DETAILED ACTION
The following Office Action is in response to the Preliminary Amendment filed on September 19, 2023. Claims 1-19 are currently pending.
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 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.
Claim Objections
Claims 1, 3, 10, 16, and 19 are objected to because of the following informalities:
Concerning claim 1, line 13 of the claim recites the phrase “so that said pressure means apply a pressure upon”, wherein the word “apply” appears to be mistakenly used in place of the word “applies”.
Concerning claim 3, line 3 of the claim recites the phrase “traverse to both a tissue force application direction and a longitudinal prevalent direction”, wherein the word “traverse” appears to be mistakenly used in place of the term “transverse”.
Concerning claim 10, line 2 of the claim recites the phrase “wherein mechanochromic indicator has a reversible colour change”, wherein the phrase appears to be missing the word “the” between “wherein” and “mechanochromic”.
Concerning claim 16, line 9 of the claim recites the phrase “are fixed one another”, wherein the word “to” appears to be missing between the words “fixed” and “one”.
Concerning claim 19, line 2 of the claim recites “pressure means”, wherein the term should be preceded by the article “the”.
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.
Claim 16 is 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. Line 2 of the claim recites the limitation of “the proximal jaw device” and “a proximal jaw”. Claim 1, the claim upon which claim 16 depends, already recites the limitation of “a proximal jaw” therein making it indefinite as to whether “the proximal jaw device” refers to “the proximal jaw” of claim 1, and if “a proximal jaw” of claim 16 is the same jaw as “the proximal jaw” of claim 1.
Furthermore, lines 6-7 of the claim recite the phrase “which support element has a higher modulus of elasticity than the front element being less elastically compliant”, wherein this phrase appears to be grammatically incorrect and it cannot be discerned what it is intended to say.
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) 1-7, 9-10, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2017/0354403, hereinafter Liu) in view of Brosig et al. (US 2019/0151502, hereinafter Brosig) and Privitera et al. (US 2006/0084974, hereinafter Privitera).
Concerning claim 1, the Liu et al. prior art reference teaches a manipulation device for minimally-invasive surgery (Figure 1; 10), comprising a grasping device configured for acting upon a tissue, which grasping device comprises a mechanochromic indicator (Figure 1; 20), wherein said mechanochromic indicator is configured to provide the operator with a visual color feedback when a pre-determined threshold force or pressure is applied upon the tissue ([¶ 0015]), wherein said manipulation device further comprises a force transmission mechanism to transfer a reaction force applied from the tissue upon a jaw of said grasping device to said mechanochromic indicator (Figure 1; end effector 12 = force transmission mechanism, which transfers force upon tissue to mechanochromic device 20), and pressure means configured to apply a pressure upon said mechanochromic indicator (Figure 1; 11), wherein said force transmission mechanism is configured so that said pressure means applies a pressure upon said mechanochromic indicator which is amplified with respect to the pressure applied from the tissue upon said jaw (Figure 1; handle 11 closes end effector, therein causing the end effector to close, wherein the closing of the end effector towards tissue transmits a force to the mechanochromic device), but it does not specifically teach the mechanochromic indicator being a polymeric matrix functionalized with mechanochromic molecules, or the jaw being a proximal jaw.
However, the Brosig reference teaches medical products that may be mechanochromic, wherein the reference states that the mechanochromic devices may comprise a polymeric matrix functionalized with mechanochromic molecules ([¶ 0027-0029]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the mechanochromic indicator of the Liu reference include a polymeric matrix functionalized with mechanochromic molecules as in the Brosig reference given this is a known method of forming a mechanochromic material or coating for a medical device (Brosig; [¶ 0021, 0027-0029]).
Furthermore, the Liu reference teaches that the end effector of the device may be a variety of different end effectors including forceps, pliers, or clamps (Liu; [¶ 0014]), while the Privitera reference teaches a manipulation device in the form of a surgical clamp including an end effector that has a distal and proximal clamp (Privitera; Figure 1; 120, 130).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the end effector of the Liu reference be a surgical clamp as in the Privitera reference, which includes a distal and proximal clamp, given the Liu reference teaches that an end effector for a surgical clamp may have such a structure (Privitera; [¶ 0022]).
Concerning claim 2, the combination of the Liu, Brosig, and Privitera references as discussed above teaches the manipulation device according to claim 1, wherein the Privitera reference teaches the end effector of the combination, which has been interpreted as the force transmission mechanism, being a lever type mechanism (Figure 1; jaws 120, 130 may be define lever arms).
Concerning claim 3, the combination of the Liu, Brosig, and Privitera references as discussed above teaches the manipulation device according to claim 2, wherein the Privitera reference further teaches said lever type mechanism having a pivoting axis extending according to a pivoting direction transverse to both a tissue force application direction and a longitudinal prevalent direction of development of said proximal jaw device (Figure 4; pivot pin of 220, 230 defines the pivot axis).
Concerning claim 4, the combination of the Liu, Brosig, and Privitera references as discussed above teaches the manipulation device according to claim 1, wherein the combination further teaches said pressure means applying a pressure upon a selected area of said mechanochromic indicator (actuation of the handle moves the jaws, therein applying pressure to the mechanochromic indicator upon the grasping of tissue).
Concerning claim 5, the combination of the Liu, Brosig, and Privitera references as discussed above teaches the manipulation device according to claim 1, wherein said pressure means comprises one or more indenter elements protruding from a base member (Figure 1; triggers of handle 11 may be interpreted as indenter elements), said one or more indenter elements being each preferably configured as a slab or pillar (Figure 1; triggers of handle 11 may be interpreted as slabs or pillars).
Concerning claim 6, the combination of the Liu, Brosig, and Privitera references as discussed above teaches the manipulation device according to claim 1, wherein the pressure means is capable of imprinting a visual message, in particular an alphanumeric message, upon said mechanochromic indicator if said pressure means was utilized to clamp the end effector on an alphanumeric shaped object.
Concerning claim 7, the combination of the Liu, Brosig, and Privitera references as discussed above teaches the manipulation device according to claim 1, wherein the pressure applied on said mechanochromic indicator and the pressure applied upon said proximal jaw are linked by the equation pi ≈ pc (Ac/Ai) wherein Ac and Ai denote the pressure application area upon the proximal jaw and the mechanochromic indicator respectively given the mechanochromic indicator is positioned on the jaw and the pressure and area will be propotional.
Concerning claim 9, the combination of the Liu, Brosig, and Privitera references as discussed above teaches the manipulation device according to claim 1, wherein the Liu reference teaches that the mechanochromic indicators may be interpreted as being shaped substantially as bricks (Figure 1; 20).
Concerning claim 10, the combination of the Liu, Brosig, and Privitera references as discussed above teaches the manipulation device according to claim 1, wherein the Liu reference further teaches the mechanochromic indicator having a reversible colour change ([¶ 0015]).
Concerning claim 17, the combination of the Liu, Brosig, and Privitera references as discussed above teaches the manipulation device according to claim 1, wherein the Liu reference teaches that such manipulation devices are used with endoscopes (Liu; [¶ 0002]) while the Brosig reference teaches that mechanochromic indicators may be observed via endoscopes (Brosig; [¶ 0019]).
Concerning claim 18, the combination of the Liu, Brosig, and Privitera references as discussed above teaches the manipulation device according to claim 17, wherein said endoscope is capable of performing an optical pumping for reverting a colour change of the mechanochromic indicator given an endoscope may have a variety of channels for introducing optical devices which are capable of optical pumping.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2017/0354403, hereinafter Liu) in view of Brosig et al. (US 2019/0151502, hereinafter Brosig) and Privitera et al. (US 2006/0084974, hereinafter Privitera) as applied to claims 1-7, 9-10, and 17-18 above, and further in view of Blurton et al. (US 2014/0276919, hereinafter Blurton).
Concerning claim 8, the combination of the Liu, Brosig, and Privitera references as discussed above teaches the manipulation device according to claim 1, but does not specifically teach one or more transparent elements to allow the operator to receive a visual feedback from said mechanocromic indicator.
However, the Blurton reference teaches a grasping device including a mechanochromic indicator similar to the Liu reference, wherein the Blurton reference teaches that said mechanochromic indicator may be positioned on a support member that is partially transparent ([¶ 0093]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the manipulation device of the Liu, Brosig, and Privitera combination include transparent elements as in the Blurton reference to allow a user to visually observe the color change of the mechanochromic indicator (Blurton; [¶ 0093]).
Claim(s) 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2017/0354403, hereinafter Liu) in view of Brosig et al. (US 2019/0151502, hereinafter Brosig) and Privitera et al. (US 2006/0084974, hereinafter Privitera) as applied to claims 1-7, 9-10, and 17-18 above, and further in view of Nofen et al. (US 2019/0393112, hereinafter Nofen).
Concerning claim 11-15, the combination of the Liu, Brosig, and Privitera references as discussed above teaches the manipulation device according to claim 1, wherein the Brosig reference teaches said mechanochromic indicator comprising a polymeric matrix functionalized with mechanochromic molecules, wherein said polymer matrix may be PDMS, PMA, PMMA, or polystyrene ([¶ 0026]), and wherein said mechanochromic molecules may be functionalized spiropyran molecules ([¶ 0036]), wherein said mechanochromic molecules may be covalenetly linked to said at least one polymeric matrix ([¶ 0028]), but does not specifically teach the weight ratio used for preparing the polymeric matrix or a weight percentage of said mechanochromic molecules in said matrix.
However, the Nofen reference teaches a method of fabricating a mechanochromic material, wherein the reference teaches that said material may have a prepolymer/curing agent weight ratio of 100:27, and a percentage by weight of mechanochromic molecules in said matrix of greater than or equal to 0.1% ([¶ 0040]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the polymer matrix of the Liu, Brosig, and Privitera combination have a prepolymer/curing agent weight ratio of 100:27 which falls between 1:1-15:1, and a percentage by weight of mechanochromic molecules in said matrix of greater than or equal to 0.1% as in the Nofen reference given the Nofen reference teaches such specifications being appropriate for forming a mechanochromic polymer matrix (Nofen; [¶ 0040]), wherein it would further be obvious to specifically have the polymeric matrix comprise a PDMS matrix functionalized with spiropyran molecules, the prepolymer/curing agent weight ratio used for preparing said PDMS matrix being equal to 2.5:1, and the percentage by weight of said SP molecules in said polymeric matrix being 2% weight as a routine optimization of the result effective variables that are described in the Nofen reference.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2017/0354403, hereinafter Liu) in view of Brosig et al. (US 2019/0151502, hereinafter Brosig) and Privitera et al. (US 2006/0084974, hereinafter Privitera) as applied to claims 1-5, 6-7, 9-10, and 17-18 above, and further in view of Sievert, Jr. et al. (US 6,394,964, hereinafter Sievert).
Concerning claim 19, the combination of the Liu, Brosig, and Privitera references teaches the surgical apparatus according to claim 17, but does not specifically teach optical fibers arranged at, or within, the pressure means acting upon said mechanochromic indicator.
However, the Sievert reference teaches a manipulation device for minimally-invasive surgery, therein being in the same field of endeavor as the Liu, Brosig, and Privitera combination wherein the device may include optical fibers that may extend from the handle portion to the end effector of the device (Column 3, Lines 41-54).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the Liu, Brosig, and Privitera combination include optical fibers extending through a lumen of the manipulation device from the handle to the end effector to analyze tissue that is being grasped by the device (Sievert; Column 9, Line 56 – Column 10, line 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Hoarau reference (US 2007/0073122) teaches a grasping device including a pressure sensitive material that may increase color intensity in response to increased pressure ([¶ 0052]); the Arya et al. reference (US 2016/0089198) teaches a grasping device which may include a thermochromic device positioned on the jaw members; and the Jiries reference (US 2022/0193870) teaches a wrench including a mechanochromic indicator.
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/MARTIN T TON/Examiner, Art Unit 3771 1/31/2026