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 .
Election/Restrictions
Applicant’s election without traverse of invention I and species D in the reply filed on 4/7/2026 is acknowledged.
Claims 14-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/7/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/27/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-13 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.
In regard to claim 1,
Line 9 recites “the plug defined by a first disc”. It is unclear what is meant by “defined by”. It is unclear if the plug is a first disc or if the plug comprises a first disc. As claim 2 recites further components of the plug, Examiner construes “the plug defined by a first disc” to be “the plug comprising a first disc”. Examiner suggests replacing “the plug defined by a first disc” in line 9 of claim 1 with “the plug comprising a first disc”.
Examiner notes claims 2-7 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 2,
Line 1-2 recites “the plug includes a second disc”. Claim 2 depends on claim 1. Claim 1 requires “the plug defined by a first disc”. It is unclear how the plug can include a second disc if the plug is defined by a first disc. For examination purposes Examiner construes “the plug defined by a first disc” in claim 1 to be “the plug comprising a first disc”. Examiner suggests amending claim 1 as suggested above.
Examiner notes claim 3 is similarly rejected by virtue of its dependency on claim 2.
In regard to claim 3,
Line 1-2 recites “the first disc is defined by a first diameter”. It is unclear what is meant by “defined by”. Claim 3 depends on claim 2 and 1. Claim 1 requires the first disc to have a cylindrical shape. It is unclear if “the first disc is defined by a first diameter” requires the first disc to have a first diameter. For examination purposes Examiner construes “the first disc is defined by a first diameter” to be “the first disc has a first diameter”. Examiner suggests replacing “the first disc is defined by a first diameter” in line 1-2 of claim 3 with “the first disc has a first diameter”.
Line 2 recites “the second disc is defined by a second diameter”. It is unclear what is meant by “defined by”. It is unclear if “the second disc is defined by a second diameter” requires the second disc to have a second diameter. For examination purposes Examiner construes “the second disc is defined by a second diameter” to be “the second disc has a second diameter”. Examiner suggests replacing “the second disc is defined by a second diameter” in line 2 of claim 3 with “the second disc has a second diameter”.
In regard to claim 6,
Line 1-2 recites “the repositioning sheath is defined by an outer sheath diameter”. It is unclear what is meant by the term “defined by” and if “the repositioning sheath is defined by an outer sheath diameter” is intended to be the repositioning sheath comprises an outer sheath diameter. Claim 6 depends on claim 1. Claim 1 requires several structures of the repositioning sheath which make up the repositioning sheath (proximal end, distal end, sheath body, and plug). It appears the repositioning sheath would be defined by several structures/portions, not just the outer sheath diameter. For examination purposes Examiner construes “the repositioning sheath is defined by an outer sheath diameter” to be “the repositioning sheath comprising an outer sheath diameter”. Examiner suggests replacing “the repositioning sheath is defined by an outer sheath diameter” in line 1-2 of claim 6 with “the repositioning sheath comprising an outer sheath diameter”.
Examiner notes claim 7 is similarly rejected by virtue of its dependency on claim 6.
In regard to claim 8,
Line 9-10 recites “the plug defined by a first disc having a cylindrical shape and a second disc having a cylindrical shape”. It is unclear what is meant by “defined by” and if the only components of the plug are the first disc and the second disc. Line 10-11 recites “the first disc and the second disc coupled by a connector portion extending between the first disc and the second disc”. It appears the connector portion would also be a component of the plug and therefore it is unclear if “the plug defined by a first disc having a cylindrical shape and a second disc having a cylindrical shape” requires “the plug comprises a first disc having a cylindrical shape and a second disc having a cylindrical shape” or “the plug is a first disc having a cylindrical shape and a second disc having a cylindrical shape”. For examination purposes Examiner construes “the plug defined by a first disc having a cylindrical shape and a second disc having a cylindrical shape” to be “the plug comprising a first disc having a cylindrical shape and a second disc having a cylindrical shape”. Examiner suggests replacing “the plug defined by a first disc having a cylindrical shape and a second disc having a cylindrical shape” in line 9-10 of claim 8 with “the plug comprising a first disc having a cylindrical shape and a second disc having a cylindrical shape”.
Examiner notes claims 9-13 are similarly rejected by virtue of their dependency on claim 8.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6-8, 10-11 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu (U.S. PG publication 20170303958).
In regard to claim 1,
Wu discloses a blood pump delivery system (see all of figure 3A; Examiner notes the system of figure 3A is construed as a blood pump delivery system as the system can be connected to a blood pump for delivery of fluid as supported by paragraph [0010] or the system could be used to deliver an appropriately sized blood pump through the lumen of figure 3A) comprising:
a repositioning sheath (figure 3A, item 16) for insertion into an access site of a blood vessel (Examiner notes “for insertion into an access site of a blood vessel” is a functional limitation. The repositioning sheath is fully capable of insertion into an access site of a blood vessel due to its structure and as supported by figure 4C for example) and for use in positioning a blood pump within the blood vessel (Examiner notes “for use in positioning a blood pump within the blood vessel” is a functional limitation. The repositioning sheath is fully capable of the recited function due to its structure. The repositioning sheath could be used to position an appropriately sized blood pump within the blood vessel via the lumen of the sheath. A blood pump is not positively required by the claim), the repositioning sheath comprising:
a distal end opposite a proximal end (see figure 3A),
a sheath body (see figure 3A wherein the circular tube 16 forms a sheath body) extending between the distal end and the proximal end (see figure 3A), the sheath body defining a sheath lumen (see figure 3A wherein item 17 forms a lumen) for receiving the blood pump (Examiner notes “for receiving the blood pump” is a functional limitation. The lumen is fully capable of the recited function due to its structure. As noted above, the blood pump is not required by the claim; see also paragraph [0010]), and
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a plug (figure 3A, item 19) arranged around the sheath body (see figure 3A) and proximally to the distal end of the repositioning sheath (see figure 3A and 4C), the plug defined by a first disc (see figure 3A above) having a cylindrical shape (see figure 3A; paragraph [0009]), the first disc is formed of an expandable material (paragraph [0009] and [0036]; see size of the first disc in figure 3A as compared to figure 3B; see also paragraph [0032]),
wherein the first disc is configured to be positioned within the blood vessel and against a wall of the blood vessel such that the plug can seal the access site (Examiner notes “configured to be positioned within the blood vessel and against a wall of the blood vessel such that the plug can seal the access site” is a functional limitation. The first disc is fully capable of being positioned within the blood vessel and against a wall of the blood vessel due to its structure and the plug is fully capable of sealing the access site due to its structure. See for example figure 4C and paragraph [0039] and [0009]).
In regard to claim 2,
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Wu discloses the blood pump delivery system of claim 1, wherein the plug includes a second disc (see figure 3A above) that is positioned adjacent the first disc (see figure 3A above) and coupled with a connector portion (see figure 3A above).
In regard to claim 3,
Wu discloses the blood pump delivery system of claim 2, wherein the first disc is defined by a first diameter (see figure 3A above) and the second disc is defined by a second diameter (see figure 3A above), the first diameter being less than or equal to the second diameter (see figure 3A above).
In regard to claim 6,
Wu discloses the blood pump delivery system of claim 1, wherein the repositioning sheath is defined by an outer sheath diameter (see figure 3A), wherein the outer sheath diameter is less than a diameter of the blood vessel such that a gap is formed between the repositioning sheath and the blood vessel (Examiner notes the blood vessel is not positively required by the claim. The blood pump delivery system is fully capable of use due to its structure in a blood vessel which has a larger diameter than the outer sheath diameter such that a gap is formed between the repositioning sheath and the blood vessel; see for example figure 4C and paragraph [0009]).
In regard to claim 7,
Wu discloses the blood pump delivery system of claim 6, wherein the plug is sized for sealing the gap formed between the repositioning sheath and the blood vessel (Examiner notes “for sealing the gap formed between the repositioning sheath and the blood vessel” is a functional limitation. The plug is fully capable of the recited function due to its structure; see for example figure 4C and paragraph [0009] and [0036]).
In regard to claim 8,
Wu discloses a blood pump delivery system (see all of figure 3A; Examiner notes the system of figure 3A is construed as a blood pump delivery system as the system can be connected to a blood pump for delivery of fluid as supported by paragraph [0010] or the system could be used to deliver an appropriately sized blood pump through the lumen of figure 3A) comprising:
a repositioning sheath (figure 3A, item 16) for insertion into an access site of a blood vessel (Examiner notes “for insertion into an access site of a blood vessel” is a functional limitation. The repositioning sheath is fully capable of insertion into an access site of a blood vessel due to its structure and as supported by figure 4C for example) and for use in positioning a blood pump within the blood vessel (Examiner notes “for use in positioning a blood pump within the blood vessel” is a functional limitation. The repositioning sheath is fully capable of the recited function due to its structure. The repositioning sheath could be used to position an appropriately sized blood pump within the blood vessel via the lumen of the sheath. A blood pump is not positively required by the claim), the repositioning sheath comprising:
a distal end opposite a proximal end (see figure 3A),
a sheath body (see figure 3A wherein the circular tube 16 forms a sheath body) extending between the distal end and the proximal end (see figure 3A), the sheath body defining a sheath lumen (see figure 3A wherein item 17 forms a lumen) for receiving the blood pump (Examiner notes “for receiving the blood pump” is a functional limitation. The lumen is fully capable of the recited function due to its structure. As noted above, the blood pump is not required by the claim; see also paragraph [0010]), and
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a plug (figure 3A, item 19) arranged around the sheath body (see figure 3A) and proximally to the distal end of the repositioning sheath (see figure 3A and 4C), the plug defined by a first disc (see figure 3A above) having a cylindrical shape (see figure 3A; paragraph [0009]) and a second disc (see figure 3A above) having a cylindrical shape (see figure 3A; paragraph [0009]), the first disc and the second disc coupled by a connector portion (see figure 3A above) extending between the first disc and the second disc (see figure 3A above),
wherein the first disc is configured to be positioned within the blood vessel and against a wall of the blood vessel (Examiner notes “configured to be positioned within the blood vessel and against a wall of the blood vessel” is a functional limitation. The first disc is fully capable of being positioned within the blood vessel and against a wall of the blood vessel due to its structure. See for example figure 4C and paragraph [0039] and [0009]),
wherein the second disc is configured to be positioned outside of the blood vessel such that the plug seals the access site (Examiner notes “configured to be positioned outside of the blood vessel such that the plug seals the access site” is a functional limitation. The second disc is fully capable of the recited function due to its structure. See for example figure 4C and paragraph [0039] and [0009]).
In regard to claim 10,
Wu discloses the blood pump delivery system of claim 8, wherein the first disc has a diameter that is approximately equal to a diameter of the second disc (see figure 3A above).
In regard to claim 11,
Wu discloses the blood pump delivery system of claim 8, wherein the connector portion has a diameter that is less than both a diameter of the first disc and a diameter of the second disc (see figure 3A above).
In regard to claim 13,
Wu discloses the blood pump delivery system of claim 8, wherein the plug comprises nitinol (paragraph [0032]-[0033]).
Claim Rejections - 35 USC § 103
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.
Claims 4-5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (U.S. PG publication 20170303958) and further in view of Gellman (U.S. PG publication 20070233041).
In regard to claim 4,
Wu discloses the blood pump delivery system of claim 1.
Wu is silent as to wherein the plug is composed of a braided material.
Gellman teaches wherein the plug (see figure 4C, item 1) is composed of a braided material (figure 4C, item 150; paragraph [0067]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Wu to substitute the material of the plug of Wu for a braided material, as taught by Gellman, because the substitution is a simple substitution that would yield the same predictable result of enabling expansion and sealing (paragraph [0014]-[0015] of Gellman and paragraph [0034] [0036] of Wu). Furthermore, Wu discloses modifications can be made (paragraph [0048] of Wu).
In regard to claim 5,
Wu in view of Gellman teaches the blood pump delivery system of claim 4, wherein the braided material is flexible such that the first disc is compressible (see analysis of claim 4 above; see figure 3A and 3B of Wu and paragraph [0003] of Gellman).
In regard to claim 12,
Wu discloses the blood pump delivery system of claim 8.
Wu is silent as to wherein the plug comprises a flexible, braided material.
Gellman teaches wherein the plug (see figure 4C, item 1) comprises a flexible, braided material (figure 4C, item 150; paragraph [0003], [0067] and [0015]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Wu to substitute the material of the plug of Wu for a flexible, braided material, as taught by Gellman, because the substitution is a simple substitution that would yield the same predictable result of enabling expansion and sealing (paragraph [0014]-[0015] of Gellman and paragraph [0034] [0036] of Wu). Furthermore, Wu discloses modifications can be made (paragraph [0048] of Wu).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wu (U.S. PG publication 20170303958).
In regard to claim 9,
Wu discloses the blood pump delivery system of claim 8.
Wu fails to disclose wherein the first disc has a diameter that is less than a diameter of the second disc.
It would have been an obvious matter of design choice to modify Wu to include wherein the first disc has a diameter that is less than a diameter of the second disc since applicant has not disclosed that having wherein the first disc has a diameter that is less than a diameter of the second disc solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the first disc has a diameter that is less than a diameter of the second disc, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Examiner notes paragraph [0057] of the instant disclosure supports that there appears to be no criticality to the diameter of the first disc being less than the diameter of the second disc as paragraph [0057] states the diameter of the first disc can be less than, equal to, or greater than the diameter of the second disc.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783 /LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
