DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1, 2, 4, 6-9, 11, 14, and 20 are currently pending and under exam herein.
Claims 3, 5, 10, 12-13, and 15-19 have been cancelled by preliminary amendment on 7 August 2023.
Priority
The instant application is a continuation of U.S. Application Serial No. 15/213,165 filed July 18, 2016, now abandoned, which is a continuation of U.S. Application Serial No. 12/765,640 filed April 22, 2010, now U.S. Patent No. 9,396,308 issued July 19, 2016. U.S. Application Serial No. 12/765,640 is a non-provisional application of U.S. Provisional Patent Application No. 61/171,628 filed on April 22, 2009.
Information Disclosure Statement
The Information Disclosure Statement filed 3 August 2022; 23 August 2022; and 5 September 2023 are compliance with the provisions of 37 CFR 1.97 and have therefore been considered. Signed copies of the IDS documents are included with this Office Action.
Drawings
The Drawings filed 27 April 2022 have been accepted.
Specification
Note: All references to the Specification herein pertain to the PG publication: US20220254465.
Claim Rejections - 35 USC § 112, 1st paragraph
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4, 6-9, 11, 14, and 20 are rejected under 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor at the time the application was filed, had possession of the claimed invention.
For a Specification to provide claims sufficient written description, the disclosure of the application relied upon must reasonably convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Ariad Pharms., Inc. V. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). The purpose of the written description requirement is to “ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.” Ariad Pharms., 598 F.3d at 1353-54 (quoting Univ. of Rochester V. G.D. Searle & Co., Inc., 358 F.3d 916, 920 (Fed. Cir. 2004)). Further, “whether the written description requirement is met is a question of fact.” Yorkey V. Diab, 601 F.3d 1279, 1283 (Fed. Cir. 2010).
The instant Specification fails to provide the limitations as in claims 1 and 20, and dependent claims therefrom, for a method and system that generates physiological imagery of any and all organs, organ systems and body parts of a patient. The Specification provides examples that include the functional status of an organ by parameters (Figure 2) that include levels of alkaline phosphate (AP), gamma glutamyl transpeptidase (GGT) and conjugated bilirubin (CB). The Specification indicates further that the system includes “rules for each physiological imagery that determine how characteristics of physiological imagery is changed to reflect the different sates of the patient, body part, organ system, etc.” [0022].
The rules provided are directed to characteristics of imagery for the gallbladder and bile duct organ system 9Figure 2) and provides that those include: “light red…mild injury…; medium red…moderate injury…; bright red…severe injury to the gallbladder and bile duct organ system” [0023-0025]. Thus, as pertain to AP, GGT and CB, the Specification provides levels for generation of intensity of the gallbladder and bile duct organ system, indicative of varying states [0022]. These particular rules, however do not provide any medications for the patient or analysis for drug therapy for the medication taken by a patient as pertain to gallbladder and bile duct representations.
The Specification further discloses that “different states of the patient or different organ systems would have different sets of rules that use different parameters and the system and method are not limited to the rules and parameters that appear in the examples set forth herein.” [0026] but does not provide examples of other sets of rules for other organs.
With respect to claims 1 and 20, the extent that the Specification provides instructions or software code for said operations as claimed, is also not disclosed. No algorithms are provided, for example to configure a server such that said system provides for any and all organ, organ systems or body parts with rules for lab results and application of results for drug therapy analysis that includes bar charts as part of said analysis in conjunction with said imagery of said organ, organ system or body part. Figure 3 exemplifies drug safety as is applies to lisinopril for hypertension and is not linked to the elements as for the imagery for gallbladder and bile duct. Despite the disclosure of “physiological imagery is rendered in real-time for the patient and are most commonly multi-factorial Boolean logic expressions (e.g., A or B and not C within time X) which provide a weighted, interpretive image of the potential to beneficially improve care for the example shown in FIG. 3” [0029], the Specification fails to disclose the elements that are weighted for obtaining bar charts for therapy analysis for efficacy, safety, tolerability, and affordability as claimed.
With respect to the “treatment intensity potential” the Specification does not provide the underlying reasoning, rules, or parameters used to generate the direction as provided in Figure 4, wherein Figure 4 shows an image with the recommendation: “Consider implantable, closed loop insulin pump. Consider gastric bypass surgery for obesity to reduce BMI,” but does not provide the protocols, algorithms, or software instructions used to obtain this recommendation. [Figure 4].
The Specification further refers to the analysis done by doctors and states that the specifics for each “imagery rule” “are not limiting to the system and method since those formula/rules and parameters can be added, deleted or modified at any time and may change with experience and new medical knowledge discovery” and “can be modified for a particular patient, organ system, drug therapy, or treatment” [0032] However, as explained above, the Specification provides “rules” for only one organ system and one drug therapy. The Specification does not include a description of algorithms or software instructions to configure a server computer to perform the operations as claimed.
As such, the Specification merely discloses disparate examples of determinations of the physiological imagery system of an organ system (Figure 2), analyzing drug therapies (Figure 3), and determining treatment intensity potential (Figure 4) but does not provide an example of using software instructions to configure a server computer or performing a method to receive a health data as claimed, receive selection of an organ, organ system, or body part, generate a coded visualization of the selected part as claimed, perform the drug analysis as claimed, and perform treatment intensity as claimed and as relevant to the organ, organ system, or body part.
As such the Specification lacks written description for the full scope of the claims herein.
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, 2, 4, 6-9, 11, 14, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1 Analysis: Are claims directed to process, machine, manufacture/composition of matter
With respect to step (1): yes, the claims are directed to a method for generating physiological imagery of an organ, organ system, or body part and a system for generating physiological imagery of an organ, organ system, or body part.
Step 2A, Prong 1 Analysis: Do claims recite abstract idea
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and in conjunction with mathematical concepts (in particular mathematical relationships and formulas).
The claim steps to abstract ideas are as follows:
Claim 1:
performing, at the physiological imagery unit, a functional analysis for the selected part of the particular patient comprising generating and displaying a coded visualization of a graphical representation of the selected part, where the color and color intensity is selected by applying the lab test results in the health data for the particular patient to one or more rules for the selected part; performing, at the physiological imagery unit, a drug therapy analysis for the medications known to be prescribed to or taken by the particular patient in the health data comprising generating and displaying a bar chart comprising bars for each of: efficacy, safety, tolerability, and affordability, where a length and color of the bars is selected based on cost and safety information for the medications retrieved from one or more databases, and reported complications for the particular patient in the health data for the particular patient; performing, at the physiological imagery unit, a treatment intensity potential analysis for the particular patient comprising generating and displaying a bar chart comprising bars for each of: efficacy, procedural intensity, lifestyle intensity, and monitoring, where a length and color of the bars is selected based on dosing information, vitals information, and visitation information in the health data for the particular patient and alternative procedure information retrieved from one or more database, wherein said operations are directed to mental processes that include steps that can be performed by pen and paper or with the aid of a computer. Said operations are those that physicians are engaged in on a daily basis wherein data are analyzed using applications of lab results, health data, and medication data to make informed decisions regarding treatment decisions. Including analysis results in a bar chart format are operations that are directed to statistical analysis that can be performed by mental operations (or alternatively with the aid of a computer program, such as Excel).
Dependent claims serve herein to further limit the judicial exceptions as recited above including further applications of data to analysis (claims 2, 6, 9, 11 (Boolean mathematical operations)). Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind (calculations by hand or pen and paper) and performance by mathematical operation (using Boolean operations). Under the BRI, one could, for example, perform said operation with pen and paper, or, alternatively with the aid of a generic computer as a tool to perform said calculations. These recitations are similar to the concepts of collecting information, analyzing it and providing certain results from the collection and analysis (Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations (Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in (Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind with pen and paper, and can include mathematical concepts.
Further, see MPEP § 2106.04(a)(2), subsection III. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation (see, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674: noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016): holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind" (see Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016): holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
Step 2A, Prong 2 Analysis: Integration to a Practical Application
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements:
Claims 1 and 20: receiving, at a physiological imagery unit comprising one or more server computers, health data for the particular patient from a health record for the particular patient stored at an electronic medical records database in electronic communication with the physiological imagery unit, said health data comprising medications data identifying medications known to be prescribed to or taken by the particular patient and lab test results for the particular patient; receiving, from a physician system in electronic communication with the physiological imagery unit, data indicating user selection of the organ, organ system, or body part to be visualized ("selected part"), wherein said steps are directed to data gathering operations.
Further with respect to the additional elements in the instant claims, those steps directed to data gathering perform functions of collecting the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
With respect to the system (claim 20) and units as claimed, said system, is a general purpose computer system and there are no details herein wherein of how the specific computer structures are used to implement the judicial exceptions beyond generic computing operations, i.e., the computer elements of the claims do not provide improvements to the functioning of the computer itself (see: DDR Holdings, LLC v. Hotels.com LP); they do not provide improvements to any other technology or technical field (see: Diamond v. Diehr); nor do they utilize a particular machine (see: Eibel Process Co. v. Minn. & Ont. Paper Co.). Hence, these are mere instructions to apply the judicial exception using a computer, and therefore the claim does not provide integration into a practical application of any judicial exception.
Steps of the dependent claims further serve to limit the data and systems herein.
Step 2B Analysis: Do Claims Provide an Inventive Concept
The claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the mental processes of receiving information are performed on generic computing systems wherein the instant Specification indicates that “each physician unit 102 may be a personal computer, a terminal, a laptop computer, a mobile device, a pocket PC device, a smartphone (Research in motion Blackberry, Apple iPhone, etc.), tablet computer, a mobile phone, a mobile email device, etc. Each physician unit 102 may also include an local physiological image unit 111, such as units 111 a, 111 b, . . . , 111 n, that maybe, in the exemplary web-based client/server implementation, an physiological imagery application (a plurality of lines of computer code stored in the physician unit and executed by the processing unit of the physician unit) that generates and/or displays physiological imagery (See FIGS. 2-4 for illustrative examples of the physiological imagery) that can be displayed using a typical browser application (not shown) executing on the physician unit wherein the physician receives data/information from the physiological imagery unit 104, such as the physiological imagery to be displayed or the one or more parameters used to generate the physiological imagery.” As such, the additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
The dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Conclusion
No claims are allowed.
The instant claims appear to be free from the prior art. The closest prior art Jung (2007/0118164-IDs document) fails to teach or fairly suggest the steps of the physiological imagery system that receives health record with medications and lab results in conjunction with user selection of an organ, organ system or body part, wherein a functional analysis for the selected part includes a coded visualization of the selected part and color intensity selected by application of lab test results that further includes drug therapy analysis and treatment intensity potential analysis, as claimed.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting following form via EFS-Web or Central Fax (571-273-8300): PTO/SB/439. Applicant is encouraged to do so as early in prosecution as possible, so as to facilitate communication during examination.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Thursday from 12:00PM to 10:00PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached on (571) 272-9047.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/Lori A. Clow/ Primary Examiner, Art Unit 1687