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 28-47 are pending (claim set as filed on 06/02/2025).
Priority
This application is a CON of 18/209,877 (now U.S. Patent no. 12,178,779), which is a DIV of 14/422,735 (now U.S. Patent no. 11,730,676), which is a 371 of PCT/US2013/056190 filed on 08/22/2013.
Drawings
The drawings filed on 11/18/2024 have been accepted.
Information Disclosure Statement
No Information Disclosure Statement (IDS) has been filed in this application. Applicant is reminded that each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the U.S. Patent and Trademark Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability (see 37 C.F.R. §1.56).
Claim Rejections - 35 USC §112, Indefinite
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.
Claims 32 and 42 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claims 32 and 42, the phrase “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention (see MPEP 2173.05(d)).
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 28-30, 33-40, and 43-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hess (WO 2006/088455 A1).
Hess’ general disclosure relates to compositions and methods associated with an improved storage and preservation of red blood cells (RBCs) (see abstract).
Hess teaches “novel compositions suitable for the storage and preservation of collected red blood cells … benefits both in terms of the integrity and physiological functioning quality of the stored and then re-infused red blood cells, and with respect to the length of time the RBCs may be stored with retention of the recoverability and hemolysis levels required under regulatory law for licensing” (see pages 4-5, bridging ¶). Hess teaches the composition confers several advantages over prior art additive solutions. The red blood cells stored therein may be stored longer, at least 8 weeks and during the storage period, the red blood cells exhibit an acceptable range of hemolysis: 0.2% at 6 weeks and 0.4% at 8 weeks, all below the FDA limit of 1% and the units were stored upright at 1-6°C for 10 weeks (see page 19, 4th ¶, page 22, 2nd ¶, and pages 24-25, adjoining ¶).
Regarding the aqueous composition, Hess teaches “a composition for storage of red blood cells at about 1 to about 6°C. The composition consists essentially of: adenine; dextrose; at least one non-metabolizable membrane-protectant sugar; and a pH buffering system. The pH buffering system comprises sodium bicarbonate and disodium phosphate and is present in an amount sufficient for the composition to have a pH of from about 8 to about 9. The composition is operable to maintain a pH of a red blood cell (RBC) suspension to which the composition is added at a value sufficient to establish and maintain during a storage period a reaction equilibrium in the red blood cell that favors glycolysis over synthesis of 2,3-diphosphoglycerate (DPG) from 1,3-DPG, thereby generating a net gain in adenosine tri phosphate (ATP) with respect to the reaction equilibrium during the storage period” (see page 5, 2nd ¶) and “substantially free of exogenously derived chloride ions” (see page 11, 2nd ¶).
Regarding claims 29 and 39 pertaining to the RBCs, Hess teaches the resulting suspensions have a RBC volume fraction of approximately 55% (see page 2, 2nd ¶).
Regarding claims 30 and 40 pertaining to the blood storage container, Hess teaches “the RBC suspension is then generally stored in standard polyvinyl chloride (PVC) blood storage bags using either the collection bag or PVC transfer packs of different sizes depending on the volume of the stored aliquot” (see page 16, 1st ¶). Hess discloses “While PVC blood storage bags are the industry-approved standard; the present invention contemplates storage in a wide variety of bags adapted for RBC suspension storage, for example, by including appropriate plasticizers as needed. Ingredients related to the bag or container component of RBC storage technology are not discussed herein but it will be readily apparent to one of ordinary skill in the art that many container technologies may be employed to practice the present invention” (see page 16, 1st ¶).
Regarding claims 33 and 43 pertaining to sodium bicarbonate, Hess teaches the at least one agent providing bicarbonate anions is sodium bicarbonate (see page 12, 1st ¶). The sodium bicarbonate is in an amount of about 26 mM (see page 14, 2nd ¶).
Regarding claims 34 and 44 pertaining to the membrane protectant sugar, Hess teaches Hess teaches the at least one non-metabolizable membrane-protectant sugar is mannitol (see page 12, 2nd ¶).
Regarding claims 35 and 45 pertaining to the osmolarity, Hess teaches the compositions have an osmolarity of about 270 mOsm (see page 13, 2nd ¶).
Regarding claims 36-37 and 46-47, Hess discloses the range of “the composition comprises adenine in an amount of about 1-3 mM, dextrose in an amount of from about 20 to about 115 mM, un-metabolizable membrane-protectant sugar in an amount of about 15 to about 60 mM, sodium bicarbonate in an amount from about 20 to about 130 mM, and disodium phosphate in an amount of from about 4 to about 20 mM” (see page 14, 2nd ¶). Hess teaches the composition comprises adenine in an amount of about 2 mM (see page 14, 2nd ¶). Hess teaches the composition comprises dextrose in an amount of about 80 mM (see page 14, 2nd ¶). Hess teaches the composition comprises a non-metabolizable membrane-protectant sugar in an amount of about 55 mM (see page 14, 2nd ¶). Hess teaches the at least one non-metabolizable membrane-protectant sugar is mannitol (see page 12, 2nd ¶). Hess teaches the composition comprises disodium phosphate in an amount of about 12 mM (see page 14, 2nd ¶).
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 31-32 and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Hess (WO 2006/088455 A1) as applied to the claims above, and in view of Becker (US 2013/0310471, with international publication date of 05/31/2012, citations made to the US publication ‘471).
Hess’ teachings are discussed above.
However, Hess does not teach: a non-phthalate plasticizer (claims 31 and 41); or wherein the non-phthalate plasticizer is 1,2-cyclohexane dicarboxylic acid diisononyl ester (DINCH) or di-2-ethyl-hexyl terephthalate (DEHT) (claims 32 and 42).
Becker discloses “polyvinyl chloride (PVC) is one of the most important commercial polymers. It is used in a wide variety of applications, in the form of plasticized PVC as well as unplasticized PVC”, “To enhance the elasticity, plasticizers are added to the PVC”, and many customary plasticizers include for example phthalic esters are known for its toxicological effects and therefore, non-phthalic esters such as di-2-ethylhexyl terephthalate (DEHT) for example or diisononyl 1,2-cyclohexanedicarboxylate (DINCH) have recently been discussed as possible alternatives (see ¶ [0002]-[0004]). Becker discloses compositions containing diisononyl 1,2-cyclohexane dicarboxylate were very surprisingly found to exhibit distinctly greater expansion behavior, leads to a lower plastisol viscosity, less volatile, and can be processed at lower temperatures (see ¶ [0014]-[0017]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to employ or add a non-phthalate plasticizer of di-2-ethylhexyl terephthalate (DEHT) or 1,2-cyclohexane dicarboxylate diisononyl (DINCH) or its ester derivatives thereof such as taught by Becker as the container plasticizer in Hess. The ordinary artisan would have been first motivated to look to the relevant field of plasticizers is because, as discussed above, Hess “contemplates storage in a wide variety of bags adapted for RBC suspension storage, for example, by including appropriate plasticizers as needed” (see Hess at page 16, 1st ¶). Therefore, arriving at the disclosure of Becker offering a non-phthalate plasticizer with the advantages of avoiding the toxic effects of conventional phthalate plasticizers, greater expansion behavior, leads to a lower plastisol viscosity, less volatile, and can be processed at lower temperatures, and thus the ordinary artisan would have been motivated and considered Becker’s non-phthalate plasticizer of 1,2-cyclohexane dicarboxylate diisononyl (DINCH) or di-2-ethylhexyl terephthalate (DEHT) as an appropriate and favorable plasticizer to be used in Hess’s container for storing red blood cells.
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 28, 30-38, and 40-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-25 of U.S. Patent no. 11,730,676 B2 (parent application no. 14/422,735). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘676 are directed to a product for storing red blood cells without periodic mixing under standard blood banking procedures at about 1-6°C, the product comprising a DEHP-lacking container and a aqueous composition (see claims 1, 25, and 30 of ‘676).
Regarding claims 30-32 and 40-42, ‘676 teaches non-phthalate plasticizers including DENT, DINCH, et. al. (see claims 2-4 of ‘676).
Regarding claims 33-37 and 43-47, ‘676 teaches the composition comprises: adenine at about 1 mM to about 3 mM; dextrose at about 20 mM to about 115 mM; disodium phosphate at about 4 mM to about 15 mM; at least one non-metabolizable membrane-protectant sugar at about 15 to about 60 mM; and a physiologically acceptable sodium salt at about 20 mM to about 130 mM (see claims 5-24 of ‘676).
Claims 28-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-21 of U.S. Patent no. 12,178,779 B2 (parent application no. 18/209,877). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘779 are directed to the storing of red blood cells without periodic mixing under standard blood banking procedures at about 1-6°C, the product comprising a DEHP-lacking container and a aqueous composition (see claim 1 of ‘779).
Regarding claims 29 and 39, ‘779 teaches wherein the RBC suspension comprises about 55% RBCs in the aqueous composition (see claim 4 of ‘779).
Regarding claims 30-32 and 40-42, ‘779 teaches non-phthalate plasticizers including DENT, DINCH, et. al. (see claims 4-9 of ‘779).
Regarding claims 33-37 and 43-47, ‘779 teaches the composition comprises: adenine at about 1 mM to about 3 mM; dextrose at about 20 mM to about 115 mM; disodium phosphate at about 4 mM to about 15 mM; at least one non-metabolizable membrane-protectant sugar at about 15 to about 60 mM; and a physiologically acceptable sodium salt at about 20 mM to about 130 mM (see claims 10-21 of ‘779).
Conclusion
No claims were allowed.
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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