DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
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 5 , 10 and 11 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.
Regarding claim 5:
The claim is unclear because of the limitation “the cross-sectional area” in the final line of the claim. The limitation is unclear because several cross-sectional areas have been established in this claim and claim 2 (on which this claim depends) raising a question of which one this limitation refers to. For the sake of examination, the office has assumed this limitation refers to the cross-sectional area established in claim 5. However, the applicant should amend the claim to clarify.
Regarding claim 10:
The claim recites the limitation "the elongated sheath" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 is rejected due to its dependence on claim 10.
Claim Rejections - 35 USC § 102
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 1-2, 4-6, 10-16, 18, 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20140236123 A1 to Birmingham et al. (Birmingham).
Birmingham discloses:
Regarding claim 1:
An expandable sheath (figures 1, 7, 8, 9 and 15) comprising:
an elongate sheath body (10) having a proximal end (12), a distal end (14), and a lumen (20) extending from the proximal end (12) to the distal end (14) (as shown in figure 15),
wherein the elongate sheath body (10) comprises:
a first layer (200), wherein the first layer (200) is a liner defining the lumen (20) (¶0067);
a second layer (100) disposed over the first layer (second layer (100)), wherein the second layer (100) is a patterned structure (coil as shown in figure 7);
a third layer (300) disposed over the second layer (100);
wherein the elongate sheath body (10) includes a slit (see the slit 340) through the second layer (100) and the third layer (300) (as shown in figure 9 and 7), wherein the slit (340) extends along at least a portion of the elongate sheath body (10) (as shown in figure 7), and
wherein a first portion (330) of the elongate sheath body (10) overlaps a second portion (320) of the elongate sheath body (10) along the slit (340) to form a fold (310 as shown in figure 1).
Regarding claim 2:
The expandable sheath of claim 1, wherein the elongate sheath body (10) is configured to radially expand from an unexpanded state to an expanded state (as shown in figures 8 and 9 the sheath 10 is able to expand or collapse) to allow passage of a portion of a medical device (¶0067) through the lumen (20), the portion of the medical device having a transverse cross-sectional area larger than a transverse cross-sectional area of the lumen (20) when the elongate sheath body (10) is in the unexpanded state (inherent since the medical device expands the sheath to a new diameter (diameter as shown in figure 9) as it passes through as indicated in ¶0067 and ¶0087).
Regarding claim 4:
The expandable sheath of claim 2, wherein, when the elongate sheath body (10) is radially expanded, the overlap between the first portion (330) of the elongate sheath body (10) and the second portion (320) of the elongate sheath body (10) is decreased (no overlap between the two as shown in figure 9) and the transverse cross-sectional area of the lumen (20) thereby increases (as shown in figure 9).
Regarding claim 5:
The expandable sheath of claim 2, wherein the elongate sheath body (10) is configured to relax (relaxed position as shown in figure 8) when the portion of the medical device (“medical device” in ¶0067) is removed from the lumen (20) such that the transverse cross-sectional area of the lumen (20) is decreased and the elongate sheath body (10) substantially returns to the cross-sectional area in the unexpanded state (see the decreased cross sectional area in the state as shown in figure 9).
Regarding claim 6:
The expandable sheath of claim1, wherein the first layer (200) is made of polytetrafluoroethylene (PTFE)(¶0070 indicates PTFE) or an elastomer.
Regarding claim 10:
The expandable sheath of claim 1, wherein the first layer (200) includes a folded portion (see the folded portion 210 as shown in figure 1) that extends along at least a portion of the elongated sheath (see how 200 extends along the fold 210 as shown in figure 1).
Regarding claim 11:
The expandable sheath of claim 10, wherein, in a transverse cross-section (see the cross section as shown in figure 1) of the first layer (200), the first layer (200) is continuous and does not include any breaks (as shown in figure 1 the first layer includes no breaks) in a circumference of the first layer (200).
Regarding claim 12:
The expandable sheath of claim 1, wherein the second layer (100) is made of metal (second layer/wire 100 is made of metal as indicated in ¶0072).
Regarding claim 13:
The expandable sheath of claim 12, wherein the metal is stainless steel or nitinol (¶0072 indicates it can be made from stainless steel or Nitinol).
Regarding claim 14:
The expandable sheath of claim 1, wherein the patterned structure is a coil (see the coil shapes as show in figures 2-7).
Regarding claim 15:
The expandable sheath of claim 1, wherein the patterned structure is embedded (embedded as shown in figures 7 and 1) within the third layer (300).
Regarding claim 16:
The expandable sheath of claim 1, wherein third layer (300) is made of thermoplastic (see ¶0071 which indicates the third layer can be made from “nylon 12”, “Pebax” and “polyethylene” which are thermoplastics).
Regarding claim 18:
The expandable sheath of claim 1, wherein the elongate sheath body (10) is tubular (as shown in figure 1).
Regarding claim 22:
The expandable sheath of claim 1, further comprising a hub (15/16), wherein the proximal end (12) of the elongate sheath body (10) is coupled to the hub (as shown in figure 15).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20140236123 A1 to Birmingham et al. (Birmingham) as applied to claim 2 above, and further in view of WO 2018165519 A1 to Korkuch.
Regarding claim 3:
Birmingham fails to disclose:
The expandable sheath of claim 2, wherein the medical device is an intracardiac heart pump.
Korkuch teaches:
An assembly (figure 2) that includes a sheath (210) and hub (250). Further, a medical device can be introduced through the sheath (¶0002). The medical device can include an intracardiac heart pump in order to support the function of the heart (¶0002).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Birmingham to include an intracardiac heart pump as the medical device as taught by Korkuch in order to support the pumping function of the heart (Korkuch, ¶0002).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20140236123 A1 to Birmingham et al. (Birmingham) as applied to claim 1 above, and further in view of US 5484425 A to Fischell et al. (Fischell).
Regarding claim 7:
Birmingham fails to disclose:
The expandable sheath of claim 1,wherein the first layer includes a lubricious coating on an interior surface of the first layer.
Fischell teaches:
An assembly including a sheath (20) and a hub (30). The reference further indicates that the interior of the lumen can include a lubricious coating (or “lubricity coating”; see column 6, lines 15-34; column 7, lines 29-34; claim 13) in order to reduce the friction of the medical device passing through the sheath.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Birmingham to further include a lubricious coating as taught by Fischell in order to reduce the friction of the medical device passing through the sheath (Fischell, column 6, lines 15-34).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20140236123 A1 to Birmingham et al. (Birmingham) as applied to claim 1 above, and further in view of US 4634432 A to Kocak.
Regarding claim 8:
Birmingham fails to disclose:
The expandable sheath of claim 1,wherein the first layer includes a hydrophilic coating on an interior surface of the first layer.
Kocak teaches:
An assembly including a sheath (38) and a hub (10). The reference further indicates that the interior of the lumen can include a hydrophilic coating (column 6, lines 5-15) in order to reduce the friction of a medical device (in this case a catheter) passing through the sheath.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Birmingham to further include a hydrophilic coating as taught by Kocak in order to reduce the friction of a medical device passing through the sheath (Kocak, column 6, lines 5-15).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20140236123 A1 to Birmingham et al. (Birmingham) as applied to claim 1 above, and further in view of US 20140275795 A1 to Little et al. (Little).
Regarding claim 9:
Birmingham fails to disclose:
The expandable sheath of claim 1, wherein the slit of the elongate sheath body is further through the first layer.
Little teaches:
A sheath (figures 2 and 7-9) that includes and inner (710/810/910) and outer layer (720/820/920). The reference further shows that the inner layer can include a slit (see layer 910 in figure 9) which allows the inner layer to expand (¶0083).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Birmingham to further include a first/inner layer with a slit through the first layer as taught by Little. This is a simple substitution of one known element (first layer with overlapping portion at the fold as taught by Birmingham) for another (first layer with a slit down the length of it as taught by Little) to obtain predictable results (to allow the first layer to expand and contract when a tool is passed through the sheath).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20140236123 A1 to Birmingham et al. (Birmingham) as applied to claim 1 above, and further in view of US 20160296332 A1 to Zhou et al. (Zhou).
Regarding claim 17:
Birmingham fails to disclose:
The expandable sheath of claim 1,wherein the third layer is made of thermoplastic polyurethane (TPU) or a polyether block amid.
Zhou teaches:
A sheath assembly (figure 3) including multiple layers (20, 22, 24). The reference further teaches that the elastic layers can be made from polyurethane (¶0089).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Birmingham to make the third/elastic layer of polyurethane as taught by Zhou. This is a simple substitution of one known element (material of the third layer in Birmingham) for another (making the third layer of polyurethane as taught by Zhou) to obtain predictable results (to allow the third layer to expand and contract).
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20140236123 A1 to Birmingham et al. (Birmingham) as applied to claim 1 above, and further in view of US 20160213882 A1 to Fitterer et al. (Fitterer).
Regarding claim 19:
Birmingham fails to disclose:
The expandable sheath of claim 1,wherein the elongate sheath body further comprises a fourth layer disposed over the third layer, the fourth layer configured to seal the fold in the elongate sheath body.
Fitterer teaches:
An expandable sheath (figure 2a) that includes an inner layer (20) and an outer layer (30). The inner layer includes several folds (¶0053) to allow the inner layer to expand. Further, the outer layer tears away allowing the sheath to expand based on the size of the inner layer (as shown in figure 10 and described in ¶0079). The outer layer holds the overall sheath to a smaller diameter when the sheath is advanced through the veins and allows it to expand when in proper position and prevent damage to the veins/ vasculature (¶0003).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Birmingham to include a fourth/outer layer over the third layer (extending over the folds) as taught by Fitterer in order to secure the sheath in its collapsed state during insertion into the vasculature (Fitterer, ¶0003).
Regarding claim 20:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 19 by Birmingham and Fitterer:
The expandable sheath of claim 19, wherein the fourth layer is made of an elastomer (see the fourth/outer layer of Fitterer incorporated into Birmingham which can be made of polyurethane (¶0082) which is an elastomer as further evidenced by US 4,826,477 to Adams which indicates polyurethane is an elastomer (column 7, lines 1-5)).
Regarding claim 21:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 19 by Birmingham and Fitterer:
The expandable sheath of claim 19, wherein the fourth layer is made of TPU or silicone (see the fourth/outer layer of Fitterer incorporated into Birmingham which can be made of silicone (¶0083)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20140121629-A1
Macaulay
See the sheath 10
US-20130090624-A1
Munsinger
See the sheath 10 with the fold in layer 15
US-5533986-A
Mottola
See the outer layer 56 with slit
CN-206372159-U
ZENG
See the fold 12/11
WO-2008002915-A2
MCCRYSTLE
See the fold 2890b
WO-2007004531-A1
HORAGUCHI
See the slit 3
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783