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 3 is objected to because of the following informalities: claim 3 should recite: “the proximal flow structure portion…” to maintain consistency of the limitations. Claim 6 is objected to because of the following informalities: claim 6 should be amended to replace “leuer” with “luer”. 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 14 and 15 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. Claims 14 and 15, which depend from claim 1, further limit the circumferential retainer. However, the retainer is set forth in claim 11 and not claim 1, and the limitation therefore lacks antecedent basis. Claims 14 and 15 should be amended to depend from claim 11.
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.
Claim(s) 1-5, 7-10, 12-13, and 16-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kalb et al. (US 5,007,897).
Regarding claim 1, Kalb et al. (henceforth Kalb) discloses a medical device comprising: a sheath (44) having a proximal end and distal end, wherein the sheath is configured to receive a penis through the proximal end to at least partially cover the penis (Figure 2; Col. 3, lines 32-39), wherein the sheath includes a distal opening in the distal end (Figure 1, for passing the distal section of 10 extending from the sheath distal end); a flow structure (e.g., end 14 of catheter 10) comprising a proximal flow structure portion extending proximally relative to an interior surface of the distal end of the sheath (Figures 1 and 2, the flow structure passes beyond the open end of sheath 44 for passage through the urethra) and configured to be inserted into the urethra of the penis (Figure 2, Col. 3, lines 66-68), wherein the flow structure is in fluid communication with or passes through the distal opening in the distal end of the sheath to allow fluid to flow through the sheath to or from the urethra (see e.g., Col. 4, lines 45-57 which disclose inserting the catheter into the urethra for the infusion of sterile water or saline therein).
Regarding claim 2, Kalb further discloses wherein the flow structure (insertion end of catheter 10) comprises a distal flow structure (for entering the urethra) and a proximal flow structure portion (portion of catheter 10 extending beyond the distal end of sheath 44 for connecting to fluid sources), wherein the distal flow structure portion is configured to extend distally from the distal end of the sheath (Figure 1).
Regarding claim 3, Kalb further discloses wherein the proximal portion and the distal flow structure portion are a single piece (it’s a single catheter as depicted in Figures 1 and 2).
Regarding claim 4, Kalb further discloses wherein the distal flow structure portion is configured to interface with a fluid connector or syringe (Col. 3, lines 19-22 disclose the infusion through lumen 28).
Regarding claim 5, Kalb further discloses wherein the distal flow structure portion includes an engagement mechanism to engage and/or lock to an external flow structure (Col. 3, lines 19-22, lumen 28 terminates at tube 30 with a valve 32 through which the desired drug is injected or continuously fed; such a valved tubing is considered to meet the limitation of the engagement mechanism).
Regarding claim 7, Kalb further discloses wherein the distal flow structure is configured to interface with a needle-less syringe (the valve 32 is disclosed as allowing for an injector to be attached; it’s fully capable of being used with a needle-less injector as it comprises an injector interface feature).
Regarding claim 8, Kalb further discloses wherein the proximal flow structure portion includes a catheter tip configured to enter the urethral meatus of the penis (Figure 2, the catheter passes through the urethra; Col. 3, lines 66-68).
Regarding claim 9, Kalb further discloses wherein the proximal flow structure portion is composed of a rigid or semi-rigid material that is configured to be inserted into the urethral meatus (Col. 2, line 64-Col. 3, line 1; any of the disclosed materials is considered substantially “rigid” as they’re configured to be passed through the urethra and no values for hardness or flexibility are claimed).
Regarding claim 10, Kalb further discloses wherein the flow structure is fused to the sheath (see e.g., Col. 2, lines 32-34 disclose the sheath as preventing the catheter from sliding up the urethra into the bladder; the only way it could prevent movement of the catheter during use is if it were attached or fused to the catheter to prevent movement through the urethra).
Regarding claim 12, Kalb further discloses wherein the sheath is a condom (Figures 1-2) configured to at least partially cover the penis and to constrict around the penis (Figure 2; Col. 3, lines 32-42).
Regarding claim 13, Kalb further discloses wherein the sheath is comprised of an elastic material (Col. 3, lines 32-36 disclose the sheath 44 is formed from the same material as the catheter and Col. 3, liens 43-47 disclose the catheter to be made from a number of elastic materials as claimed).
Regarding claim 16, Kalb discloses a method comprising: inserting a flow structure (insertion end of catheter 10) attached to a sheath (44) into a urethra of a penis through the urethral meatus of the penis (Figure 2); disposing the sheath over the penis (Figure 2), and supplying fluid to the urethra through the flow structure (Col. 3, lines 66-68 disclose delivery to the urethra).
Regarding claim 17, Kalb further discloses connecting an external fluid supply to the flow structure to fluidly communicate the external fluid supply to the flow structure and the urethra (Col. 3, lines 19-22 disclose fluid delivery via tube 30 and connection to an injection or continuous flow source).
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.
Claim(s) 11, 14-15, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kolb in view of Ireland (US 5,855,206).
Regarding claim 11, Kolb discloses the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose a circumferential retainer attached to the sheath to fasten and maintain a position of the sheath axially on the penis.
Ireland teaches (Figures 1-3) a condom sheath (10) comprising a circumferential retainer (20) attached to the sheath on an outside of the sheath (Figures 1-2) and configured to circumferentially fasten to maintain a position of the sheath axially on the penis (12; Col. 6, lines 10-16 disclose using closure 20 to reduce the opening diameter to secure the condom to the penis; see also Col. 7, lines 40-48).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sheath of Kolb to comprise the circumferential securement means of Ireland so as to ensure that the sheath is tightly secured to the penis during use to prevent unwanted movement of the sheath during use as taught by Ireland.
Regarding claims 14, and 18-19, Ireland further discloses wherein the circumferential retainer (20) is a strap including a hook and loop fastener to allow selective tightening of the strap using the fastener (Col. 6, lines 41-50 disclose the use of a hook and loop fastener; the strap is used to tighten the sheath to axially fix the sheath to the penis as per claims 18 and 19).
Regarding claims 15 and 20, Ireland further discloses wherein the circumferential retainer (20) is positioned on the sheath in an axial location such that the circumferential retainer is configured to be tightened proximal to the glans of the penis to create an axial stop (it’s secure at the base of the penis which is proximal to the glans as claimed).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalb in view of Sisley et al. (US 4,405,313).
Regarding claim 6, Kalb discloses the claimed invention substantially as set forth above for claim 1, but does not explicitly disclose the use of a luer-lock mechanism.
Sisley et al. (henceforth Sisley) discloses (Figure 1) a catheter (10) comprising a plurality of fluid connectors (24, 26) which are luer-lock connectors (Col. 5, lines 37-41).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the fluid connector of Kalb to comprise a luer-lock connector to provide a known secure means of connecting fluid delivery/withdrawal means to a catheter device during a procedure as taught by Sisley.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783