DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 01/23/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 22 is objected to because of the following informality:
Claim 22, line one, should read “wherein the fibers of the implant consist
Claim Rejections - 35 USC § 112, Second Paragraph
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 1-2, 4-15, and 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.
Claim 1 is indefinite because it recites, “the mineral coating is uniformly distributed on multiple surfaces of each individual fiber” in lines 6-7. This is indefinite because it is not clear how there are multiple surfaces of each fiber. Fibers have just one continuous outer surface and it’s this outer surface that’s coated in the instant invention (Figures 2-3 where 210 and 212 are the fibers and 208 is the coating). Further clarification/appropriate correction is required.
Claim Rejections - 35 USC § 112- Failure to Further Limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 22 recites, ““the fibers of the implant consist essentially of individually coated fibers”. Claim 1 already defines that the plurality of coated bone material particles are fibers and each fiber is individually coated with said mineral coating. Therefore, claim 22 doesn’t further limit claim 1.
Claim Rejections - 35 USC § 103 (Maintained)
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.
Claims 1-2, 4-9, 12-15, and 22 are rejected under 35 U.S.C. 103 as being as being obvious over Kalpakci et al. (US 2019/0255216 A1) in view of Bufler (US 2016/0144071 A1).
Regarding claims 1 and 14, Kalpakci discloses an implant material to promote bone growth comprising lyophilized demineralized bone matrix (DBM) particles in fiber form (abstract). The DBM is homogeneously distributed within the implant [0012] [0064] [0174].
Kalpakci does not disclose the fibers have a mineral coating thereon, the mineral coating having nanostructures, each fiber being individually coated with said mineral coating, wherein the mineral coating is uniformly distributed on multiple surfaces of each individual fiber, as recited in claims 1 and 14, nor a coating having a thickness of 1000 nm or less, as recited in claim 14.
Bufler discloses an implant material with fibers coated with nanocrystalline hydroxyapatite (abstract). Bufler teaches that the hydroxyapatite covered fibers are used as an implant to support bone formation, bone regeneration, bone repair and/or bone replacement [0001], that hydroxyapatite gives bone its strength and rigidity [0006], and that hydroxyapatite crystals on the surface of the fibers provides the material with the elasticity, resistance to torque and toughness of natural bone [0016]. Each cylindrical piece of fibrous collagen (i.e., fiber) is coated with hydroxyapatite [0081]-[0086] [0057] and the mineral coating is uniformly distributed on the surface [0086] [0063]-[0066].
Since Kalpakci generally teaches an implant material to promote bone growth, it would have been prima facie obvious to one of ordinary skill in the art to include the nanocrystalline hydroxyapatite coating of Bufler, within the teachings of Kalpakci, because Bufler teaches that the hydroxyapatite covered fibers are used as an implant to support bone formation, bone regeneration, bone repair and/or bone replacement [0001], that hydroxyapatite gives bone its strength and rigidity [0006], and that hydroxyapatite crystals on the surface of the fibers provides the material with the elasticity, resistance to torque and toughness of natural bone [0016].
Further regarding claims 1 and 14, the limitation of “individually coated” is interpreted as a product-by-process limitation. Even though the 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, then the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113. In the instant invention, the process of individually coating the fibers leads to a product where each fiber is uniformly coated [0061]. In the product of Bufler, each cylindrical piece of fibrous collagen (i.e., fiber) is coated with hydroxyapatite [0081]-[0086] [0057] and the mineral coating is uniformly distributed on the surface [0086]. While figures 1-3 [0063]-[0066] show the uniform coverage of the coating on a membrane-shaped fibrous collagen scaffold [0076], it would be reasonably expected that same uniform coverage would be seen with the coating of the cylindrical pieces of fibrous collagen (i.e., fibers) disclosed at [0081]-[0086]. As such, the patentability of the instant product does not depend on its method of production, and the Applicant' s limitation regarding the process of “individually coating” the fibers is not patentable, in view of Kalpakci and Bufler.
Examiner’s note: As discussed above, it is not clear how there are multiple surfaces of each fiber, as claimed. Fibers have just one continuous outer surface and it’s this outer surface that’s coated in the instant invention (Figures 2-3 where 210 and 212 are the fibers and 208 is the coating). The combined teachings of Kalpakci and Bufler read on “the mineral coating is uniformly distributed on multiple surfaces of each individual fiber” as it is understood in the context of the instant invention because Bufler teaches that each cylindrical piece of fibrous collagen (i.e., fiber) is uniformly coated on the entire outer cylindrical surface.
Further regarding claim 14, it would have been prima facie obvious to use the coating of Bufler, as previously discussed, and Bufler discloses the hydroxyapatite coating has a thickness of 30 ± 15 nm [Claim 1].
Claims 2 and 15 are rendered prima facie obvious because Kalpakci discloses the bone material particles are demineralized bone (abstract).
Claims 4-5 and 12 are rendered prima facie obvious because it would have been obvious to use the coating of Bufler, as previously discussed, and Bufler discloses the coating is a nanocrystalline hydroxyapatite coating (abstract).
Claims 6 and 7 are rendered prima facie obvious because Kalpakci discloses the implant comprises a matrix which is in the form of a putty [0038].
Claim 8 is rendered prima facie obvious because Kalpakci discloses the matrix is hydratable [0135]-[0143].
Claim 9 is rendered prima facie obvious because Kalpakci discloses the implant is dehydrated [0144]-[0147] [0081] .
Claim 13 is rendered prima facie obvious because Kalpakci discloses the fibers are fibrous bone tissue (abstract) [0053].
Regarding claim 22, absent a clear disclosure in the specification regarding what would materially change the composition, "consisting essentially of" is interpreted to be "comprising" language. See MPEP 2111.03. If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant' s invention.
Claim 22 is rendered prima facie obvious because it would have been obvious to coat the fibers of Kalpakci, with the mineral coating of Bufler, as previously discussed and Bufler teaches that each cylindrical piece of fibrous collagen (i.e., fiber) is coated with hydroxyapatite [0081]-[0086] [0057].
Claim 10 is rejected under 35 U.S.C. 103 as being as being obvious over Kalpakci et al. (US 2019/0255216 A1) in view of Bufler (US 2016/0144071 A1) and further in view of Wei et al. (US 2009/0220605 A1).
The 35 U.S.C. 103 rejection over Kalpakci in view of Bufler was previously discussed.
The combined teachings of the prior art do not disclose a mineral coating with a peptide, as recited in claim 10.
Wei teaches a bone matrix implant (abstract) with therapeutic factors, such as peptides, which are coated on the bone matrix. Wei teaches that the therapeutic factors, such as peptides, promote cellular response and tissue regeneration. [0081]-[0082].
Since Kalpakci generally teaches an implant material to promote bone growth, it would have been prima facie obvious to one of ordinary skill in the art to include a coating comprising a peptide, within the teachings of Kalpakci, because Wei teaches therapeutic factors, such as peptides, are coated on bone matrix. An ordinarily skilled artisan would be motivated to use peptides because Wei teaches that the therapeutic factors, such as peptides, promote cellular response and tissue regeneration. [0081]-[0082].
Claim 11 is rejected under 35 U.S.C. 103 as being as being obvious over Kalpakci et al. (US 2019/0255216 A1) in view of Bufler (US 2016/0144071 A1) and as evidence by Tank et al. (Journal of Crystal Growth, 2014, 401: 474-479).
The 35 U.S.C. 103 rejection over Kalpakci in view of Bufler was previously discussed.
Regarding claim 11, it would have been prima facie obvious to use the nanocrystalline hydroxyapatite coating of Bufler, within the teachings of Kalpakci, as previously discussed. However, Bufler does not teach that the coating reduces bacterial adhesion to a surface of the coated bone material particle.
As evidenced by Tank, nanocrystalline hydroxyapatite has good antibacterial activity against a variety of bacteria (abstract; pg. 475-476, Fig 1-2).
Therefore, while Bufler does not specifically disclose the mineral coating reduces bacterial adhesion, nanocrystalline hydroxyapatite is known to have antibacterial activity as evidenced by Tank (abstract; pg. 475-476, Fig 1-2). It would be reasonably expected that coating the fibers of Kalpakci with the nanocrystalline hydroxyapatite coating of Bufler would reduce bacterial adhesion.
Response to Arguments
Applicant's arguments filed 01/23/2026 have been fully considered but they are not persuasive.
Applicant argues that the individually coated fiber is not a product-by-process feature, instead it is a structural feature of the fiber and the overall implant.
The Examiner disagrees and maintains that “each fiber being individually coated” is a product-by-process limitation. In the instant invention, the process of individually coating the fibers leads to a product where each fiber is uniformly coated [0061]. In the product of Bufler, each cylindrical piece of fibrous collagen (i.e., fiber) is coated with hydroxyapatite [0081]-[0086] [0057] and the mineral coating is uniformly distributed on the surface of the fiber [0086]. While figures 1-3 [0063]-[0066] of Bufler show the uniform coverage of the coating on a membrane-shaped fibrous collagen scaffold [0076] it would be reasonably expected that same uniform coverage would be seen with the coating of the cylindrical pieces of fibrous collagen (i.e., fibers) disclosed at [0081]-[0086]. As such, the patentability of the instant product does not depend on its method of production, and the Applicant' s limitation regarding the process of “individually coating” the fibers is not patentable, in view of Kalpakci and Bufler.
Applicant argues that Bufler does not disclose individually coated fibers and one of ordinary skill in the art would know that Bufler’s method of coating a pre-formed scaffold would not and could not result in coating of individual fibers, as such, coating will not coat the individual fiber within the scaffold.
The Examiner disagrees. Claim 1 defines that the plurality of coated bone material particles are fibers and the fibers are individually coated with the mineral coating. Bufler teaches the coating of “cylindrical pieces of fibrous collagen” (i.e., fibers) and each of the cylindrical pieces of fibrous collagen are coated [0081]-[0086]. There also does not appear to be any limitations in the method of forming the implant of Kalpakci [0148] where the fibers could not first be coated with the coating as described by Bufler [0081]-[0086] and it would have been prima facie obvious to include the mineral coating for fibers, as taught by Bufler, to coat the fibrous material of Kalpakci, for the reasons discussed above.
Applicant argues that none of the cited references make obvious that the implant consists essentially of individually coated fibers.
As discussed above, absent a clear disclosure in the specification regarding what would materially change the composition, "consisting essentially of" is interpreted to be "comprising" language. Additionally, “the implant consists essentially of individually coated fibers” is not recited in the claims. Claim 22 recites that “the fibers of the implant consist essentially of individually coated fibers”. It would have been obvious to coat the fibers of Kalpakci, with the mineral coating of Bufler, as previously discussed and Bufler teaches that each cylindrical piece of fibrous collagen (i.e., fiber) is coated with hydroxyapatite [0081]-[0086] [0057].
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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/ASHLEE E WERTZ/Examiner , Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612