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 12-13 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 12 lines 12 recite a method step in an apparatus claim. A single claim which claims both an
apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA
35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs.
(MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97
USPQ2d 1737 (Fed. Cir. 2011)). Claim 13 is rejected due to its dependence upon claim 12.
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, 4, 11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Patil (US 20180093078 A1) in view of Santos (US 20150074995 A1).
Regarding claim 1, Patil teaches an intraluminal device, comprising:
a flexible elongate member [0006 “Because of the limited space and flexibility required from guidewires, any sensors and/or electrodes positioned along their length are desirably correspondingly constructed”, the system of Fig. 37C] configured to be positioned within a body lumen of a patient [0095 “…detecting intravascular fluid pressure”], wherein the flexible elongate member comprises:
a proximal portion [Fig. 37C, the proximal portion is being interpreted as the portion to the right of the midpoint of Fig. 37C Item 430] comprising a core member [Fig. 37C Item 482] and a proximal electrical conductor [0123 “The conductive traces or wires along the flex circuit 430 may be attached directly to one or more corresponding conducting wires 440 which may extend proximally through the guidewire body”], wherein the core member comprises a distal end [Fig. 37C, the end of the proximal portion, as interpreted above, that is closest to the midpoint of Item 430];
a distal portion [Fig. 37C, the proximal portion is being interpreted as the portion to the left of the midpoint of Fig. 37C Item 430] coupled to the proximal portion [see Fig. 37C, the examiner is interpreting the joining of the proximal and distal portions, as interpreted above, by Item 430] wherein the distal portion comprises the core member [Fig. 37C Item 482], a sensor [Fig. 37C Item 242], and a distal electrical conductor coupled to the sensor [0123 “The flex circuit 430 is shown connected to the pressure sensor and sensor core 428 and extending proximally from the sensor casing 422. The conductive traces or wires along the flex circuit 430 may be attached directly to one or more corresponding conducting wires 440 which may extend proximally through the guidewire body”], wherein the core member comprises a proximal end [Fig. 37C, the end of the distal portion, as interpreted above, that is closest to the midpoint of Item 430]; and
a flex circuit [Fig. 37C Item 430] positioned over the distal end of the proximal core member and the proximal end of the distal core member [see Fig. 37C and interpretations of “proximal portion” and “distal portion” above], wherein the flex circuit comprises a proximal portion coupled to the proximal electrical conductor and a distal portion coupled to the distal electrical conductor such that the proximal electrical conductor is in electrical communication with the sensor via the flex circuit and the distal electrical conductor [0123 “The flex circuit 430 is shown connected to the pressure sensor and sensor core 428 and extending proximally from the sensor casing 422. The conductive traces or wires along the flex circuit 430 may be attached directly to one or more corresponding conducting wires 440 which may extend proximally through the guidewire body”].
Patil teaches a core member [Fig. 37C Item 482] but fails to explicitly teach a separate proximal core member and a distal core member.
Santos teaches a separate proximal core member [Fig. 7E Item 24] and a distal core member [Fig. 7E Item 56].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Patil and incorporate the teachings of Santos to include a separate proximal core member and a distal core member. Doing so configures the system to “…allow for maintaining adequate space for securement of the sensor along the housing while maintaining a low profile guidewire assembly”, as recognized by Santos par. 0023, as well as increasing the flexibility of the system.
Regarding claim 4, Patil and Santos teach the intraluminal device of claim 2, wherein the flex circuit further comprises:
a distal conductive pad formed on the polymer base at a distal portion of the flex circuit [Patil 0017 “The one or more conductive traces (e.g., nano silver, nano gold, nano copper, etc.) may then be printed directly upon the polymer layer such that the traces extend from one or more corresponding distal pads to one or more corresponding proximal pads”]; and
a proximal conductive pad formed on the polymer base at a proximal portion of flex circuit [Patil 0017 “The one or more conductive traces (e.g., nano silver, nano gold, nano copper, etc.) may then be printed directly upon the polymer layer such that the traces extend from one or more corresponding distal pads to one or more corresponding proximal pads”],
wherein the conductive trace coupled to the distal conductive pad and the proximal conductive pad [Patil 0017 “The one or more conductive traces (e.g., nano silver, nano gold, nano copper, etc.) may then be printed directly upon the polymer layer such that the traces extend from one or more corresponding distal pads to one or more corresponding proximal pads”],
wherein the proximal electrical conductor is coupled to the flex circuit at the proximal conductive pad [Patil 0123 “The conductive traces or wires along the flex circuit 430 may be attached directly to one or more corresponding conducting wires 440 which may extend proximally through the guidewire body”], and
wherein the distal electrical conductor is coupled to the flex circuit at the distal conductive pad [Patil 0123 “The conductive traces or wires along the flex circuit 430 may be attached directly to one or more corresponding conducting wires 440 which may extend proximally through the guidewire body”].
Regarding claim 11, Patil and Santos teach the intraluminal device of claim 1, wherein the flex circuit [Patil Fig. 37C Item 430] extends parallel to a longitudinal axis of the flexible elongate member [see Patil Fig. 37C where Item 430 extends parallel to Item 482 direction of extension] over the distal end of the proximal core member [Fig. 7E Item 24] and the proximal end of the distal core member [Fig. 7E Item 56].
Regarding claim 14, Patil and Santos teach the intraluminal device of claim 1,
wherein the proximal portion further comprises a polymer layer surrounding the proximal core member [Patil 0017 “A polymer layer (e.g., PET, PTFE, etc.) may be coated over the guidewire core…”],
wherein a proximal portion of the proximal electrical conductor is embedded in the polymer layer [Patil 0017 “The one or more conductive traces (e.g., nano silver, nano gold, nano copper, etc.) may then be printed directly upon the polymer layer such that the traces extend from one or more corresponding distal pads to one or more corresponding proximal pads”],
wherein a distal portion of the proximal electrical conductor extends distal of the polymer layer such that the distal portion of the proximal electrical conductor is not embedded in the polymer layer [Patil 0017 “The one or more conductive traces (e.g., nano silver, nano gold, nano copper, etc.) may then be printed directly upon the polymer layer such that the traces extend from one or more corresponding distal pads to one or more corresponding proximal pads”], and
wherein the distal portion of the proximal electrical conductor is coupled to the flex circuit [Patil 0123 “The conductive traces or wires along the flex circuit 430 may be attached directly to one or more corresponding conducting wires 440 which may extend proximally through the guidewire body”].
Regarding claim 15, Patil teaches an apparatus, comprising:
an intravascular guidewire [the system of Fig. 37C] configured to be positioned within a blood vessel of a patient [0095 “…detecting intravascular fluid pressure”], the intravascular guidewire comprising:
a proximal portion [Fig. 37C, the proximal portion is being interpreted as the portion to the right of the midpoint of Fig. 37C Item 430] comprising a core member [Fig. 37C Item 482] and a proximal electrical conductor [0123 “The conductive traces or wires along the flex circuit 430 may be attached directly to one or more corresponding conducting wires 440 which may extend proximally through the guidewire body”], wherein the core member comprises a distal end [Fig. 37C, the end of the proximal portion, as interpreted above, that is closest to the midpoint of Item 430];
a distal portion [Fig. 37C, the proximal portion is being interpreted as the portion to the left of the midpoint of Fig. 37C Item 430] coupled to the proximal portion [see Fig. 37C, the examiner is interpreting the joining of the proximal and distal portions, as interpreted above, by Item 430] wherein the distal portion comprises the core member [Fig. 37C Item 482], a sensor [Fig. 37C Item 242], and a distal electrical conductor coupled to the sensor [0123 “The flex circuit 430 is shown connected to the pressure sensor and sensor core 428 and extending proximally from the sensor casing 422. The conductive traces or wires along the flex circuit 430 may be attached directly to one or more corresponding conducting wires 440 which may extend proximally through the guidewire body”], wherein the core member comprises a proximal end [Fig. 37C, the end of the distal portion, as interpreted above, that is closest to the midpoint of Item 430]; and
a flex circuit [Fig. 37C Item 430] positioned over the distal end of the proximal core member and the proximal end of the distal core member [see Fig. 37C and interpretations of “proximal portion” and “distal portion” above], wherein the flex circuit comprises a proximal portion coupled to the proximal electrical conductor and a distal portion coupled to the distal electrical conductor such that the proximal electrical conductor is in electrical communication with the sensor via the flex circuit and the distal electrical conductor [0123 “The flex circuit 430 is shown connected to the pressure sensor and sensor core 428 and extending proximally from the sensor casing 422. The conductive traces or wires along the flex circuit 430 may be attached directly to one or more corresponding conducting wires 440 which may extend proximally through the guidewire body”].
Patil teaches a core member [Fig. 37C Item 482] but fails to explicitly teach a separate proximal core member and a distal core member.
Santos teaches a separate proximal core member [Fig. 7E Item 24] and a distal core member [Fig. 7E Item 56].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Patil and incorporate the teachings of Santos to include a separate proximal core member and a distal core member. Doing so configures the system to “…allow for maintaining adequate space for securement of the sensor along the housing while maintaining a low profile guidewire assembly”, as recognized by Santos par. 0023, as well as increasing the flexibility of the system.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Patil and Santos as applied to claim 1 above, and further in view of Halac (US 20190120785 A1).
Regarding claim 2, Patil and Santos teach the intraluminal device of claim 1, wherein the flex circuit comprises:
a base [Patil Fig. 37C Item 430]; and
a conductive trace formed on the polymer base [Patil 0123 “…conductive traces directly upon the device substrate…”], but fails to explicitly teach the base is a polymer.
Halac teaches the flex circuit comprises a polymer base [0211 “…an elongated flexible strip of a planar substrate such as a thin, flat, polymer flex circuit”].
In the same field of circuits, it would have been obvious to one skilled in the art at the filing date of the invention to modify the teachings of Patil and Santos by Halac, since it has been held to be within the general skill of a worker in the art to select a known component or material on the basis of suitability for the intended use as a matter of obvious mechanical design expediency. In re Leshin, 125 USPQ 416. Also see MPEP 2144.07. Sinclair & Carroll Co. v. Interchemical Corp. states "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.). It is noted that a polymer is known to be used as a substrate/base.
Regarding claim 3, Patil, Santos, and Halac teach the intraluminal device of claim 2, wherein the flex circuit further comprises a polymer coating formed over the conductive trace [Patil 0018 “…another layer of polymer (such as PTFE, paralyne, etc.) may be deposited upon the exposed conductive traces using, e.g., physical vapor deposition, dip coating, etc”].
Claims 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Patil and Santos as applied to claim 1 above, and further in view of Scott (US 20150273184 A1).
Regarding claim 5, Patil and Santos teach the intraluminal device of claim 1, wherein Patil teaches the flex circuit is positioned between proximal portion and distal portion and Santos teaches a proximal core member and distal core member, but fails to explicitly teach adhesive positioned between the flex circuit, the distal end of the proximal core member, and the proximal end of the distal core member.
Scott teaches coupling the flex circuit to an intermediate material using an adhesive [0050 “…an adhesive layer 319 (such as depicted in FIGS. 3A-B), of the flex circuit ribbon 102, and attaching an intermediate material…”].
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 teachings of Patil and Santos and incorporate the teachings of Scott to include coupling the flex circuit to the distal end of the proximal core member and the proximal end of the distal core member by an adhesive. Doing so configures the system to bond the flexible circuit to the assembly to reduce/prevent movement, vibration, and/or loosening which would potentially damage the components and/or provide improper operation of the assembly.
Regarding claim 9, Patil and Santos teach the intraluminal device of claim 1, wherein the combination of Patil and Santos teach a flex circuit [Patil Fig. 37C Item 430] over a core member [Fig. 37C Item 482] with Santos teaching a proximal and distal core members, but fail to explicitly teach the flex circuit is wrapped in a spiral pattern over the distal end of the proximal core member and the proximal end of the distal core member.
Scott teaches flex circuit [Fig. 1A Item 102] is wrapped in a spiral pattern [see Fig. 1A, see also 0044 “Such a helical winding can include the flex circuit ribbon 102 covering about half of the inner surface of the outer portion (e.g., the flex circuit ribbon 102 can be helically situated with a gap about the size of the width of the flex circuit ribbon 102 between windings of the flex circuit ribbon 102)”] over the elongated member [Fig. 1A Item 100].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Patil and Santos and incorporate the teachings of Scott to include the flex circuit is wrapped in a spiral pattern over the distal end of the proximal core member and the proximal end of the distal core member. Doing so configures the system to “…provide sufficient area between windings of the flex circuit ribbon 102 so as to allow the inner portion and the outer portion to be sufficiently joined or fused together between the windings”, as recognized by Scott par. 0044.
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Patil and Santos as applied to claim 1 above, and further in view of Shireman (US 20070123805 A1).
Regarding claim 6, Patil and Santos teach the intraluminal device of claim 1, wherein Patil teaches a tubular member [Fig. 37C Item 488] and Santos teaches a proximal core member and distal core member but fail to explicitly teach a tubular member positioned around the distal end of the proximal core member and the proximal end of the distal core member.
Shireman teaches a tubular member [Fig. 1 Item 18] positioned around the distal end [Fig. 1 Item 47] of the proximal core member [Fig. 1 Item 14] and the proximal end [Fig. 1 Item 43] of the distal core member [Fig. 1 Item 16].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Patil and Santos and incorporate the teachings of Shireman to include a tubular member positioned around the distal end of the proximal core member and the proximal end of the distal core member. Doing so configures the system to provide “…a smooth and uniform profile across the connection, or to straighten out small misalignments between the proximal and distal guidewire sections…”, as recognized by Shireman par. 0071.
Regarding claim 8, Patil, Santos, and Shireman teach the intraluminal device of claim 6, wherein the flex circuit [Patil Fig. 37C Item 430] is positioned over the tubular member [Patil Fig. 37C Item 488].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Patil, Santos, and Shireman as applied to claim 6 above, and further in view of Scott.
Regarding claim 7, Patil, Santos, and Shireman teach the intraluminal device of claim 6, wherein Patil teaches the flex circuit is positioned between proximal portion and distal portion and Santos teaches a proximal core member and distal core member, but fails to explicitly teach adhesive positioned between the flex circuit, the distal end of the proximal core member, and the proximal end of the distal core member.
Scott teaches coupling the flex circuit to an intermediate material using an adhesive [0050 “…an adhesive layer 319 (such as depicted in FIGS. 3A-B), of the flex circuit ribbon 102, and attaching an intermediate material…”].
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 teachings of Patil, Santos, and Shireman and incorporate the teachings of Scott to include coupling the flex circuit to the distal end of the proximal core member and the proximal end of the distal core member by an adhesive. Doing so configures the system to bond the flexible circuit to the assembly to reduce/prevent movement, vibration, and/or loosening which would potentially damage the components and/or provide improper operation of the assembly.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Patil and Santos as applied to claim 1 above, and further in view of Minas (US 20200297305 A1).
Regarding claim 10, Patil and Santos teach the intraluminal device of claim 1, wherein Patil teaches the flex circuit is positioned between proximal portion and distal portion and Santos teaches a proximal core member and distal core member, but fail to teach the flex circuit is wrapped in a cylindrical configuration over the distal end of the proximal core member and the proximal end of the distal core member.
Minas teaches the flex circuit [Fig. 3 Item 214] is configured to wrapped in a cylindrical configuration around the support member [Fig. 3 Item 230].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Patil and Santos and incorporate the teachings of Minas to include the flex circuit is wrapped in a spiral pattern over the distal end of the proximal core member and the proximal end of the distal core member. Doing so configures the system to form to the profile of a desired component (i.e., cylindrical tube/core member) to reduce the profile of the assembly.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Patil, Santos, and Shireman as applied to claim 6 above, and further in view of Garai (US 20200330007 A1).
Regarding claim 12, Patil, Santos, and Shireman teach the intraluminal device of claim 6, wherein Patil teaches the flex circuit and the tubular member but fails to teach the flex circuit is formed prior to being applied to the tubular member.
Garai teaches forming the circuit prior to being applied to a surface [0054 “…the top surface 21 is processed first, with both the circuitry 30 and the integrated circuit devices 40 being formed thereon, before the bottom surface 22 is processed. However, this order of processing is not required. For example, in one embodiment, the sensor 50 may be formed over the bottom surface 22 before the integrated circuit device 40 is mounted over the top surface 21”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Patil, Santos, and Shireman and incorporate the teachings of Garai to include teach the flex circuit is formed prior to being applied to the tubular member. Doing so configures the manufacturing process of the system to provide a reduced risk of damaging the conductors and pads of the circuit during the coupling process to the core/tubular member where core/tubular member movement can cause stress on the circuit.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Patil, Santos, Shireman, and Garai as applied to claim 12 above, and further in view of Minas.
Regarding claim 13, Patil, Santos, Shireman, and Garai teach the intraluminal device of claim 12, wherein the flex circuit is formed as a sheet [see Patil Fig. 37C Item 430],
wherein the conductive trace of the flex circuit is formed across the sheet [Patil 0123 “The conductive traces or wires along the flex circuit 430…”], and
wherein the conductive trace extends over to at least one of the distal end of the proximal core member or the proximal end of the distal core member [Patil 0123 “The conductive traces or wires along the flex circuit 430 may be attached directly to one or more corresponding conducting wires 440 which may extend proximally through the guidewire body (not shown for clarity) for electrical connection to a controller or processor”], but fails to explicitly teach the sheet is wrapped around the tubular member such.
Minas teaches the flex circuit [Fig. 3 Item 214] is configured to wrapped in a cylindrical configuration around the support member [Fig. 3 Item 230].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Patil and Santos and incorporate the teachings of Minas to include the flex circuit is wrapped in a spiral pattern over the distal end of the proximal core member and the proximal end of the distal core member. Doing so configures the system to form to the profile of a desired component (i.e., cylindrical tube/core member) to reduce the profile of the assembly.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN M HANEY/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights