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 .
Response to Amendment
This Office action is in response to the applicant’s communication filed 06/04/2026.
Status of the claims:
Claims 39 – 58 are pending in the application.
Claims 39, 41, 42, 44, 46 – 48, and 52 – 55 are amended.
Drawings
The replacement drawings for Figs. 4C and 4E were received on 06/04/2026. These drawings are acceptable and overcome the previous drawing objections in the Non-Final office action mailed on 03/04/2026.
Specification
The objections to specification in the previous action dated 03/06/2026 have been withdrawn in light of the Applicant’s amendments filed 06/04/2026. Specifically, the objection to the specification, regarding the phrase “segment 901”, has been withdrawn as the appropriate corrections have been made.
Claim Objections
The objections to claims 39, 44, 47, 48, 52, and 54 in the previous action dated 03/06/2026 have been withdrawn in light of the Applicant’s amendments filed 06/04/2026. Specifically, the objection to claim 39, regarding the phrase “sheath segment”, the objection to claim 44, regarding the phrase “to distal opening surfaces associated with each of the other sheath segments”, the objection to claim 47, regarding the phrases “a longitudinal axis” and “other sheath segments of the telescoping vascular sheath”, the objection to claim 48, regarding the phrase “the outer sheath segment including a first proximal section that is”, the objection to claim 52, regarding the phrase “the proximal section”, and the objection to claim 54, regarding the phrase “A method of a telescoping vascular sheath”, have all been withdrawn as the appropriate corrections have been made. However, new objections have been set forth below, in light of Applicant’s amendments.
Claims 39 and 54 are objected to because of the following informalities:
Claims 39 and 54 recite “each of the plurality of sheath segments” in lines 9 and 14, respectively, although the lines do not rise to the level of being indefinite, as the lines are understood by the Examiner to mean “each of the sheath segments of the plurality of sheath segments”, as Applicant’s disclosure does not disclose or suggest multiple pluralities of sheath segments (such that there are at least 4 sheath segments), the Examiner suggests the lines be amended to recite “each of the sheath segments of the plurality of sheath segments” for the purpose of maintaining consistent language throughout the claims;
Claim 54 recites “at least one sheath segment” in line 11, although the line is understood by the Examiner to mean “at least one sheath segment of the plurality of sheath segments” as previously defined and repeated in several lines throughout the claim set, the Examiner suggests the line be amended to mean “at least one sheath segment of the plurality of sheath segments” for the purpose of maintaining consistent language throughout the claims;
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.
The rejections of claims 39 – 54 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 03/06/2026 have been withdrawn in light of the Applicant’s amendments filed 06/04/2026. Specifically, the rejection of 39 and 54 regarding the antecedent issue in the phrase "one or more distal opening surfaces", the rejection of claim 41, 42, and 46 regarding the lack of clarity in one of the phrases "the proximal section includes" or “the tapered distal section”, the rejection of claim 47 regarding the lack of clarity in the phrase "a first sheath", and the rejection of claims 40 – 53 for being dependent on an indefinite claim have all been withdrawn as the appropriate corrections have been made.
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 39 – 48 and 50 – 54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Imran (US 5,833,650) (previously cited).
Regarding claim 39, Imran discloses a telescoping vascular sheath (catheter assembly 11) for insertion into a carotid artery (abstract, col. 3 lines 1 – 52, col. 4 line 66 – col. 5 line 40, and Figs. 1 – 5) comprising:
a plurality of sheath segments (tubular members 16, 31, 51) each having a tapered distal section (tapered portion) and a proximal section (section proximal of the tapered portion) (col. 3 lines 54 – 65, col. 4 lines 7 – 65, and Fig. 1), each tapered distal section including a distal opening surface and each proximal section including an outer proximal surface (Fig. 1), each sheath segment of the plurality of sheath segments (tubular members 16, 31, 51) being slidably engaged with at least one adjacent sheath segment of the plurality of sheath segments (tubular members 16, 31, 51) along the distal opening surfaces, the outer proximal surface, or both (col. 3 lines 54 – 65, col. 4 lines 7 – 20, col. 4 lines 39 – 50, and Fig. 1);
wherein each of the sheath segments of the plurality of sheath segments (tubular members 16, 31, 51) has a length configured for transcarotid access (Examiner’s note: the preceding limitation is intended use which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, each of the sheath segments of Imran is capable of being used for transcarotid access. Therefore, Imran discloses the device as claimed); and
a working passageway (lumen 37) extending through the plurality of sheath segments and along a longitudinal axis of the telescoping vascular sheath (col. 4 lines 7 – 20 and Figs. 1 – 4), the working passageway providing access to an inner lumen of the carotid artery (left carotid 67) (col. 4 lines 7 – 20, col. 4 line 66 – col. 5 line 40, and Figs. 1 – 5).
Regarding claim 40, Imran discloses wherein each sheath segment of the plurality of sheath segments (tubular members 16, 31, 51) is independently moveable along the longitudinal axis (col. 4 lines 39 – 50) (Examiner’s note: as stated in col. 4 lines 39 – 50 each of the tubular members 31 and 51 are slidably mounted to the catheter, and thus are independently slidable relative to the tubular member 16; additionally, that means that the tubular member 16 is slidable relative to the other two tubular members).
Regarding claim 41, Imran discloses wherein at least one of the proximal section includes a tubular shape that extends a distance along the longitudinal axis (Fig. 1).
Regarding claim 42, Imran discloses wherein at least one of the tapered distal section includes a distal opening defined by the distal opening surface (Fig. 1).
Regarding claim 43, Imran discloses wherein the distal opening surface is approximately linear and parallel to the longitudinal axis (Fig. 1).
Regarding claim 44, Imran discloses wherein the working passageway is defined by a first sheath segment (second tubular member 31 – inner most tubular member) of the plurality of sheath segments (tubular members 16, 31, 51), the distal opening surface of the first sheath segment being smaller in diameter compared to distal opening surfaces associated with each of the other sheath segments of the plurality of sheath segments (Fig. 1).
Regarding claim 45, Imran discloses wherein the distal opening surface of a second sheath segment (third tubular member 51) of the plurality of sheath segments (tubular members 16, 31, 51) forms a sliding fit along the proximal section of the first sheath segment (col. 4 lines 39 – 50).
Regarding claim 46, Imran discloses wherein at least one of the tapered distal section provides atraumatic insertion of the telescoping vascular sheath into tissue and the inner lumen of the carotid artery (left carotid 67) (col. 4 line 66 – col. 5 line 40 and Figs. 1,5) (Examiner’s note: each of the tapered distal sections are tapered with a smooth outer surface and thus provide an atraumatic insertion of the telescoping vascular sheath as claimed).
Regarding claim 47, Imran discloses wherein the sheath segment (second tubular member 31 – inner most tubular member) of the plurality of sheath segments positioned closest to a longitudinal axis of the telescoping vascular sheath includes the proximal section having a smaller diameter and an overall length that is longer compared to other sheath segments of the plurality of sheath segments (tubular members 16, 51) (Fig. 1).
Regarding claim 48, Imran discloses wherein an outer sheath segment (tubular member 16 – outer most tubular member) of the plurality of sheath segments (tubular members 16, 31, 51) is positioned furthest away from the longitudinal axis of the telescoping vascular sheath (Fig. 1), wherein the proximal section of the outer sheath segment (tubular member 16) is a first proximal section that is greater in diameter and shorter in length compared to proximal sections associated with each of the other sheath segments of the plurality of sheath segments (tubular members 31, 51) (Fig. 1).
Regarding claim 50, Imran discloses further comprising a port (Luer-type fitting 38) positioned at a proximal end of at least one sheath segment of the plurality of sheath segments (tubular members 16, 31, 51) and including a fluid pathway that is in fluid communication with the working passageway (col. 4 lines 7 – 20 and Fig. 1).
Regarding claim 51, Imran discloses wherein at least one sheath segment (tubular members 16, 31, 51) of the plurality of sheath segments (tubular members 16, 31, 51) includes an inflatable balloon (balloons 19, 58, 36) (col. 3 lines 35 – 53, col. 4 lines 7 – 20, col. 4 lines 51 – 65, and Fig. 1).
Regarding claim 52, Imran discloses wherein the inflatable balloon (tubular members 16, 31, 51) expands radially out from the proximal section of the at least one sheath segment of the plurality of sheath segments when in an inflated state (Figs. 1, 5).
Regarding claim 53, Imran discloses wherein at least one sheath segment of the plurality of sheath segments (tubular members 16, 31, 51) provides atraumatic dilation of tissue and atraumatic dilation into the carotid artery (left carotid 67) (col. 4 line 66 – col. 5 line 40 and Figs. 1,5) (Examiner’s note: all of the tubular members 16,31,51 (i.e., the sheath segments) are tapered and, thus, are atraumatic; additionally, all of the tubular members are capable of dilation of tissue dilation into the carotid artery).
Regarding claim 54, Imran discloses a method of a telescoping vascular sheath (catheter assembly 11) (abstract, col. 3 lines 1 – 52, col. 4 line 66 – col. 6 line 66, and Figs. 1,5,6A-E), the method comprising:
advancing a first sheath segment (outer most tubular member with balloon 19 – tubular member 16) of the telescoping vascular sheath into an inner lumen of a carotid artery (left carotid artery 67) (col. 4 line 66 – col. 5 line 40, and Fig. 6A) (Examiner’s note: it should be understood that the specification of Iman seems to be inconsistent with the reference numbers for the outer most tubular member, it appears that Iman numbers the outer most catheter with reference numbers 12, 16, 19. For the purpose of clarity, although the Examiner is only reciting the “first sheath segment” as the ‘tubular member 16’, any disclosure of Imran cited by the Examiner comprising different reference numbers for the outermost tubular member / the first tubular member, should be understood to equate to the “tubular member 16”) ;
advancing a second sheath segment (second tubular member 31) of the telescoping vascular sheath into the inner lumen of the carotid artery (left carotid 67) (col. 4 line 66 – col. 5 line 40, col. 5 line 51 – col. 6 line 6, col. 6 lines 7 – 25, and Figs. 5,6D), wherein the telescoping vascular sheath (catheter assembly 11) comprises:
a plurality of sheath segments (tubular members 16, 31, 51) each having a tapered distal section (tapered portion) and a proximal section (section proximal of the tapered portion) (col. 3 lines 54 – 65, col. 4 lines 7 – 65 and Fig. 1), the plurality of sheath segments (tubular members 16, 31, 51) including the first sheath segment and the second sheath segment (tubular members 16,31) (Fig. 1), each tapered distal section including a distal opening surface and each proximal section including an outer proximal surface (Fig. 1), each sheath segment of the plurality of sheath segments being slidably engaged with at least one adjacent sheath segment along the distal opening surfaces, the outer proximal surface, or both (col. 3 lines 54 – 65, col. 4 lines 7 – 20, col. 4 lines 39 – 50, and Figs. 1, 6A-E),
wherein each of the sheath segments of the plurality of sheath segments (tubular members 16, 31, 51) has a length configured for transcarotid access (Examiner’s note: the preceding limitation is intended use which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, each of the sheath segments of Imran is capable of being used for transcarotid access. Therefore, Imran discloses the device as claimed); and
a working passageway (lumen 37) extending through the plurality of sheath segments and along a longitudinal axis of the telescoping vascular sheath (col. 4 lines 7 – 20 and Figs. 1 – 4), the working passageway providing access to an inner lumen of the vessel (col. 4 lines 7 – 20 and Figs. 1 – 4); and
slidably translating the first sheath segment (first tubular member 16) relative to the second sheath segment (second tubular member 31) (col. 5 line 51 – col. 6 line 6, col. 6 lines 7 – 25, and Fig. 6D).
Claims 55, 57, and 58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Viole et al (US 2004/0019251 A1) (previously cited).
Regarding claim 55, Viole discloses a blood flow system (heart assist system 210) (abstract, paragraph [0082], and Fig. 6), comprising:
a first arterial access device (outflow conduit 252A) for accessing a first carotid artery (left carotid artery) (paragraph [0082] and Fig. 6),
a second arterial access device (outflow conduit 252B) (paragraph [0082] and Fig. 6) for accessing a second carotid artery (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the outflow conduit 252B is capable of accessing a second carotid artery. Therefore, Viole discloses the system as claimed),
an arterial return device (inflow conduits 250A) for accessing a femoral artery (femoral artery) (paragraph [0082] and Fig. 6); and
wherein the arterial return device (inflow conduit 250A) is in fluid communication with the first arterial access device and the second arterial access device (outflow conduits 252A,B) (paragraph [0082] and Fig. 6).
Regarding claim 57, Viole discloses further comprising a splitter (y-shaped convergence) that directs fluid flow from the arterial return device to both the first arterial access device and the second arterial access device (outflow conduits 252A,B) (paragraph [0082] and Fig. 6).
Regarding claim 58, Viole discloses further comprising one or more of a flow control element (pump 232) that controls rate of flow between the arterial return device and the splitter (paragraphs [0033], [0082], and Fig. 6).
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 49 is rejected under 35 U.S.C. 103 as being unpatentable over Imran (US 5,833,650) (previously cited), as applied to claim 39 above, and further in view of Heuser (US 2004/0147877 A1) (previously cited).
Regarding claim 49, as discussed above, Imran discloses the telescoping vascular sheath of claim 39.
However, Imran is silent regarding (i) a valve positioned at a proximal end of at least one sheath segment of the plurality of sheath segments.
As to the above, Heuser teaches, in the same field of endeavor, a telescoping vascular sheath (catheter introducer system 10) comprising a plurality of sheath segments (cylindrical bodies 34, 56, 72, 14; which equate to the tubular members 16, 31, 51 of Imran) with tapering distal ends and proximal portions, and a valve at a proximal end of each one of the sheath segments of the plurality of sheath segments for the purpose of preventing blood leaks between shafts and to provide a friction fit around the shafts (abstract, paragraphs [0022 – 0033], [0039 – 0041], and Figs. 1 – 3).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify at least one (or all) of the sheath segments of the plurality of sheath segments, based on the teachings of Heuser, for the purpose of preventing blood leaks between shafts and to provide a friction fit around the shafts (paragraphs [0039 – 0041] – Heuser).
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Viole et al (US 2004/0019251 A1) (previously cited), as applied to claim 55 above, and further in view of Smith (US 4,862,891) (previously cited).
Regarding claim 56, as discussed above, Viole discloses the blood access system of claim 55.
However, Viole is silent regarding (i) wherein one or more of the first arterial access device, the second arterial access device, and the arterial return device comprise a telescoping vascular sheath.
As to the above, Smith teaches, in the same field of endeavor, a blood access system (device for percutaneous dilation) comprising a first arterial access device (dilator 10) comprising a telescoping vascular sheath (dilators 41,40,39,36) for the purpose of minimizing blood loss and damage to tissue when accessing the vessel (abstract, col. 2 lines 3 – 15, col. 2 lines 18 – 35, col. 4 line 57 – col. 5 line 10, col. 5 lines 11 – 39, col. 5 lines 46 – 61, and Figs. 1,7).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify any one of the first arterial access device, the second arterial access device, and the arterial return device of Viole to incorporate a telescoping vascular sheath, based on the teachings of Smith, for the purpose of minimizing blood loss and damage to tissue when accessing the vessel (col. 2 lines 18 – 35 – Smith).
Response to Arguments
Applicant's arguments filed 06/04/2026 have been fully considered but they are not persuasive. More specifically, Applicant’s arguments directed to the newly added claim limitations were not persuasive; said arguments responded to within the rejection of each limitation in the rejection above.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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