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 .
Response to Arguments
Applicant's arguments filed October 20, 2025 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. 112(b), Applicant has amended independent claim 21 in an attempt to overcome the rejections. However, in amending the claim, Applicant has introduced limitations that do not comply with the statute. As such, claim 21 is still rejected under 35 U.S.C. 112(b).
With respect to the rejection under 35 U.S.C. 101, Applicant has amended the claims to recite “administering to the subject the volume of blood wherein the subject is determined to be in need thereof” and argues that the amended limitation presents a practical application to the judicial exception. The Examiner contends that the limitation of replacing blood in a subject is not a practical application, but instead represents insignificant extra-solution activity (MPEP 2106.05(g). As set forth in the MPEP, conventional or obvious post-solution activity does not transform an unpatentable principle into a patentable process. Also, the step of administering a volume of blood to a subject determined to be in need of blood is merely a nominal or tangential addition to the claim that does not pose a meaningful limit on the judicial exception. As such, the Examiner contends that the limitations of the instant claims are directed to a judicial exception without significantly more, thus the rejection under 35 U.S.C. 101 is maintained.
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 3, 5, 6, 8-12, 20, 21, 24, and 28-33 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.
Claim 21 recites the limitation "the container" in line 10. There is insufficient antecedent basis for this limitation in the claim. Claims 3, 5, 6, 8-12, 20, 24, and 28-33 depend directly or indirectly from claim 21 and are also indefinite.
For claim 21, “the measurement of the stable red blood cell level” at lines 10-11 is inconsistent with the “volumetric measurement of a stable red blood cell sedimentation level” recited at lines 8-9. The Examiner requests Applicant amend the claims so that the language with respect to the stable red blood cell level is consistent.
For claim 5, the claim is unclear as the Examiner is unable to determine the metes and bounds of “about 50%.” The term “about” is indefinite as the Examiner is unable to determine a deviation from 50% that encompasses “about 50%” as the claim does not define a deviation from the claimed percentage that would be suitable to meet the claim limitations.
For claim 10, the claim is unclear as the Examiner is unable to determine the metes and bounds of the phrase “about 320 mg.” The term “about” is indefinite as the Examiner is unable to determine a deviation from 320 mg that encompasses “about 320 mg” as the claim does not recite a deviation that would be suitable to meet the claim limitation.
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 3, 5, 6, 10-12, 20, 21, 24, and 28-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) an abstract idea. This judicial exception is not integrated into a practical application because the claims do not recite any additional limitations that utilizes the abstract idea in a manner that imposes a meaningful limit on the exception. Independent claim 21 is directed to a method for accelerating measurement of a volume of blood comprising combining in a container a volume of fluid and an amount of a red blood cell flocculant to accelerate red blood cell sedimentation, determining a volume of settled red blood cells in the container at room temperature and without centrifugation to provide a volumetric measurement of a stable red blood cell sedimentation, and approximating the volume of blood in the fluid according to the formula Vb=Vₘ/(Hct x ɳ) wherein Vb is blood volume in milliliters, Vₘ is sedimentation of red blood cells in milliliters, Hct is an average hematocrit, and n is the red blood cell packing ratio of the container, wherein approximating the blood volume is accelerated compared to approximating blood volume in the absence of the red blood cell flocculant. Determining a volume of settled red blood cells, approximating the volume of blood, and comparing the determined volumes to approximated volumes in the absence of a red blood cell flocculant are mental steps that only require viewing the container and recording the volumes of sedimented red blood cells and blood volume. The Examiner notes that the claims do not recite a practical application as nothing is done after the determinations of sedimented red blood cells and blood volume are determined. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of the claim are directed to combining a fluid and a red blood cell flocculant in a container. Receiving a volume of fluid in a container is considered as routine and conventional activity as fluids are commonly received in containers. Additionally, administering a volume of blood to a subject in need of blood is considered as insignificant extra-solution activity that does not integrate the judicial exception into a practical application. As set forth in the MPEP, conventional or obvious post-solution activity does not transform an unpatentable principle into a patentable process. Also, the step of administering blood to a subject in need is merely a nominal or tangential addition to the claim that does not pose a meaningful limit on the judicial exception. With respect to the flocculant, the Examiner makes note of reference to Sauvignet et al., (US 2011/0147304) and Chiattello (US 2018/0028431) who teach polyDADMAC added to a container. The Examiner also makes note of reference to Van Ness et al., (US 2004/0029143) who teach utilizing polyDADMAC to separate red blood cells from a whole blood sample. As such, the limitation of adding a red blood cell flocculant to a container is also known in the art and does not provide significantly more to the instant claims. Therefore, based on the limitations of the instant claims, the Examiner contends that claims 3, 5, 6, 10-12, 20, 21, 24, and 28-33 are directed to an abstract idea without significantly more, and therefore are directed to ineligible subject matter under 35 U.S.C. 101.
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 DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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/DWAN A GERIDO/Examiner, Art Unit 1797
/BRIAN R GORDON/Primary Examiner, Art Unit 1798