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 .
Formal matters
1. The Art Unit location of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Art Unit 1675.
Election/Restrictions
2. Applicant’s election without traverse of species of 1B chemical stimulation in the reply filed on July 17, 2026 is acknowledged.
3. Claims 1-16 are pending in the instant patent application.
Claims 1-16 are under examination.
Claim Rejections - 35 USC § 112
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.
4. Claims 1-16 are 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.
5. Claims 1 and 16 are vague and ambiguous for reciting limitation “modulating [or to modulate] one or more nerves of a patient.” The specification refers to a block 205 within the Figures and to [0035] to [0036] to explain the term.
MPEP § 2111 Claim Interpretation; Broadest Reasonable Interpretation, states,
During patent examination, the pending claims must be “given their broadest reasonable interpretation consistent with the specification.” (The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005) expressly recognized that the USPTO employs the “broadest reasonable interpretation” standard: The Patent and Trademark Office (“PTO”) determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction “in light of the specification as it would be interpreted by one of ordinary skill in the art.” In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827] (Fed. Cir. 2004)). See also, In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is
justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA
1969).
The broadest reasonable interpretation of the term to modulate is to change or adjust. However, with respect to modulation of “one or more nerves,” one must have a clear understanding what parameters are intended to be modulated to meet the claims’ limitations. Currently, the art does not teach, and the specification does not explain what specific physical, objective and repeatable steps are intended by the claim to practice “modulating one or more nerves of a patient.” This renders the claims indefinite.
6. Further, claim 1 is vague and indefinite because it is directed to a method of treatment without specifically pointing out as treatment of what and of whom. Moreover, the claim specifically recites “the patient in need of [a therapeutic agent],” which makes no sense because the need of a patient cannot be established from the claim or the specification as filed.
7. Regarding claim 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Also, the limitation “other,” see “other autoimmune diseases,” fails to define what pathologies are part of Applicant’s invention.
8. Claim 5 is indefinite because it is not obvious what stands for “the monitoring step establishes one or more baselines.” Clarification is required.
9. Similarly, claim 6 expressly requires “monitoring […] to confirm the nerve modulation,” however, fails to provide any active steps to support the limitation.
10. Claim 7 is indecipherable. Briefly, it is not obvious and cannot be determined from the claim or the specification as filed what stands for “the step of monitoring […] to inform the nerve modulation, the administration of the therapeutic agent, or both.” Applicant is advised to rewrite the claim to better express claimed subject matter.
11. Claim 8 does not make sense. Specifically, the claim depends of claim 5 (effectively of claim 1), which recites the first step as “modulating one or more nerves,” wherein claim 8 expressly requires monitoring, which is the third step of claim 1, to establish when to begin modulation of a nerve. Applicant is advised to rewrite the claim to better express claimed subject matter.
12. Claim 13 recites the limitation “the step of monitoring […] integrates physiological parameter data across a patient population,” which in the absence of any active physical steps to support integration renders the claim indefinite.
13. Claims 2, 4, 9-12, 14 and 15 are indefinite for being dependent from indefinite claim(s).
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.
14. Claims 1-15 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1-15 are broadly drawn to methods of treatment by modulating nerves, administering therapeutic agents and optionally monitoring physiological parameters of the patient under treatment. However, the specification does not provide sufficient guidance to enable practice the full scope of the claimed invention without undue experimentation.
The enablement requirement is met when one skilled in the art, having read the specification, could practice the invention without “undue experimentation.” Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d at 1336 (Fed. Cir. 2013). The factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (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 breadth of the claims. In re Wands, 8 USPQ2d, 1400 (CAFC 1988).
The specification discloses series of experiments performed on rats in which capsaicin and compounds GSK1016790A and WS-12 were applied to the vagus nerve, pp. 21-26. Further, Figures 1-5 are block diagrams to depict the steps of the methods as written within the claims. The specification provides no further information regarding treatment of any clinical pathology, or treatment in general, of any patient by modulating the nerves of the patient, administering therapeutic agents and monitoring any physiological parameters in the order as presented and claimed.
The nature of the invention involving biological molecules and their effect on a physiological system is complex and unpredictable. As was found in Ex parte Hitzeman, 9 USPQ2d 1821 (BPAI 1987), a single embodiment may provide broad enablement in cases involving predictable factors such as mechanical or electrical elements, but more will be required in cases that involve unpredictable factors such as most chemical reactions and physiological activity. This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology", Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970); Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991).
Medical devices for neural stimulation and drug delivery are known in the prior art, see reference 5 of IDS filed on 10/10/2024, for example. However, methods of treatments in general by modulating any nerve and administering any therapeutic agent to the patient have not been reported.
With respect to claim breadth, the standard under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. In addition, when analyzing the enablement scope of the claims, the teachings of the specification are to be taken into account because the claims are to be given their broadest reasonable interpretation that is consistent with the specification (see MPEP 2111 [R-1], which states that claims must be given their broadest reasonable interpretation“During patent examination, the pending claims must be "given *>their< broadest reasonable interpretation consistent with the specification." In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).”
As such, the broadest reasonable interpretation of the claimed method is that it allows treatment, and is not particularly limited to any specific disease or disorder, by modulating, such as inducing changes of any kind in any, many or all of the nerves of the patient under treatment, and administering any agent that meets the limitation of being therapeutic agent and being needed. Thus, the claims encompass an unreasonable number of treatment protocols, which include imposing essentially any change to any nerve in the patient followed by administration of any therapeutic agent, which the skilled artisan would not know how to evaluate. As opposed to the claims, what is disclosed about the claimed method is narrow: a set of experiments to stimulate vagus nerve and no other obvious specific examples of modulating, administering or monitoring any parameters, or any meaningful guidance as how to practice the full scope of instant claimed method.
Applicant has left those skilled in the art with too much experimentation to research and discover for themselves the pathologies to be treated, means of modulating nerves and specific types of nerves, as well as types of therapeutic agents to be administered to a patient. The art does not teach that modulation of nerves is directly associated with every known pathology. The specification does not teach how to make decisions about the types of disorders, means of modulation, types of nerves, or specific routes and regimes of administration of particular therapeutic agents, or what physiological parameters are suitable for monitoring for meaningful outcome. As such, Applicant has merely provided a starting point for research and experimentation and not a meaningful enabling disclosure of how to practice the claimed invention. Therefore, the claimed method of treatment clearly lacks enablement, as disclosed. In fact, the specification does not describe a single embodiment that satisfies the claim limitations.
A mere wish or plan of obtaining the claimed invention is not sufficient. The standard of an enabling disclosure is not the ability to make and test if the invention worked but one of the ability to make and use with a reasonable expectation of success.
A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. In the decision of Genentec, Inc, v. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997), the court held that:
“[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable” and that “[t]ossing out the mere germ of an idea does not constitute enabling disclosure.” The court further stated that “when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art,” “[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement.”
The instant specification is not enabling because one cannot follow the guidance presented therein and practice the claimed methods without first making a substantial inventive contribution to perfect the method and complete the invention.
15. Claim 16 is 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.
Claim 16 encompasses an apparatus comprising a device to modulate one or more nerves of a patient combined with a device to deliver a therapeutic agent to the patient and a device to monitor physiological parameter(s) of the patient. However, the instant specification is devoid of any evidence that Applicant was in possession of even a single operable embodiment of the claimed product.
As stated in M.P.E.P. § 2163(II)(A)(3), a specification may describe an actual reduction to practice by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose. Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896, 1901 (Fed. Cir. 1998). See also UMC Elecs. Co. v. United States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987) (“[T]here cannot be a reduction to practice of the invention ... without a physical embodiment which includes all limitations of the claim.”); Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1614 (Fed. Cir. 1997) (“[A] reduction to practice does not occur until the inventor has determined that the invention will work for its intended purpose.”); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that the invention will work for its intended purpose may require testing depending on the character of the invention and the problem it solves).
Whereas a reduction to practice of an uncomplicated invention such as a simple mechanical or electrical device can be achieved by merely providing a diagram of the device wherein one skilled in the relevant art can predict the likely operability of the device by reviewing the diagram, the operability of the claimed invention cannot be predicted by merely reviewing diagrams or illustrations. To demonstrate the reduction to practice of an apparatus comprising essentially three devices—to modulate nerves, to deliver therapeutic agent(s), and to monitor physiological parameter(s)— all described by reference of what they do or intend to do rather than what they are, requires either a working embodiment, a demonstration of operability in the treatment method when applied to an art accepted animal model of the condition to be treated wherein that animal model has been shown to be reliably predictive of efficacy in the treatment of the condition, or a demonstration that the devices employed therein reasonably correlate with the similar products of the prior art. In the instant case, Applicant has provided none of these. Consequently, Applicant has failed to demonstrate possession of the claimed apparatus as of the earliest effective filing date of the instant application.
Conclusion
16. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
August 21, 2026
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