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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 3/25/2025, 10/24/2025,12/15/2025, 1/13/2026, 2/14/2026 and 4/1/2026 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 1-11 and 14-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meade et al. (US 2006/0069396).
Meade discloses (see Figs. 1-23) an apparatus and method for minimally invasive suturing comprising the following claim limitations:
(claim 1) A method of suturing tissue of a patient using a suturing device (see Abstract), comprising: introducing an elongate surgical device (50, Fig. 1) into a patient (see claims 18-20; [0019]-[0020]; [0066]; [0080]; [0083]-[0084]), the elongate surgical device (50) comprising an elongate flexible steerable portion (54/58, Fig. 1) (flexing at joint 58 at distal end of barrel 54; as shown in Figs. 2A-2B); a suturing device (56, Fig. 1) coupled to a distal end region of the elongate flexible steerable portion (54) (as shown in Figs. 1-2B), the suturing device (56) comprising: a body (90, Fig. 3A) having a proximal end, a distal end (as shown in Figs. 1-2B) and defining a laterally-facing tissue capture gap (118, Figs. 2A-2B) (as shown in Figs. 2A-2B and 22-23; see claims 5-6; [0013]; [0040]; [0066]; [0073]; [0080]; lateral articulation expressly depicted and disclosed) between the proximal end of the suturing device and the distal end of the suturing device (56) (as shown in annotated Fig. 2A below; when articulated laterally, aperture 118 is disposed between the marked distalmost tip and the opposed proximal end of the suturing device 56); a needle driver (70/98/102/78, Figs. 4A and 8) configured to (i.e., capable of) advance a suturing needle (120, Fig. 3A) along a pathway along a first direction (i.e., counterclockwise as depicted) across the laterally facing tissue capture gap (118) and into a passageway defined in the body of the suturing device (56) (driven rotation as shown between Figs. 5A-6B); and an actuation tether (86, Fig. 3A) operably coupled to the needle driver (70/98/102/78) (as best shown in Figs. 4A and 8), the actuation tether (86) being configured to (i.e., capable of) operate the needle driver (70/98/102/78) when tension is applied to the actuation tether (86) (as shown in Figs. 4A and 8-9; [0028]; [0060]; [0067]-[0068]; tension applied to actuation tether 102 to initiate driving of needle 120); introducing at least one tissue segment to be sutured into the laterally-facing tissue capture gap (118) (see claims 18-20; [0066]; [0080]; the step of introducing and articulating the capture gap laterally against tissue is expressly disclosed); and applying a tensile force to the actuation tether (86) to cause the needle driver (70/98/102/78) to advance a suturing needle (120) across the laterally facing tissue capture gap (118), through the at least one tissue segment, and into the passageway defined in the body (90) of the suturing device (56) (see claims 18-20; [0060]; [0067]-[0068]; applying tension to actuation tether 86 to initiate driving of needle 120 expressly disclosed);
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(claim 2) further comprising disengaging the needle driver (70/98/102/78) from the suturing needle (120) after the suturing needle has been received into the passageway defined in the body (90) of the suturing device (56) (as expressly shown between Figs. 6A-6B; [0030]; [0062]-[0063]; needle driver (at pawl 98) expressly disengages needle 120 after the needle 120 is driven across aperture 118 and back into the suturing device 56);
(claim 3) further comprising preventing the suturing needle (120) from traveling in a second direction opposite (i.e., clockwise as depicted) the first direction while the needle driver (at 98) is disengaging from the suturing needle (120) (as expressly shown in Figs. 6A-6B; [0030]; [0062]-[0063]; as needle driver (at pawl 98) expressly disengages needle 120 and resets to its initial/start position, anti-rotate spring 136 expressly prevents reverse motion of the needle 120);
(claim 4) further comprising forming a mechanical engagement (at notch 134) of the suturing needle (120) to a pawl (i.e., bent free end of anti-rotate spring 136, as shown in Figs. 5A-5B) distinct from the needle driver to facilitate disengagement of the needle driver (at 98) from the suturing needle (120) (as shown in Figs. 5A-6B; [0063]; free end of spring 136 expressly prevents reverse rotation of the needle 120 as pawl 98 resets its position);
(claim 5) wherein the pawl (i.e., bent free end of anti-rotate spring 136, as shown in Figs. 5A-5B) is disposed in a path of travel of the suturing needle (120) prior to mechanically engaging the suturing needle (120) (as shown in Figs. 5A-6B; the pawl/tip of spring 136 is disposed in the path of travel of needle 120 until a notch or blunt end engages with the pawl);
(claim 6) wherein the pawl (i.e., bent free end of anti-rotate spring 136, as shown in Figs. 5A-5B) engages an indentation (e.g., 134/126) formed into the suturing needle (120) to achieve the mechanical engagement (as shown in Figs. 5A-6B);
(claim 7) wherein the pathway is defined by an arcuate shape (as shown in Figs. 2A-6B and 10-16; [0020]; [0057]; [0059]-[0060]);
(claim 8) further comprising returning the needle driver (at 98) to a starting position after the needle driver (at 98) is disengaged from the suturing needle (120) (as shown in Figs. 5A-6B; [0063]; free end of spring 136 expressly prevents reverse rotation of the needle 120 as pawl 98 resets its position);
(claim 9) wherein the suturing needle (120) comprises a needle body (128, Fig. 19B) and a length of suturing material (146, Fig. 19B) trailing from the needle body (128) (as expressly shown in Fig. 19B), and further wherein the method further comprises pulling the length of suturing material (146) through the at least one tissue segment (as shown in Figs. 5A-6B; [0063]-[0064]; continuous suturing cycle pulls suture through the tissue behind needle 120);
(claim 10) wherein the introducing step includes introducing a distal end of the suturing device (56) into the patient through a natural orifice of the patient ([0003]; [0079]; step of minimally invasive surgery introduction through a natural orifice for paraesophageal hernia repair expressly disclosed);
(claim 11) wherein the introducing step includes introducing a distal end of the suturing device (56) into the patient through an esophagus of the patient and further wherein the at least one tissue segment includes tissue of the patient's stomach ([0003]; [0079]; step of minimally invasive surgery introduction through a patient’s esophagus for paraesophageal hernia repair expressly disclosed);
(claim 14) An elongate surgical device (50, Fig. 1) comprising an elongate flexible, steerable portion (54/58, Fig. 1) (flexing at joint 58 at distal end of barrel 54; as shown in Figs. 2A-2B); a suturing device (56, Fig. 1) coupled to a distal end of the elongate flexible, steerable portion (54) (as shown in Figs. 1-2B), the suturing device (56) comprising: a body (90, Fig. 3A) having a proximal end, a distal end (as shown in Figs. 1-2B) and defining a laterally-facing tissue capture gap (118, Figs. 2A-2B) (as shown in Figs. 2A-2B and 22-23; see claims 5-6; [0013]; [0040]; [0066]; [0073]; [0080]; lateral articulation expressly depicted and disclosed) between the proximal end of the suturing device and the distal end of the suturing device (56) (as shown in annotated Fig. 2A below; when articulated laterally, aperture 118 is disposed between the marked distalmost tip and the opposed proximal end of the suturing device 56); a needle driver (70/98/102/78, Figs. 4A and 8) configured to (i.e., capable of) advance a suturing needle (120, Fig. 3A) along a pathway along a first direction (i.e., counterclockwise as depicted) across the laterally facing tissue capture gap (118) and into a passageway defined in the body of the suturing device (56) (driven rotation as shown between Figs. 5A-6B); and an actuation tether (86, Fig. 3A) operably coupled to the needle driver (70/98/102/78) (as best shown in Figs. 4A and 8), the actuation tether (86) being configured to (i.e., capable of) operate the needle driver (70/98/102/78) when tension is applied to the actuation tether (86) (as shown in Figs. 4A and 8-9; [0028]; [0060]; [0067]-[0068]; tension applied to actuation tether 86 to initiate driving of needle 120);
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(claim 15) wherein the body (90) of the suturing device (56) extends distally beyond the pathway traveled by the suturing needle (120) (as shown in annotated Fig. 2A above; when articulated laterally, aperture 118 and the pathway of needle 120 is disposed proximal to the marked distalmost tip of the body 90 of the suturing device 56);
(claim 16) wherein the suturing device (56) is configured and arranged to (i.e., capable of) permit the needle driver (70/98/102/78) to disengage from the suturing needle (120) after the suturing needle (120) has been received into the passageway defined in the body (90) of the suturing device (56) (as expressly shown between Figs. 6A-6B; [0030]; [0062]-[0063]; needle driver (at pawl 98) expressly disengages needle 120 after the needle 120 is driven across aperture 118 and back into the suturing device 56);
(claim 17) wherein the suturing device (56) is configured and arranged to (i.e., capable of) prevent the suturing needle (120) from traveling in a second direction opposite (i.e., clockwise as depicted) the first direction while the needle driver (at 98) is disengaging from the suturing needle (120) (as expressly shown in Figs. 6A-6B; [0030]; [0062]-[0063]; as needle driver (at pawl 98) expressly disengages needle 120 and resets to its initial/start position, anti-rotate spring 136 expressly prevents reverse motion of the needle 120);
(claim 18) further comprising a pawl (i.e., bent free end of anti-rotate spring 136, as shown in Figs. 5A-5B) disposed in a path of travel of the suturing needle (120) that is configured to (i.e., capable of) form a mechanical engagement (at notch 134) with the suturing needle (120) to facilitate disengagement of the needle driver (at 98) from the suturing needle (120) (as shown in Figs. 5A-6B; [0063]; free end of spring 136 expressly prevents reverse rotation of the needle 120 as pawl 98 resets its position);
(claim 19) wherein the pawl (i.e., bent free end of anti-rotate spring 136, as shown in Figs. 5A-5B) is configured to (i.e., capable of) engage an indentation (e.g., 134/126) formed into the suturing needle (120) to achieve the mechanical engagement (as shown in Figs. 5A-6B);
(claim 20) wherein the pathway is defined at least in part by an arcuate shape (as shown in Figs. 2A-6B and 10-16; [0020]; [0057]; [0059]-[0060]); and
(claim 21) wherein the suturing device (56) is configured and arranged to (i.e., capable of) permit the needle driver (at 98) to return to a starting position after the needle driver (at 98) is disengaged from the suturing needle (120) (as shown in Figs. 5A-6B; [0063]; free end of spring 136 expressly prevents reverse rotation of the needle 120 as pawl 98 resets its position).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12-13 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Meade as applied to claims 1 and 14 above, and further in view of Meade et al. (US 2002/0193809) (hereinafter “Meade II”).
Meade discloses (see Figs. 1-23) an apparatus and method for minimally invasive suturing comprising the following claim limitations:
(claims 12 and 22) wherein the elongate surgical device (50) further comprises an actuator (60, Fig. 1) coupled to a proximal region of the elongate flexible steerable portion (as expressly shown in Fig. 1), the actuator (60) comprising a trigger (i.e., pivoting grip portion of handle 60) operably coupled to the actuation tether (86) (as shown in Figs. 8-9; [0066]-[0068]), wherein the trigger is configured to (i.e., capable of) move the needle driver (at 98) along the first direction (i.e., counterclockwise) and along a second direction (i.e., clockwise) opposite the first direction ([0067]-[0068]).
Meade, as applied above, discloses an apparatus and method for minimally invasive suturing comprising all the limitations of the claim except for the trigger being configured to not permit movement along the second direction until the suturing needle has been advanced along the pathway along the first direction and into the passageway defined in the body of the suturing device, and wherein the trigger is operably coupled to a ratchet that prevents movement of the needle driver along the second direction until the suturing needle has been advanced along the pathway along the first direction and into the passageway defined in the body of the suturing device.
However, Meade II teaches (see Figs. 1 and 20A-20C) a similar apparatus and method for surgical suturing comprising the trigger (16, Fig. 1) being configured to (i.e., capable of) not permit movement along the second direction until the suturing needle has been advanced along the pathway along the first direction and into the passageway defined in the body of the suturing device ([0068]-[0069]; unidirectional rotation until contact between the shuttle and first wedge, wherein reverse rotation of an equal distance is then permitted), and wherein the trigger (16) is operably coupled to a ratchet (134, Fig. 20A) that prevents movement of the needle driver along the second direction until the suturing needle has been advanced along the pathway along the first direction and into the passageway defined in the body of the suturing device ([0068]-[0069]; unidirectional rotation until contact between the shuttle and first wedge, wherein reverse rotation of an equal distance is then permitted) in order to beneficially provide for the actuation step of the suturing device being pre-determined wherein the ratchet assembly prevents the user from performing an incomplete actuating event that could result in an improper or incomplete suture by causing the needle to snag in the tissue ([0069]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Meade to have the trigger being configured to not permit movement along the second direction until the suturing needle has been advanced along the pathway along the first direction and into the passageway defined in the body of the suturing device, and wherein the trigger is operably coupled to a ratchet that prevents movement of the needle driver along the second direction until the suturing needle has been advanced along the pathway along the first direction and into the passageway defined in the body of the suturing device in order to beneficially provide for the actuation step of the suturing device being pre-determined wherein the ratchet assembly prevents the user from performing an incomplete actuating event that could result in an improper or incomplete suture by causing the needle to snag in the tissue, and further allowing for operation of the trigger in a manner independent of its orientation with respect to the trigger and actuator handle, such as for example, when it is oriented in an upside down or sideways configuration, as taught by Meade II.
Conclusion
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.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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