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 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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph et al. Patent Application Publication US 2022/0305191.
As to claim 1, Joseph teaches a non-invasive female catheter arrangement comprising:
a collection bag 104 being configured to receive urine (Joseph para. 0028);
a catheter head 102 being configured to be placed over the vulva of a user (Joseph para. 0025);
tubing 108 being configured and disposed to connect the collection bag to the catheter head 102 to conduct urine from the catheter head 102 to the collection bag 104 (Joseph para. 0021).
Joseph teaches a fluid collection system having a fluid collection portion 102. Joseph incorporates by reference (Joseph para. 0025) Sanchez et al. USPN 10390989 who teaches an example of female fluid collection assemblies 1602, 1802 comprising a shell 1604, 1804 and absorbent 1630,1830 (Fig. 32, 35, and 35). Joseph/Sanchez do not specifically teach the catheter head comprises a plastic shell. However, Sanchez teaches embodiments of the system can be formed or constructed of polymers, including synthetic polymers (Sanchez col. 4, line 66 through col. 5, line 6). Specifically, Sanchez teaches assemblies 1602 and 1802 (Fig. 32 and Fig. 35). Sanchez teaches assemblies 1602, 1802 includes an impermeable casing 1604, 1804 formed of an impermeable material, such as silicone and/or another polymer (Sanchez col. 21, lines 21-23; col. 22, lines 63-65; col. 24, lines 24-26). The polymers taught in Sanchez include plastics, such as polyethylenes (Sanchez col.4, lines 66 through, col. 5, line 6). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to use a plastic for the shell, using one or a combination of the known polymers taught in Sanchez. In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed that it is obvious to choose from among known solutions to a problem: When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. The fact that a combination was obvious to try establishes a prima facie case of obviousness.
Joseph/Sanchez teach the shell 1604, 1804 having an elongated spoon or scoop shape being concave (Sanchez Fig. 32-35) and substantially wider in the middle portion than at the end portions 1620, 1820 (Sanchez Fig. 32, 34, and 35).
Joseph/Sanchez teach the catheter head 102/1602/1802 comprising an absorbent structure 1630, 1830 mounted on the plastic shell (Sanchez Fig 32, 34, and 35). Sanchez teaches the permeable membranes 130, 1630, 1830 comprise absorbent material such as gauze or similar absorbent material (Sanchez col. 5, lines 31-36).
Joseph/Sanchez teach the plastic shell having an elongated spoon or scoop shape being concave (Sanchez Fig. 32) and substantially wider in the middle portion than at the end portions 1620, 1820 (Fig. 32, 34, 35);
the absorbent structure 1630, 1830 being configured and disposed to fill the plastic shell 1604, 1804 and form an essentially flat face (Fig. 35) configured to be disposed to face and or lie on the vulva of a user.
Joseph/Sanchez teach a permeable support 140, 1640, 1840 can be positioned relative to the permeable membrane (absorbent structure) 130, 1630, 1830. The permeable support 140, 1640, 1840 maintains the permeable membrane in a particular shape and allows for fluid, such as, for example, urine, to flow through the permeable membrane 130, through the permeable support 140, and into the reservoir (Sanchez col. 5, lines 55-60). The permeable support 1640 includes a drain comprising a drainage channel having tubing 1621, 1821 inserted into the channel defined by the permeable support 1640, 1840 (col. 23, lines 6-17; col. 24, lines 58-65) - disposed therein and connected to the tubing for the drainage of urine of the absorbent structure (Sanchez Fig. 32, 34; col. 23, lines 6-17; col. 24, lines 38-46).
As to claim 2, Joseph/Sanchez teach the absorbent structure (permeable membrane) comprises gauze or similar absorbent material (Sanchez col. 5, lines 31-36).
As to claim 3, Joseph/Sanchez teach the drainage channel 1621,1821 has a curved cross-section (Fig. 32, 34) that essentially follows the concave shape of the plastic shell 1604,1804 such that the absorbent structure is thicker in the middle than at the ends 1620, 1820 to provide maximum absorbent material closest to the urethra of the user (Sanchez Fig. 35; col. 5, line 55 through col. 6, line 2).
As to claim 4, the non-invasive female catheter arrangement of claim 3, comprises a pump 106 – where Joseph teaches the suction force may be applied to the suction device 106 by an actuator 112, which may include a pump (Joseph para. 0020 and 0023);
the pump 106 is disposed between and to connect a first section of the tubing 108 and a second section of the tubing 110; and
the pump 106 is configured to pump urine through the tubing and into the collection bag 104 (Joseph 0032-0033).
As to claim 5, the non-invasive female catheter arrangement of claim 3, Joseph does not specifically teach the collection bag 104 comprises a hanger. However, Joseph does teach the collection bag 104 may be configured or positioned below the suction device 106. Thus, when the fluid is discharged from the suction device 106, the fluid may drain from the suction device 106 into the fluid collection bag 104 via gravity (Joseph Fig. 1B, para. 0030). In this case, the arm 126, functions to hold and position the suction device at a lower height than the catheter head 102 such that urine absorbed by the catheter head 102 drains from the suction device 106 via gravity into the collection bag 104, and thus is functionally equivalent to the hanger.
As to claim 6, Joseph/Sanchez teach the drainage channel 1621,1821 has a curved cross-section (Fig. 32, 34) that essentially follows the concave shape of the plastic shell such that the absorbent structure is thicker in the middle than at the ends 1620, 1820 to provide maximum absorbent material closest to the urethra of the user (Sanchez Fig. 35; col. 5, line 55 through col. 6, line 2).
As to claim 7, the non-invasive female catheter arrangement comprises a pump 106 – where Joseph teaches the suction force may be applied to the suction device 106 by an actuator 112, which may include a pump (Joseph para. 0020 and 0023);
the pump 106 is disposed between and to connect a first section of the tubing 108 and a second section of the tubing 110; and
the pump 106 is configured to pump urine through the tubing and into the collection bag 104 (Joseph 0032-0033).
As to claim 8, Joseph does not specifically teach the collection bag 104 comprises a hanger. However, Joseph does teach the collection bag 104 may be configured or positioned below the suction device 106. Thus, when the fluid is discharged from the suction device 106, the fluid may drain from the suction device 106 into the fluid collection bag 104 via gravity (Joseph Fig. 1B, para. 0030). In this case the arm 126, functions to hold and position the suction device at a lower height than the catheter head 102 such that urine absorbed by the catheter head 102 drains from the suction device via gravity into the collection bag 104, and thus is functionally equivalent to the hanger.
As to claim 9, Joseph teaches a method of using the non-invasive female catheter arrangement of claim 1, the method comprising the steps of:
placing the catheter head 102 over the vulva of a user with the absorbent structure facing or lying on the vulva of a user (Joseph para. 0025);
absorbing expelled urine into the absorbent structure; and
draining absorbed urine through the drainage channel, then through the tubing, and then into the collection bag 104 (Josephs para. 0006, 0019, 0025; Sanchez col. 23, lines 25-38; col. 24, lines 39-46; col. 26, line 66 through col. 27, line 8).
As to claim 10, the non-invasive female catheter arrangement of claim 9, wherein: the non-invasive female catheter arrangement comprises a pump 106 – where Joseph teaches the suction force may be applied to the suction device 106 by an actuator 112, which may include a pump (Joseph para. 0020 and 0023);
the pump 106 is disposed between and to connect a first section of the tubing 108 and a second section of the tubing 110; and
the method further comprises pumping urine with the pump 106 through the tubing and into the collection bag 104 (Joseph 0032-0033).
As to claim 11, Joseph does not specifically teach the collection bag 104 comprises a hanger. However, Joseph does teach the collection bag 104 may be configured or positioned below the suction device 106. Thus, when the fluid is discharged from the suction device 106, the fluid may drain from the suction device 106 into the fluid collection bag 104 via gravity (Joseph Fig. 1B, para. 0030). In this case, the arm 126, functions to hold and position the suction device at a lower height than the catheter head 102 such urine absorbed by the catheter head 102 drains from the suction device by gravity into the collection bag 104, and thus is functionally equivalent to the hanger.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Radl et al. US Patent Application Publication 2021/0023279 and Kuntz USPN 4747166 are cited to show female external catheters.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781