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 .
Response to Amendment
Claims 16, 18-24, 26-36 are pending in the application. Claims 26-35 are withdrawn. Claims 16, 19, 20 have been amended. Claims 17 and 25 have been cancelled. Claim 36 is newly added. Claims 16, 18-24, and 36 are rejected.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 25, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 16, 18-23, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant Yang et al (US PG Pub 2018/0193026) in view of Hannes et al (US PG Pub 2014/0058498).
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Regarding claim 16, Yang teaches a medical set (See Figs. 3A, 11A, and 11E) for treatment1 of an aneurysm comprising:
a main catheter (104) (See paragraphs [0094]-[0098]); and
a covering device (device 10) adapted to move through the main catheter to a treatment site to cover the aneurysm (See paragraphs [0094]-[0098]; Figs. 12A-12I), the covering device adapted to connect to a transport wire (24) (See paragraphs [0059], [0094]-[0098]), the covering device including a self-expandable mesh structure (See Figs. 11A & 11E, note lattice structure; see also paragraph [0093] which states the device is self-expanding) having webs (struts) connected together in one piece and that delimit inner cells and edge cells (See annotated Fig. 11E above), wherein at a longitudinal end of the mesh structure, the edge cells form a closed edge cell ring connected to the inner cells on only one side (See Figs. 11A and 11E, note the edge cell struts are connected to the inner cell struts on only one side),
wherein the mesh structure is provided with a covering (60) having at least 10 pores (See Figs. 2A and 11E; paragraph [0053]) over an area of 100,000 µm2 (See paragraph [0062] which provides a range of lengths2 and diameters for the device) and wherein at least one inner cell of the mesh structure is at least partially covering-free (See Fig. 11E, paragraphs [0091]-[0092]).
Yang does not explicitly teach the covering is produced from an electrospun fabric having pores of irregular sizes wherein the pore size is at least 15µm2. Yang teaches the covering may be a variety of known suitable polymeric materials including various fluoropolymers and silicones (See paragraph [0087]) applied by a variety of processes including vapor deposition, spray coating, dip coating, spin coating, sputter deposition (See paragraphs [0008]; [0044]; [0045]; [0047]). Yang also teaches the covering (coating) may be applied differently to different regions and may have variable porosity (See paragraph [0053] and [0091]) and that additional perforations of varying sizes may be added to the covering (See paragraph [0053]).
Hannes teaches an analogous medical set for treatment of an aneurysm (See paragraphs [0002]-[0003]) featuring a covering device (stent) made of a self-expandable mesh (stent) having webs connected together (See paragraphs [0033] and [0039]) and covered with an electrospun fabric (membrane) (See paragraphs [0012] and [0018]) having pores of irregular sizes3 where the covering as at least 10 pores with a size of at least 15µm2. (See Figs. 4-6; paragraphs [0014]-[0016]). Hannes teaches a pore size of at least 15µm2 is especially favorable for the ingrowth of endothelial cells (See paragraph [0016]) Hannes teaches the membrane may be formed by immersion or spray coating (See paragraph [0011]), but that the membrane is most preferably formed by electrospinning (See paragraphs [0012]). Electrospinning is known to produce a thin and uniform membrane which bonds with the stent framework and allows for control of the degree of porosity as desired. (See paragraphs [0012], [0025], [0026], and [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by Yang so as to apply the covering via electrospinning as taught by Hannes such that the covering pore size is at least 15µm2 since electrospinning is known to be an advantageous and preferably means of applying a coating to a stent and pores of at least 15µm2 are known in the art to be optimally sized for the ingrowth of endothelial cells. Using an electrospun process as taught by Hannes to form the covering in the device of Yang is a simple substitution of one known element for another to obtain predictable results. Furthermore, it is deemed to be within the level of ordinary skill in the art to use a known material. Yang expressly contemplates using a variety of different processes. (See paragraph [0045]). Additionally, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183) As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B).
As disclosed, the number of pores of a particular size over an area of the electrospun covering is disclosed to be a result effective variable which assists with colonization by endothelial cells and sufficient perfusion of the covering by blood. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Yang to have an electrospun covering which has at least 10 pores with a size of at least 15µm2 over an area of 100,00µm2, as it only involves adjusting the dimension of a component already disclosed to be adjustable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the number of pores of a particular size over an area as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05
Regarding claim 18, modified Yang teaches the medical set as required by claim 16 above and further teaches the covering device (10) is reversibly connectable to the transport wire (24) and, in an expanded state, is open on both end sides and perfusible by blood. (See Figs. 11A and 11E; paragraphs [0059]; [0064]; [0077]; [0093]-[0099]).
Regarding claim 19, modified Yang teaches the medical set as required by claim 16 above and further teaches the webs (struts) of the inner cells are respectively associated with one of a further inner cell or edge cell (note the inner cells are those directly inward at the outer band and are associated with further inner cells). (See Fig. 11E as annotated above; paragraphs [0093]-[0099])
Regarding claim 20, modified Yang teaches the medical set as required by claim 16 above and further teaches the covering ends at the webs of the inner cells are free from the covering such that the covering does not protrude into the at least one inner cell. (See Fig. 11E; paragraphs [0091]-[0092])
Regarding claim 21, modified Yang teaches the medical set as required by claim 16 above and further teaches the covering at least partially overlaps the webs of the at least one inner cell such that part of the covering protrudes into the at least one inner cell which is free from the covering. (See Fig. 11E; paragraphs [0091]-[0092]; note the covering is on the struts surrounding the uncovered cells)
Regarding claim 22, modified Yang teaches the medical set as required by claim 16 above and further teaches a plurality4 of inner cells immediately adjacent in a circumferential direction of the mesh structure is covering-free. (See annotated Fig. 11E ; paragraphs [0091]-[0092])
Regarding claim 23, modified Yang teaches the medical set as required by claim 16 above and further teaches a plurality5 of inner cells immediately adjacent in a longitudinal direction of the mesh structure is covering-free. (See annotated Fig. 11E; paragraphs [0091]-[0092])
Regarding claim 36, modified Yang teaches the medical set as required by claim 16 above and further teaches wherein the edge cells respectively have two webs (struts) which are not associated with one of other inner cells or edge cells (See annotated Fig. 11E.)
Claim 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant Yang et al (US PG Pub 2018/0193026) in view of Hannes et al (US PG Pub 2014/0058498) as applied to claim 16 above and further in view of previously cited Cox et al (US PG Pub 2017/0245862).
Regarding claim 24, modified Yang teaches the medical set as required by claim 16 above and further teaches the covering extends by at most 50% over a circumference of the mesh structure. (See paragraph [0092] which states the covering may be applied only on a portion of the device or on selective sections of the device).
Alternatively, Cox teaches an analogous medical set for treating aneurysms featuring a catheter (110), a covering device (100) connected to a transport wire (112) the covering device including a self-expandable mesh structure (132) having webs (struts) that delimit inner cells (near the center of the device) and outer cells (at the respective ends of the device) where the mesh structure (132) is provided with a covering (134) which extends along only a portion of the middle of the device and covers less than 50% over a circumference of the mesh structure (See Figs. 16 and 18).
It would have been obvious to one of ordinary skill in the art at the time of invention to further modify Yang to incorporate the teachings of Cox such that the covering extends by at most 50% over a circumference of the mesh structure since Yang already contemplates having the covering extend only over certain desired portions of the device (See paragraphs [0091]-[0092]) and Cox teaches having a covering which only spans the opening of the aneurysm is advantageous for redirecting flow and reducing the likelihood the aneurysm will burst. (See paragraphs [0094]-[0095]; [0098]).
Response to Arguments
Applicant's arguments filed September 25, 2025 have been fully considered. Applicant’s arguments with respect to the 35 U.S.C. §112 indefinite rejections are persuasive. The 112 rejections have been withdrawn.
Applicant’s arguments, filed September 25, 2025, with respect to the rejection(s) of claim(s) 16-25 under Yang et al (US PG Pub 2018/0193026) in view of Cox et al (US PG Pub 2017/0245862) further in view of Heiferman (US PG Pub 2019/0110881) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yang et al (US PG Pub 2018/0193026) in view of Hannes et al (US PG Pub 2014/0058498) as set forth above.
It is noted the incorporation of the limitations of claims 17 and 25 into claim 16 has changed the scope of the claims and necessitates the new ground of rejection.
The Heiferman reference is no longer being applied in any grounds of rejection.
The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary reference. For the reasons set forth above, this is unpersuasive.
Conclusion
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 RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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/R.S.H/Examiner, Art Unit 3774
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
1 It is noted that this is a recitation of intended use in the preamble and not given full patentable weight, in that the prior art is not required to disclose this function/method of use. Since the body of the claim in the instant case fully and intrinsically sets forth all the limitations of the claimed invention, the preamble recitation of intended use is not considered a claim limitation. Additionally, MPEP 2111.02(II) states: “If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)”. In the instant case, Yang expressly contemplates using the medical set to treat aneurysms (See Title, Abstract, Summary of the Invention, etc.)
2 Paragraph [0062] states the stent may be at least 5mm to more than 25mm in length and at least 2mm to more than 10mm in diameter. Using the standard, known equation for calculating the area of a cylinder (
A
=
2
π
r
h
+
2
π
r
2
), this results in a range of area between roughly 37.6991mm2 to 942.4778mm2 which encompasses the claimed area value of 100,000µm2 which is equal to 100mm2.
3 It is noted that the process of electrospinning is known to inherently create pores of irregular sizes. (As stated in applicant’s arguments page 7 dated 9/25/2025)
4 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, a “plurality” is two or more. As seen in annotated Fig. 11E there are at least two uncovered inner cells which are immediately adjacent to one another in a circumferential direction.
5 See footnote 3 above