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 Interpretation
In claims 1, 15 and 18, Applicant requires “the protector having a fixed length”. A first interpretation would be that the protector has an unchanging length. This is not consistent with Applicant’s specification as the protector is either item 20 (fig 2) or item 90 (fig 12). In both instances, the protector is comprised of telescoping elements, such that the protector cannot be considered to have a fixed length in a traditional sense. Further, this telescoping is critical to some claimed elements (such as 3, which allows the catheter hub and distal end of the elongated member to be positioned at certain points along the device, which would not be possible if the protector had to be a single, unchanging length but still capable of covering the needle extending from the elongated member). Instead it is interpreted as having a fixed length in that it is rigid (as opposed to collapsible).
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 10-12 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.
In claim 10, Applicant requires “the restraining portion” and “the pair of support arms”, both of which lack antedecent basis. It is treated as if it depends from claim 5.
Similarly to claim 10, claim 11 has “the pair of support arms” and claim 12 has “the restraining portion”, again lacking antecedent basis. Both claims are treated as if they depend from claim 5.
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.
Claim(s) 1, 2, 6-9, 13, 14, 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard et al (US 2011/0282285) in view of Carrell et al (US 4,944,728).
Regarding claim 1, Blanchard discloses a catheter assembly comprising: a catheter 44; a catheter hub 46 configured to be fixed to a proximal end portion of the catheter (fig 12A); a needle 116 having a needlepoint (fig 11D), the needle configured to be inserted into the catheter and separated from the catheter (fig 14F); a protector 146; an elongated member 110 coupled to the needle and overlapping at least a portion of the needle that is distal of the protector in an initial state (fig 12A); the protector being displaceable in an axial direction with respect to the elongated member (figs 14A-14F), and wherein in the initial state, the catheter and the needle are exposed from a distal end of the elongated member, and the elongated member overlaps the catheter hub and the protector (fig 14A).
While Blanchard substantially discloses the invention as claimed, it does not disclose the protector having a fixed length configured to overlap an entire length of the needle protruding from the elongated member in accordance with evulsion of the needle from the catheter.
Carrell discloses a protector 26 having a fixed length configured to overlap an entire length of the needle 18 protruding from the elongated member 22 in accordance with evulsion of the needle from the catheter (figs 2 and 4).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Blanchard such that the protector has a fixed length configured to overlap an entire length of the needle protruding from the elongated member in accordance with evulsion of the needle from the catheter as taught by Carrell to fully shield the needle body after its use.
Regarding claim 2, wherein the needle is a rigid tubular member (fig 11C, rigid in that it is capable of piercing the skin and guiding/implanting the catheter), and the needle in the initial state includes a part in a longitudinal direction inserted into the catheter hub and a proximal end of the needle is inside of the elongated member (fig 11D).
Regarding claim 6, wherein an operating portion 172 for operating the catheter hub is provided on the catheter hub; and in the initial state, at least a part of the operating portion is exposed from the elongated member (fig 14A).
Regarding claim 7, further comprising: wherein the elongated member includes a slit extending in the axial direction of the elongated member (fig 14B); and wherein the at least the part of the operating portion exposed from the elongated member is exposed on an outside of the elongated member through the slit (fig 14B).
Regarding claim 8, wherein the operating portion includes a pair of flexible wings mutually protruding in opposite directions from the catheter hub (fig 14D).
Regarding claim 9, wherein the protector is detachably fitted to a proximal end of the catheter hub (figs 14E and 14F).
Regarding claim 13, wherein the elongated member and the protector overlap the entire length of the needle (see combination in claim 1).
Regarding claim 14, wherein the protector located at the proximal side of the catheter hub is configured to move in a distal direction against the elongated member to cover a needlepoint of the needle (fig 14F).
Regarding claim 18, Blanchard discloses an assembly comprising: an outer needle 44; a hub 46 configured to be fixed to a proximal end portion of the outer needle (fig 12A); an inner needle 116 having a needlepoint (fig 11D), the inner needle configured to inserted into the outer needle and to be separated from the outer needle (fig 14F); a protector 146; an elongated member 110 coupled to the inner needle and overlapping at least a portion of the inner needle that is distal of the protector in an initial state (fig 12A); the protector being displaceable in an axial direction with respect to the elongated member (figs 14A-14F); and wherein in the initial state, the inner needle and the outer needle are exposed from a distal end of the elongated member, and the elongated member overlaps the hub and the protector (fig 14A).
While Blanchard substantially discloses the invention as claimed, it does not disclose the protector having a fixed length configured to overlap an entire length of the needle protruding from the elongated member in accordance with evulsion of the needle from the catheter.
Carrell discloses a protector 26 having a fixed length configured to overlap an entire length of the needle 18 protruding from the elongated member 22 in accordance with evulsion of the needle from the catheter (figs 2 and 4).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Blanchard such that the protector has a fixed length configured to overlap an entire length of the needle protruding from the elongated member in accordance with evulsion of the needle from the catheter as taught by Carrell to fully shield the needle body after its use.
Regarding claim 20, further comprising: an operating portion 172 configured to operate the hub disposed on the hub (fig 14A), and in the initial state, at least a part of the operating portion is exposed from the elongated member (fig 14A); and wherein the protector is detachably fitted to a proximal end of the hub (fig 14F).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2 and 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,173,037. Although the claims at issue are not identical, they are not patentably distinct from each other because they are generally broader and any differences are obvious in view of the references used in the art rejections.
Claims 1, 2 and 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,953,201. Although the claims at issue are not identical, they are not patentably distinct from each other because they are generally broader and any differences are obvious in view of the references used in the art rejections.
Allowable Subject Matter
Claim 3 is 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 examiner did not find a teaching or suggestion for modifying closest art Blanchard in view of Carrell wherein in the initial state, a proximal end of the catheter hub is positioned on a proximal end side beyond a position of a center in the axial direction of the elongated member, and the distal end of the elongated member is positioned on a distal end side beyond a position of a center in a longitudinal direction of the catheter, absent impermissible hindsight. While a telescoping protector is also known in the art (see for example Nakajima – US 2004/0044313; a telescoping arrangement being the closest one could get to the claimed arrangement), it would not necessarily follow that the combination would result in the claimed arrangement, and the examiner did not find any other teaching or suggestion for the arrangement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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