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
Claim 23 is objected to because of the following informalities: “ultransonically” should read “ultrasonically”. Appropriate correction is required.
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.
Claim(s) 1-3, 7-9, 15, 19, 22, 26-28, and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis et al. (Publication No. US 2018/0228642 A1).
Regarding claim 1, Davis discloses a fluid collection device (device 10; Figure 1-7 is the first embodiment; Paragraph 0052 and 0086), comprising:
a fluid impermeable barrier at least partially defining a chamber (covering 20 is a fluid impermeable barrier and defines a chamber within it; Paragraph 0052; Figure 1), an opening extending longitudinally along the fluid impermeable barrier and configured to be positioned at least proximate to a urethra of a user (fenestration 30 is aligned to user’s urethral opening to collect urine; Figure 1; Paragraph 0052), and an aperture configured to receive a conduit therethrough (open first end 33 to receive tube 32; Figure 1 and 4; Paragraph 0060);
a fluid permeable body positioned at least partially within the chamber to extend across at least a portion of the opening and configured to wick fluid away from the opening (outer collection layer 40 is a fluid permeable material that extends across fenestration 30 to wick fluid away from user; Paragraph 0056-0057; Figure 7); and
one or more arms including an adhesive surface oriented towards the fluid impermeable barrier (anchor 50 has two arms and an adhesive surface that faces towards the covering 20 of the device to be secured to the device 10; Paragraph 0091 and Figure 6), the one or more arms being one of (1) detachably secured or securable to the fluid impermeable barrier in a position selected by the user or a caregiver (anchor 50 is secured/connected to the open first end 22 of the device 10 by tape – open first end of the device is formed by the impermeable covering 20 thus the tape is secured to the impermeable covering 20; Paragraph 0091) or (2) secured or securable to the conduit, the conduit being configured to be inserted into the aperture (anchor 50 can be secured to tube 32 and to the user – where the tube 32 is connected to device 10; Paragraph 0092),
wherein the one or more arms are positioned to attach to at least one of an abdominal region, a pubic region, or a pelvic region of the user when the opening of the fluid impermeable barrier is positioned at least proximate to the urethra of the user (anchor is attached to pelvic region of the user; Figure 10; Paragraph 0061).
Regarding claim 2, Davis discloses the device of claim 1. Davis further discloses wherein the one or more arms include two arms aligned laterally (wings of anchor 50 are aligned laterally; Figure 1-7; Paragraph 0086).
Regarding claim 3, Davis discloses the device of claim 2. Davis further discloses wherein the two arms are connected to one another (wings of anchor 50 are connected to one another; Paragraph 0086; Figure 1-7).
Regarding claim 7, Davis discloses the device of claim 2. Davis further discloses wherein each of the two arms includes a non-adhesive surface opposite to the adhesive surface (adhesive surface is only on side that attaches to skin of user; Paragraph 0088 and 0090).
Regarding claim 8, Davis discloses the device of claim 7. Davis further discloses further comprising a removable cover on the adhesive surface of each of the two arms (Paragraph 0088).
Regarding claim 9, Davis discloses the device of claim 2. Davis further discloses wherein the two arms are detachably secured or securable to the fluid impermeable barrier in a position selected by the user or the caregiver (Paragraph 0091-0092).
Regarding claim 15, Davis discloses the device of claim 9. Davis further discloses wherein the two arms are secured to the fluid impermeable barrier with an adhesive (Paragraph 0091).
Regarding claim 19, Davis discloses the device of claim 2. Davis further disclose further comprising the conduit extending through the aperture such that a first portion of the conduit is disposed within the chamber and a second portion of the conduit is disposed outside the chamber, wherein the two arms are secured or securable to the second portion of the conduit (conduit 32 extends through open first end 22 – where first portion of conduit 32 is inside of the chamber of device 10 and second portion of conduit 32 is outside of first end 22 of device 10 and arms of anchor 50 is secured to second portion of conduit; Figure 4, Paragraph 0091-0092).
Regarding claim 22, Davis discloses the device of claim 19. Davis further discloses wherein the two arms are secured to the second portion of the conduit with an adhesive (anchor 50 has adhesive to attach tube 32 to user; Paragraph 0092).
Regarding claim 26, Davis discloses a method of collecting fluids from a user (Abstract; Paragraph 0052), the method comprising:
positioning a fluid permeable body of a fluid collection device to cover a urethra of a user (fenestration 30 is aligned to user’s urethral opening to collect urine – device 10 has outer collection layer 40 that is a permeable material that extends across fenestration to wick fluid away from user; Figure 1 and 7; Paragraph 0052 and 0056-0057);
applying one or more adhesive arms to at least one of a pubic region, a pelvic region, or an abdominal region of the user effective to secure the fluid collection device to the user (anchor is attached to pelvic region of the user; Figure 10; Paragraph 0061), the one or more adhesive arms being one of: (1) detachably secured or securable to a fluid impermeable barrier of the fluid collection device in a position selected by the user or a caregiver (anchor 50 is secured/connected to the open first end 22 of the device 10 by tape – open first end of the device is formed by the impermeable covering 20 thus the tape is secured to the impermeable covering 20; Paragraph 0091) or (2) secured or securable to a conduit of the fluid collection device extending through an aperture in the fluid impermeable barrier (anchor 50 can be secured to tube 32 and to the user – where the tube 32 is connected to device 10; Paragraph 0092); and
receiving fluids discharged from the urethra into a chamber of the fluid collection device (covering 20 of device 10 forms a chamber for urine collection; Figure 1; Paragraph 0052).
Regarding claim 27, Davis discloses the method of claim 26. Davis further discloses wherein applying one or more adhesive arms to at least one of a pubic region, a pelvic region, or an abdominal region of the user effective to secure the fluid collection device to the user includes applying the one or more adhesive arms to the pelvic region of the user (anchor is attached to pelvic region of the user; Figure 10; Paragraph 0061), the one or more adhesive arms being secured to the fluid impermeable barrier distal to an opening in the fluid impermeable barrier through which the fluids are collected from the urethra (arms of anchor 50 is secured/connected to the open first end 22 of the device 10/distal to fenestration 30 – open first end of the device is formed by the impermeable covering 20 thus the tape is secured to the impermeable covering 20; Paragraph 0091; Figure 3).
Regarding claim 28, Davis discloses the method of claim 27. Davis further discloses further comprising securing the one or more arms to the fluid impermeable barrier (anchor 50 is secured/connected to the open first end 22 of the device 10 by tape – open first end of the device is formed by the impermeable covering 20 thus the tape is secured to the impermeable covering 20; Paragraph 0091).
Regarding claim 30, Davis discloses the method of claim 26. Davis further discloses wherein applying one or more adhesive arms to at least one of a pubic region, a pelvic region, or an abdominal region of the user effective to secure the fluid collection device to the user includes applying the one or more adhesive arms to the abdominal region of the user (anchor is attached to pelvic region of the user; Figure 10; Paragraph 0061), the one or more adhesive arms being secured to the conduit that is in fluid communication with the chamber (anchor 50 can be secured to tube 32 and to the user – where the tube 32 is connected to device 10; Paragraph 0092).
Regarding claim 31, Davis discloses the method of claim 30. Davis further discloses further comprising securing the one or more arms to the conduit (anchor 50 can be secured to tube 32 and to the user – where the tube 32 is connected to device 10; Paragraph 0092).
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) 4-6, 10-14, 20-21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (Publication No. US 2018/0228642 A1).
Regarding claim 4, Davis discloses the device of claim 2. The embodiment of Davis in Figures 1-7 does not teach wherein each of the two arms include a width of at least about 2.5 cm.
However, the embodiment of Figure 23A-B of Davis teaches wherein each of the two arms include a width of at least about 2.5 cm (second to fourth sizes of the anchor has an anchor 50 with each arm having a width that ranges from approximately 2 to 20 centimeters wide; Paragraph 0086; Figure 23A-B).
Davis is considered to be analogous to the claimed invention because they are in the same field of external urine collection devices. 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 Davis to incorporate the embodiment of Figures 23A-B of Davis and have the anchor of Davis to be the anchors of different sizes, as taught by the embodiment of Figures 23A-B of Davis. This would allow for the anchor to adhere to users of different sizes, such as a larger width for users who are larger in size (Davis; Paragraph 0086).
Regarding claim 5, Davis discloses the device of claim 2. The embodiment of Davis in Figures 1-7 does not teach wherein each of the two arms include a width of at least about 5.1 cm.
However, the embodiment of Figure 23A-B of Davis teaches wherein each of the two arms include a width of at least about 2.5 cm (third to fourth sizes of the anchor has an anchor 50 with each arm having a width that ranges from approximately 6 to 20 centimeters wide; Paragraph 0086; Figure 23A-B).
Davis is considered to be analogous to the claimed invention because they are in the same field of external urine collection devices. 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 Davis to incorporate the embodiment of Figures 23A-B of Davis and have the anchor of Davis to be the anchors of different sizes, as taught by the embodiment of Figures 23A-B of Davis. This would allow for the anchor to adhere to users of different sizes, such as a larger width for users who are larger in size (Davis; Paragraph 0086).
Regarding claim 6, the modified Davis teaches the device of claim 4. The modified Davis further teaches wherein the width of each of the two arms tapers towards the fluid collection device or the conduit (Figure 23A-B; Paragraph 0086).
Regarding claim 10, Davis discloses the device of claim 9. The embodiment of Figures 1-7 of Davis does not teach wherein each of the two arms extend at least about 2.5 cm from the fluid impermeable barrier.
However, the embodiment of Figure 23A-B of Davis teaches wherein each of the two arms extend at least about 2.5 cm from the fluid impermeable barrier (second to fourth sizes of the anchor has an anchor 50 with each arm having a extends longitudinally from the cover 20/fluid impermeable barrier of the device 10 that ranges from approximately 2 to 20 centimeters wide; Paragraph 0086; Figure 23A-B).
Davis is considered to be analogous to the claimed invention because they are in the same field of external urine collection devices. 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 Davis to incorporate the embodiment of Figures 23A-B of Davis and have the anchor of Davis to be the anchors of different sizes, as taught by the embodiment of Figures 23A-B of Davis. This would allow for the anchor to adhere to users of different sizes, such as a larger width for users who are larger in size (Davis; Paragraph 0086).
Regarding claim 11, Davis discloses the device of claim 9. The embodiment of Figures 1-7 of Davis does not teach wherein each of the two arms extend at least about 5.1 cm from the fluid impermeable barrier.
However, the embodiment of Figure 23A-B of Davis teaches wherein each of the two arms extend at least about 5.1 cm from the fluid impermeable barrier (third to fourth sizes of the anchor has an anchor 50 with each arm having a extends longitudinally from the cover 20/fluid impermeable barrier of the device 10 that ranges from approximately 6 to 20 centimeters wide; Paragraph 0086; Figure 23A-B).
Davis is considered to be analogous to the claimed invention because they are in the same field of external urine collection devices. 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 Davis to incorporate the embodiment of Figures 23A-B of Davis and have the anchor of Davis to be the anchors of different sizes, as taught by the embodiment of Figures 23A-B of Davis. This would allow for the anchor to adhere to users of different sizes, such as a larger width for users who are larger in size (Davis; Paragraph 0086).
Regarding claim 12, Davis discloses the device of claim 9. Davis does not expressly teach wherein the two arms are positioned or positionable less than about 7.6 cm from the aperture on the fluid impermeable barrier.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the two arms of Davis to be positioned less than about 7.6 cm from the aperture on the fluid impermeable barrier since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04(IV)(A). In the instant case, the arms of the device would not operate differently with the positioning of the arms with respect to the aperture of the fluid impermeable barrier since the device of Davis has similar components and structure resembling the claimed invention and is intended to adhere the device onto the body of the user for urine collection. Further, applicant places no criticality on the distance of the arms claimed, indicating simply that the distance “may” be the given ranges (specification; paragraph 0034).
Regarding claim 13, Davis discloses the device of claim 9. Davis does not expressly teach wherein the two arms are positioned or positionable less than about 5.1 cm from the aperture on the fluid impermeable barrier.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the two arms of Davis to be positioned less than about 5.1 cm from the aperture on the fluid impermeable barrier since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04(IV)(A). In the instant case, the arms of the device would not operate differently with the positioning of the arms with respect to the aperture of the fluid impermeable barrier since the device of Davis has similar components and structure resembling the claimed invention and is intended to adhere the device onto the body of the user for urine collection. Further, applicant places no criticality on the distance of the arms claimed, indicating simply that the distance “may” be the given ranges (specification; paragraph 0034).
Regarding claim 14, Davis discloses the device of claim 9. Davis does not expressly teach wherein the two arms are positioned or positionable less than about 2.5 cm from the aperture on the fluid impermeable barrier.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the two arms of Davis to be positioned less than about 2.5 cm from the aperture on the fluid impermeable barrier since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)(MPEP 2144.04(IV)(A). In the instant case, the arms of the device would not operate differently with the positioning of the arms with respect to the aperture of the fluid impermeable barrier since the device of Davis has similar components and structure resembling the claimed invention and is intended to adhere the device onto the body of the user for urine collection. Further, applicant places no criticality on the distance of the arms claimed, indicating simply that the distance “may” be the given ranges (specification; paragraph 0034).
Regarding claim 20, Davis discloses the device of claim 19. The embodiment of Figures 1-7 of Davis does not teach wherein each of the two arms extend at least about 2.5 cm from the second portion of the conduit.
However, the embodiment of Figure 23A-B of Davis teaches wherein each of the two arms extend at least about 2.5 cm from the second portion of the conduit (second to fourth sizes of the anchor has an anchor 50 with each arm having a extends longitudinally from the second portion of the tube 32 that is aligned with the open first end 22 of the device 10 that ranges from approximately 2 to 20 centimeters wide; Paragraph 0086; Figure 23A-B).
Davis is considered to be analogous to the claimed invention because they are in the same field of external urine collection devices. 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 Davis to incorporate the embodiment of Figures 23A-B of Davis and have the anchor of Davis to be the anchors of different sizes, as taught by the embodiment of Figures 23A-B of Davis. This would allow for the anchor to adhere to users of different sizes, such as a larger width for users who are larger in size (Davis; Paragraph 0086).
Regarding claim 21, Davis discloses the device of claim 19. The embodiment of Figures 1-7 of Davis does not teach wherein each of the wherein each of the two arms extend at least about 5.1 cm from the second portion of the conduit.
However, the embodiment of Figure 23A-B of Davis teaches wherein each of the two arms extend at least about 5.1 cm from the second portion of the conduit (third to fourth sizes of the anchor has an anchor 50 with each arm having a extends longitudinally from the second portion of the tube 32 that is aligned with the open first end 22 of the device 10 that ranges from approximately 6 to 20 centimeters wide; Paragraph 0086; Figure 23A-B).
Davis is considered to be analogous to the claimed invention because they are in the same field of external urine collection devices. 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 Davis to incorporate the embodiment of Figures 23A-B of Davis and have the anchor of Davis to be the anchors of different sizes, as taught by the embodiment of Figures 23A-B of Davis. This would allow for the anchor to adhere to users of different sizes, such as a larger width for users who are larger in size (Davis; Paragraph 0086).
Regarding claim 24, Davis discloses the device of claim 19. The embodiment of Figures 1-7 does not teach wherein the two arms are molded onto the device.
However, the embodiment of Figure 21A of Davis teaches that the anchor 50 with the two arms can be molded onto the open first end 22 of the device 10 at the fluid impermeable barrier or layer 20 (Figure 21A; Paragraph 0091). It is known to one of ordinary skill in the art that a shrink wrap would mold onto the shape of the device when heated.
Davis is considered to be analogous to the claimed invention because they are in the same field of external urine collection devices. 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 Davis to incorporate the embodiment of Figures 21A of Davis and have the anchor of Davis to be molded onto the device of Davis. This would allow for the anchor to be securely wrapped around the shape of the device of Device while sealing the end of the device as well (Davis; Paragraph 0091).
Davis does not teach wherein the two arms are molded to the second portion of the conduit.
However, Davis teaches that the anchor can be attached at the conduit, above the fluid permeable barrier, or on the fluid impermeable barrier (Paragraph 0091-0092).
Since Davis discusses that there are only a select number of methods to attach the anchor onto the device, onto the fluid impermeable barrier or onto the conduit/tube, and so there are a limited number of potential solutions when selecting the method of attachment. As there are only a finite number of solutions, one of ordinary skill in the art would have had a reasonable expectation of success by selecting from this finite list, and thus it would have been obvious to try to shrink wrap/mold the anchor onto the conduit/tube of Davis because there is a finite number of identified, predictable solutions. Choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. at 421, 82 USPQ2d at 1397 (see MPEP § 2143, E.). The modified Davis further teaches wherein the two arms are molded to the second portion of the conduit (see combination above).
Claim(s) 18, 25, 29, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (Publication No. US 2018/0228642 A1), as applied to claim 9 above, and further in view of Brenikov (Patent No. GB 2,507,318 A).
Regarding claim 18, Davis discloses the device of claim 9. Davis does not teach further comprising a ring configured to friction fit around the fluid impermeable barrier, wherein the two arms are secured to the ring.
However, Brenikov teaches further comprising a ring configured to friction fit around a tubular structure (tube-receiving portion 3 is configured to hold a tubing in place – obvious that a frictional force is applied between holder and tube to hold tube stably; Abstract; Page 1, lines 18-21; Figure 1), wherein the two sides of the adhesive are secured to the ring (both left and right sides of patch is secured to tube-receiving portion 3 through molding; Abstract; Figure 1).
Davis and Brenikov are considered to be analogous to the claimed invention because they are in the same field of devices with medical tubing. 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 Davis to incorporate the teachings of Brenikov and have the ring of Brenikov fit around the fluid impermeable barrier of Davis with the arms of Davis secured to the ring of Brenikov. This would allow for the ring to prevent any movement between the tubular structure and the user (Brenikov; Page 1, lines 18-21) while preventing the molded adhesive to be dislodged from the ring structure of the apparatus (Brenikov; Page 3, lines 4-6). The combination of Davis in view of Brenikov further teaches further comprising a ring configured to friction fit around the fluid impermeable barrier, wherein the two arms are secured to the ring (see combination above).
Regarding claim 25, Davis discloses the device of claim 19. Davis does not teach further comprising a ring friction fit around the second portion of the conduit, wherein the two arms are secured to the ring.
However, Brenikov teaches further comprising a ring friction fit around a tubular structure (tube-receiving portion 3 is configured to hold a tubing in place – obvious that a frictional force is applied between holder and tube to hold tube stably; Abstract; Page 1, lines 18-21; Figure 1), wherein the two sides of the adhesive are secured to the ring (both left and right sides of patch is secured to tube-receiving portion 3 through molding; Abstract; Figure 1).
Davis and Brenikov are considered to be analogous to the claimed invention because they are in the same field of devices with medical tubing. 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 Davis to incorporate the teachings of Brenikov and have the ring of Brenikov fit around the second portion of the conduit of Davis with the arms of Davis secured to the ring of Brenikov. This would allow for the ring to prevent any movement between the tubular structure and the user (Brenikov; Page 1, lines 18-21) while preventing the molded adhesive to be dislodged from the ring structure of the apparatus (Brenikov; Page 3, lines 4-6). The combination of Davis in view of Brenikov further teaches further comprising a ring friction fit around the second portion of the conduit, wherein the two arms are secured to the ring (see combination above).
Regarding claim 29, Davis discloses the method of claim 28. Davis does not teach wherein securing the one or more arms to the fluid impermeable barrier includes friction fitting a ring on the fluid impermeable barrier, the one or more arms being secured to the ring.
However, Brenikov teaches wherein securing the one or more arms to the tubular structure includes friction fitting a ring on the tubular structure (tube-receiving portion 3 is configured to hold a tubing in place – obvious that a frictional force is applied between holder and tube to hold tube stably; Abstract; Page 1, lines 18-21; Figure 1), the two sides of the adhesive being secured to the ring (both left and right sides of patch is secured to tube-receiving portion 3 through molding; Abstract; Figure 1).
Davis and Brenikov are considered to be analogous to the claimed invention because they are in the same field of devices with medical tubing. 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 Davis to incorporate the teachings of Brenikov and have the ring of Brenikov fit around the fluid impermeable barrier of Davis with the arms of Davis secured to the ring of Brenikov. This would allow for the ring to prevent any movement between the tubular structure and the user (Brenikov; Page 1, lines 18-21) while preventing the molded adhesive to be dislodged from the ring structure of the apparatus (Brenikov; Page 3, lines 4-6). The combination of Davis in view of Brenikov further teaches wherein securing the one or more arms to the fluid impermeable barrier includes friction fitting a ring on the fluid impermeable barrier, the one or more arms being secured to the ring (see combination above).
Regarding claim 32, Davis discloses the method of claim 31. Davis does not teach wherein securing the one or more arms to the conduit includes fitting a ring on the conduit, the one or more arms being secured to the ring.
However, Brenikov teaches wherein securing the one or more arms to the tubular structure includes friction fitting a ring on the tubular structure (tube-receiving portion 3 is configured to hold a tubing in place – obvious that a frictional force is applied between holder and tube to hold tube stably; Abstract; Page 1, lines 18-21; Figure 1), the two sides of the adhesive being secured to the ring (both left and right sides of patch is secured to tube-receiving portion 3 through molding; Abstract; Figure 1).
Davis and Brenikov are considered to be analogous to the claimed invention because they are in the same field of devices with medical tubing. 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 Davis to incorporate the teachings of Brenikov and have the ring of Brenikov fit around the conduit of Davis with the arms of Davis secured to the ring of Brenikov. This would allow for the ring to prevent any movement between the tubular structure and the user (Brenikov; Page 1, lines 18-21) while preventing the molded adhesive to be dislodged from the ring structure of the apparatus (Brenikov; Page 3, lines 4-6). The combination of Davis in view of Brenikov further teaches wherein securing the one or more arms to the conduit includes fitting a ring on the conduit, the one or more arms being secured to the ring (see combination above).
Claim(s) 23 is rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (Publication No. US 2018/0228642 A1), as applied to claim 19 above, and further in view of Dikeman et al. (Publication No. US 2012/0059328 A1).
Regarding claim 23, Davis discloses the device of claim 19. Davis further teaches wherein the anchor 50 with the two arms can be bonded through adhesive to the second portion of the conduit (Paragraph 0091-0092). Davis does not teach wherein the two arms are ultrasonically bonded to the second portion of the conduit.
However, Dikeman teaches that the adhesive membrane 18 can be attached to the platform of the conduit, comprising platform 20 and strap 22, by suitable manufacturing methods such as adhering, RF welding, ultrasonic welding, heat staking, or overmolding (Paragraph 0060; Figure 4).
Since the prior art of Dikeman recognized the equivalency of adhering and ultrasonic welding as a method of manufacturing in the field of devices with medical tubing, it would have been obvious to a person having ordinary skill in the art to substitute the adhesive bonding with ultrasonic bonding since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so, with the predictable result of securing two components together. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781