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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-15 in the reply filed on 12/14/25 is acknowledged. Applicant does not present any specific arguments directed towards the unity of inventions or lack thereof, and the restriction requirement is made final.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
Claim 1 and 12 both read “single units of plasma by transferring the plasma for the sample bag to a product bag” (emphasis added) and it is believed the word “for” should be “from” for grammatical purposes.
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.
Claims 1-15 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.
Claims 1 and 12 are rejected for lacking a transitional phrase (i.e., “consisting of”, “comprising”, “consisting essentially of”). For each claim, it cannot be determined what the scope of the claim is because there is no transitional phrase linking the preamble to the body of the claim, and whether the claim excludes other limitations other than what is claimed. For the purpose of examination, it is interpreted the method comprises the claimed limitations.
Claim 1 is rejected for reciting limitation “other pathogens” as it is not clear what other pathogens are being claimed and therefore the scope of the claim cannot be determined and the claim is indefinite. For the purpose of examination, it is interpreted that limitation reads “A method for the pathogen reduction of viruses and
Claim 1 is rejected for reciting the limitation “SuperFluids”. The term is, as set forth in par. 2 of p. 6 of the instant specification as filed, directed towards a trademarked term. 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 a supercritical or near-supercritical fluid and, accordingly, the identification/description is indefinite. For the purpose of examination, it is interpreted the SuperFluids are supercritical or near supercritical fluid.
The remaining claims are also rejected for including the term “SuperFluids”.
Claim 1 is rejected for reciting the limitation “decompressing the product bag, … and decompressing the product bag” and it is not clear if they second recitation of decompressing is a further decompressing step that is separate from the first or the limitation is merely further limiting the step of decompressing. It cannot be determined if there is one decompressing step or two as claimed, and therefore the scope of the claim cannot be determined and the claim is indefinite. For the purpose of examination, it is interpreted there is one or two decompressing steps.
Claims 1 and 12 both recite “the sample bag” in lines 2 of the claims. There is a lack of antecedent basis for this limitation in the claims. For the purpose of examination, it is interpreted there is some bag.
Claims 2-5 all recite the limitation "a bag" or “the bag” and it is not clear whether the limitations are directed towards the sample bag or product bag or some other bag. For the purpose of examination, it is interpreted that the bag is the product bag or the sample bag.
The term “near-critical” in claim 6 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It cannot be determined how close the fluid would have to be to a supercritical or critical state in order to be considered “near-critical” as opposed to not “near-critical”. For the purpose of examination, it is interpreted the fluid is approximately a supercritical state.
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.
Claims 1-4 and 6-15 are rejected under 35 U.S.C. 103 as being unpatentable over Castor (5,877,005) in view of Dumont (US 2004/0009542).
Regarding claim 1, Castor (5,877,005) discloses –
A method for the pathogen reduction of viruses and other pathogens in single units of plasma (col. 1 lines 10-12 and col. 5 lines 17-28 disclose the methods are for pathogen reduction in units of plasma) by transferring the plasma to a container containing SuperFluids at a specified pressure and temperature (col. 1 line 66-67 and col. 2 line 1-6 disclose the contact of the fluid to a supercritical fluid, col. 5 lines 59-67 disclose a sealed package, col. 5 lines 11-15 disclose the material to be treated is brought into contact with the supercritical fluid, therefore requiring the plasma to be brought into contact with the SuperFluids), and
decompressing the product bag, wherein the product bag is maintained as a closed and sterile system (col. 5 lines 59-64), and decompressing the product bag to separate the SuperFluids from the plasma to yield plasma suitable for transfusion (col. 5 lines 59-64 disclose the decompression of the bag for phase separation for subsequent use).
Castor appears to be silent with regards to a transferrin of the plasma from a sample bag to a product bag.
Dumont (US 2004/0009542) teaches a method of transferring a blood product from a sample bag to another product bag (par. 10, 55 – figs. 2-3 and 7 show bags being connected to each other for transfer). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method discloses by Castor such that the blood product is transferred from a sample bag to a product bag in order to be contacted with the SuperFluids as taught by Dumont to arrive at the claimed invention. One would have been motivated to do so to use a known-appropriate container for transfer, treatment, and decompression of blood products as required by Castor to arrive at an improved invention. The combination of familiar prior art elements, including the inclusion of blood bags for use with blood treatment methods, according to known means to arrive at results that are nothing more than predictable is prima facie obvious. MPEP 2143(I)(A).
Regarding claim 2, modified Castor further teaches the blood plasma is in a bag having one or more ports configured for sterile fluid transfer (col. 7 lines 60-66 and Fig. 2 show container 50 with bottom outlet lines 58 col. 5 lines 58-59 disclose the containers are configured for aseptic transfers).
Regarding claim 3, modified castor teaches multiple ports on the top and bottom of the bag for transfer and venting (Fig. 2 of Castor show container 50 with ports on the top and bottom, fig. 2 of Dumont shows 3 connectors on a bottom surface). Castor appears to be silent with regards to specifically 3 ports on top of the bag and 1 port on the bottom, however it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bags of Castor such that there are 3 ports on the top of the bag and one of the bottom to arrive at the claimed invention. One would have been motivated to do so as this modification is merely a duplication of existing parts, and mere duplication of parts has no patentable significance unless a new and unexpected result is produced. There is no new nor unexpected result that would be produced by configuring the ports in this manner, as the ports would similarly perform their stated function of transfer of fluids.
Regarding claim 4, modified Castor further teaches the bags are made from PVC (par. 52 of Dumont).
Regarding claim 6, modified Castor further teaches the SuperFluids are nitrous oxide (N20) and carbon dioxide (C02) in a supercritical or near-critical state (see claim 10 of Castor).
Regarding claims 7 and 8, modified Castor appears to be silent with regards to the specific concentrations of nitrous oxide and carbon dioxide, however modifying the superfluids container nitrous oxide and carbon dioxide taught by Castor to the claimed concentrations would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention. The modification of these concentrations is nothing more than routine optimization as differences in concentration do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There is no evidence indicating the claimed concentrations are critical and the ranges are obvious, and the concentrations of a pathogen reduction fluid is readily understood as a variable that affects the pathogen reduction performance. See MPEP 2144.05(II)(A).
Regarding claim 9, modified Castor further teaches the SuperFluids are at a pressure of 2,000 to 5,000 psig and a temperature of 20°C to 50°C effective to inactivate viruses and other pathogens while preserving plasma proteins (col. 5 lines 28-33 disclose plasma being treated at 3,000 psig and 40 degrees Celsius, and the stated purpose of Castor is to inactivate viruses and preserve the plasma).
Regarding claim 10, modified Castor further teaches the SuperFluids are at a pressure of 2,500 to 3,500 psig and a temperature of 35 to 40°C (col. 5 lines 28-33 disclose plasma being treated at 3,000 psig and 40 degrees Celsius, and the stated purpose of Castor is to inactivate viruses and preserve the plasma).
Regarding claim 11, modified Castor further teaches the SuperFluids are at a pressure of 3,000 psig and a temperature of about 37°C (col. 5 lines 28-33 disclose plasma being treated at 3,000 psig and 40 degrees Celsius, and the stated purpose of Castor is to inactivate viruses and preserve the plasma). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Castor such that the temperature is exactly 37 degrees Celsius, as this modification would only be the product of routine experimentation. The temperature of a pathogen reduction treatment is readily understood as a variable that affects the effectiveness of the treatment and there is no evidence that the temperature is critical. See MPEP 2144.05(II)(A).
Regarding claim 12, Castor teaches –
A method for the pathogen reduction of viruses and other pathogens in single units of plasma (col. 1 lines 10-12 and col. 5 lines 17-28 disclose the methods are for pathogen reduction in units of plasma) by
transferring the plasma to a container containing SuperFluids at a specified pressure and temperature (col. 1 line 66-67 and col. 2 line 1-6 disclose the contact of the fluid to a supercritical fluid, col. 5 lines 59-67 disclose a sealed package, col. 5 lines 11-15 disclose the material to be treated is brought into contact with the supercritical fluid, therefore requiring the plasma to be brought into contact with the SuperFluids), and
decompressing the product bag to separate the SuperFluids from the plasma (col. 5 lines 59-64 disclose the decompression of the bag for phase separation for subsequent use).
Castor appears to be silent with regards to a transferrin of the plasma from a sample bag to a product bag and subsequently transferring the plasma back to the sample bag.
Dumont teaches a method of providing an aseptic connection between a blood sample container, bag, or sampler and a bacteria culture bottle or other container (para [0010]) wherein a sample bag and a product bag are fluidly connected to each other (para [0010]; para [0055], The sampler can also be a sample bag 250 as shown in FIG. 3 connected at 215 as described above with respect to the sample bulb; and para [0056]). It would have been obvious to one of ordinary skill in the art to provide the sample in the sample bag taught by Dumont and flow the plasma sample to product bag for mixing with SuperFluids and decompression because Castor states that the decompression can take place in a sealed package (col 5, In 59-67, In the case of a Solution containing, for example, a protein, to accomplish Separation, the mixture is decompressed thereby resulting in a phase Separation of the fluid from the Solution containing the proteinaceous product. The material then is isolated under aseptic conditions. By isolating the material, it is meant Separating the material from the equipment of the invention such as in a sterile bottle or a container (e.g. a flask) or in a package such as a hermetically Sealed package), and further, performing the mixing and decompression in the same bag will reduce the amount of materials needed for the method. Further, it would have been obvious to one of ordinary skill in the art to return the plasma back to the sample bag and back to the product bag before compression because Castor states the mixture of a biological components with a SuperFluid ideally occurs under laminar flow conditions (col 3, In 11-13, Biological materials having a liquid component are capable of forming an admixture with the SCoCoNC fluid. Preferably, the admixture is formed under laminar flow conditions), and therefore, flowing the plasma between the bags will improve the performance of the pathogen reduction method.
Regarding claims 13-15, modified Castor appears to be silent with regards to the number of times the plasma is transferred between the sample and product bag before decompression being n where n = 3 to enhance pathogen exposure to the SuperFluids. However, as modified Castor renders obvious the step of transferring the plasma back and forth between the bags to perform the pathogen reduction as set forth above in the rejection of claim 12, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Castor such that the plasma transfer is repeated n times where n = 3 to arrive at the claimed invention. One would have been motivated to do so as the selection of the number of times to repeat this transfer would merely be an optimization of a number of times to repeat a known process step, which would amount to nothing more than routine optimization achievable through routine experimentation. MPEP 2144.05(II)
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Castor (5,877,005) in view of Dumont (US 2004/0009542) as applied to claim 4 above and further in view of Waldo (US 2003/0165398).
Regarding claim 5, modified Castor is set forth with regards to claim 4 above but appears to be silent with regards to PTFE.
Waldo (US 2003/0165398) discloses a blood treatment method where the container for holding blood (container 206) is made of PTFE (par. 145 discloses container 206 is made from PTFE). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bag to be made from PTFE as taught by Waldo to arrive at the claimed invention. One would have been motivated to do so to use a known-appropriate material for holding a corresponding biological product to arrive at an improved device. The combination of familiar prior art elements, including known blood bag materials for the use of containing blood, according to known means to arrive at results that are nothing more than predictable is prima facie obvious. MPEP 2143(I)(A).
Claims 12-15 is rejected under 35 U.S.C. 103 as being unpatentable over Castor (5,877,005) in view of Dumont (US 2004/0009542) as applied to claim 4 above and further in view of Petrie (US 2017/0274105).
Regarding claims 12-15, should it be found that Castor in view of Dumont fails to render the limitation of transferring the plasma back and forth for successive treatments obvious:
Petrie (US 2017/0274105) teaches a blood treatment method (title) where the blood is transferred back and forth for multiple successive passes through the treatment medium (pars. 55 and 59 disclose multiple exposures of the blood to UV light for more thorough exposure of the cells to the light). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process disclosed by Castor such that the transfer is repeated n times where n = 3 to arrive at the claimed invention. One would have been motivated to do so to better treat the plasma as suggested by Petrie to arrive at an improved treatment method.
Response to Arguments
Applicant's arguments filed 12/14/25 have been fully considered but they are not persuasive.
Applicant argues the claimed invention is distinct over the prior art, however distinctness of the claim was not asserted in the Restriction Requirement mailed 8/14/25. Lack of unity of invention was the basis for the restriction, and Applicant fails to identify a special technical feature that was shared between the two groups of inventions as set forth in the same requirement.
Applicant’s arguments directed towards the patentability of the claims are further not persuasive. Any alleged deficiencies of Castor are remedied by the inclusion of Dumont as set forth above.
Conclusion
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/BRENDAN A HENSEL/ Examiner, Art Unit 1758