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 .
Formal Matters
Applicant’s Response and Amendments filed 30 October 2025 are acknowledged. Claims 4, 8-23, 27-30, 38-60, 64, and 76-346 are cancelled. Claims 1-3, 5-7, 24-26, 31-37, 61-63, 65-75, and 347-355 are pending and under examination. Claims 1, 2, and 61 are currently amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5 August 2025 has been considered by the examiner. A signed copy is attached.
Objections Withdrawn
The objection to claim 2 is withdrawn in light of Applicant’s amendments.
Response to Remarks
Applicant traverses the claim interpretation under 35 USC 112(f) (Remarks, numbered pages 8-16). Accordingly, the terms are read in their broadest reasonable interpretation.
The amendments to independent claims 1 and 61 reorienting the second bar “to move away from” the first bar by the at least one deflector by the push member, is noted. However, the deflectors in Bailly are: the rib 51 with sloping face 51a (beside the needle) and the transverse finger 59 with sloping face 59a (below the needle). See ¶¶58-61, 73, 74, and FIGs 4–6, 13–15. These structures guide/pivot the catching bar 3 so it “no longer butts against the needle” and “moves away therefrom,” i.e., away from the first bar 2 located in the needle. Because the first bar (anchoring bar 2) is located in the needle and Bailly teaches that the deflectors move the catch bar 3 (second bar) away from the needle, this also necessarily moves the second bar away from the first bar. Accordingly the rejection is maintained.
Applicant is advised that this Office Action is NON-FINAL in light of the new objections and rejections set forth below.
New Claim Objection
There is a “slash” bar in claim 66 that is indicative of an alternative. It is suggested that this slash bar be replaced with an “or” to more clearly indicate the alternative.
Claim Interpretation
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.
Claim Rejections Maintained and Modified
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 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 1-3, 5-7, 24-26, 61, 65-75, 349, and 353 are rejected under 35 U.S.C. 103 as being unpatentable over Bailly et al., US 20030187465 (2 October 2003) (previously cited of record), for the reasons of record and the reasons set forth herein.
Regarding currently amended independent claim 1, Bailly teaches a fastening device (Abstract, FIGs 11-16) comprising:
a shaft (FIGs 2, 3, 10-16, shaft 40);
a handle (FIGs 2, 10, handgrip 6);
a needle (50) extending from the shaft (FIGs 11-16, shaft 40)
the needle (50) comprising a slot (slot 52, 53) extending along at least a portion of the needle (¶30),
wherein the fastening device (FIGs 2,3) is configured to receive a fastener (FIG 1, A) comprising a first bar (anchor bar 2) and a second bar (catch bar 3) connected by a bar connector (inclined connecting strip 4) (FIGs 11-16; ¶¶11, 42),
the first bar (2) positioned within the needle (50) and the second bar (3) positioned outside the needle (50) within the shaft (FIGs 11-13);
and a push member (42) configured to push the fastener (FIG1, A) out of the needle (50) (FIGs 3, 11, 13), and
at least one deflector (Abstract; ¶¶73, 74; the rib 51 with sloping face 51a (beside the needle) and the transverse finger 59 with sloping face 59a (below the needle)) positioned in proximity to the slot (FIGs 11-16), wherein the at least one deflector (51, 51a, 59) is configured relative to the slot (52, 53) such that the second bar (3) is reoriented to move away from the first bar (2) by the at least one deflector (51, 51a, 59) as the fastener (FIG 1, A) is pushed distally by the push member (42) (Abstract; FIGs 11-16).
The deflectors in Bailly are: the rib 51 with sloping face 51a (beside the needle) and the transverse finger 59 with sloping face 59a (below the needle). See ¶¶58-61, 73, 74, and FIGs 4–6, 13–15. These structures guide/pivot the catching bar 3 so it “no longer butts against the needle” and “moves away therefrom,” i.e., away from the first bar 2 located in the needle. Because the first bar (anchoring bar 2) is located in the needle and Bailly teaches that the deflectors move the catch bar 3 (second bar) away from the needle, this also necessarily moves the second bar away from the first bar, as recited in the amended claim. It is also noted that the amendment that the second bar is reoriented to move away from the first bar by the at least one deflector (1) is a function of the deflector in a device claim and (2) the function of moving “away from” does not appear to be a critical limitation in the disclosure. Thus, the movement “away from” does not appear to be an unexpected result. MPEP 716.02.
Regarding claim 2, Bailly teaches the fastening device of claim 1, the received fastener is positioned such that the first bar is positioned within the needle and the second bar is positioned outside the needle within the shaft (FIG 11).
Regarding claim 3, Bailly teaches the fastening device of claim 1, further comprising a fastener reservoir within the shaft, wherein the fastener is configured to convey down the fastener (FIG 16; ¶¶28, 79 and claim 3 “row of fasteners”; ¶4 “strip of fasteners in a magazine”; ¶30; see FIGs 11-16 for demonstration of the conveyance mechanism).
Regarding claim 5, Bailly teaches the fastening device of claim 1, wherein the at least one deflector (Abstract; ¶¶73, 74, “transverse finger” 59) is configured to lift the bar
Regarding claim 6, Bailly teaches the fastening device of claim 1, further comprising a stop (¶44, hairpin spring 10) positioned at a fixed or adjustable distance proximal to a distal end of the needle and configured to control an insertion depth of the needle (FIG 10, “[a] hairpin spring 10, in contact with the handgrip 6, roughly midway through its travel, forms a tactile threshold which alerts the operator to the fact that the needle is fully deployed, without ejecting a fastener).
Regarding claim 7, Bailly teaches the fastening device of claim 1, further comprising a trigger configured to deploy the fastener by engaging the push member (FIG 10; ¶¶44-45, two-finger fork 6a).
Regarding claim 24, Bailly teaches the fastening device of claim 1, comprising a first deflector (Abstract; ¶¶73, 74, “transverse finger” 59) extending from a surface on one side of the needle, the first deflector (Abstract; ¶¶73, 74, “transverse finger” 59) extending away from the surface and configured to lift the bar connector and second bar to another side of the needle (FIGs 13-16) as the fastener is being pushed distally.
Regarding claim 25, Bailly teaches the device of claim 1, further comprising a side ramp extending from a sidewall and configured to rotate the second bar as the fastener is being pushed distally, such that the second bar is moved towards an orientation parallel to a material being fastened (¶13, sloping ramp; ¶14, inclined ramp; FIG 6, ¶80, ramp 54; claim 7, inclined plane 54).
Regarding claim 26, Bailly teaches the fastening device of claim 25, further comprising a surface configured to maintain the second bar in a rotated position (FIG 4, ¶30 vertically inclined resting plane; claim 7, vertically inclined resting plane 56).
Regarding currently amended independent claim 61, Bailly teaches a method for fastening onlay material (FIGs 11-16; reinforcement material, ¶9; textile reinforcement 61) to tissue (¶¶1, 9, 15, 26, 68, 73, 74), the method comprising:
piercing the onlay material (FIGs 12-15, textile reinforcement 61¶26, 68) and tissue with a needle of a fastening device (needle 50), the needle comprising a slot (slots 52, 53) extending along at least a portion of the needle (50), a deflector (rib 51 with sloping face 51a, transverse finger 59) positioned in proximity to the slot (52, 53), and a push member (42); and
advancing a fastener (FIG 1, A) comprising a first bar (2) positioned within the needle (50), the first bar (2) connected to a second bar (3) by a bar connector (4) (FIGs 11-16);
wherein advancing the fastener (FIG 1, A) distally out of the needle (50) comprises reorienting the second bar (3) to move away from to the first bar (2) by the deflector (51, 51a, 59).
The deflectors in Bailly are: the rib 51 with sloping face 51a (beside the needle) and the transverse finger 59 with sloping face 59a (below the needle). See ¶¶58-61, 73, 74, and FIGs 4–6, 13–15. These structures guide/pivot the catching bar 3 so it “no longer butts against the needle” and “moves away therefrom,” i.e., away from the first bar 2 located in the needle. Because the first bar (anchoring bar 2) is located in the needle and Bailly teaches that the deflectors move the catch bar 3 (second bar) away from the needle, this also necessarily moves the second bar away from the first bar, as recited in the amended claim. It is also noted that the amendment that the second bar is reoriented to move away from the first bar by the at least one deflector (1) is a function of the deflector in a device claim and (2) the function of moving “away from” does not appear to be a critical limitation in the disclosure. Thus, the movement “away from” does not appear to be an unexpected result. MPEP 716.02.
Regarding claim 65, Bailly teaches the method of claim 61, as set forth above.
wherein advancing the fastener comprises activating a deployment mechanism on the fastening device (¶3, displacement of a plunger (42); claim 1).
Regarding claim 66, Bailly teaches the method of claim 61, as set forth above, further comprising maintaining/stabilizing a position of the needle (50) within the onlay material (61) and tissue while deploying the fastener (FIG 1, A) (FIGs 12-16; ¶77).
Regarding claim 67, Bailly teaches the method of claim 61, as set forth above, wherein reorienting the second bar (2) comprises lifting the bar connector (4) away from the needle (50) (FIGs 13-15).
Regarding claim 68, Bailly teaches the method of claim 61, as set forth above, wherein reorienting the second bar (3) comprises moving the second bar (3) to avoid engaging the needle (50) (FIGs 13-15).
The deflectors in Bailly are: the rib 51 with sloping face 51a (beside the needle) and the transverse finger 59 with sloping face 59a (below the needle). See ¶¶58-61, 73, 74, and FIGs 4–6, 13–15. These structures guide/pivot the catching bar 3 so it “no longer butts against the needle” and “moves away therefrom,” i.e., away from the first bar 2 located in the needle. Because the first bar (anchoring bar 2) is located in the needle and Bailly teaches that the deflectors move the catch bar 3 (second bar) away from the needle, this also necessarily moves the second bar away from the first bar, as recited in the amended claim. It is also noted that the amendment that the second bar is reoriented to move away from the first bar by the at least one deflector (1) is a function of the deflector in a device claim and (2) the function of moving “away from” does not appear to be a critical limitation in the disclosure. Thus, the movement “away from” does not appear to be an unexpected result. MPEP 716.02.
Regarding claim 69, Bailly teaches the method of claim 61, as set forth above, wherein reorienting the second bar (3) comprises moving the second bar (3) towards a position parallel to a surface of the onlay material (61) or tissue. (FIGs 13-15).
Regarding claim 70, Bailly teaches the method of claim 61, as set forth above, wherein reorienting the second bar (3) comprises rotating (pivot upwards) the second bar (3) such that the second bar (3) moves towards being parallel to a surface of the onlay material (61) or tissue (¶71, 74; FIGs 13-15).
Regarding claim 71, Bailly teaches the method of claim 61, as set forth above, further comprising deploying the first bar (2) within the tissue. (FIGs 13-15).
Regarding claim 72, Bailly teaches the method of claim 61, as set forth above, further comprising deploying the second bar (3) such that it rests adjacent to the onlay material (61) (¶74; FIGs 13-15).
Regarding claim 73, Bailly teaches the method of claim 61, as set forth above, further comprising deploying the fastener (FIG 1, A) such that the tissue and the onlay material (61) are approximated and fixed together by the fastener (FIGs 13-15).
Regarding claim 74, Bailly teaches the method of claim 61, as set forth above, further comprising withdrawing the needle (50) from the onlay material (61) and tissue after the fastener is deployed (¶75, FIGs 15-16).
Regarding claim 75, Bailly teaches the method of claim 61, as set forth above, further comprising supporting the onlay material (61) and tissue while withdrawing the needle (FIGs 15-16).
Regarding independent claim 349, Bailly teaches a system comprising: the fastening device of claim 1, as set forth above and a fastener (FIG 1, A) , the fastener comprising a first bar (2), a second bar (3); and a connector (4) joining the first bar (2) to the second bar (3), wherein the connector (4) is configured to be strong enough to withstand deployment of the first bar (FIGs 11-16; ¶¶11, 42).
Regarding claim 353, Bailly teaches the method of claim 61, as set forth above, further comprising deploying the fastener (FIG 1, A) by advancing the fastener within the needle (50) and out of a distal end of the needle (50) such that the bar connector (4) extends through the slot (52, 53) and exits the slot (52, 53) at the distal end of the needle (50) (¶57; FIGs 13-15).
Claim 31-37, 62, 63, 347, 348, 350-352, 354, and 355 are rejected under 35 U.S.C. 103 as being unpatentable over Bailly et al., US 20030187465 (2 October 2003) in view of Viker et al., US 20140031835 (30 January 2014) (previously cited of record).
Regarding claim 31, Bailly teaches the fastening device of claim 1, as set forth above.
Bally does not teach wherein edges of the needle slot comprise rounded, broken, polished, or other non-sharp edge configurations.
Viker teaches wherein edges of the needle slot comprise rounded, broken, polished, or other non-sharp edge configurations (FIGs 5A, 5B, 5C, distal end tip 106; ¶47).
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses edges of the needle slot comprise rounded, broken, polished, or other non-sharp edge configurations. Because Viker includes a longitudinal needle slot and a push rod path that advances the same type of bar-style fastener, a person of ordinary skill in the art, seeking to control fastener orientation in Bailly’s architecture would reasonably consult Viker’s deflector solution. Viker’s non-sharp edge configurations can be incorporated alongside Bailly’s slot (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding non-sharp edge configurations to the needle slot), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 32, Bailly teaches the fastening device of claim 1, as set forth above.
Bailly does not teach wherein a size of an inner diameter of the needle and a size of an outer diameter of the needle are selected to provide a sufficiently sized passageway through the material to be joined so the fastener's bar and bar connector pass through the material to be joined with minimal force. This is taught by Viker at ¶51 (“each staging space 142a, 142b, is sized to accept a leg 124 or 125 of an anchor 114, e.g., has a length that is at least equal and preferably slightly greater than a length of each of legs 124 and 125, and is aligned with an aperture 120 of a needle 115 to allow ejection from tip 106 in a distal direction”).
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses the needle size and the size of the passageway to accommodate the material to be joined with minimal force. Because Viker specifies the staging space and size of the needle, passageway, fasteners, aperture, and needle, a person of ordinary skill in the art, seeking to control the force required to join material using Bailly’s architecture would reasonably consult Viker’s sizing and controlled force solution. Viker’s needle sizing configurations can be incorporated alongside Bailly’s base device (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (sizing according to device, fastener, material), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 33, Bailly modified by Viker teaches the fastening device of claim 32, as set forth above.
Viker teaches wherein the inner diameter of the needle and outer diameter of the needle are sized to provide minimal insertion force in the material to be joined (¶51).
Regarding claim 34, Bailly teaches the fastening device of claim 1.
Bailly does not teach wherein a tip of the needle comprises a bevel angle such that the tip is configured to provide minimal insertion force in a material to be joined. This is taught by Viker at FIG 5C.
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses the needle size and bevel angle to accommodate the material to be joined with minimal force. Because Viker specifies the needle and needle angle to accommodate the material to be joined with minimal force, a person of ordinary skill in the art seeking to control the force required to join material using Bailly’s architecture would reasonably consult Viker’s needle and bevel solution. Viker’s needle angle configurations can be incorporated alongside Bailly’s base device (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (sized and angled according to device, fastener, material), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 35, Bailly modified by Viker teaches the fastening device of claim 34, as set forth above.
Viker teaches wherein the bevel angle of the tip is configured to withstand repeated use (FIG 5C, hollow sharp needle 122; ¶¶47-48).
Regarding claim 36, Bailly teaches the fastening device of claim 1.
Bailly does not teach wherein a length of the needle is sized to minimize or avoid contact with tissue underlying a repair site. This is taught by Viker at FIG 5C.
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses the needle length and size to accommodate the material to be joined with minimal force. Because Viker specifies the needle length and size to accommodate the material to be joined with minimal force, a person of ordinary skill in the art seeking to control the force required to join material using Bailly’s architecture would reasonably consult Viker’s needle and bevel solution. Viker’s needle size and length configurations can be incorporated alongside Bailly’s base device (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (sized according to device, fastener, material), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 37, Bailly teaches the fastening device of claim 1.
Bailly does not teach wherein a length of the needle is sized to be suitable for depositing one end or more than one end of the fastener in tissue.
Viker teaches “tip 106 can also include a sharpened needle end 122, which includes aperture 120 in the form of an internal channel 120 (extending into needle 115) through which a portion of soft tissue anchor 114 (e.g., such as leg 124, 125) can be passed, and from which the portion of soft tissue anchor 114 can be ejected to enter (and optionally pass through) tissue, with needle 115 being inserted into the tissue or through the tissue” (¶47; FIG 1A).
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses the needle size to accommodate the fastener and material to be joined. Because Viker specifies the needle and fastener sizing to accommodate the material to be joined, a person of ordinary skill in the art seeking to control the force required to join material using Bailly’s architecture would reasonably consult Viker’s needle sizing solution. Viker’s needle sizing configurations can be incorporated alongside Bailly’s base device (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (sized according to device, fastener, material), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 62, Bailly teaches the method of claim 61, as set forth above.
Bailly does not expressly teach wherein the fastening device comprises a stop and wherein the method further comprises using a stop to control an insertion depth of the needle.
Bailly teaches a hairpin spring 10 (FIG 10, ¶44), in contact with the handgrip 6, that forms a tactile threshold which alerts the operator to the fact that the needle is fully deployed, without ejecting a fastener.
Viker teaches a pin or molded feature 166 that provides a stop to ensure correct alignment (FIGs 8C, 9, 10; ¶59).
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses the needle size to accommodate the fastener and material to be joined. Because Viker specifies the needle and fastener sizing to accommodate the material to be joined, a person of ordinary skill in the art seeking to control the force required to join material using Bailly’s architecture would reasonably consult Viker’s needle sizing solution. Viker’s needle sizing configurations can be incorporated alongside Bailly’s base device (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (sized according to device, fastener, material), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 63, Bailly teaches the method of claim 61, as set forth above.
Bailly teaches the method further comprising withdrawing the needle (50) out of the tissue from a first location in tissue (FIG 16; ¶82)
Bailly does not expressly teach positioning or tensioning the onlay material on the needle, and piercing the tissue at a second location. Bailly does teach “arming the device for a subsequent movement of the buffer rod” at ¶82.
Viker teaches device (100) comprising a delivery and indexing cycle including four steps and a reset step (¶70).
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses the reset step. Because Bailly discloses that the device is rearmed for subsequent movement and Viker specifies the reset step, a person of ordinary skill in the art seeking to continue to use the fastening system comprising Bailly’s architecture would reasonably consult Viker’s solution of repeating the methodology of steps 1-4. Viker’s use of repetitive steps can be incorporated alongside Bailly’s base device (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (repeating as necessary or as determined by the skilled practitioner), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 347, Bailly modified by Viker teaches the fastening device of claim 1, as set forth above.
Bailly does not expressly teaches wherein the slot extends through a distal end of the needle.
However, Bailly teaches that the needle (50) is hollow and split having two longitudinal slots arranged near its edges (¶30).
Viker teaches that “tip 106 can also include a sharpened needle end 122, which includes aperture 120 in the form of an internal channel 120 (extending into needle 115) through which a portion of soft tissue anchor 114 (e.g., such as leg 124, 125) can be passed, and from which the portion of soft tissue anchor 114 can be ejected to enter (and optionally pass through) tissue, with needle 115 being inserted into the tissue or through the tissue” (¶47; FIG 1B, 5C).
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses the needle slot configuration and location. Because Viker specifies the needle and slot aperture as an internal channel as extending into the needle, a person of ordinary skill in the art seeking to utilize a needle where the slot comprises an internal channel that extends to the distal end of the needle to join material using Bailly’s architecture would reasonably consult Viker’s needle solution. Viker’s needle configurations can be incorporated alongside Bailly’s base device (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (needle selection), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 348, Bailly teaches the fastening device of claim 1, as set forth above.
Bailly does not specifically teach wherein the needle comprises a sharp tip.
Viker teaches sharpened needle end 122 (FIGs 1A, 4).
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses the needle tip sharpness. Because Viker specifies the needle type to accommodate the material to be joined, a person of ordinary skill in the art seeking to vary the needle type based on tissue or onlay type, density, thickness, and related parameters, to join material using Bailly’s architecture would reasonably consult Viker’s needle selection solution. Viker’s needle selection configurations can be incorporated alongside Bailly’s base device (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (selection of the needle according to the configuration, fastener, material), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 350, Bailly modified by Viker teaches the system of claim 349, as set forth above.
Bailly does not expressly teach wherein at least one of a height, length, or width of the second bar is different from a corresponding dimension of the first bar.
Viker teaches that the soft tissue anchor can be of any useful dimension (¶36; see also, FIG 2A; ¶¶ 38, 39, 40; claim 2).
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses the dimensions of the soft tissue anchor. Because Viker specifies the dimensions of the soft tissue anchor can be variable to accommodate the material to be joined, a person of ordinary skill in the art seeking to join different kinds of material or tissue using Bailly’s architecture would reasonably consult Viker’s soft tissue anchor solution. Viker’s soft tissue anchor configurations can be incorporated alongside Bailly’s base device (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (the soft tissue anchors can be sized according to the material and tissue), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 351, Bailly teaches the system of claim 349 as set forth above.
Bailly does not expressly teach wherein at least one of the first bar and the second bar comprise one or more blunt ends (but see FIG 1, A).
Viker teaches wherein at least one of the first bar and the second bar comprise one or more blunt ends (¶40, “each of the tie and legs can exhibit a cross section that is preferably solid, and that can be of any form, such as a circular, square, rectangular, triangular, oval, or otherwise shaped cross section”; FIGs 2A, 2B).
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses the structure of the fastener. Because Viker specifies the fastener may be shaped and sized to accommodate the material to be joined, a person of ordinary skill in the art seeking to control the force required to join material using Bailly’s architecture would reasonably consult Viker’s fastener shape solution. Viker’s fastener shape configurations can be incorporated alongside Bailly’s base device (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (shape of the fasteners according to material and tissue), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 352, Bailly modified by Viker teaches the system of claim 349, as set forth above
Bailly does not teach wherein at least one of the first bar, the second bar, and the connector comprises a rectangular cross section
Viker teaches that “each of the tie and legs can exhibit a cross section that is preferably solid, and that can be of any form, such as a circular, square, rectangular, triangular, oval, or otherwise shaped cross section” (¶40).
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses the structure of the fastener. Because Viker specifies the fastener may be shaped and sized to accommodate the material to be joined, a person of ordinary skill in the art seeking to control the force required to join material using Bailly’s architecture would reasonably consult Viker’s fastener shape solution. Viker’s fastener shape configurations can be incorporated alongside Bailly’s base device (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (shape of the fasteners according to material and tissue), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 354, Bailly teaches the method of claim 61, as set forth above.
Bailly does not teach wherein the onlay material comprises acellular dermal matrix (ADM).
Viker teaches wherein the onlay material (¶30, elongate pieces of material (e.g., mesh, molded implant material, suture, or biologic material) comprises acellular dermal matrix (ADM) (¶32, an implant may include portions, pieces, or sections that are synthetic or of biologic material (e.g., porcine, cadaveric, etc.))
ADM is old and well-understood in the surgical arts to be a genus of acellularized dermal matrix biological-based materials including acellularized porcine dermis (e.g., pig skin).
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses the type of onlay material to be joined. Because Viker specifies the type of onlay material to be joined, including porcine (ADM) a person of ordinary skill in the art seeking to control the force required to join material using Bailly’s architecture would reasonably consult Viker’s biologically compatible onlay material solution. Viker’s biologically compatible onlay material solutions can be incorporated alongside Bailly’s base device (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (material selected according to use case or end user), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 355, Bailly teaches the method of claim 61, as set forth above.
Bailly does not teach wherein piercing the onlay material comprises piercing the onlay material with a sharp tip of the needle.
Viker teaches “tip 106 can also include a sharpened needle end 122, which includes aperture 120 in the form of an internal channel 120 (extending into needle 115) through which a portion of soft tissue anchor 114 (e.g., such as leg 124, 125) can be passed, and from which the portion of soft tissue anchor 114 can be ejected to enter tissue, with needle 115 being inserted into the tissue or through the tissue” (¶47; FIG 1A).
Bailly and Viker teach surgical fasteners including “I” and “H”-type fasteners and methods of use. Bailly teaches the claimed base needle-based fastener delivery system (shaft, needle with longitudinal slot, inner and outer bar fastener arrangement, and push member) and method of use. Viker specifically addresses the needle type to accommodate the fastener and material to be joined. Because Viker specifies the needle type to accommodate the material to be joined, a person of ordinary skill in the art seeking to control the force required to join material using Bailly’s architecture would reasonably consult Viker’s needle type solution. Viker’s needle type configurations can be incorporated alongside Bailly’s base device (same general location and interaction with the advancing fastener) using known assembly methods without redesigning Bailly’s core delivery path. Because the references address the same engineering problem (needle-based deployment of surgical fasteners) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (typed according to material to be pierced), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
New Objections/Rejections
Drawings - Objections
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the sidewall in claim 25 must be shown or the features canceled from the claims. The only indication of a “sidewall” in the disclosure is at ¶18 where the device comprises a ramp extending from a sidewall and the ramp extending away from a sidewall. Paragraph 18 of the disclosure also recites that the device can comprise a surface or sidewall. There are no figures or element indicators showing what a sidewall is or where it is located. Accordingly, there is no indication in the drawings of what structure is being referred to by the term “sidewall” in claim 25. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112(b) Indefiniteness
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.
Claims 25, 26, 31 are 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 25, line 2 recites a “sidewall”. The structure of a “sidewall” is unclear and confusing. A sidewall of what? The only indication of a “sidewall” in the disclosure is at ¶18 where the device comprises a ramp extending from a sidewall and the ramp extending away from a sidewall. Paragraph 18 of the disclosure also recites that the device can comprise a surface or sidewall. However, there is no indication of what structure is being referred to by the term “sidewall”.
Claim 26 is rejected as being dependent on a rejected claim.
Claim 31, line 2 recites that the needle slot comprise broken or other non-sharp edge configurations. It is unclear what is meant by broken configurations. The metes and bounds of the term “broken” are not defined in the specification. Paragraph 342 recites “broken edges” in a list, but does not define what it means or how to identify that edges are broken. The only other mention of “broken” in the disclosure is at ¶22.
Applicant is referred to Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (2008). A five member expanded panel of the Board held that "if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 USC 112, second paragraph, as indefinite."
Applicant is also referred to Nautilus Inc., v. Biosig Instruments, Inc., 572 U.S. 898, 908-909 (2014) in which the Court held that a claim is indefinite if the specification and prosecution history fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. The Court also held that a patent must be precise enough to afford clear notice of what is claimed thereby "appris[ing] the public of what is still open to them (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (1996)), in a manner that avoids "[a] zone of uncertainty which enterprise and experimentation may enter only at the risk of infringement claims," (citing United Carbon Co., v. Binney & Smith Co., 317 U.S. 228, 236 (1942)) (Nautilus 909).
Conclusion
No claim is allowed. This Office Action is NON-FINAL.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Green et al., US 5,549,617 (27 August 1996) teaches apparatus and method for applying and adjusting an anchoring device.
Moss et al., US 5,085,661 (4 February 1992) teaches surgical fastener implantation device.
Adams et al., US 6,736,828 (18 May 2004) teaches method for performing endoluminal fundoplication and apparatus for use in the method.
Kortenbach, US 6,086,600 (11 July 2000) teaches flexible endoscopic surgical instrument for invagination and fundoplication.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771