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 .
Drawings
The drawings are objected to because figs. 1A-6B include shadings making it difficult to appreciate the details of the invention. In addition, the figures 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 Objections
Claims 2, 3, 7, and 8 are objected to because of the following informalities:
Regarding claims 2, 3, 7, and 8, “longitudinal strip” should be recited as --one of the longitudinal strips-- for clarity.
Appropriate correction is required.
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 4 and 9 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.
Regarding claims 4 and 9 “the distance between two consecutive attachment points” lacks antecedent basis and it is unclear whether the “attachment points’ are one and the same as the previously claimed pivot points.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim-(s) 1, 5, 6, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Angel (9,433,738).
Regarding claim 1, 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).
Regarding claim 5, 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).
Regarding claim 6, Angel discloses an expandable lattice (40; fig. 1) comprising a plurality of longitudinal strips (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 and contracting mesh like stent thereby including pivot points for expansion).
Regarding claim 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).
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) 2-4 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Angel in view of Cartledge (2013/0046373).
Regarding claim 2, Angel substantially teaches the claimed invention except for a first longitudinal strip and a second longitudinal strip are connected by a fastener passing through coincident holes formed in the first longitudinal strip and second longitudinal strip. However, Cartledge discloses 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) passing through coincident holes formed in the first longitudinal strip and second longitudinal strip ([0215] lines 1-15, [0216], [0218] lines 1-10). 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 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 claim 3, Angel substantially teaches the claimed invention except for a first longitudinal strip forms a receiving portion of a coupling mechanism and a second longitudinal strip forms a donating 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. However Cartledge discloses in figs. 43-63 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 disclose the struts are linked to pivot via connected screws/rivets). 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 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 claim 4, Angel discloses a mesh link stent (fig. 1) but does not specifically disclose wherein 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, Cartledge discloses in figs. 43-63 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 disclose the struts are linked to pivot via connected screws/rivets). 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 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]).
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 claim 7, Angel substantially teaches the claimed invention except for a first longitudinal strip and a second longitudinal strip are connected by a fastener passing through coincident holes formed in the first longitudinal strip and second longitudinal strip. However, Cartledge discloses 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) passing through coincident holes formed in the first longitudinal strip and second longitudinal strip ([0215] lines 1-15, [0216], [0218] lines 1-10). 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 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 claim 8, Angel substantially teaches the claimed invention except for a first longitudinal strip forms a receiving portion of a coupling mechanism and a second longitudinal strip forms a donating 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. However Cartledge discloses in figs. 43-63 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 disclose the struts are linked to pivot via connected screws/rivets). 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 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 claim 9, Angel discloses a mesh link stent (fig. 1) but does not specifically disclose wherein 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, Cartledge discloses in figs. 43-63 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 disclose the struts are linked to pivot via connected screws/rivets). 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 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]).
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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’Neil (8,807,136) discloses an endotracheal tube with struts.
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/LaToya M Louis/ Primary Examiner, Art Unit 3785