Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The current application is a continuation of Application No. 17/373,280, now Patent No. 12,1255,66, which is a continuation of Application No. 12/038,650, now US Patent No. 11,062,795, which claims benefit to provisional Application No. 60/892,793, filed 03/02/2007.
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 1-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 2A Prong One
Claim 1 recites establishing a diagnosis for the patient; establishing symptoms corresponding to the diagnosis; establishing a weight for each symptom; periodically collecting data from the patient relating to symptoms; processing the collected data to measure progress of treatment, and taking into account the weight established for each symptom; and reporting the measured progress.
These limitations, as drafted, given the broadest reasonable interpretation, encompass managing interactions between people, which is a subgrouping of Certain Methods of Organizing Human Activity. For example, establishing a diagnosis, symptom, and weight could be carried out manually by a physician following medical guidelines and providing care for a patient. Similarly, periodically collecting data from the patient, processing it to measure treatment progress, and reporting the progress could be manually performed by the physician as they continue to provide medical care for the patient. Therefore, the limitations, considered as a whole, encompass Certain Methods of Organizing Human Activity.
Claims 2-6, 9, and 12-17 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claims 2-3, 13, and 17 further define the symptom weight and reporting of the measured progress. Therefore, these claims also encompass Certain Methods of Organizing Human Activity for the reasons set forth above. Claims 4-6 further comprises changing from an initial method of collecting patient data via a telephone voice response system to a direct telephone call from a provider. This further encompasses manual steps that could be carried out by the provider providing care for the patient, noting that the claims do not require carrying out the voice response system, simply establishing and changing the method. Therefore, these claims also encompass Certain Methods of Organizing Human Activity. Claim 9 further comprising alerting a provider if the measured progress fails to meet a predetermined standard. This further encompasses manual steps that could be carried out by manually notifying the provider, which also encompass Certain Methods of Organizing Human Activity. Claim 12 further recites collecting the data by identifying symptoms to the patient and requesting data reflecting the severity of the symptoms. This further encompasses manual steps that could be carried out by the provider manually interacting with the patient to acquire this information, which also encompass Certain Methods of Organizing Human Activity. Claims 14-16 further expand on comparing the measured progress and collecting data from a plurality of additional patients. These steps could similarly be carried out manually by the provider as explained above, which also encompass Certain Methods of Organizing Human Activity.
Claims 7-8 and 10-11 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea, but for the recitation of generic computer components. Claims 7-8 further define the collecting of data from the patient which, as identified above, is capable of being carried out manually. Therefore, but for the recitation of “using a digital data device,” these limitations also encompass Certain Methods of Organizing Human Activity. Claims 10-11 further define the alerting of the provider and the collecting of the data from the patient which, as identified above, is capable of being carried out manually. Therefore, but for the recitations of “sending an electronic message” and “a user device chosen from the group…,” these limitations also encompass Certain Methods of Organizing Human Activity.
Claim 18 recites a treatment provider for entering data relating to a diagnosis for the patient and symptoms corresponding to the diagnosis; a patient to periodically enter data from the patient relating to severity of symptoms; and receiving and processing the severity data in order to measure progress of treatment, and for reporting the measured progress to at least one of: the patient, the treatment provider, a provider organization of the treatment provider, and a payer that pays for at least a portion of the treatment.
These limitations, as drafted, given the broadest reasonable interpretation, encompass managing interactions between people, but for the recitation of generic computer components, which is a subgrouping of Certain Methods of Organizing Human Activity. For example, but for the recitation of “a provider data entry system,” “a patient data entry system,” and “a data processing system,” entering diagnosis and symptom data could be carried out manually by a physician following medical guidelines and providing care for a patient who responds to the provider. Similarly processing the collected data to measure treatment progress and reporting the progress could be manually performed by the physician as they continue to provide medical care for the patient, but for the recitation of the generic computer components. Therefore, the limitations, considered as a whole, encompass Certain Methods of Organizing Human Activity, but for the recitation of generic computer components.
Claims 19-24 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea, but for the recitation of generic computer components. But for the recitation of the recited systems, claims 19-24 further define the severity, data entered by the patient, and measured progress data. Therefore, but for the recitations of the generic computer components, these limitations also encompass Certain Methods of Organizing Human Activity.
Step 2A Prong Two
Claims 1-17 do not integrated into a practical application because Claims 1-6, 9, and 12-17 do not recite any additional elements other than the abstract idea. Furthermore, the additional elements recited in claims 7-8 and 10-11 amount to no more than generic computer components (digital data device, electronic message, user device) utilized to carry out insignificant, extra-solution data gathering and transmitting activity. Additionally, the written description discloses that the recited computer components encompass generic components including “the computer 130 is used by individual healthcare providers (e.g., a therapist, doctor, or other provider of mental or medical healthcare), the computer 132 is used by a provider organization/facility, the computer 134 is used by an insurer/payer, and the computer 136 is used by a patient.” (see paragraph 0021). Therefore, these additional elements, whether considered individual or as an ordered combination, do not integrate the abstract idea into a practical application.
Claims 18-24, directly or indirectly, recite the following generic computer components configured to implement the abstract idea: “a provider data entry system,” “a patient data entry system,” “a data processing system,” “an interactive voice response system,” “keypad on the telephone,” “mobile device,” “computer,” “database associated with the data processing system” to carry out the abstract idea. The written description discloses that the recited computer components encompass generic components including “the computer 130 is used by individual healthcare providers (e.g., a therapist, doctor, or other provider of mental or medical healthcare), the computer 132 is used by a provider organization/facility, the computer 134 is used by an insurer/payer, and the computer 136 is used by a patient.” (see paragraph 0021). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 “merely include[ing] instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Additionally, utilizing generic computer components to perform insignificant, extra-solution data gathering and transmitting activity and generally linking the abstract idea to a particular technological environment also do not integrate the abstract idea into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application. Claims 1-6, 9, and 12-17 do not recite any additional elements other than the abstract idea. Additionally, the additional elements recited in claims 7-8, 10-11, and 18-24 are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”).
Receiving and transmitting data over a network (i.e. receiving and communicating) has been recognized as well-understood, routine, and conventional activity of a general-purpose computer (see MPEP 2106.05(d) and buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014)).
Insignificant, extra solution, data gathering activity has been found to not amount to significantly more than an abstract idea (see MPEP 2106.05(g) and Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)).
Storing and retrieving information in memory has been recognized as well-understood, routine, and conventional activity of a general-purpose computer (see MPEP 2106.05(d) and Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93).
Additionally, the aforementioned additional elements, considered in combination, do not provide an improvement to a technical field or provide a technical improvement to a technical problem. Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
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 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.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1-8, 11-13, 15-19, and 23 are rejected under 35 U.S.C. 102(e) as being anticipated by Salgado, US Patent Application Publication No. 2007/0226012.
As per claim 1, Salgado teaches a method for evaluating healthcare treatment of a patient, comprising: establishing a diagnosis for the patient (see paragraph 0018; clinical diagnosis established); establishing symptoms corresponding to the diagnosis (see paragraph 0020; collected patient-reported symptoms); establishing a weight for each symptom (see paragraph 0020; symptoms have “values” used in calculating composite score, which functions as a weight); periodically collecting data from the patient relating to symptoms (see paragraph 0020; patient provides symptom data in interviews); processing the collected data to measure progress of treatment, and taking into account the weight established for each symptom (see paragraphs 0020 and 0027; collected data is processed to generate composite score, which is used to determine disease progression); and reporting the measured progress (see paragraph 0039; score provided showing measured progress of treatment).
As per claim 2, Salgado teaches the method of claim 1 as described above. Salgado further teaches the weight for each symptom is based on the importance of the symptom to the patient (see paragraph 0020; severity is provided by patient).
As per claim 3, Salgado teaches the method of claim 1 as described above. Salgado further teaches the step of establishing a weight for each symptom comprises: providing a pre-established weight for each symptom (see paragraph 0020); and modifying the pre-established weight so that the weight for each symptom is based on the importance of the symptom to the patient (see paragraph 0020; i.e. initial plurality of symptoms versus those selected for calculating the composite score based on patient scoring).
As per claim 4, Salgado teaches the method of claim 1 as described above. Salgado further teaches the step of periodically collecting data from the patient comprises: establishing an initial method of collecting data from the patient (see paragraph 0029; patient provides responses to questions over IVRS); and changing the initial method of collecting data if the collection does not meet a predetermined standard (since this step is conditional on “if the collection does not meet a predetermined standard,” the prior art need not disclose the conditional step to anticipate the claim).
As per claim 5, Salgado teaches the method of claim 4 as described above. Salgado further teaches the initial method of collecting data from the patient comprises the use of a telephone voice response system (see paragraph 0029; patient provides responses to questions over IVRS).
As per claim 6, Salgado teaches the method of claim 5 as described above. Salgado further teaches changing the initial method of collecting data comprises a direct telephone call from a provider (since this step is conditional on “if the collection does not meet a predetermined standard,” the prior art need not disclose the conditional step to anticipate the claim).
As per claim 7, Salgado teaches the method of claim 1 as described above. Salgado further teaches the step of periodically collecting data from the patient comprises using a digital data device by the patient (see paragraph 0029; patient provides responses to questions internet into a computer database).
As per claim 8, Salgado teaches the method of claim 7 as described above. Salgado further teaches periodically collecting of data from the patient further comprises having the patient respond to data messages from a provider (see paragraph 0073; questions can be provided to patient by healthcare worker).
As per claim 11, Salgado teaches the method of claim 1 as described above. Salgado further teaches the step of periodically collecting data from the patient comprises entering patient feedback at a user device chosen from a group consisting of a telephone in communication with an interactive voice response system, a mobile phone receiving a text message, a personal digital assistant device responding to a data message, and a computer responding to an email (see paragraph 0029; patient provides responses to questions over IVRS or computer over internet).
As per claim 12, Salgado teaches the method of claim 1 as described above. Salgado further teaches the step of periodically collecting data comprises: identifying to the patient each of the established symptoms (see paragraph 0025); and requesting entry of data reflecting the severity of the identified symptom (see paragraph 0029; patient provides responses to questions over IVRS).
As per claim 13, Salgado teaches the method of claim 1 as described above. Salgado further teaches the measured progress is reported to at least one of the patient, a treatment provider, a provider organization with which the provider is associated, and a payer that pays for at least a portion of the treatment (see paragraph 0040 accurate scores are provided to users of the system).
As per claim 15, Salgado teaches the method of claim 13 as described above. Salgado further teaches collecting data from a plurality of patients in addition to the patient whose healthcare is being evaluated (see paragraph 0020; interviews conducted for one or more patients); processing the collected data from the plurality of patients to measure progress of treatment for the plurality of patients (see paragraph 0020; measured progress of treatment based on analysis of collected data); and comparing the measured progress of treatment of the patient whose healthcare is being evaluated against the measured progress of treatment for the plurality of patients (see paragraph 0022; results are compared for patients).
As per claim 16, Salgado teaches the method of claim 15 as described above. Salgado further teaches the plurality of patients all of a characteristic of having the same diagnosis as the patient (see paragraph 0023).
As per claim 17, Salgado teaches the method of claim 1 as described above. Salgado further teaches the step of establishing a weight for each symptom further comprises: establishing a first group of weights based on the importance of each symptom to the patient (see paragraph 0020); and establishing a second group of weights based on the clinically established importance of each symptom to the provider (see paragraph 0026; known diagnostic criteria represents clinical importance to provider).
Claims 18, 19, and 23 recite substantially similar system limitations to method claims 1 and 5 and, as such, are rejected for similar reasons as given above.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 9, 10, 14, and 24 are rejected under 35 U.S.C. 103(a) as being unpatentable over Salgado, US Patent Application Publication No. 2007/0226012 in view of Zakim, US Patent No. 7,379,885.
As per claims 9 ad 10, Salgado teaches the method of claim 1 as described above. Salgado does not explicitly teach alerting a provider of healthcare treatment if the measured progress fails to meet a predetermined standard by sending an electronic message to the provider. Zakim teaches alerting a provider of healthcare treatment if the measured progress fails to meet a predetermined standard by sending an electronic message to the provider (see paragraph 31, lines 41-57). It would have been obvious to one of ordinary skill in the art at the time of the invention to add is alerting feature to alert a provider in the system of Salgado with the motivation of speeding the notification of important information to a provider (see column 24, lines 18-20 of Zakim).
As per claim 14, Salgado teaches the method of claim 13 as described above. Although Salgado teaches comparing progress against data taken from other patients having a similar diagnosis, Salgado does not explicitly teach comparing progress against a longitudinal study of other patients. Zakim teaches comparing data against a longitudinal study of patients having a similar diagnosis (see paragraph 34, lines 39-58). It would have been obvious to one of ordinary skill in the art at the time of the invention to supplement the analysis of Salgado with such a longitudinal study with the motivation of accounting for differences in onsets of disease in different patients in Salgado (see column 34, lines 39-41 of Zakim).
Claim 24 recites substantially similar system limitations to method claim\s 14 and, as such, is rejected for similar reasons as given above.
Claim 20 is rejected under 35 U.S.C. 103(a) as being unpatentable over Salgado, US Patent Application Publication No. 2007/0226012 in view of Brown, US Patent Application No. 2009/0112624.
As per claim 20, Salgado teaches the method of claim 13 as described above. Although Salgado teaches the severity data is entered by the patient, Salgado does not explicitly teach the data is entered at a keypad on the telephone. Brown teaches a patient entering data at a keypad on a telephone (see paragraph 0063). It would have been obvious to one of ordinary skill in the art at the time of the invention to add keypad data entry to the existing telephone data providing of Salgado with the motivation of improving user preferences for data entry by taking advantage of many existing methods of data collection (see paragraph 0063 of Brown).
Claims 21 and 22 are rejected under 35 U.S.C. 103(a) as being unpatentable over Salgado, US Patent Application Publication No. 2007/0226012 in view of Alpsten, US Patent Application Publication No. 2007/0280431.
As per claim 21, Salgado teaches the method of claim 18 as described above. Although Salgado teaches a patient using a mobile device for data entry, Salgado does not explicitly teach that patient data is entered in response to messages transmitted from the data processing system and formatted as short messaging service messages. Alpsten teaches sending a patient messages transmitted from the data processing system and formatted as short messaging service messages (see paragraph 0028). It would have been obvious to one of ordinary skill in the art at the time of the invention utilize SMS messaging to communicate to patients in the system of Salgado with the motivation of encouraging the patients to be more likely to respond (see paragraph 0028 of Alpsten.
As per claim 22, Salgado teaches the method of claim 18 as described above. Salgado does not explicitly teach the patient enters data in response to email messages transmitted from the data processing system. Alpsten teaches sending email messages to a patient to prompt a patient response (see paragraphs 0006-0007). It would have been obvious to one of ordinary skill in the art at the time of the inventio`n to add email messages to the system of Salgado with the motivation of improving communications with patients using the system (see paragraph 0039 of Alpsten).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tawil, US Patent No. 8,165,894, discloses recording patient reported symptoms, scoring improvement in a patient’s condition, and generating outcome indexes to compare results of providers.
Lang, US Patent Application Publication No. 2006/0241972, discloses monitoring patient data to track improvement or deterioration due to medical treatment.
Bardy, Canadian Publication No. CA 2325657 C, discloses patient submitted quality of life and symptom measurements to a server system to identify chances in a health condition.
Luciano, US Patent No. 6,063,028, discloses a self-reported symptom scale obtained from a patient.
Spencer et al., Validation of a guideline-based composite outcome assessment tool for asthma control, discloses evaluation of patient symptom reaction to treatment and discusses weighting of evaluated parameters.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to C. Luke Gilligan whose telephone number is (571)272-6770. The examiner can normally be reached on Monday through Friday 9:00 - 5:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683