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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/20/2026 has been entered.
Claims 18-19, 22, 24-42 and 44 are pending for examination. Claim 1-17, 20-21, 23, 43, and 45 are cancelled.
Applicant’s amendments and remarks filed on 05/20/2026 have been fully considered.
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(s) is/are: “a control unit adapted to determine” in claim 18; “at least one output interface… adapted to provide”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The “control unit” is interpreted as “processor” as described in paragraphs [0139] and [0148] of the PGPUB and the “output interface” is interpreted as “a monitor or a display” as described in paragraph [0092] of the PGPUB.
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.
Claims 33-41 and 44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions of abstract idea without significantly more. Claims 33-41 and 44 recite a method, which fall within one of statutory categories (i.e. process) (Step 1: YES).
Step 2A Prong One analysis: Claim 33 recites “determining a measure for microcirculation on the basis of the tissue oxygen level and the arterial blood oxygen level; extrapolating the tissue oxygen level and the arterial blood oxygen level and predicting, based on the measure for microcirculation, an impaired tissue perfusion, when the arterial blood oxygen level and the tissue oxygen level are no longer corresponding parameters to each other”. The claims involve calculation/ determination of parameter(s) constitutes an abstract idea of mathematical relationships/ calculations and/or mental process, which fall within at least one of the groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance (Mathematical Concepts) (Step 2A Prong One: YES).
Step 2A Prong Two analysis: Claims 33-40 and 44 do not recite any element(s). Claim 41 recites “a computer”. This judicial exception is not integrated into a practical application because no specific elements/ sensors are recited in the claims but merely additional calculations/ determinations and/or data gathering steps to be insignificant extra-solution activity. Thus, there is no improvement or change in the function of the device/ computer (see at least MPEP 2106.05(a), (f) and (g)). And the providing steps associated with the levels/ data are considered as data gathering steps to be insignificant extra-solution activity. And/ or the abstract idea (mental process) is directed as being performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept (see MPEP 2106.04(a)(2).III.C). And/ or the abstract idea (mental process) is directed as “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea” (see MPEP 2106.04(a)(2).III.B) “(Step 2A Prong Two: YES).
Step 2B: The claims do not recite any element(s) and therefore there is no specific element(s) sufficient to amount to significantly more than the judicial exception. Claims 35-37 recite how the levels are being measured without reciting any associated structures/ sensors and claims 38-40 and 44 recite additional types of data, which are associated with data gathering steps of insignificant extra-solution activity (see MPEP 2106.05(g)) and mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)) and do not improve the functioning of a computer, e.g. an improvement in the application of the mathematical relationship in determining the parameter(s), which is, itself, an abstract idea (see MPEP 2106.05(a)). The claims merely cover the providing/ collecting of data obtained from known and existing technology and then using the data to make a correlation for parameter(s) (Step 2B: No). Dependent claims do not recite additional elements/ features and do not add significantly more (i.e. an “inventive concept”) to the exception.
For these reasons, there is no inventive concept in the claims, and thus claims 33-41 and 44 are ineligible.
It is noted that claim 18 recites a device with similar functions which are performed according to specific sensors (i.e. BOTH of a transcutaneous measurement sensor and a pulsoximetric sensor adapted for measuring the arterial blood oxygen level by optical detection of oxygen saturation), which are considered as significantly more than the judicial exception.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 25-28, 31, 35-36, 40-41, and 44 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims that depend directly or indirectly from claim 35 is/are also rejected due to said dependency.
In regard to claim 25-27, the claims recite “the sensor for measuring data indicative of an arterial blood oxygen level and/or the sensor for measuring data indicative of a tissue oxygen level are…”. It is unclear whether “the sensor for measuring data indicative of an arterial blood oxygen level and/or the sensor for measuring data indicative of a tissue oxygen level” lack of sufficient antecedent bases. I is unclear whether they refer to the “at least one sensor for measuring data indicative of a tissue oxygen level; and at least one sensor for measuring data indicative of an arterial blood oxygen level”. Clarification is requested by amendments. If they are the same, it is suggested that “the at least one sensor for… ” should be set forth. OR “the sensor for measuring data indicative of an arterial blood oxygen level and/or the sensor for measuring data indicative of a tissue oxygen level are…” can be replaced by “the first sensor element and the second element are adapted for continuous and/or intermittent and/or alternating measurements/ arranged in a common housing/ adapted to be placed on a part of the skin”.
In regard to claim 28, the claim recites “the difference between a first and a second oxygen level, the ratio of a first and a second oxygen level”, which lack of sufficient antecedent bases. It is also unclear how many levels are recited. Clarification is requested by amendments. It is suggested that “a difference between a first and a second oxygen levels, a ratio of a first and a second oxygen levels and/or an index based on a first and a second oxygen levels” should be set forth.
In regard to claim 31, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In regard to claim 35, the claim recites “measuring an arterial blood oxygen level … and measuring a tissue oxygen level.” It is unclear whether “an arterial blood oxygen level and a tissue oxygen level” are the same or different arterial blood oxygen level/ tissue oxygen level as recited in claim 33 which claim 35 depends. Clarification is requested by amendments If they are the same, it is suggested that “measuring the arterial blood oxygen level … and measuring the tissue oxygen level” should be set forth.
In regard to claims 39-40, the claims recite “wherein data indicative of a carbon dioxide level, a pH-level and/or a temperature”. It is unclear whether “data indicative of a carbon dioxide level, a pH-level and/or a temperature” are the same or different data as recited in claim 38 which claims 39-40 depend from. Clarification is requested by amendments If they are the same, it is suggested that “wherein the data indicative of the carbon dioxide level, the pH-level and/or the temperature” should be set forth.
In addition, claim 40 recites “data indicative of a carbon dioxide level, a pH-level and/or a temperature, are provided by measuring data indicative of a carbon dioxide level, a pH-level and/or a temperature”. It is unclear whether the “carbon dioxide level, pH-level and/or temperature” recited in the measuring step are the same or different parameter(s) as recited in claim 38 which claim 40 depends. Clarification is requested by amendments. If they are the same, it is suggested that “by measuring the data indicative of the carbon dioxide level, the pH-level and/or the temperature” should be set forth. OR claim 40 should be read as “wherein the data indicative of the carbon dioxide level, the pH-level and/or the temperature, are provided by measuring”.
In regard to claim 42, the claim recites “…using the correlation between the carbon dioxide levels”, which lack of sufficient antecedent bases. It is unclear whether “the carbon dioxide levels” includes or excludes the “measuring data indicative of a carbon dioxide level”. Clarification is requested by amendments. It is suggested that “…using a correlation between the carbon dioxide level…” should be set forth.
Allowable Subject Matter
Claims 18-19, 22, 24, 29-30, and 32 are allowed.
Claims 25-28, 31 and 42 would be allowable if overcome the 35 USC 112(b) rejections.
The following is an examiner’s statement of reasons for allowance: The prior art of record does not teach or suggest each and every limitations recited in claim 18.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed on 05/20/2026 have been fully considered but they are not persuasive. In regard to the claim interpretation, applicant alleged that the amendments of claim 18-19 recite sufficient structure to avoid being interpreted under 35 USC 112(f). In response, the amendments of claims 18-19 do not recite sufficient structures and the amended claim limitations are directed to use a generic placeholder that is coupled with functional language (see the claim interpretation section above). The applicant may consider to recite “a processor” and “a monitor or a display” to avoid being interpreted under 35 USC 112(f).
Applicant’s arguments, see page 8 of Remarks, filed on 05/20/2026, with respect to claims 18-45 have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 18-45 have been withdrawn.
Applicant’s arguments, see pages 8-11 of Remarks, filed on 05/20/2026, with respect to claims 18-19, 22, 24-42 and 44 have been fully considered and are persuasive. The 35 USC 103 rejections of claims 18-19, 22, 24-42 and 44 have been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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/CHU CHUAN LIU/ Primary Examiner, Art Unit 3791
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