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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/17/2026 has been entered.
Response to Amendment
The Amendments filed January 16, 2026 have been entered. Applicant’s amendments have overcome the 112(b) rejection previously set forth in the Final Office Action mailed on 11/17/2025. Currently, claims 1-2, 7-8, 13, 16, and 19 have been amended, claim 6 has been cancelled, and claims 1-4 and 7-11, 13, 16-17, 19-20 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 16 is rejected to because it is dependent on a cancelled claim. For examination purposes and to advance prosecution, Examiner will treat claim 16 as being dependent on claim 13. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 8-11 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.
Claim 8 recites the limitation "the tube" in line 11. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this tube is referring to the “elongate tube”, “tube proximal portion”, “tube distal portion”, or “tube distal end”. For examination purposes, Examiner will treat the tube as being the elongate tube. Claims 9-11 are also rejected because they are dependent on claim 8.
Claim 10 recites the limitation "the tube" in line 2. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this tube is referring to the “elongate tube”, “tube proximal portion”, “tube distal portion”, or “tube distal end” previously cited in independent claim 8. For examination purposes, Examiner will treat the tube as being the elongate tube.
Claim 11 recites the limitation "the tube" in line 1. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this tube is referring to the “elongate tube”, “tube proximal portion”, “tube distal portion”, or “tube distal end” previously cited in independent claim 8. For examination purposes, Examiner will treat the tube as being the elongate tube.
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.
Claims 1-4, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (U.S. Patent No. 8702692 B2), in view of Appling (U.S. Application No. 20160106501 A1), and further in view of Christian (U.S. Application No. 20140163548 A1).
Regarding independent claim 1, and claim 7, Davies discloses a system for use in puncturing a pericardium (226) of a patient’s heart (Col. 2, lines 31-34), the system comprising:
a stylet (100) (Col. 5, lines 42-46 & Figs. 1A, 1D) comprising:
an elongate shaft (102) having a proximal portion (104) and a distal portion (108) (Col. 5, lines 42-46), wherein the shaft comprises a metallic body (122) (Col. 6, lines 14-15) and is rigid (Col. 16, lines 34-36), and wherein the distal portion defines a distal end that is blunt (see Fig. 1D);
a radiofrequency puncture electrode (112) at the distal end of the shaft (Col. 5, lines 50-54; Col. 15, lines 32-33), wherein the radiofrequency puncture electrode is electrically connectable to a radiofrequency generator (not shown) (Col. 9, lines 8-12); and
a hub (118) joined to the proximal portion of the shaft, wherein the hub is configured to electrically connect the metallic body to the radiofrequency generator, for delivery of radiofrequency energy along the metallic body from the proximal portion of the shaft to the radiofrequency puncture electrode (Col. 6, lines 8-10);
wherein the elongate shaft includes a longitudinally extending lumen (120) coupled to a fluid port (i.e., distal end of the lumen) (Col. 6, lines 10-14); and
an introducer (224) comprising a lumen for receiving the stylet (Col. 8, lines 50-59; Col. 15, lines 66-67 – Col. 16, lines 1-3 & Figs. 5A-5D).
However, Davies does not disclose the proximal portion of the elongate shaft includes a lock for securing the shaft to the introducer, nor the introducer having an outer layer and an inner reinforcing layer, the outer layer extending distally of the inner reinforcing layer to form a distal tip.
Appling, in the same field of endeavor, teaches a sheath (1) (analogous to the introducer of Davies) comprising a shaft/outer layer (3), a lumen (4), a hub (2), and a distal tip (5) (pa. 0031 & Figs. 1-2), wherein the shaft/outer layer is comprised of a translucent material or other natural polymer material (pa. 0035) and is reinforced with a wire/inner reinforcing layer (8) that is embedded within the shaft/outer layer for the purpose of enhancing maneuverability during insertion and advancement through a target tissue (pa. 0039). As seen in Fig. 2, the shaft/outer layer extends distally of the wire/inner reinforcing layer to form the distal tip.
Furthermore, Appling teaches a dilator (17) (analogous to the stylet of Davies) which is inserted and advanced through the distal tip of the sheath (pa. 0032 & Figs. 5-6), wherein a proximal end of the dilator includes a male luer fitting (19) that creates a threaded connection with the dilator hub (pa. 0047, 0050); thereby, securing the dilator to the sheath.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the introducer of Davies with the introducer taught by Appling for the purpose of providing an introducer with a reinforced shaft that provides increased resistance to kinking during insertion and advancement (Appling, pa. 0039).
Moreover, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the luer connection lock taught by Appling to the system of Davies in order to provide further stabilization to the stylet when inserted into the introducer, as well as avoiding unwanted separation during a procedure.
However, Davies/Appling combination do not disclose the fluid port being disposed proximally to the radiofrequency puncture electrode.
Christian, in the same field of endeavor, teaches an ablation electrode assembly (10) comprising an elongate catheter shaft (18) with an RF electrode (46) at its distal end (pa. 0033-0034 & Figs. 1, 3), wherein the shaft comprises an irrigation passageway (62) with a distal port (108) (pa. 0063) for delivering fluid proximal to the electrode in order to reduce char and coagulum formation, thereby enabling greater energy delivery during RF ablation (pa. 0043).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the port of Davies to be located on the side and proximal to the puncture electrode of Davies, in order to reduce char and coagulum formation and enabling greater RF energy delivery (Christian, pa. 0043).
Regarding claim 2, Davies/Appling/Christian combination discloses wherein the shaft comprises an electrically insulative material (116) on the metallic body (Davies, Col. 6, lines 3-5 & Fig. 1D).
Regarding claim 3, Davies/Appling/Christian combination discloses wherein the radiofrequency puncture electrode comprises an electrically exposed tip (Davies, i.e., proximal portion of the electrode that is electrically connected to the metallic portion) of the metallic body.
Regarding claim 4, Davies/Appling/Christian combination discloses wherein the radiofrequency puncture electrode comprises a metallic piece (i.e., the conductive material of the electrode) joined to the metallic body (Davies, Col. 6, lines 6-7).
Examiner is highlighting the various techniques explicitly described in similar embodiments, such as welding and soldering methods, to electrically connect two conductive regions together to allow radiofrequency energy to flow from the metallic body to the electrode at the distal end of the shaft.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (U.S. Patent No. 8702692 B2), in view of Appling (U.S. Application No. 20160106501 A1), and further in view of Wegrzyn (U.S. Application No. 20180036060 A1).
Regarding independent claim 8, Davies discloses a system of medical devices for use in puncturing a pericardium (226) of a patient’s heart (Col. 2, lines 31-34 & Figs. 1A-1D, 5A-5D), the system comprising:
a radiofrequency generator (not shown) (Col. 9, lines 8-12);
a stylet (100) comprising (i) an elongate shaft (102) having a shaft proximal portion (104) and a shaft distal portion (108) defining a shaft distal end (Col. 5, lines 42-46 & Figs. 1A, 1D), wherein the shaft is rigid (Col. 16, lines 34-36), and (ii) a radiofrequency puncture electrode (112) at the shaft distal end (Col. 5, lines 50-54; Col. 15, lines 32-33), wherein the radiofrequency puncture electrode is electrically connectable to the radiofrequency generator (Col. 9, lines 8-12); and
an introducer (224) comprising an elongate tube extending between a tube proximal portion and a tube distal portion defining a tube distal end (Col. 8, lines 50-59 & Fig. 5A-5D), wherein the shaft is receivable in the tube (the elongate tube) with the electrode proud of the tube distal end (see Figs. 5C-5D);
wherein the shaft is configured to be slidably received within the elongate tube.
However, Davies does not disclose the tube proximal portion having a first diameter, the tube distal portion, including a distal tip having a second diameter that is less than the first diameter, and wherein the elongate tube includes an outer layer and an inner reinforcing layer, the outer layer extending distally of the inner reinforcing layer to form the distal tip.
Appling, in the same field of endeavor, teaches a sheath (1) (analogous to the introducer of Davies) comprising a shaft/outer layer (3), a lumen (4), a hub (2), and a distal tip (5) (pa. 0031 & Figs. 1-2), wherein the shaft/outer layer is comprised of a translucent material or other natural polymer material (pa. 0035) and is reinforced with a wire/inner reinforcing layer (8) that is embedded within the shaft/outer layer for the purpose of enhancing maneuverability during insertion and advancement through a target tissue (pa. 0039). As seen in Fig. 2, the shaft/outer layer extends distally of the wire/inner reinforcing layer to form the distal tip. Also seen in Fig. 2 is the distal tip including a tapered outer profile which aids in insertion and advancement of the sheath (pa. 0032), wherein a proximal portion of the sheath has a first diameter (approximately 0.079″), a distal portion of the sheath, including the distal tip has a second diameter (approximately 0.058″) that is less than the first diameter (pa. 0032).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the introducer of Davies with the introducer taught by Appling for the purpose of providing an introducer with a reinforced shaft that provides increased resistance to kinking during insertion and advancement (Appling, pa. 0039).
However, Davies/Appling combination do not teach wherein the distal tip has a length of between 1 cm and about 4 cm.
Wegrzyn, in the same field of endeavor, teaches a removable stylet (140) slidably received inside probe (100) (pa. 0060 & Figs. 1A-1C), wherein the probe comprises a distal tip (101) with a length of about 20mm (2cm) (pa. 0059).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the distal tip to be within the range of 1cm-4cm, as taught by Wegrzyn, for the purpose of properly penetrating the targeted tissue.
Regarding claim 9, Davies/Appling/Wegrzyn combination discloses wherein the shaft distal end is blunt (Davies, see Fig. 1D).
Regarding claim 10, Davies discloses the shaft being received in the tube and the electrode proud of the tube distal end (see Figs. 5A-5D).
However, Davies/Wegrzyn combination do not disclose wherein the stylet is lockable to the introducer.
Appling, in the same field of endeavor, teaches a dilator (17) (analogous to the stylet of Davies) which is inserted and advanced through the distal tip of the sheath (pa. 0032 & Figs. 5-6), wherein a proximal end of the dilator includes a male luer fitting (19) that creates a threaded connection with the dilator hub (pa. 0047, 0050); thereby, securing the dilator to the sheath.
Moreover, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the luer connection lock taught by Appling to the system of Davies in order to provide further stabilization to the stylet when inserted into the introducer, as well as avoiding unwanted separation during a procedure.
Regarding claim 11, Davies discloses the shaft comprising a metallic body (122) (Col. 6, lines 14-15), and the distal end of the introducer (224) is comprised of a compliant (yielding) material to further facilitate forming a seal with the parietal pericardium (801) (Col. 17, lines 15-17).
However, Davies does not explicitly disclose the tube comprises an electrically insulative material.
Appling, in the same field of endeavor, teaches the sheath (1) comprises a shaft/outer layer (3) (pa. 0031 & Figs. 1-2), wherein the shaft/outer layer is comprised of a translucent material such as nylon or other natural polymer material such as Teflon or polyethylene (pa. 0035), and the distal tip includes an outer layer (16) also made from a translucent material (pa. 0033) in order to provide a smooth, low-friction outer surface during insertion, advancement and withdrawal of the device through the tissue (pa. 0034).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the introducer of Davies with the introducer taught by Appling, which includes the insulative materials, for the purpose of providing an introducer with a smooth, low-friction outer surface during insertion, advancement and withdrawal of the device through the tissue (Appling, pa. 0034).
Claims 13, 16-17, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (U.S. Patent No. 8702692 B2), and further in view of Appling (U.S. Application No. 20160106501 A1).
Regarding independent claim 13, Davies discloses a method for puncturing a pericardium of a patient's heart (Col. 2, lines 31-34 & Figs. 1A-1D, and 5A-5D):
positioning a stylet (100, 200) having a distal electrode (112, 212) (Col. 5, lines 50-54; Col. 15, lines 32-33) in an introducer (224) such that the electrode extends beyond a distal end of the introducer (see Fig. 5D), the introducer comprising an elongate tube having a proximal portion and a distal tip (see Figs. 5A-5D);
percutaneously advancing the stylet and the introducer towards the patient’s heart (Col. 8, lines 34-38 & Figs. 2A-2F);
delivering radiofrequency energy from the distal electrode (112, 212) of the stylet to puncture the pericardium of the patient’s heart (Col. 9, lines 8-12).
However, Davies does not disclose the proximal portion of the elongate tube having a first diameter and the distal tip of the elongate tube having a second diameter that is less than the first diameter, the elongate tube including an outer layer and an inner reinforcing layer, the outer layer extending distally of the inner reinforcing layer to form the distal tip.
Appling, in the same field of endeavor, teaches a sheath (1) (analogous to the introducer of Davies) comprising a shaft/outer layer (3), a lumen (4), a hub (2), and a distal tip (5) (pa. 0031 & Figs. 1-2), wherein the shaft/outer layer is comprised of a translucent material or other natural polymer material (pa. 0035) and is reinforced with a wire/inner reinforcing layer (8) that is embedded within the shaft/outer layer for the purpose of enhancing maneuverability during insertion and advancement through a target tissue (pa. 0039). As seen in Fig. 2, the shaft/outer layer extends distally of the wire/inner reinforcing layer to form the distal tip. Also seen in Fig. 2 is the distal tip including a tapered outer profile which aids in insertion and advancement of the sheath (pa. 0032), wherein a proximal portion of the sheath has a first diameter (approximately 0.079″), a distal portion of the sheath, including the distal tip has a second diameter (approximately 0.058″) that is less than the first diameter (pa. 0032).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the introducer of Davies with the introducer taught by Appling for the purpose of providing an introducer with a reinforced shaft that provides increased resistance to kinking during insertion and advancement (Appling, pa. 0039).
Regarding claim 16, as best understood, Davies/Appling combination discloses further comprising advancing a distal end of the stylet and the distal end of the introducer through the puncture (Davies, Col. 9, lines 33-37).
Regarding claim 17, Davies/Appling combination discloses further comprising retracting the stylet from the introducer (Davies, Col. 14, lines 21-25).
Regarding claim 19, Davies discloses the stylet (100, 200) configured to be inserted inside the introducer (Col. 8, lines 50-52 & Fig. 2C-2D).
However, Davies does not disclose the stylet being locked to the introducer.
Appling, in the same field of endeavor, teaches a dilator (17) (analogous to the stylet of Davies) which is inserted and advanced through the distal tip of the sheath (pa. 0032 & Figs. 5-6), wherein a proximal end of the dilator includes a male luer fitting (19) that creates a threaded connection with the dilator hub (pa. 0047, 0050); thereby, securing the dilator to the sheath.
Moreover, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the luer connection lock taught by Appling to the system of Davies in order to provide further stabilization to the stylet when inserted into the introducer, as well as avoiding unwanted separation during a procedure.
Regarding claim 20, Davies/Appling combination discloses further comprising delivering a contrast agent through the stylet and out of a port (i.e., distal end of lumen 120) of the stylet (Davies, Col. 6, lines 10-14; Col. 8, lines 9-12).
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 13 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Application No. 20230149067 A1 in view of Appling (U.S. Application No. 20160106501 A1).
Regarding instant claim 13, it is the Examiner’s position that copending independent claims 1 and 11 are narrower in some aspects given that the copending claims recite a plurality of the limitations that overlap, or otherwise narrower in scope than, those in instant claim 13. These narrower aspects include the claimed stylet, a radiofrequency electrode, and an introducer. With respect to the narrower aspects, the Examiner notes that it has been held that the generic aspects of the instant invention would be anticipated by the narrower species aspects of the copending claim. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
With respect to the broader aspects of the copending claim, the Examiner notes that the difference between the instant claim 13 and the copending claims 1 and 11 exists in that the copending claims 1 and 11 fail to provide “the introducer comprising an elongate tube having a proximal portion with a first diameter and a distal tip with a second diameter that is less than the first diameter, the elongate tube including an outer layer and an inner reinforcing layer, the outer layer extending distally of the inner reinforcing layer to form the distal tip”. Appling, however, provides for a similar device as that of the copending claim and specifically contemplates substituting the introducer of the copending claims with the introducer/sheath taught by Appling to compensate for changes in the diameter and to include the outer layer and the inner reinforcing layer (pa. 0032, 0035, 0039 & Figs. 1-2). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have substituted the introducer of the copending application for the purpose of providing an introducer with a reinforced shaft that provides increased resistance to kinking during insertion and advancement (Appling, pa. 0039).
With respect to dependent claim 16, see copending application independent claim 1.
Claims 13 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, and 15 of U.S. Patent No. 20230181236 A1 in view of Davies (U.S. Patent No. 8702692 B2).
Regarding instant claim 13, it is the Examiner’s position that copending independent claims 1, 12, and 15 are narrower in some aspects given that the copending claims recite a plurality of the limitations that overlap, or otherwise narrower in scope than, those in instant claim 13. These narrower aspects include the claimed stylet, a radiofrequency electrode, and an introducer. With respect to the narrower aspects, the Examiner notes that it has been held that the generic aspects of the instant invention would be anticipated by the narrower species aspects of the copending claim. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
With respect to the broader aspects of the copending claim, the Examiner notes that the difference between the instant claim 13 and the copending claims 1 and 11 exists in that the copending claims 1 and 11 fail to provide “the introducer comprising an elongate tube having a proximal portion with a first diameter and a distal tip with a second diameter that is less than the first diameter, the elongate tube including an outer layer and an inner reinforcing layer, the outer layer extending distally of the inner reinforcing layer to form the distal tip”. Appling, however, provides for a similar device as that of the copending claim and specifically contemplates substituting the introducer of the copending claims with the introducer/sheath taught by Appling to compensate for changes in the diameter and to include the outer layer and the inner reinforcing layer (pa. 0032, 0035, 0039 & Figs. 1-2). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have substituted the introducer of the copending application for the purpose of providing an introducer with a reinforced shaft that provides increased resistance to kinking during insertion and advancement (Appling, pa. 0039).
With respect to dependent claim 16, see copending application independent claim 15.
Response to Arguments
Applicant’s arguments, on page 1-2, filed 01/16/2026, with respect to either the Davies reference alone or in combination with the Cosman, Christian, Wegrzyn references not disclosing the newly amended features of each of the independent claims 1, 8, and 13 which includes, “an introducer comprising a lumen for receiving the stylet, the introducer having an outer layer and an inner reinforcing layer, the outer layer extending distally of the inner reinforcing layer to form a distal tip”, have been fully considered and are persuasive. Therefore, the prior rejections based on the references previously used have been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-4, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (U.S. Patent No. 8702692 B2), in view of Appling (U.S. Application No. 20160106501 A1), and further in view of Christian (U.S. Application No. 20140163548 A1).
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (U.S. Patent No. 8702692 B2), in view of Appling (U.S. Application No. 20160106501 A1), and further in view of Wegrzyn (U.S. Application No. 20180036060 A1).
Claims 13, 16-17, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (U.S. Patent No. 8702692 B2), and further in view of Appling (U.S. Application No. 20160106501 A1).
It is the Examiner’s position that the newly filed rejections based on the combinations above are tenable for at least the reasoning set forth in the action above.
Conclusion
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794