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 .
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claim 38 objected to because of the following informalities:
In Claim 38, “the updated at least one parameter” should read “the updated one or more parameters.”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: blood glucose monitoring device in claims 23, 25, and 38.
Claims 23, 25, and 38 recites “blood glucose monitoring device.” The limitation has been interpreted under 112f as a means plus function limitation because of the combination of a non-structural generic placeholder term “device” and functional language of “blood glucose monitoring.”
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Claims 23, 25, and 38 regarding “blood glucose monitoring device” is interpreted as a continuous glucose monitor as disclosed in Page 32 lines 18-25.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 23-41 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The following claim limitations are reciting a human organism: “a PPG sensor attached to a subject” in the independent claims. The examiner suggest the claim limitations are amened to “a PPG sensor configured to be attached to a subject”.
In the interest of compact prosecution, the following 101 rejection assuming the amendment is made to resolve the positively recited human organism as noted above.
Claims 23-41 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. Each of Claims 23-41 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 23-41 recites at least one step or instruction for estimating an individual’s blood glucose, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 23-41 recites an abstract idea.
Specifically, Claims 23 and 38 recite:
Claim 23 | “A method of improving blood glucose estimation accuracy of an adaptive predictive model, the method comprising the following steps performed by at least one processor: a) receiving, within a receiving period, real-time PPG data from a PPG sensor attached to a subject and a blood glucose measurement from a blood glucose monitoring device (Observation); b) generating features from the received PPG data (Observation); c) storing the features and the blood glucose measurement (Observation); and d) updating one or more parameters of the adaptive predictive model in real-time by processing the stored features in context with the stored blood glucose measurement, wherein the updated one or more parameters improves the blood glucose estimation accuracy of the adaptive predictive model (Observation).”
Claim 38 | “A system for improving blood glucose estimation accuracy of an adaptive predictive model, the system comprising at least one processor configured to: receive, within a receiving period, real-time PPG data from a PPG sensor attached to a subject and a blood glucose measurement from a blood glucose monitoring device (Observation); generate features from the received PPG data (Observation); store the features and the blood glucose measurement (Observation); and update one or more parameters of the adaptive predictive model in real-time by processing the stored features in context with the stored blood glucose measurement, wherein the updated at least one parameter improves blood glucose estimation accuracy of the adaptive predictive model (Observation).”
Regarding the dependent claims, the following dependent claims are directed to steps that are also abstract or organizing human activity:
Claims 24-29, 34, 39, 40 include steps that are also abstract as a mental process through additional data gathering or analysis
Claims 30, 32, and 33 contain additional elements.
Claims 31, 35-37, and 41 include steps that are also abstract because the analysis model is updated through a mental process.
Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrowing idea is still an abstract idea and an abstract idea with additional well-known equipment/functions are not significantly more than the abstract idea.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 23 and 38 (and their respective dependent Claims 24-37 and 39-41) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 23 and 38), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: at least one processor, PPG sensor, blood glucose monitoring device, imaging sensor, data buffer, and remote device are generically recited computer elements in independent Claims 23 and 38 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 23 and 38 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., at least one processor and data buffer as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 23 and 38 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 23 and 38 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 23 and 38 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of at least one processor, PPG sensor, blood glucose monitoring device, imaging sensor, data buffer, and remote device.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, at least one processor received signals/data and generates a blood glucose estimation (Page 5 lines 14-30); imaging sensor is the PPG sensor, where it measures biometric data from the subject (Page 14 lines 30-31 to Page 15 lines 1-18); blood glucose monitoring device is a continuous glucose monitor that measures the subject’s blood glucose levels (Page 32 lines 18-25); data buffer stores blood glucose measurements (Page 4 lines 13-14); remote device can be considered a smartphone or nurse’s station which receives an alert regarding user’s blood glucose estimation is either above or below a threshold (Page 20 lines 17-21).
Accordingly, in light of Applicant’s specification, the claimed term at least one processor and data buffer is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the at least one processor and data buffer. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 23-41 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method and system of Claims 23-41 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 23-41 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 23-41 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 23-41 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 23-41 amounts to significantly more than the abstract idea itself. Accordingly, Claims 23-41 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 23, 24, 31, 32, 38, 39, and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Menon et al. (US 20190192085 A1).
Regarding Claim 23, Menon discloses a method of improving blood glucose estimation accuracy of an adaptive predictive model, the method comprising the following steps performed by at least one processor (Paragraphs 0009, 0013):
a) receiving, within a receiving period, real-time PPG data from a PPG sensor attached to a subject and a blood glucose measurement from a blood glucose monitoring device (Paragraph 0009);
b) generating features from the received PPG data (Paragraph 0009);
c) storing the features and the blood glucose measurement (Paragraphs 0009-0011, 0032); and
d) updating one or more parameters of the adaptive predictive model in real-time (Paragraphs 0033, 0037, 0041, 0052) by processing the stored features in context with the stored blood glucose measurement (Paragraphs 0009-0011, 0038), wherein the updated one or more parameters improves the blood glucose estimation accuracy of the adaptive predictive model (Paragraphs 0009-0011, 0041).
Regarding Claim 24, Menon discloses the method of Claim 23, further comprising repeating steps a) - d) over one or more subsequent time periods (Paragraphs 0033, 0038-0041; [Examiner’s note, where there is continuous monitoring for estimating the blood glucose, then the device has to repeat steps a-d.]).
Regarding Claim 31, Menon discloses the method of Claim 23, wherein the adaptive predictive model comprises one of a regression model (Paragraph 0041), a machine learning model (Paragraphs 0041), or a classifier model (Paragraph 0042).
Regarding Claim 32, Menon discloses the method of Claim 23, wherein the features and the blood glucose measurement are stored in a data buffer (memory unit – element 566; Paragraphs 0011, 0049).
Regarding Claim 38, Menon discloses a system for improving blood glucose estimation accuracy of an adaptive predictive model (Figs. 1 and 3), the system comprising at least one processor (Paragraphs 0009, 0013) configured to:
receive, within a receiving period, real-time PPG data from a PPG sensor attached to a subject and a blood glucose measurement from a blood glucose monitoring device (Paragraph 0009);
generate features from the received PPG data (Paragraph 0009);
store the features and the blood glucose measurement (Paragraphs 0009-0011, 0032); and
update one or more parameters of the adaptive predictive model in real-time (Paragraphs 0033, 0037, 0041, 0052) by processing the stored features in context with the stored blood glucose measurement (Paragraphs 0009-0011, 0038), wherein the updated at least one parameter improves blood glucose estimation accuracy of the adaptive predictive model (Paragraphs 0009-0011, 0041).
Regarding Claim 39, Menon discloses the system of Claim 38, wherein the at least one processor is further configured to: generate a blood glucose estimation via the adaptive predictive model (Menon | Paragraphs 0009-0011); determine whether the generated blood glucose estimation above or below a threshold (Menon | Paragraphs 0011-0012); and in response to determining that the generated blood glucose estimation the is above or below the threshold (Menon | Paragraphs 0011-0012; [Examiner’s note, an alert occurs when the blood glucose is within or above the set threshold range.]), updating the one or more parameters of the adaptive predictive model in real-time (Paragraphs 0033, 0038-0041).
Regarding Claim 41, Menon discloses the system of Claim 38, wherein the adaptive predictive model comprises one of a regression model (Paragraph 0041), a machine learning model (Paragraphs 0041), or a classifier model (Paragraph 0042).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 25 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Menon et al. (US 20190192085 A1) in view of Doniger et al. (US 20110077494 A1).
Regarding Claim 25, Menon discloses the method of Claim 23, further comprising: generating a blood glucose estimation for the subject via the adaptive predictive model (Menon | Paragraphs 0009-0011); determining whether the generated blood glucose estimation is above or below a threshold (Menon | Paragraphs 0011-0012); responsive to determining that the generated blood glucose estimation is above or below the threshold (Menon | Paragraphs 0011-0012; [Examiner’s note, an alert occurs when the blood glucose is within or above the set threshold range.]); and updating the one or more parameters of the adaptive predictive model in real-time (Menon | Paragraphs 0033, 0038-0041).
Menon is silent in teaching receiving another measurement of blood glucose via the blood glucose monitoring device;
Doniger teaches receiving another measurement of blood glucose via the blood glucose monitoring device (Doniger | Paragraphs 0041-0044). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Menon to incorporate the teachings of measuring blood glucose when the blood glucose estimation is within the threshold from Doniger. Doing so would allow users to be notified of both hyperglycemic and hypoglycemic events, enabling them to take necessary actions to prevent dangerous highs or lows (Doniger | Paragraph 0005).
Regarding Claim 34, Menon discloses the method of Claim 23, processing the stored features in context with the stored blood glucose measurement (Menon | Paragraphs 0009-0011). Menon is silent in teaching processing a function of at least one of the stored features;
Doniger teaches processing a function of at least one of the stored features (Doniger | Figure 4a; Paragraphs 0041-0044). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Menon to incorporate the teachings of capturing a function of at least one stored feature from Doniger. Doing so would allow users to visually see when they may be approaching a hyperglycemic and hypoglycemic event, enabling them to take necessary actions to prevent dangerous highs or lows (Doniger | Paragraph 0005).
Claims 26 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Menon et al. (US 20190192085 A1) in view of Zambotti et al. (US 20200013511 A1).
Regarding Claim 26, Menon discloses the method of Claim 23, wherein generating features from the received PPG data comprises generating features (Menon | Paragraphs 0009-0011).
Menon is silent in disclosing the received PPG data comprises feature generation intervals within the receiving period via a sliding time window;
Zambotti teaches the received PPG data comprises feature generation intervals within the receiving period via a sliding time window (Zambotti | Paragraph 0066, 0096). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Menon to incorporate the teachings of a sliding time window from Zambotti. Doing so would eliminate old out of date information and use more accurate and recent data in determinations. Thus allowing improved and updated reference data to enhance the quality of the predictive model’s output (Zambotti | Paragraphs 0066, 0096).
Regarding claim 40, Menon in view of Zambotti teaches the system of Claim 39, wherein the at least one processor is further configured to send an alert to a remote device that the generated blood glucose estimation is above or below the threshold (Menon | Paragraphs 0011-0012; [Examiner’s note, an alert occurs when the blood glucose is within or above the set threshold range.]).
Claims 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Menon et al. (US 20190192085 A1) in view of Zambotti et al. (US 20200013511 A1) and Shimol et al. (US 20200054289 A1).
Regarding Claim 27, Menon discloses the method of Claim 23, wherein updating the one or more parameters of the adaptive predictive model (Menon | Paragraphs 0033, 0037, 0041, 0052) further comprises processing the stored blood glucose measurement (Paragraphs 0009-0011, 0038).
Menon is silent in teaching wherein updating the one or more parameters of the adaptive predictive model further comprises processing a previously stored biometric measurement;
Zambotti teaches updating the one or more parameters (Zambotti | Paragraph 0036) of the adaptive predictive model further comprises processing a previously stored biometric measurement (Zambotti | Paragraph 0042).
Menon teaches the biometric measurement as blood glucose (Menon | Paragraph 0009-0011), and Zambotti teaches processing previously stored biometric measurements (Zambotti | Paragraphs 0036, 0042). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the blood glucose measurement within the method of Menon to incorporate the teachings of updating stored biometric measurements from Zambotti because doing so would provide improved and updated reference data to enhance the quality of the predictive model’s output (Zambotti | Paragraphs 0067, 0070).
Additionally, Menon in view of Zambotti are silent in teaching generating an interpolation between the stored biometric measurement and the previously stored biometric measurement;
Shimol teaches generating an interpolation between the stored biometric measurement and the previously stored biometric measurement (Shimol | Paragraph 0077).
Menon teaches the biometric measurement as blood glucose (Menon | Paragraph 0009-0011), and Shimol teaches generating an interpolation between the stored biometric measurement and the previously stored biometric measurement (Shimol | Paragraph 0077). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the blood glucose measurement within the method of Menon in view of Zambotti to incorporate the teachings of interpolation from Shimol because doing so would allow to fill in missing data and provide two data sets with easily comparable data (Shimol | Paragraph 0077).
Regarding Claim 28, Menon in view of Zambotti and Shimol teaches the method of Claim 27, regarding processing the stored blood glucose measurement (Menon | Paragraphs 0009-0011). Menon in view of Zambotti and Shimol are silent in teaching processing the previously stored biometric measurement further comprises processing a plurality of previously stored biometric measurements;
Zambotti teaches wherein processing the previously stored biometric measurement further comprises processing a plurality of previously stored biometric measurements (Zambotti | Paragraphs 0039-0050).
Menon teaches the biometric measurement as blood glucose (Menon | Paragraph 0009-0011), and Zambotti teaches processing a plurality of previously stored biometric measurements (Zambotti | Paragraphs 0036, 0042). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the blood glucose measurement within the method of Menon to incorporate the teachings of updating stored biometric measurements from Zambotti because doing so would provide improved and updated reference data to enhance the quality of the predictive model’s output (Zambotti | Paragraphs 006, 0070).
Regarding Claim 29, Menon in view of Zambotti and Shimol teaches the method of Claim 28, regarding processing the stored blood glucose measurement (Menon | Paragraphs 0009-0011). Menon in view of Zambotti and Shimol is silent in teaching processing the previously stored biometric measurement;
Zambotti teaches processing the previously stored biometric measurement (Zambotti | Paragraph 0042).
Menon teaches the biometric measurement as blood glucose (Menon | Paragraph 0009-0011), and Zambotti teaches processing the previously stored biometric measurements (Zambotti | Paragraphs 0036, 0042). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the blood glucose measurement within the method of Menon to incorporate the teachings of updating stored biometric measurements from Zambotti because doing so would provide improved and updated reference data to enhance the quality of the predictive model’s output (Zambotti | Paragraphs 0067, 0070).
Additionally, Menon in view of Zambotti and Shimol is silent in teaching generating an interpolation of expected biometric measurements;
Shimol teaches generating an interpolation of expected biometric measurements (Shimol | Paragraph 0077).
Menon teaches the biometric measurement as blood glucose (Menon | Paragraph 0009-0011), and Shimol teaches generating an interpolation of the expected biometric measurement (Shimol | Paragraph 0077). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the blood glucose measurement within the method of Menon in view of Zambotti to incorporate the teachings of interpolation from Shimol because doing so would allow to fill in missing data and provide two data sets with easily comparable data (Shimol | Paragraph 0077).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Menon et al. (US 20190192085 A1) in view of Muhlsteff et al. (US 20170202463 A1).
Regarding Claim 30, Menon discloses the method of Claim 23. Menon is silent in disclosing the PPG sensor comprises an imaging sensor;
Muhlsteff teaches the PPG sensor comprises an imaging sensor (Muhlsteff | Figure 1; Paragraph 0041, 0043). One having an ordinary skill in the art the time the invention was filed would have found it obvious to substitute the PPG sensor of Menon to incorporate the teachings of the PPG sensor comprising an image sensor from Muhlsteff. Doing so would allow for the device to estimate blood glucose levels by analyzing how light is absorbed and scattered by the blood (Muhlsteff | Paragraph 0043). Additionally, it would have been a mere matter of obvious substitution to substitute one sensor for another to measure the same PPG data already collected in Menon.
Claims 33, 35, 36, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Menon et al. (US 20190192085 A1) in view of DeGroot et al. (US 20190298195 A1).
Regarding Claim 33, Menon discloses the method of Claim 32. Menon is silent in disclosing the data buffer comprises a FIFO (first-in-first-out) buffer;
DeGroot teaches the data buffer comprises a FIFO (first-in-first-out) buffer (DeGroot | Paragraph 0041). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the data buffer of Menon to incorporate the teachings of the data buffer comprising a FIFO buffer. Doing so would ensure that data is processed in the exact order it was received, especially in a system that collects real-time data (DeGroot | Paragraph 0041).
Regarding Claim 35, Menon discloses the method of Claim 23, regarding the stored blood glucose measurements (Menon | Paragraphs 0009-0011). Menon is silent in teaching processing the stored features in context with the stored biometric measurement comprises calculating statistical information for a temporal sequence of at least one of the stored features.
DeGroot teaches processing the stored features in context with the stored biometric measurement comprises calculating statistical information for a temporal sequence of at least one of the stored features (DeGroot | Paragraphs 0057-0058).
Menon teaches the biometric measurement as blood glucose (Menon | Paragraph 0009-0011), and DeGroot teaches processing the stored features in context with the stored biometric measurement comprises calculating statistical information for a temporal sequence of at least one of the stored features (DeGroot | Paragraphs 0057-0058). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the blood glucose measurement within the method of Menon to incorporate the teachings of calculating statistical information from DeGroot. Doing so would allow a trained model to predict and adjust measurements in real time and effectively reducing error from data collection (DeGroot | Paragraph 0074).
Regarding Claim 36, Menon discloses the method of Claim 23, regarding the stored blood glucose measurements (Menon | Paragraphs 0009-0011). Menon is silent in disclosing the stored features in context with the stored biometric measurement comprises calculating statistical information for a plurality of temporal sequences of at least one of the stored features;
DeGroot teaches processing the stored features in context with the stored blood glucose measurement comprises calculating statistical information for a plurality of temporal sequences of at least one of the stored features (DeGroot | Paragraphs 0057-0058).
Menon teaches the biometric measurement as blood glucose (Menon | Paragraph 0009-0011), and DeGroot teaches processing the stored features in context with the stored blood glucose measurement comprises calculating statistical information for a plurality of temporal sequences of at least one of the stored features (DeGroot | Paragraphs 0057-0058). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the blood glucose measurement within the method of Menon to incorporate the teachings of calculating statistical information from DeGroot. Doing so would allow a trained model to predict and adjust measurements in real time and effectively reducing error from data collection (DeGroot | Paragraph 0074).
Regarding Claim 37, Menon discloses the method of Claim 23, regarding the stored blood glucose measurements (Menon | Paragraphs 0009-0011). Menon is silent in disclosing the stored features in context with the stored biometric measurement comprises calculating weighted statistical information for a plurality of temporal sequences of at least one of the stored features;
DeGroot teaches processing the stored features in context with the stored blood glucose measurement comprises calculating weighted statistical information for a plurality of temporal sequences of at least one of the stored features (DeGroot | Paragraphs 0057-0058).
Menon teaches the biometric measurement as blood glucose (Menon | Paragraph 0009-0011), and DeGroot teaches processing the stored features in context with the stored blood glucose measurement comprises calculating weighted statistical information for a plurality of temporal sequences of at least one of the stored features (DeGroot | Paragraphs 0057-0058). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the blood glucose measurement within the method of Menon to incorporate the teachings of calculating statistical information from DeGroot. Doing so would allow a trained model to predict and adjust measurements in real time and effectively reducing error from data collection (DeGroot | Paragraph 0074).
Double Patenting
The nonstatutory 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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 23-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-41 of copending Application No. 18/256018 in view of Doniger et al. (US 20110077494 A1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Examiner’s note, all the bolded text are what is identical between the instant application and reference application.
Instant Application
(18/256024)
Reference App. - US Patent Application
(18/256018)
23. A method of improving blood glucose estimation accuracy of an adaptive predictive model, the method comprising the following steps performed by at least one processor:
a) receiving, within a receiving period, real-time PPG data from a PPG sensor attached to a subject and a blood glucose measurement from a blood glucose monitoring device;
b) generating features from the received PPG data;
c) storing the features and the blood glucose measurement; and
d) updating one or more parameters of the adaptive predictive model in real-time by processing the stored features in context with the stored blood glucose measurement, wherein the updated one or more parameters improves the blood glucose estimation accuracy of the adaptive predictive model.
23. A method of improving blood pressure estimation accuracy of an adaptive predictive model, the method comprising the following steps performed by at least one processor:
a) receiving, within a receiving period, real-time PPG data from a PPG sensor attached to a subject and a real-time blood pressure measurement from a blood pressure monitoring device attached to the subject;
b) generating features from the received PPG data;
c) storing the features and the blood pressure measurement; and
d) updating one or more parameters of the adaptive predictive model in real-time by processing the stored features in context with the stored blood pressure measurement, wherein the updated one or more parameters improves the blood pressure estimation accuracy of the adaptive predictive model.
24. The method of Claim 23, further comprising repeating steps a) - d) over one or more subsequent time periods.
24. The method of Claim 23, further comprising repeating steps a) - d) over one or more subsequent time periods.
25. The method of Claim 23, further comprising:
generating a blood glucose estimation for the subject via the adaptive predictive model;
determining whether the genera