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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “hinge system skeleton, one or more adjustable railings, one or more telescoping tubes, or a gear system” from claim 9 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The above is not a common feature to urinary catheters, and it is unclear what the inventor envisions by the terms for example a hinge could very broadly be a fold, but it is unclear what is meant by a “hinge system skeleton”. While the remaining terms are self-explanatory in terms of understanding what they would look like is unclear how these would function within the device.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 12 is 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 12 recites the limitation "a conduit" in line 2. A conduit is already claimed in claim 1. The invention does not appear to have a second conduit, as such the suggestion correction would be “the conduit”. For the purposes of compact prosecution the conduits of claim 1 and 12 have been considered to be the same.
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) 1, 3, 6-12, 14, and 25-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis US 2018/0228642 A1.
With regards to claim 1, Davis discloses a urine collection device (abstract), comprising: a fluid impermeable barrier (20, fig 1 and [0052] which discloses impermeability of the external covering 20) that is adjustable between an extended configuration and a compact configuration (abstract and [0077] discloses how the device is able to be further curved or compacted to better fit the user), the fluid impermeable barrier at least partially defining a chamber, an aperture configured to receive a conduit therethrough for connecting the urine collection device to a vacuum source, and an opening (fig 7 shows the external cover 20 is hollow to accommodate additional elements thereby having a chamber, additionally an opening can clearly been seen (element 30) and conduit (or tube 32) allows urine to pass from the collection device to a vacuum source (via an aperture in the tube) if applied [0060]); and a fluid permeable structure (40 and 42, fig 7 and [0057-59]) positioned within the chamber to extend across at least a portion of the opening, the fluid permeable structure being configured to wick fluid away from the opening (fig 7 shows element 42 fits inside of the chamber and [0059]describes the wicking properties).
With regards to claim 3, Davis discloses wherein the fluid impermeable barrier includes a fluid impermeable fabric material ([0053] discloses the material for the outer layer (20) or impermeable barrier can be silicone or polyurethane or other polymeric material or film).
With regards to claim 6, Davis discloses further comprising a support member (32c wires fig 11c, [0064]) secured to the fluid impermeable barrier, the support member configured to retain the fluid impermeable barrier in the extended configuration and in the compact configuration (the support member resides within the fluid permeable barrier and therefore it is secured to the barrier and provides adjustability of the device [0064]).
With regards to claim 7, Davis discloses wherein the support member includes a slotted support member secured to the fluid impermeable barrier distal to the opening (the wires are wrapped in the slotted manner element 32c- fig 11c).
With regards to claim 8, Davis discloses wherein the fluid impermeable barrier includes: a first axial length in the extended configuration; a second axial length in the compact configuration, the first axial length being greater than the second axial length; a first width in the extended configuration; and a second width in the configuration, the second width being greater than the first width; the support member expands the fluid impermeable barrier from the first width to the second width responsive to manipulation of the fluid impermeable barrier from the extended configuration to the compact configuration (when the device as whole is moved from a flat or less curved to curved or more curved configuration the dimensions will change as claimed e.g. if I increase the curvature the length will decrease along an axis and the width will also increase as the curve is increased).
With regards to claim 9, Davis discloses wherein the support member includes at least one of a hinge system skeleton (see wires 32c in fig 11c which provides a moveable (therefore hinged) skeleton system as the wires form a “frame” like a skeleton).
With regards to claim 10, Davis discloses wherein the fluid permeable structure is secured to the fluid impermeable barrier proximate to the opening (the support member resides within the fluid permeable barrier and therefore it is secured to the barrier [0064]).
With regards to claim 11, Davis discloses wherein the fluid permeable structure expands to extend across the opening when the fluid impermeable barrier is manipulated from the extended configuration to the compact configuration (the fluid permeable structure is extended across the opening regardless of the configuration therefore the claim is met).
With regards to claim 12, Davis discloses further comprising a conduit extending through the aperture at least partially into the chamber (fig 7 shows the external cover 20 is hollow to accommodate additional elements thereby having a chamber, additionally an opening can clearly been seen (element 30) and conduit (or tube 32) allows urine to pass from the collection device to a vacuum source if applied [0060] as such the conduit extends into the chamber via an aperture).
With regards to claim 14, Davis discloses wherein the conduit includes a first portion positioned at least partially within the chamber and a second portion slidably connected to the first portion, the second portion at least partially positioned outside the chamber and at least partially retractable within the chamber ([0060] the tube (32) resides within the chamber and extends outside the chamber such that is can be connected to the vacuum source, [0078] notes the tube is spaced away from the terminal end of the device which could prevent urine flow, as such the tube since it is not permanently fixed can be moved or retracted within the chamber).
With regards to claim 25, Davis discloses a method of collecting urine ([0002]), comprising: adjusting a fluid impermeable barrier (20, fig 1 and [0052] which discloses impermeability of the external covering 20), the fluid impermeable barrier at least partially defining a chamber, an aperture configured to receive a conduit therethrough for connecting the urine collection device to a vacuum source, and an opening (fig 7 shows the external cover 20 is hollow to accommodate additional elements thereby having a chamber, additionally an opening can clearly been seen (element 30) and conduit (or tube 32) allows urine to pass from the collection device to a vacuum source (via an aperture in the tube) if applied [0060] and figs 33-34 which is flow chart for the method of using the device and [0077] discloses how the device is able to adjusted to fit the user);
positioning a fluid permeable structure (40 and 42, fig 7 and [0057-59]) of the urine collection device at least proximate to a urethra of a user (fig 34 step 404), the fluid permeable structure extending at least partially across the opening defined by the impermeable structure (fig 7 shows elements 40 and 42 fits inside of the impermeable structure (20);
receiving fluids discharged from urethra into the chamber (fig 33 step 305); promoting urine from the chamber through the conduit fluidly coupled to the reservoir and connected to a vacuum source (Fig 33 step 305 which removed the urine from the device vias suction thereby promoting urine through the conduit).
With regards to claim 26, Davis discloses wherein adjusting a configuration of a fluid impermeable barrier includes unrolling and/or unfolding the fluid impermeable barrier and the fluid permeable structure from a compact configuration to an extended configuration. (abstract and [0077] discloses how the device is able to be further curved or compacted to better fit the user).
With regards to claim 27, Davis discloses retaining the fluid impermeable barrier in the compact configuration or the extended configuration with a support member (32c wires fig 11c, [0064]) secured to the fluid impermeable barrier (the support member resides within the fluid permeable barrier and therefore it is secured to the barrier and provides adjustability of the device [0064]).
With regards to claim 28, Davis discloses wherein adjusting a configuration of a fluid impermeable barrier includes manipulating a support member secured to the fluid impermeable barrier to adjust at least one of an axial length of the fluid impermeable barrier or a width of the fluid impermeable barrier (when the device as whole is moved from a flat or less curved to curved or more curved configuration the length will change as claimed).
With regards to claim 29, Davis discloses wherein manipulating a support member secured to the fluid impermeable barrier to adjust at least one of an axial length of the fluid impermeable barrier or a width of the fluid impermeable barrier includes manipulating the support member to decrease the axial length of the fluid impermeable barrier and increase the width of the fluid impermeable barrier (when the device as whole is moved from a flat or less curved to curved or more curved configuration the dimensions will change as claimed e.g. if I increase the curvature the length will decrease along an axis and the width will also increase as the curve is increased).
With regards to claim 30, Davis discloses wherein expanding the fluid permeable structure to extend across the opening when the width of the fluid impermeable barrier is increased (the fluid permeable structure is extended across the opening regardless of the configuration therefore the claim is met).
With regards to claim 31, Davis discloses extending a length of a conduit positioned at least partially within the chamber by pulling a portion of the conduit slidably connected to a second portion of the conduit ([0060] the tube (32) resides within the chamber and extends outside the chamber such that is can be connected to the vacuum source, [0078] notes the tube is spaced away from the terminal end of the device which could prevent urine flow, as such the tube since it is not permanently fixed can be moved or retracted within the chamber).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2, 4 and 15-22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Davis US 2018/0228642 A1 in view of Washington US 4886508.
Regarding claim 2, Davis fails to explicitly disclose wherein the fluid impermeable barrier and the fluid permeable structure are rollable or foldable over one another to form a roll in the compact configuration. (Emphasis added by the examiner as claim 2 requires both impermeable barrier and the fluid permeable structure to be rollable not just the impermeable barrier to be adjustable.)
Davis teaches the overall device can be flexed or curved to fit various body curvatures ([0063]) rolling is narrower than simply forming a curve as rolling requires rotation about an axis. Davis however teaches the material for the outer layer (20) or impermeable barrier can be silicone or polyurethane or other polymeric material ([0053]). Additionally, Davis teaches the fluid permeable structure (40 and 42) or outer collection layer (40) and inner collection core (42) can be formed from an athletic clothing material ([0057-59]) and athletic clothing is known to be flexible and rollable. Applicant’s specification allows for the same materials for the impermeable barrier such as silicone or polyurethane (applicant’s specification [0028]). Applicant’s specification allows for the same material for the fluid permeable structure such as “any material that can wick fluid” such as polyethylene (applicant’s specification [0032-33]).
Washington teaches a flexible urine collection device that is used for urine collection (abstract) thereby being in a related field of endeavor. Washington teaches a silicone impermeable barrier (or catheter body) that is able to be rolled up (Col 2 lines 40-51). Washington additionally teaches a screen insert (or the fluid permeable structure) that is made from polypropylene or other nonabsorbent plastic material (Col 12 lines 17-31) and able to be deformed (Col 2 lines 60-65).
Therefore, it would have been obvious to one or ordinary skill in the art before the effective filling date to have deformed the article of Davis firstly because the same material would be expected to have the same properties (e.g. the ability to be rolled) and secondly because Washington teaches a similar device formed from similar material can be rolled or compacted. Compacting the article has an obvious advantage for storing and shipping considerations as space is limited and expensive.
With regards to claim 4, Davis discloses wherein: the fluid impermeable barrier includes a distal end positioned distal to the aperture (fig 1 which shows the external covering 20 extending beyond the opening 30). Davis fails to disclose the fluid impermeable barrier tapers for at least about 2.5 cm towards the distal end.
Washington teaches a flexible urine collection device that is used for urine collection (abstract) thereby being in a related field of endeavor. Washington teaches the overall length is 25cm and the entire length of the opening is 8.3cm (Col 11 line 60- Col 12 line 15). As seen in figure 1 the opening is centrally positioned as such fluid impermeable barrier tapers at least 2.5cm beyond the opening.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified and optimized the distance the impermeable barrier extended and tapered beyond the opening to meet the claimed limitation as Washington clearly teaches the specific measurements and Davis’s figures suggest it providing a reasonable expectation of success as the measurements are known. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” MPEP 2144.05. II. A.
With regards to claim 15 and 16, Davis discloses a urine collection device (abstract), comprising: a fluid impermeable barrier (20, fig 1 and [0052] which discloses impermeability of the external covering 20) that is adjustable between an extended configuration and a compact configuration (abstract and [0077] discloses how the device is able to be further curved or compacted to better fit the user), the fluid impermeable barrier at least partially defining a chamber, an aperture configured to receive a conduit therethrough for connecting the urine collection device to a vacuum source, and an opening (fig 7 shows the external cover 20 is hollow to accommodate additional elements thereby having a chamber, additionally an opening can clearly been seen (element 30) and conduit (or tube 32) allows urine to pass from the collection device to a vacuum source (via an aperture in the tube) if applied [0060]); and a fluid permeable structure (40 and 42, fig 7 and [0057-59]) positioned within the chamber to extend across at least a portion of the opening, the fluid permeable structure being configured to wick fluid away from the opening (fig 7 shows element 42 fits inside of the chamber and [0059]describes the wicking properties).
Davis fails to disclose the fluid impermeable barrier tapers for at least about 2.5 cm towards the distal end.
Washington teaches a flexible urine collection device that is used for urine collection (abstract) thereby being in a related field of endeavor. Washington teaches the overall length is 25cm and the entire length of the opening is 8.3cm (Col 11 line 60- Col 12 line 15). As seen in figure 1 the opening is centrally positioned as such fluid impermeable barrier tapers at least 2.5cm beyond the opening.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified and optimized the distance the impermeable barrier extended and tapered beyond the opening to meet the claimed limitation as Washington clearly teaches the specific measurements and Davis’s figures suggest it providing a reasonable expectation of success as the measurements are known. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” MPEP 2144.05. II. A.
Regarding claim 17, Davis fails to explicitly disclose wherein the fluid impermeable barrier and the fluid permeable structure are rollable or foldable over one another to form a roll in the compact configuration. (Emphasis added by the examiner as claim 2 requires both impermeable barrier and the fluid permeable structure to be rollable not just the impermeable barrier to be adjustable.)
Davis teaches the overall device can be flexed or curved to fit various body curvatures ([0063]) rolling is narrower than simply forming a curve as rolling requires rotation about an axis. Davis however teaches the material for the outer layer (20) or impermeable barrier can be silicone or polyurethane or other polymeric material ([0053]). Additionally, Davis teaches the fluid permeable structure (40 and 42) or outer collection layer (40) and inner collection core (42) can be formed from an athletic clothing material ([0057-59]) and athletic clothing is known to be flexible and rollable. Applicant’s specification allows for the same materials for the impermeable barrier such as silicone or polyurethane (applicant’s specification [0028]). Applicant’s specification allows for the same material for the fluid permeable structure such as “any material that can wick fluid” such as polyethylene (applicant’s specification [0032-33]).
Washington teaches a flexible urine collection device that is used for urine collection (abstract) thereby being in a related field of endeavor. Washington teaches a silicone impermeable barrier (or catheter body) that is able to be rolled up (Col 2 lines 40-51). Washington additionally teaches a screen insert (or the fluid permeable structure) that is made from polypropylene or other nonabsorbent plastic material (Col 12 lines 17-31) and able to be deformed (Col 2 lines 60-65).
Therefore, it would have been obvious to one or ordinary skill in the art before the effective filling date to have deformed the article of Davis firstly because the same material would be expected to have the same properties (e.g. the ability to be rolled) and secondly because Washington teaches a similar device formed from similar material can be rolled or compacted. Compacting the article has an obvious advantage for storing and shipping considerations as space is limited and expensive.
With regards to claim 18, Davis discloses wherein the fluid impermeable barrier includes a fluid impermeable fabric material ([0053] discloses the material for the outer layer (20) or impermeable barrier can be silicone or polyurethane or other polymeric material or film).
With regards to claim 19, Davis discloses wherein the fluid permeable structure includes an wicking layer (40- outer collection layer, fig 7 and [0056]) and an transport layer (42- inner collection core, fig 7 and [0056] which discloses the layer maybe a moisture wicking layer such as jersey mesh or athletic fabric (which can include as nylon) or polyester blend [0059]) configured to wick fluid from the opening to the chamber of the fluid impermeable barrier ([0056]).
With regards to claim 20, Davis discloses further comprising a support member (32c wires fig 11c, [0064]) secured to the fluid impermeable barrier, the support member configured to retain the fluid impermeable barrier in the extended configuration and in the compact configuration (the support member resides within the fluid permeable barrier and therefore it is secured to the barrier and provides adjustability of the device [0064]).
With regards to claim 21, Davis discloses wherein the support member includes a slotted support member secured to the fluid impermeable barrier distal to the opening (the wires are wrapped in the slotted manner element 32c- fig 11c).
With regards to claim 22, Davis discloses further comprising a conduit extending through the aperture at least partially into the chamber (fig 7 shows the external cover 20 is hollow to accommodate additional elements thereby having a chamber, additionally an opening can clearly been seen (element 30) and conduit (or tube 32) allows urine to pass from the collection device to a vacuum source if applied [0060] as such the conduit extends into the chamber via an aperture).
With regards to claim 24, Davis discloses wherein the conduit includes a first portion positioned at least partially within the chamber and a second portion slidably connected to the first portion, the second portion at least partially positioned outside the chamber and at least partially retractable within the chamber ([0060] the tube (32) resides within the chamber and extends outside the chamber such that is can be connected to the vacuum source, [0078] notes the tube is spaced away from the terminal end of the device which could prevent urine flow, as such the tube since it is not permanently fixed can be moved or retracted within the chamber).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Davis US 2018/0228642 A1 in view of Sanchez US 8287508 B1.
With regards to claim 5, Davis discloses wherein the fluid permeable structure includes an outer portion (40- outer collection layer, fig 7 and [0056]) and an inner porous nylon portion (42- inner collection core, fig 7 and [0056] which discloses the layer maybe a moisture wicking layer such as jersey mesh or athletic fabric (which can inculde as nylon) or polyester blend [0059]) configured to wick fluid from the opening to the chamber of the fluid impermeable barrier ([0056]). Davis fails to disclose the fluid permeable structure includes an outer portion made form gauze.
Sanchez teaches an external urinary catheter (abstract) thereby being in the same field of endeavor. Sanchez teaches gauze can be used as wicking material (Col 4 lines 10-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted one wicking material for another known wicking material such as gauze as taught by Sanchez with a reasonable expectation of success since it is a simple substitution that is known in the art.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Davis US 2018/0228642 A1 in view of Skow US 5628735.
With regards to claim 13, Davis fails to disclose wherein at least a portion of conduit positioned in the chamber includes a plurality of slots or eyelets sized to pull urine from the chamber into the conduit when the conduit is fluidly coupled to a vacuum.
Skow teaches a fluid removing device thereby being in the same field of endeavor. Skow teaches eyelets or holes (32) within a suction tube (26) (fig 1) with the purpose of pulling fluid at specific locations into the tube and away from less desirable sites (Col. 5 lines 19-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added additional holes to the tube of Davis with a reasonable expectation of success since Skow teaches multiple holes in a tube under vacuum pressure is not only functional but also provides improved fluid transfer from one area to an area by the hole for improved fluid removal and wicking.
Claim(s) 23 is rejected under 35 U.S.C. 103 as being unpatentable over Davis US 2018/0228642 A1 in view of Washington US 4886508 and in further view of Skow US 5628735.
With regards to claim 23, Davis and Washington fail to disclose wherein at least a portion of conduit positioned in the chamber includes a plurality of slots or eyelets sized to pull urine from the chamber into the conduit when the conduit is fluidly coupled to a vacuum.
Skow teaches a fluid removing device thereby being in the same field of endeavor. Skow teaches eyelets or holes (32) within a suction tube (26) (fig 1) with the purpose of pulling fluid at specific locations into the tube and away from less desirable sites (Col. 5 lines 19-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added additional holes to the tube of Davis with a reasonable expectation of success since Skow teaches multiple holes in a tube under vacuum pressure is not only functional but also provides improved fluid transfer from one area to an area by the hole for improved fluid removal and wicking.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA E BURNETTE whose telephone number is (571)272-9574. The examiner can normally be reached M-S: 0830-1900 EST.
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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781