U.S. Serial No. 15/987,794
`Office Action mailed August 31, 2018
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`REMARKS
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`Claims 1, 3, 4, 6-1 1, 13-15, 17, and 20-36 were pending prior to entry of the amendments
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`presented in this response. Claims 1, 9, ll, 13, and 15 have been amended. Claim 14 has been
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`canceled. No new matter is added by any of these amendments. Accordingly, claims 1, 3, 4, 6-
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`ll, 13, 15, 17, and 20-36 are currently pending.
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`Reconsideration and allowance of this application is respectfully requested in light of the
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`abovementioned amendments and the following remarks.
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`Claim amendments
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`Claim 1 has been amended to clarify the claimed subject matter. This amendment is fully
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`supported by the application as originally filed, US. Patent Application No. 15/987,794, now
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`US. Patent Publication No. 20180268942 (“the Application”) at, for example, paragraphs
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`[0006], [00141—[0015], [0027]-[0028], [00901—[0092], [00106], and [001411—[00145].
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`Claims 9, 11, and 13 have been amended for antecedent basis or clarity purposes. Claim
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`15 has been amended to depend from amended claim 1 instead of canceled claim 14.
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`Claim objections
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`Claim 9 stands objected to. Applicant has amended claim 9 to recite “to determine
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`disorder states of the brain tissue associated with the plurality of subjects”.
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`Accordingly Applicant respectfully requests withdrawal of the objection to claim 9.
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`35 U.S.C. § 112
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`Claim 11 stands rejected under 35 U.S.C. § ll2(b) or 35 U.S.C. § 112 (pre-AIA), second
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`paragraph.
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`Without conceding in the basis of rejection, and solely to expedite the prosecution of this
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`application, Applicant has amended claim 11 to recite “the one or more measured MRI
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`parameters [[is]] E selected from the group consisting of: a longitudinal relaxation time (T1), a
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`transverse relaxation time (T2), and a diffusion coefficient.”
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`Accordingly Applicant respectfully submits that the § ll2(b) or § 112 (pre-AIA), second
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`paragraph rejection of claim 11 be withdrawn.
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`U.S. Serial No. 15/987,794
`Office Action mailed August 31, 2018
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`35 U.S.C. § 101
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`Claims 1, 3, 4, 6-11, 13-15, 17, and 20-36 stand rejected under 35 U.S.C. § 101.
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`Applicant respectfully traverses the § 101 rejection of these claims for at least the reasons set
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`forth below.
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`MPEP §2106.04 provides a subject matter eligibility test. “A claim is directed to a
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`judicial exception when a law of nature, a natural phenomenon, or an abstract idea is recited (i.e.,
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`set forth or described) in the claim.” MPEP § 2106.04(II). A claim that is directed to at least one
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`exception “requires further analysis
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`to determine whether the claim recites a patent-eligible
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`application of the exception.” MPEP § 2106.04(b)(1). However, “[i]f the claim as a whole does
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`recite significantly more than the exception itself, the claim is eligible
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`and the eligibility
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`analysis is complete.” MPEP § 2106.05(II). (emphasis added).
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`Furthermore, “[fjor a claim that is directed to a judicial exception to be patent-eligible, it
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`must include additional features to ensure that the claim
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`is more than a drafting effort
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`designed to monopolize the exception.” MPEP § 2106.05(e). “When evaluating whether
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`additional elements meaningfully limit the judicial exception, it is particularly critical that
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`examiners consider the additional elements both individually and as a combination.
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`[E]ven in
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`the situation where the individually-viewed elements do not add significantly more, those
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`additional elements when viewed in combination may amount to significantly more than the
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`judicial exception by meaningfully limiting the exception.” Id.
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`MPEP § 2106.05(I)(A) sets out limitations that may qualify as “significantly more” when
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`recited in a claim with an alleged judicial exception, including:
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`o
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`Improvements to a technology or technical field,
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`0 Adding a specific limitation other than what is well-understood, routine,
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`conventional activity in the field, or adding unconventional steps that confine the
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`claim to a particular useful application, or
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`o Other meaningful limitations beyond generally linking the use of the judicial
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`exception to a particular technological environment.
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`a. Claim 1 and dependent claims thereof are not directed to a Zudicial exception
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`WSGR Docket No. 53242-701301
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`U.S. Serial No. 15/987,794
`Office Action mailed August 31, 2018
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`Initially under § 101 analysis, Applicant submits that claims 1, 3, 4, 6-1 1, 13-15, 17, and
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`20-36 are not directed to a judicial exception. The claims when viewed as a whole do not “seek
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`to tie up any judicial exception such that others cannot practice it.” MPEP § 2106.06(a).
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`For example, amended claim 1 recites in part, “obtaining magnetic resonance imaging
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`(MRI) data .
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`.
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`. for the voxel of the plurality of voxels, using one or more computer processors to
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`process the one or more measured MRI parameters with one or more simulated MRI parameters
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`for the voxel, the one or more simulated MRI parameters being generated from one or more
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`microstructural models at the voxel, wherein the one or more microstructural models comprise
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`predicted values of at least one parameter selected from the group consisting of: cell density, cell
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`shape, cell geometry, cell size, cell distribution, intercellular spacing, extracellular matrix
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`composition, extracellular matrix distribution, extracellular matrix homogeneity, and interstitial
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`tortuosity within the voxel.”
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`This claim recites tangible elements and as a whole is not directed to a law of nature, a
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`natural phenomenon, or an abstract idea. Hence, claim 1 and dependent claims thereof do not
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`seek to tie up any judicial exception. Accordingly, claim 1 and dependent claims thereof are not
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`directed to a judicial exception.
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`I). Claim 1 and de endent claims thereo recite si
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`i icantl more than a 'ua’icial
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`excthion
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`Even if claims 1, 3, 4, 6-1 1, 13-15, 17, and 20-36 are found to be directed to ajudicial
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`exception (Applicant is not conceding that these claims are directed to a judicial exception),
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`Applicant submits that these claims are patent eligible because they include elements that are
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`unconventional and non-routine. For example, Claim 1 recites additional elements that are not
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`routine or conventional.
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`Applicant notes that the recent April 19, 2018 Memorandum from Deputy Commissioner
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`Robert W. Bahr to the Patent Examining Corps regarding Recent Subject Matter Eligibility
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`Decision Berkheimer v. HP, Inc. (the “Berkheimer memo”) clarifies that “an examiner should
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`conclude that an element (or combination of elements) represents well-understood, routine,
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`conventional activity only when the examiner can readily conclude that the element(s) is widely
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`prevalent or in common use in the relevant industry. [S]uch a conclusion must be based upon a
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`factual determination that is supported as discussed in section III below.” Berkheimer memo,
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`U.S. Serial No. 15/987,794
`Office Action mailed August 31, 2018
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`Section II at p. 3. (second emphasis added). The Berkheimer memo further emphasizes that “a
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`showing that additional elements are obvious under 35 U.S.C. § 103, or even that they lack
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`novelty under 35 U.S.C. § 102, is not by itself sufficient to establish that the additional elements
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`are well-understood, routine, conventional activities or elements to those in the relevant field.”
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`Id.
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`The Berkheimer memo further specifies that an additional combination of elements “is
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`not well-understood, routine or conventional unless the examinerfinds, and expressly supports a
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`rejection in writing with, one or more of the following: (1) A citation to an express statement in
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`the specification or to a statement made by an applicant that demonstrates the well-understood,
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`routine, conventional nature of the additional elements ...(2) A citation to one or more of the
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`court decisions discussed in MPEP § 2106.05(d)(II) as noting the well-understood, routine,
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`conventional nature of the additional elements
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`(3) A citation to a publication that
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`demonstrates the well-understood, routine, conventional nature of the additional elements
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`(4)
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`A statement that the examiner is taking official notice...” Berkheimer memo, Section III at p. 3-
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`4. (emphasis added).
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`For example, nothing in the references cited under the § 102 / § 103 rejections (see
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`below) teaches or discloses “(b) for the voxel of the plurality of voxels, using one or more
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`computer processors to process the one or more measured MRI parameters with one or more
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`simulated MRI parameters for the voxel, the one or more simulated MRI parameters being
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`generated from one or more microstructural models at the voxel, wherein the one or more
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`microstructural models comprise predicted values of at least one parameter selected from
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`the group consisting of: cell density, cell shape, cell geometry, cell size, cell distribution,
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`intercellular spacing, extracellular matrix composition, extracellular matrix distribution,
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`extracellular matrix homogeneity, and interstitial tortuosity within the voxe ,” as recited in
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`amended claim 1.
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`There is nothing routine or conventional about utilizing one or more microstructural
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`models comprising predicted values of cell density, cell shape, cell geometry, cell size, cell
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`distribution, intercellular spacing, extracellular matrix composition, extracellular matrix
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`distribution, extracellular matrix homogeneity, and interstitial tortuosity within the voxel.
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`In addition, Applicant submits that the claimed invention provides an improvement to a
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`technology or a technical field. For example, based at least in part on the manner in which the
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`U.S. Serial No. 15/987,794
`Office Action mailed August 31, 2018
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`“one or more microstructural models” are generated, “an output indicative of the disorder state of
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`the brain tissue associated with at least the voxel” may be generated. Such output may provide an
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`indication of the disorder state of the brain by taking into account cellular and/or sub-cellular
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`features (e.g., cell density, cell shape, cell geometry, cell size, cell distribution, intercellular
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`spacing, extracellular matrix composition, extracellular matrix distribution, extracellular matrix
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`homogeneity, and interstitial tortuosity), which may provide a more accurate assessment of the
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`disorder state of the brain tissue.
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`Accordingly, Applicant respectfully requests that the § 101 rejection of claim 1, and
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`dependent claims 3, 4, 6-1 1, 13-15, 17, and 20-36 thereof, be withdrawn.
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`35 U.S.C. § 102
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`Claims 1, 6-1 1, 24-30, and 33-36 stand rejected under 35 U.S.C. § 102(a)(2) over US.
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`Patent Publication No. 2016/023 9969 to Davatzikos et al. (hereinafter “Davatzikos”).
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`Without conceding in the basis of rejection, and solely to expedite the prosecution of this
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`application, Applicant has amended claim 1 to clarify certain differences between the claimed
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`subject matter and the cited art. Applicant submits that claim 1 is not anticipated by Davatzikos
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`because this reference does not meet all of the elements of this claim.
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`Davatzikos discloses analyzing “the target image by using sparse decomposition and a set
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`of normative images spatially aligned with the target image (e. g, MR images of a normal or
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`healthy brain).” See Davatzikos at paragraph [0032]. However, nothing in Davatzikos teaches or
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`discloses “for the voxel of the plurality of voxels, using one or more computer processors to
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`process the one or more measured MRI parameters with one or more simulated MRI parameters
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`for the voxel, the one or more simulated MRI parameters being generated from one or more
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`microstructural models at the voxel, wherein the one or more microstructural models
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`comprise predicted values of at least one parameter selected from the group consisting of:
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`cell density, cell shape, cell geometry, cell size, cell distribution, intercellular spacing,
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`extracellular matrix composition, extracellular matrix distribution, extracellular matrix
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`homogeneifl, and interstitial tortuosifl within the voxe ,” as recited in claim 1.
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`Accordingly, Applicant respectfully requests that the § 102 rejection of claim 1 be
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`withdrawn.
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`WSGR Docket No. 53242-701301
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`U.S. Serial No. 15/987,794
`Office Action mailed August 31, 2018
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`Claims 3, 4, 6-1 1, 24-30, and 33-36 depend from and include all of the elements of claim
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`1, and recite additional elements of particular advantage and utility. Davatzikos does not meet all
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`of the elements of claim 1, much less the combination of elements of claims 3, 4, 6-1 1, 24-30,
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`and 33-36. Accordingly, Applicant respectfully requests that the § 102 rejections of claims 3, 4,
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`6-1 1, 24-30, and 33-36 also be withdrawn.
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`35 U.S.C. § 103
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`Claims 3, 4, 13-15, 17,20-23, 31, and 32 stand rejected under 35 U.S.C. § 103 over
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`Davatzikos in view of US. Patent Publication No. 2015/0073258 to Mazer et al. (hereinafter
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`“Mazer”).
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`Without conceding in the basis of rejection, Applicant submits that claims 3, 4, 13-15, 17,
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`20-23, 3 l, and 32 are not obvious over the asserted combination of Davatzikos and Mazer for at
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`least the reason that these claims depend from and include all of the elements of claim 1, and
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`recite additional elements of particular advantage and utility. Davatzikos fails does not teach or
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`disclose all of the elements of claim 1, much less the combination of elements of claims 3, 4, 13-
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`15, 17, 20-23, 3 l, and 32, and Mazer does not cure the abovementioned deficiencies of
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`Davatzikos. Accordingly Applicant respectfully requests that the § 103 rejections of claims 3, 4,
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`13—15, 17, 20—23, 31, and 32 be withdrawn.
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`>l<>l<>l<
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`It shall be understood herein that any instance in which Applicant has addressed certain
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`comments of the Office shall not be construed as a concession to other comments or arguments
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`advanced by the Office. Any circumstance in which Applicant has amended or canceled a claim
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`also does not necessarily mean that Applicant concedes to the arguments or positions advanced
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`by the Office with respect to that claim or other claims pending herein.
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`U.S. Serial No. 15/987,794
`Office Action mailed August 31, 2018
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`CONCLUSION
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`Applicant submits that this paper fully addresses the issues presented in the Non-Final
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`Office Action mailed August 3 l, 2018 (the “Office Action”). In view of the amendments and
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`remarks above, favorable reconsideration of the application is respectfully requested and
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`Applicant respectfully requests the Examiner to move this application to issuance. Should the
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`Examiner have any questions, the Examiner is encouraged to contact the undersigned.
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`The Commissioner is authorized to charge any additional fees which may be required,
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`including petition fees and extension of time fees, to Deposit Account No. 23-2415 (Docket No.
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`53242-701301).
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`Respectfully submitted,
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`WILSON SONSINI GOODRICH & ROSATI
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`By: /Daniel Kennedy/
`Daniel J. Kennedy, PhD.
`Reg. No. 76,220
`Ali R. Alemozafar, Ph.D., Esq.
`Reg. No. 68,180
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`Dated: October 31 2018
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`650 Page Mill Road
`Palo Alto, CA 94304-1050
`Telephone: (650) 849-3139
`Customer No. 2197 l
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`WSGR Docket No. 53242-701301
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