DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/225, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 23 of U.S. Patent No. 9,220,897.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the below reasons:
The claims of ‘897 patent recites a stimulator/method comprising one or more electrodes, a first antenna configured to receive, from a second antenna through electrical radiative coupling, an input signal containing electrical energy and a circuit coupled to the first antenna and the electrodes and configured to generate electrical impulses suitable for modulation of neural tissue solely using energy contained in the input received wirelessly from the second antenna and to supply the electrical impulses to the one or more electrodes.
The present claims also recite one or more electrodes, a first antenna configured to receive, from a second antenna through electrical radiative coupling and input signal containing electrical energy and a circuit coupled to the first antenna and the one or more electrodes and configured to generate stimulation pulses to stimulate the tissue using the electrical energy contained in the input signal and to supply the stimulation pulses to the one or more electrodes but differs only in that the present claims recite do not require modulation of neural tissue solely using said electrical energy contained in the input signal.
The difference between the limitations of the present claims and claims of ‘897 do not render the claims patentably distinct and both claim sets would have been obvious to one of ordinary skill in the art because both claimed sets relate to the generation of electrical pulses using energy contained in an input signal received wirelessly from a second antenna. Accordingly, the claimed invention as a whole is considered to be an obvious variation of the invention claimed in the ‘897 patent and the present claims are not patentably distinct over those claims.
*The same analysis applies for the method claims between the present claims and the claims of patent ‘897.
Claims 2 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 19 of U.S. Patent No. 9,789,314.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the below reasons:
The claims of the ‘314 patent recite a stimulator/method comprising an enclosure housing the one or more electrodes, a first antenna configured to receive from a second antenna through electrical radiative coupling, an input signal containing electrical energy and one or more circuits coupled to the first antenna and the electrodes and configured to create one or more electrical pulses suitable for stimulation of neural tissue using the electrical energy contained in the input signal and supply the electrical impulses to the one or more electrodes.
The present claims also recite one or more electrodes, a first antenna configured to receive, from a second antenna through electrical radiative coupling and input signal containing electrical energy and a circuit coupled to the first antenna and the one or more electrodes and configured to generate stimulation pulses to stimulate the tissue using the electrical energy contained in the input signal and to supply the stimulation pulses to the one or more electrodes but differs only in that the present claims do not recite an enclosure housing said one or more electrodes, antenna and one or more circuits, wherein said enclosure is shaped and arranged for delivery into a subject’s body through an introducer or a needle.
The difference between the limitations of the present claims and claims of ‘314 do not render the claims patentably distinct and both claim sets would have been obvious variations to one of ordinary skill in the art because both claimed sets relate to the generation of electrical pulses using energy contained in an input signal received wirelessly from a second antenna. Accordingly, the claimed invention as a whole is considered to be an obvious variation of the invention claimed in the ‘314 patent and the present claims are not patentably distinct over those claims.
*The same analysis applies for the method claims between the present claims and the claims of patent ‘314.
Claims 2 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 18 of U.S. Patent No. 10,238,874.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the below reasons:
The claims of the ‘874 patent recite a stimulator/method comprising an enclosure shaped and configured for delivery, which further provides housing for the one or more electrodes, a first antenna configured to receive from a second antenna through electrical radiative coupling, an input signal containing electrical energy and a circuit coupled to the first antenna and the electrodes configured to create one or more electrical pulses suitable for modulation of neural tissue solely using the electrical energy contained in the input signal and supply the electrical impulses to the one or more electrodes.
The present claims also recite one or more electrodes, a first antenna configured to receive, from a second antenna through electrical radiative coupling and input signal containing electrical energy and a circuit coupled to the first antenna and the one or more electrodes and configured to generate stimulation pulses to stimulate the tissue using the electrical energy contained in the input signal and to supply the stimulation pulses to the one or more electrodes but differs only in that the present claims do not recite an enclosure housing said one or more electrodes, antenna and said circuit, wherein said enclosure is shaped and arranged for delivery into a subject’s body through an introducer or a needle and the generated electrical pulses of modulation are ‘solely’ using the electrical energy contained in the input signal.
The difference between the limitations of the present claims and claims of ‘874 do not render the claims patentably distinct and both claim sets would have been obvious variations to one of ordinary skill in the art because both claimed sets relate to the generation of electrical pulses using energy contained in an input signal received wirelessly from a second antenna. Accordingly, the claimed invention as a whole is considered to be an obvious variation of the invention claimed in the ‘874 patent and the present claims are not patentably distinct over those claims.
*The same analysis applies for the method claims between the present claims and the claims of patent ‘874.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 & 16 of U.S. Patent No. 11,872,400.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the below reasons:
The claims of the ‘400 patent recite a stimulator comprising one or more electrodes, a first antenna configured to receive from a second antenna through electrical radiative coupling, an input signal containing electrical energy and a circuit coupled to the first antenna and the electrodes configured to create one or more electrical pulses suitable to stimulate the neural tissue using the electrical energy contained in the input signal and supply the electrical impulses to the one or more electrodes, wherein the circuit is flexible and proximal relative to the electrodes (claim 1), wherein the implantable stimulator includes an enclosure and comprises a cylindrical or semi-cylindrical shape and the one or more electrodes are positioned along the enclosure (claim 6) and wherein the first antenna comprises an conductive trace (claim 16).
The present claims also recite one or more electrodes, a first antenna configured to receive, from a second antenna through electrical radiative coupling and input signal containing electrical energy and a circuit coupled to the first antenna and the one or more electrodes and configured to generate stimulation pulses to stimulate the tissue using the electrical energy contained in the input signal and to supply the stimulation pulses to the one or more electrodes but differs only in that the present claims do not recite the circuit being flexible and placed proximal, having an enclosure comprising a cylindrical or semi-cylindrical shape and one or more electrodes positioned along the enclosure and said first antenna comprising a conductive shape.
The difference between the limitations of the present claims and claims of ‘400 do not render the claims patentably distinct and both claim sets would have been obvious variations to one of ordinary skill in the art because both claimed sets relate to the generation of electrical pulses using energy contained in an input signal received wirelessly from a second antenna. Accordingly, the claimed invention as a whole is considered to be an obvious variation of the invention claimed in the ‘400 patent and the present claims are not patentably distinct over those claims.
And;
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 2 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 2 of prior U.S. Patent No. 10,953,228. This is a statutory double patenting rejection.
Claim 2 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 17 of prior U.S. Patent No. 11,872,400. This is a statutory double patenting rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 2, 4-9, 12-13, 16-19 & 21 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Hastings et al. (US 2009/0234407).
Hastings et al. discloses;
2.
An implantable stimulator comprising: one or more electrodes configured to apply one or more stimulation pulses to tissue;
E.G. via the disclosed electrostimulation assembly 210/440 including the stimulation electrode assembly 401 {[0055], [0106] & (Fig 4A-4D)}.
a first antenna configured to receive, from a second antenna through electrical radiative coupling, an input signal containing electrical energy, the second antenna being physically separate from the implantable stimulator;
E.G. via the disclosed communication 214b captured by the electrode assembly 210 by using the inductive pick up 212 {[0056, [0059] & (Fig 2)} and the inductive antenna 206, which is separate from the wireless electrostimulation electrode assembly and said inductive pick up {[0052], [0056]-[0057] & (Fig 2)}.
and a circuit coupled to the first antenna and the one or more electrodes and configured to generate the stimulation pulses suitable to stimulate the tissue using the electrical energy contained in the input signal and to supply the stimulation pulses to the one or more electrodes.
E.G. via the disclosed stimulus control logic 216, blocking device 218 and shunt device 219, which form a network configured to select and adjustably program a desired electrostimulus waveform via the inductive pick up 212 and the coupled electrostimulus electrodes {[0060]-[0064] & (Fig 2)}.
4.
The implantable stimulator of claim 2, further comprising a lumen configured to accommodate a navigating stylet.
E.G. via the disclosed electrostimulation electrode assemblies to pass through the lumen of a delivery catheter [0101].
5.
The implantable stimulator of claim 2, further comprising: one or more antenna coupling contacts, and wherein: the circuit includes waveform conditioning circuitry, the one or more antenna coupling contacts are connected by one or more conducting wires to the first antenna and the waveform conditioning circuitry, and the waveform conditioning circuitry uses the electrical energy contained in the input signal to create the stimulation pulses for application at the one or more electrodes to stimulate the tissue.
E.G. via the disclosed stimulus control logic 216, blocking device 218 and shunt device 219, which form a network configured to select and adjustably program a desired electrostimulus waveform via the inductive pick up 212 and the coupled electrostimulus electrodes {[0060]-[0064] & (Fig 2)}.
6.
The implantable stimulator of claim 5, wherein the waveform conditioning circuitry includes diodes, resisters, and/or capacitors.
E.G. via the disclosed blocking device 218 and shunting device 219 being in the form of circuitry elements including an capacitor and resistor {[0063] & (Fig 2)}.
7.
The implantable stimulator of claim 2, wherein the implantable stimulator has a cylindrical or semi-cylindrical shape.
E.G. via the disclosed electrostimulation electrode assembly 440 being ‘shaped’ and/or captured by a cylindrically shaped delivery catheter {[0106] & (Figs. 4A-4D)}.
8.
The implantable stimulator of claim 7, further comprising an external coating of biocompatible polymer, the biocompatible polymer includes at least one of: polymethymethacrylate (PMMA), polydimethylsiloxane (PDMS), parylene, polyurethance, polytetrafluoroethylene (PTFE), or polycarbonate.
E.G. [0106].
9.
The implantable stimulator of claim 2, wherein the one or more electrodes comprise a cylindrical or semi-cylindrical array of one or more electrodes.
E.G. via the disclosed shape of the electrodes, such as the first electrode 150 and the second electrode 160, {[0051] & (Fig 1)}.
12.
The implantable stimulator of claim 2, wherein the one or more electrodes comprise of at least one of: platinum, platinum-iridium, gallium-nitride, titanium-nitride, iridium-oxide, or combinations thereof.
E.G. [0120].
13.
The implantable stimulator of claim 2, wherein the circuit is flexible and placed proximal to the one or more electrodes.
E.G. via the disclosed electrostimulation electrode assembly 401, which includes an electrostimulation circuit 440, wherein said assembly is further designed to folded, compressed or collapsed into a ‘less area’ configuration [0106].
15.
The implantable stimulator of claim 2, wherein the circuit further comprises charge balance circuitry and isolation circuitry.
E.G. via the disclosed shunt device 219 that can provide charge neutralization [0096].
16.
The implantable stimulator of claim 2, wherein the tissue is associated with a spinal column.
E.G. via the disclosed ability of the electrostimulation electrode assemblies being able to be used in other locations within a patient such as through modulation of one or more neurological pathways [0140].
17.
The implantable stimulator of claim 2, wherein the first antenna comprises a conductive trace.
E.G. [0052].
18.
The implantable stimulator of claim 2, wherein the first antenna comprises a conductive wire.
E.G. [0052].
19.
A method comprising: receiving, at a first antenna associated with an implantable stimulator from a second antenna via electrical radiative coupling, an input signal containing electrical energy such that stimulation pulses, generated from the electrical energy, are supplied to one or more electrodes of the implantable stimulator and applied to tissue in a patient.
E.G. via the disclosed method receiving wireless energy using a wireless electrostimulation electrode assembly and delivering at least some of the received wireless energy via stimulus control logic 216, blocking device 218 and shunt device 219, which form a network configured to select and adjustably program a desired electrostimulus waveform via the inductive pick up 212 and the coupled electrostimulus electrodes {[0022], [0060]-[0064] & (Fig 2)}.
21.
A system comprising: an implantable stimulator including: one or more electrodes configured to apply one or more stimulation pulses to tissue,
a first antenna configured to receive, from a second antenna through electrical radiative coupling, an input signal containing electrical energy, the second antenna being physically separate from the implantable stimulator,
E.G. via the disclosed communication 214b captured by the electrode assembly 210 by using the inductive pick up 212 {[0056, [0059] & (Fig 2)} and the inductive antenna 206, which is separate from the wireless electrostimulation electrode assembly and said inductive pick up {[0052], [0056]-[0057] & (Fig 2)}.
and a circuit coupled to the first antenna and the one or more electrodes and configured to generate the stimulation pulses suitable to stimulate the tissue using the electrical energy contained in the input signal and to supply the stimulation pulses to the one or more electrodes;
E.G. via the disclosed stimulus control logic 216, blocking device 218 and shunt device 219, which form a network configured to select and adjustably program a desired electrostimulus waveform via the inductive pick up 212 and the coupled electrostimulus electrodes {[0060]-[0064] & (Fig 2)}.
and an external device including the second antenna configured to transmit, through electrical radiative coupling, the input signal to the first antenna.
E.G. via the disclosed controller/transmitter 320 that includes one or more wireless couplings to the wireless electrostimulation electrode assemblies {[0098] & (Fig 3)}.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 3 & 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hastings et al. (US 2009/0234407) in view of one having ordinary skill in the art.
Hastings et al. discloses the steps of steering, introducing, advancing, etc. a delivery catheter to a location within the heart of a patient, wherein the electrostimulation electrode assembly is housed within said catheter [0106], in which the examiner is interpreting the disclosed delivery catheter introduced into the patient as providing the claimed introducer, except said delivery catheter performing the claimed introducer does not have a diameter no larger than gauge 13. It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize a delivery catheter having a diameter no larger than gauge 13, 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).
Claims 10-11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hastings et al. (US 2009/0234407) in view of one having ordinary skill in the art.
Hastings et al. discloses an electrostimulation electrode assembly 401 comprising one or more electrodes sized in order to be delivered, introduced and/or advanced to an implant location 402 [0106] except wherein said electrodes are explicitly one to sixteen electrodes and have a longitudinal length of about 1.0 to 6.0 mm and a width of about 0.4 to 3.0 mm and are between about 1 mm to 6 mm apart and have a combined surface area of between about 0.8 mm² to 60.00 mm². It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the electrostimulation electrode assembly with utilizing one to sixteen electrodes and have a longitudinal length of about 1.0 to 6.0 mm and a width of about 0.4 to 3.0 mm and are between about 1 mm to 6 mm apart and have a combined surface area of between about 0.8 mm² to 60.00 mm², 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/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hastings et al. (US 2009/0234407) in view of one having ordinary skill in the art.
Hastings et al. discloses an electrostimulation electrode assembly 401, which includes an electrostimulation circuit 440, wherein said assembly is further designed to folded, compressed or collapsed into a ‘less area’ configuration, therefore providing the claimed circuit that is sufficiently flexible to bend [0106], except wherein said flexible circuit explicitly is flexible to bend over a radius under 0.5mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize a delivery catheter having a diameter no larger than gauge 13, 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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/NICOLE F JOHNSON/ Primary Examiner, Art Unit 3796