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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 8-15, drawn to a tamper device, classified in A61B2017/00623.
II. Claims 16-20, drawn to a method for sealing a puncture, classified in A61B2017/00623.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the method of invention II can use a solid, rigid, cylindrical tamper instead of a tamper that has cuts that allows it to flex.
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:
Prior art applicable to one invention may not be applicable to the other invention. There will be a burden to search and consider the distinct limitations i.e. a tamper with cuts or a method with a sealing element that is deployed into an artery. Because of the distinct limitations of each of the inventions, the burden exists.
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 Erik Nyre on 02/20/2026 a provisional election was made without traverse to prosecute the invention of invention I, claims 8-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-20 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.
Information Disclosure Statement
Of Note: The IDS filed 04/16/2025 has sections “U.S. Patents” and “U.S. Patent Publications” where U.S. Patent Publications are listed both in the U.S. Patent section and the U.S. Patent Publication section. The IDS has been considered but it is recommended any future IDS be clearly organized.
Claim Interpretation
Original claim 8 states that the first cut and the second cut are at “the distal end” of the tamper. The specification does not define “distal end” of the tamper whether it is a distal end portion or the distal most end of the device. The figures support the cuts are at the distal end “portion” of the tamper but not specifically the distalmost end of the tamper. Therefore the “distal end” of the tamper where the cuts are located will be interpreted to be a distal end “portion” of the tamper.
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 8-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 6,156,056 to Kearns.
As to claim 8, Kearns discloses a tamper (200, the suture buttress can read on a tamper, see below), comprising: a tamper body (402, col. 7 ll. 5-20, figure 23-25) that is elongate along a longitudinal direction, the tamper body defining a distal end, a proximal end opposite the distal end, and an outer surface; a tamper channel (406) that extends from the proximal end to the distal end along the longitudinal direction (figure 24), the tamper channel configured to receive a suture assembly therethrough (col. 7 ll. 5-20, figure 10, col. 4 ll. 33-53, the channel 406 is capable of being used with a system that can comprise a suture, therefore the channel can receive a suture assembly), at least one first cut (distal 418, figure 24, 25) at the distal end and that extends from the outer surface toward the tamper channel; and at least one second cut (distal 428, figure 24, 25) at the distal end opposite the first cut and that extends from the outer surface toward the tamper channel, wherein the at least one first cut and the least one second cut are configured to permit the distal end of the tamper to flex (figure 25). The specification does not define “tamper” and there are no further claim limitations to the tamper. Since the suture buttress reads on the structural limitations, can receive a suture assembly, would be able to push down something that is distal to the distal end, the suture buttress 400 can read on a tamper.
As to claim 9, Kearns discloses the at least one first cut and the at least one second cut are configured to permit the distal end to flex more readily along a first plane than a second plane that is perpendicular to and intersects the first plane (figure 25). The buttress can more easily bend in the plane as seen in figure 25, then out of the plane based on the slits.
As to claim 10, Kearns discloses the at least one first cut and the at least one second cut extend only partially around the outer surface (figure 23, 24).
As to claim 11, Kearns discloses the first cuts and the second cut are separated by a portion of the outer surface (figure 23, 24).
As to claim 12, Kearns discloses the at least one first cut is a set of first cuts (figure 24, the set of slits 418), and the least one second cut is a set of second cuts (the set of 428), wherein the set of first cuts and the set of second cuts are offset with respect to each other along the longitudinal direction (figure 23-25).
As to claim 13, Kearns discloses the first cut is configured to open and the second cut is configured to compress when the tamper flexes along the plane (figure 25).
As to claim 14, Kearns discloses the first cut and the second cut are slits (col. 7 ll. 13-20).
Claims 8, 10, 11, 14, 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 7,963,952 to Wright.
As to claim 8, Wright discloses a tamper (10, the catheter can read on a tamper, see below), comprising: a tamper body (90/100, col. 6 ll. 30-col. 7 ll. 2, figure 3e-4a) that is elongate along a longitudinal direction, the tamper body defining a distal end, a proximal end opposite the distal end, and an outer surface; a tamper channel (lumen of catheter, figure 3e,g, 4a, 1, col. 3 ll. 66-col. 4 ll. 57) that extends from the proximal end to the distal end along the longitudinal direction (figure 1), the tamper channel configured to receive a suture assembly therethrough (col. 4 ll. 21-39, figure 1, the catheter is able to receive a medical instrument which can read on a suture assembly), at least one first cut (92, figure 3e; or 102/110, figure 3g, 4a ) at the distal end and that extends from the outer surface toward the tamper channel; and at least one second cut (94, figure 3e; or 104/112, figure 3g, 4a) at the distal end opposite the first cut and that extends from the outer surface toward the tamper channel (the second cut can be on the opposite side of the catheter, at least disclosed by figure 4a which can a slit orientation of previous slits), wherein the at least one first cut and the least one second cut are configured to permit the distal end of the tamper to flex (col. 3 ll. 66-col. 4 10). The catheter can have different slit orientations/shapes that can read on the cuts as claimed, i.e. the wavy cuts of figure 3e, spiral cuts of figure 3g. The cuts as seen in figure 4a can be used as the cuts for the previous cuts, which can be the spiral cuts of figure 3g. Further the cuts allow the catheter to expand which can allow the “tamper to flex”. The specification does not define “tamper” and there are no further limitations to the tamper. Since the catheter reads on the structural limitations, can receive a suture assembly, would be able to manipulate something as the catheter expands, or manipulate something that is positioned within the catheter, the catheter can read on a tamper.
As to claim 10, Wright discloses the at least one first cut and the at least one second cut extend only partially around the outer surface (figure 3e,g).
As to claim 11, Wright discloses the first cuts and the second cut are separated by a portion of the outer surface (figure 3e,g).
As to claim 14, Wright discloses the first cut and the second cut are slits (col. 6 ll. 30 to col. 7 ll. 2).
As to claim 15, Wright discloses the first cut and the second cut are spiral cuts (figure 3g).
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.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,089,828. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims a tamper (claim 1), comprising: a tamper body (claim 1) that is elongate along a longitudinal direction, the tamper body defining a distal end (claim 1), a proximal end (claim 1) opposite the distal end, and an outer surface (claim 1); a tamper channel (claim 1) that extends from the proximal end to the distal end along the longitudinal direction, the tamper channel configured to receive a suture assembly therethrough (claim 1, the suture assembly extends through the channel), at least one first cut (claim 1) at the distal end and that extends from the outer surface toward the tamper channel (claim 1); and at least one second cut (claim 1) at the distal end opposite the first cut and that extends from the outer surface toward the tamper channel (claim 1), wherein the at least one first cut and the least one second cut are configured to permit the distal end of the tamper to flex (claim 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 6,053,922 to Kraus, U.S. Patent 6,706,064 to Anson, U.S. Patent 8,292,918 to Hill, U.S. Patent Publication 2002/0099410 to Ben David, U.S. Patent Publication 2007/0038230 to Stone, and U.S. Patent Publication 2016/0228109 to Jacobs all disclose similar devices capable of disclosing, rendering obvious, and/or providing evidence on the claims of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771