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 1, 9-13 and claims dependent thereon are objected to because it is suggested that claim 1 be amended to positively recite the at least one operable hydraulic constriction element. As currently written the support element only needs to be configured to surround and support at least one operable hydraulic constriction element, the hydraulic constriction element itself is not part of the claim. This becomes particularity important for example for claim 10 and 11. Claim 10 and 11 are interpreted as the support element just has to be capable of surrounding and supporting 2 hydraulic constriction elements with 2 different volumes, including one being at least 1.5 times larger than another. However, for compact prosecution rejections have been applied as if the hydraulic constriction elements are positively recited.
Claim 10 is objected to because of the following informalities:
Claim 10 reads the limitation “at least 1,5 times bigger” and should be corrected to “at least 1.5 times bigger”
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.
Claims 1, 15 and claims dependent thereon 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.
Regarding claim 1, the phrase “axis defining the angle of entry/exit” is not defined by the claim or the applicant’s specification. Therefore, it is unclear exactly what feature of the device is meant to disaligned, and where the angles of entry/exit are on the device. Please clarify if the angle of entry/exit is the angle the fluid conduit enters/exits the support element (fig. 1D , elements 24A or 24B) or the angle the fluid conduits enter the hydraulic constriction elements (fig. 1D, element 101A or C).
Regarding claim 15, there is a lack of antecedent basis for the term “the surrounding structure”. It is unclear if the surrounding structure in claim 15 is the same as the surrounding structure in claim 1 or a different surrounding structure.
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, 12, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Forsell (US 6709385).
Regarding claim 1, Forsell discloses a
support element for an implantable constriction device for constricting a urethra of a patient (abstract ”The restriction device engages the urethra”),
the support element being configured to form at least a portion of a surrounding structure (fig. 11, element 96. Column 17, line 26 “the tissue soft elastic hose 96”)
configured to surround and support at least one operable hydraulic constriction element (column 17, line 16- 23 “a hydraulic motor comprises two interconnected cylinders 78 and 80 and two pistons 82 and 84 in the respective cylinders 78,80.” “The core 88 defines a restriction opening” The examiner notes elastic hose 96 surrounds core 88 which houses hydraulic constriction elements 78, 80.) configured to constrict the urethra for restricting the flow of urine therethrough (column 13, line 53 “restrict the urine passageway and to release the urine passageway when the patient wants to urinate”),
wherein the support element comprises at least one fluid conduit at least partially integrated in the support element (column 17, line 27 “the cylinders 90,92.” The examiner notes elements 90, 92 are partially housed inside support element 96 (shown in figures 11-12), and are therefore partially integrated.),
wherein an axis defining the angle of entry of the at least one fluid conduit into the support element and an axis defining the angle of exit of the at least one fluid conduit out of the support element, are disaligned (Figure 12, element 86, 90, and 92. The examiner notes the angle of entry of element 86 is disaligned with the angle of entry of 90 and 92 as the fluid conduits split into different directions).
Regarding claim 3, Forsell teaches the support element according to claim 1, wherein the support element comprises at least one curvature adapted for the curvature of the urethra. (Column 2, line 36 “restriction device generally is adapted to form an at least substantially closed loop around said portion of the urethra or urine bladder”. The examiner notes that the device has a curvature adapted for the curvature of the urethra.)
Regarding claim 12, Forsell teaches the support element according to claim 1, and wherein wherein the support element comprises an outer surface configured to be directed away from the urethra, when implanted, wherein the outer surface comprises at least one inlet to the at least one fluid conduit (column 17, line 28 “The hose 96 has an outer tubular wall 98”; column 17 line 31 “By supplying fluid to or withdrawing fluid from the inlet 86”) and wherein the at least one inlet is configured to be in fluid connection with a hydraulic pump for pumping fluid (column 12, line 49 “As should be realised by a skilled person, in many of the above-described embodiments of the invention the adjustment device may be operated by control means or manual manipulation means implanted under the skin of the patient, such as a pump”).
Regarding claim 15, Forsell teaches a surrounding structure for an implantable constriction device for constricting a urethra of a patient (abstract ”The restriction device engages the urethra”), the surrounding structure being configured to surround the urethra when implanted (column 2, line 59 “forming the restriction member into at least a substantially closed loop around said portion of the urethra or urine bladder,”), the surrounding structure comprises at least one support element according to claim 1 (Please see claim 1 rejection).
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, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US 6709385).
Regarding claim 2, Forsell teaches the support element according to claim 1, but fails to teach wherein the at least one fluid conduit is completely integrated in the support element.
It would be prima facie obvious to modify the system taught by Forsell to have the fluid conduit completely integrated in the support element. One of ordinary skill in the art would have been able to recognize that this would reduce leak risks by not needing additional connectors and therefore increase the reliability of the medical device. Making something integral is generally recognized as being within the level of ordinary skill in the art. Please see MPEP 2144.04, section V; In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965); and Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983).
Regarding claim 13, Forsell teaches wherein the support element has a length in the axial direction of the urethra, when implanted, and wherein at least one operable hydraulic constriction element has a length in the axial direction of the urethra, when implanted, but fails to teach wherein the length of the at least one operable hydraulic constriction element is longer than the length of the support element.
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the proportions between the length of hydraulic constriction element and the length of support element. One of ordinary skill in the art would have been able to recognize that limitations relating to the size or scaled up proportion would not establish patentability over the prior art. Please see MPEP section 2144.04, section IV, A; In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forsell in view of Taylor (US 2017/0020644).
Regarding claim 9, Forsell teaches the support element according to claim 1,
wherein the support element comprises a second fluid conduit at least partially integrated in the support element (column 17, line 15 “two interconnected cylinders 78 and 80”) ),
However, Forsell fails to teach and wherein the first at least partially integrated fluid conduit is configured to conduct fluid to the first operable hydraulic constriction element and the second at least partially integrated fluid conduit is configured to conduct fluid to a second operable hydraulic constriction element.
Taylor teaches a restriction cuff with hydraulic constriction elements. (paragraph [0048] “FIG. 4B is an end view of one embodiment of a cuff 28′ provided with a pair of opposing inflatable balloons 32a,32b…. Each of the balloons 32a, 32b includes a conduit connector (not shown) that is attachable to the tubing 24 (FIG. 1) to allow the balloons 32a, 32b to be inflated with saline or other liquid.” The examiner is modifying the system taught by Forsell to have the hydraulic constriction elements (32A and B) to be connected to the tubing (one balloon for each cylinder (78, 80)).
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Forsell to have the hydraulic restriction elements taught by Taylor. One of ordinary skill in the art would have been able to recognize that the interior balloons would provide additional comfort and restriction to the patient to prevent unintentional urination.
Regarding claims 10-11, Forsell teaches the support element according to claim 9, but fails to teach wherein the first operable hydraulic constriction element has a larger volume than the second operable hydraulic constriction element (of claim 10) and wherein the first operable hydraulic constriction element has a volume which is at least 1,5 times larger than the volume of the second operable hydraulic constriction element (of claim 11).
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify one hydraulic element to have a larger volume than the other. One of ordinary skill would have been able to recognize 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. Please see MPEP 2144.04, IV, A; and Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forsell in view of Gallagher (GB 2355937)
Regarding claim 4, Forsell teaches the device of claim 3, but fails to teach wherein the curvature has a radius in the range 3mm - 50mm, or in the range 5mm - 30mm.
Gallagher teaches a urinary sphincter device that has a radius in the range of 2 cm to 12 cm. (page 10, line 28 “Preferably the cuff portion is provided in a range of sizes ranging from 2 cm to 12 cm in radius.” The examiner notes that since the range taught in the prior art overlaps with the claimed range of 5 mm to 30 mm there is an embodiment that is in the claimed range.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Forsell to have the range by Gallagher. One of ordinary skill in the art would have been able to recognize that 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. Please see MPEP 2144.04, II, A; In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Regarding claim 5, Forsell teaches the support element according to claim 1, but fails to teach wherein the support element comprises: a first curvature having a first radius, and a second curvature having a second radius, and wherein the first radius is smaller than the second radius.
Gallagher teaches a first curvature having a first radius (figure 1, element 36),
and a second curvature having a second radius (figure 1, element 34),
and wherein the first radius is smaller than the second radius (page 10, line 18 “wherein the radius of curvature of the inner elastic membrane is reduced but is substantially parallel to the radius of curvature of the membrane in a deflated condition”).
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Forsell to have two radii where one is smaller than the other. One of ordinary skill in the art would have been able to recognize the device should be made available in a variety of different sizes so to be suitable for use on a range of patients of different anatomical size. Please see page 10, line 24 of Gallagher.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forsell in view of Hou (US 2012/0136199).
Regarding claim 6, Forsell teaches the support element according to claim 1, but fails to teach wherein a major portion of the support element is made from a material having a modulus of elasticity in the range 0,2 GPa - 1000 GPa or in the range 1 GPa - 400 GPa.
Hou teaches a urinary incontinence device with an elastic modulus of 2 GPa. (paragraph [0035] “Preferred high modulus polymers have an elongation at yield of at least 3% and an elastic modulus of at least 2 Gpa.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Forsell to have the range by Hou. One of ordinary skill in the art would have been able to recognize that 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. Please see MPEP 2144.04, II, A; In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Claim(s) 7-8, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forsell in view of Koss (US 4643169).
Regarding claims 7-8, Forsell teaches the support element according to claim 1, but fails to teach wherein the support element comprises a connection portion for connecting the support element to another support element for at least partially forming the surrounding structure (of claim 7) and wherein the support element comprises a portion of a hinge for hingedly connecting the support element to another support element for at least partially forming the surrounding structure (of claim 8).
Koss teaches a incontinence device with a hinge connector that connects one support element to another. (column 8, line 12 “two half shell portions 1 and 2 of silicone rubber, which are connected together by way of a film hinge 3 which is only shown in diagrammatic form.” The examiner is modifying the system taught in Forsell to have a hinge connector that connects both support elements to the other.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Forsell to have the hinge connector taught by Koss. One of ordinary skill in the art would have been able to recognize that having an open/close hinge connection would make it significantly easier to attach and adjust the restriction band to urethra,
Regarding claim 18, Forsell teaches the surrounding structure according to claim 17 but fails to teach wherein the first and second support elements are hingedly connected to each other for forming the surrounding structure, such that a periphery of the surrounding structure is possible to open, such that the surrounding structure can be placed around the urethra.
Koss teaches a incontinence device with a hinge connector that connects one support element to another. (column 8, line 12 “two half shell portions 1 and 2 of silicone rubber, which are connected together by way of a film hinge 3 which is only shown in diagrammatic form.” The examiner is modifying the system taught in Forsell to have a hinge connector that connects both support elements to the other. The examiner notes that the prior art taught by Forsell the periphery of the structure opens and surrounds the urethra, see claim 17 rejection.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Forsell to have the hinge connector taught by Koss. One of ordinary skill in the art would have been able to recognize that having an open/close hinge connection would make it significantly easier to attach and adjust the restriction band to urethra.
Claim(s) 14, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forsell in view of Forsell (US 2015/0359617), as cited in the applicant’s IDS, herein referred to as Forsell 2.
Regarding claims 14 and 20, Forsell teaches the support element according to claim 1, but fails to teach wherein the support element (of claim 14) and the surrounding structure (of claim 20) further comprises an electrode arrangement configured to be arranged between the support element and the urethra and to engage and electrically stimulate muscle tissue of the urethra to exercise the muscle tissue to improve the conditions for long term implantation of the implantable constriction device.
Forsell 2 teaches a constriction device with an electrode that can stimulate the muscle to close an opening. (paragraph [0375] “A multiplicity of electrical elements 7 (such as electrodes)” paragraph [0432] “The electrical elements 7 of the constriction elements 208A-208C stimulate the constricted wall portions with electric pulses so that the wall portions thicken and close” paragraph [0437] “Generally speaking, the implanted energy-transforming device 302 may be placed in the abdomen, thorax, muscle fascia (e.g. in the abdominal wall), subcutaneously, or at any other suitable location.” Paragraph [0009] “A disadvantage common to all prior artificial sphincters is that hard fibrosis may form around the artificial sphincter over time and may cause malfunction of the artificial sphincter. Thus, the formed fibrosis may sooner or later become a hard fibrotic layer which may make it difficult for the artificial sphincter to work.” The examiner notes that this device may prevent fibrosis it will improve conditions for longer term implantation of the implantable constriction device.)
It would be prima facie obvious to one of ordinary skill in the art to modify the system in Forsell to have the electrode stimulator in Forsell 2. One of ordinary skill in the art would have been able to recognize that users may not be able to control the movement of their urethra themselves and may need additional support to control fluid movement.
Claim(s) 16-17, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forsell in view of Eton (US 2004/0138684).
Regarding claim 16, Forsell teaches the surrounding structure according to claim 15, but fails to teach wherein the surrounding structure comprises a second support element, and wherein the first and second support elements are configured to be connected and together form at least a portion of the surrounding structure.
Eton teaches an implantable cuff with a first and second support element. (paragraph [0016] “in an exemplary embodiment of the invention the shell 16 is formed in two parts 20,22”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Forsell to be made of two support elements as taught by Eton. One of ordinary skill in the art would have been able to recognize that having two support elements would allow for easier adjustability and implantation of the device around the urethra.
Regarding claim 17, Forsell teaches the surrounding structure according to claim 16, wherein the first and second support elements are configured for forming the surrounding structure and thereby surround the urethra (column 2, line 59 “a substantially closed loop around said portion of the urethra or urine bladder,”),).
Regarding claim 19, Forsell teaches the surrounding structure of claim 16 but fails to teach wherein the second support element comprises at least one cushioning element configured to contact the urethra, wherein the cushioning element is more resilient than the support element.
Eton teaches an implantable cuff with a rigid frame and an inflatable balloon. . (paragraph [0029] “The cuff 28 includes a rigid frame 30 and an inflatable balloon 32 attached to an interior surface 34 of the rigid frame 30.” The examiner notes the rigid frame would not be able to recover after withstanding pressure as the inflatable balloons could therefore the cushioning element (balloon) is more resilient than the support element (frame). The examiner is modifying each support element as taught in claim 16 to be rigid as the frame.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the second support element to have a resilient cushion (flexible inner support membrane) as taught by Eton. One of ordinary skilll in the art would have been able to recognize that to prevent irritation and fibrosis of the contact region of the device with a cushioning element would be necessary.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sayet (US 7011621) teaches a body fluid flow control device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA JOY LACAY DECASTRO whose telephone number is (571)272-8316. The examiner can normally be reached Monday - Friday 9:00 AM - 5:30.
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights