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 .
Notice of Priority
This application claims priority for Japanese Application JP2022-055850 filed 30 March 2022.
DETAILED ACTION
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on 03 September 2024 and 29 July 2025 have been considered by the Examiner.
Claim Status
Claim(s) 1, 3-4, and 8-22 are examined on the merits herein.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
According to MPEP 2111.02(II):
The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)
In light of this passage, no patentable weight will be applied to the preambles of Claim(s) 9-13, reading “method for preventing onset of periodontal disease and/or suppressing progression of periodontal disease in a human” or “for preventing onset of oral mucositis and/or caries and/or suppressing progression of the same”; the stated purpose, alone, of preventing/suppressing periodontal diseases does not breathe life into the body of the claim or impose structural limitations onto the method, wherein the body of the claim only details the application of an ascorbyl/tocopherol phosphate diester salt composition to simply an oral cavity, not unambiguously the oral cavity of a subject in need thereof (i.e. animal subject).
Similarly, no patentable weight will be given to the preambles of Claim(s) 14-22, which either read “for enhancing an oral mucosal epithelial barrier function and/or inhibiting matrix metalloproteinase activity in an oral cavity in a human” or “for inhibiting matrix metalloproteinase activity in the oral cavity”; these are purposes, alone, and do not breathe life into the body of the claim, whose only structural limitation is adoption of the composition “to a subject”, which may not necessarily be the subject in need thereof, either (i.e. animal subject).
Therefore, Claim(s) 9-13 are interpreted inasmuch as they are simply methods of applying a composition containing dl-a-tocopherol phosphoric acid diester compounds to an oral cavity, and Claim(s) 14-22 are interpreted inasmuch as they are simply methods of adopting a composition containing dl-a-tocopherol phosphoric acid diester compounds to any subject.
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(s) 14-22 are 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.
MPEP 2173.05(a)(I) states:
The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). Applicants need not confine themselves to the terminology used in the prior art, but are required to make clear and precise the terms that are used to define the invention whereby the metes and bounds of the claimed invention can be ascertained. During patent examination, the pending claims must be given the broadest reasonable interpretation consistent with the specification. In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997); In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969). See also MPEP § 2111 - § 2111.01. When the specification states the meaning that a term in the claim is intended to have, the claim is examined using that meaning, in order to achieve a complete exploration of the applicant’s invention and its relation to the prior art. In re Zletz, 893 F.2d 319, 13 USPQ2d 1320 (Fed. Cir. 1989).
The mentioned claims cite reference to a method “wherein a composition comprising an L-ascorbic acid dl-a-tocopherol phosphoric acid diester alkali metal salt is adopted to a subject”. The metes and bounds of the term “adopted to” are not defined in the specification, and is a general term applied to an object as to be “associated” to another object. In context to the Instant claims, the nature of this adoption are unclear. The incongruency of possible method interpretations therefore yields the claim language as broad/unclear, and the phrase “is adopted to a subject” is given its broadest reasonable interpretation as applying in any fashion.
Therefore, Claim(s) 14-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
(g)(1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.
Claim(s) 1, 4, 9, 11, 13-15, and 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ogata et al (Published: 12 December 1995; US 5,474,991; henceforth Ogata).
Ogata teaches compositions comprising EPC-K, the potassium salt of the ascorbyl/tocopheryl phosphodiester, below:
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wherein R1 and R2 may be hydrogen or methyl [Col. 1; lines 50-60]. In doing so, Ogata meets several requirements the mentioned claims.
Claim 1 details an oral composition that comprises an L- ascorbic acid dl-a-tocopherol phosphoric acid diester alkali metal salt, with a proviso that excludes at least one member selected from the group consisting of polyoxyethylene alkyl phenyl ethers, polyoxyethylene alkyl ethers, and polyoxyethylene fatty acid esters. In regards to Claim 1, Ogata teaches an oral tablet composition that comprises the potassium salt of the mentioned compound, EPC-K [Col. 6; Example 1] and excludes the mentioned polyoxyethylene phenyl/alkyl ethers and fatty acid esters, as also required by Claim 4. Additionally, Ogata also teaches a liquid composition of EPC-K and distilled water, which was methodically applied orally to a clinical subject [Col. 3; lines 01-03], also required by Claim(s) 9, 11, 13-15, and 17.
Therefore, Claim(s) 1, 4, 9, 11, 13-15, and 17 are rejected under 35 USC § 102.
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 non-obviousness.
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.
Claim(s) 3, 8, 10, 12, 16, and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ogata (cited previously), as also applied to Claim(s) 1, 4, 9, 11, 13-15, and 17 above, in view of Kozuka et al (Published: June 2004; Kozuka M, et al. Dentin Is Dissolved by High Concentrations of L-Ascorbic Acid 2-[3,4-Dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-1-benzopyran-6-yl-hydrogen Phosphate Potassium Salt with or without Hydrogen Peroxide. Biol. Pharm. Bull. 27(6) 831—834 (2004); provided in IDS; henceforth Kozuka), Gendron et al (Published: May 1999; Gendron R, et al. Inhibition of the Activities of Matrix Metalloproteinases 2, 8, and 9 by Chlorhexidine. CLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY. May 1999. 6(3). pg 437–439; henceforth Gendron), and Boothe et al (Published: 25 January 1969; Boothe RL, et al.; A Reversible, Calcium-dependent, Copper-catalyzed Inactivation of Guinea Pig Liver Transglutaminase*. 24(2). Pg. 399-405. 25 January 1969; henceforth Boothe).
Ogata teaches as described above.
However, Ogata does not teach the use of EPC-K in compositions at ranges that overlap with 0.001 to 1 mass%, nor does Ogata teach EPC-K for inhibiting matrix metalloproteinase (MMP) activity.
Kozuka teaches the effects of EPC-K upon tooth whitening, and in doing so, meets several limitations of the Instant invention. Claim(s) 3, 8, 10, 12, 16, and 18 detail the use of EPC-K in oral compositions at mass range of 0.001-1 mass percent. In regards to the mentioned claims, Kozuka teaches compositions for use in a simulated oral cavity (i.e. dentin block) with an EPC-K concentration range of 0.025 – 25 mM, which converts in the therein aqueous media to 0.0017 – 1.7 mass percent [pg. 832; Figure 1] and overlaps with the Instant range. In regards to ranges, it is noted that “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Kozuka also teaches that EPC-K contributes to a four-fold decrease in the normal dentin calcium:phosphorus ratio upon exposure, due to its ability to chelate calcium [pg. 834; par. 2].
Kozuka does not teach EPC-K for inhibiting matrix metalloproteinase activity.
Gendron teaches the mechanism of a different calcium chelator chlorhexidine (CHX) for inhibiting MMP activity in the treatment of periodontal disease. Claim(s) 19-22 detail the use of the oral composition to act as an MMP inhibitor in the oral cavity. In regards to this mentioned limitation, Gendron teaches the mechanism of inhibiting MMP using CHX to be calcium-dependent and reversible recovery of MMP activity with excess calcium [pg. 438; Results and Discussion; par. 1].
A prima facie case of obviousness can be made for one of ordinary skill in the art to implement the oral formulations of an L-ascorbic acid dl-a-tocopherol phosphoric acid diester potassium salt (EPC-K) taught by Ogata at the mass percent ranges taught by Kozuka, to act as calcium-chelating MMP inhibitors in the oral cavity, taught by Gendron. Principally, the mass percent ranges of use reported by Kozuka (0.0017 – 1.7 mass perecent) overlap significantly with the Instant ranges (0.001 - 1 mass percent) across three orders of magnitude, even exceeding at the upper portion of the range. As far as minimizing the range from 0.0017 (Kozuka) to 0.0010 (Instant) mass percent, it is again noted that, “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would be motivated to implement the mass percent ranges taught by Kozuka, with slight optimization to meet the lower margin of the Instant range to ensure that the appropriate amount of EPC-K is provided to, potentially, an oral cavity to observe functionality, while minimizing potential side effects of EPC-K use in said environments. Second, provided that Kozuka also teaches EPC-K to be a chelator of calcium, one would be motivated to also recognize EPC-K as an inhibitor of MMP due to it’s activity of chelating calcium, as Gendron teaches two MMP inhibitors (i.e. EDTA, CHX) that function as such by chelating calcium themselves (in the case of CHX); in the case of EDTA, support is provided by Boothe teaching that EDTA is an effective-enough chelator of calcium to restore enzyme function that results from calcium inhibition [pg. 400; Results; par. 1]. Therefore, the artisan would be motivated to both use the ranges disclosed by Kozuka and also to recognize EPC-K as a calcium-chelating MMP inhibitor, to be met with an expectation of success by combining these teachings to reproduce the Instant invention prior to the effective filing date of the Instant disclosure.
Therefore, Claim(s) 3, 8, 10, 12, 16, and 18-22 are rejected under 35 USC § 103.
Conclusion
No claims are allowed in this action.
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/STANLEY BRAM/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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