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 .
Status of Claims
Claims 1-20 are currently pending and under investigation.
Claim Objections
Claim 18 objected to because of the following informalities: “impedes relative movement between wherein the leadless neurostimulation device and the patient tissue when implanted” contains grammar that is difficult to understand. Examiner recommends amending the claim to recite “impedes relative movement between the leadless neurostimulation device and the patient tissue when implanted”. 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 6-8, 10, 11, 13, and 19 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.
The term “about” in claims 6-8, 11, 13, and 19 is a relative term which renders the claim indefinite. The term “about” 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 what the bounds of “about” entail, whether that is +/- 5% of +/-15% of the claimed range. For example, a limitation of “about 5 mm to 10 mm” renders it difficult to understand whether this range could include +/- 1 mm or +/- 5 mm. An appropriate definition of the implications of “about” or removal of the relative term “about” is recommended. Claims 10 and 20 are also indefinite for the same reasons set forth for claims 6 and 19, respectively.
Claim 10 recites the limitation "the dielectric surface treatment" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 9, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Min et. al, (US 8831747 B1, published 09/09/2014, hereinafter known as Min).
Regarding claim 1, Min discloses a leadless neurostimulation device (“a leadless neurostimulation (NS) device is provided” Col. 16, lines 7-8) comprising:
a header unit (body end 204 as shown in annotated Fig. 3 below) comprising:
at least one primary electrode having a contact surface that defines an external surface of the leadless neurostimulation device (electrode 230 as shown in annotated Fig. 3 below, Col. 8, lines 47-57); and
a housing (body side 208 as shown in annotated Fig. 4 below) comprising a secondary electrode positioned on the same side of the leadless neurostimulation device as the at least one primary electrode (electrode 230A as shown in annotated Fig. 3 below), wherein the at least one primary electrode and the secondary electrode are configured to transmit an electrical stimulation signal therebetween to provide electrical stimulation therapy to a target nerve of a patient (“the NS device also includes electrodes forming a multi-electrode array along the active side of the device body…the multi-electrode array is configured to interface with nervous tissue in an epidural space of a patient and generate electric fields along the nervous tissue” Col. 2, lines 10-14).
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Regarding claim 9, Min discloses a dielectric coating or a dielectric surface treatment that electrically insulates (“the device body may include one or more insulative materials” Col. 9, lines 2-3) at least one primary electrode from the secondary electrode along an exterior surface of the device (electrodes are electrically coupled to the electronic sub-system or, more specifically, the switching circuitry through a plurality of wire conductors”, as shown in Fig. 3, the wire conductors 240 separate the primary electrodes from the secondary electrodes along the surface of the device, Col. 9, lines 23-25).
Regarding claim 12, Min discloses a mounting plate (device body 202 as shown in Fig. 3), wherein the housing is coupled to a first side of the mounting plate (housing 210 coupled to first body side as shown in Fig. 3) and the header unit is coupled to a second side of the mounting plate (header 204 coupled to second body side as shown in Fig. 3).
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Min in light of Kondabatni et al. (US 20130338747 A1, published 12/19/2013, hereinafter known as Kondabatni).
Regarding claim 2, Min discloses a leadless neurostimulation device of claim 1 above. Min discloses the header unit further comprises an outer housing (body side 210 as shown in annotated Fig. 4 above) that forms a side of the header unit opposite of the contact surface of the primary electrode (as shown in annotated Fig. 4 above); and a mount (“the device body may include one or more insulative materials…non-limiting examples of such materials include polyimide, polyetheretherketone (PEEK), polyethylene terephthalate (PET) film (also known as polyester or Mylar), polytetrafluoroethylene (PTFE) (e.g., Teflon), or parylene coating, polyether bloc amides, polyurethane”, all materials listed are commonly known in the art to be dielectric, Col. 9, lines 2-8) device body comprising that receives at least a portion of the at least one primary electrode and at least partially surrounds the at least one primary electrode (“electrodes and an electronic sub-system that are coupled to the device body…electrodes and the electronic sub-system are at least partially embedded within the device body” Col. 8, lines 49-51).
For the limitation of dielectric mount, the insulative polymeric materials, PEEK, PET, and PTFE of Min are dielectric as evidenced by Kondabatni [0260].
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.
Claim 3 is rejected under 35 U.S.C. as being unpatentable over Min in light of Kondabatni and further in view of Tischendorf et. al (US 20180168564 A1, published 06/21/2018, hereinafter known as Tischendorf).
Regarding claim 3, Min in light of Kondabatni discloses a leadless neurostimulation device of claim 2 above. However, Min in light of Kondabatni do not teach wherein the dielectric mount is configured to electrically insulate the at least one primary electrode from the outer housing, the dielectric mount being received and fixed within a recessed portion of the outer housing.
However, Tischendorf teaches neuromodulation therapy is delivered via at least one electrode implanted subcutaneously and superficially to a fascia layer superficial to a nerve of a patient (Abstract). Lead is tethered to the housing via an electrically insulated, sealed feedthrough [0160]. The distal portion includes a bottom recessed surface for receiving IMD…IMD retaining sleeve extends through bracket to distal tool end to secure IMD between recessed surface and a top surface of sleeve [0111].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the dielectric mount and recessed portion of the housing of Tischendorf with the Min in light of Kondabatni because dielectric insulators very effectively store electrical energy which is useful in neurostimulation.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Min.
Regarding claim 4, Min discloses a leadless neurostimulation device of claim 1 above. Min further discloses wherein the header unit comprises two to four primary electrodes each having a contact surface that forms an exterior surface of the header unit (electrodes 230 as shown below in annotated Fig. 3). According to MPEP 2144.05, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists in the absence of criticality.
The specification discloses the appropriate ranges that apply to the claimed amount of primary electrodes in claim 4 of the applicant’s printed publication. However, the specification does not disclose that the specifically claimed range(s) of primary electrodes is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
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Claims 5, 7, 10, 14-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Tischendorf.
Min discloses a leadless neurostimulation device of claims 1 and 4 above.
Regarding claim 5, Min does not teach at least one of the two to four primary electrodes is configured to sense a relative location of a tibial nerve prior to delivery of stimulation therapy.
However, Tischendorf teaches in some embodiments tool and other delivery tools described herein may include nerve locating electrodes for identifying a nerve location prior to fixation of IMD at an implant site [0113]. The minimally invasive IMD signal generating portion may be located superficial to the deep fascia near the tibial nerve and one or more stimulating electrodes delivering an IMD generated signal pierce or pass through the deep fascia, allowing the stimulating electrode to be located near or adjacent the tibial nerve [0086].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the modulation of the tibial nerve of Tischendorf with the leadless neurostimulation device of Min because the IMD can provide numerous types of neurostimulation therapies, such as for pain control, autonomic nervous system modulation, functional electrical stimulation, tremor, and more (Tischendorf, [0079]).
Regarding claim 7, Min does not teach wherein the at least one primary electrode and the secondary electrode define a separation distance of about 10 mm to about 20 mm.
However, Tischendorf teaches lead includes one or more electrodes spaced apart and typically carried near a distal lead end…lead is not more than approximately 5 cm in length. In another example, lead is less than approximately 2 cm in length. In yet another example, lead is approximately 1 cm in length or less [0160].
The specification discloses the appropriate ranges that apply to the claimed lead spacing in [0052] of the specification of the applicant’s printed publication. However, the specification does not disclose that the specifically claimed range(s) of lead spacing is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
Because Applicants fail to disclose that the claimed range of lead spacing provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art recognizes stimulation duration is a result effective variable, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range of lead spacing by normal optimization procedures known in the neurostimulation arts.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the lead spacing of Tischendorf with the leadless neurostimulation device of Min because proper spacing of electrodes has an effect on the efficacy of a neurostimulator.
Regarding claim 10, Min discloses a boundary defined by the dielectric coating or the dielectric surface treatment defines the secondary electrode (wire conductors 240 as shown above in Fig. 3 define the boundary between primary electrodes 230 and secondary electrodes 230a).
Regarding claim 14, Min teaches a leadless neurostimulation device (“a leadless neurostimulation (NS) device is provided” Col. 16, lines 7-8) comprising:
a header unit (body end 204 as shown in annotated Fig. 3 above) comprising:
at least one primary electrode having a contact surface that defines an external surface of the leadless neurostimulation device (electrode 230 as shown in annotated Fig. 3 above, Col. 8, lines 47-57); and
a housing (body side 208 as shown in annotated Fig. 4 above) comprising a secondary electrode positioned on the same side of the leadless neurostimulation device as the at least one primary electrode (electrode 230A as shown in annotated Fig. 3 above), wherein the at least one primary electrode and the secondary electrode are configured to transmit an electrical stimulation signal therebetween to provide electrical stimulation therapy to a target nerve of a patient (“the NS device also includes electrodes forming a multi-electrode array along the active side of the device body…the multi-electrode array is configured to interface with nervous tissue in an epidural space of a patient and generate electric fields along the nervous tissue” Col. 2, lines 10-14).
Min does not teach a suture anchor device comprising at least one suture point for securing the leadless neurostimulation device to patient tissue.
However, Tischendorf teaches a proximal end of elongate body, which can be threaded through an eye of a surgical needle, may be anchored in tissue near tab using a suture stitch that allows elongate body to be pulled in the proximal direction, tightened across top surface, and subsequently knotted or clipped to hold bottom face securely against the tissue layer by elongate body [0132].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the suture anchor tab of Tischendorf with the leadless neurostimulation device of Min because this leaves the IMD stably anchored at the implant site (Tischendorf, [0116]).
Regarding claim 15, Min does not teach wherein the housing comprises a tubular body and an endcap coupled together, wherein the endcap comprises the suture anchor device.
However, Tischendorf teaches IMD includes a sealed housing, which may include an end cap bonded or welded to a first housing end [0162]. IMD housing has a generally circular cross-section [0163].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the sealed circular housing with an end cap of Tischendorf with the leadless neurostimulation device of Min because an end cap seals and protects joints or seams of the housing (Tischendorf, [0162]).
Regarding claim 17, Min does not teach wherein the suture anchor device comprises at least one suture point arranged flush with a side of the suture anchor device that is on the same side of the leadless neurostimulation device as the secondary electrode.
However, Tischendorf teaches a fixation member is provided at a single end of IMD corresponding to a location of electrodes [0119]. Tabs include an inner surface defining an aperture through which a housing fixation member can be threaded…elongate body is threaded through apertures of tabs such that a portion of body extends along top face [130], Fig. 13.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the orientation of the suture anchor tab of Tischendorf with the leadless neurostimulation device of Min because this leaves the IMD stably anchored at the implant site (Tischendorf, [0116]).
Regarding claim 18, Min does not teach the leadless neurostimulation device or the suture anchor device further comprises at least one protrusion nub configured to create mechanical resistance that impedes relative movement between wherein the leadless neurostimulation device and the patient tissue when implanted.
However, Tischendorf teaches the normally flared position may correspond to the position shown in FIG. 12 and generally described above in conjunction with FIG. 10, though other positions may be taken which effectively secure fixation member under or within a tissue layer to resist movement of IMD…post will bend such that a descending portion bends or curves into a lateral portion that approaches a plane parallel to bottom face [0127].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the protrusion post of Tischendorf with the leadless neurostimulation device of Min because it not only reduces movement between the IMD and the patient tissue during implantation, it also may then function both as an electrode for delivering a neurostimulation therapy and a fixation member (Tischendorf, [0093]).
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Li et. al (US 20190030346 A1, published 01/31/2019, hereinafter known as Li).
Min discloses a leadless neurostimulation device of claim 1 above.
Regarding claim 6, Min does not teach wherein the contact surface of the at least one primary electrode is about 20 mm2 to about 25 mm2.
However, Li teaches devices and methods for a leadless implantable medical device (LIMD) comprising a housing (Abstract). The dome shaped pacing electrode can include a diameter of about 1.5-2.5 mm and can protrude distally from the end of the pacemaker approximately 0.05″ to 0.3 (meaning a contact surface area of approximately 14-40mm^2) [0033].
The specification discloses the appropriate ranges that apply to the claimed contact surface area in [0048] of the specification of the applicant’s printed publication. However, the specification does not disclose that the specifically claimed range(s) of contact surface area is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
Because Applicants fail to disclose that the claimed range of contact surface area provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art recognizes stimulation duration is a result effective variable, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range of contact surface area by normal optimization procedures known in the neurostimulation arts.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the contact surface area of Li with the leadless neurostimulation device of Min because increased contact surface area of an electrode increases the amount of electrical current that can reach the target nerve.
Regarding claim 8, Min does not teach wherein the secondary electrode defines a contact surface area of about 40 mm2 to about 120 mm2.
However, Li teaches devices and methods for a leadless implantable medical device (LIMD) comprising a housing (Abstract). The dome shaped pacing electrode can include a diameter of about 1.5-2.5 mm and can protrude distally from the end of the pacemaker approximately 0.05″ to 0.3 (meaning a contact surface area of approximately 14-40mm^2) [0033].
The specification discloses the appropriate ranges that apply to the claimed contact surface area in [0048] of the specification of the applicant’s printed publication. However, the specification does not disclose that the specifically claimed range(s) of contact surface area is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
Because Applicants fail to disclose that the claimed range of contact surface area provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art recognizes stimulation duration is a result effective variable, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range of contact surface area by normal optimization procedures known in the neurostimulation arts.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the contact surface area of Li with the leadless neurostimulation device of Min because increased contact surface area of an electrode increases the amount of electrical current that can reach the target nerve.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Lim et. al, (US 20190232066 A1, published 08/01/2019, hereinafter known as Lim).
Regarding claim 11, Min discloses a leadless neurostimulation device of claim 1 above. Min does not disclose the device defines a total volume of about 0.5 cubic centimeters (cc) to about 5 cc.
However, Lim teaches the IMD (implantable medical device) may be configured to be relatively small (e.g., between 2-10 cc in volume) [0040]. While the dimensions, types of materials and coatings described herein are intended to define various parameters, they are by no means limiting and are illustrative in nature [0099].
The specification discloses the appropriate ranges that apply to the claimed device volume in [0048] of the specification of the applicant’s printed publication. However, the specification does not disclose that the specifically claimed range(s) of device volume is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
Because Applicants fail to disclose that the claimed range of device volume provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art recognizes stimulation duration is a result effective variable, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range of device volume by normal optimization procedures known in the neurostimulation arts.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the volumetric range of Lim with the leadless neurostimulation device of Min because this will reduce risk of infection during implant procedure, afford the use of a small incision, afford the use of a smaller subcutaneous pocket and the like. The small footprint may also reduce implant time and introduce less change in body image for patients (Lim, [0040]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Faltys et. al (US 20170209705 A1, published 07/27/2017, hereinafter known as Faltys).
Regarding claim 13, Min discloses a leadless neurostimulation device of claim 1 above. Min does not disclose at least one primary electrode is sized and shaped to have an impedance of about 200 ohms to about 2,000 ohms when the leadless neurostimulation device is implanted.
However, Faltys teaches a leadless, implantable microstimulator devices (neurostimulators) for treating chronic inflammation [0013]. The bipolar impedances of the electrodes may be less than 1000 ohms [0101].
According to MPEP 2144.05, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. The instant specification does not disclose any criticality associated with the claimed range of impedance. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the impedance as described by Flatys in the system/method of Min, since Flatys teaches an overlapping range of an impedance of less than 1000 ohms would provide the predictable results of the implantable neurostimulation device as described in the present invention.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Tischendorf (hereinafter known as the modified Min) as applied to claim 14 above, and further in view of Olson (US 20060173520 A1, published 08/03/2006).
Modified Min discloses a leadless neurostimulation device of claim 14 above.
Regarding claim 16, modified Min do not teach wherein the suture anchor device comprises a flexible endcap configured to receive a portion of the housing.
However, Olson teaches an exemplary embodiment of a neurostimulation or drug delivery system used to provide therapy [0015]. Soft, flexible ends (reference number 130 in Fig. 8) may be provided on the ends of the end caps (reference number 114 in Fig. 8).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the flexible end cap of Olson with the modified Min in order to mitigate potential lead issues related to bending of the lead as it enters the fascia (Olson, [0040]).
Claims 19 and 20 is rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Tischendorf and Lim and further evidenced by Kondabatni.
Regarding claim 19, Min teaches a leadless neurostimulation device (“a leadless neurostimulation (NS) device is provided” Col. 16, lines 7-8) comprising:
a header unit (body end 204 as shown in annotated Fig. 3 above) comprising:
at least one primary electrode having a contact surface that defines an external surface of the leadless neurostimulation device (electrode 230 as shown in annotated Fig. 3 above, Col. 8, lines 47-57);
an outer housing (body side 210 as shown in annotated Fig. 4 above) that forms a side of the header unit opposite of the contact surface of the primary electrode (as shown in annotated Fig. 4 above); and
a mount that receives at least a portion of the at least one primary electrode and at least partially surrounds the at least one primary electrode (“electrodes and an electronic sub-system that are coupled to the device body…electrodes and the electronic sub-system are at least partially embedded within the device body” Col. 8, lines 49-51)
a housing (body side 208 as shown in annotated Fig. 4 above) comprising a secondary electrode positioned on the same side of the leadless neurostimulation device as the at least one primary electrode (electrode 230A as shown in annotated Fig. 3 above), wherein the at least one primary electrode and the secondary electrode are configured to transmit an electrical stimulation signal therebetween to provide electrical stimulation therapy to a target nerve of a patient (“the NS device also includes electrodes forming a multi-electrode array along the active side of the device body…the multi-electrode array is configured to interface with nervous tissue in an epidural space of a patient and generate electric fields along the nervous tissue” Col. 2, lines 10-14);
dielectric coating or a dielectric surface treatment that electrically insulates (“the device body may include one or more insulative materials…non-limiting examples of such materials include polyimide, polyetheretherketone (PEEK), polyethylene terephthalate (PET) film (also known as polyester or Mylar), polytetrafluoroethylene (PTFE) (e.g., Teflon), or parylene coating, polyether bloc amides, polyurethane”, all materials listed are commonly known in the art to be dielectric, Col. 9, lines 2-8) at least one primary electrode from the secondary electrode along an exterior surface of the device (electrodes are electrically coupled to the electronic sub-system or, more specifically, the switching circuitry through a plurality of wire conductors”, as shown in Fig. 3, the wire conductors 240 separate the primary electrodes from the secondary electrodes along the surface of the device, Col. 9, lines 23-25), wherein a boundary defined by the dielectric coating or the dielectric surface treatment defines the secondary electrode (wire conductors 240 as shown above in Fig. 3 define the boundary between primary electrodes 230 and secondary electrodes 230a). For the limitation of dielectric coating or a dielectric surface treatment, the insulative polymeric materials, PEEK, PET, and PTFE of Min are dielectric as evidenced by Kondabatni [0260].
Min does not disclose a suture anchor device comprising at least one suture point for securing the leadless neurostimulation device to patient tissue,
wherein the at least one primary electrode and the secondary electrode define a separation distance of about 10 mm to about 20 mm.
However, Tischendorf teaches a proximal end of elongate body, which can be threaded through an eye of a surgical needle, may be anchored in tissue near tab using a suture stitch that allows elongate body to be pulled in the proximal direction, tightened across top surface, and subsequently knotted or clipped to hold bottom face securely against the tissue layer by elongate body [0132]. Lead includes one or more electrodes spaced apart and typically carried near a distal lead end…lead is not more than approximately 5 cm in length. In another example, lead is less than approximately 2 cm in length. In yet another example, lead is approximately 1 cm in length or less [0160].
The specification discloses the appropriate ranges that apply to the claimed lead spacing in [0052] of the specification of the applicant’s printed publication. However, the specification does not disclose that the specifically claimed range(s) of lead spacing is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
Because Applicants fail to disclose that the claimed range of lead spacing provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art recognizes stimulation duration is a result effective variable, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range of lead spacing by normal optimization procedures known in the neurostimulation arts.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the suture anchor tab and lead spacing of Tischendorf with the leadless neurostimulation device of Min because this leaves the IMD stably anchored at the implant site and proper spacing of electrodes has an effect on the efficacy of a neurostimulator (Tischendorf, [0116]).
Min in view of Tischendorf do not disclose the leadless neurostimulation device defining a total volume of about 1.5 cubic centimeters (cc) to about 3.5 cc.
Lim teaches the main body, including the platform (reference number 150 in Fig. 3), is formed of ceramic which has a relatively high dielectric constant [0069]. The IMD (implantable medical device) may be configured to be relatively small (e.g., between 2-10 cc in volume) [0040]. While the dimensions, types of materials and coatings described herein are intended to define various parameters, they are by no means limiting and are illustrative in nature [0099].
According to MPEP 2144.05, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. The instant specification does not disclose any criticality associated with the claimed range of volume. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the IMD volume of Lim in the system/method of Min, since Lim teaches an overlapping range of 2-10 cc in volume would provide the predictable results of the implantable neurostimulation device as described in the present application.
Regarding claim 20, Min does not teach wherein the housing comprises a tubular body and an endcap coupled together, wherein the endcap comprises the suture anchor device.
However, Tischendorf teaches IMD includes a sealed housing, which may include an end cap bonded or welded to a first housing end [0162]. IMD housing has a generally circular cross-section [0163].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the sealed circular housing with an end cap of Tischendorf with the leadless neurostimulation device of Min because an end cap seals and protects joints or seams of the housing (Tischendorf, [0162]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/F.M.K./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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