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 .
Priority
This application claims priority from provisional application 63/300,810, filed 01/19/2022.
Status of Claims
Claims 1 and 3-20 are pending.
Claim 2 has been cancelled.
Information Disclosure Statement
The Information Disclosure Statements filed on 03/11/2026 and 05/27/2026 have been considered by the examiner.
Drawings
The previous drawing objections have been withdrawn in view of the applicant’s amendments.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the gap that couples the first and second segments (see 112 rejection below for more details) and a circumferential gap extending entirely around a circumference of the elongated tubular member (the applicant’s disclosure refers to Figures 12 and 12A to show the gap, but there is a zigzag portion filling and preventing the gap from extending entirely around the circumference) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke § 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke § 112(f) except as otherwise indicated in an Office action.
Claim Objections
Claim 18 is objected to because it appears to have a typo. The examiner believes the applicant intended for lines 3-4 to be addressing the recently defined 5th and 6th plurality of filaments and not the 1st and 2nd pluralities defined in claim 14. Clarification is required.
Claim 20 is objected to for repeating the same clause two times. Lines 2-3 clearly define the first and second plurality of filaments and require them to extend in first and second helical directions. However, Claim 20 then repeats the same requirement again in lines 3-4. The applicant is advised to delete the second recitation of these limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 is rendered indefinite because of antecedent basis issues. Line 5 introduces “a plurality of cells arranged in rows”, but this limitation was already defined in claim 19, from which it depends. The applicant is advised to amend the claim to say “the plurality of cells arranged in rows”. Additionally, the claim goes on to require the first and second plurality of filaments are cut away to disrupt the cells. However, the cut away filaments are already defined in claim 19, from which it depends. The applicant is advised to amend the claim to say that “the one or more rows that are cut away to disrupt the cells are part of the first and second plurality of cells”.
Claim 21 is rendered indefinite by the requirement for the first and second segments to be coupled together via a circumferential gap extending entirely around the circumference. It seems logical that a gap between segments can increase flexibility, but it is unclear how a gap can couple the two segments together. A gap is a break or space between two objects. A gap cannot provide any structural support or attach to any object. The gap is an absence of structure. Therefore, it is unclear how a gap can be considered to couple the two segments together.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 is considered to be an improper dependent claim because it fails to further limit the claims from which it depends. Specifically, Claim 13 requires the segments to be formed by disrupting all of the cells within a row of cells. However, claim 13 depends upon claim 8 which depends upon claim 7. Claim 7 recites the same requirement in slightly different wording. Both claims 7 and 13 define the two segments to be separated by the row of cells which include only disrupted cells. There are no other structural limitations or modification within claim 13 that are not already provided for in claim 7.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 3-7, and 14-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clerc et al (Clerc) USPN 6,860,900 B2.
1. Clerc discloses a stent (210 Figure 5), comprising:
an elongated tubular member expandable from a radially collapsed configuration to a radially expanded configuration (6:31-33), the elongate tubular member comprising a first plurality of filaments extending in a first helical direction and a second plurality of filaments extending in a second helical direction (236 extending up to the right and up to the left), the first plurality of filaments and the second plurality of filaments being interwoven to form a braid such that the first plurality of filaments extending in the first helical direction and the second plurality of filaments extending in the second helical direction extend over and under each other (6:31-33) to form a plurality of cells (diamond shaped opening) arranged in a plurality of rows extending circumferentially about the elongated tubular member (Figure 5);
wherein portions of at least some of the first plurality of filaments and portions of at least some of the second plurality of filaments within one or more rows of the plurality of rows are cut away to disrupt at least some of the cells (Section 232 Figure 5 6:33-36), thereby increasing flexibility of the stent (a section with less filaments is inherently more flexible than a more dense section), and
wherein the stent is braided and annealed to set a remembered shape prior to cutting away portions of the filaments. (Claim limitations directed at the annealing, braiding, and cutting steps for making the stent amounts to product by process limitations. The current set of claims are directed at the final product and not a method of making the device. Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. Product by process claims are not construed as being limited to the product formed by the specific process recited. In this case the stent of Clerc is fully capable of being braided and annealed prior to cutting the filaments because it would result in the same final structure.)
3. Clerc discloses at least some of the plurality of cells have a generally diamond shape having four sides formed by a pair of filaments of the first plurality of filaments extending in the first helical direction and a pair of filaments of the second plurality of filaments extending in the second helical direction (Figure 5).
4. Clerc discloses a disrupted cell comprises a cell that has had at least one of the four sides of the generally diamond shape removed (see section 232 Figure 5).
5. Clerc discloses the stent further comprises a polymeric covering (450 7:32-46) extending along the elongate tubular member.
6. Clerc discloses one or more rows of cells include at least one intact cell and a plurality of disrupted cells (see bottom row of section 232 Figure 5).
7. Clerc discloses one or more rows of cells include only disrupted cells (see intermediate rows of section 232 Figure 5), thereby separating the elongate tubular member into two or more distinct segments (203 234 Figure 5).
14. Clerc discloses a braided stent (210 Figure 5 6:31-33), comprising
an elongated tubular member (210 Figure 5) expandable from a radially collapsed configuration to a radially expanded configuration (6:31-33), the elongate tubular member including:
a first segment 234 comprising a first plurality of filaments extending in a left to right helical direction (filaments moving up to the right in Figure 5) and a second plurality of filaments extending in a right to left helical direction (filaments moving up to the left in Figure 5), the first plurality of filaments and the second plurality of filaments being interwoven to form a braid such that the first plurality of filaments and the second plurality of filaments extend over and under each other (6:31-33), the first plurality of filaments and the second plurality of filaments together forming a first plurality of cells arranged in rows extending circumferentially about the first segment (diamond shaped openings within 234 of Figure 5); and
a second segment 230 comprising a third plurality of filaments extending in the left to right helical direction (filaments moving up to the right in Figure 5) and a fourth plurality of filaments extending in the right to left helical direction (filaments moving up to the right in Figure 5), the third plurality of filaments and the fourth plurality of filaments being interwoven to form a braid such that the third plurality of filaments and the fourth plurality of filaments extend over and under each other (6:31-33), the third plurality of filaments and the fourth plurality of filaments together forming a second plurality of cells arranged in rows extending circumferentially about the second segment (diamond shaped openings within 230 of Figure 5);
wherein the first segment and the second segment are coupled together in a manner that provides the braided stent with increased flexibility (a section with less filaments is inherently more flexible than a more dense section);
wherein portions of at least some of the first plurality of filaments and portions of at least some of the second plurality of filaments within one or more rows of the first segment are cut away to disrupt at least some of the cells (6:33-36), thereby increasing flexibility of the stent (a section with less filaments is inherently more flexible than a more dense section), and wherein the stent is braided and annealed to set a remembered shape prior to cutting away portions of the filaments (see explanation within claim 4).
15. Clerc discloses the first segment and the second segment are coupled together by having one or more of the third plurality of filaments being extensions of one or more of the first plurality of filaments and/or by having one or more of the fourth plurality of filaments being extensions of one or more of the second plurality of filaments (all of the filaments of sections 234 and 230 extend into section 230 to be connected forming extension from the pluralities to each other).
16. Clerc discloses the first segment and the second segment are coupled together by a continuous polymeric layer that extends over at least part of the first segment and at least part of the second segment (Clerc discloses the cover can be in a variety of configurations including one that covers both the upper and lower segments as shown in Figure 13 that is made from a polymer 7:32-46).
17. Clerc discloses the first segment 234 has a first end having a plurality of cells within a first terminal row (upper row of 234 Figure 5); the second segment 230 has a second end having a plurality of cells within a second terminal row (lower row of 234 Figure 5); and the first segment and the second segment are coupled together via a fixation element (section 232 Figure 5) woven between the plurality of cells within the first terminal row and the plurality of cells within the second terminal row (Figure 5).
18. Clerc discloses comprising a third segment (upper half of the rows of section 230) comprising a fifth plurality of filaments extending in a left to right helical direction (filaments moving up to the right in Figure 5) and a sixth plurality of filaments extending in a right to left helical direction (filaments moving up to the left in Figure 5),
the first plurality of filaments and the second plurality of filaments together forming a first plurality of cells arranged in rows extending circumferentially about the first segment (see claim 14 for explanation and the claim objection);
wherein the second segment and the third segment are coupled are coupled together in a manner that provides the braided stent with increased flexibility (the claims does not compare what the flexibility needs to be increased relative to, since the filaments are all braided and not welded they inherently have increased flexibility compared to a laser cut tubular stent).
19. Clerc discloses a braided stent (210 Figure 5 6:31-33), comprising:
an elongated tubular member (Figure 5) expandable from a radially collapsed configuration to a radially expanded configuration (6:31-33), the elongated tubular member being formed by a plurality of interwoven filaments forming a braided structure (6:31-33), the elongated tubular member comprising a plurality of cells arranged in rows that extend circumferentially about the elongated tubular member (diamond shaped openings Figure 5);
wherein at least some of the plurality of cells are adapted to increase flexibility of the stent (the cells with removed walls and larger openings are more flexible than fully supported smaller cells), wherein portions of at least some of the plurality of interwoven filaments within one or more rows are cut away to disrupt at least some of the cells (6:33-36), thereby increasing flexibility of the stent (a section with less filaments is inherently more flexible than a more dense section), and wherein the stent is braided and annealed to set a remembered shape prior to cutting away portions of the filaments (see explanation within claim 4).
20. Clerc discloses the elongated tubular member comprises
a first plurality of filaments extending in a first helical direction (struts extending up to the left in Figure 5) and a second plurality of filaments extending in a second helical direction (struts extending up to the right in Figure 5), the first plurality of filaments extending in the first helical direction and the second plurality of filaments extending in the second helical direction overlapping to form a plurality of cells (diamond shaped openings Figure 5) arranged in rows extending circumferentially about the elongated tubular member (Figure 5);
wherein at least some of the first plurality of filaments and at least some of the second plurality of filaments within one or more rows of the plurality of rows are cut away to disrupt at least some of the cells (6:33-36), thereby increasing flexibility of the stent (a section with less filaments is inherently more flexible than a more dense section).
21. Clerc discloses the first segment and the second segment are coupled together via a circumferential gap extending entirely around a circumference of the elongated tubular member in a manner that provides the braided stent with increased flexibility (In view of the 112 rejection and drawing objections, the stent of Clerc reads on this recitation in the same manner as the applicant’s own invention, [0128] and [0130] of the applicant’s disclosure describe the gap as the space between the segments but filled with the zigzag shaped filament, accordingly the upper and lower segments 234/230 of Clerc are spaced apart by a gap section 232 filled by filaments shown in Figure 5).
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.
Claim(s) 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clerc et al (Clerc) USPN 6,860,900 B2 in further view of Richter (US 8382821 B2).
Clerc discloses a first segment 234 of the two or more distinct segments has a first end having a plurality of cells within a first terminal row (upper most row of 234 Figure 5); a second segment 230 of the two or more distinct segments has a second end having a plurality of cells within a second terminal row (lower most row of 230 Figure 5)
However, Clerc fails to teach the rotated nested terminal rows.
Richter teaches an expandable filament stent (abstract) wherein the second segment (fig 7, 2nd row) is rotated relative to the first segment (fig 7, 1st row) in the same field of endeavor such that the plurality of cells within the first terminal row (peaks, incomplete cells) nest (see fig 7) between the plurality of cells within the second terminal row (valleys, incomplete cells) allowing for better coverage and better contraction in the compressed state.
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 device of Clerc by rotating the terminal end connection of the second segment thereby forming a nested connection, as taught by Richter, in order to allowing for better coverage and better contraction in the compressed state.
9. 10. Clerc discloses a first segment of the two or more distinct segments have a first braiding pattern and a second segment of the two or more distinct segments have a second braiding pattern that is different from the first braiding pattern (5:47-65 disclose that the anchor section can have its braid patterns modified with different braid angles compared to the other segments in order to increase or decrease anchoring support).
11. 12. Clerc discloses the two or more distinct segments are joined together via a fixation element comprising a filament woven between adjacent segments (236 of section 232 in Figure 5).
13. Clerc discloses the two or more distinct segments are formed by disrupting all of the cells within a row of cells (Middle row of section 232 in Figure 5).
Response to Arguments
As explained above, it is noted that the claim limitations directed at the steps the applicant’s intends to follow for making the stent amounts to product by process limitations. The current set of claims are directed at the final product and not a method of making the device. Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. Product by process claims are not construed as being limited to the product formed by the specific process recited. Prior art stents go back to at least the 1990s that disclose forming by laser cuts or braiding/weaving (5,843,172).
However, in order to promote compact prosecution, the examiner has incorporated the teachings of Clerc who specifically discloses the braiding in combination with removing portions.
Applicant's arguments filed 02/24/2026 have been fully considered but they are not persuasive. The applicant’s arguments are focused on the braiding/weaving nature of the stent. This argument is not persuasive because the rejection has been modified to include Clerc as the base reference. Rafter is still relied upon for the nesting configuration, but the base reference for all claim rejections has been changed..
Additionally, it is noted that all helical shaped filaments extend both left to right and right to left. There is no single flow or direction because the extension depends upon the starting and stopping points of the viewer.
Conclusion
THIS ACTION IS MADE FINAL. 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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
