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 .
Status of Claims
Claims 1-20 are pending.
This communication is in response to the communication filed November 3, 2025.
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
Claim limitations pathway modeling subsystem, user interaction subsystem, module customization subsystem, and communication subsystem have been interpreted under 35 U.S.C. 112(f), because they use generic placeholders “subsystem” coupled with functional language without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f), claims 9-16 have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that there does not appear to be any corresponding structure described in the specification for the 35 U.S.C. 112(f) limitations.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Claims 9-16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim limitations: pathway modeling subsystem, user interaction subsystem, module customization subsystem, and communication subsystem invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite systems, apparatuses, and methods for navigating and managing clinical care continuum, which are statutory categories of inventions.
Specifically, the independent claims, taking claim 17 as exemplary recite generating a pathway map representing a hierarchy of clinical stages within a first clinical process, the pathway map comprising a first stage indicative of a first step of the first clinical process; displaying the pathway map; receiving a first user input; and updating the pathway map based on a first parameter associated with the first user input. The dependent claims recite limitations directed to further explaining the pathway map, medical information, updating the pathway map, first input, second data, and decision or scenario stations.
The claims as a whole are interpreted as being grouped within the “certain methods of organizing human activity” grouping of abstract ideas because in this case, the claims involve collecting information, analyzing it, and outputting a result of the collection and analysis as a pathway map used to manage clinical care. See MPEP 2106.04. The claims are interpreted to recite concepts relating to tracking or organizing health care information. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. Integration into a practical application requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. Here, the additional elements of the claims include various computer elements: storage medium, databases, processing unit, memory, user interface, network device, display device, information processing engine, and various subsystems (pathway modeling subsystem, user interaction subsystem, module customization subsystem, and communication subsystem).
The claims merely use the additional elements as tools to perform abstract ideas and generally link the use of a judicial exception to a particular technological environment. The use of the additional elements as tools to implement the abstract idea and generally to link the use of the abstract idea to a particular technological environment does not render the claim patent eligible, because it requires no more than a computer performing functions that correspond to acts required to carry out the abstract idea. Specifically, the various subsystems may be a part of a system and are recited at a high level of generality. The various computer elements are recited at a high level of generality and may be any kind of computer device performing various data input, processing, output, display, analysis, storage functions (specification p. 30-33).
The additional elements do not show an improvement to the functioning of a computer or to any other technology, rather the additional elements perform general computing functions and do not indicate how the particular combination improves any technology or provides a technical solution to a technical problem. See Apple v. Ameranth, 842 F.3d 1229, 1240 (Fed. Cir. 2016). The additional elements do not use the exception to affect a particular treatment or prophylaxis for a disease, do not apply the exception using particular machines, and do not effect a transformation or reduction of a particular article to a different state or thing, rather the computer elements are generally stated as to their structure and function and are only used to manage clinical care continuum instead of directly providing specific treatment or prophylaxis. Therefore, the additional elements do not impose any meaningful limits on practicing the abstract idea and the additional limitations are not indicative of materializing into a practical application. Accordingly, the claim is directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the steps of the claims amount to no more than using computer related devices to automate or implement the abstract idea of navigating and managing clinical care continuum.
The use of a computer or processor to merely automate or implement the abstract idea cannot provide significantly more than the abstract idea itself. (See MPEP 2106.05(f) where mere instructions to apply an exception does not render an abstract idea patent eligible). There is no indication that the additional limitations alone or in combination improves the functioning of a computer or any other technology, improves another technology or technical field, or effects a transformation or reduction of a particular article to a different state or thing. Therefore, the claims are not patent eligible.
In conclusion, the claims are directed to the abstract idea of navigating and managing clinical care continuum. The claims do not provide an inventive concept, because the claims do not recite additional elements or a combination of elements that amount to significantly more than the judicial exception of the claims. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and the collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an order combination, the claims 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 1-8 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being Anticipated by Levin et al. (IDS Reference, hereinafter Levin).
As per claim 1 Levin teaches
an apparatus for navigating and managing clinical care continuum, comprising: a storage medium configured to store a first database, the first database comprising a first data associated with first clinical information (Levin par. 7-9 teaches "these methods may include using a domain-specific treatment language to encode user (e.g., physician, therapist, dentist, orthodontist, etc.) preferences as part of a treatment template (also referred to as a treatment protocol). The treatment template, in the domain-specific treatment language, may be read manually (e.g., by the user, technician, etc.) and is also machine readable and parsed by a processor into a set of treatment planning instructions that may applied by a treatment planning engine to one or more patient cases. The treatment planning engine may use the treatment planning instructions, along information about the patient (e.g., the patient's oral cavity, such as a scan of the patient's teeth or other relevant body regions) to automatically generate one or more treatment plans specific to the patient The orthodontic treatment planning engine may use the treatment planning instructions, along information about the patient's oral cavity (such as a scan of the patient's teeth) to automatically generate one or more treatment plans specific to the patient. Because the treatment plan(s) is/are generated using the treatment planning instructions derived from a user's customized treatment template, the resulting treatment plan(s) may also be customized to the user. The resulting treatment plans may be reviewed and approved by the user A treatment plan may refer to a series of steps, devices and/or schedules for altering a subject's physiology to achieve or approach a desired outcome. In some cases the treatment plan is an orthodontic' treatment plan and may refer to a series of steps, devices and/or schedules for altering a subject's dental arch to achieve or approach a desired outcome."; par. 134 teaches "the treatment template engine(s) 104 may implement one or more automated agents configured to generate, aggregate, and/or collect a treatment template in a domain-specific orthodontic treatment language. The treatment template engine(s) may include one or more outputs (screens, printers, etc.) 103 for listing, displaying, etc., use orthodontic treatment plans, and may connect to one or more datastores (e.g., treatment template datastores) containing a library or libraries of treatment templates. The treatment template engine may include one or more user interfaces (UIs) for selecting, modifying, storing, reviewing, etc., one or more treatment template.");
a processing unit coupled to the storage medium and configured to: retrieve the first data from the storage medium; and generate a pathway map using at least the first data, the pathway map representing a hierarchy of clinical stages within a first clinical process (Levin par. 7-9, 236 teaches "The customized treatment steps may comprise one or more Iterative treatment steps repeating application of at least a portion of the treatment plan on the patient. As noted herein, the one or more automated iterative treatment steps may repeat a treatment option across a series of related portions of anatomy. Further, the one or more automated iterative treatment steps may repeat an orthodontic treatment option across a specific portion of dentition of the patient. In various implementations, the customized treatment steps may comprise one or more nested treatment steps that organize parts of the treatment plan according to a hierarchy of treatment rules");
a memory coupled to the processing unit and configured to store the pathway map (Levin par. 211 teaches "The user and/or technician may indicate if the current selected treatment protocol, which resulted in the test treatment plan, is correct, or if it should be modified. If the user and/or technician indicates that the treatment protocol is sufficient, the selected treatment protocol may be finalized (approved). Alternatively, if the selected treatment protocol is not final, the user and/or technician may further modify it 1607. For example, the system may receive proposed modifications to the selected treatment protocol from the user and/or technician 1609. These proposed modifications may be converted into a set of modification instructions in the domain-specific orthodontic treatment language as described above 1611. The set of domain-specific modification instructions may then be used to modify the selected treatment protocol to form a putative final treatment protocol 1613, The putative final treatment protocol may then be used as the selected treatment protocol and again used to generate a test treatment plan using a sample patient dataset, as described above 1605, the results displayed and analyzed/approved as mentioned above, and further approval or modifications made. This entire process may be iterated until the treatment protocol is finally approved. In some variations, this final treatment protocol may then be stored (e.g., as a new user-associated treatment protocol) and used in the immediate case and/or in a future case to generate, in conjunction a digital model of a patient's teeth, a treatment plan 1615. For example, the system may generate a treatment plan using the final treatment protocol.");
a user interface coupled to the processing unit and configured to receive a first user input (Levin par. 18 teaches "A user interface may be provided for selecting the treatment template from the library. For example, any of these methods may include displaying the treatment template selected to the user and allowing the user to modify the orthodontic treatment planning language (e.g., the domain-specific orthodontic treatment language) in the treatment template. Modifying the template may include presenting a graphical user interface (GUI) to the user, wherein the GUI receives user-selected parameters that modify the treatment template.");
and a network device coupled to the processing unit and configured to communicate with a second database (Levin par. 47 teaches "presenting the display showing the selected treatment protocol as applied to one or more sample patients to the user may include applying the treatment protocol to one or more digital models of the one or more sample patients' teeth from a library of sample patients' teeth.").
As per claim 2, Levin teaches all the limitations of claim 1 and further teach wherein the pathway map comprises a first stage of the first clinical process, and the first stage comprises a first module configured to provide medical information associated with the first stage and a medical condition of a first patient (Levin par. 44).
As per claim 3, Levin teaches all the limitations of claim 2 and further teach wherein the medical information comprises at least one of treatment options, educational resources, risk assessments, nutritional guidance, support services, or medication information (Levin par. 105).
As per claim 4, Levin teaches all the limitations of claim 1 and further teach wherein the processing unit is further configured to update the pathway map based on a first parameter, the first parameter being associated with the first user input (Levin par. 211).
As per claim 5, Levin teaches all the limitations of claim 1 and further teach wherein the first user input comprises at least one of stage identification, medical diagnosis, diagnostic test result, treatment decision, symptom report, or user preference (Levin par. 105, 211)
As per claim 6, Levin teaches all the limitations of claim 1 and further teach wherein the processing unit is further configured to update the pathway map based on a second parameter associated with an update of the first data (Levin par. 106).
As per claim 7, Levin teaches all the limitations of claim 1 and further teach wherein the second database comprises a second data associated with patient-specific information, the patient-specific information comprises at least one of medical history, genetic information, biomarker information, diagnostic results, current medications, allergy information, financial information, or insurance information (Levin par. 150).
As per claim 8, Levin teaches all the limitations of claim 1 and further teach wherein the user interface further comprises a display device configured to display the pathway map (Levin fig. 26, par. 221).
As per claim 17-20, see claim rejections 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 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 9-12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Levin in view of Bates et al. (IDS Reference, hereinafter Bates.
As per claim 9, Levin teaches
a system for navigating and managing clinical care continuum, comprising a pathway modeling subsystem configured to generate a pathway map representing a hierarchy of clinical stages within a first clinical process, the pathway map comprising a first stage indicative of a first step of the first clinical process; (Levin par. 7-9, 236)
a user interaction subsystem configured to display the pathway map and receive a first user input; (Levin par. 18, 211)
a module customization subsystem configured to update the first stage based on the first user input; and (Levin par. 18, 211)
Levin does not teach the following limitations met by Bates, a communication subsystem configured to communicate with an external database (Bates par. 63-65 teaches a medical data system comprising a main orchestration engine, patient kiosk interface, doctor interface, kiosk located sensors, medical equipment, which may be couples to sensor board, administrator web interface, AIU, and exam notes generation).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Levin to use a communication subsystem configured to communicate with an external database as taught by Bates with the motivation to allow population of internal HER database and billing systems (Bates par. 65).
As per claim 10, Levin and Bates teach all the limitations of claim 1 and further teach, wherein the first stage comprises a decision station or a scenario station (Levin par. 18).
As per claim 11, Levin and Bates all the limitations of claim 9 and further teach wherein the first stage comprises a first module configured to provide medical information associated with the first stage (Levin par. 44).
As per claim 12, Levin and Bates teach all the limitations of claim 11 and further teach wherein the medical information comprises at least one of treatment options, educational resources, risk assessments, nutritional guidance, support services, or medication information (Levin par. 105).
As per claim 14, Levin and Bates teach all the limitations of claim 9 and further teach a data integration subsystem configured to integrate with the external database, the external database comprises at least one of electronic health records, payor portals, or prescription systems (Bates par. 65).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Levin to use a data integration subsystem configured to integrate with the external database as taught by Bates with the motivation to allow population of internal HER database and billing systems (Bates par. 65).
As per claim 15, Levin and Bates teach all the limitations of claim 9 and further teach wherein the pathway map is generated based on first clinical information (Levin par. 7-9).
As per claim 16, Levin and Bates teach all the limitations of claim 9 and further teach an information processing engine configured to perform content adaptation within the pathway map based on user preference (Levin par. 105, 150).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Levin in view of Bates in further view of Subramanian et al. (IDS Reference, hereinafter Subramanian).
As per claim 13, Levin and Bates teach all the limitations of claim 9 and further teach accessing the pathway map (Levin par. 7-9, 18, 236), but do not teach the following limitations met by Subramanian, an account management subsystem configured to manage user profiles and permissions for (Subramanian par. 121 teaches an association between a remote provider and a hospital is created on the back end by matching providers to hospitals based on licensing and credentialing at sites. Alternatively, in some cases, remote providers can self-select hospitals by creating associations with one or more hospitals. As an example, after login, a provider can add themselves via the Settings element 604 in FIG. 6 to teams and hospitals that they are affiliated with. The authentication with the hospital to validate the provider as an authorized caregiver may happen in the background via a 2-step process. The provider may receive an email link from the hospital using their standard practice. The provider can then add himself to the hospital that is part of the network of hospitals deploying the system. At that time, another authentication process may be initiated after which a provider may be permitted to use the system via a login process on the device 100. Upon successful login, the provider may be presented with a dashboard as shown in FIG. 6 that shows a complete list of patient related messages 606, broadcast by nurses, as described earlier, regarding the patients that are admitted to a hospital unit that the provider is affiliated with.).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Levin and Bates to use an account management subsystem configured to manage user profiles and permissions as taught by Subramanian with the motivation to allow validating the provider as an authorized caregiver (Subramanian par. 121).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY M. PATEL whose telephone number is (571)272-6793 and email is jay.patel2@uspto.gov. The examiner can normally be reached on Monday-Friday 8AM-4:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H. Choi can be reached on (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAY M. PATEL/Primary Examiner, Art Unit 3686
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