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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/30/26 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant did not submit any argument pointing out disagreements with the examiner’s contentions on dependent claims or teaching references. Thus since the argument was against the independent claim, applicant did not explain how the claims avoid the references or distinguish from them, these teaching references are maintained.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,6,8, 9,21-23 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Johnson et al. (2015/0086607) or, in the alternative, under 35 U.S.C. 103 as obvious over Addison et al. (2010/0063467). Johnson et al. shows (Fig. 6) an intraluminal endoprosthesis comprising: a supporting structure and a sleeve applied to the supporting structure. Johnson et al. disclose (paragraphs 24, 32) the sleeve is formed from a composite material layer of a fibre mixture of polymer fibres and hydrogel fibres (inherent since same material is disclosed-alginate), and wherein the polymer fibres comprise at least one biodegradable polymer such as a polytrimethylene carbonate-based polymer. However, in the alternative Johnson et al. did not explicitly state the fibers are of hydrogel type. Addison et al. teach (paragraph 9) that hydrogel fibers include alginate and are capable of absorbing large amounts of water. It would have been obvious to one of ordinary skill in the art to alternatively provide the alginate or second type of the composite fiber material as a hydrogel as taught by Addison et al. with the sleeve of Johnson et al. such that it provides a sufficient substrate support to maintain a covering on the stent, whereas the other material is able to degrade, see paragraph 2 of Addison suggesting maintaining some structure when another fiber of a composite is degradable. Regarding claim 6, Johnson et al. disclose the hydrogel can comprise at least one biodegradable hydrogel which is selected from the group consisting of: polysaccharide; hyaluronic acid (crosslinked); chitosan; alginate; chitosan alginate; gelatine; proteins; collagen. With respect to claim 8, Johnson et al. disclose (paragraph 35) there can be an active substance incorporated into or anchored to a surface of the polymer fibers, such as providing an antithrombotic effect or a growth factor. Regarding claim 9, Johnson et al. also disclose (paragraphs 27,31) an active substance is incorporated into or anchored to a surface of the hydrogel fibres, wherein the active substance is selected from the group consisting of: an active substance with coagulation-promoting effect; fibrinogen; calcium; thrombin, thrombokinase; an antifibrinolytic; para-aminomethyl benzoic acid; tranexamic acid; aprotinin; chelate; citrate; EDTA; protamine; vitamin K; a wound-healing or tissue-like substance for promoting the formation of new tissue and/or cell integration and/or cell attachment; a stimulating factor; a growth factor; a substance having its own cells; a substance having keratinocytes; fibrin fibres, an extracellular matrix protein; collagen; laminine; hyalurone. With respect to claims 21,22 the same explanation as above for claim 1 is applicable to the scope of this claim and regarding the sleeve on the outer surface, see Fig. 6 showing the polymer sleeve of electrospun fibers applied on the support structure stent. Regarding claim 23, as mentioned for claim 21, the same explanation above for claim 1 having the stent support structure covered with an outer sleeve as seen in Fig. 6 and materials detailed above by Johnson. It can be construed the use of “hybrid” can be synonymous with composite and explained above for Johnson stating combinations of materials can be used to provide composite fiber mix or what one of ordinary skill can consider a “hybrid” of polymer and hydrogel, see paragraph 35.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2,10, 11,17,20 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (2015/0086607) and alternatively in view of Addison and in view of Weber et al. (2007/0244569). Johnson et al. and alternatively in view of Addison is explained supra. However, Johnson et al. and alternatively modified with Addison did not explicitly state a polymer coating on the supporting structure. Weber teaches a polymer (paragraphs 39,115) coating 30 on the supporting structure 10, see Fig. 1B. Regarding claim 11, Weber teaches (paragraph 41) the coating layer can contain a medicament, paragraph 97 and can included heparin, paragraph 124. It would have been obvious to one of ordinary skill in the art to utilize a coating on the support and provide a therapeutic agent therein, such as heparin taught by Weber et al. with the intraluminal prosthesis of Johnson et al. alternatively modified with Addison such that it prevents clotting and assists in preventing restenosis about the scaffold. With respect to claims 2, 17, it is noted that the supporting structure of Johnson can be metal, paragraph 18. However, Johnson et al. did not explicitly state the metal supporting structure is nitinol, a Ni-Ti alloy or a Co-Cr alloy. Weber et al. teach (paragraphs 147, 155, claim 10 of doc.) the supporting structure can be nitinol or a Co-Cr alloy. It would have been obvious to one of ordinary skill in the art to select a known metal such as nitinol or Co-Cr alloy for the support structure as taught by Weber et al. in the stent of Johnson et al. and alternatively in view of Addison such that the appropriate flexibility for the stent is provided in order to deliver in tortuous vessels, but also utilize its superelastic properties in order to deliver minimally invasively. Selecting the material appropriate for the intended use only involves routine skill in the art. Regarding claim 20, Weber et al. teach (paragraphs 79, 124) the polymer coating is a medicament eluting polymer.
Claim(s) 4,18 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (2015/0086607) and alternatively in view of Addison and in view of Shulze et al. (2003/0225450). Johnson et al. and alternatively modified with Addison is explained supra. However, Johnson et al. and alternatively modified with Addison did not explicitly detail the polymer is a polymer D,L lactide-co- glycolide with a lactide proportion from 5 wt% to 85 wt% or between 50-85 wt%. Shulze et al. teach (paragraph 23) that poly D,L lactides can be used as coatings on stents. Shulze et al. teach (paragraphs 53,54) that the amount or proportion of the polymer can be provided in the range of within 5-85 wt%, but even within the range of 50-85 wt%. It would have been obvious to one of ordinary skill in the art to select the appropriate polymer composition amount proportion to be within 5-85 wt% or even to be within 50- 85 wt% as taught by Shulze et al. with the stent of Johnson et al. and alternatively in view of Addison to sufficiently maintain the desired amount of drug therein and provide the proper elution rate. Further selecting the appropriate poly D,L lactide and use D,L lactide-co-glycolide only involves routine skill in the art and is a result expected variable, in using its specific properties based on known differences with the D,L lactides. Finding the optimal polymer to use is an obvious expedient based on desired needs of the patient conditions in which it will be placed.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (2015/0086607) and alternatively in view of Addison and in view of Baker et al. (6221102). Johnson et al. and alternatively modified in view of Addison is explained supra. It is noted that Johnson et al. did disclose (paragraphs 25,27) the sleeve fibers comprises a substance that is visible under X-ray. However, Johnson et al. alternatively modified with Addison did not explicitly detail the material that is visible under X-ray, such as platinum. Baker et al. teach that a graft or sleeve is to include a substance that is visible under X-ray, such as platinum. Baker et al. teach (Fig. 10) that the sleeve 121 comprise a substance or marker 156 that is visible under X-ray, such as platinum, col. 12, lines 6-15. It would have been obvious to one of ordinary skill in the art to utilize a substance that is visible under X-ray, such as platinum taught by Baker et al. with the stent sleeve of Johnson et al. and alternatively in view of Addison such that it provides the surgeon or radiologist ability to see and determine location of the stent with the sleeve its placement.
Claim(s) 12,19 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (2015/0086607) alternatively in view of Addison and in view of Agnew (2007/0027528). Johnson et al. and alternatively in view of Addison is explained supra. However, Johnson et al. alternatively in view of Addison did not disclose the radiopaque compound is zircon dioxide. Agnew teaches (paragraph 43) that a stent support device provided with a radiopaque compound that can be zirconium dioxide and can be in a polymer cover/sleeve. It would have been obvious to one of ordinary skill in the art to select a known radiopaque compound such as zirconium dioxide taught by Agnew with the stent of Johnson et al. alternatively modified with Addison such that the appropriate imaging capability is provided.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (2015/0086607) and alternatively in view of Addison and in view of Falotico et al. (CN 10102). Johnson et al. as alternatively modified in view of Addison is explained supra. However, Johnson et al. and alternatively modified in view of Addison did not explicitly detail the sleeve comprises an adhesive to adhere to a balloon of a balloon catheter. Falotico et al. teach (paragraphs 26,40,41) balloon catheters can be used to deliver a stent and adhesive properties of coatings used thereon bond the stent coated device on the balloon catheter, paragraphs 43,47. It would have been obvious to one of ordinary skill in the art to utilize adhesive property coatings as taught by Falotico et al. with the stent of Johnson et al. and alternatively in view of Addison as it would assure the stent does not slip or move along the catheter during delivery to the site.
Claim(s) 15, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (2015/0086607) alternatively in view of Addison and in view of Blanzy (2011/0160838). Johnson et al. alternatively modified with Addison is explained supra. It is noted that the supporting structure of Johnson can be metal, paragraph 18. However, Johnson et al. and alternatively in view of Addison did not explicitly state the metal supporting structure is Co-Cr-alloy and specifically the alloy being L605. Blanzy teaches that a Co-Cr alloy such as L605 is used in stents. Blanzy teaches (paragraphs 21,22) that Co-Cr Alloy such as L605 has a relatively high yield strength and a high ultimate tensile strength along with a high modulus. It would have been obvious to one of ordinary skill in the art to select a known alloy such as L605 to be the selected Co-Cr Alloy as taught by Blanzy in the stent of Johnson et al. and alternatively in view of Addison such that a high yield strength and high ultimate tensile strength could be provided to give strong support to the vessel wall of the lumen it is placed therein.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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