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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/14/2026 has been entered.
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 1-3, 5, 7-11, 14-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Griffin (US 8485992) (previously cited) in view of Cornish (US 20120065622) and Blackledge (WO 9420015) (previously cited).
Regarding claim 1, Griffin teaches a modular guidewire system (Col. 1, lines 36-39) comprising: at least one guidewire module (Fig. 1, elongate member 110), wherein each guidewire module has a solid polygonal shaped prism (See Fig. 3C, square protrusion 336) extending from a body of the guidewire module at a first end and a recess (See Fig. 3C, 338) having a polygonal prism shape at a second end; at least one guidewire tip module (member 112), wherein each guidewire tip module has a tip (114) at a first end and connecting end (See Fig. 1, joint section 140) at a second end, wherein the connecting end comprises: (i) a solid polygonal shaped prism extending from a body of the guidewire tip module, or (ii) a recess having a polygonal prism shape (See Fig. 1); wherein a first guidewire module (110) is configured to be attachable to a first guidewire tip module (112) by: (i) inserting the solid polygonal shaped prism of the first guidewire module into the polygonal prism shaped recess of the first guidewire tip module, or (ii) inserting the solid polygonal shaped prism of the first guidewire tip module into the polygonal prism shaped recess of the first guidewire module, to form a guidewire (Col. 11, lines 42-47; Col. 7, lines 48-54); and wherein the solid polygonal shaped prism and the polygonal shaped recess are configured to cooperate to prevent rotation (e.g., the shape of the inserting elongate member 332 and the receiving recess 338 prevents rotation because of friction between elongate member 332 and the receiving recess 338), and allow longitudinal movement between the first guidewire module and first guidewire tip module. (Col. 11, lines 52-55 The generally non-circular recesses and protrusions shown in these figures have the advantage of enhancing the torque transmission from one elongate member to the other.)
However, Griffin does not teach “a sleeve threadingly and movably coupled with the body of the guidewire module, the sleeve movable relative to the body of the guidewire module between a first configuration and a second configuration, where in the first configuration the sleeve is offset from and between the first end and the second end” and “wherein the sleeve is configured to rotate about the body to move from the first configuration to the second configuration such that the sleeve extends from the first end or the second end and couples the first guidewire module and the first guidewire tip module.”
Cornish, in a related field of endeavor, teaches (Figs. 10-11), a sleeve (500) movably coupled with the body of the guidewire module (510), the sleeve movable relative to the body of the guidewire module between a first configuration and a second configuration, where in the first configuration the sleeve is offset from and between the first end and the second end, (Paragraphs [0042]-[0043]), and wherein the sleeve (500) is configured to rotate about the body to move from the first configuration (Fig. 11-12), to the second configuration (Fig. 14), such that the sleeve extends from the first end or the second end and couples the first guidewire module and the first guidewire tip module. (Figs. 11-12; Paragraphs [0042] the lumen 504 of the tubular sleeve has a diameter that is greater than the maximum diameter of the undulating wire 516, but is less than the maximum diameter of the tapered proximal section thereby allowing the tubular sleeve to slide as well as rotate about the body until it is lodged tightly on the guide wire assembly).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the modular guidewire system of Griffin to teach “a sleeve movably coupled with the body of the guidewire module, the sleeve movable relative to the body of the guidewire module between a first configuration and a second configuration, where in the first configuration the sleeve is offset from and between the first end and the second end” and “wherein the sleeve is configured to rotate about the body to move from the first configuration to the second configuration such that the sleeve extends from the first end or the second end and couples the first guidewire module and the first guidewire tip module” as taught by Cornish. Doing so enables the sleeve to slide over the guidewire assembly or be removed from the guidewire assembly, as per the operational needs of the physician. (Paragraph [0048]).
Blackledge, in a related field of endeavor, teaches (Figs. 1-2) a guidewire system comprising a sleeve (30) wherein the sleeve is threadably coupled to the guidewire (14), (Page 12, lines 4-10).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the modular guidewire system of Griffin as modified by Cornish to teach “a sleeve threadingly coupled with the body of the guidewire module”, as taught by Blackledge. Doing so minimizes the possibility of system failure by kinking or undesirable bending at the connection between the guidewire and the extension wire, (Page 6, lines 12-16), and enables connection of the guidewire to an extension wire with little possibility for disengagement of the exterior or extension wire from the guidewire during normal use. (Page 14, lines 2-6).
Regarding claim 2, Griffin teaches wherein the tip is selected from a group consisting of: a straight guidewire tip (Col. 9, lines 54-61 guidewire 100 may include additional structure, such as a sleeve, sheath, tube disposed on the distal end of the elongated member 112).
Regarding claim 3, Griffin teaches a sleeve configured to cover connecting ends of the first guidewire module and first guidewire tip module when connected. (Col. 15, lines 45-47).
Regarding claim 5, Griffin teaches wherein the guidewire is configured to be used through manual manipulation by a user. (Col. 7, lines 3-6).
Regarding claim 7, Griffin teaches (Fig. 1) a second guidewire module (106) coupled to the first guidewire module (110), at an end of the first guidewire module opposite from the guidewire tip module (112). (See annotated Fig. 1 below, relevant elements indicated in red circle).
Regarding claim 8, Griffin teaches (Fig. 1) a second guidewire tip module (102) coupled to the second guidewire module (106), at an end of the second guidewire module opposite from the first guidewire module (110). (See relevant elements indicated in red circle in annotated Fig. 1 below).
Regarding claim 9, Griffin teaches a second guidewire tip module (102) coupled to the first guidewire module (110), at an end of the first guidewire module opposite from the first guidewire tip module (112). (See annotated Fig. 1 below, relevant elements indicated in red circle).
Regarding claim 10, Griffin teaches at least three guidewire modules (104, 106, 110). (See annotated Fig. 1 below, relevant elements indicated in red circle).
Regarding claim 11, Griffin teaches two guidewire tip modules (102, 112). (See annotated Fig. 1 below, relevant elements indicated in red circle).
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Regarding claim 14, Griffin teaches a method for building a guidewire of customizable length, (Col. 1, lines 33-35), the method comprising: selecting at least one guidewire module (Fig. 1, elongate member 110), wherein each guidewire module has a solid polygonal shaped prism (Fig. 3C, protrusion 336) extending from a body of the guidewire module at a first end and a recess (Fig. 3C, 338) having a polygonal prism shape at a second end; selecting at least one guidewire tip module (112), wherein each guidewire tip module has a tip (114) at a first end and a connecting end (140) at a second end, wherein the connecting end comprises: (i) a solid polygonal shaped prism extending from a body of the guidewire tip module, or (ii) a recess having a polygonal prism shape (See Fig.1); attaching a first guidewire module (110) to a first guidewire tip module (112) by: (i) inserting the solid polygonal shaped prism of the first guidewire module into the polygonal prism shaped recess of the first guidewire tip module, or (ii) inserting the solid polygonal shaped prism of the first guidewire tip module into the polygonal prism shaped recess of the first guidewire module, to form a guidewire (Col. 11, lines 42-47; Col. 7, lines 48-54), such that the solid polygonal shaped prism and the polygonal prism shaped recess cooperate to prevent rotation (e.g., the shape of the inserting elongate member 332 and the receiving recess 338 prevents rotation because of friction between elongate member 332 and the receiving recess 338) and allow longitudinal movement between the first guidewire module and first guidewire tip module. (Col. 11, lines 52-55 The generally non-circular recesses and protrusions shown in these figures have the advantage of enhancing the torque transmission from one elongate member to the other.)
However, Griffin does not teach “a sleeve threadingly and movably coupled with the body of the guidewire module, the sleeve movable relative to the body of the guidewire module between a first configuration and a second configuration, where in the first configuration the sleeve is offset from and between the first end and the second end” and “rotating the sleeve about the body to move the sleeve from the first configuration to the second configuration such that the sleeve extends from the first end or the second end and couples the first guidewire module and the first guidewire tip module.”
Cornish, as previously discussed, teaches (Figs. 10-11), a sleeve (500) movably coupled with the body of the guidewire module (510), the sleeve movable relative to the body of the guidewire module between a first configuration and a second configuration, where in the first configuration the sleeve is offset from and between the first end and the second end, (Paragraphs [0042]-[0043]), and rotating the sleeve (500) about the body to move the sleeve from the first configuration (Fig. 11-12), to the second configuration (Fig. 14), such that the sleeve extends from the first end or the second end and couples the first guidewire module and the first guidewire tip module. (Figs. 11-12; Paragraphs [0042] the lumen 504 of the tubular sleeve has a diameter that is greater than the maximum diameter of the undulating wire 516, but is less than the maximum diameter of the tapered proximal section thereby allowing the tubular sleeve to slide as well as rotate about the body until it is lodged tightly on the guide wire assembly).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the modular guidewire system of Griffin to teach “a sleeve movably coupled with the body of the guidewire module, the sleeve movable relative to the body of the guidewire module between a first configuration and a second configuration, where in the first configuration the sleeve is offset from and between the first end and the second end” and “rotating the sleeve about the body to move the sleeve from the first configuration to the second configuration, such that the sleeve extends from the first end or the second end and couples the first guidewire module and the first guidewire tip module” as taught by Cornish. Doing so enables the sleeve to slide over the guidewire assembly or be removed from the guidewire assembly, as per the operational needs of the physician. (Paragraph [0048]).
Blackledge, as previously discussed, teaches (Figs. 1-2) a guidewire system comprising a sleeve (30) wherein the sleeve is threadably coupled to the guidewire (14), (Page 12, lines 4-10).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the modular guidewire system of Griffin as modified by Cornish to teach “a sleeve threadingly coupled with the body of the guidewire module”, as taught by Blackledge. Doing so minimizes the possibility of system failure by kinking or undesirable bending at the connection between the guidewire and the extension wire, (Page 6, lines 12-16), and enables connection of the guidewire to an extension wire with little possibility for disengagement of the exterior or extension wire from the guidewire during normal use, (Page 14, lines 2-6).
Regarding claim 15, Griffin teaches comprising covering the connecting ends of the first guidewire module and first guidewire tip module with a sleeve. (Col. 15, lines 45-47).
Regarding claim 17, Griffin teaches selecting at least two guidewire modules and attaching the first guidewire module (110) to a second guidewire module (106). (Col. 11, lines 42-47; Col. 7, lines 48-54).
Regarding claim 20, Griffin teaches wherein the tip is selected from a group consisting of: a straight guidewire tip (Col. 9, lines 54-61 guidewire 100 may include additional structure, such as a sleeve, sheath, tube disposed on the distal end of the elongated member 112).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Griffin in view of Cornish and Blackledge, further in view of Noone (US 20060184186) (previously cited).
Regarding claim 6, Griffin as modified does not teach “wherein the guidewire is configured to be used with a drill attachment.”
Noone, in a related field of endeavor, teaches a guidewire device configured to be used with a drill attachment (340). (Paragraph [0022]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the modular guidewire system of Griffin to teach “wherein the guidewire is configured to be used with a drill attachment” as taught by Noone. Doing so provides a mechanism to controllably rotate the guidewire. (Paragraph [0022]).
Claims 12 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Griffin.
Regarding claim 12, Griffin teaches wherein the at least one guidewire module (110) and the at least one guidewire tip module (112) are configured to be rigidly locked together (at joint 140). (Col. 11, lines 42-47; Col. 7, lines 48-54). However, Griffin does not specifically teach “for advancement into bone tissue.”
Nevertheless, it would it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the modular guidewire system of Griffin to be adapted to be used “for advancement into bone tissue” as the device is known to be applicable to drive shafts for medical devices (Col. 4, line 7), and such known work in one field of endeavor, i.e., intravascular, may prompt variations of it for use in a similar field of endeavor, i.e., bone, as the variations are predictable to one of ordinary skill in the art.
Regarding claim 18, Griffin teaches selecting at least one guidewire comprising at least two guidewire modules (106, 110).
However, Griffin does not teach specifically teach “selecting from a kit of guidewire modules”.
Nevertheless, it would it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the building of the guidewire system of Griffin such that selecting at least one guidewire comprises “selecting from a kit of guidewire modules” comprising at least two guidewire modules, as it provides all the necessary parts in one package, which saves time and effort compared to researching, sourcing, and purchasing individual components separately.
Regarding claim 19, Griffin teaches selecting at least one guidewire tip module comprising at least two guidewire tip modules (102, 112).
However, Griffin does not teach specifically teach “selecting from a kit of guidewire modules”.
Nevertheless, it would it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the building of the guidewire system of Griffin such that selecting at least one guidewire tip module comprises “selecting from a kit of guidewire modules” module comprising at least two guidewire tip modules, as it provides all the necessary parts in one package, which saves time and effort compared to researching, sourcing, and purchasing individual components separately.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Griffin in view of Cornish and Blackledge, further in view of Simpson (US 20160303353) (previously cited).
Regarding claim 13, Griffin as modified does not teach a modular guidewire system comprising “a plurality of sleeves.”
Simpson, in a related field of endeavor, contemplates a modular guidewire system comprising a plurality of sleeves. (Paragraph [0040]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the modular guidewire system of Griffin as modified to teach a modular guidewire system comprising “a plurality of sleeves” as taught by Simpson. Doing so provides a mechanism that joins multiple segments together. (Paragraph [0040]).
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 1/14/2026, with respect to the rejections of claims 1-3, 5-15 and 17-20 have been fully considered. However, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Blackledge and Cornish are relied upon for the amended feature.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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