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 .
Response to Amendment
In response to the amendment filed on 01/12/2026, Claim 9 has been cancelled, and Claims 1-8 and 10-15 are pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 and 10-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 1, the limitation “a solid guidewire free of a lumen, having a sufficient torsional rigidity to maintain a proximal end substantially aligned with a distal end during rotation” is considered new matter because while Applicant has support for rotating the guidewire (Page 24, Lines 16-18 and Page 27, Lines 1-2), Applicant does not have support for the limitation “to maintain a proximal end substantially aligned with a distal end during rotation”. In essence, Applicant has support for rotating the guidewire to orient the implant, but does not have support for maintaining alignment of the proximal and distal ends during rotation.
Claims 2-8 and 10-15 are rejected for incorporating errors from the parent claim by dependency.
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.
Claim(s) 1-8, 10 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lamson (US PGPub 2015/0127050) in view of Kilemnick (US PGPub 2011/0276081) and Palmer (US Patent 6,458,139).
Regarding Claim 1, Lamson teaches a urethral implant delivery system comprising:
an overtube (3300; Figure 33A) including a first elongated passage (3312), a second elongated passage (3302) and a handle connector (see annotated Figure 33A below, in which these elements are all ports which are configured to slidably attach to handles of either suction devices, medical devices being introduced, or aspiration devices which can deliver air; the examiner is interpreting these elements to be handle connectors because it connects the handle to other devices positioned within the lumen of the overtube),
PNG
media_image1.png
224
435
media_image1.png
Greyscale
a handle (see annotate Figure 33A above)
a camera (cystoscope; Paragraph 0309), located at a distal end of said first elongated passage (Paragraph 0309 states that the scope extends the distal end of cystoscope lumen 3314);
a urethral implant (Figures 33D), located within said second elongated passage (working device lumen 3304; Paragraph 0309)
wherein said handle connector is configured to be coupled with a handle (elements 3304 and 3314 are all ports which provide entry to working device lumens; Paragraph 0309. These handle connectors are integral to the handle and thus are configured to be coupled with said handle since they are formed coupled with said handle).
While Lamson does teach a plurality of devices (Figures 33A-33N; Paragraphs 0310- 0317) which can be inserted through the working lumen (3304; second elongate passage) Lamson fails to explicitly disclose:
a guidewire, coupled with said urethral implant, said guidewire enabling said urethral implant to be pushed through said overtube until said urethral implant exits said overtube, wherein said guidewire extends towards a proximal direction of said overtube and exits said handle.
Kilemnick teaches a urethral implant (Abstract), wherein the urethral implant (212) is configured to be located within a working lumen (of element 202; see Figures 4A-4C), wherein a guidewire (208; internal tube; the Examiner notes that the term guidewire is not impart structure into the claims and the internal tube 208 is considered to read on a guidewire as claimed), coupled with said urethral implant (212), said guidewire (208) enabling said urethral implant (212) to be pushed through said overtube (202/204) until said urethral implant (212) exits said overtube (202/204; see Figure 4C), wherein said guidewire (208) extends towards a proximal direction of said overtube (202 and 204) and exits the handle (206) .
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the urethral implant taught by Lamson with the urethral implant and guidewire teachings of Kilemnick since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; Since Lamson teaches a working lumen for delivering medical devices, substituting known medical devices, such as that of Kilemnick, into the working lumen the device taught by Lamson would be within the skill of an ordinary person in the art and would be operable. Furthermore, it would have been obvious to one of ordinary skill in the art to have the guidewire exit the handle of the overtube at the proximal end for the advantage that one can manipulate the guidewire (208) with a guidewire handle (210) proximal and distally relative to the overtube and the overtube handle.
While Kilemnick does not disclose that tube (208) comprises a lumen, Lamson is silent that the tube is a guidewire free of a lumen, having sufficient torsional rigidity to maintain a proximal end substantially aligned with a distal end during rotation.
Palmer teaches an implantable device (Figures 3A-13) comprising an expandable implant (82; Figure 7) which is coupled to a distal end of a solid guidewire (44; Figure 3A) (84; Figure 7) free of a lumen (Column 6, Lines 1-5 and Column 8, Lines 41-45), which is to be delivered from an overtube (28; Figure 3A), the solid guidewire having sufficient torsional rigidity to maintain a proximal end substantially aligned with a distal end during rotation (Column 6, Lines 1-5; Column 7, Lines 7-20; and Column 8, Lines 33-40).
Therefore, it would have been obvious to one of ordinary skill in the art to modify/substitute the tube of Kilemnick to be a solid tube or a guidewire with no lumen having sufficient torsional rigidity during rotation, as taught by Palmer, since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, a single guidewire comprising a single strand of material formed of stainless steel (a Column 6, Lines 1-5) would be sufficient to deliver the implant out of the working lumen of the overtube and have sufficient torsional rigidity during rotation.
Regarding Claim 2, the combination of references disclosed above teaches the urethral implant delivery system according to Claim 1, wherein Kilemnick said urethral implant (212) includes at least one wire having a closed shape (see Figures 4A-4C; Figure 6A; Paragraph 0062), said urethral implant exhibiting an expanded configuration (Figure 4C) and being foldable into a folded configuration (Figure 4A), said urethral implant is configured to expand from said folded configuration (Figure 4A) to said expanded configuration (Figure 4B), wherein said urethral implant is configured to be implanted within a restricted location of a urethra and for applying pressure on surrounding tissue of the urethra (Paragraph 0054).
Regarding Claim 3, the combination of references disclosed above teaches the urethral implant delivery system according to claim 2 wherein Kilemnick teaches said urethral implant is configured for creating incisions in said urethra (abstract; Paragraph 0047).
Regarding Claim 4, the combination of references disclosed above teaches the urethral implant delivery system according to claim 1, wherein Kilemnick said urethral implant is configured for implantation in a prostatic urethra (Paragraph 0003 and Paragraph 0007).
Regarding Claim 5, the combination of references disclosed above teaches the urethral implant delivery system according to claim 2 wherein Kilemnick said urethral implant further includes an anchor (530; Figure 13A-13B) OR (624; Figures 16A-16B) configured to prevent said urethra implant from moving in a direction of extension of said anchor (Paragraph 0076-0081).
Regarding Claim 6, the combination of references disclosed above teaches the urethral implant delivery system according to claim 1, wherein Kilemnick teaches said urethral implant is removable from an implantee (Paragraph 0054).
Regarding Claim 7, the combination of references disclosed above teaches the urethral implant delivery system according to claim 1, wherein said urethral implant delivery system is configured for a single use.
The recitation in the claims that the device is “the urethral implant delivery system is configured to single use” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that combination of references discloses a urethral implant delivery system as presently claimed, it is clear that the system taught would be capable of performing the intended use, i.e. (being used a single time), presently claimed as required in the above cited portion of the MPEP. In other words, the system taught by the combination of references can be discarded after every use.
Regarding Claim 8, the combination of references disclosed above teaches the urethral implant delivery system according to claim 1, wherein Kilemnick teaches said urethral implant is configured for temporary implantation (Paragraph 0054).
Regarding Claim 10, the combination of references disclosed above teaches the urethral implant delivery system according to claim 1, wherein Lamson teaches said second elongated passage (3304) is further employed to transport fluids to or from a urethra or a bladder (Paragraph 0309 states that the second elongate passage has port 3318 for removing or introducing fluids).
Regarding Claim 12, the combination of references disclosed above teaches the urethral implant delivery system according to claim 1, wherein Lamson teaches an optical axis of said camera is aligned with an axis of said overtube (Paragraph 0309 states 0 degree angle for the camera).
Regarding Claim 13, the combination of references disclosed above teaches the urethral implant delivery system according to claim 1, wherein Lamson teaches an optical axis of said camera is at an angle shift relative to an axis of said overtube (Paragraph 0309 states 30, 70, 120 degree on camera angle).
Regarding Claim 14, the combination of references disclosed above teaches the urethral implant delivery system according to claim 1, wherein Kilemnick said guidewire (208) is rotatable for maneuvering said urethral implant (212) at a desired orientation (Figure 4A-4C; it’s the examiners position that since the guidewire 208 is within tube 204 and there is no structure to restrict rotation, the device taught by Kilemnick is capable of rotating the medical device (212) via handle (210) since both of those structures are rigidly connected by element 208) .
Regarding Claim 15, the combination of references disclosed above teaches the urethral implant delivery system according to claim 1, wherein Kilemnick teaches said guidewire (see Paragraph 0072) enables positioning said urethral implant into a prostatic urethra by pulling said guidewire (Figures 11A-11B) (see also 506 in Figure 12 and Paragraph 0073).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lamson (US PGPub 2015/0127050) in view of Kilemnick (US PGPub 2010/0137893) and Palmer (US Patent 6,458,139) as applied to claim 1 above, and further in view of Schoellhorn (US PGPub 2002/0156348).
Regarding Claim 11, the combination of references disclosed above teaches the urethral implant delivery system according to claim 1, wherein Lamson teaches said handle (3300) includes a saline delivery port (3320/3318), an optics connector (3316), and a guidewire exit port (3306).
Lamson fails to disclose a connector lock and an optics cable.
Schoellhorn teaches a medical instrument for endoscopic removal (abstract) comprising a handle (16; Figures 1-3) comprising a connector lock (52; Paragraph 0083; Figures 2-3), an optics cable (not shown; Paragraph 0064), an optics connector (30; Figure 1; Paragraph 00645).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of the combination of references to include the teachings of Schoellhorn, for the advantage that cystoscope of Lamson can be integral to the handle the implant delivery system in order to reduce the amount of working moving parts.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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, Jackie Ho can be reached on (571) 270-5953. 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.
/MOHAMED G GABR/Primary Examiner, Art Unit 3771
Prosecution Insights