Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) "calculating...a ratio of a peak value of a hemoglobin F peak to a peak value of an entire hemoglobin peak; and . This judicial exception is not integrated into a practical application because the additional elements fail to integrate the abstract idea into a practical application; the limitation. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because "from a chromatogram obtained by subjecting a blood sample to liquid chromatography" is data gathering MPEP 2106(g) and further liquid chromatography is well known, routine, and conventional. Dependent claims 2-3 and 6 are directed towards the abstract idea; dependent claim 4 is directed towards cation-exchange chromatography which is well-known, routine, and conventional. Dependent claim 5 is directed towards the source of the blood sample which is well-known, routine, and conventional. Dependent claims 7-8 are directed towards the chromatography modes and elution steps which is well-known, routine, and conventional.
Claim Rejections - 35 USC § 103
Claims 1-4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2019060653 by Arkray et al. (Arkray).
In regard to claims 1 and 7, Arkray teaches a method of measuring hemoglobin F ([0008]). Arkray teaches calculating, from a chromatogram obtained by subjecting a blood sample to liquid chromatography ([0008], blood sample, separation analysis method; [0011], HPLC which is high pressure liquid chromatography; [0023]), a ratio of a peak value of a hemoglobin F peak to a peak value of an entire hemoglobin peak ([0008], ratio of hemoglobin F (HbF) content to total hemoglobin content in the sample). Arkray teaches automatically correcting a value of the hemoglobin F peak with respect to the entire hemoglobin peak by multiplying the ratio by a predetermined factor ([0008], ratio of hemoglobin F (HbF) content to total hemoglobin content in the sample, calibrated for the ratio, set reference value; [0020]; [0029]).
Arkray teaches the predetermined factor is a value obtained in advance as a ratio of a peak value of hemoglobin F [0008], ratio of hemoglobin F (HbF) content to total hemoglobin content in the sample, calibrated for the ratio, set reference value; [0020]; [0029]; [0023], capillary electrophoresis, liquid chromatography). Arkray teaches that capillary electrophoresis and liquid chromatography are two techniques to determine a predetermined ratio ([0023], capillary electrophoresis, liquid chromatography; [0091]; [0100]). Arkray does not teach comparing the peak values from hemoglobin F determined by capillary electrophoresis and liquid chromatography. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate both capillary electrophoresis and liquid chromatography as they are both known analytical separation methods of determining blood sample properties. Further, Arkray teaches calibrating the values results in a more true total hemoglobin content and greater accuracy in determination of blood conditions ([0043]).
Arkray teaches a liquid chromatography measurement performed using a first mode or a second mode of the liquid chromatography ([0023]; reading on claim 7).
In regard to claims 2-3 and 6, Arkray teaches calibrating the device with respect to Hemoglobin F and total hemoglobin content ([0028]-[0029]). Arkray teaches it is important to maintain the accuracy of the measurement with a standard sample comprising known parameter values ([0028]-[0029]). Arkray teaches a conversion process and calibration curve for setting the correction coefficient ([0028]-[0029]). Arkray does not specifically teach the factor is 1.15 to 1.25 (claim 2), or more specifically 1.2 (claim 3); or 1.18 to 1.23 (claim 6).
As the measurement accuracy and calibration are variables that can be modified, among others, by adjusting said factor, the precise factor would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed factor cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the factor in the method of Arkray to obtain the desired balance between the measurement accuracy and calibration (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
In regard to claim 4, Arkray teaches the liquid chromatography is cation-exchange chromatography ([0023], cation exchange).
In regard to claim 8, Arkray teaches the first mode comprises a first elution step and a second elution step ([0146]-[0150]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over JP 2019060653 by Arkray et al. (Arkray), as noted above, in view of U.S. Patent Publication No. 2019/0265255 by Cambot et al. (Cambot).
In regard to claim 5, modified Arkray teaches the limitations as noted above. Arkray does not teach the blood sample is from a patient having hemoglobinopathy or thalassemia. Arkray teaches the blood sample is from a patient with feto material transfusion syndrome ([0002]).
Cambot teaches hemoglobin F is a common marker measured when treating thalassemia ([0009]; [0020]; [0024]; [0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to utilize a blood sample from a patient having thalassemia as thalassemia is a common blood condition monitored by hemoglobin F.
Response to Arguments
Applicant's arguments filed 6/18/2026 have been fully considered but they are not persuasive.
In regard to the Applicant’s arguments regarding the 101 rejection; the Examiner does not find this persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., eliminating repeated comparative measurements; reducing redundant analysis processes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). These limitations are neither claimed nor excluded by the claims.
In regard to the applicant’s arguments regarding the anticipation rejection of the claims; the Examiner notes the rejection is updated above and no longer relies on anticipation.
The Obviousness Double Patenting rejection is removed in light of the claim amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA M PEO whose telephone number is (571)272-9958. The examiner can normally be reached 9 to 5:30.
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/KARA M PEO/Primary Examiner, Art Unit 1777
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