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 .
Claims 9 and 28-34 have been cancelled. Claims 1-8 and 10-27 have been amended. Claims 1-8 and 10-27 are pending.
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 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because Claim 11 recites a “recording medium for causing a computer to…,” which under the broadest reasonable interpretation can be interpreted as software per se. There are no physical components positively recited in the claim and/or the “recording medium” is not modified with “non-transitory,” and the recording medium can be interpreted as being transitory. Examiner notes that if the claim is amended to include “non-transitory” it would fall within one of the four statutory categories, specifically manufacture.
Claims 1-8 and 10-27 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.
Claims 1-8 and 12-27 are drawn to a system for medical care assistance which is within the four statutory categories (i.e. machine). Claim 10 is drawn to a method for medical care assistance which is within the four statutory categories (i.e. process). Claim 12 is drawn towards a “recording medium for causing a computer to…” which does not fall within any of the statutory categories. Examiner notes that if the claim is amended to include “non-transitory” it would fall within one of the four statutory categories.
Claims 1-8 and 11-27 (Group I) recite a medical care assistance system, comprising:
a blood pressure monitor configured to measure blood pressure as a measured value information of a patient (apply it, MPEP § 2106.05(f)); and
a central processing unit (apply it, MPEP § 2106.05(f)) configured to:
select a guideline related to treatment of the patient based on predetermined input information;
acquire patient information including measured value information related to biological information on the patient from the blood pressure monitor and medication information as information of a medicine prescribed to the patient;
perform determination related to appropriateness of a current treatment strategy including a prescription content of a medicine for the patient based on the selected guideline and the patient information and the measure value information that was acquired from the blood pressure monitor;
generate recommended treatment information regarding an action recommended to be performed on the patient according to a determination result; and
output the recommended treatment information,
wherein the central processing unit if further configured to (apply it, MPEP § 2106.05(f)) determine at least whether or not the prescription content currently adopted is excessive for a medical condition of the patient based on the patient information; and
the central processing unit is further configured to unit (apply it, MPEP § 2106.05(f)) generates the recommended treatment information that recommends reduction in type and/or amount of medicine prescribed to the patient when the prescription content currently adopted is excessive for the medical condition of the patient.
The bolded limitations given the broadest reasonable interpretation, cover a certain method of organizing human activity because it recites fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationships or interactions between people. Any limitations not identified above as part of the abstract idea are underlined and are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claims 10 and 11 is identical as the abstract idea for Claims 1-8 and 11-27 (Group I), because the only difference is they are directed towards different statutory categories.
Dependent Claims 2-8 and 12-27 include other limitations, for example Claim 2 recites wherein the predetermined input information is information including at least any of a medical history, a biochemical test result, an electrocardiographic finding, a left ventricular ejection fraction by echocardiogram, and an arteriosclerosis index; and the central processing unit is further configured to specify a disease of the patient based on the predetermined input information, and select a guideline related to treatment of the disease of the patient, Claims 3 and 12 recite wherein the central processing unit is further configured to determine at least whether or not the medicine according to the prescription content currently adopted is replaceable with a compounded medicine; and the central processing unit is further configured to generate the recommended treatment information that recommends a prescription change to the compounded medicine when the medicine according to the prescription content currently adopted is replaceable with the compounded medicine, Claims 4 and 13 recite wherein the guideline defines a recommended prescription content according to a medical condition; the central processing unit is further configured to determine at least whether or not the prescription content currently adopted matches the recommended prescription content; and the central processing unit is further configured to generate the recommended treatment information that recommends a prescription change to the recommended prescription content when the prescription content currently adopted does not match the recommended prescription content, Claims 5 and 14-16 recites wherein the guideline defines a recommended prescription content according to a medical condition, the patient information includes a predetermined improvement target reference related to the biological information, the central processing unit is further configured to determine at least whether the prescription content currently adopted matches the recommended prescription content, and whether the measured value information has achieved the improvement target reference, and the central processing unit is further configured to generates, when the measured value information has not achieved the improvement target reference and the prescription content currently adopted matches the recommended prescription content, the recommended treatment information that recommends a prescription change based on the recommended prescription content one step ahead in the guideline or the recommended treatment information that recommends a test to be performed on the patient, Claim 6 recites the central processing unit is further configured to determine presence or absence of a non-recommended medicine that is unrecommended to be prescribed to the patient based on the patient information; wherein the central processing unit is further configured to generate, when the non-recommended medicine is present, the recommended treatment information that recommends a prescription change to a prescription content excluding the non-recommended medicine, Claims 7 and 17-21 recite wherein the predetermined input information includes an international disease classification code related to a disease of the patient, Claims 8 and 22-27 recites wherein the biological information includes at least a blood pressure value, and a disease targeted for treatment of the patient is hypertension, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1, 10 and 11.
Furthermore, Claims 1-8 and 10-27 are not integrated into a practical application because the additional elements (i.e. the limitations 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 central processing unit and a computer, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraphs [0035-0036] and [0048] of the present Specification, see MPEP 2106.05(f)
generally link the abstract idea to a particular technological environment or field of use – for example, the recitation of a computer and a central processing unit, which amounts to limiting the abstract idea to the field of a computer, see MPEP 2106.05(h))
Furthermore, the Claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than 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 [0035-0036] and [0048] of the Specification discloses that the additional elements (i.e. CPU, computer, recording medium) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Dependent Claims 2-8 and 11-27 include other limitations, but none of these functions are deemed significantly more than the abstract idea because they merely include additional elements already recited in the aforementioned independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. 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 1-8 and 10-27 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 21 and 26 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.
Claim 6 recites “determin[ing the] presence or absence of a non-recommended medicine that is unrecommended to be prescribed to the patient based on the patient information.” It is unclear what is meant by “the presence or absence of a non-recommended medicine” wouldn’t be prescribed to a patient, and therefore, the metes and the bounds of the claims are unclear, rendering it indefinite. It is unclear how “a non-recommended medication” that is not prescribed to the patient could be detected. As currently written, the system is checking for everything, which renders it indefinite as its unclear what it is doing. If the drug is not found, and no action is taken, it is unclear what this does with respect to limiting the claim language, and therefore, Examiner recommends that portion of the claim limitation be removed.
Claim 21 and 26 are rejected as they depend from claim 6.
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.
Claims 1-5, 8, 10-16 and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Takeyama (U.S. Pub. No. 2016/0140305 A1) in view of Patwardhan (U.S. Pub. No. 2009/0281835 A1).
Regarding claim 1, Takeyama discloses a medical care assistance system, comprising:
a blood pressure monitor configured to measure blood pressure as a measured value of patient information (Paragraphs [0089] and [0188] discuss that the patient’s blood pressure is measured and fed into the system for analysis, construed as including a blood pressure monitor.);
a central processing unit configured to (Paragraphs [0082] and [0121] discuss a center server or system server apparatus, which includes a CPU.):
select a guideline related to treatment of the patient based on predetermined input information (Paragraphs [0082], [0089] and [0100] discuss a server to select patient information including medical records, lab results, and patient visit data.);
acquire patient information including measured value information related to biological information on the patient from the blood pressure monitor and medication information as information of a medicine prescribed to the patient (Paragraphs [0082], [0089] and [0136-0138] discuss a server patient information including measured vitals of vital signs, such as blood pressure and previously administered drugs.);
perform determination related to appropriateness of a current treatment strategy including a prescription content of a medicine for the patient based on the selected guideline and the patient information and the measured value information that was acquired from the blood pressure monitor (Paragraphs [0082] and [0222-0223] discuss a server computer evaluating the appropriateness of the treatment plan including the prescription drug dose.);
generate recommended treatment information regarding an action recommended to be performed on the patient according to a determination result (Paragraphs [0082] and [0223] discuss outputting the results of the determination.); and
at least one output device that outputs the recommended treatment information (Paragraph [0127] discusses displaying the judgment and treatment results on a CPU.), wherein
the central processing unit is further configured to determine at least whether or not the prescription content currently adopted is excessive for a medical condition of the patient based on the patient information (Paragraphs [0195] and [0222] discuss evaluating the dosage of the medication.);
Takeyama does not explicitly disclose wherein the central processing unit is further configured to generate the recommended treatment information that recommends reduction in type and/or amount of medicine prescribed to the patient when the prescription content currently adopted is excessive for the medical condition of the patient.
Patwardhan teaches wherein the central processing unit is further configured to generate the recommended treatment information that recommends reduction in type and/or amount of medicine prescribed to the patient when the prescription content currently adopted is excessive for the medical condition of the patient (Paragraphs [0052], [0056] and [0058] discuss recommending lowering the drug dose for the patient.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify Takeyama to include recommending lower the dose of a drug, as taught by Patwardhan, in order to take in account all relevant factors, such as patient’s age (Paragraph [0041]).
Regarding claim 2, Takeyama discloses wherein:
the predetermined input information is information including at least any of a medical history (Paragraph [0089] discusses the input information including the patient’s medical history.); and
the central processing unit is further configured to specify a disease of the patient based on the predetermined input information, and selects a guideline related to treatment of the disease of the patient (Paragraph [0114] discusses the disease/condition being including as part of the diagnosis support process.).
Regarding claim 3, Takeyama does not appear to explicitly disclose wherein
the central processing unit is further configured to determine at least whether or not the medicine according to the prescription content currently adopted is replaceable with a compounded medicine; and
the central processing unit is further configured to generate the recommended treatment information that recommends a prescription change to the compounded medicine when the medicine according to the prescription content currently adopted is replaceable with the compounded medicine.
Patwardhan teaches:
the central processing unit is further configured to determine at least whether or not the medicine according to the prescription content currently adopted is replaceable with a compounded medicine (Paragraph [0061] discusses compounded medications being presented an option for patients.); and
the central processing unit is further configured to generate the recommended treatment information that recommends a prescription change to the compounded medicine when the medicine according to the prescription content currently adopted is replaceable with the compounded medicine (Paragraph [0061] discusses recommended a compounded medication as a substitute).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify Takeyama to include recommending a compounded medication, as taught by Patwardhan, in order to “allow[] a prescribing physician to tailor a prescription as per the special need, such as “dysphagic patients may need to change the form of the medication from a solid pill to a liquid (Paragraph [0061]).”
Regarding claim 4, Takeyama discloses wherein
the guideline defines a recommended prescription content according to a medical condition (Paragraphs [0032] and [0114] discuss the diagnosis support program being used to determine a treatment plan for a particular disease or condition, which includes prescription drugs.);
the central processing unit is further configured to determine at least whether or not the prescription content currently adopted matches the recommended prescription content (Paragraph [0102] discusses the server receiving the judging information and treatment plan to approve or not approve of the proposed treatment plan.); and
the central processing unit is further configured to generate the recommended treatment information that recommends a prescription change to the recommended prescription content when the prescription content currently adopted does not match the recommended prescription content (Paragraph [0144] discusses proposes an alternate drug treatment based on the judgment information.).
Regarding claim 5, Takeyama discloses wherein
the guideline defines a recommended prescription content according to a medical condition ((Paragraph [0114] discusses the disease/condition being including as part of the diagnosis support process.),
the patient information includes a predetermined improvement target reference related to the biological information (Paragraph [0092] discusses targeting a lower blood pressure value from their measured vital signs.),
the central processing unit is further configured to determine at least whether the prescription content currently adopted matches the recommended prescription content, and whether the measured value information has achieved the improvement target reference (Paragraphs [0102] and [0204[ discuss the server receiving the judging information and treatment plan with vital sign information to see if the treatment plan is effective.),
but Takeyama does not explicitly disclose the central processing unit is further configured to generate, when the measured value information has not achieved the improvement target and the prescription content currently adopted matches the recommended prescription content, the recommended treatment information that recommends a prescription change based on the recommended prescription content one step ahead in the guideline or the recommended treatment information that recommends a test to be performed on the patient.
Patwardhan teaches the central processing unit is further configured to generate, when the measured value information has not achieved the improvement target and the prescription content currently adopted matches the recommended prescription content, the recommended treatment information that recommends a prescription change based on the recommended prescription content one step ahead in the guideline or the recommended treatment information that recommends a test to be performed on the patient (Paragraph [0056] discusses adjusting the dosage if ineffective.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify Takeyama to include recommending a compounded medication, as taught by Patwardhan, in order to gradually increase the dosage as necessary (Paragraph [0043]).
Regarding claim 8, Takeyama discloses wherein the biological information includes at least a blood pressure value (Paragraph [0089] discusses the input data including blood pressure readings.),
but Takeyama does not appear to explicitly disclose wherein a disease targeted for treatment of the patient is hypertension.
Patwardhan teaches wherein a disease targeted for treatment of the patient is hypertension (Paragraph [0064] discusses using the system to treat chronic diseases, like hypertension.)
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify Takeyama to include treatment hypertension, as taught by Patwardhan, in order to monitor “the response of the drug dose (Paragraph [0056]).”
2025Attorney Docket No. 317EP.001US01
Claim 10 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above.
Claim 11 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above. Claim 11 further recites recording medium for causing a computer to function as the medical care assistance device (Takeyama paragraph [0121] discusses the computer including a memory, construed as a recording medium.).
Claim 12 recites substantially similar limitations as those already addressed in claim 3, and, as such, is rejected for similar reasons as given above.
Claim 13 recites substantially similar limitations as those already addressed in claim 4, and, as such, is rejected for similar reasons as given above.
Claim 14 recites substantially similar limitations as those already addressed in claim 5, and, as such, is rejected for similar reasons as given above.
Claim 15 recites substantially similar limitations as those already addressed in claim 5, and, as such, is rejected for similar reasons as given above.
Claim 16 recites substantially similar limitations as those already addressed in claim 5, and, as such, is rejected for similar reasons as given above.
Claim 22 recites substantially similar limitations as those already addressed in claim 8, and, as such, is rejected for similar reasons as given above.
Claim 23 recites substantially similar limitations as those already addressed in claim 8, and, as such, is rejected for similar reasons as given above.
Claim 24 recites substantially similar limitations as those already addressed in claim 8, and, as such, is rejected for similar reasons as given above.
Claim 25 recites substantially similar limitations as those already addressed in claim 8, and, as such, is rejected for similar reasons as given above.
Claim 26 recites substantially similar limitations as those already addressed in claim 8, and, as such, is rejected for similar reasons as given above.
Claims 7, 17-21 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Takeyama in view of Patwardhan, and in further view of Hyde (U.S. Pub. No. 2013/0173284 A1).
Regarding claim 7, Takeyama does not appear to explicitly disclose wherein the predetermined input information includes an international disease classification code related to a disease of the patient.
Hyde teaches the predetermined input information includes an international disease classification code related to a disease of the patient (Paragraphs [0199-0200] discusses identifying conditions using the International Classification of Diseases.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify Takeyama to include using the International Classification of Diseases, as taught by Hyde, in order to treat the patient according to a specific protocol for the specified condition (Paragraph [0197-0199]).”
Claim 17 recites substantially similar limitations as those already addressed in claim 7, and, as such, is rejected for similar reasons as given above.
Claim 18 recites substantially similar limitations as those already addressed in claim 7, and, as such, is rejected for similar reasons as given above.
Claim 19 recites substantially similar limitations as those already addressed in claim 7, and, as such, is rejected for similar reasons as given above.
Claim 20 recites substantially similar limitations as those already addressed in claim 7, and, as such, is rejected for similar reasons as given above.
Claim 21 recites substantially similar limitations as those already addressed in claim 7, and, as such, is rejected for similar reasons as given above.
Claim 27 recites substantially similar limitations as those already addressed in claim 8, and, as such, is rejected for similar reasons as given above.
Response to Arguments
Applicant's arguments filed 08/22/2025 have been fully considered but they are not persuasive.
Claim Objections
The claim objection has been withdrawn in view of the amendments.
Interpretation under 35 U.S.C. § 112(f)
The previous section 112(f) interpretation of the claims has been withdrawn in view of the amendments.
Rejections under 35 U.S.C. § 112(a)/(b)
The 112a/b rejection resulting from the 112(f) interpretation have been withdrawn in view of the amendments.
Rejections under 35 U.S.C. § 112(d)
The 112(d) rejection has been withdrawn in view of the amendments.
Rejections under 35 U.S.C. § 101
Applicant argues that since the “claimed invention is directed to…a medical care assistance system that recommends treatment information to be performed on the patient” that the “subject matter of the claims do not fall within the scope of ‘certain methods of organizing human activity’ as asserted by the Examiner (Remarks, 14).” Examiner disagrees as the MPEP § 2106.04(a)(2)(II)(C) provides an example of a “mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer,” as an example of organizing human activity. Making recommendations on how to diagnose and treat a patient is organizing human activity. Applicant further cites a blood pressure monitor and a central processing unit. Both of these devices are recited at an apply it level, as they simply invoke computers or other machinery (in this case a blood pressure monitor device) merely as a tool to perform an existing process (executing steps and taking blood pressure readings). The claims still recite an abstract idea even with the addition of the central processing unit and blood pressure monitor, as these are considered additional elements, which are recited at the apply it level, which do not result in a practical application of the abstract idea. Furthermore, they do not result in significantly more than the abstract idea.
Therefore, the claims remain rejected as being directed towards an abstract idea without a practical application or significantly more.
Rejections under 35 U.S.C. § 103
Applicant’s arguments have been considered but are not persuasive.
Applicant argues that the Takeyama does not disclose “determination related to the appropriateness of a current treatment strategy….” Takeyama discusses considering how drug administration affects the patient, and even discusses the affect it has on blood pressure as those readings are taken into account when doing the analysis as indicated in at least paragraphs [0082], [0089] and [0136-0138] as cited in the above rejection.
Applicant also argues that Patwardhan does not disclose “recommending reduction…when the prescription content is currently adopted is excessive…[emphasis is original].” Examiner disagrees as Patwardhan states that compliance is routinely monitored along with concurrent medications. Furthermore, the limitation of “prescription content currently adopted is excessive…” under the broadest reasonable interpretation and in view of the specification does not necessarily that the prescription is already being taken by the patient themselves as it is just the content that is “currently adopted” not the drug itself.
The claims remain rejected under section 103.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Dunham can be reached on (571)272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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