DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on January 28, 2026 were received and fully considered. Claims 1 and 14 were amended. Please see corresponding rejection headings and response to arguments section below for more detail.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on January 28, 2026 has been entered.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Gianchandani et al. (US PG Pub. No. 2005/0273014 A1) (hereinafter “Gianchandani”) in view of Nguyen et al. (US PG Pub. No. 2021/0127998 A1) (hereinafter “Nguyen”)
Gianchandani and Nguyen were applied in the previous office action.
With respect to claim 1, Gianchandani teaches a signal transmitting element comprising: a body having a head portion and an extension portion extending outwards from the head portion (Figs. 3A-3C depict cuff 62 with penetrating electrodes 64 connected to telemetry circuit 50 via wires 70/72, of which telemetry circuit 50 equates to a head portion and cuff 62 equates to an extension portion; See also par.0055+), wherein the extension portion completely or partially surrounds a blood vessel and includes a plurality of protruding structures protruding from a surface thereof, such that when the extension portion surrounds the blood vessel, all or a portion of the plurality of protruding structures contacts with the blood vessel (extension portion 62 includes penetrating electrodes 64 that surround blood vessel 60 as depicted in Figs. 3A-3C; see also par.0055+); wherein the body further comprises: a signal sensing portion disposed in the extension portion, including a signal sensing structure configured to sense a blood flow information of the blood vessel surrounded and contacted by the body, thereby generating a blood vessel signal; and a signal transmitting portion disposed in the head portion, coupled with the signal sensing portion for receiving the blood vessel signal and including a signal sensing structure configured to convert the blood vessel signal into a transmission signal (telemetry chip 50 is disposed/connected to the extension portion 62 via wires 70/72 so as to generate a blood flow signal and convert/transmit the signal via wireless connection 74; see Figs. 3A-3C; par.0055+).
Although Gianchandani’s embodiment depicted in Figs. 3A-3C does not explicitly teach a body formed as an elongated sheet-like structure made of a biodegradable material, such a modification would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for at least several reasons.
First, Gianchandani expressly discloses the following:
[0048] The micro-EDM fabrication process described in the above-referenced materials advantageously relies upon planar metal foil or sheets as a starting material, but other materials and other shapes (e.g., tubular metal sheets) may be used to fabricate the disclosed device. In these embodiments, the structural material of the structure, e.g., stainless steel, also provides the electrical connections necessary for operation. However, in alternative embodiments, electrical traces may be disposed on a different material, such as a dielectric, used as a non-conductive structural support. In such cases, the shapes of the electrodes (and any other electrically functional components) are not as limited to the shape of the structural support or frame.
[0080] … Another conductive material, such as gold, may be used instead of, or in addition to, copper. The planar structures were then coated with 1-.mu.m thick parylene-C, which is a biocompatible polymer suitable for biomedical applications. The plates of the electrode 206 of the cuff were left uncoated. The diode was packaged with epoxy for both electrical and mechanical protection in this case. The device was deployed inside a 3-mm i.d. silicone mock artery with 0.25-mm wall thickness (Dynatek-Dalta, Inc., Mo.) by using the balloon catheter.
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Gianchandani such that the body is formed of an elongated sheet-like structure made of a biodegradable material as this would be a simple substitution, and it is known to utilize biocompatible/biodegradable material for biomedical applications, as expressly disclosed by Gianchandani (par.0048, 0080).
However, Gianchandani does not teach the plurality of protruding structures is made of a material including at least polycaprolactone.
Nguyen teaches an implantable pressure sensor, and encapsulating PLA layers of through the use of additional biodegradable materials such as polycaprolactone (PCL) (abstract; par.0051).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Gianchandani’s protruding structures such that they are made of materials such as polycaprolactone in order to fine tune the functional lifetime of the sensing electrodes, as suggested by Nguyen (par.0051). Nguyen also discloses encapsulating biodegradable layers in relation to implantable electrodes (par.0047), thereby providing PHOSITA added motivation to encapsulate Gianchandani’s electrodes for the purpose of increase the functional lifetime of the sensor, as suggested by Nguyen (par.0051). For purposes of compact prosecution, Examiner also cites other references that further demonstrate it is known to utilize polycaprolactone in implantable devices. Please see prior art of record section at the end of the current office action for additional example teachings.
With respect to claim 4, Gianchandani teach a signal transmitting element, wherein the signal sensing section is located in the extension portion of the body to form the signal sensing portion (see Figs. 3A-3C), wherein the signal transmitting section has a working frequency used for transmitting the blood flow information sensed by the signal sensing section (Gianchandani’s antenna impliedly utilizses a working frequency for transmitting blow flow information).
However, Gianchandani does not explicitly teach wherein the body includes at least one metal structure, wherein each of the at least one metal structure is made of a biodegradable metal, wherein each of the at least one metal structure includes a signal transmitting section and a signal sensing section
Nguyen teaches the body includes at least one metal structure, wherein each of the at least one metal structure is made of a biodegradable metal, wherein each of the at least one metal structure includes a signal transmitting section and a signal sensing section (abstract “Mg or Mo… These materials are biodegradable… does not require invasive removal surgery”; see also par.0040+; claim 3).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Gianchandani to utilize a biodegradable metal (e.g. magnesium) as the material for the body, signal transmitting section, and signal sensing section for the purposes of eliminating the need for latter invasive removal surgery, as evidence by Nguyen (abstract).
With respect to claim 5, Nguyen teaches the at least one metal structure includes a plurality of metal structures (par.0007 “on or more magnesium wires… first magnesium electrode, a second magnesium electrode…”). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Gianchandani to utilize a biodegradable metal for a plurality of metal structures for the purposes of eliminating the need for latter invasive removal surgery, as evidence by Nguyen (abstract). While Gianchandani and Nguyen do not explicitly teach the working frequency of one of the plurality of metal structures is identical to that of another of the plurality of metal structures, such a modification would have been prima facie obvious to PHOSITA when the invention was filed as it is widely established in the art to tune working frequencies to a desired level. Moreover, Gianchandani’s antenna can be configured to modify the resonant frequency that is monitored (par.0062+) thereby providing additional motivation for PHOSITA to keep all the frequencies identical.
With respect to claim 6, Nguyen teaches the at least one metal structure includes a plurality of metal structures (par.0007 “on or more magnesium wires… first magnesium electrode, a second magnesium electrode…”). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Gianchandani to utilize a biodegradable metal for a plurality of metal structures for the purposes of eliminating the need for latter invasive removal surgery, as evidence by Nguyen (abstract). While Gianchandani and Nguyen do not explicitly teach the working frequency of one of the plurality of metal structures is different from that of another of the plurality of metal structures, such a modification would have been prima facie obvious to PHOSITA when the invention was filed as it is widely established in the art to tune working frequencies to a desired level. Moreover, Gianchandani’s antenna can be configured to modify the resonant frequency that is monitored (par.0062+) thereby providing additional motivation for PHOSITA to set/tune the frequencies of each metal structure to a different level.
With respect to claim 7, Gianchandani and Nguyen do not explicitly teach the working frequency is between 350 MHz and 450 MHz. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 8, Gianchandani and Nguyen do not explicitly teach the working frequency is between 401 MHz and 406 MHz. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 9, Nguyen teaches a material of each of the at least one metal structure is at least selected from magnesium or magnesium alloy (par.0007). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Gianchandani to utilize a magnesium metal as the material for the body, signal transmitting section, and signal sensing section for the purposes of eliminating the need for latter invasive removal surgery, as evidence by Nguyen (abstract).
With respect to claim 10, Gianchandani teaches a gold-plated layer coated on a surface of at least one of the at least one metal structure (par.0080 “gold, may be used instead”).
With respect to claim 11, Gianchandani does not explicitly teach the gold-plated layer has a thickness between 0.01 pm and 10 pm. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 12, Gianchandani does not explicitly teach the gold-plated layer is formed under a condition including a plating temperature of 15°C-35°C, a pretreatment time of 60-150 seconds, a plating time of 45-75 seconds, and a stirring speed of 100-300 rpm. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 13, Gianchandani does not explicitly teach the gold-plated layer is formed under a condition including a plating temperature of25 C, a pretreatment time of 120 seconds, a plating time of 60 seconds, and a stirring speed of 150 rpm. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
With respect to claim 16, Gianchandani suggests a signal transmitting element, head portion, and extension portion, as set forth above.
Although Gianchandani does not explicitly teach wherein the head portion has a length between 5 mm and 35 mm, a width between 5 mm and 35 mm, and a thickness between 50 pm and 350 pm, and wherein the extension portion has a width between 2 mm and 15 mm and a thickness between 50 pm and 350 pm, such a modification would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Gianchandani and Nguyen, as applied to claim 4 above, in further view of Majercak (US PG Pub. No. 2020/0179144 A1).
With respect to claim 14, Gianchandani and Nguyen teach the signal transmitting element, as established above. Nguyen further teaches a first protective layer and a second protective layer, wherein the at least one metal layer is enveloped between the first protective layer and the second protective layer (abstract “encapsulated by layers”; par.0047 “two layers of a polymer film… sandwiched between biodegradable metal... electrodes… can include more or fewer layers”; par.0051 “will increase the functional lifetime of the pressure sensor”).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Gianchandani to further incorporate first/second protective layers, in the manner recited, in order to fine tune the functional lifetime of the sensing electrodes, as suggested by Nguyen (par.0051). Nguyen also discloses encapsulating biodegradable layers in relation to implantable electrodes (par.0047), thereby providing PHOSITA added motivation to encapsulate Gianchandani’s electrodes for the purpose of increase the functional lifetime of the sensor, as suggested by Nguyen (par.0051).
However, Gianchandani and Nguyen do not teach wherein the first protective layer and the second protective layer are made of a material selected from at least one of polyhydroxybutyrate and polyhydroxyvalerate .
Majercak teaches an implantable device that can be formed from biodegradable polymers such as polylactic acid (i.e., PLA), polyglycolic acid (i.e., PGA), polydioxanone (i.e., PDS), polyhydroxybutyrate (i.e., PHB), polyhydroxyvalerate (i.e., PHV), and copolymers or a combination of PHB and PHV (available commercially as Biopol®), polycaprolactone (available as Capronor®), polyanhydrides (aliphatic polyanhydrides in the back bone or side chains or aromatic polyanhydrides with benzene in the side chain), polyorthoesters, polyaminoacids (e.g., poly-L-lysine, polyglutamic acid), pseudo-polyaminoacids (e.g., with back bone of polyaminoacids altered), polycyanocrylates, or polyphosphazenes (par.0043).
Therefore, Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Gianchandani and Nguyen to further incorporate the use of PHB or PHV as a design choice and for the purpose of achieving a desired biodegradability with other known biodegradable materials, as suggested by Majercak (par.0043).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gianchandani and Nguyen, as applied to claim 4 above, in further view of Alam (US PG Pub. No. 2018/0085573 A1).
Alam was applied in the previous office action.
With respect to claim 15, Gianchandani and Nguyen a signal transmitting element and at least one metal structure includes a plurality of metal structures, as established above.
However, Gianchandani and Nguyen do not explicitly teach each two adjacent metal structures have an insulating layer disposed therebetween, and wherein the insulating layer is made of a material including at least poly-L-lactic acid.
Alam teaches an insulating layer disposed therebetween, and wherein the insulating layer is made of a material including at least poly-L-lactic acid (par.0105 “flexible insulator housing the conductive discs may comprise… polylactic acid…or some other flexible, biocompatible polymeric insulating material”).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Gianchandani and Nguyen to utilize an insulating later made of poly-L-lactic acid in order to provide insulation between electrical components of the implantable device, as evidence by Alam (par.0105).
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Newly cited:
PG Pub. No. 2021/0187170 A1, par.0018; claim 24
PG Pub. No. 2010/0076556 A1, par.0060
Previously cited:
Boutry et al., Biodegradable and flexible arterial-pulse sensor for the wireless monitoring of blood flow. Nat Biomed Eng. 2019 Jan;3(1):47-57. doi: 10.1038/s41551-018-0336-5. Epub 2019
Rabeeh et al., Iron - Gold Composites for Biodegradable Implants: In Vitro Investigation on Biodegradation and Biomineralization, ACS Biomaterials Science & Engineering 2023 9 (7), 4255-4268
Response to Arguments
Applicant’s arguments filed with respect to the 35 USC 112B rejections raised in the previous office actions were persuasive in view of amendment. Therefore, these rejections are withdrawn.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action have been considered, but were not persuasive. Applicant argues that Gianchandani and Nguyen, as an ordered combination, fail to teach and/or suggest the plurality of protruding structures is made of a material including at least polycaprolactone. Examiner respectfully disagrees. While Gianchandani does not expressly teach that its penetrating electrodes 64 (equates to protruding structures) are made of polycaprolactone, Examiner maintains that Nguyen discloses and provides motivation for utilizing polycaprolactone as a protective layer with respect to components of an implantable device, sensor, electrodes, etc. As such, Gianchandani and Nguyen, as an ordered combination, render obvious to PHOSITA the claimed invention, as currently amended. Please see prior art section above for more detail, updated citations, and updated obviousness rationale.
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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