CTNF 19/030,591 CTNF 97104 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Double Patenting 08-33 AIA 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. 08-34 AIA Claim s 1, 3, 6-8,10-11, 14-17, 19-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-2, 4-5, 7-14 of U.S. Patent No. U.S. Patent No. 12239341 Although the claims at issue are not identical, they are not patentably distinct from each other because : Regarding claim 1, ‘341 discloses a tissue-removing catheter for removing tissue in a body lumen, the tissue- removing catheter comprising (Col. 13, lines 32-33): an elongate body having an axis (Col.13, line 34), and proximal and distal end portions spaced apart from one another along the axis (Col. 13 lines 35-36), wherein the elongate body is sized and shaped to be received in the body lumen (Col. 13 lines 36-37); a handle mounted to the proximal end portion of the elongate body, the handle comprising a housing enclosing components operable to cause rotation of the elongate body (Col. 13 lines 38-41); a tissue-removing element mounted on the distal end portion of the elongate body, the tissue-removing element being configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen (Col. 13 lines 42-46); an inner liner received within the elongate body and defining a guidewire lumen (Col. 13 lines 47-48); and an advancer mounted on the handle and movable relative to the housing (Col. 13 lines 49-50), the inner liner being coupled to the advancer at a proximal end portion of the inner liner such that movement of the advancer causes a corresponding movement of the inner liner to exert a push force on the tissue-removing element to advance the tissue-removing element and a pull force on the tissue-removing element to retract the tissue-removing element for moving the tissue-removing element relative to the handle (Col. 14 lines 4-11). The below links the dependent claim of the instant application to ‘341: Instant application claim # Corresponding claim # of ‘341 3 2 6 1 7 4 8 5 10 7 11 8 14 9 15 10 16 11 17 12 19 13 20 14 07-30-03-h AIA Claim Interpretation 07-30-03 AIA The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 07-30-05 The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. 07-30-06 This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: Tissue removing element in claims 1, 3, 7, 20 will be interpreted according to para. [0029] as any structure that has a rotational element to remove tissue from a body lumen Coupling assembly in claims 2-6, 18 will be interpreted according to para. [0040] as any structure that couples the liner assembly to the advancer. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1-3, 18-20 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Jamous et al. (CN 110582243 A) . Regarding claim 1, Jamous discloses a tissue-removing catheter 10 (Fig. 1) for removing tissue in a body lumen, the tissue- removing catheter comprising: an elongate body 12 having an axis (Fig. 1), and proximal and distal end portions spaced apart from one another along the axis (Fig. 1), wherein the elongate body is sized and shaped to be received in the body lumen (Fig. 1); a handle 40 mounted to the proximal end portion of the elongate body (Fig. 1), the handle comprising a housing (i.e., surrounding the inner components indicated by the line and at 40) enclosing components operable to cause rotation of the elongate body (Fig. 1); a tissue-removing element (i.e., tissue removing element 20 is equivalent in structure to the rotatable tissue removing body as discussed above with regard to 112f) mounted on the distal end portion of the elongate body (Fig. 1), the tissue-removing element being configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen (Fig. 1); an inner liner 14 received within the elongate body (Fig. 6) and defining a guidewire lumen 24 (Fig. 5); and an advancer 45 mounted on the handle and movable relative to the housing (Fig. 1, slider 45), the inner liner being coupled to the advancer at a proximal end portion of the inner liner (i.e., such that inner liner extends through 14) such that movement of the advancer causes a corresponding movement of the inner liner to exert a push force on the tissue-removing element to advance the tissue-removing element and a pull force on the tissue-removing element to retract the tissue-removing element for moving the tissue-removing element relative to the handle (Figs. 1-7; and disclosed in para. [0019]). Regarding claim 2, Jamous discloses the tissue removing catheter as set forth in claim 1. Jamous also discloses further comprising a coupling assembly (coupling assembly indicated at 44 of Fig. 1 is equivalent in structure to the coupling assembly as discussed above with regard to 112f) in the handle coupling the inner liner to the advancer (Fig. 1). Regarding claim 3, Jamous discloses the tissue-removing catheter as set forth in claim 2. Jamous also discloses wherein the inner liner is coupled to the tissue-removing element at a distal end portion of the inner liner (Figs. 2-7; i.e., at least indirectly). Regarding claim 18, Jamous discloses the tissue-removing catheter as set forth in claim 2. Jamous also discloses wherein the coupling assembly fixedly couples the inner liner to the advancer such that movement of the advancer causes an identical corresponding movement of the inner liner (Fig. 6 shows the inner liner being sandwiched between outer layer 64 and inner layer 60 and as shown in Fig. 1 extends to the coupling assembly which is connected to the advancer). Regarding claim 19, Jamous discloses the tissue-removing catheter as set forth in claim 18. Jamous also discloses wherein the inner liner is fixedly coupled to the elongate body at the distal end portion of the elongate body (Fig. 1; at least since inner liner 14 includes inner layer 60, intermediate braid 62 and outer layer 64 and). Regarding claim 20 Jamous discloses the tissue-removing catheter as set forth in claim 1. Jamous also discloses wherein the inner liner is free of direct attachment to a tissue-removing element (Fig. 5) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-21-aia AIA Claim s 4, 5, 13, 14, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Jamous in view of Kelly (US 2020/0360047) . Regarding claims 4, 5, 13, 14, 16 Jamous discloses the tissue-removing catheter as set forth in claim 3. Jamous doesn’t disclose a key fixedly attached to a proximal end of the inner liner, wherein the coupling assembly is directly attached to the key, a buckle tube in the handle, wherein the coupling sleeve is received in the buckle tube in a non- rotational, sliding engagement a guidewire port mounted on a proximal end of the buckle tube, the coupling sleeve attaches to the key by a snap-fit connection. In the same field of endeavor, namely tissue removing catheters, Kelly discloses an identical device to Jamous (see Fig. 1) and discloses key 221’ coupled to the inner liner 14, wherein the coupling assembly 47’ is directly attached to the key (Fig. 47), wherein the coupling assembly comprises a coupling sleeve 223’ fixedly attached to the key (Fig. 47). Kelly also discloses further comprising a buckle tube 71 in the handle, wherein the coupling sleeve is received in the buckle tube in a non- rotational, sliding engagement (Fig. 47), Kelly also discloses further comprising a guidewire port mounted on a proximal end of the buckle tube (Fig. 47), Kelly also discloses wherein the coupling sleeve attaches to the key by a snap-fit connection (para. [0100]). 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 device of Jamous to have the above limitations for the purposes of connecting the inner liner to the tissue remover and to the advancer (para. [0110], Fig. 47) . 07-21-aia AIA Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Jamous in view of Kelly and further in view of Savastano et al. (US 2019/0038300 A1) . Regarding claim 15, Jamous discloses the tissue-removing catheter as set forth in claim 5. Jamous doesn’t directly disclose wherein the coupling sleeve includes at least one magnet configured to attach to the key. In the same field of endeavor, namely hydrodynamic vortex aspiration catheter, Savastano discloses using magnets to enforce the axial force of the rotating parts (para. [0134]). As such, 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 device of Jamous to have the coupling sleeve includes at least one magnet configured to attach to the key for the purpose of enforcing the axial force of the rotating shaft (para. [0134]) . Allowable Subject Matter Claims 6-8, 10-11, 17 are rejected over the double patenting rejection above but would otherwise be in condition for allowance if rewritten in independent form including all of the limitations of the base claim and any intervening claims and terminal disclaimer filed. 12-151-08 AIA 07-43 12-51-08 Claim s 9 and 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claim 6, the closest art is Kelly (US 2020/030047). Kelly fails to disclose both a coupling sleeve and a guide tube and further fails to disclose a guide tube attached to a distal end portion of the coupling sleeve. Claims 7-12 are allowable for their dependency on claim 6. Regarding claim 17, Jamous discloses the tissue-removing catheter as set forth in claim 16. Jamous doesn’t disclose wherein one of the coupling sleeve and key includes deflectable arms configured for snap-fit engagement with the other of the coupling sleeve and key. There is no reason, suggestion, or motivation to modify Jamous with the above limitations such that one of ordinary skill in the art would arrive at the claimed invention. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm 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, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /RACHAEL L GEIGER/ Examiner, Art Unit 3771 /BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771 Application/Control Number: 19/030,591 Page 2 Art Unit: 3771 Application/Control Number: 19/030,591 Page 3 Art Unit: 3771 Application/Control Number: 19/030,591 Page 4 Art Unit: 3771 Application/Control Number: 19/030,591 Page 5 Art Unit: 3771 Application/Control Number: 19/030,591 Page 6 Art Unit: 3771 Application/Control Number: 19/030,591 Page 7 Art Unit: 3771 Application/Control Number: 19/030,591 Page 8 Art Unit: 3771 Application/Control Number: 19/030,591 Page 9 Art Unit: 3771 Application/Control Number: 19/030,591 Page 10 Art Unit: 3771 Application/Control Number: 19/030,591 Page 11 Art Unit: 3771 Application/Control Number: 19/030,591 Page 12 Art Unit: 3771
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