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 .
Status of the Claims
Claims 1-40 are pending (claim set as filed on 10/05/2023).
Election/Restrictions
Applicant’s election of Group I, composition claims, in the reply filed on 05/04/2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP 818.01(a)).
Method claims 32-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, composition claims 1-31 are presented for examination.
Priority
This application is a 371 of PCT/US2022/023873, which has a provisional application no.: 63/172,039 filed on 04/07/2021.
Drawings
The drawings filed on 10/05/2023 have been accepted.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 10/05/2023 and 04/27/2026 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.
Claim Rejections - 35 USC §102, Anticipation
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.
Claims 1, 4-7, 12, 18, 20-21, and 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thatte (US 2016/0081328 A1 - cited in the IDS filed on 10/05/2023).
Thatte’s general disclosure relates to compositions and methods for cell storage (see abstract & ¶ [0003]).
Regarding claims 1, 12, 18, 20, 21, and 24, Thatte discloses that it is known in the art for the storage of blood into anticoagulant solutions (acid, citrate, dextrose) or CPDA-1 (citrate phosphate dextrose adenine) (see ¶ [0004]). Thatte teaches “the synthetic physiological salt solution portion of the composition/solution comprises calcium chloride, potassium chloride, potassium phosphate, magnesium chloride, magnesium sulfate (e.g., heptahydrate), sodium chloride, sodium bicarbonate, and sodium phosphate. Other ingredients include D-glucose, glutathione (e.g., reduced), and/or ascorbic acid”, mannitol, et al. (see ¶ [0010], [0018]-[0020]).
Regarding claims 4-5, Thatte teaches the composition also contains adenosine and/or adenine (a component of adenosine triphosphate (ATP) (see ¶ [0009]).
Regarding claims 6-7 and 23, Thatte teaches the solution comprises dextrose or glucose (see ¶ [0010], [0018]-[0020]).
Claims 1, 4-7, 12, 18, 20-21, and 23-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zia (US 2015/0190309 A1).
Zia’s general disclosure relates to compositions and methods associated with the storage of red blood cells (RBCs). In particular, it relates to an improved RBC storage composition in combination with a blood storage container (see ¶ [0002]).
Zia teaches a combination of blood storage container and aqueous composition suitable for the storage and preservation of collected red blood cells (see ¶ [0011]). The combination product having a container comprising a wall defining an interior chamber, an aqueous composition, and a pH buffering system (see ¶ [0012], [0024]-[0025], [0082]). Zia teaches collecting whole blood units, pooling, and splitting in whole blood leukocyte reduction filtration system with SolX/Dinch and a blood-pack unit with integral leukocyte reduction filter (see ¶ [0114]-[0115]). Zia teaches the RBCs are stored for 6 weeks (i.e., 42 days), or stored for 8 weeks (i.e., 56 days), or stored for 10 weeks (i.e., 70 days), or stored for 12 weeks (i.e., 84 days) (see ¶ [0025]).
Zia teaches collecting the whole blood into CPD (e.g., 142 mM dextrose, 104 mM Na3Citrate, 18 mM NaH2PO4) or CP2D (e.g., 284 mM dextrose, 104 mM Na3Citrate, 18 mM NaH2PO4) and then leuko-reducing the whole blood (e.g., by passage through a filter or centrifuging) to obtain leuko-reduced whole blood (see ¶ [0025]-[0026], [0064], [0096], & Tables 1-2). Zia teaches adenine, bicarbonate anions is sodium bicarbonate, phosphate anions is disodium phosphate (see ¶ [0012], [0022]-[0031], & Tables 1-2). Zia teaches “the composition may contain adenine from about 1 to 3 mM, dextrose from about 20 to 115 mM, Na2HPO4 from about 4 to 15 mM (where a combination ofNa2HPO4 and NaH2PO4 can also be used), mannitol from about 15 to 60 mM, and at least one physiologically acceptable sodium salt from about 20 to 130 mM. Preferably, adenine is about 2 mM, dextrose is about 50 to 110 mM, Na2HPO4 is about 9 to 12 mM, mannitol is about 20 to 50 mM, and at least one physiologically acceptable sodium salt is about 25 to 75 mM. Suitable sodium salts useful in the composition include those salt compounds containing a sodium cation which are physiologically acceptable in humans. Non-limiting sodium salts include sodium chloride, sodium acetate, sodium citrate, sodium bicarbonate, and the like” (see ¶ [0103]-[0105]).
Zia teaches “suitable metal cations include, but are not limited to, the cationic forms of sodium, potassium, calcium, and magnesium” (see ¶ [0050], [0085], [0100]). Zia teaches “For example, the dextrose may be separated from the phosphate, which may be separated from the sodium bicarbonate, which may be separated from the adenine, which may be separated from the nonmetabolizable membrane-protectant sugar. Of course, some components may be combined (e.g., the nonmetabolizable membrane-protectant sugar and dextrose may be together and the bicarbonate and adenine may be together)” (see ¶ [0075], [0094]-[0095]). Zia teaches storage in blood storage bags or collection bag of different sizes (see ¶ [0097]-[0098], [0108], [0124]). Zia teaches whole blood units in whole blood leukocyte reduction filtration system with SolX/Dinch and a blood-pack unit with integral leukocyte reduction filter (see ¶ [0115]). Zia teaches “As shown in FIGS.11 and 12, container 10 may include one or more container walls 12 which define an interior chamber 15 for receiving the RBC composition 20. In one embodiment, two sheets made of a plastic material are brought together and sealed along their peripheries 14 to form container 10. Other ways of making container 10 will be known to those of skill in the art and are within the scope of the present disclosure … Container 10 may include one or more access ports 16 for connection with tubing 22, docking devices and the like to establish flow into and out from the interior chamber 15 of container 10” (see ¶ [0124]-[0125]). Zia teaches storage for 6 weeks (i.e., 42 days), or stored for 8 weeks (i.e., 56 days), or stored for 10 weeks (i.e., 70 days), or stored for 12 weeks (i.e., 84 days) (see ¶ [0025]).
Zia discloses that “acid-citrate-dextrose (ACD, 1943), comprising citrate as an anti-coagulant and dextrose as the sole nutrient utilized by red blood cells, and Citrate phosphate-dextrose solution (CPD, 1957), adding phosphate as a metabolic source and for membrane retention, were subsequently approved for 21-day storage of whole blood. CPD with adenine (CPDA-1, 1979) was later introduced and used for extending the shelf life of stored whole blood and packed RBCs for up to 5 weeks” (see ¶ [0005], [0058], [0096]).
Zia teaches additive solutions for providing a storage environment for RBCs that will allow cell function and cell metabolism to be preserved and maintained have been developed and are commonly used. The additive solutions can prolong the storage life of RBCs for up to 42 days. These additive solutions often include a nutrient for the RBCs, a buffer to help maintain the pH of the RBCs, electrolytes, a RBC membrane-protecting compound and other additives to enhance and extend the life of the RBCs (see ¶ [0006], [0026], [0030], [0051]- [0056]).
Claim Rejections - 35 USC §103, Obviousness
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Claims 2-3, 8-11, 13-17, 19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Zia as applied to claims 1, 4-7, 12, 18, 20-21, and 23-31 above, and in view of Liu (US 2019/0246629 A1) and Debrauwere (US Patent no. 5,445,629).
Zia’s teaching is discussed above as it pertains to a composition for cell storage.
However, Zia does not teach: magnesium citrate or sodium bisphosphate.
Liu teaches “a source of magnesium can be present in an amount ranging between about 0.5 mM and about 2.5 mM” and “sources of magnesium include magnesium chloride, magnesium citrate, magnesium sulfate and a combination thereof”, and “magnesium ion in the medium should maintain the optimal intercellular magnesium levels in the platelets and may promote oxidative phosphorylation in the platelets and in so doing help maintain the pH of the medium. Furthermore, Mg2 plays important roles in membrane stability by contributing to the electrical continuity of lipids and proteins” (see ¶ [0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ or use magnesium citrate such as taught by Liu in the composition of Zia. The ordinary artisan would have been motivated to do so is because magnesium citrate is a routine and known source of magnesium ions which is a main intracellular ion and plays important roles in membrane stability by contributing to the electrical continuity of lipids and proteins. The ordinary artisan would have had a reasonable expectation of success because both of the references are directed to cellular preservative compositions.
It would have been further obvious to add or use sodium bisphosphate because Debrauwere teaches the storage of blood in storage solutions typically includes a sugar component and other components such as sodium bisphosphate, adenine, and mannitol (see col. 1, lines 34-38). These are considered routine additives in blood storage compositions.
Furthermore, if not expressly taught by the references, based upon the overall objective provided by the cited references with respect maximizing the integrity of the cell components, the adjustments of particular conventional working conditions (e.g., concentration of ingredients) are deemed a matter of judicious selection and routine optimization which is within the purview of the skill artisan. This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Absent any teaching of criticality by the Applicant concerning the concentration of ingredients, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variable which can be met as a matter of routine optimization (MPEP 2144.05 II).
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 4-7, 12, and 18 are rejected on the ground of non-statutory double patenting as being unpatentable over U.S. Patent no. 11,730,676 B2 and U.S. Patent no. 12,178,779 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claimed invention and ‘676 are drawn to a composition comprising adenine, dextrose, mannitol, sodium bicarbonate (see at least claims 1, 5-16, and 23-24 of ‘676; and see at least claims 1, 10-16, and 20-21 of ‘779).
Claims 1-2, 4-7, 12, 18, 20-21, and 24-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of co-pending Application no. 18/553,595. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed invention and co-pending ‘595 are drawn to compositions comprising an anticoagulant, dextrose, sodium bicarbonate, adenine (see claims 1-16 of co-pending ‘595).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims were allowed.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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