Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Request for Continued Examination
A Request for Continued Examination pursuant to 37 CFR § 1.114, including the fee set forth in 37 CFR § 1.17(e), was filed in this application after final rejection. Because this application is eligible for continued examination pursuant to 37 CFR § 1.114, and Applicants have timely paid the fee set forth in 37 CFR § 1.17(e), the finality of the previous Office Action has been withdrawn pursuant to 37 CFR § 1.114. Applicant's submission filed on 29 December 2025 has been entered.
Status of the Claims
Applicants filed claims 1, 4, 15, and 16 with the instant application according to 37 CFR § 1.114, on 29 December 2025. In an Amendment entered with the Request for Continued Examination, Applicants amended claims 4, 14, and 15, and added new claim 16. Consequently, claims 1, 4, and 14 - 16 are available for active consideration.
Information Disclosure Statement
The Examiner has considered the information disclosure statement (IDS) filed 30 November 2025, which is now of record in the file.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 103
The obviousness rejection set forth in the Action of 17 July 2025 is hereby withdrawn in light of Applicants’ amendment of the claims and in favor of the new grounds of rejection set forth below.
NEW GROUNDS OF REJECTION
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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.
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 absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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, 4, and 14 – 16 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2015/0190549 A1 to Sapoznikov, L., et al., published 9 July 2015 (“Sapoznikov ‘549”), in view of US 2003/0068815 A1 to Stone, K. and T. Turek, published 10 April 2003 (“Stone ‘815”), as evidenced by Applicants’ specification.
The Invention As Claimed
Applicants claim a xenograft bone graft comprising a powder from crushed mammalian teeth, wherein the powder is acellular, comprises an RGD (Arg-Gly-Asp) peptide sequence that exhibits positive reactivity with an anti-RGD antibody, the sequence being associated with collagen I present in dentine, wherein the xenograft bone graft is used as a xenograft in regenerative medicine, for use in replacing a missing bone in dental surgery, and wherein the powder is substantially free of eukaryotic microorganisms, spores, bacteria, viruses, proteins, lipopolysaccharides, and nucleic acids.
Applicants also claim a matrix comprising mammalian teeth, or parts thereof, that were immersed in an alcoholic solution of an alkali hydroxide for a period of from 0.25 to 5 hours, heated in an oven to a temperature between 110 and 190° C for a period of from 0.1 to 5 hours, and exposed to ɣ-irradiation.
The Teachings of the Cited Art
Sapoznikov ‘549 discloses a bone graft, and a method of producing the graft, the method comprising the steps of providing a tooth, converting the tooth into a plurality of particles, and selecting from available particles a subset of particles according to particle size (see Abstract), wherein the selected subset of particles is placed into a human jaw to act as a bone graft, and wherein selecting the subset of particles comprises sifting the plurality of particles to obtain particles having a size suitable for implanting as a bone graft (see ¶[0005]), wherein a tooth, such as a cadaver tooth, or a porcine tooth is provided (see ¶[0024]; see also ¶[0055]), wherein the source tooth comprises dentin in a range of 85 to 97% (see ¶[0038]), wherein the plurality of tooth particles are sifted, with the particles being passed through one or more sieves (see ¶[0046]), wherein the particles are subjected to preparation procedures chosen to result in a graft having chemical and/or physical properties similar to bone, and/or to bring the tooth particles into a configuration that better adapts to bone (see ¶[0050]), wherein the particles are washed with a strong alkali, such as a 0.25 to 0.75 M solution of sodium hydroxide in 20 – 40% ethanol (see ¶[0051]), and wherein the particles are heated by placing the particles on a hot plate set to a temperature of between 120 - 150° C for, by way of example, 2 – 10 minutes (see ¶[0052]). The reference does not disclose that the graft material comprising crushed mammalian teeth is acellular, or is substantially free of eukaryotic microorganisms, spores, bacteria, viruses, proteins, lipopolysaccharides, and nucleic acids, or graft material that is irradiated is with ɣ-radiation, or that the implants comprise an RGD peptide sequence that reacts positively with an anti-RGD antibody. The teachings of Stone ‘815 remedy these deficiencies.
Stone ‘815 discloses an article of manufacture comprising a substantially non-immunogenic xenograft for implantation into humans, and a method for sterilizing the xenograft comprising the steps of obtaining xenograft material, subjecting the xenograft to cellular disruption treatment and subjecting the xenograft material to radiation treatment (see Abstract; see also ¶[0006])), wherein the material is irradiated is with ɣ-irradiation (see ¶[0008]), and wherein cellular disruption and ɣ-irradiation are treatments for killing cells (see ¶[0014]; see also, ¶[0038]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare a xenograft by providing a tooth from a non-human mammal, converting the tooth into a plurality of particles, and selecting from the available particles a subset of particles according to particle size, wherein the selected subset of particles is placed into a human jaw to act as a bone graft, wherein the tooth particles comprise dentin in a range of 85 to 97%, wherein the particles are washed with a strong alkali, such as a 0.25 to 0.75 M solution of sodium hydroxide in 20 – 40% ethanol, wherein the particles are heated to a temperature of 120 - 150° C for a time period of two to ten minutes, as taught by Sapoznikov ‘549, wherein the particles are subjected to ɣ-irradiation and cellular disruption treatments to kill cells in the tissue of the xenograft, as taught by Stone ‘815. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Stone ‘815 to the effect that xenografts require treatment, such as by ɣ-irradiation and cellular disruption, in order to reduce the immunogenicity of the graft material (see, for example, ¶¶[0009] – [0010]).
With respect to the limitation recited in claim 1 directed to the implant comprising an RGD peptide sequence that reacts positively with an anti-RGD antibody, the Examiner notes that the cited references do not expressly teach whether the disclosed implant materials possess peptides with the RGD sequence that positively reacts with an anti-RGD antibody. However, the Examiner would first note that such limitation (antibody reaction) is not directed to a compositional, or structural, characteristic of the implant material, but to a functional characteristic or property of the bone graft/replacement. Also, the invention as claimed is not structurally distinguishable from xenografts according to the disclosures of Sapoznikov ‘549 and Stone ‘229/Stone ‘815. Specifically, the tooth material of Sapoznikov ‘549 comprises up to 97% dentin, which, as evidenced by Applicants’ specification (see ¶[0013]), the RGD sequence is known to comprise collagen I, which is a part of dentin. Therefore, the bone graft of Sapoznikov ‘549, comprising tooth particles with dentin-derived collagen would necessarily comprise the RGD sequence and would, therefore, necessarily react positively with an anti-RGD antibody Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
With respect to the limitations recited in claims 1 and 15, the Examiner notes that the cited references do not expressly disclose that the processes used to prepare the tooth particles for implantation comprise “immersing” the particles in the alcoholic hydroxide solution “for a period of from 0.25 to 5 hours.” However, it is the Examiner’s position that such recitations effectively render the claims at issue product by process claims wherein the recited process steps do not serve to distinguish the claimed invention from the prior art. These types of claims are examined on the limitations of the product. See MPEP § 2113, citing In re Thorpe, 111 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” Furthermore, upon establishing a prima facie case, the burden of persuasion shifts to the Applicant. MPEP 2113, citing In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974) “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. Consequently, unless Applicants can provide evidence to establish that the claimed product of the invention differs from that according to the cited art on the basis of the recited method steps, the evidence sufficient to overcome the prima facie case of obviousness, the process-related limitations will not serve to distinguish over the cited art.
With respect to claims 4 and 14, which claims recite limitations directed to uses of the bone graft of the invention in “regenerative medicine” (claim 4) and “replacing missing bone in dental surgery” (claim 14), it is the Examiner’s position that the claims are directed merely to intended uses of the composition of the invention. Claim 1, from which claims 4 and 14 depend, is directed to a composition of matter. Thus, its subject matter must be distinguished from the prior art by its structure or composition. See Hewlett Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) (holding that “apparatus claims cover what a device is not what a device is, does.”). Statements of intended use or function normally are not given patentable weight because they are not structurally limiting. See Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1354-55 (Fed. Cir. 2020) (discussing effect of intended use recitations in claim preamble).
With respect to newly added claim 16, which claim recites a limitation directed to the crushed mammalian teeth being substantially free of eukaryotic microorganisms, spores, bacteria, viruses, proteins, lipopolysaccharides, and nucleic acids, the Examiner notes that the cited references do not explicitly address such characteristics of the graft material. However, it is the Examiner’s position that sterilization the ɣ-irradiation treatment and cellular disruption treatments of Stone ‘229 and Stone ‘815, along with the alcoholic base treatment of Sapoznikov ‘549, would necessarily result in removal and/or destruction of materials such as recited in claim 16.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1, 4, 14, 15, and 16 would have been obvious within the meaning of 35 USC § 103.
Response to Applicants’ Arguments
The Examiner has considered the arguments submitted by Applicants on 29 December 2025 but does not find them persuasive, to the extent still relevant in light of the new grounds of rejection set forth above. The principal thrust of Applicants’ arguments is that xenograft materials such as those prepared according to the Sapoznikov ‘549, when treated according to Stone ‘229 and Stone ‘815, cannot be both cell-free and, at the same time, retain the dentin of Sapoznikov ‘549. The Examiner respectfully disagrees, largely on the basis that Applicants fail to appreciate the logical structure of the rejection of record. Applicants’ arguments in this regard are appear to be predicated on the presumption that the xenografts of Sapoznikov ‘549 are subjected to the full range of treatments disclosed in Stone ‘815. However, the rejection of record cites to the disclosures of Stone ‘815 solely for its teachings of the use of ɣ-irradiation to sterilize the xenografts and cellular disruption to kill cells, and not for additional treatments that could result in the destruction of dentin, the source of the RGD sequence. The Examiner also notes, in this regard, that Applicants acknowledge that Sapoznikov ‘549 “aims to preserve dentine structure for regenerative purposes.” It is the Examiner’s position that this acknowledgement supports the logical structure of the rejection in that one of ordinary skill in the art would know to preserve the dentin content, consistent with Sapoznikov ‘549, and would, therefore, be motivated to select those treatments from Stone ‘815 that would sterilize and reduce the immunogenicity of the xenografts.
Consequently, in light of the above discussion, Applicants’ arguments are unpersuasive and claims 1, 4, and 14 - 16 stand rejected as obvious pursuant to 35 U.S.C. § 103.
NO CLAIM IS ALLOWED.
CONCLUSION
Any inquiry concerning this communication or any other communications from the examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619