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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/07/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim recites the limitation “a perimeter of the hollow inner.” It appears the applicant intended to recite “a perimeter of the hollow inner member.” Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
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 1-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hossack et al. (Pub. No.: 2004/0044286, Applicant’s IDS filed 01/07/2025) in view of Rich et al. (Pub. No.: US 2013/0258814).
Consider claim 1, Hossack discloses an apparatus (paragraph [0031], Fig. 1, catheter-based ultrasonic imaging system), comprising:
an intravascular ultrasound (IVUS) catheter (paragraph [0032], Fig. 1, catheter 10 having a distal end 14 that may be inserted into a blood vessel of a patient), comprising:
a flexible elongate member (Fig. 1, distal end 14) configured to be positioned within a blood vessel of a patient (paragraph [0032], Fig. 1, distal end 14 that may be inserted into a blood vessel of a patient);
a support member (paragraph [0057], Fig. 3a, support structure 86) coupled to a distal portion of the flexible elongate member (paragraph [0057], Fig. 3a, structure 86 may form a portion of guide wire lumen portion 31 that protrudes towards the distal end 14), wherein the support member comprises:
a hollow inner member (paragraph [0057], Fig. 3a, Structure 86 may have a bore 87), wherein an outer surface of the hollow inner member comprises retaining ring portions 90 and 92 formed as an integral portion of the plastic (or other material) that makes up structure 86 (paragraph [0057]); and
one or more annular members positioned around a perimeter of the hollow inner (paragraphs [0057], [0058], Fig. 3a, retaining ring portions 90 and 92 and Fig. 3b, retaining ring portions 102 and 104), wherein the one or more annular members extends radially outward from the hollow inner member (paragraph [0057], Figs, 3a, 3b, rings define an annular gap 94); and
a flexible substrate comprising a transducer array (paragraph [0055], Fig. 2, transducer array 80 mounted on the end of flex circuit 72) configured to obtain an IVUS image of the blood vessel (paragraph [0033], providing images of the patient's blood vessel), wherein the flexible substrate is positioned around the one or more annular members such that the flexible substrate is distinct from the one or more annular members (paragraph [0052], Fig. 5, flex circuit may be wrapped around a support lumen to form a cylindrical transducer wherein the flex circuit 72 forms a helix about support 100).
Hossack does not specifically disclose wherein an outer surface of the hollow inner member comprises at least one of a first recess or a first groove that does not extend completely through a sidewall of the hollow inner member.
Rich discloses wherein an outer surface of the hollow inner member comprises at least one of a first recess or a first groove that does not extend completely through a sidewall of the hollow inner member (paragraph [0017], Fig. 2B, a recess of the base 110, wherein a bore 112 or lumen located within the base 110 may not be accessible through the prismatic segment 120 and/or the set of surfaces 122, see paragraph [0019]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the integral portion of the support structure as disclosed by Hossack with the recessed base as taught by Rich to provide suitable surface geometry that allows conformation of an ultrasound transducer panel to a surface of the base for coupling of the ultrasound transducer to the base (paragraph [0017]).
Consider claim 2, Hossack discloses wherein a first annular member (paragraphs [0057], [0058], Fig. 3a, retaining ring portion 90 or Fig. 3b, retaining ring portion 102) of the one or more annular members is positioned as an integral portion of the plastic (or other material) that makes up structure 86 (paragraphs [0057]);
Hossack does not specifically disclose a first annular member is positioned within at least one of the first recess or the first groove.
Rich discloses a first annular member is positioned within at least one of the first recess or the first groove (Rich, paragraph [0017], Fig. 2B, ultrasound transducer panel 130 may have a protrusion configured to couple to a corresponding recess of the base 110).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the integral portion of the support structure as disclosed by Hossack with the recessed base as taught by Rich to provide suitable surface geometry that allows conformation of an ultrasound transducer panel to a surface of the base for coupling of the ultrasound transducer to the base (paragraph [0017]).
Consider claim 3, the combination of Hossack and Rich discloses wherein the first annular member and at least one of the first recess or the first groove are located at a proximal portion of the hollow inner member (Hossack, paragraph [0057], Fig. 4, retaining ring portion 90 (or 102 of Fig. 3B) formed as an integral portion of the material that makes up structure 86).
Consider claim 4, Hossack discloses wherein the outer surface of the hollow inner member comprises retaining ring portions 90 and 92 may be formed as an integral portion of the plastic (or other material) that makes up structure 86 (paragraph [0057]).
Hossack does not specifically disclose at least one of a second recess or a second groove that does not extend completely through the sidewall of the hollow inner member.
Rich discloses at least one of a second recess or a second groove that does not extend completely through the sidewall of the hollow inner member (paragraph [0017], Fig. 2B, a recess of the base 110 wherein a bore 112 or lumen located within the base 110, see paragraph [0019]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the integral portion of the support structure as disclosed by Hossack with the recessed base as taught by Rich to provide suitable surface geometry that allows conformation of an ultrasound transducer panel to a surface of the base for coupling of the ultrasound transducer to the base (paragraph [0017]).
Consider claim 5, Hossack discloses wherein a second annular member (paragraphs [0057], [0058], Fig. 3a, retaining ring portion 92 or Fig. 3b, retaining ring portion 104) of the one or more annular members is positioned as an integral portion of the plastic (or other material) that makes up structure 86 (paragraphs [0057]).
Hossack does not specifically disclose a second annular member is positioned within at least one of the second recess or the second groove.
Rich discloses a second annular member is positioned within at least one of the second recess or the second groove (Rich, paragraph [0017], Fig. 2B, ultrasound transducer panel 130 may have a protrusion configured to couple to a corresponding recess of the base 110).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the integral portion of the support structure as disclosed by Hossack with the recessed base as taught by Rich to provide suitable surface geometry that allows conformation of an ultrasound transducer panel to a surface of the base for coupling of the ultrasound transducer to the base (paragraph [0017]).
Consider claim 6, the combination of Hossack and Rich discloses wherein the second annular member and at least one of the second recess or the second groove are located at a distal portion of the hollow inner member (Hossack, paragraph [0057], Fig. 4, retaining ring portion 92 (or 104 of Fig. 3B) formed as an integral portion of the material that makes up structure 86).
Consider claim 7, the combination of Hossack and Rich discloses wherein at least one of the first recess or the first groove is located at an intermediate portion of the hollow inner member (Rich, Fig. 1, prismatic segment 120 including recessed ultrasound transducer panels 130 (see paragraph [0017]) centered on base 110).
Consider claim 8, Hossack discloses wherein the one or more annular members comprises a first annular member located at a proximal portion of the hollow inner member and a second annular member located at a distal portion of the hollow inner member (paragraphs [0057], [0058], Fig. 3a, retaining ring portions 90 and 92 or Fig. 3b, retaining ring portions 102 and 104),
wherein at least an annular gap is located between the first annular member and the second annular member (paragraphs [0057], [0058], Figs. 3a, 3b, annular gap 94).
Hossack does not specifically disclose wherein at least one of the first recess or the first groove is located between the first annular member and the second annular member.
Rich discloses wherein at least one of the first recess or the first groove is located between the first annular member and the second annular member (paragraph [0020], base 110 (having a recess, see paragraph [0017], Fig. 2B) can include one or more non-prismatic segments (e.g., cylindrical with an approximately circular cross-section) wherein the non-prismatic segments can be located at an end of the base 110, centrally in the base 110 between two ends of the base, or in any other suitable portion of the base 110).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the annular gap as disclosed by Hossack with the recessed base as taught by Rich to provide suitable surface geometry that allows conformation of an ultrasound transducer panel to a surface of the base for coupling of the ultrasound transducer to the base (paragraph [0017]).
Consider claim 11, the combination of Hossack and Rich discloses wherein the hollow inner member comprises a cylindrical shape (paragraph [0052], support lumen may be a hollow plastic cylinder).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hossack and Rich in view of Morris et al. (Pub. No.: US 2004/0176742).
Consider claim 9, the combination of Hossack and Rich discloses wherein the support member further comprises a sleeve member positioned around the perimeter of the hollow inner member (Hossack, paragraph [0047], Fig. 1, sheath 60 may be affixed to the exterior of flex circuit 20),
The combination of Hossack and Rich does not specifically disclose wherein the sleeve member is positioned within at least one of the first recess or the first groove.
Morris discloses wherein the sleeve member is positioned within at least one of the first recess or the first groove (paragraph [0053], Fig. 9A, exterior surface 70 includes at least one recessed area 72 to receive sleeve 64 wherein the outer diameter of sleeve 64 is substantially the same as an outer diameter of a non-recessed portion of catheter body 62, see paragraph [0054]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the sheath as disclosed by the combination of Hossack and Rich with the sleeve as taught by Morris to reduce the likelihood of thrombus formation from turbulence and/or stagnancy in the blood flow (Morris, paragraph [0054]).
Consider claim 10, the combination of Hossack, Rich, and Morris discloses wherein an outer surface of the sleeve member is continuous with a portion of the outer surface of the hollow inner member that proximal to or distal to at least one of the first recess or the first groove (Morris, paragraph [0054], Fig. 9A, the exterior surface of sleeve 64 is substantially flush with exterior surface 70 of catheter body 62).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hossack and Rich in view of Field et al. (Pub. No.: US 2004/0193055).
Consider claim 12, the combination of Hossack and Rich discloses wherein the hollow inner member comprises a cylindrical surface (paragraph [0052], support lumen may be a hollow plastic cylinder).
The combination of Hossack and Rich does not specifically disclose wherein the hollow inner member comprises a uniform inner surface.
Field discloses wherein the hollow inner member comprises a uniform inner surface (paragraph [0016], Figs. 2, 3, inner surface 14, providing the surface of the bore 10, is completely smooth).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the cylindrical surface as disclosed by the combination of Hossack and Rich with the completely smooth inner surface as taught by Field to provide a smooth inner surface for the catheter (Field, paragraph [0016]).
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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12/186,131 in view of Rich et al. (Pub. No.: US 2013/0258814). The patent contains every element in the instant application except the for below highlighted portion thereof:
Instant Application
U.S. Patent No. 12/186,131
1. An apparatus, comprising:
an intravascular ultrasound (IVUS) catheter, comprising:
a flexible elongate member configured to be positioned within a blood vessel of a patient; a support member coupled to a distal portion of the flexible elongate member, wherein the support member comprises:
a hollow inner member, wherein an outer surface of the hollow inner member comprises at least one of a first recess or a first groove that does not extend completely through a sidewall of the hollow inner member; and
one or more annular members positioned around a perimeter of the hollow inner, wherein the one or more annular members extends radially outward from the hollow inner member; and a flexible substrate comprising a transducer array configured to obtain an IVUS image of the blood vessel, wherein the flexible substrate is positioned around the one or more annular members such that the flexible substrate is distinct from the one or more annular members.
1. An intraluminal ultrasound imaging catheter, comprising:
a flexible elongate member configured to be positioned within a body lumen of a patient; a support member coupled to a distal portion of the flexible elongate member, wherein the support member comprises: a hollow inner member comprising a first material; and a first annular member positioned around a perimeter of the hollow inner member at a proximal portion of the hollow inner member, wherein the first annular member extends radially outward from the hollow inner member, and wherein the first annular member comprises a second material that is different from the first material; and an ultrasound scanner assembly configured to obtain ultrasound imaging data of the body lumen, wherein the ultrasound scanner assembly comprises a flexible substrate positioned around the first annular member such that the flexible substrate is distinct from the first annular member.
Rich discloses wherein an outer surface of the hollow inner member comprises at least one of a first recess or a first groove that does not extend completely through a sidewall of the hollow inner member (paragraph [0017], Fig. 2B, a recess of the base 110, wherein a bore 112 or lumen located within the base 110 may not be accessible through the prismatic segment 120 and/or the set of surfaces 122, see paragraph [0019]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the integral portion of the support structure as disclosed by Hossack with the recessed base as taught by Rich to provide suitable surface geometry that allows conformation of an ultrasound transducer panel to a surface of the base for coupling of the ultrasound transducer to the base (paragraph [0017]).
Conclusion
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/Gerald Johnson/
Primary Examiner, Art Unit 3797