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
Applicant’s election without traverse of Group I, claims 1-19 in the reply filed on 06/25/2026 is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/25/2026.
Claim Objections
Claims 7-9 and 16-18 are objected to because of the following informalities:
Claims 7-9 and 16-18 each recite in lines 2-3 “has distal outer diameter” and is suggested to read “has a distal outer diameter” for better grammar.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “reinforcing member” in claims 1 and 10.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-5, 7, 10-14, 16 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lenker et al. (US PGPub 2015/0359549), hereinafter known as “Lenker.”
With regards to claim 1, Lenker discloses (Figures 1-2, 4A-4B, and 20; although directed to different embodiments, paragraph 131 discloses “Although primarily described in the context of a an expandable distal segment aspiration catheter with a single central lumen, catheters of the present invention can readily be modified to incorporate additional structures, such as permanent or removable column strength enhancing mandrels, two or more lumen such as to permit drug or irrigant infusion or radiation delivery or to supply inflation media to an inflatable balloon, or combinations of these features, as will be readily apparent to one of skill in the art in view of the disclosure herein”) a delivery device 500 for an occlusive implant 602, the delivery device 500 comprising:
a delivery sheath 10/526 having a proximal region 33 and a distal tip region 34 (paragraph 134);
a reinforcing member (see Note below) extending along the proximal region 33 (paragraph 150);
wherein the distal tip region 34 has a grooved distal section (figures 4A and 4B; paragraphs 141 and 144), the grooved distal section 34 being configured to shift between a delivery configuration (figure 1) and an expanded configuration (figure 2);
a core member 812/818 slidably disposed within the delivery sheath 526 (paragraphs 209-210); and
an occlusive implant 602 releasably coupled to the core member 812/818 (paragraphs 209-210 - releasable via coupler 816).
Note – 112(f) interpretation – Applicant’s reinforcing member is a mesh, coil, braid formed therein, embedded therein, attached thereto, etc. along at least a portion of a length of the delivery sheath (spec. [0050]); Lenker’s reinforcing member is a metal or polymeric braid or other conventional reinforcing layer (paragraph 150 of Lenker); therefore both reinforcing members are equivalent in providing reinforcement and being a braid.
With regards to claim 2, Lenker discloses wherein the grooved distal section 34 is fluted (figure 4B; paragraph 144).
With regards to claim 3, Lenker discloses wherein the grooved distal section 34 includes one or more pleats (figure 4B; paragraph 144).
With regards to claim 4, Lenker discloses wherein the grooved distal section 34 includes one or more folds (figure 4A; paragraph 141).
With regards to claim 5, Lenker discloses wherein the grooved distal section 34 includes one or more folds when in the delivery configuration (figure 4A; paragraph 141).
With regards to claim 7, Lenker discloses wherein the proximal region 33 includes a proximal outer diameter and wherein the grooved distal section 34 has distal outer diameter that is substantially the same as or smaller than the proximal outer diameter when in the delivery configuration (figure 1 – distal section 34 has a smaller diameter than proximal region 33)
With regards to claim 10, Lenker discloses (Figures 1-2, 4A-4B, and 20; although directed to different embodiments, paragraph 131 discloses “Although primarily described in the context of a an expandable distal segment aspiration catheter with a single central lumen, catheters of the present invention can readily be modified to incorporate additional structures, such as permanent or removable column strength enhancing mandrels, two or more lumen such as to permit drug or irrigant infusion or radiation delivery or to supply inflation media to an inflatable balloon, or combinations of these features, as will be readily apparent to one of skill in the art in view of the disclosure herein”) a delivery device 500 for an occlusive implant 602, the delivery device 500 comprising:
a delivery sheath 10/526 having a proximal region 33 and a distal tip region 34 (paragraph 134);
wherein the distal tip region 34 includes a grooved distal section (figures 4A and 4B; paragraphs 141 and 144);
wherein the grooved distal section 34 is configured to allow the distal tip region 34 to shift between a delivery configuration (figure 1) and an expanded configuration (figure 2); and
a proximal reinforcing member (see Note below) disposed along the proximal region 33 (paragraph 150).
Note – 112(f) interpretation – Applicant’s reinforcing member is a mesh, coil, braid formed therein, embedded therein, attached thereto, etc. along at least a portion of a length of the delivery sheath (spec. [0050]); Lenker’s reinforcing member is a metal or polymeric braid or other conventional reinforcing layer (paragraph 150 of Lenker); therefore both reinforcing members are equivalent in providing reinforcement and being a braid.
With regards to claim 11, Lenker discloses wherein the grooved distal section 34 is fluted (figure 4B; paragraph 144).
With regards to claim 12, Lenker discloses wherein the grooved distal section 34 includes one or more pleats (figure 4B; paragraph 144).
With regards to claim 13, Lenker discloses wherein the grooved distal section 34 includes one or more folds (figure 4A; paragraph 141).
With regards to claim 14, Lenker discloses wherein the grooved distal section 34 includes one or more folds when in the delivery configuration (figure 4A; paragraph 141).
With regards to claim 16, Lenker discloses wherein the proximal region 33 includes a proximal outer diameter and wherein the grooved distal section 34 has distal outer diameter that is substantially the same as or smaller than the proximal outer diameter when in the delivery configuration (figure 1 – distal section 34 has a smaller diameter than proximal region 33)
With regards to claim 19, Lenker discloses further comprising a core member 812/818 slidably disposed within the delivery sheath 526 and an occlusive implant 602 releasably coupled to the core member 812/818 (paragraphs 209-210 - releasable via coupler 816).
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 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lenker in view of DeBeer et al. (US PGPub 2023/0068326), hereinafter known as “DeBeer.”
With regards to claims 6 and 15, Lenker discloses the delivery device as claimed in claims 1 and10, respectively. Lenker is silent wherein the grooved distal section includes one or more axial slits.
However, in a similar field of endeavor of delivery devices, DeBeer teaches (Figure 40A) wherein the distal section 1600 includes one or more axial slits 1675 (paragraph 279).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery device of Lenker to include wherein the distal section includes one or more axial slits as taught by DeBeer for the purpose of providing pressure release along an upper aspect of the device (paragraph 279 of DeBeer).
The combination of Lenker in view of DeBeer results in the grooved distal section (34 of Lenker) to include one or more axial slits (1675 of DeBeer).
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lenker in view of McConnell et al. (US PGPub 2021/0085924), hereinafter known as “McConnell.”
With regards to claims 8 and 17, Lenker discloses the delivery device as claimed in claims 1 and 10, respectively. Lenker is silent wherein the proximal region includes a proximal outer diameter and wherein the grooved distal section has distal outer diameter that is larger than the proximal outer diameter when in the delivery configuration.
However, in a similar field of endeavor of delivery devices, McConnell teaches (Figures 1-3 and 8-11) wherein the proximal region 128 includes a proximal outer diameter and wherein the grooved distal section 132 has distal outer diameter that is larger than the proximal outer diameter when in the delivery configuration (figures 3 and 9; paragraphs 89, 92 and 108 – diameter of 132 at the ridges 136a-136d is larger than the diameter of the proximal region 128).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery device of Lenker to include wherein the proximal region includes a proximal outer diameter and wherein the grooved distal section has distal outer diameter that is larger than the proximal outer diameter when in the delivery configuration as taught by McConnell for the purpose of increasing the tactility of the distal section and/or make the distal section easier to grip or handle (paragraph 86 of McConnell).
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lenker.
With regards to claims 9 and 18, Lenker discloses the delivery device as claimed in claims 1 and 10 with respect to the figures 1-2, 4A-4B, and 20 embodiment. Lenker is silent wherein the proximal region includes a proximal outer diameter and wherein the grooved distal section has distal outer diameter that is larger than the proximal outer diameter when in the expanded configuration.
However, Lenker teaches in the figures 45A-45B embodiment wherein the proximal region 4504 includes a proximal outer diameter (where window 4508 lies) and wherein the distal section 4506 has distal outer diameter that is larger than the proximal outer diameter when in the expanded configuration (figure 45B – in the expanded configuration of figure 45B, the distal section 4506 has a larger outer diameter than the outer diameter of the proximal region 4504 at the region where the window 4508 is).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery device of Lenker to include wherein the proximal region includes a proximal outer diameter and wherein the distal section has distal outer diameter that is larger than the proximal outer diameter when in the expanded configuration as taught by the figures 45A-45B embodiment of Lenker for the purpose of establishing fluid communication and perfusing downstream issues, thus relieving ischemia (paragraph 330 of Lenker).
The combination of Lenker results in the proximal region (33 of the figures 1-2 embodiment of Lenker) to include the window/port (4508 of the figure 45A-45B embodiment of Lenker) so that the grooved distal section (34 of the figures 1-2 and 4A-4B embodiment of Lenker) has distal outer diameter that is larger than the proximal outer diameter when in the expanded configuration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 07/10/2026
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