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 .
Claim Rejections - 35 USC § 101
Claims 1 to 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 1 to 14 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 to 14 recites at least one step or instruction for observing, judging or evaluating data, which is grouped as a mental process under the 2019 PEG. Accordingly, each of Claims 1 to 14 recites an abstract idea.
Specifically, Claim 1 recites A display data generation device comprising:
an input interface (additional element) configured to receive vital signs information of a subject (observation, which is a mental process under the 2019 PEG);
one or more processors (additional element); and
one or more memories configured to store at least one instruction executable by the processor (additional element), wherein when the at least one command is executed by the processor, the display data generation device (additional element) generates display data, the display data including the vital signs information and background information that indicates a background corresponding to a condition of the subject determined based on the vital signs information (judgement or evaluation, which is a mental process under the 2019 PEG); and a determination method for determining the condition of the subject, the background information overlapping with the vital signs information (judgement or evaluation, which is a mental process under the 2019 PEG).
13. A display data generation method executed by a display data generation device (additional element), the method comprising: generating display data, the display data including vital signs information of a subject and background information that indicates a background corresponding to a condition of the subject determined based on the vital signs information (judgement or evaluation, which is a mental process under the 2019 PEG) and a determination method for determining the condition of the subject, the background information overlapping with the vital signs information (judgement or evaluation, which is a mental process under the 2019 PEG).
14. A non-transitory computer-readable storage medium storing a computer program executable by one or more processors (additional element) provided in a display data generation device (additional element), when being executed, the computer program causing the display data generation device to generate display data, the display data including vital signs information of a subject and background information that indicates a background corresponding to a condition of the subject determined based on the vital signs information (judgement or evaluation, which is a mental process under the 2019 PEG) and a determination method for determining the condition of the subject, the background information overlapping with the vital signs information (judgement or evaluation, which is a mental process under the 2019 PEG).
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 2-12 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A, Prong 2
The above-identified abstract idea in independent Claim 1 (and its respective dependent Claims 2-13) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claim 1, 13-14), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: an input interface, memories, processors, a display data generation device are generically recited computer elements in independent Claim 1, 13-14 (and its respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claim 1, 13-14 (and its respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., memories and processors as claimed). In other words, independent Claim 1, 13-14 and its dependent claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer and insignificant extra-solution activity related to a sensing unit collecting data. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 1, 13-14 (and its dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 1, 13-14 (and its dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-14 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: processors, memories, input interface, display data generation device.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the elements. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Furthermore, Muhsin (U.S. Patent Application Publication No. 20180317826) discloses processors, memories, input interface, display data generation device (paragraph 0100) (Fig 1a).
Adding hardware that performs “‘well understood, routine, conventional activities]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-14 amounts to mere instructions to collect data with extra-solution activity and implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system of Claims 1-14 are directed to applying an abstract idea (e.g., mental process) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of Claims 1-14 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 1, 13-14 (and its dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-14 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-14 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-14 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
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.
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.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kouchi (US 7371214) in view of Lamb (US 20190355481)
Regarding claim 1, Kouchi discloses A display data generation device (100) (Fig 1-6) comprising: an input interface configured to receive vital signs information of a subject; one or more processors (10); and one or more memories (17) configured to store at least one instruction executable by the processor (10), wherein when the at least one command is executed by the processor (10), the display data generation device generates display data, the display data including the vital signs information (col. 6, lines 29-66) and background information that indicates a background corresponding to a condition of the subject determined based on the vital signs information; a determination method for determining the condition of the subject (col. 5, lines 16-57, col. 7, lines 24-55).
Kouchi discloses all of the claim limitations except determination method information indicating a determination method, and type information associated with each determination method information and indicating a type of the vital signs information used for calculating a score in the determination method indicated by the determination method information, and wherein, the background information overlaps with the vital signs information; the background information overlaps with the vital signs information associated with the type information corresponding to the determination method information.
Lamb teaches determination method information indicating a determination method, and type information associated with each determination method information and indicating a type of the vital signs information used for calculating a score in the determination method indicated by the determination method information, and wherein, the background information overlaps with the vital signs information; the background information overlaps with the vital signs information associated with the type information corresponding to the determination method information (Fig 3). Therefore it would have been obvious at the effective filing date of the invention to modify Kouchi by Lamb to display both background and vital signs information for the purpose of allowing providers to provide prompt patient specific medical care to increase patient comfort and safety.
Regarding claim 2, Kouchi discloses The display data generation device according to claim 1, wherein a color tone related to a display mode of the background information is different from a color tone related to a display mode of the vital signs information (col.6, lines 14-17, col. 8, lines 1-40, col. 16, lines 31-62).
Regarding claim 3, Kouchi discloses The display data generation device according to claim 2, wherein a color related to the display mode of the background information is lighter than a color related to the display mode of the vital signs information (col. 6, lines 14-17, col. 8, lines 17-36, col. 16, lines 44-62).
Regarding claim 4, Kouchi discloses The display data generation device according to claim 1, wherein the display data further includes normal range information indicating a normal range of the vital signs information that is set for each piece of the vital signs information and abnormal range information indicating an abnormal range of the vital signs information that is set for each piece of the vital signs information, and the vital signs information overlaps with the background information and at least one of the normal range information and the abnormal range information (col. 5, lines 25-67, col. 10, lines 58-67, col. 11, lines 29-67, col. 12, lines 1-67, col. 16, lines 31-62).
Regarding claim 5, Kouchi discloses The display data generation device according to claim 4, wherein a color tone related to a display mode of the normal range information is different from a color tone related to a display mode of the abnormal range information (col. 5, lines 25-67, col. 6, lines 14-17, col. 16, lines 44-62)
Regarding claim 6, Kouchi discloses The display data generation device according to claim 4, wherein the display data generation device generates the display data in which a plurality of pieces of the vital signs information received by the input interface are collectively displayed in a unified range, the unified range being based on the normal range information and the abnormal range information corresponding to each piece of the vital signs information, the unified range being used to uniformly define normal ranges and abnormal ranges of the plurality of pieces of vital signs information (col. 5-6, 10-14 and 16 generally discuss all of the ranges which qualify as normal/abnormal).
Regarding claim 7, Kouchi discloses The display data generation device according to claim 1, wherein a vital graph of the vital signs information extending on a timeline is displayed in the display data (“as indicated by an arrow 40 in Fig 1A, an indication point moves clockwise in the circle radar 50 as the measurement time increases”) (col. 5, lines 20-24).
Regarding claim 8, Kouchi discloses The display data generation device according to claim 1, wherein the display data further includes condition information that indicates a condition of the subject and is generated based on the vital signs information and the determination method, and the condition information and the background information are displayed in correspondence along a timeline (col. 5, lines 20-67, col. 6, lines 1-18).
Regarding claim 9, Kouchi discloses The display data generation device according to claim 8, wherein the condition information does not overlap with the vital signs information (Fig 4)
Regarding claim 10, Kouchi discloses The display data generation device according to claim 9, wherein a hue related to a display mode of the condition information corresponds to a hue related to the display mode of the background information (col. 5, lines 25-67, col. 6, lines 14-17, col. 16, lines 44-62).
Regarding claim 11, Kouchi discloses The display data generation device according to claim 10, wherein a color related to the display mode of the condition information is darker than a color related to the display mode of the background information (col. 5, lines 25-67, col. 6, lines 14-17, col. 16, lines 44-62).
Regarding claim 12, Kouchi discloses The display data generation device according to claim 8, wherein the condition information is displayed above a portion where the vital signs information overlaps with the background information (Fig 4).
Regarding claim 13, Kouchi discloses A display data generation method executed by a display data generation device, the method comprising: generating display data, the display data including vital signs information of a subject and background information that indicates a background corresponding to a condition of the subject determined based on the vital signs information and a determination method for determining the condition of the subject (col. 5, lines 16-57, col. 7, lines 24-55) (Fig 1 and 4).
Kouchi discloses all of the claim limitations except determination method information indicating a determination method, and type information associated with each determination method information and indicating a type of the vital signs information used for calculating a score in the determination method indicated by the determination method information, and wherein, the background information overlaps with the vital signs information; the background information overlaps with the vital signs information associated with the type information corresponding to the determination method information.
Lamb teaches determination method information indicating a determination method, and type information associated with each determination method information and indicating a type of the vital signs information used for calculating a score in the determination method indicated by the determination method information, and wherein, the background information overlaps with the vital signs information; the background information overlaps with the vital signs information associated with the type information corresponding to the determination method information (Fig 3). Therefore it would have been obvious at the effective filing date of the invention to modify Kouchi by Lamb to display both background and vital signs information for the purpose of allowing providers to provide prompt patient specific medical care to increase patient comfort and safety.
Regarding claim 14, Kouchi discloses A non-transitory computer-readable storage medium storing a computer program executable by one or more processors provided in a display data generation device, when being executed, the computer program causing the display data generation device to generate display data, the display data including vital signs information of a subject and background information that indicates a background corresponding to a condition of the subject determined based on the vital signs information and a determination method for determining the condition of the subject (col. 5, lines 25-67, col. 10, lines 58-67, col. 11, lines 29-67, col. 12, lines 1-67, col. 16, lines 31-62) (Fig 1, 4).
Kouchi discloses all of the claim limitations except determination method information indicating a determination method, and type information associated with each determination method information and indicating a type of the vital signs information used for calculating a score in the determination method indicated by the determination method information, and wherein, the background information overlaps with the vital signs information; the background information overlaps with the vital signs information associated with the type information corresponding to the determination method information.
Lamb teaches determination method information indicating a determination method, and type information associated with each determination method information and indicating a type of the vital signs information used for calculating a score in the determination method indicated by the determination method information, and wherein, the background information overlaps with the vital signs information; the background information overlaps with the vital signs information associated with the type information corresponding to the determination method information (Fig 3). Therefore it would have been obvious at the effective filing date of the invention to modify Kouchi by Lamb to display both background and vital signs information for the purpose of allowing providers to provide prompt patient specific medical care to increase patient comfort and safety.
Response to Arguments
Applicant's arguments filed 7/01/2026 have been fully considered but they are not persuasive.
In response to applicant’s arguments regarding the 101 rejection:
Claims 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 21 follows. Regarding claim 21, the claim recites a system for monitoring gastrointestinal motility. Thus, the claim is directed to a machine/apparatus, which is one of the statutory categories of invention. The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception: "…receive vital signs information…store at least one instruction…generates display data…indicating a determination method…indicating a type of the vital signs information used for calculating a score for determining the condition of the subject…indicated by the determination method information…corresponding to the determination method information." These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper. Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application. For this part of the 101 analysis, the following additional limitations are considered: "A display data generation device comprising: an input interface…one or more processors…one or more memories…" These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, e.g., mere data gathering steps necessary to perform the identified judicial exception do not integrate the claims into a practical application. See MPEP 2106.05(g). The additional limitations also do not add significantly more to the identified judicial exception because they are recited at a high level of generality. Moreover, Examiner takes official notice that "a sensor configured to obtain an electrical signal including data associated with motility in a gastrointestinal tract of a patient" is widely- understood, routine, and conventional. Independent claims 13 and 14 are also not patent eligible for substantially similar reasons. Dependent claims 1-12 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above. Therefore, claims 1-14 are not patent eligible under 35 USC 101 and the 101 rejection is maintained.
Applicant’s arguments with respect to claim(s) 1-14 102 rejection have been considered but are moot because the new grounds of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASMEEN S WARSI whose telephone number is (571)272-9942. The examiner can normally be reached Monday-Friday 9 am to 5 pm.
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/YASMEEN S WARSI/Examiner, Art Unit 3791
/MAY A ABOUELELA/Primary Examiner, Art Unit 3791