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 .
Please note the examiner in this case has changed. All future correspondence should be directed to Teresa Knight, Art Unit 1634.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-17) in the reply filed on June 8, 2026 is acknowledged. The traversal is on the ground(s) that groups I and II share a special technical feature, that is the groups share the additive solution containing: disodium hydrogen phosphate; adenine; D-glucose; guanosine; sodium chloride; and trisodium citrate in the claimed concentration ranges; that the restriction requirement incorrectly calculated the concentrations of the components of the additive solutions, that the restriction requirement used the erythrocyte concentrate (end product), not the additive solution (starting product) when assessing the concentrations, and the concentrations of disodium hydrogen phosphate and trisodium citrate differ between the cited prior art and the claims by a factor of 2 to 5.
The amendments to the claims (dated June 8, 2026) changing the group II claims to “use” claims would render these claims indefinite and potentially subject matter ineligible, as under US Patent law, “use of a product” is not clearly directed to either a method (“a method of using an additive product with the follow components…said method comprising the steps of…”) or a product claim (“a composition comprising…”). For the purposes of responding to this election traversal, the claims are interpreted as reciting product claims.
This is not found persuasive because (1) under U.S. Patent law, the product claims (group II, claims 18-24), which recite “an additive solution for storing red blood cell (RBC) concentrates” is regarded as intended use – this means that so long as the erythrocyte concentrate (end product) could be used as an additive solution, it would meet the claimed intended use. See MPEP 2114 (Apparatus Claims Must Be Structurally Distinguishable From the Prior Art); and (2) under US Patent law, similar ranges (such as two components out of six being double what the prior art teaches) may still be prima facie obvious, “particularly when there [is] no showing of criticality of the claimed range.” See MPEP 2144.05. In this application, it appears that UG65, an additive solution with a specific composition, not the wide ranges cited in the additive solution, was used and demonstrated strong results with respect to hemolysis rate and bacterial and virus inactivation. (See Specification, Experiments 1-7). These results might rise to the level of rebutting a prima facie showing of obviousness with unexpected results; however, the results are not commensurate in scope with the concentrations recited in the product claims.
For at least these reasons, a special technical feature is not found to be present between the method of using and product claims.
The requirement is still deemed proper and is therefore made FINAL.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/DE2022/100535, filed July 22, 2022. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d), with German application DE 10 2021 119 408.3 filed on July 27, 2021.
Thus, the earliest possible priority for the instant application is July 27, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Jan. 26, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 2, 4, 7, 10, 11, and 13-16 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 2 recites “…in particular 20 to 25 mmol/L…”
Claim 4 recites “…preferably greater than 7.5, in particular a pH of 8 to 9…”
Claim 7 recites “…preferably 0.50 to 0.70 L/L of erythrocytes…” and “…preferably 0.25 to 0.50 L/L…”
Claim 10 recites “…preferably has an hct of less than 0.5…”
Claim 11 recites “…in particular 0.5 to 0.7.”
Claims 13 recites in particular ranges for every component in alternative listed.
Claim 14 recites “…in particular less than 0.5 mmol/L…”
Claim 15 recites “…preferably replaced…”
Claim 16 recites “…and preferably 260 to 240 nm”.
In each of these claims, the use of the term preferably or in particular renders the claim indefinite, as it is unclear if the scope of the claim is further limited to what is preferable or particularly noted. If the entire, broader range is intended to be the scope of the claim, it is suggested that only this range be recited within the claim, thereby clearly setting forth the metes and bounds of the limitations.
Claim 13 also recites that optionally sodium dihydrogen phosphate and citric acid are present in ranges that are completely different (lower and non-overlapping) than alternative A or alternative B. This is indefinite as is not clear how alternative A or alternative B could be present, but optionally, completely different ranges could replace alternative A or B?
Claim 7 also has a (,) between “0.50 to 0.70 L/L” and “of erythrocytes” which is improper.
Conclusion
Claims 1, 3, 5, 6, 8, 9, 12 and 17 are allowed.
Handke et al. (Blood Components, 2022), which post-dates applicants inventive date and concerns the inventive aspect of the method of treating red blood cells, is cited for additional information concerning the inventiveness of the method of treating red blood cells.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached at 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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