DETAILED ACTION
This Office Action is in response to the Amendment filed 10 June 2026. Claim(s) 1-19 are currently pending. The Examiner acknowledges the amendments to claim(s) 1, 2, 9, and 14.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 June 2026 has been entered.
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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘inflatable element’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.”
Claim Objections
Claim 13 is objected to because of the following informalities: please change “sealing a sealing” to “sealing”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-13 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.
Claim 9 recites the limitation "the location" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 4, and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Diederich et al. (US 6,746,465, “Diederich”).
Regarding claim 1, Diederich discloses a hemostasis device including a catheter (10; Fig. 1) having a proximal portion, a middle portion and a distal portion. The distal portion having a distal end (Fig. 3). The catheter has a first lumen (30) and a second lumen (38). The first lumen is sealed at the distal end of the catheter. The first and second lumens are not in fluid communication with one another. At least one opening (32, 36) in an outer wall of the catheter between the middle portion and the distal end and into the first lumen. An inflatable element (20) is attached to and in fluid communication with the second lumen through the at least one opening (C8:L20-55). 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 (C8:L20-55).
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Regarding claim 3, Diederich 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. 3).
Regarding claim 4, Diederich discloses that the inflatable element is attached along only a portion of a length of the catheter (Fig. 3).
Regarding claim 7, Diederich discloses that the inflatable element is configured to expand in a radial direction upon introduction of a fluid into the first lumen (C8:L20-55). The inflatable element is capable of contacting an internal surface of a blood vessel into which it is inserted.
Claim(s) 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (US 2018/0325480A1, “Liu”).
Regarding claims 14-17, Liu discloses a hemostasis device including a catheter (300; Fig. 6) having proximal, middle and distal portions. The catheter has a first catheter lumen (310, 320) and a second catheter lumen (318; [0075, 0077]). The first catheter lumen is sealed at a distal end (Fig. 6) of the catheter. The second catheter lumen is centered in the first catheter lumen (Fig. 6), wherein the first catheter lumen is formed by a first tubular member (324) and fourth tubular member (334) that may be formed from a single tubular member through which second lumen (318) is disposed [0079]. At least one opening (332) in the catheter between the middle portion and the distal end and in fluid communication with the first catheter lumen. An inflatable element (306) 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 [0075]. The inflatable element is attached along only a portion of a length of the catheter (Fig. 6). The second lumen is capable of receiving a guide wire to guide catheter in a blood vessel (Fig. 6; [0081]).
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) 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diederich in view of Rusnak et al. (US 2021/0106794A1, “Rusnak”).
Regarding claims 6 and 8, Diederich 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 Diederich with a plurality of channels, as taught by Rusnak, for the predictable result of inflating the inflatable element.
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Rusnak et al. (US 2021/0106794A1, “Rusnak”).
Regarding claims 18 and 19, Liu 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 Liu with a plurality of channels, as taught by Rusnak, for the predictable result of inflating the inflatable element.
Claim(s) 9 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2018/0325480A1; Liu) in view of Cragg et al. (US 5,795,331, “Cragg”).
Regarding claims 9 and 11-13, Liu discloses a method of sealing an opening in the wall of a blood vessel including providing a hemostasis device having a catheter (300; Figs. 6) with a proximal portion, a middle portion and a distal portion having a distal end. The catheter has a first lumen (310) and a second lumen (318). The first lumen is sealed at the distal end of the catheter (Fig. 6). At least one opening (332; Fig. 6) in an outer wall of the catheter between the middle portion and the distal end and into the first lumen. An inflatable element (306) is attached to and in fluid communication with the first lumen through the at least one opening. At least a portion of the hemostasis device is inserted into an insertion blood vessel away from the opening in the blood vessel and the inflatable element is moved to a location of the opening in the blood vessel [0087]. Fluid is introduced into the inflatable element through the catheter to expand the inflatable element [0087]. The insertion blood vessel is a different blood vessel as the blood vessel with the opening (Fig. 8). The balloon blocks the opening the blood vessel while simultaneously allowing blood to flow past the hemostasis device when inflated (Fig. 8). However, Lui does not disclose that the wall includes an opening.
In the same field of endeavor, balloon catheters, Cragg teaches a method involving introducing and advancing a balloon catheter through a patient’s blood vessels and is positioned alongside an opening of a vessel, inflating the balloon to isolate it from the opening. Cragg further teaches isolating an opening in the vessel in the form of an aneurysm or peripheral vessel, wherein blood may pass by the inflatable element to reach a distal portion of the blood vessel. 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 method of Liu with means to seal an opening in the wall of the vessel by inflating the balloon, as taught by Cragg, to provide means for visualizing and treating an opening in the vessel wall in which an implant may be implanted.
Allowable Subject Matter
Claims 2, 5 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 10 June 2026 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. Davis (US 6,045,531) discloses a balloon catheter having an inflatable element, at least one opening and first and second lumens.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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