DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/30/26 has been entered.
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.
Claim(s) 22-39 is/are rejected under 35 U.S.C. 101 333because the claimed invention is directed to an abstract idea without significantly more.
Representative claim 22 recites:
22. (currently amended) A method for measuring a blood glucose concentration comprising:
a) illuminating a biological sample with a light beam directly from a light generating device;
b) receiving an induced change of a light signal of one or more non-blood glucose components from the sample with a detector, wherein the induced change of the light signal is caused by physical or chemical interaction of glucose with the one or more non-blood glucose components;
c) implementing a cyclic plot providing algorithm by an algorithm implemented computing device, wherein the cyclic plot providing algorithm excludes optical absorption by constituents not in the capillaries
d) converting the induced change of the light signal to algorithm implemented computing device readable data;
e) using the blood glucose device to generate and display spectral data of the one or more non-blood glucose components by using an algorithm implemented computing device configured to provide a cyclic plot to exclude optical absorption by constituents not in the capillaries, utilizing the algorithm implemented computing device readable data, with peaks and valleys corresponding to a minimum amount of blood and a maximum amount of blood in the capillaries;
and f) analyzing spectral data in the cyclic plot of one or more blood components, wherein the one or more blood components comprise non-blood glucose;
wherein light absorption measured of the one or more non-blood glucose components contains a change of an absorption amount that is induced by an amount of a presence of a blood glucose which is used indirectly determine the concentration of the blood glucose.
(abstract portions shown in emphasis)
Step 2A Prong One
The recitation of a method comprising illuminating a sample, receiving and analyzing a signal, and generating and analyzing spectral data encompasses performance of the limitation in the mind but for the recitation of mere extrasolutionary activity (i.e., data gathering and output) and generic computer elements (2019 Guidance – hereafter ‘2019 PEG’ - p. 55; see also MPEP § 2106.05(a), (d) and (g)).
For example, but for the recitation of signal generation via illuminating a sample, ‘analyzing’ data encompasses a clinician reviewing spectral data of a sample and (mentally) determining a blood glucose value from the data by (mentally) reviewing specific non-glucose spectra (e.g., mentally focusing on spectra peaks from water or other non-glucose wavelengths).
If a claim, under BRI, covers performance of the limitations in the mind but for the mere recitation of extrasolutionary activity and generic computer elements, then the claim falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under the first part of step 2A of the Mayo framework as set forth in the 2019 PEG.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. Claim 22 only recites additional elements of extrasolutionary activity — in particular, data gathering — and a nominal computing element of a ‘detector’ without further sufficient detail that would tie the abstract portions of the claim into a specific practical application (2019 PEG p. 55 - the instant claim, for example, does not tie into a particular machine, a sufficiently particular form of data or signal collection, or a sufficiently particular form of computing componentry).
Independent claim(s) 27 and 33 encounter the same issues as claim 22 mutatis mutandis — along with generic computing elements.
Dependent claim(s) 23, 25, 28, 30, 34-36, and 39 encounter the same issues as their respective independent claims from which they depend in that they encompass insignificant extrasolutionary activity which is not adequately tied to a particular application and/or generic computing elements.
Dependent claim(s) 24, 26, 29, 31-32, and 37-38 merely add detail to the abstract portions of the claim but do not otherwise encompass any additional elements which tie the claim(s) into a particular application / integration. Accordingly, the claims do not integrate the abstract portions into any practical application under Step 2A prong two.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of extrasolutionary activity (data gathering and nominal output/display) and generic computing elements cannot amount to significantly more than an abstract idea.
For the independent claim portions and dependent claims which provide additional elements of extrasolutionary data gathering and output, MPEP § 2106.05(g) establishes that mere data gathering for determining a result and nominal output of the result does not amount to significantly more
2106.05(g) Insignificant Extra-Solution Activity
Another consideration when determining whether a claim integrates the judicial exception into a practical application in Step 2A Prong Two or recites significantly more in Step 2B is whether the additional elements add more than insignificant extra-solution activity to the judicial exception. 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. Extra-solution activity includes both pre-solution and post-solution activity. An example of pre-solution activity is a step of gathering data for use in a claimed process, e.g., a step of obtaining information about credit card transactions, which is recited as part of a claimed process of analyzing and manipulating the gathered information by a series of steps in order to detect whether the transactions were fraudulent. An example of post-solution activity is an element that is not integrated into the claim as a whole, e.g., a printer that is used to output a report of fraudulent transactions, which is recited in a claim to a computer programmed to analyze and manipulate information about credit card transactions in order to detect whether the transactions were fraudulent.
As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). In Flook, the Court reasoned that "[t]he notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance. A competent draftsman could attach some form of post-solution activity to almost any mathematical formula". 437 U.S. at 590; 198 USPQ at 197; Id. (holding that step of adjusting an alarm limit variable to a figure computed according to a mathematical formula was "post-solution activity"). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 79, 101 USPQ2d 1961, 1968 (2012) (additional element of measuring metabolites of a drug administered to a patient was insignificant extra-solution activity).
Examiners should carefully consider each claim on its own merits, as well as evaluate all other relevant considerations, before making a determination of whether an element (or combination of elements) is insignificant extra-solution activity. In particular, evaluation of the particular machine and particular transformation considerations (see MPEP § 2106.05(b) and (c), respectively), the well-understood, routine, conventional consideration (see MPEP § 2106.05(d)), and the field of use and technological environment consideration (see MPEP § 2106.05(h)) may assist examiners in making a determination of whether an element (or combination of elements) is insignificant extra-solution activity. Note, however, that examiners should not evaluate the well-understood, routine, conventional consideration in the Step 2A Prong Two analysis, because that consideration is only evaluated in Step 2B.
This consideration is similar to factors used in past Office guidance (for example, the now superseded Bilski and Mayo analyses) that were described as mere data gathering in conjunction with a law of nature or abstract idea. When determining whether an additional element is insignificant extra-solution activity, examiners may consider the following:
(1) Whether the extra-solution limitation is well known. See Bilski v. Kappos, 561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010 (2010) (well-known random analysis techniques to establish the inputs of an equation were token extra-solution activity); Flook, 437 U.S. at 593-95, 198 USPQ at 197 (a formula would not be patentable by only indicating that is could be usefully applied to existing surveying techniques); Intellectual Ventures I LLC v. Erie Indem. Co., 850 F.3d 1315, 1328-29, 121 USPQ2d 1928, 1937 (Fed. Cir. 2017) (the use of a well-known XML tag to form an index was deemed token extra-solution activity). Because this overlaps with the well-understood, routine, conventional consideration, it should not be considered in the Step 2A Prong Two extra-solution activity analysis.
(2) Whether the limitation is significant (i.e. it imposes meaningful limits on the claim such that it is not nominally or tangentially related to the invention). See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715-16, 112 USPQ2d 1750, 1755 (Fed. Cir. 2014) (restricting public access to media was found to be insignificant extra-solution activity); Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1242, 120 USPQ2d 1844, 1855 (Fed. Cir. 2016) (in patents regarding electronic menus, features related to types of ordering were found to be insignificant extra-solution activity). This is considered in Step 2A Prong Two and Step 2B.
(3) Whether the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). This is considered in Step 2A Prong Two and Step 2B.
Below are examples of activities that the courts have found to be insignificant extra-solution activity:
Mere Data Gathering:
i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989);
Some cases have identified insignificant computer implementation as an example of insignificant extra-solution activity. See e.g., Fort Props., Inc. v. Am. Master Lease LLC, 671 F.3d 1317, 1323-24, 101 USPQ2d 1785, 1789-90 (Fed. Cir. 2012); Bancorp Servs., LLC v. Sun Life Assur. Co. of Canada, 687 F.3d 1266, 1280-81, 103 USPQ2d 1425, 1434-35 (Fed. Cir. 2012). Other cases have considered these types of limitations as mere instructions to apply a judicial exception. See MPEP § 2106.05(f) for more information about insignificant computer implementation.
For claim limitations that add insignificant extra-solution activity to the judicial exception (e.g., mere data gathering in conjunction with a law of nature or abstract idea), examiners should explain in an eligibility rejection why they do not meaningfully limit the claim. For example, an examiner could explain that adding a final step of storing data to a process that only recites computing the area of a space (a mathematical relationship) does not add a meaningful limitation to the process of computing the area. For more information on formulating a subject matter eligibility rejection, see MPEP § 2106.07(a).
Accordingly, the insignificant extrasolutionary activity of sample illumination and spectral signal generation as presently limited, cannot provide an inventive concept. The nominal computing elements to merely execute the judicial exceptions without sufficient structure also cannot amount to significantly more. The claims are not eligible under step 2B.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 22-32 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Lepper (US 5743262 A).
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
For claim(s) 22, 27, and 33, Lepper teaches A method, device, and system for measuring a blood glucose concentration [entire disclosure – see at least abstract] comprising:
a) illuminating a biological sample using a light generating device having a light beam directly passing from the light generating device to the biological sample; [unfiltered LEDs in an optional embodiment per col. 5 ll. 50-65 — where the use of a filter is for the halogen lamp embodiment]
b) using a detector to receive the light beams from the biological sample, wherein the light beam contains an induced change of a light signal is caused by physical or chemical interaction of glucose with the one or more non-blood glucose components; [Fig. 11-12; col. 6 ll. 50-60; optical signal from (inter alia) body constituents and (separately) water-glucose (water being a non blood-glucose component) in col. 8 l. 55 – col. 9 l. 20]
c) implementing a glucose measuring algorithm to a blood glucose measuring device, wherein the glucose measuring algorithm excludes optical absorption by constituents not in the capillaries and generating a cyclic plot without an interference of the absorption signal cause by a change of an amount of the constituents; [via DSP per col. 6 ll. 50-60]
d) using the blood glucose measuring device to generate and display spectral data of the one or more non-blood glucose components in a cyclic plot with peaks and valleys corresponding to a minimum amount of blood and a maximum amount of blood in the capillaries; [via DSP per col. 6 ll. 50-60, then analysis throughout col. 8 onto col. 9 l. 20 and per Fig. 11-12 in col. 15 l. 60 – col. 16 l. 10]
and e) using the blood glucose measuring device to analyze spectral data in the cyclic plot of one or more blood components, [Fig. 11-12; col. 6 ll. 50-60], [optical signal from (inter alia) body constituents and (separately) water-glucose (water being a non blood-glucose component) in col. 8 l. 55 – col. 9 l. 20]
wherein light absorption measured of the one or more non-blood glucose components contains a change of an absorption amount that is induced by an amount of a presence of a blood glucose which is used indirectly determine the concentration of the blood glucose. [effect of water on glucose absorbance and vice-versa in col. 2 l. 45 – col. 3 l. 5 and throughout col. 22]
For claim(s) 23, 28, and 34, Lepper teaches the light generating device comprises a Laser, a light emitting diode (LED), an incandescent lamp, a halogen lamp or a combination thereof. [col. 5 ll. 45-65]
For claim(s) 24, 29, and 38, Lepper teaches eliminating light signal data of the one or more non-blood glucose components for changes in absorbance not related to interactions with the glucose. [flesh artifact extraction in col. 15 ll. 25-35 and 50-60]
For claim(s) 25, 30, and 35-36, Lepper teaches forming a Visible or NIR spectra using the light signal . [wavelengths of cols. 5-6 include NIR wavelengths — approximately centered around 1000 nm]
For claim(s) 26 and 32, Lepper teaches the measurement of the light absorption excludes an interference of a measurement by fat, muscle and interstitial fluid. [flesh extraction (exclusion) of col. 15 includes thereby an exclusion of fat, muscle, and interstitial fluid absorption]
For claim(s) 31, Lepper teaches the programmable computing device is configured to avoid analyzing light signal of glucose. [water-based analysis of light signal constitute(s), under BRI, a form of the device being ‘configured to avoid’ analyzing the light signal of glucose — i.e., the system of Lepper utilizes an indirect measurement of glucose instead of measuring glucose signal directly]
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 33-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lepper in view of Ruchti (US 20040068163 A1).
For claim(s) 33, Lepper teaches A method, device, and system for measuring a blood glucose concentration [entire disclosure – see at least abstract] comprising:
a) illuminating a biological sample using a light generating device having a light beam directly passing from the light generating device to the biological sample; [unfiltered LEDs in an optional embodiment per col. 5 ll. 50-65 — where the use of a filter is for the halogen lamp embodiment]
b) using a detector to receive the light beams from the biological sample, wherein the light beam contains an induced change of a light signal is caused by physical or chemical interaction of glucose with the one or more non-blood glucose components; [Fig. 11-12; col. 6 ll. 50-60; optical signal from (inter alia) body constituents and (separately) water-glucose (water being a non blood-glucose component) in col. 8 l. 55 – col. 9 l. 20]
c) implementing a glucose measuring algorithm to a blood glucose measuring device, wherein the glucose measuring algorithm excludes optical absorption by constituents not in the capillaries and generating a cyclic plot without an interference of the absorption signal cause by a change of an amount of the constituents; [via DSP per col. 6 ll. 50-60]
d) using the blood glucose measuring device to generate and display spectral data of the one or more non-blood glucose components in a cyclic plot with peaks and valleys corresponding to a minimum amount of blood and a maximum amount of blood in the capillaries; [via DSP per col. 6 ll. 50-60, then analysis throughout col. 8 onto col. 9 l. 20 and per Fig. 11-12 in col. 15 l. 60 – col. 16 l. 10]
and e) using the blood glucose measuring device to analyze spectral data in the cyclic plot of one or more blood components, [Fig. 11-12; col. 6 ll. 50-60], [optical signal from (inter alia) body constituents and (separately) water-glucose (water being a non blood-glucose component) in col. 8 l. 55 – col. 9 l. 20]
wherein light absorption measured of the one or more non-blood glucose components contains a change of an absorption amount that is induced by an amount of a presence of a blood glucose which is used indirectly determine the concentration of the blood glucose. [effect of water on glucose absorbance and vice-versa in col. 2 l. 45 – col. 3 l. 5 and throughout col. 22]
Lepper fails to teach where the light absorption is averaged over a period of time to determine the glucose concentration.
Ruchti teaches a non-invasive glucose measurement system and method [abstract] including a function / step of averaging light absorption over a period of time to determine glucose concentration. [¶75 ¶102]
It would have been obvious to one of ordinary skill at the time the invention was made to modify the system of Lepper to incorporate the spectral averaging of Ruchti in order to aid in improving precision and accuracy of glucose measurement. As motivated by Ruchti ¶¶39-40.
For claim(s) 34, Lepper teaches the light generating device comprises a Laser, a light emitting diode (LED), an incandescent lamp, a halogen lamp or a combination thereof. [col. 5 ll. 45-65]
For claim(s) 38, Lepper teaches eliminating light signal data of the one or more non-blood glucose components for changes in absorbance not related to interactions with the glucose. [flesh artifact extraction in col. 15 ll. 25-35 and 50-60]
For claim(s) 35-36, Lepper teaches forming a Visible or NIR spectra using the light signal . [wavelengths of cols. 5-6 include NIR wavelengths — approximately centered around 1000 nm]
For claim(s) 37, Lepper teaches the computing device is configured to mathematically compare changes in absorbance of the one or more blood components to changes in blood glucose concentration. [derivation and linearization throughout cols. 19-26 constitute(s), under BRI, a form of mathematical comparison of absorbances to changes in glucose concentration, see at least col. 22 l. 40 – col. 23 l. 5 and col. 26 ll. 15-55][more generally, ‘mathematical comparison’ of absorbance(s) to changes in blood glucose is/are central inventive feature(s) detailed throughout the majority (if not the entirety) of the disclosure of Lepper]
For claim(s) 39, Lepper teaches the biological sample comprises a portion of at least one of a human finger, toe, ear lobe, tongue or arm. [finger 130 in Fig. 1; finger analysis is/are central inventive feature(s) detailed throughout the majority (if not the entirety) of the disclosure of Lepper — see at least cols. 6-7]
In consideration of Examiner’s interpretation and citation for the ‘direct’ illumination of a sample, and in earnest and good faith advancement of prosecution, claim(s) 22 and 27 is/are alternately rejected under 35 U.S.C. 103 as being unpatentable over Lepper in view of Rosenthal (US 20040181132 A1) (and claim(s) 33 being similarly alternately rejected over Lepper, Ruchti, and Rosenthal).
If (arguendo) Lepper fails to teach “directly” illuminating the sample, then:
Rosenthal teaches a non-invasive blood glucose measurement system and method [abstract] comprising a function / step of directly illuminating a biological sample. [Fig(s). 1 ¶¶32-34 detailing illuminating a finger through a optically clear window without the use of a bandpass optical filter]
It would have been obvious to one of ordinary skill at the time the invention was made to modify the illumination step of Lepper to incorporate the direct illumination as taught by Rosenthal in order to improve accuracy and efficiency of the measurement. As motivated by Rosenthal ¶¶32-34.
Response to Arguments
Applicant's 12/30/25 arguments with respect to § 101 and the prior art have been fully considered but they are not persuasive.
Applicant argues in remarks p. 7-8 that the claim(s) are significantly more than the abstract idea under steps 2A and 2B of § 101 analysis. Examiner respectfully disagrees and reiterates the previous response. The claim(s) recite analytical steps (mental process) with otherwise generic data gathering and data presenting elements and, as such, do not integrate into a practical application nor present significantly more when considered each as a whole.
Applicant argues in remarks p. 8-9 that Lepper fails to teach direct illumination of the sample. Examiner respectfully disagrees and reiterates the response set forth previously. Namely, Lepper teaches a first embodiment in col. 5 ll. 45-60 with a lamp and filter and then at col. 5 ll. 60-63, Lepper states “several LED’s could be used in place of the lamp” before going on to detail how source 110 (which is the halogen lamp) operates with filter 120 in col. 6. Where then Lepper goes on to detail in col. 6 l. 60 – col. 7 l. 10 that
“In operation, when light 115 is emitted from the broadband light source 110 over a wavelength range of approximately 700 nanometers to 1,700 nanometers, this broadband light 115 shines through the rotating dichroic filter 120. It should be noted that the light 115 is focused onto a portion of the filter 120 by means of fiber optics, a lens assembly (e.g., the lens 117), or the like. As the dichroic filter 120 rotates, the broadband light 115 is filtered through a portion of the dichroic filter 120 producing the filtered optical radiation 125. As indicated above, the dichroic filter 120 is coated with optical layers of varying thickness so that different portions of the dichroic filter 120 pass different wavelengths of light. Thus, as the filter 120 rotates, the optical radiation 125 output from the filter includes optical radiation of various wavelengths.”
To wit, one embodiment is a broadband halogen that is filtered to the desired wavelengths and one embodiment is pre-configured LEDs that emit at fixed wavelengths.
In any event, in earnest advancement of prosecution, an alternate rejection has been provided and thus the argument is moot on such grounds.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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/BENJAMIN S MELHUS/Primary Examiner, Art Unit 3791
Prosecution Insights