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 .
This Office Action is responsive to the Amendment filed 13 July 2026. Claims 1, 3-13, 15-20, 22, and 23 are currently under consideration. The Office acknowledges the amendments to claims 1, 3-7, 16, and 18, as well as the cancellation of claims 14 and 21, and the addition of new claims 22 and 23.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-5 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. Each claim recites the limitations “wherein the lumen defined by the sidewall of the inflatable member includes a first portion having a first diameter [and] a second portion having a second diameter.” It is not clear if these portions are intended to be the same first and second portions of the lumen recited in claim 1 or to be separate portions.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claims 1, 3-6, 10-13, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Lund et al. (U.S. Pub. No. 2014/0309490 A1; hereinafter known as
"Lund"), in view of Morningstar (U.S. Pub. No. 2009/0270675 A1).
Regarding claim 1, Lund discloses an implant (Abstract; Figs. 1, 12), comprising:
an inflatable member 102 and a pump assembly 104 configured to facilitate a transfer of
a fluid from a reservoir 106 to the inflatable member ([0036]-[0037])), the inflatable
member having a sidewall that defines a lumen 122, the sidewall having an outer
surface 114 and an inner surface 116/126 disposed opposite the outer surface, the lumen having a first portion and a second portion, the second portion of the lumen having a spiral shape ([0042]; [0047]; [0067]). Lund fails to disclose that the first portion of the lumen extends substantially linearly; Lund does teach that the inflatable members include rear tips 118 and fluid conduits that connect tubing 110 (which is connected to the pump assembly and reservoir) to the inflatable members ([0039]), but does not further describe such fluid conduits. Morningstar discloses a similar implant (Abstract; Figs. 1, 1a) comprising an inflatable member I with a rear tip 10, further including a lumen portion 16 extending substantially linearly to connect tubing 18 to the inflatable member ([0012]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lund with a first portion of the lumen that extends substantially linearly, as taught by Morningstar, in order to provide a connection between the tubing and the spiral-shaped chamber section/second portion of the lumen.
Regarding claim 3, the combination of Lund and Morningstar discloses the invention as claimed, see rejection supra, and Lund further discloses that the lumen defined by the sidewall of the inflatable member includes a first portion having a first diameter and a second portion having a second diameter, the second diameter being larger than the first diameter ([0072]; e.g., a first portion may have a first diameter in an uninflated condition, a second portion may have a second, larger diameter in an inflated condition).
Regarding claim 4, the combination of Lund and Morningstar discloses the invention as claimed, see rejection supra, and Lund further discloses that the lumen defined by the sidewall of the inflatable member includes a first portion having a first diameter, a second portion having a second diameter, and a third portion having a third diameter, the second portion being disposed between the first portion and the third portion, the second diameter begin larger than the first diameter, the second diameter being larger than the third diameter ([0072]; e.g., a first portion towards a proximal end may have a first diameter in an uninflated condition, a third portion towards a distal end may have a third diameter in an uninflated condition, and a second portion in the middle may have a second, larger diameter in an inflated condition).
Regarding claim 5, the combination of Lund and Morningstar discloses the invention as claimed, see rejection supra, and Lund further discloses that the lumen defined by the sidewall of the inflatable member includes a first portion having a first diameter, a second portion having a second diameter, and a third portion having a third diameter, the second portion being disposed between the first portion and the third portion, the second diameter begin larger than the first diameter, the second diameter being larger than the third diameter, the second portion being disposed between the first portion and the third portion along a longitudinal axis of the inflatable member ([0072]; e.g., a first portion towards a proximal end may have a first diameter in an uninflated condition, a third portion towards a distal end may have a third diameter in an uninflated condition, and a second portion in the middle may have a second, larger diameter in an inflated condition).
Regarding claim 6, the combination of Lund and Morningstar discloses the invention as claimed, see rejection supra, and Lund further discloses that the outer surface of the sidewall of the inflatable member is substantially smooth (Fig. 1; [0036]; [0040]).
Regarding claim 10, the combination of Lund and Morningstar discloses the invention as claimed, see rejection supra, and Lund further discloses that the inflatable member is configured to be placed in an inflated configuration and a deflated configuration ([0036]-[0037]).
Regarding claim 11, the combination of Lund and Morningstar discloses the invention as claimed, see rejection supra, and Lund further discloses that the inflatable member is configured to be placed in an inflated configuration or a deflated configuration, the inflatable member having a tubular shape when in the deflated configuration (Fig. 1; [0036]-[0037]).
Regarding claim 12, the combination of Lund and Morningstar discloses the invention as claimed, see rejection supra, and Lund further discloses that the inflatable member is configured to be placed in an inflated configuration or a deflated configuration, the inflatable member configured to extend along a longitudinal axis when placed in the inflated configuration (Fig. 1; [0036]-[0037]).
Regarding claim 13, the combination of Lund and Morningstar discloses the invention as claimed, see rejection supra, and Lund further discloses a first cap 120 coupled to a first end portion of the inflatable member and a second cap 118 coupled to a second end portion of the inflatable member ([0039]).
Regarding claim 22, the combination of Lund and Morningstar discloses the invention as claimed, see rejection supra, and Morningstar further discloses that the first portion of the lumen extends along a longitudinal axis of the inflatable member (Fig. 1a).
Regarding claim 23, the combination of Lund and Morningstar discloses the invention as claimed, see rejection supra, and Morningstar further discloses that the first portion of the lumen is fluidically coupled to the second portion of the lumen (Fig. 1a).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lund and Morningstar as applied to claim 1 above, and further in view of Kuyava (U.S. Pub. No. 2009/0105530 A1). The combination of Lund and Morningstar discloses the invention as claimed, see rejection supra, but fails to disclose that the outer surface of the sidewall of the inflatable member includes a series of undulations. Kuyava discloses a similar implant (Abstract) comprising an inflatable member with an outer surface of a sidewall of the inflatable member that includes a series of undulations in order to allow for a smaller deflated state without a smaller inflated state, allowing easier installation and providing greater comfort ([0016]-[0020]; [0028]). It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the combination of Lund and Morningstar with a series of undulations on the outer surface of the sidewall of the inflatable member, as taught by Kuyava, in order to allow easier installation and provide greater comfort.
Claims 8 and 9 rejected under 35 U.S.C. 103 as being unpatentable over Lund and Morningstar as applied to claim 1 above, and further in view of Morningstar (U.S. Pub. No. 2012/0053401 A1; hereinafter known as “Morningstar ‘401”). The combination of Lund and Morningstar discloses the invention as claimed, see rejection supra, but fails to disclose that the inflatable member is unitarily formed or is monolithic. Morningstar ‘401 discloses a similar implant (Abstract) comprising an inflatable member that is unitarily formed and monolithic in order to integrally form a one-piece unit ([0026]-[0029]). It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the combination of Lund and Morningstar so that the inflatable member that is unitarily formed and monolithic, as taught by Morningstar ‘401, in order to integrally form a one-piece unit.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lund and Morningstar as applied to claim 1 above, and further in view of Taylor (U.S. Pub. No. 2017/0027696 A1). The combination of Lund and Morningstar discloses the invention as claimed, see rejection supra, but fails to disclose that the pump assembly includes a valve body and a pump bulb member (though Fig. 1 of Lund appears to show a pump bulb). Taylor discloses a similar implant (Abstract) comprising a pump assembly that includes a valve body and a pump bulb member in order to control fluid flow for inflation/deflation ([0036]; [0065]). It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the combination of Lund and Morningstar with a valve body and a pump bulb member, as taught by Taylor, in order to control fluid flow for inflation/deflation.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kubalak et al. (U.S. Pub. No. 2017/0065419 A1; hereinafter known as "Kubalak"), in view of George et al. (U.S. Pub. No. 2009/0132044 A1; hereinafter known as "George").
Regarding claim 16, Kubalak discloses an apparatus (Abstract; Figs. 1-3), comprising: a core member 40/70 for forming an elongate member of a bodily implant, the core member having a longitudinal axis and an outer surface ([0048]), the core member being formed of a material that is configured to dissolve ([0040]; [0043]; [0046]; [0075]); and a tubular member 28 defining a lumen configured to receive at least a portion of the core member and to adhere to a material disposed between the core member and the tubular member ([0031]; [0034]; [0039]; Kubalak’s tubular member is capable of achieving this intended use; Kubalak teaches that its tubular member can be made of silicone, which is the same material taught by the present invention). Kubalak fails to disclose that the outer surface having a series of undulations, but does teach that the core member improves the implantation procedure ([0039]). George discloses a similar apparatus (Abstract; Figs. 1-3) that comprises a core member 100 with an outer surface having a series of undulations 110/112/114/118/120/122 in order to require less force to bend and reduce springback ([0007]; [0010]-[0014]). It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the invention of Kubalak so that the outer surface of the core member has a series of undulations, as taught by George, in order to require less force to bend and reduce springback, thus further easing implantation.
Regarding claim 17, the combination of Kubalak and George discloses the invention as claimed, see rejection supra, and Kubalak further discloses that the core member defines a lumen 74, the lumen extends substantially parallel to the longitudinal axis of the core member (Figs. 3A-B; [0048]).
Allowable Subject Matter
Claims 18 and 19 are allowed.
The following is an examiner’s statement of reasons for allowance: none of the prior art of record teaches or reasonably suggests such a method of making an elongate member for a bodily implant that includes placing material within the lumen of the tubular member, such that the material flows around the core member and adheres to the tubular member, in combination with the other recited steps.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments with respect to the objections to claims 3-5 and 18, as well as the rejections under 35 U.S.C. 112(b), have been fully considered and are persuasive in light of the amendments. The objections and rejections have been withdrawn.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102 and 103 based upon Lund have been fully considered and are persuasive in light of the amendments. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made, as detailed supra.
Applicant's arguments with respect to the rejections of claims 16 and 17 under 35 U.S.C. 103 based upon Lund have been fully considered but they are not persuasive. As detailed supra, the proposed combination does indeed still teach the amended limitations.
Applicant’s arguments with respect to the rejections of claims 18 and 19 under 35 U.S.C. 103, as well as the double patenting rejections, have been fully considered and are persuasive in light of the amendments. The rejections have been withdrawn.
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 THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791
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