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 .
Election/Restrictions
The Applicant’s election of Group I in the reply filed on 31 March 2026 is acknowledged. The Applicant stated that the election is made with traverse. However, no arguments were made with respect to the Restriction Requirement, nor reasons for traversal. Because the Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 18 and 34, directed to Groups II and III respectively, have been withdrawn.
Therefore, Group I, directed to Claims 1-17, are presently pending.
Claim Objections
Claim 10 is objected to because of the following informalities:
The claim recites “a open configuration” in Line 3. This should be amended to “an open configuration” for grammatical clarity. Appropriate correction is required.
Claims 14 and 15 are objected to because of the following informalities:
The claims recite “wherein each prong”. This should be amended to “wherein each prong of the at least two prongs” to match the language in Claim 14 for consistency purposes. Appropriate correction is required.
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 1-3, 5-10, 12, 13, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-23 of U.S. Patent No. 12,426,891.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader in scope and fully encompassed by those of U.S. Patent No. 12,426,891.
Claims 1 and 2 of the instant application is directed to the same device for applying a hemostatic clip assembly and are fully encompassed by Claims 1, 4, 7, 13, and 18 of U.S. Patent No. 12,426,891.
Claim 3 of the instant application is directed to the same device for applying a hemostatic clip assembly and is fully encompassed by Claims 13 and 18 of U.S. Patent No. 12,426,891.
Claims 5-7 of the instant application is directed to the same device for applying a hemostatic clip assembly and are fully encompassed by Claims 1, 3, 4, 6, 7, 11, 12, 15-17 and 18 of U.S. Patent No. 12,426,891.
Claims 8-10 of the instant application is directed to the same device for applying a hemostatic clip assembly and are fully encompassed by Claims 1, 2, 4, 7, 11, 15, 17, 18, and 22 of U.S. Patent No. 12,426,891.
Claims 12 and 13 of the instant application is directed to the same device for applying a hemostatic clip assembly and are fully encompassed by Claims 7-9 and 18-19 of U.S. Patent No. 12,426,891.
Claim 17 of the instant application is directed to the same device for applying a hemostatic clip assembly and is fully encompassed by Claim 18 of U.S. Patent No. 12,426,891.
Claim Rejections - 35 USC § 102
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 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 1-10, 12-15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sjostrom et al. (International Pub. No. WO 2021/087464 A2, previously cited).
Regarding Claim 1, Sjostrom et al. discloses a device for applying a hemostatic clip assembly (10, Fig. 1; Page 2, Lines 1-15; Abstract) comprising:
a proximal delivery catheter (101, Figs. 1-3) including a proximal handle assembly (103, Fig. 1; Page 13, Line 10-Page 14, Line 10),
an elongated catheter body (105, Figs. 1-3) defining a longitudinal axis and extending distally from the proximal handle assembly (Page 13, Line 10-Page 14, Line 10; Claim 1),
a drive wire (109, Figs. 1-3, 16-20) movably positioned within the elongated catheter body (Page 13, Line 17 – Page 14, Line 5; Page 18, Line 15 – Page 19, Line 5; Page 24, Lines 1-15);
a spring release (release pin housing, 163, Figs. 8-9) coupled to a distal end of the drive wire (“The drive wire 109 is mechanically coupled to a proximal portion of the release pin housing 163 “, Page 18, Lines 15-20; see also Pages 18-19),
and a shaft spring (142, Figs. 1-3, 12) positioned radially outward from the spring release (release pin housing, 163, Figs. 8-9), wherein the shaft spring includes an annular portion (155, Figs. 3, 8-9, 12, 13), wherein the spring release (release pin housing, 163, Figs. 8-9. 13) is configured and adapted to abut the annular portion of the shaft spring (142, Figs. 1-3) upon proximal translation of the spring release (Page 20, Line 16 - Page 21, Line 12; Page 19, Lines 5-19);
and a distal clip assembly (100, Figs. 1-3) removably connected to the distal end of the elongated catheter body (Page 13, Lines 9-16; Page 14, Lines 5-20),
wherein the proximal delivery catheter (101, Figs. 1-3; Pages 13-14) is configured and adapted to transmit linear motion along the longitudinal axis and torsion about the longitudinal axis to at least a portion of the distal clip assembly (Page 14, Lines 5-20; Claim 1).
Regarding Claim 2, Sjostrom et al. discloses the device further wherein the shaft spring (142, Figs. 1-3; positioned radially inward from catheter 105) is positioned radially inward from the elongated catheter body (Page 14, Lines 5-20; Page 20, Lines 15-24).
Regarding Claim 3, Sjostrom et al. discloses the device further wherein the annular portion (155, Figs. 3, 8-9, 12, 13) of the shaft spring (142, Figs. 1-3, 12) is positioned around the drive wire (109, Fig. 13), wherein a proximal facing surface of the spring release is configured and adapted to interfere with the annular portion of the shaft spring upon proximal translation of the spring release (see Fig. 13; Page 20, Line 16 – Page 21, Line 16; Pages 18-19).
Regarding Claim 4, Sjostrom et al. discloses the device further wherein the shaft spring (142, Figs. 1-3, 12) is configured and adapted to translate proximally relative to the elongated catheter body (see Figs. 14, 17, 19-20; Pages 21-22).
Regarding Claim 5, Sjostrom et al. discloses the device further wherein the distal clip assembly includes a distal clip housing (102, Figs. 2-3, 6-7), wherein the shaft spring (142, Figs. 1-3, 12) includes at least one arm (146, Figs. 2-3, 12) removably coupled to the distal clip housing (Page 14, Lines 14-20; Claim 3; Page 2).
Regarding Claim 6, Sjostrom et al. discloses the device further wherein the at least one arm (146, Figs. 2-3, 12) includes an outwardly extending flange (158, Fig. 12) that removably engages with an aperture (148, Fig. 7) defined in a proximal end of the distal clip housing (see Figs. 14-15; Pages 20-21; Claim 15).
Regarding Claim 7, Sjostrom et al. discloses the device further wherein the outwardly extending flange (158, Fig. 12) of the at least one arm (146, Figs. 2-3, 12) is configured and adapted to bend and release from the aperture (148, Fig. 7) of the distal clip housing (102, Figs. 2-3, 6-7) as the spring release moves proximally to move the shaft spring proximally relative to the distal clip housing (see Pages 21-23; see bend/release of mechanism in Figs. 19-20; Claim 16).
Regarding Claim 8, Sjostrom et al. discloses the device further wherein the distal clip assembly includes a distal clip housing (102, Figs. 2-3, 6-7), a jaw adapter yoke (106, Fig. 3, 11) slidably positioned within the distal clip assembly (Pages 18-20), and a jaw assembly (104, Figs. 2-3; Page 14, Lines 5-20) having a pair of cooperating jaw members (108, Figs. 2-3) fixed to the jaw adapter yoke by a first pin (110, see Fig. 3 annotated below; Pages 14-15; Claims 41, 47-48), the first pin oriented orthogonally relative to the longitudinal axis (110, see Fig. 3 annotated below; first pin orthogonal to longitudinal axis), wherein at least one of the jaw members (108, Figs. 2-3) is configured and adapted to rotate about the first pin and to rotate about the longitudinal axis (“jaw members 108 are configured and adapted to rotate about the first pin 110 between an open configuration and a closed configuration”; Page 14, Lines 20-25; Claims 2, 21).
PNG
media_image1.png
574
775
media_image1.png
Greyscale
Regarding Claim 9, Sjostrom et al. discloses the device further wherein the distal clip assembly includes a second pin (118, Figs. 2-3) connecting between the jaw members (108, Figs. 2-3) and the distal clip housing (distal clip housing 102 encompasses jaw adapter yoke 106; see Fig. 3 annotated above), wherein each jaw member includes a proximal body portion (116, Fig. 4) and a distal end effector (120, Fig.4) , wherein the proximal body portion of each jaw member includes a respective cam slot (122, Figs. 4-5; Pages 14-15) configured and adapted to receive the second pin (118, Figs. 2-3) and a pivot aperture (134, Figs. 3-5) configured and adapted to receive the first pin (110, Figs. 3-5).
Regarding Claim 10, Sjostrom et al. discloses the device further wherein the cam slots (122, Figs. 3-5; Pages 14-15) are configured and adapted to translate along the second pin (118, Figs. 2-3) to move axially relative to the distal clip housing (Pages 14-16) and to move the jaw members (108, Figs. 2-3) between an open configuration, where respective distal tips of the jaw members are moved away from one another, a closed configuration where the respective distal tips of the jaw members are approximated towards one another to grasp tissue, and a locked configuration (“The second pin can be configured and adapted to translate within the cam slots to move axially relative to the distal clip housing and the jaw assembly to move the jaw members between the open configuration, where respective distal tips of the jaw members are moved away from one another, the closed configuration where the respective distal tips of the jaw members are approximated towards one another to grasp tissue, and a locked configuration.”; Page 2, Line 15 – Page 3, Line 15).
Regarding Claim 12, Sjostrom et al. discloses the device further wherein the jaw adapter yoke (106, Fig. 3, 11) includes a proximal receiving portion and the spring release (release pin housing, 163, Figs. 8-9) includes a distal portion configured and adapted to be received within the proximal receiving portion of the jaw adapter yoke (106, Fig. 3, 11) to transmit axial and rotational force from the drive wire (109, Figs. 1-3, 16-20) to the jaw adapter yoke (see Pages 18-19; see connections of Figs. 8A).
Regarding Claim 13, Sjostrom et al. discloses the device further wherein the drive wire (109, Figs. 1-3, 16-20) is coupled to a proximal portion of the spring release (release pin housing, 163, Figs. 8-9) to transmit linear and rotational motion from the drive wire to the jaw adapter yoke (see Pages 18-19; see connections of Figs. 8A).
Regarding Claim 14, Sjostrom et al. discloses the device further wherein the distal portion of the spring release (release pin housing, 163, Figs. 8-9) is divided into at least two prongs (165, Figs. 8-9), wherein each prong has a mating surface selectively engageable with an inner surface of the receiving portion of the jaw adapter yoke (see connections of Figs. 8A and 9; Pages 19-20).
Regarding Claim 15, Sjostrom et al. discloses the device further wherein each prong (165, Figs. 8-9) is configured and adapted to deflect inwardly and release from the receiving portion (receiving portion of jaw adapter yoke 106, Figs. 3, 8A, 9) when an axial force in a proximal direction is applied to the spring release (Page 25, Lines 10-20; see connections of Fig. 3, 8A, 9).
Regarding Claim 17, Sjostrom et al. discloses the device further wherein the spring release (release pin housing, 163, Figs. 8-9) includes a distal portion, a proximal portion, and a neck portion therebetween (see 163, Figs. 8, 9, 13), wherein the distal portion of the spring release (arms 165 and distal portions of housing 163, Figs. 9, 13) is configured and adapted to be received within a bore of the jaw adapter yoke (e.g. slots 168, bore of 106, see Fig. 3, 11, 8A, 9) to transmit axial and rotational force from the drive wire to the jaw adapter yoke (see Pages 18-20).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Sjostrom et al. (International Pub. No. WO 2021/087464 A2, previously cited).
Regarding Claim 11, Sjostrom et al. discloses the device further wherein each cam slot (122, Figs. 3-5; Pages 14-15) includes a distal locking neck (130, Figs. 3-5) projecting into the cam slot (122, Figs. 3-5; Pages 14-15) defining a distal locking area (132, Figs. 3-5).
Sjostrom et al. further discloses that the “The jaw members 108 are in the locked configuration when the second pin 118 is proximal relative to the proximal locking neck 130 in the proximal locking area 132.” (Page 16, Lines 17-24), but does not disclose wherein the jaw members are in the locked configuration when the second pin is distal relative to the distal locking neck in the distal locking area. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the jaw members to be in the locked configuration when the second pin is distal relative to the distal locking neck in the distal locking area, since this would merely require a reversed or flipped configuration of the cam slots and/or locking neck mechanism, and it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955).
Regarding Claim 16, Sjostrom et al. discloses the device further wherein the jaw adapter yoke (106, Fig. 3, 11, 8A) includes a pair of axially extending spaced apart arms (113, Figs. 3, 8A, 9), wherein each arm includes an elongated opening (160, Fig. 3, 10-11), wherein a pin (118, Figs. 3, 10-11) is slidably received within each elongated opening (Page 19, Line 19 – Page 20, Line 16), wherein the elongated opening is configured and adapted to allow a first of the jaw members (108, Figs. 2-3) to be angled at a first angle relative to the longitudinal axis (see Figs. 2, 3, 14) and a second of the jaw members (108, Figs. 2-3) to be angled at a second angle relative to the longitudinal axis (see Figs. 2, 3, 14; Pages 2-3).
Sjostrom et al. does not explicitly disclose wherein the pin is specifically the first pin. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the arms of the jaw adapter yoke to also include receiving the first pin, or to combine/alter the shape of the first pin and second pin of Sjostrom et al. to be a single pin received in the elongated opening (160, Fig. 3), since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). And/or alternatively, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 10:00am - 6:00pm EST.
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, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
Prosecution Insights