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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/3/25 has been entered.
Claims 1-5 and 7-20 are pending. Claims 8-15 have been withdrawn. Claim 1 has been amended. Claims 1-5, 7 and 16-20 are under consideration.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
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 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 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(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 1-5, 7 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gayer et al. (US 6,214,049; 2001) in view of Pitaru et al. (US 5,955,438; cited in IDS) and Kim et al. (PLOS ONE; 2019).
Gayer et al. teach. bone augmentation in a mammalian body to enhance the mechanical strength of a prosthesis is provided by reinforcement of bone in the region surrounding the implant device (e.g. abstract). Gayer et al. teach that the implant comprises the elected species of titanium wires coated with a biodegradable collagen membrane (e.g. abstract; column 7 lines 27-33, column 10, lines 36-end; claim 6 and 8).
Gayer et al. do not teach that the collagen includes multiple regions, and the multiple regions include different degrees of crosslinking and different degrees of density, with controllable biodegradation. This is made up for by the teachings of Pitaru et al. and Kim et al.
Pitaru et al. teach novel collagen-based matrix and devices comprising the matrix (e.g. abstract). Pitaru et al. teach that the main drawbacks of other collagen treatments are toxicity and inability to accurately control the degree of cross-linking (e.g. column 2, lines 2-4). Pitaru et al. teach that collagen can be rendered resistant to a collagenolytic degradation by means of cross-linking the collagens by reacting it with a reducing sugar, the collagen can be maintained substantially intact within the body for long periods of time and is thus useful as a building material of various collagen-based implantable devices (e.g. column 2, lines 21-28). Pitaru et al. teach that the degradation rate of the collagen matrix can be controlled by the extent of cross-linking between the collagen molecules in the matrix, which may in turn be controlled by the concentration of the sugar (ribose) during the preparation of the matrix, the temperature, and the extent of time during which the collagen is exposed to the sugar (e.g. column 4, lines 45-56). Pitaru et al. teach that in order to produce a membrane having portions which are degraded at different degradation rates, those parts that are designated to withstand degradation for longer periods of time are brought into contact with the ribose solution for different lengths of time resulting in different levels of crosslinking (e.g. column 7, lines 15-35).
While Pitaru et al. are silent as to the density of the resulting collagen matrices, they do teach the degradation rate of the collagen matrix can be controlled by the extent of cross-linking between the collagen molecules in the matrix, which may in turn be controlled by the concentration of the sugar (ribose) during the preparation of the matrix, the temperature, and the extent of time during which the collagen is exposed to the sugar (e.g. column 4, lines 45-56).
Kim et al. analyzed the chemical bond and ultrastructural change of collagen crosslinking with different types and concentrations of carbohydrates on rabbit sclera using Raman spectrometry, atomic force microscopy (AFM), and histology (e.g. page 3). Kim et al. found that crosslinking using glycation increased the matrix biomechanical rigidity and these results were particularly pronounced in ribose (e.g. abstract). Kim et al. teach that the collagen density was found to be increased in the ribose treated group compared to the control group (e.g. page 10, paragraph 4).
Regarding Claims 1-3, it would have been obvious to one of ordinary skill in the art at the time of filing to crosslink the collagen to different degrees as disclosed by Pitaru et al., which would have also resulted in different degrees of density, as disclosed by Kim et al., for use with the implants of Gayer et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both of Gayer and Pitaru are directed to collagen coated implants, and one of ordinary skill would have been motivated in order to provide the benefits of non-toxicity and controlled degradation, as taught by Pitaru et al.
Regarding Claims 4 and 5, Gayer et al. teach that the implant comprises anti-inflammatory agents (e.g. column 5, lines 34-43; column 11, lines 34-38; Claim 12). Pitaru et al. also teach the inclusion of anti-inflammatory agents (e.g. column 4, lines 57-63).
Regarding Claims 7 and 17, Gayer et al. teach the inclusion of a layer of synthetic bone material comprising hydroxyapatite (e.g. column 9, lines 44-63; Claim 7), which meets the definition of “space maintainer” as described in the Specification in paragraphs [0054] and [0055]. Pitaru et al. also teach the inclusion of space maintainers (e.g. column 7, lines 35-end).
Regarding Claim 16, Gayer et al. teach that the implant is used for dental bone regeneration (e.g. column 1, lines 5-10, column 12, lines 3-18).
Regarding Claims 18 and 19, as the kit does not comprise any elements in addition to those recited in Claim 1, the claim has been met by the teachings of Gayer et al. and Pitaru et al. described supra. Regarding the instructions, to be given patentable weight, the printed matter and associated product must be in a functional relationship. A functional relationship can be found where the printed matter performs some function with respect to the product to which it is associated, “[f]or example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864.” (see MPEP 2111.05).
Regarding Claim 20, Pitaru et al. further teach the inclusion of NaOH (e.g. column 6, lines 50-56), which meets the definition of “fibrillation agent” as described in the Specification in paragraph [0041].
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5, 7 and 16-20 have been considered, but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/Primary Examiner, Art Unit 1619