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 .
This action is in response to the application filed on 09/11/25.
Claim Objections
Claims 23 and 31 are objected to because of the following informalities: in claim 23, “compromise” appears to be a typographical error. Appropriate correction is required.
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 22-38 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.
In claims 22, 29, 30, 37 and 38, the limitation of “one or more current characteristics of the tissue” renders the claim indefinite in that it is unclear whether the limitation refers to electrical current, present-time existing tissue characteristic, or another characteristic.
In claims 24, 25, 32 and 33, the limitation of periodically determined “velocity variation” renders the claims indefinite because it lacks limits and boundaries. It is unclear whether velocity variation means a change amount, a new velocity, a rate of change, etc.
In claims 26, 27, 34 and 35, the limitation of “tissue coverage” renders the claims indefinite in that it is unclear what are the limits and boundaries. What exactly constitutes “coverage”? Is it percentage coverage, linear coverage area coverage?
In claim 29, the limitation of “based on a combination thereof” renders the claim indefinite in that it is unclear what are the combined characteristics and/or parameters and/or the algorithm for combining parameters?
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Such claim limitation(s) is/are:
means for determining one or more characteristics of the tissue clamped between the first and second jaws prior to firing in claim 38 (sensors and a controller).
means for determining and initial velocity of the displacement member and initiating firing of the displacement member in claim 38 (sensors and a controller).
means for determining, periodically during firing, the one or more current characteristics of the tissue clamped in claim 38 (sensors and a controller).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure (i.e. control circuit and sensors) described in the specification as performing 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.
Claim limitation “means for determining whether to vary the velocity” in claim 38 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The written description does not disclosed specific function and/or algorithm that converts the sensed tissue characteristic into the claimed velocity. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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(s) 22-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trees et al. (2015/0282823) in view of Zemlok et al. (2015/0209035).
Regarding claims 22, 30 and 38, Trees discloses a method of varying a velocity of a displacement member (28) to control displacement of a knife (cutting member not shown) along a length of a first jaw during a firing thereof in a robotic surgical system (par. 128), the jaw having tissue clamped therebetween, the method comprising: determining, by a control circuit (controller and sensors), one or more current characteristics of the tissue clamped between the first and second jaws prior to the firing and based thereon (tissue impedance; par. 5), determining an initial velocity of the displacement member and initiating firing of the displacement member at the determined initial velocity (pars. 5, 124-126); and determining, periodically during the firing by a control circuit subsequent to the initiating of the firing, the one or more current characteristics of the tissue clamped between the first and second jaws and, based thereon, determining whether to vary, by the control circuit, the velocity of the displacement member as the knife is displaced along the length of the jaw, wherein one or more of the one or more current characteristic of the tissue may vary over the length of the staple cartridge and/or during the firing and the control circuit increases, decreases or does not change the velocity based thereon (i.e. adjusting firing speed based on tissue sensed impedance; pars. 5, 7, 11, 28, 60, 111-112, 124-126).
but fails to disclose wherein the displacement member is displaced along a length of a staple cartridge and wherein the staple cartridge is installed in the first jaw.
Zemlok discloses a powered surgical stapler having a motor-driven displacement member (213) configured to advance a knife through a staple cartridge during a firing stroke (Fig. 9), the staple cartridge is installed on a first jaw, wherein the firing member and knife are displaced through the staple cartridge under control of a motor and controller for the purposes of firing staples and cut tissue simultaneously to reduce bleeding and increase efficiency by creating a staple line while tissue is severed.
Simultaneously stapling and cutting process by adjusting motor speed based on sensed tissue conditions is well known in the art. It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to have provided Trees’ method of varying a velocity of a displacement member to control displacement of a knife with a staple cartridge as taught by Zemlok because both references are directed to powered surgical devices and both seek to optimize displacement of a knife performance through controlled firing operations.
Regarding claims 23 and 31,Trees discloses wherein the displacement of the knife may compromise advancing or retracting the knife (par. 69).
Regarding claims 24 and 32, Trees discloses wherein the initial velocity and/or periodically determined velocity variation is further determined based on a force needed to clamp the tissue between the first and second jaws prior to the firing (par. 89).
Regarding claims 25 and 33, Trees discloses wherein the initial velocity and/or periodically determined velocity variation is further determined based on a force needed to displace the displacement member as the knife is displaced along the length of the jaw, the force being dependent upon the one or more current characteristics of the tissue clamped between the first and second jaws (par. 90).
Regarding claims 26 and 34, Trees discloses wherein the one or more current characteristics of the tissue comprise tissue thickness or tissue electrical impedance (pars. 3, 5, 7, 11, 28, 79, 60).
Regarding claims 27 and 35, Trees discloses wherein when, during firing, the thickness of the tissue, the electrical impedance of the tissue is determined by the control circuit to decrease, the velocity is increased and when, during firing, the thickness of the tissue, the electrical impedance of the tissue is determined by the control circuit to increase, the velocity is decreased (pars. 6, 108, 119, 121, 124).
Regarding claims 28 and 36, Zemlok also discloses discloses wherein one of the first or second jaws comprise position sensors coupled with the control circuit and which sense a presence of tissue in contact therewith and generate data indicative of a location of the clamped tissue between proximal and distal ends of the first and second jaws (pars. 126, 136).
Regarding claims 29 and 37, Trees discloses determining, by the control circuit two or more current characteristics of the tissue clamped between the first and second jaws prior to the firing (i.e. varying load force at different positions).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE LOPEZ whose telephone number is (571)272-4464. The examiner can normally be reached Monday thru Friday 8:30 am to 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached at (571) 270 - 1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELLE LOPEZ/ Primary Examiner, Art Unit 3731
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