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 .
Claim Objections
Claims 1, 8, and 15 and their depending claims are objected to because of the following informalities:
Claim 1, 8, and 15, have the same typographical error appears “said cassette having an outport port couple via a collection line to said cassette output port”. The claims have been understood to mean “said cassette having an outport port couple via a collection line to said chamber output port” since the input port of the chamber and cassette are connected, and something cannot be connected to itself.
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 1-20 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.
Claim 1 recites the limitation "first and second walls" in lines 12 and 13. There is insufficient antecedent basis for this limitation in the claim. The suggested correction would be to either write “… having a first and second walls which are planar, parallel, and opposed to each other… in lines 5-6 or to write “said first and second planar, parallel, opposed walls are transparent”. As currently written, there is confusion to if the walls are the same or different walls. For the sake of compact prosecution, the walls have been treated as the same walls. Claims 2-7 are rejected because they depend from claim 1.
Claim 1 line 20 recites the limitation “a plurality of electrodes” and later “said electrodes”. There is insufficient antecedent basis for this limitation in the claim. Suggested correction would be “said plurality of electrodes” As currently written, there is confusion to if the electrodes are the same or different electrodes. For the sake of compact prosecution, the electrodes have been treated as the same plurality of electrode. Claims 2-7 are rejected because they depend from claim 1.
Claim 1 lines 18 recites “said channels” Suggested correction would be “said plurality of parallel channels” As currently written, there is confusion to if the channels are the same or different channels. For the sake of compact prosecution, the channels have been treated as the same plurality of channels.
Claim 4 line 1 recites “said electrodes” There is insufficient antecedent basis for this limitation in the claim. Suggested correction would be “said plurality of electrodes” As currently written, there is confusion to if the electrodes are the same or different electrodes. For the sake of compact prosecution, the electrodes have been treated as the same plurality of electrodes.
Additionally for clarification the “each said electrode” in line 2 should be rewritten as “each electrode in each pair...”. Electrode has only been referred to in the plural before as such while it is understood a pair of electrodes has two induvial electrodes the use of the term said causes ambiguity.
Claim 5 line 2 recites “said electrodes” There is insufficient antecedent basis for this limitation in the claim. Suggested correction would be “said plurality of electrodes” As currently written, there is confusion to if the electrodes are the same or different electrodes. For the sake of compact prosecution, the electrodes have been treated as the same plurality of electrodes.
Claim 5 line 2 recites “said electrical insulators” There is insufficient antecedent basis for this limitation in the claim. Suggested correction would be “one insulator from said plurality of electrical insulators”. As currently written, there is confusion to if the singular electrical insulator is one of the plurality of insulators or a different insulator. For the sake of compact prosecution, the singular insulator has been treated as the same as the plurality of insulators. Alterative phrasing could be “one or more insulators” thereby implying a plurality.
Claim 8 recites the limitation "first and second walls" in lines 12 and 13. There is insufficient antecedent basis for this limitation in the claim. The suggested correction would be to either write “… having a first and second walls which are planar, parallel, and opposed to each other… in lines 5-6 or to write “said first and second planar, parallel, opposed walls are transparent”. As currently written, there is confusion to if the walls are the same or different walls. For the sake of compact prosecution, the walls have been treated as the same walls. (All additional uses of said channels should be corrected also.) Claims 9-14 are rejected because they depend from claim 8.
Claim 8 line 18 recites “said channels” Suggested correction would be “said plurality of parallel channels” As currently written, there is confusion to if the channels are the same or different channels. For the sake of compact prosecution, the channels have been treated as the same plurality of channels. (All additional uses of said channels should be corrected also.) Claims 9-14 are rejected because they depend from claim 8.
Claim 15 recites the limitation "first and second opposed walls" in line 20. There is insufficient antecedent basis for this limitation in the claim. The suggested correction would be to either write “… having a first and second walls which are planar, parallel, and opposed to each other… in lines 4-5 or to write “said first and second planar, parallel, opposed walls are transparent”. As currently written, there is confusion to if the walls are the same or different walls. For the sake of compact prosecution, the walls have been treated as the same walls. Claims 16-20 are rejected because they depend from claim 15.
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.
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.
Claim(s) 1-3, and 6-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Terumo BCT Biotechnologies LLC US 2017/0021042 A (hereafter referred to Terumo) in view of Alentic Microscience Inc. US 20220256889 (hereafter referred to Alentic).
Regarding claim 1, 3, 6, 8, 15, and 17 Terumo discloses a cassette for the treatment of blood having pathogen cells therein (see flow cell 1500, Fig 15, [0092]; flow cell 1500 for a fluid [0094-0095]; for fluid such as blood, [0041]), comprising:
said cassette having therein at least one chamber which has an interior space ([0092] and fig 16-17 discloses the flow cell has pathways comprising at least one chamber or channel 1520; walls of piece 1512 create a plurality of channels, 1520 that provide communication between manifolds 1516A-B), an input port (see a left input port into the channels 1520 between 1516A and 1516B, Fig 16-17) and an output port (see a right output port out of the channels 1520 between 1516A and 1516B, Fig 16-17), an input port (see a left input port into the channels 1520 between 1516A and 1516B, Fig 16-17 ) and an output port (see a right output port out of the channels 1520 between 1516A and 1516B, Fig 16-17), said chamber having first and second planar, parallel, opposed walls on opposite sides of the interior of said chamber (see how the chambers have parallel opposing planar walls 1504 and 1508 on opposite upper and lower sides of the chamber, Fig 16; 1504 and 1508 are transparent, [0093]),
said cassette having an input port (see an upper input into manifold portions 1516A,C,E, Fig 17, manifolds 1516, [0092]; in a method of using 1500, fluid is introduced into an inlet manifold, [0094-0095]) coupled via a first transfer line to said chamber input port for transporting said blood from said cassette input port to said chamber (see how the upper input port is coupled via line 1516A to the input port of channels 1520, Fig 17; fluid communication is provided between 1516A and the channels 1520, [0092]), said cassette having an output port (see a lower output of manifold portions 1516B,D,F, Fig 17, manifolds 1516, para [0092]; in a method of using 1500, fluid is provided to an outlet manifold, para [0095]; after reducing pathogens the fluid is collected, para [0098]) coupled via a second transfer line to said chamber (see objection and that the claim has been understood to mean chamber output) output port for transporting said blood from said chamber to said cassette output port (see how the lower output port is coupled via line 1516B to the output port of channels 1520, Fig 17; fluid communication is provided between the channels 1520 and 1516B, [0092]),
said first and second walls transparent to at least a selected band of light (1504 and 1508 are transparent to a predetermined wavelength of light, [0093]), each of said first and second walls having an interior wall open to the interior of said chamber (see how inner walls of 1508 and 1504 are open to the interior of the chamber channels 1520, Fig 16-17; piece 1512 has walls and is positioned between 1504 and 1508 to create the channels 1520, [0092]),
said chamber having an exposure zone which is proximate said chamber input port (see a left half of the channels 1520 of the chamber proximate the left input, Fig 17) and a processing zone proximate said chamber output port (see a right half of the channels 1520 of the chamber proximate the right output, Fig 17),
a plurality of parallel channels extending from a first end wall of said chamber to a second chamber end wall of said chamber (see how the chamber includes a plurality of parallel channels 1520 extending from a left end wall to a right end wall, Fig 16-17), said channels passing through said exposure zone and said processing zone (see how each channel 1520 passes through said left and right zones of the chamber, Fig 16-17).
additionally, per claim 6 and 8 and 15: said channels defined by a plurality of parallel ridges and by the interior surfaces of said first and second walls (see how the channels 1520 are defined by a plurality of parallel ridges/walls on piece 1512 and the interior surfaces of 1504 and 1508, Fig 16- 17, para [0092]),
additionally, per claim 15: said chamber having a rectangular configuration with a width dimension, a length dimension and a thickness dimension (fig 16 and 17 clearly show a rectangular configuration); and, said chamber having an input port positioned on the width dimension of said chamber, said input port having essentially a same width as the width dimension of said chamber, said chamber having an outport port positioned on the width dimension of said chamber and on the opposite side of said chamber from said chamber input port, said output port having essentially a same width as the width dimension of said chamber (see fig below)
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Terumo fails to disclose a plurality of electrodes within said chamber, said electrodes positioned respectively to said channels within said processing zone.
Terumo additionally fails to disclose an electrical driver circuit mounted to said cassette and electrically coupled to said electrically conductive elements for selectively applying electrical power to said blood in said chambers proximate to said electrically conductive elements per claims 3 and 8 and 17.
Terumo teaches wherein a lighting system may be used to illuminate the processing zone in order to cause pathogens in the blood to die using light energy in combination with other methods. The fluid may be illuminated while it passes through the channels by a lighting system such that the fluid may be pathogen reduced by light energy, [0098]; an additional material may also work in combination with the light energy to effect pathogen reduction, [0098]; light sources such as UV light to provide a pathogen reducing effect such as causing pathogens to die, [0048].
Alentic teaches a device for the treatment of blood having pathogen cells thereby being in the related field in endeavor.
Alentic teaches the blood specimen may be placed in chamber and may include cells, [0113-0114]), The chamber may have at least one channel (see channel 101 between inlet 153 and outlet 155, Fig 2; the liquid specimen is placed into chamber 101 through fluid channels 153, 155, [0113]) and a plurality of pairs of electrodes (see pairs of transparent electrodes including 631 and 619, Fig 6H; electrodes 631 positioned to contact the top of chamber 101, [0108]; plurality of electrodes 619 and 631 on imaging circuit 613 such that application of potential may be applied between 619 and 631, [0148]), said electrodes positioned respectively to said channel (see how electrodes 631 are positioned above 101, Fig 2; see imaging integrated circuit 113 below 101, Fig 2; see how electrodes 619 are positioned on similar imaging circuit 613, Fig 6H; plurality of electrodes 619 to cover the imaging integrated circuit 613, [0148]) in order to allow for application of an electric potential between any pair of electrodes (application of an electric potential between any electrode 631 and 619, para [0146]-[0148]; a potential is applied between the imaging circuit at the bottom of the chamber and that of the top of the chamber, para [0149]) in order to selectively kill the pathogen cells within the channel between the pairs of electrodes (para [0149]-[0150]).
Alentic additionally teaches a plurality of electrical driver circuits coupled to said heater elements for selectively applying electrical power to said heater elements (an input switchable applying device 635 allows for addressable application of electric potential between any pair of electrodes 619 and 631, [0148]) in order to selectively kill the pathogen cells within the channel between the heater elements ([0149-0150]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the cassette of Terumo such that it comprises a plurality of electrodes within said chamber, said electrodes positioned respectively to said channels within said processing zone as taught by Alentic in order to allow for selectively kill the pathogen cells within the channels between the pairs of electrodes.
Additionally , it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the cassette of Terumo such that it comprises a plurality of resistive heater elements corresponding respectively to said channels and located in said processing zone of said chamber, and a plurality of electrical driver circuits mounted to said cassette and coupled to said heater elements for selectively applying electrical power to said heater elements as taught by Alentic in order to allow for selectively killing the pathogen cells within the channels.
Regarding claims 2, 12, and 16 Terumo and Alentic teach a cassette as recited in Claim 1 but do not explicitly teach including a plurality of optical markers in surfaces of said channels, said optical markers at least partially nontransparent to said light. Alentic teaches wherein a portion of the channels in an optical path of the system is transparent (at least the segment of the conduit in the optical path is transmissive to light, [0115]) so that blood within those portions of said channels may be imaged in the presence of a light source ( [0116]), However, it would have been obvious to a person having ordinary skill in the art to modify the surfaces of said channels such that they include a plurality of optical markers at least partially nontransparent to said light such that only the surfaces of said channels used for imaging are transparent while the other surfaces of said channels are nontransparent to said light given only a portion of the channel is transparent the other portion would nontransparent..
Regarding claim 7, 10, and 18, Terumo discloses wherein said cassette comprises two planar layers of plastic bonded together and at least one of said layers having said chambers and said distribution and collection lines molded therein ([0054-56] disclose the flow cell can be made from a polymer which includes plastics and that they bonded together and [0092] discloses a molded piece to provide walls for the channels that is placed between two layers that form the cassette, fig 16 and 17).
Regarding claim 9, Terumo fails to disclose wherein the interior surfaces of said chamber opposed walls are spaced apart by no more than 10 microns. However, Terumo teaches in [0061-0065] the depth or space between the cassette layers 212A is 0.025-.2mm and that depth of the channel (or space between the opposed walls) is a result effective variable based on the flow rate and the workable range can be optimized ([0060]). Therefore, it would have been obvious to one of ordinary skill int the art to have optimized the depth of the channel based on the flow rate of the material and how quickly the energy could kill the pathogen based on Terumo [0060]. “[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 II. A .
Regarding claim 11 and 19, Terumo discloses wherein said ridges comprise spacers between said first and said second walls ([0061-0065] disclose the channels are formed by ridges or spacers (212) between the walls the depth or space between the cassette layers, fig 4).
Regarding claim 13, Terumo discloses wherein said cassette has a plurality of said chambers therein (see at least a first column chamber between 1516A and 1516B and a second column chamber between 1516C and 1516B each with a plurality of channels 1520, Fig 17; walls of piece 1512 create a plurality of channels 1520 that provide communication between manifolds 1516A-C, para [0092]), said first transfer line comprises an input manifold (see how the first line is an input manifold with portions 1516A and C, Fig 17, manifolds 1516, para [0092]; inlet manifold, para [0094]-[0095]) having the input thereof coupled to said cassette input port (see how 1516A and C are coupled to the upper input, Fig 17) and multiple outputs thereof coupled respectively to the input ports of said plurality of chambers (see how output portions 1516A and C are coupled to the inputs of the first and second chambers, Fig 16-17), and said second transfer line comprises an output manifold (see how 1516B is an outlet manifold, Fig 17, manifolds 1516, para [0092]) having the inputs thereof coupled to respective output ports of said plurality of chambers (see how 1516B is coupled between the outputs of the first and second chambers, Fig 17) and the output of said output manifold coupled to said cassette output port (see how an output of 1516B is coupled to the lower output port, Fig 17).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Terumo BCT Biotechnologies LLC US 2017/0021042 A (hereafter referred to Terumo) in view of Alentic Microscience Inc. US 20220256889 (hereafter referred to Alentic) per claim 8 above and in further view of Blatter US 2001/0007931 A1.
Regarding claim 14, Terumo and Alentic fail to disclose wherein said cassette is fabricated of a plastic which includes an anti-thrombogenic component therein.
Blatter discloses a vascular access system thereby being drawn to a similar problem as blood follows through the system. Blatter teaches the cartridge (or cassette) should be lined with an antithrombogenic to prevent blood from clotting ([0139]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added a thrombogenic agent to the cassette to prevent the clotting of blood during use of the cassette.
Claim(s) 4-5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Terumo BCT Biotechnologies LLC US 2017/0021042 A (hereafter referred to Terumo) in view of Alentic Microscience Inc. US 20220256889 (hereafter referred to Alentic) and in further view of Ruan US 2008/0099406 A1.
Regarding claim 4, Terumo and Alentic fail to disclose wherein said electrodes are arranged in pairs, each said electrode in each said pair of electrodes on opposed sides of a corresponding channel.
Regarding claim 5, Terumo and Alentic fail to disclose a plurality of electrical insulators respectively for said electrodes, each said electrical insulator positioned to electrically insulate a one of said electrodes from the interior of a corresponding one of said channels.
Regarding claim 20, Terumo and Alentic fail to disclose wherein said plurality of electrodes are organized in pairs of electrodes, each said pair of electrodes corresponding to a one of said channels, a first electrode of each said pair of electrodes positioned on one side of a corresponding channel and a second electrode of each pair of electrodes positioned on the opposite side of the corresponding channel from the first electrode of the pair of electrodes.
Ruan teaches fluid treatment device thereby being in a related field of endeavor. Ruan teaches wherein said electrodes are arranged in pairs (see a pair of electrodes 102 and 104 for a channel 110, Fig 1, [0026]), each said electrode in each said pair of electrodes on opposed sides of a corresponding channel (see how 102 and 104 are on opposed sides of a channel 110, Fig 1), and a plurality of electrical insulators respectively for said electrodes (see insulators 106 and 108 for electrodes 102 and 104, Fig 1; each electrode 102 and 104 is isolated from 110 by barriers 102 and 104, [0026]; 106 and 108 are electrical insulating materials, [0055]), each said electrical insulator positioned to electrically insulate a one of said electrodes from the interior of a corresponding one of said channels (see how 106 and 108 are positioned to electrically insulate 102 and 104 from the interior of channel 110, Fig 1, [0026], [0028]). Ruan additionally teaches a first electrode of each said pair of electrodes positioned on one side of a corresponding channel (see first electrode 102 on an upper side of 110, Fig 1) and a second electrode of each pair of electrodes positioned on the opposite side of the corresponding channel from the first electrode of the pair of electrodes (see second electrode 104 on an opposite lower side of 110, Fig 1).
Terumo teaches wherein a lighting system may be used to illuminate the processing zone in order to cause pathogens in the blood to die using light energy in combination with other methods (the fluid may be illuminated while it passes through the channels by a lighting system such that the fluid may be pathogen reduced by light energy, [0098]; an additional material may also work in combination with the light energy to effect pathogen reduction, [0098]; light sources such as UV light to provide a pathogen reducing effect such as causing pathogens to die, [0048]), but does not teach by using a plurality of electrodes. Ruan further teaches a fluid treatment device for killing pathogens in the fluid (para [0025]) comprising at least one channel (see chamber device 100 with channel/gap 110 for fluid, Fig 1, para [0026]) and a plurality of electrodes (see electrodes 102 and 104, Fig 1; electrodes 102 and 104, para [0026]), said electrodes positioned respectively to said channel (see how electrodes 102 and 104 are positioned on opposite sides of said channel 110, Fig 1) in order to generate an electric field across the channel for killing pathogens in the channel (AC voltage applied to 102 and 104 generates an electric field across 110, para [0028]; for destroying pathogens in the fluid within 110, para [0025]-[0026]). Therefore, it would have been obvious to a person having ordinary skill in the art to modify the chamber of Terumo such that it further comprises a plurality of electrodes positioned respectively to said channels within said processing zone as taught by Ruan in order to generate an electric field across each of the channels for killing additional pathogenic cells in the channels.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA E BURNETTE whose telephone number is (571)272-9574. The examiner can normally be reached M-S: 0830-1900 EST.
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/GABRIELLA E BURNETTE/ Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781