DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 16/132,530 (now US 12,214,198); 14/336,688 (now US 10,076,663); 13/309,107 (now US 8,788,047) fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. There is no support for the limitation of “helically coiled lead” or “coiled lead” in the prior-filed applications.
Therefore, for the purposes of prior art, the effective priority filing date is the filing date of the instant application, February 3, 2025.
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/25, 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 1 and 3-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,076,562 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because US 12,076,562 has been found to anticipate each and every element of the present invention of claim 1, for instance both provide:
19/043,657 (claim 1)
US 12,076,562 B2
A system to reduce a perception of pain, the system comprising:
electrical stimulation is applied for a treatment time to relieve pain (claim 6).
a helically coiled lead;
helically coiled percutaneous lead (claim 3)
a single contact electrode extending from the helically coiled lead,
a lead comprising an electrode (claim 1); electrode is a single contact electrode (claim 2)
the single contact electrode insertable into the patient; and
the electrode is at a therapeutically effective distance from a target efferent nerve fiber (claim 1);
and an electrical stimulator operatively coupled with the helically coiled lead,
electrically stimulating is performed by an electrical stimulation device (claim 4)
the electrical stimulator electrically stimulating through the single contact electrode a plurality of target efferent motor nerve fibers to generate an action potential in the plurality of target efferent motor nerve fibers while avoiding generation of action potentials in small sensory nerve fibers
and electrically stimulating through the electrode the target efferent nerve fiber to induce an action potential in the target efferent nerve fiber while avoiding generation of action potentials in a non-target nerve fiber, wherein the target efferent nerve fiber is neurologically upstream from a perceived point of pain (claim 1)
wherein the electrical stimulator applies electrical stimulation having an intensity of 0.01-200 mA and a frequency of 0.05-40 Hz.
(claims 9-13)
As set forth above, the present invention of claim 1 is not viewed to be patentably distinct from US 12,076,562 B2.
Claims 1 and 3-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,668,285 B2.
19/043,657 (claim 1)
US 10,668,285 B2 (claim 20)
A system to reduce a perception of pain, the system comprising:
A system for reducing and/or relieving pain in a painful region comprising:
a helically coiled lead;
a percutaneous open-core coiled (open-core coiled is “helically coiled”) fine wire lead
a single contact electrode extending from the helically coiled lead,
a percutaneous open-core coiled fine wire lead having a monopolar electrode
the single contact electrode insertable into the patient; and
to apply stimulation to a spinal nerve innervating a painful region perceived by a patient with the monopolar electrode inserted into muscle tissue
and an electrical stimulator operatively coupled with the helically coiled lead,
an external stimulating device operatively coupled with the percutaneous open-core coiled fine wire lead
the electrical stimulator electrically stimulating through the single contact electrode a plurality of target efferent motor nerve fibers to generate an action potential in the plurality of target efferent motor nerve fibers while avoiding generation of action potentials in small sensory nerve fibers
the monopolar electrode inserted into muscle tissue that is: ii) spaced from the spinal nerve to recruit target fibers in the spinal nerve while minimizing recruitment of non-target fibers in the spinal nerve,
As stated above, US 10,668,285 B2 has been found to anticipate each and every element of the present invention, as detailed above, but does not explicitly disclose “wherein the electrical stimulator applies electrical stimulation having an intensity of 0.01-200 mA and a frequency of 0.05-40 Hz”. Balzer et al. et al. discloses “The particular waveform of the stimuli depends upon the symptoms of the particular patients. In one embodiment, the stimulus can have a waveform with a current of approximately 0.5 mA to 10 mA, a pulse duration of approximately 20 microseconds-500 milliseconds, and a frequency of approximately 10 Hz-200 Hz” ([0038]). Therefore, Balzer et al. discloses “electrical stimulator applies electrical stimulation having an intensity of 0.01-200 mA and a frequency of 0.05-40 Hz ([0038-0041]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stimulation parameters and electrode contact surface area of US 10,668,285 to “electrical stimulation having an intensity of 0.01-200 mA and a frequency of 0.05-40 Hz in order to provide the predictable results of optimizing treatment to meet specific patient therapeutic needs and requirements (Balzer et al., [0038]).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 19-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 11, from which claims 19 and 20 depend, recites “the electrical stimulator applies electrical stimulation having an intensity of 0.01-200 mA and a frequency of 0.05-40 Hz”.
Therefore, claim 19 now reciting “wherein the electrical stimulation comprises a frequency of 1 Hz to about 300 Hz” fails to include all the limitations of the claim upon which it depends and claim 20 reciting “wherein the electrical stimulation comprises a frequency of 0.05-40 Hz” fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 1-20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Boggs et al. (US 2018/0236222 A1).
As to claim 1, Boggs et al. discloses a system to reduce a perception of pain (Abstract) comprising: a helically coiled lead ([0256]; Figure 20); a single contact electrode extending from the helically coiled lead ([0256]; Figure 20), the single contact electrode insertable into a patient ([0161, 0163-0165, 0171]; Figure 11C); and an electrical stimulator (depicted as 28 in Figures 11A, 11C, 16B and 17B; [0181-0182]) operatively coupled with the helically coiled lead ([0161, 0163-0165]; Figure 11C), the electrical stimulator electrically stimulating through the single contact electrode a plurality of target efferent motor nerve fibers to generate an action potential in the plurality of target efferent motor nerve fibers while avoiding generation of action potentials in small sensory nerve fibers ([0161, 0163-0165, 0286]; Figure 11C), wherein the electrical stimulator applies electrical stimulation having an intensity of 0.01-200 mA and a frequency of 0.05-40 Hz ([0234-0237]).
As to claim 2, Boggs et al. discloses the single contact electrode has a surface area of approximately 20 mm.sup.2 ([0241]).
As to claim 3, Boggs et al. discloses the helically coiled lead is configured to be percutaneously inserted into the patient (Figure 11C; [0191, 0195, 0204]).
As to claim 4, Boggs et al. discloses the electrical stimulator is an external electrical stimulator (Figure 11C; [0205, 0208, 0216]).
As to claim 5, Boggs et al. discloses the electrical stimulator comprises an implantable electrical stimulator ([0216]; Figure 11D).
As to claim 6, Boggs et al. discloses a system to reduce a perception of pain (Abstract) comprising: a helically coiled lead ([0256]; Figure 20); a single contact electrode monolithically formed on a distal end of the helically coiled lead ([0161, 0163-0165, 0256]; Figures 11C and 20), the single contact electrode configured to be inserted into a patient ([0161, 0163-0165, 0171]; Figure 11C) at a therapeutically effective distance from a target Type I or Type Ib afferent nerve fiber ([0286]; claim 19 on page 21); and an electrical stimulator operatively coupled with the helically coiled lead ([0161, 0163-0165]; Figures 11C and 20), the electrical stimulator electrically stimulating through the single contact electrode the target Type I or Type Ib afferent nerve fiber and wherein a waveform of the electrical stimulation is configured to generate an action potential in the target Type I or Type Ib afferent nerve fiber while avoiding generation of unwanted responses in non-target Type III and Type IV afferent nerve fibers to reduce a perception of pain ([0286]; claim 19 on page 21), wherein the electrical stimulator applies electrical stimulation having an intensity of 0.01-200 mA and a frequency of 0.05-40 Hz ([0234-0237]).
As to claim 7, Boggs et al. discloses the single contact electrode has a surface area of approximately 20 mm.sup.2 ([0241]).
As to claim 8, Boggs et al. discloses the helically coiled lead is configured to be percutaneously inserted into the patient (Figure 11C; [0191, 0195, 0204]).
As to claim 9, Boggs et al. discloses the electrical stimulator is an external electrical stimulator (Figure 11C; [0205, 0208, 0216]).
As to claim 10, Boggs et al. discloses the electrical stimulator comprises an implantable electrical stimulator ([0216]; Figure 11D).
As to claim 11, Boggs et al. discloses a system to reduce a perception of pain (Abstract ), the system comprising: a helically coiled lead ([0256]; Figure 20); a single contact electrode monolithically formed on a distal end of the helically coiled lead ([0161, 0163-0165, 0256]; Figures 11C and 20), the single contact electrode configured to be inserted into a patient ([0161, 0163-0165, 0171]; Figure 11C); an anchor (anchoring element; [0178-0179]) positioned at the distal end of the helical coiled lead configured to keep the single contact electrode at a therapeutically effective distance from a target Type I or Type Ib afferent nerve fiber ([0286]; claim 19 on page 21); and an electrical stimulator operatively coupled with the helically coiled lead ([0161, 0163-0165]; Figures 11C and 20), the electrical stimulator electrically stimulating through the single contact electrode the target Type I or Type Ib afferent nerve fiber and wherein a waveform of the electrical stimulation is configured to generate an action potential in the target Type I or Type Ib afferent nerve fiber while avoiding generation of unwanted responses in non-target Type III and Type IV afferent nerve fibers to reduce a perception of pain ([0286]; claim 19 on page 21), wherein the electrical stimulator applies electrical stimulation having an intensity of 0.01-200 mA and a frequency of 0.05-40 Hz ([0234-0237]).
As to claim 12, Boggs et al. discloses the single contact electrode has a surface area of approximately 20 mm.sup.2 ([0241]).
As to claim 13, Boggs et al. discloses the helically coiled lead is configured to be percutaneously inserted into the patient (Figure 11C; [0191, 0195, 0204]).
As to claim 14, Boggs et al. discloses the electrical stimulator is an external electrical stimulator (Figure 11C; [0205, 0208, 0216]).
As to claim 15, Boggs et al. discloses the electrical stimulator comprises an implantable electrical stimulator ([0216]; Figure 11D).
As to claim 16, Boggs et al. discloses the electrical stimulation comprises passive charge recovery to generate the stimulation waveform ([0231]).
As to claim 17, Boggs et al. discloses the electrical stimulation comprises passive charge recovery to generate regulated voltage of 10 mV to 20 V ([0231]).
As to claim 18, Boggs et al. discloses the electrical stimulation comprises a monophasic pulse ([0232]).
As to claim 19, Boggs et al. discloses the electrical stimulation comprises a frequency of 1 Hz to about 300 Hz ([0234-0237]).
As to claim 20, Boggs et al. discloses the electrical stimulation comprises a frequency of 0.05-40 Hz ([0234-0237]).
Claims 1-5 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Bennett et al. (US 2010/0036454 A1).
As to claim 1, Bennett et al. discloses a system to reduce a perception of pain (Abstract), the system comprising: a helically coiled lead ([0141, 0145]); a single contact electrode ([0142]; monopolar) extending from the helically coiled lead, the single contact electrode insertable into a patient (Figure 11A); and an electrical stimulator ([0142]) operatively coupled with the helically coiled lead ([0142]), the electrical stimulator electrically stimulating through the single contact electrode a plurality of target efferent motor nerve fibers to generate an action potential in the plurality of target efferent motor nerve fibers while avoiding generation of action potentials in small sensory nerve fibers (claims 1 and 5; [0159-0160]), wherein the electrical stimulator applies electrical stimulation having an intensity of 0.01-200 mA ([0159]) and a frequency of 0.05-40 Hz ([0157]).
As to claim 2, Bennett et al. discloses the single contact electrode comprises an electrode contact surface area of approximately 20 mm2 ([0162]).
As to claim 3, Bennett et al. discloses the helically coiled leas is configured to be percutaneously inserted into the patient (Abstract; [0004, 0012, 0024]).
As to claim 4, Bennett et al. discloses the electrical stimulator is an external electrical stimulator (Abstract; [0041]; Figure 3A).
As to claim 5, Bennett et al. discloses the electrical stimulator comprises an implantable electrical stimulation ([0041]; Figure 3B).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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