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 to Amendment
The amendment filed 07/31/2026 has been entered. Claims 1-20 are pending in the application.
Terminal Disclaimer
The terminal disclaimer filed on 07/31/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. - US 12279915 B2 & U.S. Patent No. - US 11690694 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 112 6th - Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Claim 1 limitation “adjusting means for adjusting a position of a tool” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claims 1 and 11 have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
The phrase “determine a stress relaxation profile” has been interpreted to correspond to – “constant strain is applied to the tissue, measurements of the stress on the tissue are taken at a preset time interval and stored in the memory 141. The stress measurements provide a stress relaxation profile of the tissue” (instant application specification [0062]).
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 1-20 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.
The term “stress relaxation profile” in claims 1, 3, 6, 11, 13, and 16 is a relative term which renders the claim indefinite. The term “relaxation profile” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Since the term “relaxation profile” is subjective and unclear what the limits are to determine what is “relaxed” is, the term/phrase stress relaxation profile is vague and indefinite. The specification indicates the relaxation profile is determined by constant strain applied with measurements taking during the strain applied. Examiner suggest reciting the relaxation profile is determined via applying strain during the clamping time period.
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 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) 1-10 is/are rejected 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 and 4-10, 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 first 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]).
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 and when characteristic of the tissue reaches a first threshold during the first period of time, control the motor to cease compression and maintain the pair of jaw members in a fixed position to clamp the tissue for a second period of time; during the second period of time, perform multiple measurements of an instantaneous stress on the tissue to define a set of measurement data: determine a stress relaxation profile for the tissue based on the set of measurement data; and identify a tissue type for the tissue based on the determined stress relaxation profile.
However, Shelton, IV et al. teaches performing multiple measurements of the instantaneous stress on the tissue (comparing thresholds [series of discrete instances during the firing stroke [0701] and when characteristic of the tissue reaches a first threshold during the first period of time (parameter associated with a characteristic, type, property, and/or status of a tissue being operated… thickness of the clamped tissue” [0691]), control the motor to cease compression and maintain the pair of jaw members in a fixed position to clamp the tissue for a second period of time (“jaws is paused after the initial clamping of the tissue (i.e., the tissue creep wait time)” [0692]); during the second period of time, perform multiple measurements of an instantaneous stress on the tissue to define a set of measurement data: determine a stress relaxation profile for the tissue based on the set of measurement data (determine if tissue stiff – “Stiff tissue can be relatively prone to tearing… weak shear strength” [0694]); and identify a tissue type for the tissue based on the determined stress relaxation profile ([0689-0705, 0720-0729] - “compare the value of the sensed tissue compression to one or more additional thresholds or continue receiving 21052 tissue parameter data and/or signals” [0692]… characterize the tissue type of the tissue being clamped [0705], fig. 96).
Shelton, IV et al. states: “value of the sensed tissue compression parameter compares to one or more thresholds and then generates a response accordingly… value of the sensed tissue compression parameter relative to a first threshold” [0692]… parameter relative to a second threshold [0693]… cause the motor 21006 to stop closing the jaws of the end effector [0697]… detect the characteristics of the tissue being clamped by the surgical instrument and adjust the closure rate(s), closure threshold(s), and other operational parameters correspondingly” [0704]… During the pause, the FTC gradually decreases 21384 as the clamped tissue relaxes” [0729].
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] and teaches when characteristic of the tissue reaches a first threshold during the first period of time (compression force curves & thresholds [0450-0479]), control the motor to cease compression and maintain the pair of jaw members in a fixed position to clamp the tissue for a second period of time (wait period before starting the fire phase to account for tissue creep); during the second period of time, perform multiple measurements of an instantaneous stress on the tissue to define a set of measurement data: determine a stress relaxation profile for the tissue based on the set of measurement data; and identify a tissue type for the tissue based on the determined stress relaxation profile ([0450-0479], figs. 31-37).
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.
Regarding claim 2, 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, Shelton, IV et al. discloses the controller is further configured to: determine a plurality of biomechanical parameters based on the determined stress relation profile (Stiffness of tissue, tissue relax during pause, impact on tissue, staple line failure, avoid compressing tissue to excessive strain values [0383-0393, 0689-0705, 0720-0729]
Allowable Subject Matter
Claims 11-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Reasons for Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance: the prior art of record fails to teach or render obvious a method of operating a surgical instrument comprising all the structural and functional limitations and further comprising, amongst other limitations/features, during a first period of time, controlling a pair of jaw members to compress tissue when a characteristic of the compressed tissue reaches a first threshold during the first period of time, controlling the pair of jaw members to cease compression and maintain a fixed position to clamp the tissue for a second period of time; during the second period of time, performing multiple measurements of an instantaneous stress on the tissue to define a set of measurement data; determining a stress relaxation profile for the tissue based on the set of measurement data; identifying a tissue type for the tissue based on the determined stress relaxation profile of the tissue; and setting at least one operational parameter of the surgical instrument based on the identified tissue type. Though Shelton, IV et al. to determine thickness of the compressed tissue and waiting for a time period to determine tissue properties, it would not be obvious to modify cable system to add the specific steps of “maintain a fixed position to clamp the tissue for a second period of time” to determining a stress relaxation profile with sense data during the wait time, determine tissue type then set an operational parameter based on the obtained measurements/data and one of ordinary skill would recognize that a having a clamping function with a pause feature to determine tissue properties to obtain the correct operating features is not an obvious modification and provides the unexpected result of correct operating parameters during clamping. Having the efficiency and speed of the added pause with analyzation feature provides an effective clamping and compressive healing closure of a surgical area.
While various features of the claimed subject matter are found individually in the prior art, a skilled artisan would have to include knowledge gleaned only from the applicant's disclosure to combine or modify the teachings of the prior art to produce the claimed subject matter, and thus obviousness would not be proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). There is no teaching, suggestion, or motivation found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to combine or modify the teachings of the prior art to produce the claimed invention, and thus obviousness would not be proper. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on the new sections of the prior art applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Claims 11-20 have been noted as allowable.
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]
WO 2019130089 A1 - “impedance changes in the tissue to determine the tissue configuration, tissue type, and/or tissue characteristics. The tissue configuration, tissue type, and/or tissue characteristics can then be utilized to determine the thresholds appropriate for force to fire (FTF), advancement speed, and/or creep rate to indicate stability” [0487] and see form 892.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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