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 April 10, 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 “health care module[s]”, “professional module”, “insurance module”, “pharmacy module,” and “patient module,” have been interpreted under 35 U.S.C. 112(f), because they use generic placeholders “module” 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 1-20 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 the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) limitations: computers.
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 § 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 1-4, 6-11, 13-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Linn et al. US2014/0244296 in view of Vishnubhatla et al. US2010/0324936.
As per claim 1, Linn teaches
a system for facilitating interoperability among health care modules, comprising: (Linn fig. 1 and associated paragraphs teaches a medical care application distribution systems implemented in a computing system configured for integrating data; Linn par. 97-102 teaches computer software and firmware, processors, program logic, and computer-readable media)
an interface configured to receive a first electronic record from a first health care module, the first electronic record having a first data structure; (Linn fig. 1, 4 and associated paragraphs teaches a medical care application may interface with subordinate applications so that the medical care application may establish an interface to coordinate the exchange of health care information)
a processor communicatively coupled to the interface, the processor configured to: analyze the first electronic record having the first data structure; based on the analysis, extract a portion of data from the first electronic record; (Linn par. 5, 24, 41, 49, 98 teaches a data processing apparatus and analyzing medical information within an integrated information ecosystem. A data processing module receives, processes, filters and/or mines one or more of retail prescription data, longitudinal patient data, reference prescriber data, and pharmaceutical purchase data for specific information.)
wherein the second data structure is configured to be compatible with a second health care module; and (Linn fig. 4, 6 and associated paragraphs teaches integration of data, coordination of information exchange, and interfacing with multiple applications and data)
wherein the interface is further configured to transmit the second electronic record for display to the second health care module (Linn par. 103 teaches implementations of the systems described may have display devices and the computer may interact with a user by sending and receiving documents).
Linn does not specifically teach the following limitations met by Vishnubhatla, create a second electronic record using the portion of data from the first electronic record, the second electronic record having a second data structure, (Vishnubhatla fig. 1 and associated paragraphs teaches utilizing various medical data to collect information to create enhanced electronic health records).
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 Linn to create records with a second data structure as taught by Vishnubhatla with the motivation to gather and complete an accurate and timely report for effective medication management (Vishnubhatla par. 6-10).
The primary reference teaches computer implemented methods and systems for managing information exchange between medical care applications and an analytical infrastructure for medical care information. The difference between the reference and the claimed subject matter is that the reference does not specifically disclose creating a second record with a second data structure. Vishnubhatla discloses utilizing various medical data to collect information to create enhanced electronic health records. Since each individual element and its function are shown in the prior art, albeit in separate references, the difference between the claimed subject matter and the prior rests not on any individual element or function but in the very combination itself.
In the combination of the references, it is well within the capabilities of one of ordinary skill in the art to utilizing various medical data to collect information to create a plurality of records with a plurality of data structures. One of ordinary skill in the art would have recognized that the results of the combination were predictable. Moreover, an enhanced electronic health record may be more accurate and up to date, allowing for more accurate medical treatments.
As per claim 2, Linn and Vishnubhatla teach all the limitations of claim 1 and further teach wherein: the interface is further configured to receive a third electronic record from a first health care database, the third electronic record having a third data structure; and the processor is further configured to: analyze the third electronic record having the third data structure; extract a portion of data from the third electronic record; and create a fourth electronic record using the portion of data from the third electronic record, the fourth electronic record having a fourth data structure, wherein the fourth data structure is configured to be compatible with a third health care module (Linn fig. 1 and associated paragraphs, par. 51 teaches receiving various types of information from a plurality of sources, here a first health care database may be a retail pharmacy sending retail prescription data, which may include a first data structure about a retail pharmacy outlet that dispenses one or more pharmaceutical products, a second data structure about one or more patients that purchased the pharmaceutical products, and a third data structure about one or more prescribers that wrote the scripts used by the patients to obtain the pharmaceutical products).
As per claim 3, Linn and Vishnubhatla teach all the limitations of claim 1 and further teach wherein: the processor is further configured to create a user profile using the portion of data from the first electronic record; and the interface is further configured to transmit the user profile for display to the second health care module (Linn fig. 3, par. 50 teaches the data processing module may create profiles for each patient, prescriber, and retail pharmacy outlet for which data is received; user profile display interfaces).
As per claim 4, Linn and Vishnubhatla teach all the limitations of claim 1 and further teach wherein the first electronic record is a prescription for a patient and the first health care module is a health care professional module; wherein the interface is further configured to access an electronic insurance record from an insurance module, the electronic insurance record comprising information about insurance coverage for the patient; wherein the processor is further configured to: determine whether the prescription is covered for the patient by analyzing the electronic insurance record; in response to determining that the prescription is not covered for the patient, determine an alternative prescription that is covered for the patient; and instruct the interface to transmit the alternative prescription to a pharmacy module to fulfill the prescription (Linn fig. 1, 6, and associated paragraphs, par. 103 teaches retail prescription data shared with an EMR system, which may used by healthcare professionals) (Vishnubhatla par. 207 teaches a prescription management facility accessing patient insurance plans; par. 207 teaches a prescription management facility performing insurance coverage checks for medication being prescribed to a patient; par. 215 teaches a prescription management facility may include a therapeutic equivalent facility which may contain a library of such therapeutic equivalents and suggest them to the prescribing professional upon order entry based on for example, whether the prescribed medication is on the patient's insurance formulary; fig. 1 and associated paragraphs, par. 88, 207-215 teaches prescribing generic medication or insurance covered medication after validation).
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 Linn to access insurance information to check for prescription insurance coverage and determine and fulfill an alternative medication as taught by Vishnubhatla with the motivation to avoid use of non-coverage medications that may result in phenomenally high expenses for the patient (Vishnubhatla par. 207).
As per claim 6, Linn and Vishnubhatla teach all the limitations of claim 1 and further teach wherein the interface is further configured to receive a third electronic record from a first health care database, the third electronic record having a third data structure; and wherein the processor is further configured to: create a first user profile using the portion of data from the first electronic record; analyze the third electronic record having the third data structure; extract a portion of data from the third electronic record; and create a second user profile using the portion of data from the third electronic record; and associate the first user profile and the second user profile.
As per claim 7, Linn and Vishnubhatla teach all the limitations of claim 1 and further teach wherein the first electronic record is prescription information and the first health care module is an insurance module.
As per claim 8-11, 13-18, and 20, see claims 1-4 and 6-7 rejection above.
Claims 5, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Linn et al. US2014/0244296 in view of Vishnubhatla et al. US2010/0324936 in further view of McCauley US2015/0294084.
As per claim 5, Linn and Vishnubhatla teach all the limitations of claim 1 and further teach
wherein the first electronic record is a prescription for a patient and the first health care module is a health care professional module; (Linn fig. 1, 6, and associated paragraphs, par. 103 teaches retail prescription data shared with an EMR system, which may used by healthcare professionals)
wherein the second electronic record is a prescription for the patient and the second health care module is a pharmacy module; (Linn par. 8 teaches medical applications for a pharmacist)
wherein the interface is further configured to access information about the status of the prescription from the pharmacy module; (Vishnubhatla par. 88 teaches the dispensing and marking facility may receive the validated prescription and the associated information in real-time from the communicatively coupled back bone network)
wherein the processor is further configured to: determine whether the prescription has been filled; (Vishnubhatla par. 88, 90 dispensing and marking facility may prepare the medication order according to the validated medication and may associate certain relevant data with the medication orders)
in response to determining that the prescription has been filled, instruct the interface to access information about the location of the pharmacy; and (Vishnubhatla par. 93, 146 teaches determining patient details and location of the patient to route the medication dispending and delivery, this is based off of immediacy of the need for medication, geographic proximity, availability, and cost of transport, a particular location may be an in-house pharmacy)
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 Linn to access information about the status of a prescription, determine whether the prescription has been filled, and access information about the location of the pharmacy as taught by Vishnubhatla with the motivation to promote efficient and effective medication management (Vishnubhatla par. 6-10, 207).
Linn and Vishnubhatla do not specifically teach the following limitations met by McCauley, wherein the interface is further configured to transmit an indication to a patient module that a prescription is fulfilled, the indication comprising information about the location of the pharmacy (McCauley par. 123 teaches a processor detects a proximity of a communication device to a pharmacy location, sends pharmacy identification information to the pharmacy computing device, sends customer identification information to the pharmacy computing device, displays a notification that a prescription is available for the prescription customer at the pharmacy, and displays a prescription pickup location associated with the pharmacy based on the determination made by the pharmacy computing device).
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 Linn and Vishnubhatla to send an indication including a location of a pharmacy of a filled prescription as taught by McCauley with the motivation to make prescription pickup efficient (McCauley par. 5).
As per claims 12 and 19, see claim 5 rejection above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,861,589. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims recite the limitations of the patented claims. Independent claims 1, 8, and 15 recite the limitations of the patented independent claims. The pending dependent claims are rejected for reciting the limitations of the dependent patented claims and being dependent on rejected claims.
Pending claim 1 recites: A system for facilitating interoperability among health care modules, comprising:
Patented claim 1 recites: A system for facilitating interoperability among health care modules, comprising:
an interface configured to receive a first electronic record from a first health care module, the first electronic record having a first data structure;
an interface configured to receive a first electronic record comprising a prescription from a first health care module, the first electronic record having a first data structure;
a processor communicatively coupled to the interface, the processor configured to: analyze the first electronic record having the first data structure;
a processor communicatively coupled to the interface, the processor configured to:
analyze the first electronic record having the first data structure;
based on the analysis, extract a portion of data from the first electronic record;
based on the analysis, extract a portion of data from the first electronic record;
create a second electronic record using the portion of data from the first electronic record, the second electronic record having a second data structure, wherein the second data structure is configured to be compatible with a second health care module;
create a second electronic record using the portion of data from the first electronic record, the second electronic record having a second data structure, wherein the second data structure is configured to be compatible with a second health care module and the second data structure is incompatible with the first health care module;
and wherein the interface is further configured to transmit the second electronic record for display to the second health care module.
wherein the interface is further configured to transmit the second electronic record for display to the second health care module;
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.
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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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