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 .
Benefit
The application filed 11 March 2025 claims benefit to US Provisional 63/565159 (14 March 2024).
Formal Matters
Claims 1-20 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3 October 2025 has been considered by the examiner. A signed copy is attached.
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 Objections
Claim 15 is objected to because of the following informalities: in line 2 the phrase “device is re-secured to comprises a slot in a” is awkward and appears to be missing punctuation. In order to promote compact prosecution, the examiner will read the phrase with a comma inserted between the words “to” and “comprises”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: in line 2 the phrase “the slot including a height” is grammatically awkward. In order to promote compact prosecution, the examiner will read the phrase as “the slot includes a height”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 9, 15, and 20 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 9 recites that “the proximal head comprises at least one transverse opening extending through the proximal head and through the slot transverse to the slot”.
Claim 15, line 2 recites that the passing needle comprises “a slot in a proximal head”. Lines 2 bridging to line 3 recites “and at least one transverse opening in the proximal head”. In lines 3 bridging to line 4, the claim recites “through the slot transverse to the slot”.
Claim 20, recites “wherein the proximal head comprises at least one transverse opening extending through the proximal head and through the slot transverse to the slot”.
In these three recitations, it is unclear and confusing which opening is intended to be designated at the slot when there is also a recitation of “a slot that is transverse to the slot.”
Clarification is important because the prior art reference to Pinchuk, US 20060136070 (22 June 2006) (set forth below) teaches an eyelet 22 as well as a slit 24 in the eyelet 22 (FIG 4D). The examiner wishes to maintain consistency in designating these elements in comparison with the multiple recitations of “slot(s)” in the claims.
For the purpose of compact prosecution, the examiner interprets the dual “slot” recitation in claims 15 and 20 as “the opening transverse to the slot”.
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).
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.
Claims 1, 12, 13, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Genuario et al., US 20230039437 (9 February 2023), as evidenced by Stryker eBrochure “XBraid TT, Force Fiber and XBraid S” 1000901977 Rev C, 2023. Stryker Sports Medicine, Colorado, USA. (www.stryker.com/content/dam/stryker/sports-medicine/products/xbraidttsurgicalsuturetape/resources/Force%20Fiber%20and%20XBraidTT%20Brochure.pdf) (Last Accessed 9/5/2026).
Regarding independent claim 1, Genuario teaches an orthopedic system (¶31) comprising:
(a) an elastomeric device (FIGs 1-12, filament 20, ¶31) of at least one elastomer material (“XBraid® TT 1.4, White/Blue Suture Tape”, ¶31; as evidenced by Stryker eBrochure p. 2, ¶1 as smooth, low profile, 100% UHMWPE suture tape);
(b) a passing needle (FIGs 1-12, needles 10/11, ¶31) comprising a distal tip (FIG 1A, “Double Armed ST-1 (double Straight Taper Needle, 60 mm)”, ¶31; as evidenced by Stryker eBrochure p. 2, product# 3910900009), a proximal head (FIG 1A, ¶31), and an elongated shaft extending between the distal tip and the elongated head (FIG 1A), wherein the proximal head comprises an opening in the proximal head that is sized and shaped to receive an end of the elastomeric device (FIG 1A, ¶31);
wherein the elastomeric device (filament, ¶33) is secured to the passing needle with the end of the elastomeric device located in the opening (FIG 1A; ¶31).
The term “orthopedic system” is broadly interpreted as a system comprising an elastomeric device and a passing needle as defined at ¶4 of the Specification.
The term “passing needle” is broadly interpreted as a needle for passing a suture through soft tissue, which is defined in the Specification at ¶3.
Regarding independent claim 12, Genuario teaches a method of using an orthopedic system (¶31),
the orthopedic system (¶¶1,2) comprising an elastomeric device (FIGs 1-12, filament 20, ¶31) comprising a flat strip of at least one elastomer material (“XBraid® TT 1.4, White/Blue Suture Tape”, ¶31; as evidenced by Stryker eBrochure p. 2, ¶1 as smooth, low profile, 100% UHMWPE suture tape) and further comprising a passing needle comprising an opening in a proximal head that is sized and shaped to receive an end of the elastomeric device (FIGs 1-12, needles 10/11, ¶31),
the elastomeric device (FIGs 1-12, filament 20, ¶31) secured to the passing needle, the method comprising:
(a) piercing a soft tissue with a distal tip of the passing needle (¶7; claims 1, 2);
(b) passing the passing needle through the soft tissue (¶7; claims 1, 2); and
(c) using the passing needle, pulling the elastomeric device at least partially through the soft tissue (¶7; claims 1, 2).
The term “orthopedic system” is broadly interpreted as a system comprising an elastomeric device and a passing needle as defined at ¶4 of the Specification.
The term “passing needle” is broadly interpreted as a needle for passing a suture through soft tissue, which is defined in the Specification at ¶3.
Regarding claim 13, Genuario teaches the method of claim 12, as set forth above, further comprising, after pulling the elastomeric device at least partially through the soft tissue, separating the elastomeric device from the passing needle (¶44).
Regarding claim 17, Genuario teaches the method of claim 12 wherein the passing needle (FIGs 1-12, needles 10/11, ¶31) comprises the distal tip (FIG 1A, “Double Armed ST-1 (double Straight Taper Needle, 60 mm)”, ¶31; as evidenced by Stryker eBrochure p. 2, product# 3910900009), the proximal head (FIG 1A, ¶31), and an elongated shaft extending between the distal tip and the elongated head (FIG 1A), wherein the elastomeric device is secured to the passing needle with the end of the elastomeric device located in the opening (FIG 1A, ¶31).
Regarding claim 18, Genuario teaches the method of claim 17 wherein the opening in the proximal head is sized and shaped to receive the end of the elastomeric device in a flat condition (FIG 1A, ¶31); and wherein the elastomeric device is secured to the passing needle with the end of the elastomeric device (“XBraid® TT 1.4, White/Blue Suture Tape”, ¶31; as evidenced by Stryker eBrochure p. 2, ¶1 as smooth, low profile, 100% UHMWPE suture tape) located in the opening in the flat condition (FIGs 1-12, needles 10/11, ¶31).
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over by Pinchuk, US 20060136070 (22 June 2006).
Regarding independent claim 1, Pinchuk teaches an orthopedic system (FIGs 1-4D, ¶35) comprising:
(a) an elastomeric device (FIG 1, elastomeric filament implant 10, ¶33) comprising a flat strip (FIG 8B, “implant to lie flat” ¶42; claim 3 “elastomeric filament has a diameter in a range between 0.1 mm to 1mm) of at least one elastomer material (ePTFE, etc., ¶25);
(b) a passing needle (FIGs 2A, 4A-D, “needle is adapted to be inserted under the surface of the skin”, ¶13) comprising a distal tip (FIGs 2A, 4D, distal end of the needle 11, ¶33), a proximal head (FIGs 1, 3, 4A-D, ¶33), and an elongated shaft extending between the distal tip and the elongated head (FIGs 2A, 4D), wherein the proximal head comprises an opening in the proximal head that is sized and shaped to receive an end of the elastomeric device (FIGs 2A, bore 15; FIG 4D, eyelet);
wherein the elastomeric device (filament, ¶33) is secured to the passing needle (FIGs 1A, 4A) with the end of the elastomeric device located in the opening (FIGs 2B, crimped; 4D eyelet). Pinchuck teaches multiple embodiments of needles comprising elastomeric filaments in the same reference. FIGs 1-2B are drawn to crimping needles as needle 11, with elastomeric filament 10. FIGs 3 is drawn to needle 20 comprising eyelet 22 and elastomeric filament 10. FIGs 4A-D are eyelet-containing needles as needle 11 and elastomeric filament 10, where the eyelet-containing needle 11 also comprises eyelet 22 and slit 24. Due to the overlap in these embodiments, where Pinchuck teaches them as a related group (¶35), the rejection refers to them as alternative embodiments of needles 11 and 20, which both utilize elastomeric filament 10. Pinchuck itself expressly teaches the multiple alternative of crimped and eyelet needles, both of which are labeled as “needle 11” in FIGs 1-2B and 4A-D, with needle 11 shown as accommodating elastomeric filament 10 (¶13) and also expressly teaches a separate eyelet needle 20 (FIG 3), which also accommodates elastomeric filament 10, but does so in a threaded manner (¶34), rather than through a slit 24 (compare needle 11 as shown in FIGs 4A-D).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the alternative teachings of the multiple embodiments of Pinchuck given that the prior art reference as a whole included each element claimed, although not necessarily in a single embodiment. The multiple embodiments in Pinchuck provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine or substitute the reference teachings with a reasonable expectation of success. The claimed invention would have been obvious because a person of ordinary skill in the art would have been motivated to combine or substitute the teachings within the four corners of a reference to achieve the claimed invention with a reasonable expectation of success. Pinchuck teaches different embodiments of needle types, each solving known problems in the art, including different ways of attaching the elastomeric filament 10 to the needle body, either by crimping (FIGs 1, 2A, 2B) or by eyelet (FIGs 3, 4A-4D) and either through threading (needle 20) comprising an eyelet or through needle 11 (comprising a slit). One of ordinary skill in the art would be motivated to select among the various embodiments of Pinchuck depending on the anatomical requirements of the surgical procedure. Given that Pinchuck teaches these alternative embodiments as equivalents, one would have a reasonable expectation of success in selecting from the finite embodiments taught by Pinchuck that are best suited for the particular end-use case.
The term “orthopedic system” is broadly interpreted as a system comprising an elastomeric device and a passing needle as defined at ¶4 of the Specification.
The term “passing needle” is broadly interpreted as a needle for passing a suture through soft tissue, which is defined in the Specification at ¶3.
Regarding claim 2, Pinchuk teaches the orthopedic device of claim 1, as set forth above, for the reasons set forth above.
Pinchuck teaches wherein the distal tip is a narrowed distal tip (FIG 2A) and wherein the proximal head is an enlarged proximal head (FIG 2A, “bore 15 is sized at a diameter slightly larger than the diameter of the filament implant 10”, ¶33).
Regarding claim 3, Pinchuk teaches the orthopedic system of claim 1, as set forth above, for the reasons set forth above.
Pinchuck teaches wherein the opening in the proximal head (FIGs 4A-4C, eyelet) is sized and shaped to receive the end of the elastomeric device (FIGs 4A-4D) in a flat condition (FIGs 4B, 4C; ¶42); and
wherein the elastomeric device (filament) is secured to the passing needle (FIG 4D) with the end of the elastomeric device located in the opening in the flat condition (FIG 8B, ¶42).
Regarding claim 4, Pinchuk teaches the orthopedic system of claim 3, as set forth above, for the reasons set forth above.
Pinchuck teaches wherein the opening in the proximal head comprises a slot in the proximal head (FIG 4D, eyelet 22, ¶34).
Regarding claim 5, Pinchuk teaches the orthopedic system of claim 4, as set forth above, for the reasons set forth above.
Pinchuck teaches wherein the passing needle (11) extends along a longitudinal axis (FIG 4D) and wherein the slot (eyelet 22) defines a rectangular cross sectional shape perpendicular to the longitudinal axis (FIG 4D, ¶34).
Regarding claim 6, Pinchuk teaches the orthopedic system of claim 4, as set forth above, for the reasons set forth above.
Pinchuck teaches wherein the elastomeric device (filament 10) extends along a longitudinal axis (FIG 4B) and wherein the elastomeric device defines a rectangular cross sectional shape perpendicular to the longitudinal axis (FIG 4B).
Regarding claim 7, Pinchuk teaches the orthopedic system of claim 4, as set forth above, for the reasons set forth above.
Pinchuck teaches wherein the slot (eyelet 22) extends across a width of the proximal head between a first open side of the slot and a second open side of the slot (FIG 4A-D, ¶34).
Regarding claim 8, Pinchuk teaches the orthopedic system of claim 4, as set forth above, for the reasons set forth above.
Pinchuck teaches wherein the slot (FIGs 3, 4D, eyelet 22, ¶34) comprises a height that is substantially the same as a thickness of the elastomeric device (FIGs 2, 4A-D, ¶34), wherein the slot (eyelet 22) comprises a width that is substantially the same as a width of the elastomeric device (FIGs 3, 4A-D, ¶34).
Regarding claim 9, Pinchuk teaches the orthopedic system of claim 8, as set forth above, for the reasons set forth above.
Pinchuck teaches wherein the proximal head (FIG 4D, proximal head of needle 11) comprises at least one transverse opening (FIGs 4A-4D, slit 24; ¶34) extending through the proximal head (FIG 4D, proximal head of needle 11) and through the slot [interpreted as the opening] (FIG 4D, slit 24, ¶34) transverse to the slot (FIG 4D, eyelet 22, ¶34).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over by Pinchuk, US 20060136070 (22 June 2006) in view of Moretti et al., US 20200078006 (12 March 2020).
Regarding claim 10, Pinchuk teaches the orthopedic system of claim 9, as set forth above, for the reasons set forth above.
Pinchuck does not expressly teach the system further comprising at least one flexible member extending through the transverse opening and piercing the elastomeric device to secure the elastomeric device to the passing needle.
Moretti teaches a suture assembly (100) comprising a needle (10), configured to suture tissue, having a cylindrical body with a sharp point on at least one end and a lumen extending transverse to a longitudinal axis of the cylindrical body and a recess in communication with an opening to the lumen in which to extend a suture (80) through the lumen (FIGs 1, 5; ¶¶23, 74). Moretti also teaches that the suture extends through the first lumen in a first direction, across the cylindrical body and through the second lumen in a second direction opposite the first direction, wherein the suture is fixed to the cylindrical body (¶38). Moretti teaches securing the needle (10) to the suture (80) by any means such that the suture (80) is fixedly coupled to the needle (10) (¶75) including examples of a sleeve (60) (¶¶13, 18), adhesive, resin, heat-shrink material, deformation, melting, interference fit (¶75), crimping (FIG 8, ¶80), friction fit into the recess cavity (¶34), pinched (FIG 6, ¶76), swagging (¶¶70, 89), wrapping a coupling member around the suture (FIGs 8, 10, ¶80), welds, soldered (¶80), compression (¶84), knotting (¶¶90, 95, 97), threaded (¶74), and fixed with screws until they pinch the suture (¶88).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Pinchuck and Moretti, given that the prior art included each element claimed, although not necessarily in a single reference. Pinchuck and Moretti teach in the same field of endeavor, surgical suture assemblies.
Although, Pinchuck discloses the claimed base system comprising a needle assembly (elastomeric device and various needles), Pinchuck does not expressly disclose the system further comprising at least one flexible member extending through a transverse opening and piercing the elastomeric device to secure the elastomeric device to the passing needle.
Moretti specifically addresses suture assembly (100) comprising a needle (10), configured to suture tissue, having a cylindrical body with a sharp point on at least one end and a lumen extending transverse to a longitudinal axis of the cylindrical body and a recess in communication with an opening to the lumen in which to extend a suture (80) through the lumen (FIGs 1, 5; ¶¶23, 74). Moretti teaches fixation of the suture to the needle by any means, and where multiple fixation means are exemplified. Moretti also provides express motivation for needle assembly modifications where the needle assembles comprise transverse recesses for securing the filament/suture, especially where in other needle assemblies, knot size can be inconsistent and may, in some examples, pull through the hole in the needle and uncouple the needle and suture, increasing surgical operation times, as operators may need to reassemble the needle and suture (¶3).
Because Pinchuck teaches multiple surgical needles with multiple filament connection profiles, a person of ordinary skill in the art, seeking to improve or control filament orientation in Pinchuck’s architecture would reasonably consult Moretti’s suture assembly where the suture needle comprises at least one transverse recess in which to secure the suture (Abstract of Moretti). Moretti’s needle comprising at least one transverse recess can be incorporated alongside Pinchuck’s elastomeric assembly (same general location and interaction with the elastomeric filament) using known assembly methods without redesigning Pinchuck’s core filament delivery path. A person of ordinary skill in the art attempting to render Pinchuck’s elastomeric filament assembly more controllable would look for established connector and articulation designs to avoid creating a novel filament/suture interface. Moretti’s recessed transverse connector profile is modular and can be adapted to the filaments of Pinchuck’s elastomeric filament assembly device to enable tissue fixation.
Because the references address the same engineering problem (needle-based deployment of surgical filaments/sutures) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting a needle type for improved elastomeric filament control), 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.
The term “flexible member” is broadly construed as a suture, as defined in the specification at ¶15.
Regarding claim 11, Pinchuk teaches the orthopedic system of claim 10, as set forth above, for the reasons set forth above.
Pinchuck does not expressly teach wherein the at least one flexible member is a suture.
Moretti teaches a suture assembly (100) comprising a needle (10), configured to suture tissue, having a cylindrical body with a sharp point on at least one end and a lumen extending transverse to a longitudinal axis of the cylindrical body and a recess in communication with an opening to the lumen in which to extend a suture (80) through the lumen (FIGs 1, 5; ¶¶23, 74). Moretti also teaches that the suture extends through the first lumen in a first direction, across the cylindrical body and through the second lumen in a second direction opposite the first direction, wherein the suture is fixed to the cylindrical body (¶38). Moretti teaches securing the needle (10) to the suture (80) by any means such that the suture (80) is fixedly coupled to the needle (10) (¶75) including examples of a sleeve (60) (¶¶13, 18), adhesive, resin, heat-shrink material, deformation, melting, interference fit (¶75), crimping (FIG 8, ¶80), friction fit into the recess cavity (¶34), pinched (FIG 6, ¶76), swagging (¶¶70, 89), wrapping a coupling member around the suture (FIGs 8, 10, ¶80), welds, soldered (¶80), compression (¶84), knotting (¶¶90, 95, 97), threaded (¶74), and fixed with screws until they pinch the suture (¶88).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Pinchuck and Moretti, given that the prior art included each element claimed, although not necessarily in a single reference. Pinchuck and Moretti teach in the same field of endeavor, surgical suture assemblies.
Although, Pinchuck discloses the claimed base system comprising a needle assembly (elastomeric device and various needles), Pinchuck does not expressly disclose the system further comprising at least one flexible member extending through a transverse opening and piercing the elastomeric device to secure the elastomeric device to the passing needle.
Moretti specifically addresses suture assembly (100) comprising a needle (10), configured to suture tissue, having a cylindrical body with a sharp point on at least one end and a lumen extending transverse to a longitudinal axis of the cylindrical body and a recess in communication with an opening to the lumen in which to extend a suture (80) through the lumen (FIGs 1, 5; ¶¶23, 74). Moretti teaches fixation of the suture to the needle by any means, and where multiple fixation means are exemplified. Moretti also provides express motivation for needle assembly modifications where the needle assembles comprise transverse recesses for securing the filament/suture, especially where in other needle assemblies, knot size can be inconsistent and may, in some examples, pull through the hole in the needle and uncouple the needle and suture, increasing surgical operation times, as operators may need to reassemble the needle and suture (¶3).
Because Pinchuck teaches multiple surgical needles with multiple filament connection profiles, a person of ordinary skill in the art, seeking to improve or control filament orientation in Pinchuck’s architecture would reasonably consult Moretti’s suture assembly where the suture needle comprises at least one transverse recess in which to secure the suture (Abstract of Moretti). Moretti’s needle comprising at least one transverse recess can be incorporated alongside Pinchuck’s elastomeric assembly (same general location and interaction with the elastomeric filament) using known assembly methods without redesigning Pinchuck’s core filament delivery path. A person of ordinary skill in the art attempting to render Pinchuck’s elastomeric filament assembly more controllable would look for established connector and articulation designs to avoid creating a novel filament/suture interface. Moretti’s recessed transverse connector profile is modular and can be adapted to the filaments of Pinchuck’s elastomeric filament assembly device to enable tissue fixation.
Because the references address the same engineering problem (needle-based deployment of surgical filaments/sutures) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting a needle type for improved elastomeric filament control), 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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Genuario et al., US 20230039437 (9 February 2023), as evidenced by Stryker eBrochure “XBraid TT, Force Fiber and XBraid S” 1000901977 Rev C, 2023. Stryker Sports Medicine, Colorado, USA. (www.stryker.com/content/dam/stryker/sports-medicine/products/xbraidttsurgicalsuturetape/resources/Force%20Fiber%20and%20XBraidTT%20Brochure.pdf) (Last Accessed 9/5/2026).
Regarding claim 14, Genuario teaches the method of claim 13, as set forth above, further comprising, after separating the elastomeric device from the passing needle, and during the surgical procedure, re-securing the elastomeric device to the same or a different passing needle (¶¶44, 46). Genuario teaches that both ends of an elastomeric filament are attached to associated (but different) needles (10, 11) (FIGs 1A-1H; ¶¶35, 37). Accordingly, after separating the elastomeric device from one passing needle (e.g. by cutting the tails, ¶44) the other end of the elastomeric filament is attached to a different passing needle during the surgical procedure. Genuario describes the re-securing as providing an adjustable loop, such as a luggage-tag configuration (¶¶37, 44).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the multiple embodiments of Genuario, including the configuration of the second length of filament or the second passing needle that can be utilized and re-secured using an adjustable loop as taught at ¶44. Genuario also teaches variations in suturing patterns using filament 20 at ¶46 with the different ends of filament 20.
The teachings of Genuario provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine the reference teachings with a reasonable expectation of success given the presence of the at least two different passing needles and two ends of the filament suture in the method of using the system. The claimed invention would have been obvious because a person of ordinary skill in the art would have been motivated to combine or substitute the teachings within the four corners of a reference to achieve the claimed invention with a reasonable expectation of success.
Because Genuario teaches different suturing embodiments using one or both lengths of filament 20 and one or both passing needles, each solution solving known problems in the art, including through various suturing techniques comprising one or both passing needles or one or both ends of filament 20, one of ordinary skill in the art would be motivated to select among the various embodiments of Genuario depending on the anatomical requirements of the surgical procedure and the suturing and pull-strength needed for each individual application of the method of using the system. Given that Genuario teaches these alternative embodiments as equivalents, one would have a reasonable expectation of success in selecting from the finite embodiments taught by Genuario that are best suited for the particular end-use case.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Genuario et al., US 20230039437 (9 February 2023), as evidenced by Stryker eBrochure “XBraid TT, Force Fiber and XBraid S” 1000901977 Rev C, 2023. Stryker Sports Medicine, Colorado, USA. (www(.)stryker.com/content/dam/stryker/sports-medicine/products/xbraidttsurgicalsuturetape/resources/Force%20Fiber%20and%20XBraidTT%20Brochure.pdf) (Last Accessed 9/5/2026), in view of Pinchuk, US 20060136070 (22 June 2006) and Moretti et al., US 20200078006 (12 March 2020).
Regarding claim 15, Genuario teaches the method of claim 14, as set forth above, for the reasons set forth above.
Genuario does not teach wherein the passing needle to which the elastomeric device is re-secured to [sic] comprises a slot in a proximal head and at least one transverse opening in the proximal head extending through the proximal head and through the slot transverse to the slot,
wherein re-securing the elastomeric device comprises inserting a portion of the elastomeric device into the slot and passing a flexible member through the transverse opening such that the flexible member pierces the elastomeric device and re-secures the elastomeric device to the passing needle. However, Genuario teaches filamentary sutures, structures and devices where a braided suture is formed into a construct of at least one splice (broadly interpreted as a pierce) in its body to create at least one adjustable suture loop (¶31).
Pinchuck teaches wherein the passing needle (FIGs 4A-D, needle 11) to which the elastomeric device (FIGs 4B-D, elastomeric filament implant 10, ¶33) is secured comprises a slot in a proximal head (FIG 4D, eyelet 22; ¶34) and at least one transverse opening (FIG 4D, slit 24; ¶34) in the proximal head extending through the proximal head and through the slot [interpreted as the opening] (FIG 4D, slit 24, ¶34) transverse to the slot (FIG 4D, eyelet 22), and re-secures the elastomeric device to the passing needle (FIGs 4B, 4C; ¶34).
Moretti provides motivation for the need to re-secure elastomeric devices (sutures) to the passing needle, stating that sutures can be pulled through the holes in the needle and uncouple the needle and suture, increasing surgical operation times, as operators may need to reassemble the needle and suture (¶3).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Genuario, Pinchuck and Moretti, given that the prior art included each element claimed, although not necessarily in a single reference. Genuario, Pinchuck and Moretti teach in the same field of endeavor, surgical suture assemblies.
Although, Genuario discloses the claimed base system comprising a needle assembly (elastomeric device and passing needles), Genuario does not expressly disclose wherein the passing needle to which the elastomeric device is re-secured to [sic] comprises a slot in a proximal head and at least one transverse opening in the proximal head extending through the proximal head and through the slot transverse to the slot, wherein re-securing the elastomeric device comprises inserting a portion of the elastomeric device into the slot and passing a flexible member through the transverse opening such that the flexible member pierces the elastomeric device and re-secures the elastomeric device to the passing needle.
Pinchuck teaches passing needles comprising elastomeric filaments (FIG 1, elastomeric filament implant 10, ¶33), comprising a flat strip (FIG 8B, “implant to lie flat” ¶42; claim 3 “elastomeric filament has a diameter in a range between 0.1 mm to 1mm) of at least one elastomer material (ePTFE, etc., ¶25), a passing needle (FIGs 4A-D, “needle is adapted to be inserted under the surface of the skin”, ¶13) comprising a distal tip (FIGs 4A-D, distal end of the needle 11, ¶33), a proximal head (FIGs 4A-D; ¶33), and an elongated shaft extending between the distal tip and the elongated head (FIG 4D), wherein the proximal head comprises an opening in the proximal head that is sized and shaped to receive an end of the elastomeric device (FIG 4D, eyelet); wherein the elastomeric device (filament, ¶33) is secured to the passing needle (FIG 4A) with the end of the elastomeric device located in the opening (FIG 4D eyelet). FIGs 4A-D are eyelet-containing needles as needle 11 and elastomeric filament 10, where the eyelet-containing needle 11 also comprises eyelet 22 and slit 24. Pinchuck teaches a solution with eyelet 22 and slit 24 that the filament implant loop is pulled until the loop necks down in diameter (due to its elastomeric nature) such that it can pass through slit 24 and into eyelet 22 (FIG 4C) (¶34). The necked down loop is then pulled through slit 24 and into the eyelet 22 (¶34). Once the elastomeric filament is in the eyelet 22, the filament implant is relaxed which causes it to expand back to its original diameter where it remains trapped and cannot pass out through the slit 24 (FIG 4D) (¶34).
Moretti provides motivation for the need to re-secure elastomeric devices (sutures) to the passing needle, stating that sutures can be pulled through the holes in the needle and uncouple the needle and suture, increasing surgical operation times, as operators may need to reassemble the needle and suture (¶3).
Pinchuck also recognizes this existing problem by teaching that the slit has a width that is smaller than the diameter of the filament implant 10 (FIG 4A) (¶34). However, it is also recognized that the filament can be re-secured to the eyelet during a surgical procedure if it becomes detached, merely by following the initial directions in ¶34 on how to secure the filament implant 10 to the eyelet 22 by passing it neck down through slit 24 (¶34).
Because both Pinchuck and Moretti recognize a known problem in the art of suture filaments becoming detached from passing needles during procedures, Pinchuck has proposed method steps by which the suture filaments can be readily re-secured during operations. A person of ordinary skill in the art, seeking to improve or control the manner in which a filament is secured in the passing needle would reasonably look to Pinchuck’s eyelet and slit solution so that a suture filament could readily be re-secured during a surgical procedure, as recognized by Moretti. Pinchuck’s passing needle comprising an eyelet and a slit can be incorporated alongside Genuario’s filamentary sutures in a method of use (same use of passing needles and elastomeric filament) using known assembly methods without redesigning Genuraio’s core elastomeric filament. It would be a passing needle substitution for use with the same elastomeric filament for the same intended use in a method of using a passing needle system. A person of ordinary skill in the art attempting to render Genuario’s elastomeric filament assembly more controllable for re-securing purposes during an operating procedure would look for established passing needle assemblies to provide the surgeon with the ability to readily re-secure the elastomeric filament should it come loose during the procedure in order to avoid creating a novel filament/suture interface.
Because the references address the same engineering problem (needle-based deployment of surgical filaments/sutures) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting a needle type for improved elastomeric filament control), 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 references.
Regarding claim 16, Genuario modified by Pinchuck and Moretti teaches the method of claim 15, as set forth above, for the reasons set forth above.
Genuario teaches the method further comprising, after re-securing the elastomeric device, using the passing needle to which the elastomeric device is re-secured to pass the elastomeric device through the same or a different soft tissue (¶¶44, 46).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Genuario et al., US 20230039437 (9 February 2023), as evidenced by Stryker eBrochure “XBraid TT, Force Fiber and XBraid S” 1000901977 Rev C, 2023. Stryker Sports Medicine, Colorado, USA. (www(.)stryker.com/content/dam/stryker/sports-medicine/products/xbraidttsurgicalsuturetape/resources/Force%20Fiber%20and%20XBraidTT%20Brochure.pdf) (Last Accessed 9/5/2026), in view of Pinchuk, US 20060136070 (22 June 2006).
Regarding claim 19, Genuario teaches the method of claim 18 as set forth above, for the reasons set forth above.
Genuario does not teach wherein the opening in the proximal head comprises a slot in the proximal head, the slot including a height that is substantially the same as a thickness of the elastomeric device, wherein the slot comprises a width that is substantially the same as a width of the elastomeric device.
Pinchuck teaches a passing needle (FIGs 4A-D, needle 11) to which an elastomeric device (FIGs 4B-D, elastomeric filament implant 10, ¶33) is secured, wherein the passing needle comprises a slot in a proximal head (FIG 4D, eyelet 22; ¶34) the slot (FIGs 3, 4D, eyelet 22, ¶34) including a height that is substantially the same as a thickness of the elastomeric device (FIGs 2, 4A-D, ¶34), wherein the slot (eyelet 22) comprises a width that is substantially the same FIGs 3, 4A-D, ¶34) as a width of the elastomeric device (claim 3 “elastomeric filament has a diameter in a range between 0.1 mm to 1mm”; ¶40).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Genuario and Pinchuck, given that the prior art included each element claimed, although not necessarily in a single reference. Genuario and Pinchuck teach in the same field of endeavor, surgical suture assemblies.
Although, Genuario discloses the claimed base system comprising a needle assembly (elastomeric device and passing needles), Genuario does not expressly disclose wherein the opening in the proximal head comprises a slot in the proximal head, the slot including a height that is substantially the same as a thickness of the elastomeric device, wherein the slot comprises a width that is substantially the same as a width of the elastomeric device.
Pinchuck expressly discloses passing needle (FIGs 4A-D, needle 11) to which an elastomeric device (FIGs 4B-D, elastomeric filament implant 10, ¶33) is secured, wherein the passing needle comprises a slot in a proximal head (FIG 4D, eyelet 22; ¶34) the slot (FIGs 3, 4D, eyelet 22, ¶34) including a height that is substantially the same as a thickness of the elastomeric device (FIGs 2, 4A-D, ¶34), wherein the slot (eyelet 22) comprises a width that is substantially the same FIGs 3, 4A-D, ¶34) as a width of the elastomeric device (claim 3 “elastomeric filament has a diameter in a range between 0.1 mm to 1mm”; ¶40). Pinchuck also expressly discloses that the elastomeric device (filament, ¶33) is secured to the passing needle (FIG 4A) with the end of the elastomeric device located in the opening (FIG 4D, eyelet 22). Pinchuck demonstrates that the elastomeric filament can be pulled until the loop “necks down” in diameter (due to its elastomeric nature) such that it can pass through slit 24 and into eyelet 22 (FIG 4C; ¶34). Once the elastomeric filament is in the eyelet 22, the elastomeric filament is relaxed which causes it to expand back to its original diameter where it remains trapped and cannot pass out through the slit 24 (FIG 4D; ¶34).
Pinchuck also teaches that the filament diameter “can be selected at the operating table” (¶40) based on the needs of the surgeon for the particular end-use case. The selection based on the individual use case is a results-effective variable which can be optimized by the surgeon. One of skill in the art would clearly recognize that widths of filament (filament diameter) can be optimized depending on the end effect desired for the use case. This is shown by the teachings of ¶40 of Pinchuck. One of ordinary skill in the art would have had a reasonable expectation of success in light of the express teaching that the filament diameter can be optimized by a person of ordinary skill in the art without undue experimentation based on the needs for the intended use case and the anatomical structures for which the devices are designed to service. As such, adjusting the width and thickness of the filament “at the operating table” would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because both Pinchuck and Moretti recognize a known problem in the art of suture filaments becoming detached from passing needles during procedures, Pinchuck has proposed method steps by which the suture filaments can be readily re-secured during operations and where elastomeric filaments can be inserted into a proximal needle head that has a slot (eyelet 22) that comprises a height that is substantially the same as a thickness of the elastomeric device and where the slot (eyelet 22) width is substantially the same as a width of the elastomeric device. A person of ordinary skill in the art, seeking to improve or control the manner in which a filament is secured in the passing needle would reasonably look to Pinchuck’s eyelet solution so that a suture filament could readily be secured and, if necessary, re-secured during a surgical procedure. Pinchuck’s passing needle comprising an eyelet can be incorporated alongside Genuario’s filamentary sutures in a method of use (same use of passing needles and elastomeric filament) using known assembly methods without redesigning Genuraio’s core elastomeric filament. It would be a passing needle substitution for use with the same elastomeric filament for the same intended use in a method of using a passing needle system. Moreover, Pinchuck expressly teaches that the selection of a filament diameter “can be selected at the operating table.” A person of ordinary skill in the art attempting to render Genuario’s elastomeric filament assembly more controllable for securing and re-securing purposes during an operating procedure would look for established passing needle assemblies to provide the surgeon with the ability to attach and readily re-secure the elastomeric filament to a passing needle should it come loose during the procedure in order to avoid creating a novel filament/suture interface.
Because the references address the same engineering problem (needle-based deployment of surgical filaments/sutures) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting a needle type for improved elastomeric filament control), 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 references.
Regarding claim 20, Genuario modified by Pinchuck teaches the method of claim 19, as set forth above, for the reasons set forth above.
Pinchuck teaches wherein the proximal head (FIGs 3, 4A-D, ¶33) comprises at least one transverse opening extending through the proximal head (FIG 4D, slit 24; ¶34) and through the slot [interpreted as the opening] (FIG 4D, slit 24; ¶34) transverse to the slot (FIG 4D, eyelet 22; ¶34).
Conclusion
No Claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Crawley et al., US 2002019670 (14 February 2002) teaches an implantable tissue augmentation device.
Hoepffner et al., US 6,530,943 (11 March 2003) teaches a surgical needle for implanting a tape.
Chu, US 20090171139 (2 July 2009) teaches devices and methods for delivering a pelvic implant.
Stone et al., US 20110208239 (25 August 2011) teaches method and apparatus for forming a self-locking adjustable loop.
Hardwick, US 3,880,167 (29 April 1975) teaches surgical needle apparatus.
Denham et al., US 20190298345 (3 October 2019) teach method and apparatus for forming a self-locking adjustable loop.
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/CHERIE M POLAND/Examiner, Art Unit 3771
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