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 1-15 are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a “control unit programmed to execute steps…” in claim 14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Paragraph [0015] of the instant specification discloses the control unit as incorporating a required number of central processing units, micro-processing units, graphics processing units, to implement the claimed invention as described in the specification.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-15 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 1-13 are drawn to a non-transient computer-readable medium for generating pain management support information, which is within the four statutory categories (i.e. manufacture). Claim 14 is drawn to a system for generating pain management support information which is within the four statutory categories (i.e. machine). Claim 15 is drawn to a method for generating pain management support information which is within the four statutory categories (i.e. process).
Step 2A | Prong One
Claims 1-15 (Group I) recite a non-transient computer-readable medium comprising a computer program that causes a computer to execute processing comprising:
repeatedly obtaining pain-related information associated with pain of a patient at required timing;
storing the obtained pain-related information (MPEP § 2106.05(g), insignificant extra-solution activity);
obtaining medical examination information associated with a medical examination of the patient;
storing the obtained medical examination information (MPEP § 2106.05(g), insignificant extra-solution activity);
generating pain management support information on a basis of the pain-related information and the medical examination information; and
outputting the generated pain management support information.
The bolded limitations, given the broadest reasonable interpretation, 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 14 and 15 is identical as the abstract idea for Claims 1-13 (Group I), because the only difference is they are directed towards different statutory categories. Examiner notes that claims 14 and 15 do not recite any additional elements beyond those already found in claim 1.
Dependent Claims 2-13 include other limitations, for example Claim 2 recites wherein the pain-related information includes at least one of an assessment index for assessing the pain, vital data, medication information, or a physical condition, Claim 3 recites wherein the medical examination information includes at least one of diagnosis information, examination information, or prescription information, Claim 4 recites wherein the pain management support information includes at least one of a pain assessment result, recommended prescription information, or an instruction for a doctor visit for supporting the patient, Claim 5 recites wherein the pain management support information includes at least one of a pain assessment result, necessity of an interview, a medication result, recommended prescription information, or a recommended treatment method for supporting a doctor who examines the patient, Claim 6 recites outputting, to a patient terminal device or a support person terminal device (MPEP § 2106.05(f), apply it), a pain assessment result indicating presence or absence of the pain of the patient on a basis of the pain-related information; and outputting recommended prescription information to the patient terminal device or the support person terminal device (MPEP § 2106.05(f), apply it), when the pain is present, Claim 7 recites outputting, to the patient terminal device (MPEP § 2106.05(f), apply it), a pain assessment result indicating an administration result before and after administration of a medicine based on the recommended prescription information; and outputting an instruction for a doctor visit to the patient terminal device (MPEP § 2106.05(f), apply it) on a basis of the administration result, Claim 8 recites outputting, to a doctor terminal device (MPEP § 2106.05(f), apply it), a temporal change of a pain assessment result indicating an effect of an analgesic on the patient who is taking the analgesic; and outputting recommendation of a medication change or necessity of an interview to the doctor terminal device (MPEP § 2106.05(f), apply it) on a basis of the effect of the analgesic, Claim 9 recites outputting, to a doctor terminal device (MPEP § 2106.05(f), apply it), a temporal change of a pain assessment result indicating an effect of an analgesic on the patient who is taking the analgesic; and outputting, to the doctor terminal device (MPEP § 2106.05(f), apply it), a coping method, a recommended treatment method, or referral information regarding a doctor experienced in the recommended treatment method on a basis of the effect of the analgesic, Claim 10 recites outputting, to a doctor terminal device (MPEP § 2106.05(f), apply it), a check item needed to select recommended prescription information or a recommended treatment method at a time of an examination; receiving input information for the check item; and outputting the recommended prescription information or the recommended treatment method to the doctor terminal device (MPEP § 2106.05(f), apply it) on a basis of the input information, Claim 11 recites outputting a question for evaluating a state of the pain of the patient to a patient terminal device (MPEP § 2106.05(f), apply it); receiving an input of an answer to the question; and outputting a coping method to the patient terminal device (MPEP § 2106.05(f), apply it) on a basis of the answer, Claim 12 recites outputting a plurality of assumed questions related to the pain of the patient to a patient terminal device (MPEP § 2106.05(f), apply it); and outputting, to the patient terminal device (MPEP § 2106.05(f), apply it), an answer to an assumed question selected by the patient from among the plurality of assumed questions, Claim 13 recites outputting a check item needed to generate the pain management support information to a doctor terminal device (MPEP § 2106.05(f), apply it); receiving input information for the check item; and generating the pain management support information on a basis of the input information, 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, 14 and 15.
Step 2A | Prong Two
Furthermore, Claims 1-15 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 terminal devices, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraph [0010] of the present Specification, see MPEP 2106.05(f); and
add insignificant extra-solution activity to the abstract idea – for example, the recitation storing data, which amounts to an insignificant application, see MPEP 2106.05(g).
Step 2B
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 [0010] of the Specification discloses that the additional elements (i.e. terminal device) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. storing data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Electronic recordkeeping, e.g. see Alice Corp v. CLS Bank – similarly, the current invention merely recites the storing of pain data on a database and/or electronic memory; and
Storing and retrieving information in memory, e.g. see Versata Dev. Group, Inc. v. SAP Am., Inc. – similarly, the current invention recites storing pain data in a database and/or electronic memory.
Dependent Claims 2-13 include other limitations, but none of these functions are deemed significantly more than the abstract idea because they merely further limit the abstract idea and the additional elements recited in the dependent claims merely recite a generic computer device (terminal devices of claims 6-13) at an “apply it” level.
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 1-15 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 and 8-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dullen (U.S. Pub. No. 2016/0198996 A1).
Regarding claim 1, Dullen discloses a non-transient computer-readable medium comprising a computer program that causes a computer to execute processing comprising:
repeatedly obtaining pain-related information associated with pain of a patient at required timing (Paragraphs [0102-0103] discuss the PMD obtaining data related to pain for the patient repeatedly at repeated intervals.);
storing the obtained pain-related information (Paragraphs [0102-0103] discuss storing the obtained pain-related information.);
obtaining medical examination information associated with a medical examination of the patient (Paragraphs [0154] discusses obtaining information associated with physical examinations of the patient.);
storing the obtained medical examination information (Paragraphs [0102-0103] and [0154] discuss storing the obtained pain-related information and examination information in the patient’s medical record.);
generating pain management support information on a basis of the pain-related information and the medical examination information (Paragraphs [0104] and [0113] discuss suggesting treatment recommendations from the obtained data.); and
outputting the generated pain management support information (Paragraph [0104] discusses presenting treatment protocols.).
Regarding claim 2, Dullen discloses wherein the pain-related information includes an assessment index for assessing the pain (Paragraphs [0043] and [0114] discuss using a pain score to evaluate a patient’s pain levels.).
Regarding claim 3, Dullen discloses wherein the medical examination information includes examination information (Paragraphs [0102-0103] and [0154] discuss storing the obtained pain-related information and examination information in the patient’s medical record.).
Regarding claim 4, Dullen discloses wherein the pain management support information includes at least one of a pain assessment result or recommended prescription information (Paragraph [0181] discuss the system providing a determined diagnosis and/or prescription.).
Regarding claim 5, Dullen discloses wherein the pain management support information includes a pain assessment result (Paragraph [0134] discusses obtaining a result of a pain assessment as a rating.).
Regarding claim 6, Dullen discloses wherein the computer program causes the computer to execute processing comprising:
outputting, to a patient terminal device or a support person terminal device, a pain assessment result indicating presence or absence of the pain of the patient on a basis of the pain-related information (Paragraphs [0094], [0099], [0114] and [0134] discuss displaying the results on an output device, construed as including the pain assessment result.); and
outputting recommended prescription information to the patient terminal device or the support person terminal device when the pain is present (Paragraph [0116] discusses outputting a prescribed treatment protocol with a timeline for the patient to follow.).
Regarding claim 8, Dullen discloses:
outputting, to a doctor terminal device, a temporal change of a pain assessment result indicating an effect of an analgesic on the patient who is taking the analgesic (Paragraphs [0115-0116] and [0150] discuss assessing the patient before and after the administration of a treatment protocol over a period of time, which is construed as including pain relieving medication.); and
outputting recommendation of a medication change to the doctor terminal device on a basis of the effect of the analgesic (Paragraphs [0114] and [0118] discuss outputting a recommendation to change the dosage of the patient’s medication shown on the care provider’s display.).
Regarding claim 9, Dullen discloses:
outputting, to a doctor terminal device, a temporal change of a pain assessment result indicating an effect of an analgesic on the patient who is taking the analgesic (Paragraphs [0115-0116] and [0150] discuss assessing the patient before and after the administration of a treatment protocol over a period of time, which is construed as including pain relieving medication.); and
outputting, to the doctor terminal device, a coping method on a basis of the effect of the analgesic (Paragraph [0113] discusses recommending coping methods for the patient, which physicians may choose to initiate for the patient.).
Regarding claim 10, Dullen discloses:
outputting, to a doctor terminal device, a check item needed to select recommended prescription information or a recommended treatment method at a time of an examination (Paragraph [0113] discusses recommending coping methods for the patient, which physicians may choose to initiate for the patient.);
receiving input information for the check item (Paragraph [0113] discusses physicians choosing to initiate the coping mechanisms for the patient.); and
outputting the recommended prescription information or the recommended treatment method to the doctor terminal device on a basis of the input information (Paragraph [0113] discusses outputting the coping methods for the patient after selected by the physician.).
Regarding claim 11, Dullen discloses:
outputting a question for evaluating a state of the pain of the patient to a patient terminal device (Paragraphs [0155-0171] discuss a questionnaire given to the patient that includes questions related to the patient’s pain.);
receiving an input of an answer to the question (Paragraphs [0155-0171] discuss a questionnaire given to the patient that includes questions related to the patient’s pain which the patient answers.); and
outputting a coping method to the patient terminal device on a basis of the answer (Paragraphs [0113] and [0171-0172] discusses outputting coping methods for the patient after selected by the physician using collected data, including survey responses from the patient.).
Regarding claim 12, Dullen discloses:
outputting a plurality of assumed questions related to the pain of the patient to a patient terminal device (Paragraph [0155] discusses that the questions in the survey may be particular to the patient’s particular health problem, construed as assumed questions.); and
outputting, to the patient terminal device, an answer to an assumed question selected by the patient from among the plurality of assumed questions (Paragraphs [0094] and [0155] discuss that the questions in the survey may be particular to the patient’s particular health problem and output to the patient’ device for viewing.)
Regarding claim 13, Dullen discloses:
outputting a check item needed to generate the pain management support information to a doctor terminal device (Paragraph [0113] discusses recommending coping methods for the patient, which physicians may choose to initiate for the patient.);
receiving input information for the check item (Paragraph [0113] discusses physicians choosing to initiate the coping mechanisms for the patient.); and
generating the pain management support information on a basis of the input information (Paragraph [0113] discusses outputting the coping methods for the patient after selected by the physician.).
2025Attorney Docket No. 317EP.001US01
Claim 14 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above.
2025Attorney Docket No. 317EP.001US01
Claim 15 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Dullen (U.S. Pub. No. 2016/0198996 A1) in view of Kang (U.S. Pub. No. 2019/0198150 A1).
Regarding claim 7, Dullen discloses wherein the computer program causes the computer to execute processing comprising:
outputting, to the patient terminal device, a pain assessment result indicating an administration result before and after administration of a medicine based on the recommended prescription information (Paragraph [0150] discusses assessing the patient before and after the administration of a treatment protocol, which is construed as including prescribed medication.); but
Dullen does not appear to explicitly disclose outputting an instruction for a doctor visit to the patient terminal device on a basis of the administration result.
Kang teaches outputting an instruction for a doctor visit to the patient terminal device on a basis of the administration result (Paragraphs [0070-0071] discuss requesting the patient schedule an appointment based on changes to the patient’s pain.).
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 the pain support system of Dullen to include outputting an instruction for a doctor to visit, as taught by Kang, in order to “intervene with the patient's physical therapy regimen in order to preempt further deviation from the group toward a group exhibiting less-positive (or negative) outcomes (Kang, Paragraph [0070]).”
Conclusion
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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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686