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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) Claim 1 recites a ". This judicial exception is not integrated into a practical application because . The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the totality of the method steps of claim 1 fails to provide adequate embodiment.
Claims 2-5 depend from rejected claim 1 and are similarly rejected.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) Claim . This judicial exception is not integrated into a practical application because . The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the totality of the method steps of claim 1 fails to provide adequate embodiment.
Claims 7-14 depend from rejected claim 6 and are similarly rejected.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) Claim 1. This judicial exception is not integrated into a practical application because . The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the totality of the method steps of claim 1 fails to provide adequate embodiment.
Claims 16-20 depend from rejected claim 15 and are similarly rejected.
The 101 analysis below applies to independent claims 1, 6 and 15.
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Step
Analysis
1: Statutory Category?
Yes. The claim recites a series of steps and, therefore, is a method.
2A- Prong 1: Judicial Exception Recited?
Yes. The claim recites the limitation of
The limitation, as drafted, is a method that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic MRI components. That is, other than reciting “performing a Na-nuclei pulse sequence module, performing an H-nuclei pulse sequence module, repeating the performing of the sequence module, generating at least one Na-based image, generating at least one H-based image and displaying one or more of the at least one Na-based image and H-based image” nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the “performing a Na-nuclei pulse sequence module, performing an H-nuclei pulse sequence module, repeating the performing of the sequence module, generating at least one Na-based image, generating at least one H-based image and displaying one or more of the at least one Na-based image and H-based image” language, the claim encompasses a user simply determining and defining the limitations cited. A high level of generality and are merely invoked as tools to perform an existing medical records update process. Simply implementing the abstract idea on a generic computer is not a practical application of the abstract idea.
2A- Prong 2: Integrated into a Practical Application?
No. The claim recites three additional elements:
Acquiring a portion of a first set of MR data from the kidney region of the subject; acquiring a portion of a second set of MR data from the kidney region of the subject. These steps are recited at a high level of generality (i.e., as a general means of processing), and amounts to mere data gathering, which is a form of insignificant extra-solution activity. The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components (Na-nuclei pulse sequence module and H-nuclei pulse sequence module). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
The claim is directed to the abstract idea.
2B: Claim provides an Inventive Concept?
No. As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using generic MRI components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic MRI system cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. Here the, acquiring a portion of a first set of MR data from the kidney region of the subject and a second set of MR data from the kidney region of the subject, steps were considered to be extra-solution activity in Step 2A, and thus it is re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The claim limitations do not provide any indication that the pulse sequence modules, generating at least one Na-based image, generating at least one H-based image and displaying one or more of the at least one Na-based image and H-based image are anything other than generic, off the-shelf computer components, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well understood, routine, and conventional function when it is claimed in a merely generic manner. Accordingly, the pulse sequence modules, generating image module and display module steps are well-understood, routine and conventional activities. For these reasons, there is no inventive concept in the claim, and thus it is ineligible
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-11 and 14-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kaditz et al. (US PAT 10,194,829), hereinafter Kaditz.
With respect to claim 1, Kaditz discloses a method for generating magnetic resonance (See the abstract of Kaditz) images of a kidney region of a subject using multinuclear magnetic resonance imaging (See Col. 36, lines 25-37 of Kaditz), the method comprising: performing, using an MRI system, a Na-nuclei (See Col. 41, lines 14-18 of Kaditz) pulse sequence module to acquire a portion of a first set of MR data from the kidney region of the subject (See Col. 1, line 59- Col. 2, line 12 of Kaditz); performing, using the MRI system, an H-nuclei pulse sequence module to acquire a portion of a second set of MR data from the kidney region of the subject (See Col. 49, line 57-Col. 50, line 6 of Kaditz in view of Col. 41, lines 8-27 of Kaditz); repeating the performing of the Na-nuclei pulse sequence module and the H-nuclei pulse sequence module in an interleaved manner until acquisition of the first set of MR data and the second set of MR data are complete (See Col. 16, lines 42-57 of Kaditz); generating at least one Na-based image using the first set of MR data (See Col. 49, line 57-Col. 50, line 6 of Kaditz); generating at least one H-base image using the second set of MR data (See Col. 2, lines 13-25 of Kaditz); and displaying one or more of the at least one Na-based image and the at least one H- based image on a display (See Col. 11, lines 40-47 of Kaditz).
With respect to claim 2, Kaditz discloses the method according to claim 1, wherein the Na-nuclei pulse sequence module is a Na density adapted gradient echo (DAR) pulse sequence module (See Col. 13, lines 40-47 of Kaditz).
With respect to claim 3, Kaditz discloses the method according to claim 1, wherein the H-nuclei pulse sequence module is a turbo spin echo (TSE) pulse sequence module (See Col. 19, lines 48-67 of Kaditz).
With respect to claim 4, Kaditz discloses the method according to claim 1, wherein one or more of the at least one Na- based image and the at least one H-based image on a display includes information related to renal impairment of the subject (See Col. 42, lines 55-58 in view of Col. 50, lines 1-6 of Kaditz).
With respect to claim 5, Kaditz discloses the method according to claim 1, wherein the portion of the first set of MR data is a line of k-space and the portion of the second set of MR data is a plurality of lines of k- space (See Col. 20, lines 1-24 of Kaditz).
With respect to claim 6, Kaditz discloses a method for generating magnetic resonance (See the abstract of Kaditz) images of a brain of a subject using multinuclear magnetic resonance imaging (See Col. 19, line 67 of Kaditz), the method comprising: performing a Na-nuclei (See Col. 41, lines 14-18 of Kaditz) pulse sequence module to acquire a portion of first set of MR data from the brain of the subject (See Col. 1, line 59- Col. 2, line 12 in view of Col. 19, line 67 of Kaditz); performing an H-nuclei pulse sequence module to acquire a portion of a second set of MR data from the brain of the subject (See Col. 49, line 57-Col. 50, line 6 in view of Col. 41, lines 8-27 and further in view of Col. 19, line 67 of Kaditz); repeating the performing of the Na-nuclei pulse sequence module and the H- nuclei pulse sequence module in an interleaved manner until acquisition of the first set of MR data and the second set of MR data are complete (See Col. 16, lines 42-57 of Kaditz); generating at least one Na-based image using the first set of MR data; generating at least one H-base image using the second set of MR data (See Col. 49, line 57-Col. 50, line 6 of Kaditz); and displaying one or more of the at least one Na-based image and the at least one H- based image (See Col. 11, lines 40-47 of Kaditz).
With respect to claim 7, Kaditz discloses the method according to claim 6, wherein the Na-nuclei pulse sequence module and the H-nuclei pulse sequence module are configured for diffusion MRI (See claim 9 of Kaditz).
With respect to claim 8, Kaditz discloses the method according to claim 7, wherein the Na-nuclei pulse sequence module is a Na density adapted gradient echo (DAR) pulse sequence module (See Col. 13, lines 40-47 of Kaditz).
With respect to claim 9, Kaditz discloses the method according to claim 7, wherein the H-nuclei pulse sequence module is a diffusion MRI pulse sequence module (See Col. 13, lines 59-67 of Kaditz).
With respect to claim 10, Kaditz discloses the method according to claim 6, wherein the Na-nuclei pulse sequence module is a Na density adapted gradient echo (DAR) pulse sequence module (See Col. 13, lines 40-47 of Kaditz).
With respect to claim 11, Kaditz discloses the method according to claim 6, wherein the H-nuclei pulse sequence module is a gradient echo EPI pulse sequence module (See Col. 13, lines 35-47 of Kaditz).
With respect to claim 14, Kaditz discloses the method according to claim 6, wherein one or more of the at least one Na- based image and the at least one H-based image on a display includes information related to epilepsy (See Col. 42, lines 50-55 of Kaditz).
With respect to claim 15, Kaditz discloses a method for generating magnetic resonance (See the abstract of Kaditz) images of a brain of a subject using multinuclear magnetic resonance imaging (See Col. 19, line 67 of Kaditz), the method comprising: performing a Na-nuclei (See Col. 41, lines 14-18 of Kaditz) pulse sequence module to acquire a portion of first set of MR data from the brain of the subject (See Col. 1, line 59- Col. 2, line 12 in view of Col. 19, line 67 of Kaditz); performing an H-nuclei pulse sequence module to acquire a portion of a second set of MR data from the brain of the subject (See Col. 49, line 57-Col. 50, line 6 in view of Col. 41, lines 8-27 and further in view of Col. 19, line 67 of Kaditz); wherein the H-nuclei pulse sequence module includes a preparation module (See Col. 27, lines 4-9 of Kaditz); repeating the performing of the Na-nuclei pulse sequence module and the H- nuclei pulse sequence module in an interleaved manner until acquisition of the first set of MR data and the second set of MR data are complete (See Col. 16, lines 42-57 of Kaditz); generating at least one Na-based image using the first set of MR data; generating at least one H-base image using the second set of MR data (See Col. 49, line 57-Col. 50, line 6 of Kaditz); and displaying one or more of the at least one Na-based image and the at least one H- based image (See Col. 11, lines 40-47 of Kaditz).
With respect to claim 16, Kaditz discloses the method according to claim 15, wherein the Na-nuclei pulse sequence module is a Na density adapted gradient echo (DAR) pulse sequence module (See Col. 13, lines 40-47 of Kaditz).
With respect to claim 17, Kaditz discloses the method according to claim 15, wherein the wherein the H-nuclei pulse sequence module is a Spin and Gradient Echo (SAGE) Echo Planar Imaging (EPI) pulse sequence module (See Col. 13, lines 40-47 of Kaditz).
With respect to claim 18, Kaditz discloses the method according to claim 17, wherein the preparation module is a chemical exchange saturation transfer (CEST) preparation module (See Col. 37, lines 10-15 of Kaditz).
With respect to claim 19, Kaditz discloses the method according to claim 15, wherein one or more of the at least one Na- based image and the at least one H-based image on a display includes information related to a brain tumor (See Col. 9, lines 53-60 of Kaditz).
With respect to claim 20, Kaditz discloses the method according to claim 15, wherein the at least one Na-based image includes a static sodium image and the at least one H-based image includes a pH- weighted image (See Col. 37, lines 36-50 of Kaditz) and an O2-weighted image (See Col. 37, lines 57-63 of Kaditz).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaditz as applied to claim 6 above, and further in view of Riederer et al. (US PUB 2015/0247910, hereinafter Riederer.
With respect to claim 12, Kaditz discloses the method according to claim 6, but fails to disclose wherein the Na-nuclei pulse sequence module and the H-nuclei pulse sequence module are configured for DSC perfusion MRI. However, Riederer does disclose wherein the Na-nuclei pulse sequence module and the H-nuclei pulse sequence module are configured for DSC perfusion MRI (See paragraph [0082] of Riederer). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method disclosed by Kaditz to include the method step disclosed by Riederer because it provides a high signal-to-noise ratio, allowing for better visualization of blood flow and other related hemodynamic parameters.
With respect to claim 13, Kaditz discloses the method according to claim 6, but fails to disclose wherein one or more of the at least one Na- based image and the at least one H-based image on a display includes information related to stroke. However, Riederer does disclose wherein one or more of the at least one Na- based image and the at least one H-based image on a display includes information related to stroke (See paragraph [0104] of Riederer). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method disclosed by Kaditz to include the method step disclosed by Riederer because it allows for life saving diagnostic and treatment protocols.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US .
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TEMILADE S RHODES-VIVOUR whose telephone number is (571)270-5814. The examiner can normally be reached M-F (flex schedule).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Huy Phan can be reached at 571-272-7924. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TEMILADE S RHODES-VIVOUR/ Examiner, Art Unit 2858
/HUY Q PHAN/Supervisory Patent Examiner, Art Unit 2858