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 .
Election/Restrictions
Applicant’s election without traverse of group I and the species where the implant is metal, the first layer comprises polylactide and silver ions, a recited second layer is present and comprises poly(lactide-co-glycolide) and antibiotic/anti-infective, and the device has an intermediate etched layer on its surface, in the reply filed on April 13, 2026 is acknowledged.
Claims 5, 8-13, 15-16, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Specification
The disclosure is objected to because it contains several embedded hyperlinks and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 2-3 are objected to because of the following informalities: the recitation of “comprises of from” in claims 2 and 3 is awkwardly worded. A clearer recitation could be “comprises from” or “comprises”. Claim 3 recites a listing of options for antibiotics where most of the names listed are followed by another name in parentheses that is a synonym for the first name. These synonyms do not appear to serve any purpose. For the sake of clarity and consistency, the applicant should choose one of the two names that are employed for these components and use the singular terminology in the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2-4, 7, and 17-18 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 2 recites the limitation the polylactide in line 2. There is insufficient antecedent basis for this limitation in the claim. Previously the claim recites “at least one polylactide”. The reference to “the polylactide” makes it unclear whether one, all, or some subset of the “at least one” grouping must abide by the limitation.
Claim 2 recites “the counterion is selected from a group of silver compounds that are soluble and non- toxic in non-polar solvents”. While a counterion is implicitly present when silver ions are present, the identity of a silver compound that can be a counterion to silver is not clear. Silver cannot be its own counterion. Further, an ion that comprises silver that also has a charge opposite that of silver is not evident. Thus the scope of the compounds embraced by this recitation is not clear.
Claim 3 recites “antiinfective/antibiotic”. It is unclear if this recitation embraces any infective compound and any antibiotic or if it just embraces antibiotics. No listing of envisioned “anti-infective” compounds is recited while several classes of antibiotics are named. Thus the intended scope is unclear. For the sake of compact prosecutions and the application of prior art, the broader interpretation will be employed; however clarification is still required.
Claim 3 recites the terms/phrases “others such as”, “e.g.”, “preferably”, “particularly preferred” and “most preferably” which render the claim indefinite because it is unclear whether the limitation(s) following the terms/phrases are part of the claimed invention. See MPEP § 2173.05(d).
Claim 3 recites “polylactides with the following properties: defined degradation rate, neutrality of influence on pH value” The meaning of “neutrality of influence on pH value” is not known. All polylactides have some degradation rate, thus it is unclear how “defined degradation rate” limits the scope of polylactides.
Claim 3 contains the trademark/trade name CAS number 1354955-03-5. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a poly(D,L-lactide- co-glycolide polymer and, accordingly, the identification/description is indefinite.
Claim 3 recites a confusing listing of options for the antibiotic. The listing ends with “…bacteriostatic substances, a group consisting of vancomycin, daptomycin, rifampicin, fosfomycin, gentamycin, and any combination thereof”. It is unclear if the “combination thereof” applies to the full listing or just the members of the “group”. In addition, “Diaminopyrimidines (trimethoprim)” is a broad limitation followed by a narrow limitation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Clam 3 recites “the antibiotic is selected from…other anti-infective…bacteriostatic substances…”. It is unclear if these options are compounds based on the plain meaning of “antibiotic” or are intended to broaden the meaning of antibiotic to include other compounds that are anti-infective or bacteriostatic and not categorized as such based on the plain meaning.
Claim 3 confusingly recites “optionally a)…and/or b)…and/or c)...and/or d)… and/or xii)…wherein optionally a) and/or…b)…and/or c)…and/or d) …and/or e)…and/or f)…” which are not completely in numerical or alphabetical order and make it unclear as to which item is a further limitation of another preceding limitation. Some later lettered items seem to repeat the scope of an earlier occurring lettered item (e.g., b) and b) as well as c) and c)). The multiple “optionally” recitations followed by a string of limitations, that may be present in the alternative or in combination, is confusing. In addition, the stringing together of the recitations with the chain of “and/or” recitations makes the claim confusing as to the scope of the products that are embraced, particularly when the “and” embodiments of the “and/or” are considered.
Claim 4 recites “a coating arranged on at least a portion of the surface of the implant, wherein the coating comprises the second coating as specified in claim 3, as a first layer, comprising at least one polylactide and/or at least one lipid and an antibiotic/antiinfective”. The structural configuration and required components of “the second coating as specified in claim 3, as a first layer” is unclear. The limitation "the second coating" lacks antecedent basis which may be the source of a portion of the confusion. The remaining wording of the phrase makes it unclear how many layers are present and the identity of their required components. Due to the incoherence of the claim, prior art cannot be applied until clarification is provided.
Claim 18 recites “etching (oxidation, passivation, roughening)” which is a broad limitation followed by a narrow limitation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims that are rejected but are not explicitly elaborated upon are also indefinite because they depend from an indefinite claim and do not add clarity.
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.
Claims 6 and 17 are 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. The claims recite that the surface of the implant comprises metal or non-metal. All possible materials for the surface are embraced by these options, therefore the claims do not limit their parent claims. 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, 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 1-3, 6-7, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US PGPub No. 2003/0153983) in view of Fox et al. (US Patent No. 5,019,096) and Wu et al. (US PGPub No. 2005/0033412).
Miller et al. teach an implantable medical device that has a coating that is resistant to microbial growth (see abstract). The device is envisioned as a stent whose surface is metal (see paragraphs 2 and 91-93, claims 35, 38, 40, and 42; instant claim 6). They go on to teach the coating to be present as multiple layers that are composed of a biodegradable as well as an antimicrobial agent and a microbial adhesion inhibitor (see paragraphs 20, 22, 28, 37, and 85; instant claim 3). The biodegradable polymer is envisioned as poly(L-lactic acid) (PLLA) and/or poly(lactic acid-co-glycolic acid) (poly(lactide-co-glycolide; PLGA), where polylactic acid, polyglycolic acid, and their copolymers are preferred options (see paragraph 40-41 and claims 6 and 9; instant claims 1-3). Miller et al. go on to teach that the multi-layered embodiment may contain different polymers in the layers along with bioactive compounds so as to release their contained bioactive compounds at different rates (see paragraph 55). Silver salts are envisioned as the antimicrobial active (see paragraph 33). A particular combination of antimicrobial agents in the multi-layered coating that includes silver salts is not detailed.
Fox et al. teach implant coatings composed of a polymer matrix and a combinations of silver salts and chlorhexidine is useful as an antimicrobial coating (see column 1 line 64-column 2 line 5 and table XXIII). The silver salts that were particularly useful include silver carbonate, silver chloride, silver palmitate, silver sulfadiazine, and silver laurate (see table XXII). They envision PLLA as a matrix polymer (see column 11 lines 35-41 and column 12 lines 24-31). The combinations of silver salt and chlorhexidine have superior antimicrobial properties as compared to the silver salt or chlorhexidine alone (see tables XXII-XXIII).
Wu et al. teach surface etching a metal stent to improve adherence of a polymer coating that is a depot for bioactive compounds (see abstract and paragraphs 13 and 15; instant claim 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare an embodiment of Miller et al. with a two layered configuration with PLLA and PGLA on a surface etched metal stent, where a silver salt in combination with chlorhexidine is employed as the antimicrobial active. These choices and modifications are obvious in view of Fox et al. and Wu et al. Amongst the teachings of Miller et al., they explicitly detail a metal stent as the device coated with their antimicrobial coatings as well as preferences for PLLA and PLGA as biodegradable polymers in the coatings. Thus the selection of PLLA and PLGA as polymers in separate layers would have been obvious given the preferred and suggested choices detailed by Miller et al. In light of Fox et al., the selection of a silver salt and chlorhexidine would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. There is a small finite number of ways the PLLA, PLGA, chlorhexidine, and silver salts in a two layered coating can be arranged. Amongst these options, placement of the silver salt and PLLA in the layer directly on the device surface and PLGA with chlorhexidine as an overlying layer would have been obvious because a selection amongst a finite set of options is obvious. In addition, surface etching of the stent would have been obvious in light of Wu et al. to improve the adhesion of the coating on the surface of the device. This would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Claims 14 and 19 are product-by-process claims. “’[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.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)” (see MPEP 2113). Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. Here the process steps do not imply/require structure beyond the presence of an elected first layer comprising at least one polylactide and silver ions on an implant surface. Thus the limitations of claims 14 and 19 are rendered obvious by the teachings of Miller et al. Therefore claims 1-3, 6-7, 14, and 19 are obvious over Miller et al. in view of Fox et al. and Wu et al.
Claims 1-3, 6-7, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. in view of Terry (US PGPub No. 2009/0319035), Kuehl et al. (Antimicrobial Agents and Chemotherapy 2016 60(4):2467-2475), and Wu et al.
Miller et al. teach an implantable medical device that has a coating that is resistant to microbial growth (see abstract). The device is envisioned as a stent whose surface is metal (see paragraphs 2 and 91-93, claims 35, 38, 40, and 42; instant claim 6). They go on to teach the coating to be present as multiple layers that are composed of a biodegradable as well as an antimicrobial agent and a microbial adhesion inhibitor (see paragraphs 20, 22, 28, 37, and 85; instant claim 3). The biodegradable polymer is envisioned as poly(L-lactic acid) (PLLA) and/or poly(lactic acid-co-glycolic acid) (poly(lactide-co-glycolide; PLGA), where polylactic acid, polyglycolic acid, and their copolymers are preferred options (see paragraph 40-41 and claims 6 and 9; instant claims 1-3). Miller et al. go on to teach that the multi-layered embodiment may contain different polymers in the layers along with bioactive compounds so as to release their contained bioactive compounds at different rates (see paragraph 55). Silver salts are envisioned as the antimicrobial active (see paragraph 33). A particular combination of antimicrobial agents in the multi-layered coating that includes silver salts is not detailed.
Terry teaches implant coatings composed of a polymer matrix and a silver salt useful as an antimicrobial coating (see abstract and paragraphs 8 and 16). The envisioned silver salts include silver nitrate and silver acetate (see paragraph 8). Terry goes on to teach the inclusion of additional antimicrobial and bioactive compounds, where antibiotics are envisioned (see paragraph 39).
Kuehl et al. teach of the benefit of pairing the antibiotics vancomycin or daptomycin with a silver ion coated implant as compared to the effect of the silver ion in order to thwart bacterial infection upon implantation (see abstract page 2468 first column second full paragraph, page 2470 second column and figure 6).
Wu et al. teach surface etching a metal stent to improve adherence of a polymer coating that is a depot for bioactive compounds (see abstract and paragraphs 13 and 15; instant claim 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare an embodiment of Miller et al. with a two layered configuration with PLLA and PGLA on a surface etched metal stent, where a silver salt in combination with an vancomycin or daptomycin is employed as the antimicrobial active. These choices and modifications are obvious in view of Terry, Kuehl et al., and Wu et al. Amongst the teachings of Miller et al., they explicitly detail a metal stent as the device coated with their antimicrobial coatings as well as preferences for PLLA and PLGA as biodegradable polymers in the coatings. Thus the selection of PLLA and PLGA as polymers in separate layers would have been obvious given the preferred and suggested choices detailed by Miller et al. In light of Terry and Kuehl et al., the addition of an antibiotic and specifically vancomycin or daptomycin would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. There is a small finite number of ways the PLLA, PLGA, chlorhexidine, and silver salts in a two layered coating can be arranged. Amongst these options, placement of the silver salt and PLLA in the layer directly on the device surface and PLGA with chlorhexidine as an overlying layer would have been obvious because a selection amongst a finite set of options is obvious. In addition, surface etching of the stent would have been obvious in light of Wu et al. to improve the adhesion of the coating on the surface of the device. This would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Claims 14 and 19 are product-by-process claims. “’[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.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)” (see MPEP 2113). Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. Here the process steps do not imply structure beyond the presence of an elected first layer comprising at least one polylactide and silver ions on an implant surface. Thus the limitations of claims 14 and 19 are rendered obvious by the teachings of Miller et al. Therefore claims 1-3, 6-7, 14, and 19 are obvious over Miller et al. in view of Terry, Kuehl et al., and Wu et al.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
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