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 . 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.
Information Disclosure Statement
The information disclosure statement filed 5 Jan, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because a reference was illegible. The copy of the reference by Qin et al in the application file was of such poor resolution to be illegible. Note that, when references are uploaded to the Patent Office’s server, they are converted to a different file format, often with loss of resolution. While the copy of the reference that applicants uploaded my have been legible, the copy in the application file is not.
Priority
Applicants have claimed priority to JP2021-112587, but there is no copy of this document in the application file. Note that, without this priority, the thesis of Prof. Masakatsu Wantanabe (March, 2021), inventor, is prior art.
Election/Restrictions
Applicant’s election of group I (formulations) and SEQ ID 28 with mineral trioxide aggregate in the reply filed on 8 Sept, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is deemed proper and is therefore made FINAL.
Applicants have claimed a formulation of SEQ ID 28 with mineral trioxide aggregate. A search was conducted for this invention, and references rendering it obvious were found. As a result, claims 1-3 and 6-8 were examined and claims 9 and 10 were withdrawn from consideration.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, note 1st paragraph of p12 of the specification as filed. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
In addition, the title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The current title is generic; there is no idea of the intended application or sequences/formulations used.
Claims Status
Claims 1-3 and 6-10 are pending.
Claims 3 and 6-8 have been amended.
Claims 9 and 10 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9 Sept, 2026.
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 1-3 and 6 are rejected under 35 U.S.C. 101 because they read on a judicial exception (natural phenomenon).
The Supreme Court has given a 2 part test for eligibility under this statute.
1) Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the first test is passed, does a judicial exception apply?
2b) If a judicial exception applies, is there anything beyond the judicial exception?
Applying the test:
Applicants are claiming compositions, a composition of matter, passing the first test.
2a) According to the UniProt entry for human S100-A8, this naturally occurring polypeptide comprises SEQ ID 28. In Ass’n for Molecular Pathology v Myriad Genetics, the Supreme Court stated that a section of DNA excised from the chromosome was still a natural product. By the same logic, fragments of a polypeptide are still natural products. Claims 3 and 6 require a supporting material or a pharmaceutically acceptable carrier (for some claims); this can be met by collagen, which is naturally occurring. Thus, all the examined claims read on either a natural product or a combination of natural products.
2b) There is no evidence of record that truncating the full length S100-A8 sequence or mixing with a carrier or supporting material materially affects the properties of the formulation. Without such a showing, the claims lack eligibility.
Claim Rejections - 35 USC § 112(b)
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.
Claims 3 and 6 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.
Claims 3 and 6 require an unspecified “supporting material.” This term is not defined by applicants, and it is unclear what limitations it imposes, making the claims indefinite.
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.
first rejection
Claim(s) 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dominique et al (FR 2924614, cited by applicants). Note that the document provided by applicants has an attached machine translation, and references to locations in the document will be to the machine translation, unless otherwise noted.
Dominique et al discuss fragments of Calgranulin A (abstract), aka S100A8 (p38, 4th paragraph). Among the sequences discussed is SEQ ID 7 (p41, 2nd paragraph), which, from the sequence listing, is a 12 amino acid sequence comprising SEQ ID 28 of the examined claims. This anticipates claim 1. Pharmaceutically acceptable mediums are mentioned for use with the peptides (p46, 4th paragraph), anticipating claim 3.
second rejection
Claim(s) 1-3 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wantanabe et al (Experimental data (June 2020), cited by applicants).
Wantanabe et al describe a peptide No. 1 (2nd page), which is identical to SEQ ID 28 of the examined claims, anticipating claims 1 and 2. The material was placed on a gelatin sponge and placed on the pulp of a molar to evaluate dentin growth (5th page), anticipating claims 3 and 6-8.
third rejection
Claim(s) 1-3 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wantanabe (Master’s thesis (2021), referred to as Wantanabe1 in this office action). Note that this document is in Japanese. A machine translation of the document is relied upon for this rejection, and references to locations in the document refer to the machine translation unless otherwise noted.
Please also note that this document is only prior art if the foreign priority is not considered. To perfect this priority, applicants need to submit a copy of the foreign priority document (or have it added to the application file some other way) and a certified translation (MPEP 213.04).
Wantanabe1 discusses using peptide No.1 (identical with SEQ ID 28 of the examined claims (p17, 2nd paragraph), with a gelatin sponge for a pulp caping experiment in rats (p22, 2nd paragraph). This sequence led to significantly more dentin formation than either controls or other sequences tested (p24, 3d paragraph). Note that this is the same sequence as used by applicants, anticipating claims 1 and 2, and a gelatin carrier, anticipating claims 3 and 6-8.
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.
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.
first rejection
Claim(s) 1, 3, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Cervino et al (Eur. J. Dent. (2020) 14 p683-691) in view of Dominique et al (FR 2924614, cited by applicants) and Lorencetti-Silva et al (Brazil. Dental J. (2019) 30(3) p201-207).
Cervino et al discuss mineral trioxide aggregate applications (title), which include pulp capping (abstract). It forms an antimicrobial surface and favors the migration and differentiation of hard tissue forming cells forming hydroxyapatite on the material and providing a biological seal (p684, 1st column, 3d paragraph).
The difference between this reference and the examined claims is that this reference does not discuss a peptide of SEQ ID 28.
Dominique et al discuss fragments of Calgranulin A (abstract), aka S100A8 (p38, 4th paragraph). Among the sequences discussed is SEQ ID 7 (p41, 2nd paragraph), which, from the sequence listing, is a 12 amino acid sequence comprising SEQ ID 28 of the examined claims. Pharmaceutically acceptable mediums are mentioned for use with the peptides (p46, 4th paragraph). Among the properties of the peptide is the transport of arachidonic acid (p43, 5th paragraph). This reference discusses a sequence comprising SEQ ID 28 for transport of arachidonic acid.
Lorencetti-Silva et al discuss mineralization of dental pulp (title). Arachidonic acid is upstream of prostaglandin E2, which enhances dentin formation in vivo (p201, 1st column, 2nd paragraph). This reference suggests that arachidonic acid will improve dentin formation.
Therefore, it would be obvious to add the peptide of Dominique et al to the mineral trioxide aggregate of Cervino et al, as Lorencetti-Silva et al show that a downstream product in the pathway will promote the formation of dentin. As Lorencetti-Silva et al show mineralization, an artisan in this field would attempt this addition with a reasonable expectation of success.
Dominique et al discuss sequences comprising SEQ ID 28 and formulations, rendering obvious claims 1 and 3.
Lorencetti-Silva et al render obvious adding the sequences of Dominique et al to the MTA of Cervino et al, rendering obvious claim 7.
second rejection
Claim(s) 1-3, and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wantanabe et al (Experimental data (June 2020), cited by applicants) in view of Cervino et al (Eur. J. Dent. (2020) 14 p683-691)
Wantanabe et al describe a peptide No. 1 (2nd page), which is identical to SEQ ID 28 of the examined claims, anticipating claims 1 and 2. The material was placed on a gelatin sponge and placed on the pulp of a molar to evaluate dentin growth (5th page).
Please note that this anticipates claims 1-3 and 6-8.
The difference between this reference and applicant’s elected species is that this reference does not discuss mineral trioxide aggregate.
Cervino et al discuss mineral trioxide aggregate (MTA) applications (title), which include pulp capping (abstract). It forms an antimicrobial surface and favors the migration and differentiation of hard tissue forming cells forming hydroxyapatite on the material and providing a biological seal (p684, 1st column, 3d paragraph).
Therefore, it would be obvious to replace the gelatin of Wantanabe et al with the MTA of Cervino et al, to improve the formation of hydroxyapatite and to provide a biological seal. As both the peptide of Wantanabe et al and the MTA of Cervino et al are used for similar purposes, an artisan in this field would attempt this modification with a reasonable expectation of success.
third rejection
Claim(s) 1-3, and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wantanabe (Master’s thesis (2021), referred to as Wantanabe1 in this office action) in view of Cervino et al (Eur. J. Dent. (2020) 14 p683-691) Note that Wantanabe1 is in Japanese. A machine translation of the document is relied upon for this rejection, and references to locations in the document refer to the machine translation unless otherwise noted.
Wantanabe1 discusses using peptide No.1 (identical with SEQ ID 28 of the examined claims (p17, 2nd paragraph), with a gelatin sponge for a pulp caping experiment in rats (p22, 2nd paragraph). This sequence led to significantly more dentin formation than either controls or other sequences tested (p24, 3d paragraph). MTA is mentioned as a compound used for the same purpose (p31, 1st paragraph).
As noted above, this reference anticipates claims 1-3 and 6-8.
The difference between this reference and applicants elected species is that it does not discuss using MTA as a supporting material.
Cervino et al discuss mineral trioxide aggregate (MTA) applications (title), which include pulp capping (abstract). It forms an antimicrobial surface and favors the migration and differentiation of hard tissue forming cells forming hydroxyapatite on the material and providing a biological seal (p684, 1st column, 3d paragraph).
Therefore, it would be obvious to replace the gelatin of Wantanabe et al with the MTA of Cervino et al, to improve the formation of hydroxyapatite and to provide a biological seal. As both the peptide of Wantanabe et al and the MTA of Cervino et al are used for similar purposes, an artisan in this field would attempt this modification with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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