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 Objections
Claim 1 is objected to because of the following informalities: At Claim 1 line 4, “having a cuff that is configured to positioned” should read --having a cuff that is configured to be positioned--. Appropriate correction is required.
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 3, 5, 12, 14, and 20 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 3 recites the limitation “the flexible printed circuit includes a split-double helix antenna”. What is a split double helix antenna? How is it different from a double helix antenna? This is not a well-known term in the art and there is no definition in the specification. Clarification is requested. For the purpose of examination, claim 3 is being interpreted such that the flexible printed circuit includes a double helix antenna which is split into units.
Claim 12 recites the limitation “a flexible sensor assembly defining a cuff”. What does it mean for a flexible sensor assembly to define a cuff? For the purpose of examination, the limitation is being interpreted as “a flexible sensor assembly having a cuff”.
Claim 14 recites the limitation “the flexible printed circuit includes a split-double helix antenna”. What is a split double helix antenna? How is it different from a double helix antenna? This is not a well-known term in the art and there is no definition in the specification. Clarification is requested. For the purpose of examination, claim 14 is being interpreted such that the flexible printed circuit includes a double helix antenna which is split into units.
Claim 20 recites the limitation “the flexible pulsation sensor”. There is a lack of antecedent basis for this limitation in the claim. It appears the claim should be amended to be dependent on claim 9 or 19 rather than claim 8. Applicant is advised that should claim 20 be amended to depend on claim 9, and should claim 10 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 102
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 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 1-2, 11-13, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toth (US 20140081154 A1 – Cited by Applicant).
Regarding claim 1, a first embodiment of Toth discloses an implantable blood flow sensor assembly for monitoring blood flow within a tubular structure within a body of a subject ([0026]), comprising: an antenna assembly (Figure 3 antenna 350); a flexible sensor assembly having a cuff that is configured to be positioned around a portion of the tubular structure within the body of the subject (Figure 3 scaffold 310, [0123], “the SDVG includes a vascular graft 300 and optionally a compliant scaffold 310 attached to the vascular graft 300. The SDVG further includes a sensory module 330 affixed to the compliant scaffold 310”); and a circuit that is operably connected to the antenna assembly and the flexible sensor assembly ([0123], “the sensory module 330 and the communication module 320 may be electrically connected via one or more links 340. Furthermore, the SDVG includes an antenna 350, e.g., a relatively soft, flexible, compliant antenna that is electrically connected to the communication module 320 ”). A second embodiment of Toth discloses a system for monitoring the patency of a vascular graft ([0135], “FIG. 5 shows a close up of a system for monitoring the patency of a vascular graft 500 provided in accordance with the present disclosure.”), which has a flexible sensor assembly and an integrated circuit that is operably connected to the antenna assembly and the flexible sensor assembly (Figure 5, modules 520, 530, [0137], “the modules 520, 530 may be formed from single silicon application specific integrated circuits. It may also be possible to achieve such levels of miniaturization by utilizing wire-bonded or flip chip techniques to bond separate dies to high density interconnect flexible circuits.”). Paragraph [0088] of Toth teaches that any of the aspects described in the specification may be used in conjunction with any or all of the other aspects disclosed.
Regarding claim 2, Toth discloses a blood flow sensor assembly, wherein the cuff of the flexible sensor is configured to be positioned around a portion of the vasculature or an implanted graft of the subject (Figure 3, [0123], “the SDVG includes a vascular graft 300 and optionally a compliant scaffold 310 attached to the vascular graft 300”).
Regarding claim 11, Toth discloses that the integrated circuit assembly includes a radio frequency integrated circuit ([0103], [0124], “power supply similar to those described above with respect to FIGS. 1 and 2 may also be provided and may be incorporated into or affixed to the complaint scaffold 310 similarly as the sensory module 330 and communication module 320 ”).
Regarding claim 12, a first embodiment of Toth discloses a blood-flow sensor assembly comprising: an antenna assembly (Figure 3 antenna 350); and a flexible sensor assembly defining a cuff that is configured to be positioned around a portion of the tubular structure of the body (Figure 3 scaffold 310, [0123], “the SDVG includes a vascular graft 300 and optionally a compliant scaffold 310 attached to the vascular graft 300. The SDVG further includes a sensory module 330 affixed to the compliant scaffold 310”), wherein the blood flow sensor assembly is configured to be disposed entirely within the body of the subject. A second embodiment of Toth discloses a blood-flow sensor system for monitoring blood flow within a tubular structure within a body of a subject ([0096], “One or more sensory modules 130 may be arranged to measure or monitor such physiological parameters as analyte concentrations, partial pressures of gaseous species, flow of a fluid, turbidity…”), comprising: a transceiver assembly ([0100], “The communication module 120 may additionally or alternatively include an RF transceiver”); and the transceiver assembly is configured to communicate with the blood flow sensor assembly by way of a wireless communication ([0100], “The communication module 120 may additionally or alternatively include an RF transceiver”, [0089], “The sensory module 130 communicates one or more signals 140 with the communication module 120 related to the interaction signal 150. The communication module 120 interacts with the sensory module 130 and an external entity such as a reader/repeater 162, a network hub 164, a mobile device 166, a person 168, or the like, e.g., via signals 160, 170, 172, 174.”).
Regarding claim 13, a first embodiment of Toth discloses the blood-flow sensor assembly further comprising a circuit that is operably connected to the antenna assembly and the sensor assembly ([0123], “the sensory module 330 and the communication module 320 may be electrically connected via one or more links 340. Furthermore, the SDVG includes an antenna 350, e.g., a relatively soft, flexible, compliant antenna that is electrically connected to the communication module 320). A second embodiment of Toth teaches an integrated circuit operably connected to the antenna assembly and the flexible sensor assembly (Figure 5, modules 520, 530, [0137], “the modules 520, 530 may be formed from single silicon application specific integrated circuits. It may also be possible to achieve such levels of miniaturization by utilizing wire-bonded or flip chip techniques to bond separate dies to high density interconnect flexible circuits.”).
Regarding claim 21, Toth discloses that the integrated circuit includes a radio frequency integrated circuit that is configured for wireless communication with the transceiver ([0103], [0124], “power supply similar to those described above with respect to FIGS. 1 and 2 may also be provided and may be incorporated into or affixed to the complaint scaffold 310 similarly as the sensory module 330 and communication module 320 ”).
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 3-5, 7-9, and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Xu et al. (Wireless Power Transfer for Miniature Implantable Biomedical Devices – Cited by Applicant), hereinafter referred to as Xu.
Regarding claim 3, Toth discloses a flexible antenna ([0123], “the SDVG includes an antenna 350, e.g., a relatively soft, flexible, compliant antenna“) with a flexible printed circuit board ([0124], “The antenna 350 may be formed from an insulated wire, braided wire, a flex laminate, a microcoil, or the like.”), where the flex laminate is made up of multiple flexible layers ([0143], “The dielectric layers in the laminate may be formed from PTFE, polyimide, polyamide, polyethylene terephthalate, polyethylene naphthalate, or elastomers such as polydimethylsiloxane, polyurethane, and the like. The conducting layers in the laminate may be formed from one or more metals including copper, silver, platinum, gold, nickel titanium, nickel chromium, and the like.”). Toth does not disclose the antenna assembly further comprising: a flexible base layer; a flexible top layer; and a flexible printed circuit disposed between the base layer and the top layer, wherein the flexible printed circuit includes a split-double helix antenna. Xu teaches a split double helix antenna where a flexible printed circuit is between a flexible base layer and a flexible top layer, where the flexible printed circuit includes a split-double helix antenna (Page 5, Figure 4, Paragraphs 1 and 2, “This PCB is made of polyimide film which is characterized by high strength, low RF energy loss, small thickness, and high flexibility….In addition to the DH coil, sensors, actuators, microprocessor and electronic elements (not shown) can be installed on the same flexible PCB. During surgery, the hermetically sealed PCB (using a biocompatible polymer material) is wrapped around the tubular structure at the position of interest forming a double helix winding along with all electronic components”, Page 6, Figure 5 depicts a split double helix antenna). The polyimide film which the electronic components and wires are on comprises the base layer, the electronic components and wires comprise the printed circuit, and the biocompatible polymer material is the top layer. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Toth such that it includes the antenna assembly further comprising: a flexible base layer; a flexible top layer; and a flexible printed circuit disposed between the base layer and the top layer, wherein the flexible printed circuit includes a split-double helix antenna because it allows for easier implantation of the antenna during surgery (Xu, Page 3, Double-helix coil for wrap-around implants, Page 4, paragraphs 1 and 2).
Regarding claim 4, Toth further discloses that the split-double helix antenna is configured to be positioned around said portion of the tubular structure of the subject ([0124], “The antenna 350 may be strategically wound around the compliant scaffold 310 so as to form a helix. Alternatively, the antenna 350 may be formed into a loop extended over the surface of the compliant scaffold 310, or may be disposed about the scaffold 310 in any other suitable configuration.”).
Regarding claim 5, Toth further discloses that both the split-double helix antenna and the cuff of the flexible sensor assembly are configured to each form a cylinder about said portion of the tubular structure of the subject (Figure 3 scaffold 310 and antenna 350, [0124], “The antenna 350 may be strategically wound around the compliant scaffold 310 so as to form a helix. Alternatively, the antenna 350 may be formed into a loop extended over the surface of the compliant scaffold 310, or may be disposed about the scaffold 310 in any other suitable configuration.”).
Regarding claim 7, Toth further discloses that the split-double helix antenna and the flexible sensor assembly are configured to be flexible independently of each other ([0124], “In general, the compliant antenna 350 may be arranged so as not to significantly impede the compliance, openness, or profile of the compliant scaffold 310.”).
Regarding claim 8, Toth further discloses that the flexible sensor assembly is configured to sense one of blood pressure or blood flow within the tubular structure ( [0131], “The sensory module 430 may be arranged to monitor patency of the vascular graft, blood flow though the synthetic vascular graft”).
Regarding claim 9, Toth further discloses that the flexible sensor assembly comprises a flexible pulsation sensor ([0153], “an array of sensory modules in accordance with the present disclosure, may be configured to collectively determine flow of a fluid through near anatomical structures (i.e., adjacent and surrounding tissues), a lumen, etc. by assessing signal peaks between each pulsation of the waveforms associated with the flow signal ”) and that the flexible sensor assembly is configured to sense blood pressure of the subject ([0090], “One or more sensory modules 130 may be arranged to measure or monitor such physiological parameters as…pressure, pressure gradients.”).
Regarding claim 14, Toth discloses a flexible antenna ([0123], “the SDVG includes an antenna 350, e.g., a relatively soft, flexible, compliant antenna“) with a flexible printed circuit board ([0124], “The antenna 350 may be formed from an insulated wire, braided wire, a flex laminate, a microcoil, or the like.”), where the flex laminate is made up of multiple flexible layers ([0143], “The dielectric layers in the laminate may be formed from PTFE, polyimide, polyamide, polyethylene terephthalate, polyethylene naphthalate, or elastomers such as polydimethylsiloxane, polyurethane, and the like. The conducting layers in the laminate may be formed from one or more metals including copper, silver, platinum, gold, nickel titanium, nickel chromium, and the like.”). Toth does not disclose the antenna assembly further comprising: a flexible base layer; a flexible top layer; and a flexible printed circuit disposed between the base layer and the top layer, wherein the flexible printed circuit includes a split-double helix antenna. Xu teaches a double helix antenna where a flexible printed circuit is between a flexible base layer and a flexible top layer, where the flexible printed circuit includes a split-double helix antenna (Page 5, Figure 4, Paragraphs 1 and 2, “This PCB is made of polyimide film which is characterized by high strength, low RF energy loss, small thickness, and high flexibility….In addition to the DH coil, sensors, actuators, microprocessor and electronic elements (not shown) can be installed on the same flexible PCB. During surgery, the hermetically sealed PCB (using a biocompatible polymer material) is wrapped around the tubular structure at the position of interest forming a double helix winding along with all electronic components”, Page 6, Figure 5 depicts a split double helix antenna). The polyimide film which the electronic components and wires are on comprises the base layer, the electronic components and wires comprise the printed circuit, and the biocompatible polymer material is the top layer. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Toth such that it includes disclose the antenna assembly further comprising: a flexible base layer; a flexible top layer; and a flexible printed circuit disposed between the base layer and the top layer, wherein the flexible printed circuit includes a split-double helix antenna because it allows for easier implantation of the antenna during surgery (Xu, Page 3, Double-helix coil for wrap-around implants, Page 4, paragraphs 1 and 2).
Regarding claim 15, Toth further discloses that the split-double helix antenna is configured to be positioned around said portion of the tubular structure of the subject ([0124], “The antenna 350 may be strategically wound around the compliant scaffold 310 so as to form a helix. Alternatively, the antenna 350 may be formed into a loop extended over the surface of the compliant scaffold 310, or may be disposed about the scaffold 310 in any other suitable configuration.”).
Regarding claim 16, Toth further discloses that both the split-double helix antenna and the cuff of the flexible sensor assembly are configured to each form a cylinder about said portion of the tubular structure of the subject (Figure 3 scaffold 310 and antenna 350, [0124], “The antenna 350 may be strategically wound around the compliant scaffold 310 so as to form a helix. Alternatively, the antenna 350 may be formed into a loop extended over the surface of the compliant scaffold 310, or may be disposed about the scaffold 310 in any other suitable configuration.”).
Regarding claim 17, Toth further discloses that the split-double helix antenna and the flexible sensor assembly are configured to be flexible independently of each other ([0124], “In general, the compliant antenna 350 may be arranged so as not to significantly impede the compliance, openness, or profile of the compliant scaffold 310.”).
Regarding claim 18, Toth further discloses that the flexible sensor assembly is configured to sense one of blood pressure or blood flow within the tubular structure ([0131], “The sensory module 430 may be arranged to monitor patency of the vascular graft, blood flow though the synthetic vascular graft”).
Regarding claim 19, Toth further discloses that the flexible sensor assembly comprises a flexible pulsation sensor ([0153], “an array of sensory modules in accordance with the present disclosure, may be configured to collectively determine flow of a fluid through near anatomical structures (i.e., adjacent and surrounding tissues), a lumen, etc. by assessing signal peaks between each pulsation of the waveforms associated with the flow signal ”) and that the flexible sensor assembly is configured to sense blood pressure of the subject ([0090], “One or more sensory modules 130 may be arranged to measure or monitor such physiological parameters as…pressure, pressure gradients.”).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Xu further in view of Sheehan et al. (US 20130178750 A1), hereinafter referred to as Sheehan.
Regarding claim 6, Toth in view of Xu discloses all of the limitations of the claim as discussed above except that an inner diameter of the cylinder formed by both the split-double helix antenna and the cuff of the flexible sensor assembly is about 3.0 mm to about 10.0 mm in diameter. Sheehan teaches an implantable device which measures blood pressure and has a diameter of 5-8mm ([0121], “The support body 600 of the device 300 may be manufactured to have a transverse dimension or diameter of about 5-8 mm”). Sheehan also teaches that the diameter of the device can be varied to adapt to different blood vessel sizes ([0121], “The outer diameter of the device 300 may be varied so as to fit within a particular blood vessel and to adapt to different blood vessel sizes.”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the blood flow sensor assembly of Toth in view of Xu such that an inner diameter of the cylinder formed by both the split-double helix antenna and the cuff of the flexible sensor assembly is about 3.0 mm to about 10.0 mm in diameter because this allows the sensor assembly to wrap around blood vessels.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Xu further in view of Grell et al. (US 20220157621 A1), hereinafter referred to as Grell.
Regarding claim 10, Toth in view of Xu discloses all of the limitations of the claim as discussed above except that the flexible pulsation sensor comprises a piezo resistive carbon black-polydimethylsiloxane nanocomposite. Grell teaches a flexible electronic device where a layer of the flexible device comprises carbon black-polydimethylsiloxane ([0197], “ The first layer 6 of the stretchable silicone substrate 4 comprises carbon black-filled polydimethylsiloxane (CB-PDMS)…The concentration of carbon black, or other conductive particle fillers or conductive liquids in the first layer 6 of the stretchable silicone substrate 4 may be chosen, during the process of designing the stretchable silicone substrate 4, to optimise the resistance and binding strength of the stretchable silicone substrate 4.”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the blood flow sensor assembly of Toth in view of Xu such that it comprises a piezo resistive carbon black-polydimethylsiloxane nanocomposite because PDMS reduces cost and makes manufacturing easier and carbon black gives the material improved stability and provides it with tunable mechanical and electrical properties (Grell, [0198]).
Regarding claim 20, Toth in view of Xu discloses all of the limitations of the claim as discussed above except that the flexible pulsation sensor comprises a piezo resistive carbon black-polydimethylsiloxane nanocomposite. Grell teaches a flexible electronic device where a layer of the flexible device comprises carbon black-polydimethylsiloxane ([0197], “ The first layer 6 of the stretchable silicone substrate 4 comprises carbon black-filled polydimethylsiloxane (CB-PDMS)…The concentration of carbon black, or other conductive particle fillers or conductive liquids in the first layer 6 of the stretchable silicone substrate 4 may be chosen, during the process of designing the stretchable silicone substrate 4, to optimise the resistance and binding strength of the stretchable silicone substrate 4.”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the blood flow sensor assembly of Toth in view of Xu such that it comprises a piezo resistive carbon black-polydimethylsiloxane nanocomposite because PDMS reduces cost and makes manufacturing easier and carbon black gives the material improved stability and provides it with tunable mechanical and electrical properties (Grell, [0198]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure.
Garza et al. (US 20220022844 A1) teaches an injectable, flexible blood pressure sensor.
Gianchandani et al. (US 20050273014 A1) teaches a flexible, implanted blood flow sensor with a helical antenna.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R UCHITEL whose telephone number is (571)305-5153. The examiner can normally be reached Mon-Fri from 8:30am – 5:00pm.
Examiner interviews are available via a variety of formats. See MPEP § 713.01. 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, Charles Marmor, can be reached at telephone number (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/EMILY R UCHITEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
Prosecution Insights