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 .
Election/Restrictions
Applicant's election with traverse of species A1 and species B1 in the reply filed on 12/8/2025 is acknowledged. The traversal is on the ground(s) that the claims are geenric and do not depend on apparatus or mode and would not require a significantly different search. This is not found persuasive because the species are mutually exclusive from one another and based on discloses in the instant specification.
The requirement is still deemed proper and is therefore made FINAL.
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 1-4 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 calculating a corrected value of the hemoglobin F peak with respect to the entire hemoglobin peak by multiplying the ratio by a predetermined factor". 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 "from a chromatogram obtained by subjecting a blood sample to liquid chromatography" is routine and conventional in the art of . 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 are directed towards the abstract idea; dependent claim 4 is directed towards cation-exchange chromatography which is well-known, routine, and conventional.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by JP 2019060653 by Arkray et al. (Arkray).
In regard to claim 1, 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 calculating a corrected 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]).
In regard to claim 4, Arkray teaches the liquid chromatography is cation-exchange chromatography ([0023], cation exchange).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2019060653 by Arkray et al. (Arkray), as noted above.
In regard to claims 2-3, 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).
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).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6-8 of copending Application No. 18123477. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed towards method of measuring hemoglobin F with the same required peak analysis based on liquid chromatography measurements. Claims 1-3 of ‘477 each reads on instant claim 1; Claims 6-8 of ‘477 reads on instant claim 4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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