DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Double Patenting
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 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/315446. Although the claims at issue are not identical, they are not patentably distinct from each other because they are substantially co-extensive in scope, at least in regard to the novel subject matter, and differ merely in equivalent terminology used as to function. Both claim a surgical tool having an effector with first and second jaws – a controller/processor configured to determine a type of tissue grasped between the first and second jaw members based on the tissue pressure/strain and the gap/stress distance measurement. Generally, all of the dependent claims of the patent set forth the equivalent subject matter of the dependent claims of the current application. Therefore, it would have been obvious to one skilled in the art to substitute the terminology recited in the current claims with the equivalent components of the patented claims, since to do so provides nothing new or unexpected.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-39 of copending Application No. 18/345066. Although the claims at issue are not identical, they are not patentably distinct from each other because they are substantially co-extensive in scope, at least in regard to the novel subject matter, and differ merely in equivalent terminology used as to function. Both claim a surgical tool having an effector with first and second jaws – a controller/processor configured to determine a type of tissue grasped between the first and second jaw members based on the tissue pressure/strain and the gap/stress distance measurement. Generally, all of the dependent claims of the patent set forth the equivalent subject matter of the dependent claims of the current application. Therefore, it would have been obvious to one skilled in the art to substitute the terminology recited in the current claims with the equivalent components of the patented claims, since to do so provides nothing new or unexpected.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of U.S. Patent No. - US 11350843 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they are substantially co-extensive in scope, at least in regard to the novel subject matter, and differ merely in equivalent terminology used as to function. Both claim a surgical tool having an effector with first and second jaws – a controller/processor configured to determine a type of tissue grasped between the first and second jaw members based on the tissue pressure/strain and the gap/stress distance measurement (current claims 1 & 11 patented claims 5-6). Generally, all of the dependent claims of the patent set forth the equivalent subject matter of the dependent claims of the current application. Therefore, it would have been obvious to one skilled in the art to substitute the terminology recited in the current claims with the equivalent components of the patented claims, since to do so provides nothing new or unexpected.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. - US 12279915 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they are substantially co-extensive in scope, at least in regard to the novel subject matter, and differ merely in equivalent terminology used as to function. Both claim a surgical tool having an effector with first and second jaws – a controller/processor configured to determine a type of tissue grasped between the first and second jaw members based on the tissue pressure/strain and the gap/stress distance measurement. Generally, all of the dependent claims of the patent set forth the equivalent subject matter of the dependent claims of the current application. Therefore, it would have been obvious to one skilled in the art to substitute the terminology recited in the current claims with the equivalent components of the patented claims, since to do so provides nothing new or unexpected.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. - US 11690694 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they are substantially co-extensive in scope, at least in regard to the novel subject matter, and differ merely in equivalent terminology used as to function. Both claim a surgical tool having an effector with first and second jaws – a controller/processor configured to determine a type of tissue grasped between the first and second jaw members based on the tissue pressure/strain and the gap/stress distance measurement. Generally, all of the dependent claims of the patent set forth the equivalent subject matter of the dependent claims of the current application. Therefore, it would have been obvious to one skilled in the art to substitute the terminology recited in the current claims with the equivalent components of the patented claims, since to do so provides nothing new or unexpected.
Claim Rejections - 35 USC § 102/103
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton, IV et al. (US 20190201018 A1) or, in the alternative, under 35 U.S.C. 103 as obvious over Shelton, IV et al. (US 20190201018 A1) in view of Viola et al. (US 20120223121 A1) and further in view of Shelton, IV et al. (US 20190200997 A1).
Regarding claims 1, 4-11 and 14-20, Shelton, IV et al. discloses a surgical instrument 150010 comprising an end effector 150300 including a pair of jaw members 150302, 150306 and method of operating the surgical instrument wherein the surgical instrument is configured to clamp and staple tissue (Note: Fig. 25); a motor 482 configured to actuate the end effector; and a controller 461 in communication with the motor 482 and configured to determine a stress and strain of the clamped tissue via sensors 152008a, b (Note: paragraphs [0450]); identify a tissue type of the clamped tissue based on the determined stress and strain of the clamped tissue (Note: paragraph [0457]); and set an operational parameter of the surgical instrument based on the identified tissue type of the clamped tissue (Note: paragraphs [0458]-[0460]); wherein the controller is configured to direct the motor to move the pair of jaw members from a first open state toward a second closed state, in which the pair of jaw members compress the tissue, the strain of the tissue being determined over a predetermined time period as the pair of jaw members move from the first state toward the second state, direct and adjust the motor operation and monitor operation at a desired parameter based upon the controller determining/calculating tissue type (Note: paragraphs [0462]-[0470]), wherein stress relaxation of the tissue is measured (Note: paragraphs [0463]-[0464]), wherein other stapling instrument parameters can be sensed such as clamping rate, firing force, staple size, clamping force via impedance sensors and algorithms imputed into the controller 461; and further discloses the associated method of instrument operation as set forth in claims 10-15 (Note also: paragraphs [0586]-[0598] for additional operational functions) and maintain the pair of jaw members in a fixed position (waiting period – WAIT, creep wait time [0532-0533, 0590, 0797-0803]) to clamp the tissue for a second period of time ([0450-0473, 0532-0540, 0598, 0634-0635, 0694, 0719-0741, 0778] claim 1); determine a stress-strain relationship for the tissue based on the set of measurement data; an identify a tissue type for the tissue based on the determined stress-strain relationship (Note: paragraph [0457]).
Regarding claim 2 and 12, Shelton, IV et al. discloses at least one of a perfusion amount through the compressed tissue and a thickness of the compressed tissue (tissue thickness sensing, proper compression, degree of compression, impedance, creep, detect squishy tissue [0490, 0590-0592, 0737-0739, 0797].
Regarding claim 3 and 13, Shelton, IV et al. discloses the controller is further configured to: determine a plurality of biomechanical parameters based on the determined stress-strain relationship (impact on tissue, staple line failure, avoid compressing tissue to excessive strain values [0383-0393].
Regarding claims 1-20 In the alternative, if it can be argued that Shelton, IV et al. fails to disclose maintaining the pair of jaw members in a fixed position to clamp the tissue for a second period of time wherein the controller is further configured to: during the second period of time, determine a stress relaxation of the tissue by performing multiple measurements of the instantaneous stress on the tissue-
Viola et al. teaches surgical stapler (10) maintaining a pair of jaw members to compress tissue for a fist time period (pre-clamp or compress) and then maintaining a pair of jaw members clamping tissue in a fixed position for a second period of time (second compression time) wherein the controller is further configured to: during the second period of time, determine a stress relaxation of the tissue by performing multiple measurements of the instantaneous stress on the tissue (teaches clamping once for a time period or a second clamping with second time period and having any number of compression intervals [0069-0070].
Shelton, IV et al. also teaches surgical stapler (201800, figs. 24-30) with jaws to compress tissue for a fist time period (compress via timer 781, figs. 22-23) and then maintaining a pair of jaw members clamping tissue in a fixed position for a second period of time (tissue creep time) wherein the controller is further configured to: during the second period of time, determine a stress relaxation of the tissue by performing multiple measurements of the instantaneous stress on the tissue (teaches clamping once for a time period or a second clamping with second time period and having any number of compression intervals (“anvil gap δ is maintained constant to allow for tissue creep” [0453-0457, 0462-0476], figs. 31-37).
Given the teachings of Shelton, IV et al. to determine thickness of the compressed tissue and waiting for a time period to determine tissue properties, 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 controller with maintaining the pair of jaw members in a fixed position to clamp the tissue for a second period of time wherein the controller is further configured to: during the second period of time, determine a stress relaxation of the tissue by performing multiple measurements of the instantaneous stress on the tissue for more precise operation of the device, determine properties of the tissue such as tissue creep, obtain optimal tissue compression to fire staples, and/or for feedback purposes as taught by Viola et al. and Shelton, IV et al.
Conclusion
Additional prior art considered pertinent:
Evans et al. (US 20180256163 A1) - perfusion sensor (64) on jaws
US 20160089175 A1 - variable compression force can be applied... a tissue response can be monitored so that tissue type and thickness can be identified [0090] and see form 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT LONG whose telephone number is (571)270-3864. The examiner can normally be reached M-F, 9am-5pm, 8-9pm (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, 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.
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/ROBERT F LONG/Primary Examiner, Art Unit 3731