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 .
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 § 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.
Claim 16 is 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 16 recites the limitation "the tube" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of art rejections, the tube will be interpreted as “the at least one tube”.
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, 8, 9, 11-14 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hart et al. (US 5,868,708, “Hart”).
Regarding claims 1 and 11-14, Hart discloses a tamponade device including a catheter (10; Fig. 2) having proximal and distal ends and a catheter lumen extending therebetween. An inflatable balloon (22) is located at the distal end of the catheter. A constraint at least partially surrounds the inflatable balloon. In an expanded configuration, the constraint/at least one tube contacts an outer perimeter surface of the inflatable balloon such that the constraint/at least one tube limits a radial expansion of the inflatable balloon when the inflatable balloon is inflated (C5;L1-7). The constraint/at least one tube includes a net structure having a plurality of segments arranged to define a plurality of openings providing a flow path between a lumen extending through the at least one tube and an area outside the lumen.
Regarding claims 8 and 9, Hart discloses that at least one of a distal end of the constraint or a proximal end of the constraint is slidable along the catheter when the tamponade device transitions from a delivery configuration to the expanded configuration (Figs. 5, 6, 7 ; C7:L55-67). The distal and proximal ends of the constraint are closer together in the expanded configuration relative to the delivery configuration (Figs. 5, 6, 7).
Regarding claim 16, Hart discloses that the tube extends along the inflatable balloon in a helical pattern (Fig. 6, 7). At least one polymer strip (C7;L25-40) extends in an opposite pattern to form a criss-crossing pattern overlaying the outer surface of the inflatable balloon.
Claim(s) 1-6, 8, 9, 11-15 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chuter (US 2016/0022966A1).
Regarding claims 1, 2 and 11-15, Chuter discloses a tamponade device including a catheter (12; Fig. 1B) having proximal and distal ends and a catheter lumen extending therebetween. An inflatable balloon (10) is located at the distal end of the catheter. A constraint at least partially surrounds the inflatable balloon [0043]. In an expanded configuration, the constraint/at least one tube contacts an outer perimeter surface of the inflatable balloon such that the constraint/at least one tube limits a radial expansion of the inflatable balloon when the inflatable balloon is inflated [0050]. The constraint/at least one tube includes a net structure having a plurality of segments arranged to define a plurality of openings providing a flow path between a lumen extending through the at least one tube and an area outside the lumen. At least a portion of the inflatable balloon extends radially outward through the plurality of openings when the inflatable balloon is inflated.
Regarding claim 3, Chuter discloses that the net structure includes an angled profile portion and a central portion that is generally cylindrical when the net structure is in the expanded configuration (Fig. 1B, 6-8, 10).
Regarding claim 4, Chuter discloses that at least one of the proximal or distal end of the net structure includes a section of a tube (Fig. 6-8, 10, the net structure is tubular) made of a polymer material [0017], and wherein the plurality of segments of the net structure include the polymer material [0017].
Regarding claims 5 and 6, Chuter discloses that the net structure is secured to at least one tube (12c) having a lumen extending therethrough. The at least one tube is in fluid communication with an inlet at a proximal end of the device (Fig. 6-8, 10). The at least one tube includes at least one opening at a distal end of the at least one tube for delivering a fluid through the lumen [0045].
Regarding claims 8 and 9, Chuter discloses that at least one of a distal end of the constraint or a proximal end of the constraint is slidable along the catheter when the tamponade device transitions from a delivery configuration to the expanded configuration [0059, 0074]. The distal and proximal ends of the constraint are closer together in the expanded configuration relative to the delivery configuration (Figs. 2).
Regarding claim 16, Chuter discloses that the tube extends along the inflatable balloon in a helical pattern (Fig. 1). At least one polymer strip [0017] extends in an opposite pattern to form a criss-crossing pattern overlaying the outer surface of the inflatable balloon.
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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hart in view of Taylor (US 3,736,939).
Regarding claim 10, Hart discloses that the catheter lumen an inflation lumen and capable of delivering a fluid to the inflatable balloon during balloon inflation via port (34). However, Hart does not disclose a second lumen is capable of draining a body fluid. In the same field of endeavor, balloon catheters, Taylor teaches a catheter that includes an inflation lumen (22) and a drainage lumen (11) to provide means to assist in the drainage of balloon walls when inflation of balloon is too large.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chuter in view of Taylor (US 3,736,939).
Regarding claim 10, Chuter discloses that the catheter lumen an inflation lumen and capable of delivering a fluid to the inflatable balloon during balloon inflation via port (34). However, Chuter does not disclose a second lumen is capable of draining a body fluid. In the same field of endeavor, balloon catheters, Taylor teaches a catheter that includes an inflation lumen (22) and a drainage lumen (11) to provide means to assist in the drainage of balloon walls when inflation of balloon is too large.
Claim(s) 17, 19 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stiger (US 2002/0193735A1).
Regarding claim 17, 19 and 20, Stiger discloses a tamponade device including a catheter (10; Fig. 1) having proximal and distal ends and a catheter lumen extending therebetween. An inflatable balloon (50) is located at the distal end of the catheter. The inflatable balloon includes a first end secured to the distal end of the catheter and a second end opposite the first end. The inflatable balloon includes a helical portion between the first and second end that coils around at least a portion of the catheter (Fig. 1; [0033]). The catheter includes a second lumen and at least one port located beneath the helical portion (Fig. 9; 20). The catheter is in fluid communication with the inflatable balloon such that the inflatable balloon is inflatable via the catheter lumen (18).
Allowable Subject Matter
Claim(s) 7 and 18 is/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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fogarty (US 4,762,130) discloses a catheter having a helical balloon.
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