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 .
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.
Claim 14 is 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.
The Applicant’s representative discloses in claim 14 that the implant is configured to have less malappositions between the implant and the inner wall of the vessel. The Examiner understands the meaning of the malapposition of a stent, however, is not clear what the Applicant’s representative is trying to claim. The claimed stent wants to claim less malapposition compare to what? It is inherent that any stent wants to avoid stent malapposition if inserted inside a vessel bend but the Applicant’s representative fails to positively claim the structural configuration of the stent that make possible the reduction of the stent malapposition. The Examiner believes that todays stents are configured to have less malapposition compare to stents from 20 years ago.
Regarding claim 31, the Examiner is not clear what does the Applicant’s representative is referring to. Does the applicant’s representative is referring to the particles created after the stent is implanted inside the body as is delaminated and form a single embolic particle. If this is what the applicant’s representative is claiming, what does it has to do with the structural limitations of the implantable device? Correction or clarification is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-6, 8, 13, 14, 22 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strauss et al US Patent 8,808,361B2.
Strauss et al discloses a self-expanding intraluminal implant, the implant comprising a generally tubular frame. The frame having a proximal portion (See figure below) comprising a ring that extends along a circumference of the tubular frame. The ring comprising a plurality of ring struts, wherein adjacent pairs of ring struts join at a plurality of proximal apexes and a plurality of distal apexes to form a chevron pattern (zig-zag pattern of struts shown in figure below). A distal portion (See figure below) comprising a ring that extends along the circumference of the tubular frame, the ring comprising a plurality of ring struts, wherein adjacent pairs of ring struts join at a plurality of proximal apexes and a plurality of distal apexes to form a chevron pattern (zig-zag pattern of struts shown in figure below). A central portion (See figure below) between the proximal portion and the distal portion. The central portion comprising a plurality of longitudinally spaced apart rings (see figure below) that extend along the circumference of the tubular frame, each ring of the plurality of rings comprising a plurality of rings struts, wherein adjacent pairs of ring struts join at a plurality of proximal apexes and a plurality of distal apexes to form a chevron pattern and a plurality of linking struts (see figure below) that extend at least partially along the circumference of the tubular frame, each linking strut of the plurality of linking struts connecting a distal apex of one ring of the plurality of rings to a proximal apex of an adjacent ring of the plurality of rings.
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Regarding claim 2, see figure above and below disclosing that each linking strut connects a distal apex of one ring of the central portion to a proximal apex of adjacent ring of the central portion, wherein each linking strut is not connected with the distal apex of he distal most ring (ring A, see below) and with the proximal apex of the proximal most ring (not shown) and wherein there are no apexes free of linking struts.
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Regarding claim 3, see the two figures above showing that each distal apex of the plurality of distal apexes of the distal most ring (ring A) of the central portion connects to a respective proximal apex of the plurality of proximal apexes of the ring of the distal portion, and wherein each proximal apex of the plurality of proximal apexes of the proximal most ring (shown in the first figure above) of the central portion connects to a respective distal apex of the plurality of distal apexes of the ring of the proximal portion.
Regarding claim 4, see figure below disclosing that the distal apexes of one ring of the plurality of rings of the central portion is rotationally offset to the proximal apex of the plurality of proximal apexes of the adjacent ring of the plurality of rings of the central portion.
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Regarding claim 5, see Fig. 3 showing that each plurality of linking struts extend along a helical path at least partially around the circumference of the tubular frame in a first helical direction.
Regarding claim 6 and 8, see first figure above disclosing the distal neck portion, the distal marker, the proximal neck portion and the proximal marker.
Regarding claim 13, see first figure above showing that the linking struts do not overlap one another.
Regarding claim 22, the implant does not positively claim a graft, covering or liner.
Regarding claim 23, see col. 16, lines 2-7.
Claim Rejections - 35 USC § 103
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 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 11, 24-27, 30-32 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Strauss et al US Patent 8,808,361B2 in view of Yang et al US Patent Pub. 2018/0193026A1.
Strauss et al discloses the invention substantially as claimed. However, Strauss et al does not disclose a wall thickness of about 45microns or less and a heparin coating thickness of about 30nm or less.
Regarding claim 11, the embodiment of figures 3-6 does not disclose proximal and/or distal portions flaring outwardly toward the ends. However, the embodiment of figure 16 discloses distal and proximal portions flaring outwardly for the purpose of attaching the implant at each end.
Therefore, it would have been obvious to one ordinary skill in the art to modify the two ends of Figure 3 with the flared ends of Figure 16 in order to create a strong attachment at the implantation site.
Regarding claims 24 and 25, Yang et al discloses a self-expanding (paragraph 9) thromboresistant intraluminal implant, the implant comprising a generally tubular frame (see Fig. 3A) comprising a plurality of longitudinally spaced apart rings that extend along a circumference of the tubular frame, each ring of the plurality of rings comprising a plurality of rings struts, wherein adjacent pairs of ring struts join at a plurality of proximal apexes and a plurality of distal apexes to form a chevron pattern, wherein the tubular frame comprises a wall thickness of about 45 pm or less (see paragraph 61), and wherein the implant comprises a heparin coating thickness of about 30nm or less (see paragraph 45) for the purpose of providing a bioactive agent around the implant without compromising the structural integrity of the implant. This type of coating avoiding improper expansion and/or compression of the implant and avoid cracking of the coating during those expansion and contractions of the implant. See paragraphs 43-46.
It would have been obvious to one ordinary skill in the art to modify the thickness of the Strauss et al struts and the specific heparin coating (30nm or less) as disclosed in the Yang et al reference, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 26, the Strauss et al and the Yang et al does not mention the heparin coating mass of 1.0 micrograms or less. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a heparin coating mass of 1.0micrograms or less, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 27, the Strauss et al and the Yang et al does not mention the ratio between the heparin coating mass and the total surface area of the implant is about 0.007 micrograms/mm^2 or more. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the claimed ratio of 0.007micrograms/mm^2, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 30, even though the ratio of not mentioned in the references, it would have been obvious to have the claimed ratio if the thickness of heparin is 3 microns and the wall thickness is at least 25 microns as disclosed in the Yang et al reference in paragraphs 45 and 61.
Regarding claim 31, as best understood, the Examiner is interpreting the particles as the particles created after the stent is implanted inside the body as is delaminated and form a single embolic particle (that is claimed as 101microns in diameter. If this is what the applicant’s representative is claiming, particles above 100 microns in diameter (as disclosed by USP 788 standard) are not acceptable in the blood stream, therefore, it would have been obvious to one ordinary skill in the art to have delaminated particles of heparin inside the body that are less than 100 microns.
Regarding claim 32, the references do not disclose a ratio of heparin activity coating to the wall thickness. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a ratio of 0.3 pmol/AT/cm^2/microns, since it has been held that finding an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 36, the Strauss et al implant does not positively claim a graft, covering or liner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 8/13/26
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