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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/13/2026 has been entered.
Response to Amendment
In response to the amendment filed on 4/13/2026, Claims 6-7 have been cancelled, thus Claims 1-5 and 8-20 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 12 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.
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.
Claims 1-5, 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 20040181246 Heppler in view of US 20200345385 Whitman et al. (hereinafter Whitman).
Regarding claim 1, Heppler discloses a scalpel guide, comprising:
a blade coupling portion (34, Fig. 2a-5) extending along a first side of the scalpel guide, the blade coupling portion configured to secure the scalpel guide to a scalpel blade (31, Fig. 1) (paragraph 53); and
a guidewire engagement portion (28, Fig. 1) extending along a second side of the scalpel guide opposite the first side, the guidewire engagement portion configured to constrain lateral displacement of the scalpel guide with respect to a guidewire (29, Fig. 4-6b) (abstract, paragraph 50, 55, 60-61), the guidewire engagement portion, including:
a first tab (52, Fig. 5) arranged for placement along a first side of the guidewire (seen in Fig. 5-6b), and
a third tab (53, Fig. 5) arranged for placement along a second side of the guidewire, the second side disposed opposite the first side (seen in Fig. 5-6b),
Heppler is silent on a second tab arranged for placement along a first side of the guidewire, a fourth tab arranged for placement along a second side of the guidewire, wherein: the second tab is disposed longitudinally between the third tab and the fourth tab, and the third tab is disposed longitudinally between the first tab and the second tab.
However, Whitman teaches a cutting device guided by a guidewire that comprises two pairs of guidewire engagement portions (506, Fig. 5, 9, 11) to reduce the risk of movement due to a torsional force (paragraph 78).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the guidewire engagement portion (28) of Heppler to have a second pair of guidewire engagement portions (28) placed further proximal to the first pair of guidewire engagement portions where the duplicated second guidewire engagement portion would have a duplicated tab 52 (this would correspond to a second tab arranged for placement along a first side of the guidewire) and a duplicated tab 53 (this would correspond to a fourth tab arranged for placement along a second side of the guidewire) and wherein the second tab is disposed longitudinally between the third tab and the fourth tab, and the third tab is disposed longitudinally between the first tab and the second tab, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (See MPEP 2144.04 (VI)(B)). Furthermore, Whitman teaches that the multiple guidewire engagement portions reduce the risk of movement due to a torsional force (paragraph 78).
Regarding claim 2, the combination of Heppler and Whitman teaches the limitations of claim 1, and modified Heppler further teaches wherein:
the first and second tabs define a first wall of the engagement portion (the first tab 52 and the duplicated second tab (duplicate of first tab 52) of the duplicated guidewire engagement portion 28 would have an inner wall defining a first wall as seen in annotated Fig. 6a below),
the third and fourth tabs define a second wall of the engagement portion, the second wall disposed laterally away from the first wall (the third tab 53 and the duplicated fourth tab (duplicate of third tab 53) of the duplicated guidewire engagement portion 28 would have an inner wall defining a second wall as seen in annotated Fig. 6a below), and
in use, the guidewire is disposed between the first wall and second wall (as seen in Fig. 6a, the guidewire 29 is in between the first wall and second wall).
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Regarding claim 3, the combination of Heppler and Whitman teaches the limitations of claim 1, and modified Heppler further teaches wherein the first, second, third, and fourth tabs include a curved portion configured to extend at least partially around the guidewire (as seen in Fig. 6a, first tab 52, third tab 53, along with duplicated tabs of 52 and 53 have a curved portion around the guidewire 29).
Regarding claim 4, the combination of Heppler and Whitman teaches the limitations of claim 1, and modified Heppler further teaches wherein the second tab is disposed in lateral alignment with the first tab (the second tab, which is a duplicate of first tab 52, is part of the duplicated second pair of guidewire engagement portions 28 that is placed further proximal to the first pair of guidewire engagement portions, and being that it is a duplicate of the first tab 52 placed on a first side of the guidewire, it is disposed in lateral alignment with the first tab 52).
Regarding claim 5, the combination of Heppler and Whitman teaches the limitations of claim 1, and modified Heppler further teaches wherein the fourth tab is disposed in lateral alignment with third tab (the fourth tab, which is a duplicate of third tab 53, is part of the duplicated second pair of guidewire engagement portions 28 that is placed further proximal to the first pair of guidewire engagement portions, and being that it is a duplicate of the third tab 53 placed on a second side of the guidewire, it is disposed in lateral alignment with the third tab 53).
Regarding claim 8, the combination of Heppler and Whitman teaches the limitations of claim 1, and modified Heppler further teaches wherein engagement portion defines a "U" shape (as seen in Fig. 6a).
Regarding claim 9, the combination of Heppler and Whitman teaches the limitations of claim 1, and modified Heppler further teaches 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 (37, Fig. 1, 5) of the scalpel blade (as seen in Fig. 2a-5).
Regarding claim 10, the combination of Heppler and Whitman teaches the limitations of claim 9, and modified Heppler further teaches wherein:
the first, second, third, and fourth tabs define a back wall of the engagement portion (as seen in annotated Fig. 6a above), and
the back wall is disposed at an angle with respect to the cutting edge of the scalpel blade (the back wall is at a flat angle with respect to the cutting 37 of the scalpel blade).
Regarding claim 11, the combination of Heppler and Whitman teaches the limitations of claim 10, and modified Heppler further teaches 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 (as seen in annotated Fig. 2b-c below).
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Whitman further teaches an embodiment of a guidewire engagement portion (Fig. 22-23, a lumen defining a guidewire engagement portion to support a guidewire 1850), the guidewire engagement portion having a back wall (as seen in annotated Fig. 23 below), the back wall is aligned parallel with the distal back side edge of a scalpel blade (1810) (as seen in annotated Fig. 22-23 below). 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 modification of Heppler with Whitman to have wherein the first, second, third, and fourth tabs form a back wall that is parallel to the distal back side edge of the scalpel blade (31) in order to further ensure alignment of the scalpel blade with the guidewire and reduce the risk of displacement between the guidewire and cutter as taught by Whitman (paragraph 101).
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Claims 12, 15, 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210106351 Hossack et al. (hereinafter Hossack) in view of Whitman.
Regarding claim 12, Hossack discloses a scalpel blade assembly, comprising:
a scalpel blade (11, Fig. 1-9), including:
a cutting edge (14, Fig. 1-7), and
a back side edge opposite the cutting edge, the back side edge including:
a proximal portion (as seen in annotated Fig. 7 below), and
a distal portion extending away from the proximal portion at an angle with respect to the proximal portion (as seen in annotated Fig. 7 below); 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), the guidewire engagement portion, including:
a length extending from a proximal end of the guidewire engagement portion to a distal end of the guidewire engagement portion (as seen in Fig. 1-4, guidewire engagement portion has a length from a proximal end to a distal end of the guidewire engagement portion);
a first wall, a second wall, and a back wall extending along the length (as seen in annotated Fig. 6b below), the second wall disposed laterally away from the first wall, and the back wall disposed between the first wall and the second wall (as seen in annotated Fig. 6b below),
wherein the back wall is:
disposed proximally away from the distal portion (as seen in Fig. 6b and 7).
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Hossack is silent on wherein the back wall is aligned parallel with the distal portion.
However, Whitman teaches a cutting device guided by a guidewire comprising a guidewire engagement portion (Fig. 22-23, a lumen defining a guidewire engagement portion to support a guidewire 1850), the guidewire engagement portion having a back wall (as seen in annotated Fig. 23 below), the back wall is aligned parallel with the distal portion of a scalpel blade (1810) (as seen in annotated Fig. 22-23 below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hossack with the teachings of Whitman to have the back wall angled that is parallel to the distal portion of the scalpel blade (11) in order to further ensure alignment of the scalpel blade with the guidewire and reduce the risk of displacement between the guidewire and cutter as taught by Whitman (paragraph 101).
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Regarding claim 15, the combination of Hossack and Whitman teaches the limitations of claim 12, and the combination further teaches 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, the combination of Hossack with Whitman teaches a scalpel, comprising: the scalpel blade assembly of claim 12; and Hossack further discloses 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, the combination of Hossack and Whitman teaches the limitations of claim 17, and the combination teaches wherein the back wall is disposed at an angle with respect to a longitudinal axis of the scalpel handle (modified Hossack with Whitman would have the back wall disposed at an angle so that it is parallel with the distal portion of the scalpel blade as described in claim 12, and therefore it would have an angle with respect to a longitudinal axis of the scalpel handle).
Claims 13-14 is rejected under 35 U.S.C. 103 as being unpatentable over Hossack in view of Whitman as applied to claim 12 above, and further in view of Heppler.
Regarding claim 13, the combination of Hossack and Whitman teaches the limitations of claim 12.
The combination is silent on wherein the scalpel guide is integrally formed with the scalpel blade.
However, Heppler 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 the modification of Hossack with Whitman with the teachings of Heppler 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, the combination of Hossack and Whitman teaches the limitations of claim 12.
The combination is silent on wherein the scalpel guide is welded to the scalpel blade.
However, Heppler 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 the modification of Hossack with Whitman with the teachings of Heppler 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 Whitman as applied to claim 12 above, and further in view of US 20160128713 A1 Rauchwerger et al. (hereinafter Rauchwerger).
Regarding claim 16, the combination of Hossack and Whitman teaches the limitations of claim 12.
The combination 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 the modification of Hossack with Whitman 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 the combination of Hossack and Whitman teaches the limitations of claim 18.
The combination 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 the modification of Hossack with Whitman 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, Whitman and Rauchwerger teaches the limitations of claim 19, and Rauchwerger 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
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
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