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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/29/2026 has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 01/29/2026.
Status of the claims:
Claims 1, 3, and 5 – 22 are pending in the application.
Claims 1, 3, 6, 10, 13, 14, 17, and 18 are amended.
Claims 19 – 22 are new.
Claim Objections
The objections to claims 6, 13, and 18 in the previous action dated 10/30/205 have been withdrawn in light of the Applicant’s amendments filed 01/29/2026. Specifically, the objection to claim 6 regarding the phrase “the tapered distal end”, the objection to claim 13 regarding the phrase “wherein a medical device …. applies an outward radial force”, and the objection to claim 18 regarding the phrase “the expansion device …. causes the expandable sheath” have been withdrawn as the appropriate corrections have been made. However, new objections have been set forth below in light of Applicant’s new amendments.
Claims 19 and 22 are objected to because of the following informalities:
Claim 19 recites “the elongated body” in line 1, although the line is understood by the Examiner to mean “the elongated body member” as previously defined and repeated throughout multiple dependent claims, the Examiner suggests the line be amended to read “the elongated body member” for the purpose of maintaining consistent language throughout the claims;
Claim 22 recites “an inflation lumen” in line 3, although the line does not rise to the level of being indefinite as the line is understood by the Examiner to mean “the inflation lumen” as the “inflation lumen” was previously defined in claim 1 and Applicant’s disclosure does not disclose more than one inflation lumen, the Examiner suggests the line be amended to read “the inflation lumen” 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 rejection of claim 3 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 10/30/205 have been withdrawn in light of the Applicant’s amendments filed 01/29/2026. Specifically, the rejection of claim 3 regarding the lack of dependency is withdrawn as claim 3 now depends on claim 1.
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, 5 – 8, 17, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gianotti et al (US 2013/0253467 A1).
Regarding claim 1, Gianotti discloses expandable introducer (balloon catheter) (abstract, paragraphs [0067 – 0070], [0104], and Figs. 1B,2,3,12B) comprising:
an elongated body member (inner tubular member 110) comprising a proximal end and a distal end with a tapered distal tip (tip 61) having a proximal end (distal point on the inner tubular member 110 that is distal to the distal connection point of the expander member 140 to the inner tubular member 110 – Fig. 12B) extending from a portion of the elongated body member (inner tubular member 110) (paragraphs [0061], [0104], and Fig. 12B);
a balloon (expandable member 140; disclosed as a balloon in paragraph [0069]) disposed at an offset from the proximal end of the tapered distal tip (Fig. 12B), the balloon expandable from a deflated configuration to an inflated configuration (paragraphs [0058], [0070]); and
an inflation lumen (inflation lumen 130) in fluid communication with the balloon, sized and configured for providing an inflation fluid to the balloon (paragraph [0069] and Figs. 2,3);
wherein, in the deflated configuration, an outer diameter of the balloon (expandable member 140) corresponds to an outer diameter of the elongated body member (inner tubular member 110) (Examiner’s note: “corresponds to” is defined as “substantially equal to” / “close to”. And at the connection point of the expandable member 140 (i.e., the balloon) to the inner tubular member 110 (i.e., the elongate body member) the outer diameter of the expandable member 140 (i.e., the balloon) is close to the outer diameter of the inner tubular member 110 (i.e., the elongate body member). Therefore, the outer diameter of the balloon (i.e., expandable member 140) is said to correspond to the outer diameter of the elongated body member (i.e., inner tubular member 110)), and in the inflated configuration, the outer dimeter of the balloon (the max OD of the expandable member 140) is greater than the outer diameter of the elongated body member (Fig. 12B),
wherein at least a portion of the balloon is sized and configured to pass through a distal opening of an expandable introducer sheath when the balloon is in the deflated configuration, and configured to expand at least a portion of a distal end of the introducer sheath as the balloon is inflated (Examiner’s note: it should be understood that the preceding limitations are functional and require only that the structure of the prior art be capable of function in the manner claimed; with that said the expandable member 140 is disclosed as being selectively expandable (see paragraph [0070]) and is sized to fit slidably through an outer member (see paragraph [0059]), therefore, the expandable member 140 is capable and configured to function as claimed).
Regarding claim 3, Gianotti discloses wherein the balloon (expandable member 140) includes a tapered surface (Fig. 12B).
Regarding claim 5, Giannotti discloses one or more flexibility features selected from: at least one circumferentially and/or longitudinally extending groove, and at least one circumferentially and/or radially extending slit (paragraph [0118]).
Regarding claim 6, Giannotti discloses wherein the expandable introducer (balloon catheter) includes one or more radiopaque markers along the elongated body member (inner tubular member 110) at a trailing end of the balloon (expandable member 140) (paragraph [0134]).
Regarding claims 7 and 8, Gianotti discloses wherein a shape of the balloon (expandable member 140 with the shape shown in Fig. 5D) in the inflated configuration comprises a stepped ballon with portions of varying diameter (Fig. 5D) (Examiner’s note: as stated in paragraph [0071] the expander member 140 (i.e., the balloon) can comprise any of the various suitable shapes of those shown in Figs. 5A-5H. Therefore, Gianotti encompasses the limitations above).
Regarding claim 17, Gianotti discloses an expansion device (balloon catheter) (abstract, paragraphs [0067 – 0070], [0104], and Figs. 1B,2,3,12B), the device comprising:
a body (inner tubular member 110) comprising an outer surface, a proximal end, and a distal end comprising a tapered distal tip (tip 61) having a proximal end (distal point on the inner tubular member 110 that is distal to the distal connection point of the expander member 140 to the inner tubular member 110 – Fig. 12B) extending from a portion of the elongated body member (inner tubular member 110) (paragraphs [0061], [0104], and Fig. 12B);
a radially extending protrusion (expandable member 140; disclosed as a balloon in paragraph [0069]) disposed at an offset from the proximal end of the tapered distal tip (Fig. 12B), the radially extending protrusion having an outer surface (Fig. 12B) and a diameter greater than a diameter of the body (Fig. 12B) (Examiner’s note: a protrusion is defined as something that sticks out from a surface; and the expandable member 140, when inflated sticks out from the outer surface of the inner tubular member 110. Thus, the expandable member 140 is a radially extending protrusion), and
wherein the device (balloon catheter) is sized and configured to be received within a central lumen of an expandable sheath such that the radially extending protrusion at least partially expands a portion of the expandable sheath (Examiner’s note: it should be understood that the preceding limitations are functional and require only that the structure of the prior art be capable of function in the manner claimed; with that said the expandable member 140 is disclosed as being selectively expandable (see paragraph [0070]) and is sized to fit slidably through an outer member (see paragraph [0059]), therefore, the expandable member 140 is capable and configured to function as claimed).
Regarding 22, Gianotti discloses wherein:
a guidewire lumen (guidewire lumen 150) extends along a centerline of the elongated body member (inner tubular member 110) (paragraph [0061] and Fig. 3), and
the inflation lumen (inflation lumen 130) extends along the elongated body member (inner tubular member 110) at a position that is radially offset the guidewire lumen (guidewire lumen 150) (Fig. 3).
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gianotti et al (US 2013/0253467 A1), as applied to claim 1 above, and further in view of Piggott (EP 3,593,854 A1) (previously cited) (See attached PDF version).
Regarding claim 9, as discussed above, Gianotti discloses the device of claim 1. Additionally, Gianotti discloses wherein the proximal portion of the balloon (expandable member 140) is adjacent the proximal end of the elongated body member (inner tubular member 110) and the distal portion of the balloon (expandable member 140) is adjacent the distal end (distal end 157) of the elongated body member (Fig. 12B) (Examiner’s note: it should be understood that Applicant’s disclosure, paragraph [0210], states where the proximal portion of the balloon is adjacent the proximal end 166 of the elongated body member 162 and the distal portion of the balloon 164 is adjacent the distal end 168 of the elongated body member 162; and in Figs. 52 – 53J, Applicant’s balloon’s distal portion (which is the equivalent to the proximal end of the expandable member 140 of Gianotti) is considered, by Applicant, to be adjacent to the distal end 168 of the elongated body member (which is the equivalent of the proximal end of expandable member 140) even though there is a considerable length of the elongated body member in between the distal end 168 and the distal portion of the balloon. Therefore, the Examiner is considering the proximal portion of the expandable member 140 of Gianotti to be adjacent to the proximal end of the inner tubular member 110 of Gianotti even though there is a considerable length of the inner tubular member 110 therebetween).
However, Gianotti is silent regarding (i) wherein a proximal portion of the balloon is composed of a less compliant material than a distal portion of the balloon. With respect to (i), based on Applicant’s disclosure, paragraph [0210] and Fig. 52, Applicant’s proximal portion of the balloon is the portion closest to the tip of the elongated member (i.e., the proximal end 166) and the distal portion of the balloon is the portion closest to handle of the device (i.e., the distal end 168); therefore, the Examiner is reading the claim limitation above in light of Applicant’s specification such that the portion of the balloon closest to the tip of the elongated member is the portion made up of a less compliant material, and the portion of the balloon closest to the user is the portion made up of a more compliant material.
As to the above, Piggott teaches an expandable introducer (outer member 11) comprising an elongated body member with a balloon (outer member 11 with balloon 15) disposed between a proximal and distal end of the elongated body member (outer member 11) (abstract, paragraph [0024], and Figs. 1, 2, and 21), wherein a proximal portion (distal portion 15b – portion closest to the tip, as defined by Applicant) of the balloon (balloon 15) is composed of a less compliant material than a distal portion (proximal portion 15 – portion closest to the user, as defined by Applicant) of the balloon (balloon 15) (paragraph [0061]).
Furthermore, it should be understood that Gianotti and Pigott are known references in the art that teach a balloon catheter (abstract, paragraphs [0067 – 0070], [0104], and Figs. 1A,1B,2,3,12B – Gianotti ; abstract and paragraphs [0024], [0061], and Figs. 1, 2, 21 – Pigott); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one inflatable balloon for another, and the results of the substitution would have been predictable and resulted in the modified expandable member 140 of Gianotti being able to function as intended to properly expand. 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), rational B, outlined in MPEP 2143.
Claims 10, 13 – 15, and 18 rejected under 35 U.S.C. 103 as being unpatentable over Gianotti et al (US 2013/0253467 A1) in view of Accisano, III (US 2017/0340867 A1) (previously cited).
Regarding claim 10, Gianotti discloses expandable introducer system (balloon catheter) (abstract, paragraphs [0067 – 0070], [0104], and Figs. 1A,1B,2,3,12B) comprising:
an introducer sheath (outer tubular member / sheath 120) (paragraphs [0059], [0088], and Fig. 1A,1B) (Examiner’s note: paragraph [0136] describes the method of use of the balloon catheter, and states wherein the outer tubular member is inserted into a body lumen; therefore, the outer tubular member is considered an introducer);
an introducer (inner tubular member 110) received within a central lumen of the intruder sheath and axially rotatably movable therein (paragraph [0059]) (Examiner’s note: Gianotti does not disclose the inner member 110 being rotationally fixed relative to the outer tubular member 120, therefore, Gianotti encompasses the inner tubular member 110 being rotatably moveable therein) the introducer comprising:
an elongated body member (inner tubular member 110) comprising a proximal end and a distal end with a tapered distal tip (tip 61) having a proximal end (distal point on the inner tubular member 110 that is distal to the distal connection point of the expander member 140 to the inner tubular member 110 – Fig. 12B) extending from a portion of the elongated body member (inner tubular member 110) (paragraphs [0061], [0104], and Fig. 12B);
a balloon (expandable member 140; disclosed as a balloon in paragraph [0069]) disposed at an offset from the proximal end of the tapered distal tip (Fig. 12B), the balloon expandable from a deflated configuration to an inflated configuration (paragraphs [0058], [0070]); and
an inflation lumen (inflation lumen 130) in fluid communication with the balloon, sized and configured for providing an inflation fluid to the balloon (paragraph [0069] and Figs. 2,3);
wherein, in the deflated configuration, an outer diameter of the balloon (expandable member 140) corresponds to an outer diameter of the elongated body member (inner tubular member 110) (Examiner’s note: “corresponds to” is defined as “substantially equal to” / “close to”. And at the connection point of the expandable member 140 (i.e., the balloon) to the inner tubular member 110 (i.e., the elongate body member) the outer diameter of the expandable member 140 (i.e., the balloon) is close to the outer diameter of the inner tubular member 110 (i.e., the elongate body member). Therefore, the outer diameter of the balloon (i.e., expandable member 140) is said to correspond to the outer diameter of the elongated body member (i.e., inner tubular member 110)), and in the inflated configuration, the outer dimeter of the balloon (the max OD of the expandable member 140) is greater than the outer diameter of the elongated body member (Fig. 12B),
wherein at least a portion of the balloon is sized and configured to pass through a distal opening of an expandable introducer sheath when the balloon is in the deflated configuration, and configured to expand at least a portion of a distal end of the introducer sheath as the balloon is inflated (Examiner’s note: it should be understood that the preceding limitations are functional and require only that the structure of the prior art be capable of function in the manner claimed; with that said the expandable member 140 is disclosed as being selectively expandable (see paragraph [0070]) and is sized to fit slidably through an outer member (see paragraph [0059]), therefore, the expandable member 140 is capable and configured to function as claimed).
However, Gianotti is silent regarding (i) wherein the outer tubular member is an expandable introducer sheath.
As to the above, Accisano, III teaches, in the same field of endeavor, an introducer sheath system (expandable introducer assembly) comprising: an expandable introducer sheath (expandable introducer sheath 110; which equates to the outer tubular member / sheath 120 of Gianotti), an introducer (expander 150; which equates to the inner tubular member 110 of Gianotti) received within a central lumen of the introducer sheath (shown in Fig. 5B/C) and axially and rotatably movable therein, a balloon (expander member 160) disposed at an offset from the tapered distal tip (Fig. 4A) and expandable from a deflated configuration to an inflated configuration (abstract, paragraphs [0027], [0033 – 0034], [0036], [0039], [0058 – 0062], [0070 – 0074], and Figs. 1A-C, 4A, 3A/B, 5A-D), and wherein at least a portion of the balloon is sized and configured to pass through a distal opening of the introducer sheath when the balloon is in the deflated condition, as the balloon is inflated at least a portion of the distal end of an introducer sheath expands, increasing a diameter of the distal opening (Examiner’s note: it should be understood that the preceding limitations are functional and require only that the structure of the prior art be capable of function in the manner claimed; with that said the expander member 160 is disclosed as being selectively expandable (see paragraph [0060]) and moveable through the introducer sheath 110, while in the relaxed state; additionally, the expander member is disclosed as being configured to expand the introducer sheath 110 (see paragraphs [0072 – 0073]), therefore, the expander member 160 (i.e., the balloon) is capable and configured to function as claimed).
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 outer tubular member / sheath (i.e., the introducer sheath) of Gianotti to be an expandable introducer, as taught by Accisano, III, for the purpose of allowing the device to be inserted into a smaller tissue puncture site, and move through the vasculature in a more compact configuration, thereby reducing the amount of tissue damage.
Additionally, it should be understood that Gianotti and Accisano, III are known references in the art that teach an introducer system for the introduction of an expandable member (abstract, paragraphs [0067 – 0070], [0104], and Figs. 1A,1B,2,3,12B – Gianotti ; abstract, paragraphs [0033 – 0034], [0058 – 0062], [0070 – 0074], and Figs. 1A-C, 3A/B, 5A-D – Accisano, III); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one outer tubular member for another, and the results of the substitution would have been predictable and resulted in the modified handle of Golden being able to function as intended to properly introduce the inner tubular member with the expandable member thereon through the vasculature. 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), rational B, outlined in MPEP 2143.
Regarding claim 13, as discussed above, it would have been obvious to modify the outer tubular member of Gianotti to be the expandable sheath of Accisano, III. Additionally, Accisano, III teaches wherein the introducer sheath (introducer sheath 110) includes at least one polymeric layer including a plurality of longitudinally-extending folds when the sheath is at the first diameter (collapsed configuration – shown in Figs. 1B and 5A) (paragraphs [0046 – 0047]). Additionally, the combination teaches wherein a medical device (inner tubular member 110 – Gianotti) passing through the central lumen of the introducer sheath applies an outward radial force on the introducer sheath causing the introducer sheath to expand radially from the first diameter to the second diameter by at least partially unfolding the plurality of longitudinally-extending folds (paragraphs [0070 – 0074], [0090], and Figs. 5A-D – Accisano, III).
Regarding claims 14 and 15, as discussed above, it would have been obvious to modify the outer tubular member of Gianotti to be the expandable sheath of Accisano, III. Additionally, Gianotti discloses a shape of the balloon (expandable member 140 with the shape shown in Fig. 5D) in the inflated configuration comprises a stepped ballon with portions of varying diameter (Fig. 5D) (Examiner’s note: as stated in paragraph [0071] the expander member 140 (i.e., the balloon) can comprise any of the various suitable shapes of those shown in Figs. 5A-5H. Therefore, Gianotti encompasses the limitations above).
Regarding claim 18, Gianotti discloses a sheath system (balloon catheter) (abstract, paragraphs [0067 – 0070], [0104], and Figs. 1B,2,3,12B) comprising:
a sheath (outer tubular member / sheath 120) (paragraphs [0059], [0088], and Fig. 1A,1B);
an expansion device (inner tubular member 110) moveable within the central lumen of the sheath (outer tubular member / sheath 120) (paragraph [0059]), the expansion device comprising:
a body (inner tubular member 110) comprising an outer surface, a proximal end, and a distal end comprising a tapered distal tip (tip 61) having a proximal end (distal point on the inner tubular member 110 that is distal to the distal connection point of the expander member 140 to the inner tubular member 110 – Fig. 12B) extending from a portion of the elongated body member (inner tubular member 110) (paragraphs [0061], [0104], and Fig. 12B);
a radially extending protrusion (expandable member 140; disclosed as a balloon in paragraph [0069]) disposed at an offset from the proximal end of the tapered distal tip (Fig. 12B), the radially extending protrusion having an outer surface (Fig. 12B) and a diameter greater than a diameter of the body (Fig. 12B) (Examiner’s note: a protrusion is defined as something that sticks out from a surface; and the expandable member 140, when inflated sticks out from the outer surface of the inner tubular member 110. Thus, the expandable member 140 is a radially extending protrusion).
However, Gianotti is silent regarding (i) wherein the sheath is expandable, the expandable sheath comprising an inner layer and an outer layer, wherein the inner layer and outer layer transition from a non-expanded and an expanded configuration, and (ii) wherein receipt of the expansion device within the central lumen of the expandable sheath [is configured to] cause
As to the above, Accisano, III teaches, in the same field of endeavor, a sheath system (expandable introducer system) (abstract, paragraphs [0027], [0034], [0058 – 0062], [0070 – 0074], and Figs. 1A – 1C, 3A/B, 5A-D) comprising an expandable sheath (introducer sheath 110) with an inner layer (layer of introducer sheath 110 covered by the thin layer of PTFE) defining a central lumen (lumen 117) of the sheath, an outer layer (thin layer of PTFE) extending at least partially around the inner layer (paragraphs [0033], [0050], and Figs. 1A-C), wherein the inner layer and outer layer transition from a non-expanded and an expanded configuration (paragraphs [0050 – 0052]), an expansion device (expander 150; which equates to the inner tubular member 110 of Gianotti) comprising a body (body of expander 150) comprising a tapered distal tip (tapered portion 157 located in the same location as reference number 153 in Fig. 3A) and a radially extending protrusion (expander member 160; which equates to the expandable member 140 of Gianotti) disposed at an offset from the tapered distal tip (paragraphs [0058 – 0063] and Fig. 3A), wherein receipt of the expansion device within the central lumen of the expandable sheath is configured to cause the expandable sheath to locally expand at least a portion of the expandable sheath in response to the outwardly directed radial force provided by the radially extending protrusion (paragraphs [0034], [0058 – 0062], [0063], [0071 – 0074], and 5A – 5D).
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 outer tubular member / sheath (i.e., the introducer sheath) of Gianotti to be an expandable introducer, as taught by Accisano, III, for the purpose of allowing the device to be inserted into a smaller tissue puncture site, and move through the vasculature in a more compact configuration, thereby reducing the amount of tissue damage.
Additionally, it should be understood that Gianotti and Accisano, III are known references in the art that teach an introducer system for the introduction of an expandable member (abstract, paragraphs [0067 – 0070], [0104], and Figs. 1A,1B,2,3,12B – Gianotti ; abstract, paragraphs [0033 – 0034], [0058 – 0062], [0070 – 0074], and Figs. 1A-C, 3A/B, 5A-D – Accisano, III); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one outer tubular member for another, and the results of the substitution would have been predictable and resulted in the modified handle of Golden being able to function as intended to properly introduce the inner tubular member with the expandable member thereon through the vasculature. 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), rational B, outlined in MPEP 2143.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gianotti et al (US 2013/0253467 A1) in view of Accisano, III (US 2017/0340867 A1) (previously cited), as applied to claim 10 above, and further in view of Shannon (US 6,537,247 B2).
Regarding claim 11, as discussed above, it would have been obvious to modify the outer tubular member of Gianotti to be the expandable sheath of Accisano, III. Additionally, the combination teaches [a portion of claim 11] wherein [a] second portion (a proximal portion) of the balloon (expandable member 140 – Gianotti) is sized and configured to dilate at least a portion of the distal end of the introducer sheath (introducer sheath 110 – Accisano) as the balloon expands from the deflated configuration to the inflated configuration (Examiner’s note: 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, because the expandable member 140 of Gianotti is selectively expandable and the introducer sheath 110 of Accisano is balloon expandable, it can be said that the modified device is capable of functioning in the manner claimed).
However, the combination of Gianotti and Accisano, III is silent regarding (i) wherein when the elongated body member is at the distal-most position a first portion of the balloon extends beyond the distal opening of the introducer sheath and a second portion of the balloon remains within the central lumen of the introducer sheath.
As to the above, Shannon teaches, in the same field of endeavor, an expandable introducer system (balloon catheter 20 with strain relief tube 40) comprising an expandable introducer sheath (strain relief tube 40 with end 30; which equates to the expandable introducer sheath 110 of Accisano in the modified system of Gianotti), an elongated body member (catheter 20; which equates to the inner tubular member 110 of Gianotti), and a balloon (balloon 10; which equates to the expandable member 140 of Gianotti), wherein when the elongated body member (catheter 20) is at the distal-most position (position shown in Fig. 2) a first portion (distal portion not within end 30 of tube 40 – shown in Fig. 2) of the balloon (balloon 10) extends beyond the distal opening of the introducer sheath (tube 40 with end 30) and a second portion (proximal portion within the end 30 of tube 40 – shown in Fig. 2) of the balloon remains within the central lumen of the introducer sheath (tube 40 with end 30) for the purpose of substantially reducing the chance of damage to the balloon upon withdraw (abstract, col. 4 line 52 – col. 5 line 17, col. 7 line 64 – col. 8 line 8, col. 8 lines 23 – 30, col. 8 lines 34 – 62).
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 balloon catheter of Gianotti in view of Accisano, III to have a distal most position of the balloon be a position that includes a portion of the balloon being distal to the distal opening of the expandable introducer and a portion of the balloon being within the expandable introducer, based on the teachings of Shannon, for the purpose of substantially reducing the chance of damage to the balloon upon withdraw (col. 8 lines 34 – 62 – Shannon).
Regarding claim 12, as discussed above, it would have been obvious to modify the outer tubular member of Gianotti to be the expandable sheath of Accisano, III and for the balloon to have the distal most position as claimed in claim 11 based on the teachings of Shannon. Additionally, the combination teaches wherein the second portion (portion of the expandable member 140 extending within of the introducer sheath) of the balloon (expandable member 140 – Gianotti) includes a tapered surface (Fig. 12B – Gianotti) adapted to dilate the at least a portion of the distal end of the introducer sheath to a corresponding tapered shape (Examiner’s note: it should be understood that the preceding limitation is functional and requires only that the structure of the prior art be capable of functioning in the manner claim. With that said, as stated in paragraph [0070] of Gianotti, that the expandable member 140 is selectively inflatable and deflatable, and as stated in paragraph [0060] of Accisano, III the inner member is moveable through the introducer sheath 110 while deflated; therefore, inner member 110 and expandable member 140 of Gianotti are capable of being / are configured to be inserted through the introducer sheath 110 of Accisano, III while in the relaxed state, and then once the expandable member 140 of Gianotti is at the distal most position, wherein a portion of the expandable member 140 of Gianotti extends distally through the distal end of the introducer sheath 110 of Accisano, III, the expandable member 140 of Gianotti can be expanded such that the distal end of the introducer sheath 110 of Accisano, III expands and includes a taper, corresponding to the taper of the expandable member 140 (i.e., towards the proximally unexpanded section of the introducer sheath 110 of Accisano, III that is proximal of the distal end of expandable member 140 of Gianotti). Therefore, the combination encompasses the limitation above).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gianotti et al (US 2013/0253467 A1) in view of Accisano, III (US 2017/0340867 A1) (previously cited), as applied to claim 10 above, and further in view of Piggott (EP 3,593,854 A1) (previously cited) (See attached PDF version).
Regarding claim 16, as discussed above, the combination of Gianotti and Accisano, III teaches the device of claim 10. Additionally, Gianotti discloses wherein the proximal portion of the balloon (expandable member 140) is adjacent the proximal end of the elongated body member (inner tubular member 110) and the distal portion of the balloon (expandable member 140) is adjacent the distal end (distal end 157) of the elongated body member (Fig. 12B) (Examiner’s note: it should be understood that Applicant’s disclosure, paragraph [0210], states where the proximal portion of the balloon is adjacent the proximal end 166 of the elongated body member 162 and the distal portion of the balloon 164 is adjacent the distal end 168 of the elongated body member 162; and in Figs. 52 – 53J, Applicant’s balloon’s distal portion (which is the equivalent to the proximal end of the expandable member 140 of Gianotti) is considered, by Applicant, to be adjacent to the distal end 168 of the elongated body member (which is the equivalent of the proximal end of expandable member 140) even though there is a considerable length of the elongated body member in between the distal end 168 and the distal portion of the balloon. Therefore, the Examiner is considering the proximal portion of the expandable member 140 of Gianotti to be adjacent to the proximal end of the inner tubular member 110 of Gianotti even though there is a considerable length of the inner tubular member 110 therebetween).
However, the combination of Gianotti and Accisano, III is silent regarding (i) wherein a proximal portion of the balloon is composed of a less compliant material than a distal portion of the balloon. With respect to (i), based on Applicant’s disclosure, paragraph [0210] and Fig. 52, Applicant’s proximal portion of the balloon is the portion closest to the tip of the elongated member (i.e., the proximal end 166) and the distal portion of the balloon is the portion closest to handle of the device (i.e., the distal end 168); therefore, the Examiner is reading the claim limitation above in light of Applicant’s specification such that the portion of the balloon closest to the tip of the elongated member is the portion made up of a less compliant material, and the portion of the balloon closest to the user is the portion made up of a more compliant material.
As to the above, Piggott teaches an expandable introducer (outer member 11) comprising an elongated body member with a balloon (outer member 11 with balloon 15) disposed between a proximal and distal end of the elongated body member (outer member 11) (abstract, paragraph [0024], and Figs. 1, 2, and 21), wherein the elongated body member (outer member 11) is disposed within an expandable introducer sheath (sheath 22) configured to be expanded by the balloon (paragraph [0030]), a proximal portion (distal portion 15b – portion closest to the tip, as defined by Applicant) of the balloon (balloon 15) is composed of a less compliant material than a distal portion (proximal portion 15 – portion closest to the user, as defined by Applicant) of the balloon (balloon 15) (paragraph [0061]).
Furthermore, it should be understood that Gianotti in view of Accisano, III and Pigott are known references in the art that teach using a medical device with a balloon at the distal end thereof to expand an expandable outer member (abstract, paragraphs [0067 – 0070], [0104], and Figs. 1A,1B,2,3,12B – Gianotti ; abstract, paragraphs [0027], [0034], [0058 – 0062], [0070 – 0074], and Figs. 1A – 1C, 3A/B, 5A-D of Accisano ; abstract and paragraphs [0024], [0061], and Figs. 1, 2, 21 of Pigott); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one inflatable balloon for another, and the results of the substitution would have been predictable and resulted in the modified expandable member 140 of Gianotti being able to function as intended to properly expand the introducer sheath. 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), rational B, outlined in MPEP 2143.
Claims 19 – 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gianotti et al (US 2013/0253467 A1), as applied to claim 1 above, and further in view of Miller et al (US 2002/0198492 A1).
Regarding claims 19 – 21, as discussed above, Gianotti discloses the device of claim 1.
However, Gianotti is silent regarding [claims 19 – 21] (i) wherein the elongated body comprises a reduced diameter section extending from the proximal end of the tapered distal tip, through the balloon and (ii) wherein the tapered distal tip and a remainder of the elongated body member each have a greater diameter than the reduced diameter section.
As to the above, Miller teaches, in the same field of endeavor, an expandable introducer (balloon catheter 102) comprising an elongated body member (elongate member 170; which equates to the inner tubular member 110 of Gianotti) and a balloon (balloon 160) (abstract, paragraphs [0059 – 0064], and Fig. 4A,4B), wherein the elongated body (elongate member 170) comprises a reduced diameter section (radial depression) extending from the proximal end of the tapered distal tip (paragraph [0011]), through the balloon (balloon 60) (paragraph [0063] and Figs. 4A,4B) and (ii) wherein the tapered distal tip (portion distal to the balloon) and a remainder of the elongated body member (portion of elongate member 170 proximal to the balloon) each have a greater diameter than the reduced diameter section (radial depression) (paragraphs [0061], [0063 – 0064] and Figs. 4A,4B).
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 elongated body member (i.e., the inner tubular member 110) of Gianotti to incorporate a reduced diameter section within the balloon and as claimed, based on the teachings of Miller, for the purpose of providing a substantially constant outer diameter of the elongated body member and to minimize the device’s profile.
Response to Arguments
Applicant’s arguments, filed 01/29/2026, with respect to the rejection of claims 1, 10, 17, and 18 under Accisano have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. Specifically, the rejections were withdrawn because Accisano does not teach wherein tapered distal tip extends from a portion of the elongated body member. It is noted that a new rejection has been made over Gianotti and/or over a combination of Gianotti in view of Accisano. The teachings of Gianotti are relied upon for teaching the newly added limitations as discussed above.
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771