DETAILED ACTION
The following is a non-final office action is response to communications received on 08/21/2023. Claims 21-40 are currently pending and addressed below.
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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 21-37, drawn to a stent, classified in a61f2/90.
II. Claims 38-40, drawn to method of making a stent, classified in D04C1/02.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the product as claimed can be made by another and materially different process (e.g., without a mandrel).
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification
the inventions have acquired a separate status in the art due to their recognized divergent subject matter
the inventions require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these 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.
During a telephone conversation with Matthew Bethards on 02/23/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 21-37. Affirmation of this election must be made by applicant in replying to this Office action. Claims 38-40 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 30-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 3-7 of U.S. Patent No. US 10,744,009. The elements of the instant application are to be found in the Patent and therefore are anticipated. Although the conflicting claims are not identical, they are not patentably distinct from each other because the Patent and the instant application all recite the same basic structure with a permutation of similar elements throughout.
Regarding Claims 30-32, patent claim 1 recites the same limitations.
Regarding Claim 33, patent claim 3 recites the same limitations.
Regarding Claim 34, patent claim 4 recites the same limitations.
Regarding Claim 35, patent claim 5 recites the same limitations.
Regarding Claim 36, patent claim 6 recites the same limitations.
Regarding Claim 37, patent claim 7 recites the same limitations.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 30, 31 & 34-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han et al. (US 10,349,944).
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Regarding Claim 30, Han teaches a stent (100) comprising:
a hollow cylindrical body (Fig 2) having an interior dimension and an exterior dimension and comprising a middle region (100) that extends to a first flared end (120) and also extends to an opposing second flared end (130),
the first flared end (120) comprising a first inner shoulder (121), a first crest (122), a first outer taper (123), and a first opening (shown), wherein the first inner shoulder extends from one end of the middle region to the first crest (Fig 2), wherein a diameter of the first crest is greater than a diameter of the middle region (Fig 2), wherein the first outer taper extends from the first crest to the first opening (Fig 2), wherein a diameter (shown) of the first opening is greater than the diameter of the middle region but less than the diameter of the first crest (Fig 2), and wherein the first opening provides a first boundary between the interior dimension and the exterior dimension,
the second flared end (130) comprising a second inner shoulder(131), a second crest (132), a second outer taper (133), and a second opening (shown), wherein the second inner shoulder extends from one end of the middle region to the second crest (Fig 2), wherein a diameter of the second crest is greater than a diameter of the middle region (Fig 2), wherein the second outer taper extends from the second crest to the second opening (Fig 2), wherein a diameter of the second opening (same as the first opening as shown) is greater than the diameter of the middle region but less than the diameter of the second crest (Fig 2), and wherein the second opening provides a second boundary between the interior dimension and the exterior dimension,
wherein a profile of at least a portion of the first inner shoulder, the first crest, and at least a portion of the first outer taper circumscribes a portion of a first arc (exploded portion of Fig 2) that lies in the longitudinal plane, and wherein a profile of at least a portion of the second inner shoulder, the second crest, and at least a portion of the second outer taper circumscribes a portion of a second arc (exploded portion of Fig 2) that lies in the longitudinal plane.
Regarding Claim 31, Han teaches wherein the hollow cylindrical body comprises braided or woven wires (Fig 2 & 16) having a constant pitch along a length of the middle region (100), the braided or woven wires having a uniformly varying pitch along the first inner shoulder (121), the braided or woven wires having a constant pitch at the first crest (122), the braided or woven wires having a uniformly varying pitch along the first outer taper (123), the braided or woven wires having a uniformly varying pitch along the second inner shoulder (131), the braided or woven wires having a constant pitch at the second crest (132), and the braided or woven wires having a uniformly varying pitch along the second outer taper (133) (Fig 2).
Regarding Claim 34, Han teaches wherein the uniformly varying pitch along the first outer taper (123) is fully capable of allowing the braided or woven wires at the first opening (shown) to expand equal to the diameter of the first crest and wherein the uniformly varying pitch along the second outer taper (133) is fully capable of allowing the braided or woven wires at the second opening (opposite first opening) to expand equal to the diameter of the second crest.
Regarding Claim 35, Han teaches wherein individual braided or woven wires are braided or woven starting from the second flared end (130), through the middle region (100), through the first flared end (120), to the first opening (shown), back through the first flared end, back through the middle region, and back through the second flared end (Figs 2 & 18).
Regarding Claim 36, Han teaches wherein for braided wires a beginning and an end of each of the individual braided wires overlap with each other or a different wire end underneath a crossover wire (i.e., braided/woven) along the second outer taper and not at the second opening of the second flared end, and wherein for woven wires a beginning and an end of each of the individual woven wires overlap with each other underneath a crossover wire along the second outer taper and not at the second opening of the second flared end (Fig 2 & 18).
Regarding Claim 37, Han teaches wherein for braided wires a beginning and an end of each of the individual braided wires overlap with each other or a different wire end underneath a crossover wire (i.e., braided/woven) along the middle region, and wherein for woven wires a beginning and an end of each of the individual woven wires overlap with each other underneath a crossover wire along the middle region (Figs 2 & 18).
Allowable Subject Matter
Claims 21-29 are allowed.
The prior art of record, which is the most pertinent art found, fails to teach and/or fairly suggest the instant invention. Han et al. (US 10,349,944) discloses the invention substantially as claimed.
Regarding Claim 21, Han discloses the invention substantially as claimed. Han teaches a stent (100) comprising:
a hollow cylindrical body having an interior dimension and an exterior dimension and comprising a middle region (100) that extends to a first flared end (120) and also extends to an opposing second flared end (130),
the first flared end comprising a first inner shoulder (near 121), a first crest (122), a first outer taper (near 123), and a first opening (left side of Fig 2), wherein the first inner shoulder extends from one end of the middle region to the first crest, wherein a diameter of the first crest is greater than a diameter of the middle region (Fig 2), wherein the first outer shoulder extends from the first crest to the first opening (Fig 2), wherein the first opening provides a first boundary between the interior dimension and the exterior dimension,
the hollow cylindrical body characterized by a longitudinal plane that bisects the hollow cylindrical body along its longitudinal axis, characterized by a first perpendicular plane that encompasses a circle (120 in cross section) defined by the first crest (122), and wherein the first perpendicular plane (shown) is perpendicular to the longitudinal plane.
However, Han either individually or in combination, does not teach or render obvious wherein a profile of at least a portion of the first inner shoulder, the first crest, and at least a portion of the first outer taper circumscribes a portion of a first elliptical arc of a first ellipse that lies in the longitudinal plane, wherein the first elliptical arc includes an upper antipodal point of the first ellipse, wherein a lower antipodal point of the first ellipse is outwardly offset along the longitudinal plane relative to the first perpendicular plane and the middle region.
Claims 32 & 33 would be allowable if: (1) rewritten in independent form including all of the limitations of the base claim and any intervening claims, and (2) a timely filed terminal disclaimer(s) in compliance with 37 CFR 1.321(c) or 1.321(d) is filed to overcome the nonstatutory double patenting rejection(s) set forth in this Office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774