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 .
Response to Amendment
This action is in response to the preliminary amendment filed on 8/13/2024. In the amendment, claims 5-8 have been amended.
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: ‘connection member’ in claim 7.
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.
Claims 1-3 & 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hebert et al. (US Pub. No. 2020/0138422 A1).
Regarding claim 1, Hebert et al. disclose an intravascular indwelling medical device 630 (Fig. 32) that dwells within a blood vessel to occlude the blood vessel, the intravascular indwelling medical device comprising: a mesh-form main body part 634 (Fig. 32); and a water-absorbing swelling material 633 (Fig. 32; paragraph [0212]) that is disposed within the main body part 634 and swells upon absorbing water (inner textile structure features described in paragraph [0206] as being absorbent, it is considered that if the textile structure is capable of absorbing blood, it would be capable of absorbing water since blood contains water).
Regarding claim 2, Hebert et al. further disclose wherein the water-absorbing swelling material 633 is fixed to each of a distal end part and a proximal end part of the main body part 634 (‘633’ is described in paragraph [0212] as being attached to marker bands 638, 639 which are attached to distal and proximal end parts of the main body part 634 - Fig. 32).
Regarding claim 3, Hebert et al. further disclose wherein the water-absorbing swelling material 633 is formed in a shape in which a wire is wound in a coil shape (it is disclosed in paragraph [0212] that inner member 632 (which 633 is part of), can have a tubular member attached to a coil as described in paragraph [0211]), one end of the wire is fixed to the distal end part of the main body part, and the other end of the wire is fixed to the proximal end part of the main body part (since the inner textile member 633 is intended to be attached at the proximal and distal end parts of the main body part 634 via marker bands 638, 639, it is considered that the shape option described would not change this arrangement).
Regarding claim 8, Hebert et al. further disclose wherein a marker member 639 (Fig. 32) is provided at the distal end part of the main body part 634, and the water-absorbing swelling material 633 is fixed to the distal end part of the main body part by being fixed to the marker member 639 (‘633’ is described in paragraph [0212] as being attached to marker bands 638, 639 which are attached to distal and proximal end parts of the main body part 634 - Fig. 32).
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.
Claims 5 & 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hebert et al. (US Pub. No. 2020/0138422 A1) in view of Naoko et al. (JP 2009261496 A).
Regarding claim 5, Hebert et al. fail to disclose wherein the wire 633 is formed of a water-absorbent polymer. Rather, Hebert et al. disclose that the wire 633 is formed of an absorbent porous yarn (paragraph [0114]). However, Naoko et al. teaches a similar embolic wire coil device wherein the absorbent material is a water-absorbent polymer. It would have been obvious to one having ordinary skill in the art at the time the invention was made to substitute the water absorbent polymer for the absorbent porous yarn, for the purpose of absorbing blood within the target site, 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.
Regarding claim 6, Hebert et al. further discloses wherein the wire is formed of a metal wire (as discussed in paragraph [0212] the inner member 632/633 can have a tubular member attached to a coil as described above - it is discussed in above paragraph [0208] that the internal member of the tubular member is in the form of a radiopaque coil - since many radiopaque materials include metals, as discussed throughout, it is considered that the radiopaque coil covers the claim element ‘metal wire’). Hebert et al. fails to further disclose wherein the tubular element that covers the radiopaque coil is made of a water absorbent polymer. Rather, Hebert et al. disclose that the tubular member 633 is formed of an absorbent porous yarn (paragraph [0114]). However, Naoko et al. teaches a similar embolic wire coil device wherein the absorbent material is a water-absorbent polymer. It would have been obvious to one having ordinary skill in the art at the time the invention was made to substitute the water absorbent polymer for the absorbent porous yarn, for the purpose of absorbing blood within the target site, 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.
11. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hebert et al. (US Pub. No. 2020/0138422 A1).
Regarding claim 7, Hebert et al. fails to explicitly disclose wherein a connection member for connecting the intravascular indwelling medical device to a pusher wire is provided at the proximal end part of the main body part, and the water-absorbing swelling material is fixed to the proximal end part of the main body part by being fixed to the connection member in the embodiment of Figure 32. However, Hebert does discuss in paragraph [0149] that the radiopaque bands are mated with the delivery wire and pusher catheter to control linear movement of the indwelling device (micrograft). Connections to the pusher catheter are shown in earlier embodiments. It is considered that since the water-absorbing swelling material 633 is attached to a radiopaque band/marker band 638 at the proximal end of the main body part 634, one of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that the marker band 638 could be used to connect the device to a pusher wire as disclosed in earlier embodiments and paragraph [0149]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the disclosure of Hebert et al. to come to the arrangement in Fig. 32’s embodiment to make marker band 638 a radiopaque band that mates with the pusher catheter (as suggested in paragraph [0149]).
Allowable Subject Matter
Claim 4 is 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to explicitly disclose, teach, or suggest wherein the main body part is formed in a hollow cylindrical shape, and in a case where an outer diameter of the main body part in a natural state is denoted by D and a distance from an axis of the water-absorbing swelling material having a coil shape to a center line extending in a spiral shape of the wire is denoted by L, 0.25D < L <0.41D is satisfied.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 November 25, 2025