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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 27 Feb 2026. As directed by the amendment: claims 1, 11, 13, 16, 19, and 33 have been amended, claims 2-5, 7, and 21-31 have been canceled, claim 17 has been withdrawn, and claims 34-36 have been added. Thus, claims 1, 6, 8-16, 18-20, and 32-36 are presently pending in this application.
Response to Arguments
Objections
Applicant’s arguments, see Remarks, filed 27 Feb 2026, with respect to the objection to claim 1 have been fully considered and are persuasive in light of the claim amendments. The objection to claim 1 has been withdrawn.
However, new objections are made below as necessitated by the claim amendments.
Claim Rejections under 35 U.S.C. § 112
Applicant’s arguments, see Remarks, filed 27 Feb 2026, with respect to the rejections of claims 2 and 16 have been fully considered and are persuasive in light of the claim amendments. The rejections of claims 2 and 16 have been withdrawn.
However, new rejections under 35 U.S.C. 112 are made below as necessitated by the claim amendments.
Claim Rejections Under 35 U.S.C. § 103
Claim 1
Applicant’s arguments, see Remarks, filed 27 Feb 2026, with respect to the rejection of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Catanese et al. (US 20170035410 A1, previously cited), hereinafter Catanese, in view of Hunter (US Publication No. 20160038087 A1, previously cited), as explained in further detail below.
New Claims 34-36
Claims 34-36 are rejected under 35 U.S.C. 103 in view of Hunter (US Publication No. 20160038087 A1, previously cited), and Skwarek et al. (US 20050096709 A1), hereinafter Skwarek, as explained in further detail below.
Dependent Claims
No specific arguments regarding dependent claims 6, 8-16, and 18-33 and the previously cited prior art references were made. Therefore, claims 6, 8-16, and 18-33 are also rejected below.
Claim Objections
Claims 35 and 36 are objected to because of the following informalities:
“Claim” in claims 35 and 36 should read “claim”
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 34-36 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 34 recites the limitation "the tissue" in line 13. There is insufficient antecedent basis for this limitation in the claim.
The term “proximity” in claim 34 is a relative term which renders the claim indefinite. The term “proximity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to how closely the first and second electrodes are placed to the first and second anchors, respectively.
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, 6, 8-10, 13-14, 18, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Catanese et al. (US 20170035410 A1, previously cited), hereinafter Catanese, in view of Hunter (US Publication No. 20160038087 A1, previously cited).
Regarding claim 1, Catanese discloses an implant for placement in a prostate of a patient (Fig. 1B, paragraph [0047], retainer 10), comprising:
a tensioning support sized and shaped for placement in the prostate of the patient (Fig. 1B, paragraph [0047], retainer 10) to maintain a patency of a urethra along the prostate (Fig. 1B, paragraph [0047], "The distance or tension between the anchors is sufficient to compress, displace or change the orientation of an anatomical region between distal anchor 12 and proximal anchor 14"; paragraph [0107], "the present invention is used for the displacement, compression, and/or retraction of the prostate gland and the opening of the prostatic urethra"),
the tensioning support extending between a first anchor configured to engage a capsule of the prostate (Fig. 1B, paragraph [0047], "distal anchor 12 is located on the outer surface of the capsule of prostate gland CP and acts as a capsular anchor") and a second anchor configured to engage the urethra (paragraph [0047], "proximal anchor 14 is located on the inner wall of urethra UT and acts as a urethral anchor") to draw a wall of the urethra toward the prostate to maintain the patency of the urethra (paragraph [0047], "Distal anchor 12 and proximal anchor 14 are implanted in the anatomy such that a desired distance or tension is created in connector 16. This causes distal anchor 12 and proximal anchor 14 to retract or compress a region of prostate gland PG to relieve the obstruction shown in FIG. 1A.");
at least one sensor positioned on the tensioning support (paragraph [0112], "such sensors can be incorporated into the anchor assembly itself"), the at least one sensor configured to measure deflection of the tensioning support between the first anchor and the second anchor (paragraph [0112], " tension or depth feedback can be monitored by these sensors").
Catanese does not explicitly disclose a transmitter positioned on the tensioning support; a circuitry coupled to the at least one sensor and the transmitter, the circuitry configured to operate the transmitter to transmit signals from the at least one sensor to an exterior of the patient; nor that the deflection of the tensioning support is related to tissue growth within the prostate.
However, Hunter teaches an implantable stent with sensors positioned on the stent (Abstract) comprising:
a transmitter positioned on the stent (Fig. 8, paragraphs [0084], [0090], antenna);
at least one sensor positioned on the stent, the at least one sensor configured to measure deflection of the stent between the first anchor and the second anchor (Fig. 1, paragraph [0055], contact sensors, position sensors, accelerometers, mechanical stress sensors, vibration sensors; paragraph [0063], "position sensors and accelerometers distributed throughout the stent capable of detecting deformation and kinking of the stent"), wherein the deflection of the tensioning support is related to tissue growth within the prostate (paragraph [0046], "stents are provided with a number of sensors to monitor ... the anatomy and pathology of the tissue surrounding the stent,... normal and abnormal healing of the tissues in contact with the stent, ... as well as to monitor the failure or impending failure of the stent due to a disease or other process (e.g., ...benign or malignant tumor growth)"; paragraph [0054], "Stent failure can be due to a multitude of causes but includes things such ... tissue ingrowth into the stent lumen (restenosis, tumor cell growth, inflammation)"; paragraph [0081], "Changes in the position of the accelerometers and/or motion sensors over time can be used as a measurement of changes in the position of the stent wall and/or vascular wall over time. Such positional changes can be used as a surrogate marker of vascular and stent anatomy—i.e. they can form an “image’ of the stent and/or vascular wall to provide information on the size, shape and location of restenosis within the stent; size, shape and location of clot formation, tumor growth, abscess formation"); and
a circuitry coupled to the at least one sensor and the transmitter, the circuitry configured to operate the transmitter to transmit signals from the at least one sensor to an exterior of the patient (Figs. 8-10, paragraphs [0084], [0087]-[0088], [0090]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Catanese with the teachings of Hunter so that the deflection of the tensioning support is related to tissue growth within the prostate, and so that the implant comprises a transmitter positioned on the tensioning support; a circuitry coupled to the at least one sensor and the transmitter, the circuitry configured to operate the transmitter to transmit signals from the at least one sensor to an exterior of the patient, because doing so provides important complementary clinical information to the doctor and can provide the patient with either an early warning indicator to seek assistance or to provide them with reassurance (Hunter, paragraph [0010]).
Regarding claim 6, the implant of claim 1 is obvious over Catanese and Hunter, as explained above. Catanese further discloses that the tensioning support comprises a barb to engage a capsule of the prostate (paragraph [0048], "distal anchor 12 assumes a T-shape that helps to anchor distal anchor 12 to an anatomical structure. Distal anchor 12 may comprise a sharp edge to help penetrate distal anchor 12 through the anatomy").
Regarding claim 8, the implant of claim 1 is obvious over Catanese and Hunter, as explained above. Catanese further discloses an agent delivery mechanism coupled to the tensioning support to deliver a therapeutic agent (paragraph [0111], "the components of the anchor assembly or selected portions thereof (of any of the anchor assemblies described or contemplated), can be coated or embedded with therapeutic or diagnostic substances (e.g. drugs or therapeutic agents)").
Regarding claim 9, the implant of claim 8 is obvious over Catanese and Hunter, as explained above. Hunter further teaches that the agent delivery mechanism is configured for rapid release of the therapeutic agent (paragraph [0072], "a drug-eluting delivery device may be included within the stent in order to release a desired drug upon demand (e.g., upon remote activation/demand)"; paragraph [0073], release kinetics of drug to be released).
Regarding claim 10, the implant of claim 8 is obvious over Catanese and Hunter, as explained above. Hunter further teaches that the agent delivery mechanism is configured for sustained release of the therapeutic agent over an extended time (paragraph [0072], "a drug-eluting delivery device may be included within the stent in order to release a desired drug ... based upon a timed schedule"; paragraph [0073], release kinetics of drug to be released).
Regarding claim 13, the implant of claim 1 is obvious over Catanese and Hunter, as explained above. Catanese further discloses that the at least one sensor comprises a plurality of sensors (paragraph [0112], "sensors").
Regarding claim 14, the implant of claim 1 is obvious over Catanese and Hunter, as explained above. Hunter further teaches an insulated conductive lead positionable to allow induction charging of a power source of the implant (paragraphs [0079], [0088], "the generator can be directly coupled by electrical wires to one or more sensors. Alternatively (or, in addition), the electricity can be transmitted wirelessly in the same way that wireless smartcards receive power from closely adjacent power sources using the appropriate send and receive antennas.").
Regarding claim 18, the implant of claim 14 is obvious over Catanese and Hunter, as explained above. Hunter further teaches that the lead comprises an antenna coupled to the transmitter (paragraphs [0084], [0090], antenna).
Regarding claim 33, the implant of claim 1 is obvious over Catanese and Hunter, as explained above. Catanese further discloses that the at least one sensor comprises a plurality of sensors (paragraph [0112], "sensors").
Hunter further teaches that the sensor comprises a plurality of sensors (Fig. 1, paragraph [0055], contact sensors, position sensors, accelerometers, mechanical stress sensors, vibration sensors), wherein the plurality of sensors comprises a first sensor and a second sensor (Fig. 1, paragraph [0055], contact sensors, position sensors, accelerometers, mechanical stress sensors, vibration sensors),
wherein the first anchor is coupled to the first sensor (Figs. 3A-3B, paragraph [0061], contact and position sensors placed in holes in stent struts),
wherein the second anchor is coupled to the second sensor (Figs. 3A-3B, paragraph [0061], contact and position sensors placed in holes in stent struts), and
wherein the first sensor is spaced at a predetermined distance from the second sensor to establish a spatial relationship profile to measure the deflection of the tensioning support caused by the tissue growth within the prostate (paragraph [0046], "stents are provided with a number of sensors to monitor ... the anatomy and pathology of the tissue surrounding the stent,... normal and abnormal healing of the tissues in contact with the stent, ... as well as to monitor the failure or impending failure of the stent due to a disease or other process (e.g., restenosis, thrombosis, inflammation, benign or malignant tumor growth)"; paragraph [0054], "Stent failure can be due to a multitude of causes but includes things such ... tissue ingrowth into the stent lumen (restenosis, tumor cell growth, inflammation)"; paragraph [0081], "Changes in the position of the accelerometers and/or motion sensors over time can be used as a measurement of changes in the position of the stent wall and/or vascular wall over time. Such positional changes can be used as a surrogate marker of vascular and stent anatomy—i.e. they can form an “image’ of the stent and/or vascular wall to provide information on the size, shape and location of restenosis within the stent; size, shape and location of clot formation, tumor growth, abscess formation").
Claims 11-12, 19-20,and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Catanese et al. (US 20170035410 A1, previously cited), hereinafter Catanese, in view of Hunter (US Publication No. 20160038087 A1, previously cited), and further in view of Scarantino et al. (US Publication No. 20100261983 A1, previously cited), hereinafter Scarantino.
Regarding claim 11, the implant of claim 1 is obvious over Catanese and Hunter, as explained above. Hunter further teaches: a power source coupled to the circuitry and the transmitter (paragraphs [0078]-[0079], [0087]-[0090]), the circuitry and transmitter configured to process signals from the at least one sensor and to transmit the signals (paragraphs [0084], [0090]).
Neither Catanese nor Hunter explicitly discloses a biocompatible material enclosing the transmitter, the power source, and the circuitry.
However, Scarantino discloses a biocompatible sensor (Abstract) comprising a biocompatible material enclosing the sensor unit body (paragraph [0120], "Each of the (implantable or injectable) sensor unit bodies is hermetically sealed with biocompatible materials"), which includes a transmitter (Fig. 6A, paragraph [0124], transmitter coil 58), power source (Fig. 5, paragraph [0120], battery or inductive power), and circuitry (Fig. 6A, paragraph [0123], electronic operating circuitry 125).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Catanese and Hunter with the teachings of Scarantino to include a biocompatible material enclosing the transmitter, the power source, and the circuitry, because doing so allows remote, real-time, dynamic monitoring of tumor growth and response to therapy, which can be used to provide improved treatment protocols for treating the patient (Scarantino, paragraphs [0032]-[0033]).
Regarding claim 12, the implant of claim 11 is obvious over Catanese, Hunter, and Scarantino, as explained above. Hunter further teaches that the transmitter comprises wireless communication circuitry (paragraphs [0084], [0090], antenna).
Regarding claim 19, the implant of claim 1 is obvious over Catanese and Hunter, as explained above. Although Hunter discloses that the sensor comprises a plurality of sensors at a plurality of locations (paragraph [0016]), Hunter does not explicitly disclose that the plurality of sensors is coupled to the circuitry with an electrically conductive line, the line extending between the plurality of sensors to be places at a plurality of locations.
However, Scarantino discloses biocompatible sensors (Abstract) coupled to circuitry with an electrically conductive line (paragraph [0123], “A separate channel 151 electrically connects the sensor element 51 to the electronic operating circuitry 125”), the line extending between the plurality of sensors to allow the plurality of sensors to be placed at a plurality of locations (paragraph [0125], "the multiple sensor elements 51 can contact different locations within (penetrate at different depths) and/or wrap to contact different exterior perimeter locations along the tumor. Alternatively, one or more arms can be attached to normal tissue to provide information regarding the status of same").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Catanese and Hunter with the teachings of Scarantino to couple the plurality of sensors to the circuitry with an electrically conductive line, the line extending between the plurality of sensors to allow the plurality of sensors to be placed at a plurality of locations, because doing so can provide increased regional data to allow for more informal analysis of the targeted tissue (Scarantino, paragraph [0125]).
Regarding claim 20, the implant of claim 19 is obvious over Catanese, Hunter, and Scarantino, as explained above. Hunter further teaches that distances between the plurality of sensors establishes a spatial relationship profile (paragraph [0063], "Sensor-containing stents of the present invention can be used to confirm proper initial placement and any ensuing migration or relocation within the vessel."; paragraph [0064], "accelerometers can be used to confirm anatomical location"; paragraph [0067], "the sensor is capable of detecting one or more ... locational (e.g., location within the subject) parameters").
Regarding claim 32, the implant of claim 19 is obvious over Catanese, Hunter, and Scarantino, as explained above. Hunter further teaches that the plurality of sensors comprises a first sensor and a second sensor (Fig. 1, paragraph [0055], contact sensors, position sensors, accelerometers, mechanical stress sensors, vibration sensors),
wherein the first anchor is coupled to the first sensor (Figs. 3A-3B, paragraph [0061], contact and position sensors placed in holes in stent struts),
wherein the second anchor is coupled to the second sensor (Figs. 3A-3B, paragraph [0061], contact and position sensors placed in holes in stent struts), and
wherein the first sensor is spaced at a predetermined distance from the second sensor to establish a spatial relationship profile to measure the deflection of the tensioning support caused by the tissue growth within the prostate (paragraph [0046], "stents are provided with a number of sensors to monitor ... the anatomy and pathology of the tissue surrounding the stent,... normal and abnormal healing of the tissues in contact with the stent, ... as well as to monitor the failure or impending failure of the stent due to a disease or other process (e.g., restenosis, thrombosis, inflammation, benign or malignant tumor growth)"; paragraph [0054], "Stent failure can be due to a multitude of causes but includes things such ... tissue ingrowth into the stent lumen (restenosis, tumor cell growth, inflammation)"; paragraph [0081], "Changes in the position of the accelerometers and/or motion sensors over time can be used as a measurement of changes in the position of the stent wall and/or vascular wall over time. Such positional changes can be used as a surrogate marker of vascular and stent anatomy—i.e. they can form an “image’ of the stent and/or vascular wall to provide information on the size, shape and location of restenosis within the stent; size, shape and location of clot formation, tumor growth, abscess formation").
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Catanese et al. (US 20170035410 A1, previously cited), hereinafter Catanese, in view of Hunter (US Publication No. 20160038087 A1, previously cited), and further in view of Tuseth et al. (US Publication No. 20170117739 A1, previously cited), hereinafter Tuseth.
Regarding claim 15, the implant of claim 14 is obvious over Catanese and Hunter, as explained above. Although Hunter further teaches that the support is sized and shaped for placement in a prostate of the patient to maintain patency of the urethra along the prostate (paragraph [0013], “Such stents may be positioned within a wide variety of lumens, including for example … genitourinary (e.g., …prostate)”; paragraph [0054], “stents are used to open up and maintain the lumen of a diseased body passageway (e.g., … urinary tract) … a stent is inserted into body a lumen to physically hold open structures and/or passageways (typically tubular organ structures such as ... the urinary tract)"), neither Catanese nor Hunter explicitly discloses that the lead is sized and shaped for placement in a urethra so as to extend along the urethra.
However, Tuseth further teaches that the lead is sized and shaped for placement in a urethra so as to extend along the urethra (paragraph [0036], "the diameter of the electromagnetic coil ... may be in the range of 1-20 mm"; although Tuseth's device is intended to be implanted in the cardiovascular system, it is capable of being placed into a urethra).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Catanese and Hunter with the teachings of Tuseth to provide a lead sized and shaped for placement in a urethra so as to extend along the urethra because a lead of this size and shape may improve tolerance when aligning the receiving and transmitting coils, resulting in a simpler method of power transfer to the patient (Tuseth, paragraph [0036]), and further since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 16, the implant of claim 14 is obvious over Catanese and Hunter, as explained above. Although Hunter further teaches that the support is sized and shaped for placement in a prostate of the patient to maintain patency of the urethra along the prostate (paragraph [0013], “Such stents may be positioned within a wide variety of lumens, including for example … genitourinary (e.g., …prostate)”; paragraph [0054], “stents are used to open up and maintain the lumen of a diseased body passageway (e.g., … urinary tract) … a stent is inserted into body a lumen to physically hold open structures and/or passageways (typically tubular organ structures such as ... the urinary tract)"), neither Catanese nor Hunter explicitly discloses that the lead is sized and shaped for placement in a urethra so as to extend along the urethra to an exterior of the patent through an opening of the urethra near an end of a penis of a patient.
However, Tuseth further teaches that the lead is sized and shaped for placement in a urethra so as to extend along the urethra to an exterior of the patent through an opening of the urethra near an end of a penis of a patient (paragraph [0036], "the diameter of the electromagnetic coil ... may be in the range of 1-20 mm"; although Tuseth's device is intended to be implanted in the cardiovascular system, it is capable of being placed into a urethra).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Catanese and Hunter with the teachings of Tuseth to provide a lead sized and shaped for placement in a urethra so as to extend along the urethra because a lead of this size and shape may improve tolerance when aligning the receiving and transmitting coils, resulting in a simpler method of power transfer to the patient (Tuseth, paragraph [0036]), and further since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claims 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Catanese et al. (US 20170035410 A1, previously cited), hereinafter Catanese, in view of Hunter (US Publication No. 20160038087 A1, previously cited), and Skwarek et al. (US 20050096709 A1), hereinafter Skwarek.
Regarding claim 34, Catanese discloses an implant for placement in a prostate of a patient (Fig. 1B, paragraph [0047], retainer 10), comprising:
a tensioning support sized and shaped for placement in the prostate of the patient (Fig. 1B, paragraph [0047], retainer 10) to maintain a patency of a urethra along the prostate (Fig. 1B, paragraph [0047], "The distance or tension between the anchors is sufficient to compress, displace or change the orientation of an anatomical region between distal anchor 12 and proximal anchor 14"; paragraph [0107], "the present invention is used for the displacement, compression, and/or retraction of the prostate gland and the opening of the prostatic urethra"),
the tensioning support extending between a first anchor (Fig. 1B, paragraph [0047], "distal anchor 12 is located on the outer surface of the capsule of prostate gland CP and acts as a capsular anchor") and a second anchor(paragraph [0047], "proximal anchor 14 is located on the inner wall of urethra UT and acts as a urethral anchor") to draw a wall of the urethra toward the prostate to maintain the patency of the urethra (paragraph [0047], "Distal anchor 12 and proximal anchor 14 are implanted in the anatomy such that a desired distance or tension is created in connector 16. This causes distal anchor 12 and proximal anchor 14 to retract or compress a region of prostate gland PG to relieve the obstruction shown in FIG. 1A.");
a first sensor positioned on the tensioning support (paragraph [0112], "such sensors can be incorporated into the anchor assembly itself"), the first sensor configured to measure deflection of the tensioning support between the first anchor and the second anchor (paragraph [0112], " tension or depth feedback can be monitored by these sensors").
Catanese does not explicitly disclose a transmitter positioned on the tensioning support; a circuitry coupled to the at least one sensor and the transmitter, the circuitry configured to operate the transmitter to transmit signals from the at least one sensor to an exterior of the patient; nor that the deflection of the tensioning support is related to tissue growth within the prostate.
However, Hunter teaches an implantable stent with sensors positioned on the stent (Abstract) comprising:
a transmitter positioned on the stent (Fig. 8, paragraphs [0084], [0090], antenna);
a first sensor positioned on the stent, the first sensor configured to measure deflection of the stent between the first anchor and the second anchor (Fig. 1, paragraph [0055], contact sensors, position sensors, accelerometers, mechanical stress sensors, vibration sensors; paragraph [0063], "position sensors and accelerometers distributed throughout the stent capable of detecting deformation and kinking of the stent"), wherein the deflection of the tensioning support is related to tissue growth within the prostate (paragraph [0046], "stents are provided with a number of sensors to monitor ... the anatomy and pathology of the tissue surrounding the stent,... normal and abnormal healing of the tissues in contact with the stent, ... as well as to monitor the failure or impending failure of the stent due to a disease or other process (e.g., ...benign or malignant tumor growth)"; paragraph [0054], "Stent failure can be due to a multitude of causes but includes things such ... tissue ingrowth into the stent lumen (restenosis, tumor cell growth, inflammation)"; paragraph [0081], "Changes in the position of the accelerometers and/or motion sensors over time can be used as a measurement of changes in the position of the stent wall and/or vascular wall over time. Such positional changes can be used as a surrogate marker of vascular and stent anatomy—i.e. they can form an “image’ of the stent and/or vascular wall to provide information on the size, shape and location of restenosis within the stent; size, shape and location of clot formation, tumor growth, abscess formation"); and
a circuitry coupled to the first sensor and the transmitter, the circuitry configured to operate the transmitter to transmit signals from the first sensor to an exterior of the patient (Figs. 8-10, paragraphs [0084], [0087]-[0088], [0090]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Catanese with the teachings of Hunter so that the deflection of the tensioning support is related to tissue growth within the prostate, and so that the implant comprises a transmitter positioned on the tensioning support; a circuitry coupled to the at least one sensor and the transmitter, the circuitry configured to operate the transmitter to transmit signals from the at least one sensor to an exterior of the patient, because doing so provides important complementary clinical information to the doctor and can provide the patient with either an early warning indicator to seek assistance or to provide them with reassurance (Hunter, paragraph [0010]).
Neither Catanese nor Hunter explicitly discloses a plurality of electrodes configured for placement on a tissue of the patient, the plurality of electrodes configured to stimulate the tissue and comprising a first electrode positioned in proximity to the first anchor and a second electrode positioned in proximity to the second anchor.
However, Skwarek teaches a system for delivery of therapeutic stimulation pulses to a prostate gland of a patient (Fig. 1, paragraph [0027], system 10) comprising a plurality of electrodes configured for placement on a tissue of the patient, the plurality of electrodes configured to stimulate the tissue (Fig. 1, paragraph [0027], electrodes 16), wherein the plurality of electrodes are positioned on the prostate (paragraph [0036], "one or more electrodes may be positioned on or within the tissue of the prostate gland").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Catanese and Hunter with the teachings of Skwarek so that the system comprises a plurality of electrodes configured for placement on a tissue of the patient, the plurality of electrodes configured to stimulate the tissue, because doing so enables the system to provide neurostimulation treatment for sexual dysfunction, benign prostatic hyperplasia (BPH), or other prostate disorders (Skwarek, paragraph [0026]).
Skwarek does not explicitly disclose that the first electrode is positioned in proximity to the first anchor and the second electrode is positioned in proximity to the second anchor. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the electrodes to be located in proximity to the first and second anchors, because Skwarek discloses any of a variety of locations adjacent the prostate gland in order to target specific nerve locations to treat BPH or other urological or prostate disorders (paragraph [0036]), since such a modification would have involved a mere change in the form or shape of the implant components. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Furthermore, it is noted that there are no limitations in the system that structurally limits the electrodes to be implanted in this particular region. The location of implantation of the electrodes is considered to be intended use. The recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 35, the implant of claim 34 is obvious over Catanese, Hunter, and Skwarek, as explained above. Catanese further discloses that the first anchor is configured to be positioned at a capsule of the prostate (Fig. 1B, paragraph [0047], "distal anchor 12 is located on the outer surface of the capsule of prostate gland CP and acts as a capsular anchor").
Regarding claim 36, the implant of claim 34 is obvious over Catanese, Hunter, and Skwarek, as explained above. Catanese further discloses a second sensor configured to measure pressure (paragraph [0112], "one or more pressure sensors or sensors providing feedback on the state of deployment of the anchor assembly during delivery or after implantation are contemplated").
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
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, Jennifer McDonald can be reached at (571) 270-3061. 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.
/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796