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 7/24/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Status of Claims
Claims 1-20 are presently under examination.
Priority
This Application claims priority to U.S. Provisional Application No. 63/283,107, filed November 24, 2021.
Withdrawn Rejections
The rejection of claims 1-7 and 10-17 under 35 U.S.C. 103 as being unpatentable over Dorin et al. (J Clin Endocrinol Metab, April 2012, 97(4):1285–1293) is withdrawn in view of applicant’s amendments.
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 1-20 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:
Regarding claim(s) 1, 11, the claimed invention is directed to a method for performing a process and therefore falls within one of the four 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:
processing, by the computing device, based on a multi-compartment model, the time series physiological measurement data, wherein the multi-compartment model represents a bidirectional flux by diffusion of the hormone between a vascular compartment and an extravascular compartment of the patient; (claims 1 and 11)
transforming, based on processing the one or more time series physiological measurement data based on the multi-compartment model, the time series physiological measurement data to physiological attribute data associated with the patient; (claims 1 and 11)
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)).
In this case, under the BRI, the above processing and transforming are not limited to any particular acts or operations and set forth or describe manipulating and/or analyzing data. As such, these steps can reasonably be performed by a scientists using their brains or a pencil and paper. Therefore, these steps encompass a mental process. 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). [Step 2A, Prong 1: YES]
Mathematical Concept
In addition, under the BRI, the processing and transforming steps require using a multi-compartment model (representing bi-directional flux) for relating patient data, which one of ordinary skill in the art would recognize as a mathematical relationship. This position is also supported by applicant’s own specification [pages 11-13], which shows mathematical equations for achieving the claimed results. Therefore, when read in light of applicant’s own specification, the claims are directed to a mathematical concept. 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 includes any additional steps/elements that integrate the recited judicial exception into a practical application of the exception. In this case, the additional steps/elements that are not part of the abstract idea are as follows:
causing, by a computing device, a rapid intravenous administration of a hormone to a patient; (claims 1 and 11)
generating, based on monitoring changes in blood hormone concentrations associated with the patient during the rapid intravenous administration of the hormone to the patient, a time series of physiological measurement data associated with the patient sampled at one or more time intervals; (claims 1 and 11)
causing, based on the physiological attribute data, the computing device to display one or more medical conditions and the physiological attribute data associated with the patient via an interactive interface of a display of the computing device. (claim 1)
adjusting, based on the one or more physiological parameters attribute data, an administration of a treatment associated with to the patient according to one or more medical conditions associated with the patient. (claim 11)
With regards to “causing a rapid intravenous administration of a hormone” to a patient, this step is recited at a high level of generality and amounts to both ‘pre-solution’ activity and ‘field-of-use’ activity. In other words, this is a diagnostic step necessary for generating the subsequent physiological measurement data being used in the downstream analysis by the abstract idea, and does not amount to a particular treatment (for reasons discussed below). It is noted that the term “extra-solution activity” can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim, and includes both pre-solution and post-solution activity. Therefore, this step amounts to “insignificant extra-solution activity” and a ‘field of use’ limitation and does not integrate the judicial exception into a practical application. See MPEP 2106.05(g). See also MPEP 2106.04(h).
With regards to generating time-series physiological measurements, this step is recited at a high level of generality and amounts to necessary data gathering for use by the abstract idea. Therefore, this step amounts to “insignificant extra-solution activity” and does not integrate the judicial exception into a practical application. See MPEP 2106.05(g). See also MPEP 2106.04(d)(2).
With regards to causing the computing device to display medical conditions and attribute data, this step merely outputs information. Therefore, this step 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 adjusting an administration of a treatment, this step is generically recited and not limited to any particular means of “adjusting” or any particular compound or modality being administered to treat a particular disorder. Accordingly, this step does not amount to a particular treatment. 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. In this case, however, the claimed adjusting step is merely instructions to “apply” the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application. Consequently, the claimed invention does not integrate the abstract idea into a “practical application.”
With regards to the recited computing device and interface, these are recited at a high level of generality and thus can be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer. In addition, “generic computer components such as a computer and database do not satisfy the inventive concept requirement.” See MPEP 2106.05(h).
In summary, the claimed invention does not provide 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). Therefore, even when viewed in combination, these additional steps/elements do not integrate the recited judicial exception into a practical application. [Step 2A, Prong 2: NO].
C. Guidance Step 2B:
Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. In this case, the claims do not include additional steps and/or elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons:
As discussed above, the non-abstract steps/elements amount to nothing more than insignificant extra-solution activity. In addition, Bornstein et al. (J Clin Endocrinol Metab, 2016, 101(2):364–389) teaches administering corticotropin to a patient as the “gold standard” diagnostic tool to establish the diagnosis and generating time-series measurements [see, e.g. Conclusions and Evidence]. In addition, Applicant’s own specification also teaches the use of previously reported measurement data [page 15] and generic computer processors and components for achieving the claimed method [pages 6-7]. In other words, there is nothing unconventional about administering a hormone to a patient (for diagnostic purposes) or how the data is being obtained. Therefore, these steps remain insignificant extra-solution activity even upon reconsideration, and do not amount to significantly more. 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.
D. Dependent Claims
Dependent claims 2-10, 12-20 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 claim(s) 2-10, 12-13, 15, 17-19 , these claims further limit the specificity of the model set forth above (i.e. abstract idea) or the nature of the data being used by the abstract idea. Accordingly, these claims are also directed to an abstract idea for reasons set forth above (Step 2A, prong 1 analysis). Regarding claim(s) 14, 16, 20, these claims further limit the hormone or the non-abstract steps step forth above and therefore are not patent eligible for all the reasons discussed above in the Step 2A (prong 2) and Step 2B analysis. For additional guidance, applicant is directed generally to the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
Response to Arguments
Applicant’s arguments, filed 07/24/2026, have been fully considered but are not persuasive for the following reasons.
Applicant argues that the amended claims do not recite a mathematical concept in light of the newly recited step of causing, by a computing device, a rapid intravenous administration of a hormone to a patient (which applicant asserts is a physical step). In response, the examiner has interpreted this “causing” step is a physical step and therefore analyzed it under the Step 2A, prong 2, and Step 2B analysis. That being said, the “causing” step is recited at a high level of generality and amounts to both ‘pre-solution’ activity and ‘field-of-use’ activity. In other words, this is a diagnostic step necessary for generating the subsequent physiological measurement data being used in the downstream analysis by the abstract idea, and does not amount to a particular treatment (Step 2A, prong 2). Therefore, this step amounts to “insignificant extra-solution activity” and a ‘field of use’ limitation and does not integrate the judicial exception into a practical application. See MPEP 2106.05(g). See also MPEP 2106.04(h). Moreover, Bornstein et al. (J Clin Endocrinol Metab, 2016, 101(2):364–389) teaches administering corticotropin to a patient as the “gold standard” diagnostic tool to establish the diagnosis and generating time-series measurements [see, e.g. Conclusions and Evidence] (Step 2B analysis). Accordingly, the examiner maintains there is nothing unconventional about administering a hormone to a patient (for diagnostic purposes) or how the subsequent data is being obtained. Therefore, these steps remain insignificant extra-solution activity even upon reconsideration, and do not amount to significantly more. In addition, as set forth in the Step 2A (prong 1) analysis, the examiner has clearly identified claim limitations that constitute the judicial exception, provided sufficient reasoning as to why these steps fall within the mathematical concept of abstract ideas, and cited the appropriate sections of the MPEP. In addition, MPEP 2106.04(a)(2) provides other examples of mathematical calculations and relationships recited in a claim including:
i. performing a resampled statistical analysis to generate a resampled distribution, SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65, 127 USPQ2d 1597, 1598-1600 (Fed. Cir. 2018), modifying SAP America, Inc. v. InvestPic, LLC, 890 F.3d 1016, 126 USPQ2d 1638 (Fed. Cir. 2018);
iii. using a formula to convert geospatial coordinates into natural numbers, Burnett v. Panasonic Corp., 741 Fed. Appx. 777, 780 (Fed. Cir. 2018) (non-precedential);
iv. managing a stable value protected life insurance policy via performing calculations, Bancorp Servs., LLC v. Sun Life Assur. Co. of Canada (U.S.), 687 F.3d 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012);
v. using an algorithm for determining the optimal number of visits by a business representative to a client, In re Maucorps, 609 F.2d 481, 482, 203 USPQ 812, 813 (CCPA 1979); and
vi. calculating the difference between local and average data values, In re Abele, 684 F.2d 902, 903, 214 USPQ 682, 683-84 (CCPA 1982).
iv. organizing information and manipulating information through mathematical correlations, Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014).
Accordingly, the examiner maintains that he has properly identified and explained the judicial exception in a manner that is consistent with the Step 2A, prong 1 analysis.
Applicant argues that the amended claims do not recite a mental concept in light of the newly recited step of causing, by a computing device, a rapid intravenous administration of a hormone to a patient (which applicant asserts is a physical step). In response, the examiner has interpreted this “causing” step is a physical step and therefore analyzed it under the Step 2A, prong 2, and Step 2B analysis. In addition, as set forth in the Step 2A (prong 1) analysis, the examiner has clearly identified claim limitations that constitute the judicial exception, provided sufficient reasoning as to why these steps fall within the mental concept of abstract ideas, and cited the appropriate sections of the MPEP. Accordingly, the examiner maintains that he has properly identified and explained the judicial exception in a manner that is consistent with the Step 2A, prong 1 analysis.
Applicant additionally argues that the amended claims integrate the alleged judicial exception into a practical application. In response, this argument is not persuasive for reasons set forth above (Step 2A, prong 2 analysis). Contrary to applicant’s assertion, the claims have indeed been analyzed “as a whole” and the claimed invention generally results in administering a hormone to a patient, generating data, analyzing said data, and causing a computing device to display information associated with a patient. It does not provide 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). Therefore, even when viewed in combination, these additional steps/elements do not integrate the recited judicial exception into a practical application. [Step 2A, Prong 2: NO].
Applicant additionally argues that the claimed invention profiles a particular improvement to the technology, namely by providing a multi-compartment model with an extra-vascular compartment and a bidirectional diffusion flux. In response, it is important to note that the judicial exception alone cannot provide the improvement. The improvement can be provided by (1) one or more additional steps/elements appended to the judicial exception; or (2) by the additional steps/elements appended to the judicial exception in combination with the recited judicial exception. See MPEP 2106.05(a). In this case, the administering and generating steps do not serve to “integrate” the abstract idea into a practical application for reasons set forth above (Step 2A, prong 2 analysis). In other words, applicant’s aggregate arguments are essentially asserting that claimed model (i.e. the “abstract idea”) is providing the improvement to the technology (by providing improved efficiency). As discussed above, the judicial exception alone cannot provide the improvement. See MPEP 2106.05(a). It is also well settled that mere computer-based efficiency does not save an otherwise abstract method. Bancorp Servs. L.L.C. v. Sun Life Assur. Co. of Canada (US.), 687 F.3d 1266, 1277-78 (Fed. Cir. 2012) (explaining that performance by computer of operations that previously were performed manually or mentally, albeit less efficiently, does not convert a known abstract idea into eligible subject matter). Similarly, the courts have also instructed that “[t]he different use of a mathematical calculation, even one that yields different or better results, does not render patent eligible subject matter.” Board Of Trustees Of Leland Stanford Junior University, 991 F.3d 1245, 1251 (Fed. Cir. 2021). In summary, 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). Therefore, the examiner maintains that the claims do not provide an improvement to the technology (under Step 2A, prong 2, or Step 2B). See MPEP 2106.04(d)(1). For at least these reasons, absent any evidence to the contrary, the rejection is maintained.
Claim rejections - 35 USC § 112a
The following is a quotation of 35 U.S.C. 112(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.
This new matter rejection is necessitated by applicant’s amendments.
Claims 1-20 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 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.
Claims 1 and 11 recite “causing, by a computing device, a rapid intravenous administration of a hormone to a patient.” While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure. In this case, however, the examiner cannot find support for the newly added limitations (as set forth above) in the original claims, drawings, or the specification as originally filed, and no basis has been pointed to for these new limitations in applicant's remarks. At best, the specification discloses an algorithm for obtaining known data and measured data [Figure 2] and administering a treatment to a patient [0062]. However, such teachings are not commensurate in scope with what is being claimed. In the absence of support for the newly recited limitations, these claims and claims dependent thereon are deemed to constitute new matter.
Claims 1 and 11 recite “transforming, based on processing the one or more time series physiological measurement data based on the multi-compartment model, the time series physiological measurement data to physiological attribute data associated with the patient.” While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure. In this case, however, the examiner cannot find support for the newly added limitations (as set forth above) in the original claims, drawings, or the specification as originally filed, and no basis has been pointed to for these new limitations in applicant's remarks. The specification teaches, for example, that one or more physiological attributes associated with the patient may be determined, or predicted, based on the one or more physiological parameters [0060]. However, such teachings are not commensurate in scope with what is being claimed. In the absence of support for the newly recited limitations, these claims and claims dependent thereon are deemed to constitute new matter.
Claim rejections - 35 USC § 112a
The following is a quotation of 35 U.S.C. 112(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.
This is a written description rejection.
Claims 1-20 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.
Regarding claims 1 and 11, the specification fails to provide written description support for the following steps:
processing, by the computing device, based on a multi-compartment model, the time series physiological measurement data, wherein the multi-compartment model represents a bidirectional flux by diffusion of the hormone between a vascular compartment and an extravascular compartment of the patient; (claims 1 and 11)
transforming, based on processing the one or more time series physiological measurement data based on the multi-compartment model, the time series physiological measurement data to physiological attribute data associated with the patient; (claims 1 and 11)
In this case, one of ordinary skill in the art would understand that the practicing these steps as claimed requires knowledge of a well-defined model associated with specific parameters such that meaningful comparative analysis or prediction can be made. However, the claimed “multi-compartment model” is generically recited and not limited to any particular parameters, variables, and/or equations that would serve to clarify the structure of the model (and how it is making use of the data being applied), i.e. the claim is essentially using a black box and encompasses all models capable of performing the claimed functions. A review of the specification does describe four non-linear differential equations that may be expressed using specific equations [0034] that account for a rate of diffusion of free cortisol [0034, 035]. However, while this does provide sufficient disclosure of the mathematical structure for a specific model, this disclosure is not representative of the entire genus and amounts to a non-limiting example of a specie of model that can be used to practice the invention which is narrower in scope than what is claimed. Applicant is reminded that it is improper to import narrowing limitations into the claims. See MPEP 2111.01 and MPEP 2163 (Section II). Moreover, one of ordinary skill in the art would recognize that models for representing biological functions are not trivial. For example, Dorin et al. (Crit Care Med. 2015 March; 43(3): 549–556) teaches a method for determining maximal cortisol secretion rates. In particular, unlike the claimed method, Dorin teaches a well-defined mathematical model that combines specific differential equations modeling total cortisol concentration based on CBG-bound, albumin-bound, and free cortisol compartments for obtaining kinetic parameters associated with cortisol appearance in sepsis. Moreover, Faghih et al. (33rd Annual International Conference of the IEEE EMBS, Boston, Massachusetts USA, August 30 - September 3, 2011, pp.1-4) teaches a plurality of different mathematical models for cortisol secretion, wherein the models are associated with different equations and produce different performance results [See entire]. As such, given the breadth of what is being claimed, it is unclear how the artisan would understand what model and associated parameters are required to practice the claimed method. Therefore, the specification does not satisfy the written description requirement with respect to the full scope of what is being claimed.
With regards to “transforming” time series measurements into “physiological attribute data” (based on the multi-component model), it is unclear this step is achieved. The claims are not limited to any particular methods for achieving this function and are not limited to any particular type of “attribute data”. The specification teaches that physiological parameters are important for predicting one or more physiological attributes associated with a patient, such as time-varying concentrations of plasma free cortisol in a vascular volume, CBG-bound cortisol in a vascular volume, albumin-bound cortisol in a vascular volume, and free cortisol in an extravascular volume [0019]. However, this disclosure is not representative of the entire genus and amounts to a non-limiting example of a specie of attribute data that can be used to practice the invention which is narrower in scope than what is claimed. Applicant is reminded that it is improper to import narrowing limitations into the claims. See MPEP 2111.01 and MPEP 2163 (Section II).
Moreover, neither the claims nor the specification provides a correlation between the claimed attribute data and the “one or more medical conditions”. The specification does generally disclose a few examples of medical conditions associated with a patient, e.g. adrenocortical disorders [0060]. However, these are narrower in scope than what is claimed and it is improper to import narrowing limitations into the claims. See MPEP 2111.01 and MPEP 2163 (Section II). Accordingly, the specification does not establish a reasonable structure-function correlation between the model/physiological data and the claimed medical condition. Therefore, the specification does not satisfy the written description requirement with respect to the full scope of what is being claimed.
Regarding claim(s) 8 and 18, these claims recite “determining, based on the physiological attribute data, an appearance and elimination rate of the hormone in the patient”. These limitations are not limited to any particular acts or operations for achieving the claimed result, i.e. they encompass all ways of performing the claimed functions. A review of the specification [0034] states that "ZF is a time-varying free cortisol appearance rate" and that "α is an elimination rate constant for free cortisol” and further describes these as the "secretion rate" and "elimination rate" factors of the model's differential equations [0035]. However, these are narrower in scope than what is claimed and it is improper to import narrowing limitations into the claims. See MPEP 2111.01 and MPEP 2163 (Section II). Accordingly, the specification does not provide sufficient information to demonstrate to one of ordinary skill in the art that the inventor possessed the invention at the time the application was filed for the full scope of what is being claimed.
For the reasons discussed above, the specification does not provide information to demonstrate to one of ordinary skill in the art that the inventor possessed the invention at the time the application was filed. For more information regarding the written description requirement, see MPEP §2161.01- §2163.07(b).
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 rejections are necessitated by amendment.
Claims 1-20 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, 11 is/are also rejected due to said dependency.
Claims 1 and 11 recite “causing, by a computing device, a rapid intravenous administration of a hormone to a patient.” In this case, the phrase “by a computing device” is problematic because the act of ‘administering’ does not flow from the computing device as claimed. In other words, the claimed method does not include any structural limitations that would serve to achieve the function of ‘administering’ something to a patient. Therefore, it is unclear in what way a ‘computing device’ is achieving this function since one of ordinary skill in the art would understand that a ‘computing device’ is for processing data and, as such, does not include the requisite structural limitations for administering anything (unless it is within the context of a computer simulation). Clarification is requested via amendment.
Claims 1 and 11 recite “processing, by the computing device, based on a multi-compartment model, the time series physiological measurement data, wherein the represents a bidirectional flux by diffusion of a hormone between a vascular compartment and an extravascular compartment of the patient.” It remains unclear as to the metes and bounds of the claimed “multi-compartment model” such that the artisan would recognize what structural limitations is/are intended. For example, one of ordinary skill in the art would recognize that a (mathematical) model is a representation of a real-world system using well defined equations, parameters, and/or variables to analyze, predict, and optimize outcomes. However, a review of the specification does not provide any limitation of the claimed model that would serve to clarify the structure of claimed model. As a result, it is also unclear in what limiting effect is intended by the phrase “represents a bidirectional flux by diffusion of a hormone between a vascular compartment and an extravascular compartment of the patient”, i.e. in what way does this phrase further limit the structure of the claimed model. Clarification is again requested via amendment. Applicant has not provided any illuminating arguments or clarifying amendments that would serve to rectify this issue.
Claims 1 and 11 recite “transforming, based on processing the one or more time series physiological measurement data based on the multi-compartment model, the time series physiological measurement data to physiological attribute data associated with the patient.” It is unclear as to the metes and bounds of the claimed “transforming” such that the artisan would recognize what computational operations are included or excluded. A review of the specification does not provide models, equations, or prose equivalent that would serve to clarify the claimed transforming. The specification teaches, for example, that one or more physiological attributes associated with the patient may be determined, or predicted, based on the one or more physiological parameters [0060]. However, this is not commensurate in scope with what is being claimed. Clarification is again requested via amendment.
Claims 9 and 19 recite “critical illness associated with corticosteroid insufficiency.” In this case, it is unclear as to the metes and bounds of the term “critical illness” as claimed. In this case, the term “critical illness” is a relative term and specification does not provide any limiting definitions, specific properties, or criteria that would serve to clarify the scope, i.e. the result is subjective and imperceptible. Clarification is again requested via amendment. Applicant has not provided any illuminating arguments or clarifying amendments that would serve to rectify this issue.
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the ''right to exclude'' granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); ln re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 C.F.R. 1.321 (c) may be used to overcome an actual or provisional rejection based on a non-statutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 C.F.R. 1.130(b). Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 C.F.R. 3.73(b). [See also MPEP 804.02].
The conclusion of obviousness-type double patenting is made in light of these factual determinations. Any obviousness-type double patenting rejection should make clear: (A) The differences between the inventions defined by the conflicting claims; and (B) The reasons why a person of ordinary skill in the art would conclude that the invention defined in the claim at issue is anticipated by, or would have been an obvious variation of the invention defined in a claim in the patent.
Claims 1-20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim(s) 1-20 of copending Application No. 19/225745. The differences between the inventions defined by the conflicting claims are as follows:
Reference claim 1 recites the same limitations of the above instant claim 1 plus additional features and/or limitations. Therefore, the instant claims 1-20 are anticipated by the narrower reference claims (i.e. species anticipates the genus). This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant’s request that the double patenting rejection be held in abeyance is denied, as applicant has not argued the merits of these rejections and no terminal disclaimer(s) in compliance with 37 C.F.R. 1.321 (c) have been filed to overcome these rejections, as required by 37 C.F.R. 1.130(b).
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.
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
