CTNF 19/028,834 CTNF 80840 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-fti AIA The present application is being examined under the pre-AIA first to invent provisions. Information Disclosure Statement The information disclosure statement(s) (IDS) submitted on 1/17/2025 and 1/29/2025 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith. 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: “a compliance feature” in claim 30. 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 Objections 07-29-01 AIA Claim 36 is objected to because of the following informalities: In claim 36 , there is an apparent typographical error in the dependency of claim 36 from claim 21 (i.e., instead of claim 31), wherein the Examiner has assumed Applicant intended dependency to be from claim 31 (or claim 36 would be duplicative of claim 28) . Appropriate correction is required. 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) 21-23, 26-30 and 37-40 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Lizardi et al. (US 2004/0260314) . Lizardi discloses (see Figs. 1-20) a tissue grasper/suture passer instrument comprising the following claim limitations: (claim 21) A medical device, comprising: a first jaw (180, Fig. 1) and a second jaw (230, Fig. 1), each jaw having a first end (i.e., proximal end) and a second end (i.e., distal end) (as shown in Figs. 1-2), the first jaw and the second jaw being coupled at the first ends (at pivot pin 235, Fig. 3B), wherein the first jaw and the second jaw are configured to (i.e., capable of) transform from an open configuration (as shown in Figs. 1-2 and 7) to a closed configuration (as shown in Figs. 8-9), the open configuration being a configuration where the second ends (i.e., distal ends) of the jaws are located away from each other (as shown in Figs. 1-2 and 7), and the closed configuration being a configuration where the second ends (i.e., distal ends) of the jaws are proximate to each other (as shown in Figs. 8-9); and a barb (350, Fig. 1) coupled to the first jaw (180) at a first end (i.e., proximal end) of the barb (350) (as shown in Figs. 1-2 and 3B), wherein the barb (350) is configured to (i.e., capable of) transform from a first configuration to a second configuration, wherein, in the first configuration, the barb (350) is configured to (i.e., capable of) be flush with the first jaw (180) (as shown in Figs. 3B and 6-8; [0036]; rod 260 is axially translatable to provide for a flush/retracted needle/barb), wherein, in the second configuration, the barb (350) is configured to (i.e., capable of) project from the first jaw (180) and point towards the second jaw (230) (as shown in Fig. 5 and between Figs. 8-9), and wherein the barb (350) is configured to be (i.e., capable of) releasable from the first jaw (180) (as shown in Figs. 12-13); (claim 22) wherein the second jaw (230) is configured to (i.e., capable of) receive a second end (i.e., distal end) of the barb (350) (as expressly shown in Figs. 9-13); (claim 23) wherein the second jaw (230) includes a hole (327, Figs. 4-6) extending from an inner surface of the second jaw (230) to an outer surface of the second jaw (230) (as shown in Figs. 3B and 5-12), and wherein, in the closed configuration of the first jaw (180) and the second jaw (230) and the second configuration of the barb (350), a second end (i.e., distal end) of the barb (350) is configured to (i.e., capable of) extend through the hole (327) (as shown in Figs. 9-12 and 15); (claim 26) wherein a second end (i.e., distal end) of the barb (350) includes a sharpened point (at 356, Fig. 3B) or a plurality of spikes; (claim 27) wherein the barb (350) is configured to (i.e., capable of) rotate about a pivot point (235, Fig. 3B) on the first jaw (180) when the barb (350) transforms from the first configuration to the second configuration (as shown between Figs. 3B, 5-6 and 8-12; needle 350 pivots about pivot point 235 in the first jaw 180 first within needle passageway 210 (see Fig. 3B) and then also when grasped by the second jaw 230 (see Fig. 12)); (claim 28) wherein the barb (350) is configured to (i.e., capable of) pierce tissue (600) of a patient when the first jaw (180) and the second jaw (230) are in the closed configuration and the barb (350) is in the second configuration (as shown in Fig. 9); (claim 29) wherein the barb (350) is configured to be (i.e., capable of) released from the first jaw (180) after piercing the tissue (600) of the patient (as shown in Figs. 12-13); (claim 30) wherein the second jaw (230) includes a compliance feature (530, Fig. 16) including elements configured to (i.e., capable of) bend outwardly when an out of plane force is applied to the compliance feature (530) ([0042]; tabs 530 grab and engage needle 350 wherein opening 522 allows for release of needle 350); (claim 37) A medical device, comprising: a clip comprising a first jaw (180, Fig. 1) and a second jaw (230, Fig. 1), the first jaw (180) and the second jaw (230) being coupled at first ends (i.e., proximal ends) of the first jaw and the second jaw (as shown in Fig. 1), respectively, a barb (350, Fig. 1), wherein, in a first configuration of the medical device, a first end (i.e., proximal end) of the barb (350) is coupled to the first jaw (180) and the clip has an open configuration (as expressly shown in Fig. 3B), wherein, in a second configuration, a second end (i.e., distal end) of the barb (350) projects from the first jaw (180) and toward the second jaw (230), and the clip has a closed configuration (as expressly shown in Fig. 9); and wherein, in a third configuration, the barb (350) is uncoupled from the first jaw (180) (as expressly shown in Figs. 12-13); (claim 38) wherein, upon transitioning from the first configuration to the second configuration, the barb (350) is configured to pierce tissue (600, Fig. 9) received between the first jaw (180) and the second jaw (230) (as shown in Fig. 9); (claim 39) wherein the second jaw (230) includes a hole (327, Figs. 4-6) extending from an inner surface of the second jaw (230) to an outer surface of the second jaw (230) (as shown in Figs. 3B and 5-12), and wherein, in the second configuration, the second end (i.e., distal end) of the barb (350) extends through the hole (327) (as shown in Figs. 9-12 and 15); and (claim 40) wherein the barb (350) is configured to (i.e., capable of) rotate about a pivot point (235, Fig. 3B) on the first jaw (180) when the barb (350) transforms from the first configuration to the second configuration (as shown between Figs. 3B, 5-6 and 8-12; needle 350 pivots about pivot point 235 in the first jaw 180 first within needle passageway 210 (see Fig. 3B) and then also when grasped by the second jaw 230 (see Fig. 12)) . 07-15 AIA Claim (s) 21-24, 26-30 and 37-40 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Duran (US 5,947,982) . Duran discloses (see Figs. 1-6D) suture-passing forceps comprising the following claim limitations: (claim 21) A medical device, comprising: a first jaw (14, Fig. 1) and a second jaw (16, Fig. 1), each jaw having a first end (i.e., proximal end) and a second end (i.e., distal end), the first jaw (14) and the second jaw (16) being coupled at the first ends (as shown in Figs. 1 and 3-5), wherein the first jaw (14) and the second jaw (16) are configured to (i.e., capable of) transform from an open configuration (as shown in Figs. 5 and 6B) to a closed configuration (as shown in Fig. 6C), the open configuration being a configuration where the second ends (i.e., distal ends) of the jaws are located away from each other (as shown in Figs. 5 and 6B), and the closed configuration being a configuration where the second ends (i.e., distal ends) of the jaws are proximate to each other (as shown in Fig. 6C); and a barb (30, Figs. 3 and 5) coupled to the first jaw (14) at a first end (i.e., proximal end) of the barb (30) (as shown in Figs. 3 and 5), wherein the barb (30) is configured to (i.e., capable of) transform from a first configuration to a second configuration, wherein, in the first configuration, the barb (30) is configured to (i.e., capable of) be flush with the first jaw (14) (as shown in Figs. 3-5; col. 3, line 52-col. 4, line 8; needle 30 is inserted into and through lower opening 44 wherein, during needle loading, the needle tip 38 is fully capable of being flush with the surface 50 of the lower jaw 14), wherein, in the second configuration, the barb (30) is configured to (i.e., capable of) project from the first jaw (14) and point towards the second jaw (16) (as shown in Fig. 5), and wherein the barb (30) is configured to be (i.e., capable of) releasable from the first jaw (14) (as shown in Fig. 6D); (claim 22) wherein the second jaw (16) is configured to (i.e., capable of) receive a second end (38) of the barb (30) (as shown in Fig. 6C); (claim 23) wherein the second jaw (16) includes a hole (56, Figs. 3-5) extending from an inner surface of the second jaw (16) to an outer surface of the second jaw (16) (as shown in Figs. 3-5), and wherein, in the closed configuration of the first jaw (14) and the second jaw (16) and the second configuration of the barb (30), a second end (i.e., distal end) of the barb (30) is configured to (i.e., capable of) extend through the hole (56) (as shown in Figs. 6C-6D); (claim 24) wherein the first end (i.e., proximal end) of the barb (30) is coupled to the first jaw (14) via a hinged connection (as shown in Figs. 3-5; col. 4, lines 37-56; needle 30 expressly hinges/pivots within suture passage hole 42); (claim 26) wherein a second end (38, Fig. 3) of the barb (30) includes a sharpened point (as expressly show in Figs. 2-3) or a plurality of spikes; (claim 27) wherein the barb (30) is configured to (i.e., capable of) rotate about a pivot point (at 40, Fig. 3) on the first jaw (14) when the barb (30) transforms from the first configuration (see Figs. 3-4) to the second configuration (see Fig. 5) (col. 4, lines 37-56; needle 30 expressly hinges/pivots within suture passage hole 42); (claim 28) wherein the barb (30) is configured to (i.e., capable of) pierce tissue (76, Figs. 6A-6D) of a patient when the first jaw (14) and the second jaw (16) are in the closed configuration (as shown in Fig. 6C) and the barb (30) is in the second configuration (as shown in Figs. 5 and 6C; col. 5, lines 14-20); (claim 29) wherein the barb (30) is configured to be (i.e., capable of) released from the first jaw (14) after piercing the tissue (76) of the patient (as shown in Fig. 6D); (claim 30) wherein the second jaw (16) includes a compliance feature (at 54, Fig. 3) including elements configured to (i.e., capable of) bend outwardly when an out of plane force is applied to the compliance feature (col. 4, lines 6-43; upper needle holding region 54 expressly comprises material having a spring/compliance force to bend and hold the needle 30 with greater force than the friction-fit of the lower needle holding region 40); (claim 37) A medical device, comprising: a clip comprising a first jaw (14, Fig. 1) and a second jaw (16, Fig. 1), the first jaw (14) and the second jaw (16) being coupled at first ends (i.e., proximal ends) of the first jaw (14) and the second jaw (16), respectively, a barb (30, Figs. 3 and 5), wherein, in a first configuration of the medical device, a first end (i.e., proximal end) of the barb (30) is coupled to the first jaw (14) and the clip has an open configuration (as shown in Fig. 5), wherein, in a second configuration, a second end (i.e., distal end) of the barb (30) projects from the first jaw (14) and toward the second jaw (16), and the clip has a closed configuration (as shown in Fig. 6C); and wherein, in a third configuration, the barb (30) is uncoupled from the first jaw (14) (as shown in Fig. 6D); (claim 38) wherein, upon transitioning from the first configuration to the second configuration, the barb (30) is configured to (i.e., capable of) pierce tissue (76, Fig. 6B) received between the first jaw (14) and the second jaw (16) (as shown in Figs. 6B-6D); (claim 39) wherein the second jaw (16) includes a hole (56, Figs. 3-5) extending from an inner surface of the second jaw (16) to an outer surface of the second jaw (16) (as shown in Figs. 3-5), and wherein, in the second configuration, the second end (i.e., distal end) of the barb (30) extends through the hole (56) (as shown in Figs. 6C-6D; col. 5, lines 14-21); and (claim 40) wherein the barb (30) is configured to (i.e., capable of) rotate about a pivot point (at 40, Fig. 3) on the first jaw (14) when the barb (30) transforms from the first configuration (see Figs. 3-4) to the second configuration (see Fig. 5) (col. 4, lines 37-56; needle 30 expressly hinges/pivots within suture passage hole 42) . Allowable Subject Matter Claims 31-36 are allowed. It is noted that claim 36 remains subject to a claim objection for an apparent error in dependency that must be resolved before claim 36 can be in proper condition for allowance. 12-151-08 AIA 07-43 12-51-08 Claim 25 is 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. Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see Pugsley, Jr. et al. (UIS 5,989,268) . Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off). If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ROBERT A LYNCH/Primary Examiner, Art Unit 3771 Application/Control Number: 19/028,834 Page 2 Art Unit: 3771 Application/Control Number: 19/028,834 Page 3 Art Unit: 3771 Application/Control Number: 19/028,834 Page 4 Art Unit: 3771 Application/Control Number: 19/028,834 Page 5 Art Unit: 3771 Application/Control Number: 19/028,834 Page 6 Art Unit: 3771 Application/Control Number: 19/028,834 Page 7 Art Unit: 3771 Application/Control Number: 19/028,834 Page 8 Art Unit: 3771 Application/Control Number: 19/028,834 Page 9 Art Unit: 3771 Application/Control Number: 19/028,834 Page 10 Art Unit: 3771 Application/Control Number: 19/028,834 Page 11 Art Unit: 3771 Application/Control Number: 19/028,834 Page 12 Art Unit: 3771 Application/Control Number: 19/028,834 Page 13 Art Unit: 3771
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