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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 80-82 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 80 recites the limitation “the fifth point” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 81 recites the limitation “the fifth point” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 74-82 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 8 of U.S. Patent No. 12178974 to Gill in view of Telang (US20180311477A1).
Instant Application No. US 18/954,104
US Patent No. 12178974
Claim 74
A method of forming a guidewire, comprising: providing an elongated tubular member having a proximal end, a distal end, an inner core member extending from the proximal end to the distal end and formed from a first material, and an outer layer formed from a second material and surrounding the inner core member; and forming a feather edged joint defining a tapered transition segment between the outer layer and the inner core member by completely removing a distal portion of the outer layer along a first constant diameter section of the inner core member.
Claim 1
A guidewire, comprising: an elongated tubular member having a proximal end and distal end; the elongated tubular member having an inner core member formed from a first material metal alloy and an outer layer formed from a second material metal alloy surrounding at least a portion of the inner core member; and a feather edged joint formed only on the outer layer and defining a tapered transition segment between the outer layer and the inner core member wherein the feather edged joint extends radially outwardly along a first constant diameter section of the inner core member.
Claim 8
The guidewire of claim 1, wherein the tapered transition segment of the feather edged joint extends a length along the elongated tubular member beginning at a first point where an average transverse single wall thickness of the outer layer is a constant and ends at a second point where the average transverse single wall thickness of the outer layer is zero.
Regarding claim 74, Patent claim 1 of Gill, U.S. Patent No. 12178974 recites a guidewire having feather-edged tapered transition along a constant-diameter core section, with the outer layer wall thickness terminating at zero (claims 1 and 8), however does not explicitly disclose a method of forming the structure (the instant application discloses “by completely removing a distal portion of the outer layer”).
Telang discloses manufacturing a guidewire by machining a drawn-filled tube so that the outer sheath tapers out at the core wire (Telang, claim 12; Paragraph 0025) and by cam grinding to remove portions of the outer sheath (Telang, Paragraph 0019).
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 limitation of complete removal of a distal portion of the outer layer with the tapered outer surface of the intermediate portion 117F as taught by Telang because tapering the outer sheath to terminate at the inner core would have exposed the nitinol core at the distal portion, thereby providing the superelastic and kink-resistant properties identified by Telang as desirable for the distal end of a guidewire (Telang, Abstract; Paragraph 0025).
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 74-77 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Telang” (US20180311477A1).
Regarding claim 74.
Telang teaches a method of forming a guidewire (The guidewire 110) (Claim 12, Paragraph 0021, and Fig. 4A), comprising:
providing an elongated tubular member (drawn filled tube 112) having a proximal end, a distal end, an inner core member (inner core wire 116) extending from the proximal end to the distal end and formed from a first material (nitinol) (Claim 12, Figure 4A, Paragraph 0021: “FIG. 4A shows a second embodiment of an exemplary guidewire 110”, “The guidewire 110 is comprised of a composite drawn filled tube 112”,” As is the case with the guidewire 10 illustrated in FIGS. 1 and 2, the drawn filled tube 112 is comprised of a core wire 116 surrounded or jacketed by an outer sheath 118”, “The core wire 116 is preferably made of nitinol being a superelastic nickel-titanium alloy wire”, and Paragraph 0022: “The core wire 116 extends along a longitudinal axis B-B from a core wire proximal portion 116A having a proximal end 116B to a core wire distal portion 1160 having a distal end 116D”) and
an outer layer (outer sheath 118) formed from a second material (stainless steel) and surrounding the inner core member (inner core wire 116) (Claims 12-13, Figure 4A, Paragraph 0021: “As is the case with the guidewire 10 illustrated in FIGS. 1 and 2, the drawn filled tube 112 is comprised of a core wire 116 surrounded or jacketed by an outer sheath 118”, “ The outer sheath 118 and coil spring 114 are made of stainless steel, preferably 304 stainless steel.”, and Paragraph 0023: “The intermediate portion 116F has a substantially constant second outer diameter 128, the second diameter 128 being less than the first diameter 122, and extends distally from the second transition 126 to a third transition indicated at 130.”, and Paragraph 0025: “the outer sheath 118 transitions to a tapered portion 118C that gradually reduces in cross-sectional diameter as it extends distally and downwardly toward the longitudinal axis B-B to terminate or taper out at the outer surface of the intermediate portion 116F of the core wire 116”);
forming a feather edged joint defining a tapered transition segment between the outer layer and the inner core member by completely removing a distal portion of the outer layer along a first constant diameter section (substantially constant second outer diameter 128 before transition 130) of the inner core member (Claim 12, Abstract: “The drawn filled tube composite wire is ground at its distal end to expose the nitinol core”, Paragraph 0023: “The intermediate portion 116F has a substantially constant second outer diameter 128, the second diameter 128 being less than the first diameter 122, and extends distally from the second transition 126 to a third transition indicated at 130.”, Paragraph 0025: “the outer sheath 118 transitions to a tapered portion 118C that gradually reduces in cross-sectional diameter as it extends distally and downwardly toward the longitudinal axis B-B to terminate or taper out at the outer surface of the intermediate portion 116F of the core wire 116”, “the outer sheath 118 transitions to a tapered portion 118C that gradually reduces in cross-sectional diameter as it extends distally and downwardly toward the longitudinal axis B-B to terminate or taper out at the outer surface of the intermediate portion 116F of the core wire 116, proximal the atraumatic tip 136.”).
Regarding claim 75, Telang teaches the method of forming the guidewire of claim 74 (see rejection of claim 74 above).
Telang teaches
wherein the feather edged joint is formed by grinding the outer layer (outer sheath 118) starting at a first point (transition 140) and tapering distally to a second point (the examiner note: a point where outer sheath 118 terminates/tapers out at the outer surface of 116F before the transition 130 in figure 4A) (Claim 12, Figure 4A, Abstract: “A guidewire made from a drawn filled tube composite wire is described. The composite wire has a stainless steel outer sheath jacketing a nitinol core wire. The drawn filled tube composite wire is ground at its distal end to expose the nitinol core, which has superelastic and kink resistant properties that are desirable for the distal end of a guidewire.”, Paragraph 0019: “The drawn filled tube 50 is then subjected to a manufacturing process, for example a cam grinding process to remove the major portion 52 of the outer sheath 18 indicated by dashed lines 54”, Paragraph 0021: “FIG. 4A shows a second embodiment of an exemplary guidewire 110 according to the present invention. The guidewire 110 is comprised of a composite drawn filled tube 112 supporting a helical or coil spring 114. As is the case with the guidewire 10 illustrated in FIGS. 1 and 2, the drawn filled tube 112 is comprised of a core wire 116 surrounded or jacketed by an outer sheath 118.”, and Paragraph 0025: “the outer diameter 138 of the outer sheath 118 jacketing the inner core wire 116 ranges from about 0.008″ to about 0.038″ extending along the length of the proximal portion 118A. At the cross-section indicated at 140, the outer sheath 118 transitions to a tapered portion 118C that gradually reduces in cross-sectional diameter as it extends distally and downwardly toward the longitudinal axis B-B to terminate or taper out at the outer surface of the intermediate portion 116F of the core wire 116”).
Regarding claim 76, Telang teaches the method of forming the guidewire of claim 75 (see rejection of claim 75 above).
Telang teaches
wherein the tapered transition segment of the feather edged joint extends a length along the elongated tubular member beginning at the first point where an average transverse wall thickness of the outer layer is constant, and ending at the second point where the average transverse wall thickness of the outer layer is zero (Claim 12, Paragraph 0023: “The intermediate portion 116F has a substantially constant second outer diameter 128, the second diameter 128”, Paragraph 0025: “a tapered portion 118C that gradually reduces in cross-sectional diameter as it extends distally and downwardly toward the longitudinal axis B-B to terminate or taper out at the outer surface of the intermediate portion 116F of the core wire 116”, “At the cross-section indicated at 140, the outer sheath 118 transitions to a tapered portion 118C”).
Regarding claim 77, Telang teaches the method of forming the guidewire of claim 76 (see rejection of claim 76 above).
Telang teaches
wherein the outer layer (outer sheath 118) is ground down from the second point (the examiner note: a point where outer sheath 118 terminates/tapers out at the outer surface of 116F before the transition 130 in figure 4A) to a third point (transition 130) on the first constant diameter section (the examiner note: 116F where outer sheath 118 terminates/tapers out at the outer surface of 116F before the transition 130 in figure 4A) on the inner core member (claim 12, Fig. 4A, Abstract: “A guidewire made from a drawn filled tube composite wire is described. The composite wire has a stainless steel outer sheath jacketing a nitinol core wire. The drawn filled tube composite wire is ground at its distal end to expose the nitinol core, which has superelastic and kink resistant properties that are desirable for the distal end of a guidewire.”, Paragraph 0021: “FIG. 4A shows a second embodiment of an exemplary guidewire 110 according to the present invention. The guidewire 110 is comprised of a composite drawn filled tube 112 supporting a helical or coil spring 114. As is the case with the guidewire 10 illustrated in FIGS. 1 and 2, the drawn filled tube 112 is comprised of a core wire 116 surrounded or jacketed by an outer sheath 118.”, Paragraph 0023: “The intermediate portion 116F has a substantially constant second outer diameter 128, the second diameter 128”, paragraph 0025: “the outer diameter 138 of the outer sheath 118 jacketing the inner core wire 116 ranges from about 0.008″ to about 0.038″ extending along the length of the proximal portion 118A. At the cross-section indicated at 140, the outer sheath 118 transitions to a tapered portion 118C that gradually reduces in cross-sectional diameter as it extends distally and downwardly toward the longitudinal axis B-B to terminate or taper out at the outer surface of the intermediate portion 116F of the core wire 116”, Paragraph 0026: “At the cross-section indicated at 140, the outer sheath 118 transitions to a tapered portion 118C that gradually reduces in cross-sectional diameter as it extends distally and downwardly toward the longitudinal axis B-B to terminate or taper out at the outer surface of the intermediate portion 116F of the core wire 116, proximal the atraumatic tip 136.”, and Paragraph 0026: “It will be readily apparent to those skilled in the art that while the core wire 116 comprising the drawn filled tube 112 is shown having three constant diameter portions 116A, 116F and 116C, and two intermediate tapered portions 116E and 116G, that is for the sake of example only. Depending on the functional requirements of a particular guidewire design, there can be a greater or lesser number of constant diameter portions separated from each other by an intermediate tapered portion.”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 78-82 are rejected under 35 U.S.C. 103 as being unpatentable over Telang in view of “Grandfield” (US20090131913A1).
Regarding claim 78, Telang teaches the method of forming the guidewire of claim 77 (see rejection of claim 77 above).
Telang teaches
wherein a first tapered section (116G, between the transitions 130 and 132) is formed from the third point (transition 130) to a fourth point distal (transition 132) of the third point (claim 12, Fig. 4A, Abstract: “A guidewire made from a drawn filled tube composite wire is described. The composite wire has a stainless steel outer sheath jacketing a nitinol core wire. The drawn filled tube composite wire is ground at its distal end to expose the nitinol core, which has superelastic and kink resistant properties that are desirable for the distal end of a guidewire.”, Paragraph 0023: “A second tapered portion 1166 extends distally and downwardly towards the longitudinal axis B-B from the third transition 130 to a fourth transition indicated at 132 where the core wire distal portion 116C begins.”).
However, Telang is silent on by grinding the inner core member.
Grandfield teaches by grinding the inner core member (Figure 8, Paragraph 0083: “The following process is provided, by way of example and not as limitation, to illustrate the method of forming the composite elongate core member 11 of the guidewire 10 in accordance with the invention.‘, Paragraphs 0084-0087 for the forming process, Paragraph 0088: “The dash lines in FIG. 8 illustrate how the core structure may be ground to provide the guidewire 110, illustrated in FIG. 7”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the tapered portion of 116G of Telang by grinding the inner core member, as taught by Grandfield because such modification would have provided the desired tapered core profile, the dimensions and shape to be adjusted to achieve desired flexibility and performance characteristics of the guidewire (Grandfield, Paragraphs 0034,0037).
Regarding claim 79, Telang teaches the method of forming the guidewire of claim 78 (see rejection of claim 78 above).
Telang teaches
wherein the inner core member has a second constant diameter section extending from the fourth point (Claim 12, Fig. 4A, Paragraph 0023: “The intermediate portion 116F has a substantially constant second outer diameter 128, the second diameter 128 being less than the first diameter 122, and extends distally from the second transition 126 to a third transition indicated at 130”, “A second tapered portion 1166 extends distally and downwardly towards the longitudinal axis B-B from the third transition 130 to a fourth transition indicated at 132 where the core wire distal portion 116C begins. The distal portion 116C has a substantially constant third outer diameter 134, the third diameter 134 being less than the second outer diameter 128.”, “The core wire distal portion 116C extends distally to the distal end 116D.”.
However, Telang is silent on to a fifth point.
Grandfield teaches a second constant diameter section from a fourth point to a fifth point (Paragraph 0037: “Although a single distally tapered section 16 is shown, the distal segment 13 of the elongate core member 11 may have two or more such tapered segments which may or may not be separated by segments of substantially constant diameter.”, Paragraph 0083: “The following process is provided, by way of example and not as limitation, to illustrate the method of forming the composite elongate core member 11 of the guidewire 10 in accordance with the invention.”, Paragraphs 0084-0087 for forming method, the examiner note: additional tapered and constant-diameter section could be provided as repetitions of the previous recited sections. Therefore, the fourth and fifth points correspond reasonably to analogous transition points of the second and the third points).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Telang’s distal core portion by incorporating additional substantially constant-diameter section associated with additional tapered sections, as taught by Grandfield, because such modification would have allowed the taper configuration of the guidewire core to be adjusted to achieve desired flexibility and performance characteristics (Grandfield, Paragraphs 0034,0037) and further would have represented a predictable design and it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Regarding claim 80, Telang teaches the method of forming the guidewire of claim 78 (see rejection of claim 78 above).
Telang does not teach
wherein the inner core member is ground down to form a second tapered section extending from the fifth point to a sixth point.
Grandfield teaches
wherein the inner core member is ground down to form a second tapered section extending from the fifth point to a sixth point (Paragraph 0034: “The distally tapered section 16 can be adjusted in length, taper angle and cross sectional shape to achieve the desired flexibility and performance characteristics for the guidewire 10.”, paragraph 0037: “Although a single distally tapered section 16 is shown, the distal segment 13 of the elongate core member 11 may have two or more such tapered segments which may or may not be separated by segments of substantially constant diameter.”, Paragraph 0083: “The following process is provided, by way of example and not as limitation, to illustrate the method of forming the composite elongate core member 11 of the guidewire 10 in accordance with the invention.”, Paragraphs 0084-0087 for forming method, and Paragraph 0088: “The dash lines in FIG. 8 illustrate how the core structure may be ground to provide the guidewire 110, illustrated in FIG. 7”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Telang’s distal core portion to include an additional tapered section, as taught by Grandfield, because incorporating multiple tapered segments, optionally separated by substantially constant-diameter segments, would have allowed the taper configuration to be adjusted to achieve desired flexibility and performance characteristics of the guidewire, as described by Grandfield (Grandfield, Paragraphs 0034, 0037) ) and further would have represented a predictable design and it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Regarding claim 81, Telang teaches the method of forming the guidewire of claim 80 (see rejection of claim 80 above).
Telang does not teach
wherein a second tapered section is formed by grinding the inner core member from the fifth point to a sixth point.
Grandfield teaches
wherein a second tapered section is formed by grinding the inner core member from the fifth point to a sixth point (Paragraph 0034: “The distally tapered section 16 can be adjusted in length, taper angle and cross sectional shape to achieve the desired flexibility and performance characteristics for the guidewire 10.”, paragraph 0037: “Although a single distally tapered section 16 is shown, the distal segment 13 of the elongate core member 11 may have two or more such tapered segments which may or may not be separated by segments of substantially constant diameter.”, Paragraph 0083: “The following process is provided, by way of example and not as limitation, to illustrate the method of forming the composite elongate core member 11 of the guidewire 10 in accordance with the invention.”, Paragraphs 0084-0087 for forming method, and Paragraph 0088: “The dash lines in FIG. 8 illustrate how the core structure may be ground to provide the guidewire 110, illustrated in FIG. 7”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Telang’s distal core portion to include an additional tapered section, as taught by Grandfield, because incorporating multiple tapered segments, optionally separated by substantially constant-diameter segments, would have allowed the taper configuration to be adjusted to achieve desired flexibility and performance characteristics of the guidewire, as described by Grandfield (Grandfield, Paragraphs 0034, 0037) and further would have represented a predictable design and it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Regarding claim 82, Telang teaches the method of forming the guidewire of claim 81 (see rejection of claim 81 above).
Telang does not teach
wherein the inner core member has a third constant diameter section extending from the sixth point to the distal end of the elongated member.
Grandfield teaches
wherein the inner core member has a third constant diameter section extending from the sixth point to the distal end of the elongated member (Paragraph 0034: “The distally tapered section 16 can be adjusted in length, taper angle and cross sectional shape to achieve the desired flexibility and performance characteristics for the guidewire 10.”, paragraph 0037: “Although a single distally tapered section 16 is shown, the distal segment 13 of the elongate core member 11 may have two or more such tapered segments which may or may not be separated by segments of substantially constant diameter.”, Paragraph 0083: “The following process is provided, by way of example and not as limitation, to illustrate the method of forming the composite elongate core member 11 of the guidewire 10 in accordance with the invention.”, Paragraphs 0084-0087 for forming method, and Paragraph 0088: “The dash lines in FIG. 8 illustrate how the core structure may be ground to provide the guidewire 110, illustrated in FIG. 7”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Telang’s distal core portion to include an additional tapered section, as taught by Grandfield, because incorporating multiple tapered segments, optionally separated by substantially constant-diameter segments, would have allowed the taper configuration to be adjusted to achieve desired flexibility and performance characteristics of the guidewire, as described by Grandfield (Grandfield, Paragraphs 0034, 0037) and further would have represented a predictable design and it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MORGAN S SHIM whose telephone number is (571)272-9032. The examiner can normally be reached Mon-Fri 7:30AM-4:30PM.
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/MORGAN SANGJO SHIM/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791