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 application 16/214130, filed 12/9/2018
Status of Claims
Claims 1-11, 13, 14, 24-34, and 36-48 are pending.
Claims 3, 5, 8, 10, 25-28, and 38 have been withdrawn from consideration.
Claims 15-23 have been cancelled.
Election/Restrictions
Applicant’s election of Invention I (Combination) and Species 10 (Figures 7, 7A, and 8) in the reply filed on 05/31/2024 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 § 818.03(a)).
Upon further review claim 38 has been withdrawn as being directed at a non-elected embodiment because the elected embodiment has covers that fully encircle the stent body not partially encircle it.
Drawings
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, 2 capes that bother overlap each other (Claim 43, see 112 rejection below for further explanation) 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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 40-48 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 40 is considered to include new matter because of the recitation that the second ends move freely about the stent body. The elected embodiment has free ends that at most could flex toward and away from the stent body during bending of the stent body, but this is not the same as adapted to move freely about the stent body. The specification only describes the ends as free with respect to them being uncovered and shifting during bending of the stent. Moving freely as currently claimed would imply much greater range of motion and is beyond that of the original disclosure.
Claim 43 is considered to include new matter because it is describing the first cape as overlapping the second cape, which contradicts or is in addition to the recitation within claim 40 that the second cape overlaps the first cape. There is no support within the original disclosure for the elected embodiment to have 2 capes that both overlap each other.
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 1, 2, 4, 6, 7, 9, 11, 13, 14, 24, 29, 30, and 36-39 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 1 is rendered indefinite by the amendment requiring the first cover to be attached to the stent body “closer to the distal end of the stent body”. This appears to be an incomplete phrase. What is closer to the distal end than? Is it closer to the distal end than to the proximal end? Is it closer to the distal end than the other cover is? Does this require it to be in the distal end or attached at the distal end? Does it require the region to actually be spaced from the distal end but just close to it? A person of ordinary skill in the art would be unable to determine the actual scope of this limitation. Claim 1 is further rendered indefinite by similar language defining the free end of the third cover to be closer to the proximal end of the stent body. The same uncertainty and questions apply. The applicant is advised to replace these limitations with the wording of claim 39.
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 37 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 37 requires “the first cover and the second cover fully encircle the stent body.” However it depends upon claim 36 which already requires the first cover and the second cover to encircle the stent body. Encircle is generally understood to mean draw a circle around something. There is no possible way for the covers to partially encircle the stent body. Therefore claim 37 is adding the term fully but it does not further limit the claims because claim 36 already requires a full encircling.
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 § 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) 1, 2, 4, 6, 7, 9, 11, 24, 29-34, 36, 37, 39-41, 43-46, and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Behan US 2012/0310138 A1 in view of Dang et al (Dang) USPN 7,118,592 B1
1. Behan discloses the invention substantially as claimed being an intravascular stent (Figures 20-21) comprising:
a) a stent body (30) including proximal and distal ends (top and bottom of Figures 20-21) and a plurality of openings (diamond shaped cutouts);
b) a first cover (top flap 31) overlying the stent body (Figure 21) and including a first region (top of first flap) attached to the stent body closer to the distal end of the stent body ([0020] discloses the top end of the stent and sleeve are connected) and an unattached region (bottom flared portion of first flap) having a free end (outer most flared portion of first flap)
c) a second cover (second flap down) overlying the stent body (Figure 21) and including a first region (upper portion of second flap under the first flap) such that the first cover overlies the first region of the second cover (Figure 21) and an unattached region (bottom flared portion of second flap) having a free end exposed from the first cover (outer most flared portion of second flap);
d) a third cover (third flap down) overlying the stent body and including a first region (upper portion of third flap under the second flap) such that the second cover overlies the first region of the third cover (Figure 21) and an unattached region (bottom flared portion of third flap) having a free end exposed from the second cover (outer most flared portion of second flap) and positioned closer to the proximal end of the stent body (the third flap is lower than the other two making it inherently closer to the bottom proximal end)
However, Behan does not disclose if the first region of the second and third covers are attached to the stent body.
Dang teaches the use of stent comprising an inner stent body 10 and a plurality of layered graft covers including unattached free ends overlapping adjacent covers and attached regions sutured or adhesively bonded to the base stent (7:47-8:18 discloses that there can be additional covers and the attached/unattached configuration) in the same field of endeavor for the purpose of allowing the graft covers to have more maneuverability and adjustability during the stent expansion without fully dislodging.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the cover layers of Behan to include attachment regions connecting each covers first region to the stent body as taught by Dang in order to maintain the maneuverability of the sleeve segments during expansion and bending of the base stent and preventing them from dislodging and not covering any portion of the stent.
It is noted that the above modification in view of Dang applies to all claimed rejected under this heading.
2. Behan discloses the first cover overlaps the second cover such that less than a majority of the second cover is overlapped by the first cover (covers can be pulled to expand exposing the majority of adjacent covers shown moving from Figure 20 to Figure 21).
4. Behan discloses the free ends of the first and second covers are axially spaced (Figure 21).
6. Behan discloses the first cover and the second cover are attached to an outer wall of the stent body ([0275] discloses the cover is attached to outside of stent 30).
7. and 46. Behan discloses the intravascular stent is capable of being inserted into a body of a patient with the first and second stent covers attached to the stent body. (The claim recitations defining how and where the applicant’s invention is used are considered to be intended use limitations. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case the stent of Behan as modified is fully capable of being assembled and inserted while covers are attached).
9. 24. 36. and 37. Behan discloses the first and second covers extend around a full 360 degrees of the circumference thereby fully encircle the stent body (Figure 21).
11. Behan discloses the first and second covers are each attached to the stent body at an attachment site, and the first and second covers are expandable independent of the stent body except at the attachment site. (The covers of Behan are floating and fully capable of expanding radially independent of the stent.)
29 and 41. Behan discloses the first and second covers are impermeable to fluid (Behan discloses the sleeves are filled with fluid driving the expansion [0322], for the covers to expand they are inherently impermeable to fluid or the expansion would fail).
30. and 48. Behan discloses the stent body includes an open lumen extending continuously therethrough from a proximal end of the stent body to a distal end of the stent body (Behan discloses his stent has a main lumen shown in Figure 23 extending from end to end, a valve is placed therein, but the lumen still extends from proximal end to the distal end, additionally Behan discloses the valve may be removed [0073]).
31. Behan as modified by Dang discloses an intravascular stent (Figures 20-21) comprising:
a) a stent body (30);
b) a first cover (upper most flap 31) overlying the stent body and including a first end (top of first flap) connected to the stent body ([0020] discloses the top end of the stent and sleeve are connected) and a free second end (lower end of first flap); and
c) a second cover (second flap) overlying the stent body and including a first end connected to the stent body (top of second flap, see modification in view of Dang with respect to claim 1 above) and a free second end (bottom of second flap), wherein the first cover and the second cover are configured for independent movement in relation to the stent body such that connection of the first cover to the stent body does not affect movement of the second cover (by their very nature the free ends of pleats or flaps as disclosed by Behan and modified by Dang are capable of at least some movement that doesn’t affect the adjacent pleat or flap).
32. Behan discloses the second cover overlaps the first cover such that the first end of the second cover is positioned between the first end and the free second end of the first cover, when the intravascular stent is in a straight configuration before implantation (Figures 20-21 clearly show the straight configuration and the overlapping of the covers).
33. Behan discloses the first cover and the second cover are separate components of the intravascular stent (the covers of Behan are separate identifiable components, the applicant’s own invention is formed from multiple components all connected together to form a final product, therefore both the invention of Behan and the applicant’s own invention read upon the claimed separate components in the same manner).
34. Behan discloses the first cover is formed from a first piece of material, and the second cover is formed from a second, different piece of material (see explanation with respect to claim 1 above, this is considered to be product by process limitation and anticipated by the covers of Behan).
39. Behan discloses the first region of the first cover (top of upper most cover) is attached to the distal end of the stent body ([0020]), and the free end of the third cover (bottom of third cover from the top) is positioned adjacent to the proximal end of the stent body (the third flap is lower than the other two making it inherently closer to the bottom proximal end).
40. Behan as modified by Dang discloses an intravascular stent (Figures 20-21) comprising:
(a) a stent body (30) and at least two stent capes (upper most flap 31 and second flap 31) dimensioned to cover a portion of the stent body (Figure 21), the at least two stent capes extending parallel to the stent body (the flaps extend in a variety of directions including parallel to the stent body as shown in Figure 21);
(b) each of the at least two stent capes having a first end and a second end (top and bottom of each flap), wherein the first end and second end are parallel to a longitudinal axis of the stent body (the ends of each flap extend in a variety of directions including parallel to the stent body as shown in Figure 21), wherein a first stent cape of the at least two stent capes is attached to the stent body along an attachment segment (see modification in view of Dang with respect to claim 1, the resulting device has each cape attached to the stent body along an attachment segment);
(c) wherein the attachment segment is attached to an external surface of the stent body (Figure 21 shows the sleeve attached and extending only along the external surface of the stent body);
(d) wherein the second ends of the at least two stent capes are adapted to move freely about the stent body (Figure 21 shows the lower second ends of each flap are unattached and free to move);
(e) wherein the second ends of the at least two stent capes expand independently of the stent body and independently of each other upon deployment of the stent body (pleats and flaps as disclosed by Behan by their very nature have movement at the free end allowing them to expand independently of the stent body); and
(f) wherein the at least two stent capes are oriented circumferentially upon the stent body, wherein each of the at least two stent capes extend fully about a circumference of the stent body to cover a full circumference of the stent body (these three clauses require the same aspect which is that the capes extend around the full circumference of the stent body which is clearly shown in Figure 21), wherein a second stent cape of the at least two stent capes overlaps at least a portion of the first stent cape (Figure 21 clearly shows an upper or second flap overlapping a lower second flap).
43. In view of the 112 rejection above this claim is being interpreted as best understood as it applies to the elected embodiment. Behan as modified discloses the one cape overlapping another stent cape (Figure 21) such that less than a majority of the second stent cape is overlapped by the first stent cape (Behan does not specifically stent the overlap is less than a majority but depending upon the position and degree of curvature within the implant site the capes of Behan are fully capable of being configured so that the overlapping is less than a majority of the inner flap).
44. Behan discloses the second ends of the first stent cape and the second stent cape are axially spaced (lower ends of each flap in Figure 21).
45. Behan as modified discloses the first stent cape and the second stent cape are attached to an outer wall of the stent body (see modification in view of Dang with respect to claim 1 above).
Claim(s) 13, 14, and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Behan and Dang (Combination 1) as applied to claims 1, 2, 4, 6, 7, 9, 11, 24, 29-34, 36, 37, 39-41, 43-46, and 48 above, and further in view of Morris USPN 6,379,382 B1.
Combination 1 discloses the invention substantially as claimed being described above. However, Behan does not disclose the use of hydrogel adhered to the cover or stent.
Morris teaches that it is known in the art of stents and stent grafts “that one or more materials can comprise therapeutic agents … for example … hydrogels [0264] [0261] in the same field of endeavor for the purpose of promoting healing or pharmaceutical delivery.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the hydrogels with the stent and or the cover as taught by Morris in order to promote healing or pharmaceutical delivery.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Behan and Dang (Combination 1) as applied to claims 1, 2, 4, 6, 7, 9, 11, 24, 29-34, 36, 37, 39-41, 43-46, and 48 above, and further in view of Kagan US 2004/0092892 A1.
Combination 1 discloses the invention substantially as claimed being described above. However, Behan does not disclose the two stent capes are partially permeable.
Kagan teaches that it is known in the art of gastrointestinal implants for the outer sleeves to be partially permeable (Figure 12A [0021] lines 8-11 discloses the outer sleeve can be partially permeable) for purpose of allowing digestive secretions to enter but prevent solids from flowing out of the walls.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sleeve of Behan to be partially permeable as taught by Kagan in order to allow digestive secretions to enter but prevent solids from flowing out through the walls of the sleeve.
Response to Arguments
Applicant's arguments filed 03/31/2025 have been fully considered but they are not persuasive. The applicant arguments focus on the newly claimed requirement for each cape to be secured to the stent body. This is not persuasive because the prior art rejection has been amended to include the teachings of Dang which provide for covers to have their first ends attached to the stent body and free ends unattached to allow for movement of the stent during expansion which will not cause the covers to dislodge or uncover the adjacent stent body. The applicant further argues that movement of one of the pleats and flaps of Behan would directly influence movement o an adjacent overlapping flap. The applicant has not provided any factual evidence for this claim and it appears to contradict how flaps and pleats function as their base level. Pleats or flaps as disclosed by Behan comprise free floating ends which by their very nature can lift away from and move independently from the flap or pleat below them. Therefore the flaps of Behan as modified are inherently capable of this type of independent movement.
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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (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