DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 2/20/2026 with regards to the 35 USC 102(a)(1) rejection of independent claims 1, 14 and 18 over Pimenta (US 2023/0233199 A1) (previously of record) have been fully considered but they are not persuasive.
Applicant contends that the device of Pimenta, and modifying references pertaining thereto, is not reasonably capable or configured to perform a release of a facial compartment, as recited in the claims, on the grounds that Pimenta is disclose to be used to transversely sever the anterior longitudinal ligament on the spine. The Examiner respectfully disagrees. While the device of Pimenta is not expressly disclosed to be configured for use in performing a release of a facial compartment, as presently claimed, the device of Pimenta comprises all of the limitations of the independent claims that are viewed to enable and facilitate the claimed function of releasing a facial compartment. Unless otherwise stated, there appears to be no reason or indication that the device of Pimenta would be unable to release a facial compartment should a user intend to use the device for such a procedure. Since Pimenta discloses an analogous device comprising the claimed structural limitations present in the independent claims, the device of Pimenta is understood to be reasonably capable of performing the claimed function.
Applicant additionally contends that the device of Pimenta does not adequately or expressly disclose the amended limitations of the independent claims. For example, Applicant contends that Pimenta does not disclose the specifics of the knife head including wherein the channel comprises a curved shaped that extends to an opening within the base and wherein the first projection includes a first forward edge that is a separate part of the projecting portions (). The Examiner respectfully disagrees. As shown in the updated rejection below, Pimenta does disclose wherein the channel comprises a curved shape that extends to an opening within the base of the knife head (see Fig. 9 of Pimenta showing channel 62 comprises an opening at the distal end thereof and is formed between fingers 74 and 76 whose curved shape defines the channel as a curved channel that extends to an opening within the knife head within which the blade is disposed as disclosed in Para. [0075]). Further, Pimenta discloses wherein the first projection includes a first forward edge that is a separate part of the projecting portion (see Examiner’s Diagram of Fig. 9_Head in the updated rejection below). The Examiner notes that the projecting portions, and components thereof, appear to be formed as a monolithic structure with no structural separate between each component. The claimed portions of the projecting portions appear to be a labeling of features of the projecting portions and are not “separate and distinct” features, but rather formations formed along the length of the projecting portions. In view of this structure, the device of Pimenta is understood to comprise all of the claimed limitations of the projecting portions as described in the updated rejection below.
Further, Applicant contends that Pimenta does not expressly disclose a bulbous peak that is a separate part from the projecting forward edge. The Examiner respectfully disagrees. As shown in Examiner’s Diagram of Fig. 9_Head below, Pimenta discloses a bulbous peak that is formed along the first projection (i.e., finger 76) that projects radially upward to form the most radially-inward portion of the first projection).
Additionally, Applicant contends that the shape of the claimed device is intended to protect adjacent tissue and direct the separated facia tissue in the channel towards the cutting blade. The device of Pimenta is not concerned with these structural limitations as the device of Pimenta is not configured to be used on facia tissue, but rather the anterior longitudinal ligament of the spine. Therefore, the device of Pimenta is not capable of performing the recited function or of being modified to comprise all of the structural limitations of the independent claims responsible for facilitating the claimed function. While the Examiner agrees that the device of Pimenta is not expressly disclosed to be used to separate facia tissue, the device of Pimenta comprises all of the structural limitations of the independent claims responsible for facilitating the functional language recited in the claims. Further, the device of Pimenta is a surgical cutting device used to sever ligaments by passing a desired tissue between the pair of fingers and into the channel (62) to be severed by the blade disposed therein. This structure is analogous to the claimed invention and is therefore understood to be reasonably capable of being used to perform the recited functional language.
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Applicant’s arguments with respect to claim(s) 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Wells is no longer relied upon to disclose the limitations of the retractor present in claim 17.
Drawings
Applicant’s arguments, see “Remarks”, filed 2/20/2026, with respect to the objection to the drawings for failing to show “the “first and second projecting portions are aligned longitudinally along the shaft” recited in Claim 1, the “two projecting head portions linearly aligned with the body” recited in Claim 14 and the “two projecting head portions positioned on an upper portion of the shaft and aligned longitudinally along the shaft” recited in Claim 18” have been fully considered and are persuasive in light of Applicant’s amendments to remove the cited claim limitations in regards to referencing wherein the projecting portions are “linearly aligned” and/or “longitudinally aligned” with the shaft which was not clearly shown in the disclosed drawings. The previously-cited objection of the drawings have been withdrawn.
Claim Objections
Applicant’s arguments, see “Remarks”, filed 2/20/2026, with respect to the objection(s) to claims 1 and 18 for including typographical/grammatical errors have been fully considered and are persuasive in light of Applicant’s amendments to correct the previously-cited typographical/grammatical errors. The previously-cited objections(s) of claims 1 and 18 has been withdrawn.
Claim Rejections - 35 USC § 112
Applicant’s arguments, see “Remarks”, filed 2/20/2026, with respect to the 35 USC 112(b) rejection of claim 1 for reciting “wherein the head comprises” which lacked proper antecedent basis for the term “the head” have been fully considered and are persuasive in light of Applicant’s amendment to provide proper antecedent basis within claim 1. The previously-cited 35 USC 112(b) rejection of claim 1 has been withdrawn.
Applicant’s arguments, see “Remarks”, filed 2/20/2026, with respect to the 35 USC 112(b) rejection of claim 14 for reciting “adjacent the curved edge” which lacked proper antecedent basis for the term “the curved edge” have been fully considered and are persuasive in light of Applicant’s amendment to provide proper antecedent basis within claim 14. The previously-cited 35 USC 112(b) rejection of claim 14 has been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites, “the first projecting portion, the channel opening and the second projecting portions sequentially positioned along an upper portion of the knife head in the longitudinal direction of the shaft” and the Examiner suggests amending the recitation of “second projecting portions to recite “second projecting portion” to be in better grammatical form since only one second projecting portion is recited previously in claim 1. The Examiner further suggests the inclusion of a linking word within the phrase “portions sequentially positioned…” to be in better grammatical form (e.g., including a word such as “being” or “are”).
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 8, 14, 18, 21 and 28-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pimenta (US 2023/0233199 A1) (previously of record).
Regarding claim 1, Pimenta discloses:
A fasciotomy knife (resector 72, see Fig. 8) for release of a closed facial compartment by cutting fascia tissue over an extended portion of the length of the compartment (see Para. [0074]-[0076]; resector 72 is reasonably capable of releasing a closed facial compartment by cutting fascia tissue over the length of the compartment as the resector comprises all of the claimed limitations recited in Claim 1 responsible for allowing the claimed function) for the treatment of compartment syndrome, the fasciotomy knife comprising:
an elongated and longitudinally extending shaft (elongate shaft 54, see Fig. 8);
a holding tab portion at one end of the shaft (handle 52, see Fig. 8); and
a knife head positioned at a second end of the shaft (distal head 56, see Figs. 8-9), opposite of the tab portion (see Fig. 8), wherein the knife head comprises:
a first projecting portion (finger 76, see Fig. 9), a second projecting portion (finger 74, see Fig. 9) and a channel (opening to channel 62, see Fig. 9), the channel having a channel opening formed between the first and second projecting portions (see Fig. 9 showing channel 62 formed between fingers 74 and 76); and
a surgical blade (blade 68, see Fig. 9) having a cutting edge positioned within the knife head at the base of the channel (see Fig. 9 and Para. [0075]);
the first projecting portion, the channel opening and the second projecting portions sequentially positioned along an upper portion of the knife head in the longitudinal direction of the shaft (see Fig. 9 showing wherein the fingers and channel opening are sequentially arranged along the longitudinal axis and all curve to extend upward toward the top of the knife head portion), the first projecting portion positioned at a forward end of the knife head (see Fig. 9), the second projecting portion positioned in a trailing position (see Fig. 9), and the channel opening positioned between the first and second projecting portions (see Fig. 9);
the first projecting portion having a first protruding bill (portion of finger 76 extending from the proximal-most point of the knife head; see Examiner’s Diagram of Fig. 9 below for reference) including a forward edge (distal-most edge of finger 76, see Examiner’s Diagram of Fig. 9_Portions below for reference), a first transition portion (curved portion of finger 76 extending between the proximal-most portion of the finger 76 and the distal-most edge, see Examiner’s Diagram of Fig. 9_Portions below for reference), and a first bulbous projecting peak (most radially-inward point of finger 76 comprises a rounded, boubous peak portion as shown in Examiner’s Diagram of Fig. 9_Portions below) positioned adjacent the channel opening (see Examiner’s Diagram of Fig. 9_Portions below), the forward edge of the first protruding bill projecting in line with the shaft and away from the first bulbous projecting peak (see Examiner’s Diagram of Fig. 9_Portions below showing wherein the distal-most edge of finger 76 extends in-line with the shaft axis and away from the first bulbous peak);
the channel extending from the channel opening into the knife head (see Figs. 8-9 and Para. [0075]-[0076]) with the base positioned relatively below the second projecting portion (see Fig. 9), the channel between the channel opening and the base having at least one curved surface (see Fig. 9 showing wherein the channel is curved along the radially inward sidewalls of fingers 74 and 76) terminating adjacent the cutting edge of the surgical blade (see Fig. 9); and
the second projecting portion having a second protruding bill (portion of finger 74 extending from the proximal-most point of the knife head; see Examiner’s Diagram of Fig. 9 below for reference) including a second forward edge (distal-most edge of finger 74, see Examiner’s Diagram of Fig. 9_Portions_2 below for reference), a second transition portion (curved portion of finger 74 extending between the proximal-most portion of the finger 74 and the distal-most edge, see Examiner’s Diagram of Fig. 9_Portions_2 below for reference) and a second bulbous projecting peak (most radially-outward point of finger 74 comprises a rounded, boubous peak portion as shown in Examiner’s Diagram of Fig. 9_Portions_2 below), the second forward edge projecting toward the first bulbous projecting peak adjacent the channel opening (see Examiner’s Diagram of Fig. 9_Portions below showing wherein the “second forward edge” extends distally towards the “first bulbous peak” located on finger 76, positioned distally to the finger 74), and the second bulbous projecting peak positioned adjacent a connection of the knife head with the shaft (see Examiner’s Diagram of Fig. 9_Portions_2 below).
wherein, as the knife head is directed into a surgical opening adjacent the facial compartment, the first protruding bill positioned below the facia tissue with the first forward edge separating the fascia tissue from the tissue within the compartment (see Fig. 9; as the knife head is directed into a surgical opening, the finger 76 would be positioned below the intended tissue so as to allow the tissue to enter channel 62 be cut by knife 68), and the first transition portion and the first bulbous projecting peak directing the separated fascia tissue into the channel opening (the distal portions of finger 76 (including the first bulbous peak and first transition region) would guide tissue along the length of the finger toward the blade positioned at the proximal end thereof), and
the second protruding bill separating the fascia tissue from the tissue above the compartment and directing the fascia tissue into the channel towards the cutting blade (see Fig. 9; as the knife head is directed into a surgical opening, finger 74 would separate the intended tissue to be cut from other tissue positioned above the finger 74 while guiding the intended tissue along the inner length thereof through channel 62 and toward blade 68), and the second transition portion and the second bulbous portion projecting peak deflecting the above tissue away from the channel opening (see Fig. 9; should the blade 68 be used to cut tissue, the finger 74 would be positioned above the intended tissue and thereby deflect any other tissue positioned above the device during a cutting procedure).
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Regarding claim 8, Pimenta discloses all of the limitations of the invention of claim 1, Pimenta further discloses wherein the blade is retained within a slot formed in at least one of the shaft and the knife head (see Para. [0075] mentioning wherein the blade is retained at the distal head within slot 70, see Fig. 5).
Regarding claim 14, Pimenta discloses:
A fasciotomy knife (resector 72, see Fig. 8) for release of body tissue over an extended length within an interior portion of a human body (see Para. [0074]-[0076]), the knife comprising:
a body (see Fig. 8) having:
an elongated shaft (elongate shaft 54, see Fig. 8)
a gripping tab portion projecting orthogonally from the body portion (handle 52, see Fig. 8); and
a knife head aligned with and projecting from one end of the elongated shaft (distal head 56, see Figs. 8-9);
the knife head comprising:
two projecting portions (finger 74 and finger 76, see Fig. 9) sequentially positioned relative to the elongated shafted (see Fig. 9 showing wherein the fingers are sequentially arranged along the longitudinal axis) and a channel (opening 62, see Fig. 9) formed between the two projecting portions (see Fig. 9);
the first projecting portion (finger 76, see Fig. 9) positioned at a forward end of the knife head (see Fig. 9) and the second projecting portion (finger 74, see Fig. 9) positioned in a trailing position, sequentially behind a channel opening (see Fig. 9);
the first projecting portion having a projecting bill (portion of finger 76 extending from the proximal-most point of the knife head; see Examiner’s Diagram of Fig. 9 below for reference) forming a first forward edge (distal-most edge of finger 76, see Examiner’s Diagram of Fig. 9_Portions below for reference) and protruding outwardly from the knife head (see Examiner’s Diagram of Fig. 9 below showing wherein the distal-most portion of finger 76 protrudes distally away from the knife head);
the channel having a curvature extending from the channel opening (see Fig. 9 showing wherein the channel is curved along the curved fingers 74 and 76) inwardly into the knife head (see Fig. 9 and Para. [0075]) and terminating at a base (see Figs. 8-9 and Para. [0075]); and
the second projecting portion having a second bill (portion of finger 74 extending from the proximal-most point of the knife head; see Examiner’s Diagram of Fig. 9 below for reference) forming a second forward edge (distal-most edge of finger 74, see Examiner’s Diagram of Fig. 9_Portions_2 below for reference) positioned adjacent the channel opening (see Examiner’s Diagram of Fig. 9_Portions_2 below showing wherein the distal-most edge of finger 74 extends adjacent (i.e., above) the channel opening) and protruding toward a first projecting portion (see Examiner’s Diagram of Fig. 9_Portions below showing wherein the “second forward edge” extends distally towards the “first bulbous peak” located on finger 76, positioned distally to the finger 74), and a bulbous peak (most radially-outward point of finger 74 comprises a rounded, boubous peak portion as shown in Examiner’s Diagram of Fig. 9_Portions_2 below) positioned rearwardly of and extending upwardly from a position adjacent the second forward edge (see Examiner’s Diagram of Fig. 9_Portions_2 below showing wherein the bulbous peak of finger 74 extends upwardly from and adjacent the distal-most edge of the finger 74), the bulbous peak further positioned adjacent a connection of the knife head with the elongated shaft (see Examiner’s Diagram of Fig. 9_Portions_2 below); and
a surgical blade (blade 68, see Fig. 9) having a cutting edge positioned within the channel adjacent the base of the channel (see Fig. 9 and Para. [0075]).
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Regarding claim 18, Pimenta discloses:
A surgical device (see Fig. 8) for release of a closed facial compartment by cutting fascia tissue over an extended length of the compartment (see Para. [0074]-[0076]; resector 72 is reasonably capable of releasing a closed facial compartment by cutting fascia tissue over the length of the compartment as the resector comprises all of the claimed limitations recited in Claim 18 responsible for allowing the claimed function), the surgical device comprising:
a fasciotomy knife (resector 72, see Fig. 8) comprising:
an elongated shaft (elongate shaft 54, see Fig. 8);
a holding tab (handle 52, see Fig. 8) positioned adjacent one end of the shaft (see Fig. 8); and
a knife head positioned at a second end of the shaft (distal head 56, see Fig. 8), opposite of the tab (see Fig. 8), the head having first and second projecting portions (finger 74 and finger 76, see Fig. 8) and a channel (opening 62, see Fig. 8) for receiving facia tissue (see Para. [0074]-[0075]; the channel is fully capable of and configured to receive tissue such that knife 68 may perform a cutting action thereon), the channel having a channel opening positioned between the first and second projecting portions (see Fig. 9), the first and second projecting portions formed on an upper surface of the knife head (see Fig. 9 showing wherein fingers 74 and 76 curve and extend upward towards the upper surface of the knife head) and aligned sequentially in the longitudinal direction of the shaft (see Fig. 9);
the first projecting portion (finger 76, see Fig. 9) comprising a front edge (distal-most edge of finger 76, see Examiner’s Diagram of Fig. 9_Portions below for reference) extending forward from the knife head (see Examiner’s Diagram of Fig. 9_Portions below showing wherein the distal-most portion of finger 76 extends distally away from the knife head) and an upper projecting peak positioned in a trailing position adjacent the front edge (most radially-inward point of finger 76 comprises a rounded, boubous peak portion as shown in Examiner’s Diagram of Fig. 9_Portions below);
the second projecting portion positioned in a trailing position on the knife head relative to the first projecting portion and behind the channel (see Fig. 9), the second projecting portion comprising a second front edge (distal-most edge of finger 74, see Examiner’s Diagram of Fig. 9_Portions_2 below for reference) extending forward into the channel opening (see Examiner’s Diagram of Fig. 9_Portions_2 below) and towards the first projecting portion (see Examiner’s Diagram of Fig. 9_Portions below showing wherein the “second forward edge” extends distally towards finger 76, positioned distally to the finger 74), and a second projecting peak positioned in a trailing position adjacent the second front edge (most radially-outward point of finger 74 comprises a rounded, boubous peak portion as shown in Examiner’s Diagram of Fig. 9_Portions_2 below); and
the channel curving from the channel opening into the knife head (see Fig. 9 showing wherein the opening 62 tapers along the length of the curved fingers 74 and 76), and ending at a base located below the second projecting portion (see Para. [0075] mentioning wherein the channel extends into the distal head but not proximally into the elongate shaft, ending at a base within the distal head); and
a surgical blade (blade 68, see Fig. 9) having a cutting edge positioned within the channel adjacent the base of the channel (see Fig. 9 and Para. [0075] mentioning wherein the blade is positioned within the distal head via an opening 70 and would thus be positioned adjacent the proximal base of the channel).
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Regarding claim 21, Pimenta discloses the invention of claim 14, Pimenta further discloses wherein the first projecting portion comprises a first bulbous peak positioned adjacent to and projecting upwardly of the position of the first forward edge (see Examiner’s Diagram of Fig. 9_Portions above identifying a “first bulbous peak” of finger 76 as the most radially-inward portion of the finger, positioned adjacent to and projecting upwardly of the position of the first forward edge).
Regarding claim 28, Pimenta discloses the invention of claim 14, Pimenta further discloses wherein the bottom surface of the first forward edge is connected to a lower surface of the knife head (see Fig. 9), the lower surface of the knife head forming a convex curved outer surface between the shaft and the first forward edge (see Fig. 9 showing wherein the finger 76 comprises a rounded, convex bottom surface extending between the outer surface of the shaft and the distal-most first forward edge).
Regarding claim 29, Pimenta discloses the invention of claim 14, Pimenta further discloses wherein the elongated shaft comprises at least one curved portion along a longitudinal length thereof (see Examiner’s Diagram of Fig. 9 below illustrating wherein the proximal portion of the shaft curves to transition to connect to the handle portion 52).
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Regarding claim 30, Pimenta discloses the invention of claim 29, Pimenta further discloses wherein the curved portion in the elongated shaft is positioned adjacent the gripping tab (see Examiner’s Diagram of Fig. 9 above showing wherein the curved portion of the shaft is adjacent the handle portion 52).
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.
Claim(s) 2 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta (US 2023/0233199 A1) (previously of record) in view of Liu (US 2014/0031621 A1) (previously of record).
Regarding claim 2, Pimenta discloses all of the limitations of the invention of claim 1.
However, Pimenta does not expressly disclose discloses wherein the holding tab portion comprises a contoured surface to facilitate gripping as the knife head is directed along the facial compartment while cutting fascia tissue)
In the same field of endeavor, namely surgical incision instruments configured to release tension in a ligament, Liu teaches wherein a handle (10, see Fig. 2) of a surgical ligament release device (see Fig. 2 and Para. [0024]) may comprise a series of parallel ribs (13, see Fig. 2) that provide a contoured surface that enhances the grip of the handle by acting as slip-resistant members (see Para. [0019]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the handle of Pimenta to include one or more ribs disposed thereon as taught and suggested by Liu to, in this case, provide a contoured surface that acts as a slip-resistant member to enhance the grip of the handle (see Liu Para. [0019]). Should the device of Pimenta directed along the facial compartment while cutting fascia tissue, the contoured gripping surface would provide enhanced grip during this procedure since the structure and associated benefit is independent of an intended area of use.
Regarding claim 15, Pimenta discloses all of the limitations of the invention of claim 14.
However, Pimenta does not expressly disclose wherein the gripping tab comprises a lateral contoured surface to facilitate gripping.
In the same field of endeavor, namely surgical incision instruments configured to release tension in a ligament, Liu teaches wherein a handle (10, see Fig. 2) of a surgical ligament release device (see Fig. 2 and Para. [0024]) may comprise a series of laterally-extending parallel ribs (13, see Fig. 2) that provide a contoured surface that enhances the grip of the handle by acting as slip-resistant members (see Para. [0019]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the handle of Pimenta to include one or more laterally-extending ribs disposed thereon as taught and suggested by Liu to, in this case, provide a contoured surface that acts as a slip-resistant member to enhance the grip of the handle (see Liu Para. [0019]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta (US 2023/0233199 A1) (previously of record) in view of Seymour (US 2016/0157881 A1) (previously of record).
Regarding claim 3, Pimenta discloses all of the limitations of the invention of claim 1.
However, Pimenta does not expressly disclose a winged stabilizer projecting transverse to the longitudinal direction of the shaft, and the stabilizer provided on the shaft at a position relatively closer to the holding tab than to the knife head portion.
In the same field of endeavor, namely surgical blades configured to release tension within a ligament, Seymour teaches wherein a surgical release device (knife 770, see Fig. 9B-9C and Para. [0006]) comprises a blade shaft (portion of knife 770 extending from the handle 772 to the distal blade 773, see Figs. 9B) that is introduced to a site through an insertion cannula (guide 700, see Fig. 4A and 9A and Para. [0006] and [0050]), wherein the blade shaft comprises at least one radially-protruding wing (pins 713 and 714, see Fig. 9B-9C), positioned closer to the proximal handle than the distal blade (see Figs. 9B-9C), and configured to mate with corresponding grooves within the insertion cannula so as to stabilize and guide the blade shaft during passage through the insertion cannula (see Para. [0006] and [0050]).
Since Pimenta discloses wherein the resector may be configured to be guided to a target site through a guiding spatula (see Para. [0074]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the elongate shaft of Pimenta to include one or more radially-protruding guide wings thereon as taught and suggested by Seymour to, in this case, aid in stabilizing and guiding the resector to a target site by mating with corresponding grooves defined within the spatula (see Seymour Para. [0006] and [0050]).
Claim(s) 4 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta (US 2023/0233199 A1) (previously of record) in view of Chase (US 2014/0148838 A1) (previously of record)
Regarding claim 4, Pimenta discloses all of the limitations of the invention of claim 1.
However, Pimenta does not expressly disclose wherein at least a portion of the shaft comprises a trapezoidal cross section.
In the same field of endeavor, namely surgical cutting devices comprising an elongate body terminating at a distal cutting end, Chase teaches wherein a surgical cutting device (see Figs. 4A-5A) comprises an elongate body (110, see Fig. 1A-2A and 4A) and a knife (cutting edge 115a, see Fig. 2A) extending from the distal end of said elongate body (see Figs. 1A and 2A and Para(s). [0053] and [0061]), wherein the elongate body defines a trapezoidal shape (see Fig. 1A) that provides increased structural rigidity, restricting wandering of the distal end during use that is typical of circular-shaped devices (see Para. [0058]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the elongate shaft of Pimenta to include a trapezoidal cross-sectional shape as taught and suggested by Chase to, in this case, provide increased structural rigidity, restricting wandering of the distal end during use (see Chase Para. [0058]).
Regarding claim 16, Pimenta discloses all of the limitations of the invention of claim 14.
However, Pimenta does not expressly disclose wherein at least a portion of the body comprises a trapezoidal cross section.
In the same field of endeavor, namely surgical cutting devices comprising an elongate body terminating at a distal cutting end, Chase teaches wherein a surgical cutting device (see Figs. 4A-5A) comprises an elongate body (110, see Fig. 1A-2A and 4A) and a knife (cutting edge 115a, see Fig. 2A) extending from the distal end of said elongate body (see Figs. 1A and 2A and Para(s). [0053] and [0061]), wherein the elongate body defines a trapezoidal shape (see Fig. 1A) that provides increased structural rigidity, restricting wandering of the distal end during use that is typical of circular-shaped devices (see Para. [0058]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the elongate shaft of Pimenta to include a trapezoidal cross-sectional shape as taught and suggested by Chase to, in this case, provide increased structural rigidity, restricting wandering of the distal end during use (see Chase Para. [0058]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta (US 2023/0233199 A1) (previously of record) in view of Goldman (US 2024/0374278 A1) (previously of record).
Regarding claim 5, Pimenta discloses all of the limitations of the invention of claim 1.
However, Pimenta does not expressly disclose a material used to form the resector device of Figs. 5-7 and thus does not expressly disclose wherein the shaft, holding tab portion and knife head are made of a surgical grade steel.
In the same field of endeavor, namely surgical blades configured to make incisions within tissue, Goldman teaches wherein a surgical tissue-cutting device (see Fig. 3) comprises a handle (46, see Fig. 3), an elongate shaft (portion of body that extends from the handle identifier “46” to the distal blade 52 as shown in Fig. 3), wherein the blade, handle and elongate shaft may be made from surgical-grade steel (see Para. [0046] and [0054]; as the handle and elongate shaft are one continuous piece of material, both the proximal-most “handle” and the elongate shaft connecting the “handle” to the distal blade are understood to be formed from surgical-grade steel as disclosed by Goldman unless otherwise stated) which is a surgical-grade material used to form various instruments having suitable rigidity and hardness (see Para. [0046] and [0054]) that has a proven clinical history to accepted material standards for bio-compatibility, strength, etc.
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the resector of Pimenta to have the shaft, tab and head portion are made of a surgical grade steel as disclosed by Goldman since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta (US 2023/0233199 A1) (previously of record) in view of Dinis (US 2013/0144318 A1) (previously of record), further in view of Shackelford (US 2020/0405340 A1) (previously of record).
Regarding claim 6, Pimenta discloses all of the limitations of the invention of claim 1.
However, Pimenta does not expressly disclose a material used to form the resector and thus does not expressly disclose wherein the shaft, holding tab portion and knife head are made of a biocompatible material.
In the same field of endeavor, namely surgical cutting devices configured for releasing tension in ligaments, Dinis teaches a surgical ligament release device (see Fig. 10 and Para. [0001]) comprising a handle (27, see Fig. 10), elongate shaft (28, see Fig. 10) and a distal blade (see Para. [0204]), wherein the handle and shaft may be made from biocompatible materials such as polyethylene (see Para. [0199] and [0248]).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the resector of Pimenta to have the shaft and handle be made of polyethylene as disclosed by Dinis since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
In the relevant field of endeavor, namely surgical blades configured to make incision within tissue, Shackelford teaches wherein a surgical scalpel blade may be formed from polypropylene (see Para. [0014], [0028] and [0044]).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the resector of Pimenta to have the shaft and handle be made of polypropylene as disclosed by Shackelford since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding claim 7, the combination of Pimenta, Dinis and Shackelford disclose the invention of claim 6, Pimenta, as modified by Dinis and Shackelford, further disclose wherein the biocompatible material comprises one or more of nylon 16, polyetheretherketone (PEEK), polyvinylchloride (PVC); polyethylene (PE) and polypropylene (PP) (see Dinis Para. [0199] and [0248] mentioning wherein polyethylene is used as a known biocompatible material to form the elongate shaft and the handle of Pimenta; see also Shackelford Para. [0014], [0028] and [0044] mentioning wherein polypropylene is used to form the blade of Pimenta).
Claim(s) 9-13 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta (US 2023/0233199 A1) (previously of record) in view of Grimmer (US 2017/0143199 A1) (previously of record).
Regarding claim 9, Pimenta discloses all of the limitations of the invention of claim 1.
However, Pimenta does not expressly disclose a first cannulation within the shaft, the first cannulation having an inlet adjacent the holding tab portion at the one end of the shaft and a first opening adjacent the knife head, the first cannulation formed to receive an elongated, flexible shaft of an a needle scope and to position a functional end of the needle scope within the first opening positioned on at the head.
In the field of endeavor of surgical devices configured to be navigated to an intended site within the body comprising guiding means therefore, Grimmer teaches wherein a surgical device (see Figs. 1-2) comprising proximal handle (see Figs. 1-2 and Para. [0090]), an elongate body (rigid tube 6, see Figs. 1-2) and a distal end effector (see Figs. 1-2) , wherein the distal end effector comprises a first edge (see Examiner’s Diagram of Grimmer Fig. 11 below illustrating a “first edge”) and a second edge (see Examiner’s Diagram of Grimmer Fig. 11 below illustrating a “second edge”) and a space disposed therebetween (lumen 10, see Fig. 11), and wherein the elongate body may additionally comprise a first cannulation within the elongate tube (left-most channel 22, see Examiner’s Diagram of Grimmer Fig. 11 below and Para. [0061]-[0062] and [0081]-[0083]), extending through the elongate body and into the “first edge” (see Fig. 11 and Para. [0061]-[0064], [0074] and [0081]-[0083]), the first cannulation having an inlet adjacent the proximal handle (hardware port 18, see Fig. 1 and Para. [0064], [0074] and [0081]-[0083]) to allow entry and exit of an imaging component (i.e., a hollow tubular member akin to a “needle”) therein (imagine component 24, see Fig. 11) and an opening adjacent the distal end effector (see Fig. 11 showing a distal opening for imaging component 24 to extend within and provide imagine functions therefrom), the first cannulation formed to receive an elongated, flexible shaft of an tubular imaging scope and to position a functional end of the image scope within the first opening at the head end (see Fig. 11 and Para. [0062]-[0064] and [0081]-[0083]) to provide imaging capabilities at the distal end of the device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the elongate shaft and finger 76 of Pimenta to comprise a lumen extending therethrough from a proximal entry port disposed within the handle to receive an elongate imaging component therein as taught and suggested by Grimmer to, in this case, provide imaging capabilities to the distal end of the device (see Grimmer Para. [0062]-[0064], [0074] and [0081]-[0083]).
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Examiner’s Diagram of Grimmer Fig. 11
Regarding claim 10, the combination of Pimenta and Grimmer disclose the invention of claim 9.
However, the combination of Pimenta and Grimmer as presently disclosed does not expressly disclose a second cannulation within the shaft.
Grimmer further discloses a second cannulation within the shaft of the elongate member (right-most channel 22, see Examiner’s Diagram of Grimmer Fig. 11 above) extending from the proximal port (hardware port 18, see Fig. 1 and Para. [0064], [0074] and [0081]-[0083]; as only one hardware port 18 is disclosed by Grimmer, the additional channel is understood to branch off from the first channel within the elongate body so as to be separate as recited in Para. [0081] and shown in Fig. 11) through the elongate member to the distal “second edge” located opposite the “first edge”(see Examiner’s Diagram of Grimmer Fig. 11 above) to receive an illumination source therein (illumination source 23, see Fig. 11) to provide illumination at the distal end of the device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the elongate shaft and finger 74 of Pimenta to comprise an additional lumen extending therethrough from the proximal entry port within the handle, as incorporated from the teachings of Grimmer, configured to receive an illumination source therein as taught and suggested by Grimmer to, in this case, provide illumination capabilities to the distal end of the device (see Grimmer Para. [0062]-[0064] and [0081]-[0083]).
Regarding claim 11, the combination of Pimenta and Grimmer disclose the invention of claim 9, Pimenta, as modified by Grimmer, further discloses wherein the first opening is positioned on the first projecting portion (the lumen for the imaging component of Grimmer, as incorporated into the device of Pimenta, comprises an exit port within the first finger 76 of Pimenta to provide clear access to the surgical field, see Grimmer Fig. 11 showing such an opening to allow for the imaging component to take images of the surgical field)
However, the combination of Pimenta and Grimmer as presently disclosed does not expressly disclose a second cannulation within the shaft, the second cannulation having a second opening positioned on the second projecting portion
Grimmer further discloses a second cannulation within the shaft of the elongate member (right-most channel 22, see Examiner’s Diagram of Grimmer Fig. 11 above) extending from the proximal port (hardware port 18, see Fig. 1 and Para. [0064], [0074] and [0081]-[0083]; as only one hardware port 18 is disclosed by Grimmer, the additional channel is understood to branch off from the first channel within the elongate body so as to be separate as recited in Para. [0081] and shown in Fig. 11) through the elongate member to the distal “second edge” located opposite the “first edge”(see Examiner’s Diagram of Grimmer Fig. 11 above) to receive an illumination source therein (illumination source 23, see Fig. 11) to provide illumination at the distal end of the device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the elongate shaft and finger 74 of Pimenta to comprise an additional lumen extending therethrough from the proximal entry port within the handle, as incorporated from the teachings of Grimmer, configured to receive an illumination source therein as taught and suggested by Grimmer to, in this case, provide illumination capabilities to the distal end of the device (see Grimmer Para. [0062]-[0064] and [0081]-[0083]).
Regarding claim 12, combination of Pimenta and Grimmer disclose the invention of claim 9, Pimenta, as modified by Grimmer, further discloses wherein the first cannulation comprises a first canal end portion (portion of the imaging component lumen housing the imaging component immediately adjacent the entry port therefore disposed within the handle, see Grimmer Fig. 1 and 11 and Grimmer Para. [0074]), the first canal end portion extending from the first cannulation to the first opening (lumen housing the imaging component of Grimmer extends from the proximal port within the handle to an opening within the first finger of Pimenta).
However, the combination as currently presented does not expressly disclose a second canal end portion, wherein the second canal end portion extending from the first cannulation to a second opening positioned at a second location on the knife head.
Grimmer further discloses a second cannulation within the shaft of the elongate member (right-most channel 22, see Examiner’s Diagram of Grimmer Fig. 11 above) extending from the proximal port (hardware port 18, see Fig. 1 and Para. [0064], [0074] and [0081]-[0083]; as only one hardware port is disclosed by Grimmer, the additional channel is understood to branch off from the first channel within the elongate body) through the elongate member to the distal “second edge” located opposite the “first edge”(see Examiner’s Diagram of Grimmer Fig. 11 above) to receive an illumination source therein (illumination source 23, see Fig. 11) to provide illumination at the distal end of the device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the elongate shaft and finger 74 of Pimenta to comprise an additional lumen extending therethrough from the proximal entry port within the handle, as incorporated from the teachings of Grimmer, configured to receive an illumination source therein as taught and suggested by Grimmer to, in this case, provide illumination capabilities to the distal end of the device (see Grimmer Para. [0062]-[0064] and [0081]-[0083]). The point within the elongate shaft at which the illumination lumen branches off from the imaging lumen is defined to be the “second cannulation end portion” which would extend from the first, imaging lumen, to the second opening within the second finger of Pimenta.
Regarding claim 13, combination of Pimenta and Grimmer disclose the invention of claim 12, Pimenta, as modified by Grimmer, further discloses wherein the first opening is positioned on the first projecting portion (see Grimmer Fig. 11 showing wherein the imaging lumen is disposed within the “first edge” and would thus be disposed within the first finger of Pimenta to provide access to the surgical site from the distal end of the device) and wherein the second opening is positioned on the second projecting portion (Grimmer Fig. 11 showing wherein the illumination lumen is disposed within the “second edge” and would thus be disposed within the second finger of Pimenta to provide access to the surgical site from the distal end of the device).
Regarding claim 19, Pimenta discloses all of the limitations of the invention of claim 14.
However, Pimenta does not expressly disclose a needle scope having a flexible wand portion and an image tip formed on the end of the needle scope, wherein body and the knife head are adapted to receive the wand portion of the needle scope and position the image tip in an opening within at least one of the first projecting portion of the second projecting portion.
In the field of endeavor of surgical devices configured to be navigated to an intended site within the body comprising guiding means therefore, Grimmer teaches wherein a surgical device (see Figs. 1-2) comprising proximal handle (see Figs. 1-2 and Para. [0090]), an elongate body (rigid tube 6, see Figs. 1-2) and a distal end effector (see Figs. 1-2) , wherein the distal end effector comprises a first edge (see Examiner’s Diagram of Grimmer Fig. 11 above illustrating a “first edge”) and a second edge (see Examiner’s Diagram of Grimmer Fig. 11 below illustrating a “second edge”) and a space disposed therebetween (lumen 10, see Fig. 11), and wherein the elongate body may additionally comprise a first cannulation within the elongate tube (left-most channel 22, see Examiner’s Diagram of Grimmer Fig. 11 above and Para. [0061]-[0062] and [0081]-[0083]), extending through the elongate body and into the “first edge” (see Fig. 11 and Para. [0061]-[0064], [0074] and [0081]-[0083]), the first cannulation having an inlet adjacent the proximal handle (hardware port 18, see Fig. 1 and Para. [0064], [0074] and [0081]-[0083]) to allow entry and exit of an elongate tubular imaging component therein (imagine component 24, see Fig. 11) and an opening adjacent the distal end effector (see Fig. 11 showing a distal opening for imaging component 24 to extend within and provide imagine functions therefrom), the first cannulation formed to receive an elongated, flexible wand of an image scope and to position a functional end of the image scope within the first opening at the head end (see Fig. 11 and Para. [0062]-[0064] and [0081]-[0083]) to provide imaging capabilities at the distal end of the device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the elongate shaft and finger 76 of Pimenta to comprise a lumen extending therethrough from a proximal entry port disposed within the handle to receive an imaging component/wand therein as taught and suggested by Grimmer to, in this case, provide imaging capabilities to the distal end of the device (see Grimmer Para. [0062]-[0064], [0074] and [0081]-[0083]).
Regarding claim 20, the combination of Pimenta and Grimmer disclose the invention of claim 19, Pimenta, as modified by Grimmer, further discloses wherein the fasciotomy knife further comprises at least one canal provided within the body (lumen receiving the imaging component of Grimmer, as incorporated into the device of Pimenta), the at least one canal having an inlet adjacent the gripping tap (port 18, see Grimmer Para. [0074] and Fig. 1, as incorporated into the handle of Pimenta to insert and receive the imaging component therein) and the at least one opening located within the first bulbous peak (distal port disposed within the first finger of Pimenta, as incorporated from the teachings of Grimmer, see Grimmer Fig. 11 showing wherein a distal opening is formed at the distal end of the device to allow the imaging component to access the surgical field; the port is understood to be incorporated into the “first bulbous peak” since this is the distal-most portion of the finger 76 that directly faces the tissue to be passed through the central channel), and wherein the at least one canal is formed to receive the wand of the image scope and to position the needle scope tip within the at least one opening directed forward of the knife head (see Grimmer Fig. 11 and Para. [0061]-[0063], [0074] and [0081]-[0083]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta (US 2023/0233199 A1) (previously of record) in view of Hoftman (US 6024696 A).
Regarding claim 17, Pimenta discloses all of the limitations of the invention of claim 18.
However, while Pimenta discloses wherein the cutting device may be used with a spatula-type retractor (see Para. [0074] mentioning the use of a spatula during insertion of the resector to a target site) having a curved lip formed at the distal end thereof (see Para. [0074] mentioning wherein the spatula may comprise a curved distal end), and a receiving channel defined between the spatula when the device is assembled (see Para. [0074] mentioning wherein a channel is present within the spatula to receive the resector therein), Pimenta does not expressly disclose:
A speculum type retractor comprising a top portion and a bottom portion, each of the top and bottom portions having a handle formed at one end and a curved lip formed at their opposite end, the top and bottom portions having opposed hemi-circular cross sections and combining [[for]] to form a substantially circular trough therebetween, the bottom portion being dimensionally longer than the top portion, such that in assembly the lip of the bottom portion projects outwardly of the lip of the top portion, and a receiving channel defined between the top and bottom portions when the device is assembled.
In the same field of endeavor, namely surgical retractor devices, Hoftman teaches a surgical speculum-type retractor (see Fig. 4) comprising:
a top portion (302, see Fig. 4) and a bottom portion (306, see Fig. 4), each of the top and bottom portions having a handle formed at one end (see Fig. 4) and a curved lip formed at their opposite end (see Fig. 4 showing wherein the distal tip of the jaw portions is tapered, forming a curved tip at the distal ends thereof), the top and bottom portions having opposed hemi-circular cross sections (see Figs. 3-4 showing wherein the top and bottom portions are both rounded, forming a hemi-circular cross section) and combining to form a substantially circular trough therebetween (see Figs. 3-4), the bottom portion being dimensionally longer than the top portion (see Figs. 3-4), such that in assembly the lip of the bottom portion projects outwardly of the lip of the top portion (see Figs. 3-4), and a receiving channel defined between the top and bottom portions when the device is assembled (see Fig. 3).
Since Pimenta does not provide adequate structural details pertaining to the retractor, it would have been obvious to one of ordinary skill in the art to have looked to the available prior art for analogous retractor devices to be used with the device of Pimenta. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have utilized the speculum-type retractor disclosed by Hoftman with the device of Pimenta as a known alternative retractor device within the art.
Claim(s) 14-15, 21-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over LaFauci (US 2011/0106123 A1) in view of Garvey (US 2021/0085361 A1).
Regarding claim 14, LaFauci discloses:
A fasciotomy knife for release of body tissue over an extended length within an interior portion of a human body (see Fig. 9; the device shown in Fig. 9 is understood to be reasonably capable of being used to release body tissue over an extended length within an interior portion of a human body since the device comprises all of the structural limitations recited below responsible for facilitating the claimed function), the knife comprising:
a body (see Fig. 9) having an elongated shaft (see Examiner’s Diagram of Fig. 9 below indicating an elongate shaft portion of the device) a gripping tab (see Examiner’s Diagram of Fig. 9 below indicating a proximal gripping tab portion), and a knife head aligned with and projecting from one end of the elongated shaft (see Examiner’s Diagram of Fig. 9 below indicating a knife head portion aligned with and projecting distally from the elongated shaft portion);
the knife head comprising two projecting portions (see Examiner’s Diagram of Fig. 9_Head below showing a first and second projection portion) sequentially positioned relative to the elongate shaft (see Examiner’s Diagram of Fig. 9_Head below showing wherein the two projecting portions are sequentially arranged along the longitudinal axis); and
a channel formed between the two projecting portions (see Fig. 9_Head showing a channel formed between the two projecting portions);
the first projecting portion positioned at a forward end of the knife head (see Examiner’s Diagram of Fig. 9_Head below illustrating the first projecting portion positioned at a forward end of the knife head portion) and the second projecting portion positioned in a trailing position, sequentially behind a channel opening (see Examiner’s Diagram of Fig. 9_Head below illustrating wherein the second projecting portion is positioned in a trailing position relative to the first projecting portion, the two projecting portions arranged sequentially along the longitudinal axis);
the first projecting portion having a projecting bill forming a first forward edge and protruding outwardly from the knife head (see Examiner’s Diagram of Fig. 9_Head below showing wherein the first projecting portion comprises a first forward edge extending distally from the knife head portion along the longitudinal axis);
the channel having a curvature extending from the channel opening (see Fig. 9), inwardly into the knife head and terminating at a base (see Fig. 9 showing the channel defined between the two projecting portions is curved along the radially-inward walls of the projecting portions and terminates at a base within the proximal portion of the channel); and
the second projecting portion having a second bill forming a second forward edge positioned adjacent the channel opening and protruding toward the first projecting portion (see Examiner’s Diagram of Fig. 9_Head below showing wherein the second projecting portion comprises a second forward edge adjacent the knife channel and projects distally toward the first projecting portion located distally thereof); and
a bulbous peak positioned rearwardly of and extending upwardly from a position adjacent the second forward edge (see Examiner’s Diagram of Fig. 9_Head below illustrating a bulbous portion along the second projecting portion extending upwardly from the device body and adjacent the second forward edge), the bulbous peak further positioned adjacent a connection of the knife head elongated shaft (see Examiner’s Diagram of Fig. 9_Head below); and
a surgical blade having a cutting edge positioned within the channel adjacent the base of the channel (blade 302, see Fig. 9)
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Examiner’s Diagram of Fig. 9
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Examiner’s Diagram of Fig. 9_Head
However, LaFauci does not expressly disclose wherein the gripping tab projects orthogonally from the body portion.
In the same field of endeavor, namely surgical cutting devices comprising a cutting head having two projecting bill portions with a cutting blade disposed within a channel therebetween, Garvey teaches a surgical cutting device (see Fig. 8C) having a handle (853, see Fig. 8C), an elongated shaft extending distally therefrom (see Examiner’s Diagram of Fig. 8C below identifying the elongated shaft of the cutting device extending from the proximal handle) and a knife head positioned at the distal end of the elongated shaft (830, 830; see Fig. 8C); the handle comprising a gripping tab that projects orthogonally from the elongated shaft body portion (see Fig. 8C showing handle features 853 extending orthogonally relative to the shaft body) which allows a user to easily grasp and move the cutter device (see Para. [0074]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known surgical cutter handle for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of having the gripping handle portion of LaFauci have a gripping portion extending orthogonally from the elongate shaft axis as disclosed as a known alternative handle configuration for surgical cutting device by Garvey. As both handle portions are configured to provide a holding platform/means for which a user to manipulate the device, one of ordinary skill in the art would have expected the device of LaFauci to function equally well with either a linearly-extending handle portion or an orthogonally-extending handle portion.
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Examiner’s Diagram of Fig. 8C
Regarding claim 15, the combination of LaFauci and Garvey disclose the invention of claim 14, LaFauci, as well as Garvey, further discloses wherein the gripping tab comprises a lateral contoured surface to facilitate gripping (see Garvey Fig. 8C showing a contoured surface along the orthogonal gripping portion; see also LaFauci Fig. 9 showing a plurality of grooves extending along the length of the proximal gripping portion).
Regarding claim 21, the combination of LaFauci and Garvey disclose the invention of claim 14, LaFauci further discloses wherein the first projecting portion comprises a first bulbous peak positioned adjacent to and projecting upwardly of the position of the first forward edge (see Examiner’s Diagram of Fig. 9_Head above showing wherein the first projecting portion comprises a first bulbous peak as the most radially-inward rounded portion of the first projecting portion).
Regarding claim 22, the combination of LaFauci and Garvey disclose the invention of claim 14, LaFauci further discloses wherein the first forward edge comprises an upper surface and a lower surface forming an acute angle with respect to one another (see Examiner’s Diagram of Fig. 9_First_Projection below showing wherein the first forward edge comprises upper and lower surfaces that are formed at an acute angle with one-another).
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Examiner’s Diagram of Fig. 9_First_Projection
Regarding claim 23, the combination of LaFauci and Garvey disclose all of the limitations of the invention of claim 22.
However, none of either LaFauci or Garvey expressly disclose wherein the first projecting portion comprises a first concave, curved transition portion positioned between the first forward edge and the first bulbous peak.
It appears that the device of LaFauci would operate equally well with the claimed concave, curved transition portion positioned between the first forward edge and the first bulbous peak since the curved projecting portions merely serve to guide tissue into the central channel to engage with the cutting blade. The shape of the transition between the distal portions of the projecting portions is not seen to serve any additional specialized function. Further, Applicant has not disclosed that the shape claimed solves any stated problem or is for any particular purpose, indicating merely that the transition regions are tapered (see Para. [0047]). There appears to be no exact corresponding disclosure pertaining to the claimed concave transition region present within the specification, instead relying on the drawings to show the claimed structural feature.
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have caused the first projecting portion of the device of LaFauci to comprise a first concave, curved transition portion positioned between the first forward edge and the first bulbous peak because it appears to be an arbitrary design consideration which fails to patentably distinguish over LaFauci.
Regarding claim 24, the combination of LaFauci and Garvey disclose the invention of claim 14, LaFauci further discloses wherein the first bulbous peak and second bulbous peak project upwardly from the knife head to a position relatively above a top surface of the elongated shaft (see Examiner’s Diagram of Fig. 9_Axis below showing wherein the first and second bulbous peaks project upwardly from the knife head to a position relative above a top surface of the elongated shaft along a shaft axis defined in the Examiner’s Diagram below).
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Examiner’s Diagram of Fig. 9_Axis
Regarding claim 25, the combination of LaFauci and Garvey disclose the invention of claim 14, LaFauci further discloses wherein the second forward edge comprises an upper surface and a lower surface forming an acute angle with respect to one another (see Examiner’s Diagram of Fig. 9_Second_Projection below showing wherein the second forward edge comprises an upper and lower surface that are formed at an acute angle with one-another).
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Examiner’s Diagram of Fig. 9_Seocnd_Projection
Regarding claim 26, the combination of LaFauci and Garvey disclose the invention of claim 25, LaFauci further discloses wherein the second projecting portion comprises a concave transition surface positioned between the upper surface of the second forward edge and the second bulbous peak (see Examiner’s Diagram of Fig. 9_Concave below illustrating wherein a concave transition surface is formed between the upper surface of the second forward edge and the second bulbous peak wherein the second bulbous peak tapers, at the distal end thereof, back toward the device body, forming a concave portion along the distal-most edge of the second bulbous peak and the outer surface of the second projecting portion).
Regarding claim 27, the combination of LaFauci and Garvey disclose the invention of claim 25, LaFauci further discloses wherein the upper surface of the second forward edge is connected to the second bulbous peak (see Examiner’s Diagram of Fig. 9_Head above).
Regarding claim 28, the combination of LaFauci and Garvey disclose the invention of claim 25, LaFauci further discloses wherein the bottom surface of the first forward edge is connected to a lower surface of the knife head (see Examiner’s Diagram of Fig. 9_Head above), the lower surface of the knife head forming a convex curved outer surface between the shaft and the first forward edge (see Examiner’s Diagram of Fig. 9_Head above showing wherein the bottom surface of the first projecting portion forms a convex outer surface between the shaft and the first forward edge due to the curvature of the first projecting portion).
Regarding claim 29, the combination of LaFauci and Garvey disclose the invention of claim 14, LaFauci further discloses wherein the elongated shaft comprises at least one curved portion along a longitudinal length thereof (see Fig. 9 showing wherein the elongate shaft is curved along the longitudinal axis).
Regarding claim 30, the combination of LaFauci and Garvey disclose the invention of claim 29, LaFauci further discloses wherein the curved portion in the elongated shaft is positioned adjacent the gripping tab (see Fig. 9 showing wherein the elongate body portion is curved along the length thereof and would thus be curved adjacent the handle portion, as incorporated from the teachings of Garvey).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 20240065726 A1, US 20220022909 A1, US 20200129200 A1, US 20260026834 A1, US 20130289596 A1, US 20140066709 A1, US 5782850 A, US 20240374278 A1, US 20230076813 A1, US 20150190165 A1, US 5026385 A, US 20110106123 A1, US 20180000508 A1, US 20120165836 A1, US 20200001485 A1, US 20120259352 A1, US 20140182140 A1, US 6383179 B1, US 20090198263 A1, US 5341822 A, US 20080243180 A1, US 4858324 A, US 20130245638 A1, US 4273127 A, US 20170333067 A1, US 20170197279 A1,US 8252011 B1, US 5827311 A, US 20170252056 A1, US 20210085361 A1, US 20140031621 A1, US 3915169 A1 and US 11529162 B2 all disclose surgical cutting devices having a pair of longitudinally extending jaw portions with a blade disposed within a channel between the two jaw portions.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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