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 .
Response to Arguments
Applicant's arguments filed 1/23/2026 have been fully considered.
Regarding the restriction requirement, the examiner acknowledges the confirmation of the election as discussed in the prior Office action.
Regarding the drawing objections, Applicant’s arguments have been considered and are not convincing. Claim 7 calls for “the preventative structure comprises a flow restrictor made of an elastomeric material secured to an outer surface of the balloon inflation lumen”. Applicant points to Figure 7 and paragraph 0065 which describe an elastomeric material covering an opening in the outer wall of the balloon inflation lumen. However, the embodiments shown in figs. 6 and 7 and described in the cited paragraphs do not include a flow restrictor, rather the elastomeric patch or blister provide a counterbalance to increased pressure by increasing the internal volume within the inflation lumen, quite the opposite of a flow restrictor. See para. 0062 – “Instead of restricting the rate of flow of inflation media using a flow restrictor…”. Therefore, the drawing objection remains as the drawings do not show a flow restrictor made of an elastomeric material secured to an outer surface of the balloon inflation lumen as required by claim 7.
Regarding the 112(b) rejection, the amendments to the claims overcome the rejection and the rejection is therefore withdrawn.
Regarding the rejection over Franklin, Applicant’s argument have been considered and are not persuasive. Applicant argues that Franklin does not teach or suggest that the adhesive 180 withstands, avoids, or counterbalances pressure peaks in the balloon guide catheter as the adhesive is used to bond the catheter to an inner wall of the hub. The preventative structure withstanding, avoiding, or counterbalancing pressure peaks in the catheter hub is interpreted to be a functional recitation. Per MPEP 2114, if an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art inherently possesses the functionally defined limitation of the claimed apparatus. As discussed in the prior Office action, the adhesive plug withstands pressure during inflation of the balloon with pressurized fluid delivered into the inflation port. This is the point of adhesive – to securely attach to the hub wall and therefore to necessarily resist pressure to dislodge the adhesive. Pressurized fluid applied to the inflation lumen 194 contacts the adhesive plug and does not dislodge the plug. Therefore, the plug inherently withstands pressure.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the balloon inflation lumen of the balloon guide catheter hub along an outer wall thereof having at least one opening defined radially therein and the preventative structure comprising a flow restrictor made of an elastomeric material secured to an outer surface of the balloon inflation lumen covering the at least one opening (claim 7) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Franklin et al (US 10,149,962).
Regarding claim 1, Franklin discloses a balloon guide catheter (abstract) comprising: a balloon guide catheter hub (fig. 6) including a through lumen 192 and a balloon inflation lumen 194 converging therewith defining a region of convergence (fig. 6: convergence near number 230; col. 26, lines 1-5; col 62, lines 54-64); and a preventative structure 180 in the guide catheter hub (fig. 6), the preventative structure withstanding, avoiding or counterbalancing pressure peaks in the balloon guide catheter hub (the adhesive plug 180 withstands pressure peaks during inflation of the balloon with pressurized fluid delivery into the inflation port 194).
Claim 1 calls for the balloon guide catheter hub to be injection molded. This is interpreted to be a product by process limitation. Such limitations are not limited to the recited manufacturing steps, but rather to the structure implied by the recited steps. See MPEP 2113. In this case, the structure implied by injection molded is a unitary hub. The hub of Franklin is formed from a unitary body and therefore is the same structure as the claimed structure formed by injection molding.
Allowable Subject Matter
Claims 2-4, 6-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: see prior Office action.
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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783