DETAILED ACTION1
ELECTION/RESTRICTION
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected groups and species, there being no allowable generic or linking claim.
Applicant's election without traverse of Group I, claims 1-15 in the reply filed on October 5, 2025 is acknowledged.
REJECTIONS UNDER 35 USC 112(b)
The following is a quotation of 35 U.S.C. 112:
(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.
Claims 1-15 are rejected under 35 U.S.C. 112 (b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 contains several issues rendering it indefinite. One, the term the bloodsteam lacks antecedent basis. It should be introduced as ‘a bloodstream’ or preferable ‘a patient’s bloodstream.’ Two, it is unclear if the phrase programmatically optimizing thyroid hormone delivery is defining a function of the embedded intelligence or is reciting a separate method step. Three, it is unclear what an embedded intelligence is and how it further limits the claim. Also, claim 1 recites that the AI computer program contains the embedded intelligence, yet claim 11 recites that the AI program of claim 9 is an embedded intelligence. It is unclear what the distinction between the two might be. Notably no other claim makes any reference to the embedded intelligence or any function or method step it performs.
Four, claim 1 fails to recite any method steps. Rather, claim 1 recites a series of structures namely a synthetic thyroid…, an artificial intelligence computer program…, and one measurement device. Method claims should be drafted as a series of method steps, and every method step should begin with an active verb describing the action being taken in the method. In the interest of clarity and advancing patent prosecution, examiner has drafted a suggested re-write of claim 1 based on his understanding of the intent of claim 1.
Suggested Claim 1 Rewrite.
A method for thyroid hormone control comprising:
providing a synthetic thyroid, the synthetic thyroid containing a drug delivery system with a delivery pump, a valve, and a reservoir containing a thyroid hormone;
measuring a concentration of thyroid hormone in a patient’s bloodstream;
using an artificial intelligence computer to determine a dosage of thyroid hormone based on the measured concentration; and
controlling the delivery pump and the valve using the artificial intelligence computer program to dispense the dosage of thyroid hormone into the patient’s bloodstream.
Claim 9 contains similar issues and is rejected for the same reasons. All remaining claims are rejected based on their dependence.
REJECTIONS UNDER 35 USC 112(a)
The following is a quotation 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.
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.
MPEP 2164.01 states that the test of enablement is whether undue experimentation would be needed to practice the invention. The MPEP lays out eight factors to consider whether the level of experimentation would be undue. These factors are: (A) the breadth of the claims; (B) the nature of the invention; (C) the state of the prior art; (D) the level of one of ordinary skill; (E) the level of predictability in the art; (F) the amount of direction provided by the inventor; (G) the existence of working examples; and (H) the quantity of experimentation needed to make or use the invention based on the context of the disclosure. See MPEP 2164.01(a) citing In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Claim 1 recites a synthetic thyroid that contains an artificial intelligence computer program controlling a delivery pump and valve with an embedded intelligence, programmatically optimizing thyroid hormone delivery. The nature of the invention is that of a surgically implanted device, fabricated using carbon nanotubes, for regulating thyroid hormone levels in a patient. The state of the art is that AI systems were known at the time of the invention. Such systems require training data, initial algorithms, and significant processing power. The state of the art is also that known methods of treating hypothyroidism were known by injecting or ingesting variants of existing thyroid hormones.
The level of ordinary skill is that of a medical device maker with 3-5 years of experience as well as 3-5 years of experience in machine learning. The level of predictability in the art is relatively low, insofar as machine learning systems at the time were highly unpredictable in how effective they could be and what approaches would effectively work, combined with the highly unpredictable nature of new medical treatments.
Turning to the breadth of the term synthetic thyroid. The specification states that the synthetic thyroid is a device that is surgically implanted into a patient, as discussed in figure 2. Assuming that claim 1 is interpreted in view of the specification, this requires that the synthetic thyroid be such a device. The specification contains no enablement of how such an implantable device would be fabricated. Paragraph [0031] of the specification recites that is would be “constructed with nanotechnologies, including nanosensors, microprocessors, and carbon nanotubes.” But the specification them provides no further explanation of how this is accomplished. No discussion of dimensions of any elements are presented. No discussion of specific fabrication methods are discussed. The specification also fails to indicate how the device would be implanted, where the device would be implanted, or how the device would be refilled with additional hormones over time. Nor are any working embodiments illustrated. The claimed device would be a rather new medical device, requiring detailed illustrated blueprints. Instead, the only figure illustrating the device shows elements as labeled boxes. As such, the synthetic thyroid is not enabled.
Turning now to the artificial intelligence computer program controlling a delivery pump and valve with an embedded intelligence, programmatically optimizing thyroid hormone delivery. The breadth of this claim is that the specification must enable the creation and abilities of such an AI program. It does not do so. There is no discussion in the specification of what initial training data would be provided, what initial algorithms would be used, or how such a system would be tested (which is rather critical in a device meant to treat humans). Nor is there any discussion of how a tiny implantable device would have sufficient processing power to run an AI system. Additionally, applicant’s background section states that current medical science does not know how to treat patients directly using either T3 or T4.
There are also no working examples provided. Applicant provides no evidence of medical tests showing an AI program that has successfully treated patients using these hormones. Indeed, there is no real evidence applicant was even in possession of the invention as described. The specification reads as an aspirational list of items that might one day be combined into a working invention.
Claim 9 contains similar issues and is rejected for the same reasons. All remaining claims are rejected based on their dependence.
REJECTIONS UNDER 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious2 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, & 9 are rejected under 35 U.S.C. 103 as being unpatentable over WO 00/04832 to Samuels in view of U.S. 2021/0178069 to Grosman.
Claim 1 as understood recites a method for thyroid hormone control. Samuels teaches such a method. Samuels relates to a system for continuously monitoring biological fluid, so as to allow effective medical treatment. See Samuels pg. 1, ll. 9-12. Samuels teaches a closed loop system of monitoring biological markers and dispensing appropriate therapeutic compounds. See Samuels pg. 19, ll. 6-14. The primary example discussed is that of an insulin pump that continuously monitors glucose levels and modulates insulin delivery levels in response. Id. But Samuels also teaches the same type of monitoring/dispensing loop system could also be used to deliver thyroid hormone by monitoring thyroid hormone levels in the bloodstream. Id.
Claim 1 recites providing a synthetic thyroid to perform the recited method. The term synthetic thyroid has two potential interpretations. It could either refer to a device that is surgically implanted to replace the existing thyroid (as presented in figure 2 of applicant’s specification) or it could be a short-hand expression for a wearable pump system that is connected to the bloodstream, akin to an insulin pump system. Both interpretations are viewed to be within the broadest reasonable interpretation.
Samuels does not teach the specific structures that would be used to perform a thyroid hormone loop process. But one of ordinary skill would look to the earlier example of an insulin pump system for appropriate structures. Figure 4 of Grosman teaches an example of such an insulin pump system. Grosman teaches the insulin pump contains a delivery pump and valve (428) as well as a measurement device (408) and a controller (410) that programmatically optimiz[es] insulin delivery. See Grosman [0078]-[0082] and Fig. 4. It is obvious to apply a known technique to a known product or method, ready for improvement, to yield predictable results. See MPEP 2143(D). In this case, it would have been obvious to modify Samuels to use similar structures to create a synthetic thyroid having a delivery pump and valve as well as a measurement device for monitoring thyroid hormone levels. Claim 1 further recites the system has an artificial intelligence program controlling the pump and optimizing thyroid hormone dosing…according to defined parameters. Grosman teaches using machine learing to create models that predict the need for insulin based on a variety of data and patterns, and teaches letting the controller (410) dispense insulin based on this predictive model. See Grosman [0130]-[0134]. It would have also been obvious to similarly create a machine learning model for thyroid dispensing levels. See MPEP 2143(D).
Claim 3 recites comparing the measured concentration of thyroid hormone to an optimal concentration and then the AI program manipulates the drug delivery system to minimize the difference. This is the process Grosman uses to control insulin dispensation and would therefore become the system for thyroid hormone dispensation.
Claim 9 recites a substantially similar set of features to claim 1 and is rejected for the same reasons.
The remaining claims are not rejected over the prior art at this time.
CONCLUSION
Any inquiry concerning this communication should be directed to Moshe Wilensky whose telephone number is 571-270-3257. Mr. Wilensky’s supervisor, Sunil Singh can be reached at 571-272-3460. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Examiner interviews are available via telephone or video conferencing using a USPTO supplied web-based collaboration tool. Applicant may also use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/MOSHE WILENSKY/
Primary Examiner, Art Unit 3726
1 The following conventions are used in this office action. All direct claim quotations are presented in italics. All non-italic reference numerals presented with italicized claim language are from the cited prior art reference. All citations to “specification” are to the applicant’s published specification unless otherwise indicated. The use of the phrase “et al.” following a reference is used solely to refer to subsequent modifying references, and not to other listed inventors of the cited reference.
2 Hereafter all uses of the word “obvious” should be construed to mean “obvious to one of ordinary skill in the art at the time the invention was filed.”