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 .
Claim Objections
Claims 1, 6-7 and 14 are objected to because of the following informalities:
Claim 1, lines 3-4 should be amended to recite, “the electrical stimulation signal is adapted to be transmitted to a target region of an organism via the electrode assembly…” in order to avoid the claim language requiring a human organism.
Claim 1, lines 8-9 should be amended to recite, “…the electrical stimulation is adapted to reduce[[s]] a level of cyclooxygenase-2…” in order to avoid the claim language requiring a human organism.
Claim 6, line 2 should be amended to recite, “…inhibit a neuroinflammatory response…”.
Claim 7, line 2 should be amended to recite, “…and/or at least partially relieves [[at least a part of]] pain on a nerve conduction path…”.
Claim 14, lines 3-4 should be amended to recite, “…inhibits a neuroinflammatory response of the organism or inhibits and/or at least partially relieves [[at least a part of]] pain on a nerve conduction path…”.
Appropriate correction is respectfully requested.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 9 recite “the burst signals have the burst frequency between 0.1 Hz and 1,000 Hz, each burst signal contains a plurality of pulses, the pulses have the pulse frequency between 1 kHz and 1,000 kHz, and the electrical stimulation signal reduces a level of cyclooxygenase-2 of the organism.” which is not sufficiently supported in the specification. Upon review of the instant disclosure, there appears to be broad teachings of burst frequency between 0.1Hz and 1000Hz [0063] as well as pulse frequency between1KHz to 1000KHz [0064]. However, it appears that Applicant only tested a burst frequency of 2Hz and a pulse frequency of 500KHz ([0084], [0099], and [0117]). Since the only application of the stimulation in the specification was delivered in a much narrower range than the claimed range, it appears that the instant disclosure does not reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for delivery of electrical stimulation with a burst frequency of 2Hz and a pulse frequency of 500KHz to reduce a level of cyclooxygenase-2 of the organism, does not reasonably provide enablement for delivery of electrical stimulation with a burst frequency between 0.1 Hz and 1,000 Hz, and a pulse frequency between 1 kHz and 1,000 kHz to reduce a level of cyclooxygenase-2 of the organism. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
In making a determination as to whether an application has met the requirements for enablement under 35 U.S.C. 112 1 1, the following factors enumerated In re Wands, 8 USPQ2d 1400, at 1404 (CAFC 1988) are considered: (1) the breadth of the claims, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the quantity of experimentation necessary.
The breadth of the claims. The breadth of the claim is broader than is reasonably supported in the specification. The claim recites the delivery of electrical stimulation using a burst frequency between 0.1 Hz and 1,000 Hz, and a pulse frequency between 1 kHz and 1,000 kHz, and the electrical stimulation signal reduces a level of cyclooxygenase-2 of the organism. However, the disclosure only teaches delivering a burst frequency of 2Hz and a pulse frequency of 500KHz and analyzing results gathered after delivering those specific frequencies.
The nature of the invention. A person of ordinary skill in the art would be able to deliver electrical stimulation with a burst frequency between 0.1 Hz and 1,000 Hz, and a pulse frequency between 1 kHz and 1,000 kHz. However, little is known about delivering electrical stimulation with a burst frequency between 0.1 Hz and 1,000 Hz, and a pulse frequency between 1 kHz and 1,000 kHz to reduce a level of cyclooxygenase-2 in an organism. As best can be determined, there is no art specifically delivering stimulation with a burst frequency between 0.1 Hz and 1,000 Hz, and a pulse frequency between 1 kHz and 1,000 kHz to reduce a level of cyclooxygenase-2.
The state of the prior art. The prior art provides using electrical stimulation to reduce inflammation, pain, or fever, which is linked to a level of cyclooxygenase-2. However, this does not provide any insight on how a burst frequency between 0.1 Hz and 1,000 Hz, and a pulse frequency between 1 kHz and 1,000 kHz would directly reduce a level of cyclooxygenase-2.
The level of one of ordinary skill. A person of ordinary skill in the art would be able to deliver electrical stimulation with a burst frequency of 2Hz and a pulse frequency of 500KHz to reduce a level of cyclooxygenase-2 of an organism, but would not be able to easily identify a burst frequency of 2Hz and a pulse frequency of 500KHz from a burst frequency between 0.1 Hz and 1,000 Hz, and a pulse frequency between 1 kHz and 1,000 kHz to reduce a level of cyclooxygenase-2 of an organism without undue experimentation.
The level of predictability in the art. The art provides not guidance to enable the instant claims, beyond known methods of delivering electrical stimulation to relieve pain. The art does not enable methods of delivering stimulation with a burst frequency between 0.1 Hz and 1,000 Hz, and a pulse frequency between 1 kHz and 1,000 kHz in order to reduce a level of cyclooxygenase-2 in an organism.
The amount of direction provided by the inventor. The inventor discloses test protocols in which electrical stimulation with a burst frequency of 2Hz and a pulse frequency of 500KHz ([0084], [0099], and [0117]), but is silent to testing any other frequencies within the range (burst frequency between 0.1 Hz and 1,000 Hz, and a pulse frequency between 1 kHz and 1,000 kHz) recited by the claims. It is unclear if testing at any of the other frequencies within the claimed range would provide the same result of reducing a level of cyclooxygenase-2 in an organism.
The existence of working examples. The discloses teaches delivering electrical stimulation with a burst frequency of 2Hz and a pulse frequency of 500KHz ([0084], [0099], and [0117]), but is silent to testing any other frequencies within the range (burst frequency between 0.1 Hz and 1,000 Hz, and a pulse frequency between 1 kHz and 1,000 kHz).
The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Because the claimed range of frequencies is extremely broad (burst frequency between 0.1 Hz and 1,000 Hz, and a pulse frequency between 1 kHz and 1,000 kHz), it would require undue experimentation by a person of ordinary skill in the art in order to determine that a burst frequency of 2Hz and a pulse frequency of 500KHz ([0084], [0099], and [0117]) are effective in reducing a level of cyclooxygenase-2 in an organism.
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 5 and 9-14 is 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 5 recites the limitation "…the level of brain-derived neurotrophic factor (BDNF) and/or substance P…" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the burst frequency" in line 5. There is insufficient antecedent basis for this limitation in the claim. Dependent claims inherit the same deficiencies.
Claim 9 recites the limitation "the pulse frequency" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Dependent claims inherit the same deficiencies.
Regarding claim 13, the recitation of “…the electrical stimulation signal relieves pain of the organism, relieves symptoms of the organism, reduces neural sensitivity of the organism or relieves overactive reaction of the organism and maintains for at least 1 hour” renders the claim unclear. Specifically, it is unclear as to what is being maintained for at least 1 hour since relieves pain of the organism, relieves symptoms of the organism, reduces neural sensitivity of the organism or relieves overactive reaction of the organism are claimed in the alternative. In order to further advance prosecution, Examiner is interpreting the claim to recite “…the electrical stimulation signal relieves pain of the organism, relieves symptoms of the organism, reduces neural sensitivity of the organism or relieves overactive reaction of the organism and maintains the pain relief, the symptom relief, the reduction in neural sensitivity, or the relief in overactive reaction for at least 1 hour”.
Claim 14 recites the limitation "the levels of brain-derived neurotrophic factor and/or substance P…" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 8 and 13 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 8 and 13, lines 1-2, recites the limitation “…the organism receives the electrical stimulation signal…”. The claim language as currently written appears to require “the organism”. Examiner suggests amending the claims to recite, “wherein after [[the organism receives]] the electrical stimulation signal is transmitted for less than or equal to 12 hours, the electrical stimulation signal is adapted to relieve[[s]] pain of the organism, relieve[[s]] symptoms of the organism, reduce[[s]] neural sensitivity of the organism or relieve[[s]] an overactive reaction of the organism and maintains for at least 1 hour.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-4, 6-9, and 11-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by De Wachter (US 2024/0024671).
Regarding claims 1 and 9, De Wachter disclose a method for reducing cyclooxygenase-2 by using an electrical stimulation device, comprising:
coupling an electrode assembly (one or more electrodes) to a target region of an organism ([0034] one or more electrodes of an electrical lead are located in the proximity of the sacral plexus and/or the pelvic plexus of the subject);
generating an electrical stimulation signal (burst stimulus), wherein the electrical stimulation signal contains a plurality of burst signals ([0066] applying a burst pattern),
the burst signals have the burst frequency between 0.1 Hz and 1,000 Hz ([0065] the interburst frequency between each burst or group of electric pulses or spikes may be in the range of 10 and 100 Hz),
each burst signal contains a plurality of pulses ([0066] each burst stimulus can comprise about 2 to about 100 electric pulses), and
the pulses have the pulse frequency between 1 kHz and 1,000 kHz ([0066] intraburst frequency within each group of electric pulses is from 50 Hz to 1000 Hz); and
providing the electrical stimulation signal to the electrode assembly coupled to the target region to reduce a level of the cyclooxygenase-2 of the organism ([0034] a pulse generator that is operably linked to the electrical lead is used to deliver electrical stimulation energy to the sacral plexus and/or the pelvic plexus of the subject; [0065-0066] apply burst pattern).
Examiner notes that the recitation of “the electrical stimulation signal reduces a level of cyclooxygenase-2 of the organism” is merely an intended result of a positively recited method/process step. Since De Wachter discloses delivering the electrical stimulation signal according to claims 1 and 9 as discussed above, De Wachter would also necessarily disclose the electrical stimulation signal reduces a level of cyclooxygenase-2 of the organism.
Regarding claims 3 and 11, De Wachter discloses wherein reducing the level of the cyclooxygenase-2 of the organism occurs within 24 hours after receiving the electrical stimulation signal ([0034] deliver electrical stimulation to sacral and/or pelvic plexus; [0065-0066]).
Examiner notes that the recitation of “…reducing the level of the cyclooxygenase-2 of the organism occurs within 24 hours…” is merely an intended result of a process/method step positively recited. Since De Wachter discloses the positively recited step of providing the electrical stimulation signal in accordance with claims 1 and 9 [0065-0066] as discussed above, De Wachter would also necessarily teach wherein reducing the level of the cyclooxygenase-2 of the organism occurs within 24 hours after receiving the electrical stimulation signal.
Regarding claims 4 and 12, De Wachter discloses wherein the electrical stimulator generates the electrical stimulation signal for a cumulative time less than or equal to 12 hours per day ([0066] each burst stimulus can comprise about 2 to about 100 electric pulses; [0069] each electric pulse or spike within the burst stimulus has a pulse width that ranges from 10 to 5000 μseconds).
Regarding claim 6, De Wachter discloses wherein the electrical stimulator uses the electrical stimulation signal to inhibit neuroinflammatory response of the organism ([0039] treating an inflammatory disorder characterized by a dysfunctional autonomous nervous system).
Regarding claim 7, De Wachter discloses wherein the electrical stimulation signal inhibits and/or relieves at least a part of pain on a nerve conduction path of the target region ([0039] treatment of chronic pain characterized by a dysfunctional autonomous nervous system).
Regarding claims 8 and 13, De Wachter discloses wherein after the organism receives the electrical stimulation signal for less than or equal to 12 hours ([0066] each burst stimulus can comprise about 2 to about 100 electric pulses; [0069] each electric pulse or spike within the burst stimulus has a pulse width that ranges from 10 to 5000 μseconds), the electrical stimulation signal relieves pain of the organism [0039], relieves symptoms of the organism, reduces neural sensitivity of the organism or relieves overactive reaction of the organism and maintains for at least 1 hour.
Examiner notes that the recitation of “…the electrical stimulation signal relieves pain of the organism [0039], relieves symptoms of the organism, reduces neural sensitivity of the organism or relieves overactive reaction of the organism and maintains for at least 1 hour” is merely an intended result of a process/method step positively recited. Since De Wachter discloses the positively recited step of providing the electrical stimulation signal in accordance with claims 1 and 9 [0065-0066] for less than or equal to 12 hours ([0066] and [0069]) as discussed above, De Wachter would also necessarily teach the electrical stimulation signal relieves pain of the organism [0039], relieves symptoms of the organism, reduces neural sensitivity of the organism or relieves overactive reaction of the organism and maintains for at least 1 hour.
Regarding claim 14, De Wachter discloses wherein the electrical stimulation signal further inhibits the levels of brain-derived neurotrophic factor and/or substance P of the organism, inhibits neuroinflammatory response of the organism or inhibits and/or relieves at least a part of pain on a nerve conduction path of the target region ([0039] treatment of an inflammatory disorder or chronic pain characterized by a dysfunctional autonomous nervous system).
Claim(s) 2 and 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by De Wachter (US 2024/0024671) as evidenced by Lau et al (W.K. Lau, W.K. Chan, J.L. Zhang, K.K.L. Yung, H.Q. Zhang (Electroacupuncture inhibits cyclooxygenase-2 up-regulation in rat spinal cord after spinal nerve ligation, Neuroscience, Volume 155, Issue 2, 2008, Pages 463-468) hereinafter Lau.
Regarding claims 2 and 10, De Wachter discloses wherein the electrical stimulation signal reduces the level of the cyclooxygenase-2 by inhibiting a protein expression of the cyclooxygenase-2 ([0034] deliver electrical stimulation to sacral and/or pelvic plexus; [0065-0066]).
The limitation of “…by inhibiting a protein expression of the cyclooxygenase-2” is merely an intended result of a positively recite method/process step. Since De Wachter discloses the positively recited step of providing the electrical stimulation signal according to claims 1 and 9 [0065-0066] as discussed above, De Wachter would also necessarily teach wherein the electrical stimulation signal reduces the level of the cyclooxygenase-2 by inhibiting a protein expression of the cyclooxygenase-2.
Further, the delivery of electrical stimulation at least partially inhibits the expression of cyclooxygenase-2 of the organism as evidenced by Lau (Abstract).
Claim(s) 5 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by De Wachter (US 2024/0024671) as evidenced by Wirtz et al (Wirtz, J., R. Chaney, M. Cefis, et al. 2025. “Electrical Stimulation-Induced Muscle Damage Alters Hippocampal BDNF Signaling.” European Journal of Neuroscience62, no. 6: e70235), hereinafter Wirtz.
Regarding claim 5, De Wachter discloses wherein the electrical stimulation signal further reduces the level of brain-derived neurotrophic factor (BDNF) and/or substance P of the organism ([0034] deliver electrical stimulation to sacral and/or pelvic plexus; [0065-0066]). Examiner notes the recitation of “reduces the level of brain-derived neurotrophic factor (BDNF) and/or substance P of the organism” is merely an intended result of a process/method step positively recited. Since De Wachter discloses the positively recited step of providing the electrical stimulation signal in accordance with claims 1 and 9 [0065-0066] as discussed above, De Wachter would also necessarily teach wherein the electrical stimulation signal further reduces the level of brain-derived neurotrophic factor (BDNF) and/or substance P of the organism.
Further, the delivery of electrical stimulation is known to reduce a level of brain-derived neurotrophic factor (BDNF) of an organism as evidenced by Wirtz (Abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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