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 Amendment
The claims filed on August 27th, 2026, have been entered. Claims 1 and 3-14 remain pending in the Application. Claim 2 has been canceled by the Applicant. Claims 4-14 have been added by the Applicant. The claim amendments overcome the previous 112(b) rejection.
Response to Arguments
The rejection of claims 1 and 3 under 102(a)(1) over Zaugg et al. (Pub. No. 2013/0310853) has been withdrawn in light of Applicant’s amendment made August 27th, 2026; specifically, Zaugg et al. does not teach directing an introducer sheath into the opening of the vessel and withdrawing, after directing the suturing mechanism through the introducer sheath, the introducer sheath from the vessel with the suturing mechanism remaining in the vessel.
Applicant’s arguments with respect to claim(s) 1 and 3-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is noted that Applicant argues that the newly added claim limitations are not taught by Zaugg et al.; however, as discussed below, the newly added reference Nobles et al. (Pub. No. 2006/0069397) teaches said limitation.
Claim Interpretation
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.
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.
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: “suturing mechanism” in claim 1.
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.
The limitation falls under 112(f) interpretation because the generic placeholder “mechanism” is coupled with the functional language “suturing” without reciting any structure to perform the suturing. The present Specification describes the structure that performs the function of suturing as the distal end of the device (FIGs. 2A-2B) extending from the shaft.
Claim Rejections - 35 USC § 112
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 14 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 14 recites the limitation "the first actuator" in line 1. There is insufficient antecedent basis for this limitation in the claim. No first actuator is introduced in claim 1. Applicant should amend claim 14 to depend on a claim which introduces a first actuator (such as claims 10 or 13), or to “wherein a first actuator is a lever.” For the purposes of examination, the suggested amendment will be used.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 3-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zaugg et al. (Pub. No. 2013/0310853) in view of Nobles et al. (Pub. No. 2006/0069397).
Regarding claim 1, Zaugg et al. discloses a method of closing an opening in a vessel (Abstract: methods of repairing a blood vessel wound; FIGs. 22A-22C: hole in T of vessel V), comprising:
directing a suturing mechanism (as noted above, this limitation is being interpreted under 112(f) as being the distal structure extending from the shaft in the present Spec FIGs. 2A-2B; in FIGs. 22A-22C, the distal end of the device including 319 is an equivalent structure and thereby satisfies the limitation) comprising a pivotal element (319; [0195]) through the opening and into the vessel interior ([0197] 319 is inserted into lumen 307 through an opening in 307) while the pivotal element is in an insertion and removal orientation ([0197] when 319 is being inserted, 319 is in a configuration where 319 is straight with the shaft of 300);
deploying the pivotal element of the suturing mechanism into a first deployed orientation (FIG. 22A: 319 is pivoted to be aligned with a first needle 308 which enters 319a) after the suturing mechanism is positioned within the interior of the vessel ([0197] 319 is pivoted after being inserted into 307);
directing a first needle (308) through the vessel wall adjacent to the opening using the suturing mechanism ([0197] 308 goes through the wall “W” as described in [0184] and FIG. 17A);
deploying the pivotal element of the suturing mechanism into a second deployed orientation (FIG. 22B: 319 is pivoted to be aligned with a second needle 308’);
directing a second needle (308’) through the vessel wall adjacent to the opening using the suturing mechanism ([0197] 308’ goes through W, as described in [0187]);
directing a tensile member (302) through the vessel wall adjacent to the opening using the suturing mechanism ([0196] the connection between 308 and 308’ is made by 302, which is directed through W when 308 is retracted);
returning the pivotal element to the insertion and removal orientation ([0197] 319 is realigned with the shaft of 300 for removal);
withdrawing the suturing mechanism ([0197] 300 is retracted after 302 is in place); and
using the tensile member to close the opening in the vessel ([0197] the opening is closed by pulling 302).
Zaugg et al. is silent regarding directing an introducer sheath into the opening of the vessel, directing the suturing mechanism through the introducer sheath and into an interior of the vessel, and withdrawing, after directing the suturing mechanism through the introducer sheath, the introducer sheath from the vessel with the suturing mechanism remaining in the vessel, thereby inhibiting blood from exiting the vessel through the opening.
Nobles et al. teaches in the same field of endeavor of wound closure methods (Abstract), and discloses an assembly (4; FIG. 1; [0058]) comprising a suturing mechanism (6) and an introducer sheath (8), where the physician first introduces the introducer sheath to allow for a medical procedure conducted within the body ([0059]), then directs the suturing mechanism through the introducer sheath and into an interior of the blood vessel ([0060] once the medical procedure is complete, and with 8 still in place, the physician inserts 6 through 8 and into femoral artery 14; FIG. 2), and then withdraws the introducer sheath from the vessel with the suturing mechanism remaining in the vessel ([0090] 8 is partially withdrawn out of the opening to expose the needle apparatus), thereby inhibiting blood from exiting the vessel through the opening (FIG. 2: 6 prevents blood from exiting 14 through the opening 10) for the purpose of being able to close a wound opening created by a medical procedure without allowing blood loss ([0059], [0090], and FIG. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of Zaugg et al. to include an introducer sheath which is directed into the opening, then directs the suturing mechanism through the opening, and is then withdrawn from the vessel while the suturing mechanism remains in the vessel, as taught by Nobles et al., for the purpose of being able to close a wound opening created by a medical procedure without allowing blood loss.
Regarding claim 3, Zaugg et al. as modified further discloses the suturing mechanism further comprises a coupling member (322; FIG. 22C; [0196]) having first and second ends (322a, 322b), and the method further comprises:
coupling the first needle to the first end ([0197] 308 connects with 322a);
coupling the second needle to the second end ([0197] 308’ connects with 322b);
retracting the first and second needles ([0197] 308 and 308’ are retracted to deploy 302); and
pulling the tensile member through the vessel wall ([0197] 302 is pulled through W by the retraction of 308 and 308’).
Regarding claim 4, Zaugg et al. as modified further discloses the deploying of the pivotal element of the suturing mechanism into the first deployed orientation includes moving an actuator in a first direction to a first position ([0288] the foot is pivoted by pushing the lever on top of the device in a first direction, causing the pivot in FIG. 22A), and the deploying of the pivotal element of the suturing mechanism into the second deployed orientation includes moving the actuator in a second direction to a second position ([0288] the foot is returned to its original position by pushing the lever to its original position, so to achieve the orientation of FIG. 22B from FIG. 22A, the lever must be pushed past the original position to a second position in the opposite direction as to place the lever in the first position of FIG. 22A).
Regarding claim 5, Zaugg et al. as modified further discloses the actuator is a lever ([0288] the foot is pivoted by a lever).
Regarding claim 6, Zaugg et al. as modified further discloses the actuator in the first position prevents movement of the second needle while allowing the first needle to be directed through the vessel wall ([0197] when 319 is in the first position of FIG. 22A, needle 306 can be advanced but needle 306’ cannot be advanced).
Regarding claim 7, Zaugg et al. as modified further discloses the actuator in the second position prevents movement of the first needle while allowing the second needle to be directed through the vessel wall ([0197] when 319 is in the second position of FIG. 22B, needle 306’ can be advanced but needle 306 cannot be advanced).
Regarding claim 8, Zaugg et al. as modified further discloses preventing movement of the second needle when the pivotal element of the suturing mechanism has been deployed into the first deployed orientation ([0197] when 319 is in the first position of FIG. 22A, needle 306 can be advanced but needle 306’ cannot be advanced).
Regarding claim 9, Zaugg et al. as modified further discloses preventing movement of the first needle when the pivotal element of the suturing mechanism has been deployed into the second deployed orientation ([0197] when 319 is in the second position of FIG. 22B, needle 306’ can be advanced but needle 306 cannot be advanced).
Regarding claim 10, Zaugg et al. as modified further discloses the directing the first needle through the vessel wall includes moving a first actuator ([0197] 306 and 306’ are actuated separately, requiring separate actuation mechanisms; the first actuator actuates 306), and the directing the second needle through the vessel wall includes moving a second actuator ([0197] 306 and 306’ are actuated separately, requiring separate actuation mechanisms; the second actuator actuates 306’).
Regarding claim 11, Zaugg et al. as modified further discloses the pivotal element in the first deployed orientation extends in a first direction (FIG. 22A), and the pivotal element in the second deployed configuration extends in a second direction that is opposite the first direction (FIG. 22B).
Regarding claim 12, Zaugg et al. as presently modified by Nobles et al. does not disclose providing, using one or more indicators, feedback as to a distance to insert the suturing mechanism into the introducer sheath when directing the suturing mechanism through the introducer sheath. However, Nobles et al. further discloses a marker (68) on the exterior surface of the introducer sheath (8) to denote the proximal position to which the introducer sheath should be withdrawn to expose the needles for deployment ([0090]) for the purpose of providing visual or tactile feedback to the physician to ensure proper positioning of the introducer sheath ([0090]). It would have been obvious to one of ordinary skill in the art before the effective filing date to have further modified Zaugg et al. to include a marker on the exterior surface of the introducer sheath, as taught by Nobles et al., for the purpose of providing visual or tactile feedback to the physician to ensure proper positioning of the introducer sheath. The placement of the marker will also allow a physician to know how far the suturing mechanism should be inserted into the introducer sheath.
Regarding claim 13, Zaugg et al. as modified further discloses the suturing mechanism includes a proximal end comprising a handle (20; FIG. 1; [0135]), the method further comprising: moving a first actuator of the handle in a first direction to a first position to deploy the pivotal element in the first deployed orientation ([0288] the foot is pivoted by pushing the lever on top of the device in a first direction, causing the pivot in FIG. 22A), the first actuator in the first position configured to prevent deployment of the second needle ([0197] when 319 is in the first position of FIG. 22A, needle 306 can be advanced but needle 306’ cannot be advanced); actuating, while the first actuator is in the first position, a second actuator of the handle in a distal direction to direct the first needle through the vessel wall ([0197] 306 and 306’ are actuated separately, requiring separate actuation mechanisms on the handle; the second actuator actuates 306); moving the first actuator of the handle in a second direction to a second position to deploy the pivotal element in the second deployed orientation ([0288] the foot is returned to its original position by pushing the lever to its original position, so to achieve the orientation of FIG. 22B from FIG. 22A, the lever must be pushed past the original position to a second position in the opposite direction as to place the lever in the first position of FIG. 22A), the first actuator in the second position configured to prevent deployment of the first needle ([0197] when 319 is in the second position of FIG. 22B, needle 306’ can be advanced but needle 306 cannot be advanced); and actuating, while the first actuator is in the second position, a third actuator of the handle in the distal direction to direct the second needle through the vessel wall ([0197] 306 and 306’ are actuated separately, requiring separate actuation mechanisms; the third actuator actuates 306’).
Regarding claim 14, Zaugg et al. as modified further discloses a first actuator is a lever ([0288] the foot is pivoted by a lever).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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