DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
8-9
Pending:
1-7 and 10-13
Withdrawn:
5 and 10-12
Examined:
1-4, 6-7 and 13
Independent:
1
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
x
112/b "Means for"
BRI
Broadest Reasonable Interpretation
x
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
102, 103
JE
Judicial Exception
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
x
Double Patenting
XXDATE
date format
Priority
As detailed on the 12/7/2020 filing receipt, this application claims priority to no earlier than 9/23/2015. All claims have been interpreted as being accorded this priority date.
Withdrawal / revision of objections and/or rejections
In view of the amendment and remarks:
The objection to the specification title is withdrawn.
The 112/b rejections are withdrawn, except as noted below.
The 103 rejection is withdrawn for the following reasons. The claims are free of the analogous art at least because close art, e.g. as cited in the now withdrawn 1/28/2026 rejection, does not teach the recited combination of similarity analysis and learning, as further discussed in Applicant's 3/18/2026 remarks beginning at p. 9.
Referring to 101 analysis as organized in MPEP 2106, the 101 rejections are withdrawn at least in view of the analysis Step 2A, 2nd prong, 1st consideration relating to an improvement over the previous state of the technology field integrating possible judicial exceptions into a practical application (MPEP 2106.04(d) and (d)(1)), the improvement to the operation of a computer and associated hardware applied to the field of in vivo analyte analysis, in this instance comprising increased accuracy in the form of is robustness to irrelevant variations (e.g., tissue state, instrumental drift) and increased stability and reliability of in vivo concentration predictions. This reason for allowance is analogous to the reasoning in MPEP-cited case law including Enfish, BASCOM and McRO (MPEP 2106.04(d) and (d)(1)), as well as Cardionet v. Infobionic (955 F.3d 1358, Fed. Cir. 2020). In this regard, Applicant's 3/18/2026 remarks beginning at p. 11 support withdrawal of the rejection.
Rejections and/or objections not maintained from previous office actions are withdrawn. The following rejections and/or objections are either maintained or newly applied. They constitute the complete set applied to the instant application.
Claim rejections - 112/b
The following is a quotation of 35 USC 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.
Response to arguments regarding Claim Rejections - 35 USC 112(b) -- Abstract idea
Applicant states (emphasis removed/added, applicant remarks: p. 8, 4th para.):
..."an intrinsic spectrum of the in vivo analyte" refers to the analyte's true optical spectrum (absorption, fluorescence, or scattering signature) as it would appear in isolation, without distortion from surrounding biological tissues.
It is not clear that there is adequate written description support for the above-asserted interpretation, and a 112/a rejection applies below, in addition to the 112/b rejection. If this interpretation is asserted as being well-known, then possibly a reference to this effect should be cited.
Applicant states (emphasis removed/added, applicant remarks: p. 8, 4th para.):
In claim 1, the concentration predicting method is calculated by both based on the learned result of the learning section and an intrinsic spectrum of the in vivo analyte.
Regarding the recited "concentration predicting algorithm" rendering the claim indefinite, first the recited "method for predicting a concentration" (preamble) and "concentration predicting algorithm" ("predicting" step) are interpreted separately, and it is the "concentration predicting algorithm" which improperly invokes 112/f.
Second, it is not clear what structure (i.e. algorithmic steps leading from inputs to outputs) correspond to the recited "concentration predicting algorithm."
Third, the above-quoted "calculated by both based on the learned result of the learning section and an intrinsic spectrum of the in vivo analyte" itself is not clearly interpretable at least due to an apparent grammar issue.
Fourth, as to those portions of the specification cited in the 3/18/2026 remarks at p. 8, last para., (i) it is not clear to which rejection and 112/f instance the remarks apply, i.e. "concentration predicting algorithm" vs. "net analyte signal algorithm." And, (ii) in order to satisfy 112/b, any support in the specification must be both clearly linked to the invoking recitation and must disclose structure, in this instance likely in the form of algorithmic steps.
Applicant states (emphasis removed/added, applicant remarks: p. 8, 5th para.):
The Office Action states that claim 1 is indefinite under l12(b) after invoking 112(f).
Claim 1 previously was rendered indefinite by each of two separate 112/f invocations. Each instance separately rendered the claim indefinite under 112/b. The interpretation and rejection according to the "concentration predicting algorithm" instance are maintained as discussed above and as described in the below rejection. The previous rejection according to the "net analyte signal algorithm" instance is withdrawn in view of the amendment as further addressed in the below interpretation section.
Claims 1-3, 5-9 and 13 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable.
The following issues cause the respective claims to be rejected under 112/b as indefinite:
Claim
Recitation
Comment (suggestions in bold)
1
predicting...
an intrinsic spectrum of the in vivo analyte
It is unclear how to interpret "intrinsic." It is unclear what is the difference between a spectrum of the analyte and an intrinsic spectrum of the analyte. The specification discloses "an intrinsic spectrum" (e.g. p. 2, line 14) but does not define the term, and the meaning is not clear from the context in either the specification or the claim. This causes the scope of the claim to be indefinite because it is unclear how the elements within the recitation relate to the claim as a whole. If no distinction is intended, then possibly the term should be deleted. This rejection is maintained. In view of Applicant's 3/18/2026 remarks, a related 112/a rejection is applied below. Also, possibly the examination of this term in the parent application and associated amendments therein may be relevant.
1
a concentration predicting algorithm
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "algorithm") and function and/or result (here "concentration predicting") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. p. 5, line 10 and p. 6, lines 15-21; p. 13, line 21 through pl. 14, line 6), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. MPEP 2181 pertains, and MPEP 2187, FP 7.34.23 lists options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains. This rejection is maintained. It may help to overcome this rejection to either: (1) specifically identify adequate support in the specification according to the issues identified above or (2) amend such that the recitation no longer invokes 112/f.
Claim rejections - 112/a
The following is a quotation of 112/a:
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Written description
Claims 1-4, 6-7 and 13 are rejected under 112/a as failing to comply with the written description requirement. The claims read on subject matter which is not described in the specification in such a way as to reasonably convey to PHOSITA that the inventors, at the time the application was filed, had possession of the claimed invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted. With regard to any suggested amendment(s) below to overcome a rejection, equivalent amendments also would be acceptable.
Claim 1 recites "...an intrinsic spectrum of the in vivo analyte" (end of "predicting" step), but it is not clear that there is adequate written description support for clear interpretation of the recited "intrinsic" in the recited context. Applicant's 3/18/2026 remarks (p. 8, 4th para.) state: "...'an intrinsic spectrum of the in vivo analyte' refers to the analyte's true optical spectrum (absorption, fluorescence, or scattering signature) as it would appear in isolation, without distortion from surrounding biological tissues." However, it is not clear that there is written description support for this interpretation of the recitation (e.g. specification p. 2, lines 14-21).
As appropriate, these rejections may be overcome, for example, (i) by narrowing to clearly supported embodiments and/or (ii) by clarifying on the record where support can be found and how that support relates to the recitations.
If this interpretation is asserted as being well-known, then possibly a reference to this effect should be cited.
Also, possibly the examination of this term in the parent application and associated amendments therein may be relevant.
In general, it is requested that any claim amendment in this regard be accompanied by citations to support in the original disclosure.
MPEP 2163 generally pertains.
Claim interpretations
The following claim interpretations apply to all instances of the following terms throughout all claims:
Claim
Recitation
Comment
5
dispersion spectrum
The recited "dispersion" is understood to refer to a process such as for example Raman scattering which results in a dispersion of propagated and emitted wavelengths, as supported in the instance specification at 2:1 and 13:14-22.
7
net analyte signal algorithm
Recites means (or an equivalent, nonce term, here "algorithm") and function and/or result (here "net analyte signal"), but the recitation does not invoke 112/f because the claim is interpreted as reciting sufficient structure (in this instance in the form of subsequent algorithmic steps) not to invoke. MPEP 2181.I.C pertains.
Nonstatutory double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine to prevent the improper timewise extension of the "right to exclude" granted by a patent and to prevent multiple suits against an accused infringer by different assignees of the same invention (MPEP 804.II.B, 1st para.). A nonstatutory double patenting rejection is appropriate where the conflicting claims (instant v. reference) are not identical, but an examined-application claim (instant claim) is not patentably distinct from a reference claim because the instant claim is either anticipated by, or would have been obvious over, the reference claim (MPEP 804.II.B, 2nd para.).
In cases of double patenting rejections versus reference claims of pending applications, as opposed to claims of an issued patent, the rejections are provisional because the reference claims have not been patented. Presently, no rejections are provisional.
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 application or patent of the reference claim either is shown to be commonly owned with the instant application or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must comply fully with 37 CFR 3.73(b).
Applicant may wish to consider electronically filing a terminal disclaimer (MPEP 1490.V pertains, along with https://www.uspto.gov/patents-application-process/applying-online/eterminal-disclaimer). Electronic filing may lead to faster approval of the disclaimer. Also, if filing electronically, Applicant is encouraged to notify the examiner by telephone so that examination may resume more quickly.
Double patenting rejections of instant claims 1-3, 5-9 and 13
Instant claims 1-4, 6-7 and 13 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference patents 10,881,333 (from application 15/270,812) and 10,966,689 (from application 15/590,094) in view of Arnold (2006/0167348 as cited on the 11/24/2020 IDS).
Although the reference claims are not identical to the instant claims, in a BRI they also are not patentably distinct from the instant claims: either (i) because the instant claims recite obviously equivalent or broader limitations in comparison to the reference claims or (ii) because the instant claims recite limitations which are obvious over the cited art. It is not clear that the instant claims recite limitations which are narrower than limitations in the reference claims.
It would have been obvious in view of the cited art to modify reference claims to arrive at the rejected instant claims. Either the instant limitations are interpreted as reading on a reference limitation, or the instant limitations would have been obvious in view of the cited art. That is, to the extent that any instant claims are narrower than reference claims, then any such narrowing would have been obvious over the cited art.
Conclusion
No claim is allowed.
Applicant's amendments necessitated the new grounds for rejection in this 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 extension fee 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 date of this final action.
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The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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