DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is responsive to the amendment filed 12 January 2026. As directed by the amendment: Claims 1, 3-6, 8-15, 17, 19, 23-24, and 26-28 have been amended, claims 16 and 18 remain cancelled, claims 3-15 remain withdrawn in response to an election requirement, and claim 31 has been added. Thus claims 1-2, 17, and 19-31 are presently pending under examination.
Response to Arguments
Response to Arguments Regarding 35 USC § 102/103
Applicant’s arguments, see pg. 8-9 of Remarks, filed 10 September 2025, with respect to the 35 U.S.C. 102 rejection of claims 1-2, 17, 19-22, and 26 under Huston et al. (US 2006/0178703 A1), hereinafter Huston have been fully considered and are not persuasive.
Examiner first makes note amended independent claim 1 reads “manipulating the subject’s parasympathetic nervous system by electrical or optogenetic blocking of the subject’s right vagus nerve”, and claim 19 further specifies wherein “blocking the subject’s right vagus nerve comprises delivering electrical pulses at a frequency ranging from 1 Hz to 10 Hz”, however, the specification states “10 Hz pulses are commonly used to activate peripheral nerves, while high-frequency pulses (e.g., 5kHZ) have been shown to block peripheral nerves”, the claim language is inconsistent with the specification. Applicant is requested to add clarification to the specification or indicate the support for the claims.
Additionally, since Huston’s device provides stimulation to the vagus nerve with the stimulation parameters as claimed in claim 19, 20, 21, and 22, thus under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) (view MPEP 2112.02 I.). Therefore, Huston’s device anticipates the electrical blocking of the subject’s right vagus nerve, thereby treating cachexia in the subject. In other words, since Huston’s device teaches these parameters for the treatment of cachexia it would be anticipated that Huston’s device would be capable of carrying out the claimed method. Applicant is advised to add detailed stimulation parameters to the claim to overcome the prior art references.
Therefore claims 1-2, 17, 19, 20-22, and 26 are rejected as described in detail below under 35 USC 102(a)(1).
No additional specific arguments were presented with previous 35 U.S.C. 103 rejections of dependent claims 23-30, nor specifically with respect to the previously cited Donders, Shafer, and Ekchian.
Therefore claims 23-30 are rejected as described below under 35 USC 103.
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.
Claim 1 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. Amended independent claim 1 reads “manipulating the subject’s parasympathetic nervous system by electrical or optogenetic blocking of the subject’s right vagus nerve”, and claim 19 further specifies wherein “blocking the subject’s right vagus nerve comprises delivering electrical pulses at a frequency ranging from 1 Hz to 10 Hz”, however, the specification states “10 Hz pulses are commonly used to activate peripheral nerves, while high-frequency pulses (e.g., 5kHZ) have been shown to block peripheral nerves”, the claim language is inconsistent with the specification. Applicant is requested to add clarification to the specification or indicate the support for the claims.
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.
(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) 1-2, 17, 19-22, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huston et al. (US 2006/0178703 A1), hereinafter Huston.
Regarding claim 1, Huston discloses a method for treating cachexia in a subject in need thereof ([0064] “the invention relates to the use of a device in the manufacture of a therapeutic article for treating inflammatory disorders in a subject,”, [0067] “Nonlimiting examples of conditions which can be usefully treated using the present invention include…cachexia”, Claim 1: “A method for treating a subject suffering from, or at risk for, an inflammatory disorder”, Claim 5: “wherein the inflammatory disorder is selected from the group consisting of cachexia…”), the method comprising manipulating the subject's parasympathetic nervous system by electrical or optogenetic blocking of the subject's right vagus nerve ([0065] “the device may be adapted specifically to treat only inflammatory disorders by direct stimulation of the vagus nerve”, [0067] ““Nonlimiting examples of conditions which can be usefully treated using the present invention include…cachexia”, Claim 1: “A method…comprising stimulating the vagus nerve in a subject with an electrical signal”), thereby treating cachexia in the subject (Claim 1 and 5: A method for treating a subjecting suffering from, or at risk for, an inflammatory disorder…the inflammatory disorder is selected from the group consisting of…cachexia”, [0024]-[0026] “the present invention, the vagus nerve is stimulated by delivering an electrical signal generated by any suitable vagus nerve stimulators. For example, a commercial vagus nerve stimulator such as the Cyberonics NCP.TM., or an electric probe can be used…The vagus nerve can be stimulated by means of either an implanted device or a device worn external to the patient's body, such as Cyberonics NCP.TM. device described in U.S. Pat. No. 5,231,988 or a Medtronic.TM. device described in U.S. Pat. No. 5,330,507. Both patents describe apparati for stimulating the right or left vagus nerve with continuous and/or phasic electrical signal.”).
Examiner would like to note that since Huston’s device provides stimulation to the vagus nerve with the stimulation parameters as claimed in claim 19, 20, 21, and 22, thus under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) (view MPEP 2112.02 I.). Therefore, Huston’s device anticipates the electrical blocking of the subject’s right vagus nerve, thereby treating cachexia in the subject.
Regarding claim 2, Huston discloses the method of claim 1 (as shown above), teaches wherein stimulating the parasympathetic nervous system in the subject ( [0063] “the invention is the use of any of the devices described above in the manufacture of a therapeutic article for treating inflammatory disorders in a subject, wherein the device, in operation directly, stimulates the vagus nerve to treat inflammatory disorders”, [0067] The inflammatory condition that can be treated with the invention is cachexia, Claim 1: “stimulating the vagus nerve”) increases expression of urea cycle enzymes in the subject's liver.
Although Huston doesn’t explicitly state that the stimulation increases expression of urea cycle enzymes in the liver, it would have been known to one skilled in the art that the stimulation as described in Huston which is used to treat cachexia would increase the expression of urea cycle enzymes in the liver, as shown by Levine and Nakagawa wherein electrically stimulating the vagus nerve can lead to the upregulation of SIRT3 and SIRT4 in the liver to treat metabolic syndromes (Levine: [0011], [0014], and [0159]) where these SIRT 3 and SIRT4 can deacetylate CPS1, an enzyme which mediates the first step of urea cycle, which increases CPS1 enzymatic activity (Nakagawa: pg. 578, Column 2, lines 1-19).
Additionally, the specification of the instant application states “Described herein is a method of treating cachexia in a subject in need thereof. The method comprises stimulating the parasympathetic nervous system of the subject thereby treating cachexia in the subject. It is contemplated that stimulating the parasympathetic nervous system may increase expression of urea cycle enzymes in the liver thereby leading to reversal or mitigation of cachexia.” (pg. 7, lines 1-5). By this definition, a method that involves stimulating a parasympathetic nervous system for treating cachexia, such as the method of Huston, can therefore also result in an increase expression of urea cycle enzymes in the liver.
Regarding claim 17, Huston discloses the method of claim 1 (as shown above), wherein manipulating comprises blocking the subject’s right cervical vagus nerve ([0023] “In one embodiment, the vagus nerve is stimulated in the cervical region”, Claim 9).
Examiner would like to note that since Huston’s device provides stimulation to the vagus nerve with the stimulation parameters as claimed in claim 19, 20, 21, and 22, thus under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) (view MPEP 2112.02 I.). Therefore, Huston’s device anticipates the electrical blocking of the subject’s right vagus nerve, thereby treating cachexia in the subject. In other words, if these parameters are applied to the vagus nerve they would inherently result in the blocking of the subject’s right vagus nerve.
Regarding claim 19, Huston discloses the method of claim 1 (as shown above), wherein blocking the subject's right vagus nerve comprises delivering electrical pulses at a frequency ranging from 1 Hz to 10Hz ([0007] and Claim 3: “signal frequency is from 0.1 Hz to 30 Hz”).
Although Huston does not explicitly teach these ranges, it would be obvious to one of ordinary skill in the art to use values within these ranges because Huston’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 20, Huston discloses the method of claim 19 (as shown above), wherein the pulses have a pulse width of about 1 millisecond to about 100 milliseconds ([0007] and Claim 3: “pulse width is from 0.1 MS to 5 MS”).
Although Huston does not explicitly teach these ranges, it would be obvious to one of ordinary skill in the art to use values within these ranges because Huston’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 21, Huston discloses the method of claim 20 (as shown above), wherein the pulses have a pulse width of about 1 millisecond to about 10 milliseconds ([0007] and Claim 3: “pulse width is from 0.1 MS to 5 MS”).
Although Huston does not explicitly teach these ranges, it would be obvious to one of ordinary skill in the art to use values within these ranges because Huston’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 22, Huston discloses the method of claim 19 (as shown above), wherein the pulses are delivered at a frequency from 5 Hz to 10 Hz ([0007] and Claim 3: “signal frequency is from 0.1 Hz to 30 Hz”).
Although Huston does not explicitly teach these ranges, it would be obvious to one of ordinary skill in the art to use values within these ranges because Huston’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 26, Huston discloses the method of claim 1 (as shown above), wherein manipulating the subject’s right vagus nerve comprises delivering electrical pulses having a pulse train duration ranging from 1 minute to 1 hour ([0007] and Claim 3: “signal on-time is from 1 second to 120 seconds”, 120 seconds is equivalent to 2 minutes)
Although Huston does not explicitly teach these ranges, it would be obvious to one of ordinary skill in the art to use values within these ranges because Huston’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim Rejections - 35 USC § 103
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.
Claim(s) 23-25 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huston as applied to claim 19 above, and further in view of Donders et al. (US 2013/0237948 A1, previously cited), hereinafter Donders.
Regarding claim 23, Huston discloses the method of claim 19 (as shown above). Huston fails to disclose wherein manipulating the subject’s right vagus nerve comprises delivering charge balanced constant current biphasic pulses with alternating anodic and cathodic leading phases.
However, Donders teaches devices and methods for treating conditions relating to metabolic disease wherein stimulating the vagus nerve comprises delivering charge balanced constant current biphasic pulses with alternating anodic and cathodic leading phases ([0096] “electrodes are bipolar pairs (i.e. alternating anode and cathode electrodes)… a plurality of electrodes may be placed overlying the anterior and/or posterior vagus nerves AVN, PVN”, It should be noted that the posterior vagus nerve stems from right vagus nerve.) with a range of 0.1 mA to 10 mA ([0282] “devices were activated approximately two weeks post-implantation. Biphasic pulses at a frequency of 5000 Hz and amplitude from 3 to 8 mA (mode=6) were applied to block vagal neural impulses”).
Although Donder’s does not explicitly teach these ranges, it would be obvious to one of ordinary skill in the art to use values within these ranges because Donders’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233.
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Huston to incorporate the teachings of Donders wherein stimulating the vagus nerve comprises delivering charge balanced constant current biphasic pulses with alternating anodic and cathodic leading phases with a range of 0.1 mA to 10 mA, as these prior art references are directed to stimulating the vagus nerve for treatment of metabolic syndromes. One would be motivated to do this to downregulate the nerve activity, as recognized by Donders ([0282]).
Regarding claim 24, Huston discloses the method of claim 1 (as shown above). Huston fails to disclose wherein manipulating the right vagus nerve comprises delivering electrical pulses at a frequency of about 5kHz.
However, Donders teaches devices and methods for treating conditions relating to metabolic disease or metabolic syndrome ([0007]) wherein electrical treatment is provided to block nerve impulses from nerves such as the vagus nerve (Abstract) wherein manipulating the vagus nerve comprises delivering electrical pulses at a frequency of about 5kHz ([0282] “biphasic pulses at a frequency of 5000 Hz…were applied to block vagal neural impulses”, [0096] “electrodes are bipolar pairs (i.e. alternating anode and cathode electrodes)… a plurality of electrodes may be placed overlying the anterior and/or posterior vagus nerves AVN, PVN”, It should be noted that the posterior vagus nerve stems from right vagus nerve.).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Huston to incorporate the teachings of Donders to deliver electrical pulses at a frequency of about 5kHZ, as these prior art references are directed to stimulating the vagus nerve for treatment of metabolic syndromes. One would be motivated to do this to downregulate the nerve activity, as recognized by Donders ([0117]).
Regarding claim 25, Huston in view of Donders teaches the method of claim 24 (as shown above). Huston further teaches wherein the pulses have a pulse width of greater than 0 and less than 0.2 milliseconds (Claim 3: “pulse width is from 0.1 to 5 MS”).
Although Huston does not explicitly teach these ranges, it would be obvious to one of ordinary skill in the art to use values within these ranges because Huston’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 28, Huston in view of Donders teaches the method of claim 24 (as shown above). Huston fails to disclose wherein manipulating the right vagus nerve comprises delivering biphasic pulses with alternating anodic and cathodic leading phases with a range of 0.1 mA to 10 mA.
However, Donders teaches manipulating the vagus nerve comprises delivering biphasic pulses with alternating anodic and cathodic leading phases ([0096] “electrodes are bipolar pairs (i.e. alternating anode and cathode electrodes)… a plurality of electrodes may be placed overlying the anterior and/or posterior vagus nerves AVN, PVN”, It should be noted that the posterior vagus nerve stems from right vagus nerve.) with a range of 0.1 mA to 10 mA ([0282] “devices were activated approximately two weeks post-implantation. Biphasic pulses at a frequency of 5000 Hz and amplitude from 3 to 8 mA (mode=6) were applied to block vagal neural impulses”).
Although Donder’s does not explicitly teach these ranges, it would be obvious to one of ordinary skill in the art to use values within these ranges because Donders’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233.
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Huston to incorporate the teachings of Donders wherein stimulating the vagus nerve comprises delivering biphasic pulses with alternating anodic and cathodic leading phases with a range of 0.1 mA to 10 mA, as these prior art references are directed to stimulating the vagus nerve for treatment of metabolic syndromes. One would be motivated to do this to downregulate the nerve activity, as recognized by Donders ([0282]).
Alternatively, Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huston in view of Donders as applied to claim 24 above, and further in view of Shafer (US 2005/0075702 A1, previously cited), hereinafter Shafer.
Regarding claim 25, Huston in view of Donders teaches the method of claim 24 (as shown above).
Huston and Donders, alone or in combination, fail to teach wherein the pulses have a pulse width of greater than 0 and less than 0.2 milliseconds.
However, Shafer teaches the stimulation of the parasympathetic nervous system including the stimulation of the vagus nerve ([0012]) to attenuate an immune response ([0003]) that can be associated with disorders such as cachexia ([0044]) wherein the pulses have a pulse width of greater than 0 and less than 0.2 milliseconds ([0085] “In an embodiment, the pulse width of a stimulation signal with which a neuron is stimulated may be within the range of about 10 µsec to about 600 µsec. In an embodiment, the pulse width is in the range of about 90 µsec to about 500 µsec.”, 10 µsec = 0.01 MS and 600 µsec is equal to 0.6 MS).
Although Shafer’s does not explicitly teach these ranges, it would be obvious to one of ordinary skill in the art to use values within these ranges because Shafer’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233.
It would have been prima facia obvious for one of ordinary skilled for one of ordinary skilled in the art before the effective filing date of the claimed invention to have modified Huston to incorporate the teachings of Shafer to stimulate the vagus nerve wherein the pulses have a pulse width of greater than 0 and less than 0.2 millisecond, as these prior art references are directed to stimulating vagus nerves for treating cachexia. One would be motivated to do this as this duration is sufficient to stimulate a neuron, as recognized by Shafer ([0085]).
Claim(s) 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huston as applied to claim 1 above, and further in view of Shafer (US 2005/0075702 A1, previously cited), hereinafter Shafer.
Alternatively, regarding claim 26, Huston discloses the method of claim 1 (as shown above). Huston fails to disclose manipulating the right vagus nerve comprises delivering electrical pulses having a pulse trained duration ranging from 1 minute to 1 hour.
However, Shafer teaches the stimulation of the parasympathetic nervous system including the stimulation of the vagus nerve ([0012]) to attenuate an immune response ([0003]) that can be associated with disorders such as cachexia ([0044]) where the duration of the stimulation can be between about “10 minutes and about 10 hours” ([0085]).
Although Shafer’s does not explicitly teach these ranges, it would be obvious to one of ordinary skill in the art to use values within these ranges because Shafer’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233.
It would have been prima facia obvious for one of ordinary skilled for one of ordinary skilled in the art before the effective filing date of the claimed invention to have modified Huston to incorporate the teachings of Shafer to manipulate the vagus nerve comprises delivering electrical pulses having a pulse trained duration ranging from 1 minute to 1 hour, as these prior art references are directed to stimulating vagus nerves for treating cachexia. One would be motivated to do this as this duration is sufficient to stimulate a neuron, as recognized by Shafer ([0085]).
Regarding claim 27, Huston discloses the method of claim 1 (as shown above). Huston fails to disclose manipulating the right vagus nerve comprises delivering electrical pulses having a pulse trained duration ranging from 20 minutes to 3 hours.
However, Shafer teaches the stimulation of the parasympathetic nervous system including the stimulation of the vagus nerve ([0012]) to attenuate an immune response ([0003]) that can be associated with disorders such as cachexia ([0044]) where the duration of the stimulation can be between about “the range between about 10 minutes and about 10 hours, the range between about 1 hour and about 6 hours, and the range between about 2 hours and about 4 hours.” ([0085]).
Although Shafer’s does not explicitly teach these ranges, it would be obvious to one of ordinary skill in the art to use values within these ranges because Shafer’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233.
It would have been prima facia obvious for one of ordinary skilled for one of ordinary skilled in the art before the effective filing date of the claimed invention to have modified Huston to incorporate the teachings of Shafer to manipulate the vagus nerve comprises delivering electrical pulses having a pulse trained duration ranging from 20 minute to 3 hour, as these prior art references are directed to stimulating vagus nerves for treating cachexia. One would be motivated to do this as this duration is sufficient to stimulate a neuron, as recognized by Shafer ([0085]).
Claim(s) 29 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huston as applied to claim 1 above, and further in view of Enchain et al. (US 2012/0143279 A1, previously cited), hereinafter Enchain.
Regarding claim 29, Huston teaches the method of claim 1 (as shown above). Huston fails to disclose wherein the cachexia is cancer-associated cachexia.
However, Enchain teaches a method for treating appetite suppressing disorders with an increased metabolic rate by neuromodulation wherein the cachexia is cancer-associated cachexia ([0023] “appetite suppressing disorders and/or disorders with an increased metabolic rate include hypermetabolic conditions, cachexia”, [0025] “cachexia occurs frequently with malignancy, is frequently seen in end-stage cancer”).
It would have been prima facia obvious for one of ordinary skilled in the art before the effective filing date of the claimed invention to have modified Huston to incorporate the teachings of Enchain wherein the cachexia is cancer-associated cachexia, as these prior art references are directed to treating eating disorders such as cachexia and anorexia. One would be motivated to do this as it is known that cachexia occurs frequently with end-stage cancer and is associated with more than 20% of cancer related deaths, as recognized by Enchain ([0025]).
Regarding claim 30, Huston in view of Enchain teaches the method of claim 29 (as shown above). Huston fails to disclose wherein the associated cancer comprises pancreatic cancer or lung cancer.
However, Enchain teaches wherein the associated cancer comprises pancreatic cancer ([0025] “patients with pancreatic cancer have an increased likelihood of developing cachectic syndrome”).
It would have been prima facia obvious for one of ordinary skilled in the art before the effective filing date of the claimed invention to have modified Huston to incorporate the teachings of Enchain wherein the cachexia is cancer-associated cachexia, as these prior art references are directed to treating eating disorders such as cachexia and anorexia. One would be motivated to do this as it is known that cachexia occurs frequently with end-stage cancer and is associated with more than 20% of cancer related deaths, as recognized by Enchain ([0025]).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huston.
Regarding claim 31, Huston discloses the method of claim 20 (as shown above), wherein the pulses have a pulse width of about 10 millisecond to about 100 milliseconds ([0007] and Claim 3: “pulse width is from 0.1 MS to 5 MS”).
Although Huston does not explicitly disclose 0.1 MS to 5 MS, Huston also discloses a “signal controller 16 controls functions of the device such as output signal current or voltage, output signal frequency, output signal pulse width, output signal on-time, output signal off-time…Such programmability allows the output signal to be adjusted for the treatment regimen.” ([0028]). Therefore, it would have been obvious to have optimized Huston’s pulse width to have the pulse width be about 10 milliseconds to about 100 milliseconds, as this parameter is result-effective in the art of electric stimulation for treatment. Additionally, upon review of Applicant’s disclosure, there appears to be no criticality to the claimed range of this parameter and one of ordinary skill in the art would have had reasonable expectation of success in optimizing these parameters. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sadhana A. Samant, Vinodkumar B. Pillai, and Mahesh P. Gupta. 2019. Cellular mechanisms promoting cachexia and how they are opposed by sirtuins. Canadian Journal of Physiology and Pharmacology. 97(4): 235-245. https://doi.org/10.1139/cjpp-2018-0479 teaches sirtuins and their role in opposing/treating cachexia (pg. 13 lines 6-11).
Pelot NA, Grill WM. Effects of vagal neuromodulation on feeding behavior. Brain Res. 2018 Aug 15;1693(Pt B):180-187. doi: 10.1016/j.brainres.2018.02.003. Epub 2018 Feb 7. PMID: 29425906; PMCID: PMC6003853. teaches subdiaphragmatic vagal stimulation and increasing appetites in and body weights in individuals below their ideal weight.
Yeh, Shing-Shing, and Michael W. Schuster. "Geriatric cachexia: the role of cytokines." The American journal of clinical nutrition 70.2 (1999): 183-197. Teaches the inflammatory aspect of cachexia
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ATTIYA SAYYADA HUSSAINI/ Examiner, Art Unit 3792
/William J Levicky/ Primary Examiner, Art Unit 3796
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