DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1-15 are rejected under the judicially created doctrine of obviousness-type double patenting as unpatentable over claims 1-11 of U.S. Patent No. 12,076,475.
Regarding application claim 1, For double patenting to exist between application claim 1 and patent claim 1, it must be determined that application claim 1 is not patentably distinct from patent claim 1. In order to make this determination, it first must be determined whether there are any differences between application claim 1 and patent claim 1 and, if so, whether those differences render the claims patentably distinct.
Patent claim 1 recites all of the elements of application claim 1, with additional elements, with two main differences in the wording between the elements of patent claim 1 and application claim 1. Patent claim 1 recites “the catheter connector comprising: … a barbed extension distal of the body configured for insertion into a lumen of the catheter” and “the sleeve having a retracted position exposing the catheter connector to permit a distal end of the catheter to be coupled thereto”, while application claim 1 recites “the catheter connector comprising: … a barbed extension distal of the body configured for insertion into a distal opening of a catheter” and “the sleeve having a retracted position exposing the catheter connector for coupling the catheter to the catheter connector via the barbed extension”. In order for the barbed extension of patent claim 1 to be inserted into the lumen of the catheter, it would need to be inserted through an opening of some kind, and because it connects to the distal end of the catheter when the sleeve is retracted, the barbed extension of patent claim 1 is configured for insertion into a distal opening in the catheter. Therefore, patent claim 1 recites all the elements of application claim 1, with additional elements.
The difference between application claim 1 and patent claim 1 lies in the fact that the patent claim includes many more elements and is thus more specific. Thus, the invention of patent claim 1 is in effect a “species” of the “generic” invention of application claim 1. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claim 1 is anticipated by patent claim 1, it is not patentably distinct from patent claim 1.
Regarding application claims 2, 9-12, and 15, patent claims 2, 5-8, and 11, which are dependent on patent claim 1, recite all the elements of application claims 2, 9-12, and 15 respectively, which are dependent on application claim 1. Therefore, because application claim 1 is not patentably distinct from patent claim 1, application claims 2, 9-12, and 15 are not patentably distinct from patent claims 2, 5-8, and 11, respectively.
Regarding application claim 3, patent claim 3, which is dependent on patent claim 2, recites all the elements of application claim 3, which is dependent on application claim 2. Therefore, because application claim 2 is not patentably distinct from patent claim 2, application claim 3 is not patentably distinct from patent claim 3.
Regarding application claim 4, patent claim 4, which is dependent on patent claim 3, recites all the elements of application claim 4, which is dependent on application claim 3. Therefore, because application claim 3 is not patentably distinct from patent claim 3, application claim 4 is not patentably distinct from patent claim 4.
Regarding application claims 5-8, patent claim 1 further recites all the elements of application claims 5-8.
Regarding application claims 13-14, patent claims 9-10, which are dependent on patent claim 8, recite all the elements of application claims 13-14 respectively, which are dependent on application claim 12. Because application claim 12 is not patentably distinct from patent claim 8, application claims 13-14 are not patentably distinct from patent claims 9-10, respectively.
Claim Rejections - 35 USC § 103
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 following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 8, 11, and 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Braga (US 2005/0228364 A1) in view of Canaud et al. (US 2004/0193119 A1).
Regarding claim 1, Braga discloses a subcutaneous tunneling device (Fig. 1A, feat. 10; ¶0013-0015, 0025, and 0028), comprising a shaft (14; ¶0027); a catheter connector extending from a distal end of the shaft (Figs. 1A-1B; 12; ¶0026), the catheter connector comprising: a body including a gripping portion (Fig. 1B, feat. 13; ¶0028); and a barbed (28) extension distal of the body configured for insertion into a distal opening of a catheter (Figs. 3A-B, feats. 20 and 26; ¶0026, 0028, and 0034); and a sleeve slidably mounted on the shaft (16; ¶0027), the sleeve having a retracted position exposing the catheter connector for coupling the catheter to the catheter connector via the barbed extension (Figs. 1A-1B; ¶0028, lines 1-13), and an extended position covering the catheter connector and the distal end of the catheter (Figs. 3A-3B; ¶0028, lines 13-16).
Braga is silent with respect to the bend in the shaft.
Canaud teaches a catheter port assembly (Fig. 1, feat. 100; ¶0038) comprising a tunneler attachment (300; ¶0044). Canaud teaches that the tunneler comprises a shaft that may comprise a bend (305; ¶0044) near the tip (308; ¶0045) that facilitates tunneling during catheter insertion (¶0044). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the claimed invention being made to modify the tunneling device so that the shaft includes a bend proximal of the catheter connector in order to facilitate tunneling during catheter insertion as taught by Canaud.
Regarding claim 2, Braga in view of Canaud discloses the subcutaneous tunneling device according to claim 1. Braga further discloses that the inner diameter of the proximal end of the sleeve is similar to the outer diameter of the shaft (Please see annotated figures 1a-1b, feat. A), while still allowing the sleeve to slide along the shaft (¶0028). If the bend of Canaud is introduced near the proximal end of the shaft, the sleeve would be inhibited from being removed from the proximal end of the shaft due to the proximal end of the sleeve catching on the inner side of the bend (Annotated figure 1b, feat. B). Therefore, in the tunneling device disclosed by Braga in view of Canaud, the bend is inherently configured to prevent the sleeve from sliding to a proximal end of the shaft.
Regarding claim 3, Braga in view of Canaud discloses the subcutaneous tunneling device according to claim 2. Braga further discloses that the sleeve has an outer surface that tapers proximally from a first diameter to a smaller second diameter [AltContent: textbox (Annotated figure 1: 1a is adapted from figure 2 of Braga. 1b is adapted from figure 3a of Braga. 1c is adapted from figure 1b of Braga. A is the inner diameter of the sleeve and outer diameter of the shaft. B is the inner side of the bend taught by Canaud introduced into the shaft of Braga. C is the taper of the inner bore of the sleeve. D is the stepped proximal end of the catheter connector.)](Fig. 2, feat. 32; ¶0027).
Regarding claim 4, Braga in view of Canaud discloses the subcutaneous tunneling device according to claim 3. Braga further discloses that the sleeve has an inner bore that tapers proximally from a third diameter to a smaller fourth diameter (Annotated figure 1a, feats. A and C – A is the smaller fourth diameter, and C is the taper of the inner bore). As discussed above with respect to claim 2, the inner diameter of the sleeve is similar to the outer diameter of the shaft (Annotated figure 1b, feat. A) which would cause the proximal end of the sleeve to catch on the inner side of the bend taught by Canaud when the sleeve is moved proximally (Annotated figure 1b, feat. B). Therefore, Braga in view of Canaud further discloses that the sleeve has an inner bore that tapers proximally from a third diameter to a smaller fourth diameter to stop a proximal end of the sleeve against the bend in the shaft in the retracted position.
Regarding claim 5, Braga in view of Canaud discloses the subcutaneous tunneling device according to claim 1. Braga further discloses that the body (Fig. 1B, feat. 13; ¶0028) includes a stepped proximal end attached to the distal end of the shaft (Annotated figure 1b-1c, feat. D).
Regarding claim 8, Braga in view of Canaud discloses the subcutaneous tunneling device according to claim 5. Braga further discloses that the sleeve (Figs. 2-3A, feat. 16; ¶0027) has an inner bore (Fig. 2) defining a shoulder (Annotated figure 1a-1b, feat. C) configured to abut the stepped proximal end of the body in the extended position (Annotated figure 1b-1c, feat. D).
Regarding claim 11, Braga in view of Canaud discloses the subcutaneous tunneling device according to claim 1. Braga teaches that the catheter connector comprises a pair of extensions (Fig. 1B, feat. 26; ¶0026) which each comprises a single barb (28). Therefore, Braga in view of Canaud discloses that the barbed extension includes a single barb.
Regarding claim 15, Braga in view of Canaud discloses the subcutaneous tunneling device according to claim 1. Braga further discloses that the tip of the tunneler is tapered (Fig. 1A, feat. 14; ¶0027) and Canaud further teaches that the tip of the tunneler beyond the bend is tapered (Fig. 1, feat. 308; Figs. 4-5, feat. 363; ¶0044-0046). Therefore, Braga in view of Canaud further discloses that the shaft tapers proximally from the bend to a smaller diameter.
Claims 6-7, 9-10, 12, and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Braga in view of Canaud and in further view of Feeley et al. (US 2007/0078396 A1).
Regarding claim 6, Braga in view of Canaud suggests the subcutaneous tunneling device according to claim 5, but is silent with respect to a nose stop opposite the stepped proximal portion.
Feeley teaches tunnelers for catheters (Figs. 1-2, feat. 100; Figs. 5-6, feat. 200; Figs. 7-10, feat. 300; Fig. 11, feat. 400; ¶0025, 0029, and 0037-0041) comprising a barbed extension (108, 216, 304, 404; ¶0026, 0030, and 0037-0041) for engaging the lumen of a catheter. Feeley teaches that the tunnelers have a cutout (110, 213; ¶0026 and 0031), stop surface (314; ¶0038), or receiving surface (406; ¶0041) which receives the tip of the catheter which advantageously streamlines the profile of the combined catheter and tunneler (¶0026). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the claimed invention being made to modify the tunneling device suggested by Braga in view of Canaud so that the body includes a nose stop opposite the stepped proximal end configured to provide an indication that the catheter connector has fully engaged the catheter in order to streamline the profile of the combined catheter and tunneler as taught by Feeley.
Regarding claim 7, Braga in view of Canaud and in further view of Feeley suggests the subcutaneous tunneling device according to claim 6. Feeley further teaches an embodiment in which the stop or receiving surface (Fig. 11, feat. 406; ¶0041) further comprises a lip (410) which mates with the tip of the catheter and advantageously assists with retaining the catheter in the tunneler (¶0041). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the claimed invention being made to modify the tunneling device suggested by Braga in view of Canaud and in further view of Feeley so that the nose stop includes a lip configured to mate with an outer surface of a distal end of the catheter when the barbed extension is inserted into the lumen of the catheter in order to assist with retaining the catheter as taught by Feeley.
Regarding claim 9, Braga in view of Canaud suggests the subcutaneous tunneling device of claim 1.
As discussed above, Feeley teaches tunnelers for catheters (Figs. 1-2, feat. 100; Figs. 5-6, feat. 200; Figs. 7-10, feat. 300; Fig. 11, feat. 400; ¶0025, 0029, and 0037-0041) comprising a barbed extension (108, 216, 304, 404; ¶0026, 0030, and 0037-0041) for engaging the lumen of a catheter. Feeley teaches an embodiment (Fig. 8) in which the barbed extension (316) is offset from the centerline of the tunneler so that the catheter is shifted off center when the barb is inserted into its lumen (¶0038). Feeley teaches that this further reduces the profile of the combined tunneler and catheter (¶0038). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the claimed invention being made to modify the tunneling device suggested by Braga in view of Canaud so that the barbed extension is offset from a central longitudinal axis of the catheter connector in order to reduce the profile of the tunneler/catheter combination as taught by Feeley.
Regarding claim 10, Braga in view of Canaud suggests the subcutaneous tunneling device according to claim 1. Braga is silent with respect to the material that the sleeve is made from.
As discussed above, Feeley teaches tunnelers for catheters (Figs. 1-2, feat. 100; Figs. 5-6, feat. 200; Figs. 7-10, feat. 300; Fig. 11, feat. 400; ¶0025, 0029, and 0037-0041). Feeley teaches an embodiment which comprises a sleeve made from high density polyethylene for covering the catheter (Figs. 6, 12, and 13, feat. 250; ¶0034). The sleeve disclosed by Braga (¶0027) and taught by Feeley (¶0034) both cover and protect the connection between the tunneling device and catheter. Therefore, the prior art contains each element claimed, with the only difference between the claimed invention and the prior art being the lack of a combination between the sleeve of the tunneling device suggested by Braga in view of Canaud and a polyethylene material in a single reference. One of ordinary skill in the art could have made a suitable sleeve for the tunneling device of Braga in view of Canaud out of polyethylene as demonstrated by the sleeve of Feeley being made of polyethylene, and recognized that a polyethylene sleeve would protect the connection between the tunneler and catheter, as demonstrated by Feeley. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the claimed invention being made to modify the tunneling device suggested by Braga in view of Canaud so that the sleeve comprises a polyethylene material as taught by Feeley. Please see MPEP §2143.I(A).
Regarding claim 12, Braga in view of Canaud suggests the subcutaneous tunneling device according to claim 1. Braga discloses a pair of barbed extensions each with a single barb (Fig. 1B, feats. 26 and 28). Therefore, the tunneling device of Braga in view of Canaud differs from the device of claim 12 by the substitution of an extension with a single barb for the claimed extension with a plurality of barbs.
As discussed above, Feeley teaches tunnelers for catheters (Figs. 1-2, feat. 100; Figs. 5-6, feat. 200; Figs. 7-10, feat. 300; Fig. 11, feat. 400; ¶0025, 0029, and 0037-0041) comprising a barbed extension (108, 216, 304, 404; ¶0026, 0030, and 0037-0041) for engaging the lumen of a catheter. Feeley teaches that the extension comprises multiple tapered barbs (Fig. 1, feat. 108; ¶0026). Therefore, an extension with a plurality of barbs was known in the art. One of ordinary skill in the art could have substituted the extension with a single barb of Braga with the extension with a plurality of tapered barbs of Feeley with the predictable result of the plurality of tapered barbs securing the protrusion in the lumen of the attached catheter as taught by Feeley. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the claimed invention being made to modify the tunneling device suggested by Braga in view of Canaud so that the barbed extension comprises a plurality of barbs as taught by Feeley. Please see MPEP §2143.I(B).
Regarding claim 14, Braga in view of Canaud and in further view of Feeley suggests the subcutaneous tunneling device according to claim 12. Feeley further teaches that the barbs are tapered (Fig. 1, feat. 108). Therefore, Braga in view of Canaud and in further view of Feeley suggests that the plurality of barbs are tapered.
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Braga in view of Canaud, in further view of Feeley, and in further view of DiMatteo et al. (US 2006/0100572 A1).
Regarding claim 13, Braga in view of Canaud and in further view of Feeley suggests the tunneling device according to claim 12. The tunneling device of Braga in view of Canaud and in further view of Feeley comprises a barbed extension with a plurality of tapered barbs (Feeley: Fig. 1, feat. 108) in contrast to the device of claim 13, which comprises a plurality of rounded barbs.
DiMatteo teaches a multi-lumen catheter (Fig. 1, feat. 100; ¶0053) and a tunneler therefor (Figs. 37-40, feat. 1270; ¶0075) which comprises an extension (1272) comprising rounded ribs or barbs (1276) which secure to the venous lumen of the catheter (¶0075). Therefore, a barbed extension comprising a plurality of rounded barbs was known in the prior art. One of ordinary skill in the art could have substituted the extension comprising a plurality of rounded barbs taught by DiMatteo for the extension comprising a plurality of tapered barbs disclosed by Braga in view of Canaud and in further view of Feeley, with the predictable result of the barbed extension continuing to secure the catheter as taught by DiMatteo. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior claimed invention being made to modify the tunneling device suggested by Braga in view of Canaud and in further view of Feeley so that the plurality of barbs are rounded as taught by DiMatteo. Please see MPEP §2143.I(B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Rome et al. (US 2006/0009783 A1) discloses a tissue tunneling device.
Voorhees et al. (US 2006/0015130 A1) discloses a catheter tunneler adapter.
Wortley et al. (US 2004/0230204 A1) discloses a flexible connection catheter tunneler.
Schweikert et al. (US 2005/0027282 A1) discloses a catheter tunneler adapter.
Stephens et al. (US 2004/0176739 A1) discloses a catheter tunneler and adapter.
Quinn (WO 2005/046778 A1) discloses a barbed catheter connector.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 5712727159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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