DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 19-38 are pending.
This action is Final.
Information Disclosure Statement
The information disclosure statement filed 3/9/2026 fails to comply with 37 CFR 1.97(c) because it lacks a timing statement as specified in 37 CFR 1.97(e). It has been placed in the application file, but the information referred to therein has not been considered. The information disclosure statement filed 3/9/2026 fails to comply with 37 CFR 1.97(c) because it lacks the timing fee set forth in 37 CFR 1.17(p). It has been placed in the application file, but the information referred to therein has not been considered.
MPEP 609.04(b) Timing Requirements for an Information Disclosure Statement [R-07.2022]
I. INFORMATION DISCLOSURE STATEMENT FILED BEFORE FIRST ACTION ON THE MERITS OR WITHIN THREE (3) MONTHS OF ACTUAL FILING DATE, NATIONAL STAGE ENTRY DATE, OR PUBLICATION UNDER ARTICLE 10(3) OF THE HAGUE AGREEMENT (37 CFR 1.97(b))
An information disclosure statement will be considered by the examiner if filed within any one of the following time periods:
(A) for national applications (not including CPAs), within three months of the filing date of the national application or before the mailing date of a first Office action on the merits;
(B) for international applications, within three months of the date of entry of the national stage as set forth in 37 CFR 1.491 or before the mailing date of a first Office action on the merits;
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The use of the term Drӓger, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities: FWHM is never set forth with a meaning for the term, presumed to be an abbreviation of full width at half maximum
Appropriate correction is required.
37 CFR 1.121
(b) Specification. Amendments to the specification, other than the claims, “Large Tables” (§ 1.58(c) ), a “Computer Program Listing Appendix” (§ 1.96(c)(5) and (7) ), a “Sequence Listing” (§ 1.825 ), or a “Sequence Listing XML” (§ 1.835 ), must be made by adding, deleting, or replacing a paragraph; by replacing a section; or by providing a substitute specification, in the manner specified in this section.
(1) Amendment to delete, replace, or add a paragraph. Amendments to the specification, including amendment to a section heading or the title of the invention which are considered for amendment purposes to be an amendment of a paragraph, must be made by submitting:
(i) An instruction, which unambiguously identifies the location, to delete one or more paragraphs of the specification, replace a paragraph with one or more replacement paragraphs, or add one or more paragraphs;
(ii) The full text of any replacement paragraph with markings to show all the changes relative to the previous version of the paragraph. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived;
(iii) The full text of any added paragraphs without any underlining; and
(iv) The text of a paragraph to be deleted must not be presented with strike-through or placed within double brackets. The instruction to delete may identify a paragraph by its paragraph number or include a few words from the beginning, and end, of the paragraph, if needed for paragraph identification purposes.
Drawings
The drawings are objected to because the size of the Fig. labels do not meet the sizing requirements as they are too small. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 detection arrangement for” in claim 32.
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.
Review of the disclosure as filed the following are correspondence structures:
“a detection arrangement for” appears to correspond to spectral filters and equivalents
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 19-38 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 claim 19, the following issues render the claim indefinite:
-claim 19 recites “irradiating light of a wavelength…detecting both light of an irradiation wavelength and longer wave light at wavelengths longer than the irradiation wavelength” are not clear how each wavelength is related. Is the irradiating light of a wavelength the same or different from an irradiation wavelength and light at wavelengths longer than the irradiation wavelength? This is not clear in the claim.
Claim 19 recites “determining bilirubin in response to the time sequence by comparing the intensity of each detection signal of the detected longer wave light to the intensity of detected light of the irradiation wavelength to obtain standardized detection signals, and deducing a non-degraded ratio of different forms of bilirubin from the time sequence of the standardized detection signals, wherein light at a power from 75 mW to 150 mW is irradiated locally into the living tissue region, so that an intensity of the light is sufficient to locally degrade a more rapidly phototransformable” which are not clear in addition to the prior raised issue of wavelength. The usage of “the intensity” lacks adequate antecedent basis (2x). It is not clear if “an intensity of light” is related to the prior intensity set forth or is a separate intensity of light related to the irradiated light. As it appears to be defining the resulting intensity of the irradiated light, it appears that the first two instances, at least one or both, are unrelated to this instance itself and there should be three separate intensities of light set forth.
For theses various reasons, the metes and bounds of the claims are unclear which renders the claim indefinite.
As there is a large amount of uncertainty in regards to the proper scope and assumptions to be made in the scope, it would be improper to speculatively make rejections in view of prior art, In re Steele. See MPEP 2173.06
“Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.”
Regarding claim 20, the limitations “wherein determining bilirubin comprises determining a total bilirubin value from an average total fluorescence over a measurement period at a beginning of a measurement” are not clear how they relate to the requirements of claim 19 including “determining bilirubin in response to the time sequence by comparing the intensity of each detection signal of the detected longer wave light to the intensity of detected light of the irradiation wavelength to obtain standardized detection signals, and deducing a non-degraded ratio of different forms of bilirubin from the time sequence of the standardized detection signals”. It does not appear that claim 20 is related to the required steps in claim 19 for determining bilirubin.
Regarding claim 22, the limitations “wherein detecting light comprises an integration time per detection signal of the time sequence of at least 100 ms” is not clear what is meant in view of claim 19 requirements “detecting light from the irradiated living tissue region, wherein detecting light comprises detecting both light of an irradiation wavelength and longer wave light at wavelengths longer than the irradiation wavelength,”. It is not clear how these two requirements function together, which makes the metes and bounds of the claim unclear, which renders the claim indefinite.
Regarding claim 25, the limitations “wherein the intensity of the light with which the more rapidly phototransformable form of bilirubin is locally degraded relative to other tissue regions is less than 20% of the light intensity used for the measurement” is not clear in view of the requirements of claim 24 “carrying out a repeated measurement of bilirubin,” and claim 19 “determining bilirubin in response to the time sequence by comparing the intensity of each detection signal of the detected longer wave light to the intensity of detected light of the irradiation wavelength to obtain standardized detection signals, and deducing a non-degraded ratio of different forms of bilirubin from the time sequence of the standardized detection signals,
wherein light at a power from 75 mW to 150 mW is irradiated locally into the living tissue region, so that an intensity of the light is sufficient to locally degrade a more rapidly phototransformable form of bilirubin,” which makes the claim unclear. It is not clear how these features are functioning together. It is not clear what is meant by the measurement, is this the repeated measurement or the measurement duration? It also does not appear to be clear what “the light intensity used” refers to in the claims as claim 1 appears to use two different light intensities in the time sequence determination, so which is being limited here? For these reasons the metes and bounds of the claim are unclear, which renders the claim indefinite.
Claim 28 is unclear what is added by the limitations “28. (Currently Amended) The method according to claim 27, wherein detecting light of the plurality of distinguishable wavelengths comprises detecting both light of the irradiation wavelength and longer wave light distinguishable therefrom” as this appears to be redundant features of claim 19 as amended. For these reasons the metes and bounds of the claim are unclear, which renders the claim indefinite.
Regarding claim 32, the claims are directed to a product which depends on the method of claim 19. As such, claim 32 is rejected for the same reasons as claim 19. In addition, the like terms being set forth a second time are indefinite as it is unclear if the method terms are being further limited or the product forms. If applicant contests these rejections, then place claim 32 in independent form and positively claim the method steps from claim 19 to ensure proper understanding, correct form, and proper antecedent basis.
The dependent claims are rejected for depending on a rejected claim.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims, drawings, and specification filed 6/9/2026; and IDS filed 3/9/2026.
Applicant’s arguments regarding the drawing objections have been fully considered. While the form of text in Figures 3-4 is sufficient, the objection to Figure labels is for all Figures and remains.
Applicant’s arguments regarding the specification objections have been fully considered but are not persuasive because the amendments do not follow proper procedures, the amendments to the specification are not entered.
Applicant’s arguments regarding the claim objections have been fully considered and are persuasive due to the amendments to the claims; the objections are withdrawn.
Applicant’s arguments regarding the claim interpretation have been fully considered and the claim interpretation is updated to account for the amendments to the claims. The examiner notes the purported implicit support and deems it sufficient for the amendments with the citations.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112(a) have been fully considered and are persuasive due to the amendments to the claims and arguments; the rejections are withdrawn.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112(b) have been fully considered and are partially persuasive due to the amendments to the claims; the rejections remain as presented above to account for the amendments to the claims.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered and are persuasive due to the form of the claims and the arguments for practical application and/or significantly more than the claimed exception; the rejections are withdrawn.
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.
No prior art rejections have been applied as addressed in the 112(b) rejections above, In re Steele.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2001/0034478, US 2012/0100625, US 2015/0148635, US 2015/0335273, US 2021/0236844, US 2022/0047192 teach related systems/methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
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