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 group I in the reply filed on 7/15/2026 is acknowledged.
Claims 24-25 and 28 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/15/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/26/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The abstract of the disclosure is objected to because:
Line 5 recites “fluid”. Line 2 recites “fluid”. If the fluid in line 5 is the same as the fluid in line 2, Examiner suggests replacing “fluid” in line 5 with “the fluid” to put the abstract in clearer form. Alternatively, if the fluid in line 5 is intended to instead be the solution, Examiner suggests replacing “fluid” in line 5 with “the solution”.
Line 7 recites “fluid”. Line 2 recites “fluid”. If the fluid in line 7 is the same as the fluid in line 2, Examiner suggests replacing “fluid” in line 7 with “the fluid” to put the abstract in clearer form.
Line 8 recites “a solution of the therapeutic agent”. Line 1 introduces a solution of a therapeutic agent. If the solution in line 1 and line 8 are the same, Examiner suggests replacing “a solution of the therapeutic agent” in line 8 of the abstract with “the solution of the therapeutic agent” to put the abstract in clearer form.
Line 8 recites “the fluid”. Line 2, 5, and 7 all introduce a fluid. Examiner suggests amending line 5 and 7 as suggested above to put the abstract in clearer form as to which fluid “the fluid” in line 8 refers to as “fluid” has been introduced three separate times.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
This application claims priority to provisional application 63/443,961 filed 2/7/2023. The specification should be amended to include the priority information regarding the provisional application below the title on page 1 of the specification.
Appropriate correction is required.
Claim Objections
Claim 1 objected to because of the following informalities:
Line 6 recites “and”. The term “and” also occurs in line 8. Examiner suggests removing “and” in line 6 to put the claim in clearer grammatical form since “and” occurs in line 8 and an infusion device and polymeric matrix are listed after the therapeutic agent conduit.
Line 8 recites “of fluid”. Line 3 recites “for holding fluid”. If the fluid of line 8 is the same fluid as the fluid of line 3, Examiner suggests replacing “of fluid” in line 8 of claim 1 with “of the fluid” to put the claim in clearer form.
Line 10 recites “a therapeutic agent”. Line 1-2 also recites “a therapeutic agent”. If the therapeutic agent of line 10 is the same therapeutic agent as the fluid of line 1-2, Examiner suggests replacing “a therapeutic agent” in line 10 of claim 1 with “the therapeutic agent” to put the claim in clearer form.
Line 11 recites “by fluid”. Line 3 recites “for holding fluid” and line 8 recites “of fluid”. If the fluid of line 11 is the same fluid as the fluid of line 3 and 8, Examiner suggests replacing “by fluid” in line 11 of claim 1 with “by the fluid” AND replacing “of fluid” in line 8 of claim 1 with “of the fluid” to put the claim in clearer form.
Line 11 recites “a solution”. Line 1 recites “a solution”. If the solution of line 11 is the same fluid as the solution of line 1, Examiner suggests replacing “a solution” in line 11 of claim 1 with “the solution” to put the claim in clearer form.
Claim 5 objected to because of the following informalities:
Line 3 recites “the entire weight of the first layer”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the entire weight of the first layer” in line 3 of claim 5 with “an entire weight of the first layer”.
Claim 6 objected to because of the following informalities:
Line 3 recites “the entire weight of the second layer”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the entire weight of the second layer” in line 3 of claim 6 with “an entire weight of the second layer”.
Claim 11 objected to because of the following informalities:
Line 1 recites “the inlet”. Claim 11 is dependent on claim 10, 7, and 1. The inlet is of the housing as claimed in claim 10. Claim 1 also recites “a fluid inlet” of the therapeutic agent conduit. Examiner suggests replacing “the inlet” in line 1 of claim 11 with “the inlet of the housing” to make abundantly clear the inlet referred to is of the housing and not of the therapeutic agent conduit.
Line 2 recites “the outlet”. Claim 11 is dependent on claim 10, 7, and 1. The outlet is of the housing as claimed in claim 10. Claim 1 also recites “a fluid outlet” of the therapeutic agent conduit. Examiner suggests replacing “the outlet” in line 2 of claim 11 with “the outlet of the housing” to make abundantly clear the outlet referred to is of the housing and not of the therapeutic agent conduit.
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 1-13, 16, and 21-23 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.
In regard to claim 1,
Line 10 recites “therein”. It is unclear if “therein” refers to in the polymeric matrix or in the therapeutic agent conduit. For examination purposes Examiner construes “therein” to be in the polymeric matrix. Examiner suggests replacing “therein” in line 10 of claim 1 with “in the polymeric matrix”.
Line 10 and 11-12 recites “the therapeutic agent”. Line 1-2 and line 10 each introduce a therapeutic agent. It is unclear which therapeutic agent line 10 and 11-12 refer to. For examination purposes Examiner construes the therapeutic agent of line 1-2 and 10 to be the same. Examiner suggests replacing “a therapeutic agent” in line 10 of claim 1 with “the therapeutic agent”.
Examiner notes claims 2-13, 16, and 21-23 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 3,
Line 2-3 recites “the therapeutic agent conduit includes an outer conduit surface having a first layer comprising the polymeric matrix”. Claim 3 depends on claim 1. Claim 1 introduces the polymeric matrix as a separate structure from the therapeutic agent conduit. It is unclear if claim 3 is intending to claim the polymeric matrix as a structure of the therapeutic agent conduit. For examination purposes Examiner construes “the therapeutic agent conduit includes an outer conduit surface having a first layer comprising the polymeric matrix” to be “the polymeric matrix includes a first layer”. Examiner suggests replacing “the therapeutic agent conduit includes an outer conduit surface having a first layer comprising the polymeric matrix” in line 2-3 of claim 3 with “the polymeric matrix includes a first layer”.
Line 3-4 recites “an interior conduit surface and the first layer defining at least a portion of the fluid flow path”. Line 1-3 recites “the therapeutic agent conduit includes an outer conduit surface having a first layer comprising the polymeric matrix oriented towards the fluid flow path”. It is unclear if the outer conduit surface has a first layer as claimed, how the first layer would define at least a portion of the fluid flow path in addition to the interior conduit surface. Based on figure 2B of the instant disclosure, it appears only the inner conduit surface defines at least a portion of the fluid flow path. For examination purposes Examiner construes “an interior conduit surface and the first layer defining at least a portion of the fluid flow path” to be “the first layer defining at least a portion of the fluid flow path”. Examiner suggests replacing “an interior conduit surface and the first layer defining at least a portion of the fluid flow path” in line 3-4 of claim 3 with “the first layer defining at least a portion of the fluid flow path”.
Examiner notes claims 4-6 are similarly rejected by virtue of their dependency on claim 3.
In regard to claim 4,
Line 1-2 recites “the outer conduit surface includes a second layer comprising the polymeric matrix coupled to the first layer”. Claim 4 depends on claim 1. Claim 1 introduces the polymeric matrix as a separate structure from the therapeutic agent conduit. It is unclear if claim 4 is intending to claim the polymeric matrix as a structure of the therapeutic agent conduit. For examination purposes Examiner construes “the outer conduit surface includes a second layer comprising the polymeric matrix coupled to the first layer” to be “the polymeric matrix includes a second layer coupled to the first layer”. Examiner suggests replacing “the outer conduit surface includes a second layer comprising the polymeric matrix coupled to the first layer” in line 1-2 of claim 4 with “the polymeric matrix includes a second layer coupled to the first layer”,
Line 2-3 recites “the second layer being disposed radially outward of the first layer”. Line 1-2 of claim 4 also recites “wherein the outer conduit surface includes a second layer comprising the polymeric matrix coupled to the first layer”. It is unclear if the outer conduit surface includes a first layer as claimed, how the outer conduit surface would also include a second layer disposed radially outward of the first layer. It appears if the second layer is radially outward of the first layer, then the outer conduit surface would be formed by the outer surface of the second layer since the first layer would be internal of the second layer and not form an outer surface. For examination purposes Examiner construes both the first layer and second layer to form an outer conduit surface even though the first layer is internal to the second layer. Examiner suggests clarifying what is meant in claim 4 and claim 3.
Line 3-4 and line 4-5 recite “the therapeutic agent”. Claim 4 is dependent on claim 3 and claim 1. Claim 1, line 1-2 and line 10 each introduce a therapeutic agent. It is unclear which therapeutic agent claim 4 refers to. For examination purposes Examiner construes the therapeutic agent of line 1-2 and 10 of claim 1 to be the same. Examiner suggests amending claim 1 as suggested above.
Examiner notes claim 6 is similarly rejected by virtue of its dependency on claim 4.
In regard to claim 5,
Line 2 recites “the therapeutic agent”. Claim 5 is dependent on claim 3 and claim 1. Claim 1, line 1-2 and line 10 each introduce a therapeutic agent. It is unclear which therapeutic agent claim 5 refers to. For examination purposes Examiner construes the therapeutic agent of line 1-2 and 10 of claim 1 to be the same. Examiner suggests amending claim 1 as suggested above.
In regard to claim 6,
Line 2 recites “the therapeutic agent”. Claim 6 is dependent on claim 4, claim 3, and claim 1. Claim 1, line 1-2 and line 10 each introduce a therapeutic agent. It is unclear which therapeutic agent claim 6 refers to. For examination purposes Examiner construes the therapeutic agent of line 1-2 and 10 of claim 1 to be the same. Examiner suggests amending claim 1 as suggested above.
In regard to claim 10,
Line 2 recites “the housing further comprises an inlet and an outlet”. Claim 10 depends on claim 7 and claim 1. Claim 7 recites the therapeutic agent conduit further comprises a housing and claim 1 recites a therapeutic agent conduit having a fluid inlet and fluid outlet. It is unclear if the inlet and outlet of the housing are additional structure to the fluid inlet and the fluid outlet. Based on the disclosure and figure 3, the fluid inlet and fluid outlet appear to be the same as the inlet and outlet of the housing. For examination purposes Examiner construes the fluid inlet to be the same as the inlet of the housing and the fluid outlet to be the same as the outlet of the housing. Examiner suggests specifying that the inlet of the housing is the fluid inlet and the outlet of the housing is the fluid outlet.
In regard to claim 11,
Line 2 recites “the fluid”. Claim 11 depends on claim 10, 7, and 1. Claim 1 introduces a fluid in line 3, line 8, and line 11. It is unclear which fluid the fluid of claim 11 refers to. For examination purposes Examiner construes the fluid of line 3, 8, and 11 of claim 1 to be the same. Examiner suggests replacing “of fluid” in line 8 of claim 1 with “of the fluid” AND replacing “by fluid” in line 11 of claim 1 with “by the fluid”.
Line 3 recites “the solution”. Claim 11 depends on claim 10, 7, and 1. Line 1 of claim 1 and line 11 of claim 1 both introduce a solution. It is unclear which solution “the solution” refers to. For examination purposes Examiner construes the solution in line 1 and line 11 of claim 1 to be the same. Examiner suggests replacing “a solution” in line 11 of claim 1 with “the solution”.
Line 4 recites “particulate polymeric matrix”. Claim 11 depends on claim 10, 7, and 1. It is unclear if particulate polymeric matrix in claim 11 refers to an additional polymeric matrix to the polymeric matrix of claim 1 and 7 or if the particulate polymeric matrix is the same as the polymeric matrix of claim 1 and 7. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “particulate polymeric matrix” in line 4 of claim 11 with “particulates of the polymeric matrix”.
In regard to claim 21,
Line 2 recites “a plurality of therapeutic agent conduits”. Claim 21 depends on claim 1. Claim 1 introduces a therapeutic agent conduit. It is unclear if the plurality of therapeutic agent conduits are in addition to the therapeutic agent conduit of claim 1 or if the therapeutic agent conduit of claim 1 is included in the plurality of therapeutic agent conduits. For examination purposes Examiner construes the therapeutic agent conduit of claim 1 to be one of the plurality of therapeutic agent conduits. Examiner suggests replacing “a plurality of therapeutic agent conduits” in line 2 of claim 21 with “a plurality of therapeutic agent conduits including the therapeutic agent conduit”.
Examiner notes claims 22-23 are similarly rejected by virtue of their dependency on claim 21.
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.
Claims 1, 3, 7-10, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nyhart (U.S. PG publication 20020065493).
In regard to claim 1,
Nyhart discloses a device (see all of figure 2) for parenteral administration of a solution of a therapeutic agent (Examiner notes “for parenteral administration of a solution of a therapeutic agent” is a functional limitation. The device is fully capable of the recited function due to its structure and as supported by paragraph [0045] and [0085]), the device comprising:
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a fluid reservoir (figure 2, item 25) comprising a chamber (see figure 2) for holding fluid (figure 2, item 24) and an outlet port (see outlet port which item 20 is connected to);
a therapeutic agent conduit (see figure 2 above; paragraph [0047]-[0048]; see also figure 3 wherein a therapeutic agent 65 is within the conduit; Examiner notes matrix 55 in figure 3 located within the conduit is construed as being a separate structure from the conduit) having a fluid inlet (inlet connected to item 25) and a fluid outlet (outlet opposite the inlet) that define a fluid flow path (see figure 2 above), the fluid inlet being fluidly coupled to the outlet port of the fluid reservoir (see figure 2 above); and,
an infusion device fluidly (see figure 2 above; paragraph [0048]: separate catheter) connected to the fluid outlet of the therapeutic agent conduit (see figure 2 above; paragraph [0048]), the infusion device being capable of parenteral administration of fluid (see figure 2 above; Examiner notes “being capable of parenteral administration of fluid” is a functional limitation. As supported by paragraph [0045] and [0047], the infusion device is capable of parenteral administration of fluid), and
a polymeric matrix (figure 3, item 55 in which item 65 is held; paragraph [0047] and [0051]) disposed in the therapeutic agent conduit (see figure 3; paragraph [0047]), the polymeric matrix having a therapeutic agent (figure 3, item 65; paragraph [0042]-[0043]) dispersed therein (paragraph [0047]), the therapeutic agent being at least partially dissolvable when contacted by fluid (paragraph [0037], [0042], [0047], [0051], and [0054]; Examiner notes when the therapeutic agent has been released, it is at least partially dissolvable when contacted by fluid), thereby forming a solution of the therapeutic agent for parenteral administration through the infusion device (paragraph [0047] and [0054]).
In regard to claim 3,
Nyhart discloses the device of claim 1, wherein the therapeutic agent conduit includes an outer conduit surface having a first layer comprising the polymeric matrix (see 112 rejection above for claim interpretation; see figure 3) oriented towards the fluid flow path (see figure 3), an interior conduit surface and the first layer defining at least a portion of the fluid flow path (see 112 rejection above for claim interpretation; see figure 3).
In regard to claim 7,
Nyhart discloses the device of claim 1, wherein the therapeutic agent conduit further comprises a housing (see housing formed by item 70 and 75 in figure 3) enclosing the polymeric matrix within the fluid flow path (see figure 3).
In regard to claim 8,
Nyhart discloses the device of claim 7, wherein the polymeric matrix comprises discrete units of polymeric material (see figure 3).
In regard to claim 9,
Nyhart discloses the device of claim 8, wherein the discrete units of polymeric matrix comprise one of pellets, fibers, and sheets of polymeric material (see figure 3; sheets of polymeric material).
In regard to claim 10,
Nyhart discloses the device of claim 7, wherein the housing further comprises an inlet and an outlet (see 112 rejection above for claim interpretation; see figure 3 and 2 wherein the housing includes an inlet and an outlet which enables fluid to pass through), which are arranged along the fluid flow path (see figure 3 and 2).
In regard to claim 16,
Nyhart discloses the device of claim 1, further comprising a piggyback junction disposed along the therapeutic agent conduit (see figure 2).
Claims 1-2 and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Theeuwes (U.S. Patent no 4439183).
In regard to claim 1,
Theeuwes discloses a device (see all of figure 3 and figure 4; wherein formulation chamber 73 can be used in parenteral delivery system shown in figure 3 as disclosed in column 6, line 60-63) for parenteral administration of a solution of a therapeutic agent (Examiner notes “for parenteral administration of a solution of a therapeutic agent” is a functional limitation. The device is fully capable of the recited function due to its structure and as supported by column 1, line 17-22), the device comprising:
a fluid reservoir (figure 3, item 50) comprising a chamber for holding fluid (see figure 3) and an outlet port (see figure 3);
a therapeutic agent conduit (figure 4, item 73) having a fluid inlet and a fluid outlet (see figure 4) that define a fluid flow path (see figure 4), the fluid inlet being fluidly coupled to the outlet port of the fluid reservoir (see figure 3 wherein item 73 when used in the system of figure 3 would be coupled to the outlet port of the fluid reservoir to receive a fluid); and,
an infusion device (figure 3, item 70) fluidly connected to the fluid outlet of the therapeutic agent conduit (see figure 3), the infusion device being capable of parenteral administration of fluid (Examiner notes “being capable of parenteral administration of fluid” is a functional limitation. As supported by figure 3 and column 1, line 17-22, the infusion device is capable of parenteral administration of fluid), and
a polymeric matrix (figure 4, item 81; column 7, line 53-column 8, line 14) disposed in the therapeutic agent conduit (see figure 4), the polymeric matrix having a therapeutic agent (figure 4, item 80) dispersed therein (see figure 4), the therapeutic agent being at least partially dissolvable when contacted by fluid, thereby forming a solution of the therapeutic agent for parenteral administration through the infusion device (column 6, line 33-42 and column 7, line 53-column 8, line 14, and column 1, line 17-22).
In regard to claim 2,
Theeuwes discloses the device of claim 1, wherein the polymeric matrix comprises one or more water-insoluble polymers chosen from poly(ethyl-vinyl acetate) (EVA), ultra low density polyethylene (ULDPE), linear low density polyethylene (LLDPE), high density polyethylene (HDPE), ethylene methyl acrylate (EMA), ethylene acrylic acid (EAA), ethylene ethyl acrylate (EEA), polypropylene, propylene copolymers, styrenic block copolymers, olefin block copolymers, polyurethanes, and insoluble polysaccharides (column 7, line 53-65).
In regard to claim 7,
Theeuwes discloses the device of claim 1, wherein the therapeutic agent conduit further comprises a housing (see caps 74 and 75 and body 72 of figure 4 which forms a housing) enclosing the polymeric matrix within the fluid flow path (see figure 4).
In regard to claim 8,
Theeuwes discloses the device of claim 7, wherein the polymeric matrix comprises discrete units of polymeric material (see figure 4).
In regard to claim 9,
Theeuwes discloses the device of claim 8, wherein the discrete units of polymeric matrix comprise one of pellets, fibers, and sheets of polymeric material (see figure 4).
In regard to claim 10,
Theeuwes discloses the device of claim 7, wherein the housing further comprises an inlet and an outlet (see 112 rejection above for claim interpretation; see figure 4 wherein a distal portion and a proximal portion of the body 72 which are connected to caps 74 and 75 form an inlet and outlet), which are arranged along the fluid flow path (see figure 4).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Nyhart (U.S. PG publication 20020065493) further in view of Fischer (U.S. PG publication 20070161968).
In regard to claim 2,
Nyhart discloses the device of claim 1.
Nyhart is silent as to wherein the polymeric matrix comprises one or more water-insoluble polymers chosen from poly(ethyl-vinyl acetate) (EVA), ultra low density polyethylene (ULDPE), linear low density polyethylene (LLDPE), high density polyethylene (HDPE), ethylene methyl acrylate (EMA), ethylene acrylic acid (EAA), ethylene ethyl acrylate (EEA), polypropylene, propylene copolymers, styrenic block copolymers, olefin block copolymers, polyurethanes, and insoluble polysaccharides.
Fischer teaches wherein the polymeric matrix (figure 1, item 11; paragraph [0036] and [0040]), comprises one or more water-insoluble polymers chosen from poly(ethyl-vinyl acetate) (EVA), ultra low density polyethylene (ULDPE), linear low density polyethylene (LLDPE), high density polyethylene (HDPE), ethylene methyl acrylate (EMA), ethylene acrylic acid (EAA), ethylene ethyl acrylate (EEA), polypropylene, propylene copolymers, styrenic block copolymers, olefin block copolymers, polyurethanes, and insoluble polysaccharides (paragraph [0036]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Nyhart to substitute one or more water-insoluble polymers chosen from poly(ethyl-vinyl acetate) (EVA), ultra low density polyethylene (ULDPE), linear low density polyethylene (LLDPE), high density polyethylene (HDPE), ethylene methyl acrylate (EMA), ethylene acrylic acid (EAA), ethylene ethyl acrylate (EEA), polypropylene, propylene copolymers, styrenic block copolymers, olefin block copolymers, polyurethanes, and insoluble polysaccharides of Fischer in place of the polymeric matrix of Nyhart, as taught by Fischer, because the substitution is a simple substitution that would yield the same predictable result of providing a matrix for a therapeutic agent (paragraph [0051] of Nyhart and paragraph [0040] of Fischer). Furthermore Nyhart discloses modifications can be made (paragraph [0097] of Nyhart).
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Nyhart (U.S. PG publication 20020065493) further in view of Fischer (U.S. Patent no 6599275). For clarity purposes Fischer (U.S. Patent no 6599275) will be referred to as Fischer275.
In regard to claim 4,
Nyhart discloses the device of claim 3.
Nyhart is silent as to wherein the outer conduit surface includes a second layer comprising the polymeric matrix coupled to the first layer, the second layer being disposed radially outward of the first layer, the first layer comprising the therapeutic agent at a first concentration and the second layer comprising the therapeutic agent at a second concentration.
Fischer275 teaches wherein the outer conduit surface includes a second layer comprising the polymeric matrix coupled to the first layer (see 112 rejection above for claim interpretation; see figure 4 wherein the inner most layer is construed as the first layer and a layer outside the inner most layer is construed as the second layer), the second layer being disposed radially outward of the first layer (see figure 4), the first layer comprising the therapeutic agent at a first concentration and the second layer comprising the therapeutic agent at a second concentration (see figure 4; column 8, line 44-67).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Nyhart to include wherein the outer conduit surface includes a second layer comprising the polymeric matrix coupled to the first layer, the second layer being disposed radially outward of the first layer, the first layer comprising the therapeutic agent at a first concentration and the second layer comprising the therapeutic agent at a second concentration, as taught by Fischer275, for the purpose of controlling the delivery rate of one or more therapeutic agents (column 3, line 58-63 and column 8, line 44-67).
In regard to claim 6,
Nyhart in view of Fischer275 teaches the device of claim 4.
Nyhart in view of Fischer275 is silent as to wherein a content of the therapeutic agent in the second layer is in the range of about 5% to about 70%, based on the entire weight of the second layer.
It would have been an obvious matter of design choice to modify Nyhart in view of Fischer275 to include wherein a content of the therapeutic agent in the second layer is in the range of about 5% to about 70%, based on the entire weight of the second layer since applicant has not disclosed that having wherein a content of the therapeutic agent in the second layer is in the range of about 5% to about 70%, based on the entire weight of the second layer solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein a content of the therapeutic agent in the second layer is in the range of about 5% to about 70%, based on the entire weight of the second layer, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Claims 5, 12, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Nyhart (U.S. PG publication 20020065493).
In regard to claim 5,
Nyhart discloses the device of claim 3.
Nyhart is silent as to wherein a content of the therapeutic agent in the first layer is in the range of about 5% to about 70%, based on the entire weight of the first layer.
It would have been an obvious matter of design choice to modify Nyhart to include wherein a content of the therapeutic agent in the first layer is in the range of about 5% to about 70%, based on the entire weight of the first layer since applicant has not disclosed that having wherein a content of the therapeutic agent in the first layer is in the range of about 5% to about 70%, based on the entire weight of the first layer solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein a content of the therapeutic agent in the first layer is in the range of about 5% to about 70%, based on the entire weight of the first layer, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 12,
Nyhart discloses the device of claim 7.
Nyhart is silent as to wherein the polymeric matrix has a porosity of greater than 5%.
It would have been an obvious matter of design choice to modify Nyhart to include wherein the polymeric matrix has a porosity of greater than 5% since applicant has not disclosed that having wherein the polymeric matrix has a porosity of greater than 5% solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the polymeric matrix has a porosity of greater than 5%, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). As supported in the instant disclosure several materials can be equivalently used as the polymeric matrix (see paragraph [0042] of the instant disclosure).
In regard to claim 21,
Nyhart discloses the device of claim 1.
The first embodiment of Nyhart is silent as to further comprising a plurality of therapeutic agent conduits.
A second embodiment of Nyhart teaches further comprising a plurality of therapeutic agent conduits (figure 10, item 20a and 20b; paragraph [0064]; It is noted that the plurality of therapeutic agent conduits are not required by the claim to have all of the structures required by the therapeutic agent conduit in claim 1).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Nyhart to include a plurality of therapeutic agent conduits, as taught by the second embodiment of Nyhart, for the purpose of conditioning fluid withdrawn and delivered to a body (paragraph [0064]-[0065] of Nyhart).
In regard to claim 22,
The first embodiment of Nyhart in view of the second embodiment of Nyhart teaches the device of claim 21, wherein at least two of the therapeutic agent conduits in the plurality of therapeutic agent conduits are fluidly connected in series (see figure 10).
In regard to claim 23,
The first embodiment of Nyhart in view of the second embodiment of Nyhart teaches the device of claim 22.
The first embodiment of Nyhart in view of the second embodiment of Nyhart is silent as to wherein at least two of the therapeutic agent conduits in the plurality of therapeutic agent conduits are fluidly connected in parallel.
It would have been an obvious matter of design choice to modify the first embodiment of Nyhart in view of the second embodiment of Nyhart to include wherein at least two of the therapeutic agent conduits in the plurality of therapeutic agent conduits are fluidly connected in parallel since applicant has not disclosed that having wherein at least two of the therapeutic agent conduits in the plurality of therapeutic agent conduits are fluidly connected in parallel solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein at least two of the therapeutic agent conduits in the plurality of therapeutic agent conduits are fluidly connected in parallel, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Nyhart (U.S. PG publication 20020065493) further in view of Wolfe (U.S. Patent no 4474574).
In regard to claim 13,
Nyhart discloses the device of claim 1.
Nyhart fails to disclose further comprising a roller clamp disposed on the therapeutic agent conduit.
Wolfe teaches a roller clamp (figure 9, item 60) disposed on the therapeutic agent conduit (see figure 9).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Nyhart to include further comprising a roller clamp disposed on the therapeutic agent conduit, as taught by Wolfe, for the purpose of regulating or stopping flow if desired (column 7, line 24-27 of Wolfe).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Nyhart (U.S. PG publication 20020065493) further in view of Urquhart (U.S. Patent no 4479793).
In regard to claim 23,
The first embodiment of Nyhart in view of the second embodiment of Nyhart teaches the device of claim 22.
The first embodiment of Nyhart in view of the second embodiment of Nyhart is silent as to wherein at least two of the therapeutic agent conduits in the plurality of therapeutic agent conduits are fluidly connected in parallel.
Urquhart teaches wherein at least two of the therapeutic agent conduits (figure 1, item 16 and 19; As noted above, the therapeutic agent conduits are not required to have the same components as the therapeutic agent conduit in claim 1 and are not required to have a polymeric matrix disposed within) in the plurality of therapeutic agent conduits are fluidly connected in parallel (see figure 1).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Nyhart in view of the second embodiment of Nyhart to include wherein at least two of the therapeutic agent conduits in the plurality of therapeutic agent conduits are fluidly connected in parallel, as taught by Urquhart, for the purpose of enabling different fluids to be separately delivered in a single system (column 6, line 21-44 of Urquhart).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Theeuwes (U.S. Patent no 4439183) further in view of Bogentoft (EP0059694 A1).
In regard to claim 11,
Theeuwes discloses the device of claim 10.
The first embodiment of Theeuwes fails to disclose wherein the inlet comprises an inlet membrane permeable to the fluid and the outlet comprises an outlet membrane permeable to the solution, at least one of the inlet membrane and the outlet membrane being impermeable to particulate polymeric matrix or other suspended solids.
A second embodiment of Theeuwes teaches the outlet (distal portion of wall 114 which contains item 120 and is connected to a cap as shown in figure 8) comprises an outlet membrane (figure 8, item 120) permeable to the solution (column 10, line 3-8), at least one of the inlet membrane and the outlet membrane being impermeable to particulate polymeric matrix or other suspended solids (column 10, line 3-8).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Theeuwes to include the outlet comprises an outlet membrane permeable to the solution, at least one of the inlet membrane and the outlet membrane being impermeable to particulate polymeric matrix or other suspended solids, as taught by the second embodiment of Theeuwes, for the purpose of removing bacterial and unwanted matter from flowing solution, thereby aiding in maintaining a sterile solution (column 10, line 3-8 of Theeuwes).
The first embodiment of Theeuwes in view of the second embodiment of Theeuwes fails to disclose wherein the inlet comprises an inlet membrane permeable to the fluid.
Bogentoft teaches wherein the inlet (proximal portion of item 14 which contains item 18 which receives fluid into item 14) comprises an inlet membrane (figure 3, item 18) permeable to the fluid (page 8, line 22-25 and page 3, line 3-9).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Theeuwes in view of the second embodiment of Theeuwes to include wherein the inlet comprises an inlet membrane permeable to the fluid, as taught by Bogentoft, for the purpose of blocking particles from leaving (page 8, line 22-25 of Bogentoft).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Theeuwes (U.S. Patent no 4439183).
In regard to claim 12,
Theeuwes discloses the device of claim 7.
Theeuwes is silent as to wherein the polymeric matrix has a porosity of greater than 5%.
It would have been an obvious matter of design choice to modify Theeuwes to include wherein the polymeric matrix has a porosity of greater than 5% since applicant has not disclosed that having wherein the polymeric matrix has a porosity of greater than 5% solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the polymeric matrix has a porosity of greater than 5%, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). As supported in the instant disclosure several materials can be equivalently used as the polymeric matrix (see paragraph [0042] of the instant disclosure).
Conclusion
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
