DETAILED ACTION
This office action is responsive to the amendment filed 6/6/2026. As directed, claims 1-4 and 6-9 have been amended and no claims have been added or canceled. Thus claims 1-10 are currently pending.
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 .
Drawings
The drawings are objected to because figs. 1A-6B lack reference numerals and fig. 1D appears to include more than one drawing figure.
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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Angel (9,433,738) in view of Cartledge (2013/0046373).
Regarding claims 1 and 6, Angel discloses an endotracheal (ET) device assembly comprising an expandable lattice (40) positioned around at a portion of the endotracheal tube circumference (bottom circumference of endotracheal tube 20; col. 13 lines 30-35), the lattice (40) comprising a plurality of longitudinal strips (i.e. lattice strips) connected at a plurality of pivot points (pivoting points for expansion) forming an expandable and retractable cylindrical lattice (col. 8 lines 24-35, col. 7 lines 63-67, figs. 1-3 disclose an expanding mesh like stent thereby including pivot points for expansion).
Angel substantially teaches the claimed invention except for wherein axial contraction of the lattice is able to result in radial expansion and axial elongation is able to result in radial contraction of the lattice. However, Cartledge teaches in figs. 43-53 a stent useable for the trachea ([0013]) including a first longitudinal strip (i.e. struts) and a second longitudinal strip (i.e. adjacent strut) are connected by a fastener (i.e. screw, rivet) ([0215] lines 1-15, [0216], [0218] lines 1-10) wherein axial contraction (fig. 48) of the lattice is able to result in radial expansion and axial elongation (figs. 49, 50) is able to result in radial contraction of the lattice. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have manufactured the stent of Angel with struts having fasteners in coincident holes enabling radial expansion and contraction as taught by Cartledge to provide the advantage of enhanced adjustability providing in situ accommodation to local anatomy as disclosed by Cartledge in [0019] and [0020]).
Regarding claims 2 and 7, The modified Angel discloses (see figs. 43-53 of Cartledge) a stent useable for the trachea ([0013]) including a first longitudinal strip (i.e. struts) and a second longitudinal strip (i.e. adjacent strut) are connected by a fastener (i.e. screw, rivet) passing through coincident holes formed in the first longitudinal strip and second longitudinal strip ([0215] lines 1-15, [0216], [0218] lines 1-10 of Cartledge).
Regarding claims 3 and 8, The modified Angel discloses (see figs. 43-53 of Cartledge) a first longitudinal strip (strut) forms a receiving portion of a coupling mechanism (hole) and a second longitudinal strip (strut with linked fastener) forms a donating portion (fastener portion) wherein the receiving portion complements the donating portion and interacts to form a pivot point between the first longitudinal strip and the second longitudinal strip ([0215] lines 1-15, [0216], [0217] lines 1-20, [0218] lines 1-10 of Cartledge disclose the struts are linked to pivot via connected screws/rivets).
Regarding claims 4 and 9, The modified Angel discloses (see figs. 43-53 of Cartledge) a stent lattice having openings as attachment points to receive screws or rivets ([0215] lines 1-15, [0216], [0217] lines 1-20, [0218] lines 1-10 of Cartledge disclose the struts are linked to pivot via connected screws/rivets).
Angel discloses the stent can have a length of 3-8 cm (col. 8 lines 24-35) and the modified Angel substantially teaches the claimed invention except for the distance between two consecutive attachment points on a strip is 1/32, 1/16, 3/32, 1/8, 5/32, 3/16, 7/32, or 1/4 of an inch. However, figs. 44-63 of Cartledge disclose the attachment points are regularly spaced in close proximity along the length of the stent. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have manufactured the stent of the modified Angel to include attachment points spaced within the claimed arrange as such would be considered a design choice fully implementable by one of ordinary skill in the art and well within an artisan’s skill. In addition, it has been held that where the general conditions of a claim are known, it is not inventive to determine optimum or workable ranges by routine experimentation.
Regarding claims 5 and 10, Angel discloses the cylindrical lattice (40) is expanded or contracted by a fixed point actuator (i.e. balloon) operatively coupled to the lattice (col. 7 lines 25-35, 60-67 disclose expansion via a balloon which thereby includes an end fixed/attached to itself).
Response to Arguments
Applicant's arguments filed 6/6/2026 have been fully considered but they are not persuasive.
Applicant argues on page 6 last paragraph through page 7 2nd paragraph that the stent of Angel does not include pivot points or a fixed-point actuator as claimed. Examiner respectfully disagrees. A shown, the stent of Angel is a lattice that expands and contracts. Thus, the strips of the lattice pivot to expand and contract; the multiple points of pivoting as pivot point. In addition, Angel discloses in col. 7 lines 25-35, 60-67 expansion via a balloon which thereby includes an end fixed/attached to itself. Thus, Angel teaches this limitation as claimed.
Applicant argues on page 8 1st paragraph that Cartledge does not disclose simple longitudinal strips. Examiner respectfully disagrees. Cartledge discloses struts and strips. Thus, Cartledge teaches this limitation as claimed.
Applicant argues on page 8 2nd and 3rd paragraphs that there is no motivation to combine and the combination does not teach the unexpected advantages. However, one or ordinary skill in the art upon seeing the mesh of Angel would recognize that the pivoting struts of Cartledge would provide the advantage of enhanced adjustability providing in situ accommodation to local anatomy as disclosed by Cartledge in [0019] and [0020]). Thus proper motivation is provided.
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 LATOYA M LOUIS whose telephone number is (571)270-5337. The examiner can normally be reached M-F 1 pm - 6:30 pm ET.
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/LaToya M Louis/ Primary Examiner, Art Unit 3785
