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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “952” has been used to designate both “a fluid passage” and “a valve” (see Figs. 4C,E). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Various lines in various paragraphs in Applicant’s Specification recite at least one of “segment 901”, however, it appears that the various lines should recite “segment 910”; thus the Examiner suggests each instance of “segment 901” be amended to “segment 910”.
Appropriate correction is required.
Claim Objections
Claims 39, 44, 47, 48, 52, and 54 are objected to because of the following informalities:
Claim 39 recites “sheath segment” in line 5, although the line is understood by the Examiner to mean “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 “sheath segment of the plurality of sheath segments” for the purpose of maintaining consistent language throughout the claims;
Claim 44 recites “to distal opening surfaces associated with each of the other sheath segments” in lines 3 – 4, although the line does not rise to the level of being indefinite as the line is understood by the Examiner to mean “to the distal opening surface associated with each of the other sheath segments” as the each of the sheath segments has only one “distal opening surface”, based on Applicant’s disclosure and what was previously defined, the Examiner suggests the line be amended to read “to the distal opening surface associated with each of the other sheath segments” for the purpose of maintaining consistent language throughout the claims;
Claim 47 recites “a longitudinal axis” in line 2, although the line is understood by the Examiner to mean “the longitudinal axis” as the “longitudinal axis” was previously defined, the Examiner suggests the line be amended to read “the longitudinal axis” for the purpose of maintaining consistent language throughout the claims;
Claim 47 recites “other sheath segments of the telescoping vascular sheath” in line 3, although the line is understood by the Examiner to mean “the other sheath segments of the plurality of sheath segments” as the “sheath segments” were previously defined and are defined as being parts of the “plurality of sheath segments”, the Examiner suggests the line be amended to read “the other sheath segments of the plurality of sheath segments” for the purpose of maintaining consistent language throughout the claims;
Claim 48 recites “the outer sheath segment including a first proximal section that is” and “proximal sections” in lines 3 and 4, although the lines are understood by the Examiner to mean “wherein the proximal section of the outer sheath segment is a first proximal section that is” and “the proximal sections”, respectively, as each of the proximal sections of each of the sheath segments, which includes the proximal section of the outer sheath segment, were previously defined in claim 39, the Examiner suggests the lines be amended to read “wherein the proximal section of the outer sheath segment is a first proximal section that is” and “the proximal sections”, respectively, for the purpose of maintaining consistent language throughout the claims;
Claim 52 recites “the proximal section” in line 2, although the line does not rise to the level of being indefinite and is understood by the Examiner to mean “the proximal section of the at least one sheath segment of the plurality of sheath segments” as the “proximal section” with the balloon is belongs to the “at least one of the sheath segments of the plurality of sheath segments” and not necessarily all of the proximal sections of all of the plurality of sheath segments, the Examiner suggests the line be amended to read “the proximal section of the at least one sheath segment of the plurality of sheath segments” for the purpose of maintaining consistent language throughout the claims;
Claim 54 recites “A method of a telescoping vascular sheath” however this is not grammatically correct and the Examiner suggests the line be amended to read “A method of using a telescoping vascular sheath”;
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.
Claims 39 – 54 are 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.
Claims 39 and 54 recites the limitation "one or more of the distal opening surfaces" in lines 6 and 11, respectively. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the phrase renders the claim indefinite because it is unclear if Applicant is intending to now recite wherein each of the sheath segments has multiple distal opening surfaces, or if Applicant is intending for the “one or more” to refer to “the distal opening surface and the proximal outer surface” of the at least one adjacent sheath. For the purpose of examination, and based on Applicant’s disclosure, the Examiner will read the claims to mean the latter, such that each sheath segment only has one distal opening surface.
Claims 41, 42, and 46, recite one of the phrases "the proximal section includes" or “the tapered distal section” which renders the claim indefinite because it is unclear if Application is intending for only one of the proximal sections / tapered distal sections of only one of sheath segments of the plurality of sheath segments to include the corresponding structure, or if Applicant is intending for the proximal section / the tapered distal section of each of the sheath segments of the plurality of sheath segments to include the corresponding structure. For the purpose of examination, the Examiner will read the claims to mean the latter, such that all of the proximal sections and all of the tapered distal sections include the corresponding structure.
Regarding claim 47, the phrase "a first sheath" renders the claim indefinite because it is unclear if the “first sheath” is one of the plurality of sheath segments previously defined or if the “first sheath” is an additional sheath, such that claim 47 requires a first sheath in addition to the plurality of sheath segments. Based on Applicants disclosure and for the purpose of examination, the Examiner will read the claim to mean that the first sheath is one of the plurality of sheath segments. Additionally, the phrase “includes the proximal section having a smaller diameter” renders the claim indefinite because it is unclear what Applicant is comparing the diameter of the proximal section of the first sheath to. For the purpose of examination, the Examiner will read the limitation to mean that the proximal section of the first sheath has a diameter compared to the other sheath segments. The Examiner suggests the claim be amended to read “a first sheath segment of the plurality of sheath segments positioned closest to the longitudinal axis of the telescoping vascular sheath, the proximal section of the first sheath having a diameter smaller and a length longer than that of the other sheath segments of the plurality of sheath segments” (note that this includes the suggested objection fixes as well).
Claims 40 – 53 are rejected as being indefinite for being dependent on an indefinite claim.
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).
Regarding claim 39, Imran discloses a telescoping vascular sheath (catheter assembly 11) (abstract, col. 3 lines 1 – 52, and Fig. 1) for insertion into a vessel, 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) (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 one or more of the distal opening surfaces and the outer proximal surface (col. 3 lines 54 – 65, col. 4 lines 7 – 20, col. 4 lines 39 – 50, and Fig. 1); 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).
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 the proximal section includes a tubular shape that extends a distance along the longitudinal axis (Fig. 1).
Regarding claim 42, Imran discloses wherein 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 the tapered distal section provides atraumatic insertion of the telescoping vascular sheath into tissue and the inner lumen of the vessel (Fig. 1) (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 a first sheath (second tubular member 31 – inner most tubular member) 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 telescoping vascular sheath (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), the outer sheath segment including 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 when in an inflated state (Fig. 1).
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 vessel (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 vessel).
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 Fig. 1), 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 vessel (col. 4 line 66 – col. 5 line 25, 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 vessel (col. 5 line 51 – col. 6 line 6, col. 6 lines 7 – 25, and Fig. 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) (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 one or more of the distal opening surfaces and the outer proximal surface (col. 3 lines 54 – 65, col. 4 lines 7 – 20, col. 4 lines 39 – 50, and Figs. 1, 6A-E), 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).
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 artery (left carotid artery), a second arterial access device (outflow conduit 252B) for accessing a second artery (left axillary artery 224), an arterial return device (inflow conduits 250A) for accessing a third 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), as applied to claim 39 above, and further in view of Heuser (US 2004/0147877 A1).
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), as applied to claim 55 above, and further in view of Smith (US 4,862,891).
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).
Related Prior art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Storz (US 4,449,532), Lazarus (US 5,158,543), Douk (US 2005/0027236 A1) teach telescopic sheaths with a plurality of segments and a method of using said telescopic sheaths within a vessel.
Conclusion
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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/Andrew Restaino/Primary Examiner, Art Unit 3771