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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/3/26 has been entered.
Notice of Amendment
In response to the amendment(s) filed on 3/3/26, amended claim(s) 1, 3-4, 16, 18, 23-24, and 29-30, canceled claim(s) 26-27 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Claim Objections
Claim 29 objected to because of the following informalities: “wherein the proximal section is square in transverse square cross section and the distal section is round in transverse cross section” appears that it should be “wherein the proximal section is square in a transverse cross section and the distal section is round in a transverse cross section.”
Claim 30 objected to because of the following informalities: “is less than a 15° when” appears that it should be “is less than 15° when.”
Appropriate correction is required.
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.
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, 5, 16-20, 22-25, and 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0028173 to Goldman et al. (hereinafter “Goldman”) in view of U.S. Patent No. 5,951,494 to Wang et al. (hereinafter “Wang”).
For claim 1, Goldman discloses a guidewire (Abstract), comprising:
an elongated metal alloy (para [0023]) wire (10 and/or 18) (Fig. 1) (para [0022]) having a proximal end (16) (Fig. 1) (para [0022]) and a distal end (12) (Fig. 1) (para [0022]);
the elongated metal alloy wire including a proximal section (unlabeled, but as can be seen in Figs. 1-4) and a distal section (unlabeled, but as can be seen in Figs. 1-4);
the proximal section having a transverse square cross-section with four corners (as can be seen in Figs. 3A-4), the four corners being rounded (as can be seen in Figs. 3A-4) (also see para [0031]);
a plurality of twists formed in only the proximal section (as can be seen in Figs. 1-4).
Goldman does not expressly disclose a proximal section having a length in a range from 12 inches to 120 inches and a distal section having a length in a range from zero inches to 12 inches; wherein the guidewire has a diameter in a range from 0.014 inch to 0.035 inch; and the distal section has less than a 15° torque delay when the proximal section is subjected to torsional forces.
However, Wang teaches a proximal section having a length in a range from 12 inches to 120 inches and a distal section having a length in a range from zero inches to 12 inches (col. 10, lines 15-25); the pitch of the plurality of twists being in a range of 1 to 3 twists per 1.0 inch (col. 1, lines 55-60, including “diameter of about 0.25 … inch” and “a pitch length from about 2 … times the outer diameter of the elements,”) (Examiner’s Note: 0.25 x 2 = makes the length of each pitch 0.5 inches. 1 inch dividend by a 0.5 inch pinch length would equate to 2 pitches (or twists) per inch); wherein the guidewire has a diameter in a range from 0.014 inch to 0.035 inch (col. 10, lines 15-24); and the distal section having less than a 15° torque delay when the proximal section is subjected to torsional forces (see Figs. 2a-b) (col. 6, lines 5-15).
It would have been obvious to a skilled artisan to modify Goldman to include a proximal section having a length in a range from 12 inches to 120 inches and a distal section having a length in a range from zero inches to 12 inches; wherein the guidewire has a diameter in a range from 0.014 inch to 0.035 inch; and the distal section has less than a 15° torque delay when the proximal section is subjected to torsional forces, in view of the teachings of Wang, for the obvious advantage of incorporating properties into the guidewire to help it be positioned more accurately.
For claim 5, Goldman does not expressly disclose wherein the four corners are rounded to a radius in a range from 0.005 inch to 0.03 inch.
However, Goldman does teach “[a]ny cross-sectional shape can be used but a square or roughly square cross-section, for example, allows equal right angles for gripping the rotated end prior to and during twisting/rotating and forms even ridges” (para [0031]).
It would also have been obvious to a skilled artisan to optimize Goldman wherein the rounded four corners have a radius in a range from 0.005 inch to 0.03 inch given that Goldman recognizes any cross-sectional shape can be used and the radius of curvature is directly correlated to the cross-sectional shape of the guidewire. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); See also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). A skilled artisan would have been motivated to make such a modification for the obvious advantage of allowing better gripping of the guidewire, but still avoiding sharp edges that can potentially puncture the walls of body lumens.
For claim 16, Goldman does not expressly disclose wherein the elongated metal alloy wire is 71 inches to 120 inches in length.
However, Wang teaches a wire 71 inches to 120 inches in length (col. 1, lines 37-39).
It would have been obvious to a skilled artisan to modify Goldman wherein the elongated metal alloy wire is 71 inches to 120 inches in length, in view of the teachings of Wang, because such a length is a suitable length for the guiewire that leads to the predictable result of being able to reach a target site through navigating through body lumens.
For claim 17, Goldman does not expressly disclose wherein the length of the distal section is in a range from 2 inches to 8 inches.
However, Wang teaches wherein the length of the of the distal section is in a range from 2 inches to 8 inches (col. 10, lines 19-24).
It would have been obvious to a skilled artisan to modify Goldman wherein the length of the distal section is in a range from 2 inches to 8 inches, in view of the teachings of Wang, because such a length is a suitable length for the guidewire that leads to the predictable result of being able to reach a target site through navigating through body lumens.
For claim 18, Goldman does not expressly disclose wherein the guidewire is 0.035 inches in diameter.
However, Wang teaches wherein the guidewire is 0.035 inches in diameter (col. 10, lines 19-24).
It would have been obvious to a skilled artisan to modify Goldman wherein the guidewire is 0.035 inches in diameter, in view of the teachings of Wang, because such a diameter is a suitable diameter that would lead to the predictable result of fitting the guidewire inside lumens of the human body.
For claim 19, Goldman further discloses wherein the elongated metal alloy wire is formed from superelastic material (para [0034]).
For claim 20, Goldman further discloses wherein the elongated metal alloy wire is formed from nitinol (para [0034]).
For claim 22, Goldman further discloses wherein the elongated metal alloy wire is provided with a polymer coating (para [0009]).
For claim 23, Goldman further discloses wherein the polymer coating extends the length of the proximal section (para [0009]).
For claim 24, Goldman further discloses wherein the polymer coating comprises a hydrophobic material (para [0042]).
For claim 25, Goldman further discloses wherein the twists are formed in only the proximal section (as can be seen in Figs. 1-4).
For claim 29, Goldman further discloses wherein the proximal section is square in a transverse cross section (as can be seen in Figs. 3A-4) and the distal section is round in a transverse cross section (as can be seen in Figs. 3A-4).
For claim 30, Goldman does not expressly disclose wherein the torque delay in the distal section is less than 15° when the proximal section is subjected to clockwise and counterclockwise rotation.
However, Wang teaches wherein the torque delay in the distal section is less than 15° when the proximal section is subjected to clockwise and counterclockwise rotation (see Figs. 2a-b) (col. 6, lines 5-15).
It would have been obvious to a skilled artisan to modify Goldman wherein the torque delay in the distal section is less than 15° when the proximal section is subjected to clockwise and counterclockwise rotation, in view of the teachings of Wang, for the obvious advantage of incorporating properties into the guidewire to help it be positioned more accurately.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldman in view of Wang, and further in view of U.S. Patent Application Publication No. 2005/0143768 to Shiber.
For claim 3, Goldman and Wang do not expressly disclose wherein the elongated wire is 120 inches in length.
However, Shiber teaches wherein the elongated wire is 120 inches in length (para [0035]).
It would have been obvious to a skilled artisan to modify Goldman wherein the elongated wire is 120 inches in length, in view of the teachings of Shiber, because 120 inches is a suitable length for a guidewire to reach a position in a body lumen. Additionally, it has been held that changes in size are within the purview of a skilled artisan. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976); Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldman in view of Wang, and further in view of U.S. Patent No. 5,497,785 to Viera.
For claim 4, Goldman and Wang do not expressly disclose wherein the elongated wire is 71 inches in length.
However, Viera teaches wherein the elongated wire is 71 inches in length (col. 4, lines 31-34).
It would have been obvious to a skilled artisan to modify Goldman wherein the elongated wire is 71 inches in length, in view of the teachings of Viera, because 71 inches is a suitable length for a guidewire to reach a position in a body lumen. Additionally, it has been held that changes in size are within the purview of a skilled artisan. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976); Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldman in view of Wang, and further in view of U.S. Patent Application Publication No. 2020/0298332 to Simpson et al. (hereinafter “Simpson”).
For claim 21, Goldman and Wang do not expressly disclose wherein the proximal section is formed from stainless steel and the distal section is formed from nitinol.
However, Simpson teaches wherein the proximal section (102, 202) is formed from stainless steel (para [0037]) and the distal section (104, 204) is formed from nitinol (para [0034]).
It would have been obvious to a skilled artisan to modify Goldman wherein the proximal section is formed from stainless steel and the distal section is formed from nitinol, in view of the teachings of Simpson, for the obvious advantage of making the distal end relatively flexible to the proximal end so that the guidewire has good maneuverability and pushability.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldman in view of Wang, and further in view of U.S. Patent Application Publication No. 2015/0157830 to Miyata et al. (hereinafter “Miyata”).
For claim 28, Goldman and Wang do not expressly disclose wherein the number of twists per 1.0 inch varies along different portions of the proximal section.
However, Miyata teaches wherein the number of twists per 1.0 inch varies along different portions of the proximal section (Examiner’s Note: zero being a “number”) (Fig. 2) (para [0047]).
It would have been obvious to a skilled artisan to modify Goldman wherein the number of twists per 1.0 inch varies along different portions of the proximal section, in view of the teachings of Miyata, for the obvious advantage of improving lubricity (see para [0048] of Miyata).
Response to Arguments
Applicant’s arguments filed 3/3/26 have been fully considered.
With respect to the objection(s) to the drawing(s), Applicant’s amendments and arguments are persuasive and thus the objection(s) is/are withdrawn.
With respect to the 112 rejections, Applicant’s amendments and arguments are persuasive and thus the rejections are withdrawn.
With respect to the 103 rejection(s), Applicant’s argument will be treated in the order they were presented. With respect to the first argument, these features of Wang are not being relied upon in the rejection. Specifically, Wang is not being used in the rejection to modify the material of the proximal section in Goldman. Therefore, the argument appears to be a red herring. With respect to the second argument, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). By arguing that Wang would not achieve its torque delay characteristics because a bodily incorporation of the features of Wang would not result in the claimed torque delay is not applying the correct standard. The claim requires a specific torque delay and Wang teaches that specific torque delay. Specifically, “KSR teaches that ‘[a] person of ordinary skill is also a person of ordinary creativity, not an automation.’ And it explains that the ordinary artisan recognizes 'that familiar items may have obvious uses beyond their primary purposes, and in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” ClassCo v. Apple, slip op., at 8 (quoting KSR v. Teleflex) (Fed. Cir. 2016). Therefore, a skilled artisan could fit the teachings of Goldman and Wang together like pieces of a puzzle and arrive at the claimed subject matter. Specifically, one piece would be the metal alloy taught in Goldman and another piece would be the torque delay taught in Wang and this could be achieved without bodily incorporation. With respect to the third argument, the rationale to combine is “for the obvious advantage of incorporating properties into the guidewire to help it be positioned more accurately.” Applicant does not appear to provide any evidence against this rationale, and therefore Applicant’s arguments appear to just be conclusory. With respect to the fourth argument, Applicant is reminded that claim 1 only requires that the “plurality of twists” be in the “proximal section,” but that the “distal section has less than a 15° torque delay.” So both can be achieved. Goldman’s ribs in the proximal section do not need to affect the torque delay in the distal section, especially when the distal section doesn’t have the ribs. Therefore, the teachings of Goldman and Wang are not inherently inconsistent and no unexpected result is produced. With respect to the arguments that the references used for the dependent claims do not cure the deficiencies of Goldman and Wang, Goldman and Wang are not deficient for the reasons listed above and therefore these arguments are moot.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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