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 .
This action is in response to the amendment filed on 09/08/2025. Claims 1, 5-8, 21, 22, 25, and 26 are pending. Claim 1 is independent. Claims 2-4, 9-20, 23, and 24 are canceled.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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, 5-8, 21, 22, 25, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fumiyama (US Pub. No.: 2016/0175566).
Regarding claims 1, 5-8, 21, 22, 25, and 26, Fumiyama discloses [claim 1] a catheter assembly (1 with four line-shaped portions, Figs. 1-5 and Para. [0037]) comprising: a catheter tube (1 excluding the line-shaped portions 11, Figs. 1-5, structures 9 and 10 are considered as part of the catheter tube) comprising a distal end portion (Figs. 1 and 2), the catheter tube being sized and shaped fully capable for delivery through a body vessel of a subject (the catheter tube being sized and shaped fully capable for delivery through a body vessel of a subject, see Abstract and Para. [0009]-[0013]); and an expandable unit (3, Figs. 1-4) attached to the distal end portion of the catheter tube, the expandable unit being adapted to be configurable in a first, collapsed, configuration (Fig. 2) to facilitate delivery of the catheter assembly through the body vessel, and a second, fully expanded, configuration (Figs. 1 and 4) for contacting an interior wall of the body vessel to cover a perforation in the body vessel (the expandable unit fully capable to be in a first, collapsed, configuration to facilitate delivery of the catheter assembly through the body lumen, and a second, fully expanded, configuration for contacting an interior wall of the body lumen to cover a perforation in the body lumen), the expandable unit defining at least one longitudinal channel (at least one longitudinal channel or passageway, such as 14a, defined between the two parts of the balloon, Fig. 4) extending from a proximal end of the expandable unit to a distal end of the expandable unit when the expandable unit is in the fully expanded configuration fully capable of permitting blood flow past the expandable unit in the blood vessel (Para. [0035]); wherein the expandable unit comprises a balloon (3, Fig. 2 and Para. [0029]) and at least one blocking strip (11, Fig. 2) disposed over the balloon preventing expansion of a radially constrained longitudinal section of the balloon (Fig. 4 and Paras. [0033]-[0038], blocking strip 11 restrict the expansion of a longitudinal section of the balloon or a radially constrained longitudinal section of the balloon) and enabling expansion of an inflatable longitudinal portion (e.g. 3a, Fig. 4) of the balloon when the balloon is inflated in the fully expanded configuration to define said at least one longitudinal channel (Fig. 4 and Para. [0035]), the blocking strip being formed integrally with the catheter tube (Para. [0040], since structures 9 and 10 are interpreted to be part of the catheter and portions 11 are integrally formed with 9 and 10, blocking strips 11 are considered as integrally formed with the catheter tube; Alternatively, see embodiment shown in Fig. 6 and Para. [0041]); [claim 5] wherein said at least one blocking strip comprises first and second blocking strips (two strips 11, Figs. 2 and 4), the radially constrained longitudinal section of the balloon comprises first and second radially constrained longitudinal sections (the first and second radially constrained longitudinal sections blocked by the first and second strips 11, Figs. 2 and 4), the inflatable longitudinal portion of the balloon comprises first and second inflatable longitudinal portions (e.g. 3a and 3b; or the diametrically opposite first and second inflatable longitudinal portions with four evenly spaced members 11, Para. [0037] and [0038]), and said at least one longitudinal channel comprises two longitudinal channels (e.g. 14a and 14b; or the diametrically opposite longitudinal channels with four evenly spaced members 11, Para. [0037] and [0038]); [claims 6] wherein the second blocking strip is diametrically opposed to the first blocking strip, and the first and second inflatable longitudinal portions of the balloon are diametrically opposed to one another (Para. [0037] and [0038], with four evenly spaced members 11, the second blocking strip is diametrically opposed to the first blocking strip, and the first and second inflatable longitudinal portions of the balloon are diametrically opposed to one another); [claim 7] wherein the blocking strip comprises a material having a stiffness that is greater than a stiffness of the balloon (Fig. 4 and Para. [0036]); [claim 8] wherein the blocking strip is formed from the same material as the catheter tube (Para. [0020] and [0040] and also see Fig. 6, the blocking strips and the attachment members/rings of the catheter assembly can be integrally formed or a single component); [claim 21] wherein the at least one longitudinal channel defines a linear passage extending continuously from a location proximal to the expandable unit to a distal end of the catheter tube (Figs. 2 and 4); [claim 22] wherein the blocking strip extends seamlessly from the catheter tube (Fig. 6); [claim 25] wherein said at least one blocking strip consists of first and second blocking strips (two strips 11), the radially constrained longitudinal section of the balloon consists of first and second radially constrained longitudinal sections (the first and second radially constrained longitudinal sections blocked by the first and second strips 11, Para. [0037]-[0038]), the inflatable longitudinal portion of the balloon consists of first and second inflatable longitudinal portions (Para. [0037] and [0038], with four evenly spaced members 11, the second blocking strip is diametrically opposed to the first blocking strip, and the first and second inflatable longitudinal portions of the balloon are diametrically opposed to one another), and said at least one longitudinal channel consists of two longitudinal channels (the channels on opposite sides of the catheter formed between the diametrically opposite balloon portions, Paras. [0037]-[0038]); and [claim 26] wherein the catheter assembly is fully capable to performed the recited functions in the blood vessel which is a coronary artery (see Abstract and Paras. [0009]-[0013], the catheter assembly is fully capable to performed the recited functions in blood vessel which a coronary artery because it is configured to be used in a blood vessel).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 5-8, 21, 22, 25, and 26 have been considered but are moot in view of new ground(s) of rejection.
In response to the argument(s) on the 35 USC 112 rejection on pages 5-6 of the remarks, the rejection of claims 1, 5-8, 21, 22, 25, and 26 under 35 U.S.C. 112(a) has been withdrawn in light of the amendment.
In response to the argument(s) on page 6 of the remarks, Fumiyama discloses a catheter assembly (1 with four line-shaped portions, Figs. 1-5 and Para. [0037]) comprising: a catheter tube (1 excluding the line-shaped portions 11, Figs. 1-5, structures 9 and 10 are considered as part of the catheter tube) comprising a distal end portion (Figs. 1 and 2), the catheter tube being sized and shaped fully capable for delivery through a body vessel of a subject (the catheter tube being sized and shaped fully capable for delivery through a body vessel of a subject, see Abstract and Para. [0009]-[0013]); and an expandable unit (3, Figs. 1-4) attached to the distal end portion of the catheter tube, the expandable unit being adapted to be configurable in a first, collapsed, configuration (Fig. 2) to facilitate delivery of the catheter assembly through the body vessel, and a second, fully expanded, configuration (Figs. 1 and 4) for contacting an interior wall of the body vessel to cover a perforation in the body vessel (the expandable unit fully capable to be in a first, collapsed, configuration to facilitate delivery of the catheter assembly through the body lumen, and a second, fully expanded, configuration for contacting an interior wall of the body lumen to cover a perforation in the body lumen), the expandable unit defining at least one longitudinal channel (at least one longitudinal channel or passageway, such as 14a, defined between the two parts of the balloon, Fig. 4) extending from a proximal end of the expandable unit to a distal end of the expandable unit when the expandable unit is in the fully expanded configuration fully capable of permitting blood flow past the expandable unit in the blood vessel (Para. [0035]); wherein the expandable unit comprises a balloon (3, Fig. 2 and Para. [0029]) and at least one blocking strip (11, Fig. 2) disposed over the balloon preventing expansion of a radially constrained longitudinal section of the balloon (Fig. 4 and Paras. [0033]-[0038], blocking strip 11 restrict the expansion of a longitudinal section of the balloon or a radially constrained longitudinal section of the balloon) and enabling expansion of an inflatable longitudinal portion (e.g. 3a, Fig. 4) of the balloon when the balloon is inflated in the fully expanded configuration to define said at least one longitudinal channel (Fig. 4 and Para. [0035]), the blocking strip being formed integrally with the catheter tube (Para. [0040], since structures 9 and 10 are interpreted to be part of the catheter and portions 11 are integrally formed with structures 9 and 10, blocking strips 11 are considered as integrally formed with the catheter tube; Alternatively, see embodiment shown in Fig. 6 and Para. [0041]).
Furthermore, even if the blocking strip and the catheter tube of a prior art were formed in two pieces, it would also have been obvious to one ordinary skill in the art to having blocking strip being formed integrally with the catheter tube, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. See MPEP 2144.04.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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/JING RUI OU/Primary Examiner, Art Unit 3771