DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed February 23, 2026 has been entered. Claims 1-6, 9-11, 13-15, and 17-19 are currently pending.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 1-6, 11, 15, and 18-19 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Skujins (US 2004/0106878, hereinafter “Skujins”).
Regarding claims 1, 11, and 19, Skujins discloses an implant delivery system (fully capable of delivering an implant), comprising:
a delivery pusher (10) (or pusher means) including a core mandrel (or core mandrel means) (portion of 11 highlighted in annotated Fig 2 below having reduced diameter at connector assembly 12; para [0042]) that is radiopaque along at least a portion of its length (radiopaque portion 18b), the core mandrel having a proximal region, a medial region, and a distal region and having a constant diameter through the proximal region, the medial region, and the distal region (see annotated Fig 2 below), wherein the pusher means is fully capable of delivering an implant; and
a radiopaque layer (or radiopaque layer means) (combination of 18a, 15, 18c) covering the proximal region, the medial region, and the distal region of the core mandrel, the radiopaque layer having a first thickness in the proximal region (at 18a), a second thickness in the medial region (at a midpoint of 15), and a third thickness in the distal region (at a midpoint or distal end of 18c), wherein the first thickness is greater than the second thickness, and wherein the third thickness is less than the first thickness and the second thickness (due to tapering; see annotated Fig 2 below; para [0043]).
[AltContent: arrow][AltContent: textbox (Core mandrel)][AltContent: rect][AltContent: textbox (Distal Region)][AltContent: textbox (Proximal Region)][AltContent: textbox (Medial Region)][AltContent: ][AltContent: ][AltContent: connector][AltContent: ][AltContent: connector][AltContent: connector][AltContent: connector]
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Regarding claim 2, wherein the first layer (at least connector member 15 of radiopaque layer may be composed of nickel titanium alloy or stainless steel – para [0025]) has a different radiopaque level than the core mandrel (at least portion 18b of core mandrel may be tungsten, tantalum, platinum, and/or gold – para [0034])
Regarding claim 3, wherein a first radiopaque value of the core mandrel (at least portion 18b of core mandrel may be tungsten, tantalum, platinum, and/or gold – para [0034]) is greater than a second radiopaque value of the radiopaque layer (at least connector member 15 of radiopaque layer may be composed of nickel titanium alloy or stainless steel – para [0025]).
Regarding claim 4, wherein the core mandrel is composed of tungsten, tantalum, platinum, or gold (at least portion 18b of core mandrel may be tungsten, tantalum, platinum, and/or gold – para [0034]).
Regarding claims 5 and 6, wherein the radiopaque layer is composed of a chromium cobalt alloy, a nickel titanium alloy, or stainless steel (at least connector member 15 of radiopaque layer may be composed of nickel titanium alloy or stainless steel – para [0025]).
Regarding claim 15, wherein a diameter of the radiopaque layer (18a) at the proximal region is greater than a diameter of the radiopaque layer at the medial region (midpoint of 15), and wherein a diameter of the radiopaque layer at the medial region (midpoint of 15) is greater than a diameter of the radiopaque layer at the distal region (midpoint or distal end of 18c) (due to tapering; see annotated Fig 2 above; para [0043]).
Regarding claim 18, wherein the core mandrel extends only partially through a length of the delivery pusher (see annotated Fig 2 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 9-10, 13-14, and 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Skujins (US 2004/0106878), as applied to claims 1 and 11 above.
Regarding claim 9, Skujins discloses the invention substantially as claimed, as shown above, including the length of the distal region of the core mandrel being a small percentage of the total length of the delivery pusher (10) (see annotated Figure 2 above). However, Skujins does not provide detailed lengths. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device such that a length of the distal region of the core mandrel was approximately 2% of a total length of the delivery pusher since it has
been held that discovering an optimum value of a result effective variable involves only routine
skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Alternatively, it would
have been obvious to one having ordinary skill in the art at the time of the invention to modify
Skujins such that a length of the distal region of the core mandrel was approximately 2% of a total length of the delivery pusher in order to appropriately size the device for a particular use since Applicant has placed no criticality on the particular length of the distal region of the core mandrel and since modifying Skujins to have the specified relative dimension would not adversely affect the function of the device. The courts have recognized that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)).
Regarding claim 10, Skujins discloses the invention substantially as claimed, as shown above, including the distal region of the core mandrel being a small percentage of the total length of the delivery pusher (10) (see annotated Figure 2 above). Furthermore, Skujins teaches the length of medial region (15) may be about 1 to 3 inches, by way of example (para [0023]). However, Skujins fails to specify the dimensions of the distal region of the core mandrel. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device such that a length of the distal region of the core mandrel was approximately 3 cm since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Alternatively, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify Skujins such that a length of the distal region of the core mandrel was approximately 3 cm in order to appropriately size the device for a particular use since Applicant has placed no criticality on the particular length of the distal region of the core mandrel and since modifying Skujins to have the specified relative dimension would not adversely affect the function of the device. The courts have recognized that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)).
Regarding claim 13, Skujins discloses the invention substantially as claimed, as shown above, including the medial region appearing to have a greater length than the distal region (see annotated Fig 2 above). However, Skujins fails to disclose details on the relative lengths of each section. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device such that the proximal region has a greater length than the medial region, and wherein the medial region has a greater length than the distal region since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Alternatively, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify Skujins such that the proximal region has a greater length than the medial region, and wherein the medial region has a greater length than the distal region in order to appropriately size the device for a particular use since Applicant has placed no criticality on the particular lengths of the proximal, medial, and distal regions and since modifying Skujins to have the specified relative dimensions would not adversely affect the function of the device. The courts have recognized that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)).
Regarding claim 14, Skujins discloses the invention substantially as claimed, as shown above. However, Skujins fails to disclose details on the relative lengths of each section. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device such that a length of the proximal region is approximately 91% of a total length of the delivery pusher, wherein a length of the medial region is approximately 7% of the total length of the delivery pusher, and wherein a length of the distal region is approximately 2% of the total length of the delivery pusher since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Alternatively, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify Skujins such that a length of the proximal region is approximately 91% of a total length of the delivery pusher, wherein a length of the medial region is approximately 7% of the total length of the delivery pusher, and wherein a length of the distal region is approximately 2% of the total length of the delivery pusher in order to appropriately size the device for a particular use since Applicant has placed no criticality on the particular lengths of the proximal, medial, and distal regions and since modifying Skujins to have the specified relative dimensions would not adversely affect the function of the device. The courts have recognized that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)).
Regarding claim 17, Skujins discloses the invention substantially as claimed, as shown above, including the core mandrel including only a percentage of the of the total diameter of the delivery pusher (see annotated Fig 2 above). However, Skujins fails to disclose claimed percentage range. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Skujins such that the core mandrel comprised about 10%-80% of a total diameter of the delivery pusher in at least a portion thereof since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Alternatively, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify Skujins such that the core mandrel comprised about 10%-80% of a total diameter of the delivery pusher in at least a portion thereof in order to appropriately size the device for a particular use since Applicant has placed no criticality on the relative diameters and since modifying Skujins to have the specified dimensional relationship in at least a portion thereof would not adversely affect the function of the device. The courts have recognized that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)).
Response to Arguments
Applicant’s arguments, see amendment, filed February 23, 2026, with respect to the rejection(s) of claim(s) 1-2, 7-9, 11-14, 16, and 18-20 under Richardson (US 6,402,706) have been fully considered and are persuasive. Richardson fails to disclose core mandrel has a constant diameter through the proximal, medial, and distal regions. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Skujins (US 2004/0106878).
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 KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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