DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant's election with traverse of Group/Invention I – claims 1-15 (drawn to a transcatheter heart valve delivery assembly) in the reply filed on 09 July 2026 is acknowledged.
The traversal is on the ground(s) that:
“First, the Examiner fails to explain how the claimed process can be practiced by hand. Applicant requests that the Examiner provide an explanation as to how a heart valve prosthesis in a patient's heart can be recaptured by hand.” This is not found persuasive because the “or by hand” is one of the two alternatives/options to “the process as claimed can be practiced by another and materially different apparatus or by hand” (which is wording straight from MPEP 806.05(e)). The Office Action (OA) clearly provided an explanation to option “a” (i.e., “another and materially different apparatus”). In other words, Applicant’s argument is moot since the Restriction Requirement did NOT rely on “by hand”, but on “another and materially different apparatus”.
“The Examiner fails to explain how a clamp and/or wires and/or hooks can move between a radially-compressed position and a radially-expanded position, as claimed. Further, it is unclear how such clamps, hooks or wires would be incorporated into a delivery system in a manner that does not interact with the vasculature, i.e., get hung up on or dissect a surgically repaired right ventricular outflow tract.” This is not found persuasive. See, for example, US PG Pub No. 2015/0313701 A1 and US PG Pub No. 2024/0225828 A1.
“The Examiner also argues that "the apparatus as claimed can be used to practice another and materially different process. For example, the apparatus as claimed can be used to capture/retrieve clogs from a clogged drain," (emphasis added).” This is not found persuasive. The OA clearly states “Alternatively, the apparatus as claimed can be used to practice another and materially different process. For example, the apparatus as claimed can be used to capture/retrieve clogs from a clogged drain.” (emphasis added).
Applicant's traversal has been carefully considered, but fails to establish error in the propriety of the present requirement for restriction and election. Though Applicant asserts that examination of all pending claims would not pose an undue burden on the Examiner, such is not an accurate assertion in light of the disparate nature of the presently claimed subject matter as noted in the Election of Species Requirement of 21 May 2026.
Consideration of the plurality of inventions that Applicant has claimed would significantly compromise and preclude a quality examination on the merits. Furthermore, execution of a search encompassing the entirety of Applicant's groups/inventions and/or species would not only constitute an undue burden on the Examiner, but consideration of the findings of such a search in accordance with the requirements of the law under 35 U.S.C. §§101,102, 103 and 112 would be unduly onerous.
(a) The inventions have acquired a separate status in the art in view of their different classification;
(b) The inventions have acquired a separate status in the art due to their recognized divergent subject matter; and
(c) The inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Moreover, it is further noted that a comprehensive search for the presently claimed subject matter is not solely limited to a search of the classes and subclasses in which they are classified. Therefore, it is obvious that a comprehensive search of the copious amounts of patent and non-patent literature for each of the patentably distinct inventions and their permutations presently claimed would necessarily place an undue burden on the Examiner.
The requirement is still deemed proper and is therefore made FINAL.
3. Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group/invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09 July 2026.
Claim Rejections - 35 USC § 103
4. 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.
5. Claims 1-3, 6, and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Murray, III et al. (US 8,512,401; cited in Applicant’s IDS) in view of Adams et al. (US PG Pub No. 2009/0099530 A1).
Regarding independent claim 1 and independent claim 11, and referring to Figures 2, 3A-3C and 6, Murray, III et al. ‘401 discloses a transcatheter heart valve delivery assembly for delivering a heart valve prosthesis to a treatment site (C1:L7-12), the transcatheter heart valve delivery assembly comprising:
a first shaft portion (Figure 2 – shaft of hub to the right of recapture sheath 32, or shaft of housing 140; Figure 6 – see below for annotated Figure 6, wherein shaft 130 is the “first shaft portion”) comprising a first wall surrounding a first chamber (Figures 3A, 3C, and 6 – the lumen of the “first shaft portion” is the chamber) and extending along an axis, the first wall comprising a first durometer value (inherent, since vascular delivery assemblies are made from materials having a durometer value);
a second shaft portion (Figures 2, 3A, and 3C – shaft 50; Figure 6 – see below for annotated Figure 6, wherein shaft 40 is the “second shaft portion”) attached to a distal end of the first shaft portion (Figure 2 – when the components are finally assembled; Figure 6 - see below for annotated Figure 6) and comprising a second wall surrounding a second chamber (Figures 3A, 3C, and 6 – the lumen of the “second shaft portion” is the chamber), the second shaft portion extending along the axis; and
a funnel portion (Figures 3A and 3C – funnel portion 42; Figure 6 – funnel portion 206) attached to a distal end (C8:L22-24; C13:L53-60) of the second shaft portion and comprising a funnel wall surrounding a funnel chamber (clearly shown in the figures), the funnel portion extending along the axis and configured to move between a radially-compressed position (Figure 3A and Figure 6), in which the funnel chamber comprises a first diameter that is less than or equal to a diameter of the second chamber, and a radially-expanded position (Figure 3C), in which the funnel chamber comprises a second diameter that is greater than the first diameter (C7:L57 to C8:L16; C10:L4-12; C13:L60 to C14:L6), the funnel portion biased into the radially-compressed position (C7:L57 to C8:L16; C10:L4-12; C13:L60 to C14:L6) and configured to receive and compress the heart valve prosthesis (160) within the funnel chamber (C4:L57-67; C7:L57 to C8:L16; C10:L4-12; C13:L60 to C14:L6).
ANNOTATED FIGURE 6 of Murray, III et al. ‘401:
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Murray, III et al. ‘401 discloses the invention as claimed, except for particularly disclosing the second wall comprising a second durometer value that is less than the first durometer value, and the funnel wall comprising a third durometer value that is less than the second durometer value. However, this is already known in the art. For example, Adams et al. ‘530 teaches (Figures 26-28) an assembly having different regions (e.g., “portions”) comprising a different durometer level, wherein the durometer of the proximal regions/portions have a harder durometer in order to prevent elongation, and the durometer of the distal regions/portions have a softer durometer in order to increase flexibility ([0100]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of the second wall comprising a second durometer value that is less than the first durometer value, and the funnel (i.e., distal region/portion) wall comprising a third durometer value that is less than the second durometer value, as taught by Adams et al. ‘530, with the invention of Murray, III et al. ‘401, in order to increase flexibility towards the distal end of the assembly.
Regarding claim 2, Murray, III et al. ‘401 discloses wherein the funnel portion comprises one or more of a polyether-based thermoplastic polyurethane material or a thermoplastic elastomer material (C8:L43-49; C9:L64-65). Notice, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 3, Murray, III et al. ‘401 discloses wherein the funnel wall comprises a funnel wall thickness (the “a funnel wall thickness” is broadly interpreted to read on the wall thickness of “runners 60”) within a range from about 0.3 millimeters to about 0.6 millimeters (C8:L37-39 of Murray, III et al. ‘401 teaches a wall thickness of 0.015 inches, which is 0.381 millimeters). Notice, the wall thickness of “polymer overlay 62”, i.e., another “a funnel wall thickness”, is less than the wall thickness of the “runners 60”, and within the claimed range.
Regarding claim 6, Murray, III et al. ‘401 discloses wherein the second shaft portion is reinforced with one or more of a frame (e.g., a braid) or a coil (C9:L65-67; C11:L21-22).
Regarding claim 9, Murray, III et al. ‘401 discloses wherein the first shaft portion is reinforced with one or more of a frame, a braid, or a coil (C9:L65-67; C11:L21-22).
Regarding claim 10, and independent claim 11, Murray, III et al. ‘401 discloses wherein the first chamber, the second chamber, and the funnel chamber extend coaxially and contiguously through the first shaft portion, the second shaft portion, and the funnel portion (clearly shown in Figures 3A-3C and 6), such that the first chamber, the second chamber, and the funnel chamber are configured to receive (i.e., capable of receiving) at least a portion (34) of the delivery assembly through the first shaft portion, the second shaft portion, and the funnel portion (C3:L33-35; C7:L43-56).
Regarding claim 12, Murray, III et al. ‘401 discloses wherein the funnel portion comprises one or more of a polyether-based thermoplastic polyurethane material or a thermoplastic elastomer material (C8:L43-49; C9:L64-65). Notice, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 13, Murray, III et al. ‘401 discloses wherein the funnel wall comprises a funnel wall thickness (the “a funnel wall thickness” is broadly interpreted to read on the wall thickness of “runners 60”) within a range from about 0.3 millimeters to about 0.6 millimeters (C8:L37-39 of Murray, III et al. ‘401 teaches a wall thickness of 0.015 inches, which is 0.381 millimeters). Notice, the wall thickness of “polymer overlay 62”, i.e., another “a funnel wall thickness”, is less than the wall thickness of the “runners 60”, and within the claimed range.
Regarding claim 14, Murray, III et al. ‘401 discloses wherein the second shaft portion comprises one or more of a thermoplastic elastomer material or a thermoplastic polyurethane elastomer (C8:L43-49; C9:L64-65). Notice, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
6. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Murray, III et al. (US 8,512,401; cited in Applicant’s IDS) in view of Adams et al. (US PG Pub No. 2009/0099530 A1), as applied to claim 1 above, and further in view of Tung et al. (US PG Pub No. 2013/0123898 A1).
Regarding claim 4, Murray, III et al. ‘401 in view of Adams et al. ‘530 discloses the invention as claimed, except for particularly disclosing wherein the first diameter is within a range from about 5 millimeters to about 10 millimeters and the second diameter is within a range from about 12 millimeters to about 20 millimeters. However, this is already known in the art. For example, paragraph [0043] of Tung et al. ‘898 teaches “the inner diameter of outer sheath 12 along proximal portion 20 may be in the range of about 0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1.016 cm (0.20 to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), or about 0.56388.+-.0.0508 cm (0.222.+-.0.002 inches). The inner diameter of outer sheath 12 along distal portion 22 may be in the range of about 0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1.016 cm (0.20 to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), or about 0.579 to 0.5842 cm (0.228 to 0.230 inches). At the distal end of distal portion 22 may be a distal tip 24, which may be flared or otherwise have a funnel-like shape. The funnel-like shape increases the outer diameter (and inner diameter) of outer sheath 12 at distal tip 24 and may aid in the sheathing and/or resheathing of implant 16 into outer sheath 12” (see Figure 2). The claim language of independent claim 1 recites “in which the funnel chamber comprises a first diameter that is less than or equal to a diameter of the second chamber”. The ranges for the inner diameter of outer sheath 12 disclosed by Tung et al. ‘898 fall within the claimed “first diameter” range of “within a range from about 5 millimeters to about 10 millimeters”.
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the first diameter is within a range from about 5 millimeters to about 10 millimeters, as taught by Tung et al. ‘898, with the invention of Murray, III et al. ‘401 in view of Adams et al. ‘530, in order to receive therein at least a portion of a heart valve and/or delivery assembly (Tung et al. ‘898 – Figure 1). When comparing Figure 3A to Figure 3C of Murray, III et al. ‘401, it is shown that the second diameter is at least twice the size of the first diameter, therefore meeting “and the second diameter is within a range from about 12 millimeters to about 20 millimeters”. Further, a person of ordinary skill in the art will be left with the choice of deciding the particular “second diameter”, depending on the dimensions of the particular prosthetic heart valve in need of recapture/retrieval, and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
7. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Murray, III et al. (US 8,512,401; cited in Applicant’s IDS) in view of Adams et al. (US PG Pub No. 2009/0099530 A1), as applied to claim 1 above, and further in view of Thommen et al. (US PG Pub No. 2009/0221967 A1).
Regarding claim 5, Murray, III et al. ‘401 in view of Adams et al. ‘530 discloses the invention as claimed, except for particularly disclosing wherein the funnel portion comprises a length between a distal funnel end of the funnel portion and a proximal funnel end of the funnel portion that is within a range from about 5 millimeters to about 10 millimeters. However, this is already known in the art. For example, Thommen et al. ‘967 teaches (Figures 2a-2d and 3) an expandable funnel portion having an axial length in the range of 5-50 mm ([0015] and claim 6).
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the funnel portion comprises a length between a distal funnel end of the funnel portion and a proximal funnel end of the funnel portion that is within a range from about 5 millimeters to about 10 millimeters, as taught by Thommen et al. ‘967, with the invention of Murray, III et al. ‘401 in view of Adams et al. ‘530, in order to remove an implant which had been positioned incorrectly before or which had moved (Abstract), and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. Further, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
8. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Murray, III et al. (US 8,512,401; cited in Applicant’s IDS) in view of Adams et al. (US PG Pub No. 2009/0099530 A1), as applied to claim 1 above, and further in view of Thommen et al. (US PG Pub No. 2009/0221967 A1).
Regarding claim 7, Murray, III et al. ‘401 in view of Adams et al. ‘530 discloses the invention as claimed, except for particularly disclosing wherein the second wall comprises a second wall thickness within a range from about 0.4 millimeters to about 0.8 millimeters. However, this is already known in the art. For example, Thommen et al. ‘967 teaches (Figures 2a-2d and 3) wherein the second wall comprises a second wall thickness within a range from about 0.4 millimeters to about 0.8 millimeters ([0013] – “the tubular catheter body and the expansion area are tubes or, as mentioned above, preferably a single tube forming the tubular catheter body and the expansion area, made of a polymeric material. Possible materials are polyether block amides (e.g. Pebax.RTM.), polyethylene, polyamide, polytetrafluorethylene, silicone, polyvinylchloride, polyurethane, polyethyleneterephthalate, polypropylene or copolymers, combinations or mixtures thereof. To provide sufficient stiffness and at the same time sufficient flexibility, such a tube typically has a wall thickness of in the range of 0.1-0.5 mm, and for example a hardness of at least 60 Shore, preferably of at least 70 Shore”).
A wall thickness of 0.5 mm falls within the claimed range “from about 0.4 millimeters to about 0.8 millimeters”.
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the second wall comprises a second wall thickness within a range from about 0.4 millimeters to about 0.8 millimeters, as taught by Thommen et al. ‘967, with the invention of Murray, III et al. ‘401 in view of Adams et al. ‘530, in order to remove an implant which had been positioned incorrectly before or which had moved (Abstract), and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. Further, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
9. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Murray, III et al. (US 8,512,401; cited in Applicant’s IDS) in view of Adams et al. (US PG Pub No. 2009/0099530 A1), as applied to claim 1 above, and further in view of Tung et al. (US PG Pub No. 2013/0123898 A1).
Regarding claim 8, Murray, III et al. ‘401 in view of Adams et al. ‘530 discloses the invention as claimed, except for particularly disclosing wherein the second chamber comprises a second chamber diameter within a range from about 5 millimeters to about 10 millimeters. However, this is already known in the art. For example, paragraph [0043] of Tung et al. ‘898 teaches “the inner diameter of outer sheath 12 along proximal portion 20 may be in the range of about 0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1.016 cm (0.20 to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), or about 0.56388.+-.0.0508 cm (0.222.+-.0.002 inches). The inner diameter of outer sheath 12 along distal portion 22 may be in the range of about 0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1.016 cm (0.20 to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), or about 0.579 to 0.5842 cm (0.228 to 0.230 inches). At the distal end of distal portion 22 may be a distal tip 24, which may be flared or otherwise have a funnel-like shape. The funnel-like shape increases the outer diameter (and inner diameter) of outer sheath 12 at distal tip 24 and may aid in the sheathing and/or resheathing of implant 16 into outer sheath 12” (see Figure 2).
The ranges for the inner diameter of outer sheath 12 disclosed by Tung et al. ‘898 fall within the claimed “wherein the second chamber comprises a second chamber diameter within a range from about 5 millimeters to about 10 millimeters”.
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the second chamber comprises a second chamber diameter within a range from about 5 millimeters to about 10 millimeters, as taught by Tung et al. ‘898, with the invention of Murray, III et al. ‘401 in view of Adams et al. ‘530, in order to receive therein at least a portion of a heart valve and/or delivery assembly (Tung et al. ‘898 – Figure 1), and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
10. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Murray, III et al. (US 8,512,401; cited in Applicant’s IDS) in view of Adams et al. (US PG Pub No. 2009/0099530 A1), as applied to claim 11 above, and further in view of Thommen et al. (US PG Pub No. 2009/0221967 A1).
Regarding claim 15, Murray, III et al. ‘401 in view of Adams et al. ‘530 discloses the invention as claimed, except for particularly disclosing wherein the second wall comprises a second wall thickness within a range from about 0.4 millimeters to about 0.8 millimeters. However, this is already known in the art. For example, Thommen et al. ‘967 teaches (Figures 2a-2d and 3) wherein the second wall comprises a second wall thickness within a range from about 0.4 millimeters to about 0.8 millimeters ([0013] – “the tubular catheter body and the expansion area are tubes or, as mentioned above, preferably a single tube forming the tubular catheter body and the expansion area, made of a polymeric material. Possible materials are polyether block amides (e.g. Pebax.RTM.), polyethylene, polyamide, polytetrafluorethylene, silicone, polyvinylchloride, polyurethane, polyethyleneterephthalate, polypropylene or copolymers, combinations or mixtures thereof. To provide sufficient stiffness and at the same time sufficient flexibility, such a tube typically has a wall thickness of in the range of 0.1-0.5 mm, and for example a hardness of at least 60 Shore, preferably of at least 70 Shore”).
A wall thickness of 0.5 mm falls within the claimed range “from about 0.4 millimeters to about 0.8 millimeters”.
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the second wall comprises a second wall thickness within a range from about 0.4 millimeters to about 0.8 millimeters, as taught by Thommen et al. ‘967, with the invention of Murray, III et al. ‘401 in view of Adams et al. ‘530, in order to remove an implant which had been positioned incorrectly before or which had moved (Abstract), and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. Further, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
At least Figures 38A-38C, 40, and 41 of US PG Pub No. 2010/0049313 A1
At least Figures 1B, 1C, 2A, and 2B of US PG Pub No. 2013/0268064 A1
At least Figures 2A, 2B, 3, and 4 of US PG Pub No. 2021/0022894 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774
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