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 Claim(s)
Claims 1-, 8, 20-21, 29-30, 32-37 have been examined. Claims 2-7, 9-19, 22-28 and 31 preliminarily have canceled. Claims1, 8, 20-21, 29-30 have been amended. Claims 32-37 have been added.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 8, 20-21, 29-30, 32-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,380,979. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite a patient device and a physician device, each including: a user interface, a network module; and a processor; and a medical network;
.
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 network module, a network module of the patient device in claim 2.
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.
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, 8, 20-21, 29-30, 32-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claim 1 recite(s) a system for managing medical treatment which is within a statutory category (machine). Accordingly, claim 1 is within the statutory categories.
Step 2A - Prong One:
Regarding Prong One of Step 2A, (see MPEP2106.04-.07), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes.
The limitation of Independent claims 1 recites at least one abstract idea. Specifically, claim 1 recites the steps of:
A system for managing food allergy immunotherapy, the system comprising:
a patient device having a network module; caregiver or trusted contact device having a network module in communication with the network module of the patient device;
a medication device associated with food allergy immunotherapy medication and having a network module in communication with the network module of the patient device; a non-transitory computer-readable storage medium storing instructions to perform a process comprising:
receiving a signal indicating use of the medication device by a patient, from the medication device,
sending a notification, to the caregiver or trusted contact device, indicating said use of the medication device by the patient, and
establishing a virtual video connection between the patient device and the caregiver or trusted contact device via their respective network modules so a caregiver or trusted contact can monitor the patient
The limitation of claim 1 “receiving a signal indicating use of the medication device by a patient, from the medication device, sending a notification, to the caregiver or trusted contact device, indicating said use of the medication device by the patient” constitutes b) organizing human activities because receiving signal, sending notification can be practically performed in the human activities.
The limitations of claim 1 “establishing a virtual video connection between the patient device and the caregiver or trusted contact device via their respective network modules so a caregiver or trusted contact can monitor the patient” b) certain method of organizing human activities because using video between patient and caregiver can be practically performed by human activities.
Furthermore, dependent claims 2-, 8, 20-21, 29-30, 32-37 further define the at least one abstract idea as set forth below:
Dependent Claims 29, 30 recite the usage or graphical user interface for displaying emergency care instruction, of displaying signal. Dependent claims 9-11 recite the usage of memory storage media, remote device, medical network. Dependent claim 13 recites the application of a cloud servers. Claim 14-14 recite the adjustment parameters of patient data. Dependent claim 24 recite the application of epinephrine auto injector. These steps expand the abstract idea of organizing human activity.
Step 2A - Prong Two
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted in the 2019 PEG, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
In the present case, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
Claim 1 recites
A system for managing food allergy immunotherapy, the system comprising:
a patient device having a network module; caregiver or trusted contact device having a network module in communication with the network module of the patient device;
a medication device associated with food allergy immunotherapy medication and having a network module in communication with the network module of the patient device; a non-transitory computer-readable storage medium storing instructions to perform a process comprising:
receiving a signal indicating use of the medication device by a patient, from the medication device (merely invokes use of computer and computer components as a tool as noted below, see MPEP 2106.05(f)(2),
sending a notification, to the caregiver or trusted contact device, indicating said use of the medication device by the patient, and
establishing a virtual video connection between the patient device and the caregiver or trusted contact device via their respective network modules so a caregiver or trusted contact can monitor the patient (merely data gathering steps as noted below, see MPEP 2106.05(g) and Symantec).
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of “a patient device having a network module; caregiver or trusted contact device having a network module in communication with the network module of the patient device; a medication device associated with food allergy immunotherapy medication”, this is pre-solution activity. The Examiner submits that these limitations are instructed to apply the above-noted abstract idea by merely invoking use of computer to perform the process, (see MPEP 2106.05(f)).
Regarding the additional limitations of “establishing a virtual video connection between the patient device and the caregiver or trusted contact device via their respective network modules so a caregiver or trusted contact can monitor the patient”, this post-solution activity. The Examiner submits that these additional limitations are instructed to apply the above-noted abstract idea by merely adds insignificant extra-solution activity of gathering data to the at least one abstract idea in a manner of post-solution activity that does not meaningfully limit the at least one abstract idea (merely data gathering steps as noted below, see MPEP 2106.05(g) and Symantec).
Particularly, the use of a processor, patient device, caregiver or trusted devices, a network, an epinephrine auto injector,a cloud server as in claims 1 is not positively claimed in the claim as it defines the service but is claimed insufficient to a structure or apparatus that it represents mere instructions to implement an abstract idea MPEP 2106.05(f). The claims recite the additional elements, using computer, processor, memory …; for receive, generating, transmitting, adjusting. The processor, patient/physician devices, computing device are recited at a high-level of generality (i.e. generic components). The Specification describes the additional elements, i.e. processor, memory, cloud server etc… as in claims 1, 8, 20-21, 29-30, 32-37. However, the specification does not describe any specialized components of the computing environment, but only describes these suitable components (Spec.; Para 0110). Furthermore, the use of computing components (i.e. processor, memory, an epinephrine auto injector, network, etc…) to receive, establish, to transmit “add nothing when looking at the elements taken individually. 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.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (see 2019 PEG and MPEP § 2106.05).
For these reasons, representative independent claim 1 does not recite additional elements that integrate the judicial exceptions into a practical application. The Examiner notes the mere recitation of a computing system, processor, an injector does not take the claims out of the mental process grouping or organizing human activity. Thus, the claims recite an abstract idea.
The remaining dependent claim limitations are not addressed above fail to integrate the abstract idea into a practical application
Further, the claims as a whole merely describes how to generally “apply” the concept of using peer-to-peer network, or a processor in a computer environment. The claimed computer components are recited at a high level of generality and are merely invoked as tools to perform the functions of receiving, establishing and transmitting. Simply implementing the abstract idea on a generic computer is not a practical application of the abstract idea. Accordingly, alone and in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Step 2B:
Regarding Step 2B of MPEP2106.04-.07, Independent claim(s) 1 does/do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reason to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Independent claim 1 limits the use of the patient device, caregiver devices, system...The Examiner submits that these limitations amount to merely using these computer devices as well-understood, routine, conventional activity (Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018).), and MPEP 2106.05(d)(I)(2). 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 patient-ineligible abstract idea into a patent-eligible invention”). Thus, claims 1, 8, 20-21, 29-30, 32-37 have been held as patent ineligible.
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.
Claims 1, 8, 20-21, 29-30, 32-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soyao et al. (US 20150216413 hereinafter Soyao) in view of Walser et al. (WO 2014159609A1 hereinafter Walser).
With respect to Claim 1, Soyao teaches a system for managing food allergy immunotherapy, the system comprising:
a patient device having a network module; caregiver or trusted contact device having a network module in communication with the network module of the patient device (‘413; Para 0016: generating insights relating to patient health using a social networking platform interconnecting a patient with a plurality of care givers. The method includes: receiving at least one characteristic of the patient, the at least one characteristic comprising a health condition of the patient; providing at least one computer application for access by the patient by way of the social networking platform, the at least one computer application configured to solicit and collect patient data from the patient, the at least one computer application selected from amongst a library of computer applications based on the at least one characteristic of the patient; receiving, by way of at the social networking platform, first patient data reflective of the health condition of the patient, as collected by the at least one computer application; transmitting, by way of at the social networking platform, a communication from at least one of the care givers to the patient; receiving, by way of the social networking platform, second patient data reflective of the health condition of the patient, the second patient data responsive to the transmitted communication; analyzing, using at least one processor) ;
a medication device associated with food allergy immunotherapy medication and having a network module in communication with the network module of the patient device; a non-transitory computer-readable storage medium storing instructions to perform a process comprising:
receiving a signal indicating use of the medication device by a patient, from the medication device (‘413; Para 0322),
sending a notification, to the caregiver or trusted contact device, indicating said use of the medication device by the patient, (‘413; Para 0093: platform 14 may automatically identify one or more widgets (or Health Quests 26) of interest to a particular patient 18, e.g., by matching the patient's health condition and the health condition associated with the widget, or by identifying applications popular amongst other patients 18 sharing one or more health conditions. Platform 14 may recommend identified widgets to a patient 18 for access, e.g., by way of notifications presented through application 100. Widgets may also be automatically matched and recommended to patients according other criteria (e.g., based on drugs that a patient is taking, organizations with which the patient is associated, research studies in which the patient is participating, etc.).) and
establishing a virtual video connection between the patient device and the caregiver or trusted contact device via their respective network modules so a caregiver or trusted contact can monitor the patient (‘413; Para 0067: Computing device 12 provides one or more patients 18 with access to a patient self-care solution application 100 executing at device 12, and a platform 14 by way of network 10. In an embodiment, computing device 12 may be a mobile device (e.g. an iPhone™ or Android™ device). In an embodiment, computing device 12 may be another type of networked computing device, such as a personal computer, workstation, server, portable computer, mobile device, personal digital assistant, laptop, tablet, WAP phone, an interactive television, video display terminals; Para 0098: A patient 18 can fulfil specific goals of the Health Quests 26 by, for example, engaging in real-life actions, and/or recording his or her actions in application 100 through various types of data entry by the patient 18, including text, photo, video, etc.)
Soyao does not, but Walser discloses providing oral immunotherapy (OIT) for subjects that are allergic to peanuts (‘609; Abstract; Para 0006).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of claimed invention to modify the system for analyzing and enhancing patient
health of Soyao with the technique of the preparation of the compositions for
immunotherapy as taught by Walser and the motivation is to provide the
food immunotherapy medication to the patient.
With respect to Claim 8, the combined art teaches the system of Claim 1, wherein the patient device comprises the non-transitory computer-readable storage medium and, a processor and wherein the one or more processor[[s]] performs the process (‘413; Para 0109).
With respect to Claim 20,the combined art teaches the system of Claim 1, wherein the process further comprises: receiving, by the patient device from an epinephrine auto injector, a signal, the signal indicating use of the epinephrine auto injector by the patient; generating, by the patient device, a communication, in response to the signal, the communication indicating the patient is in need of medical attention; and transmitting, by the patient device, the communication to one or more emergency services (‘609; Para 0083)
.
With respect to Claim 21, the combined art teaches the system of Claim 20, wherein generating the communication and/or transmitting the communication occurs automatically, substantially immediately upon receiving the signal (‘413; Para 0016).
With respect to Claim 29, the combined art teaches the system of Claim 21, wherein the process further includes:
unlocking, access to a graphical user interface of the patient device (‘413; Para 0325); and
displaying, by the patient device, emergency care instructions, to inform bystanders on how to care for the patient, on the graphical user interface of the patient device (‘413; Para 0325.
With respect to Claim 30, the combined art teaches the system of Claim 29, wherein unlocking and/or displaying occur automatically, substantially immediately upon receiving the signal (‘413; Paras 0305-0306).
With respect to Claim 32, the combined art teaches the system of Claim 1, wherein the patient device and the caregiver or trusted contact device each comprise a camera (‘413; Para 0074).
With respect to Claim 33, the combined art teaches the system of Claim 1, wherein the virtual video connection is established automatically, substantially immediately upon the notification being sent (’413; Para 0093).
With respect to Claim 34, the combined art teaches the system of Claim 1, wherein the medication device is in wireless communication with the patient device (‘413; Para 0066, 0314).
With respect to Claim 35, the combined art teaches the system of Claim 1, wherein the patient device is in wireless communication with the caregiver or trusted contact device (‘413; Para 0066, 0314).
With respect to Claim 36, the combined art teaches the system of Claim 1, wherein the medication device is a container having the food allergy immunotherapy medication (‘609; Para 0717).
With respect to Claim 37, the combined art teaches the system of Claim 1, wherein the patient device and the caregiver or trusted contact device each comprise a speaker and a microphone providing for audible communication (‘413; Para 0074: Each of platform 14 and application 100 may include one or more input devices, such as a keyboard, mouse, camera, touch screen, sensors, and a microphone, and may also include one or more output devices such as a display screen (with three dimensional capabilities) and a speaker).
Conclusion
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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686
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