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 foreign application KR10/2021-002392, filed 03/03/2021.
Status of Claims
Claims 1-3 are pending.
Claims 4-8 have been cancelled.
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 3 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.
Claim 3 has been amended to define the membrane portion as comprising a uniform coating layer on the body portion, but this claim depends upon claim 1 which defines the membrane layer as having a micro-rough surface with a plurality of irregular embossing protrusions. It is unclear how the membrane which the original disclosure describes as being formed by the coating, can be both uniform as well as have the claimed protrusions. At best it appears the membrane is only uniform at the initial stage of manufacturing the micro-roughness. Clarification is required
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Fleury et al (Fleury) US 2014/0277443 A1 in view of Boyle et al (Boyle) US 2018/0010230 A1.
1. Fleury discloses a stent (Figure 9) with an improved stickiness of a membrane [0096], comprising:
a body portion 40 including a hollow cylindrical shape (Figure 9), wherein wires are woven to form a mesh structure (Figure 9);
a membrane portion 309 provided in the body portion to cover the mesh structure (Figure 9 and [0096]); and
a micro-rough surface formed on all or at least a part of the membrane portion [0106],
wherein the micro-rough surface has a first surface roughness in a range of 30 um to 300 um ([0094] discloses the roughness is 100-200um),
such that surface contact between inner faces of the membrane portion is reduced to thereby reduce stickiness of the membrane portion (the peaks and valleys of Fleury inherently reduce surface contact between faces in the same manner as the applicant’s invention, which will then have the same result of reducing stickiness or reducing adhesion as described in [0096]).
Fleury discloses the micro-rough surface comprises a plurality of embossing protrusions that are considered irregular because of their random surface structures shown in Figure 6B. However, Fleury does not disclose the plurality of irregular embossing protrusions are disorderly formed without a repetitive pattern.
Boyle teaches the use of a stent (Figure 4) comprising a body portion 1 (Figure 1) covered with a film comprising a micro-roughness defined by a plurality of pores that can be arranged in a variety of patterns or an irregular pattern (Claims 12 and 13 disclose the regular and irregular patterns are interchangeable depending on the needs of the implant site) in the same field of endeavor for the purpose of providing a variety of surface textures that meet the specific needs of each implant site.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the micro-roughness of Coleman defined by the protrusions in an irregular pattern as taught by Boyle in order to provide a surface with unpredictable distribution of attachment sites.
2. Fleury discloses the first surface roughness of the micro-rough surface corresponds to a second surface roughness provided on an outer circumference of a coating jig ([0096] discloses the first micro surface and while this isn’t an exact product by process claim, it is implying that a jig can be used to form the micro-roughness, which the micro-roughness of Fleury is fully capable of being formed with, and therefore it will inherently correspond to any jig surface used to make it).
3. Fleury discloses the membrane portion comprises a uniform coating layer on the body portion (this is being interpreted as best understood in view of the 112 rejection above, as seen in figures 6B and 6C the protrusions of the membrane are as uniform as the applicant’s own invention), the uniform coating layer having a thickness distribution resulting from axial rotation of the coating jig (the examiner recognizes the applicant’s attempt to get away from a product by process limitation, but any coating layer applies by rotation of a coating jig will inherently have the thickness distribution be a result from the rotation, in this case the implant of Fleury is fully capable of having its membrane formed using a coating jig that is axially rotated, this is an old and well know procedure and will inherently result in the claimed thickness distribution).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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).
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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
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