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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract is objected to because it includes the phrase "The disclosure includes," which is a phrase that can be implied. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 3, 5 and 6 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. It is unclear how a surface can comprise a wall as required by line 2 of claim 3.
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 2 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 2 does not add any additional limitations. 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.
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 1, 8-13 and 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer et al. (US 2006/0282041) in view of McNiven et al. (US 10,661,052).
Regarding claims 1, 21 and 26, Melsheimer et al. disclose a catheter (50, Figures 3A and 3B) comprising: a proximal end; a distal end located opposite the proximal end; a working lumen (59) extending between the proximal end and the distal end; an outer surface (exterior surface of 42) extending between the proximal end and the distal end, the outer surface defining an outer diameter; an inner, textured ribbed surface (defined by turns of coil 43a and inner surface of 42; a textured surface can be completely covered – see comments below) extending between the proximal end and the distal end, the inner ribbed surface defining an inner diameter and formed (in part) from a catheter reinforcement structure (43a), wherein the inner ribbed surface is located opposite the outer surface; and a second coating (44) located on the inner ribbed surface, the second coating comprising a textured second coating ribbed surface (surface facing coils 43a and tube 42; the claims allow for the completely covered inner ribbed surface to be regarded as a surface; therefor the completely covered second ribbed surface of Melsheimer et al. can be regarded as a textured, ribbed surface) formed from the inner ribbed surface (evident from Figure 3A).
Melsheimer et al. fail to disclose a first hydrophilic coating as claimed or that the second coating is hydrophilic. Melsheimer et al. disclose that members 42 and 44 can include a lubricious material to reduce friction (¶[0068]).
McNiven et al. disclose that a hydrophilic layer may be disposed on an outer layer (112) to reduce friction (col. 7, lines 10-12) and further disclose that an inner layer or coating (986) can be a hydrophilic material to reduce friction (col. 22, lines 27-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of McNiven et al. to have provided a hydrophilic coating/layer on the outer surface of Melsheimer et al. and to have made the second coating from a hydrophilic material in order to reduce friction. Since PTFE is hydrophobic, the hydrophilic coatings or liners provided above would not be PTFE
Regarding claims 8 and 10, the first and second hydrophilic coatings extend between the proximal end and the distal end of the catheter (a coating located anywhere along catheter 50 would extend between the ends as claimed).
Regarding claims 9 and 25, the catheter does not include a polytetrafluoroethylene (PTFE) liner (PTFE is hydrophobic, therefore the hydrophilic coatings provided above would not be PTFE).
Regarding claim 11, the second hydrophilic coating extends along a surface (inner ribbed surface) extending between the proximal end and the distal end.
Regarding claims 12 and 13, Melsheimer et al. disclose that the catheter outer diameter may be about 0.111 inches or about 0.098 inches (¶[0082]) but fail to disclose the inner diameter as claimed.
However, Melsheimer et al. disclose that the inner and outer diameters may be adjusted depending upon a vessel size for which an implant is to be deployed (¶[0083]) and as such the inner diameter is disclosed to be a result effective variable in that changing the inner diameter allows for various sized implants to be contained therein.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the inner diameter of Melsheimer et al. about 0.100 inches or about 0.088 inches as a matter of routine optimization since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 22 and 28, the second coating is connected or bonded to the textured surface which can be considered as an adherence.
Regarding claims 23 and 29, the catheter reinforcement structure includes a coil (43a of Melsheimer et al.).
Regarding claims 24 and 30, the coil includes a pitch smaller than 0.03 inches (¶[0071] of Melsheimer et al.).
Regarding claim 27, the inner surface includes a textured inner surface formed from a catheter reinforcement structure (the inner surface is formed by the inner surface of 42 and turns of coil 43a of Melsheimer et al.).
Response to Arguments
Applicant’s arguments with respect to the pending claims 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
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 Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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