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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/2025 has been entered.
Response to Amendment
The amendment filed 11/21/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “a second member having a first coupling portion, a second coupling portion, and a middle portion extending from the first coupling portion and disposed between the first coupling portion and the second coupling portion, the middle portion having a width that is larger than a width of the first coupling portion of the second member, the width of the middle portion being larger than a width of the second coupling portion of the second member “ .
Applicant is required to cancel the new matter in the reply to this Office Action.
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
Applicant’s amendment to the claims appears to have introduced new matter. Regarding the prior art rejection, the primary reference to Jahns et al(2008/0103353) shows a number of embodiments with varied shapes and the examiner considers the embodiment of figure 2 as modified by other embodiments within the reference still reads on the claims as amended. Also considering the scope of independent claim 16 is not limited to any aspect of a penile implant, a new ground of rejection is included to Bentley (7354330). Bentley (7354330) is directed to Connection Beads With Locked And Articulating Engagement for toys and industrial applications. The examiner suggests including language to narrow the scope of claims 16-19 to include subject matter corresponding to penile implants to overcome future rejections on prior art outside the scope of penile implants.
Drawings
The drawings are objected to because Elements 224 and 244 are not shown as set forth in the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-20 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. Claims 1, 16 and 20 have been amended to include the language “a second member having a first coupling portion, a second coupling portion, and a middle portion extending from the first coupling portion and disposed between the first coupling portion and the second coupling portion, the middle portion having a width that is larger than a width of the first coupling portion of the second member, the width of the middle portion being larger than a width of the second coupling portion of the second member “ which does not appear in the original specification as is considered new matter.
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) 16-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bentley (7354330) hereinafter Bentley.
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The scope of independent claim 16 and it’s corresponding dependent claims does not incorporate any aspect of a penile implant. The examiner suggests including language to narrow the scope of the claim(s) to include subject matter corresponding to penile implants.
Bentley teaches a system for interlocking a plurality of parts such as beads. In a preferred embodiment each part includes at least one extension structure that is adapted to be received into an opposite cavity on an adjacent part to form an interlocking relationship. The relationship between the extension structure and the opposite cavity allows for variable engagement arrangements including a first arrangement that permits articulating movement and an alternative locking engagement that maintains the resulting assembly in a linear relationship. Parts may be assembled into catenulate chains or, by providing for additional connection structures originating from other surfaces of the part, the parts may be assembled into networks or matrixes that extend in multiple directions. In addition to the articulating chain arrangement and locked engagement arrangement, a further engagement is disclosed that prevents rotational movement from one part to another.
Regarding claim 16, Bentley teaches an elongate member formed of a plurality of segment member, the elongate member configured to be placed in a first non-linear configuration and in a linear configuration,
a first segment member of the plurality of segment members having a coupling portion and a locking portion, the coupling portion of the first segment member including a closed cavity, the locking portion being disposed within the closed cavity a second segment member of the plurality of segment members member having a first coupling portion, a second coupling portion, a middle portion, and a locking portion, the middle portion having a width that is larger than a width of the first coupling portion of the second segment, the width of the middle portion being larger than a width of the second coupling portion of the second segment, the first coupling portion of the second segment member having a spherical surface, the locking portion of the second segment member including a projection extending from the spherical surface of the first coupling portion of the second segment member. Note the annotated figures 10-12 above where is can been seen that each segment may include plural cavities or protrusions and the cavity(403,450) of the first segment includes a locking member or ridge(455), the first coupling member( 214) of the second segment includes a locking portion( collar 410 ) which extends from the spherical coupling portion 214 and which engages the cavity(403, 450) or coupling portion(455) of the first segment. The second segment includes a first coupling portion 214 and a second coupling portion cavity (403,450) and in between the first and second coupling portions is a middle portion that has a width that is larger than both the first and second coupling portions.
Regarding claim 17, Bentley teaches wherein the coupling portion of the first segment member is configured to engage the first coupling portion of the second segment member to movably couple the first segment member to the second segment member. Note annotated figures 10 -12 above.
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, 2, 4-8 and 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jahns et al(2008/0103353, hereinafter Jahns).
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Jahns teaches [0006] Disclosed is an implantable malleable penile prosthetic device comprising stacked column segments. A first one of the column segments comprises a ball surface facing along a column axis. The ball surface has a generally convex shape that is articulable in a mating socket of a second one of the column segments. The first one of the column segments comprises a socket surface facing an opposite direction along the column axis. The socket surface has a generally concave shape that is articulable on a mating ball of a third one of the column segments. Multiple column segments similar to the first column segment are stacked to form the column.
[0024] In one embodiment, the column segments 102-116 are held together with a resilient compression force. In one embodiment, the compressive force is provided by a stretched resilient sleeve that surrounds the column 100. In another embodiment, the resilient compressive force is provided by a stretched member 118 (shown in phantom), such as a spring or cord, for example, that passes through the center of the column 100. The member 118 is secured at either end of the column through the attachment of the member 118 to components 120 and 122 that are recessed within the end column segments 102 and 116 and maintain the member 118 in a stretched state. The column 100 can also include shaped end caps (not illustrated), as needed, to provide desired end shapes to the column 100.
Regarding Claims 1 and 16 Jahns teaches, a penile implant, including: a first member having a coupling portion and a locking portion, the coupling portion of the first member including a closed cavity; and
a second member having a first coupling portion, a second coupling portion, and a middle portion extending from the first coupling portion and disposed between the first coupling portion and the second coupling portion, the middle portion having a width that is larger than a width of the first coupling portion of the second member, the width of the middle portion being larger than a width of the second coupling portion of the second member, the first coupling portion of the second member having a locking portion, the locking portion of the second member including a projection,
the coupling portion of the first member configured to engage the first coupling portion of the second member to movably couple the first member to the second member such that the first member is configured to be placed in a first position with respect to the second member and a second position with respect to the second member, the locking portion of the first member being configured to engage the locking portion of the second member help retain the first member in its second position with respect to the second member. Note the annotated figures above regarding the embodiment of Fig. 2 and paragraph [0024], [0030], [0031], and [0057], it teaches the embodiments may be held together by a compressive force, a sleeve, or a central string or cord thru a central lumen.
However, Jahns the embodiment shown in figure 2, does not teach where the coupling portion of the first member includes a closed cavity as claimed.
Jahns teaches in paragraphs [0024] and [0057] that the embodiments may be held together by a compressive force, a sleeve, or a central string or cord thru a central lumen.
With respect to the embodiment of figure 2, it would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to modify the embodiment of Fig. 2 to include a closed cavity without the central as taught for other embodiments such as those in figs 7 and fig. 11 thus making the column easier to manufacture and less costly. Compressive material can be used for increased ball to socket friction, holding strength and rigidity.
Such a combination would produce predictable results of the device of Jahns figure 2 having a closed cavity and ball and sockets that snap together as taught by Jahns [0024] and [0057]. With a high expectation of success because closed cavity without a central lumen with an interference fit locking connection is old and well known and will provide the benefit of improved column strength and easier to manufacture as taught by Jahns.
Regarding Claims 2 and 17 Jahns teaches, the coupling portion of the first member includes a cavity portion configured to receive the first coupling portion of the second member(see labelled figure 2 above).
Regarding Claim 4 Jahns teaches a socket surface 206 along the column axis 204, facing in a direction opposite that of ball surface 202. One embodiment of the socket surface 206 includes a generally concave shape with a radius R2.
Regarding Claim 5 Jahns teaches the first coupling portion of the second member includes a rounded surface. [0025] As illustrated in FIG. 2, one embodiment of the column segment 104 includes a ball surface 202. It is understood in embodiments that do not include a central lumen the ball surface would comprise a complete and not truncated spherical surface as shown In the dotted outline of Fig. 2 above.
Regarding Claim 6 Jahns teaches wherein the locking portion of the first member is disposed within the cavity as set forth in the annotated figure 2 above.
Regarding Claim 7 Jahns teaches wherein the coupling portion of the first member includes a side wall defining the cavity, the locking portion of the first member includes a groove defined by the side wall. See the annotated figure 2 above, note the side wall 206 with the locking portion 210.
Regarding Claim 8 Jahns teaches wherein the locking portion of the second member is disposed on the first coupling portion of the second member. See the annotated figure 2 above, the first locking portion 208 of the second member.
Regarding Claims 14 and 19 Jahns teaches a sheath 1406 defining a lumen, the lumen being configured to house the first member and the second member. Note fig. 14. [0047] FIG. 14 illustrates an exemplary malleable penile prosthesis 1400, in accordance with embodiments of the invention, that includes a column 1404 formed of exemplary column segments. The column 1404 is formed of column segments such as those described above in connection with FIGS. 1-13. The column 1404 is embedded in a body 1410 of resilient material that can include a lubricant for the column segments. In one embodiment, a centering disc 1008 centers the body 1410 with respect to an outer sheath 1406 which contains the body 1410 and the lubricant.
Regarding Claim 15 Jahns teaches a first end cap, the first element in the line of members shown above, coupled to the first member; a second end cap, the last member in the line of members shown above, coupled to the second member; and a sheath -1406-defining a lumen, the lumen being configured to house the first member, the second member, a least a portion of the first end cap, and at least a portion of the second end cap. Note fig. 14. Paragraph [0047].
Regarding Claim 18 Jahns teaches wherein the locking portion of the first segment member is configured to engage the locking portion of the second segment member to help retain the elongate member in its linear configuration. Note annotated figure 2 above and [0028] One embodiment of the socket surface 206 includes a recessed portion 210 that is configured to receive or engage the protrusion 208 of the ball surface 202 of a mating column segment. The engagement with, or reception of, the recessed annular portion 210 with the annular protrusion of the ball surface 202 resists articulation away from a central alignment.
Regarding Claim 20 Jahns teaches , an elongate member formed of a plurality of segment members, a first end member, and a second end member, the elongate member configured to be placed in a first non-linear configuration and in a linear configuration; and
a sheath defining a lumen, the lumen being configured to house the plurality of segment members, at least a portion of the first end member, and at least a portion of the second end member,
a first segment member of the plurality of segment members having a coupling portion and a locking portion, the coupling portion of the first segment member including a closed cavity,
a second segment member of the plurality of segment members member having a first coupling portion, a second coupling portion, a middle portion, and a locking portion, the first coupling portion of the second segment member including a solid protrusion, the middle portion extending between the first coupling portion of the second segment member and the second coupling portion of the second segment member, the middle portion having a width that is larger than a width of the first coupling portion of the second segment, the width of the middle portion being larger than a width of the second coupling portion of the second segment, the locking portion of the second segment member including a projection extending from the solid protrusion.
Note the figures above regarding the embodiment of Fig. 2 and paragraph [0024], [0030], [0031], and [0057], it teaches the embodiments may be held together by a compressive force, a sleeve, or a central string or cord thru a central lumen. Also note fig. 14. Paragraph [0047].
However, Jahns the embodiment shown in figure 2, does not teach where the coupling portion of the first member includes a closed cavity as claimed.
Jahns teaches in paragraphs [0024] and [0057] that the embodiments may be held together by a compressive force, a sleeve, or a central string or cord thru a central lumen.
With respect to the embodiment of figure 2, it would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to modify the embodiment of Fig. 2 to include a closed cavity without the central as taught for other embodiments such as those in figs 7 and fig. 11 thus making the column easier to manufacture and less costly. Compressive material can be used for increased ball to socket friction, holding strength and rigidity.
Such a combination would produce predictable results of the device of Jahns figure 2 having a closed cavity and ball and sockets that snap together as taught by Jahns [0024] and [0057]. With a high expectation of success because closed cavity without a central lumen with an interference fit locking connection is old and well known and will provide the benefit of improved column strength and easier to manufacture as taught by Jahns.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10980638 ( hereinafter DiLoreto(638)) in view of Jahns et al(2008/0103353, hereinafter Jahns).
The patent claims 1, 13 and 17 to DiLoreto(638) set forth all the limitations of instant claims 1, 16, and 20 except “ a middle portion extending from the first coupling portion and disposed between the first coupling portion and the second coupling portion, the middle portion having a width that is larger than a width of the first coupling portion of the second member, the width of the middle portion being larger than a width of the second coupling portion of the second member”.
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Jahns teaches in the same field of endeavor a penile implant with varied shaped segments and ball and socket coupling and locking arrangements and notes in paragraph [0041] that the shapes shown are exemplary and other shapes may be used.
Fig. 2 of Jahns teaches a prosthetic device comprises stacked column segments that include a second coupling portion, and a middle portion extending from the first coupling portion and disposed between the first coupling portion and the second coupling portion, the middle portion having a width that is larger than a width of the first coupling portion of the second member, the width of the middle portion being larger than a width of the second coupling portion of the second member.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize in DiLoreto(638) a stacked column segments having a shape including a middle portion that is wider than a first and second coupling portion as taught by Jahns as an obvious substitute for one stacked column segment with interlocking ball and socket coupling portions and locking portions for another with a reasonable expectation for yielding a functioning penile implant in DiLoreto(638).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11717409 ( hereinafter DiLoreto(409)) in view of Jahns et al(2008/0103353, hereinafter Jahns).
The patent claims 1, 16, 20 to DiLoreto(409) set forth all the limitations of instant claims 1, 16, and 20 except “ a middle portion extending from the first coupling portion and disposed between the first coupling portion and the second coupling portion, the middle portion having a width that is larger than a width of the first coupling portion of the second member, the width of the middle portion being larger than a width of the second coupling portion of the second member”.
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Jahns teaches in the same field of endeavor a penile implant with varied shaped segments and ball and socket coupling and locking arrangements and notes in paragraph [0041] that the shapes shown are exemplary and other shapes may be used.
Fig. 2 of Jahns teaches a prosthetic device comprises stacked column segments that include a second coupling portion, and a middle portion extending from the first coupling portion and disposed between the first coupling portion and the second coupling portion, the middle portion having a width that is larger than a width of the first coupling portion of the second member, the width of the middle portion being larger than a width of the second coupling portion of the second member.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize in DiLoreto(409) stacked column segments having a shape including a middle portion that is wider than a first and second coupling portion as taught by Jahns as an obvious substitute for one stacked column segment with interlocking ball and socket coupling portions and locking portions for another with a reasonable expectation for yielding a functioning penile implant in DiLoreto(409).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
CHOJNICKI(2008036426) teaches stabilization systems (30) for stabilizing one or more vertebral levels are provided. The systems (30) include anchors (32, 132, 232, 332) engageable to the vertebrae and an elongate connecting member (50, 150, 250) that maintains distraction between the vertebrae while allowing at least limited vertebral motion of the stabilized vertebral levels.
MEYER(US 3323325) teaches Stringless Beads Having Frictionally Retained Insert.
Wolfe(US 5797784) teaches A system for coupling components of toy assemblages, educational models, hobby constructions, component attachments, or the like together using a compact single point snap together axial connector, which is configured or formed with a key like portion included as part of the male connector part, and a corresponding female connector configured to prevent rotational movement about the connectors axis, and/or to limit the selective attachment of the components.
DEMARAIS(US 20080234795) teaches a catheter (200) has a sheath (124) slidably arranged over an elongate flexible member. A set of self-expanding tubular prostheses (128) is carried in axially spaced-apart locations along the elongate flexible member within the sheath.
Barrington(4151840) teaches mechanical penile prosthesis designed to be surgically implanted in the penis for the treatment of erectile impotence or as a functional component of a penile replacement prosthesis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791