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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities: On page 16, line 5 of the specification in the brief description of Figure 12, the brief description of Figure 12 should be amended to include both Figures 12A and 12B since the drawings depict Figures 12A and 12B.
Appropriate correction is required.
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 1-23 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. On lines 3-4 of claim 1, the step of “calculating a parameter related to a centroid point from a differential curve of the coagulation reaction data” includes the broad calculation of any type of “parameter related to a centroid point from a differential curve of the coagulation reaction data”. However, the specification only describes the parameters related to a centroid point from a differential curve of coagulation reaction data as being those parameters of the centroid point in a prescribed region of a primary differential curve selected from a centroid height vHg, a centroid peak width vWg, a B flattening vABg, a W flattening vAWg, and a W time rate vTWg, as recited and calculated using the specific formulas in claims 3-4 and as described in paragraphs 0039-0049 of the specification, or being those parameters of the centroid point in a prescribed region of a positive peak of a secondary differential curve selected from a centroid height pHg, a centroid peak width pWg, a B flattening pABg, a W flattening pAWg, and a W time rate pTWg, as recited and calculated using the specific formulas in claims 6 and 8 and as described in paragraphs 0039-0049 of the specification, or as being those parameters of the centroid point in a prescribed region of a negative peak of a secondary differential curve selected from a centroid height mHg, a centroid peak width mWg, a B flattening mABg, a W flattening mAWg, and a W time rate mTWg, as recited and calculated using the specific formulas in claims 7 and 9 and as described in paragraphs 0039-0049 of the specification. Therefore, it is not clear that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of all embodiments that the step of “calculating a parameter related to a centroid point from a differential curve of the coagulation reaction data” in claim 1 encompasses.
Additionally, the step of “evaluating coagulation properties of the blood specimen using the parameter related to the centroid point” recited on lines 5-6 of claim 1 broadly includes many different types of coagulation properties. However, the specification only describes the specific coagulation properties evaluated using the parameter related to the centroid point as comprising those described in paragraph 0015 of the instant specification and those recited in claims 10-17 (i.e. a concentration of a coagulation factor, a presence or degree of coagulation abnormality, an evaluation of a coagulation time elongation factor, etc.). Therefore, it is not clear that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of all types of possible coagulation properties that the step of “evaluating coagulation properties of the blood specimen using the parameter related to the centroid point” in claim 1 encompasses.
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 1-23 are 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.
On line 2 of claim 1, the phrase “acquiring coagulation reaction data” is indefinite since it is not clear what constitutes being “coagulation reaction data” in the method. Is the coagulation reaction data obtained from optically measuring a blood sample by detecting light scattered or absorbed from the blood sample at different time points? On lines 3-4 of claim 1, the phrase “calculating a parameter related to a centroid point from a differential curve of the coagulation reaction data” is indefinite since it is not clear what constitutes the parameter in this phrase. Without knowing what types of parameters are calculated in the method which are related to a centroid point from a differential curve of the coagulation reaction data, one of ordinary skill in the art would not know how to perform the method and would not know whether they are infringing on the method or not. On lines 5-6 of claim 1, the phrase “evaluating coagulation properties of the blood specimen using the parameter related to the centroid point” is indefinite since it is not clear what constitutes being a “coagulation property” in the instant method. Without knowing what types of coagulation properties are evaluated in the instant method, one of ordinary skill in the art would not know how to perform the method and would not know whether they are infringing on the method or not.
In claim 21, the phrase “the number of the different regions” lacks antecedent basis.
Claim 22 is indefinite since it is not clear what components the “program” comprises or contains. Does the program contain non-transitory computer-readable instructions for performing the steps of the method recited in claim 1?
Claim 23 is indefinite since it is not clear what physical components the apparatus contains or comprises for performing the method according to claim 1. What specific physical or structural components in the apparatus serve to perform each of steps (1), (2) and (3) in claim 1?
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 1-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more. The claim(s) recite(s) a method for analyzing blood comprising acquiring coagulation reaction data on a subject blood specimen, calculating a parameter related to a centroid point from a differential curve of the coagulation reaction data using the specific formulas recited in claims 3, 6 and 7, and evaluating coagulation properties of the blood specimen using the parameter related to the centroid point. This method represents a judicial exception in the form of abstract ideas comprising mathematical calculations (i.e. calculating a parameter related to a centroid point from a differential curve of the coagulation reaction data using the specific formulas recited in claims 3, 6 and 7) and mental evaluations (i.e. evaluating coagulation properties of the blood specimen using the parameter related to the centroid point). This judicial exception is not integrated into a practical application because the claims do not recite any application of the judicial exception (i.e. abstract ideas) after calculating the parameter related to the centroid point and evaluating coagulation properties of the blood specimen using the parameter. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional steps of acquiring coagulation reaction data and obtaining coagulation properties using the calculated parameter related to a centroid point in the method only amount to data gathering and well-understood, routine and conventional post solution activity.
When considering the claims under the 2019 Revised Patent Subject Matter Eligibility Guidance (January 2019), it is noted that the claims meet step 1 of the guidance since the claims are directed to one of the statutory categories of invention (i.e. are directed to a process). The claims meet prong one of revised step 2A since the claims recite a judicial exception comprising abstract ideas or mental processes including performing several calculations (i.e. calculations of the specific parameters related to a centroid point in either a first or a second differential curve of a coagulation reaction curve, see claims 1-9), and making mental evaluations of coagulation properties in a subject blood specimen using the calculated parameters. These calculation steps in the claims are abstract ideas in that they can be performed in the human mind, or by a person using a pen and paper (MPEP 2106.04(a)(2) III). The claims only recite mathematical calculations (see claims 1-9), and making mental evaluations of coagulation properties based on the calculations (see claims 10-17), which all fall under the judicial exception category of abstract ideas. Additionally, the Examiner notes that even if the claims recited performing the calculations and mental analysis steps using a computer or processor, this would also not make the claims patent eligible under 35 US C 101 since performing a mental process or mathematical calculations on a generic computer, or using a generic computer as a tool to perform a mental process or calculation represents abstract ideas when the computer is presented at a high level of generality. See MPEP 2106.04(a)(2) III and MPEP 2106.04(a)(2)(C).
The claims do not meet prong two of revised step 2A since the claims do not recite additional elements that integrate the judicial exception into a practical application, such as an improvement in the functioning of a computer or other technology, effecting a particular treatment or prophylaxis for a disease or medical condition, implementing the judicial exception with a particular machine or manufacture that is integral to the claim, effecting a transformation or reduction of a particular article to a different state or thing, or applying the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. As stated above, both the step of calculating the parameters related to a centroid point of a differential curve of coagulation reaction data in the method (claims 1-9), and the step of evaluating coagulation properties using the calculated parameters (claims 10-17) constitute a judicial exception (i.e. abstract ideas), and the additional recitations in the claims constitute routine extra-solution activity which is incidental to the primary process and/or are nominal or tangential additions to the claims. See MPEP 2106.05(g). With regards to claim 18-21, these claims merely recite how a subject blood specimen evaluated in the method is prepared and analyzed to obtain the data required to perform the abstract ideas (i.e. is pre-solution activity). With regards to claims 22 and 23, these claims do not confer patent eligibility to the claims since according to MPEP 2106.04(d), “It is notable that mere physicality or tangibility of an additional element or elements is not a relevant consideration in Step 2A Prong Two. As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) ("The fact that a computer ‘necessarily exist[s] in the physical, rather than purely conceptual, realm,’ is beside the point"). See also Genetic Technologies Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1547 (Fed. Cir. 2016) (steps of DNA amplification and analysis are not "sufficient" to render claim 1 patent eligible merely because they are physical steps). Conversely, the presence of a non-physical or intangible additional element does not doom the claims, because tangibility is not necessary for eligibility under the Alice/Mayo test. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016) ("that the improvement is not defined by reference to ‘physical’ components does not doom the claims"). See also McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016), (holding that a process producing an intangible result (a sequence of synchronized, animated characters) was eligible because it improved an existing technological process).”
The claims also do not meet step 2B of the guidance since the additional elements of the claims concerning acquiring coagulation reaction data, measuring coagulation properties of the subject blood specimen using the parameter related to the centroid point, steps to prepare and analyze a blood specimen as recited in claims 18-21, and a program or apparatus for performing the method in claims 22-23 only amount to data gathering, mental analysis steps, and/or well-understood, routine and conventional pre- and post-solution activity rather than additional steps that provide an inventive concept to confer patent eligibility under 35 USC 101. The steps recited in claims 18-19 represent well-known, routine and conventional steps used to perform a blood cross-mixing test, as described in paragraph 0004 of the instant specification. Claims 20-21 recite the abstract ideas of acquiring and calculating parameters related to a centroid point, comparing the parameters to a reference, and making a mental evaluation based on the comparison. Claims 22-23 merely recite a generic program and apparatus for performing a blood analysis method. According to MPEP 2106.05, “An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?") (emphasis added)); RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). Instead, 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., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966)”. Therefore, the elements recited in the claims which are in addition to the judicial exception (i.e. obtaining coagulation reaction data, steps to prepare and analyze a blood specimen as recited in claims 18-19, and a program or apparatus for performing the method as recited in claims 22-23) do not amount to an inventive concept that qualifies as significantly more to the judicial exception. For this reason, the claims are not patent eligible under step 2B of the 35 USC 101 analysis.
Inventorship
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 5, 10-19 and 22-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawabe et al (WO 2020/101025, submitted in the IDS filed on November 15, 2022, English-language translation is US 2021/0333295, also submitted in the IDS filed on November 15, 2022).
It is noted that Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216. The reference to Kawabe et al (WO 2020/101025 qualifies as prior art under 35 USC 102(a)(1) since it as published on May 22, 2020, which is prior to the current effective filing date of the instant application, which is July 15, 2021 (i.e. the filing date of PCT/IB2021/056379).
It is noted that all references to paragraph numbers in this rejection refer to paragraphs in the English-language translation of Kawabe et al (US 2021/0333295).
With regards to claim 1, Kawabe et al teach of a blood analysis method comprising acquiring coagulation reaction data on a subject blood specimen (see paragraph 0019 in Kawabe et al), calculating a parameter related to a centroid point from a differential curve of the coagulation reaction data (see paragraphs 0020-0021 in Kawabe et al), and evaluating coagulation properties of the blood specimen using the parameter related to the centroid point (see paragraph 0022 in Kawabe et al).
With regards to claim 2, Kawabe et al teach that the centroid point is one selected from a centroid point in a prescribed region of a primary differential curve of a coagulation reaction curve of the blood specimen and a centroid point in a prescribed region of a secondary differential curve of the coagulation reaction curve. See paragraph 0023 in Kawabe et al.
With regards to claim 5, Kawabe et al teach that the centroid point in the prescribed region of the secondary differential curve includes one or more selected from the group consisting of a centroid point in a prescribed region of a positive peak of the secondary differential curve, and a centroid point in a prescribed region of a negative peak of the secondary differential curve. See paragraphs 0036 and 0044 in Kawabe et al.
With regards to claims 10-17, Kawabe et al teach that the evaluation of the coagulation properties in the method comprises a measurement of a concentration of a coagulation factor such as coagulation factor VIII and coagulation factor IX, an evaluation of presence or degree of a coagulation abnormality such as hemophilia A or B, evaluation of a coagulation time elongation factor, and a measurement of a titer of a coagulation factor inhibitor such as a coagulation factor VIII inhibitor. See paragraphs 0055, 0058, 0074, 0348, 0354, 0553 and Table 11 in Kawabe et al.
With regards to claims 18-19, Kawabe et al teach that the analysis method comprises preparing a mixed specimen by mixing a subject blood specimen with a normal blood specimen, heating the mixed specimen to a temperature between 35-390C, acquiring coagulation reaction data on the heated and unheated mixed specimen, and calculating parameters related to a centroid point of the heated and unheated mixed specimen based on the coagulation reaction data. See paragraphs 0064-0072, 0075 and 0083 in Kawabe et al.
With regards to claims 22-23, Kawabe et al teach of a program and an apparatus for performing the blood analysis method. See paragraphs 0001, 0398-0399 and 0405 of Kawabe et al.
Claim(s) 1-2, 10-12 and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawabe (JP 2019-086518, submitted in the IDS filed on November 15, 2022).
With regards to claims 1-2, 10-12 and 14-15, Kawabe (JP 2019-086518) teach of a blood analysis method that comprises preparing a reaction solution containing plasma and reagents for APTT measurement, obtaining a coagulation reaction curve of the reaction solution, wherein an X -axis of the coagulation reaction curve represents a reaction time and a Y-axis represents a coagulation reaction amount), calculating a first differential curve of the coagulation reaction curve (i.e. a coagulation rate curve), calculating a parameter related to a centroid point of the first differential curve (i.e. a position corresponding to a weighted average value of photometric points of the coagulation reaction rate curve), and evaluating one or more coagulation properties in the reaction solution based on parameter. The coagulation properties evaluated in the method comprise a concentration of a coagulation factor such as coagulation factor VIII, a coagulation abnormality, and a coagulation time elongation factor such as coagulation factor deficiencies. See paragraphs 0012-0024 in Kawabe (JP 2019-086518).
Claim(s) 1-2, 10-17 and 22-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by any one of Non-Patent references 25, 26 or 27 submitted in the IDS filed on November 15, 2022.
Non-Patent references 25, 26 or 27 submitted in the IDS filed on November 15, 2022 correspond to Documents 1, 2 and 3 cited in the corresponding PCT application to this application (PCT/IB2021/056379). With regards to claims 1-2, 10-17 and 22-23 and according to the Written Opinion of this PCT application, documents 1-3 (i.e. Non-Patent references 25, 26 or 27 submitted in the IDS filed on November 15, 2022) teach of a blood analysis method where various parameters are generated from a centroid point of a first derivative (i.e. velocity) curve of an APTT coagulation waveform. The parameters generated in the methods comprise each of a height Vwx, a time Twx, a baseline width Bx, a flatness Vwx/Bx, and a time rate Twx/Bx of a coagulation velocity waveform (i.e. the first derivative (i.e. velocity) curve ) of the APTT coagulation waveform. Blood coagulation properties of a blood specimen are evaluated based on the APTT coagulation waveform centroid parameters. The blood coagulation properties comprise hemophilia A and factor VIII abnormalities. These references also teach that an algorithm for hemophilia A diagnosis was developed based on APTT coagulation waveform template matching, and an APTT cross-mixing test was performed. See the full description of these non-English references and how they anticipate claims 1-2, 10-17 and 22-23 in the Written Opinion of PCT/IB2021/056379.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Kawabe et al (both WO 2020/218425 and US 2022/0326262) who teach of a method for measuring a titer of a coagulation factor inhibitor; Kawabe et al (US 12,313,638) who teach of a method for analyzing blood coagulation characteristics; Anderson (US 6,524,861) who teach of a blood coagulation analyzer and method that includes the use of a non-linear equation having coefficients related to the clotting process; and Kawabe et al (both US 2023/0152335 and US 2023/0213497) who teach of blood coagulation measurement methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 December 16, 2025