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
This application claims benefit of provisional application 63/458692, filed April 12, 2023, and is also a continuation in part of US application 17/074888, currently pending, filed October 20, 2020, which is a continuation of PCT/US2018/061993, filed November 20, 2018, which claims benefit of provisional application 62/660804, filed April 20, 2018. Claims 1-20 are pending in this application and examined on the merits herein.
Priority
This application is a continuation in part of US application 17/074888, and additionally relies for priority of international application PCT/US2018/061993 and provisional application 63/458682. However, none of these priority documents provides written description under 35 USC 112(a) for the subject matter of present claims 1-20. At minimum both base claim 1 and base claim 13, from which all other claims depend, describe steps of the claimed process including contacting a surface with an ethylenically unsaturated silane compound, grafting a polymeric hydrogel onto the surface, for example. As the subject matter of the present claims does not find support in the disclosures of these documents, the effective filing date of the present claims is the filing date of provisional application 63/458692, which is April 12, 2023.
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 3, 13, and 16 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 3 recites a list of possible metal surface materials, including nickel-titanium alloy, which is then followed by the term (Nitinol) in parentheses. The name “Nitinol” refers to a specific alloy composed of roughly equal amounts of nickel and titanium and having specific shape memory properties. (See Sleiman et al., Reference included with PTO-892, p. 2 left column last paragraph) It does not refer to all possible alloys of nickel and titanium. Therefore the occurrence of this name in parentheses after the broader term “nickel-titanium alloy” creates confusion as to whether the claims includes other nickel titanium alloys besides nitinol.
Claims 13 and describe the polymeric surface as selected from one of a number of options including “(vanillyl alcohol-containing copolyoxalate) copolymer (PVAX)”. The parenthesis surrounding (vanillyl alcohol-containing copolyoxalate) makes it unclear whether this species is one of the positively recited species in the list or is merely exemplary of some other member.
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 12 and 20 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. These claims are directed to medical devices. However they depend from claims 1 and 13, respectively, which are directed to processes of manufacturing medical devices, wherein the processes comprise various specific method steps which would not necessarily be required by the dependent claims directed to the device itself. While a device can be defined by the method of its manufacture using so-called “product-by-process” limitations, a dependent claim directed to a device will only be seen to necessarily include all of the limitations of a base claim directed to a method of manufacturing said device if the device must necessarily have been manufactured by said method and there is no alternate way to manufacture a device infringing the dependent claim that does not also infringe the base claim. In the present case, it is unclear whether this is the case. 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-8, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cahalan et al. (US patent 5607475, cited in PTO-892)
Independent claim 1 is directed to a process for manufacturing a heparin coating on a pipeline flow diverter or a stent comprising activating a metal surface with an ethylenically unsaturated silane functional compound, grafting a polymeric hydrogel to the surface, bonding a positively charged spacer to the polymeric hydrogel, and bonding heparin to the spacer. The claim further describes the various reactions grafting the molecular entities onto the surface as “wet chemistry” which is reasonably considered as requiring that the reactants be in solution rather than, for example, in gas phase. The claim further requires that the reactant follow a blood flow path through the medical device, which is interpreted as requiring in its broadest reasonable interpretation that the reactants be allowed to contact the portions of the device which would be in contact with blood after implantation.
Cahalan et al. discloses a medical device having a metal or glass surface having an adherent coat composed of a graft polymer derived from a vinyl-containing silane, a polymer of acrylic acid or acrylamide, which is a hydrogel, and a biomolecule such as heparin which is attached by a positively charged spacer such as a polyamine. (column 3 line 33 – column 4 line 22) Stents are described as a particular embodiment of the disclosed device. (column 4 lines 34-46) A process for manufacturing said device is described column 4 line 60 – column 7 line 51) which includes sequential treatments with the silane, an aqueous solution of acrylic acid, and an aqueous solution of polyethyleneimine, followed by covalent grafting of oxidized heparin. (see columns 7-8 example 1) This process would anticipate all of the steps recited in present claim 1. Regarding present claims 2 and 12, these claims require that the device is a pipeline flow diverter for treating intracranial aneurisms. While Cahalan et al. does not specifically describe the devices manufactured by the disclosed method as pipeline flow diverters, a review of the prior art indicates that such devices are basically similar in structure and function to endovascular stents. (See e.g. the description of such devices in the reference Kim et al., included with PTO-892, which refers to flow diverters and stents interchangeably) The difference between them lies mainly in the intended use, in particular whether they are implanted to reopen occluded blood vessels or to divert blood flow in the vicinity of an aneurism. Therefore the devices described as “stents” by Cahalan et al. are also reasonably considered to fall within the scope of pipeline flow diverters. Regarding claim 3, Cahalan et al. describes stents made from tantalum or stainless steel. (column 4 lines 39-41) Regarding claims 5-6, column 5 lines 3-4 describe trichlorovinylsilane as a preferred silane. Regarding claim 7, column 5 lines 21-32 describe acrylate and acrylamides as preferred monomers for the graft polymer. Regarding claim 8, column 8 lines 10-13 of Cahalan et al. describes using polyethyleneimine as the positively charged layer.
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.
Claims 13 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Atanasoska et al. (US pre-grant publication 2007/0154513, cited in PTO-892)
Independent claim 13 is directed to a process for manufacturing a heparin coating on a catheter comprising activating a metal surface with treatment such as a plasma or corona discharge treatment, grafting a polymeric hydrogel to the surface, bonding a positively charged spacer to the polymeric hydrogel, and bonding heparin to the spacer. The claim further requires that the reactant follow a blood flow path through the medical device, which is interpreted as requiring in its broadest reasonable interpretation that the reactants be allowed to contact the portions of the device which would be in contact with blood after implantation.
Atanasoska et al. discloses a medical device comprising multiple coating layers of alternating charge, and a method of making such a device comprising successively applying layers of alternating charge to the device. (p. 1 paragraphs 6 and 7) The device may be a catheter, or alternately a stent such as a coronary vascular stent or cerebral stent. (pp. 1-2 paragraph 16) The device can be made out of various materials including fluoropolymers. (p. 3 paragraph 31) The surface can be initially activated by plasma treatment including for example corona discharge, (p. 4 paragraph 35) or alternately laser irradiation. (p. 4 paragraph 40) The treated surface is then coated by alternately treating with oppositely charged materials. (p. 5 paragraphs 50-51) The negatively charged polymers can include for example acrylic acid polymers, which are hydrogels. (p. 3 paragraph 27) The positively charged layer can include for example polyamines such as polyethyleneimine. (p. 2 paragraph 26) While the various layers can be noncovalently coupled to the device, covalent coupling can be used as well. (p. 4 paragraph 41-42) Finally, antithrombotic agents such as heparin can be used as the therapeutic agent. (p. 7 paragraph 72)
While Atanasoska et al. does not specifically disclose a process comprising all of the elements of the claimed manufacturing method, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine all of the specific elements (e.g. base implant material, surface activation method, negative and positively charged polymers, covalent grafting) recited in present claim 13. One of ordinary skill in the art would have found it to be obvious to do so because each element is described individually as an option to be used in the general description of Atanasoska et al.
Therefore the invention taken as a whole is prima facie obvious.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Cahalan et al. as applied to claims 1-8 and 12 above, and further in view of Atanasoska et al. (US pre-grant publication 2007/0154513, cited in PTO-892)
The disclosure of Cahalan et al. is discussed above. Cahalan et al. does not disclose a method further comprising attaching further layers of negatively and positively charged spacers to the surface of the device. However, as discussed above, Atanasoska et al. discloses coating a medical device, including a stent or a cerebral stent (i.e. a pipeline flow diverter) with alternating positive and negatively charged layers. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to prepare a coated stent such as that described by Cahalan et al. having multiple alternating negatively and positively charged layers, in view of the description of such devices by Atanasoska et al. suggesting such an arrangement of layers.
Regarding claim 11, while Cahalan et al. does not describe using dextran sulfate as a positively charged layer, Atanasoska et al. describes dextran sulfate as a therapeutic agent that is useful as a coating agent for inhibiting restenosis. (p. 8 paragraph 77) Therefore it would further have been obvious to one of ordinary skill in the art at the time of the invention to include dextran sulfate in at least some of the negatively charged layers of a coated stent, with the expectation that doing so would reduce the risk of restenosis.
Therefore the invention taken as a whole is prima facie obvious.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Atanasoska et al. as applied to claims 13 and 17-20 above, and further in view of Hussain et al. (US pre-grant publication 2014/0288592, cited in PTO-892)
The disclosure of Atanasoska et al. is discussed above. Atanasoska et al. does not specifically disclose a method wherein the plasma treatment is a propene plasma treatment. However Hussain et al. discloses polymer-based surgical articles coated with surface treating layers including heparin to control tissue adhesion. (p. 5 paragraph 60) This device is manufactured by a process comprising treating the surface with plasma and acrylic monomer to form a substrate layer of polyacrylic acid to which further biomolecules are attached. (p. 6 paragraph 62) In certain embodiments the device is a catheter or stent. (p. 8 paragraph 97) Substrates usable in this process include the fluorinated copolymer polytetrafluoroethylene. (p. 8 paragraph 96) In a particular embodiment the surface is initially modified using a plasma treatment of propene plasma. (p. 19 paragraph 200)
It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to use a propene plasma as the plasma treatment in the method of Atanasoska et al. One of ordinary skill in the art would have regarded this as a viable embodiment of the plasma treatments generally described by Atanasoska et al. because Hussain specifically describes propene plasma as usable for a similar coating treatment.
Therefore the invention taken as a whole is prima facie obvious.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Atanasoska et al. as applied to claims 13 and 17-20 above, and further in view of Morra et al. (US pre-grant publication 2003/0163198, cited in PTO-892)
The disclosure of Atanasoska et al. is discussed above. Atanasoska et al. does not specifically disclose a method wherein the plasma treatment is a propene plasma treatment. However Morra discloses a method for surface treating medical devices including catheters. (p. 2 paragraph 12) This process comprises exposing the surface of the device to a plasma and a reactive gas to deposit a coating on the surface. (p. 2 paragraph 13) Such methods can be used to attach biomolecules to the grafted surface, for example to render it blood compatible. (p. 3 paragraphs 21 and 27) IN one embodiment the reactive gas is propylene. (p. 3 paragraph 28) This method is compatible with various substrate materials including PTFE. (p. 4 paragraph 36)
It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to use a propene plasma as the plasma treatment in the method of Atanasoska et al. One of ordinary skill in the art would have regarded this as a viable embodiment of the plasma treatments generally described by Atanasoska et al. because Morra specifically describes propene plasma as usable for a similar coating treatment.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 8/21/2026
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