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 .
Status of Claims
Claims 1-14 are under examination.
Priority
The instant application does not claim the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) to any prior applications. Accordingly, the effective priority date for the instant application is the filing date of 06/17/2022.
Drawings
The drawings filed 06/17/2022 are acceptable.
Information Disclosure Statement(s)
The two (2) information disclosure statement (IDS) document(s) submitted are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
Formal Matters
Applicant is advised that should claim 1 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The United States Patent and Trademark Office published revised guidance on the application of 35 U.S.C. § 101. USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”). Under the Guidance, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (Guidance Step 2A, Prong 1); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)) (Guidance Step 2A, Prong 2).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that are not “well-understood, routine and conventional in the field” (see MPEP § 2106.05(d)); or 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50-57 (January 7, 2019).
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.(Guidance Step 2B). See Guidance, 84 Fed. Reg. at 54-56.
Guidance Step 1:
The instant invention (claims 1 and 12 being representative) is directed to a method that performs a series of processes. Thus, the claims are directed to one of the statutory categories of invention. MPEP 2106.03.
A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any judicial exception to patent eligibility is recited in the claim. The Revised Guidance identifies three judicially-excepted groupings identified by the courts as abstract ideas: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. Regarding claim(s) 1, the claimed steps that are part of the abstract idea are as follows:
detecting a sedation level of the subject;
calculating an amount of the sedative to be released transdermally to the subject;
calculating a time for releasing the amount of the sedative transdermally to the subject;
Mental Processes
Under the broadest reasonable interpretation, the above italicized steps amount to observing data and performing calculations. Notably, claims do not impose any boundaries on how the italicized functions are actually being achieved. Accordingly, the above steps clearly fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III [Step 2A, Prong 1: YES].
Mathematical Concept
In addition, the above calculating steps explicitly require calculating various parameters (e.g. amount of sedative, time for releasing sedative). While no specific equations are being claimed, Applicant is reminded that there is no particular word or set of words that indicates a claim recites a mathematical calculation. Therefore, when read in light of the specification, the above steps reasonably encompass a mathematical concept. See MPEP 2106.04(a)(2) [Step 2A, Prong 1: YES].
B. Guidance Step 2A, Prong 2
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception or whether the claim is “directed to” the judicial exception. This evaluation is performed by (1) identifying whether there are any additional steps/elements recited in the claim beyond the judicial exception, and (2) evaluating those additional steps/elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See MPEP 2106.04(d).
In this case, the additional steps/elements recited in the claim beyond the judicial exception are as follows:
releasing the calculated amount of the sedative at the calculated time transdermally to the subject, the sedative is released transdermally to the subject during imaging of the subject.
With regards to said “releasing”, the “sedative” being released is generically recited and the subject is not associated with any particular disease or condition. Therefore, the claim does not recite a treatment or prophylaxis that is “particular”, i.e. specifically identified so that it does not encompass all applications of the judicial exception(s). See MPEP 2106.04(d)(2). For example, consider a claim that recites “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype.” This administration step recites a particular dosage and type of medication and it integrates the mental analysis step into a practical application. The Federal Circuit also has rejected the premise that “claims drafted to include treatment steps are automatically patent eligible.” INO Therapeutics LLC v. Praxair Distribution Inc., 782 F. App’x 1001, 1007 (Fed Cir. 2019). Therefore, after careful consideration, this limitation amounts to insignificant extra-solution activity and/or generally linking the use of a judicial exception to a particular technological environment or field of use. MPEP 2106.04(g) and (h). Consequently, the claimed invention does not integrate the abstract idea into a “practical application.” See MPEP 2106.04(d)(1) for a list of considerations when evaluating whether additional elements integrate a judicial exception into a practical application. [Step 2A, Prong 2: NO].
C. Guidance Step 2B:
This part of the eligibility analysis evaluates whether the claim as a whole amount to significantly more than the recited exception i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. See MPEP 2106.05.
As discussed above, the non-abstract steps/elements amount to insignificant extra-solution activity and/or generally linking the use of a judicial exception to a particular technological environment or field of use. MPEP 2106.04(g) and (h). In addition, Abdulla (Depth Of Anaesthesia Control Techniques and Human Body Models, Dissertation, 2012, pp.1-170) teaches anaesthesia control techniques that include administering sedatives to a patient via injection (i.e. transdermally) [pages 28, 54]. Therefore, even upon reconsideration, there is nothing unconventional with regards to the above non-abstract elements. See MPEP 2106.05(d)(Part II). Thus, the independent claim(s) as a whole do not amount to significantly more than the exception itself. Therefore, the claim(s) is/are not patent eligible. [Step 2B: NO].
D. Dependent Claims
Dependent claims 2-11, 13, 14 have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. Regarding claims 2-6, and 11, these claims are entirely directed to limitations that further limit the specificity of the abstract idea or the type of data being used by the abstract idea. Accordingly, these claims are also directed to an abstract idea for the reasons set forth above (Step 2A, prong 1, analysis). Regarding claim(s) 7-10, these claims are further directed to non-abstract steps for monitoring sedative amounts and releasing sedatives (e.g. via microneedle). Accordingly, these limitations amount to insignificant extra-solution activity and/or generally linking the use of a judicial exception to a particular technological environment or field of use as set forth above. MPEP 2106.04(g) and (h).
Regarding claim(s) 13 and 14, these claims comprise a processing unit and computer readable medium for performing the method of claim 12. However, these features are generically recited and merely used as tools to obtain information or perform the abstract idea. Moreover, applicant is reminded that “generic computer components such as a computer and database do not satisfy the inventive concept requirement.” See MPEP 2106.05(f) and 2106.05(h). Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Claim rejections - 35 USC § 112, 2nd Paragraph
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 1-14 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 pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 1 and 12 are also rejected due to said dependency.
Claims 1 and 12 recite “the sedative is released transdermally to the subject during imaging of the subject.” This limitation is problematic because there are no prior steps in the claim that requires performing “imaging” of a subject. As a result, it does not further limit any of the mechanics of the claimed method (or any structures used by said method), but merely states an overall objective or intended result/use. Accordingly, it is unclear what positive process limitation is intended as this phrase merely describes the environment in which the sedative is released, i.e. it does not impose any additional positive process limitations of the method as claimed. In addition, claim 1 appears to be grammatically incorrect and should be amended to recite “wherein the sedative”. Clarification is requested via amendment.
Claim 4 recites “performed by a machine learning methods”. It is unclear as to the metes and bounds of “a machine learning methods”. A review of the specification does not provide any limiting definition for “learning methods” nor does it describe, to any appreciable extent, any algorithm or computational operations that correspond to this function. Therefore, the claim(s) is/are indefinite for failing to point out the requisite computational techniques that are included or excluded by the claim language, such that the artisan would know how to avoid infringement. In addition, the presence of the letter “a” in the phrase renders the claim as grammatically incorrect. Clarification is requested via amendment.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bibian et al. (European Journal of Control, 2005, 11:535–557).
Bibian teaches an automated drug delivery controller for clinical anesthesia. Regarding claim(s) 1 and 12, Bibian teaches using the controller for determining (i.e. detecting) hypnotic, analgesic, and paralytic states of the patient based on physiological signals [p. 541, col. 1 and Figure 1], which reads on detecting a “sedation level” given the breadth of what is claimed. Bibian teaches using the controller for calculating and adjusting the infusion rates of anesthetic drugs, opioids, and NMBs in order to drive the patient to the desired setpoints [p. 541, col. 1 “Section 3” and Figure 1], which reads on calculating an amount of sedative as claimed. Bibian does not specifically teaches calculating a time for releasing the amount of sedatives. However, Bibian suggests this limitation because infusion rates are necessarily a function of amount versus time and further teaches modeling drug infusion as a function of time [Figure 6].
Bibian additionally teaches administering said drugs to the patient via intravenously means [Figure 1 and Section 2.5.1], which reads on releasing a calculated amount of sedative transdermally as claimed.
Bibian does not specifically teach releasing the sedative during imaging of the subject, as recited in claims 1 and 12. However, Bibian makes obvious this limitation by teaching various modalities for monitoring the effects of anesthetic drugs on the patient based upon images, e.g. EEG images which represent measures of analgesia and the commercially available BIS Monitor that displays sedation states [See at least Section 4.1, pp.541-542, entire, Figure 2, Section 4.3.1, and Figure 3] and because one of ordinary skill in the art would recognize that these monitoring modalities are used during the sedative process [See at least Figures 3 and 4 and Section 4.4].
Regarding dependent claims 2-11, 12, 13, Bibian teaches or suggests all aspects of these claims for the following reasons. Regarding claim(s) 2, Bibian teaches the that controller compares detected sedation levels with desired set values [Figure 1 and p.541, col. 1]. Regarding claim(s) 3, Bibian teaches models for calculating the amount of sedative based on the type/dose of sedative [Section 5.1.3]. Regarding claim(s) 4, Bibian does not specifically teach performing machine learning for calculating amounts of sedative. However, Bibian reasonably suggests this feature by teaching an automated drug delivery system that relies upon a PK model (i.e. learning model) for calculating drug delivery amounts [Figure 1 and Section 5.2]. Regarding claim(s) 5, Bibian teaches a feedback-based control algorithm constantly adjusts the infusion rates of anesthetic drugs, opioids, and NMBs in order to drive the patient to the desired setpoints [p. 541, col. 1 “Section 3” and Figure 1], which reads on repeated calculations as claimed.
Regarding claim(s) 6, Bibian does not specifically teach calculating start time, stop time, or duration for releasing the amount of the sedative. However, Bibian makes obvious this limitation because their feedback-based control algorithm constantly adjusts the infusion rates of anesthetic drugs in order to drive the patient to the desired setpoints [p. 541, col. 1 “Section 3” and Figure 1], which suggests start/stop times, and by additionally teaching administering boluses at specific times when the anesthesia was determined to be light [Section 4.4, Case #1, and Figures 3 and 4].
Regarding claim(s) 7, 9, Bibian teaches administering said drugs to the patient via intravenously means [Figure 1 and Section 2.5.1], which broadly reads on releasing a calculated amount of sedative transdermally and via a microneedle as claimed. Regarding claim(s) 10, Bibian teaches the use of a combination of drugs for synergistic benefits [Section 2.4], which broadly reads on applying a drug penetration enhancement methods (since this improves drug update). Regarding claim(s) 11, as set forth above, Bibian teaches a feedback-based control algorithm that constantly adjusts the infusion rates of anesthetic drugs in order to drive the patient to the desired setpoints [p. 541, col. 1 “Section 3” and Figure 1], and additionally teaches using BIS-analysis for classifying a patient based on sedation state [Section 4.1.2 and Figure 2], which broadly reads on classifying the subject into a category.
Regarding claim(s) 13, 14, Bibian does not specifically teach a computer program and processor for implementing the above methods. However, Bibian reasonably suggests these limitations because their automated control algorithm and PK models are necessarily run by a suitably programmed computer.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bibian et al. (European Journal of Control, 2005, 11:535–557), as applied to claims 1-7 and 9-14, and further in view of Krause (Advanced Drug Delivery Reviews, 1999, 37: 159–173).
Bibian teaches an automated drug delivery controller for clinical anesthesia, as set forth above. Bibian does not specifically teach detecting a contrast agent released together with the sedative, as in claim 8.
However, Krause teaches methods for detecting tissue-specific contrast agents in subjects undergoing CT [Abstract].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the method of Bibian by additionally detecting a contrast agent, as claimed, since methods for detecting contrast agents were routine and conventional, as taught by Krause, and since one of ordinary skill in the art would recognize that imaging modalities such as x-ray/ CT are routinely used in combination with patients undergoing anesthesia (e.g. during surgery). The motivation would have been improving patient care by using contrast agents with minimal side effects during imaging, as suggested by Krause [Abstract].
Citation of Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant' s disclosure.
Simanski et al. (Mediterranean Conference on Control and Automation, 2007, pp. 1-6), which teaches a review of automatic drug delivery methods in anesthesia. Regarding claim(s) 1 and 12, Simanski teaches methods for measuring muscle relaxation [Section II-A], depth of hypnosis [Section II-B], and level of analgesia [Section II-C]. Simanski teaches models for calculating drug infusion rates [Section III-B and Figure 5a].
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619