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 Amendment
In response to the amendment filed on 12/10/2025, Claim 7 have been cancelled, thus Claims 1-6 and 8-20 are pending.
The drawings objection has been withdrawn due to the amendment of claim 6.
Claim amendments to claim 1 and 12 to address USC 112(b) issues have been acknowledged and the rejections have been withdrawn.
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
Applicant argues that, “Hossack fails to disclose "wherein, in use, [...J the scalpel guide defines a non-zero angle of the guidewire with respect to a longitudinal axis of the scalpel guide" as required by independent claim 1.”, and “Applicant has amended claim 12 to be independent and to include "wherein, in use, [...] the guide defines a non-zero angle of the guidewire with respect to a longitudinal axis of the scalpel guide" similar to independent claim 1. As such, the arguments set forth above regarding independent claim 1 apply equally well to independent claim 12. Accordingly, Hossack fails to disclose each and every element of independent claim 12, and therefore, Hossack fails to anticipate independent claim 12.”. However, examiner respectfully disagrees. Hossack discloses in Fig. 4 and Fig. 11 that there is a non-zero angle of the guidewire (53) with respect to a longitudinal axis (93) of the scalpel guide (21) as shown in the below annotated figures.
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Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 8-12, 15, 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20210106351 A1 Hossack et al. (hereinafter Hossack).
Regarding claim 1, Hossack discloses a scalpel guide 21 (Fig.1-14) , comprising:
a blade coupling portion (31) extending along a first side of the scalpel guide (as seen in Fig. 1-4), the blade coupling portion configured to secure the scalpel guide to a scalpel blade 11 (paragraph 66); and
a guidewire engagement portion (51) extending along a second side of the scalpel guide opposite the first side (as seen in Fig. 1-4), the guidewire engagement portion configured to constrain lateral displacement of the scalpel guide with respect to a guidewire (53), wherein, in use, the scalpel guide:
constrains lateral displacement of the scalpel blade with respect to the guidewire (paragraph 66, 77-78), and
defines a non-zero angle of the guidewire (53) with respect to a longitudinal axis (93) of the scalpel guide (21) (Fig. 4, 11, there is a non-zero angle of the guidewire (53) with respect to a longitudinal axis (93) of the scalpel guide (21) as shown in the above annotated figures).
Regarding claim 2, Hossack discloses the limitations of claim 1, and further discloses wherein:
the engagement portion (51) includes a first wall and a second wall disposed laterally away from the first
in use, the guidewire is disposed between the first wall and second wall (paragraph 66).
Regarding claim 3, Hossack discloses the limitations of claim 2, and further discloses wherein the first wall and/or the second wall include a curved portion configured to extend at least partially around the guidewire (as seen in Fig. 6a-6b, 10-11).
Regarding claim 4, Hossack discloses the limitations of claim 2, and further discloses wherein the second wall is disposed in longitudinal alignment with the first wall (as seen in Fig. 6a-6b).
Regarding claim 8, Hossack discloses the limitations of claim 1, and further discloses wherein engagement portion defines a "U" shape (as seen in Fig. 6b, 10).
Regarding claim 9, Hossack discloses the limitations of claim 1, and further discloses wherein the blade coupling portion is configured to secure the scalpel guide to the scalpel blade along a back side of the scalpel blade, the back side disposed opposite a cutting edge of the scalpel blade (as seen in Fig. 1-14, blade coupling portion 31 configures the scalpel blade 11 to secure to the scalpel guide along a linear back side of the blade that is opposite a cutting edge 12 of the blade).
Regarding claim 10, Hossack discloses the limitations of claim 9, and further discloses wherein the longitudinal axis of the scalpel guide is disposed at an angle with respect to the cutting edge of the scalpel blade (as seen in Fig. 12, longitudinal axis 93 of scalpel guide is at an angle with respect to the cutting edge 12 of the blade).
Regarding claim 12, Hossack further discloses a scalpel blade assembly comprising:
a scalpel blade (11, Fig. 1-9); and
a scalpel guide (21, Fig.1-14) coupled with the scalpel blade (paragraph 66), the scalpel guide comprising:
a blade coupling portion (31) extending along a first side of the scalpel guide (as seen in Fig. 1-4), the blade coupling portion configured to secure the scalpel guide to the scalpel blade (paragraph 66); and
a guidewire engagement portion (51) extending along a second side of the scalpel guide opposite the first side (as seen in Fig. 1-4), the guidewire engagement portion configured to constrain lateral displacement of the scalpel guide with respect to a guidewire (53), wherein, in use, the scalpel guide:
constrains lateral displacement of the scalpel blade with respect to the guidewire (paragraph 66, 77-78), and
defines a non-zero angle of the guidewire (53) with respect to a longitudinal axis (93) of the scalpel guide (21) (Fig. 4, 11, there is a non-zero angle of the guidewire (53) with respect to a longitudinal axis (93) of the scalpel guide (21) as shown in the above annotated figures).
Regarding claim 15, Hossack discloses the limitations of claim 12, wherein the scalpel guide is capable of being over-molded onto the scalpel blade.
The limitation “the scalpel guide is over-molded onto the scalpel blade” is considered a product by process claim. Product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
Although the reference does not disclose “the scalpel guide is over-molded onto the scalpel blade”, it is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.
Regarding claim 17, Hossack discloses a scalpel, comprising: the scalpel blade assembly of claim 12; and a scalpel handle 41 (Fig. 6a-6b, 8-9, where a user 91 holds the housing 41), coupled with the scalpel blade assembly.
Regarding claim 18, Hossack discloses the limitations of claim 17, and further discloses wherein the longitudinal axis of the scalpel guide is disposed at an angle with respect to a longitudinal axis of the scalpel handle (as seen in Fig. 1, longitudinal axis of the scalpel guide is disposed at a parallel angle with respect to a longitudinal axis of the scalpel handle).
Claim Rejections - 35 USC § 103
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hossack in view of US 20120226299 A1 Heppler (hereinafter Heppler ‘299).
Regarding claim 5, Hossack discloses the limitations of claim 2.
Hossack is silent on wherein the second wall is disposed longitudinally offset from the first wall.
However, Heppler ‘299 teaches a guide system for a scalpel that comprises two wire guides (28, Fig. 1-4) that includes a forward guide (41) having a first wall and a rearward guide (42) having a wall disposed longitudinally offset from the first wall (as seen in Fig. 1-4).
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 Hossack with the teachings of Heppler ‘299 to achieve wherein the second wall is disposed longitudinally offset from the first wall in order to attach the scalpel guide to the guidewire without having to thread an end of the guidewire through the guides as disclosed by Heppler ‘299 (paragraph 24).
Claims 6, 11, 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hossack in view of US 20040181246 A1 Heppler (hereinafter Heppler ‘246).
Regarding claim 6, Hossack discloses the limitations of claim 2.
Hossack is silent on wherein the second wall is composed of a first tab and a second tab positioned longitudinally away from the first tab, and first and second tabs are positioned longitudinally from the first wall.
However, Heppler ‘246 teaches a guide system for a scalpel that comprises a guidewire engagement portion (28, Fig. 20a) having a first wall, and a second wall, wherein the second wall is composed of a first tab and a second tab positioned longitudinally away from the first tab, and first and second tabs are positioned longitudinally from the first wall (as seen in annotated Fig. 20a below).
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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 Hossack with the teachings of Heppler ‘246 to achieve wherein the second wall is composed of a first tab and a second tab positioned longitudinally away from the first tab, and first and second tabs are positioned longitudinally from the first wall in order to provide better securement of the engagement portion to the guidewire.
Regarding claim 11, Hossack discloses the limitations of claim 9, and further discloses wherein the back side includes proximal back side edge and a distal back side edge extending away from the proximal back side edge at an angle with respect to the proximal back side edge (seen in Fig. 7 and annotated below).
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Hossack is silent on the scalpel guide constrains the guidewire to be parallel with the distal back side edge.
However, Heppler ‘246 teaches a guide system for a scalpel that comprises a scalpel guide (28, Fig. 1-22c), a scalpel blade (31) having a back side that includes a proximal back side edge and a distal back side edge extending away from the proximal back side edge at an angle with respect to the proximal back side edge (as seen in Fig. 14a and annotated below), the scalpel guide constrains the guidewire (29) to be parallel with the distal back side edge (as seen in Fig. 18-19, the scalpel guide 28 is constraining the guidewire 29 at an angle to be parallel with the distal back side edge).
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 Hossack with the teachings of Heppler ‘246 to have the scalpel guide constraining the guidewire to be parallel with the distal back side edge, in order to provide smoother guidance and least interference along the guidewire.
Regarding claim 13, Hossack discloses the limitations of claim 12.
Hossack is silent on wherein the scalpel guide is integrally formed with the scalpel blade.
However, Heppler ‘246 teaches a guide system for a scalpel that comprises wire guides (28, Fig. 7) that are integrally formed with a scalpel blade (31) (paragraph 62, the pair of wire guides could be stamped from a single piece of metal with the blade).
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 Hossack with the teachings of Heppler ‘246 to achieve wherein the scalpel guide is integrally formed with the scalpel blade in order to reduce the number of manufacturing steps and reduce material waste.
Regarding claim 14, Hossack discloses the limitations of claim 12.
Hossack is silent on wherein the scalpel guide is welded to the scalpel blade.
However, Heppler ‘246 teaches a guide system for a scalpel that comprises wire guides (28, Fig. 8) that are welded to a scalpel blade (31) (paragraph 62).
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 Hossack with the teachings of Heppler ‘246 to achieve wherein the scalpel guide is welded to the scalpel blade in order to securely fix the guide to the scalpel blade.
Claims 16, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hossack in view of US 20160128713 A1 Rauchwerger et al. (hereinafter Rauchwerger).
Regarding claim 16, Hossack discloses the limitations of claim 12.
Hossack is silent on wherein the scalpel guide is attached to the scalpel blade via a snap fit.
However, Rauchwerger teachers a surgical instrument for guiding a scalpel over a guidewire wherein the scalpel guide (114, Fig. 5-6) is attached to the scalpel blade (500) via a snap fit (paragraph 30).
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 Hossack with the teachings of Rauchwerger to achieve wherein the scalpel guide is attached to the scalpel blade via a snap fit in order to securely fix the guide to the scalpel blade.
Regarding claim 19, Hossack discloses the limitations of claim 18.
Hossack is silent on further comprising a blade cover configured to extend over the scalpel assembly including the scalpel guide.
However, Rauchwerger teaches a surgical instrument for guiding a scalpel over a guidewire wherein the surgical instrument comprises a blade cover (108, Fig. 1-8) configured to extend over a scalpel (500) and a scalpel guide (114, Fig. 1-8, paragraph 17-24).
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 Hossack with the teachings of Rauchwerger to achieve further comprising a blade cover configured to extend over the scalpel assembly including the scalpel guide in order to protect a user from being injured by the blade.
Regarding claim 20, the combination of Hossack and Rauchwerger teaches the limitations of claim 19, and Rauchwerger further teaches wherein the cover is selectively positionable between: an extended position covering the scalpel blade assembly, and a retracted position exposing the scalpel blade assembly (as seen in Fig. 3-5, paragraph 18, 23-24).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771