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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/24/2024 and 02/26/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
All claims have non-traditional capitalization of words such as “Claim” or “Bioflux” or “Coulter Multisizer” among others. This needs to be corrected.
Claims 1 and 3 are objected to because of the following informalities: Abbreviation SWFI need to be spelled out at the first instance of their usage in the claims for greater clarity. Appropriate correction is required.
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.
Claim 2, 4, 8-9, 17, 19, and 21 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 4 requires a clinical reference range. It is not clear from the wording of the claim as to what range is being referred here. It is generally known that clinical ranges can differ internationally, as well as according to age, among other variables of the patient (pediatric versus adult range).
Claims 2, 19 and 21 contain the trademark/trade name Coulter Multisizer. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe PARTICLE ANALYZING, SIZING AND COUNTING MACHINES and, accordingly, the identification/description is indefinite.
Claim 8 required that the claimed composition “when reconstituted, has an amount of von Willebrand factor (vWF) that induces clot formation. It is not clear from the wording of the claim as to what concentration of vWF is expected by the claim. Appropriate clarification is required.
Claim 9 contains the trademark/trade name Bioflux. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe measurement of platelet activity triggered in the presence of elevated shear and, accordingly, the identification/description is indefinite.
Claim 17 requires reduced number of cholesterol compared to lyophilized plasma when viewed at 100X magnification. It is noted that the number of cholesterol crystals can vary based on field size, or methods of preparing samples. As such this limitation is not clear. Further, it is submitted that reduced cholesterol compared to a freeze-dried product cannot be interpreted as an absolute number. The specification does not provide a concrete reading for baseline value of cholesterol and to what quantity the cholesterol crystals are being compared. As such the claim is indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-4, 11-12, 14, 16, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over 8,407,912 (Publication April 2, 2013; hereinafter "Hubbard;" See IDS 07/24/2024).
Regarding claims 1, 3 and 16: Hubbard disclosed a spray-dried plasma powder which can later be rapidly and easily reconstituted to produce transfusion grade plasma. The spray dried powder can be stored at least 2-3 years at virtually any temperature (e.g., −180° C. to 50° C.). (Hubbard col. 3, lines 10-15) Hubbard disclosed that the plasma powder may exhibit, a recovery rate for the protein between the plasma and the physiologically active reconstituted plasma, of at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, etc. (Hubbard col. 13, para 2, lines 5-15) This falls within the claimed within 25% recovery of plasma proteins compared to the levels before storage. It is also noted that −180° C. to 50° C reads on the claimed −80° C. to 45° C limit and at least 2-3 years reads on the claimed 1 day to 48 months limit.
As such it would have been obvious to a person of ordinary skill in the art to store the spray-dried plasma of Hubbard under a range of temperatures and durations, including those recited in the claim. Hubbard’s teaching of high protein recovery and comparable physiological activity would have reasonably suggested that the spray dried plasma retains protein levels within about 25% of pre-storage levels. The person would have had a reasonable expectation of success in achieving the claimed stability in view of teachings of Hubbard.
It is noted that claim 16 is to a product by process. Product by process limitations are only given patentable weight to the extent that the process imparts a structural or functional distinction in the spray-dried plasma as compared to the prior art. Accordingly the process limitations do not distinguish the claimed product from the spray dried plasma disclosed in the prior art.
Regarding claim 2 and 19-21: Hubbard indicated that the powder has an average particle size of about 30 microns or less. (Hubbard col. 5, lines 35-40) This value falls within the subsections (a) and (b) of claim 19.
Regarding claim 4: As indicated above Hubbard indicated that the plasma powder may exhibit, a recovery rate for the protein between the plasma and the physiologically active reconstituted plasma, of at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, etc, and a recovery rate for the protein between the plasma and the physiologically active reconstituted plasma, of at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, etc. (Hubbard col. 13, para 2, lines 5-15) As such this reads on the claimed clinical reference range, there being no definite range recited in the claim.
Regarding claim 11: Hubbard taught that the plasma powder described comprises ”less than 1% moisture by weight” (Hubbard, col. 12, lines 5-10).
Regarding claim 12: Hubbard indicated that “reconstituted plasma to a human patient utilizing the integrated storage and reconstitution device” (see cols. 1-3, in particular, col. 1, lines 56-61). As such Hubbard envisioned infusing their reconstituted plasma composition into a human subject.
Regarding claim 14: Hubbard taught spray-dried plasma that exhibits stability over extended periods and across a broad range of storage temperatures. It is well known in the art that biological materials , including plasma products \, are routinely stored under standard conditions such as room temperature (approximately 20-25 ºC) to preserve stability. For example, Hubbard taught “In an embodiment, spray dried plasma of the present invention can be stored at room temperature (e.g., between about 20° C. and 25° C.) for at least about 1 hour to about 12 months.” A person of ordinary skill in the art would have been motivated to store the spray-dried plasma at conventional temperature conditions as taught by Hubbard to maintain product stability and usability. The selection of specific storage temperatures and durations, including those recited in the claim represents a matter of routine optimization of result-effective variables. Therefore, the claimed subject matter would have been obvious.
Claims 5 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over 8,407,912 (Publication April 2, 2013; hereinafter "Hubbard;" See IDS 07/24/2024) in view of Rogers et al (Transfusion. 2019 Apr; hereinafter "Rogers;" See PTO-892).
Regarding claim 5 and 22: As indicated above Hubbard taught plasma powder can be dried directly into the final, attached sterile container, which can later be rapidly and easily reconstituted to produce transfusion grade plasma. (Hubbard col. 2, line 9) It is noted that Hubbard did not explicitly teach that the spray dried plasma can be used for transfusion for up to about 26 hours. It is however noted that Hubbard taught a spray dried plasma which can be stored at least 2-3 years at virtually any temperature (e.g., −180° C. to 50° C). (see above). Hubbard noted that their spray-dried plasma when reconstituted, exhibits physiological activity substantially equivalent to Thawed Plasma, Liquid Plasma, FP24 (Plasma frozen within 24 hrs of phlebotomy), or FFP. (Hubbard col. 4, lines 40-45) As such it is recognized that spray dried plasma can be stored at room temperature for 24 hrs at 4º C. (See Rogers Table 2).
It would have been obvious for a person of ordinary skill in the art to apply the post-reconstitution handling conditions of Rogers to the spray-dried plasma of Hubbard. It is noted that both references are directed to spray-dried plasma products intended for transfusion. A person of ordinary skill in the art would have recognized that the storage conditions disclosed in Rogers represent a period during which the reconstituted plasma remains suitable for its intended use.
Further, regarding claim 22, Hubbard, as indicated above, disclosed that the plasma powder may exhibit, a recovery rate for the protein between the plasma and the physiologically active reconstituted plasma, of at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, etc. (Hubbard col. 13, lines 5-15) As such the disclosure of hubbard supports that a level of one or more plasma proteins of the reconstituted spray dried plasma is within about 20%, as compared to a level of the one or more plasma proteins in reconstituted spray dried plasma contemporaneously after being spray dried.”
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over 8,407,912 (Publication April 2, 2013; hereinafter "Hubbard;" See IDS 07/24/2024) as evidenced by Hopkins (StatPearls Publishing; [Updated 2022 Sep 12; See PTO-892).
Regarding claim 6: Hubbard taught reconstitution with water. It is noted that Hubbard did not explicitly teach reconstitution with water when reconstituted with SWFI has the claimed pH values. It is however noted that Hubbard taught that “For example, in some embodiments, the spray dried plasma may have a pH level which differs from native plasma, and a buffering agent may be used to adjust the pH level of the reconstituted plasma to more closely match that of the native plasma.” (Hubbard col. 14, lines 28-31). One of ordinary skill in the art would have been motivated to adjust the pH of the reconstituted plasma in an optimal range for plasma infusion. It is noted that physiological pH of plasma is 7.4-7.5 as evidenced by Hopkins which falls within the claimed range.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over 8,407,912 (Publication April 2, 2013; hereinafter "Hubbard;" See IDS 07/24/2024) in view of Liu et al (Transfusion. 2019 Feb; hereinafter "Liu;" See IDS 07/24/2024).
Regarding claim 7-10: The teachings of Hubbard are set forth above. It is noted that Hubbard did not teach or suggest the claimed ranges of C5a or vWF. Liu taught that single donor spray-dried plasma comprises 9.6 ± 3.7 nm/ml C5a which falls within the claimed range of claim 7. Further Liu taught that although spray drying cleaves HMW vWF multimers and often reduces vWF:RCo to less than 30% compared with the untreated starting plasma Regarding the presence of vWF” “ODP had FVIII levels comparable to other coagulation factors, albeit at the low end, indicating that the ability of vWF to stabilize FVIII was largely unaffected by the change of size distribution.” As such it can be gleaned that when reconstituted, has an amount of von Willebrand factor that induces clot formation. Liu indicated that the amount of vWF was 50–200 IU/dL.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over 8,407,912 (Publication April 2, 2013; hereinafter "Hubbard;" See IDS 07/24/2024) in view of Shakiba et a; (Advanced Powder Technology; hereinafter "Shakiba;" See PTO-892) Chen et al (Adv Drug Deliv Rev. 2021 May; hereinafter "Chen;" See PTO-892).
Regarding claim 17: The teachings of Hubbard are set forth above. It is noted that Hubbard did not teach or suggest low crystallization of cholesterol as required by instant claims, as compared to lyophilization. It is noted that a reduced number of cholesterol crystals, when viewed at 100X magnification, as compared to freeze dried plasma as recited in the instant claim is interpreted to mean lower number of cholesterol crystals in spray died formulation as compared to lyophilized formulation.
Spray drying is known to hinder crystallization. For example, Shakiba taught that “[t]he challenge of crystalline particle formation is the relatively long time scale nature of crystallization. In contrary, spray drying is a fast drying method in which most of the moisture is evaporated and the total residence time in the order of seconds, which conventionally hinders crystallization.” (Shakiba, p. 2300, col. 1, para 1). In contrast lyophilization is known to cause crystallization by decreasing solubility of the compositions of a formulation causing phase separation. For example, Chen taught that “Drying techniques such as lyophilization and spray-freeze drying involve freezing of solutions. Freezing involves a combination of different stresses destabilizing proteins, including cold denaturation, stress at interfaces, phase separation, and changes induced by concentrated components.“ (See Chen, p. 221, col. 1 -2) “Cooling rate dictates the number of ice nuclei and the size of the crystals, which is affected by the formulation composition. A faster cooling rate results in greater nuclei formation and smaller crystals. A fast-freezing step used for lactate dehydrogenase demonstrated larger extent of structural damage and lower activity recovery than for a slow-freezing rate. As smaller ice crystals have a larger surface area for proteins to be adsorbed, formulations with smaller ice crystals tends to lose their secondary and tertiary structures.
Differences in solubility of formulation composition causes phase separation in freezing, and certain components crystallize instead of maintaining in the amorphous matrix.” (Chen p. 221, col. 2, para 2).
As such, given the nature of the preparation of the dry powders, one of ordinary skill in the art would expect more cholesterol crystals in a lyophilized plasma versus a spray dried plasma. A person of ordinary skill in the art would have expected that different drying techniques give raise to different microstructures , with spray drying suppressing crystallization and freeze drying promoting crystallization. A person of ordinary skill would have expected to arrive at a composition comprising reduced number of cholesterol crystals by spray drying as compared to freeze drying.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6-12, 16, 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,201,920 in view of 8,407,912 (Publication April 2, 2013; hereinafter "Hubbard;" See IDS 07/24/2024).
Regarding claim 1, 3-4 ,16 and 19-21: Claim 4 of the reference application taught a dried plasma product, which showed stability when stored for a period of time ranging from about 1 day to about 48 months at a temperature ranging from about 1° C. to about 45° C. It is noted that the claims of the reference application did not teach or suggest levels of plasma proteins when reconstituted with water is within 25% as compared to plasma proteins before storage. However, as noted above, Hubbard taught that the plasma powder may exhibit, a recovery rate for the protein between the plasma and the physiologically active reconstituted plasma, of at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, etc. (Hubbard, col. 13, lines 5-15) This falls within the claimed within 25% recovery of plasma proteins compared to the levels before storage. One of ordinary skill in the art would have easily been able to arrive at the claimed composition in view of the teachings of Hubbard and the reference application, as Hubbard’s teaching of high protein recovery and comparable physiological activity would have reasonably suggested that the spray dried plasma retains protein levels within about 25% of pre-storage levels.
Regarding claim 2: Claim 1 of the the reference patent taught that when measured with a cell analyzer using an electrical sensing zone method ranging from about 2 μm to 60 μm, as compared to the mean size of particulates in the donor plasma.
Regarding claim 6-10: Claim 7 of the reference patent taught that dried plasma when reconstituted with SWFI has a pH of about 6.7, 6.8, 6,9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, or 7.8; a C5a level ranges from about 0.1 to about 30 ng/m: (Claim 8 of reference patent); amount of vWF is measured by von Willebrand Factor Ristocetin Cofactor and the amount of vWF within about 20% of an amount of vWF in the donor plasma, wherein the amount of vWF is measured by von Willebrand Factor Ristocetin Cofactor and the amount of vWF within about 10% of an amount of vWF in the donor plasma.(claims 10-11 of reference patent) and an amount of von Willebrand Ristocetin Cofactor (VWF:RCo) ranging from about 10 to 200 IU/dL (claim 4 of reference patent).
Regarding claims 11-12: Claim 3 of the reference application taught that the residual moisture is about 2.5%, 2.0%, 1.5%, 1.0% or 0.5% in the dried plasma product and claims 12-13 taught the mammal or human limitations of claim 12.
Claims 1-4, 6-12, 16-17, 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,975,274 in view of 8,407,912 (Publication April 2, 2013; hereinafter "Hubbard;" See IDS 07/24/2024).
Regarding claim 1, 3-4,16 and 19-21: Claim 1 of the reference application taught a dried plasma product, which showed stability when stored for a period of time ranging from about 1 day to about 48 months at a temperature ranging from about 1° C. to about 45° C. Claim 3 of the reference patent noted that “spray dried plasma, when stored is stable, wherein a level of one or more plasma proteins of the spray dried plasma when reconstituted is within about 20%, as compared to a level of the one or more plasma proteins in reconstituted spray dried plasma before storage.” It is noted that the claims of the reference application did not teach or suggest levels of plasma proteins when reconstituted with water is within 25% as compared to plasma proteins before storage. However, as noted above, Hubbard taught that the plasma powder may exhibit, a recovery rate for the protein between the plasma and the physiologically active reconstituted plasma, of at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, etc. (Hubbard, col. 13, lines 5-15) This falls within the claimed within 25% recovery of plasma proteins compared to the levels before storage. One of ordinary skill in the art would have easily been able to arrive at the claimed composition in view of the teachings of Hubbard and the reference application, as Hubbard’s teaching of high protein recovery and comparable physiological activity would have reasonably suggested that the spray dried plasma retains protein levels within about 25% of pre-storage levels.
Regarding claim 2: Claim 1b of the reference patent taught that when measured with a cell analyzer using an electrical sensing zone method ranging from about 2 μm to 60 μm, as compared to the mean size of particulates in the donor plasma.
Regarding claim 6-10: Claim 5 of the reference patent taught that dried plasma when reconstituted with SWFI has a pH of about 6.7, 6.8, 6,9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, or 7.8; a C5a level ranges from about 0.1 to about 30 ng/m: (Claim 6 of reference patent); amount of vWF is measured by von Willebrand Factor Ristocetin Cofactor and the amount of vWF within about 20% of an amount of vWF in the donor plasma, wherein the amount of vWF is measured by von Willebrand Factor Ristocetin Cofactor and the amount of vWF within about 10% of an amount of vWF in the donor plasma.(claims 8-11 of reference patent) and an amount of von Willebrand Ristocetin Cofactor (VWF:RCo) ranging from about 10 to 200 IU/dL (claim 1h of reference patent).
Regarding claim 17: Claim 1c taught a reduced number of cholesterol crystals, when viewed at 100× magnification, as compared to reconstituted freeze dried plasma
Regarding claims 11-12: Claim 12 of the reference application taught that the residual moisture is about 2.5%, 2.0%, 1.5%, 1.0% or 0.5% in the dried plasma product and claims 13-14 taught the mammal or human limitations of claim 12.
Claims 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,405,057 in view of 8,407,912 (Publication April 2, 2013; hereinafter "Hubbard;" See IDS 07/24/2024).
Regarding claim 11: The teachings of Hubbard are set forth above. Claim 10 of reference application taught a spray dried plasma comprises a residual moisture ranging from about 1% to about 2.5%.
One of ordinary skill in the art would have easily been able to arrive at the claimed composition in view of the teachings of Hubbard and the reference application, as Hubbard’s teaching of high protein recovery and comparable physiological activity would have reasonably suggested that the spray dried plasma retains protein levels within about 25% of pre-storage levels.
Conclusion
No claim is free of art.
No claim is allowed.
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/JAGAMYA NMN VIJAYARAGHAVAN/ Examiner, Art Unit 1633
/EVELYN Y PYLA/ Primary Examiner, Art Unit 1633