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 .
Response to Arguments
Applicant’s arguments combined with the claim amendments have been fully considered but are not found persuasive. With respect to the rejection under 101, although the claim language has been amended to further recite details of the imaging apparatus, the claims recite the functional language of acquiring the resultant (final product) image from this device and are not claiming details of performing the step of applying radiation to the patient in the specific manner that the applicant appears to be arguing. In addition, reciting “dynamic imaging with radiation without using a contrast agent” is a broad type of imaging which does not include details or specifics that would fall under a technical solution; accordingly, the 101 rejection is maintained below. With regard to the prior art rejection, an updated grounds of rejection is presented below, necessitated by amendment.
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 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are determined to be directed to a judicial exception, specifically an abstract idea, without significantly more.
Step 1
The claimed inventions in claims 1, 12, and 13 are directed to statutory subject matter as the claim(s) recite(s) a method and a system of detecting QRS complexes in an ECG signal.
Step 2A, Prong One
Claims 1, 12, and 13 recite the following steps or instructions to/for “acquire/ing a dynamic image”, “generate/ing information…”, and “output the generated information”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106.04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I).
These limitations concern image data collection, data analysis and recording the results of data analysis, which could be done mentally or by hand with pen and paper, and are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper and mathematical concepts. For example, these limitations are nothing more than a medical professional analyzing previously measured chest x-ray images and presenting an observed analysis of those images.
Accordingly, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
In addition, Claims 1 and 12 recite additional elements of “a hardware processor”.
Step 2A, Prong Two
The above-identified abstract idea in each of independent Claims 1, 12, and 13 (and their respective dependent Claims 2-11) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1, 12, and 13), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) and appear to be extra solution activity where data to be analyzed by the abstract idea is acquired or obtained.
More specifically, the additional elements of: “a hardware processor” is a generically recited computer elements in independent Claims 1, 12, and 13 (and their respective dependent Claims 2-11) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) 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 according to MPEP 2106.04(d)(2) and 2106.05(e). 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 in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1, 12, and 13 (and their respective dependent Claims 2-11) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and using mathematical concepts) using rules (e.g., computer instructions) executed by a computer (e.g. “hardware processor” as claimed). In other words, these 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 according to MPEP 2106.05(f). 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 according to MPEP 2106.05(a). 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 Claims 1, 12, and 13 (and their respective dependent Claims 2-11) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1, 12, and 13 (and their respective dependent Claims 2-11) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B
Claims 1, 12, and 13 do not include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons:
These claims require the additional elements of: “a hardware processor”. This additional element is a 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, MPEP 2106.05(d)(II) along with 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.
Per Applicant’s specification:
A “hardware processor” is described in the disclosure as a component that is generic and conventionally used and known in the art: “The controller 31 (hardware processor) includes a central processing unit (CPU) and a random access memory (RAM) (not illustrated).” [¶¶ 72 – published app]. Accordingly, in light of Applicant’s specification, the “hardware processor” and its function is considered well-understood routine and conventional in the art, performing activities that are merely data gathering and processing steps for the abstract idea in Claim 1.
Additionally, the claimed term “hardware processor” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “hardware processor”. 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 MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1, 12, and 13 (and their respective dependent Claims 2-11) amounts to mere instructions to 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 MPEP 2106.05(f) along with 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. See MPEP 2106.05(a) along with 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, per MPEP 2106.05(a), 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 apparatus/method of Claims 1, 12, and 13 (and their respective dependent Claims 2-11) are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing 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 according to MPEP 2106.04(d)(2) and 2106.05(e).
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 Claims 1, 12, and 13 (and their respective dependent Claims 2-11) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). 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 according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements 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 according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, 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 according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Regarding dependent claims 2-11, the limitations of these claims further define limitations directed to the abstract idea. As such, claim 1-13 when analyzed as a whole, do not appear to be patent eligible for the reasons set forth above.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
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 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains 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 or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claim 1, the newly added recitation of “…performing dynamic imaging with radiation without using a contrast agent,…” in combination with other elements/steps of the claims, fails to be supported by the disclosure as originally filed. The specification does not appear to disclose the negative limitation of explicitly performing imaging without using a contrast agent as recited. In order to overcome this rejection, it is required applicant indicate where support lies or amend the language to fall within the scope of the disclosure as originally filed.
Claims 12 and 13 share the same language and are rejected under the same rationale.
Claims 2-11 are rejected under the same rationale as being dependent upon claim 1 and its limitations.
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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Aben (US 2002/0125398; hereinafter “Aben”) in view of Tearney et al. (US 2016/0029894; hereinafter “Tearney’).
Regarding claim 1, Aben discloses a dynamic image analysis apparatus comprising: a hardware processor (e.g. ¶¶ 21) is configured to, execute processing to acquire a dynamic image of a chest, the dynamic image having been imaged by an imaging apparatus by performing dynamic imaging with radiation (e.g. ¶¶ 55), execute processing to generate information on pulmonary valve regurgitation (e.g. ¶¶ 13) based on dynamic image information of a site related to at least one of a pulmonary artery and a heart in the dynamic image (e.g. ¶¶ 69-83, 62 – “The disclosed method is not limited to the left side of the heart and can also be performed for the right side of the heart, for the tricuspid valve and pulmonary valve”), and execute processing to output the generated information on pulmonary valve regurgitation (e.g. ¶¶ 90).
Aben fails to expressly disclose performing dynamic imaging with radiation without using a contrast agent. In the same field of endeavor, Tearney discloses the dynamic imaging of the chest with radiation without using a contrast (e.g. ¶¶ 30) in order to further examine an object located in the cardiac region of the patient. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of imaging the chest with radiation without using a contrast as taught by Tearney, to the known device of Aben, ready for improvement, to yield the predictable results of providing an option for imaging for patients who physiologically cannot be exposed to a contrast agent.
Regarding claim 12, Aben discloses a non-transitory computer-readable recording medium storing a program, wherein the program, when executed by a hardware processor (e.g. ¶¶ 21), causes the hardware processor to perform operations comprising: a process of acquiring a dynamic image of a chest obtained by dynamic imaging with radiation (e.g. ¶¶ 55); a process of generating information on pulmonary valve regurgitation based on dynamic image information of a site related to at least one of a pulmonary artery and a heart in the dynamic image (e.g. ¶¶ 69-83, 62 – “The disclosed method is not limited to the left side of the heart and can also be performed for the right side of the heart, for the tricuspid valve and pulmonary valve”); and a process for outputting the generated information on pulmonary valve regurgitation (e.g. ¶¶ 90).
Aben fails to expressly disclose performing dynamic imaging with radiation without using a contrast agent. In the same field of endeavor, Tearney discloses the dynamic imaging of the chest with radiation without using a contrast (e.g. ¶¶ 30) in order to further examine an object located in the cardiac region of the patient. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of imaging the chest with radiation without using a contrast as taught by Tearney, to the known device of Aben, ready for improvement, to yield the predictable results of providing an option for imaging for patients who physiologically cannot be exposed to a contrast agent.
Regarding claim 13, Aben teaches a dynamic image analysis method comprising: acquiring a dynamic image of a chest obtained by dynamic imaging with radiation (e.g. ¶¶ 55); generating information on pulmonary valve regurgitation based on dynamic image information of a site related to at least one of a pulmonary artery and a heart in the dynamic image (e.g. ¶¶ 69-83, 62 – “The disclosed method is not limited to the left side of the heart and can also be performed for the right side of the heart, for the tricuspid valve and pulmonary valve”); and outputting the generated information on pulmonary valve regurgitation (e.g. ¶¶ 90).
Aben fails to expressly disclose performing dynamic imaging with radiation without using a contrast agent. In the same field of endeavor, Tearney discloses the dynamic imaging of the chest with radiation without using a contrast (e.g. ¶¶ 30) in order to further examine an object located in the cardiac region of the patient. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of imaging the chest with radiation without using a contrast as taught by Tearney, to the known device of Aben, ready for improvement, to yield the predictable results of providing an option for imaging for patients who physiologically cannot be exposed to a contrast agent.
Regarding claim 2, Aben discloses the site is at least an inside of any one of left and right lung field regions and includes a region of a proximal part of left and right pulmonary arteries (e.g. ¶¶ 57 – where the examiner notes the x-rays of the cardiac region necessarily overlap with left and right lung regions).
Regarding claim 3, Aben discloses the site is a target region set inside right and left lung field regions and in a proximal part of right and left pulmonary arteries, and the information on pulmonary valve regurgitation is an average value of values in both left and right target regions (e.g. ¶¶ 69).
Regarding claim 4, Aben discloses the dynamic image information is a signal value of a pixel, and the hardware processor generates the information on pulmonary valve regurgitation on the basis of information obtained from a signal value of a pixel in the site (e.g. ¶¶ 69-73).
Regarding claim 5, Aben discloses the dynamic image information is a signal value of a pixel, and the hardware processor generates the information on pulmonary valve regurgitation on the basis of an average value of the signal value of the pixel in the site (e.g. ¶¶ 69-73).
Regarding claim 6, Aben discloses the information on pulmonary valve regurgitation is information on presence or absence of pulmonary valve regurgitation (e.g. ¶¶ 90 – “zero regurgitation as derived within a pixel is represented by the color blue, in which high regurgitation as derived within a pixel is represented by a red color in case the color scaling goes from blue (min value) to red (maximum value).”).
Regarding claim 7, Aben discloses the information on pulmonary valve regurgitation is information on severity of pulmonary valve regurgitation (e.g. ¶¶ 90 – “zero regurgitation as derived within a pixel is represented by the color blue, in which high regurgitation as derived within a pixel is represented by a red color in case the color scaling goes from blue (min value) to red (maximum value).”).
Regarding claim 8, Aben discloses the hardware processor generates information on a shape of a blood flow waveform at the site as the information on pulmonary valve regurgitation (e.g. ¶¶ 90 – “zero regurgitation as derived within a pixel is represented by the color blue, in which high regurgitation as derived within a pixel is represented by a red color in case the color scaling goes from blue (min value) to red (maximum value).”).
Regarding claim 9, Aben discloses the hardware processor generates information in which a blood flow in the site is visualized as the information on pulmonary valve regurgitation (e.g. ¶¶ 90 – “zero regurgitation as derived within a pixel is represented by the color blue, in which high regurgitation as derived within a pixel is represented by a red color in case the color scaling goes from blue (min value) to red (maximum value).”).
Regarding claim 10, Aben discloses the hardware processor generates the information on pulmonary valve regurgitation on the basis of a blood flow waveform in the site (e.g. Fig. 11).
Regarding claim 11, Aben discloses the hardware processor generates the information on pulmonary valve regurgitation based on an index obtained in the site (e.g. ¶¶ 76-82).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
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