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.
Drawings
The drawings are objected to as failing to comply with 37 C.F.R. § 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: #113 in Fig. 6, and #213 in Fig. 10.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b), 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. 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.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: INTRAVENOUS CATHETER AND GUIDEWIRE ADVANCEMENT MECHANISM.
The disclosure is objected to because of the following informalities: the status of the parent application should be updated in [0001].
Appropriate correction is required.
Claim Objections
Claims 4 and 18 are objected to because of the following informalities:
in Claim 4, line 2, “such that track” is missing a word; and
in Claim 18, line 3, “formed at distal” is missing a word.
Appropriate correction is required.
Claim Interpretation
The pending claims are given their broadest reasonable interpretation consistent with the specification, as it would be interpreted by one of ordinary skill in the art. The words of the claims are given their plain the ordinary and customary meaning given to the term by those of ordinary skill in the art as of the effective filing date of the patent application, unless such meaning is inconsistent with the specification. The only exceptions to giving the words in a claim their ordinary and customary meaning in the art are: (1) when the applicant acts as their own lexicographer; and (2) when the applicant disavows or disclaims the full scope of a claim term in the specification. See M.P.E.P. § 2111.
Claim 1 recites, inter alia, “An intravenous catheter device comprising . . . a guide wheel disposed in the housing and operable to rotate about a first axle . . . a support wheel . . . wherein the support wheel is operable to rotate about a second axle” and thus positively recites the guide and support wheels. The clauses “operable to rotate about a first axle” and “operable to rotate about a second axle” are not (currently) indefinite (35 U.S.C. § 112(b)), but instead require functions of the wheels with unclaimed axles; the claim has been treated as not including the first or second axle, as being the broadest reasonable interpretation of the claim.
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 M.P.E.P. § 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, 16, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-8 of U.S. Patent No. 11,617,863 (granted from the parent application; “ ‘863 patent”) in view of any one of U.S. Patent App. Pub. No. 2010/0094310, by Warring et al. (“Warring”), U.S. Patent App. Pub. No. 2005/0245847, by Schaeffer (“Schaeffer”), U.S. Patent No. 5,346,498, granted to Greelis et al. (“Greelis”), and U.S. Patent No. 5,318,541, granted to Viera et al. (“Viera”), all cited in the parent application and herewith.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘863 patent name the same inventive entity, and the aforementioned claims cover the same subject matter. In the following, the text of the “claims under examination” (i.e., the claims of the instant application) are rendered in plain text, and the text of the “reference claims” (i.e., the claims of the ‘863 patent) are rendered in italics; reference to particular claims of the ‘863 patent are presented in the format ‘863:X, for Claim X. Applicant should note that, as dependent Claims ‘863:2-8 include all of the features of Claim 1, they each are also a basis for this rejection. Additional explanations are provided in line with the text.
Claim 1 (‘863:1): An intravenous catheter device comprising (An intravenous catheter system comprising):
a housing (a housing);
a guidewire completely disposed within the housing (a guidewire completely disposed within a track defined by the housing);
a guide wheel disposed in the housing (a guide wheel disposed in the housing) and operable to rotate about a first axle (see treatment above), the guide wheel comprising an inner surface configured to engage the guidewire and move the guidewire (the guide wheel comprising an inner surface configured to engage the guidewire and move the guidewire);
‘863:1 does not recite:
a support wheel operable to engage the guidewire opposite the guide wheel,
wherein the support wheel is operable to rotate about a second axle (see treatment above).
Each of Warring, Schaeffer, Greelis, and Viera relates to medical devices including mechanisms used to advance an intraluminal device (a guidewire or a catheter) using a thumbwheel which contacts the exterior surface of the intraluminal device and pushes/pulls the intraluminal device upon rotation of the thumbwheel by a practitioner, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Each of Warring, Schaeffer, Greelis, and Viera teaches that the mechanism can be provided with a support wheel operable to engage the guidewire opposite the guide wheel, wherein the support wheel is operable to rotate about a second axle, to reduce friction at the point of contact with the intraluminal device by providing a complementary rolling surface:
Warring: Fig. 6, support wheel 23, intraluminal device 11
Schaeffer: Fig. 3, support wheel 34, intraluminal device 17
Greelis: Fig. 3, support wheel 83, intraluminal device 19
Viera: Fig. 3, support wheel 28, intraluminal device 12
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 include, in the subject matter of ‘863:1, a support wheel operable to engage the guidewire opposite the guide wheel, wherein the support wheel is operable to rotate about a second axle, because each of Warring, Schaeffer, Greelis, and Viera teaches doing so in a closely related medical device to reduce friction at the point of contact with the intraluminal device by providing a complementary rolling surface.
Claim 16 (‘863:1): (The intravenous catheter device as recited in claim 1,) wherein the guide wheel further comprises an outer surface radially spaced from the inner surface (an outer surface spaced from the inner surface) and having a textured surface (Viera, 33; Schaeffer, Fig. 2, texture shown on thumbwheel 32; Greelis, Fig. 2, texture shown on thumbwheel 79; all to provide extra grip for the practitioner and thus improve use of the wheel).
Claim 17 (‘863:1): (The intravenous catheter device as recited in claim 16,) wherein the textured surface includes a plurality of ridges and valleys (id.).
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-8 the ‘863 patent in view of any one of Warring, Schaeffer, Greelis, and Viera, and further in view of U.S. Patent App. Pub. No. 20120/0283640, by Anderson et al. (“Anderson”, cited in the parent application and herewith).
‘863:1 in view of any one of Warring, Schaeffer, Greelis, and Viera claims the same subject matter as Claim 18; in addition, ‘863:1 recites:
a track formed in the housing (a track defined by the housing); and
a ball element disposed on a trailing end of the guidewire (a ball element disposed on a trailing end of the guidewire) . . . the ball element centers the guidewire in the track and the ball stop prevents the guidewire from further advancing once the ball element contacts [an element] (that centers the guidewire in the track and also stops the guidewire from proceeding beyond the guide wheel).
‘863:1 in view of any one of Warring, Schaeffer, Greelis, and Viera does not, however, cover a ball stop formed at a distal end of the track (that is, the “element” is a ball stop formed at a distal end of the track).
Anderson relates to medical guidewire advancement devices and it therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Anderson teaches that such a device, when used with a guidewire (120 in Fig. 11) provided with a ball stop (152), can be provided with a ball stop (150) formed at a distal end of the track of movement of the ball stop (tapered funnel structure immediately proximal of the ball stop, corresponding to the claimed “track”), to “interlock” the guidewire to the rest of the device ([0085]) and “to inhibit proximal movement once it engages with the through hole 150” ([0086]).
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 include, in the subject matter of ‘863:1, a ball stop formed at a distal end of the track, because Anderson teaches doing so in a closely related medical device, for the foregoing reasons.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 7-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Warring.
Warring discloses a device as claimed by Applicant, as follows.
Claim 1: An intravenous catheter device (Fig. 6) comprising:
a housing (1);
a guidewire (11) completely disposed within the housing (when wound on spool 24);
a guide wheel (22) disposed in the housing and operable to rotate about a first axle (see treatment above; rotates at its center hole), the guide wheel comprising an inner surface configured to engage the guidewire ([0113]) and move the guidewire ([0114]);
a support wheel (23) operable to engage the guidewire opposite the guide wheel ([0113]-[0114]), wherein the support wheel is operable to rotate about a second axle (at its center hole).
Claim 7: (The intravenous catheter device as recited in claim 1,) further comprising a needle (8) extending from a distal end of the housing (Fig. 6) and operable to receive the guidewire therethrough (Fig. 6).
Claim 8: (The intravenous catheter device as recited in claim 7,) further comprising a passageway extending from a distal end of the needle to a second end located within the housing ([0115], describing advancing the guidewire through the needle and observing blood flashback).
Claim 9: (The intravenous catheter device as recited in claim 8,) further comprising a chamber located within the housing ([0102]: “A small cavity or blood flashback chamber that communicates with the lumen of the access needle 8 is positioned within the needle carrier 6, between the needle carrier nose 5 and the needle carrier 6.”).
Claim 10: (The intravenous catheter device as recited in claim 9,) wherein the chamber forms an aperture to the passageway (id.).
Claim 11: (The intravenous catheter device as recited in claim 10,) wherein the aperture is located proximal to the distal end of the housing (id.).
Claim 12: (The intravenous catheter device as recited in claim 9,) wherein the chamber is visible through the housing, such that when blood enters the chamber, a blood flash can be visible to an operator (id.).
Claim 13: (The intravenous catheter device as recited in claim 7,) further comprising a plastic catheter operable to fitted over the needle (13; [0105], ANGIOCATHs are formed of plastic).
Claim 14: (The intravenous catheter device as recited in claim 13,) wherein the plastic catheter comprises a tab that extends therefrom (Fig. 2, on hub 27; Fig. 9).
Claim 15: (The intravenous catheter device as recited in claim 13,) wherein the plastic catheter is operable to slide away from the distal end of the housing while the needle remains fixed (Fig. 9).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Warring as applied to Claim 1 above, and further in view of U.S. Patent App. Pub. No. 2010/0241177, by Schaller et al. (“Schaller”).
Warring describes a device substantially as claimed by Applicant; see above. It does not, however, describe that the housing per se defines a track for receiving the guidewire.
Schaller relates to guidewire advancement devices and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Schaller teaches that the housing 136, 138 of such a device can be formed to include a track (within 136) for receiving the guidewire, which “houses, protects and controllably contains the guide wire 122 and pusher member 126” ([0071]).
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 Warring’s device so that the housing per se defines a track for receiving the guidewire, because Schaller teaches doing so in a closely related device, for the foregoing reasons.
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Warring and Schaller as applied to Claim 2 above, and further in view of Anderson.
Warring and Schaller together describe a device substantially as claimed by Applicant; see above. It does not, however, describe the further inclusion of a ball element disposed on a trailing end of the guidewire that centers the guidewire in the track and contacts a ball stop formed within the track and proximal to the guide wheel.
See above concerning Anderson.
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 a Warring-Schaller device to include a ball element disposed on a trailing end of the guidewire that centers the guidewire in the track and contacts a ball stop formed within the track and proximal to the guide wheel, because Anderson teaches doing so for the reasons stated above.
Claim 4: (The intravenous catheter device as recited in claim 2,) wherein the track includes a portion that curves such that track [sic] is longer than a length of the housing (Schaller, track in 136 is longer that 138).
Claim 5: (The intravenous catheter device as recited in claim 4,) wherein the track includes a portion that is substantially parallel to an exterior of the housing (Schaller, at 228 the track is substantially parallel to the exterior of 138).
Claim 6: (The intravenous catheter device as recited in claim 4,) wherein the track includes a portion that is sloped relative to an exterior of the housing (Schaller, Fig. 8, distance between exterior of track in 136 and exterior of housing 138 changes, and thus is relatively “sloped”).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Warring as applied to Claim 1 above, and further in view of Viera.
Warring describes a device substantially as claimed by Applicant; see above. It does not, however, describe that:
the guide wheel further comprises an outer surface radially spaced from the inner surface and having a textured surface (Claim 16); or
the textured surface includes a plurality of ridges and valleys (Claim 17).
See above concerning Viera and Claims 16 and 17 in the double patenting rejection. Additionally, Viera (among other documents of record) teaches that such a device can be constructed so that there are only two wheels, a guide wheel and a support wheel, rather than Warring’s three-wheel design, which a person of ordinary skill in the art would immediately appreciate reduces complexity of the device, and thus cost, while fully retaining the functionality of Warring’s device.
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 Warring’s device such that the guide wheel further comprises an outer surface radially spaced from the inner surface and having a textured surface, and the textured surface includes a plurality of ridges and valleys, because Viera teaches doing so for the aforementioned reasons.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure as having been cited in the parent application.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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