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 06/20/2023.
Status of the claims:
Claims 18 – 38 are pending in the application.
Claims 21 – 25 and 30 are amended.
Claim Objections
Claims 6 and 7 are objected to because of the following informalities:
Claims 6 and 7 recite “a length of the sheath body”, although the lines are understood by the Examiner to mean “the length of the sheath body” as the “length of the sheath body” was previously defined in claim 1, the Examiner suggests the lines be amended to recite “the length of the sheath body” for the purpose of maintaining consistent language throughout the claims;
Appropriate correction is required.
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.
Claims 1 – 7, 9 – 10, 21 – 31 are rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (US 2017/0333147 A1) (previously cited) and in view of Delaloye et al (US 2016/0193047 A1) (previously cited).
Regarding claim 1, Bernstein discloses an introducer sheath system (surgical instrument 108 and surgical drape 200) (abstract, paragraph [0027 – 0038], and Figs. 1 – 2) comprising:
an introducer sheath (surgical instrument 108) configured to be inserted through a surface of a subject (paragraph [0027]) and including:
a sheath body (surgical instrument 108) having a distal end and a proximal end, an outer surface, and a length between the distal end and the proximal end (paragraph [0027 – 0035] and Fig. 1),
a housing (instrument carriage 106) positioned at the proximal end of the sheath body (paragraph [0027 – 0035] and Fig. 1); and
an expandable sheath (surgical drape 200) configured to cover a portion of the sheath body between the surface of the subject and the housing to retain fluid from the subject within the expandable sheath (paragraphs [0030 – 0038] and Figs. 1, 2, 3).
However, Bernstein is silent regarding (i) the sheath body including an interior lumen for a delivery apparatus to be passed through to move to a location within the subject, wherein the sheath body includes a seam on the outer surface of the sheath body which extends along at least a portion of the length of the sheath body, and (ii) the expandable sheath is configured to cover at least a portion of the seam as the sheath body is withdrawn from the subject.
As to the above, Delaloye teaches, in the same field of invention, an introducer sheath system (guide catheter 30 and sheath 52) (abstract, paragraph [0063 – 0069], and Figs. 1 – 4) comprising an introducer sheath (guide catheter 30; which is equated to the surgical instrument 108 of Bernstein) configured to be inserted through a surface of a subject and including a sheath body (guide catheter 30; which is equated to the surgical instrument 108 of Bernstein) and a housing (hub – Fig. 10) (paragraph [0062] and Fig. 10), wherein the sheath body (guide catheter 30) has a length between the distal end and the proximal end of the sheath body (Fig. 10), and includes a seam (folding of the material) on an outer surface of the sheath body (paragraphs [0015], [0063 – 0064] and Fig. 4), the seam extending along at least a portion of the length of the sheath body (paragraphs [0015], [0063], and [0064]) (Examiner’s note: as stated in paragraph [0063] part (iii), the guide catheter 30 (i.e., the sheath body) is made up of flexible material which allows for the guide catheter 30 to form the seam; therefore, the entire length of the guide catheter can fold and form the seam along the entire length thereof), and an expandable sheath (sheath 52; which is equated to the surgical drape 200 and port 110 of Bernstein) is configured to cover at least a portion of the seam as the sheath body is withdrawn from the subject (paragraph [0060]).
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 the system of Bernstein to incorporate introducer system of Delaloye, as taught by Delaloye, for the purpose of allowing the introduction of a delivery catheter for implanting a prosthetic valve at an implantation site (paragraph [0062] part (ii) – Delaloye). It should be understood that Bernstein recites wherein the term “surgical instrument” is defined as “any medical device for insertion into a patient’s body and used in a surgical procedures” (paragraph [0028]); therefore, Bernstein does not limit the use of only surgical instruments with end-effectors with the medical drape 200 (i.e., the expandable sheath), and one of ordinary skill in the art would have a reasonable expectation of success in using the guide catheter system of Delaloye with the medical drape 200 of Bernstein, and the results of the modification would be predictable and result in the system operating as intended to form a fluid tight encloses system. With respect to (ii), the 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 because expandable sheath (the surgical drape 200) of Bernstein covers the entire body of the surgical instrument 108 (modified to be the guide catheter 30 of Delaloye) in the fully withdrawn state (shown in Fig. 1 and 3), the modification above makes obvious / encompasses wherein the expandable sheath (the surgical drape 200) is capable of covering at least a portion of the seam as the sheath body is withdrawn from the subject. Thus, the combination makes obvious / encompasses the limitation as claimed.
Regarding claims 2, 3, 4, and 5, as disclosed above, it would be obvious to the introducer system of Delaloye with the instrument drape of Bernstein. Additionally, Bernstein discloses [claims 2, 3, and 5] wherein the expandable sheath (surgical drape 200) includes a proximal portion (base coupler 204) and a distal portion (port coupler 206) (paragraph [0034] and Fig. 2A), the distal portion is configured to be pressed towards the surface of the subject (Fig. 1), and the proximal portion (base coupler 204) includes a seal (O-ring) for sealing an interior of the expandable sheath (paragraph [0034]), and the distal portion (port coupler 206 and entry guide 110) includes a seal / a ring (handling ring 212 and entry guide 110) for sealing against the surface of the subject and configured to extend around an insertion point of the introducer sheath into the subject (paragraph [0035] and Fig. 2A) (Examiner’s note: the entry guide 110, which is a cannula, forms the fluid tight seal against the skin and the handling ring 212 forms the fluid tight seal on the entry guide 110; therefore, the distal portion of the expandable sheath is for sealing against the surface of the subject); and [claim 4] a coupler (base coupler 204) positioned at the proximal portion of the expandable sheath for coupling with the housing (paragraph [0034] and Figs. 1,2A).
Regarding claims 6 and 7, as disclosed above, it would be obvious to the introducer system of Delaloye with the instrument drape of Bernstein. Additionally, Bernstein discloses wherein the expandable sheath (surgical drape 200) is configured to expand axially along a length of the sheath body as the sheath body is withdrawn from the subject and to be compressed axially along a length of the sheath body (paragraphs [0004 – 0005], [0012], and Figs. 1 – 4B) (Examiner’s note: it should be understood that the proceeding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning as claimed; and because the surgical drape 200 (i.e., the expandable sheath) can expand and compress axially, it is capable of expand and compress with the movement of the sheath body (i.e., the guide tube 30 of Delaloye). Therefore, the combination encompasses the limitation above).
Regarding claims 9 and 10, as discussed above, it would have been obvious to modify the surgical instrument of Bernstein in view of Delaloye. Additionally, Bernstein discloses [claim 9] wherein the expandable sheath (surgical drape 200) is configured to extend to form an interior cavity for retaining fluid from the subject (Fig. 2A), and the expandable sheath is configured to receive the sheath body (surgical instrument 108) within the interior cavity (Fig. 1) and [claim 10] the expandable sheath (surgical drape 200) is configured to extend over an entirety of the sheath body from the proximal end to the distal end (Fig. 1).
Regarding claims 21 and 22, as disclosed above, it would be obvious to the introducer system of Delaloye with the instrument drape of Bernstein. Additionally, Bernstein discloses [claim 21] wherein the surface of the subject is skin, and the distal portion (port coupler 206 and entry guide 110) of the expandable sheath (surgical drape 200) is configured to be pressed towards the skin as the sheath body (guide catheter 30 of Delaloye) is withdrawn from the subject to form a seal with the skin and [claim 22] wherein the distal portion (port coupler 206 and entry guide 110) of the expandable sheath (surgical drape 200) is configured to extend around an insertion point of the introducer sheath into the surface of the subject (Examiner’s note: the previous limitations are both intended use limitations which require only that the structure of the prior art be capable of functioning as claimed; with that said, the entry guide 110 of the surgical drape 200 is capable of being pressed against the skin and forming a seal with the skin and extends around the insertion point (i.e., the opening of the entry guide 110) of the introducer sheath (i.e., the guide catheter 30), the entry guide 110 is capable of functioning as claimed. Therefore, the combination encompasses the device as claimed) .
Regarding claim 23, as disclosed above, it would be obvious to the introducer system of Delaloye with the instrument drape of Bernstein.
However, the combination is silent regarding (i) how the wherein the expandable sheath (i.e., the surgical drape 200 of Bernstein) is connected to the ring (i.e., the handling ring 212 of Bernstein) / wherein the wall of the expandable sheath (i.e., the surgical drape of Bernstein) loops around the ring (handling ring 212 of Bernstein).
It has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). It can be seen that there are only a finite number of positions that the wall of the expandable sheath can be in relation to the ring, the wall can either: fully loop around the ring, connect to the ring at the proximal or distal ends, or partially cover the inside or outside of the ring. Therefore, it would have been obvious to one of ordinary skill in the art to modify the expandable sheath (i.e., the surgical drape 200) to have the wall fully loop around and cover the ring since there are a limited number of possible connection options for the expandable sheath (i.e., the surgical drape 200) to the ring, and having the expandable sheath (i.e., the surgical drape 200) to have the wall fully loop around and cover the ring would have yielded, with a reasonable expectation of success, a solid, fluid tight, seal and connection between the expandable sheath (i.e., the surgical drape 200) the ring. Furthermore, it would have been prima facie obvious to a person of ordinary skill in the art to modify the expandable sheath (i.e., the surgical drape 200) to have the wall fully loop around and cover the ring, so that the system is more fluid tight. “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103.” KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007). Therefore, it would have been obvious to try having the wall of the expandable sheath (i.e., the surgical drape 200) fully loop around and cover the ring. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rationale E, outlined in MPEP 2143.
Regarding claims 24 and 25, as disclosed above, it would be obvious to the introducer system of Delaloye with the instrument drape of Bernstein. Additionally, Bernstein discloses [claim 24] wherein the ring (handling ring 212) is a resilient body [claim 25] and made of an elastic material (Examiner’s note: as stated in paragraph [0030] all of the components of the surgical drape 200, which includes the handling ring 212, is made up of thermoplastic polyurethane; and thermoplastic polyurethane is a resilient material and highly elastic. Therefore, the handling ring 212 (i.e., the ring) is a resilient body made up of an elastic material).
Regarding claims 26 and 27, as disclosed above, it would be obvious to the introducer system of Delaloye with the instrument drape of Bernstein. Additionally, Delaloye teaches wherein the distal end of the sheath body (guide catheter 30) includes an opening for the delivery apparatus (a delivery catheter) to be passed through and further comprises an introducer body (a delivery catheter), wherein the interior lumen of the sheath body is configured to receive the introducer body (Examiner’s note: as stated in paragraph [0062] part (ii) the guide catheter 30 serves to introduce a delivery catheter into the body; therefore, the guide catheter 30 must have an opening for the delivery apparatus to enter and have the interior lumen be configured to receive the delivery catheter (i.e., the delivery catheter)). Therefore, the combination of Bernstein and Delaloye encompasses the system as claimed.
Regarding claims 28, 30, and 31, as disclosed above, it would be obvious to the introducer system of Delaloye with the instrument drape of Bernstein. Additionally, Delaloye teaches [claim 28] wherein the introducer body (delivery catheter) has a distal end that is configured to protrude from the distal end of the sheath body (guide catheter 30) (paragraph [0062] part (ii)) (Examiner’s note: it should be understood that the delivery catheter has a distal end; and the distal end of the delivery catheter has to leave / protrude from the distal end of the guide catheter 30 (i.e., the sheath body) in order to deliver the heart valve to the target location. Additionally, it should be understood that the proceeding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning as claimed; with that said, because Delaloye recites, in paragraph [0062] part (ii), wherein the guide catheter 30 (i.e., the sheath body) is independent of the other catheters introduced therein, the delivery catheter is capable of protruding from the distal end of the guide catheter 30 (i.e., the sheath body)), [claim 30] wherein the introducer body (delivery catheter) and the sheath body (guide catheter 30) are configured to be inserted together into the subject and the introducer body is configured to be withdrawn proximally from the sheath body to leave the sheath body within the subject (Examiner’s note: it should be understood that the proceeding limitations are intended use limitations which require only that the structure of the prior art be capable of functioning as claimed; with that said, because Delaloye recites, in paragraph [0062] part (ii), wherein the guide catheter 30 (i.e., the sheath body) is independent of the other catheters introduced therein, the delivery catheter (i.e., the introducer body) is capable of being inserted with the guide catheter 30 (i.e., the sheath body) and capable of being withdrawn proximally form the guide catheter 30 (i.e., the sheath body) to leave the guide catheter 30 (i.e., the sheath body)within the subject), and [claim 31] wherein the interior lumen is for a prosthetic heart valve delivery apparatus (delivery catheter – for a prosthetic heart) to be passed through to move to the location within the subject (paragraph [0062] part (ii)). Therefore, the combination of Bernstein and Delaloye encompasses the system as claimed.
Regarding claim 29, as disclosed above, it would be obvious to the introducer system of Delaloye with the instrument drape of Bernstein. Additionally, Delaloye makes obvious wherein a portion of the introducer body (distal portion / tip of the delivery catheter) that is configured to protrude from the distal end of the sheath body has a tapered profile (Examiner’s note: Delaloye recites in paragraph [0062] part (ii) wherein it is known for delivery catheters to have an atraumatic (i.e., tapered) tip for the purpose of tacking along a guidewire; therefore, it would be obvious to one of ordinary skill in the art to have the delivery catheter of Delaloye have an atraumatic (i.e., tapered tip) for the purpose of tracking along a guidewire). Therefore, the combination of Bernstein and Delaloye makes obvious the system as claimed.
Response to Arguments
Applicant's arguments filed 03/31/2026 have been fully considered but they are not persuasive. More specifically:
Regarding the argument “The Office Action equates the "sheath body" with Bernstein's "surgical instrument 108" and equates the "expandable sheath" with Bernstein's "surgical drape 200." (See Office Action at pages 4-5). However, the portion of Bernstein's system that is covered by the "surgical drape 200" is a "shaft 124" and is not a sheath body. Bernstein's "shaft 124" does not include an interior lumen for a delivery apparatus to be passed through to move to a location within the subject. Bernstein's "shaft 124" is a "surgical tool[], such as the forceps 128 shown" and does not include an interior lumen for a delivery apparatus to be passed through to move to a location within the subject.”, the Examiner notes that the modification above is such that the medical instrument 108 of Bernstein is replaced with the medical instrument of Delaloye, and the medical instrument of Delaloye does have an interior lumen; furthermore, because the body of the surgical instrument of Bernstein is covered by the surgical drape, the prior art makes obvious wherein the modified device would be such that the surgical drape also covers the surgical instrument of Delaloye. Therefore, Applicant’s argument is not persuasive.
Regarding the argument that “Delaloye teaches away from Claim 1. Delaloye touts the benefits of providing "one or more blood-communication openings" in a guide catheter "along its length to allow blood flow between the exterior and [interior] of the guide catheter and for example, allow for pressure equalization between the interior and exterior as a functional catheter/device is advanced or withdrawn with the interior of the guide catheter." (See Delaloye at para. [0063] (emphasis added))”, the Examiner is not modifying the system of Delaloye, the Examiner is modifying the system of Bernstein to include the device of Delaloye. Additionally, Delaloye in paragraph [0063] recites wherein “some embodiments” of the guide catheter “may comprise” the one or more blood communications; therefore, the Examiner is not relying upon an embodiment with said blood communications. Furthermore, the Applicant has not provided any evidence to prove the modified device would not operate as intended. Merely, saying that the modification would result in the inoperability of the device is not sufficient to show inoperability of the device. Furthermore, the examiner notes that the arguments of the attorney cannot take place of evidence. See In Re Schulze, 346, F.2d 600,602, 145 USPQ 716, 718 (CCPA 1965).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/Andrew Restaino/Primary Examiner, Art Unit 3771
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