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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/16/2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 10, 12, 15, 19-20, 233, 235-238, 240 and 242-245 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Status
Claims 1, 10, 12, 15, 19-20, 233, 235-238, 240 and 242-249 are examined below.
Claim Objections
Claim 12 objected to because of the following informalities: "the plurality of cuts" in line 3 should read "the series of cuts". Appropriate correction is required.
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.
Claim 245 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.
Claim 245 recites “a position of the implant retention area” in line 4. It is unclear if this is the same position of the implant retention area recited in claim 244 lines 2-3 or a separate and distinct position of the implant retention area.
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.
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.
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.
Claim(s) 1, 10, 12, 15, 19-20, 240 and 246 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeung (US 2014/0046435 A1) in view of Gerrans (US 2016/0096004 A1).
Regarding claim 1, Yeung teaches a delivery system for delivering an implant to a location within a patient's body (18, heart valve repair system, fig. 3, ¶ [0002]), the delivery system comprising:
an elongate shaft (26, sheath assembly, fig. 3) having a proximal end (see annotated fig. 3, below) and a distal end (see annotated fig. 3, below), and including:
an implant retention area (see annotated fig. 3, below) configured to retain the implant (¶ [0040]), and
a hypotube (80, tube, fig. 5A, ¶ [0046]), coupled to the implant retention area (fig. 3), and defining:
a series of cuts arranged consecutively in a helical path (fig. 5A), and
a gap separating each cut of the series from a successive cut of the series (136, spines, fig. 5B, ¶ [0055]).
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Yeung fails to teach a repeating pattern of a long cut, flowed by a long cut, followed by a short cut. However, Gerrans discloses a steerable catheter that teaches a cut pattern can have varied length cuts (¶ [0095]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the series of cuts of Yeung to include a repeating pattern of a long cut, followed by a long cut, followed by a short cut as taught by Gerrans in order to obtain the desired flexibility of the delivery system and since it is combining prior art element according to known method to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 10, Yeung further teaches the repeating pattern extends along a length of the hypotube such that the pattern repeats at least 30 times (fig. 5A).
Regarding claim 12, Yeung further teaches includes a distal section (94a, first intermediate section) and the hypotube includes a proximal section (94b, second intermediate section) including the plurality of cuts forming a plurality of turns and providing equal flexibility of the hypotube in all radial directions (plurality of cuts are seen in 94a, it would be obvious to try the plurality of cuts forming the plurality of rings on the proximal section in order to obtain the desired flexibility).
Yeung fails to teach one or more cuts bias a flexibility of the distal section in a single direction. However, Gerrans further teaches one or more cuts bias a flexibility of the distal section in a single direction (¶ [0083], fig. 4). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Yeung to include one or more cuts bias a flexibility of the distal section in a single direction as taught by Gerrans in order to in order to obtain the desired flexibility of the delivery system and since it is combining prior art element according to known method to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 15, Yeung further teaches gaps formed by the plurality of cuts are configured to reduce in size when a force is applied to the hypotube in a distal direction to allow the plurality of rings to contact and compress against each other. The catheter of Yeung discloses all the claimed structural features and is considered capable of allowing the cuts to reduce in size causing them contact and compress against each other.
Regarding claim 19, Yeung further teaches the hypotube is configured to move proximally relative to the implant retention area to allow the implant to deploy (¶ [0071]).
Regarding claim 20, Yeung further teaches the hypotube is configured to move distally relative to the implant retention area to recapture the implant (¶ [0073]).
Regarding claim 240, Yeung further teaches the hypotube has a length (see annotated fig. 5A, below), and a plurality of rings extends circumferentially for the length of the hypotube (fig. 5A).
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Regarding claim 246, Yeung further teaches the gaps are aligned to define three spines that extend longitudinally along the hypotube (¶ [0055]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the at least one spine to be three spines, since these are result effective variables that contribute to the flexibility of the hypotube, 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 and modifying the hypotube to have three spines, as taught and suggested by Yeung, would allow for flexibility in preferred directions. (MPEP 2144.05)
Regarding claim 249, the device of Yeung and Gerrans teaches the series of cuts provide equal flexibility of the hypotube in all radial directions. The phrase “ the series of cuts provide equal flexibility of the hypotube in all radial directions” is a functional recitation that is not given full patentable weight. The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the Yeung and Gerrans device discloses all the claim structural features and is considered to be capable of providing equal flexibility of the hypotube in all radial directions.
Claim(s) 233 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeung in view of Gerrans as applied to claim 1 above, and further in view of Salstrom (US 2015/0231367 A1).
Regarding claim 233, Yeung teaches a short cut extends less than 360 degrees around the hypotube (fig. 5A).
Yeung and Gerrans fail to teach a long cut extends more than 360 degrees. However, Salstrom discloses flexible deliver sheath that teaches a long cut of the plurality of cuts extends more than 360 degrees around the hypotube (¶ [0015]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the repeating pattern of Yeung and Gerrans to include a long cut extends more than 360 degrees as taught by Salstrom since it is a combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Claim(s) 235 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeung in view of Gerrans as applied to claim 1 above, and further in view of Kilma (US 2012/0078351 A1).
Regarding claim 235, Yeung and Gerrans fail to teach a covering layer on the elongate shaft including reinforcing fibers or beads. However, Klima discloses a delivery system for delivery a collapsible prosthetic heart with a hypotube that teaches a covering layer (160, polymer layer, ¶ [0032], Klima) on the elongate shaft including reinforcing fibers or beads (braided metal wired, ¶ [0033], Klima). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Yeung and Gerransto include a covering layer on the elongate shaft including reinforcing fibers or beads as taught by Klima in order to enhance the columnar strength of the sheath (¶ [0033], Klima).
Claim(s) 236 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeung in view of Gerrans as applied to claim 1 above, and further in view of Panian (US 2019/0307985 A1).
Regarding claim 236, Yeung and Gerrans fail to teach an outer jacket layer and an interior liner layer. However, Panian discloses a catheter with a hypotube that teaches an outer jacket layer (808, outer jacket, ¶ [0118], Panian) surrounds the hypotube, and the hypotube surrounds an interior liner layer (806, inner liner, ¶ [0118], Panian). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Yeung and Gerrans to include an outer jacket layer and an interior liner layer as taught by Panian in order to improve performance characteristics (abstract, Panian).
Claim(s) 237 and 238 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeung in view of Gerrans and Panian as applied to claim 236 above, and further in view of Beeckler (US 2018/0169380 A1).
Regarding claim 237, Yeung and Gerrans fail to teach a braid layer. However, Panian further teaches a braid layer (816, braid, ¶ [0123], Panian) positioned between the outer jacket layer and the hypotube. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Yeung and Gerrans to include a braid layer as taught by Panian in order to improve performance characteristics (abstract, Panian).
Yeung in view of Gerrans and Panian fails to teach a buffer layer between the braid layer and the outer jacket layer. However, Beeckler discloses a catheter shaft with a braid layer that teaches a buffer layer (40, middle layer, ¶ [0028], Beeckler) positioned between the braid layer and the outer jacket layer and configured to prevent flow of the outer jacket layer into the braid layer. In this case the delivery device discloses all the claimed structural features and is considered capable of preventing flow of the outer jacket layer into the braid layer. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery device of Yeung, Gerrans and Panian to include a buffer layer between the braid layer and the outer jacket layer as taught by Beeckler in order to allow the layers to slide upon one another when the shaft flexes (Beeckler, ¶ [0028]).
Regarding claim 238, Yeung and Gerrans fail to teach the outer jacket layer comprises a polymer and the interior liner layer comprises polytetrafluoroethylene (PTFE). However, Panian further teaches the outer jacket layer comprises a polymer (Pebax 2533, ¶ [0130], Panian), and the interior liner layer comprises polytetrafluoroethylene (PTFE, ¶ [0121], Panian). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery device of Yeung and Gerrans to include the outer jacket layer comprises a polymer and the interior liner layer comprises polytetrafluoroethylene (PTFE) as taught by Panian in order to improve performance characteristics (abstract, Panian).
Yeung, Gerrans and Panian fail to teach the buffer layer comprises expanded polytetrafluoroethylene (ePTFE). However, Beeckler further teaches the buffer layer comprises expanded polytetrafluoroethylene (ePTFE is a thermoplastic and ¶ [0028] states a thermoplastic can be used, Beeckler). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery device of Yeung, Gerrans and Panian to include the buffer layer comprises expanded polytetrafluoroethylene as taught by Beeckler in order to allow the layers to slide upon one another when the shaft flexes (Beeckler, ¶ [0028]).
Claim(s) 242-245 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeung in view of Gerrans as applied to claim 1 above, and further in view of Yeung (US 2014/0046435 A1) in view of Cooper (US 2017/0056171 A1).
Regarding claim 242, Yeung and Gerrans fail to teach a rail assembly. However, Cooper discloses an implant delivery system that teaches a rail assembly (20, mid shaft assembly, fig. 5) for forming a bend of the elongate shaft in a direction (¶ [0128]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Yeung and Gerrans to include a rail assembly as taught by Cooper in order to facilitate steering of the delivery component (abstract, Cooper).
Regarding claim 243, Yeung and Gerrans fail to teach the hypotube is configured to be retracted over the bend assembly and flex in the direction of the bend. However, Cooper further teaches the hypotube is configured to be retracted over the bend of the rail assembly and flex in the direction of the bend (In this case, the combination catheter of Yeung and Cooper discloses all the claimed structural features and the hypotube is considered capable of being retracted over the bend assembly and flex in the direction of the bend). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Yeung and Gerrans to include the hypotube is configured to be retracted over the bend assembly and flex in the direction of the bend as taught by Cooper in order to facilitate steering of the delivery component (abstract, Cooper).
Regarding claim 244, Yeung and Gerrans fail to teach the hypotube is configured to advance distally relative to the rail assembly. However, Cooper further teaches the hypotube is configured to advance distally relative to the rail assembly to vary a position of the implant retention area relative to the rail assembly (In this case, the combination catheter of Yeung and Cooper discloses all the claimed structural features and is considered capable of allowing the hypotube to advance distally relative to the rail assembly to vary a position of the implant retention area relative to the rail assembly). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Yeung and Gerrans to include the hypotube is configured to advance distally relative to the rail assembly as taught by Cooper in order to facilitate steering of the delivery component (abstract, Cooper).
Regarding claim 245, Yeung and Gerrans fail to teach an inner shaft and retention member. However, Cooper further teaches an inner shaft (42, inner retention shaft, fig. 6, ¶ [0154]) positioned inward of the rail assembly, the inner shaft including a retention member (32, inner retention member, fig. 6) for retaining the implant, the inner shaft configured to advance distally relative to the rail assembly to vary a position of the implant retention area relative to the rail assembly (In this case, the combination catheter of Yeung, Gerrans and Cooper discloses all the claimed structural features and the inner shaft is considered capable of advancing distally relative to the rail assembly to vary a position of the implant retention area relative to the rail assembly.). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Yeung and Gerrans to include an inner shaft and retention member as taught by Cooper in order to facilitate steering of the delivery component (abstract, Cooper).
Allowable Subject Matter
Claims 247-248 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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