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 .
Applicant's amendments and remarks, filed 06/01/2026, are acknowledged. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Non-Elected Invention/Election By Original Presentation
Claims 15-20 are newly added. However, newly added claims 16 and 17 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 2, hereinafter referred to as the invention of Species A(i), has been previously examined and is drawn to a species of calculating the amount of the sedative (by comparing the detected sedation level with a set value of the sedation level). Newly added claims 15-17 contain claims directed to the following patentably distinct species of the claimed invention hereinafter referred to as the invention of Species A(ii) and A(iii) (as set forth below). The inventions are distinct and divergent, each from the other because of the following reasons:
SPECIES A: Claims 2 and 15-17 recite patentably distinct species of calculating sedative amounts. In order to begin examination on the merits, Applicant is required to select a single disclosed species from ONE of the groups set forth below:
calculating by comparing the detected sedation level with a set value of the sedation level (claims 2, 15)
calculating by considering at least one of: a type of the sedative, data of the subject, a type of an imaging procedure, or a purpose of sedation. (claims 16)
using an artificial intelligence module configured for calculating the amount of the sedative by a machine learning regression method (claim 17)
The above species are independent or distinct for the following reasons. The disclosed species of calculating are directed to distinct and non-overlapping limitations (e.g. using distinct mathematical techniques, operations, and or modules) that would require different prior art searches. In addition, these species are not obvious variants of each other based on the current record. See MPEP 806.04(b), § 806.04(f) and § 806.04(h). Moreover, at least one of these species recites limitations that would introduce additional rejections under 35 USC 112, (a), (b), and/or (f) due to the “artificial intelligence module” limitation.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 16 and 17 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Status of Claims
Claims 1-6, 9-13, 15, 18-20 are under examination.
Claims 16 and 17 are withdrawn.
Claims 7, 8, 14 are cancelled.
Priority
This application is a 371 of PCT/EP2020/086334, filed 12/16/2020. Applicant’s claim for the benefit of foreign priority under 35 U.S.C. 119(a)-(d) to European Patent 19217941.4, filed 12/19/2019, is acknowledged. The certified copy of the aforementioned application is acknowledged. However, Applicant is reminded that the filing date of the foreign priority document is not the effective filing date of the U.S. application. MPEP §§ 201.13 III. and 706.02 V. Thus, the one-year bar of 35 U.S.C. § 102(b) dates from the effective U.S. filing date and not from the foreign filing date. This means that a reference with a publication or patent date less than a year before the priority date but more than a year before the effective U.S. filing date, is a reference under 35 U.S.C. § 102(b). This also applies when the claimed invention had been into a public use or on sale in this country more than one year prior to the effective U.S. filing date. 35 U.S.C. § 119(a). Accordingly, the effective filing date for the instant application is 12/16/2020.
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.
The following rejection is modified in view of applicant’s amendments.
Claims 1-6, 9-13, 15, 18-20 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. In this case, 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 MPEP §2111, during patent examination, claims must be interpreted in their broadest reasonable manner consistent with the specification. This means that examiners consider the claim language in light of the specification as understood by a person of ordinary skill in the art, ensuring that the claims are not unduly narrowed by implicit limitations not explicitly recited in the claim (37 CFR 1.75(d)(1)).
With regards to said detecting, under the BRI, the recited act is generically recited sets forth or describes observing data (which scientists can performing using their minds). As such, this encompasses a mental process of observing data. MPEP 2106.04(a)(2), section III.
With regards to said calculating, under the BRI, the recited acts are generically recited and set forth or describe manipulating data (to generate additional data). Moreover, scientists routinely performed calculations and this can be done in the mind or using a pencil/paper. As such, this step encompasses a mental process of observing data and manipulating data to generate additional data. MPEP 2106.04(a)(2), section III.
It is important to note that “Claims that recite performing information analysis as well as the collection and manipulation of information related to such analysis, have been determined by our reviewing court to be an abstract concept that is not patent eligible. See SAP, 898 F.3d, 1165, 1167, 1168 (Claims reciting "[a] method for providing statistical analysis" (id. at 1165) were determined to be "directed to an abstract idea" (id. at 1168)); see also Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat'l Ass 'n, 776 F.3d 1343, 1345, 1347 (Fed. Cir. 2014). "As many cases make clear, even if a process of collecting and analyzing information is limited to particular content or a particular source, that limitation does not make the collection and analysis other than abstract." SAP, 898 F.3d at 1168 (internal quotation marks omitted))." [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 equation is being claimed, Applicant is reminded that there is no particular word or set of words that indicates a claim recites a mathematical calculation. As such, this step recites a mathematical concept. MPEP 2106.04(a)(2) Section I. Similar to the ineligible claims at issue for In re: Board of Trustees of the Leland Stanford Junior University, 991 F.3d 1245 (Fed. Cir. 2021), the instant claims are written effectively as a method for mathematically manipulating or relating data to ascertain additional data. See MPEP 2106.04 and 2106.05(II). [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:
imaging the subject with a medical imaging device;
releasing the calculated amount of the sedative at the calculated time transdermally to the subject, wherein the sedative is released transdermally to the subject during the imaging of the subject,
monitoring the amount of the sedative released transdermally to the subject;
detecting a contrast agent released together with the sedative, thereby monitoring the amount of the sedative released transdermally to 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). 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).
With regards to the medical imaging device, this is recited at a high level of generality and performs that act of obtaining data. As such, this amounts to “insignificant extra-solution activity” and does not integrate the judicial exception into a practical application. See MPEP 2106.05(g).
With regards to monitoring and detecting, these limitations are generically recited and 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). 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 and devices for administering, monitoring, and detecting sedatives to a patient via injection (i.e. transdermally) [see entire; specifically pages 28, 54]. In addition, Tremoleda et al. (2012) teaches imaging-based methods for monitoring anaestheia including magnetic resonance imaging (MRI), computed tomography (CT), PET, and high frequency ultrasound [page 2, col. 1]; detecting contrast agents to improve image enhancement [page 2, col. 2]; and protocols for administering anaesthesia [pages 7-10 and Tables 1 and 2]. ]. Moreover, Grimm et al. (2002) teaches methods and modalities for administering sedatives including transdermal delivery devices [page 158, 209] and intravenous delivery [page 210]. 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 2-6, 9-11, 13, 15, 18-20 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) 9-10, 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, 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.
Regarding claim(s) 15, 18-20, 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). Therefore, the claims as a whole are not patent eligible. For additional guidance, applicant is directed generally to MPEP 2106.
Response to Arguments
Applicant’s arguments, filed 06/01/2026, have been fully considered but are not persuasive for the following reasons.
Applicant argues that the amended claims recite a specific and unconventional combination of additional elements that integrate any alleged judicial exception into a practical application, namely (i) imaging the subject with a medical imaging device; (ii) releasing the calculated amount of the sedative transdermally to the subject during the imaging of the subject; (iii) monitoring the amount of the sedative released transdermally to the subject; and (iv) detecting a contrast agent released together with the sedative, thereby monitoring the amount of the sedative released transdermally to the subject.
In response, the unconventional combination of steps fall under the Step 2B analysis. In this case, however, step (ii) has been interpreted as part of the judicial exception and therefore is not considered under Step 2B analysis (which covers additional steps/elements that amount to significantly more than the judicial exception). That being said, steps (i), (iii), and (iv) have been interpreted as “additional steps/elements” and analyzed under the Step 2A prong 2 and Step 2B analysis (as discussed above). It is noted with particularity that the claims are not limited to any particular type of transdermal modality and therefore broadly encompass any modality wherein a sedative is administered through the skin (which includes IV injections). In addition, Abdulla (Depth Of Anaesthesia Control Techniques and Human Body Models, Dissertation, 2012, pp.1-170) teaches anaesthesia control techniques that include administering, monitoring, and detecting sedatives to a patient via injection (which broadly reads on transdermal release) [pages 28, 54]. In addition, Tremoleda et al. (2012) teaches imaging-based methods for monitoring anaestheia including magnetic resonance imaging (MRI), computed tomography (CT), PET, and high frequency ultrasound [page 2, col. 1]; detecting contrast agents to improve image enhancement [page 2, col. 2]; and protocols for administering anaesthesia [pages 7-10 and Tables 1 and 2]. Moreover, Grimm et al. (2002) teaches methods and modalities for administering sedatives including transdermal delivery devices [page 158, 209] and intravenous delivery [page 210]. Therefore, alone or in combination, there is nothing unconventional with regards to the above non-abstract steps/elements.
Applicant additionally argues that the amended claims provide an improvement to the technology (by addressing technical problems in certain imaging procedures, e.g., long magnetic resonance imaging acquisitions, wherein the patient is located inside a scanner bore and is therefore not readily accessible to a clinician for repeated administration of additional sedative. In response, neither Applicant nor the specification provides any objective evidence of an improvement to the technology, nor does the specification explain the details of an unconventional technical solution expressed in the claim, or identify technical improvements realized by the claim over the prior art. See MPEP 2106.04(d)(1) and MPEP 2106.05(a). Moreover, the claims do not recite any limitations directed to the use of MRI imaging or performing imaging procedures autonomously with access constraints. As such, applicant is arguing narrowing limitations that are not commensurate in scope with what is being claimed. As such, the claimed invention does not appear to result in improvements to the functioning of a particular machine or add a specific limitation other than what is well-understood, routine, conventional activity in the field. For these reasons, the examiner maintains that the claims are not patent eligible and the rejection is maintained.
Claim rejections - 35 USC § 112a
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
The following rejection is necessitated by amendment.
Claims 12, 15, 18-20 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement is separate and distinct from the enablement requirement. The specification must: (1) describe the claimed invention in a manner understandable to a person of ordinary skill in the art, and (2) show that the inventor actually invented the claimed subject matter. Claims depending from rejected claims are rejected similarly, unless otherwise noted.
Amended claim 12 is directed to a system for controlling transdermal and automatic release of a sedative during imaging of a subject, the method comprising the steps of system including a medical imaging device and a processor configured for: imaging the subject with the medical imaging device; 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; releasing the calculated amount of the sedative at the calculated time transdermally to the subject, wherein the sedative is released transdermally to the subject during imaging of the subject; monitoring the amount of the sedative released transdermally to the subject; and detecting a contrast agent released together with the sedative, thereby monitoring the amount of the sedative released transdermally to the subject.
In this case, the claim is not limited to any particular structure or modality for releasing a sedative transdermally; monitoring the amount of sedative released transdermally; or detecting a contrast agent released together with the sedative. The specifically generally proposes “a system for controlled transdermal release of a sedative during an imaging procedure. The imaging procedure can be at least partially automated. The sedative is applied transdermally to the patient, which results in an incorporation of the sedative through the skin in a noninvasive and easy dosed way” [page 2]. However, this does not provide a sufficient disclosure of a system for performing the claimed functions. As such, the specification lacks written description for a particular structure of the claimed system that is capable of performing these functions as claimed (since the artisan would recognize that neither a processor or a generically recited imaging device, e.g. x-ray, perform these functions). It may be clear how a human would perform these functions in a process claim, but it is not clear how these specialized functions are to be automated in a system that merely comprises a generically recited imaging device and a processor. See MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation", which also pertains. As appropriate, this rejection may be overcome, for example, (i) by narrowing to clearly supported embodiments and/or (ii) by clarifying on the record where support can be found and how that support relates to the recitations. In general, it is requested that any claim amendment in this regard be accompanied by citations to support in the original disclosure. MPEP 2163 generally pertains.
Claim rejections - 35 USC § 112b
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.
The following rejection is necessitated by amendment.
Claims 1-6, 9-13, 15, 18-20 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 “imaging the subject with a medical imaging device.” It is unclear as to the metes and bounds of the claimed “imaging device”. A review of the specification does not provide any limiting definition that would serve to clarify what structural limitation is intended. The specification teaches medical imaging systems like magnetic resonance imaging, computed tomography, positron emission tomography, or ultrasonic measurement systems [on page 25]. However, examples are not limiting definitions and it is improper to import narrowing limitations into the claims. MPEP 2111.01. Moreover, it is well understood that some imaging modalities do not require a contrast agent (e.g. ultrasound), as required by the detecting step, in which case the claim lends itself to one or more implausible interpretations. According, the claim is indefinite. Clarification is requested via amendment.
Claims 1 and 12 recite “monitoring the amount of sedative released…, detecting a contrast agent released together with the sedative, thereby monitoring the amount of the sedative released transdermally to the subject.” In this case, the “thereby” phrase renders this limitation problematic because the previous step is already directed to “monitoring” the amount of the sedative released transdermally. Therefore, it is unclear in what way the “detecting” step further limits the claimed method (and system) since it encompasses the same subject matter as the “monitoring” step. In addition, the system of claim 12 has been amended to comprises a processor and an imaging device. As such, it is unclear what particular structure of the claimed system achieves the function of transdermally releasing a sedative; monitoring the amount of sedative transdermally released to a subject; and detecting a contrast agent released together with the sedative (since the artisan would recognize that neither a processor or a generically recited imaging device, e.g. x-ray, perform these functions). Clarification is requested via amendment.
Claim 15 recites “…further configured for calculating the amount of the sedative by comparing the detected sedation level with a set value of the sedation level.” One of ordinary skill in the art would recognize that a calculation is a mathematical operation that results in a value, whereas a “comparison” can be any type of comparison (e.g. a visual comparison) and does not inherently result in a value. Accordingly, it is unclear in what way the claimed “calculating” is achieved by generically “comparing” a detected level with a set level (since no value is generated by said comparison). 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.
The following rejection is necessitated by amendment.
Claims 1-6, 9-13, 15, 18, 19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bibian et al. (European Journal of Control, 2005, 11:535–557) in view of Grimm et al. (Veterinary Anesthesia and Analgesia; 2002; pp. 1-1074), and Tremoleda et al. (EJNMMI Research, 2012, 2:44, pp.1-23).
For purposes of applying prior art, it is noted with particularity that the claimed method/system are not limited to any particular methods or structures for administering or releasing sedatives transdermally, and therefore broadly encompass any modality wherein a sedative is administered through the skin (including IV injections). In addition, it is noted that the instant claims are not limited to any particular type of imaging modality.
Bibian teaches an automated drug delivery controller for clinical anesthesia. Regarding claim(s) 1 and 12, Bibian teaches a controller for detecting sedation levels (hypnotic, analgesic, and paralytic states) of the patient based on physiological signals [p. 541, col. 1 and Figures 1 and 2], which reads on detecting a “sedation level” given the breadth of what is claimed. Bibian teaches a feedback control paradigm and for calculating and adjusting the infusion rates of sedatives 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 teach calculating an amount of sedative to be released transdermally. However, the type of modality for releasing a sedative is interpreted as nothing more than a design choice and Applicant has not disclosed that this particular feature provides an advantage, is used for a particular purpose, or solves a stated problem.
Bibian does not specifically teach calculating a time for releasing the amount of sedatives transdermally. However, Bibian suggests this limitation because infusion rates are necessarily a function of amount versus time and since Bibian further teaches a PK-based method of modeling drug bolus and infusion rates as a function of time [Section 5; Figures 4 and 6].
Moreover, Grimm teaches methods and modalities for administering sedatives including transdermal delivery devices [page 158, 209] and intravenous delivery [page 210]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the teachings of Bibian by calculating amounts and times for sedative release transdermally, since Grimm specifically provides routine and conventional transdermal modalities for administering sedatives to subjects, as set forth above. One of ordinary skill in the art would have been able to perform this modification with a reasonable expectation of success since both references teach using the same types of sedatives and PK parameters. The motivation would have been to improve health care using modalities that bypass the GI tract.
Bibian additionally teaches a feedback control paradigm for administering said drugs to the patient via intravenously means [Figure 1, Section 2.5.1, and Section 3], which reads on releasing a calculated amount of sedative transdermally given the breadth of what is 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].
Bibian teaches various modalities for monitoring the effects of anesthetic drugs on the patient based upon images and the commercially available BIS Monitor that displays sedation states monitoring the amount of sedative released transdermally [Section 4.3, Figures 2 and 3], which broadly reads on monitoring as claimed.
Bibian does not specifically teach imaging the subject with a medical imaging device; and detecting a contrast agent released together with the sedative, as claimed. It is noted with particularity that none of the imaging data is required to be used in any of the computational method steps.
That being said, Tremoleda teaches imaging-based methods for monitoring anaestheia and disease progression. In particular, Tremoleda teaches suitable imaging modalities including magnetic resonance imaging (MRI), computed tomography (CT), PET, and high frequency ultrasound [page 2, col. 1]. Tremoleda teaches using and detecting contrast agents to improve image enhancement [page 2, col. 2]. Tremoleda teaches protocols for administering anaesthesia at different rates and time periods [pages 7-10 and Tables 1 and 2].
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 made obvious by Bibian and Grimm by additionally imaging a subject and detecting a contrast agent, as claimed, since imaging and detecting modalities were routine and conventional, as taught by Tremoleda, 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.
Regarding dependent claims 2-6, 9-11, 13, 15, 18, 19, 20, Bibian, Grimm, and Tremoleda 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) 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, 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.
Regarding claim(s) 15. Bibian teaches comparing measured depth of sedation values (WAV) with threshold values (response boundaries) at different time periods [Figures 3 and 4], which broadly reads on comparing as claimed. Bibian additionally teaches a pharmacokinetic model for controlling drug concentration and administered dosages [Section 5].
Regarding claim(s) 18, 19, Bibian teaches a feedback control paradigm for detecting and calculating sedation levels [as set forth above; Section 3], including adjusting drug titrations based on durations [Section 2.4]. However, Bibian suggests these limitations by teaching a PK-based method of modeling drug bolus and infusion rates as a function of time [Section 5; Figures 4 and 6] and since one of ordinary skill in the art would recognize that that infusion rates are necessarily a function of amount versus time. Bibian does not specifically teach calculating time and amounts of sedatives to be released, or determining start, stop, and duration times. However, such times are considered results-effective variables that are routinely optimizable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the teachings of Bebian by additionally determining start, stop, and duration times with a reasonable expectation of success, since Bebian already provides amount and duration information associated with various sedatives being administered, and since one of skill in the art would recognize that such variables and could easily be optimized based on the drugs being used and the patient condition.
Regarding claim(s) 20, Bebian teaches a BIS Monitor that displays sedation states monitoring the amount of sedative released transdermally [Section 4.3, Figures 2 and 3], which broadly reads a sedation level monitoring system configured for measuring a degree of sedation of the subject.
Response to Arguments
Applicant’s arguments have been fully considered but are moot in view of the modified rejection that includes newly recited prior art that is necessitated by amendment.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619
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