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 .
Status of Claims
Claims 16-17, 20, 23-25 and 27- 33 are pending. Claims 1-15, 18-19, 21-22 and 26 are canceled. Claims 16, 20 and 27 are amended.
Claims 30-31 and 33 are withdrawn as being drawn to a non-elected invention or species, there being no linking or generic claim.
Claims 16-17, 20, 23-25, 27-29 and 32 are examined on their merits.
Previous Rejections
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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.
Objections/ Rejections Withdrawn
Claim Objection
In light of the amendments to the claims the objection to claim 27 is withdrawn.
Claim Rejections - 35 USC §112(b)
In light of the amendments to the claims the rejection of claims 19 and 22 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention are withdrawn.
New Rejections/Rejections Maintained
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.
Claim 20 is 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 20 is rejected under 35 USC 112(b) for reciting the limitation “said polycatechol” and depends from claim 16. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 16 does not recite polycatechol. However, claim 16 does recite “pyrocatechol”.
For the purposes of this office action, it will be assumed that claim 20 is referring to the pyrocatechol in claim 16.
Claim Rejections - 35 USC §112(d)
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.
Claims 17 is rejected under 35 U.S.C. 112(d) 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 17 is rejected as being indefinite for failing to further limit in the recitation of “wherein said further substance for binding the metal ions or the nanoparticles is a pyrocatechol” wherein claim 17 depends from claim 16.
Claim 16 already recites “said further substance containing pyrocatechol molecules incorporated or attached to said organic-polymeric matrix and binds the metal ions or the nanoparticles”. Since the further substance is already recited to be pyrocatechol in claim 16, claim 17 does not further limit claim 16. This is a failure to further limit the claim from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 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.
The rejection of claims 16-17, 20-22, 24-25, 27-29 and 32 under 35 U.S.C. 103 as being unpatentable over Colfen et al. DE 102015002398 (8/26/2016) (1/19/2022 IDS) in view of Xie et al. Long-Term Prevention of Bacterial Infection and Enhanced Osteoinductivity of a Hybrid Coating with Selective Silver Toxicity, Adv. Healthcare Materials 8(5) Article No. 1801456 pp 1-12 (2019) (1/19/2022 IDS) and KR 100902167 (6/10/2019)(“KR”) is maintained.
Colfen et al. (Colfen) teaches a bone implants and a material for bone implants comprising (a) a surface, comprising a material selected from the group consisting of oxidic ceramic materials, titanium, polymer materials and composite materials, (b) a matrix that is covalently bonded to this surface, comprising collagen and/or gelatin, and (c) calcium phosphate which is incorporated into this matrix. (See Colfen claim 1 and [0012]). Colfen thus teaches a surface that can be titanium. Colfen also teaches the concept of layers over the surface, thus teaching the possibility of a titanium layer as called for in instant claim 16. (See Example 9). Colfen also teaches an organic matrix that is covalently bonded to this surface and calcium phosphate incorporated into the organic polymeric matrix as called for in instant claim 16. Colfen thus suggests the surface having a titanium covering it called for in instant claim 16.
The matrix can have a thickness of 1 nm to 10 micrometers. (See [0028]) 1 nm to 10 micrometers overlaps with the between 1 micrometer and 20 micrometers in claim 28. 1 nm to 10 micrometers also overlaps with the between 0.5 micrometers and 50 micrometers in claim 24. 10 micrometers is also called for in instant claim 29. Colfen also teaches wherein the matrix covers the entire surface of the material as called for in claim 25 and even teaches that this is preferred. (See Colfen claim 9.) Colfen teaches that the matrix can comprise collagen and gelatin and a matrix containing gelatin and collagen is called for in instant claim 16.
Colfen teaches that the bone implant materials have a higher biocompatibility, better healing in the natural bones and increased mechanical strength. (See [0047]).
Colfen teaches that in preferred embodiments, the bone implant materials comprise PEEK wherein the collagen of the covalently bonded matrix is via a linker consisting of dicarboxylic acid linker, a maleimide liner and a hexamethylene diisocyanate linker to which PEEK is attached. Colfen expressly states that corresponding linkers are known in the art. (See [0027]). Colfen teaches a number of different linkers that can form covalent attachments.
The calcium phosphate can be calcium orthophosphate in all mineral forms. (See Colfen claim 4). One of these forms can be amorphous calcium orthophosphate.
Colfen does not teach a substance that binds metal ions or nanoparticles. This deficiency is made up for with the teachings of Xie et al. and KR.
Xie et a. (Xie) discloses bone implants having a titanium substrate and a hybrid coating containing polydopamine (PDA) hydroxyapatite (HA), silver nanoparticles and chitosan. (See Abstract), page 2, last paragraph in left column). A bone implant which has a solid material substrate is called for in instant claim 32. Xie teaches polydopamine which is dopamine which is also a polycatechol that has a pyrocatechol as a main structure as called for in instant claim 20. A pyrocatechol is called for in instant claim 17. Hydroxyapatite is called for in instant claim 26. Chitosan is called for in instant claim 19. Polydopamine is called for in instant claim 26.
KR teaches bone strengthening components added to food material that produces a solid material processed product that has excellent bone strengthening activity. (See Abstract). KR teaches that protocatechualdehyde is a bone enhancing component. (See Example 1). Protocatechualdehyde itself is called for in instant claim 27.
It would have been prima facie obvious to one of ordinary skill in the art before the earliest effective filing date making the bone implant of Colfen with a titanium covered oxide ceramic surface, a gelatin containing organic matrix incorporating calcium phosphate covalently bonded to the surface to include polydopamine and chitosan in the matrix and make the calcium phosphate hydroxyapatite as taught by Xie in order to have the long-term prevention of bacterial infection and enhanced osteoconductivity as taught by Xie. It would have been prima facie obvious to one of ordinary skill in the art before the earliest effective filing date making the bone implant of Colfen with a titanium covered oxide ceramic surface, a gelatin containing organic matrix incorporating calcium phosphate covalently bonded to the surface to incorporate the protocatechualdehyde taught by KR into the bone implants of Colfen in order to have a bone enhancing component in the bone implant as taught by KR.
With respect to claim 16, Colfen teaches a gelatin containing matrix, Xie teaches chitosan and polydopamine. KR teaches protocatechualdehyde that is a bone enhancing component as well as a pyrocatechol. The protocatechualdehyde will be incorporated into the bone implant material containing gelatin and chitosan via some of the covalent linkers taught in Colfen, thereby modifying the gelatin and chitosan to have pyrocatechol-modified gelatin and pyrocatechol-modified chitosan in the matrix as called for in instant claim 16.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Colfen et al. DE 102015002398 (8/26/2016) (1/19/2022 IDS) in view of Xie et al. Long-Term Prevention of Bacterial Infection and Enhanced Osteoinductivity of a Hybrid Coating with Selective Silver Toxicity, Adv. Healthcare Materials 8(5) Article No. 1801456 pp 1-12 (2019) (1/19/2022 IDS) and KR 100902167 (6/10/20019)(“KR”) as applied to claims 16-17, 20-22, 24-25, 27-29 and 32 and further in view of McGowan et al. CA 2843144 (1/31/2013).
Colfen in view of Xie and KR are described supra. Xie teaches a carboxylic acid linker. Colfen in view of Xie and KR teach a carboxylic linker but do not teach a phosphonic acid linker. This deficiency is made up for with the teachings of McGowan et al.
McGowan et al. (McGowan) discloses a functionalized composition and resulting functionalized body or prosthesis for in vitro and in vivo use comprising at least one calcium phosphate containing phase that is functionalized with a linker group comprising at least one of an organic acid molecule, a phosphoric acid, an amine, N,N-dicyclohexylcarbodiimide and 3-maleimidoproponionic acid N-hydroxysuccinimide estern wherein the linker group provides for a reactive location for the attachment of one or more of a chemical and/or a biologically active moiety to the calcium phosphate containing phase. The functionalized compositions have a pliable physical property when mixed with water and adhere to natural bone and subsequently harden at ambient temperatures. (See Abstract). The linker may be a phosphoric acid as called for in instant claim 23. (See Figure 21). The linker may also be a carboxylic acid. (See Figure 22). McGowan thus teaches the equivalence of a carboxylic acid linker and a phosphoric acid linker. (See Figures 21 and 22).
It would have been prima facie obvious to one of ordinary skill in the art before the earliest effective filing date making bone implants of Colfen with a titanium covered oxide ceramic surface, a gelatin containing organic matrix incorporating hydroxyapatite covalently bonded to the surface to include polydopamine and chitosan in the matrix to use phosphoric acid instead of the carboxylic acid taught by Xie in light of McGowan’s teaching that a carboxylic acid linker is equivalent to a phosphoric acid linker.
Response to Arguments
The comments filed January 26, 2025 have been considered and are found to be mostly unpersuasive.
Applicants note the amendments to the claims. Applicants argue that the amendments remedy the objections to and indefiniteness of the claims. The objections and indefiniteness rejection have been withdrawn above.
Applicants argue that none of the prior art references, alone or in combination, teach or suggest the features of the claims. Applicants note that Colfen concerns a material for bone implants but fails to disclose the features of amended claim 16 describing that the organic-polymeric matrix bonded covalently do the surface contains pyrocatechol-modified gelatin, pyrocatechol-modified chitosan and polydopamine and that the further substance includes pyrocatechol molecules incorporated or attached to the organic-polymeric matrix and binds the metal ions or the nanoparticles.
Xie at least fails to disclose the features of amended claim 16 described that the organic-polymeric matrix bonded covalently to the surface contains pyrocatechol-modified gelatin, pyrocatechol-modified chitosan and polydopamine and that the further substance includes pyrocatechol molecules incorporated or attached to the organic-polymeric matrix and binds.
KR ‘167 concerns materials derived from a mushroom extract containing bone-reinforcing active substances fails to disclose the features of amended claim 16 described that the organic-polymeric matrix bonded covalently to the surface contains pyrocatechol-modified gelatin, pyrocatechol-modified chitosan and polydopamine and that the further substance include pyrocatechol molecules incorporated or attached to the organic-polymeric matrix and binds. Applicants notes that KR ‘167 does teach that the mushrooms do provide bone-enhancing components include protocatechualdehyde but this is a component of the mushrooms and have nothing to do with coating a titanium-based bone implant. Applicants assert that protocatechualdehyde is not pyrocatechol although they are chemically similar. KR ‘167 is not believed to mention pyrocatechol in its specification. Applicants note that you should not eat or ingest pyrocatechol since it is a highly toxic, dangerous chemical used primarily for industrial or laboratory purposes.
Applicants’ obviousness rejections have been carefully reviewed and in light of the amendments are found to be unpersuasive. Applicants argument that none of the prior art references, alone or in combination, teach or suggest the features of the claims is not found to be persuasive. As described in the rejections described above, in combination the prior art of Colfen, Xie and KR teach all of the elements of the claims.
Specifically, it would have been prima facie obvious to one of ordinary skill in the art before the earliest effective filing date making the bone implant of Colfen with a titanium covered oxide ceramic surface, a gelatin containing organic matrix incorporating calcium phosphate covalently bonded to the surface to include polydopamine and chitosan in the matrix and make the calcium phosphate hydroxyapatite as taught by Xie in order to have the long-term prevention of bacterial infection and enhanced osteoconductivity as taught by Xie. It would have been prima facie obvious to one of ordinary skill in the art before the earliest effective filing date making the bone implant of Colfen with a titanium covered oxide ceramic surface, a gelatin containing organic matrix incorporating calcium phosphate covalently bonded to the surface to incorporate the protocatechualdehyde taught by KR into the bone implants of Colfen in order to have a bone enhancing component in the bone implant as taught by KR.
With respect to claim 16, Colfen teaches a gelatin containing matrix, Xie teaches chitosan and polydopamine. KR teaches protocatechualdehyde that is a bone enhancing component as well as a pyrocatechol. The protocatechualdehyde will be incorporated into the bone implant material containing gelatin and chitosan via some of the covalent linkers taught in Colfen, thereby modifying the gelatin and chitosan to have pyrocatechol-modified gelatin and pyrocatechol-modified chitosan in the matrix as called for in instant claim 16.
Applicants’ argument that protocatechualdehyde is not pyrocatechol, although they are chemically similar, is contradicted by the instant specification at paragraph [0033]:
In one preferred embodiment of the invention, the substance which binds metal ions or nanoparticles is a pyrocatechol. . . The pyrocatechol may be any pyrocatechol considered by the skilled person to be usable; preferably the pyrocatechol is selected from a group consisting of protocatechuic alcohol, protocatechualdehyde, protocatoic acid, 3-(3,4-dihydroxyphenyl)propionic acid, and 3,4-dihydroxyphenylacetic acid.
According to Applicants’ specification the mention of protocatechualdehyde is a mention of a preferred pyrocatechol, since pyrocatechol is a category of compounds. This is how it is defined in Applicants’ specification, and Applicants claims are interpreted using the broadest reasonable interpretation in light of the definitions in the specification. Applicants have defined pyrocatechol to be a category of compounds and have used the word pyrocatechol so that it includes the compounds mention in paragraph [0033] of the instant specification. Therefore, protocatechualdehyde is a pyrocatechol as claimed. Since protocatechualdehyde is a pyrocatechol, there are no concerns regarding its toxicity because it is able to be a bone-enhancing component that is safe to ingest.
Applicants’ argument that KR ‘167 does teach that the mushrooms do provide bone-enhancing components including protocatechualdehyde but this is a component of the mushrooms and have nothing to do with coating a titanium-based bone implant is not found to be persuasive because a bone-enhancing component is of very high interest in a bone implant because it can enhance bone growth and bone strength.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
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/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619