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 Arguments
Applicant's arguments filed 3/11/2026 have been fully considered but they are not persuasive. Regarding the rejection of claims 1-10, 12, and 13 under 35 U.S.C. 112(a), the amendments overcome the rejection of claims 12 and 13, but claims 1-10 are still rejected under 35 U.S.C. 112(a) since claim 1 recites “connected to the least one of the plurality of webs only in the longitudinal direction”. See the rejection below for further information.
Regarding the rejection of claims 1-10, 12, and 13 under 35 U.S.C. 112(b), the amendments overcome the previous rejection except for claim 13. Applicant argues figs. 5-7 show the joint element distributed in the circumferential direction. This is not persuasive because the claim actually requires “wherein the plurality of joint elements is provided along an entire circumference of the structure”. As discussed previously and below, it is unclear how the joint elements can be “along an entire circumference of the structure” when the bridge webs are “unconnected in the circumferential direction”.
Arguments regarding the rejection of claims 1-3, 5, 7, 8, 10, and 11 under 35 U.S.C. 102(a)(1) as being anticipated by Braido have been fully considered. In light of the claim amendments, the embodiment of figs.14A-14B of Braido is no longer applied in the rejection.
Arguments regarding fig.21F of Braido are not persuasive. Applicant argues claims 1 and 12 were amended to define the ends of the webs to distinguish from the examiner’s application of Braido. Applicant only refers to fig.21F of Braido, but the examiner previously also relied upon the embodiment of fig. 21G which applicant does not address in the arguments. While applicant mentions fig.21F, applicant does not explain why the amendments overcome the embodiment of fig.21F of Braido. It is clear from Braido figs. 21F and 21G that opposing ends of the web are arranged longitudinally separated by the gap and between the bridge webs such that when a predetermined axial pressure is exceeded, the opposing ends are compressed so as to bear on one another. See the annotated figs.21F and 21G below which show a gap capable of allowing the opposing ends of the web to be compressed and bear on one another. Also see par.238 which explains that support struts 2204F can “shorten” which means the opposing ends are capable of being compressed together to bear on one another. Applicant may consider amending the claims to distinguish over Braido by clarifying that each web comprises opposing free ends/cantilevered/flanged portions within a space formed between the bridge webs as shown in figs.5-15. The examiner is referring to portions with reference numbers 64, 164, 264, 364, 464, and 564 as shown in figs. 10-15 of the instant application.
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Regarding new claim 14, applicant argues the claim is added in view of the surprising interpretations that the examiner applied to claims 1 and 12. Applicant does not explain what interpretations were surprising, but the examiner notes that claims 1-10, 12, and 13 are directed to “An implant” and claim 8 specifically says “the implant being a stent”. New claim 14 is directed to “A catheter sleeve connected to the outer shaft of a catheter” which is an invention that is independent and distinct from the invention originally claimed and is withdrawn as discussed in detail below.
Election/Restrictions
Newly submitted claim 14 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 14 and claims 1-10, 12, and 13 are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because claim 14 does not require (at a minimum) an implant or that each bridge web is unconnected to any other one of the plurality of webs in the circumferential direction. The subcombination has separate utility such as a stent valve implant (claims 1 and 12 are directed to “an implant” while claim 14 is directed to a catheter sleeve and a catheter). The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination (in this case by original presentation), and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 14 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 1 is objected to because of the following informalities: In claim 1, line 9, “the least one of the plurality of webs” is believed to be in error for --the at least one of the plurality of webs--. In claim 1, line 11, “one the plurality” is believed to be in error for --one of the plurality--. Appropriate correction is required.
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 1-10 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.
Claim 1, lines 8-10 recite “each bridge web being connected to the least one of the plurality of webs only in the longitudinal direction”, but this limitation is not disclosed in the originally filed application. Figures 5-15 of the application clearly show the bridge webs extending circumferentially outward from their respective web. Therefore, this limitation is directed to new matter. (Note that claim 12 was amended to delete “only” which overcomes the 112(a) rejection.)
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.
Claim 13 is 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 13 lines 1-2 recite “the plurality of joint elements is provided along an entire circumference of the structure”. It is unclear how the joint elements can be “along an entire circumference of the structure” when the bridge webs are “unconnected in the circumferential direction”. In other words, since there are gaps between the joint elements, they cannot extend along an entire circumference of the structure.
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, 7, 8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braido et al. US 2012/0078347 (hereafter referred to as Braido).
Regarding claim 1, see Braido figs. 18A-18C, figs. 21F and 21G (par.235 says any embodiment can use the support struts of 21A-21J). Specifically, Braido discloses an implant 2100, comprising: a tubular discontinuous structure formed of a plurality of webs 2104 that extend in a longitudinal direction (figs.18A-18C), a joint element (considered the central element 2204s in fig. 21F and the central element in fig.21G) formed in at least one of the plurality of webs (par.235 says any embodiment can use the support struts of 21A-21J, in this case the examiner relies on use of the support struts of figs. 21J and/or 21G as a support strut 2104 in figs. 18A-18C), the joint element being formed by a gap (see 2204q in fig.21F and the center gap in fig.21G) and a bridge web (2204u in fig.21F and 2204v in fig.21G) arranged next to the gap in a circumferential direction on each circumferential side of the gap (figs. 21F-21G), each bridge web being connected to the at least one of the plurality of webs in the longitudinal direction distally and proximally on each side of the gap, wherein each bridge webs is unconnected to any other one of the plurality of webs in the circumferential direction (figs.21F-21G shows the bridge webs are only connected to the main web at distal and proximal locations) to transmit axial and radial forces and permit the tubular discontinuous structure in a region of the joint element to flare in the circumferential direction (at least fig. 18B shows the structure is capable of flaring/expansion in the circumferential direction), wherein opposing ends of the at least one of the plurality of webs are arranged longitudinally separated by the gap and between the bridge webs (see the annotated figs. 21F and 21G above which point out the opposing ends, gap, and bridge webs) such that when a predefined axial pressure is exceeded, the opposing ends are compressed so as to bear on one another (this limitation is directed to an intended use of the implant; the joint elements of figs. 21F-G of Braido are capable of being used/functioning as claimed upon application of some axial pressure).
Regarding claim 2, see figs. 21F and 21G for at least U-shaped and meander shaped.
Regarding claim 3, at least fig.21G shows notches at distal portions of the bridge webs. Note that applicant’s specification states notched portions can be designed as u-shaped (pg.7, line 7) and can be a change in the direction of the bend (pg.14, line 3). As such, the u-shaped/change in direction of the bend of fig.21G of Braido is considered a notched portion.
Regarding claim 5, see figs.21F and 21G for the bridge webs each being half the width of the main web.
Regarding claims 7 and 10, see par.90 for nitinol which is a shape memory alloy.
Regarding claim 8, the implant of 18A-18C is a stent for heart valves.
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 4, 6, 9, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Braido.
Regarding claims 4 and 9, Braido discloses the invention substantially as claimed and as discussed above with respect to claim 1, but Braido does not disclose a specific size of the gap in the main web being greater than 20 microns or 40-500 microns. It is likely that the gaps of figs. 21F and 21G of Braido are greater than 20 microns since this range includes every value greater than 20 microns. Further, before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to provide a gap width of 40-500 microns because Applicant has not disclosed that the claimed gap width provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the device of Braido to operate equally well with the claimed range of gap width since the gaps of Braido perform the same function of allowing for bending, twisting, shortening and elongating (see Braido par.238). Therefore, it would have been prima facie obvious to modify Braido, if necessary, to obtain the invention as specified in claims 4 and 9 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Braido.
Regarding claims 6 and 12, Braido discloses the implant of claim 1 as discussed above. While Braido discloses in par.235 that any embodiment can use the support struts of 21A-21J, Braido does not specifically show joint elements of figs. 21F-21G arranged next to one another in the circumferential direction. Claim 12 requires a plurality of webs where each web forms a main web that extends in a longitudinal direction and each web comprises a joint element. While Braido discloses the implant of claim 1 as discussed above, the embodiments of 21F-21G only show one web and joint element and do not specifically show that the joint elements and the gaps in each web are arranged such that the joint elements and gaps of adjacent ones of the plurality of webs are arranged next to each other in a circumferential direction. However, all figures showing a plurality of the longitudinal support struts show middle elements, equivalent to the claimed joint elements, arranged next to one another in the circumferential direction (see at least figs. 2, 11D, 17A, 18A, and 18C). Par. 235 says any of the stent embodiments can include different kinds of support struts depending on the desired post flexibility. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the support struts/webs of either fig. 21J or 21G, depending on desired flexibility, for the support struts of the stent of figs. 18A-18C and it would follow that the joint elements of the support struts of figs. 21J or 21G would be aligned and next to one another in a circumferential direction in the same manner as the middle portions are aligned and next to one another in a circumferential direction.
Regarding claim 13, see fig.18B for the joint elements provided around the circumference and allowing the structure to permit a funnel-shaped radial expansion of the structure.
Conclusion
THIS ACTION IS MADE FINAL. 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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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