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 .
Claim Status
The preliminary amendment submitted on December 13th, 2024 has been entered. Claims 40-45 and 58-78 are currently pending and under consideration. Claims 40-45 have been amended. Claims 1-39 and 46-57 have been cancelled. Claims 58-78 have been newly added.
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 67 and 75 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 67 recites the limitation "a fluidic substance" in line 2 and claim 75 recites “the fluidic substance” in line 3. Due to the presence of multiple priorly introduced fluidic substances, it is unclear as to which fluidic substance “a fluidic substance” and “the fluidic substance” is referring to. For the purpose of examination “a fluidic substance” is being interpreted as independent from the prior introduced fluid substances and “the fluidic substance” of claim 75 is being interpreted to be referring to the fluidic substance contained in the third fluid reservoir.
Claim Rejections - 35 USC § 102
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.
Claim(s) 40-45, 58-61, and 78 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson (U.S. Publication 2005/0148991).
Regarding claim 40, Johnson discloses an apparatus (Fig. 2 including ¶0010 blood tubing connected to patient’s circulatory system; ¶0010 arms one and two of tubing connect to blood collection chamber, arm three connects to patient), comprising:
a patient access subassembly (¶0010 blood tubing, which is connected to the patient’s circulatory system; arm three connects to patient);
a first fluid reservoir (Fig. 2 blood collection chamber) fluidically coupled to the patient access subassembly (¶0010 blood tubing connected to patient’s circulatory system; ¶0010 arms one and two of tubing connect to blood collection chamber, arm three connects to patient), wherein the first fluid reservoir comprises a fluid inlet (¶0012 first tubing for transporting blood from the patient to the blood collection chamber) and a fluid outlet (¶0012 second tubing for transporting blood admix from the blood collection chamber to the patient; ¶0010 arm two connects to the blood collection chamber optionally contains a filter by which the blood admix may be filtered prior to transport back to the patient; ¶0011 Y joint contains a gating device, such as a stopcock whereby blood admix flow to the patient is directed through either arm one or arm two with the filter) and is configured to contain a first fluid fluidic substance (¶0033 appropriate amount of blood stabilizing agent (e.g. an anti-clotting agent) can be present in the blood collection chamber, mixing with blood would cause it to be fluidic); and
an assembly (arms 1-3, filter and stopcock) having a first configuration in which the patient access subassembly is in fluidic communication with the first fluid reservoir via the fluid inlet (Fig. 2 shows gating means of stopcock, ¶0011 describes stopcock as gating device for manipulating directing of fluids, first configuration would consist of stopcock allowing fluid communication through arm 1) and a second configuration in which the first fluid reservoir is in fluidic communication with the patient access subassembly via the fluid outlet (Fig. 2 shows gating means of stopcock, ¶0011 describes stopcock as gating device for manipulating directing of fluids, first configuration would consist of stopcock allowing fluid communication through arm 2).
Regarding claim 42, Johnson discloses the apparatus of claim 40, Johnson further discloses the first fluidic substance comprises an anticoagulant (¶0033 anti-clotting agent).
Regarding claim 43, Johnson discloses the apparatus of claim 40. Johnson does not expressly disclose the first fluidic substance comprising an antioxidant, however, the claim limitation of “configured to contain a first fluidic substance” is considered functional language (only required the first fluid reservoir to be capable of containing a first fluidic substance) and as such the current claim limitations only require that the first fluid reservoir be capable of performing the function of containing a first fluidic substance comprising an antioxidant as the first fluidic substance is not in itself positively claimed. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Johnson discloses all the structure as claimed, and is further used to contain fluidic components within it. As such, it is capable of performing the functions as claimed (i.e. of containing a first fluidic substance comprising an antioxidant).
As such the limitations of claim 43 are anticipated by Johnson.
Regarding claim 44, Johnson discloses the apparatus of claim 40. Johnson further discloses the apparatus further comprises a second fluid reservoir (Fig. 2 drug chamber), wherein, the second fluid reservoir contains a second fluidic substance (¶0033 drug present as a solution), wherein the second fluidic substance comprises a medicament (drug).
Regarding claim 45, Johnson discloses the apparatus of claim 44. Johnson further discloses the medicament being a chemotherapy drug (¶0030 chemotherapeutic agent).
Regarding claim 58, Johnson discloses the apparatus of claim 42. Johnson does not expressly disclose the anticoagulant being selected from the group consisting of ACD-A, ACD-B, EDTA, and heparin. However, the claim limitation of “configured to contain a first fluidic substance” is considered functional language (only required the first fluid reservoir to be capable of containing a first fluidic substance) and as such the current claim limitations only require that the first fluid reservoir be capable of performing the function of containing a first fluidic substance comprising an anticoagulant selected from the group consisting of ACD-A, ACD-B, EDTA, and heparin and as the first fluidic substance comprising an anticoagulant selected from the group consisting of ACD-A, ACD-B, EDTA, and heparin is not in itself positively claimed. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Johnson discloses all the structure as claimed, and is further used to contain fluidic anticoagulant components within it. As such, it is capable of performing the functions as claimed (i.e. of containing a first fluidic substance comprising an anticoagulant selected from the group consisting of ACD-A, ACD-B, EDTA, and heparin).
Regarding claim 59, Johnson discloses the apparatus of claim 44. Johnson further discloses the patient access subassembly is fluidically coupled to the first fluid reservoir and the second fluid reservoir via the assembly (¶0010 arms one and two of the tubing connect to the blood collection chamber, and arm three connects to the patient, second fluid reservoir fluidically coupled to first and thus fluidically coupled to patient access subassembly through arm 3 as well).
Regarding claim 60, Johnson discloses the apparatus of claim 59. Johnson further discloses the patient access subassembly being configured to: receive cells from a patient (blood contains cells); and transfer the cells into the first fluid reservoir such that the cells and the first fluidic substance form a third fluidic substance (¶0033 appropriate amount of a blood stabilizing agent can be present in the blood collection chamber during the collection process, collection of blood into the chamber would result in incorporation of anti-clotting agent).
Regarding claim 61, Johnson discloses the apparatus of claim 60. Johnson further discloses the cells comprise a combination of packed red blood cells, white blood cells, or platelets (blood from a patients comprises a combination of these elements).
Regarding claim 78, Johnson discloses the apparatus of claim 45. Johnson further discloses the medicament comprises the chemotherapy drug, and the chemotherapy drug is selected from a topoisomerase II inhibitor (¶0030 amsacrine is a topoisomerase II inhibitor).
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.
Claim(s) 62-67 and 75-76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (U.S. Publication 2005/0148991) in view of Gobbi Frattini (U.S. Publication 2019/0298612) herein further referred to as Frattini.
Regarding claim 62, Johnson discloses the apparatus of claim 60. Johnson further discloses a further configuration wherein the first fluid reservoir is in fluidic communication with the second fluid reservoir, wherein the further configuration allows for a portion of the third fluidic substance to be transferred from the first fluid reservoir through the assembly and into the second fluid reservoir such that the portion of the third fluidic substance and the second fluidic substance can form a fourth fluidic substance (combination of third fluid substance of blood and anticoagulant with the drug of the second fluid substance present in second fluid reservoir forms fourth fluidic substance); and wherein the fourth fluidic substance can be transferred from the second fluid reservoir into the first fluid reservoir
Johnson does not expressly disclose the first fluid reservoir being fluidically isolated from the patient access subassembly or the fourth fluidic substance being transferred from the second fluid reservoir through the assembly and into the first fluid reservoir such that a remainder of the third fluidic substance and the fourth fluidic substance can form a fifth fluidic substance.
However, Frattini, in the same field of endeavor of preparing drug solutions for intravenous delivery to a patient, teaches an assembly configuration (Figs. 1-5) wherein a first fluidic reservoir 3 is fluidically isolated from patient supply (Fig. 1-5 cap 8 closed) comprising a fluidic substance 4 in the first fluidic reservoir and a second reservoir 9 comprising a second fluidic substance 10 wherein the first fluidic reservoir and the second reservoir are in fluidic communication (communicate through adjustment of 18) wherein the further configuration allows for a portion of the fluidic substance within the first fluidic reservoir to be transferred from the first fluid reservoir through an assembly (18, 22, 12,13, 42) and into the second fluid reservoir (Fig. 2 shows portion of 3 pulled into syringe 22 and then Fig. 3 shows transfer to second fluid reservoir 9) such that the portion of the fluid substance from the first assembly and the second fluidic substance can form an additional fluidic substance 24; and wherein the additional fluidic substance can be transferred from the second fluid reservoir through the assembly and into the first fluid reservoir such that a remainder of the fluidic substance within the first reservoir and the additional fluidic substance formed by the portion of the fluidic substance of the first reservoir transferred form a second additional fluidic substance 25 (Fig. 4 and Fig. 5 depict transfer of the mixture 24 back to first reservoir to form 25) for the purpose of creating a drug or nutrient with the desired dosing (¶0032 creating a drug or nutrient with the desired dosing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second reservoir and assembly of Johnson to have included the components of the assembly of Frattini in order to arrive at the further configuration taught by Frattini for the purpose of creating a drug or nutrient with the desired dosing (¶0032 creating a drug or nutrient with the desired dosing) before administration to the patient.
Regarding claim 63, Johnson in view of Frattini suggest the apparatus of claim 62. Johnson in view of Frattini do not expressly suggest the portion of the third fluidic substance having a first volume, the fourth fluidic substance having a second volume, wherein the second volume is at least about two times the size of the first volume.
However, Frattini, in the same field of endeavor of preparing drug solutions for intravenous delivery to a patient, further teaches the ability to reconstituted in any dose desired and suitable for the therapeutic treatment of the patient (¶0015). The volumes of the fluids that are transferred are directly correlated to the dose of the medication to be supplied to the patient and as such it would have been obvious to one of ordinary skill in the art to have had the second volume be at least about two times the size of the first volume in a situation where the reconstituted dose required such a dilution in order to be suitable for the therapeutic treatment of the patient.
Regarding claim 64, Johnson in view of Frattini suggest the apparatus of claim 62. Johnson in view of Frattini further suggest the first fluid reservoir being in fluidic communication with the patient access subassembly, wherein the fifth fluidic substance can be transferred from the first fluid reservoir through the assembly, through the patient access subassembly, and into the patient (admix transferred from patient through tubing connected to the first reservoir of Johnson and then through the tubing connected to patient and into patient).
Regarding claim 65, Johnson in view of Frattini suggest the apparatus of claim 62. Johnson in view of Frattini further suggest the further configuration is obtained by adjusting an orientation of one or more valves of the assembly (valve 18 of Frattini and stopcock of Johnson).
Regarding claim 66, Johnson in view of Frattini suggest the apparatus of claim 65. Johnson in view of Frattini further suggest the one or more valves of the assembly comprising a first valve (valve 18) and a second valve (stopcock of Johnson).
Johnson in view of Frattini do not expressly suggest a third valve, however, in a separate embodiment, Johnson, in the same field of endeavor of medicament delivery, discloses an assembly comprising first and second stopcocks (Fig. 1) as a variation to a single stopcock (Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the combined Y-connected assembly stopcock of Fig. 2 of Johnson that performs the function of controlling fluid flow from the patient for the two separate tubes with separate stopcocks of Fig. 1 of Johnson since these elements perform the same function of controlling fluid flow from the patient to the blood collection chamber and from the blood collection chamber to the patient. Simply substituting one flow control means for another would yield the predictable result of allowing a(n) device to control fluid flow. See MPEP 2143.
Regarding claim 67, Johnson in view of Frattini suggest the apparatus of claim 66. Johnson in view of Frattini do not expressly suggest the apparatus further comprising a third fluid reservoir that contains a fluidic substance.
However, Johnson, in the same field of endeavor of medicament delivery, teaches the ability to include additional fluid reservoirs (¶0034 additional chambers are contemplated in the device) for the purpose of allowing for preparation of a drug solution prior to the admixing of the drug with the blood (¶0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a third fluid reservoir for the purpose of allowing for preparation of a drug solution prior to the admixing of the drug with the blood (¶0034).
Regarding claim 75, Johnson in view of Frattini suggest the apparatus of claim 67. Johnson further suggests the apparatus being configured such that the third fluid reservoir is in fluidic communication with the patient access subassembly via the assembly, and at least a portion of the fluidic substance can be transferred from the assembly to the patient access subassembly (preparation of drug solution prior to admixing with addition fluid from reservoir would result in the fluid from reservoir being introduced into the drug solution and then into the blood during admixing and then fluidically transferred from the assembly to the patient access assembly during the administration of the admixed blood to the patient).
Regarding claim 76, Johnson in view of Frattini suggest the apparatus of claim 67. Johnson further discloses the first fluid reservoir being prefilled with the first fluidic substance (¶0033 blood stabilizing agent present in the blood collection chamber).
Claim(s) 72 and 73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (U.S. Publication 2005/0148991) in view of Gobbi Frattini (U.S. Publication 2019/0298612) herein further referred to as Frattini and Lamb (U.S. Publication 2013/0102975).
Regarding claims 72 and 73, Johnson in view of Frattini suggest the apparatus of claim 67. Johnson in view of Frattini do not expressly disclose or suggest the fluidic substance comprising a saline solution or the assembly being coupled to a tube of the third fluid reservoir via a filter.
However, Lamb, in the same field of endeavor of patient blood infusion, teaches providing a fluid reservoir 110 comprising saline (Fig 1. Saline bag) comprising a tube (tube of connection 120 connecting saline bag 110 coupled to an assembly via filter 130 for the purpose of priming the delivery system before providing blood, combining with the blood, and/or as an independent fluid administered to the patient (¶0005).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Johnson in view of Frattini to have included the fluid reservoir comprising saline for the purpose of priming the delivery system before providing blood, combining with the blood, and/or as an independent fluid administered to the patient (¶0005) which can have the benefits of eliminating any air in the pathway through the priming as well as maintaining a proper hydration of the patient through the provision of the saline. Furthermore, one would have been motivated to have included the blood filter for the purpose of filtering any unwanted components from the blood/saline before delivery to the patient.
Claim(s) 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (U.S. Publication 2005/0148991) in view of Gobbi Frattini (U.S. Publication 2019/0298612) herein further referred to as Frattini and Lamb (U.S. Publication 2013/0102975) and further in view of O’Hara (U.S. Publication 2005/0049539).
Regarding claim 74, Johnson in view of Frattini and Lamb suggest the apparatus of claim 73. Lamb does not expressly suggest the filter being configured to trap microbubbles and remove debris as Lamb does not expressly disclose what the filter is “filter” simply stating that it is a blood filter.
However, O’Hara in the same field of endeavor of filter blood fluids, discloses removing contaminates and other undesired materials from blood while at the same time facilitating the release of trapped gases from the treated blood ¶0138, wherein the filter media has a pore size of approximately 200 microns ¶0131.
It would have been obvious to have substituted the filter of Lamb that performs the function of filtering blood for the filter of O’Hara since these elements perform the same function of filtering a fluid to be transported back to a patient’s blood supply. Simply substituting one infusion fluid filtering means for another would yield the predictable result of allowing a(n) fluid infusion device to filter infused fluid before return to patient’s circulatory system. See MPEP 2143.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the filter of Lamb to have been configured to trap microbubbles and remove debris, as taught by O’Hara, in order to remove contaminants and other undesired materials from the treated blood while at the same time facilitating the release of trapped gases from the treated blood (¶0138 of O’Hara).
Claim(s) 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (U.S. Publication 2005/0148991) in view of Gobbi Frattini (U.S. Publication 2019/0298612) herein further referred to as Frattini and Wagner et al. (U.S. Publication 2008/0167621).
Regarding claim 77, Johnson in view of Frattini suggest the apparatus of claim 67. Johnson in view of Frattini do not expressly disclose at least one of the first fluid reservoir and the second fluid reservoir comprising a syringe.
However, Wagner, in the same field of endeavor of vascular drug delivery (¶0065 connected to vasculature of a patient), discloses two fluid reservoirs 62 and 66 that comprise syringes connected to one another for the purpose of being able to sequentially inject each of the individual components as well as to push remaining second medical fluid from the chamber of the second barrel into the chamber of the first barrel (¶0065 sequential injection of multiple fluids into a patient from the chambers…T-shaped valve may be selectively adjusted to the position of Fig. 6B, allowing fluid communication between the first conduit 74 and the second conduit 76, pushed from the chamber 666 of the second barrel into the chamber 62 of the first barrel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second fluid reservoir containing the drug suggested by Johnson in view of Frattini to have been a syringe as taught by Wagner, for the purpose of being able to push any residual material contained within the second chamber out of the second chamber (¶0065 of Wagner) during the further configuration addressed above in claim 62.
Allowable Subject Matter
Claims 68-71 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The suggested device of Johnson in view of Frattini are seen to disclose the apparatus of claim 67. Neither Johnson or Frattini suggest the fluid reservoir being in selective fluidic communication with the second reservoir via the first valve and the second valve wherein the patient access subassembly is in selective fluidic communication with the first fluid reservoir via the first valve, and the third valve is coupled to the third fluid reservoir such that the third fluid reservoir is in selective fluidic communication with the patient access subassembly via the first valve and the second valve.
Johnson in view of Frattini specifically do not disclose a valve, first or otherwise, that both acts to selectively place the first fluid reservoir both in fluidic communication with the patient access subassembly and in fluidic communication with the second fluid reservoir while also allowing for the configuration detailed in claim 62 from which claim 68 depends such that fluid isolation from the patient access subassembly is accomplished while allowing for a portion of the third fluidic substance to be transferred from the first fluid reservoir through the assembly and into the second fluid reservoir such that the portion of the third fluidic substance and the second fluidic substance can form a fourth fluidic substance and wherein the fourth fluidic substance can be transferred from the second fluid reservoir through the assembly and into the first fluid reservoir such that a remainder of the third fluidic substance and the fourth fluidic substance can form a fifth fluidic substance, and also allow for fluidic connection to the patient assembly of a first fluid reservoir that comprises fluid configurations of fluid communication with the patient access assembly via the fluid inlet and the fluid outlet of the patient access assembly.
As such claim 68 is seen to contain allowable subject matter that would be allowable if incorporated with the entirety of the limitations from which the claim depends upon in independent form.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hart et al. (U.S. Patent No. 6,520,937) discloses a fluid manifold comprising multiple valves for injection of a fluid to a patient.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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