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`2016 Pat. App. LEXIS 2105
`
`Patent Trial and Appeal Board
`
`May 17, 2016, Decided
`
`Appeal 2013-009212; Application 12/646,615; Technology Center 3600
`
`Reporter
`2016 Pat. App. LEXIS 2105
`
`Ex parte GUY ROBERT VESTO
`
`
`Notice:
` [*1]
`
`ROUTINE OPINION. Pursuant to the Patent Trial and Appeal Board Standard Operating Procedure 2, the opinion
`below has been designated a routine opinion.
`
`Core Terms
`
`
`patient, medical case, symptom, unpatentable, calculate, rejected claim, collaborate, recite, label, clinical trial,
`feature-sets, apparatus, diagnose, medical condition, health issues, prior art, parameter, diagnose, network,
`module, patent
`
`Panel: Before ANTON W. FETTING, BIBHU R. MOHANTY, and BRADLEY B. BAYAT, Administrative Patent
`Judges.
`
`Opinion By: ANTON W. FETTING
`
`Opinion
`
`
`
`FETTING, Administrative Patent Judge.
`
`
`DECISION ON APPEAL
`
`
`1
`STATEMENT OF THE CASE
`
`
`
`
`Guy Robert Vesto (Appellant) seeks review under 35 U.S.C. § 134 of a final rejection of claims 1-27, the only claims
`pending in the application on appeal. We have jurisdiction over the appeal pursuant to 35 U.S.C. § 6(b).
`
`
`
`
`
`1 Our decision will make reference to the Appellant's Appeal Brief ("App. Br.," filed February 27, 2013) and Reply Brief ("Reply
`Br.," filed July 12, 2013), and the Examiner's Answer ("Ans.," mailed May 6, 2013), and Final Action ("Final Act.," mailed August
`1, 2012).
`
`
`
`Telit Wireless Solutions Inc. and Telit Communications PLC Exh. 1232 p.1
`
`

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`2016 Pat. App. LEXIS 2105
`
`Page 2 of 7
`
`The Appellant invented a form of integrated medical case research and collaboration. Specification para. 1.
`
`
`An understanding of the invention [*2] can be derived from a reading of exemplary claim 1, which is reproduced
`below (bracketed matter and some paragraphing added).
`
`1. A method to provide medical case research and collaboration, comprising:
`
`[1] generating,
`
`by a processor,
`
`a medical case
`
`based on information related to one or more health issues of a person;
`
`[2] calculating a likelihood
`
`associated with a potential cause of the one or more health issues,
`
`wherein the likelihood is representative of a probability that the potential cause of the one or more health
`issue is an accurate diagnosis;
`
`[3] determining whether the likelihood indicates that the medical case is complex; and
`
`[4] when the medical case is determined to be complex based on the likelihood, granting the person access to
`a collaboration module.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`The Examiner relies upon the following prior art:
`
`Gray
`US 6,149,585
`Soll
`US 7,593,952 B2
`Boyce
`US 2009/0313045 A1
`Seward
`US 2010/0094648 A1
`Finlay
`US 2010/0299155 A1
`
`
`
`Nov. 21, 2000
`Sep. 22, 2009
`Dec. 17, 2009
`Apr. 15, 2010
`Nov. 25, 2010
`
`Claims 1, 2, 4-6, 10, 11, 13-15, 26, and 27 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Soll and
`Boyce. [*3]
`
`
`Claims 3, 8, 12, 18, and 20-22 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Soll, Boyce, and
`Seward.
`
`
`Claims 7, 9, and 16 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Soll, Boyce, and Finlay.
`
`
`
`
`
`
`
`Telit Wireless Solutions Inc. and Telit Communications PLC Exh. 1232 p.2
`
`

`

`2016 Pat. App. LEXIS 2105
`
`Page 3 of 7
`
`
`
`Claim 25 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Soll, Boyce, and Gray.
`
`
`Claims 17, 19, and 24 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Soll and Seward.
`
`
`Claim 23 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Soll, Seward, and Finlay.
`
`
`ISSUES
`
`
`The issues of obviousness turn primarily on the weight to be afforded the labels attached to the recited data and
`whether the claims are sufficiently broad to encompass the prior art within their scope.
`
`
`FACTS PERTINENT TO THE ISSUES
`
`
`The following enumerated Findings of Fact (FF) are believed to be supported by a preponderance of the evidence.
`
`
`Facts Related to the Prior Art
`
`
`Soll
`
`01. Soll is directed to disease management by integrating a plurality of separate functions into a seamless
`diagnostic and treatment system that enhances patient [*4] assessment, activates (primes) and educates
`patients to become maximally involved in their care, and improves the efficiency of physician management
`process. Soll 1:6-19.
`
`02. Soll's Comprehensive Patient Management ("CPM") system supports a new paradigm of health care
`delivery by integrating biomedical and psychosocial approaches to patient management and providing tools to
`improve and measure patient assessment, quality of life, and physician process. Soll 4:37-44.
`
`03. Soll's screening sequence is designed to identify probable symptom complexes. Soll 16:44-46.
`
`04. Multiple, overlapping symptom complexes present a common challenge: they may be separate problems
`or they may in fact represent the same underlying process. These distinctions have a substantial impact on the
`diagnostic and therapeutic process. Soll improves the patient's ability to accurately describe multiple,
`overlapping symptom complexes and the physician's ability efficiently work with this information. Soll 21:36-44.
`
`05. The CPM analysis of symptom complexes reveals situations where symptoms apparently share features.
`Physicians are informed of any apparent overlap. For example, if the patient has functional [*5] symptoms
`such as heartburn, indigestion, acid dyspepsia, and/or irritable bowel syndrome, this suggests the possibility of
`a widespread irritable gut. Although organic disease should be considered, this scenario is likely for functional
`disorders. Soll 22:43-49.
`
`
`
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`
`
`
`
`
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`
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`
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`Telit Wireless Solutions Inc. and Telit Communications PLC Exh. 1232 p.3
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`

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`2016 Pat. App. LEXIS 2105
`
`Page 4 of 7
`
`06. Soll describes using a problem list that describes the probability of some diagnoses (e.g. Irritable Bowel
`Syndrome, Probable) .
`
`Soll 34: 1-35:13.
`
`
`
`
`
`Boyce
`
`07. Boyce is directed to a network for medical research and clinical trial and to improve targeting of
`participants, capturing of patient data and better distribution and processing of patient data through a network
`for medical research and clinical trial. Boyce para. 2.
`
`08. The information to be entered in a database for potential participants should have the data and profiles that
`are relevant to selecting a participant for a trial. Boyce para. 45.
`
`09. Boyce describes setting, implementing and executing rules related to what may include the selection and
`qualification of participants. Boyce para. 116.
`
`10. Boyce describes identifying a patient as a potential participant in a clinical trial based on parameters
`related to the requirements of the clinical [*6] trial. Other examples of selection parameters for identifying a
`potential participant may include: an existing illness, an existing complaint, age, weight, gender, blood-
`pressure, pulse, temperature, use of drugs, one or more symptoms such as a cholesterol level within a certain
`range, and one or more symptoms such as a cholesterol level outside a certain range. Boyce para. 119.
`
`11. Boyce describes qualifying the patient as a participant once a patient is identified as a potential
`participant. A second set of parameters applied to qualify a potential participant as an actual participant may
`have narrower of broader margins than the first set of parameters. Boyce para. 120.
`
`12. A patient may be identified as having a certain status in a project. A patient may be invited to join a
`network for clinical trial or medical research. A patient may for instance be invited by a physician or a
`healthcare provider to join a network. After the patient agrees to join a network, a set of data providing
`relevant information related to future clinical trials and research is entered. Such data contains age, gender,
`vitals, occupation, medical history, current symptoms, complaints, use of medication [*7] and any other data
`that may be used to identify a patient as a participant or candidate in a specific project. Such data may be
`marked for selecting participants in research or a trial. Boyce para. 198.
`
`
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`
`
`Seward
`
`13. Seward is directed to the application of complexity science and expert knowledge to analyses of medical
`data for evaluation of risk for emergent diseases and diagnoses wherein medical data of a person is obtained,
`feature-sets of associated features of medical conditions are accessed from a medical knowledgebase, and
`values of the medical data are compared to ranges of values of the features of relevant feature-sets to identify
`any at-risk medical conditions of the person. Seward para. 1.
`
`
`
`
`
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`
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`Telit Wireless Solutions Inc. and Telit Communications PLC Exh. 1232 p.4
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`

`

`2016 Pat. App. LEXIS 2105
`
`Page 5 of 7
`
`14. Seward identifies those feature-sets, i.e., a subset of all feature-sets that have the highest correlation of
`features with the input medical data of an individual person. Based on the input medical data, one or more
`feature-sets may be identified. A person's medical data may indicate that the person has one or more medical
`conditions or disease states. Similarly, the medical data may not correlate with any existing feature-set in the
`knowledgebase. In this case, the medical [*8] data pertaining to the person may be highlighted for further
`review by a human expert. Thus, the processes and components execute to correlate medical data to features
`and predict, quantify, and may suggest or monitor treatment for pre-emergent, or emerging or clinically
`apparent medical conditions and identify possible courses of action. Seward para. 47.
`
`
`
`ANALYSIS
`
`
`Before launching into Appellant's arguments, we initially observe the breadth of claim 1. Claim 1 is a method claim
`with four steps. The steps are (1) generating a datum A labeled a "medical case; " (2) calculating some likelihood
`in some unspecified format and manner associated with B labeled potential health issue cause, where the
`likelihood is in some sense representative of a probability of C, labeled potential cause is an accurate diagnosis;
`(3) determining whether the likelihood indicates D, labeled the medical case is complex; and (4) when step (3)
`evaluates as TRUE, granting access to some module labeled collaboration. Thus, the claim is directed to
`generating a datum and calculating a likelihood represented in some manner of a probability, and using the
`likelihood as a criterion for granting access to some module. [*9] Nothing in the claim requires or enforces the
`labels as the claim suggests the data to be perceived as. Mental perceptions of what data represents are non-
`functional and given no weight. King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010) ("[T]he
`relevant question is whether 'there exists any new and unobvious functional relationship between the printed
`matter and the substrate.'") (citation omitted). See also In re Lowry, 32 F.3d 1579, 1583 (Fed.Cir.1994) (describing
`printed matter as "useful and intelligible only to the human mind") (quoting In re Bernhart, 417 F.2d 1395, 1399
`(CCPA 1969)).
`
`
`The Examiner finds that Soll describes a patient healthcare system, which by definition stores data regarding
`patient health; i.e. medical case based information. The system identifies probable symptom complexes and acts
`to make diagnoses more accurate by separating out underlying health problems. This occurs by revealing
`situations where symptoms apparently share features that suggest the possibility of specific underlying cause, such
`as widespread irritable gut. The system also [*10] identifies the probability of some diagnoses. Thus, Soll
`calculates the likelihood associated with such causes and that likelihood is historically representative, that a cause
`being associated with the specified symptoms, and therefore in that sense representative of the accuracy of such a
`diagnosis.
`
`
`The Examiner applies Boyce to show deciding to grant access to a collaborative clinical trial based on the
`likelihood that a patient meets the criteria for the trial. Such trials are frequently for complex medical issues.
`
`
`We are not persuaded by Appellants' argument that Soll fails to describe calculating the recited likelihood. App. Br.
`13-14. As the claim does not recite any particular calculation, whether the calculation is quantitative or qualitative,
`how a likelihood or probability is expressed, or even whether the calculation is done mentally or by machine, any
`evaluation of a likelihood of an accurate diagnosis, which is by definition representative of some probability, is
`within the scope of the limitation. Soll explicitly describes using a system to assist in determining likely and probable
`diagnoses. As no particular calculation is recited, any distinction between the likelihood [*11] of a symptom being
`due to a particular cause is within the scope of the likelihood of the cause being an accurate diagnosis. As a mental
`calculation is within the claim scope; even a physician rough guess at a likelihood is within the scope of claim 1.
`
`
`
`
`
`
`
`
`Telit Wireless Solutions Inc. and Telit Communications PLC Exh. 1232 p.5
`
`

`

`2016 Pat. App. LEXIS 2105
`
`Page 6 of 7
`
`We are not persuaded by Appellant's argument that Soll fails to describe determining whether a likelihood
`representative of a probability that a potential cause is an accurate diagnosis indicates that a medical case is
`complex (App. Br. 14-16) for similar reasons.
`
`
`We are also not persuaded by Appellant's argument that Soll fails to describe granting access to a collaboration
`module when a medical case is determined to be complex. App. Br. 16-17. The language of claim 1 provides no
`implementation for determining a case to be complex, and thus, Boyce's determination that a case is suitable for a
`trial is within the scope, because any medical trial is complex if only by virtue of regulatory requirements.
`
`
`The arguments in support of claim 10 are essentially the same as those in support of claim 1, and therefore are
`equally unpersuasive.
`
`
`As to claim 17, the Examiner applies Seward instead of Boyce. Appellant's arguments related to Soll are [*12]
`similar to those in support of claim 1 and are equally unpersuasive here.
`
`
`Claim 17 is an apparatus claim, not a process claim as in claim 1. As to structural inventions, such claims must be
`distinguished from the prior art in terms of structure rather than function, see, e.g., In re Schreiber, 128 F.3d 1473,
`1477-78 (Fed. Cir. 1997). In order to satisfy the functional limitations in an apparatus claim, however, the prior art
`apparatus as disclosed must be capable of performing the claimed function. Id. at 1478. When the functional
`language is associated with programming or some other structure required to perform the function, that
`programming or structure must be present in order to meet the claim limitation. Typhoon Touch Techs., Inc. v. Dell,
`Inc., 659 F.3d 1376, 1380 (Fed. Cir. 2011) (discussing Microprocessor Enhancement Corp. v. Texas Instruments,
`Inc., 520 F.3d 1367 (Fed. Cir. 2008)). In some circumstances, generic structural disclosures may be sufficient to
`meet the functional requirements, see Ergo Licensing, LLC v. CareFusion 303, Inc., 673 F.3d 1361, 1364 (Fed. Cir.
`2012) [*13] (citing Telcordia Techs., Inc. v. Cisco Sys., Inc., 612 F.3d 1365, 1376-77 (Fed. Cir. 2010)).
`
`
`Also, a structural invention is not distinguished by the work product it operates upon, such as data in a computer.
`"[E]xpressions relating the apparatus to contents thereof during an intended operation are of no significance in
`determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969).
`Furthermore, "inclusion of material or article worked upon by a structure being claimed does not impart patentability
`to the claims." In re Otto, 312 F.2d 937, 940 (CCPA 1963).
`
`
`Thus, the limitations regarding the nature of the data in claim 17 are given no patentable weight for these reasons
`as well as the reasons in claim 1. Similarly the limitations as to what the apparatus does are only given weight to
`the extent the art must be capable of performing the recited functions of generating information and calculating a
`likelihood based on some parameters. Again, the claim does not narrow the manner of implementation or how the
`likelihood is expressed. We found Boyce does [*14] so supra.
`
`
`The Examiner applies Seward here for the recited "medical case builder to generate a medical case based on
`information related to one or more health issues of a person." Final Act. 16. We find Seward does correlate medical
`data to features and may predict, quantify, and suggest or monitor treatment for pre-emerging or emerging, or
`clinically apparent medical conditions, and may identify possible courses of action, which fall within the scope of this
`limitation.
`
`
`We are not persuaded by Appellant's argument that Soll fails to describe determining "whether the likelihood
`indicates that the medical case is complex, and wherein the case analyzer is to grant the person access to a
`
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`
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`Telit Wireless Solutions Inc. and Telit Communications PLC Exh. 1232 p.6
`
`

`

`2016 Pat. App. LEXIS 2105
`
`Page 7 of 7
`
`collaboration module when the case analyzer determines that the medical case is complex based on the
`likelihood." App. Br. 23-25; Claim 17. We found Soll describes such likelihood supra. As no implementation for
`granting access is recited, Soll's description of a physician to efficiently work with (access) this information is within
`its scope. Also, as the Examiner made of record the rejection of substantially similar subject matter over Soll and
`Boyce, the Examiner's analysis of Soll and Boyce [*15] combined with Seward is within the scope of this rejection.
`
`
`CONCLUSIONS OF LAW
`
`
`The rejection of claims 1, 2, 4-6, 10, 11, 13-15, 26, and 27 under 35 U.S.C. § 103(a) as unpatentable over Soll and
`Boyce is proper.
`
`
`The rejection of claims 3, 8, 12, 18 and 20-22 under 35 U.S.C. § 103(a) as unpatentable over Soll, Boyce, and
`Seward is proper.
`
`
`The rejection of claims 7, 9, and 16 under 35 U.S.C. § 103(a) as unpatentable over Soll, Boyce, and Finlay is
`proper.
`
`
`The rejection of claim 25 under 35 U.S.C. § 103(a) as unpatentable over Soll, Boyce, and Gray is proper.
`
`
`The rejection of claims 17, 19, and 24 under 35 U.S.C. § 103(a) as unpatentable over Soll and Seward is proper.
`
`
`The rejection of claim 23 under 35 U.S.C. § 103(a) as unpatentable over Soll, Seward, and Finlay is proper.
`
`
`DECISION
`
`
`The rejections of claims 1-27 are affirmed.
`
`
`No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. §
`1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv) (2011) [*16] .
`
`AFFIRMED
`
`
`
`
`End of Document
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`Telit Wireless Solutions Inc. and Telit Communications PLC Exh. 1232 p.7
`
`

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