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 Objections
Claims 37-38 are objected to because of the following informalities:
Claim 37, line 2: “a first inside sublayer” should read “a first inside sub-layer”;
Claim 37, line 2: “plurality of first sub-layers” should read “the plurality of first sub-layers”;
Claim 38, line 1: “the inside first inside sub-layer” should read “the first inside sub-layer”. 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.
Claim 48-49 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 48 recites the limitation "the rigid conduit and the tube conduit" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the rigid conduit” is interpreted to be “the rigid element” that is recited in claim 48 and “the tube conduit” is interpreted to be “the conduit” that is recited in claim 48.
Claim 49 recites the limitation “further including a collection bag coupled to the second end” in lines 1-2. It is unclear how “a rigid element having a first end and a second end, the first end coupled to the conduit, wherein the rigid element defines a urinary catheter for insertion into a urinary tract of a patient to allow drainage of urine through the rigid conduit and the tube conduit” (see claim 48) would have the second end available to be connected to a collection bag, since it is understood to one of ordinary skill in the art that a catheter has an opening at the other end, opposing the conduit to deliver or receive fluid/substance. The specification of the instant application is silent to the discussion of the second end of a rigid element, a catheter, that would be attached to a collection bag. For the purposes of examination, “the second end” is interpreted to be the second end of the tube, as shown in Figure 13 of the instant application and discloses in the Specification, page 12, lines 11-23.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 29-30, 34-36, 43, 48-50, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Fifield (Patent No. US 4,029,099 A) in view of Iselau et al. (Publication No. US 2021/0330937 A1) and Noone et al. (Patent No. EP 0664864 B1).
Regarding claim 1, Fifield teaches a conduit (collapsible section 13; Figure 1 and 3; Column 2, lines 35-56) having a length defined along a longitudinal axis and a width defined along a transverse direction relative to the longitudinal axis (section 13 has a length along a longitudinal axis and a width in the transverse direction relative to the longitudinal axis; Figure 1 and 3), the conduit comprising:
a conduit wall to define a tubular body having an inner lumen and an exterior surface (tube wall of section 13 forms a tubular body having an inner lumen and exterior surface; Column 2, lines 35-56; Figure 1 and 3), the conduit wall defining a plurality of ridges along the length of the conduit that project outwardly in the transverse direction (edges 15 along the length of the section 13 and defined by the conduit wall, projects outwardly in the transverse direction; Figure 3; Column 2, lines 35-56) and a plurality of grooves along the length of the conduit between adjacent ridges of the plurality of ridges that project inwardly in the transverse direction (inwardly bowed portions 14 along the length of section 13 between edges 15 and projects inwardly in the transverse direction; Figure 3; Column 2, lines 35-56). Fifield does not teach the conduit wall including a first portion secured to a second portion, wherein the conduit wall includes a multi-layer film material including a first layer, a second layer, and a third layer, the second layer positioned between the first and third layers.
However, Iselau teaches the conduit wall including a first portion secured to a second portion (layer 274/275 and layer 273/276 is a first portion and a second portion; Figure 11d; Paragraph 0133), wherein the conduit wall includes a multi-layer film material including a first layer (film 276; Figure 11d; Paragraph 0133), a second layer (layers 273/274; Paragraph 0133; Figure 11d), and a third layer (film 275; Figure 11d; Paragraph 0133), the second layer positioned between the first and third layers (layers 273/274 are between film 276 and film 275; Figure 11d; Paragraph 0133).
Fifield and Iselau are considered to be analogous to the claimed invention because they are in the same field of urinary drainage systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fifield to incorporate the teachings of Iselau to have the conduit wall of Fifield to be made of the first, second, and third layers and having a first and second portion of Iselau. This allows for the multi-layered tube to have different material properties at the different layers of the tube (Iselau; Paragraph 0157 and 0160).
The combination of Fifield in view of Iselau does not teach the conduit wall including the first portion secured to the second portion along a longitudinal seal.
However, Noone teaches the conduit wall including the first portion secured to the second portion along a longitudinal seal (multilayer tube with multiple laminated layers is formed by co-extrusion, a longitudinal heat seal, and molded to provide corrugation; Paragraph 0013).
Fifield in view of Iselau and Noone are considered to be analogous to the claimed invention because they are in the same field of corrugated conduits. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fifield in view of Iselau to incorporate the teachings of Noone to have the first portion and second portion of the multilayer conduits of Fifield in view of Iselau to be coextruded together to form a longitudinal heat seal and to be molded, as taught by Noone, to have the corrugated shaped conduit of Fifield in view of Iselau. This allows for the layers of the conduit to be secured together for the formation of the corrugations (Noone; Paragraph 0013).
Regarding claim 30, Fifield in view of Iselau and Noone teaches the conduit of claim 29. The combination of Fifield in view of Iselau and Noone further teaches wherein the first layer is an innermost layer defining the inner lumen of the tubular body (Iselau; film 276 is the innermost layer defining the inner lumen of the tubular body; Figure 11d; Paragraph 0133) and the third layer is an outermost layer defining the exterior surface of the tubular body (Iselau; film 275 is the outermost layer defining the exterior surface of the tubular body; Figure 11d; Paragraph 0133).
Regarding claim 34, Fifield in view of Iselau and Noone teaches the conduit of claim 29. The combination of Fifield in view of Iselau and Noone further teaches wherein the plurality of ridges and the plurality of grooves define a sequence of alternating ridges and grooves extending along the length (Fifield; ridges 15 and grooves 14 are alternating along the length of section 13; Figure 3; Column 2, lines 35-56).
Regarding claim 35, Fifield in view of Iselau and Noone teaches the conduit of claim 29. The combination of Fifield in view of Iselau and Noone further teaches wherein the first portion and the second portion are joined together by a plurality of longitudinal seals each angularly offset from one another about a circumference of the conduit (first portion or layer 274/275 and second portion or layer 273/276 of Iselau are joined together by a plurality of longitudinal seals that is formed during the coextrusion and molding of the corrugated multi-layer conduit, as taught by Noone, with the longitudinal seals are angularly offset about a circumference of the conduit due to the corrugated molding of Noone; see rejection of claim 29 above; Noone; Paragraph 0013; Iselau; Figure 11d; Paragraph 0133).
Regarding claim 36, Fifield in view of Iselau and Noone teaches the conduit of claim 29. The combination of Fifield in view of Iselau and Noone further teaches wherein the longitudinal seal is a thermal seal (Noone; longitudinal seal is a thermal seal from the coextrusion between the layers; Paragraph 0013), and the first portion is thermally bonded to the second portion (first portion or layer 274/275 and second portion or layer 273/276 of Iselau are joined together by thermal bonding through coextrusion, as taught by Noone; see rejection of claim 29 above; Noone; Paragraph 0013; Iselau; Figure 11d; Paragraph 0133).
Regarding claim 43, Fifield in view of Iselau and Noone teaches the conduit of claim 29. The combination of Fifield in view of Iselau and Noone further teaches a system comprising the conduit of claim 29 (Fifield; Figure 1; Column 2, lines 10-20; see rejection of claim 29 above) and a rigid connector coupled to a first end of the conduit (Fifield; sleeve 31 with annular ring 32 is the connector that connects to the first end of the section 13; Figure 7; Column 3, line 47 to Column 4, line 4), the rigid connector forming a lumen from an inlet end of the rigid connector to an outlet end of the rigid connector (Fifield; sleeve 31 with annular ring 32 has a lumen from an inlet end to the outlet end; Figure 7; Column 3, line 47 to Column 4, line 4).
Regarding claim 48, Fifield in view of Iselau and Noone teaches the conduit of claim 29. The combination of Fifield in view of Iselau and Noone further teaches a urinary collection system comprising: the conduit of claim 29 (Fifield; Figure 1; Column 2, lines 10-20; see rejection of claim 29 above); and a rigid element having a first end and a second end (Fifield; catheter 10 with first portion of tube 12 has a first end and a second end; Figure 1; Column 2, lines 10-20), the first end coupled to the conduit (Fifield; first end of catheter 10 at first portion of tube 12 is connected to section 13; Figure 1; Column 2, lines 10-20 and Column 2, lines 35-56), wherein the rigid element defines a urinary catheter for insertion into a urinary tract of a patient to allow drainage of urine through the rigid conduit and the tube conduit (Fifield; catheter 10 is inserted into the urinary tract to drain urine through catheter 10, first portion of tube 12, and section 13; Figure 1; Column 2, lines 10-20 and Column 2, lines 35-56).
Regarding claim 49, Fifield in view of Iselau and Noone teaches the conduit of claim 48. The combination of Fifield in view of Iselau and Noone further teaches further including a collection bag coupled to the second end (Fifield; container 11 is a plastic bag that is connected to second end of section 13; Figure 1; Column 2, lines 21-34).
Regarding claim 50, Fifield teaches a method of making a conduit (collapsible section 13; Figure 1 and 3; Column 2, lines 35-56; Abstract) having a length defined along a longitudinal axis (section 13 has a length along a longitudinal axis and a width in the transverse direction relative to the longitudinal axis; Figure 1 and 3), a lumen extending along the length, and a width defined along a transverse direction relative to the longitudinal axis (section 13 has a lumen comprising a length along a longitudinal axis and a width in the transverse direction relative to the longitudinal axis; Figure 1 and 3). Fifield does not teach the method comprising:
an outer surface of a multi-layer film, the conduit having a first portion and a second portion, the multi-layer film material including a first layer, a second layer, and a third layer, the second layer positioned between the first and third layers.
However, Iselau teaches the method comprising: an outer surface (film 275 is the outer surface; Figure 11d; Paragraph 0133) of a multi-layer film (layers 274/275/276/273; Figure 11d; Paragraph 0133), the conduit having a first portion and a second portion (layer 274/275 and layer 273/276 is a first portion and a second portion; Figure 11d; Paragraph 0133), the multi-layer film material including a first layer (film 276; Figure 11d; Paragraph 0133), a second layer (layers 273/274; Paragraph 0133; Figure 11d), and a third layer (film 275; Figure 11d; Paragraph 0133), the second layer positioned between the first and third layers (layers 273/274 are between film 276 and film 275; Figure 11d; Paragraph 0133).
Fifield and Iselau are considered to be analogous to the claimed invention because they are in the same field of urinary drainage systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fifield to incorporate the teachings of Iselau to have the conduit wall of Fifield to be made of the first, second, and third layers and having a first and second portion of Iselau. This allows for the multi-layered tube to have different material properties at the different layers of the tube (Iselau; Paragraph 0157 and 0160).
The combination of Fifield in view of Iselau does not teach heating the outer surface of the multi-layer film,
longitudinally sealing the first and second portions together to define a conduit wall of the conduit; and
blow moulding at least a portion of the conduit wall to form a sequence of ridges extending outwardly in the transverse direction and a sequence of grooves extending inwardly in the transverse direction, such that a sequence of ridges and grooves are defined along the length of the conduit.
However, Noone teaches heating the outer surface of the multi-layer film (coextrusion of multi-layered film applies heat to the outer surface of the film and permeates the heat to the other layers; Paragraph 0013),
longitudinally sealing the first and second portions together to define a conduit wall of the conduit (multilayer tube with multiple laminated layers is formed by co-extrusion, a longitudinal heat seal; Paragraph 0013); and
blow moulding at least a portion of the conduit wall to form a sequence of ridges extending outwardly in the transverse direction and a sequence of grooves extending inwardly in the transverse direction, such that a sequence of ridges and grooves are defined along the length of the conduit (film is molded to form corrugated pattern with ridges and grooves; Paragraph 0013).
Fifield in view of Iselau and Noone are considered to be analogous to the claimed invention because they are in the same field of corrugated conduits. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fifield in view of Iselau to incorporate the teachings of Noone to have the method of manufacturing of the first portion and second portion of the multilayer conduits of Fifield in view of Iselau to be coextruded together to form a longitudinal heat seal and to be molded, as taught by Noone, to have the corrugated shaped conduit of Fifield in view of Iselau. This allows for the layers of the conduit to be secured together for the formation of the corrugations (Noone; Paragraph 0013).
Regarding claim 52, Fifield in view of Iselau and Noone teaches the method of claim 50. The combination of Fifield in view of Iselau and Noone further teaches further including forming the sequence of ridges and sequence of grooves such that the ridges and grooves are alternating along the length (Fifield; ridges 15 and grooves 14 are alternating along the length of section 13; Figure 3; Column 2, lines 35-56).
Claim(s) 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Fifield (Patent No. US 4,029,099 A) in view of Iselau et al. (Publication No. US 2021/0330937 A1) and Noone et al. (Patent No. EP 0664864 B1), as applied to claim 30 above, and further in view of Wolkenstoerfer et al. (Publication No. US 2018/0117295 A1), hereby referred to as “Wolkenstoerfer ‘295”.
Regarding claim 31, Fifield in view of Iselau and Noone teaches the conduit of claim 30. The combination of Fifield in view of Iselau and Noone does not teach wherein the innermost layer is formed of a first thermoplastic material and the outermost layer is formed of a second thermoplastic material different from the first thermoplastic material.
However, Wolkenstoerfer ‘295 teaches wherein the innermost layer is formed of a first thermoplastic material and the outermost layer is formed of a second thermoplastic material different from the first thermoplastic material (innermost layer 16 is made of EVA and outermost layer 14’ is made of COC; Figure 2; Paragraph 0056).
Fifield in view of Iselau and Noone and Wolkenstoerfer ‘295 are considered to be analogous to the claimed invention because they are in the same field of medical conduits. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fifield in view of Iselau and Noone to incorporate the teachings of Wolkenstoerfer ‘295 to have the outermost layer and the innermost layer of Fifield in view of Iselau and Noone to be made of COC and EVA, as taught by Wolkenstoerfer ‘295. This allows for the tube to have good thermoplastic flowability, high stiffness, strength, and hardness and is not expensive to produce (Wolkenstoerfer ‘295; Paragraph 0017-0019).
Regarding claim 32, Fifield in view of Iselau, Noone, and Wolkenstoerfer ‘295 teaches the conduit of claim 31. The combination of Fifield in view of Iselau, Noone, and Wolkenstoerfer ‘295 further teaches wherein the first thermoplastic material can include at least one of polyethylene (PE) or ethylene vinyl acetate (EVA) and the second thermoplastic can include at least one of high impact polystyrene (HIPS), acrylonitrile butadiene styrene (ABS), polyvinyl chloride (PVC), PMMA Acrylic, polycarbonate (PC), cyclic olefin polymer (COC), polypropylene (PP), polyethylene (PE), ethylene vinyl acetate (EVA), or polyamide (PA) (Wolkenstoerfer ‘295; innermost layer 16/first thermoplastic material is made of EVA and outermost layer 14’/second thermoplastic material is made of COC; Figure 2; Paragraph 0056).
Claim(s) 33 is rejected under 35 U.S.C. 103 as being unpatentable over Fifield (Patent No. US 4,029,099 A) in view of Iselau et al. (Publication No. US 2021/0330937 A1), Noone et al. (Patent No. EP 0664864 B1), and Wolkenstoerfer et al. (Publication No. US 2018/0117295 A1), as applied to claim 31 above, and further in view of Labib et al. (Publication No. US 2011/0300202 A1).
Regarding claim 33, Fifield in view of Iselau, Noone, and Wolkenstoerfer ‘295 teaches the conduit of claim 31. The combination of Fifield in view of Iselau, Noone, and Wolkenstoerfer ‘295 does not teach wherein a material of the outer layer and a material of the inner layer have different melting points, and the material of the inner layer has a higher melting point than the outer layer.
However, Wolkenstoerfer ‘295 teaches that the melting point of COC is within the ranges of 65 to 190 degrees Celsius (Paragraph 0016) and Labib teaches that the melting point of EVA is within the range of 67 to 98 degrees Celsius (Paragraph 0129).
Therefore, when there is a finite number of identified, predictable solutions, i.e. to have the melting point of COC to be less than the melting point of EVA out of the predictable solutions of having the melting point of COC being more, equal, or less to EVA, a person of ordinary skill has a good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, i.e. allows for the multi-layered tubing to have different material properties at the inner and the outer surfaces of the tubing, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance, the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103 (KSR Int' l Co. v. Teleflex Incl, 127 S. Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007)). See MPEP 2143(I)(E). The combination of Fifield in view of Iselau, Noone, Wolkenstoerfer ‘295, and Labib further teaches wherein a material of the outer layer and a material of the inner layer have different melting points, and the material of the inner layer has a higher melting point than the outer layer (material of the EVA inner layer has a higher melting point than the material of the COC outer layer; see combination above).
Claim(s) 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Fifield (Patent No. US 4,029,099 A) in view of Iselau et al. (Publication No. US 2021/0330937 A1) and Noone et al. (Patent No. EP 0664864 B1), as applied to claim 29 above, and further in view of Nielsen (Publication No. US 2013/0131647 A1).
Regarding claim 37, Fifield in view of Iselau and Noone teaches the conduit of claim 29. The combination of Fifield in view of Iselau and Noone does not teach wherein the first layer is formed by a plurality of first sub-layers, plurality of first sub-layers including a first inside sublayer and two first middle sub- layers on either side of the first inside sub-layer.
However, Nielsen teaches a plurality of first sub-layers, plurality of first sub-layers including a first inside sublayer and two first middle sub-layers on either side of the first inside sub-layer (three layer construction with the same thermoplastic polymer material on the two first middle sub-layers and the thermoplastic elastic material on the first inside sublayer; Paragraph 0055).
Fifield in view of Iselau and Noone and Nielsen are considered to be analogous to the claimed invention because they are in the same field of medical conduits. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fifield in view of Iselau and Noone to incorporate the teachings of Nielsen to have the first layer of Fifield in view of Iselau and Noone to be constructed with the first inside sublayer and two first middle sub-layers of Nielsen. This allows for the tube to have both flexibility and withhold water (Nielsen; Paragraph 0014). The combination of Fifield in view of Iselau, Noone, and Nielsen further teaches wherein the first layer is formed by a plurality of first sub-layers, plurality of first sub-layers including a first inside sublayer and two first middle sub- layers on either side of the first inside sub-layer (see combination above).
Regarding claim 38, Fifield in view of Iselau, Noone, and Nielsen teaches the conduit of claim 37. The combination of Fifield in view of Iselau, Noone, and Nielsen further teaches wherein the inside first inside sub-layer is formed of a different material than the two first middle sub-layers (Nielsen; three layer construction with the same thermoplastic polymer material on the two first middle sub-layers and the thermoplastic elastic material on the first inside sublayer; Paragraph 0055).
Claim(s) 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Fifield (Patent No. US 4,029,099 A) in view of Iselau et al. (Publication No. US 2021/0330937 A1) and Noone et al. (Patent No. EP 0664864 B1), as applied to claim 29 above, and further in view of Stalter et al. (Patent No. US 2,143,960 A).
Regarding claim 39, Fifield in view of Iselau and Noone teaches the conduit of claim 29. The combination of Fifield in view of Iselau and Noone does not teach further including at least one longitudinally extending support configured to substantially prevent stretching of the conduit in the longitudinal direction, the at least one longitudinally extending support being less elastically deformable than the first and third layers.
However, Stalter teaches further including at least one longitudinally extending support configured to substantially prevent stretching of the conduit in the longitudinal direction (fins 16 reinforces the shape of the hose, including stretching in the longitudinal direction; Figure 1; Page 2, right column, lines 11-48).
Fifield in view of Iselau and Noone and Stalter are considered to be analogous to the claimed invention because they are in the same field of conduits. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fifield in view of Iselau and Noone to incorporate the teachings of Stalter to have the longitudinal fins of Stalter molded onto the third layer of Fifield in view of Iselau and Noone. This allows for the fins to provide reinforcement to the structure of the hose (Stalter; Page 2, Right column, lines 25-48).
The combination of Fifield in view of Iselau, Noone, and Stalter further teaches the at least one longitudinally extending support being less elastically deformable than the first and third layers (Stalter; “The webs or fins 16 being formed from the same material as the hose, are flexible and preferably of such a nature that when the hose is bent if one of the webs or fins is located at the rear edge of the bend it will fold upon itself between the corrugation so as not to materially interfere with such bending action, while the webs or fins at the outer edge of the bend act as tension members between adjacent corrugations and act to resist such bending action. Likewise any tortional forces applied to opposite ends of the hose act to place both of the webs or fins 16 under tension and thus act to reinforce the hose against the collapsing action which naturally tends to occur under tortional stresses in the tube.”, meaning that the number of fins 16 provides resistance against torsional forces applied to the tubing, thus the fins are less elastically deformable than the first and third layers of Iselau; Page 2, Right column, lines 25-48; Page 4, Left column, line 44 to Right column, line 8).
Regarding claim 40, Fifield in view of Iselau, Noone, and Stalter teaches the conduit of claim 39. The combination of Fifield in view of Iselau, Noone, and Stalter further teaches wherein the at least one longitudinally extending support is formed as part of the third layer (Stalter; fins 16 are molded into the tubing at the third layer of Iselau; Page 2, Right column, lines 49-78; see rejection of claim 39 above).
Claim(s) 41 is rejected under 35 U.S.C. 103 as being unpatentable over Fifield (Patent No. US 4,029,099 A) in view of Iselau et al. (Publication No. US 2021/0330937 A1), Noone et al. (Patent No. EP 0664864 B1), and Stalter et al. (Patent No. US 2,143,960 A), as applied to claim 39 above, and further in view of Logan et al. (Publication No. US 2018/0015248 A1).
Regarding claim 41, Fifield in view of Iselau, Noone, and Stalter teaches the conduit of claim 39. The combination of Fifield in view of Iselau, Noone, and Stalter does not teach wherein the at least one longitudinally extending support is a wire coupled to the third layer.
However, Logan teaches wherein the at least one longitudinally extending support is a wire coupled to the third layer (wire 318 is a coil that is coupled to the outer surface of the tube; Paragraph 0041; Figures 6-7A; Paragraph 0041 and 0050).
Fifield in view of Iselau, Noone, and Stalter, and Logan are considered to be analogous to the claimed invention because they are in the same field of corrugated catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fifield in view of Iselau, Noone, and Stalter to incorporate the teachings of Logan to have the coil wire of Logan coupled to the outer surface of the third layer of Fifield in view of Iselau, Noone, and Stalter. This allows for the flexibility of the tubing while being resistant to compression or kinking (Logan; Paragraph 0050).
Claim(s) 42 is rejected under 35 U.S.C. 103 as being unpatentable over Fifield (Patent No. US 4,029,099 A) in view of Iselau et al. (Publication No. US 2021/0330937 A1) and Noone et al. (Patent No. EP 0664864 B1), as applied to claim 29 above, and further in view of Wolkenstorfer (Publication No. US 2010/0298812 A1), hereby referred to as “Wolkenstorfer ‘812”.
Regarding claim 42, Fifield in view of Iselau and Noone teaches the conduit of claim 29. The combination of Fifield in view of Iselau and Noone does not teach wherein the first portion has at least one of a different color or a different texture than the second portion.
However, Wolkenstorfer ‘812 teaches wherein the first portion has at least one of a different color or a different texture than the second portion (outer layer and inner layer of the tube having different color tones; Paragraph 0039).
Fifield in view of Iselau and Noone and Wolkenstorfer ‘812 are considered to be analogous to the claimed invention because they are in the same field of medical conduits. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fifield in view of Iselau and Noone to incorporate the teachings of Wolkenstorfer ‘812 to have the first portion and the second portion of Fifield in view of Iselau and Noone to have different colors from each other, as taught by Wolkenstorfer ‘812. This allows for a visual distinction between the first and second portion and can assist in quality control and testing of the tube during production (Wolkenstorfer ‘812; Paragraph 0039).
Claim(s) 44-47 are rejected under 35 U.S.C. 103 as being unpatentable over Fifield (Patent No. US 4,029,099 A) in view of Iselau et al. (Publication No. US 2021/0330937 A1) and Noone et al. (Patent No. EP 0664864 B1), as applied to claim 29 above, and further in view of Marasco et al. (Patent No. US 6,635,035 B1).
Regarding claim 44, Fifield in view of Iselau and Noone teaches the system of claim 43. The combination of Fifield in view of Iselau and Noone does not teach further including a pump in fluid communication with the inner lumen of the conduit and configured to pump fluid through the inner lumen and a liquid reservoir fluidly coupled to the pump.
However, Marasco teaches further including a pump in fluid communication with the inner lumen of the conduit and configured to pump fluid through the inner lumen and a liquid reservoir fluidly coupled to the pump (pump 50 is in fluid communication with inner lumen of conduit 44 and is configured to pump fluid through the conduit 44 and a source of fluid 40 fluidly coupled to the pump 50; Figure 1; Column 5, lines 30-38 and Column 5, line 49 to Column 6, line 4).
Fifield in view of Iselau and Noone and Marasco are considered to be analogous to the claimed invention because they are in the same field of irrigation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fifield in view of Iselau and Noone to incorporate the teachings of Marasco to have irrigation system of Marasco be the system of Fifield in view of Iselau and Noone with the conduit 44 of Marasco replaced by the conduit with the rigid connector of Fifield in view of Iselau and Noone. This allows for a simultaneous aspiration and irrigation of a body portion to prevent the spread of pathogens (Marasco; Column 2, lines 42-50).
Regarding claim 45, Fifield in view of Iselau, Noone, and Marasco teaches the system of claim 44. The combination of Fifield in view of Iselau, Noone, and Marasco further teaches further including a collection bag coupled to an outlet end of the rigid connector (rigid connector outlet end of Fifield in view of Iselau, Noone, and Marasco is connected to the collection bag 34 of Marasco; see rejection of claim 44 above; Column 5, lines 49-51).
Regarding claim 46, Fifield in view of Iselau and Noone teaches the conduit of claim 29. The combination of Fifield in view of Iselau and Noone does not teach an irrigation system comprising:
a pump;
a liquid reservoir fluidly coupled to the pump; and
the conduit in fluid communication with the pump such that the pump delivers fluid through the inner lumen of the conduit from a first end of the conduit to a second end of the conduit.
However, Marasco teaches an irrigation system (Column 4, line 66 to Column 5, line 8; Figure 1) comprising:
a pump (pump 50; Figure 1; Column 5, lines 55-59);
a liquid reservoir fluidly coupled to the pump (reservoir 40 fluidly coupled to pump 50; Figure 1; Column 5, line 55 to Column 6, line 1); and
the conduit in fluid communication with the pump such that the pump delivers fluid through the inner lumen of the conduit from a first end of the conduit to a second end of the conduit (conduit 70 is in fluid communication with pump 50 so that fluid is delivered through the inner lumen of the conduit 70 from a first end to a second end of the conduit 70; Figure 1; Column 6, line 15-25).
Fifield in view of Iselau and Noone and Marasco are considered to be analogous to the claimed invention because they are in the same field of irrigation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fifield in view of Iselau and Noone to incorporate the teachings of Marasco to have irrigation system of Marasco be the system of Fifield in view of Iselau and Noone with the conduit 70 of Marasco replaced by the conduit with the rigid connector of Fifield in view of Iselau and Noone. This allows for a simultaneous aspiration and irrigation of a body portion to prevent the spread of pathogens (Marasco; Column 2, lines 42-50).
Regarding claim 47, Fifield in view of Iselau, Noone, and Marasco teaches the conduit of claim 46. The combination of Fifield in view of Iselau, Noone, and Marasco further teaches further including a probe coupled to the first end of the conduit and defining a probe conduit from an inlet to an outlet (gun 24 with nozzle 42 of Marasco coupled to first end of the conduit of Fifield in view of Iselau and Noone and defining a conduit within it from an inlet to an outlet; Marasco; Figure 1; Column 5, lines 12-18), the probe having a rigidity exceeding the rigidity of the multi-layer film (gun 24 with nozzle 42 of Marasco is a handheld manipulable device for the user to hold and to control the positioning of the delivery of fluid to the tissue site and the positioning of tubing 70, thus it is obvious to one of ordinary skill that the gun with nozzle of Marasco is more rigid than the multi-layer film of Fifield in view of Iselau, Noone, and Marasco; Marasco; Figure 1; Column 5, lines 12-18).
Claim(s) 51 is rejected under 35 U.S.C. 103 as being unpatentable over Fifield (Patent No. US 4,029,099 A) in view of Iselau et al. (Publication No. US 2021/0330937 A1) and Noone et al. (Patent No. EP 0664864 B1), as applied to claim 50 above, and further in view of Jarvenkyla et al. (Patent No. US 5,975,143 A).
Regarding claim 51, Fifield in view of Iselau and Noone teaches the method of claim 50. The combination of Fifield in view of Iselau and Noone does not teach wherein the ridges and grooves are formed prior to longitudinally sealing the first and second portions.
However, Jarvenkyla teaches wherein the ridges and grooves are formed prior to longitudinally sealing the first and second portions (ridges and grooves on layers 5 and 6 are formed prior to the sealing of the first portion layers 5 and 6 to the second portion layers 2 and 3; Figure 1 and 2; Column 2, lines 41-67).
Fifield in view of Iselau and Noone and Jarvenkyla are considered to be analogous to the claimed invention because they are in the same field of method of making corrugated conduits. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fifield in view of Iselau and Noone to incorporate the teachings of Jarvenkyla to have the molding of the grooves and ridges prior to the sealing of the first and second portions of the tubing, as taught by Jarvenkyla, in the making of the tubing of Fifield in view of Iselau and Noone. This allows for the ability to tailor the individual material properties of the layers in the tubing and to resist bucking on the inner surface of the tubing (Jarvenkyla; Column 1, line 63 to Column 2, line 9).
Conclusion
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
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