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 invention I (claims 1-12) in the reply filed on 06/30/26 is acknowledged.
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/30/26.
Claim Objections
Claims 1-5, 7, 9-12 are objected to because of the following informalities:
Claim 1 is objected to for referring to “individual struts” when it is unclear whether or how these relate to the previously claimed “struts”.
Further, the claim is unclear for claiming the struts are “connected at apices” but it is unclear what the struts are connected to at the apices (e.g. themselves, the connectors, the helical turns, the zig-zag pattern, something else?).
Further, the claim is unclear for referring to “the shape”, “the inner apices”, “the unconstrained state” and “the positions” with improper antecedent basis.
Further, the claim is unclear for referring to “two axially adjacent helical turns” when it is unclear how, if at all, this relates to the previously claimed “adjacent helical turns”.
Further, the claim is unclear for claiming “at a position between the two connectors delimiting it” when it is unclear what “it” is referring to.
Claim 2 is unclear for referring to “the luminal and/or abluminal surface” with improper antecedent basis.
Further, the claim is unclear for claiming the covering material covers at least “parts” when it is unclear whether or not this means the covering material must cover more than one part of either the luminal surface or the abluminal surface, more than one part of both surfaces, or one part of one or the other surface. It is unclear what the “s” on “parts” adds to the meaning of the claim.
Claim 3 is objected to for referring to “the apices” when it is unclear whether this is referring back to the previously claimed “apices”, or “the inner apices” or something else.
Claim 4 is objected to for referring to “the larger one of the second axial dimensions” with improper antecedent basis.
Claim 5 is objected to for referring to “struts” when it is unclear how, if at all, this is related to the previously claimed “struts”.
Claim 7 is objected to for referring to “the rectangle”, “the axial direction” and “the unconstrained implant” with improper antecedent basis.
Claim 9 is objected to for referring to “the apices” when it is unclear which of the previously claimed “apices” or “inner apices” may or may not be being referenced here.
The claim is further unclear for referring to “the axial direction”, “the unconstrained implant” with improper antecedent basis.
The claim is further unclear for referring to a “direction of extension of the struts” since the claims have not identified the struts extending anywhere.
Claim 10 is objected to for referring to “the thickness” of the apices and “the thickness” of the struts when it is unclear how, if at all, these relate to the previously claimed “thickness (W)” and “thickness (w)”.
Further, it is again unclear which of the previously claimed “apices” is being referenced with this claim.
Claim 11 is objected to for referring to “the entirety of the base stent” with improper antecedent basis.
Claim 12 is objected to for referring to “ePTFE, PET, and/or PU” without first typing out the meaning of these acronyms.
Appropriate correction is required.
Drawings
The drawings are objected to because:
item 132 is in the figures but not the specification
item 112 is used to represent “helical turns”, “first turns” ,and “adjacent helical windings”
item 120’ is used to represent both elements “bent line” and “connecting line”
Figure 4 shows item “W” as pointing to various different items, and does not show “w”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: the specification brief description refers to figure 4, and does not refer to the actual figures 4a-d.
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 4-5, 7 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 pre-AIA the applicant regards as the invention.
Claim 4 is indefinite for claiming the first axial dimensions is at least 105%...of “the larger one of the second axial dimensions” when it is unclear what is referring to, since there is not understood to be different second axial dimensions. It is unclear what this means.
Claim 5 is indefinite for claiming the struts are arranged in a ring-like shape, when it is unclear what “ring-like” means. For example, the Examiner understands what a ring shape is, but it isn’t know what Applicant might consider to be “ring-like” in shape, and exactly how close to a ring (or how far from a ring shape) the shape can deviate and still be considered to be ring-like in shape. The specification does not appear to provide any direction or guidance regarding this, making the Examiner unclear on its meaning.
Claim 7 is indefinite for claiming the markers are “essentially” rectangular but the Examiner is uncertain on what it means to be “essentially rectangular”, for example as opposed to being rectangular, or not rectangular. The specification does not appear to give any guidance regarding what is considered essentially rectangular, as compared to any other shape, let alone rectangular, and so the Examiner cannot understand what might fall within the guidelines of what is “essentially rectangular” and what is outside the boundaries. For example, it is unclear whether something that is oval shape, or square in shape, or rectangular in shape, to be “essentially rectangular” or not.
Remaining claims are rejected for depending on a rejected claim.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-5, 8-9, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong et al. (US 20120303112 A1) hereinafter known as Armstrong in view of Cottone et al. (US 7169175 B2) hereinafter known as Cottone.
Regarding claim 1 Armstrong discloses an implant comprising:
a base stent having a tubular shape (Figure 1 item 100; [0003] tube-like support structure) and surrounding a lumen (Figure 1; [0006]) the stent comprising a first section (Figure 1 and 2a-b item 120) having helical turns (Figures 1 and 2a-b item 121, 122), wherein adjacent helical turns are connected to each other by connectors that extend between adjacent helical turns (Figures 1 and 2a-b item 125) and that limit movement of the adjacent helical turns relative to each other (this is considered to be inherent by the presence of the connectors),
wherein the helical turns comprise struts that are connected in a zig-zag pattern (Figures 1 and 2a-b, item 124) with individual struts being connected at apices (Figures 1 and 2a-b item 123), and
wherein the shape that is defined by the inner apices of two axially adjacent helical turns and by two connectors that are adjacent one another is roughly hexagonal (see Annotated figure 3c, below) and has, in the unconstrained state of the implant, at a position between the two connectors delimiting it, a longer first axial dimension (T) than second axial dimensions (t) at the positions of the two connectors (),
but is silent with regards to a first axial dimension (T) between the two connectors, being longer than the second axial dimension (t) at the connectors.
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However, regarding claim 1 Cottone teaches wherein stents can have, in its unconstrained state, at a position between the two connectors delimiting it, a longer first axial dimension (T) than second axial dimensions (t) at the positions of the two connectors (see Annotated Figure 2 below). Shanley and Cottone are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of Shanley so that connector is shorter than the axial dimensions therebetween as is taught by Cottone since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any shape or dimension of connector is considered obvious to the person of ordinary skill to try.
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Regarding claim 2 the Armstrong Cottone Combination teaches the implant of claim 1 substantially as is claimed,
wherein Armstrong further discloses a covering material that covers at least parts of the luminal and/or abluminal surface of the stent ([0059]).
Regarding claim 3 the Armstrong Cottone Combination teaches the implant of claim 1 substantially as is claimed,
wherein Armstrong further discloses in the unconstrained state of the implant, the struts are arranged within a cylindrical surface of the implant so that they do not extend inwardly or outwardly, with the apices arranged within the cylindrical surface (see Figures 1-9).
Regarding claim 4 the Armstrong Cottone Combination teaches the implant of claim 1 substantially as is claimed,
wherein Cottone further teaches the first axial dimension (T) is at least 105% of the larger one of the second axial dimensions (t) (Annotated Figure 2 above).
Regarding claim 5 the Armstrong Cottone Combination teaches the implant of claim 1 substantially as is claimed,
wherein Armstrong further discloses the first section is arranged at a central part of the stent (Figures 1, 2a-b),
wherein the stent further comprises one section adjacent to the first section which is configured by struts that are arranged in a ring-like shape (Figures 1, 2a-b item 110p and 110d).
Regarding claim 8 the Armstrong Cottone Combination teaches the implant of claim 1 substantially as is claimed,
wherein Armstrong further discloses the stent comprises a self-expanding material ([0041]).
Regarding claim 9 the Armstrong Cottone Combination teaches the implant of claim 1 substantially as is claimed,
wherein Armstrong further discloses some of the apices have a thickness (W) along the axial direction of the unconstrained implant that is greater than or equal to a thickness (w) of the struts connected to those apices when measured along a direction perpendicular to a direction of extension of the struts (Figure 4a-b, [0087] table 2 the strut width is 0.1mm and the apex width is 0.2 mm).
Regarding claim 11 the Armstrong Cottone Combination teaches the implant of claim 2 substantially as is claimed,
wherein Armstrong further discloses the entirety of the stent is covered with the covering material ([0123]).
Regarding claim 12 the Armstrong Cottone Combination teaches the implant of claim 2 substantially as is claimed,
wherein Armstrong further discloses the covering material comprises ePTFE, PET, and/or PU ([0059]).
Claims 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong and Cottone as is applied above in view of Bales et al. (US 20090204200 A1) hereinafter known as Bales.
Regarding claim 6 the Armstrong Cottone Combination teaches the implant of claim 1 substantially as is claimed,
wherein Armstrong further discloses radiopaque markers ([0123]), but is silent with regards to them being at one longitudinal end.
However, regarding claim 6 Bales teaches that markers can be located on a longitudinal end of the implant (Figure 1 item 60; [0045]). Armstrong and Bales are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the location of the markers of Armstrong so they are on the longitudinal end as is taught by Bales since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the positioning of the markers on any known location of the stent would have been obvious to the person of ordinary skill to try.
Regarding claim 7 the Armstrong Cottone Combination teaches the implant of claim 6 substantially as is claimed,
but is silent with regards to the markers being essentially rectangular.
However, regarding claim 7 Bales teaches that markers on the end of stents can be essentially rectangular (Figure 1 item 60; [0045]). Armstrong and Bales are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the shape of the markers of Armstrong to have them be essentially rectangular as is taught by Bales since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by Armstrong.
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong and Cottone as is applied above, further in view of Akimoto (US 20200375767 A1).
Regarding claim 10 the Armstrong Cottone Combination teaches the implant of claim 9 substantially as is claimed,
but is silent with regards to the thickness of some of the apices along the axial direction of the implant is less than 120% the thickness of the struts connected thereto.
However, regarding claim 10 Akimoto teaches that the thickness of apices of a zig-zag helical strut pattern can be less than 120% the thickness of the struts connected to those apices ([0045], Figures 2-3). Armstrong and Akimoto are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the width of the apices or the strut so that the apices remain thicker than the strut, but are less than 120% the thickness, as is taught by Akimoto since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by Armstrong.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 07/13/26
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