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 .
DETAILED ACTION
Claim status
Claims 1-33 are pending
Claims 7-33 are withdrawn
Claims 1-6 are under examination
It is noted that the examiner of record has changed
Election/Restrictions
Applicant’s election of the following invention without traverse in the reply filed on 11/18/2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Group I, claims 1-6, drawn to a tissue-derived matrix.
Claims 7-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/01/2023, 3/08/2023, 4/03/2023, 10/04/2023, 5/07/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 5-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claims recite a modified boned tissue matrix which is not markedly different from its naturally occurring counterpart. This judicial exception is not integrated into a practical application because the natural product is not linked to a particular technology. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are well-understood, routine and conventional in cell biology.
Briefly summarized here, the guidance for subject matter eligibility cites a two part test: is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
In regard to Step 1, Claims 1-3, and 5-6 are drawn to a composition of matter-a bone tissue matrix.
In regard to Step 2A prong one, Claims 1-3, and 5-6 are drawn to a nature-based product which is not markedly different from its naturally occurring counterpart. Specifically, independent claim 1, as well as dependent claims 2-3 and 5-6 are directed to a bone tissue-derived matrix produced by a process of co-precipitating endogenous minerals. These claims all encompass any naturally growing bone tissue that forms by the co-precipitation of minerals such as hydroxyapatite. This option of the claims is a naturally occurring product. Because instant claims are directed to a nature-based product, i.e., a developing bone matrix, the nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. Applicant is directed to the publication of Mahamid et al., (J Struct Bio, 2011, 527-535), which demonstrates that well before the time of invention it was known that natural bone matrix is formed by the process of calcium phosphate co-precipitation into crystalline carbonated hydroxyapatite thereon (Abstract, Figs. 3-5). Thus, instant claims encompass a bone matrix with co-precipitated minerals that is identical (no difference in structural or functional characteristics) to naturally occurring bone matrix. Furthermore, the fact that instant claim recites “modified” does not differentiate it from the bone matrix of Mahamid because although the claimed bone matrix may be modified by man, it is identical to what exists in nature (i.e., same structure and function). Because there is no difference between the claimed and naturally occurring bone matrix, the claimed bone matrix does not have markedly different characteristics, and thus are a “product of nature” exception. Accordingly, instant claims are directed to a judicial exception.
In regard to Step 2A prong two, the judicial exception is not integrated into a practical application. In particular, Claims 1-3, and 5-6 recite no additional elements to integrate the claimed bone matirx into a practical application.
In regard to Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As stated supra, Claims 1-3, and 5-6 recite no additional elements to the bone matrix.
Therefore, Claims 1-3, and 5-6 are directed to a natural bone matrix, that is not markedly different from its natural counterpart, is not integrate a practical application, and does not include elements that amount to significantly more than the natural product itself and do not qualify as patent eligible subject matter under 35 U.S.C. § 101.
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.
Claims 1-3, and 5-6 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Mahamid et al., (J Struct Bio, 2011, 527-535)
In regard to claim 1-3, and 5-6, Mahamid teaches a natural bone matrix formed by the process of calcium phosphate co-precipitation into crystalline carbonated hydroxyapatite thereon (Abstract, Figs. 3-5).
Accordingly, Mahamid anticipates instant claims.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Baig et al., (US2019/0216693, filed 1/17/2019, published 7/18/2019)
In regard to claim 1, Baig teaches a modified tooth-derived matrix, which has been produced by processing a tooth sample comprising bioactive mineral substances co-precipitated thereon, wherein one of the bioactive mineral substances is the endogenous mineral hydroxyapatite (HAP) and the bioactive substance is the non-endogenous mineral fluorapatite (FAP) (Remineralization and Demineralization, [0098-0107], see also Claims 11-17 of Baig).
In regard to claims 2 and 3, as stated supra, the endogenous mineral is hydroxyapatite (e.g., Ca5(PO4)3(OH) or Ca10(PO4)5(OH)2), which Baig teaches is a naturally occurring inorganic calcium phosphate substance found in the tooth [0002].
In regard to claim 4, as stated supra, Baig teaches the modified tooth-derived matrix further comprises the precipitated non-endogenous bioactive mineral substance of fluorapatite (FAP), which strengthens tooth enamel because it has a lower critical pH than HAP [005].
In regard to claim 5, as stated supra, Baig teaches a tooth-derived matrix, which is dental tissues.
Accordingly, Baig anticipates instant claims.
Claims 1-3, 5 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soicher et al., (J Biomed Mater Res A, 2014, 102(12):4480-4490)
In regard to claim 1, Soicher teaches a modified equine metacarpal bone matrix, which has been produced by processing demineralized bone comprising endogenous bioactive mineral substances co-precipitated thereon by an alternating solution immersion (ASI) method, wherein the endogenous bioactive mineral substances is an endogenous calcium phosphate (Methods, p. 3, Section 2.2).
In regard to claims 2 and 3, as stated supra, the endogenous mineral is a calcium phosphate, which is a naturally occurring inorganic substance found in bone in the form of hydroxyapatite (Discussion, p. 10, 2nd para.).
In regard to claims 5 and 6, as stated supra, Soicher teaches bone derived tissue.
Accordingly, Soicher anticipates instant claims.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631