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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-6 and 15-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
There is inadequate written description of the subject matter of claims 5-6 and 15-16.
Independent claim 1 sets forth a device including a tip “having a thickness that decreases towards the distal portion of the tip” and “wherein the distal end of the second jaw includes a resilient cantilevered segment supported on the distal end of the second jaw”. This embodiment is shown in figure 51.
Claim 5, which depends from claim 1, sets forth “spaced arms”, a “pin”, and “the tip includes a hinge portion that is supported within the spaced arms by the pin”. This embodiment is shown in figures 17-18.
There is no disclosure in the originally filed application for an anvil and tip that includes both a tip “having a thickness that decreases towards the distal portion of the tip” and “wherein the distal end of the second jaw includes a resilient cantilevered segment supported on the distal end of the second jaw” and “spaced arms”, a “pin”, and “the tip includes a hinge portion that is supported within the spaced arms by the pin”.
It appears claims 5-6 and 15-16 claim a combination of elements not disclosed in the originally filed application.
Accordingly, the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the claimed invention.
The subject matter of these elements has not been described in the specification in such a way as to reasonably convey to one skilled in the art how to make and use the invention, and comprise new matter.
Claim 6 depends from claim 5 and is likewise rejected.
Claims 15-16 are rejected for the same reasons as claims 5-6.
While no prior art has been applied with respect to claims 5-6 and 15-16, this is not an indication of allowable subject matter in claims 5-6 and 15-16.
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 11-18 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 11 recites the limitation "”the distal end" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "”the second jaw" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "”the second jaw" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claims 12-16 and 18 depend from claim 11, and are likewise rejected.
Claim Rejections - 35 USC § 102
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 –
Claims 1-3, 7-9, 11-13, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (KR 101209589).
With respect to claim 1, Kim et al. disclose a surgical stapling device (fig. 1) comprising: a shaft having a proximal portion and a distal portion (shaft 20, fig. 1); and an end effector defining a longitudinal axis (stapling anastomosis device 10, pg. 3, 1st full para.) and including: a first jaw configured to receive a staple cartridge (jaw 14 configured to receive tray 142, fig. 2); a second jaw defining a longitudinal axis and comprising an anvil including a proximal portion and a distal portion (rotating jaw 12 with guide 13 to form staples, fig. 2), the first jaw coupled to the second jaw at a proximal end thereof such that the end effector is moveable from an open position to a clamped position (open position of fig. 2, clamped position of fig. 3); a tip having a proximal portion and a distal portion and having a thickness that decreases towards the distal portion of the tip (extension jaw 12a with decreasing thickness, fig. 2), the tip being movably coupled to a distal end of the second jaw for movement between a first position substantially aligned with the longitudinal axis (fig. 3) and a second position defining an acute angle with the longitudinal axis (fig. 2); and the distal end of the second jaw engaged with the tip to releasably retain the tip in one of the first or second positions (extension jaw 12a is releasably retained in position of fig. 2), wherein the distal end of the second jaw includes a resilient cantilevered segment supported on the distal end of the second jaw (leaf spring 32, fig. 3, pg. 3, last paragraph). Kim et al. disclose that, when the rotating jaw 12b is opened from the closed position, the connecting member 34, hinge H, and leaf spring 32 switch the extension jaw 12a from the position aligned with the longitudinal axis (fig. 3) to the position defining an acute angle with the longitudinal axis (fig. 2), separating end faces of the extension jaw 12a and the rotating jaw 12b, and therefore the tip is releasably retained in one of the first or second positions. Kim et al. disclose that one side of the leaf spring 32 is inserted in the groove 114b of the jaw 12b, and is therefore considered to be a resilient cantilevered segment. Kim et al. also disclose that the spring may comprise a torsion spring based in the jaw 12b, and thus the torsion spring is also considered to be a resilient cantilevered segment (pg. 4, para. 1-2).
With respect to claim 2, Kim et al. disclose the resilient cantilevered segment supports a protrusion (the spring 32 supports the protrusion 42 via the extension jaw 12a, fig. 2).
With respect to claim 3, Kim et al. disclose the protrusion extends distally from the resilient cantilevered segment (portion 44 of the protrusion 42 extends distally from the spring 32, fig. 2).
With respect to claim 7, Kim et al. disclose the resilient cantilevered segment is positioned proximally from where the tip is coupled to the distal end of the second jaw (the proximal-most end of the spring 32 is positioned proximally from the hinge H, fig. 2).
With respect to claim 8, Kim et al. disclose the tip is configured to be manually moved between the first and second positions (the jaws are opened and closed by an operator, pg. 3, 3rd para.).
With respect to claim 9, Kim et al. disclose a width of the tip decreases in a distal direction (fig. 2).
With respect to claim 11, Kim et al. disclose an anvil assembly comprising: an anvil including a proximal portion and a distal portion (rotating jaw 12 with guide 13 to form staples, fig. 2); a tip having a proximal portion and a distal portion and having a thickness that decreases towards the distal portion of the tip (extension jaw 12a with decreasing thickness, fig. 2), the tip being movably coupled to the anvil for movement between a first position substantially aligned with a longitudinal axis (fig. 3) and a second position defining an acute angle with the longitudinal axis (fig. 2); and the distal end of the anvil engaged with the tip to releasably retain the tip in one of the first or second positions (extension jaw 12a is releasably retained in position of fig. 2), wherein the distal end of the second jaw includes a resilient cantilevered segment supported on the distal end of the anvil (leaf spring 32, fig. 3, pg. 3, last paragraph). Kim et al. disclose that, when the rotating jaw 12b is opened from the closed position, the connecting member 34, hinge H, and leaf spring 32 switch the extension jaw 12a from the position aligned with the longitudinal axis (fig. 3) to the position defining an acute angle with the longitudinal axis (fig. 2), separating end faces of the extension jaw 12a and the rotating jaw 12b, and therefore the tip is releasably retained in one of the first or second positions. Kim et al. disclose that one side of the leaf spring 32 is inserted in the groove 114b of the jaw 12b, and is therefore considered to be a resilient cantilevered segment. Kim et al. also disclose that the spring may comprise a torsion spring based in the jaw 12b, and thus the torsion spring is also considered to be a resilient cantilevered segment (pg. 4, para. 1-2).
With respect to claim 12, Kim et al. disclose the resilient cantilevered segment supports a protrusion (the spring 32 supports the protrusion 42 via the extension jaw 12a, fig. 2).
With respect to claim 13, Kim et al. disclose the protrusion extends distally from the resilient cantilevered segment (portion 44 of the protrusion 42 extends distally from the spring 32, fig. 2).
With respect to claim 17, Kim et al. disclose the resilient cantilevered segment is positioned proximally from where the tip is coupled to the distal end of the second jaw (the proximal-most end of the spring 32 is positioned proximally from the hinge H, fig. 2).
With respect to claim 18, Kim et al. disclose the tip is configured to be manually moved between the first and second positions (the jaws are opened and closed by an operator, pg. 3, 3rd para.).
With respect to claim 19, Kim et al. disclose an anvil assembly comprising: an anvil including a proximal portion and a distal portion (rotating jaw 12 with guide 13 to form staples, fig. 2); a tip having a proximal portion and a distal portion and having a thickness that decreases towards the distal portion of the tip (extension jaw 12a with decreasing thickness, fig. 2), the tip being movably coupled to the anvil for movement between a first position substantially aligned with a longitudinal axis (fig. 3) and a second position defining an acute angle with the longitudinal axis (fig. 2); and means, disposed on a distal end of the anvil, for releasably retaining the tip in one of the first or second positions (connecting member 34, hinge H, leaf spring 32, fig. 3, pg. 3, last paragraph). Kim et al. disclose that, when the rotating jaw 12b is opened from the closed position, the connecting member 34, hinge H, and leaf spring 32 switch the extension jaw 12a from the position aligned with the longitudinal axis (fig. 3) to the position defining an acute angle with the longitudinal axis (fig. 2), separating end faces of the extension jaw 12a and the rotating jaw 12b, and therefore the tip is releasably retained in one of the first or second positions.
With respect to claim 20, Kim et al. disclose means for pivotably coupling the tip to the distal end of the anvil (connecting member 34, hinge H).
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. in view of Whitman (KR 100778729).
With respect to claim 10, Kim et al. fail to disclose the proximal portion of the shaft including a handle assembly, the proximal portion of the shaft coupled to the handle assembly.
Whitman disclose a surgical stapling device including a handle assembly coupled to a proximal portion of a shaft (fig. 1) for an operator to grip the device and operate the stapler.
It 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 to modify the surgical stapling device of Kim et al. to include the handle assembly as taught by Whitman to provide a hand-held device, especially since both Kim et al. and Whitman disclose surgical staplers.
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, 4, 11, 14, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 4, 15, 16, and 26 of U.S. Patent No. 12,508,022 (the patent). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 3, 4, 15, 16, and 26 of the patent “anticipate” application claims 1, 4, 11, 14, and 19. It is apparent that the application claims differ from the patent claims in that the patent claims are more specific. Any remaining differences are only differences in verbiage without any difference in meaning. Application claims 1, 4, 11, 14, and 19 are not patentably distinct from patent claims 3, 4, 15, 16, and 26 because the more specific patent claims anticipate the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
The application claims and patent claims match up as follows:
Application Claims
Patent Claims (US Patent No. 12,508,022)
1. A surgical stapling device comprising:
3. A surgical stapling device comprising:
a shaft having a proximal portion and a distal portion; and
a shaft having a proximal portion and a distal portion; and
an end effector defining a longitudinal axis and including:
an end effector including:
a first jaw configured to receive a staple cartridge;
a first jaw configured to receive a staple cartridge;
a second jaw defining a longitudinal axis and comprising an anvil including a proximal portion and a distal portion, the first jaw coupled to the second jaw at a proximal end thereof such that the end effector is moveable from an open position to a clamped position;
a second jaw defining a longitudinal axis and comprising an anvil including a proximal portion and a distal portion, the first jaw pivotably coupled to the second jaw at a proximal end thereof such that the end effector is moveable from an open position, with the first and second jaws being non-parallel to each other, to a clamped position;
a tip having a proximal portion and a distal portion and having a thickness that decreases towards the distal portion of the tip, the tip being movably coupled to a distal end of the second jaw for movement between a first position substantially aligned with the longitudinal axis and a second position defining an acute angle with the longitudinal axis; and the distal end of the second jaw engaged with the tip to releasably retain the tip in one of the first or second positions,
a tip having a proximal portion and a distal portion and having a thickness that decreases towards the distal portion of the tip, the tip being movably coupled to a distal end of the second jaw for movement, independent of the open or clamped position of the end effector, between a first position substantially aligned with the longitudinal axis and a second position defining an acute angle with the longitudinal axis; and wherein the distal end of the second jaw is engaged with the tip to releasably retain the tip in one of the first or second positions.
wherein the distal end of the second jaw includes a resilient cantilevered segment supported on the distal end of the second jaw.
wherein the distal end of the second jaw includes a resilient cantilevered segment supported on the distal end of the second jaw.
4. The surgical stapling device of claim 1, wherein the tip includes a proximal face that defines a protrusion and the resilient cantilevered segment defines spaced recesses, the protrusion received within one of the spaced recesses to retain the tip in one of the first or second positions.
4. The surgical stapling device of claim 3, wherein the tip includes a proximal face that defines a protrusion and the cantilevered segment defines spaced recesses, the protrusion received within one of the spaced recesses to retain the tip in one of the first or second positions.
11. An anvil assembly comprising
15. An anvil assembly comprising:
an anvil including a proximal portion and a distal portion;
an anvil defining a longitudinal axis and having a plurality of staple forming pockets formed therein, the anvil including a distal portion distal to the staple forming pockets;
a tip having a proximal portion and a distal portion and having a thickness that decreases towards the distal portion of the tip, the tip being movably coupled to the anvil for movement between a first position substantially aligned with a longitudinal axis and a second position defining an acute angle with the longitudinal axis; and the distal end of the anvil engaged with the tip to releasably retain the tip in one of the first or second positions,
a tip having a proximal portion, a distal portion, and a body having a thickness that decreases towards the distal portion of the tip and having no staple forming pockets, the tip being movably coupled to the distal portion of the anvil for movement about an axis transverse to the longitudinal axis of the anvil between a first position substantially aligned with the longitudinal axis and a second position defining an acute angle with the longitudinal axis; and wherein the distal portion of the anvil is engaged with the tip to releasably retain the tip in one of the first or second positions independent of a position of the anvil relative to an opposing jaw.
wherein the distal end of the second jaw includes a resilient cantilevered segment supported on the distal end of the anvil.
wherein the distal portion of the anvil includes a resilient cantilevered segment supported on the distal portion of the anvil.
14. wherein the tip includes a proximal face that defines a protrusion and the resilient cantilevered segment defines spaced recesses, the protrusion received within one of the spaced recesses to retain the tip in one of the first or second positions.
16. wherein the tip includes a proximal face that defines a protrusion and the cantilevered segment defines spaced recesses, the protrusion received within one of the spaced recesses to retain the tip in one of the first or second positions.
19. An anvil assembly comprising: an anvil including a proximal portion and a distal portion;
26. A surgical stapling device comprising: a shaft having a proximal portion and a distal portion; and an end effector including: a first jaw configured to receive a staple cartridge; a second jaw defining a longitudinal axis and comprising an anvil including a proximal portion and a distal portion, the first jaw pivotably coupled to the second jaw at a proximal end thereof such that the end effector is moveable from an open position, with the first and second jaws being non-parallel to each other, to a clamped position;
a tip having a proximal portion and a distal portion and having a thickness that decreases towards the distal portion of the tip, the tip being movably coupled to the anvil for movement between a first position substantially aligned with a longitudinal axis and a second position defining an acute angle with the longitudinal axis;
a tip having a proximal portion and a distal portion and having a thickness that decreases towards the distal portion of the tip, the tip being movably coupled to a distal end of the second jaw for movement, independent of the open or clamped position of the end effector, between a first position substantially aligned with the longitudinal axis and a second position defining an acute angle with the longitudinal axis; and
and means, disposed on a distal end of the anvil, for releasably retaining the tip in one of the first or second positions.
means for retaining, engaged with the tip, to releasably retain the tip in one of the first or second positions.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shelton et al. (US Patent Publ. No. 2018/0168649) disclose a pivoting anvil tip.
Hufnagel (EP 2,777,523) discloses interchangeable anvil tips.
Krehel (US Patent Publ. No. 2013/0334280) discloses a releasable anvil tip.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linda J. Hodge whose telephone number is (571)272-0571. The examiner can normally be reached Monday-Friday 8:00-5:00.
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, Shelley Self can be reached at (571) 272-4524. 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.
/LINDA J. HODGE/Primary Examiner, Art Unit 3731
Prosecution Insights