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 .
Response to Arguments
The amendment, filed 08/06/2025, has been entered. The examiner notes claims 26-34 and 36-47 are pending.
Response to Arguments
There are new claim objections in view of the amendment.
Applicant’s arguments, see Remarks page 8, filed 08/06/2025, with respect to the objection to the drawings have been fully considered and are persuasive. The examiner agrees that Figure 5 shows the MRI scanner. The objection to the drawings has been withdrawn.
Applicant’s arguments, see Remarks page 8, filed 08/06/2025, with respect to the objection to the specification have been fully considered and are persuasive. The applicant has amended the abstract to have the required length. The objection to the specification has been withdrawn.
Applicant's arguments, see Remarks pages 8-12, filed 08/06/2025, with respect to the 35 USC 101 rejection of claims 26-34 and 36-46 have been fully considered but they are not persuasive.
In response to the applicant’s argument that “administering a treatment” is not a mental process, the examiner respectfully disagrees. The examiner recognizes that there appears to be a misinterpretation by the applicant of the examiner’s use of the word “produce”. While the examiner concedes that one definition of “produce” does mean to create or make, this logically does not make sense in the context of the rejection as, even if it were possible for a human to produce acetaminophen, this would be a physical/chemical process. The examiner contends that the use of the word “produce” uses the definition of to show or provide something. For example, the sentence “I produced a wallet from my pocket,” is best understood in that a wallet has not been created from within a pocket, but rather brought out of the pocket. The examiner maintains that “administering a treatment” is indeed a mental process and that the example provided in the previous office action is just one example of numerous examples of “administering a treatment” as a mental process (i.e., phycological and behavioral therapies). Furthermore, in an effort to conduct compact prosecution, the examiner notes that the “administering a treatment” could also be considered an “insignificant extra-solution activity” as the treatment is performed prior to the data gathering, processing, and output steps disclosed in the claims. The examiner maintains that the practical application/treatment route of overcoming 101 needs to be a treatment in response to the abstract idea.
In response to the applicant’s argument that the step of “performing a scan of a region” is not a mental process, the examiner respectfully disagrees. The applicant asserts that the examiner’s example is merely observing external features. However, the examiner notes that the example of “performing a scan” given in the previous rejection is only one example of “performing a scan” as a mental process. To clarify, “performing a scan” can be on internal and/or external regions of a patient. In addition to the external example provided in the previous office action, the human mind is capable of performing a scan on an internal region of the human body, either by surgical intervention or by examination means (such as a laryngoscopy). The additional element of performing the method via an MRI scanner fails step 2B of the Alice/Mayo framework, as an MRI scanner is a well-understood, routine, and conventional means for data-gathering (as recognized by Miyazaki, see 35 USC 101 rejection below).
In response to the applicant’s argument that “generating an image” is not a mere data gathering step, the examiner respectfully disagrees. The applicant argues that generating the image using a qCEST sequence cannot be considered mere data gathering. The examiner contends that, regardless of the means used to create said image, the generation/creation of an image is by definition gathering data into a visual representation (i.e., an image).
In response to the applicant’s argument that in a parent application, a previous 35 USC 101 rejection was withdrawn and the claims found patent eligible (by a different examiner), the examiner notes that each case has to be examined on its own merits. The examiner has interpreted the claims to the best of his ability while being as fair as possible to the applicant. However, the examiner believes the 35 USC 101 rejection is valid for the reasons provided above.
Therefore, the 35 USC 101 rejection of claims 26-34 and 36-46 is maintained.
Applicant’s arguments, see Remarks page 12, filed 08/06/2025, with respect to the 35 USC 112 rejection of claim 46 have been fully considered and are persuasive. The amendment resolves the 35 USC 112 rejection. The 35 USC 112 rejection of claim 46 has been withdrawn.
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.
Claims 26-34 and 36-47 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claim 26 recites:
A method for treating a subject diagnosed with a condition, comprising:
administering a treatment to a subject diagnosed with a condition, wherein the subject was diagnosed with the condition by a method comprising:
performing a scan of a region of the subject's body using a magnetic resonance imaging (MRI) scanner;
generating an image of the region of the subject's body from the performed scan using a quantitative chemical exchange saturation transfer (qCEST) sequence;
processing the image to detect one or more physiological biomarkers within the image of the region,
wherein the physiological biomarkers comprise a labile proton exchange rate (ksw) between a solute pool and a water pool; and
determining that the subject has the condition if the labile proton exchange rate is increased relative to a reference value,
wherein the increased labile proton exchange rate is greater than 200 exchanges/second.
Step 1:
After applying the Alice/Mayo test to the claims, the examiner finds during step 1 that claim 26 is drawn to a method.
Step 2A Prong 1:
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of administering, performing, generating, processing, and determining recite mental processes and mathematical concepts (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations).
The step of “administering a treatment” in independent Claim 26 is a mental process capable of being performed by the human mind. For example, the human mind may determine that a patient suffering from mild headaches should be treated with acetaminophen, thereby instructing the body to produce acetaminophen for the patient to aid them. The step of “performing a scan of a region” in independent Claim 26 is a mental process capable of being performed by the human mind. For example, the human mind is capable of observing a region of a patient to observe imperfections such as cuts, scrapes, burns, etc. The step of “generating an image” in independent claim 26 is a mere data gathering step using a computational device. The step of “processing the image” is a mathematical calculation to retrieve, transform, and/or classify information into a more “usable” form. The step of “determining that the subject has the condition” in independent claim 26 is a mathematical process of drawing correlations from data for the purpose of selecting, identifying, and defining the data needed for a specific purpose, project, or analysis.
The claimed steps of administering, performing, generating, processing, and determining can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for estimation that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind,
Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind,
University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims 27-34 and 36-47, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Step 2A Prong 2 and Step 2B:
This judicial exception (abstract idea) in Claims 26-34 and 36-47 is not integrated into a practical application because:
• The abstract idea amounts to simply implementing the abstract idea on a computing device. For example, the recitations regarding the generic computing components for administering, performing, generating, processing, and determining merely invoke a computer as a tool.
• The data-gathering step (generating) and the data-output step do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
• There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computing device that is used as a tool for administering, performing, generating, processing, and determining.
• The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to estimate bio-information.
• The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computing device for administering, performing, generating, processing, and determining. The claims do not apply the obtained prediction to a particular machine. Rather, the data is merely output in a post-solution step.
The additional elements are identified as follows: magnetic resonance imaging (MRI) scanner and body array coils.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
• Miyazaki (US 20140361776 A1) which discloses “Conventional magnetic resonance imaging includes methods referred to as MTC (Magnetization Transfer Contrast) effects and CEST (Chemical Exchange Saturation Transfer)” (see Miyazaki par. 0003);
• Peacock, III (US 20110087087 A1) which discloses “Conventional MRI systems use multi-channel acquisition coils for spine detectors…” (see Peacock, III para. 0226);
• Applicant’s Background in the specification; and
• The non-patent literature of record in the application.
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HANEY/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791