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
This office action is responsive to the amendment filed on 04/12/2024. As directed by the amendment: claims 64, 65, 70 and 75 have been amended, claims 1-63, 67, 68 and 78-107 have been cancelled and no new claims have been added. Thus, claims 64-66 and 69-77 are presently pending in this application, and currently examined in the Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 64-66 and 69-77 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The last 3 lines of claim 64 set forth the parameter of “achieving sufficient re-endothelialization of the blood vessel within 3 months of the stent implantation such that vascular function restoration can be achieved within 12 months of the stent implantation”; however this parameter fails to comply with written description requirements since the originally filed disclosure does not describe a correlation between the function, of the above mentioned claimed parameter, and the structure(s) responsible for the function. Additionally, one having ordinary skill in the art would not be able to envisage the product arising from the disclosed process/function. Specifically, nowhere in the entire originally filed disclosure is there any explanation or detailing of what exactly would be needed, i.e. structurally, chemically etc., in order to meet the claimed function, disclosed above, and set forth on the last 3 lines of claim 64.
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 64-66 and 69-77 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.
Regarding claim 64, which recites the limitations “the stent implantation”, on lines 3, 4, 5, 7 and 8, “the smooth muscle cell proliferation”, on line 4, and “the first 30 days”, on line 5; there is insufficient antecedent basis for these limitations in the claim. In order to overcome this issue, keep claim terminology consistent and avoid confusion, it is suggested: (i) the word “the” before the word “stent” on line 3, and the word “smooth” on line 4, be deleted, and (ii) the words “the first” before the words “30 days”, on line 5, be deleted. Additionally, the term “sufficient” is considered a relative term which renders the claim indefinite, since the term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Furthermore, the last 3 lines of the claim set forth the parameter of “achieving sufficient re-endothelialization of the blood vessel within 3 months of the stent implantation such that vascular function restoration can be achieved within 12 months of the stent implantation”; however, this parameter is found to be confusing for multiple reasons. Firstly, it is unclear what exactly causes/would be needed to meet, i.e. what structure, chemical, dosage, etc., the function of “achieving sufficient re-endothelialization of the blood vessel within 3 months of the stent implantation. Secondly, it is further unclear if the re-endothelialization is what causes vascular function restoration to be achieved within 12 month, or is there some other structure/mechanism which causes this function. Lastly, it is not clear if the vascular function restoration step is even part of the claimed invention, or if it is merely a recitation of what naturally would occur in the body within a certain time period after impanation of the stent. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 65, which recites the limitations “the thinner portion”, on the 4th to last line of the claim, and “the thicker portion”, on the 3rd to last line of the claim; there is insufficient antecedent basis for these limitations in the claim. Additionally, line 15 and the last line of the claim set forth the limitation of “a vessel”; is this vessel the same blood vessel as first introduced in independent claim 64, from which this claim depends. If so, as it seems to be, it is suggested the limitation be amended to state “the vessel”, on line 15 and the last line of the claim, in order to keep claim terminology consistent. Furthermore, the 4th to last line – the 3rd to last line set forth the parameter of “the thinner portion of the drug-containing layer releases the drug faster than the thicker portion of the drug-containing layer, within 10 to 20 days” (emphasis added); however, this parameter is found to be confusing since it is not clear which portion of the drug-containing layer, i.e. the thinner portion or the thicker portion or both, releases the drug “within 10 to 20 days”. Lastly, the term “about”, on the 3rd to last line, is considered a relative term which renders the claim indefinite, since the term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 66, which sets forth the parameter of “suppressing the smooth muscle proliferation is achieved by controlled release of a suitable drug from the implanted stent through proper dosage and release curve” (emphasis added); however, this parameter is found to be confusing since it is not clear what exactly, quantitatively, is meant by the term “proper dosage” and/or “release curve”. Specifically, it is unclear what exact amount, of the suitable drug, would be needed in order to meet the function of suppressing the smooth muscle proliferation; and further unclear what exactly the release curve is and/or what it represents, i.e. release of what, when, at what amount etc. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 69, which recites the limitation “the biocompatible and biodegradable carrier”, on lines 1-2; there is insufficient antecedent basis for this limitation in the claim. Additionally, it is not clear what exactly “the biocompatible and biodegradable carrier” is, and/or how it relates to the structure of the implanted stent, and/or how it relates to the claimed method.
Regarding claim 70, which recites the limitation “the drug carrier layer”, on line 1; there is insufficient antecedent basis for this limitation in the claim. Additionally, it is not clear what exactly “the drug carrier layer” is, and/or how it relates to the structure of the implanted stent, and/or how it relates to the claimed method.
Regarding claim 71, which recites the limitations “the surface”, on line 1, “the endothelial cell”, on line 2, “the proper”, on line 3, “the cells”, on line 3, and “the stent strut surface”, on line 4; there is insufficient antecedent basis for these limitations in the claim. In order to overcome this rejection, keep claim terminology consistent and avoid confusion, it is suggested: (i) the word “the”, before the word “surface” on line 1, be deleted and replaced with the word “a”, (ii) the word “the”, before the words “endothelial”, on line 2, “proper”, on line 3, and “cells”, on line 3, be deleted, and (iii) the word “strut”, between the words “stent” and “surface”, be deleted. Additionally, line 3 sets forth the parameter of “to reestablish the proper interaction among the cells”; however, this parameter is found to be confusing for multiple reasons. Firstly, it is unclear what exactly, structurally and/or functionally, is meant by the term “proper interaction”, i.e. what does “proper interaction” entail/how would one having ordinary skill in the art know if/when “proper interaction” is achieved; and the originally filed specification does not aid in explaining or clarifying such a term. Secondly, it is not clear what exactly is meant by the term “the cell”, what/which cells are these exactly; are they the cells which achieved re-endothelialization (as set forth in claim 64 from which claim 71 depends), or are they the endothelial cells (as set forth on line 2 of this claim), or are they other completely different cells, and/or are they a combination of cells, and if so, which cells/what combination. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 72, which recites the limitation “the surface”, on line 1; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection and avoid confusion, it is suggested the word “the” be deleted and replaced with the word “a”.
Regarding claims 73 and 74, the term “about” is considered a relative term which renders the claim indefinite, since the term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 75, which recites the limitation “the suitable drug”, on line 1; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection, keep claim terminology consistent and avoid confusion, it is suggested claim 75 depend from claim 66, which first introduces the limitation of “a suitable drug” on line 2, instead of depending from claim 64.
Regarding claims 76 and 77, which recite the limitation “the suitable stent”, on line 1 of both claims; there is insufficient antecedent basis for this limitation in the claims. In order to overcome this rejection, keep claim terminology consistent and avoid confusion, it is suggested the word “suitable” be deleted from the above mentioned limitation in both claims.
Examiner’s Note
Examiner cites particular columns, pages and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 64, 66, 69, 70-72, 75 and 76 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hou et al. (A prospective randomized controlled 3 and 12 months OCT study to evaluate the endothelial healing between a novel sirolimus eluting stent BUMA and an everlimus eluting stent XIENCE V; access at https://www.sinomed.com/wp-content/uploads/2013/05/BuMA-OCT-study-vs_-XIENCE-V-EuroPCR2013.pdf; Euro PCR 2013), hereinafter Hou.
Regarding claims 64, 66, 75 and 76, Hou discloses a method of reducing and/or eliminating the restenosis, thrombosis, or Major Adverse Cardiovascular Events (MACE) of a blood vessel associated with a stent implantation, comprising the steps of suppressing smooth muscle cell proliferation of the blood vessel after the stent implantation within 30 days of the stent implantation, achieved by controlled release of sirolimus from the implanted stent through proper dosage and release curve, wherein the implanted stent is a metal stent; and achieving sufficient re-endothelialization of the blood vessel within 3 months of the stent implantation such that vascular function restoration can be achieved within 12 months of the stent implantation (Pg. 3, 4th bullet point; Pg. 4 – Pg. 6).
Regarding claim 69, Hou discloses the method of claim 64, wherein the biocompatible and biodegradable carrier material is PLGA (Pg. 4).
Regarding claim 70, Hou discloses the method of claim 64, wherein the drug carrier layer (biodegradable PLGA polymer + Sirolimus layer) completely disappears within 60 days of implantation (Pg. 4).
Regarding claim 71, Hou discloses the method of claim 64, wherein the surface of the implanted stent is smooth, or without significant obstacles for the endothelial cell to grow upon, to reestablish the proper interaction among the cells and to cover the stent strut surface (illustrated on Pg. 6, 2nd Column, Top Figure – BUMA stent).
Regarding claim 72, Hou discloses the method of claim 66, wherein the surface of the stent is coated with polymer using electro-grafting coating technology (Pg. 3, 4th bullet point; Pg. 4 & Pg. 6).
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 73, 74 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Hou as applied to claim 66 above, and in view of Vyas et al. (WO 2016/005991), hereinafter Vyas.
Regarding claims 73 and 74, Hou discloses the method of claim 66, but does not specifically disclose the stent has a thickness of about 100mm to 110mm.
However, Vyas teaches a stent, in the same field of endeavor, wherein the stent has a thickness about 100mm to 110mm (Pg. 10, Lines 9-10 & Pg. 13, Lines 10-11).
In view of the teachings of Vyas, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the stent, of the method of Hou, to have a thickness of about 100mm to 110mm, as taught by Vyas, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05).
Regarding claim 77, Hou discloses the method of claim 66, but does not specifically disclose the stent is a polymeric stent, partially or completely biodegradable.
However, Vyas teaches a stent, in the same field of endeavor, wherein the stent is a biodegradable polymeric stent (Pg. 10, Lines 8-9 & Pg. 13, Lines 9-10).
In view of the teachings of Vyas, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the stent, of the method of Hou, to comprise a biodegradable polymer, as taught by Vyas, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07).
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774