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 .
DETAILED ACTION
This Office Action is a response to Applicant’s Amendment and Remarks filed June 1, 2026.
Claim 26 has been canceled. Claims 21 and 27-29 have been amended.
Claims 21-25 and 27-40 are pending in the present application.
This application contains claims 35-40 drawn to an invention nonelected without traverse in the reply filed April 14, 2025. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Accordingly, claims 21-25 and 27-34 have been examined on the merits as detailed below:
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103
In the previous Office Action mailed March 3, 2026, claims 21-34 were rejected under 35 U.S.C. 103 as being unpatentable over Jarvie et al. (Nature Neuroscience, 2017 Vol. 20(2):167-169) as evidenced by Lee et al. (Nature, April 4, 2019, Vol. 568:93-97, plus Extended Data) and Sangjun Lee, Doctor of Philosophy Thesis, CALIFORNIA INSTITUTE OF TECHNOLOGY, (Defended May 15th, 2020). This rejection is moot against claim 26 in view of Applicant’s Amendment filed June 1, 2026 to cancel this claim. This rejection is maintained against the remaining claims for the reasons of record set forth in the previous Office Action mailed March 3, 2026.
Response to Arguments
In response to this rejection Applicants traverse and argue that, as an initial matter, the Lee article and the Lee Thesis were both published after the priority date of the instant application and prior to the effective filing date of the instant application. Applicant submit that it was not known whether optogenetic or chemogenetic stimulation of the pre-LCPDYN neurons alone, and not the NTSHSD2 neurons of Jarvie, would modulate salt appetite, as recited in the present claims.
This traversal and argument have been fully considered by the Examiner, however they are not found to be persuasive. First, the Examiner relied on the Lee article and the Lee Thesis to evidence that the stimulation of HSD2 neurons will subsequently activate downstream pre-LCPDYN neurons. Applicant should note that post-filing evidence can be used and cited to show a universal fact need not be available as prior art before the effective filing date of Applicant’s claimed invention. See MPEP 2124. Also, see In re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962)
Second, regarding the argument that it was not known whether optogenetic or chemogenetic stimulation of the pre-LCPDYN neurons alone, and not the NTSHSD2 neurons of Jarvie would modulate salt appetite, this is not persuasive because the claims are not drawn to stimulation of the pre-LCPDYN neurons alone. The claims do not recite or require the stimulation of the pre-LCPDYN neurons alone. It appears that Applicant is arguing against limitations not found in the instant claims. Applicant is reminded that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, Applicant's arguments regarding stimulation of the pre-LCPDYN neurons alone appear to be misplaced.
Instead, the claims are drawn to a method of stimulating sodium appetite in a subject in need thereof, the method comprising: stimulating a plurality of prodynorphin (PDYN)-positive neurons in the pre-locus coeruleus (pre-LCPDYN neurons) of the subject, thereby increasing sodium appetite in the subject, wherein stimulating the plurality of pre-LCPDYN neurons of the subject comprises optogenetic or chemogenetic stimulation, thereby increasing sodium appetite in the subject. NOTE: The claims recite, “comprising” language. Applicant is reminded that:
The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., >Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) ("like the term 'comprising,' the terms 'containing' and 'mixture' are open-ended.").< Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) ("The transition 'comprising' in a method claim indicates that the claim is open-ended and allows for additional steps."); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) ("Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising" leaves "the claim open for the inclusion of unspecified ingredients even in major amounts"). >In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to "a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades" encompasses razors with more than three blades because the transitional phrase "comprising" in the preamble and the phrase "group of" are presumptively open-ended. "The word 'comprising' transitioning from the preamble to the body signals that the entire claim is presumptively open-ended." Id.
Therefore, the claims do not exclude optogenetic or chemogenetic stimulation of other brain regions, including the NTSHSD2 neurons of Jarvie.
Applicants next argue that the NTSHSD2 neurons of Jarvie were found to project to three distinct terminal fields, however, the reference does not teach which of these regions are involved in the modulation of salt appetite.
This argument has been considered but is not found persuasive because the claims are as described supra. The Examiner maintains that Jarvie taught the administration of AAV1-DIO-hM3Dq:mCherry (optogenetic activation) or CNO (chemogenetic manipulation) specifically targeted and activated NTSHSD2 neurons in the hindbrain to modulate salt appetite. Jarvie also taught that HSD2 axonal neurons excitatory project to the pre-LC. Furthermore, the evidence of both the Lee article and the Lee Thesis demonstrate that stimulation of NTSHSD2 neurons activate pre-LCPDYN neurons. Given this information, the Examiner maintains that the method steps of Jarvie will inherently carry out the methods as present claimed, absent some evidence to the contrary. See MPEP 2112 with respect to inherency.
The claims are not drawn to optogenetic or chemogenetic stimulation of the pre-LCPDYN neurons alone. Instead, the claims recite, “comprising” language which is open-ended and does not exclude stimulation in other brain regions, including the NTSHSD2 neurons of Jarvie. The prior art of Jarvie taught the excitation of NTS HSD2 neurons drives sodium appetite. Jarvie also taught that HSD2 axonal neurons project to the pre-LC. Jarvie along with the evidence of Lee article and the Lee Thesis confirms that stimulating HSD2 neurons is expected to drive stimulation in pre-LCPDYN neurons.
At the time of invention, a method of stimulating sodium appetite in a subject in need thereof, the method comprising: stimulating NTSHSD2 neurons of the subject, thereby increasing sodium appetite in the subject was known as taught and suggested by Jarvie. Evidence on the record demonstrates that signals/connections from NTSHSD2 neurons are transmitted to a subset of excitatory neurons characterized by the expression of prodynorphin (PDYN) in the pre-locus coeruleus (pre-LC). See the Lee article and the Lee Thesis. In other words, activation of the upstream HSD2 neurons leads to the stimulation and activation of the downstream pre-LC PDYN neurons, absent some other evidence to the contrary.
The Examiner has provided sound basis in fact and technical reasoning that reasonably supports the determination that the allegedly inherent characteristic necessarily flows from what has been specifically disclosed within the prior art and has shifted the burden to Applicant to provide evidence, to the contrary.
Turning to the facts, the presumption of obviousness applies here, and none of the means for rebutting it has been shown. In view of the foregoing, when all the evidence is considered, the totality of the rebuttal evidence of non-obviousness fails to outweigh the evidence of obviousness made of record. Thus, it is maintained that the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERRA C GIBBS/Primary Examiner, Art Unit 1635
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