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 .
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-15 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-15 of prior U.S. Patent No. 12048792B2. This is a statutory double patenting rejection.
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 6-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17 of U.S. Patent No. 12161790 Although the claims at issue are not identical, they are not patentably distinct from each other because:
claim16 of the current application discloses A preformed peritoneal dialysis (PD) catheter (Claim 15 of the Patent see Col 7, line 20 up to Col. 8, line13) comprising: a preformed weighted anchor, wherein the weighted anchor comprises: a preformed curled watertight sleeve having distal ends (Claim 15 of the Patent see Col 7, line 20 up to Col. 8, line13); at least two plugs, each affixable to each of the distal ends of the preformed curled watertight weight sleeve to form a watertight chamber within the preformed curled watertight sleeve (Claim 15 of the Patent see Col 7, line 20 up to Col. 8, line13); a plurality of outer weights, wherein the plurality of outer weights are enclosed within the watertight chamber and form an internal watertight chamber between the plurality of outer weights; and at least one inner weight, wherein the at least one inner weight is disposed between the plurality of outer weights in the internal watertight chamber (Claim 15 of the Patent see Col 7, line 20 up to Col. 8, line13). Note that claim 16 of the current application is Browder than claim 15 of the patent which discloses an inner sheath.
Also claim 17 (Claim 15 of the Patent see Col 7, line 20 up to Col. 8, line13) , claim 18 ( Claim 16 of the Patent see Col 8, lines 14-16), claim 19 ( Claim 17 of the Patent see Col 8, lines 17-18), claim 20 (Claim 15 of the Patent see Col 7, line 20 up to Col. 8, line13).
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) 1-7, 10-17, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tolkoff. (US 4,654,036) in view of Esashi et al. (US. 3799186) (” Esashi”).
Re Claim 1, Tolkoff discloses a peritoneal weighted dialysis (PD) catheter anchor (Figs. 1-2) comprising: two distal ends (close to 25 and 26, Fig. 2); at least two plugs (25, 26), each affixable to each of the distal ends to form a watertight chamber within the watertight sleeve (Fig, 2); and further it discloses a sleeve between the two distal ends ( sleeve for 20, Fig. 2) comprises a plurality of outer weights (20), wherein the plurality of outer weights are enclosed within the watertight chamber (Fig. 2), but it fails to discloses a plurality of preformed segmented watertight weight sleeves between the two distal ends, wherein each of the plurality of preformed segmented watertight weight sleeves comprises a plurality of outer weights.
However, Esashi discloses a tube (Fig. 1-2) has a segmented watertight weight sleeve (25, ¶0057) between the two distal ends ( close to 2b, 2a), wherein each of the plurality of preformed segmented watertight weight sleeve comprises plurality of weight (22).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the catheter anchor of Tolkoff to include sleeve so that the anchor has a plurality of preformed segmented watertight weight sleeves between the two distal ends, wherein each of the plurality of preformed segmented watertight weight sleeves comprises a plurality of outer weights as taught by Esashi for the purpose of easily to bend and manipulation during insertion to the body cavity (Esashi, abstract, ¶0049, ¶0053, note several sleeves are added similar to the sleeve of Esashi to increase the flexibly of bending).
Re Claim 2, the modified Tolkoff discloses the plurality of preformed segmented watertight sleeves comprises medical grade silicone tubing. (Esashi, ¶0057).
Re Claim 3, Tolkoff discloses the plugs comprise biologically inert material selected from the group consisting of stainless steel, titanium, or medical grade polymers (Col. 3, lines 49-53).
Re Claim 4, Tolkoff fails to disclose wherein the plurality of outer weights each comprise stainless steel weights.
However, Esashi discloses a tube (Fig. 1-2) has a segmented watertight weight sleeve (25, ¶0057) between the two distal ends ( close to 2b, 2a), wherein each of the plurality of preformed segmented watertight weight sleeve comprises plurality of weight (22) made from stainless steel (¶0057).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the weights of Tolkoff so that the plurality of outer weights each comprise stainless steel weights as taught by Esashi for the purpose of using an art recognized material that can be inserted inside the body (Esashi, abstract, ¶0057).
Re Claim 5, Tolkoff discloses further comprising at least one inner weight disposed between the plurality of outer weights (at least the middle one is the inner weight, Fig. 2).
Re Claim 6, Tolkoff fails to disclose wherein the at least one inner weight comprises a biologically inert material selected from the group consisting of stainless steel, titanium, or tungsten.
However, Esashi discloses a tube (Fig. 1-2) has a segmented watertight weight sleeve (25, ¶0057) between the two distal ends ( close to 2b, 2a), wherein each of the plurality of preformed segmented watertight weight sleeve comprises the inner (middle) weight (22) made from stainless steel (¶0057).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the at least inner weight of Tolkoff so that the at least one inner weight comprises a biologically inert material selected from the group consisting of stainless steel, titanium, or tungsten as taught by Esashi for the purpose of using an art recognized material that can be inserted inside the body (Esashi, abstract, ¶0057).
Re Claim 7, Tolkoff fails to disclose wherein each of the plurality of preformed segmented watertight weight sleeves further comprise an inner sheath for biologically isolating the at least one inner weight.
However, Esashi discloses a tube (Fig. 1-2) has a segmented watertight weight sleeve (25, ¶0057) and an inner sheath for biologically isolating the at least one inner weight (51, 21b. ¶0057).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the at least inner weight of Tolkoff so that each of the plurality of preformed segmented watertight weight sleeves further comprise an inner sheath for biologically isolating the at least one inner weight as taught by Esashi for the purpose of using an art recognized material that can be inserted inside the body (Esashi, abstract, ¶0057).
Re Claim 10, Tolkoff discloses a preformed peritoneal dialysis (PD) catheter (Fig. 1-2, abstract) comprising: a preformed weighted anchor ( 12), wherein the weighted anchor comprises: a preformed watertight sleeve (12) having distal ends (ends close to plugs 25, 26); at least two plugs (25, 26), each affixable to each of the distal ends of the preformed curled watertight weight sleeve to form a watertight chamber within the preformed curled watertight sleeve (Fig. 2); a plurality of outer weights (top 3 of 20 and lower 3 of 20), wherein the plurality of outer weights are enclosed within the watertight chamber and form an internal watertight chamber between the plurality of outer weights (chamber between the third one of 20 from top and third one of 20 from the bottom, Fig. 2); and at least one inner weight ( middle 20), wherein the at least one inner weight is disposed between the plurality of outer weights in the internal watertight chamber ( Fig. 2), but it fails to disclose that sleeve is a curled watertight sleeve
However, Esashi discloses a tube (Fig. 1-2) has a segmented watertight weight sleeve (25, ¶0057) is curled watertight sleeve (Fig. 2).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the catheter anchor of Tolkoff so that as taught by Esashi for the purpose of easily to bend and manipulation during insertion to the body cavity (Esashi, abstract, ¶0049, ¶0053).
Re Claim 11, Tolkoff discloses wherein the preformed curled watertight sleeve comprises medical grade silicone tubing (Col. 3, lines 36-48).
Re Claim 12, Tolkoff discloses wherein the plugs comprise biologically inert material selected from the group consisting of stainless steel, titanium, or medical grade polymers (Col. 3, lines 36-48).
Re Claim 13, Tolkoff fails to disclose wherein the plurality of outer weights each comprise stainless steel weights.
However, Esashi discloses a tube (Fig. 1-2) has a segmented watertight weight sleeve (25, ¶0057) between the two distal ends ( close to 2b, 2a), wherein the plurality of outer weights each comprise stainless steel weights (¶0057).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the weights of Tolkoff so that the plurality of outer weights each comprise stainless steel weights as taught by Esashi for the purpose of using an art recognized material that can be inserted inside the body (Esashi, abstract, ¶0057).
Re Claim 14, Tolkoff discloses wherein the at least one inner weight comprises a biologically inert material selected from the group consisting of stainless steel, titanium, or tungsten (Col. 3, lines 20-35).
Re Claim 15, Tolkoff discloses an inner sheath for biologically isolating the at least one inner weight.
However, Esashi discloses a tube (Fig. 1-2) has a segmented watertight weight sleeve (25, ¶0057) and an inner sheath for biologically isolating the at least one inner weight (51, 21b. ¶0057).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the at least inner weight of Tolkoff so that an inner sheath for biologically isolating the at least one inner weight as taught by Esashi for the purpose of using an art recognized material that can be inserted inside the body (Esashi, abstract, ¶0057).
Re claim 16, Esashi discloses a preformed weighted peritoneal dialysis (PD) catheter anchor (Fig. 1-2) comprising: a preformed straight watertight sleeve having distal ends ( sleeve contain 20 has end close to 25 and end close to 26), wherein the preformed straight watertight sleeve comprises medical grade silicone tubing (Col. 3, lines 36-48); at least two plugs (25, 26), each affixable to each of the distal ends of the preformed straight watertight weight sleeve to form a watertight chamber within the watertight sleeve ( Fig, 2), wherein the plugs comprise biologically inert material selected from the group consisting of stainless steel, titanium, or medical grade polymers (Col. 3, lines 50-60); a plurality of outer weights ( top three and lower three of weights 20), wherein the plurality of outer weights are enclosed within the watertight chamber (Fig. 2) and form an internal watertight chamber between the plurality of outer weights (Fig, 2), and at least one inner weight ( middle 20), wherein the at least one inner weight is disposed between the plurality of outer weights in the internal watertight chamber (Fig. 2), and wherein the at least one inner weight comprises a biologically inert material selected from the group consisting of stainless steel, titanium, or tungsten (Col. 3, lines 20-35), but it fails to disclose that the plurality of outer weights each comprise stainless steel wrights.
However, Esashi discloses a tube (Fig. 1-2) has a segmented watertight weight sleeve (25, ¶0057) between the two distal ends ( close to 2b, 2a), wherein the plurality of outer weights each comprise stainless steel weights (¶0057).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the weights of Tolkoff so that the plurality of outer weights each comprise stainless steel weights as taught by Esashi for the purpose of using an art recognized material that can be inserted inside the body (Esashi, abstract, ¶0057).
Re Claim 17, Tolkoff fails to disclose further comprising an inner sheath for biologically isolating the at least one inner weight from body fluid contact.
However, Esashi discloses a tube (Fig. 1-2) has a segmented watertight weight sleeve (25, ¶0057) and an inner sheath for biologically isolating the at least one inner weight (51, 21b. ¶0057).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the at least inner weight of Tolkoff so that an inner sheath for biologically isolating the at least one inner weight from body fluid contact as taught by Esashi for the purpose of using an art recognized material that can be inserted inside the body (Esashi, abstract, ¶0057).
Re claim 20, Esashi discloses further comprising a preformed curled PD catheter ( the catheter is capable to be curled PD catheter).
Claim(s) 8-9, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tolkoff. in view of Esashi and further in view of Haarala (US 2003/0004520A1).
Re claims 8-9, Tolkoff fails to disclose comprising an anchoring suture and the anchoring suture comprises at least one hook.
However, Haarala discloses the anchor further comprising an anchoring suture that comprises one hook (¶0046).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the anchor of Tolkoff so that the anchor further comprising an anchoring suture that comprises one hook as taught by Haarala for the purpose of using subcutaneous hooks to anchor the patient's skin to the device (Haarala, Fig. 6, and ¶0046).
Re claims 18-19, Tolkoff fails to disclose comprising an anchoring suture and the anchoring suture comprises at least one hook.
However, Haarala discloses the anchor further comprising an anchoring suture that comprises one hook (¶0046).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the anchor of Tolkoff so that the anchor further comprising an anchoring suture that comprises one hook as taught by Haarala for the purpose of using subcutaneous hooks to anchor the patient's skin to the device (Haarala, Fig. 6, and ¶0046).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
