amendment.
Applicant’s amendments, see pg 6, filed 8/11/2026, with respect to claim 3, 5, 6, 8, 9, and 11 have been fully considered. The 112(b) rejection of 05/12/2026 has been withdrawn.
Applicant’s amendments, see pg 7-9, filed 8/11/2026, with respect to claim 1 have been fully considered but they are moot because the amendment to claim 1 prompt a new ground of rejection. The 101 rejections of 05/12/2026 has been modified with regards to the amendment. ADD THE REASONING
Applicant’s arguments with respect to claims 1, 2, 4, 5, 8, 9, 11, and 12 have been considered but are moot because the amendment to the claim 1 prompts a new ground of rejection. The rejection below has been modified to reflect that amendment to the claims; however, still in part relies on the previously applied prior art to Belikov.
Applicant’s arguments with respect to claims 3, 6, 7, 10, and 13 have been considered but are moot because the amendment to the claim 1 prompts a new ground of rejection. The rejection below has been modified to reflect that amendment to the claims; however, still in part relies on the previously applied prior art to Belikov.
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 1-15 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 1 recites the limitation "the sample surface" in step (b) and step (c). That limitation is not defined in the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the uncoated portion" in step (c). That limitation is not defined in the claim. There is insufficient antecedent basis for this limitation in the claim. The applicant can amend the limitation to say “an uncoated portion” for clarity.
Claim 1 recites the limitation "the uncoated sample surface" in step (c), (d), and (e). That limitation is not defined in the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 2-15 are dependent on Claim 1, and thus also rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea with significantly more.
1. Step 1: Claim 1 recites at least one step or act. Thus, the claim is a method, which is one the statutory categories of invention. Claims 2-15 are dependent on Claim 1. (Step 1: Yes).
2. Step 2A Prong One: Claim 1 recites a judicial exception and identify the abstract idea/law of nature/natural phenomenon. Claim 1 recites analyzing and comparing the differences positive control, negative control, and test sample. This would be considered an evaluation one can do with the mind and therefore an abstract idea. (Step 2A -Prong 1: Yes)
3. Step 2A Prong Two: The judicial exception is not integrated into a practical application because the claim does not impose any meaningful limits on practicing the abstract idea. It only generally describes comparing the differences positive control, negative control, and test sample. In claim 1, steps a-f are mere data gathering steps thus insignificant extra-solution activities (See MPEP 2106.05(g)). Futhermore, in claim 1 step (g) recites “(i) capturing surface morphology images of the negative control, the positive control, and the test surface, (ii) measuring a step height difference between the positive control and the test surface, and (iii) calculating a percent repair based on the difference between the positive control and the test surface” which are also mere data gathering steps. Therefore, there appears to be no integration much less a particular practical application. (Step 2A -Prong 2: No)
4. Step 2B: There appears to be no additional steps which are significantly more than the abstract idea. Claim 2-10 and 14-15 define parameter of the method to be performed which are well known in the art and taught by the reference below. Claim 11-13 adds further steps which do not appear to have ‘significantly’ more and all steps in the method in Claim 1 are well understood routine and conventional. Claim 11 reference the treatment step of the method, however, the claim does not add anything significantly more to the method of analysis and is taught by references below. In the method of analyzing the enamel repair claims 12 and 13, lists what that analysis could be done with, which includes visual observation. All the types of analysis mentioned in claims 12 and 13 are well known in the art and taught by references below. Claims 2-15 are ineligible because, the step of comparing the difference is claimed at a high level of generality, there is no meaningful limitation claimed, such as a particular or unconventional machine or transformation of a particular article. (Step 2B: No)
Thus, claim 1 is ineligible. Claims 2-15 are dependent on Claim 1, do not include anything more than the abstract idea or anything that is significantly more, thus also rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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. Applicant is 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, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Belikov et al. (US 20080280260 A1), and further in view of non-patent literature "Measuring enamel erosion: A comparative study of contact profilometry, non-contact profilometry and confocal laser scanning microscopy" by Paepegaey et al.
Regarding Claim 1, Belikov teaches a method for quantifying the repair of damaged tooth enamel resulting from the treatment of the damaged tooth enamel with a test composition, wherein the method comprises the steps of:
providing a sample of human or animal tooth or enamel having a flat or substantially flat upper surface of enamel (para 0016);
covering a portion of the sample surface with an impermeable, removable coating as a negative control (para 0202);
treating the uncoated portion of the sample surface with an agent to cause damage to the enamel of the uncoated sample surface (para 0170);
covering a portion of the uncoated sample surface with an impermeable removable coating as a positive control (para 0170);
treating the remaining portion of uncoated, damaged sample surface with the test composition as a test surface (para 0170);
removing the impermeable, removable coatings (para 0289); and
analyzing and comparing the differences between the negative control, the positive control, and the test surface (para 0304).
However, Belikov does not teach analyzing and comparing the differences comprises quantifying enamel repair by (i) capturing surface morphology images of the negative control, the positive control, and the test surface, (ii) measuring a step height difference between the positive control and the test surface, and (iii) calculating a percent repair based on the difference between the positive control and the test surface.
Paepegaey teaches three instruments from their ability to quantify enamel loss after acid erosion (pg 1265, Abstract). Paepegaey further teaches capturing detailed 3D image of the surface (pg 1266, Section: Introduction), and measuring the step height difference (pg 1267, Section 2.2. Measurement of enamel loss). Although Paepegaey does not explicitly teach calculating a percent repair based on the step height difference, it teaches the obtaining the step height difference. The step height difference can be used to calculate the percent repair as a matter of design choice for the benefit of normalizing the data for analysis. Thus it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teaching of Belikov with teach analyzing and comparing the differences comprises quantifying enamel repair by (i) capturing surface morphology images of the negative control, the positive control, and the test surface, (ii) measuring a step height difference between the positive control and the test surface, and (iii) calculating a percent repair based on the difference between the positive control and the test surface as taught by Paepegaey for the benefit of accuracy due non-contact analysis (pg 1266, Section 1: Introduction).
Regarding Claim 2, Belikov in view Paepegaey teaches the invention of claim 1. Belikov teaches the sample of human or animal tooth or enamel is human tooth or enamel (para 0289).
Regarding Claim 3, Belikov in view Paepegaey teaches the invention of claim 2.
Belikov does not teach the sample is a bovine enamel block.
Paepegaey teaches bovine enamel samples being used to measure acid erosion (pg 1266, Section 2.1.1 Summary outline). Thus, it would be obvious to one of ordinary skill in the art to modify Belikov with the sample being bovine enamel blocks as taught by Paepegaey because it is readily available and cost effective.
Regarding Claim 4, Belikov in view Paepegaey teaches the invention of claim 1. Belikov teaches the impermeable coating is acid-resistant (para 0061 and 0202).
Regarding Claim 5, Belikov in view Paepegaey teaches the invention of claim 1. Belikov teaches the impermeable coating is a polymeric coating (para 0202).
Regarding claim 6, Belikov in view Paepegaey teaches the invention of claim 1.
Belikov does not teach the agent used to cause damage to the enamel surface is an acid.
Paepegaey teaches the agent used to cause damage to the enamel surface is an acid (pg 1265, Section Abstract). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Belikov with the agent used to cause damage to the enamel surface is an acid as taught by Paepegaey for the benefit of effective enamel erosion (para 1265, Section Abstract).
Regarding Claim 7, Belikov in view Paepegaey teaches the invention of claim 6.
Belikov does not teach the agent used to cause damage to the enamel surface is 1 wt.% aqueous citric acid solution.
However, Paepegaey teaches that the agent used to cause damage to the enamel surface aqueous citric acid solution (pg 1266, Section 2.1.1 summary outline). Although, 1 wt.% aqueous citric acid solution is not specified, the concentration taught in the prior art can be adjusted to be 1 wt.% as a matter of design choice. Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Belikov with the agent used to damage the enamel being 1 wt.% aqueous citric acid solution as taught by Paepegaey for the benefit of using an acid with higher acidity for erosion (pg 1266, Section Abtract).
Regarding Claim 8, Belikov in view Paepegaey teaches the invention of claim 1. Belikov teaches the test composition is a dentifrice (para 0136).
Regarding Claim 9, Belikov in view Paepegaey teaches the invention of claim 8. Belikov teaches the test composition being a toothpaste (para 0136).
Regarding Claim 10, Belikov in view Paepegaey teaches the invention of claim 1. Belikov teaches the test composition being an aqueous solution (Abstract).
Regarding Claim 11, Belikov in view Paepegaey teaches the invention of claim 1. Belikov teaches treating the sample of human or animal tooth or enamel, after application of the test composition, with a remineralization solution (para 0138).
Regarding Claim 12, Belikov in view Paepegaey teaches the invention of claim 1. Belikov teaches the analysis of step (g) comprises of scanning electron microscopy (SEM) (para 0297).
Regarding Claim 13, Belikov in view Paepegaey teaches the invention of claim 1.
Belikov does not teach the analysis of step (g) comprises 3D-image enhancement.
Paepegaey teaches using detailed 3D image of the surface of the enamel for analysis because images can be calibrated to the micrometer level (pg 1266, Section 1: Introduction). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Belikov with the analysis of step (g) comprising 3D-image enhancement as taught by Paepegaey for the benefit of images being calibrated to the micrometer level (pg 1266, Section 1: Introduction).
Regarding Claim 14, Belikov in view Paepegaey teaches the invention of claim 6.
Belikov does not teach the acid is selected from the group consisting of acetic acid, citric acid, hydrochloric acid, sulfuric acid, and lactic acid.
However, Paepegaey teaches the acid used to damage the tooth enamel to be citric acid (pg 1266, Section 2.1.1 Summary outline) for the benefit of higher acidity for effective erosion (pg 1265, Abstract). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Belikov with the acid is selected from the group consisting of acetic acid, citric acid, hydrochloric acid, sulfuric acid, and lactic acid as taught by Paepegaey for the benefit of higher acidity for effective erosion (pg 1265, Abstract).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Belikov et al. (US 20080280260 A1) in view of non-patent literature "Measuring enamel erosion: A comparative study of contact profilometry, non-contact profilometry and confocal laser scanning microscopy" by Paepegaey et al as applied to claim 1, and further in view of Xie (CN 104305203 A). The examiner has obtained a machine translation of the CN document above from Espacenet. The rejection below is based off the machine translation.
Regarding Claim 15, Belikov in view Paepegaey teaches the invention of claim 1. Belikov teaches the test composition comprising malic acid (para 0116).
Belikov in view Paepegaey does not teach the test composition comprises a solution of epsilon-polylysine and malic acid.
However, Xie teaches a method of preparation for the prevention of dental caries (pg 2, para 0003). Xie further teaches an agent for the prevention of dental caries that comprises epsilon- polylysine and could include malic acid (pg 3, para 0012-0013) for the benefit of effectively preventing tooth decay and it being harmless to the human body (pg 4, para 0015). Thus, it would be obvious to one of ordinary skill in the art before the effect filing date to modify the teachings of Belikov in view of Paepegaey with the test composition comprises a solution of epsilon-polylysine and malic acid as taught by Xie for the benefit of effectively preventing tooth decay and it being harmless to the human body (pg 4, para 0015).
Conclusion
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 HENA BERA whose telephone number is (571)272-9964. The examiner can normally be reached Mon-Fri 8:00-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.R.B./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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