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 .
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: “oxygen source … for providing the periodic hypoxia challenge” in claim 17 - see [0047] of instant specification as filed “oxygen tank 135”..
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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-4 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Christodoulou et al., Abstract #0154 "Probing Mitochondria Function in Intact Fetal Brains with Ungated 4D Oxy-wavelet MRI in an Irradiation Injury Mouse Model" “Abstract #0154”.
Regarding claim 1, Abstract #0154 discloses a method of non-invasively assessing mitochondrial function in live tissue of a subject (see e.g., Title, Synopsis section and Introduction sections), comprising: providing periodic hypoxia challenges to the subject during a cyclic oxygenation period (page 2, under methods sub-heading “During acquisition, shortbursts of 3-min hypoxia (10% O2) interleaved with 3-min hyperoxia (100% O2) were supplied …”); acquiring 4D BOLD fMRI data from the live tissue of the subject during the cyclic oxygenation period (page 2, under methods sub-heading “4D-fMRI was acquired …During acquisition…”); and analyzing the acquired 4D BOLD fMRI data to determine a measure of mitochondrial function for each of a number of regions of the live tissue ((page 2, under introduction subheading “…analyzed by a continuous wavelet transform” and/or page methods sub-heading or page 3 text associated with Fig. 3 “automated time-frequency analysis scheme for 4D oxy-wavelet MRI”).
Regarding claim 16, see overlapping subject matter in claim 1 above, see page 2 methods section regarding “a 7-Tesla preclinical scanner (Bruker Biospec USR 70/30) … automated time-frequency analysis scheme” and Fig. 3, the scanner is an fMRI system that includes a magnet RF system and controller, and the controller will be configured to perform the associated method steps.
Regarding claims 2-3 and 18-19, see Fig. 3 and associated text in page 3.
Regarding claims 4 and 20, see page 2, under methods sub-heading “During acquisition, shortbursts of 3-min hypoxia (10% O2) interleaved with 3-min hyperoxia (100% O2) …”).
Regarding claim 17, an oxygen source that is an equivalent oxygen tank 135 in [0047] of instant specification is an inherent feature, to provide the shortbursts of hypoxia and hyperoxia discussed in the method steps.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims are 1, 5-8, 15-16 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Wu et al., US 20210349167 A1 ("Wu") in view of Christodoulou et al. Abstract #3202 "4D Real-time BOLD MRI in Genetically Engineered Mouse Brains with Acute Hypoxia Challenge" (“Abstract #3202”).
Regarding claims 1, 15 and 16, Wu discloses A method, system and associated non-transitory computer readable medium storing instruction to perform the method of non-invasively assessing mitochondrial function in live tissue of a subject (see Title, Abstract, Fig. 1, [0003], [0018] and [0050] “… once the dynamic 4D is generated as described herein, it may be used for any of a number of potential measurements and applications including … BOLD responses including normal to hyperoxygenation and oscillating hypoxia challenge to probe mitochondrial functions… automatic diagnosis…”), comprising: providing periodic hypoxia challenges to the subject during a cyclic oxygenation period (inherent step in [0050] “… BOLD responses including normal to hyperoxygenation and oscillating hypoxia challenge to probe mitochondrial functions”); acquiring 4D BOLD fMRI data from the live tissue of the subject during the cyclic oxygenation period ([0037] and Fig. 2 @ 100 “… spatially encoded data is collected for patient 6 using MRI system 2”); and analyzing the acquired 4D BOLD fMRI data to determine a measure of mitochondrial function for each of a number of regions of the live tissue ([0050] “.. to probe mitochondrial function” requires analysis of the 4D BOLD fMRI data), the system is disclosed as comprising an fMRI system including a magnet, an RF system and a controller configured to perform the method (see Fig. 1, [0033-0034]) and associated computer readable medium ([0018] and [0035]).
Even in the event it is argued that Wu does not explicitly disclose providing step and the acquiring step, "Abstract #3202" discloses this aspect in Results section and second figure and associated text in page 3. In view of the teachings of "Abstract #3202”, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to include providing periodic hypoxia challenges to the subject during a cyclic oxygenation period and include acquiring 4D BOLD fMRI data from the live tissue of the subject during the cyclic oxygenation period, so as to obtain BOLD responses that include normal to hyperoxygenation and oscillating hypoxia challenge, so as to probe mitochondrial functions form the BOLD responses as suggested by Wu.
Regarding claims 5 and 21, see Wu, Fig. 2, @100 and @105 and associated discussion in e.g., [0037] and [0043], training data read on D1 and non-training data read on D2 as claimed and/or "Abstract #3202” methods section.
Regarding claims 6 and 22, see Wu Fig. 2 @ 115 and 120 and associated discussion in [0044-0045], and/or "Abstract #3202” methods section.
Regarding claim 7 and 23, see Wu Fig. 2 @ 125 , @130 and associated discussion in [0046] and/or "Abstract #3202” methods section.
Regarding claims 8 and 24, see Wu Fig. 2 @ 125, @130 and associated discussion in [0046] and/or "Abstract #3202” methods section. Wu does not disclose wherein the analyzing comprises segmenting the final 4D image signal to create a segmented BOLD waveform, however, "Abstract #3202” discloses in Results section, “Temporal BOLD signal responses to the oscillating hypoxia challenge in selected regions (R1, R2, R3) are displayed as magnitude (Fig.2, G-I) and phase (Fig.2 J-L)”, see second figure in page 3, a process that involve segmentation of regions R1, R2 and R3 to perform analysis. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Wu to include analyzing that comprises segmenting the final 4D image signal to create a segmented BOLD waveform, so as to analyze different sections within the final 4D image signal for diagnosis purposes.
Allowable Subject Matter
Claims 9-14 and 25-30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the claims include subject matter of claim 9 or 25, that when combined with the subject matter of claim 8 or 24, would be nonobvious over the combined prior art of record, as the claimed invention further require forcing the BOLD waveform to be zero-mean and frequency normalized to create a modified segmented BOLD waveform for analysis. It is noted that "Abstract #3202” teaches in text associated with Figure 2, normalizing of color scales that is distinct from forcing the BOLD waveform to be zero-mean and frequency normalized. In light of the prior art failing to fully disclose the features of claims 9 and 25, the claims would be allowable over the prior art, but are currently objected to as being dependent upon a rejected base claim. Claims 10-14 and 26-30 are likewise objected to, as they include all limitations of base claim 9 or 25 and would be allowable for the same reason.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797
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