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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
This Action is responsive to the Reply filed on 24 June 2025 (“Reply”). As directed in the Reply:
Claims 21, 22, 24, 25, 29, 30, and 34-37 have been amended;
Claims 1-20, 27, 28, 32, 33, 38, and 39 have been and/or remain cancelled; and
no claims have been added.
Thus, Claims 21-26, 29-31, 34-37, and 40 are presently pending in this application, with no claims having been previously withdrawn from consideration.
Applicant’s amendment to the drawings, Abstract, and Specification are sufficient to overcome the objections from the previous Action and are therefore withdrawn.
Response to Arguments
Applicant's arguments filed in the Reply have been fully considered but they are not persuasive.
Applicant's arguments fail to comply with 37 C.F.R. § 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 C.F.R. § 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant’s only argument of any substance in support of the alleged patentability of the claims appears at pg. 13, third full paragraph
No obvious combination of Miraki and Armistead result in such a structure. Miraki does not disclose a conical sealing surface on anything comparable to the recited movable member. Armistead discusses a catheter tube 17 with a conical distal end 16, but the structure that mates with conical upper I.D. 16 has a "rounded lower edge 11."3 Accordingly, no obvious combination of Miraki and Armistead result in the device currently recited in the independent claims.
As identified in the prior Action (pg. 11) and below, Miraki has a conical sealing surface on the proximal-facing surface of its movable member, one which is nearly identical to that disclosed , much less broadly claimed, by Applicant. That Armistead discloses a rounded lower edge 11 which seals with its conical surface 16 does not detract from its teaching that the sealing surface against which that rounded edge 11 seals is, in fact, conical as claimed. Applicant presents neither additional evidence nor anything other than conclusory statements in its arguments, thus not rebutting the prior Action’s prima facie case under sec. 103.
Claim Objections
Claim 40 is objected to because its status indicator should be “currently amended” and not “previously presented.” Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claims 21-26, 29-31, 34-37, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Int’l Patent App. Pub. No. WO 2016/004114, by Miraki (“Miraki”), in view of U.S. Patent App. Pub. No. 2011/0245810, by Armistead (“Armistead”).
Miraki describes a device substantially as claimed by Applicant as follows.
Claim 21: An apparatus (Figs. 1, 2, 11) comprising:
a tip body (160) defining a fluid chamber (inner cavity of 160) and receiving a stylet therethrough (120); and
a movable member coupleable to the stylet (102) and including a conical distal end (104; a frustocone is conical) and a conical rearward surface (106; a frustocone is conical) to sealably engage a distal end of the fluid chamber (see Fig. 11; [045]);
wherein the stylet is configured to move the movable member to open the fluid chamber (id.).
Miraki does not, however, describe that the distal end of its fluid chamber includes a conical surface that engages at least a portion of the conical or cone shaped proximal side.
Armistead relates to catheters having valves at their distal ends which are actuated from the proximal end of the catheter and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Armistead teaches that, in order to form a better seal by the valve and thus inhibit leakage, to form the catheter-side proximal valve seat surface, in the fluid chamber, to include a conical surface (16) that engages at least a portion of the proximal side of the valve (11), which a person of ordinary skill in the art understands creates a valve seat surface which is more tolerant of misalignment of the two valve surfaces while still maintaining a seal.
It 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, to construct Miraki’s valved catheter such that that the distal end of its fluid chamber includes a conical surface that engages at least a portion of the cone shaped proximal side, because Armistead teaches does so in a closely-related device, in order to form a better seal by the valve and thus inhibit leakage.
Claim 22: (The apparatus of claim 21,) wherein the movable member includes a pointed distal end (108 can be flat, [030], and thus the upper and lower points of Fig. 1 would be points).
Claim 23: (The apparatus of claim 21,) wherein the movable member includes an annular seal (surface 106) configured to sealably engage an outer surface of the tip body ([045]).
Claim 24: (The apparatus of claim 21,) wherein the rearward conical surface is configured to diffuse fluid flow out of the fluid chamber upon extension of the stylet to move the movable member ([045]).
Claim 25: (The apparatus of claim 21,) wherein the movable member includes symmetric distal and proximal sides (the portions of surfaces 104, 106 immediately adjacent to the laterally widest portion of 102, assigned 112 in the text but not in the drawings, are symmetrical).
Claim 26: (The apparatus of claim 25,) wherein the distal end of the fluid chamber includes a shape configured to receive the proximal side of the movable member (Fig. 11, shape of distal end of 152 forms a seal with 106, and thus is shaped as claimed).
Claim 29: An apparatus to deliver a fluid to a target tissue location (Figs. 1, 2, 11), the apparatus comprising:
an elongate lumen (defined by 160) terminating in a distal tip including a fluid chamber (Miraki, Fig. 11), the fluid chamber including a conical distal sealing surface (Armistead, 16);
a stylet (Miraki, 120) extending through the elongate lumen into the distal tip and the fluid chamber (Miraki, Fig. 11), the fluid chamber configured to retain fluid between the stylet and an inner surface of the distal tip of the elongate lumen (Miraki, [045]), the stylet distally extendable to open the fluid chamber (id.); and
a movable member (Miraki, 102) affixed to a distal end of the stylet (Miraki, Fig. 11) to form the distal tip of the elongate lumen (id.), the movable member configured to transition between a sealed state sealing the conical distal sealing surface of the fluid chamber and an unsealed state, wherein in the unsealed state the apparatus is configured to release a fluid from the fluid chamber (Miraki, [045]; Armistead, [0023]), the movable member transitionable from the sealed state to the unsealed state through distal extension of the stylet (id.).
Claim 30: (The apparatus of claim 29,) wherein the movable member includes symmetric distal and proximal sides (the portions of surfaces Miraki’s 104, 106 immediately adjacent to the laterally widest portion of 102, assigned 112 in the text but not in the drawings, are symmetrical).
Claim 31: (The apparatus of claim 30,) wherein the distal end of the fluid chamber includes a shape configured to receive the proximal side of the movable member (Miraki Fig. 11, shape of distal end of 152 forms a seal with 106, and thus is shaped as claimed).
Claim 34: An apparatus (Miraki Figs. 1, 2, 11) comprising:
a tip body (Miraki 160) defining a fluid chamber (hollow interior of 160) and receiving a stylet therethrough (Miraki 120), wherein the fluid chamber includes a conical sealing surface (Armistead, 16) and is configured to retain fluid (Miraki [045], Armistead [0023]) surrounding a length of the stylet (id.); and
a movable member coupleable to the stylet (Miraki 102) and including a pointed distal end (Miraki’s end 108 can be flat, [030], and thus the upper and lower points of Fig. 1 would be points) and a conical sealing surface configured to seal the fluid chamber (Miraki 106; a frustocone is conical), the movable member being configured to move and to open the fluid chamber responsive to extension of the stylet by:
(i) causing the cone-shaped sealing surface to prevent release of the fluid from the fluid chamber prior to the extension of the stylet (Miraki [045]), and
(ii) causing the cone-shaped sealing surface to permit release of the fluid from the fluid chamber upon the extension of the stylet (id.).
Claim 35: (The apparatus of claim 34,) wherein the conical sealing surface is configured to redirect flow of fluid dispensed from the distal opening (id.).
Claim 36: (The apparatus of claim 34,) wherein the movable member includes symmetric distal and proximal sides (the portions of Miraki’s surfaces 104, 106 immediately adjacent to the laterally widest portion of 102, assigned 112 in the text but not in the drawings, are symmetrical).
Claim 37: (The apparatus of claim 34,) wherein the conical distal sealing surface (Armistead 16) of the fluid chamber includes a shape configured to receive the conical sealing surface of the movable member (Miraki Fig. 11, shape of distal end of 152 forms a seal with 106, and thus is shaped as claimed).
Claim 40: (The apparatus of claim 34,) wherein the conical sealing surface is an annular seal configured to sealably engage an outer surface of the tip body (because 160 is cylindrical and 106 is frustoconical, the surface at which they seal is an annulus).
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 Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 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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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783