DETAILED ACTION
Notice to Applicant
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the amendment filed on 12/23/25. Claims 1-20 are pending.
.
Drawings
The drawings of Fig. 1 and 10 and are objected to because the use of grayscale and the poor resolution renders the text illegible, and the details of the images cannot be discerned. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The replacement drawings were received on 12/23/25. The drawings for Fig. 1 and 10 are not acceptable.
The drawing for Fig. 2 is acceptable.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 14 have been amended to recite a computer model “comprising a reduced order model including fluid-structure interaction for calculating deflection of a tissue of intramural segment wall.” However, the “ calculating deflection of a tissue of intramural segment walI” or the results of this calculation do not appear to be included in the subsequent steps of the recited method and system. It is therefore unclear how this phrase is intended to further modify the claimed method and system. (i.e. it is unclear how this calculation impacts the incorporation of the biomarkers into the model)
Claims 2-13 and 15-20 inherit the deficiencies of claims 1 and 14, respectively, through dependency, and are therefore also rejected.
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 1-20 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.
35 USC 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of Section 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007). Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Applicant’s claims fall within at least one of the four categories of patent eligible subject matter because claims 1-13 are drawn to a method, and claims 14-20 are drawn to an article of manufacture
Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 USC 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not complete the eligibility analysis. Claims drawn only to an abstract idea, a natural phenomenon, and laws of nature are not eligible for patent protection. As described in MPEP 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l,134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
In 2019, the United States Patent and Trademark Office (USPTO) prepared revised guidance (2019 Revised Patent Subject Matter Eligibility Guidance) for use by USPTO personnel in evaluating subject matter eligibility. The framework for this revised guidance, which sets forth the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas), is described in MPEP sections 2106.03 and 2106.04.
As explained in MPEP 2106.04(a)(2), the 2019 Revised Patent Subject Matter Eligibility Guidance explains that abstract ideas can be grouped as, e.g., mathematical concepts, certain methods of organizing human activity, and mental processes. Moreover, this guidance explains that a patent claim or patent application claim that recites a judicial exception is not ‘‘directed to’’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception. A claim that recites a judicial exception, but is not integrated into a practical application, is directed to the judicial exception under Step 2A and must then be evaluated under Step 2B (inventive concept) to determine the subject matter eligibility of the claim.
Step 2A asks: Does the claim recite a law of nature, a natural phenomenon (product of nature) or an abstract idea? (Prong One) If so, is the judicial exception integrated into a practical application of the judicial exception? (Prong Two) A claim recites a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is set forth or described in the claim. While the terms “set forth” and “describe” are thus both equated with “recite”, their different language is intended to indicate that there are different ways in which an exception can be recited in a claim. For instance, the claims in Diehr set forth a mathematical equation in the repetitively calculating step, while the claims in Mayo set forth laws of nature in the wherein clause, meaning that the claims in those cases contained discrete claim language that was identifiable as a judicial exception. The claims in Alice Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.” A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.
In the instant case, claims 1-20 recite(s) a certain methods of organizing human activity, and mathematical relationships which is subject matter that falls within the enumerated groupings of abstract ideas described in MPEP 2106.04 (2019 Revised Patent Subject Matter Eligibility Guidance)
In particular, the claims recite a method and system for simulating hemodynamics under stress conditions by incorporating a plurality of variables into a computer model, to predict a profile risk.
Claims 1 and 14 recite:
extracting, from the medical imaging data, patient-specific morphological imaging biomarkers pertaining to anomalous aortic origin of a coronary artery (AAOCA); (interpreted as taking measurements of morphology)
incorporating the biomarkers into a computer model;
simulating, using the computer model, hemodynamics of the patient under simulated stress conditions and a combination of variables, the variables comprising physiological properties of the patient; and
predicting a patient-specific risk profile of ischemia and/or sudden cardiac death based on simulated hemodynamics, including prediction of fractional flow reserve
This judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting by themselves, claims that integrate these exceptions into an inventive concept are thereby transformed into patent-eligible inventions. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). Thus, the second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Id. An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 134 S. Ct. at 2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute Sections 102, 103, and 112 inquiries for the better established inquiry under Section 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the Section 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp.,838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
As described in MPEP 2106.05, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)). Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 1 and 14 also recite: receiving medical imaging data of a patient and outputting a patient-specific risk profile of ischemia and/or sudden cardiac death based on simulated hemodynamics; and outputting a predication. The additional steps amount to insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)). Examples of insignificant extra-solution activity include mere data gathering, selecting a particular data source or type of data to be manipulated, and insignificant application. I n the instant case the additional steps amount to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering)
Exemplary claim 1 recites also computer implemented. Claim 14 recites a processor and machine readable medium. The additional components is/are generic components that perform well-understood, routine and conventional activities that amount to no more than implementing the abstract idea with a computerized system.
The generic nature of the computer system used to carryout steps of the recited method is underscored by the system description in the instant application, which discloses: “processing unit 220 may be a standard programmable processor that performs arithmetic and logic operations necessary for operation of the computer system 200. While only one processing unit 220 is shown, multiple processors may be present. As used herein, processing unit and processor refers to a physical hardware device that executes encoded instructions for performing functions on inputs and creating outputs, including, for example, but not limited to, microprocessors (MCUs), microcontrollers, graphical processing units (GPUs), and application specific circuits (ASICs). Thus, while instructions may be discussed as executed by a processor, the instructions may be executed simultaneously, serially, or otherwise executed by one or multiple processors. The computer system 200 may also include a bus or other communication mechanism for communicating information among various components of the computer system 200. “(par. 93)
The application explains: “computer system 200 may have additional features/functionality. For example, computer system 200 may include additional storage such as removable storage 240 and nonremovable storage 250 including, but not limited to, magnetic or optical disks or tapes … The computer system 200 may also have input device(s) 270 such as keyboards, keypads, switches, dials, mice, track balls, touch screens, voice recognizers, card readers, paper tape readers, or other well-known input devices. Output device(s) 260 such as printers, video monitors, liquid crystal displays (LCDs), touch screen displays, displays, speakers, etc. may also be included. The additional devices may be connected to the bus in order to facilitate communication of data among the components of the computer system 200. All these devices are well known in the art and need not be discussed at length here.” (see par. 94) Such language underscores that the applicant's perceived invention/ novelty focuses on the computerized implementation of the abstract idea, not the underlying structure of generic system components.
Furthermore, the courts have recognized certain computer functions as well‐understood, routine, and conventional functions when they are 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)). Among these are the following features, which are recited in claims 1 and claim 14:
- Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
- Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
- Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;
- Electronically scanning or extracting data from a physical document, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) (optical character recognition); and
Because Applicant’s claimed invention recites a judicial exception that is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception itself, the claimed invention is not patent eligible.
Claims 2-13 are dependent from Claim 1 and include(s) all the limitations of claim(s) 1. However, the additional limitations of the claims 2-13 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 2--13 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claims 15-20 are dependent from Claim 14 and include(s) all the limitations of claim(s) 14. However, the additional limitations of the claims 12-20 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 15-20 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lorito et al (WO 2021/234616) in view of Itu et al ( US 20180310888 A1), and in further view of Spilker et al (US 20140249790 A1)
Claims 1 and 14 Lorito teaches computer readable medium and computer-implemented method (pg. 10,lines 10-20) comprising:
receiving medical imaging data of a patient (pg. 9, lines 5-20; pg. 10, lines 5-11);
extracting, from the medical imaging data, patient-specific morphological imaging biomarkers pertaining to anomalous aortic origin of a coronary artery (AAOCA); (pg. 9, lines 5-20- b) Extrapolating and/or processing of one or more medical images and/or clinical data of the patient referred to in item a) with the measurement of specific parameters (2); pg. 15, lines 24-26-morphological parameters);
incorporating the biomarkers into a computer model; (pg. 12, lines 10-20: the measurements effected on the form of the cross section of the lumen (10) deriving in vivo from the IVUS (9) and magnetic resonance imaging (MRI) (9) preferably contribute to the definition of this 3D geometric model (8), from which the thicknesses of the vascular walls of interest ( 11) are derived)
simulating, using the computer model, hemodynamics of the patient under simulated stress conditions and a combination of variables, the variables comprising physiological properties of the patient; and (pg. 10, lines 20-25: These measures serve for feeding the method of the invention by obtaining the patient-specific simulation of the condition both at rest and under stress; pg. 12, lines 19-22;)
predicting and outputting a patient-specific risk profile of ischemia and/or sudden cardiac death based on simulated hemodynamics. (Fig. 4; pg. 14, lines 10-16)
Claims 1 and 14 further recites:
predicting and outputting a patient-specific risk profile of ischemia and/or sudden cardiac death based on simulated hemodynamics, including prediction of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR).
Lorito does not disclose, but Itu teaches predicting and outputting a patient-specific risk profile of ischemia and/or sudden cardiac death based on simulated hemodynamics, including prediction of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR). (par. 16-17 the techniques described herein utilize ML algorithms for predicting hemodynamic measures of interest (FFR, IFR, wall stress, etc.) in ACS patients; par. 37-39; par. 53- the trained surrogate model is used to predict patient-specific measures of interest such as diagnostic indices (FFR, CFR, etc.), WSS, or risk of plaque rupture; par. 58) At the time of the effective filing it would have been obvious to one of ordinary skill in the art to modify the system and method of Lorito with the teaching of Itu to provide a risk of ischemia and/or sudden cardiac death based on simulated hemodynamics, including prediction of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR). One would have been motivate to include this feature to reduce the risk of patient death or other possible future events, by warning clinicians and patients while preventative treatment(s) is/are possible.
Claims 1 and 14 further recite: incorporating the biomarkers into a computer model comprising a reduced order model including fluid-structure interaction for calculating deflection of a tissue of intramural segment wall;
Lorito does not disclose, but Spilker teaches incorporating the biomarkers into a computer model comprising a reduced order model including fluid-structure interaction for calculating deflection of a tissue of intramural segment wall (par. 220-222; par. 225) At the time of effective filing, it would have been obvious to one of ordinary skill in the art to modify the system and method of Lorito and Itu in combination with the teaching Spilker with the motivation of generating a patient specific-model with improved prediction accuracy.
claim 2, 15 Lorito teaches wherein the computer model that incorporates the biomarkers and solves for the hemodynamics comprising dynamic pressure and/or flow changes from ostium through distal coronary artery under the simulated stress conditions. (pg. 9, lines 15-25: c) Patient-specific simulation of the aortic root and/or coronary artery at rest and under stress (3) by evaluating the dynamic variations of the coronary dimensions with subsequent compression and/or altered expansion in the stress condition ( 4 )); d) Assessing and quantifying the change in the coronary flow following the stress condition referred to in item c) ( 5);
claims 3 Lorito teaches The computer-implemented method of claim 1, wherein the physiological properties comprise material properties of the patient’s heart over an age span. (pg. 16, lines 1-17)
claim 4. Lorito teaches the computer-implemented method of claim 1, wherein the physiological properties comprise the biomarkers. (pg. 13, lines 20-26)
claim 5 Lorito discloses the computer-implemented method of claim 1, wherein the simulated stress conditions comprise flow and/or stress conditions of the patient at rest and during exercise. (p. 14, lines 4-10)
claim 6, 16 Lorito teaches the computer-implemented method of claim 1, further comprising performing sensitivity analysis to determine sensitivity scores of the variables on the hemodynamics. (p. 2, lines 22-25)
claim 7, 17 Lorito discloses the computer-implemented method of claim 1, further comprising predicting a dominating mechanism of ischemia and/or sudden cardiac death in AAOCA based on the simulated hemodynamics. (pg. 8, lines 9-25)
claim 8, 18. Lorito discloses the computer-implemented method of claim 1, further comprising outputting simulated changes in FFR, iFR, and/or percent flow for a range of physiological properties. (p. 7, lines 3-11)
claim 9, 19 Lorito discloses the computer-implemented method of claim 1, wherein the medical imaging data comprise computed tomography (CT), magnetic resonance imaging (MRI), and/or ultrasound aortic and coronary imaging data of the patient. (p. 11, lines 20-24)
claim 10 Lorito discloses the computer-implemented method of claim 1, wherein the biomarkers comprise coronary ostial location, ostial branching pattern, ostial shape, proximal coronary caliber, intramural length, interarterial length, thickness of the intercoronary pillar, thickness of the intimal wall, or a combination thereof. ( p. 3,lines 2-6: ostial shape; p. 12, lines 10-18; p. 15, lines 23-p. 16, line 1)
claim 11, 20 Lorito discloses the computer-implemented method of claim 1, further comprising performing principal component analysis (PCA) on the medical imaging data to extract the biomarkers. (p. 12, lines 10-18)
claim 12. Lorito teaches the computer-implemented method of claim 1, further comprising deriving Z-scores of variation in the biomarkers in AAOCA. (p. 9, lines 13-19)
claim 13. Lorito teaches the computer-implemented method of claim 1, further comprising using K-means clustering to characterize discriminatory power of imaging indices and proximal coronary shape for ischemia through a matching matrix. (p. 5, lines 7-p. 6, line 12)
Response to Arguments
Applicant's arguments filed 12/23/25 have been fully considered but they are not persuasive.
(A) Applicant argues the rejections of claims under 35 USC 101. Applicant argues that the claims do not recite a mental process, and that the claims are drawn to a technological improvement.
In response, the claims have not been analyzed as a mental process. Moreover, the examiner disagrees with applicant’s assertion that the claims are drawn to an improvement in technology.
Consideration of improvements is relevant to the integration analysis regardless of the technology of the claimed invention. That is, the consideration applies equally whether it is a computer-implemented invention, an invention in the life sciences, or any other technology. See, e.g., Rapid Litigation Management Ltd. v. CellzDirect, Inc., in which the court noted that a claimed process for preserving hepatocytes could be eligible as an improvement to technology because the claim achieved a new and improved way for preserving hepatocyte cells for later use, even though the claim is based on the discovery of something natural.(See 827 F.3d 1042, 1048 (Fed. Cir. 2016)) Notably, the court did not distinguish between the types of technology when determining that the invention improved technology. However, it is important to keep in mind that an improvement in the judicial exception itself (e.g., a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG LLC, the court determined that the claim simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology. (921 F.3d 1084, 1093-94 (Fed. Cir. 2019) Note, there is no requirement for the judicial exception to provide the improvement.
The advantages and improvements argued by applicant reflect an improvement to the abstract idea (e.g. making better patient profiles or better predictions)
The newly added claim limitations have been incorporated and addressed in the updated rejection under 35 USC 101.
(B) Applicant argues that the new claim limitations are not taught by the prior art.
In response, the examiner has provided new grounds of rejection to address the newly added limitations.
Conclusion
THIS ACTION IS MADE FINAL. 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 Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RACHEL L. PORTER
Primary Examiner
Art Unit 3684
/Rachel L. Porter/Primary Examiner, Art Unit 3684