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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/17/2026 has been entered.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9 and 53-55 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.
Claims 1-9 and 53-55 are not clear with respect to what applicant is claiming. The claims does not clearly set forth the metes and bounds of the patent protection desired. For example, claim 1 recites “a receiver configured to receive the ultrasonic signal that interacted with the blood sample and to convert the received ultrasonic signal to an electrical signal corresponding to a time-displacement curve data generated from the ultrasonic signal. However, it is unclear what structural configuration of the receiver is being claimed that the receiver receives and converts the received ultrasonic signal. While the specification appears to show support for a receiver configured to receive the ultrasonic signal that interacted with the blood sample, it does not provide support for a receiver configured to convert the received ultrasonic signal to an electrical signal corresponding to a time-displacement curve data generated from the ultrasonic signal. For these reasons, dependent claims relating to above limitations are similarly unclear.
Claim limitation “a receiver configured to receive the ultrasonic signal that interacted with the blood sample and to convert the received ultrasonic signal to an electrical signal corresponding to a time-displacement curve data generated from the ultrasonic signal” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function; and/or the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-9, 53 & 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (US 2012/0244564 A1; incorporated references Cohen et al. US 6,225,126, and Walker et al. US 8,306,293 (U.S. Application Serial No. 12,467,216 filed May 15, 2009)) in view of Bystryak et al. (US 2009/0053688 A1) or Barone et al. (US 5,273,517), and further in view of Corey et al. (US 2007/0266778 A1).
Regarding claim 1, Walker et al. teach:
1. A system for measuring a parameter of a blood sample (throughout the reference), the system comprising:
a holding assembly (e.g., cup carrier 18 of the incorporated reference Cohen et al. US 6,225,126) configured to holding a consumable cartridge (e.g., stationary container 240; see also sample cup 24 in ‘126 for example) containing the blood sample by applying pressure to the consumable cartridge (¶ 0122+);
an ultrasonic signal generator (e.g., ultrasound transducer 18, transducer 120, printed circuit board 110) configured to generate and direct an ultrasonic signal to interact with the blood sample in the consumable cartridge (see ¶ 0092-0093, 0099-0102, 0113-0115+ & claim 53 for example);
a receiver (e.g., ultrasound transducer 18, transducer 120, printed circuit board 110) capable of determining at least one characteristic of the ultrasonic signal that interacted with the blood sample (see ¶ 0006, 0011-0016, 0091-0112+ for example) by fitting a model to a time-displacement curve data generated from the ultrasonic signal (see ¶ 0097-0098, and Example 2 C30/L19-C32/L27 of the incorporated reference Walker et al. US 8,306,293 (U.S. Application Serial No. 12,467,216 filed May 15, 2009));
a receiver (e.g., ultrasound transducer 18, transducer 120, printed circuit board 110) configured to receive the ultrasonic signal that interacted with the blood sample (see ¶ 0006, 0011-0016, 0091-0112+ for example);
a processor (e.g., computer 150) coupled to the receiver (¶ 0113+);
the processor configured to convert the received ultrasonic signal to an electrical signal (via a transducer 120 ¶ 0115) corresponding to a time-displacement curve data generated from the ultrasonic signal (see ¶ 0143 for example) and
a non-transitory memory (e.g., hard disk drive 512, removable storage drive 514, main memory 508, secondary memory 510 ¶ 0130-0133+) in communication with the processor, the memory comprising computer-executable instructions (¶ 0134-0138+), wherein execution of the instructions, cause the processor to determine, from at least one characteristic obtained by fitting a model to the time-displacement curve data (¶ 0143-0144+), a hemostasis parameter (see Fig. 1C & ¶ 0104) and at least one parameter (see ¶ 0006, 0011-0016, 0091-0112+ for example).
However, Walker et al. do not explicitly teach: a clamp assembly configured to clamp a consumable cartridge containing the blood sample by applying pressure to the consumable cartridge.
Bystryak et al. teach an ultrasound-assisted particle agglutination assay methods and apparatuses, comprising a clamp assembly (e.g., grips 581, 582) configured to clamp a consumable cartridge (e.g., 501) containing a blood sample (¶ 0002+) by applying pressure to the consumable cartridge (¶ 0060-0061).
Barone et al. teach a system for measuring a parameter of a blood sample comprising a clamp assembly (e.g., deck assembly 12) configured to clamp a consumable cartridge (e.g., cassette 24) containing a blood sample (C1/L61-C2/L5+) by applying pressure to the consumable cartridge (C5/L15-68+).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Walker et al., with the clamp assembly as taught by Bystryak et al./Baron et al., to secure a consumable cartridge containing a blood sample by applying pressure to the consumable cartridge (Bystryak et al. (¶ 0060-0061), Barone et al. (C2/L25-41+)).
However, modified Walker et al. do not explicitly teach: at least one parameter selected from a group consisting of hematocrit (HCT), hemoglobin concentration (HGB), mean corpuscular volume (MCV), red cell count (RBC), mean cellular hemoglobin concentration (MCHC), mean cellular hemoglobin (MCH) and combinations thereof.
Corey et al. teach an apparatus comprising:
an ultrasonic signal generator and receiver (see e.g., an ultrasonic field-portable system (i.e., integrated) in Fig. 1 having transducer(s) 82, signal generator circuit 230, and a sensing surface 228) comprising an ultrasonic transducer (227/82) configured to receive an ultrasonic signal that interacted with the blood sample (see ¶ 0088-0090+ & Fig. 12 for example) and to convert the received ultrasonic signal to an electrical signal (see ¶ 0066, 0103-0104 for example);
wherein the application of the one or more ultrasonic signals include a first application of a first ultrasonic signal associated with detection of a hemostasis parameter (e.g., hematocrit (HCT) ¶ 0108-0110+; HCT, MCV, RBC ¶ 0086) and a second ultrasonic signal associated with detection of an oxygen transport parameter (e.g., hemoglobin concentration ¶ 0108-0110+; HCT, MCV, RBC ¶ 0086);
a processor (260) coupled to the receiver (¶ 0103+); and
a non-transitory memory (e.g., RAM 270) in communication with the processor (¶ 0103), the memory comprising computer-executable instructions, wherein execution of the instructions, cause the processor to:
direct the application of the one or more ultrasonic signals, including the second signal, through the integrated ultrasonic receiver (¶ 0103-0106+);
receive, from the receiver, data characterizing the one or more responses resulting from the application of the one or more signals to the blood sample (¶ 0103-0106); and
determine: the hemostasis parameter by evaluating the blood sample associated with the first application of the first ultrasonic signal (¶ 0108-0110+) and the oxygen transport parameter by evaluating the one or more responses associated with the second application of the second ultrasonic signal (¶ 0108-0110+), wherein the second ultrasonic signal is applied over the same signal path as the first ultrasonic signal (see Fig. 12 for example),
wherein the determined hemostasis parameter (HCT) is determined based on an assessed displacement of the blood sample via an assessed reflection from blood cells in the blood sample (¶ 0108-0114), and
wherein the determined oxygen transport parameter (HCT, MCV, RBC, HGB) is determined based on an assessed reflection of the second ultrasonic signal from a reflector (e.g., the far wall of the sample chamber 22, ¶ 0114) in the sample container (¶ 0108-0114) and includes a parameter selected from the group consisting of hematocrit, hemoglobin concentration, mean corpuscular volume, red cell count, mean cellular hemoglobin concentration, and mean cellular hemoglobin (¶ 0086, 0108-0114); and
present, via a graphical user interface, the determined oxygen transport parameter and the determined hemostasis parameter (¶ 0130).
wherein the processor is configured to report the HCT (¶ 0061, 0108-0110, ¶ 0124+).
wherein the processor is configured to compare the HCT to a predetermined HCT and communicate a difference therebetween (Claim 18).
wherein the processor is configured to determine when the HCT is within a range affecting the parameter and communicate a warning about the parameter (¶ 0061).
wherein the one or more ultrasonic signals applied to the blood sample are generated by the integrated ultrasonic receiver acting as an ultrasonic generation source (¶ 0103-0104+);
wherein, execution of the instructions, cause the processor to determine the oxygen transport parameter based on an associated speed of sound through the blood sample, the sound being generated by the ultrasonic generation source (¶ 0108-0114+);
wherein, execution of the instructions, cause the processor to determine an attenuation parameter associated with an ultrasonic signal generated by the ultrasonic generation source, wherein the oxygen transport parameter is determined based on the attenuation parameter (¶ 0126);
wherein the processor is further configured to use the oxygen transport parameter determined based on the associated speed of sound through the blood sample to calibrate the apparatus (¶ 0086); and
wherein the sample container is included in a consumable cartridge (e.g., disposable blood sampling device 12) having a plurality of sample containers (e.g., capillary tube 11, aperture 21; see also ¶ 0032).
It would have been obvious to one of ordinary skill in the art at the time the invention was made combine the hemostasis parameter of Walker et al., with a hemostasis parameter and at least one parameter selected from a group consisting of hematocrit (HCT), hemoglobin concentration (HGB), mean corpuscular volume (MCV), red cell count (RBC), mean cellular hemoglobin concentration (MCHC), mean cellular hemoglobin (MCH) and combinations thereof, as taught by Corey et al. since they are related in the coagulation cascade, and therefore a correlation would be expected. The Supreme Court has articulated a number of exemplary rationales that support a conclusion of obviousness including Rationale E. “Obvious To Try” – Choosing From a Finite Number of Identified, Predictable Solutions, with a Reasonable Expectation of Success. The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art (MPEP 2143).
With regard to limitations in claims 1, 3-6, 8, 9, 53-55 (e.g., [...] to convert the received ultrasonic signal to an electrical signal corresponding to a time-displacement curve data generated from the ultrasonic signal, [...] to adaptively adjust, via the processor, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
Regarding claims 2-6, 53, further modified Walker et al. teach:
2. The system of Claim 1, wherein the processor is further configured, via execution of computer-executable instructions on the memory, to generate a corrected hemostasis parameter using the at least one parameter selected from a group consisting of HCT, HGB, MCV, RBC, MCHC, MCH and combinations thereof (see i.e., The ensemble of the time delays forms a time-displacement curve 20 that describes the viscoelastic properties of the sample being analyzed, see FIG. 1B. This process is then repeated M times (where M is a positive integer), with intervening relaxation periods, to provide data about the dynamics of clot formation and dissolution. ¶ 0100; see also i.e., FIG. 3 is a flow chart illustrating use of adaptive radiation force sonorheometry to adaptively adjust the applied radiation force in order to maintain low strains and improve dynamic ranges of stiffness measurement according to an embodiment of the present invention. ¶ 0110; ¶ 0101-0100+).
3. The system of Claim 2, wherein the hemostasis parameter is selected from a group consisting of clot initiation time (TC1), clot stabilization time (TC2), clotting angle, estimated stiffness S, baseline viscosity, and post-lyses viscosity (¶ 0104+).
4. The system of Claim 2, wherein the hemostasis parameter is an index for a clinical parameter selected from a group consisting of (1) coagulation factors, (2) platelet function, (3) fibrinogen and (4) fibrinolysis (¶ 0092+).
5. The system of Claim 4, wherein the processor is configured, via execution of computer-executable instructions on the memory, to adjust a transfusion protocol using the clinical parameter (¶ 0152).
6. The system of Claim 5, wherein the clinical parameter comprises is at least one of (1) fresh frozen plasma, (2) platelet concentrates, (3) cryoprecipitate, (4) antifibrinolytics, or (5) packed RBCs.
53. The system of claim 1, wherein the ultrasonic signal generator is capable of generating, via the processor, the ultrasonic signal to generate a convoluted pulse (see Example 4 of the incorporated reference Walker et al. ‘293).
Regarding claims 7-9, modified Walker et al. teach:
wherein the processor is configured, via execution of computer-executable instructions on the memory, to report the at least one parameter (¶ 0045+).
wherein the processor is configured, via execution of computer-executable instructions on the memory, to compare the at least one parameter to a predetermined at least one parameter and communicate a difference therebetween (¶ 0010-0011+).
wherein the processor is configured, via execution of computer-executable instructions on the memory, to determine when the at least one parameter is within a range affecting the parameter and communicate about the parameter (¶ 0010-0011+).
However, modified Walker et al. do not explicitly teach: 7. The system of Claim 1, wherein the processor is configured, via execution of computer-executable instructions on the memory, to report the HCT. 8. The system of Claim 7, wherein the processor is configured, via execution of computer-executable instructions on the memory, to compare the HCT to a predetermined HCT and communicate a difference therebetween. 9. The system of Claim 7, wherein the processor is configured, via execution of computer-executable instructions on the memory, to determine when the HCT is within a range affecting the parameter and communicate a warning about the parameter.
See Corey et al. above.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to further modify the device of Walker et al. to program the processor to determine hematocrit (HCT) of a blood sample, as taught by Corey et al., to further characterize the blood sample using the HCT. The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141.
Regarding claim 54, modified Walker et al. teach the use of finite element models (see i.e., Application of sonorheometry according to the present invention requires neither moving mechanical parts nor direct contact with the sample and viscoelasticity measurements can be performed with minimal mechanical strain on the blood. The shear strains generated by the acoustic radiation force are kept below 3%, which is within the linear range of blood (the shear levels were also confirmed by simulations using finite element models). ¶ 0151; and C2/L32-33 of the incorporated reference ‘293 i.e., Finite impulse response (FIR) and infinite impulse response (IIR) filters have been used to improve SNR.). See also C33/L65-C34/L1 i.e., A-lines (a scan line in ultrasound imaging, the position of the ultrasound beam axis during one pulse-echo sequence) were formed by convolving the acoustic targets, modeled as Gaussian white noise, with the PSF of the ultrasound pulse, which was represented as a Gaussian enveloped sinusoid. Autocorrelation method in C4/L17-29 of the incorporated reference ‘293 i.e., Motion estimators are commonly classified based upon the domain in which they operate. The most common phase domain techniques are Kasai's 1D autocorrelator, see Kasai et al., “Real-time two-dimensional blood flow imaging using autocorrelation technique”, IEEE Trans Sonics Ultrason. 32:458-463, 1985, which is hereby incorporated herein, in its entirety, by reference thereto, and Loupas' 2D autocorrelator, see Loupas et al., “Experimental evaluation of velocity and power estimation for ultrasound blood flow imaging, by means of a two-dimensional autocorrelation approach”, IEEE Trans Ultrason Ferroelect Freq Contr. 42:689-699, 1995, which is hereby incorporated herein, in its entirety, by reference thereto.
However, modified Walker et al. do not explicitly teach: 54. The system of claim 53, wherein the convoluted pulse is convolved with a Barker code.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to further modify Walker et al., for the purpose of using a mathematical model suitable for improving the signal-to-noise ratio. The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141. Therefore, although a Barker code convolution is not taught, selecting a mathematical model suitable for improving the signal-to-noise ratio would have been obvious to one of ordinary skill in the art.
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (US 2012/0244564 A1; incorporated references Cohen et al. US 6,225,126, and Walker et al. US 8,306,293 (U.S. Application Serial No. 12,467,216 filed May 15, 2009)) in view of Bystryak et al. (US 2009/0053688 A1) or Barone et al. (US 5,273,517), in view of Corey et al. (US 2007/0266778 A1), and further in view of Walker et al. (US 2011/0034805 A1).
Regarding claim 55, modified Walker et al. teach the use of a modified Voigt model (see C31/L1-11+ of the incorporated reference ‘293 i.e., Displacement profiles of coagulating blood were calculated, and the material properties were estimated by fitting displacement responses to a discrete viscoelastic model. The model used was a modified Voigt model with an added mass, which has been shown to characterize the response of coagulating blood to a step excitation of acoustic radiation force, i.e., see Viola et al., “Sonorheometry: A noncontact method for the dynamic assessment of thrombosis”, Ann Biomed Eng 2004; 32(5):696-705, which is hereby incorporated herein, in its entirety, by reference thereto.).
However, modified Walker et al. do not explicitly teach: 55. The system of claim 1, wherein a curve a superimposed on a model prediction, and wherein mechanical properties of the forming thrombus corresponding to the hemostasis parameter are modeled by a modified Voigt model.
Walker et al. ‘805 teach: wherein a curve a superimposed on a model prediction, and wherein mechanical properties of the forming thrombus corresponding to the hemostasis parameter are modeled by a modified Voigt model (¶ 0050).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to further modify Walker et al. with the teaching of Walker et al. ‘805 to improve the response of the blood during formation of a clot with correlation between the data and the model (Walker et al. ‘805, ¶ 0054). The Court stated that if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Id. at ___, 82 USPQ2d at 1396.
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground(s) of rejection.
Applicant’s amendments have been considered and have been addressed within the above new rejections and amended art rejection.
The 35 USC § 112 rejections have been revised.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Teixeira (US 2019/0012608 A1, see Related U.S. Application Data) teach an algorithm used to generate a reference signal in the form of a first probability distribution from the model’s current (time=t) physiological state. The reference signal probability distribution and a probability distribution generated from a measured signal from a sensor at a subsequent time (time=t+n) are convoluted using Bayesian statistics to estimate the true value of the measured physiological parameter (¶ 0144).
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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