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 .
Priority
Applicant’s claim of priority, based on continuation, to 17/125,720, filed on December 17, 2020, now U.S. Patent No. 11,978,558, is acknowledged.
Drawings
The 13 page drawings have been considered and placed on record in the file.
Status of Claims
Claims 129-156 are pending. Claims 1-128 are canceled.
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.
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.
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 limitations are: “a processing platform for …”, “a data network interface … ” in Claims 143-156.
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.
Double Patenting
The non-statutory 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 time-wise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory obviousness-type 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); and 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 a non-statutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). In order to expedite the processing/approval of the terminal disclaimer, Applicants may choose to file an electronic terminal disclaimer (eTerminal Disclaimer) by referring to the following website:
http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp
Claims of the instant application are rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims of its parent U.S. Patent No. 11,978,720. Although the conflicting claims are not identical, they are not patentably distinct from each other, because claims of the instant application is generic to all that is recited in claims of the above-listed parent U.S. patent. For example, the following chart compares method Claim 129 of the instant application with Claim 1 of the parent Patent No. 11,978,720.
Instant Application
U.S. Patent No. 11,978,720
Claim 129. A method for use in medical evaluation of a condition of a subject concerning an illness, injury, or other health status, comprising:
receiving, at a processing platform, sensor data collected employing a first user device regarding said condition of said subject, wherein said sensor data includes image data concerning said subject from a camera;
processing said image data at said processing platform by operating a processing system including a machine learning module to correlate said image data to first diagnostic information for said subject and operating said processing platform to determine second care information based at least in part on said first diagnostic information and to generate output information, based at least in part on said first diagnostic information and said second care information, for assisting a caregiver in caring for said subject; and
outputting, from said processing platform to a second user device, the same as or different from said first user device, said output information, based at least in part on said first diagnostic information and said second care information, for assisting said caregiver in caring for said subject.
Claim 1. A method for use in medical evaluation of a time constrained critical illness or injury (TCCI) condition of a subject, comprising:
obtaining input data regarding said TCCI condition of said subject, said input data related to one or more physiological, anatomical, or pathological parameters of said subject, said input data based on sensor information acquired via a mobile device;
providing said input data to a processing system including a machine learning module to determine evaluation information including at least one of diagnostic evaluation data and risk stratification data, wherein said processing platform is operative for preprocessing said sensor data for use by said machine learning module, said preprocessing comprising using motion microscopy to generate at least a portion of said input data, said processing system further being operative to generate, based on said evaluation information, output information including intervention information describing a course of treatment for said subject; and
outputting, at a user device, the same as or different than said mobile device, said output information for use in treating said TCCI condition of said subject.
Claim Rejections - 35 USC § 103
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 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 129-136, 138, 143-150, and 152 are rejected under 35 U.S.C. 103 as being unpatentable over Michelle Longmire (US 8,548,828).
Consider Claim 129 (and similarly Claim 143, it should be noted that Fig. 1. Of Longmire shows a processing platform and network interface) Longmire discloses “A method for use in medical evaluation of a condition of a subject concerning an illness, injury, or other health status” (Abstract, “ In the instant application a novel mobile technology powered by unique image analysis software based on machine learning process to evaluate the submitted images for diagnostic purposes”), “comprising: receiving, at a processing platform, sensor data collected employing a first user device regarding said condition of said subject” (Column 12, lines 40-43 disclose:
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), “wherein said sensor data includes image data concerning said subject from a camera” (Column 12, lines 43-47 disclose:
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and it is disclosed that upon providing this information in the system, the user taps submit); “processing said image data at said processing platform by operating a processing system including a machine learning module to correlate said image data to first diagnostic information for said subject and operating said processing platform to determine second care information based at least in part on said first diagnostic information and to generate output information, based at least in part on said first diagnostic information and said second care information, for assisting a caregiver in caring for said subject” (Column 12, lines 57-61 disclose:
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wherein the disclosure is made that the machine learning algorithm provides diagnosis and care information (treatment) to the health care provider (“HCP” or caregiver); “and outputting, from said processing platform to a second user device, the same as or different from said first user device, said output information, based at least in part on said first diagnostic information and said second care information, for assisting said caregiver in caring for said subject” (Column 12, lines 57-61 disclose that the machine learning algorithm based on the information received from the user’s data, provides output, which include both the machine learned diagnosis and treatment to the HCP. In addition, in a further embodiment, Column 13, lines 43-45 discloses that the HCP accesses the information from the disease management system using a mobile device, i.e., second user device).
Accordingly, before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to combine different embodiments of the Longmire reference to disclose output of the results of the machine learned diagnostics results and treatment to a second (HCP) user device. One of ordinary skill in the art could have combined the elements in the disclosed embodiments of Longmire according to the known methods and the results of the combination would yield predictable results of receiving at the second user’s device the generated information. Accordingly, it would have been obvious to combine various embodiments of Longmire to obtain the invention of Claim 129.
Consider Claim 130 (and similarly Claim 144), Longmire discloses “The method of claim 129, wherein said first diagnostic information comprises information concerning one of an identification and a nature of an underlying medical issue or illness of said subject” (Column 12, lines 57-61 disclose: “machine learning involving algorithms for image processing provide a machine-suggested diagnosis”, i.e., identifies the underlying medical issue).
Consider Claim 131 (and similarly Claim 145), Longmire discloses “The method of claim 130, wherein said second care information comprises medical information converted into a medical record format to at least partially automate a recording process related to said condition of said subject” (Column 8, lines 17-23, where the diagnoses be used to automatically generate treatment recommendations communicated to the HCP or user; and Column 12, lines 55-57, where diagnosis is provided to the patient).
Consider Claim 132 (and similarly Claim 146), Longmire discloses “The method of claim 130, wherein said second care information comprises a recommendation for care based on one of a location of and resources available to said subject” (Column 12, lines 50-52, calculation of parameters, such as location of the user; and lines 63-65 disclose: once the HCP has provided the treatment, he may send the prescription to the nearest pharmacy or pharmacy of choice for the user”, i.e., based on location of the resources available to the subject).
Consider Claim 133 (and similarly Claim 147), Longmire discloses “The method of claim 132, wherein said recommendation concerns transport to a specified care facility” (Column 13, lines 1-3 disclose: the HCP may provide alternative treatment, such as physiotherapy, for which it may require transporting to a clinic).
Consider Claim 134 (and similarly Claim 148), Longmire discloses “The method of claim 129, wherein said processing platform is separate from said first user device” (Fig. 1, the Disease Management System).
Consider Claim 135 (and similarly Claim 149), Longmire discloses “The method of claim 129, wherein said user device comprises a mobile phone” (Fig. 1:116 and Column 5, line 65).
Consider Claim 136 (and similarly Claim 150), Longmire discloses “The method of claim 135, wherein said mobile phone is employed to obtain video information” (Column 6, lines 53-56).
Consider Claim 138 (and similarly Claim 152), Longmire discloses “The method of claim 129, wherein said sensor data further comprises audio information concerning said subject” (Column 7, line 31).
Claims 137 and 151 are rejected under 35 U.S.C. 103 as being unpatentable over Michelle Longmire (US 8,548,828) in view of Ayman Salem (US 2020/0242984).
Consider Claim 137 (and similarly Claim 151), Longmire does not explicitly disclose “The method of claim 129, wherein said user device comprises a drone.” However, in an analogous field of endeavor, Salem discloses use of a rechargeable drone in its tele-healthcare application (Abstract and Paragraph [0092]).
Accordingly, before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to combine Longmire with the teachings of Salem to use a drone for taking images of a patient/user. One of ordinary skill in the art could have combined the Longmire and Salem references in order to obtain certain images of the areas that require wider field of view (FOV) for a more accurate diagnostic (Paragraph [0092] could be used as examples of these enhanced images). Accordingly, it would have been obvious to combine Longmire and Salem to obtain the invention of Claim 137.
Claims 139–141 and 153-155 are rejected under 35 U.S.C. 103 as being unpatentable over Michelle Longmire (US 8,548,828) in view of Tzvieli et al. (US 2020/0085311).
Consider Claim 139 (and similarly Claim 153), although Longmire discloses processing image data received from the user mobile device (Column 10, line 66-Column 11, line 7), it does not explicitly disclose “wherein said processing platform is operative for preprocessing said sensor data for each use by said machine learning module”. However, in an analogous field of endeavor, Tzvieli discloses its processing platform, i.e., a computer, to preprocess photoplethysmography (PPG) signals (Tzvieli, Paragraph [0095], where it is disclosed that calculations are based on machine learning and Paragraph [0136], where preprocessing of PPG signals is disclosed).
Accordingly, before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to combine Longmire with the teachings of Tzvieli to use the processing platform to preprocess image data/signal. One of ordinary skill in the art could have combined the Longmire and Tzvieli references to further expand/enhance the Longmire telehealth system to enable it to diagnose more advanced medical issues. Accordingly, it would have been obvious to combine Longmire and Tzvieli to obtain the invention of Claim 139.
Consider Claims 140 and 141 (and similarly Claims 154 and 155), the combination of Longmire and Tzvieli discloses “The method of claim 139, wherein said preprocessing comprises one of identifying a region of interest and identifying a signal of interest” and “The method of claim 139, wherein said preprocessing comprises one of performing and individual component analysis on the data, using motion microscopy data, and using remote photoplethysmography data” (Tzvieli, Abstract, where the region of interest if the left and right sides of the face of a person and the signal of interest is the PPGSL and PPGSR). The proposed combination as well as the motivation for combining the Longmire and Tzvieli references presented in the rejection of Claim 139, apply to Claims 140 and 141 and are incorporated herein by reference. Thus, the methods recited in Claims 140 and 141 is met by Longmire and Tzvieli.
Claims 142 and 156 are rejected under 35 U.S.C. 103 as being unpatentable over Michelle Longmire (US 8,548,828) in view of Tzvieli et al. (US 2020/0085311), and in further view of Narayan et al. (US 2019/0000350).
Consider Claim 142 (and similarly Claim 156), the combination of Longmire and Tzvieli does not explicitly disclose “The method of claim 129, wherein said machine learning module is operative for developing diagnostic models for input data subsets for each of multiple investigational phenotypes.” However, in an analogous field of endeavor, Narayan discloses “Sensed signatures illustrated in FIG. 4 represent the functional domains of that bodily task for an individual person. This forms a type of digital or computerized phenotype for that bodily function. It is recognized that nervous and non-nervous physiological elements can be deeply integrated biologically, but this formulation is a convenient approach to parameterize complex physiology into tracks that can be measured, mathematically modeled and learned. Other more integrated formulations are possible” (Narayan Paragraph [0218]).
Accordingly, before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to combine the combination of Longmire and Tzvieli with the teachings of Narayan to develop diagnostic models of multiple investigational phenotype. One of ordinary skill in the art could have combined the combination of Longmire and Tzvieli with the teachings of Narayan in order to create mathematical models to learn more medical issues from a user using a machine learning system. Accordingly, it would have been obvious to combine Longmire, Tzvieli, and Narayan to obtain the invention of Claim 142.
Conclusion
The prior art made of record and not relied upon are considered pertinent to Applicant’s disclosure: Kevin Keraudren (US 2020/0402245) and Konkle et al. (US 2019/0099150).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Siamak HARANDI whose telephone number is (571)270-1832. The examiner can normally be reached Monday - Friday 9:30 - 6:00 ET.
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/Siamak Harandi/Primary Examiner, Art Unit 2662
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