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 .
Reopening of Prosecution After Appeal Brief
In view of the Appeal Brief filed on 02/02/2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/ELIZABETH HOUSTON/ Supervisory Patent Examiner, Art Unit 3771
Response to Arguments
Applicant’s arguments, see pages 12-13 of the appeal brief, filed 02/02/2026, with respect to the rejection(s) of claim(s) 3, 14, and 24 under 35 U.S.C. 112(b) rejection is persuasive. The examiner agrees that the limitation “wherein each clip of the pair of guidewire clips includes an opening that opens toward the back edge of the scalpel blade and away from a different side of the scalpel blade” is not indefinite and the 112(b) rejection is withdrawn.
Applicant’s arguments, see pages 20-21 of the appeal brief, filed 02/02/2026, with respect to the rejection(s) of claim(s) 41, 43, and 45 under 35 U.S.C. 102/103 rejection over Heppler have been fully considered and are persuasive. Examiner agrees that the embodiment of Figs. 11A-C relied upon in Heppler fails to disclose “each guidewire clip of the pair of guidewire clips is molded to include a rivet shank extending therefrom” as required in claim 41. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection under 35 U.S.C. 103 rejection is made in view of Heppler.
Applicant's arguments in appeal brief filed 02/02/2026 have been fully considered but they are not persuasive.
Dependent claims 3, 14, and 24
Applicant argues that Heppler fails to disclose “each clip of the pair guidewire clips including an opening that opens toward the back edge and away from a different side of the blade” as required by claims 3, 14, and 24.
The examiner respectfully disagrees. As shown in annotated Fig. 17 of Heppler below, the distal guidewire clip includes an opening that opens towards the back edge and away from a side of the blade contacting blade end 34 and the proximal guidewire clip including an opening that opens towards the back edge and away from face 36 of the blade 31. Therefore, Heppler discloses the limitation as claimed.
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Annotated Fig. 17 of Heppler
Dependent claims 5, 16, and 26
Applicant argues that each clip of the pair of guidewire clips of Heppler fails to include “an opening that opens along a side of the scalpel blade” as required by claims 5, 16, and 26.
The examiner respectfully disagrees. As shown in the annotated Fig. 17 of Heppler above, each clip of the pair of guidewire clips of Heppler include an opening that opens along an inner side of the scalpel blade 31 in relation to the distal guidewire clip and an outer side of the scalpel blade 31 in relation to the proximal guidewire clip. Therefore, Heppler discloses the limitation as claimed.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-30 are rejected under 35 U.S.C. 103 as being unpatentable over Heppler (US 20040181246) in view of Shackelford, Jr (US 20200405340) [hereinafter Shackelford].
[The examiners notes that the scalpel blade embodiment of Figs. 14A-17 relied upon for the rejection. However, the other embodiments are relied upon for like features not described in Figs. 14A-17 (para. 0050).]
Regarding claims 1, 11, and 21, Heppler discloses a scalpel assembly (see Fig. 16, para. 0055), comprising:
a guidewire 29 (Fig. 16, para. 0055: “The pair of wire guides are adapted to engage a wire 29... The "wire" is broadly defined for the purposes of the present invention, and can be any such guidewire”;
a scalpel handle 32 (Figs. 14A-B, para. 0053); and
a scalpel blade 31 coupled to the scalpel handle 32 (Figs. 14A-B, para. 0053: “The blade end of the scalpel receives the blade 31”), the scalpel blade 31 (Figs. 15A-B) including:
a blade edge terminating with a blade tip 38 at a distal end of the scalpel blade 31 (see annotated Fig. 15A of Heppler below); and
a back edge (see annotated Fig. 15A below; The examiner notes that the “back edge” of the blade is the bottom edge of the blade as defined in the instant application specification; see Fig. 1, para. 0068: “The back edge 104 includes a pair of guidewire clips 110”) including a pair of guidewire clips 28 (see Figs. 15A-B, para. 0062: “both of the pair of wire guides 28 can extend from the blade 31) configured to clip onto a guidewire with sufficient clearance for slidably guiding the scalpel blade along the guidewire when skin-nicking a patient's skin and fascia around an insertion site established by a percutaneous puncture (see Fig. 16 for example, para. 0055: “the pair of wire guides 28 mount to the scalpel 27. The pair of wire guides are adapted to engage a wire 29, as shown in FIGS. 4, 5, 6A, 6B, 9A, 9B, 9C, 12, 16, 18, and 19. The "wire" is broadly defined for the purposes of the present invention, and can be any such guidewire or filament, as conventionally employed in surgical techniques that involve the insertion of such a wire or strand”).
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Annotated Fig. 15A of Heppler
For the embodiment of Figs, 14-17 in which the pair of guidewire clips extend from the blade, Heppler fails to disclose that the pair of guidewire clips are made from plastic.
However, in the case where the pair of guidewire clips are extending from the blade, the reference discloses that the blade and the pair of guidewire clips may be formed together, resulting in a metal blade comprising a pair of metal guidewire clips (para. 0062: “ In an alternative embodiment of the present invention, both of the pair of wire guides 28 can extend from the blade 31 of the scalpel 27, as shown in FIGS. 7, 8, 10A, 10B…The blade of the scalpel can include the pair of wire guides, each embodied by a metal hook 55 extending from the blade. For this embodiment, the pair of wire guides could be stamped from a single piece of metal with the blade”).
Further, in the case where the pair of guidewire clips are extending from the handle, Heppler further discloses that the handle and the pair of guidewire clips may be formed together, resulting in a plastic handle comprising a pair of plastic guidewire clips (para. 0065: “In a most preferred embodiment of the present invention, the pair of wire guides 28 both extend from the handle 32 of the scalpel 27, as discussed above... Conventional metal blades are not manufactured with the pair of wire guides. Preferably, the handle of the scalpel includes the pair of wire guides, with each extending from the handle. The pair of wire guides can be molded with the handle, or otherwise formed from a single piece of plastic or alternatively metal”).
Therefore, the material of the pair of guidewire clips may be based off the element in which they are manufactured with (i.e. metal blade stamped with metal pair of guidewire clips or plastic handle molded with plastic pair of guidewire clips”).
Shackelford in the same field of endeavor of surgical scalpel blades teaches that it is known in the art to for a scalpel blade to be made of plastic material (para. 0028: “The surgical blade member 14 further consists of a body member 16 having a distal end formed into a surgical blade 18 with an edge 19 suitable for cutting. Blade 18 may be made of plastic material”) by way of molding (para. 0044: “Plastic blade member may also be formed by injection molding, thermoforming, CNC, and other similar methods”) as a known alternative to metal blades (para. 0003).
In light of this disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the scalpel blade of Heppler to be formed of the plastic material, as taught by Shackelford, such that the pair of guidewire clips may also be formed from plastic during manufacturing, since Heppler discloses that the pair of guidewire clips and the blade may be formed together and that the plastic guidewire clips can result from being molded with the plastic element in which it is attached to. Furthermore, Shackelford teaches that a plastic blade is advantageous, in comparison to a surgical grade metal blade, because it reduces the incidence of inadvertent stabbing and cutting of a user during use and reduces the cost in manufacturing (para. 0003-0005, 0009) and since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use. (In re Leshin 125 USPQ 416; MPEP 2144.07).
Regarding claims 2, 13, and 23, modified Heppler discloses wherein the pair of guidewire clips 28 are disposed along a side of the back edge of the scalpel blade (see annotated Fig. 15A of Heppler above).
Regarding claims 3, 14, and 24, modified Heppler discloses wherein each clip of the pair of guidewire clips 28 includes an opening that opens toward the back edge of the scalpel blade and away from a different side of the scalpel blade (see annotated Fig. 17 below which illustrates the distal guidewire clip including an opening that opens towards the back edge and away from side of the blade contacting blade end 34 of the handle and the proximal guidewire clip including an opening that opens towards the back edge and away from face 36 of the blade 31).
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Annotated Fig. 17 of Heppler
Regarding claims 4, 15, and 25, modified Heppler discloses all of the limitations set forth above in claims 3, 14, and 24. Modified Heppler further discloses that the pair of wire guides may be “substantially J shaped” and that the curved end of the J shape provides additional containment and grip to the wire (para. 0058). For example, see Figs. 20A-C which illustrates J shaped wire guides. However, modified Heppler fails to disclose wherein each clip of the pair of guidewire clips is a three-quarter sector of a circle in transverse cross section.
Since Heppler discloses a curved shape embodiment of the pair of wire guides and discusses the benefit of having the curved shape for additional containment and grip of the guidewire, it would have been an obvious matter of design choice to modify the pair of guidewire clips in modified Heppler to have the three-quarter sector of a circle shape since such a modification would allow the guidewire to be better contained within the pair of wire guides as intended by modified Heppler and since the modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claims 5, 16, and 26, modified Heppler discloses wherein each clip of the pair of guidewire clips 28 includes an opening that opens along a side of the scalpel blade 31 (see annotated Fig. 17 above which illustrates each clip of the pair of guidewire clips of Heppler including an opening that opens along an inner side of the scalpel blade 31 in relation to the distal guidewire clip and an outer side of the scalpel blade 31 in relation to the proximal guidewire clip), and each clip of the pair of guidewire clips is mutually exclusive of the other clip of the pair of guidewire clips with respect to the opening thereof (see annotated Fig. 17 above for example).
Regarding claims 6, 17, and 27, modified Heppler discloses wherein each clip of the pair of guidewire clips is a semicircle in transverse cross section (para. 0062 of Heppler discloses that the pair of wire guides may be “substantially J shaped”. For example, see Figs. 20A-C which illustrates J shaped wire guides such that the curved portion of the J shape is semicircle in transverse cross section).
Regarding claims 7, 18, and 28, modified Heppler discloses wherein each clip of the pair of guidewire clips 28 is separated along the back edge of the scalpel blade 31 from the other clip of the pair of guidewire clips (see Figs. 15A-B) to allow the guidewire 29 to easily cross over the back edge of the scalpel blade 31 without appreciably bending the guidewire 29 when loading the guidewire 29 into each clip of the pair of guidewire clips (see Figs. 9A-C for example which illustrates and describes how the guidewire is loaded onto the clips without bending, para. 0070).
Regarding claims 8, 19, and 29, modified Heppler discloses wherein the guidewire 29 is coaxial with the pair of guidewire clips 28 when the guidewire is loaded therein (best shown in Fig. 6A of Heppler).
Regarding claims 9, 20, and 30, modified Heppler discloses wherein the guidewire 29 is coaxial with the pair of guidewire clips 28 (best shown in Fig. 6A of Heppler) for rotating the scalpel blade 31 around the guidewire to a desired rotational angle for the skin-nicking of the patient's skin and fascia around the insertion site (see note below).
Note: “for rotating the scalpel blade around the guidewire to a desired rotational angle for the skin-nicking of the patient's skin and fascia around the insertion site” is interpreted as functional language and intended use of the claimed invention. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Since Heppler discloses all of the structural components required for the functional limitation i.e. a scalpel blade comprising a pair of guidewire clips (see Figs. 15A-B of Heppler), Heppler thereby discloses the functional limitation such that the scalpel blade is capable of rotating around the guidewire to a desired rotational angle for the skin-nicking of the patient's skin and fascia around the insertion site. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 10, 12, and 22, modified Heppler discloses wherein the scalpel handle 32 includes a blade-attachment fixture 34 (Figs. 14A-B, para. 0053), the scalpel blade 31 further includes a handle-attachment slot (see annotated Fig. 15A [1] of Heppler below), and the blade-attachment fixture 34 is disposed in the handle- attachment slot coupling the scalpel blade 31 to the scalpel handle 32 (Figs. 14A-B, para. 0053: “The handle 32 of the scalpel 27 includes a butt end 33 and a blade end 34…The blade end of the scalpel receives the blade 31”).
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Annotated Fig. 15A [1] of Heppler
Claim(s) 41-46 are rejected under 35 U.S.C. 103 as being unpatentable over Heppler (US 20040181246) in view of Shackelford, Jr (US 20200405340) as applied to claim 1 and further in view of Haining (US 5556409).
Regarding claims 41, 43, and 45, modified Heppler discloses all of the limitations set forth above in claim 1. Modified Heppler further discloses alternative ways to attach plastic pair of guidewire clips to a plastic element (para. 0065-0066 of Heppler: “Preferably, the handle of the scalpel includes the pair of wire guides, with each extending from the handle. The pair of wire guides can be molded with the handle, or otherwise formed from a single piece of plastic… Also alternatively, the pair of wire guides 28 can be soldered or in some similar way attached, mounted or otherwise adherered to the handle 32 of the scalpel 27”). However, modified Heppler fails to disclose wherein each guidewire clip of the pair of guidewire clips is molded to include a rivet shank extending therefrom, and the rivet shank is disposed in a through hole die-cut or drilled into the scalpel blade (see note below in regards to product-by-process language).
Haining in the same field of endeavor of scalpel blades teaches that it is known in the art to use rivet shanks 32 as a means for securely attaching an element to a scalpel blade 20 (Figs. 1-2, and 6, col. 2 lines 66-67: “A blade 20 is secured on a blade carrier 30 as by rivets 32”. The reference teaches that the blade carrier includes the rivet shanks 32 extending therefrom (see Figs, 1-2), and the rivet shanks are disposed in through holes of the scalpel blade 20 (see Fig. 6).
Since modified Heppler contemplates other ways to attach the pair guidewire clips besides molding the pair of guidewire clips with the element in which it is attached to, one skilled in the art would have readily recognized that providing the pair of wire guides of modified Heppler each with a rivet shank to dispose within through holes of the blade, as taught by Haining, would provide an alternative way to securely attach the plastic blade to the pair of plastic guidewire clips of modified Heppler, thereby positively preventing their separation or disengagement; KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Note: The examiner notes that the claims are directed towards an apparatus not a method of manufacturing. The claimed limitation “wherein each guidewire clip of the pair of guidewire clips is “molded” to include a rivet shank extending therefrom, and the rivet shank is disposed in “a through hole die-cut or drilled into” the scalpel blade” is being treated as a product by process limitation; that is the product-by-process limitation is limiting only in so far as the final structure necessitated by the process. The final structure necessitated by molding each clip of the pair of guidewire clips with a rivet shank extending therefrom and through-hole die cutting or drilling into would be a pair of guidewire clips each comprising a rivet shank and a scalpel blade comprising a pair of through holes in which the rivets are disposed within (see para. 0072 of the written description in the instant application). Since modified Heppler discloses the final structure necessitated by the process i.e. the pair of plastic guidewire clips attached to the scalpel blade by way of rivet shanks of the pair of guidewire clips disposed within through holes of the scalpel blade (see rejection of claims 41, 43, and 45 above), it is considered to meet this product-by-process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
Regarding claims 42, 44, and 46, modified Heppler discloses wherein the rivet shank is further rolled up or melted in the through hole of the scalpel blade (see note below in regards to product-by-process).
Note: The examiner notes that the claims are directed towards an apparatus not a method of manufacturing. The claimed limitation “wherein the rivet shank is further rolled up or melted in the through hole of the scalpel blade” is being treated as a product by process limitation; that is the product-by-process limitation is limiting only in so far as the final structure necessitated by the process. The final structure necessitated by rolling up or melting the rivet shank in the through hole of the scalpel blade would be the rivet shank of each of the pair of guidewire clips being permanently attached within a pair of through holes of the scalpel blade (see para. 0072 of the written description in the instant application). Since modified Heppler discloses the final structure necessitated by the process i.e. the pair of plastic guidewire clips permanently attached to the scalpel blade by way of rivet shanks of the pair of guidewire clips disposed within through holes of the scalpel blade (see rejection of claims 41, 43, and 45 above), it is considered to meet this product-by-process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights