DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in reply to a request for continued examination (“RCE”) filed 3 December 2025, on an application filed 18 August 2023, which claims foreign priority to an application filed 22 August 2022.
Claims 1, 6, 15-17 and 19 have been amended.
Claims 1 and 3-19 are currently pending and have been examined.
The prior art rejection of claims 17 and 19 have been removed as the claims present novel material.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3 December 2025 has been entered.
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 and 3-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1 and 3-19 are within the four statutory categories. Claims 1, 3-14 and 17-19 are drawn to a medical information processing device, which is within the four statutory categories (i.e. machine). Claim 15 is drawn to a medical information processing method, which is within the four statutory categories (i.e. process). Claim 16 is drawn to a non-transitory computer readable medium storing a computer program, which is within the four statutory categories (i.e. manufacture).
Prong 1 of Step 2A
Claim 1 recites: A medical information processing device comprising processing circuitry configured to
receive a selection by an operator of a therapeutic technique for cell therapy based on an output of an input interface in response to an operation input by the operator,
acquire medical treatment data about a patient via a network from a further device communicatively connected to the medical information processing device via the network,
determine whether the medical treatment data includes information on a cause of damage to a site of the patient and, when the medical treatment data includes the information on the cause, perform a support process for the cell therapy,
wherein the support process includes
specifying an area where the damage is present in a medical image including the site, the specifying including calculating a volume of the area,
identifying a tissue structure of the area where the damage is present,
determining a type of cells included in the identified tissue structure as a cell type for the cell therapy for the damage to the site,
determining an amount of cells for the cell therapy for the damage to the site on a basis of the acquired information on the cause and the volume of the specified area where the damage is present, wherein the cells for the cell therapy have the determined cell type, and
displaying, on a display, the determined type and amount of cells for the selected therapeutic technique.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite a process of managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case the steps of acquiring information, determining damage and an amount of cells to use for cell therapy), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea(s) are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for claims 15 and 16 are identical as the abstract idea for claims 1, because the only difference between claims 1, 15, and 16 is that claim 1 recites a device, whereas claim 15 recites a method and claim 16 recites a computer program product.
Dependent claims 3-14 and 17-19 include other limitations, for example claims 3, 7, 12, 13 further describe the cells or damage, claims 4-6, 9-11 and 14 further indicates treatment of the patient, claim 8 discloses a patient interview and claims 17-19 further describe the supplementary information and the viability rate, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Additionally, any limitations in dependent claims 3-14 and 17-19 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claims 3-14 and 17-19 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 15 and 16.
Prong 2 of Step 2A
Claims 1, 15 and 16 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the structural components of the computer, which amounts to merely invoking a computer as a tool to perform the abstract idea, see MPEP 2106.05(f).
Additionally, dependent claims 3-14 and 17-19 include other limitations, but these limitations also amount to no more than amount to mere instructions to apply the exception (e.g. description of medicine or various treatments of claims 4-6, 9-11 and 14), and/or do not include any additional elements beyond those already recited in independent claims 1, 15 and 16, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claims 1, 15 and 16 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the dispensing device and the one or more processors), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the insignificant extra-solution activity comprises limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs 20-23 of the Specification discloses that the additional elements (i.e. processing circuitry) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receive and process data ) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare).
Dependent claims 3-14 and 17-19 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1, 15 and 16, and/or the additional elements recited in the aforementioned dependent claims similarly amount to mere instructions to apply the exception (e.g. description of medicine or various treatments of claims 4-6, 9-11 and 14), and hence do not amount to “significantly more” than the abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1 and 3-19 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Appropriate correction is required.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 15 and 16 are rejected under 35 U.S.C. 103 as being obvious over Nathan et al. (U.S. PG-Pub 2011/0087110 A1), hereinafter Nathan, in view of West (U.S. PG-Pub 2004/0091936 A1), hereinafter West, further in view of Carreel et al. (U.S. PG-Pub 2024/0299052 A1), hereinafter Carreel.
As per claims 1, 3, 15 and 16, Nathan discloses a non-transitory computer readable medium storing a computer program including a computer program product comprising instructions, a medical information processing method performed by a medical information processing device and medical information processing device comprising processing circuitry (Nathan, Figs. 1 and 2, and paragraph 78.) configured to
acquire medical treatment data about a patient via a network from a further device communicatively connected to the medical information processing device via the network (Nathan, Fig. 1 step B, system identifies and calculates the mass of infarct or peri-infarct tissue using a medical image that includes the site of damage to the patient. The cause of damage is the infarct or per-infarct tissue, see also paragraph 25. Information acquired for medical treatment would comprise medical treatment data. Paragraphs 36 and 78 disclose acquiring information over a network.), and
… when the medical treatment data includes the information on the cause, perform a support process for the cell therapy (Nathan, Fig. 1 step B, system identifies and calculates the mass of infarct or peri-infarct tissue using a medical image that includes the site of damage to the patient. The cause of damage is the infarct or per-infarct tissue, see also paragraph 25.), wherein the support process includes
specifying an area where the damage is present in a medical image including the site, the specifying including calculating a volume of the area (Nathan, Fig. 1 step B, system identifies and calculates the mass and volume of infarct or peri-infarct tissue using a medical image that includes the site of damage to the patient, see also paragraphs 25 and 26),
identifying a tissue structure of the area where the damage is present (Nathan, Fig. 1 step B, system identifies tissue as infarct or peri-infarct tissue using a medical image that includes the site of damage to the patient, see also paragraphs 25 and 66.),
determining a type … for the cell therapy for the damage to the site (Nathan determines a therapy based on the identified tissue structure of the area, see paragraph 66-67.),
determining an amount of cells for the cell therapy for the damage to the site on a basis of the acquired information on the cause and the volume of the specified area where the damage is present (Nathan, Fig. 1 step C calculates the amount of stem cells to delivery to the identified cardiac tissue based on the identified infarct or per-infarct tissue and the corresponding calculated volume thereof, see also paragraphs 27 and 66-68.);
3. wherein the site includes a myocardium (Nathan, Fig. 1 Step A.).
Nathan fails to explicitly disclose:
receive a selection by an operator of a therapeutic technique for cell therapy based on an output of an input interface in response to an operation input by the operator,
determine whether the medical treatment data includes information on a cause of damage to a site of the patient,
determine a type of cells included in the identified tissue structure as a cell type …, and wherein the cells for the cell therapy have the determined cell type, and
displaying, on a display, the determined type and amount of cells for the selected therapeutic technique.
West teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide wherein the cells for the cell therapy have the determined cell type (West, paragraph 117 discloses identifying the type of cells needed for transplant based on the cells needed to be transplanted.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of calculation of the amount of stem cells needed to treat an injury of Nathan to include determination of treatment type cells based on cells to be treated, as disclosed by West, because to do so would result in a method of calculation of the amount of stem cells needed to treat an injury that considers the cells to be treated when providing a treatment.
Neither Nathan nor West disclose:
receiving a selection by an operator of a treatment based on an output of an input interface,
determining whether acquired data includes information on damage to a patient,
determining a type of cells included in the identified tissue structure as a cell type …, and
displaying output data corresponding to treatment.
Carreel teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide
receiving a selection by an operator of a treatment based on an output of an input interface (Carreel discloses an operator selecting a treatment, see paragraphs 196 and 230.),
determining whether acquired data includes information on damage to a patient (Carreel, paragraphs 193 and 194.),
determining a type of cells included in the identified tissue structure as a cell type (Carreel discloses identification of cell type, see paragraphs 149 and 194 at least.), and
displaying output data corresponding to treatment (Carreel, paragraph 431.), in order to provide a treatment system that interacts with a user to improve patient outcomes.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of calculation of the amount of stem cells needed to treat an injury of Nathan/West to include receiving a selection by an operator of a treatment based on an output of an input interface, determining whether acquired data includes information on damage to a patient, determining a type of cells included in the identified tissue structure as a cell type …, and displaying output data corresponding to treatment, as disclosed by Carreel, because to do so would result in a method of calculation of the amount of stem cells needed to treat an injury that provides a treatment system that interacts with a user to improve patient outcomes.
Nathan, West and Carreel are all directed to the electronic processing of patient healthcare data and specifically to the use of therapy techniques that consider cellular conditions to treat a patient. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Regarding claim 1, as set forth in Schulhauser, a method claim that includes a conditional step can be thought of as covering two methods - one method where the condition for the step is met and the step is performed, and the second method where the condition is not met and the step is not performed. See Schulhauser, 2016 WL 6277792, at *4. The broadest reasonable interpretation of such a claim encompasses the method where only the non-conditional steps are performed (i.e., this occurs when the condition is not met). See id. at *3-4. Furthermore, Schulhauser determines that if a method's conditional step does not need to be performed, it does not need to be shown to invalidate the method claim. Id. at *4. Accordingly, claim 1 does not require all of the limitations pursuant to when the medical treatment data includes the information on the cause, perform a support process for the cell therapy, wherein the support process includes … .
Appropriate correction is required.
Claims 12, 13 and 18 are rejected under 35 U.S.C. 103 as being obvious over Nathan/West/Carreel further in view of Hubel (U.S. Patent 7,112,576 B1), hereinafter Hubel.
As per claims 12, 13 and 18, Nathan/West/Carreel discloses claim 1, discussed above. Nathan also discloses:
12. acquire information on a … cells to be provided for the cell therapy to the site, and correct the amount of cells for the cell therapy (Nathan determines the needed amount of cells for a given therapy based on the relevant cell information, see Fig. 1, step D, and paragraphs 27 and 66-68.); and
13. acquire information on … cells to be provided for the cell therapy to the site in a culturing phase, and correct the amount of cells for the cell therapy according to the survival rate in the culturing phase (Nathan determines the needed amount of cells for a given therapy based on the relevant cell information, see Fig. 1, step D, and paragraphs 27 and 66-68.).
Nathan fails to explicitly disclose, but Hubel teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide:
12. viability rate of cells … and correct the amount of cells for the cell therapy according to the viability rate (Hubel discloses consideration of viability rate and survival rate in the culturing phase of calculating the amount of cells for cell therapy, see C2L30-45, C15L15-34 and C22L32-41.); and
13. survival rate of cells … and correct the amount of cells for the cell therapy according to the survival rate in the culturing phase (Hubel discloses consideration of viability rate and survival rate in the culturing phase of calculating the amount of cells for cell therapy, see C2L30-45, C15L15-34 and C22L32-41.).
18. wherein the viability rate is a viability rate for the site after the cells are administered to the patient in the cell therapy (As shown above, Hubel discloses consideration of viability rate and survival rate in the culturing phase of calculating the amount of cells for cell therapy, see C2L30-45, C15L15-34 and C22L32-41.), and
the correcting the amount of cells includes determining an amount of correction in the amount of cells on a basis of the acquired viability rate and information indicating a relationship between a viability rate and a correction ratio, the information indicating the relationship being determined in advance and stored in a memory (As shown above, Hubel discloses consideration of viability rate and survival rate in the culturing phase of calculating the amount of cells for cell therapy, see C2L30-45, C15L15-34 and C22L32-41.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of calculation of the amount of stem cells needed to treat an injury of Nathan/West/Carreel to include consideration of a cellular viability or survivability, as disclosed by Hubel, because to do so would result in a method of calculation of the amount of stem cells needed to treat an injury that modifies calculations based on the properties of the cells being utilized.
Both Nathan and Hubel are directed to the electronic processing of patient healthcare data and specifically to the use of cellular therapy techniques to treat a patient. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Claims 4, 5 and 9-11 are rejected under 35 U.S.C. 103 as being obvious over Nathan/West/Carreel, further in view of Yu et al. (U.S. PG-Pub 2009/0234627 A1), hereinafter Yu.
As per claims 4, 5 and 9-11, Nathan/West/Carreel discloses claim 1, discussed above. Nathan also discloses:
11. on a basis of a … size of the specified area where the damage is present, the processing circuitry predicts an area where damage is present …, and determines the amount of cells for the cell therapy on a basis of a size of the predicted area where the damage is present (Nathan, Fig. 1 step D calculates the amount of stem cells to delivery to the identified cardiac tissue based on the identified infarct or per-infarct tissue and the corresponding calculated mass thereof, see also paragraphs 27 and 66-68.).
Nathan fails to explicitly disclose, but Yu teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide:
4. wherein the information on the cause includes information on administration of a medicine to the patient (Input model information includes treatment information, see paragraph 56.);
5. wherein the information on the administration of the medicine to the patient includes information on a type of the medicine (Input model information includes treatment information, see paragraph 56.);
9. acquire supplementary information on radiation therapy for the patient, and specify the area where the damage is present when a plan or a history of dose to the site indicated by the supplementary information satisfies a predetermined condition (Input model information includes tumor information and treatment information, see paragraph 56.);
10. wherein the information on the cause includes information on radiation therapy for the patient, and on a basis of a plan or a history of dose to the site in the radiation therapy, the processing circuitry is further configured to correct the amount of cells for the cell therapy (Input model information includes tumor information and treatment information, see paragraph 56.);
11. wherein the information on the cause includes information on radiation therapy for the patient, and on a basis of a plan or a history of dose to the site in the radiation therapy …, the processing circuitry is further configured to predict an area where damage is present at a time point after radiation is applied to the site according to the plan or the history of the dose(Input model information includes treatment information, see paragraph 56, which is used to make damage predictions, see paragraphs 42 and 78-81.);
because to do so would provide a system that predicts outcomes for patients based on their history of treatments.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of calculation of the amount of stem cells needed to treat an injury of Nathan/West/Carreel to include consideration of a patient’s medical or radiation therapy when making a damage prediction of Yu, because to do so would result in a method of calculation of the amount of stem cells needed to treat an injury that also provides a system that predicts outcomes for patients based on their history of treatments.
Both Nathan and Yu are directed to the electronic processing of patient healthcare data and specifically to the identification of damage to a patient and appropriate remedies to treat said damage. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
As per claims 6 and 7, Nathan/West/Carreel/Yu discloses claim 4 and Nathan/West discloses claim 1, respectively, as discussed above. Nathan also discloses:
6. … on a basis of the a size of the specified area where the damage is present, …, and on a basis of the size of the predicted area where the damage is present, the processing circuitry is further configured to determine the amount of cells for the cell therapy (Nathan, Fig. 1 step D calculates the amount of stem cells to delivery to the identified cardiac tissue based on the identified infarct or per-infarct tissue and the corresponding calculated mass thereof, see also paragraphs 27 and 66-68.); and
7. specify the area where the damage is present (Nathan, Fig. 1 step B, system identifies and calculates the mass of infarct or peri-infarct tissue using a medical image that includes the site of damage to the patient. The cause of damage is the infarct or per-infarct tissue, see also paragraph 25.);
Nathan fails to explicitly disclose, but Yu teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide:
6. wherein the information on the administration of the medicine to the patient includes information on a total dosage of the medicine at a specific time point …, and on a basis of the total dosage at the specific time point …, wherein the medicine is a designated drug determined in advance and stored in a memory, the designated drug generating reactive oxygen species in a metabolic process, … the processing circuitry is further configured to predict an area where damage caused by the medicine is present at a time point of disappearance, … wherein the time point of disappearance is a dose-dependent point of time when a distribution concentration of the designated drug in cells reaches zero (Input model information includes treatment information, see paragraph 56, which is used to make damage predictions, see paragraphs 42 and 78-81. Models are created using all clinical characteristics, including medicine information. The Office notes that the limitation designated drug generating reactive oxygen species in a metabolic process comprises a non-functional descriptive limitation as the claim operates the same regardless of what type of drug is described in its use.);
7. acquire supplementary information on a blood test for the patient, and specifies the area where the damage is present when a marker is positive, wherein the marker is a marker that increases in blood with an occurrence of the damage to the site indicated by the supplementary information, and the marker is determined positive when a result of a blood test indicated by the supplementary information shows that a value of the marker is equal to or greater than a predetermined threshold value (Blood test provides predictions based on identified biomarkers, see paragraphs 8, 9 and 56. It is old and well known in the blood marker arts that this is how blood markers work and are used.),
because to do so would provide a system that predicts outcomes for patients based on their history of treatments.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of calculation of the amount of stem cells needed to treat an injury of Nathan/West to include
Damage prediction and specification of a damaged area of Yu, because to do so would result in a method of calculation of the amount of stem cells needed to treat an injury that also provides a system that predicts outcomes for patients based on their history of treatments.
Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Claim 8 is rejected under 35 U.S.C. 103 as being obvious over Nathan/West/Carreel further in view of Chian (U.S. PG-Pub 2011/0028859 A1), hereinafter Chian.
As per claim 8, Nathan/West/Carreel discloses claim 1, discussed above. Nathan also discloses acquire supplementary information …, and specify the area where the damage is present when the supplementary information includes a chief complaint of the patient suggestive of the damage to the site (Nathan, Fig. 1 step B and paragraph 25.).
Nathan fails to disclose:
8. using an interview to the patient to determine an area where damage is present
Chian discloses using an interview to the patient to determine an area where damage is present (Chian discloses determining damage to a patient based on interviewing the patient while undergoing imaging, see paragraphs 82 and 85.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of calculation of the amount of stem cells needed to treat an injury of Nathan/West/Carreel to include using an interview to the patient to determine an area where damage is present, as disclosed by Chian, because to do so would result in a method of calculation of the amount of stem cells needed to treat an injury that bases treatment based on patient input to more specifically identify damage to the patient.
Both Nathan and Chian are directed to the electronic processing of patient healthcare data and specifically to the use of cellular therapy techniques to treat a patient. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Claim 14 are rejected under 35 U.S.C. 103 as being obvious over Nathan/West/Carreel in view of Silverman et al. (U.S. PG-Pub 2012/0296675 A1), hereinafter Silverman.
As per claim 14, Nathan/West/Carreel discloses claim 1, discussed above. Nathan also discloses display, on a display, a list of therapeutic techniques that contribute to the cell therapy (Nathan, Fig. 3.).
Nathan fails to explicitly disclose, but Silverman acquire information on surgery of the patient, and determine a display order of the therapeutic techniques in the list on a basis of the information on the surgery of the patient and a degree of invasiveness of the therapeutic techniques.
Nathan fails to disclose but Silverman discloses a list of therapeutic techniques that contribute to the cell therapy, acquire information on surgery of the patient, and determine a display order of the therapeutic techniques in the list on a basis of the information on the surgery of the patient and a degree of invasiveness of the therapeutic techniques (Silverman, Fig. 1 and corresponding text.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method of calculation of the amount of stem cells needed to treat an injury of Nathan/West/Carreel to include a list of therapeutic techniques that contribute to the cell therapy, acquire information on surgery of the patient, and determine a display order of the therapeutic techniques in the list on a basis of the information on the surgery of the patient and a degree of invasiveness of the therapeutic techniques, as disclosed by Silverman, because to do so would result in a method of calculation of the amount of stem cells needed to treat an injury that considers the risk of therapeutic complications in determining treatment.
Both Nathan and Silverman are directed to the electronic processing of patient healthcare data and specifically to the use of therapy techniques to treat a patient. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Response to Arguments
Applicant’s arguments filed 3 December 2025 concerning the interpretation of claims 6 and 72 and 6-14 under 35 U.S.C. 112(b) have been fully considered and they are deemed persuasive. Accordingly, these rejections have been removed.
With regard to the rejection of the claims under 35 USC 101, Applicant argues on pages 10-11 that the claims:
A. Represent an improvement that require medical images and use of patient parameters and therefore cannot be performed as a process of managing human activity or a mental process;
B. are integrated into a practical application that represent a technically meaningful improvement in cell therapy support technology; and
C. represent an ordered combination that provide a particular improvement by enabling a computer-implemented determination that cannot be achieved through routine data processing or generic computer functions.
The Office respectfully disagrees. Please see the rejection of the claims above where the claims are shown to be directed to an abstract idea without significantly more.
Regarding A., MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves another technology. See also MPEP 2106.05(a)(II). Applicant’s claim is confined to a general-purpose computer and does not recite “another technology.” Because no other technology is recited in the claim, the claim cannot improve another technology (see, e.g., MPEP 2106.05(I)(A)(i) describing an example of an improvement to another technology where the abstract idea implemented on a computer improved the claimed additional element of a rubber molding machine).
Further, the claims are shown to be directed to a method of organizing human activity and not to a mental process so the remaining argument fails.
Regarding B. and C., the claims are composed of generic computer functions, even as an ordered combination, as evidenced by the specification at paragraphs 20-23. There is no other technology present in the claims beyond the recited computer technology.
MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves another technology. See also MPEP 2106.05(a)(II). Applicant’s claim is confined to a general-purpose computer and does not recite “another technology.” Because no other technology is recited in the claim, the claim cannot improve another technology (see, e.g., MPEP 2106.05(I)(A)(i) describing an example of an improvement to another technology where the abstract idea implemented on a computer improved the claimed additional element of a rubber molding machine).
With regard to the rejection of the claims under 35 USC 103, Applicant argues on pages 13-16 that the cited references fail to disclose the claims as amended.
In particular, the Applicant argues:
A. Nathan and West fail to disclose determining a type of cells included in the indentified tissue structure as a cell type for the cell therapy for the damage to the site;
B. Nathan and West also fail to disclose the amended limitations to the independent claims;
C. Chain fails to disclose the material in claims 8 and 17;
D. Chang fails to disclose the material in claim 19.
Regarding A. and B., Applicant's arguments have been fully considered but are moot in view of the new ground(s) of rejection, specifically with reference to the new reference necessitated by amendment, Carreel, as detailed above, or because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Regarding C., Chian discloses the material in claim 8, as shown above, the combination of the cited references disclose the material as claimed. However, the Office agrees with respect to claim 17, and has therefore removed the prior art rejection.
Regarding D., the Office agrees and has therefore removed the prior art rejection.
In conclusion, all of the limitations which Applicant disputes as missing in the applied references, including the features newly added by amendment, have been fully addressed by the Office as either being fully disclosed or obvious in view of the collective teachings of Nathan, West, Carreel, Hubel, Yu, Chian, Chang and Silverman, based on the logic and sound scientific reasoning of one ordinarily skilled in the art at the time of the invention, as detailed in the remarks and explanations given in the preceding sections of the present Office Action and in the prior Office Actions (4 September 2025 and 29 January 2025), and incorporated herein.
Conclusion
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
18 December 2025
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