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 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.
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: “tension member” in claims 1, 15, 16, 22 and 27; “proximal locking portion” in claim 1; “pulling member” in claim 22; “connection element” in claim 22; “mating connection element” in claim 22.
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 § 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.
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.
Claims 1-3, 5, 9-12, 14-18, 22, 27, 28, 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 2021/0121183).
Regarding claim 1, Sharma discloses a vascular occluder (Figure 6A; Abstract), comprising: an occluder body (605) extending longitudinally between an occluder body distal end (distal end of 616) and an occluder body proximal end (at the distal end of 613), the occluder body comprising a proximal tubular body segment (e.g. from folded perimeter to “605” in configuration 603 in Figure 6A or whatever portion will invert - see obviousness statement below; the body segments can be arbitrarily designated) and a distal tubular body segment (e.g. from folded perimeter to any point distally thereof in configuration 603 - e.g. to point at “Wire Mesh”), and wherein the occluder body is elastically compressible (¶[0106]; a shape memory nitinol braid being readable by this limitation - ¶[0178] of Applicant’s disclosure) longitudinally from a preliminary deployed configuration (602) to a compressed deployed configuration (603; Figure 6A; ¶[0103]), and wherein the occluder body reduces gradually in diameter in a direction from the occluder body proximal end to the occlude body distal end when in the preliminary deployed configuration (see tapered section beginning at “620” in Figure 6A; the claim does not require the diameter to gradually reduce along the entire length of the occluder, nor does Applicant’s diameter; the claim only requires the diameter to gradually reduce for some length --along the claimed direction--) and a tension member (610 - Figure 6A or 615 as shown in Figure 6C; interpreted under 35 U.S.C. 112(f) as equivalent to Applicant’s tension member 106) coupled to the occluder body distal end; a proximal locking portion (613; interpreted under 35 U.S.C. 112(f) as equivalent to Applicant’s proximal locking portion 111) coupled to the occluder body proximal end and configured to engage the tension member to tether the occluder body proximal end to the occluder body distal end when the occluder body is in the compressed deployed configuration (Figure 6A; ¶[0108] [0112]).
Sharma fails to explicitly disclose that the proximal locking portion is located inside of a more distal section of the occluder body (or distal tubular body segment) when in the compressed deployed configuration. However Sharma discloses that the embodiment of Figure 6A assumes a shape of an umbrella when in the compressed deployed configuration (¶[0103]). Sharma discloses numerous times that the umbrella-shaped embodiments have an “inverted bowl” shape at the proximal end (¶[0089], [0090], [0095]-[0097]). Sharma also appears to depict the occluder in Figure 6A with a concave-shaped proximal end.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the umbrella-shaped occluder of Figure 6A with an inverted bowl configuration at its proximal end as this is the only specific guidance given by Sharma for making an umbrella-shaped occluder. Furthermore, one skilled in the art would find it obvious that some amount of inversion of the proximal end would likely be necessary in order to connect to the proximal end of the “rigid” (¶[0103]) tension member which is shown as being deep within the conical distal section in Figure 6A. With this modification, the proximal locking portion an some portion of the occluder (i.e. proximal tubular body segment) would have to be within some more distal portion of the occluder which can be designated as part of the distal tubular body segment.
Regarding claim 2, a proximal occluding section (portion of mesh 605 proximal to anchors 655) extends between the occluder body proximal end and the proximal tubular body segment, and/or a distal occluding section (e.g. from “Wire Mesh 605” to distal end in configuration 601) extends between the occluder body distal end and the distal tubular body segment, configured to cover and/or at least partially occlude most or all cross-sectional area of a passage, when the occluder body is in the compressed deployed configuration.
Regarding claim 3, the proximal occluding section and/or the distal occluding section includes a meshed, braided and/or porous pattern and/or material across most or all area thereof, configured to reduce flow velocity, and/or to prevent localized increase of flow velocity, of blood passing therethrough, when the occluder body is in the compressed deployed configuration (evident from ¶[0103] and Figure 6A).
Regarding claim 5, when the occluder body changes from the preliminary deployed configuration to the compressed deployed configuration, the proximal tubular body segment gradually and continuously (gradual deployment can be created by gradually pulling the tension member toward 613) becomes inserted into, and/or inwardly folded into, and/or tucked in, and/or stuffs, the distal tubular body segment, thereby forcing the distal tubular body segment to expand radially and/or to reshape elastically (evident from ¶[0112] and “umbrella” - ¶[0103]; if some amount of “forcing” did not occur, the phalanges 630 would not need to be pulled through 613).
Regarding claim 9, the occluder body includes a portion between the occluder body proximal end and the distal tubular body segment comprising a crease and/or configured to facilitate a predetermined fold location and/or folding pattern when the proximal tubular body segment is pushed to advance towards the distal tubular body segment (the crease forming the widest perimeter in configuration 603 would begin to form before configuration 603 is fully achieved; this could occur as 613 is being pushed distally as claimed).
Regarding claim 10, the proximal tubular body segment is greater in average diameter than the distal tubular body segment, when the occluder body is in the preliminary deployed configuration (evident from Figure 6A, noting that the distal body segment could include the entire conical portion including all of the narrow diameter sections therealong - which would reduce its average diameter to below that of the proximal body segment).
Regarding claim 11, the proximal tubular body segment is greater in diameter than the distal tubular body segment along most or (of the) length thereof (length thereof the distal tubular body segment - the distal tubular body segment including the entire conical portion), when the occluder body is in the preliminary deployed configuration.
Regarding claim 12, a proximal portion of the proximal tubular body segment when the occluder body is in the preliminary deployed configuration, is configured to engage a distal portion of the distal tubular body segment when the occluder body is in the compressed deployed configuration (at least some portions around “605” in configuration 603 would engage longitudinally opposite portions of the distal tubular body segment - which could be at a distal portion of the distal tubular body segment if so designated).
Regarding claim 14, at least part of the occluder body is cone-like shaped when in the preliminary deployed configuration (evident from Figure 6A) and is dome-like shaped when in the compressed deployed configuration (portion surrounding/adjacent to 613 is dome-like shaped in configuration 603).
Regarding claim 15, the occluder body covers an entire length of the tension member when in the compressed deployed configuration (the tension member can be considered as the portion of 615 proximal to threads 670 and within the cone - Figure 6C).
Regarding claim 16, the tension member is fixated with a tension member distal end thereof to the occluder body distal end (¶[0103]; 616 is fixed to 610 and/or 615).
Regarding claim 17, the occluder body, when in the compressed deployed configuration, is configured to apply pressure to a wall portion enclosing a passage, thereby generating radial stress and/or friction sufficient for fixating the vascular occluder to the wall portion, wherein the passage is equal to or smaller in diameter than the occluder body when in the preliminary deployed configuration (evident from Figure 6A - the occluder could be deployed in a sufficiently narrow vessel such that the radial stress or friction occurs).
Regarding claim 18, a resistance to radial inward compression of the occluder body when changing from the preliminary deployed configuration to the compressed deployed configuration is increased by at least 10% (portions of the body would have two adjacent/contacting layers of mesh in the compressed deployed configuration, verses only one layer in the preliminary deployed configuration, thereby increasing the resistance to some directions of radial compression by at least 10%).
Regarding claim 22, a puling member (668; interpreted under 35 U.S.C. 112(f) as equivalent to Applicant’s pulling member 107) includes a connection element (669) at a distal end thereof configured to selectively connect to or disconnect from a mating connection element (670; interpreted under 35 U.S.C. 112(f) as equivalent to Applicant’s mating connection element 106C) provided at a proximal end of the tension member (Figure 6C).
Regarding claim 27, the proximal locking portion includes an inner surface configured to engage one or more motion resisting discrete recesses or protuberances emerging from a surface of tension member, and/OR to lock to the tension member by way of friction with an outer surface (the proximal surface of the phalanges 630 can be regarded as an outer surface thereof) of the tension member, so as to resist and/or prevent axial motion of the proximal locking portion relative to the tension member (¶[0108],[0112]).
Regarding claim 28, the occluder body is elastically stretchable longitudinally into a delivery configuration (601; Figure 6A; ¶[0106]; a shape memory nitinol braid being readable by this limitation - ¶[0178] of Applicant’s disclosure) having a delivery length and a delivery diameter, wherein the occluder body, when in the preliminary deployed configuration, has a preliminary deployed length smaller than the delivery length and a preliminary deployed diameter greater than the delivery diameter (evident from Figure 6A).
Regarding claim 32, the occluder body is at least partially meshed, woven and/or braided (¶[0103]).
Regarding claim 33, the occluder body is at least partially impermeable (membrane - ¶[0103]) and/or is covered or impregnated with an impermeable or hydrophilic substance or material.
Response to Arguments
Applicant's arguments filed December 22nd 2025 have been fully considered but they are not persuasive. Applicant has argued that the proximal portion of the Sharma occluder body is flat. It is respectively asserted that one of ordinary skill in the art would not take this view. The occluder is described as having an umbrella shape which is notoriously well-known as a shape having a concave proximal face. The proximal face is also depicted as being at least slightly concave in Figure 6A. All of the other embodiments described as umbrella-shaped are also described as having an “inverted bowl” shape at the proximal end (¶¶[0089], [0090], [0095]-[0097]). Furthermore, the proximal locking portion (613) must connect to the proximal end of the rigid tension member (610) which is shown being deep within the distal conical section. This alone would likely necessitate some amount of inversion of the proximal locking portion within the occluder body. As claimed, any portion of the occluder body which inverts within a more distal section can be regarded as the proximal tubular body segment. After inversion, the distal end of the proximal locking portion would be the most distally-located part of the inverted portion and would be within some section of the occluder body which can be regarded as part of the distal tubular body segment. It is noted that claim 1, as presently amended, does not require the proximal tubular body segment to provide structural support to the distal tubular body segment (although the inverted segment of Sharma would provide some structural support to the segment it is within). Applicant has argued that occluder body does not “[reduce] gradually in diameter from proximal to distal ends”. Claim 1 actually requires the occluder body to “[reduce] gradually in diameter in a direction from the occluder body proximal end to the occluder body distal end…”. This limitation only requires some length of the occluder body to gradually reduce in diameter in a direction which runs from the occluder body proximal end to the occluder body distal end. This is clearly shown by the conical portion of the occluder body in Sharma. For the above reasons, the pending claims are respectfully asserted to be obvious in view of Sharma.
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 Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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