DETAILED ACTION
This office action is in response to the communication received on November 24, 2025 concerning application No. 18/853,128 filed on September 30, 2024.
Claims 1, 3-8, and 10-15 are currently pending.
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
Applicant's arguments filed 11/24/2025 regarding the objection to the specification have been fully considered. The amendments to the abstract have been entered and overcome the objection to the specification previously set forth.
Applicant's arguments filed 11/24/2025 regarding the claim interpretation have been fully considered. The amendments to the claims have been entered and overcome the claim interpretation under 35 USC 112f previously set forth.
Applicant's arguments filed 11/24/2025 regarding the rejection under 35 USC 112 have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 112b rejection of claim 7 previously set forth. Examiner notes that the claim amendments have led to further 35 USC 112 issues.
Applicant's arguments filed 11/24/2025 regarding the 35 USC 101 rejection have been fully considered but they are not persuasive. In response to applicant’s arguments that amending the claims to include a step of obtaining a nuclear magnetic resonance signal of hepatocellular carcinoma tissue overcome the 35 USC 101 rejection, examiner respectfully disagrees. Adding the step of obtaining a nuclear magnetic resonance signal of hepatocellular carcinoma tissue is a step that does not integrate the judicial exception into a practical application because it amounts to data gathering recited at a high level of generality. Additionally the element does not amount to significantly more than the judicial exception. Therefore the limitation does not pass steps 2A prong two and step 2B, making the claim not eligible subject matter under 35 USC 101. Please see the 35 USC 101 rejection below for further details.
Applicant’s arguments with respect to claim(s) 1-11 regarding the prior art rejection, specifically the reliance of the rejection on the Zhou reference have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Zhou reference is no longer being relied upon for rejecting the claims.
Claim Objections
Claims 14-15 are objected to because of the following informalities:
Claim 14, line 2, “said instruction” should read “said instructions”,
Claim 15, line 2, “said instruction” should read “said instructions”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 14-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 14 recites the limitation, “said instruction further comprises a user input of said reference value”, which is not described in the specification in such a way as to reasonably convey that the inventor had possession of the limitation as the time the application was filed. No where in the specification could it be found that discloses the reference value is input by a user. For at least that reason the limitation is considered new matter.
Claim 15 recites the limitation “said instruction further comprises machine learning step to allow adjustment or refinement of said reference value based on a set of database”, which is not described in the specification in such a way as to reasonably convey that the inventor had possession of the limitation as the time the application was filed. No where in the specification could it be found that discloses a machine learning step to allow adjustment or refinement of said reference value based on a set of database. For at least that reason the limitation is considered new matter.
Claims 6-7, 10, and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “about” in claims 6 and 12 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear to the examiner how close the reference value needs to be to 5% or 15% in order to be considered about 5% to about 15%.
Claim 10 recites the limitation "the hepatocellular carcinoma tissue" in line 3. There is insufficient antecedent basis for this limitation in the claim. The claim does not previously recite a hepatocellular carcinoma tissue.
Claim 10 recites the limitation "the nuclear magnetic resonance signal" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. The claim does not previously recite a nuclear magnetic resonance signal.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
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 1, 3-8, and 10-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract without significantly more:
Claim 1 recites “determining susceptibility of hepatocellular carcinoma to an immune checkpoint inhibitor, comprising a step of:…determining a fat fraction in said hepatocellular carcinoma tissue using said MR signal, wherein hepatocellular carcinoma tissue having a fat fraction equal to or higher than a reference value is an indication hepatocellular carcinoma is susceptible to or has high susceptibility to an immune checkpoint inhibitor”.
The limitation of determining susceptibility of hepatocellular carcinoma to an immune checkpoint inhibitor, is a process, that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “determining” in the context of the claim encompasses a user observing an MR image and measuring the total number of fat cells compared to non-fat cells and further determining whether the patient is susceptible to the immune checkpoint inhibitor based on whether the fat fraction is equal to or higher than a reference value. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The judicial exception is not integrated into a practical application. The additional step of claim 1 is an obtaining step. The obtaining of a nuclear magnetic resonance signal of hepatocellular carcinoma tissue amounts to data gathering recited at a high level of generality which is required to obtain the input data for the determining of a fat fraction step. Accordingly,
the additional element does 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 an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The obtaining of the nuclear magnetic resonance signal of hepatocellular carcinoma has been determined to be well-understood, routine, and conventional activity in the field, as evidenced by, pg. 16 of the present applications specification discloses, “Any known method may be used as an obtainment method for the image from the liver cancer tissue or the signal for displaying the image, and examples thereof include abdominal MRI”. For these reasons, the additional step does not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Claim 3 further limits the MR signal by providing an example of the type of signal being obtained. The claim does not recite any additional elements.
Claim 4 further limits the fat fraction calculation by providing an example protocol for calculating the fat fraction. The claim does not recite any additional elements.
Claim 5 further recites the comparing of the fat fraction to the reference value is performed using a central processing unit. The limitation of comparing the fat fraction to the reference value, is a process, that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of a generic computer component. That is, other than reciting “a central processor unit”, nothing in the claim element precludes the step from practically being performed in the mind.
Claims 6-7 further limit the comparing step by providing examples of the reference value. The claims do not recite any additional elements.
Claim 8 further limits the testing step by providing examples of the immune checkpoint inhibitors. The claim does not recite any additional elements.
Claims 10 and 11 recite, “testing susceptibility of hepatocellular carcinoma to an immune checkpoint inhibitor, comprising…calculate(ing) a fat fraction in the hepatocellular carcinoma tissue from intensities of a water signal and a fat signal each resolved from the nuclear magnetic resonance signal having been detected from the hepatocellular carcinoma tissue and output(ting) a susceptibility level to the immune checkpoint inhibitor based on comparison between the calculated fat fraction and a reference value”.
The limitation of testing susceptibility of hepatocellular carcinoma to an immune checkpoint inhibitor, is a process, that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of a generic computer component. That is, other than reciting “a central processing unit” in claim 10 and “a non-transitory computer-readable medium” in claim 11, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the ”central processing unit” and “non-transitory computer-readable medium” language, “testing” in the context of the claim encompasses a user either mentally or by hand analyzing a water signal and a fat signal and using the values to determine a fat fraction as outlined on pgs. 18-19 of the present applications specification. The user will then wither mentally or by hand compare the fat fraction to a reference value to test whether the hepatocellular carcinoma is susceptible to an immune checkpoint inhibitor. If a claim, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. The claims do not include additional elements other than the judicial exception.
Claims 12-13 further limit the comparing step by providing examples of the reference value. The claims do not recite any additional elements.
Claim 14 recites the additional element of the reference value being input by a user, which is a process, that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, a user can mentally think of a reference value to be used for the comparison.
Claim 15 recites the additional element of using a machine learning step to adjust the reference value, which is a process, that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of a generic computer component. That is, other than reciting “machine learning”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “machine learning” language, “adjustment” encompasses a user mentally modifying the reference value to be used for the comparison.
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.
Claim(s) 1, 3-8, and 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nomura et el. (JP2021012102A, hereinafter Nomura) in view of Tang et al. (“Nonalcoholic Fatty liver Disease: MR Imaging of Liver Proton Density Fat Fraction to Assess Hepatic Steatosis”, hereinafter Tang).
Regarding claim 1, Nomura teaches a method of determining susceptibility of hepatocellular carcinoma to an immune checkpoint inhibitor (pg. 1, “a method for determining the responsiveness of cancer patients to immune checkpoint inhibitors”. Pg. 3, para. 2 discloses the cancer is hepatocellular carcinoma), comprising a step of:
determining a fat fraction in said hepatocellular carcinoma tissue (pg. 5, para. 2, “the level of at least one short chain fatty acid in a sample taken from the cancer patient is measured”. Pg. 3, para. 6 discloses the level of short chain fatty acid means the amount of short chain fatty acids contained within a sample and is expressed as a ratio, which corresponds to a fraction. Pg. 3, para. 4 further discloses the sample in which the level of short chain fatty acid is determined is a biopsy tissue sample from the cancer (hepatocellular carcinoma) tissue),
wherein hepatocellular carcinoma tissue having a fat fraction equal to or higher than a reference value is an indication hepatocellular carcinoma is susceptible to or has high susceptibility to an immune checkpoint inhibitor (pg. 4, para. 2, “a patient may be determined to be responsive to an immune checkpoint inhibitor if the patient's level of short chain fatty acids is greater than or equal to the cutoff value for the level of short chain fatty acids”).
Nomura does not specifically teach obtaining a nuclear magnetic resonance (MR) signal of hepatocellular carcinoma tissue; analyzing said MR signal; and determining a fat fraction in said hepatocellular carcinoma tissue using said MR signal.
However,
Tang in a similar field of endeavor teaches obtaining a nuclear magnetic resonance (MR) signal of liver tissue (pg. 424, “MR Imaging Examination” discloses obtaining MR images of the patient liver);
analyzing said MR signal (pg. 424, “MR Imaging Examination” and “MR imaging Post Processing” disclose processing the MR images); and
determining a fat fraction in said liver tissue using said MR signal (pg. 424, “MR imaging Post Processing” discloses generating MR imaging-PDFF (proton density fat fraction) from the MR source images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention modify the method of Nomura to have obtained a nuclear magnetic resonance (MR) signal of hepatocellular carcinoma tissue; analyzed said MR signal; and determined a fat fraction in said hepatocellular carcinoma tissue using said MR signal in order to generate the fat fraction noninvasively, thereby increasing efficiency and reducing potential complications, as recognized by Tang (pg. 423).
Regarding claim 3, Nomura in view of Tang teaches the method of claim 1, as set forth above. Tang further teaches the MR signal is a signal for chemical-shift imaging (pg. 429, “Discussion” subsection discloses “chemical shift-based MR technique…accurately quantifies fat in vivo in an animal model”).
Regarding claim 4, Nomura in view of Tang teaches the method of claim 3, as set forth above. Tang further teaches the fat fraction is calculated using intensities of a water signal and a fat signal each resolved from the MR signal (pg. 424, “MR Imaging Examination” and “MR imaging Post Processing” disclose determining the fat fraction as the ratio of the fat proton density to the total (fat + water) proton density, where the fat-water signal was obtained from the MR imaging).
Regarding claim 5, Nomura in view of Tang teaches the method of claim 4, as set forth above. Nomura further teaches a step of comparing the fat fraction with a reference value using a central processor unit (pg. 4, para. 2 discloses comparing the level of fat to a preset (reference) cutoff value. Pgs. 4, paras. 3 and 5 disclose using software for processing the level of fat which requires the use of a central processor).
Regarding claim 6, Nomura in view of Tang teaches the method of claim 1, as set forth above. Nomura further teaches the reference value is set according to the factors of the procedure (pg. 4, para. 7-pg. 5, para. 1, disclose examples cutoff values and that “The cutoff value is not limited to these values, and is appropriately set according to factors such as the purpose of diagnosis, patient characteristics, cancer type, stage, sample type, and immune checkpoint inhibitor type”).
Nomura in view of Tang does not specifically teach the reference value for the fat fraction is from about 5% to about 15%. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the method of Nomura in view of Tang to have a reference value for the fat fraction range from about 5% to 15%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller , 105 USPQ 233 (See MPEP 2144.05 II). In the instant case, the method Nomura in view of Tang would not operate differently with the claimed reference value since the method is intended to compare the fat fraction to a reference value and would function appropriately having the claimed reference value range. Further, the application places no criticality on the specific reference value range, indicating that, “The reference value by which the susceptibility level is determined as a level of having high susceptibility to the immune checkpoint inhibitor or having susceptibility thereto may be, for example, a value selected from the range of 1% or more and 40% or less, for example, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%,9%, 10%, 11%, 12%, 13%, 14%, 15%, 17%, 20%, 25%, 30%, or 40%”, meaning there could be other applications where the reference value is more or less (specification, [0032]).
Regarding claim 7, Nomura in view of Tang teaches the method of claim 6, as set forth above. Nomura further teaches the reference value is set according to the factors of the procedure (pg. 4, para. 7-pg. 5, para. 1, disclose examples cutoff values and that “The cutoff value is not limited to these values, and is appropriately set according to factors such as the purpose of diagnosis, patient characteristics, cancer type, stage, sample type, and immune checkpoint inhibitor type”).
Nomura in view of Tang does not specifically teach the reference value for the fat fraction is 10%. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the method of Nomura in view of Tang to have a reference value for the fat fraction range from about 10%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller , 105 USPQ 233 (See MPEP 2144.05 II). In the instant case, the method Nomura in view of Tang would not operate differently with the claimed reference value since the method is intended to compare the fat fraction to a reference value and would function appropriately having the claimed reference value. Further, the application places no criticality on the specific reference value, indicating that, “The reference value by which the susceptibility level is determined as a level of having high susceptibility to the immune checkpoint inhibitor or having susceptibility thereto may be, for example, a value selected from the range of 1% or more and 40% or less, for example, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%,9%, 10%, 11%, 12%, 13%, 14%, 15%, 17%, 20%, 25%, 30%, or 40%”, meaning there could be other applications where the reference value is more or less (specification, [0032]).
Regarding claim 8, Nomura in view of Tang teaches the method of claim 1, as set forth above. Nomura further teaches the immune checkpoint inhibitor is an anti-PD-L1 antibody or an anti PD-1 antibody (pg. 2, para. 4, discloses the immune checkpoint inhibitor is an anti-PD-L1 antibody or anti PD-1 antibody).
Regarding claim 10, Nomura teaches an apparatus for testing susceptibility of hepatocellular carcinoma to an immune checkpoint inhibitor (pg. 1, “a method for determining the responsiveness of cancer patients to immune checkpoint inhibitors”. Pg. 3, para. 2 discloses the cancer is hepatocellular carcinoma. Pg. 4, paras. 3 and 5 disclose the use of software which require the use of a computer which is considered the apparatus), comprising:
a fat fraction calculation unit comprising a central processor unit (Pgs. 4, paras. 3 and 5 disclose using software for processing the level of fat which requires the use of a central processor) configured to
calculate a fat fraction in the hepatocellular carcinoma tissue (pg. 5, para. 2, “the level of at least one short chain fatty acid in a sample taken from the cancer patient is measured”. Pg. 3, para. 6 discloses the level of short chain fatty acid means the amount of short chain fatty acids contained within a sample and is expressed as a ratio, which corresponds to a fraction. Pg. 3, para. 4 further discloses the sample in which the level of short chain fatty acid is determined is a biopsy tissue sample from the cancer (hepatocellular carcinoma) tissue),
an output unit comprising said central processor unit or a second central processor unit (Pgs. 4, paras. 3 and 5 disclose using software for processing the level of fat which requires the use of a central processor) configured to output a susceptibility level to the immune checkpoint inhibitor based on a comparison between the calculated fat fraction and a reference value (pg. 4, para. 2, “a patient may be determined to be responsive to an immune checkpoint inhibitor if the patient's level of short chain fatty acids is greater than or equal to the cutoff value for the level of short chain fatty acids”. The determined responsiveness is considered the output susceptibility level).
Nomura does not specifically teach calculating the fat fraction from intensities of water signal and a fat signal each resolved from the nuclear magnetic resonance (MR) signal having been detected from the hepatocellular carcinoma tissue.
However,
Tang in a similar field of endeavor teaches obtaining a nuclear magnetic resonance (MR) signal of liver tissue (pg. 424, “MR Imaging Examination” discloses obtaining MR images of the patient liver) and calculating a fat fraction in said liver tissue from intensities of water signal and a fat signal each resolved from the MR signal (pg. 424, “MR imaging Post Processing” discloses generating MR imaging-PDFF (proton density fat fraction) from the MR source images. pg. 424, “MR Imaging Examination” and “MR imaging Post Processing” disclose determining the fat fraction as the ratio of the fat proton density to the total (fat + water) proton density, where the fat-water signal was obtained from the MR imaging).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention modify the apparatus of Nomura to have calculated the fat fraction from intensities of water signal and a fat signal each resolved from the nuclear magnetic resonance (MR) signal having been detected from the hepatocellular carcinoma tissue in order to generate the fat fraction noninvasively, thereby increasing efficiency and reducing potential complications, as recognized by Tang (pg. 423).
Regarding claim 11, Nomura teaches an a non-transitory computer-readable medium for determining susceptibility of hepatocellular carcinoma to an immune checkpoint inhibitor (pg. 1, “a method for determining the responsiveness of cancer patients to immune checkpoint inhibitors”. Pg. 3, para. 2 discloses the cancer is hepatocellular carcinoma. Pg. 4, paras. 3 and 5 disclose the use of software which requires instructions and is therefore considered a non-transitory computer-readable medium), comprising the following instructions:
calculating a fat fraction in a hepatocellular carcinoma tissue (pg. 5, para. 2, “the level of at least one short chain fatty acid in a sample taken from the cancer patient is measured”. Pg. 3, para. 6 discloses the level of short chain fatty acid means the amount of short chain fatty acids contained within a sample and is expressed as a ratio, which corresponds to a fraction. Pg. 3, para. 4 further discloses the sample in which the level of short chain fatty acid is determined is a biopsy tissue sample from the cancer (hepatocellular carcinoma) tissue), and
outputting a susceptibility level to the immune checkpoint inhibitor based on a comparison between the calculated fat fraction and a reference value (pg. 4, para. 2, “a patient may be determined to be responsive to an immune checkpoint inhibitor if the patient's level of short chain fatty acids is greater than or equal to the cutoff value for the level of short chain fatty acids”. The determined responsiveness is considered the output susceptibility level).
Nomura does not specifically teach calculating the fat fraction from intensities of a water signal and a fat signal each resolved from the nuclear magnetic resonance (MR) signal having been detected from the hepatocellular carcinoma tissue.
However,
Tang in a similar field of endeavor teaches obtaining a nuclear magnetic resonance (MR) signal of liver tissue (pg. 424, “MR Imaging Examination” discloses obtaining MR images of the patient liver) and calculating a fat fraction in said liver tissue from intensities of water signal and a fat signal each resolved from the MR signal (pg. 424, “MR imaging Post Processing” discloses generating MR imaging-PDFF (proton density fat fraction) from the MR source images. pg. 424, “MR Imaging Examination” and “MR imaging Post Processing” disclose determining the fat fraction as the ratio of the fat proton density to the total (fat + water) proton density, where the fat-water signal was obtained from the MR imaging).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention modify the instructions of Nomura to have calculated the fat fraction from intensities of water signal and a fat signal each resolved from the nuclear magnetic resonance (MR) signal having been detected from the hepatocellular carcinoma tissue in order to generate the fat fraction noninvasively, thereby increasing efficiency and reducing potential complications, as recognized by Tang (pg. 423).
Regarding claim 12, Nomura in view of Tang teaches the non-transitory computer-readable medium of claim 11, as set forth above. Nomura further teaches the reference value is set according to the factors of the procedure (pg. 4, para. 7-pg. 5, para. 1, disclose examples cutoff values and that “The cutoff value is not limited to these values, and is appropriately set according to factors such as the purpose of diagnosis, patient characteristics, cancer type, stage, sample type, and immune checkpoint inhibitor type”).
Nomura in view of Tang does not specifically teach the reference value for the fat fraction is from about 5% to about 15%. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the method of Nomura in view of Tang to have a reference value for the fat fraction range from about 5% to 15%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller , 105 USPQ 233 (See MPEP 2144.05 II). In the instant case, the method Nomura in view of Tang would not operate differently with the claimed reference value since the method is intended to compare the fat fraction to a reference value and would function appropriately having the claimed reference value range. Further, the application places no criticality on the specific reference value range, indicating that, “The reference value by which the susceptibility level is determined as a level of having high susceptibility to the immune checkpoint inhibitor or having susceptibility thereto may be, for example, a value selected from the range of 1% or more and 40% or less, for example, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%,9%, 10%, 11%, 12%, 13%, 14%, 15%, 17%, 20%, 25%, 30%, or 40%”, meaning there could be other applications where the reference value is more or less (specification, [0032]).
Regarding claim 13, Nomura in view of Tang teaches the non-transitory computer-readable medium of claim 11, as set forth above. Nomura further teaches the reference value is set according to the factors of the procedure (pg. 4, para. 7-pg. 5, para. 1, disclose examples cutoff values and that “The cutoff value is not limited to these values, and is appropriately set according to factors such as the purpose of diagnosis, patient characteristics, cancer type, stage, sample type, and immune checkpoint inhibitor type”).
Nomura in view of Tang does not specifically teach the reference value for the fat fraction is 10%. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the method of Nomura in view of Tang to have a reference value for the fat fraction range from about 10%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller , 105 USPQ 233 (See MPEP 2144.05 II). In the instant case, the method Nomura in view of Tang would not operate differently with the claimed reference value since the method is intended to compare the fat fraction to a reference value and would function appropriately having the claimed reference value. Further, the application places no criticality on the specific reference value, indicating that, “The reference value by which the susceptibility level is determined as a level of having high susceptibility to the immune checkpoint inhibitor or having susceptibility thereto may be, for example, a value selected from the range of 1% or more and 40% or less, for example, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%,9%, 10%, 11%, 12%, 13%, 14%, 15%, 17%, 20%, 25%, 30%, or 40%”, meaning there could be other applications where the reference value is more or less (specification, [0032]).
Regarding claim 14, Nomura in view of Tang teaches the non-transitory computer-readable medium of claim 11, as set forth above. Nomura further teaches said instruction further comprises a user input of said reference value (pg. 5, para. 1 discloses basing the cutoff on the immune checkpoint inhibitor. Pg. 6, para. 1, discloses a person skilled in the art (user) sets the immune checkpoint inhibitor and dose. Since the user is setting the immune checkpoint inhibitor they are also setting the cutoff because the cutoff is based on the immune checkpoint inhibitor used).
Regarding claim 15, Nomura in view of Tang teaches the non-transitory computer-readable medium of claim 11, as set forth above. Nomura further teaches said instruction further comprises machine learning step to allow adjustment or refinement of said reference value based on a set of database (pg. 4, para. 3 discloses the use of software (machine learning) for setting the cutoff value based on the characteristics (database) of the patient group).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office 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 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.
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798
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