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 .
Amendment
This office action is responsive to the amendment filed on 5/26/26. As directed by the amendment: no claims have been amended, claims 1-6, 8-9, 12, 14-15 and 17-18 have been canceled, and no new claims have been added. Thus, claims 7, 10-11, 13 and 16 are presently pending in the application.
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.
Claims 7, 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Seder et al. (2005/0256573) in view of Faulconer et al. (5,261,396), Bailey et al. (4,986,310) and Thor et al. (4,394,939).
Regarding claim 7, in fig. 1-2 Seder discloses a voice prosthesis 10 for insertion into a fistula opening in a tracheoesophageal wall (see fig. 1 [0065]), comprising: a tubular elastomeric body (12 [0065]) having a central passage therein (within 12, shown in fig. 2) and a pair of flanges (14 and 16) each extending radially outwardly from opposite ends of the tubular elastomeric body; and a disc valve 60 supported in at least a portion of the tubular elastomeric body (Fig. 2), but is silent regarding that the tubular elastomeric body has a valve seat on one end thereof, the disc valve including a valve body and a stem extending from a center of the valve body, the stem being supported by a support that extends across the central passage. However, in fig. 4 Faulconer teaches a tubular body having a valve seat 110 on one end thereof, the disc valve including a valve body 94 and a stem 96 extending from a center of the valve body, the stem being supported by a support 106 that extends across the central passage. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Seder’s tubular body and valve with a valve seat and valve having a stem and support, as taught by Faulconer, for the purpose of providing an alternate tube and valve structure having the predictable results of allowing for one-way flow. The modified Seder discloses that the valve body of the disc valve engaging the valve seat in a normal state (Fig. 4, Faulconer), but is silent regarding that the support is a flexible support that is made from an elastomeric material and the flexible support being deformed to allow the valve body of the disc valve to be lifted axially away from the valve seat in an open actuated state. However, Bailey teaches a flexible support made of elastomeric material (flexible element 20 is elastomeric Col. 2, ll. 62-65 and supports the valve 48) and the flexible support being deformed to allow the valve body of the disc valve to be lifted axially away from the valve seat in an open actuated state (Fig. 3, Col. 4, ll. 28-59), as well as a rigid valve member (Col. 3, ll. 25-28). 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 modified Seder’s supporting structure material with an elastomeric material and disc valve material with a rigid disc valve material, as taught by Bailey, for the purpose of providing a strong seal (Col. 4, ll. 28-59 Bailey). The modified Seder is silent regarding that the flexible support includes a plurality of spiral shaped arms that support a central hub with an aperture that receives the stem of the disc valve. However, in fig. 1-3 Thor teaches a flexible support (24, 25 and 26) that includes a plurality of spiral shaped arms 26 that support a central hub (portion of support immediately surrounding aperture that receives 27) with an aperture that receives the stem of the disc valve (Col. 5, ll. 51-53). 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 modified Seder’s support with spiral arms, as taught by Thor, for the purpose of providing an alternate support shape having the predictable results of supporting the disc valve.
Regarding claim 10, the modified Seder discloses that the disc valve is made from a rigid material (Col. 3, ll. 25-28 Bailey).
Regarding claim 13, in fig. 1-2 Seder discloses a voice prosthesis 10 for insertion into a fistula opening in a tracheoesophageal wall (see fig. 1 [0065]), comprising: a tubular elastomeric body (12 [0065]) having a central passage therein (within 12, shown in fig. 2) and a pair of flanges (14 and 16) each extending radially outwardly from opposite ends of the tubular elastomeric body; and a valve 60 supported in at least a portion of the tubular elastomeric body (Fig. 2), but is silent regarding that the tubular elastomeric body has a valve seat on one end thereof, an umbrella-shaped valve including a round canopy and a stem extending from a center of the round canopy, the stem being supported by a support that extends across the central passage. However, in fig. 4 Faulconer teaches a tubular body having a valve seat 110 on one end thereof, an umbrella-shaped valve (94 and 96) including a round canopy 84 and a stem 96 extending from a center of the round canopy, the stem being supported by a support 106 that extends across the central passage. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Seder’s tubular body and valve with a valve seat and umbrella valve having a round canopy and stem and support, as taught by Faulconer, for the purpose of providing an alternate tube and valve structure having the predictable results of allowing for one-way flow. The modified Seder discloses that the round canopy of the umbrella-shaped valve engaging the valve seat in a normal state (Fig. 4, Faulconer), but is silent regarding that the support is a flexible support that is made from an elastomeric material and the flexible support being deformed to allow the entire round canopy of the umbrella-shaped valve to be lifted axially away from the valve seat in an open actuated state. However, Bailey teaches a flexible support made of elastomeric material (flexible element 20 is elastomeric Col. 2, ll. 62-65 and supports the valve 48) and the flexible support being deformed to allow the entire round canopy of the umbrella-shaped valve to be lifted axially away from the valve seat in an open actuated state (Fig. 3, Col. 4, ll. 28-59). 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 modified Seder’s supporting structure material with an elastomeric material, as taught by Bailey, for the purpose of providing a strong seal (Col. 4, ll. 28-59 Bailey). The modified Seder is silent regarding that the flexible support includes a plurality of spiral shaped arms that support a central hub with an aperture that receives the stem of the umbrella-shaped valve. However, in fig. 1-3 Thor teaches a flexible support (24, 25 and 26) that includes a plurality of spiral shaped arms 26 that support a central hub (portion of support immediately surrounding aperture that receives 27) with an aperture that receives the stem of the umbrella-shaped valve (Col. 5, ll. 51-53). 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 modified Seder’s support with spiral arms, as taught by Thor, for the purpose of providing an alternate support shape having the predictable results of supporting the disc valve.
Claims 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Seder, Faulconer, Bailey and Thor, as applied to claims 7 and 13 above, respectively, and further in view of Malec et al. (2011/0168723).
Regarding claim 11, the modified Seder is silent regarding that the disc valve is made from an elastomeric material. However, in fig. 1 Malec teaches a valve disc 8 that is able to axially translate to open the valve as well as flex [0020][0022] “the closing element 8 is supported in the support 17 in such a way that it is able to execute a predetermined axial opening stroke. The opening of the closing element 8 can take place through an axial stroke of the closing element 8 and/or through an elastic bending of the closing section 16”). 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 modified Seder’s valve material with an elastomeric valve material, as taught by Malec, for the purpose of providing an alternate one-way valve material having the predictable results of directing flow in one direction.
Regarding claim 16, the modified Seder is silent regarding that the umbrella-shaped valve is made from an elastomeric material. However, in fig. 1 Malec teaches a valve disc 8 that is able to axially translate to open the valve as well as flex [0020][0022] “the closing element 8 is supported in the support 17 in such a way that it is able to execute a predetermined axial opening stroke. The opening of the closing element 8 can take place through an axial stroke of the closing element 8 and/or through an elastic bending of the closing section 16”). 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 modified Seder’s valve material with an elastomeric valve material, as taught by Malec, for the purpose of providing an alternate one-way valve material having the predictable results of directing flow in one direction.
Response to Arguments
Applicant's arguments filed 5/26/26 have been fully considered but they are not persuasive.
Applicant argues on page 7 that Thor’s spiral shaped arms are part of the inlet valve member 18, rather than the support.
Examiner disagrees since Thor’s flexible support (24, 25 and 26) that includes a plurality of spiral shaped arms 26 supports a central hub (portion of support immediately surrounding aperture that receives 27) with an aperture that receives the stem of the disc valve (Col. 5, ll. 51-53). It can be seen in fig. 1-3 of Thor that structure 24, 25 and 26 supports the disc valve 28 and rivet 27 via the hub and then flex to open the valve. Modifying the shape of the arms of a flexible support that receives a valve stem would have been obvious to one of ordinary skill in the art based on the teachings of Thor.
Conclusion
THIS ACTION IS MADE FINAL. 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 RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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