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 Numbering
The presently filed claims are misnumbered as a claim numbered "11" does not appear in the current claim listing. The current numbering has been preserved for the purposes of examination. Applicant is invited to correct the claim numbering in the next filing.
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.
Claim 2-3, 6, 9, 13 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 claims 3 and 13, the limitation “a distance…increasing along an arc” renders the claim indefinite because it is unclear how a static distance increases.
Regarding claim 9, the limitations “proximal face” and “distal face” in line 10 renders the claim indefinite because it is unclear that the limitation is referring to the face of the paddle. It is suggested the claim be amended to read “proximal face of the paddle opposite a distal face of the paddle”.
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) 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Borgoanker (US 2012/0157764).
Regarding claim 9, Borgaonker teaches a penile implant assembly comprising:
a penile implant comprising a distal portion implantable into a corpus of an external portion of a penis (paragraph [0021] “The one or more inflatable cylinders 4 further include an inflatable portion 10” The examiner notes in figure 2, element 4 is in the corpus of external portion of a penis) and a proximal portion implantable into a crus of an internal portion of the penis (paragraph [0021] “a rear tip portion 12”),
a rear tip extender (RTE) attachable to the proximal portion of the penile implant (paragraph [0023] “the implantable penile prosthesis 2 can comprise a telescoping rear tip extender 20 affixable to the rear tip 12 of each inflatable cylinder 4.” The examiner notes that the edge of the implant closest to the pump lines is the proximal portion as noted by the applicant and the prior art cites that the RTE would attach at end 12.);
wherein the penile implant comprises a key extending longitudinally from the proximal portion of the penile implant (paragraph [0023] “The locking feature can 16 include a locking nub.”),
With the key comprising a paddle connected to a post, (The examiner notes that in figure 1, the key that consists of the paddle which is the triangle tip of element 16 connected to the penile implant by a post (the rectangle portion length connecting to rear tip of the implant 12) that extends longitudinally.);
with the paddle having a paddle length measured between a proximal face opposite a distal face (The examiner notes that the paddle of element 16 inherently has a paddle length between a proximal face (edge of the RTE) opposite a distal face (end of the penile implant).);
wherein the RTE forms an opening including a slot communicating with a cavity, with the cavity having a longitudinal boundary formed by a proximal RTE wall opposite a distal RTE wall (paragraph [0023] “The interface segment 22 defines a receiving port 28” paragraph [0024] “the interface segment 22 defines a bore 36 for receiving the telescoping segments 24” Figure 4D, element 30 is a distal RTE wall and element 26 is the proximal RTE wall; Paragraph [0023] “receiving port 28 having a shoulder 30”; paragraph [0024] “conical end segment 26” The examiner notes the port 28 is the slot and the bore 36 is the cavity.);
wherein, when the key is inserted into the opening, the post is received within the slot and the paddle length is received within the cavity (paragraph [0023] “ The interface segment 22 defines a receiving port 28 having a shoulder 30 for engaging a locking feature 16 of the inflatable cylinder 4.“ paragraph [0032] “The telescoping rear tip extender 20 is fitted to the rear tip 12 of the inflatable cylinder 4, e.g., snap-fit, nub elements, detents, threading, and the like.” The examiner notes that element 16 in figures 1 and 2 connect to the extender element 20 in figure 2 and that since the locking feature engages the element 22 that the post is received within the slot and paddle is received within the cavity.)
and rotation of the RTE relative to the key moves the RTE toward the penile implant by forcing the distal RTE wall against the distal face of the paddle (paragraph [0025] “In embodiments of the present invention, the interface segment 22, the telescoping segments 24 and the conical end segment 26 can each include a locking mechanism or assembly 40.The locking assembly 40 is adapted to lock the segments in an extended position by twisting the segment relative to the preceding segment to engage the locking assembly 40. The locking assembly 40 can comprise a threaded assembly, a locking ring, a detent mechanism, a snap-fit feature, a press-fit feature and other means of locking the segments in the extended position.”).
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) 1, 4, 6-7, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borgaonker (US 2012/0157764) in view of Terlecki (US 2015/0011823)
Regarding claim 1, Borgaonker teaches a penile implant assembly comprising:
a penile implant comprising a distal portion implantable into a corpus of an external portion of a penis (paragraph [0021] “The one or more inflatable cylinders 4 further include an inflatable portion 10” The examiner notes in figure 2, element 4 is in the corpus of external portion of a penis) and a proximal portion implantable into a crus of an internal portion of the penis (paragraph [0021] “a rear tip portion 12”), with the proximal portion of the penile implant comprising:
a key comprising a paddle connected to a post (paragraph [0023] “The locking feature can 16 include a locking nub.” The examiner notes that in figure 1, that the locking nub is the key that consists of the paddle which is the triangle tip of element 16 connected to the penile implant by a post (the rectangle portion length connecting to the rear tip of implant 12) that extends longitudinally.), with the post connected to the penile implant and extending longitudinally (The examiner notes that in figure 1, the post can be seen of element 16 connected to the penile implant and extends longitudinally.); and a rear tip extender (RTE) attachable to the key (paragraph [0023] “the implantable penile prosthesis 2 can comprise a telescoping rear tip extender 20 affixable to the rear tip 12…with interface segment 22…the interface segment 22 defines a receiving port 28 having a shoulder 30 for engaging a locking feature 16”), with the RTE forming an opening including a slot (paragraph [0023] “The interface segment 22 defines a receiving port 28”) communicating with a cavity (paragraph [0024] “the interface segment 22 defines a bore 36 for receiving the telescoping segments 24”), with the cavity bounded by a proximal RTE wall and a distal RTE wall (Figure 4D, element 30 is a distal RTE wall and element 26 is the proximal RTE wall; Paragraph [0023] “receiving port 28 having a shoulder 30”; paragraph [0024] “conical end segment 26”); wherein, when the RTE is attached to the key, the post is received within the slot and the paddle is received within the cavity (paragraph [0023] “ The interface segment 22 defines a receiving port 28 having a shoulder 30 for engaging a locking feature 16 of the inflatable cylinder 4.“ paragraph [0032] “The telescoping rear tip extender 20 is fitted to the rear tip 12 of the inflatable cylinder 4, e.g., snap-fit, nub elements, detents, threading, and the like.” The examiner notes that element 16 in figures 1 and 2 connect to the extender element 20 in figure 2 and that since the locking feature engages the element 22 that the post is received within the slot and paddle is received within the cavity.)
and rotation of the RTE relative to the key captures the paddle between the proximal RTE wall and the distal RTE wall (paragraph [0025] “The locking assembly 40 is adapted to lock the segments in an extended position by twisting the segment relative to the preceding segment to engage the locking assembly 40. The locking assembly 40 can comprise a threaded assembly, a locking ring, a detent mechanism, a snap-fit feature, a press-fit feature and other means of locking the segments in the extended position.”).
However, Borgaonker fails to teach a recess formed in a distal direction into the proximal portion and the key located within the recess.
Terlecki teaches a penile implant with a collar that forms a recess. (Figure 7A, element 60. Paragraph [0056] “a collar 60 resides on the cylinder 20 on the rear end portion” The examiner is modifying the system taught by Borgaonker where the rear tip extender meets the implant. Thus, the collar would form a recess in a distal direction into the proximal portion, and house the key (element 16 in Boargaonker).)
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 Borgaonker to have a collar as taught by Terlecki. One of ordinary skill would be able to recognize that the collar and the recess it forms would provide additional protection of the connecting parts of the implant so they do not separate unintentionally as it would create the recess that would secure the key of the locking mechanism of the RTE.
Regarding claim 4, Borgaonker and Terlecki teach the device of claim 1 and Borgaonker further teaches that wherein rotation of the RTE relative to the key drags the distal RTE wall against a distal face of the paddle to pull the RTE in a direction toward the penile implant. (paragraph [0023] “ The interface segment 22 defines a receiving port 28 having a shoulder 30 for engaging a locking feature 16 of the inflatable cylinder 4.“ paragraph [0032] “The telescoping rear tip extender 20 is fitted to the rear tip 12 of the inflatable cylinder 4, e.g., snap-fit, nub elements, detents, threading, and the like.” The examiner notes that since the shoulder engages the locking feature that rotating the RTE would drag the key (locking feature) against the distal RTE wall (shoulder) thus pulling the RTE in a direction toward the penile implant.)
Regarding claim 6, Borgaonker and Terlecki teach the assembly of claim 1, but fail to teach wherein a portion of the paddle extends longitudinally in the proximal direction a distance outside the recess.
It would be prima facie obvious to one of ordinary skill in the art to have the paddle extend longitudinally past the recess. One of ordinary skill in the art would have been able to recognize that the only difference between the prior art the claims is a recitation of relative dimension claimed by the assembly and that the claimed relative dimensions would not perform differently than the prior art device. Please see MPEP 2144.04, section IV, and in 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).
Regarding claim 7, Borgaonker and Terlecki teach the assembly of claim 1, and wherein the paddle has a paddle width extending in a lateral direction and that the paddle width is wider than the post (figure 1, element 16 is in the shape similar to an arrow that has a paddle width wider than the post connecting to the penile implant.) but fail to teach that the paddle and the post have an identical thickness.
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to have the paddle and the post have an identical thickness. One of ordinary skill in the art would have been able to recognize that the only difference between the prior art the claims is a recitation of relative dimension claimed by the assembly and that the claimed relative dimensions would not perform differently than the prior art device. Please see MPEP 2144.04, section IV, and in 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).
Regarding claim 13, Borgoanker and Terlecki teach that the distance of the distal RTE wall measured from the distal end of RTE wall measured from the distal end of the RTE increases along an arc of the distal RTE wall such that rotation of the RTE relative to the key forces the paddle to pull the RTE towards the penile implant. (The examiner is interpreting this as the distal RTE wall having a round / circular shape based on figure 9 and the distance on an arc / circular shape inherently increases.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the shape of the distal RTE wall to be round/circular. One of ordinary skill would be able to recognize that this would be a change of shape and that this configuration is a matter of choice of which a person of ordinary skill in the art would have found obvious absent persuasive evidence that this particular configuration of the claimed container was significant. The examiner notes that since this is lock and key connector that the key would pull the paddle towards the penile implant despite the shape of the RTE wall. Please see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borgaonker in view of Terlecki in view of Augthun (US 2003/0157459).
Regarding claim 2, Borgaonker and Terlecki teach the assembly of claim 1 and Borgaonker and Terlecki further teach wherein the post is connected to a base wall of the recess (The examiner notes that since the post is connected to the implant system taught by Borgaonker that has been modified by the recess taught by Terlecki, the post is therefore connected to a base wall of the recess) and such that rotation of the RTE relative to the key forces the paddle against the distal RTE wall (paragraph [0023] “ The interface segment 22 defines a receiving port 28 having a shoulder 30 for engaging a locking feature 16”.)
However, Borgaonker and Terlecki fail to teach that a length of the post measured from the base wall to the paddle is not greater than a distance of the distal RTE wall from a distal end of the RTE.
Augthun teaches a medical implant connector with a male component that has a shorter length than the female component. (Paragraph [0012] “the length of the cylindrical section of the connecting bridge, measured in the direction of the longitudinal axis of the implant, should be slightly smaller than the length of the cylindrical section of the receiving recess, also measured in the direction of the longitudinal axis of the implant.”)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the length of the male component to be shorter than the female component. One of ordinary skill would have been able to recognize that this provides a safe contact with the contact surfaces of the medical device on one hand and of the implant on the other hand, which is essential for an even application of forces across a large surface. The difference in length should be such that, while taking the production tolerances of the individual elements into consideration, even in the most unfavorable case, contact in the area of the contact surfaces is always ensured. The difference in length, however, should not be selected too high in order to avoid unnecessarily large gaps between the connecting bridge and the receiving recess in the area of the tapering cross-sections. Please see paragraph [0012] of Augthun.
Regarding claim 3, Borgoanker and Terlecki teach that the distance of the distal RTE wall measured from the distal end of RTE wall measured from the distal end of the RTE increases along an arc of the distal RTE wall such that rotation of the RTE relative to the key forces the paddle to pull the RTE towards the penile implant. (The examiner is interpreting this as the distal RTE wall having a round / circular shape based on figure 9 and the distance on an arc / circular shape inherently increases.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the shape of the distal RTE wall to be round/circular. One of ordinary skill would be able to recognize that this would be a change of shape and that this configuration is a matter of choice of which a person of ordinary skill in the art would have found obvious absent persuasive evidence that this particular configuration of the claimed container was significant. The examiner notes that since this is lock and key connector that the key would pull the paddle towards the penile implant despite the shape of the RTE wall. Please see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 5, 12, 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borgaonker in view of Terlecki further in view of Hakky (US 2020/0289269).
Regarding claim 5, Borgaonker in view of Terlecki teach the system of claim 1, and wherein an exterior wall of the penile implant forms a collar surrounding the recess (The examiner notes that in claim 1, the system taught by Borgaonker was modified to have a collar taught by Terlecki, thus providing an exterior wall around the edge of the implant and creating a recess housing the key.) however, both Borgaonker and Terlecki fail to teach that the RTE comprises a flange insertable into the collar of the penile implant and the rotation of the RTE relative to the key engages a thread flight on the collar with a complimentary thread flight on the flange.
Hakky teaches a penile implant with a matching thread pattern for an RTE. (Figure 1, elements 400, 440 show the collar. Figure 2, shows the flange. paragraph [0020] “Receiving segment 400 is coupled to the support segment 200 by rotating the support segment 200 into the receiving segment 400 to secure the device at a desired extension distance D.sub.1. Threaded portion 240 includes a plurality of threads 250. Receiving segment 400 includes a hole 420, and the hole 420 including a plurality of internal grooves 440” The examiner notes that element 240 is the flange insertable into the receiving segment 400 (the collar). The examiner is modifying the shoulder taught by Borgaonek and the collar the taught by Terlecki to have the complimentary threaded portions so that when the RTE is rotated the threads are engaged as taught by Hakky.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the implant and RTE to have threaded portions. One of ordinary skill in the art would have been able to recognize that having threaded portions of the male and female components would ensure that the extender is securely attached to the implant and prevent unnecessary detachment.
Regarding claim 12, Borgaonker teaches the assembly of claim 9, and further teaches that the RTE comprises a flange (This can be seen in figure 1, element 16, the flange is the a
However, Borgaonker fails to teach wherein an exterior wall of the penile implant forms a collar surrounding the key, and the RTE comprises a flange insertable into the collar of the penile implant, and the rotation of the RTE relative to the key engages a thread flight on the flange with a complimentary thread flight on the collar.
Terlecki teaches a penile implant with a collar that forms a recess. (Figure 7A, element 60. Paragraph [0056] “a collar 60 resides on the cylinder 20 on the rear end portion” The examiner is modifying the system taught by Borgaonker where the rear tip extender meets the implant. Thus, the collar would form a recess in a distal direction into the proximal portion, and house the key (element 16 in Boargaonker).)
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 Borgaonker to have a collar as taught by Terlecki. One of ordinary skill would be able to recognize that the collar and the recess it forms would provide additional protection of the connecting parts of the implant so they do not separate unintentionally as it would create the recess that would secure the key of the locking mechanism of the RTE.
However, both Borgaonker and Terlecki fail to teach that the RTE comprises a flange insertable into the collar of the penile implant and the rotation of the RTE relative to the key engages a thread flight on the collar with a complimentary thread flight on the flange.
Hakky teaches a penile implant with a flange and matching thread pattern for an RTE. (Figure 1, elements 400, 440 show the collar. Figure 2, shows the flange. paragraph [0020] “Receiving segment 400 is coupled to the support segment 200 by rotating the support segment 200 into the receiving segment 400 to secure the device at a desired extension distance D.sub.1. Threaded portion 240 includes a plurality of threads 250. Receiving segment 400 includes a hole 420, and the hole 420 including a plurality of internal grooves 440” The examiner notes that element 240 is the flange insertable into the receiving segment 400 (the collar). The examiner is modifying the shoulder taught by Borgaonek and the collar the taught by Terlecki to have the complimentary threaded portions so that when the RTE is rotated the threads are engaged as taught by Hakky.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the implant and RTE to have threaded portions. One of ordinary skill in the art would have been able to recognize that having threaded portions of the male and female components would ensure that the extender is securely attached to the implant and prevent unnecessary detachment.
Regarding claim 14, Borgaonker teaches an erectile dysfunction treatment system, the system comprising:
a pump and a reservoir attachable to a penile implant assembly (paragraph [0021] “…comprises one or more inflatable cylinders 4 (e.g., 2 adjacent cylinders) each operably linked to an inflating apparatus or reservoir 6….The inflating apparatus 6 can include a pump 18”), the penile implant assembly comprising:
a penile implant comprising a distal portion implantable into a corpus of an external portion of a penis (paragraph [0021] “The one or more inflatable cylinders 4 further include an inflatable portion 10” The examiner notes in figure 2, element 4 is in the corpus of external portion of a penis) and a proximal portion implantable into a crus of an internal portion of the penis (paragraph [0021] “a rear tip portion 12”), with the proximal portion of the penile implant
and a rear tip extender (RTE) attachable to the proximal portion of the penile implant. (paragraph [0023] “the implantable penile prosthesis 2 can comprise a telescoping rear tip extender 20 affixable to the rear tip 12”);
wherein the penile implant comprises a key, with the key comprising a paddle connected to a post that extends longitudinally from the recess, with the paddle having a paddle length measured between a proximal face and a distal face of the paddle (paragraph [0023] “The locking feature can 16 include a locking nub.” The examiner notes that locking nub includes the key (arrow shaped tip) and a paddle (the length connecting the locking nub to the penile implant. The examiner notes that the paddle has a length measurable between a proximal and distal face of the paddle.) and a paddle width that is larger than a width of the post (The examiner notes that since the nub is in a shape of an arrow the paddle width is larger than the width of the post, this can be seen in figure 1, element 16.);
However, Borgaonker fails to teach an external wall of the proximal portion of the penile implant comprises collar surrounding a recess.
Terlecki teaches a penile implant with a collar that forms a recess. (Figure 7A, element 60. Paragraph [0056] “a collar 60 resides on the cylinder 20 on the rear end portion” The examiner is modifying the system taught by Borgaonker where the rear tip extender meets the implant. Thus, the collar would form a recess in a distal direction into the proximal portion, and house the key (element 16 in Boargaonker).)
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 Borgaonker to have a collar as taught by Terlecki. One of ordinary skill would be able to recognize that the collar and the recess it forms would provide additional protection of the connecting parts of the implant so they do not separate unintentionally as it would create the recess that would secure the key of the locking mechanism of the RTE.
However, both Borgaonker and Terlecki fail to teach wherein the RTE comprises a flange insertable into the recess and an opening formed in the flange including a slot communicating with a cavity, with the cavity bounded by a proximal RTE wall and a distal RTE wall and wherein, when the flange is inserted into the collar and the key is inserted into the opening, the paddle is received within the cavity, and rotation of the flange within the collar compresses the distal RTE wall against the distal face of the paddle to draw the RTE toward the penile implant.
Hakky teaches a penile implant with a flange on the RTE. (Figure 1, elements 400, 440 show the collar. Figure 2, shows the flange. paragraph [0020] “Receiving segment 400 is coupled to the support segment 200 by rotating the support segment 200 into the receiving segment 400 to secure the device at a desired extension distance D.sub.1.” The examiner notes that element 240 is the flange insertable into the receiving segment 400 (the collar). The examiner is modifying the shoulder taught by Borgaonek and the collar the taught by Terlecki to have the complimentary threaded portions so that the flange will be inserted into the collar, the key into the opening, and the paddle within the cavity. Since, the flange and collar are modified to be threaded, the collar would compress the distal RTE against the face of the paddle to draw the RTE toward the penile implant.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the implant and RTE to have the flange and engaging threaded portions as taught by Hakky. One of ordinary skill in the art would have been able to recognize that having a flange and complimentary of the male and female components would ensure that the extender is securely attached to the implant and prevent unnecessary detachment.
Regarding claim 15, Borgaonek, Terlecki, and Hakky teach the system of claim 14, but fail to teach wherein a surface of the distal RTE wall is not orthogonal relative to a distal end of the flange. (The examiner is interpreting this as the shape of the distal RTE wall is a shape that has no 90 degree angles.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the shape of the distal RTE wall to not be orthogonal relative to the distal end of the flange. One of ordinary skill would be able to recognize that this would be a change of shape and that this configuration is a matter of choice of which a person of ordinary skill in the art would have found obvious absent persuasive evidence that this particular configuration of the claimed container was significant. Please see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 16, Borgaonek, Terlecki, and Hakky teach the system of claim 14, but fail to teach wherein a distance of the distal RTE wall measured from a distal end of the flange increases along an are of the distal RTE wall such that rotation of the RTE relative to the key forces the paddle to pull the RTE toward the penile implant. (The examiner is interpreting this as the distal RTE wall having a round / circular shape based on figure 9 and the distance on an arc / circular shape inherently increases.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the shape of the distal RTE wall to be round/circular. One of ordinary skill would be able to recognize that this would be a change of shape and that this configuration is a matter of choice of which a person of ordinary skill in the art would have found obvious absent persuasive evidence that this particular configuration of the claimed container was significant. The examiner notes that since this is lock and key connector that the key would pull the paddle towards the penile implant despite the shape of the RTE wall. Please see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 17, Borgaonek, Terlecki, and Hakky teach the system of claim 14, and Hakky further teaches wherein rotation of the flange within the collar engages a thread flight on the collar with a complimentary thread flight on the flange. (paragraph [0020] “Threaded portion 240 includes a plurality of threads 250. Receiving segment 400 includes a hole 420, and the hole 420 including a plurality of internal grooves 440” The examiner is modifying the shoulder taught by Borgaonek and the collar the taught by Terlecki to have the complimentary threaded portions so that when the RTE is rotated the threads are engaged as taught by Hakky.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the implant and RTE to have the engaging threaded portions as taught by Hakky. One of ordinary skill in the art would have been able to recognize that having a flange and complimentary of the male and female components would ensure that the extender is securely attached to the implant and prevent unnecessary detachment.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borgaonker in view of Terlecki further in view of Poucher (US 2018/0214271).
Regarding claim 8, Borgaonker and Terlecki teach the assembly of claim 1, but fail to teach wherein a proximal end and lateral sides of the paddle have a clearance space relative to surfaces of the cavity when the paddle is captured between the proximal RTE wall and the distal RTE wall.
Poucher teaches penile implant with a clearance fit for the length extender and the implant. (Paragraph [0068] “A clearance fit is a description of the relative diameters between the pushrod 28 and the hole 66 that allows the pushrod 28 to slide into the hole 66 with no interference from the channel 68” The examiner notes that by having the system taught by Borgaonker and Terlecki modified to have a clearance fit as taught by Poucher that the proximal end and lateral sides of the paddle have a clearance space relative to surfaces of the cavity when the paddle is captured between the proximal RTE wall and the distal RTE wall.)
It would be prima facie obvious to modify the system taught by Borgaonker and Terlecki have a clearance fit as taught by Poucher. One of ordinary skill in the art would have been able to recognize that a clearance fit would facilitate easy assembling and disassembling of implant while leaving room for the possible expansion of the parts due to heat.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Werschmidt (US 5620427) teaches a Luer Lock system which has a similar shaping to the claimed invention.
Bartholomew (US 4943091) teaches a medical connector with similar shaping to the claimed invention.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights