The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of Group I, claims 1-7, 23-27, 33-36, in the reply filed on December 4, 2025 is acknowledged.
Claims 8-22, 28-32 have been withdrawn from further consideration by the examiner because they are drawn to non-elected inventions. Claims 1-7, 23-27, 33-36 are under consideration.
Priority: This application is a 371 of PCT/US21/38606, filed June 23, 2021, which claims benefit of provisional application 63/042668, filed June 23, 2020.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 33-35 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. The instant claims recite a nature-based product, i.e. a preparation of salts. The salts in the preparation recited in the claims are not markedly different from naturally occurring salts.
Claim 33 and its dependent claims are directed to a liquid low ionic solute preparation comprising the noted salts sodium, potassium, calcium, magnesium, chloride, bicarbonate, and phosphate at the recited quantities. Because the salts are composed of matter, the claim is directed to a statutory category, e.g. a composition of matter (step 1: YES). The claimed salts sodium, potassium, calcium, magnesium, chloride, bicarbonate, and phosphate are all naturally occurring and exist in nature together in liquid. There is no indication that the salts together at the recited concentrations in a solution changes the structure, function, or other properties of the salts in solution in any marked way. Thus, the claimed liquid preparation as whole does not display markedly different characteristics compared to a naturally occurring counterpart. Accordingly, each component (liquid, sodium, potassium, calcium, magnesium, chloride, bicarbonate, phosphate) is a product of nature exception, and the claim is directed to at least one exception (step 2A: YES). Next, the claim as a whole is analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exceptions. As noted above, the claimed salts sodium, potassium, calcium, magnesium, chloride, bicarbonate, and phosphate are all naturally occurring and exist in nature together in liquid. There is no indication that the salts together at the recited concentrations in a solution changes the structure, function, or other properties of the salts in solution in any marked way. The combination of salts in liquid are naturally occurring and exist in humans and mammals and it is well-understood, routine and conventional in the field to mix specific amounts of salts in solution in varying amounts to arrive at solutions as carriers for proteins (Abuchowski et al. paragraphs 0085, 0251; US 20100311657). Thus, the combination of the salts sodium, potassium, calcium, magnesium, chloride, bicarbonate, and phosphate, in a liquid, when recited at this high level of generality, does not meaningfully limit the claim, and the claim as a whole does not amount to significantly more than each “product of nature” by itself (step 2B: NO). The claim does not qualify as eligible subject matter.
Claims 34-35 are included in this rejection because they are dependent on claim 33 and also for the same reasons noted above for claim 33.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meledeo et al. (2019 J Trauma Acute Care Surg 87: S83-S90; IDS 02.22.24). Meledeo et al. teach a liquid formulation comprising a hemoglobin-based oxygen carrier (HBOC-201) and FDP (freeze-dried plasma) and/or a liquid formulation comprising HBOC-201 and WB (whole blood) (at least p. S84; instant claim 1).
Regarding instant claims 2-5, 7, Meledeo et al. teach liquid formulations comprising 25%, 40%, 50% mixtures of additives (HBOC-201, FDP, or HBOC-201 and FDP at a 1:1 ratio) with WB (at least p. S83-S84) and a second set of the liquid formulations comprising 25%, 40%, 50% mixtures of additives (HBOC-201, FDP, or HBOC-201 and FDP at a 1:1 ratio) with WB prediluted with 25% plasmalyte A (at least p. S83-84).
Regarding instant claim 6, Meledeo et al. teach the HBOC-201 is a purified hemoglobin that has been polymerized (at least p. S83-S84). Therefore, Meledeo et al. can be deemed to teach hemoglobin that is hyperpolymerized.
Claims 1-7, 23-25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dubé et al. (US 20220354930). Dubé et al. teach a liquid formulation comprising HBOC-201 and FDP (at least paragraphs 0057-0058, see also example I; instant claim 1).
Regarding instant claims 2-5, 7, Dubé et al. teach liquid formulations comprising 50% replacement of WB with equal parts water-rehydrated FDP (25% of total final volume) plus HBOC (25% of total final volume) (at least examples II).
Regarding instant claim 6, Dubé et al. teach the HBOC is polymerized hemoglobin having a molecular weight from about 130-6000 kD (at least paragraphs 0045-0046). Therefore, Dubé et al. can be deemed to teach hemoglobin that is hyperpolymerized.
Regarding instant claims 23-25, Dubé et al. teach a field-ready flexible container system comprising a container comprising a polymerized hemoglobin solution, a container comprising freeze-dried plasma, a container comprising freeze-dried platelets (at least paragraphs 0016, 0020-0025).
Claims 1, 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abuchowski et al. (US 20100311657; IDS 01.12.23). Abuchowski et al. teach compositions or solutions comprising PEG-Hb (Pegylated hemoglobin) (at least paragraphs 0040, 0045). Abuchowski et al. teach the PEG-Hb based resuscitation fluid has at least 75%-100% efficacy to fresh frozen plasma, where exemplary formulations include coagulation factors, platelets, or other substances known to aid in coagulopathy (at least paragraph 0103). Abuchowski et al. teach formulations comprising the PEG-Hb and a blood composition enriched in platelets and/or additional stabilizing agents (at least paragraph 0182). Therefore, Abuchowski et al. can be deemed to anticipate instant claims 1, 7.
Regarding instant claim 6, Abuchowski et al. teach the hemoglobin is conjugated with polymers having various molecular weights (at least paragraphs 0053-0057). Therefore, Abuchowski et al. can be deemed to teach hemoglobin that is hyperpolymerized.
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.
Claims 1-7, 23-27, 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Abuchowski et al. (US 20100311657; IDS 01.12.23). The teachings of Abuchowski et al. over at least instant claims 1, 6-7 are noted above.
Regarding instant claims 23-25, Abuchowski et al. disclose providing a kit in which two or more components are present and stored separately prior to their combination; the kit can include two or more ampoules, each containing an element of the combination formulation of the invention in liquid or dry form (at least paragraph 0215). Abuchowski et al. also disclose the composition includes a pharmaceutically acceptable carrier, such as a diluent fraction comprising a salt (at least paragraph 0085). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at a kit or package comprising a container comprising a HBOC, a container containing a blood composition enriched in platelets, and a container comprising an acceptable carrier or solution, where the blood composition enriched in platelets is in dried form (instant claims 23-25). The motivation to do so is given by Abuchowski et al., which disclose HBOCs can be provided in combination with blood compositions in kits. One of ordinary skill would have a reasonable expectation of success because formulations of HBOCs and blood compositions were known and available in the prior art.
Regarding instant claim 26, Abuchowski et al. disclose that the PEG-Hb itself or the entire formulation can be formulated to be hypotonic, isotonic or hypertonic with respect to the tonicity of the subject’s blood (at least paragraph 0216). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the blood composition enriched in platelets in dried form and to prepare the HBOC preparation in a low ionic solute solution in the kit of Abuchowski et al. noted above (instant claim 26). The motivation to do so is given by Abuchowski et al., which disclose that the components of the kits can be prepared in liquid or dry form and that the HBOC can be formulated in a hypotonic solution. One of ordinary skill would have a reasonable expectation of success because formulating and preparing HBOCs and blood compositions were known and available in the prior art.
Regarding instant claims 27, 33-35, Abuchowski et al. disclose that the PEG-Hb are formulated in solutions, including hypotonic salt solutions (at least paragraphs 0045, 0085, 0216). Abuchowski et al. disclose preparing the PEG-Hb in a buffer solution containing 5.0 mM sodium bicarbonate, 1.0 mM sodium phosphate, 150 mM sodium chloride, 4.7 mM potassium chloride, 2.5 mM magnesium sulfate, 0.5 mM calcium chloride (at least paragraph 0251). It is known that “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the recited low ionic solute solution for a HBOC, where the low ionic solute solution comprises lowering the concentrations of the sodium, potassium, calcium, magnesium, chloride, bicarbonate, and phosphate disclosed in Abuchowski et al. to arrive at the recited low salt concentrations in the instant claims by routine optimization. The motivation to do so given by Abuchowski et al., which disclose a PEG-Hb preparation in a buffer solution comprising the same solutes recited and further disclose that the solutions comprising PEG-Hb can be formulated to be a low salt solution. One of ordinary skill would have a reasonable expectation of success because preparing low salt solutions comprising a HBOC was known at the time of the invention.
Regarding instant claim 36, as noted above, Abuchowski et al. also disclose compositions of the PEG-Hb includes about 6% of the PEG-Hb (paragraph 0241) and Abuchowski et al. also disclose the composition includes a pharmaceutically acceptable carrier, such as a diluent fraction comprising a salt (at least paragraph 0085). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to incorporate a PEG-Hb quantity of about 6% and an amount of a pharmaceutically acceptable carrier of the noted quantities in an optimized low salt solution of Abuchowski et al. noted above, by routine optimization. The motivation to do so is given by Abuchowski et al., which disclose preparing a PEG-Hb in a low salt solution comprising the same components recited in the instant claims. One of ordinary skill would have a reasonable expectation of success because the elements and amounts for preparing low salt solutions comprising a HBOC was known at the time of the invention.
Regarding instant claims 2-5, Abuchowski et al. disclose the invention provides a PEG-Hb-based resuscitation fluid having at least 75%, at least 80%, at least 85%, at least 90% at least 95% or about 100% of the efficacy equal to fresh frozen plasma in correcting coagulopathy; exemplary formulations according to this embodiment further include coagulation factors, platelets or other substances known to aid in the mitigation of coagulopathy (paragraph 0103). Abuchowski et al. disclose providing PEG-Hb resuscitation fluids having coagulation factors present; in various embodiments, the coagulation factors are present in an amount not less than 60%, not less than 70%, not less than 80% or not less than 90% of fresh frozen plasma (paragraph 0106). Abuchowski et al. disclose in an exemplary embodiment, the resuscitation fluid includes platelets; it is generally preferred that the resuscitation fluids of the invention including platelets have a cell count and activity that is not less than 60%, not less than 70% (paragraph 0107). Abuchowski et al. disclose that the platelets are a blood composition (paragraph 0182) and Abuchowski et al. also disclose compositions of the PEG-Hb includes about 6% of the PEG-Hb (paragraph 0241). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the quantities of HBOC from about 5% to about 95%, a blood composition comprising from about 5% to about 95%, and a pharmaceutically acceptable carrier or diluent at the noted quantities, by routine optimization. The motivation to do so is given by Abuchowski et al., which disclose preparing a PEG-Hb in a resuscitation fluid comprising the same components recited in the instant claims and at similar quantities. One of ordinary skill would have a reasonable expectation of success because the elements and amounts for preparing resuscitation fluids comprising a HBOC were known at the time of the invention.
No claim is allowed.
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/Marsha Tsay/Primary Examiner, Art Unit 1656