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 Arguments
Applicant's arguments filed 3/9/2026 have been fully considered but they are not persuasive. Applicant argues that the Lund reference does not teach the amended claim language. However, examiner of record respectfully disagrees as the Lund has an inflatable implant where the wall of the device is seen as a sidewall. Further the wall of the device has an outer and inner surface as the inside of the device is seen as the inner surface and the outside is seen as the outer surface. The device is cylindrical and therefore the sidewall and surfaces would therefore be circular in shape in a cross-sectional cut. The porous material is inside of the device and therefore is seen as adjacent and contacting the inner wall of the sidewall as it is inside and touching the walls of the implant. Therefore, the 102(a)(1) stands. See below. Applicant is encouraged to better define the shape of the lumen and extent of the porous material with in the lumen to overcome the interpretation that the separate chambers that touch the inner wall of the prior art can be interpreted as teaching the claimed language.
Applicant’s arguments with regard to the 112(b) rejection have been fully considered and are persuasive. The 112(b) rejection of claims 1-15 has been withdrawn.
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 1-15 and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 14-15 of U.S. Patent No. 11399944. Although the claims at issue are not identical, they are not patentably distinct from each other because the parent application’s claims are narrower than the present applications, see below.
Application 17809157
Patent 11399944
1 and 21. An implant, comprising: an inflatable member including a sidewall having an outer surface and an inner surface, the inner surface and the outer surface having circular cross-sectional shapes, the sidewall defining a lumen; and a pump assembly configured to facilitate a transfer of a fluid from a reservoir to the inflatable member, the inflatable member a porous structure disposed within the lumen and disposed adjacent/contacting the inner surface of the sidewall.
1. An implant, comprising: an inflatable member, the inflatable member having an outer sheath including a sidewall, the sidewall having an outer surface and an inner surface that defines a lumen, the inflatable member including a porous structure disposed within the lumen; an end cap coupled to a first end portion of the sidewall and defining a lumen, the porous structure being disposed within the lumen defined by the end cap; and a pump assembly configured to facilitate a transfer of a fluid from a reservoir to the lumen of the inflatable member to place the inflatable member in an inflated configuration.
2 and 22. The implant of claim 1/21, wherein the porous structure defines a plurality of cavities.
2. The implant of claim 1, wherein the porous structure defines a plurality of cavities.
3 and 23. The implant of claim 1/21, wherein the inflatable member defines a longitudinal axis, the porous structure extends along the longitudinal axis.
3. The implant of claim 1, wherein the inflatable member defines a longitudinal axis, the porous structure extends along the longitudinal axis.
4 and 24. The implant of claim 1/21, wherein the outer surface of the sidewall is substantially smooth.
1. “the sidewall having an outer surface and an inner surface” and 4. The implant of claim 1, wherein the outer surface of the sidewall is substantially smooth.
5 and 25. The implant of claim 1/25, wherein the inflatable member is configured to be placed in an inflated configuration and a deflated configuration.
5. The implant of claim 1, wherein the inflatable member is configured to be placed in an inflated configuration and a deflated configuration.
6. The implant of claim 1, wherein the inflatable member is configured to be placed in an inflated configuration and a deflated configuration, the inflatable member having a tubular shape when in the deflated configuration.
6. The implant of claim 1, wherein the inflatable member is configured to be placed in an inflated configuration and a deflated configuration, the inflatable member having a tubular shape when in the deflated configuration.
7. The implant of claim 1, wherein the inflatable member is configured to be placed in an inflated configuration and a deflated configuration, the inflatable member having a tubular shape when in the inflated configuration.
7. The implant of claim 1, wherein the inflatable member is configured to be placed in an inflated configuration and a deflated configuration, the inflatable member having a tubular shape when in the inflated configuration.
8. The implant of claim 1, wherein the inflatable member is configured to be placed in an inflated configuration and a deflated configuration, the inflatable member having a tubular shape when in the deflated configuration and having a tubular shape when in the inflated configuration.
8. The implant of claim 1, wherein the inflatable member is configured to be placed in an inflated configuration and a deflated configuration, the inflatable member having a tubular shape when in the deflated configuration and having a tubular shape when in the inflated configuration.
9. The implant of claim 1, wherein the inflatable member is configured to be placed in an inflated configuration and a deflated configuration, the inflatable member configured to extend along a longitudinal axis of the inflatable member when placed in the inflated configuration.
9. The implant of claim 1, wherein the inflatable member is configured to be placed in an inflated configuration and a deflated configuration, the inflatable member configured to extend along a longitudinal axis of the inflatable member when placed in the inflated configuration.
10. The implant of claim 1, wherein the inflatable member is configured to be placed in an inflated configuration and a deflated configuration, the inflatable member configured to extend in a direction transverse to a longitudinal axis of the inflatable member when placed in the inflated configuration.
10. The implant of claim 1, wherein the inflatable member is configured to be placed in an inflated configuration and a deflated configuration, the inflatable member configured to extend in a direction transverse to a longitudinal axis of the inflatable member when placed in the inflated configuration.
11. The implant of claim 1, wherein the porous structure defines a plurality of cavities, the fluid being configured to be disposed within the plurality of cavities when the inflatable member is placed in an inflated configuration.
11. The implant of claim 1, wherein the porous structure defines a plurality of cavities, the fluid being configured to be disposed within the plurality of cavities when the inflatable member is placed in an inflated configuration.
12. The implant of claim 1, further comprising: a first cap coupled to a first end portion of the sidewall; and a second cap coupled to a second end portion of the sidewall.
12. The implant of claim 1, wherein the end cap is a first end cap and the first cap is coupled to the first end portion of the sidewall such that a portion of the first cap is disposed within the lumen defined by the inner surface of the inflatable member, the implant further comprising: a second cap coupled to a second end portion of the sidewall.
13. The implant of claim 1, further comprising: a first cap coupled to a first end portion of the sidewall; and a second cap coupled to a second end portion of the sidewall, the porous structure being disposed between the first cap and the second cap.
1. “an end cap coupled to a first end portion of the sidewall and defining a lumen, the porous structure being disposed within the lumen defined by the end cap;”
12. The implant of claim 1, wherein the end cap is a first end cap and the first cap is coupled to the first end portion of the sidewall such that a portion of the first cap is disposed within the lumen defined by the inner surface of the inflatable member, the implant further comprising: a second cap coupled to a second end portion of the sidewall.
14. The implant of claim 1, further comprising: a reservoir configured to retain the fluid, wherein the pump is configured to help facilitate a transfer of the fluid from the reservoir to the inflatable member when the implant is in an inflation mode.
14. The implant of claim 1, further comprising: a reservoir configured to retain the fluid, wherein the pump is configured to help facilitate a transfer of the fluid from the reservoir to the inflatable member when the implant is in an inflation mode.
15. The implant of claim 1, wherein the pump assembly includes a valve body and a pump bulb member.
15. The implant of claim 1, wherein the pump assembly includes a valve body and a pump bulb member.
Claims 1 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11399944 as the porous material of the patent extends along the cavity that is defined by the sidewall with inner and outer surfaces and therefore would have to be adjacent and touching the sidewall if the cavity it takes up is made by the sidewall.
It is noted by the examiner that application 17658182 is co-pending at this time. However, it does not appear to need a provisional non-statutory double patenting rejection at this time due to the different scopes of the claim language. This could change in the future as both applications claim language evolves throughout the examination process.
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) 1-15 and 21-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lund et al., WO 2013/096615, herein referred to a “Lund”.
Regarding claim 1 and 21, Lund teaches: an implant (paragraph [0008]), comprising: an inflatable member (paragraphs [0008] and 11; figure 1, element 102); and a pump assembly (figure 1, element 104) including a sidewall having an outer surface (Figs 1-12; specifically figure 9 which illustrates a cut away where the outer surface is that of the outside of the cross section) and an inner surface (Figure 9 and the inner surface is that of inside the cross section where 122 is touching), the inner surface and the outer surface having circular cross-sectional shapes (Figure 9), the sidewall defining a lumen (figure 2A - 12) configured to facilitate a transfer of a fluid from the reservoir (element 106) to the inflatable member, the inflatable member having a porous structure (paragraph [0069]) disposed within the lumen and adjacent/contacting the inner surface of the sidewall (Fig. 9; specifically 122 is filled with porous material and as 122 is seen as the porous structure as it includes the porous material and it contacts the inner wall of 114 of the sidewall it is seen as adjacent and contacting said wall and paragraph [0069]).
Regarding claims 2, 22 and 11, Lund teaches: wherein the porous structure defines a plurality of cavities and the fluid being configured to be disposed within the plurality of cavities when the inflatable member is placed in an inflated configuration ([0069]; specifically the “open-cell” or porous material would inherently have a plurality of cavities as it is open cell and when inflated the fluid would inherently fill the plurality of cavities as seen in the paragraph).
Regarding claims 3 and 23, Lund teaches: the inflatable member defines a longitudinal axis (Figure 1) and the porous material would extend along the axis of the inflatable member (paragraph [0069], inflatable members “filled with open-cell material” which if the material is I the inflatable member it would therefore extend along the axis).
Regarding claims 4 and 24, Lund teaches: w the outer surface of the sidewall is smooth (Figure 1, element 114 is smooth which is an outer surface of the sidewall as interpreted as the outer surface of the inflatable member).
Regarding claims 5-10 and 25, Lund teaches: the device operates in an inflated/deflated condition (abstract, inflatable members), the inflatable member having a tubular shape when in the deflated and inflated configuration (Fig. 1 and the different cross sections of embodiments showing deflated and inflated which show tubular in shape regardless of inflated status) The inflatable members extend in a longitudinally tubular shape (Figure 1 and the different cross sections show inflated and deflated states showing the inflatable member does extend along a along an longitudinal axis when inflated and traverse as it extends in 3D space).
Regarding claims 12-13, Lund teaches: the inflatable members include a first cap coupled to a first end portion of the sidewall (118) and a second cap coupled to a second end portion of the sidewall (120), the porous structure being disposed between the first cap and second cap (the porous material is that of the inside of the inflatable member which is between 118 and 120).
Regarding claim 14, the reservoir configured to retain the fluid (106), wherein the pump is configured to help facilitate a transfer of the fluid from the reservoir to the inflatable member when the implant is in an inflation mode ([0019]).
Regarding claim 15, the pump (104) includes a valve body and pump bulb member (Figure 1 shows pump 104 which includes both a valve body (inside) and a bulb member (ribbed end of the pump) which are well known types of bulb pumps in penile prosthesis devices and have internal valves ([0004]-[0005]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Felton et al is cited to further show the well-known pump (201), pump bulb (231) and valve body (233) used with similar inflatable devices (Figure 3, paragraph [0059]) as cited in the parent.
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 JOANNE M RODDEN whose telephone number is (303)297-4276. The examiner can normally be reached Monday - Friday 9:00 AM-5:00 PM MST.
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, Jonathan Moffat can be reached at 571-272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOANNE M RODDEN/ Supervisory Patent Examiner, Art Unit 3794
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