DETAILED ACTION
This Office Action is in response to the Amendment filed 19 November 2025. Claim(s) 1-19 are currently pending. The Examiner acknowledges the amendments to claim(s) 1, 7, 9-12, 14 and 17.
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 .
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Claim(s) 1-4 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gershowitz (US 7,291,139).
Regarding claim 1, Gershowitz discloses a hemostasis device including a catheter (10; Figs. 1) having a proximal portion, a middle portion and a distal portion. The distal portion having a distal end (please see annotated figure below). The catheter has a first lumen (22) and a second lumen (16). The first lumen is sealed at the distal end of the catheter. At least one opening (30) in an outer wall of the catheter between the middle portion and the distal end and into the first lumen. An inflatable element (12) is attached to and in fluid communication with the second lumen through the at least one opening. The inflatable element is configured to expand in a radial direction upon insertion of a fluid into the first lumen and the at least one opening to at least partially seal an opening in a blood vessel wall. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
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Regarding claim 2, Gershowitz discloses that the catheter has an outside wall forming the first lumen and an inside wall within the first lumen and forming the second lumen inside the second lumen (Fig. 1).
Regarding claim 3, Gershowitz discloses that the catheter has an outside wall and the first and second lumens are separated by a septum which is in the form of a wall (Fig. 1).
Regarding claim 4, Gershowitz discloses that the inflatable element is attached along only a portion of a length of the catheter (Fig. 1).
Regarding claim 7, Gershowitz discloses that the inflatable element is configured to expand in a radial direction upon introduction of a fluid into the first lumen (C1;L60-67, C2:L1-25). The inflatable element is capable of contacting an internal surface of a blood vessel into which it is inserted.
Claim(s) 1-4, 6-8, 14-16, 18 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meno (US 4,484,579).
Regarding claim 1, Meno discloses a hemostasis device including a catheter (Fig. 1) having a proximal portion, a middle portion and a distal portion. The distal portion having a distal end (4;please see annotated figure below). The catheter has a first lumen (2) and a second lumen (20; C3;L4-22). The first lumen is sealed at the distal end of the catheter. At least one opening (18) in an outer wall of the catheter between the middle portion and the distal end and into the first lumen. An inflatable element (inflatable element includes 13-16) is attached to and in fluid communication with the second lumen through the at least one opening. The inflatable element is configured to expand in a radial direction upon insertion of a fluid into the first lumen and the at least one opening (C3;L4-22) to at least partially seal an opening in a blood vessel wall. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
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Regarding claim 2, Meno discloses that the catheter has an outside wall forming the first lumen and an inside wall within the first lumen and forming the second lumen inside the second lumen (Fig. 1, C3;L4-22).
Regarding claim 3, Meno discloses that the catheter has an outside wall and the first and second lumens are separated by a septum which is in the form of a wall (Fig. 1, C3;L4-22).
Regarding claim 4, Meno discloses that the inflatable element is attached along only a portion of a length of the catheter (Fig. 1).
Regarding claim 6, Meno discloses that the inflatable element includes at least one channel that is in fluid communication with the at least one opening in the catheter. The inflatable element includes channels leading from (13, 14) in fluid communication with two openings (18).
Regarding claim 7, Meno discloses that the inflatable element is configured to expand in a radial direction upon introduction of a fluid into the first lumen (first lumen expands portions (15, 16) through openings (19), C3;L4-22). The inflatable element is capable of contacting an internal surface of a blood vessel into which it is inserted.
Regarding claim 8, Meno discloses that the at least one opening includes a plurality of openings and the at least one channel includes a plurality of channels (Fig. 1, see inflatable element includes channels leading from 13, 14 in fluid communication with two openings 18; C3;L4-22). A respective one of each of the plurality of openings being in fluid communication with a respective one of the plurality of channels.
Regarding claims 14-16, Meno discloses a hemostasis device including a catheter having proximal, middle and distal portions. The distal portion includes a distal end (4;please see annotated figure above). The catheter has a first catheter lumen (2) and a second catheter lumen (20; C3:L4-22). The first catheter lumen is sealed at the distal portion and end of the catheter and the second catheter lumen is centered in the first catheter lumen (Fig. 1). At least one opening (18) in the catheter between the middle portion and the distal end and in fluid communication with the first catheter lumen. An inflatable element (13-16) is attached to and wrapped around the catheter. The inflatable element is in fluid communication with the first catheter lumen through the at least one opening. The inflatable element is capable of expanding radially upon insertion of a fluid into the first catheter lumen and at least one opening causing an outer wall of the inflatable element to contact the interior wall surface of the blood vessel to at least partially seal an opening in the blood vessel while simultaneously allowing blood to flow past the hemostasis device, wherein the blood is capable of flowing past the device when the inflatable element is partially expanded. The inflatable element is attached along only a portion of a length of the catheter (Fig. 1).
Regarding claims 18 and 19, Meno discloses that the at least one opening includes a plurality of openings and the at least one channel includes a plurality of channels (Fig. 1, see inflatable element includes channels leading from 13, 14 in fluid communication with two openings 18; C3;L4-22). A respective one of each of the plurality of openings being in fluid communication with a respective one of the plurality of channels.
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gershowitz in view of Sullivan et al. (US 2016/0354219A1, “Sullivan”).
Regarding claim 5, Gershowitz does not disclose that the second lumen receives a guide wire capable of guiding the catheter in a blood vessel. In the same field of endeavor, therapeutic balloon devices, Sullivan teaches a balloon catheter (10; Fig. 1; [0047-0048]). The central lumen includes a guidewire (22) to reinforce the catheter for improved navigation (Fig. 1, [0048, 0050]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a guidewire in the central, second lumen of the catheter taught by Gershowitz to improve navigation of the catheter to a target location thus minimizing further damage and improving patient safety.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meno in view of Sullivan et al. (US 2016/0354219A1, “Sullivan”).
Regarding claim 5, Meno does not disclose that the second lumen receives a guide wire capable of guiding the catheter in a blood vessel. In the same field of endeavor, therapeutic balloon devices, Sullivan teaches a balloon catheter (10; Fig. 1; [0047-0048]). The central lumen includes a guidewire (22) to reinforce the catheter for improved navigation (Fig. 1, [0048, 0050]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a guidewire in the central, second lumen of the catheter taught by Gershowitz to improve navigation of the catheter to a target location thus minimizing further damage and improving patient safety.
Claim(s) 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meno in view of Rusnak et al. (US 2021/0106794A1, “Rusnak”).
Regarding claims 6 and 8, Meno does not disclose that the inflatable element includes at least one channel that is in fluid communication with the at least one opening in the catheter. In the same field of endeavor, balloon catheters, Rusnak teaches a balloon catheter including channels (786, 796) within the balloon that are connected to multiple openings of the lumens. The at least one opening includes a plurality of openings and the at least one channel includes a plurality of channels (Fig. 12). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the inflatable element of Meno with a plurality of channels, as taught by Rusnak, for the predictable result of inflating the inflatable element.
Claim(s) 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gershowitz in view of Rusnak et al. (US 2021/0106794A1, “Rusnak”).
Regarding claims 6 and 8, Gershowitz does not disclose that the inflatable element includes at least one channel that is in fluid communication with the at least one opening in the catheter. In the same field of endeavor, balloon catheters, Rusnak teaches a balloon catheter including channels (786, 796) within the balloon that are connected to multiple openings of the lumens. The at least one opening includes a plurality of openings and the at least one channel includes a plurality of channels (Fig. 12). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the inflatable element of Gershowitz with a plurality of channels, as taught by Rusnak, for the predictable result of inflating the inflatable element.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meno in view of Verin et al. (US 5,976,106, “Verin”).
Regarding claim 17, Meno does not disclose that the second lumen is configured to receive a guide wire to guide the catheter in a blood vessel. However, the second lumen is capable of receiving a guide wire therein. The second lumen is centered within the first lumen which is sealed. In the same field of endeavor, balloon catheters, Verin teaches a balloon catheter including dual lumens. In one embodiment (Fig. 1) the lumen is open and in Fig. 3, the lumen (33) is sealed and a guide wire (36) is received therein. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the second lumen of Meno with a guide wire, as taught by Verin, to provide means for the predictable result of guiding the catheter. A person of ordinary skill has good reason to pursue the known options within their technical grasp with the reasonable expectation that at least one would be successful.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meno in view of Roucher, JR. (US 2004/0230219A1, “Roucher”).
Regarding claim 17, Meno does not disclose that the second lumen is configured to receive a guide wire to guide the catheter in a blood vessel. However, the second lumen is capable of receiving a guide wire therein. The second lumen is centered within the first lumen which is sealed. In the same field of endeavor, balloon catheters, Roucher teaches a balloon catheter including dual lumens (34, 38) and a balloon (36; Fig. 2). A guide wire is capable of being received within the second lumen (38; [0036]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the second lumen of Meno with a guide wire, as taught by Roucher, to provide means for the predictable result of guiding the catheter.
Allowable Subject Matter
Claim(s) 9-13 is/are allowed.
Regarding claim 9, the prior art of record does not disclose or suggest a method of sealing an opening in the wall of a blood vessel, the method including providing a hemostasis device including a catheter having a first lumen and a second lumen, the first lumen is sealed at the distal end, at least one opening in an outer wall of the catheter between the middle portion and the distal end and into the second lumen, an inflatable element attached to and in fluid communication with the second lumen of the catheter through the at least one opening, inserting at least a portion of the hemostasis device into an insertion blood vessel, moving the inflatable element to the location of the opening in the blood vessel, introducing a fluid into the inflatable element through the catheter to expand the inflatable element to block the opening in the wall of the blood vessel while simultaneously allowing the blood to flow past the hemostasis device when inflated, in combination with the other claimed limitations.
Response to Arguments
Applicant’s arguments with respect to claim(s) 19 November 2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Myers et al. (US 5,725,551) discloses a closure device including a balloon and catheter.
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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771