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 .
Election/Restrictions
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/10/2026.
Applicant’s election of Species A, claims 1-12 and 16-20, in the reply filed on 9/10/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 11 is objected to because of the following informalities: Claim 11 recites “a distalmost” in line 1 which should read “the distalmost” and “proximalmost ends” in line 2 which should read “the proximalmost ends”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: Claim 19 recites “the proximalmost end of the coil” in lines 11-12 which should read “a proximalmost end of the coil”. Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a grasping portion in claims 16 and 19.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 7-8 and 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moulis (US 2005/0025798 A1).
Regarding claim 1, Moulis discloses a medical device (embodiment 400 which may be used with a liquid delivery catheter, such as that described in Fig. 1; Figs. 4A-4C; [0021]) comprising: a sheath (elongated body 101); an actuation wire (mechanical interlink 109; see for example, Fig. 1A) extending through the sheath and movable relative to the sheath (as the extending and retracting of support wires 412 is effectuated by mechanical interlink 109; Figs. 1A-1D; [0018]); and a grasping portion (including at least support wires 412) affixed to a distal end of the actuation wire (Fig. 4A), wherein the grasping portion includes a plurality of members (support wires 412) configured to receive a capsule (squeezable material 408; Fig. 4B), and wherein proximal movement of the actuation wire (109) is configured to move at least a proximal portion of the grasping portion (412) within the sheath in order to deploy a fluid from the capsule ([0018]; [0021]).
Regarding claim 2, Moulis discloses wherein each of the plurality of members (412) includes a proximal portion and a distal portion (Figs. 4A-4B), wherein the distal portions of the plurality of members extend approximately parallel to one another (as adjacent hooks at the distal ends of 412 are parallel to each other.
Regarding claim 3, Moulis discloses wherein the proximal portion of each of the plurality of members (412) extends radially outward in a distal direction (Fig. 4A).
Regarding claim 4, Moulis discloses wherein each member of the plurality of members includes a wire (support wires; [0021]).
Regarding claim 5, Moulis discloses wherein, in a configuration in which the capsule (408) is received by the plurality of members (Fig. 4B), distalmost ends of the plurality of members (hooks at ends of 412) are proximal of a distalmost end of the capsule (as 408 extends into mesh or net 411 which is distal of hooks; Fig. 4B).
Regarding claim 7, Moulis discloses wherein the fluid is a first fluid (liquid; [0018]), wherein the capsule is configured to further contain a second fluid (as 408 may also contain air, which is a fluid).
Regarding claim 8, Moulis discloses a handle (Fig. 4A) having an actuator (handle stock 106) configured to move the actuation wire (109) proximally as 412 is extended and retracted based on pushing the handle stock 106 into or out of the handle base 103; [0018]).
Regarding claim 16, Moulis discloses a medical system (Figs. 1A-1D) comprising: a medical device (embodiment 100), including: a sheath (elongate portion of catheter 100); an actuation wire (mechanical interlink 109) extending through the sheath and movable relative to the sheath (extending and retracting of the retractable basket 112 is effectuated by a mechanical interlink 109 disposed within the catheter 100 which is attached to or integrated with the retractable basket; [0018]); and a grasping portion (interpreted under 112(f) as a plurality of expandable members and equivalents thereof, and Moulis discloses a plurality of expandable members that make up retractable basket 112) affixed to a distal end of the actuation wire (Fig. 1B); and a capsule (squeezable material 108) removably received by the grasping portion (Fig. 1A), wherein proximal movement of the actuation wire (109) is configured to move at least a proximal portion of the grasping portion (112) and a proximal portion of the capsule within the sheath in order to deploy a fluid from the capsule (as 112 is retractable into the catheter via pulling 106; [0018]).
Regarding claim 17, Moulis discloses wherein the grasping portion (112) comprises a plurality of members (wires of basket 112) surrounding the capsule (Fig. 1B).
Regarding claim 18, Moulis discloses wherein the capsule (108) includes a cylindrical central portion and two tapered end portions (Figs. 1A-1D).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moulis (US 2005/0025798 A1) in view of Preston et al. (US 2017/0014639 A1).
Regarding claim 6, Moulis discloses wherein the plurality of members (412) are flexible ([0021]), but fails to explicitly disclose wherein the plurality of members have a shape-memory property.
However, Preston teaches a medical device (Figs. 25a, 25b) comprising an actuation wire (proximal end of choke cord) and a grasping portion (distal end of choke cord within the cord channel 234; [0186]) configured to receive a capsule (inner line 152), wherein proximal movement of the actuation wire is configured to squeeze the capsule in order to deploy a fluid from the capsule (Figs. 25a, 25b), wherein the grasping portion is made of a wire with a shape-memory property (as the choke cord and loops can be made all or partially from a resilient material e.g., Nitinol, which is a shape-memory material; [0189]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of members of Moulis to be made of nitinol, i.e., have a shape-memory property as taught by Preston, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moulis (US 2005/0025798 A1).
Regarding claim 9, Moulis fails to explicitly disclose wherein, in a first configuration (extended; Fig. 4A), a distalmost end of the actuation wire (109) is distal to a distalmost end of the sheath (101).
However, Moulis teaches an alternative embodiment (Figs. 2A-2C) wherein a distalmost end of the actuation wire is distal to a distalmost end of the sheath (see annotated Fig. 2A below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distalmost end of the actuation wire of Moulis to be distal to a distalmost end of the sheath in the first configuration as taught by Moulis. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of allowing the actuation wire to extend and retract relative to the sheath.
Regarding claim 10, Moulis modified discloses wherein, in the first configuration (Fig. 4A), proximalmost ends of the plurality of members are distal to the distalmost end of the sheath (as the proximalmost ends of 412 are attached to the distalmost end of the actuating wire 109 which is distal to the sheath in modified Moulis, as discussed above with respect to claim 9).
Regarding claim 11, Moulis modified discloses the invention as claimed above, and Moulis further discloses wherein, in a second configuration (retracted), a distalmost end of the actuation wire (109) and proximalmost ends of the plurality of members (412) are proximal to the distalmost end of the sheath (as 412 is retracted into 101).
Claim(s) 12 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moulis (US 2005/0025798 A1) in view of Fischell et al. (US 2023/0088977 A1).
Regarding claim 12, Moulis fails to disclose wherein the sheath includes a coil.
However, Fischell teaches a medical device (catheter extension system 100”; Fig. 11) comprising: a capsule (balloon member 144’) configured to deploy a fluid (thrombolytic/saline infusion) and a sheath (sheath 170 of outer catheter 110; Fig. 11) that includes a coil ([0121]-[0122]) to increase flexibility thereto required for a retraction of an actuation member (inner catheter 108) relative to the sheath (170) during the procedure ([0120]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath of Moulis to include a coil as taught by Fischell in order to increase flexibility while reinforcing the tubular member of the sheath.
Regarding claim 19, Moulis discloses a medical device (embodiment 400 which may be used with a liquid delivery catheter, such as that described in Fig. 1; Figs. 4A-4C; [0021]), comprising: a handle (Fig. 4A), including an actuator (handle stock 106); a shaft (elongated body 101) extending from the handle (Fig. 4A), the shaft comprising a wire (mechanical interlink 109) disposed within the shaft (Fig. 1A), wherein the wire (109) may translate along a longitudinal axis relative to the shaft based on actuation of the actuator (as the extending and retracting of support wires 412 is effectuated by mechanical interlink 109; Figs. 1A-1D; [0018]); and a grasping portion (interpreted under 112(f) as a plurality of expandable members and equivalents thereof, and Moulis discloses a plurality of expandable support wires 412) affixed to a distal end of the wire and configured to removably receive a capsule (as squeezable material 408 is not affixed to wires 412), wherein actuation of the actuator (109) transitions the grasping portion from a first configuration (extended) to a second configuration (retracted), wherein, in the second configuration, the distalmost end of the wire and the proximalmost end of the grasping portion are proximal to the proximalmost end of the shaft (as 412 is retracted into 101; [0018]).
Moulis fails to explicitly discloses wherein, in the first configuration, a distalmost end of the wire and a proximalmost end of the grasping portion are distal to a distalmost end of the coil and wherein the shaft comprises a coil.
However, Moulis teaches an alternative embodiment (Figs. 2A-2C) wherein a distalmost end of the actuation wire is distal to a distalmost end of the sheath (see annotated Fig. 2A below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distalmost end of the actuation wire of Moulis to be distal to a distalmost end of the sheath in the first configuration as taught by Moulis. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of allowing the actuation wire to extend and retract relative to the sheath.
Modified Moulis fails to disclose wherein the shaft comprises a coil.
However, Fischell teaches a medical device (catheter extension system 100”; Fig. 11) comprising: a capsule (balloon member 144’) configured to deploy a fluid (thrombolytic/saline infusion) and a sheath (sheath 170 of outer catheter 110; Fig. 11) that includes a coil ([0121]-[0122]) to increase flexibility thereto required for a retraction of an actuation member (inner catheter 108) relative to the sheath (170) during the procedure ([0120]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath of modified Moulis to include a coil as taught by Fischell in order to increase flexibility while reinforcing the tubular member of the sheath.
Regarding claim 20, Moulis modified discloses the invention as claimed above, and Moulis further discloses wherein, in the second configuration (retracted), a volume of the capsule (408) is smaller than in the first configuration (as 408 is squeezed as 412 is retracted within 101; [0018]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fox et al. (US 2018/0093079 A1) is noted for teaching a grasping portion that collapses a capsule (Figs. 3A-3C). Smith et al. (US 2017/0274189 A1) is noted for teaching a sheath that squeezes fluid from a capsule. Weber (US 2011/0054443 A1) is noted for teaching a grasping portion with a plurality of members axially aligned (Figs. 5-7). Shannon (US 2002/0183777 A1) is noted for teaching a grasping portion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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