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 .
Response for Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19) in the reply filed on 7/1/2026 is acknowledged. Claims 1-19 read on the elected invention.
Election was made without traverse in the reply filed on 7/1/2026.
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 7 and 16 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 pre-AIA the applicant regards as the invention.
Regarding claims 7 and 16, the claim recites the limitations “wherein the elongated introducer may include multiple slots on the locking hub”. It is not clear to the examiner if everything after “may” is part of the invention or not resulting in the scope of the claim to be unclear. The word “may” introduces ambiguity in the claim. Appropriate correction is required.
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 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 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 of this title, 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 1-7, 9 and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Moriyama (US Pub No. 2021/0275246) in view of Carrillo (US Pub No. 2004/0162465).
Regarding claim 1, Moriyama discloses (Figures 1-2G) a radiofrequency perforation system (Figure 1A) for accessing a location in or near a patient's heart (Figures 2B-2G) (Paragraph 0027), the system comprising: a radiofrequency puncture wire (10) (Paragraph 0073) having a wire proximal portion and a wire distal portion including an electrically active distal tip (114d) (Figure 1A) (Paragraph 0073); and an elongated introducer (20) defining a lumen adapted to receive and allow longitudinal translation of the radiofrequency puncture wire therein (Figure 2F) (Paragraph 0156), the elongated introducer having an introducer proximal portion and an introducer distal portion (Figure 1A), the introducer proximal portion including a locking hub (21) (Figure 1E) (Paragraph 0111).
Moriyama fails to disclose wherein the locking hub includes a slot and an engaging surface configured so that the wire proximal portion can be positioned in the slot and against the engaging surface, so as to generate a securing frictional force between the wire proximal portion and the engaging surface, the securing friction force sufficient to inhibit the longitudinal translation of the radiofrequency puncture wire with respect to the elongated introduce.
Carrillo, in the analogous art of guidewire devices used in surgery, teaches a locking hub (192, 200) (Figure 9) that includes a slot (214) (Figure 10) and an engaging surface (tapered end surface as shown in Figure 10) configured so that a wire proximal portion (36) can be positioned in the slot and against the engaging surface (Figure 11) (Paragraph 0043), so as to generate a securing frictional force between the wire proximal portion and the engaging surface (Paragraph 0043). It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the locking hub of Moriyama to have included a slot and an engaging surface configured so that the wire proximal portion can be positioned in the slot and against the engaging surface, so as to generate a securing frictional force between the wire proximal portion and the engaging surface as taught by Carrillo, in order to facilitate the surgical procedure by freeing the physician from having to manually hold the wire in place while manipulating other devices (Carrillo, Paragraph 0048).
[Moriyama modified by Carrillo would result in the securing friction force to be sufficient to inhibit the longitudinal translation of the radiofrequency puncture wire with respect to the elongated introducer]
Regarding claim 2, Moriyama modified by Carrillo further discloses wherein the slot is a J-shaped opening (Carrillo, Figure 10).
Regarding claim 3, Moriyama modified by Carrillo further discloses wherein the slot further includes an entry slot (Carrillo, 218) (Figure 10).
Regarding claim 4, Moriyama modified by Carrillo further discloses wherein the slot further includes a locking slot (Carrillo, 222) (Figure 10).
Regarding claim 5, Moriyama modified by Carrillo further discloses wherein the wire proximal portion can be positioned in the entry slot and bent towards the locking slot (Carrillo, Figure 11) (Paragraph 0043).
Regarding claim 6, Moriyama modified by Carrillo discloses the invention above including that the wire proximal portion bends with respect to the locking hub (Carrillo, Figure 11) (Paragraph 0043) but fails to disclose wherein the wire proximal portion bends at about 45 degrees to 90 degrees with respect to the locking hub.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Moriyama modified by Carrillo to have the wire proximal portion to bend at about 45 degrees to 90 degrees with respect to the locking hub since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 7, Moriyama modified by Carrillo further discloses wherein the elongated introducer may include multiple slots on the locking hub (clearly shown in Figure 10 of Carrillo).
Regarding claim 9, Moriyama modified by Carrillo further discloses wherein the engaging surface is an interior surface of the slot that engages the wire proximal portion of the RF puncture wire (clearly shown in Figure 11 of Carrillo).
Regarding claim 11, Moriyama discloses (Figures 1-2G) a perforation system (Figure 1A) for epicardial or transeptal access (Figures 2B-2G) (Paragraph 0027), the system comprising: a dilator (30A) having a dilator body defining a dilator lumen and a tapered distal tip (Figure 1B), a puncture device (10) (Paragraph 0073) having a proximal portion and a distal portion including a distal tip (114d) (Figure 1A) (Paragraph 0073); and an elongated introducer (20) defining a lumen adapted to receive and allow longitudinal translation of the puncture device therein (Figure 2F) (Paragraph 0156), the elongated introducer having an introducer proximal portion and an introducer distal portion (Figure 1A), the introducer proximal portion including a locking hub (21) (Figure 1E) (Paragraph 0111).
Moriyama fails to disclose wherein the locking hub includes a slot and an engaging surface configured so that the proximal portion can be positioned in the slot and against the engaging surface, so as to generate a securing frictional force between the proximal portion and the engaging surface, the securing friction force sufficient to inhibit the longitudinal translation of the puncture device with respect to the elongated introduce.
Carrillo, in the analogous art of guidewire devices used in surgery, teaches a locking hub (192, 200) (Figure 9) that includes a slot (214) (Figure 10) and an engaging surface (tapered end surface as shown in Figure 10) configured so that a wire proximal portion (36) can be positioned in the slot and against the engaging surface (Figure 11) (Paragraph 0043), so as to generate a securing frictional force between the wire proximal portion and the engaging surface (Paragraph 0043). It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the locking hub of Moriyama to have included a slot and an engaging surface configured so that the proximal portion can be positioned in the slot and against the engaging surface, so as to generate a securing frictional force between the proximal portion and the engaging surface as taught by Carrillo, in order to facilitate the surgical procedure by freeing the physician from having to manually hold the puncture device in place while manipulating other devices (Carrillo, Paragraph 0048).
Regarding claim 12, Moriyama modified by Carrillo further discloses wherein the slot is a J-shaped opening (Carrillo, Figure 10).
Regarding claim 13, Moriyama modified by Carrillo further discloses wherein the slot further includes an entry slot (Carrillo, 218) (Figure 10) and a locking slot (Carrillo, 222) (Figure 10).
Regarding claim 14, Moriyama modified by Carrillo further discloses wherein the proximal portion of the puncture device is inserted into the slot via the entry slot and is manipulated by a user into the locking slot for the puncture device to be locked therein (Carrillo, Figure 11) (Paragraph 0043).
Regarding claim 15, Moriyama modified by Carrillo discloses the invention above including that the proximal portion bends with respect to the locking hub (Carrillo, Figure 11) (Paragraph 0043) but fails to disclose wherein the wire proximal portion bends at about 45 degrees to 90 degrees with respect to the locking hub.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Moriyama modified by Carrillo to have the proximal portion to bend at about 45 degrees to 90 degrees with respect to the locking hub since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 16, Moriyama modified by Carrillo further discloses wherein the elongated introducer may include multiple slots on the locking hub (clearly shown in Figure 10 of Carrillo).
Regarding claim 17, Moriyama modified by Carrillo further discloses wherein the puncture device is a radiofrequency puncture wire (Moriyama, Paragraph 0073).
Regarding claim 18, Moriyama modified by Carrillo further discloses wherein the engaging surface is an interior surface of the slot that engages the proximal portion of the puncture device (clearly shown in Figure 11 of Carrillo).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Moriyama (US Pub No. 2021/0275246) in view of Carrillo (US Pub No. 2004/0162465) as applied to claim 1 above, and further in view of Silvestro (US Pub No. 2021/0267626).
Regarding claim 8, Moriyama modified by Carrillo discloses the invention above except for wherein the radiofrequency puncture wire is a Nitinol radiofrequency guidewire.
Silvestro, in the analogous art of guidewire devices used in surgery, teaches (Figures 1-2) a guidewire (20) that is made of Nitinol (Paragraph 0021). It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the radiofrequency puncture wire of Moriyama modified by Carrillo to have been made of Nitinol as taught by Silvestro, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Moriyama (US Pub No. 2021/0275246) in view of Carrillo (US Pub No. 2004/0162465) as applied to claims 1 and 11 above, and further in view of Lindekugel (US Pub No. 2023/0128853).
Regarding claims 10 and 19, Moriyama modified by Carrillo discloses the invention above except for wherein the engaging surface is made of a high coefficient of friction material to enhance the frictional force between the engaging surface and the puncture device.
Lindekugel, in the analogous art of guidewire devices used in surgery, teaches (Figure 4D) a slot (clearly shown in Figure 4D where the guidewire 30 enters) that includes an engaging surface (434) (Figure 4D) being a gripping surface and is made of a high coefficient of friction material to enhance the frictional force between the engaging surface and the guidewire (Paragraphs 0059-0060). It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Moriyama modified by Carrillo to have included the engaging surface being made of a high coefficient of friction material to enhance the frictional force between the engaging surface and the puncture device as taught by Lindekugel, in order to provide increased pressure to the puncture device in the locked position ensuring a secure grip and also, to prevent kinking of the puncture device when gripped by the engaging surface (Lindekugel, Paragraphs 0059-0060).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771
Prosecution Insights