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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/03/2026 has been entered.
Applicant' s amendment and response filed on 03/03/2026 has been received and entered into the case.
Amendments
In the reply filed 03/03/2026, Applicant has amended claims 1, 3, 15, 17, 19 and 20, newly canceled claim 18, and added new claim 22.
Claim Status
Claims 1-17, 19-20 and 22 are pending.
Claims 4-17 and 19-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/18/2024.
Claims 1-3 and 22 are considered on the merits.
Withdrawn Claim Objections
The prior objection to claim 3 because of minor informalities is withdrawn in light of Applicant’s amendment to the claim.
Withdrawn Claim Rejections - 35 USC § 103
The prior rejection of claims 1-3 under 35 U.S.C. 103 as being unpatentable over Bitensky (US Patent 5,476,764. IDS 01/14/2022) in view of MemorialCare Health System (Blood Types and Facts. Published 11/07/2016. P. 1-2. Downloaded from https://web.archive.org/web/20161107044305/https://www.memorialcare.org/services/blood-donation/blood-types-and-facts. Downloaded on 2/13/2025. Prior art of record) and Yoshida et al., (Vox Sanguinis. 2007;92:22-31. Cited in IDS 01/14/2022) is withdrawn in light of Applicant’s amendment to claim 1 to recite new limitations of a step (d) typing the blood for use in transfusion medicine comprising contacting the blood with the stored and preserved CO-Hb RBCs, which is not taught by cited art.
New Claim Rejections - 35 USC § 103
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 1-3 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al., (Blood Transfus. 2013; 11: 305-307) in view of Raman et al., (ISBT Science Series. 2008; (3): 33-60), Bitensky (US Patent 5,476,764. IDS 01/14/2022) and Yoshida et al., (Vox Sanguinis. 2007;92:22-31. Cited in IDS 01/14/2022).
With respect to claim 1, it is noted that the limitation “for use in transfusion medicine" is interpreted as intended use. MPEP 2111.02 II states “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. Thus, the limitation “for use in transfusion medicine” is reasonably interpreted as the blood is suitable for use in transfusion medicine.
Gao teaches a method for preparing A2 reverse grouping red blood cells (e.g., title) and a method of using these A2 red blood cells and control red blood cells for blood typing of blood from donors (see e.g., p. 306, para 1 “Blood group typing” and see Fig 2 for typing results). Thus, Gao teaches a method for blood typing of blood that is suitable for use in transfusion medicine.
Regarding step (a) of claim 1, Gao teaches fresh human whole blood (blood group A2B) was obtained and the buffy coat was removed. Enzymatic conversion was performed in 1 mL reaction mixtures containing 30% packed RBC (p. 305, right col, para 1), thus teaches claim 1 (a) obtaining packed red blood cells from donor blood of a known phenotype.
Regarding step (c) of claim 1, Gao teaches the enzyme-converted RBC were stored in monoammonium phosphate nutrient solution at 4 °C (p. 305, right col, para 1), thus teaches part of claim 1 (c) storing the RBCs under refrigerated conditions to prepare stored and preserved RBCs.
Regarding step (d) of claim 1, Gao teaches the anti-B or anti-A1 sera from donors are contacted with the enzyme-converted RBCs and the control of native A2 RBCs (see e.g., p. 306, para 1 “Blood group typing”), thus teaches claim 1 (d) typing the blood that is suitable for use in transfusion medicine (i.e., the donor blood) comprising contacting the blood (the serum) with the stored and preserved RBCs.
However, Gao is silent on flushing the RBCs with CO in claim 1 (b) and claim 2 or storing the CO-Hb RBCs under anaerobic conditions in claim 1 (c).
Regarding storing the reagent red blood cells (i.e., the reverse grouping red blood cells of Gao), Raman teaches refrigerated storage of reagent red cells suspended in a preservative fluid (p. 33, right col, section “Blood samples”, para 1), and teaches “in order to preserve blood specimens so that they retain their properties and give the correct results on testing, they should be cooled to about +4°C in the laboratory refrigerator as soon as possible after being taken, and kept refrigerated both before and after testing” and “the actual testing of the specimen should take place within 3 days of collection for serological testing, to avoid the danger of antigens or antibodies deteriorating” (p. 54, last para). Thus, Raman teaches the red blood cells (either in the specimen or the reagent red cells) should be stored under refrigerated conditions (as done by Gao) to avoid possible antigen deteriorating.
Regarding flushing the RBCs with CO in claim 1 (b) and claim 2, Bitensky teaches a method for using carbon monoxide for extending the useful shelf-life of refrigerated red blood cells (see e.g., abstract and reference claim 1 “a method for storing red blood cells”). Bitensky teaches the commercially pure (CP Grade) carbon monoxide (CO) (thus does not comprise oxygen) is delivered into the pouch containing the packed red blood cells, and after gentle shaking for 2-6 hours the gas phase is exhausted from the pouch, and fresh CO is added in order to expel the residual oxygen, and saturate the sample with CO. This latter procedure may be repeated in order to ensure CO saturation (col. 7, sample “C” and see e.g., reference claim 1 (e) and claim 2). Thus, Bitensky teaches claim 1 (b) flushing the packed red blood cells with a gas comprising carbon monoxide to prepare carbon monoxide saturated RBCs (CO-Hb RBCs), and claim 2 the gas does not comprise oxygen. Bitensky acknowledges that cumulative oxidative damage is a limitation on the useful storage life of refrigerated red blood cells (col. 2, last para), and teaches CO stabilizes hemoglobin thus reduces exposure of the stored red blood cells to oxygen radicals and other species harmful to the cell membrane with the result that useful refrigerated storage periods may be prolonged (col. 5, para 4), suggesting reducing exposure of the stored refrigerated red blood cells to oxygen would be beneficial to prolong the shelf life.
Regarding storing the CO-Hb RBCs under anaerobic conditions, Yoshida teaches a method of extended storage of refrigerated red blood cells under anaerobic conditions (see title and abstract), related to claim 1 (c). Yoshida teaches red blood cells are reacted with CO by repeatedly injecting 100% CO into the storage bag (as done by Bitensky) and the CO-saturated red blood cells are stored in an anaerobic chamber filled with 20% H2 and 80% Ar in the presence of a Pd catalyst at 4 °C (p. 24, left col., last para. It is noted that since the RBCs are CO-saturated, the stored RBCs are in the presence of carbon monoxide). Yoshida teaches near-complete removal of oxygen from red cells during storage eliminates contribution of reactive oxygen species to the red cell storage lesion, and teaches anaerobic storage allows reduction in the effect of the storage lesion (see e.g., abstract).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for blood typing comprising storing the grouping RBCs under refrigerated conditions disclosed by Gao, by combining flushing the RBCs with carbon monoxide and storing under anaerobic refrigerated conditions as suggested by Bitensky and Yoshida with a reasonable expectation of success. Since Gao teaches reverse grouping cells are important to resolve ABO discrepancies (p. 305, “Introduction”), since Raman teaches the stored red blood cells (either in the specimen or the reagent/grouping red cells) have the danger of antigens deteriorating even when stored under refrigerated conditions (p. 54, last para), since Bitensky reduces to practice a method of using carbon monoxide for extending the useful shelf-life of stored refrigerated red blood cells (see e.g., abstract), and since Yoshida reduces to practice a method of extended storage of refrigerated red blood cells under anaerobic conditions (see title and abstract), one of ordinary skill in the art would have had a reason to combine steps of flushing the grouping RBCs with carbon monoxide and storing the CO-saturated RBCs under anaerobic refrigerated conditions as suggested by Raman, Bitensky and Yoshida in order to reduce exposure to oxygen radicals and other species harmful to the RBC cell membrane to reduce storage lesions and thus to prolong the useful shelf-life of the grouping RBCs.
Regarding the wherein clause directed to the surface antigens of the stored CO-Hb RBCs are stabilized and the stabilized surface antigens of the RBCs reduce oxidative storage lesion accumulation and thereby prolong shelf life in claim 1 (c), it must be noted that this wherein clause does not recite an active step in the claimed method, but only the results of the steps of flushing the grouping RBCs with carbon monoxide and storing the CO-saturated RBCs under anaerobic refrigerated conditions as suggested by Raman, Bitensky and Yoshida. In method claims only those steps that must be performed are considered in the broadest reasonable interpretation of the claims and do not include steps that are not required to be performed, and a “‘whereby (or wherein) clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”. See MPEP 2111.04 I. Nevertheless, as stated supra, Bitensky specifically teaches CO stabilizes hemoglobin thus reduces exposure of the stored RBCs to oxygen radicals and other species harmful to the cell membrane with the result that useful refrigerated storage periods may be prolonged (col. 5, para 4), and Yoshida teaches near-complete removal of oxygen from red cells during storage eliminates contribution of reactive oxygen species to the red cell storage lesion (see e.g., abstract), thus both teach the cell membrane (thus the surface antigens) of the stored RBCs is stabilized, the oxidative storage lesion is reduced, and the shelf life is prolonged.
With respect to claim 3 directed to the RBCs are blood group O cells that are positive for the surface antigen D, as stated supra, Gao teaches reverse grouping cells, including A, B, O and A2 type red blood cells (RBC), are important to resolve ABO discrepancies and the presence of an anti-A1 should be confirmed by testing serum against A1, A2, and O red cells (p. 305, “Introduction”). Raman teaches Group O reagent red cells used in reverse grouping (i.e., reverse blood typing, see Table 4.10 in p. 40, right col) and teaches Group O reagent red cells and D+ reagent red cells used in ABO and anti-D grouping controls (see Table 4.2 and Table 4.3 in p. 39, left col).
Accordingly, one of ordinary skill in the art would have combined group O D+ grouping/reagent RBCs as suggested by Gao and Raman in the method for blood typing suggested by Gao in view of Raman, Bitensky and Yoshida with a reasonable expectation of success. Since both Gao and Raman teach Group O D+ grouping/reagent RBCs are important to resolve ABO discrepancies by reverse grouping, one of ordinary skill in the art would have had a reason to combine RBCs of this blood type in order to perform reverse grouping to resolve ABO discrepancies.
With respect to claim 22 directed to the typing comprising performing an agglutination test, Gao teaches agglutination reactions were carried out by contacting anti-B sera from ten donors (the blood suitable for use in transfusion medicine) with the stored grouping RBCs (p. 306, para 1 “Blood group typing”).
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 03/03/2026 are acknowledged.
Applicant argues that (1) a combination of Bitensky, MemorialCare, and Yoshida does not teach, suggest, or otherwise provide for all the elements of the amended claims; (2) there is no suggestion or motivation to modify Bitensky to arrive at the recited amended method, and there is no reasonable expectation of success associated with the proposed modification (Remarks, p. 14-18).
Applicant’s arguments have been fully considered and they are persuasive. Therefore, the prior rejection over Bitensky, MemorialCare, and Yoshida has been withdrawn. However, as necessitated by amendment, a new ground of rejection has been made over Gao in view of Raman, Bitensky and Yoshida as discussed above. Specifically, Gao teaches a method for blood typing comprising obtaining, storing and typing with grouping/reagent red blood cells having known phenotype.
Applicant further argues that (3) the recited method provides unexpected results compared to the prior art, including "the stabilization of Hb by CO is beneficial during storage and can extend shelf life of the Reagent RBCs not only prior to being opened or reconstituted for use, but also after opening." Specification at [0007]. Further, Applicant's Specification provides that "CO-treatment of reagent RBCs reduces storage lesion accumulation and prolongs the shelf life." Id Additionally, the CO-preserved reagent RBCs of Applicant's Specification are "highly characterized and carefully controlled reagents of great value[, as] [e]ven small improvements to the shelf life can significantly reduce costs for blood banking operations” (Remarks, p. 19).
Applicant’s arguments have been fully considered but they are not persuasive.
As a first matter, Applicant’s above arguments are fully based on instant specification [0007] which is under the section “Background Of The Invention”. In other words, the paragraph [0007] merely describes the background state of the art in the field, but does not disclose the purported “unexpected results” of the instant invention. MPEP § 2145 states that a showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997) (conclusory statements that claimed compound possesses unusually low immune response or unexpected biological activity that is unsupported by comparative data held insufficient to overcome prima facie case of obviousness). Thus, Applicant does not provide side-by-side comparative factually supported objective evidence supporting the purported unexpected results.
Furthermore, as stated supra, Bitensky specifically teaches CO stabilizes hemoglobin thus reduces exposure of the stored RBCs to oxygen radicals and other species harmful to the cell membrane with the result that useful refrigerated storage periods may be prolonged (col. 5, para 4), and Yoshida teaches near-complete removal of oxygen from red cells during storage eliminates contribution of reactive oxygen species to the red cell storage lesion (see e.g., abstract), thus both teach the cell membrane of the stored RBCs is stabilized, the oxidative storage lesion is reduced, and the shelf life is prolonged. Thus, the method of blood typing suggested by Gao in view of Raman, Bitensky and Yoshida would have been expected to have the purported beneficial results.
Withdrawn Double Patenting Rejections
The prior rejection of claims 1-3 on the ground of nonstatutory double patenting as being unpatentable over the patented claims in each of US Patent No: 5624794, 8071282, 11433164, 10603417, 10251387, 9199016, 9339025, or 5789151, in view of Bitensky (US Patent 5,476,764) and MemorialCare Health System (Prior art of record) is withdrawn in light of Applicant’s amendment to claim 1 to recite new limitations of a step (d) typing the blood for use in transfusion medicine comprising contacting the blood with the stored and preserved CO-Hb RBCs, which is not taught by cited patent claims.
Withdrawn Provisional Double Patenting Rejections
The prior provisional rejection of claims 1-3 on the ground of nonstatutory double patenting as being unpatentable over the copending claims in each of Application No. 17241648, 17872127, 17772947, 18827514, or 17639823, in view of Bitensky (US Patent 5,476,764) and MemorialCare Health System (Prior art of record) is withdrawn in light of Applicant’s amendment to claim 1 to recite new limitations of a step (d) typing the blood for use in transfusion medicine comprising contacting the blood with the stored and preserved CO-Hb RBCs, which is not taught by cited application claims.
Response to Traversal:
Applicant’s arguments filed on 03/03/2026 are acknowledged.
Applicant argues that the cited patents and applications are silent on typing of blood for use in transfusion medicine comprising contacting the blood with the stored and preserved CO-Hb RBCs, as recited in instant claim 1 (Remarks, p. 19-23).
Applicant’s arguments have been fully considered and they are persuasive. Therefore, the prior rejection over patent claims or application claims in view of Bitensky and MemorialCare has been withdrawn.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jianjian Zhu whose telephone number is (571)272-0956. The examiner can normally be reached M - F 8:30AM - 4PM (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Douglas (Doug) Schultz can be reached on (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JIANJIAN ZHU/Examiner, Art Unit 1631
Prosecution Insights