DETAILED ACTION
Applicant’s arguments, filed 02/06/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicant has amended their claims, filed 02/06/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant canceled claim 10 and added claims 23-26 in the response filed 02/06/2026, which is acknowledged and entered. Thus, claims 1-9, 11-12, 14-15, 17-21, and 23-26 are the current claims hereby under examination.
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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 12, “the” should be removed before “delayed fluorescence”.
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(s) is/are:
“control unit” first recited in claim 14;
The identified structure for the corresponding claim limitations are as follows:
“control unit” is identified as “The control unit may be configured to obtain repetitive or continuous measurements of the luminescence or triplet triplet absorption … Devices comprising these features are known in the state of the art, e.g., the COMET device (Photonics Healthcare)” (Page 23, paragraph 5 of the specification).
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.
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 § 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 1-9, 11-12, 14-15, 17-21, and 23-26 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.
Regarding claims 1 and 26, the phrase "wherein second order reactions involving two excited triplet states of the probe are considered" is unclear. Is the reaction only taken into consideration, or is there a measurement or fitting method used with a second order reaction to determine a concentration? For examination purposes, this limitation will be interpreted from a range of having no influence to some influence. Claims 2-9, 11-12, 14-15, 17-21, and 23-25 are also rejected due to their dependence on claim 1.
Regarding claims 1 and 26, the claims recite a method; however, there is no structure claimed for performing the method. Examiner suggests incorporating the structural elements of claim 14 into claims 1 and 26.
Regarding claims 1, 4, 14 and 26, the phrase "essentially simultaneously" renders the claim indefinite because it is unclear how “simultaneous” the delayed fluorescence is supposed to be measured. For examination purposes, it will be interpreted to be within a range of being simultaneous to partially delayed.
Regarding claims 1 and 26, the phrases “suitable for excitation of the probe” in line 5 and “suitable for distinguishing delayed fluorescence of probe monomers and probe excimers” in lines 14-15 and 7-8, respectively, are unclear as the metes and bounds of the claim cannot be determined as to how “suitable” the wavelength and/or the fluence rate must be to excite the probe and to distinguish between probe monomers and excimers. For examination purposes, any wavelength capable of exciting the probe and any wavelengths capable of measuring a probe excimer and probe monomer will read on the claim limitations.
Regarding claim 3, the phrase "wherein the concentration of excited triplet states of the probe is considered for determining the concentration of the quencher or the probe” is unclear. Is the concentration of the triplet states a part of the measurement for the concentration of the quencher/probe? For examination purposes, the concentration of the excited triplet states must be used in the quencher/probe concentration determination to read on the claim.
Regarding claim 14, it is unclear if the excitation light source in line 3 is the same, similar, or different than the excitation light sources of lines 17 and 19. Is one or two excitation light sources required to meet the claim limitations? For examination purposes, only one light source will be required.
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 1-3, 9, 11-12, 14-15, 17-19, 22, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ince (EP 1742038 – cited by Applicant).
Regarding claim 1, Ince teaches a method for determining a concentration of a quencher and/or the concentration of a probe capable of exhibiting a triplet-state based luminescence or transient triplet absorption in a cell that is part of a tissue or organ, comprising steps of
a) exciting the probe by irradiation with light having a wavelength and a fluence rate suitable for excitation of the probe (Paragraph 0016, “exciting an endogenous compound of said compartment … wherein said compartment … if excited, exhibits a luminescence and/or transient absorption”; Paragraph 0027 and 0049),
b) measuring temporal evolution of the triplet-state based luminescence or transient triplet absorption of the probe at at least one emission or absorption wavelength, wherein, in the presence of the quencher, the triplet-state luminescence or transient triplet absorption decays more quickly compared to the decay in the absence of the quencher (Fig. 4; Paragraph 0026), and
c) correlating said temporal evolution with said concentration(s) (Paragraph 0016, “correlating said luminescence lifetime with said concentration of said substance”),
wherein second order reactions involving two excited triplet states of the probe are considered (Per the 112(b) rejection and claim interpretation above regarding the second order reactions, being “considered” is interpreted as having no influence to some influence on the method. With regards to Ince, there is no influence; thus, Ince reads on the limitation), wherein
the emission of the delayed fluorescence is measured simultaneously or essentially simultaneously at at least two emission wavelengths, in the same sample volume, wherein these two wavelengths are suitable for distinguishing delayed fluorescence of probe monomers and of probe excimers, or
the fluence rate (intensity) or fluence of the light for excitation is used to determine the relative contribution of first and second order triplet deactivation and/or luminescence processes wherein the probe is excited by irradiation with light having at least two different fluence rates or fluences or
wherein the probe is excited by irradiation with light having at least two different light doses, wherein pulse durations are shorter than de-excitation times, or
wherein the probe is excited by irradiation with light having at least two excitation wavelengths (Paragraph 0049 and Fig. 5).
Regarding claim 2, Ince further teaches wherein the temporal evolution of triplet-state based luminescence measured in step b) is delayed fluorescence (DF) (Paragraph 0026).
Regarding claim 3, Ince further teaches wherein the concentration of excited triplet states of the probe is considered for determining the concentration of the quencher or of the probe, wherein the concentration of the probe is determined, and then, the concentration of the quencher is determined (Paragraph 0023).
Regarding claim 9, Ince further teaches wherein the probe is protoporphyrin IX (PplX) (Paragraph 0029) and the quencher is oxygen (Paragraph 0023), and, before step a), a precursor of PpIX is administered to the cell or has been administered to the cell (Paragraph 0068).
Regarding claim 11, Ince further teaches a method for assessment of mitochondrial function in a sample comprising a tissue or organ, comprising restricting or ceasing the supply of oxygen to said sample and carrying out the method of claim 1 with said sample (see Example 1 [Paragraphs 0055-0065]), wherein the probe is protoporphyrin IX (PpIX) (Paragraph 0029) and the quencher is oxygen (Paragraph 0023).
Regarding claims 12, Ince further teaches a method for assessment of the status of a patient selected from the group consisting of a sepsis patient, a critically ill patient, a patient undergoing a tumor treatment (e.g., phototherapy or photodynamic therapy), a patient undergoing surgery, a patient suffering from a neurodegenerative condition, or a decubitus patient, or for selecting an organ potentially suitable for transplantation to a patient (Paragraph 0002; Examiner notes that Ince discusses various claimed disease states where measuring the concentration of oxygen is important. A cell could be taken in any of the types of patients and used to carry out the method of claim 1), comprising carrying out the method of claim 1, wherein the cell is a cell of said patient or organ (Paragraph 0021).
Regarding claim 14, Ince further teaches a device suitable for carrying out the method of claim 1, comprising
- an excitation light source arranged to illuminate a sample volume (Paragraph 0056, “the wavelength-dependent transient absorption was measured using a white light source”), and
- a time and intensity-resolved light detector arranged to detect luminescence, such as fluorescence or phosphorescence from the sample volume, or triplet absorption by the sample volume (Paragraph 0055, “the spectra of prompt and delayed luminescence were recorded using a LS50B luminescence spectrometer”), such as fluorescence or phosphorescence from the sample volume, or triplet absorption by the sample volume, and
- a control unit configured to obtain measurements of luminescence from or transient triplet absorption by the sample volume (Paragraph 0056, “The output of the PMT was fed into an oscilloscope (Tektronix 2440, TEKTRONIX INC., Beaverton Oregon, USA) and transferred to a computer by the serial bus”), wherein said device comprises
i) a spectral filter, grating or spectrometer for determining the delayed fluorescence lifetimes and intensities of a probe simultaneously or essentially simultaneously at two emission wavelengths suitable for distinguishing delayed fluorescence of probe monomers and of probe excimers; and/or
ii) an excitation light source for exciting the probe with at least two different excitation fluence rates or fluence; and/or
iii) an excitation light source for exciting the probe with at least two different excitation wavelengths (Paragraph 0049 and Fig. 5).
Regarding claim 15, Ince further teaches wherein the device comprises
a processing unit capable of processing the obtained measurements (Paragraphs 0056-0057, wherein the measurements are sent to a computer for analysis) and configured to apply the adaptive Stern-Volmer relationship (Paragraph 0043).
Regarding claim 17, Ince further teaches wherein the quencher is oxygen (Paragraph 0023), and wherein the probe is a heme precursor (Paragraph 0068).
Regarding claim 18, Ince further teaches wherein the heme precursor is protoporphyrin IX (PplX) (Paragraph 0029).
Regarding claim 19, Ince further teaches wherein the temporal evolution of triplet-state based luminescence measured in step b) is temporal evolution of delayed fluorescence (Paragraph 0026).
Regarding claim 22, Ince further teaches wherein the precursor of PplX is 5-aminolevulinic acid (Paragraph 0068).
Regarding claim 25, Ince further teaches wherein the excitation light source is a light emitting diode (Paragraph 0076, using a green LED).
Response to Arguments
Applicant’s arguments, see page 9, filed 02/06/2026, with respect to the specification objections have been fully considered and are persuasive. Applicant has amended the abstract and specification per the suggestions of the Examiner. The objections of the specification have been withdrawn.
Applicant’s arguments, see page 9, filed 05/06/2026, with respect to claim objections have been fully considered and are persuasive. Applicant has amended the claims per the suggestion of the Examiner. The objection of the claims has been withdrawn.
Applicant has amended the “means for …” language recited in claim 14; thus, those limitations are no longer interpreted under 35 U.S.C. §112(f).
Applicant’s arguments, see page 9, filed 02/06/2026, with respect to the 35 U.S.C. §112(b) rejections have been fully considered. Applicant has amended the limitations to correct for a lack of antecedent basis, to properly reciting a Markush group, and to remove the indefinite language. These rejections of the claims have been withdrawn. However, Applicant has failed to argue or correct the limitation of a second order reaction being “considered”. Additionally, new 112(b) rejections have been applied.
Applicant's arguments, see page 10, filed 02/06/2026, with respect to the 35 U.S.C. §102(a)(1) rejections have been fully considered but they are not persuasive.
Applicant asserts that Ince fails to teach a second order reaction. While Examiner agrees, in light of the 112(b) rejection above and interpretation of the claim, second order reactions being “considered” includes having no influence on the method. Thus, Ince meets the limitation of the claim.
Applicant further asserts that Ince fails to teach measuring excimers. Examiner agrees; however, Applicant has amended claim 1 to require distinguishing between probe monomers and probe excimers in the alternative. As the rejection above does not read on this alternative limitation of the claim, Ince reads on the claim.
Applicant’s arguments, see page 10, filed 02/06/2026, with respect to the 35 U.S.C. §102(a)(1) rejections of claim 4 have been fully considered and are persuasive. The rejection of the claim has been withdrawn. See below.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record, Ince, teaches an analogous device for measuring oxygen partial pressure as described above. Regarding claims 4-5, 20-21, and 26, Ince discloses measuring delayed fluorescence (Paragraph 0049) but fails to disclose measuring the emission of the delayed fluorescence at at least two emission wavelengths to distinguish between probe monomers and probe excimers. Regarding claims 6 and 8, Ince discloses the use of a first order reaction (Fig. 4) but fails to disclose second order triplet activation / second order reactions. Regarding claim 7 and 23, Ince discloses using a mono-exponential fit procedure to the measured decay curves (Paragraph 0067) but fails to disclose using it to correlate the temporal evolution of the concentration of the quencher and wherein the fitting rejects the initial non-exponential part of the decay.
Claims 4-8, 20-21, and 23 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 26 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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