DETAILED ACTION
All referenced to the instant specification have been cited using PG Pub US20240374310A1.
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 .
Status of Claims
Claims 62 and 65-99 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 20, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on August 6, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference characters "805" and "810" have both been used to designate lateral support members.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “515” has been used to designate both “tension sensor” and “tensioning mechanism”;
Reference character “452” has been used to designate both “translation mechanism” and “laser pulses”; and
Reference characters “840”, “842”, “844”, and “846” have been used to designate both “tensioning belts” and “belt fixation devices”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because:
In Fig. 9D, elements 300 and 310 both point to the same part;
In Fig. 13D, element 351 and 356 both point to the same part;
In Fig. 14B, element 410 is located on the same surface as element 10; and
In Fig. 16B, element 415 points to two different components.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Element 572 “engagement feature” should appear in Fig. 9D-9F ¶[0277];
Element 205 “optical fiber” should appear in Fig. 14B ¶[0332];
Element 400 “robotic assembly” should appear in Fig. 16A ¶[0346];
Element 805 “lateral support members” should appear in Fig. 23A ¶[0381]; and
Elements “842”, “844”, and “846” should appear in Fig. 27A ¶[0385].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Element 404 in Fig.’s 14A and 14B;
Element 460 in Fig. 16B;
Element 22 in Fig. 21; and
Element 24 in Fig. 21.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Specification
The disclosure is objected to because of the following informalities:
“involving in small animals” in ¶[0179] should be changed to “involving small animals” for grammar;
“intensity is bel ow a threshold” in ¶[0196] should be changed to “intensity below a threshold”;
“sufficiently high to that the energy” in ¶[0197] should be changed to “sufficiently high so that the energy” for grammar;
“In such as case” in ¶[0215] should be changed to “In such a case” for grammar;
“delivery tool enable extrusion” in ¶[0236] should be changed to “delivery tool to enable extrusion” for grammar;
“can limited” in ¶[0257] should be changed to “can be limited” for grammar;
“laser pulses to may be controlled” in ¶[0257] should be changed to “laser pulses may be controlled”;
“inferred thermal” in ¶[0258] should be changed to “infrared thermal” for spelling;
“for facilitate the” in ¶[0272] should be changed to “for facilitating the” for grammar;
“capable applying tension” in ¶[0273] should be changed to “capable of applying tension” for grammar;
“tensioning belt 55” in ¶[0277] should be changed to “tensioning belt 550”;
the word “rigidity” in ¶[0278] should be removed or otherwise incorporated into the sentence;
“the although the” in ¶[0358] should be changed to “although the” for grammar;
“Fig. 24 illustrates shows one example” in ¶[0384] should be changed to remove either the word “illustrates” or “shows” for grammar;
“guideline 220A” in ¶[0393] should be changed to “guideline 220”;
“minimum incision length for as a function” in ¶[0399] should be changed to “minimum incision length as a function” for grammar; and
“incision closure structure 600” in ¶[0402] should be changed to “incision closure structure 700”.
Appropriate correction is required.
The use of the terms, “Ethicon” and “3M” in ¶[0367] which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 62 is objected to because of the following informalities: “is configured to apply to sufficient tension to” should be changed to “is configured to apply sufficient tension to” in the first line of the last limitation. Appropriate correction is required.
Claim 87 is objected to because of the following informalities: “such a prescribed amount” should be changed to “such that a prescribed amount” in the second line of the claim. Appropriate correction is required.
Claim 89 is objected to because of the following informalities: “an elastic deformation limit skin tissue” should be changed to “an elastic deformation limit of skin tissue” in the fourth line of the claim. Appropriate correction is required.
Claim 90 is objected to because of the following informalities: “formation of the incision.” should be changed to “formation of the incision;” in the fifth line of the claim to make the claim one sentence. Appropriate correction is required.
Claim 95 is objected to because of the following informalities: “amount to deflection” should be changed to “amount of deflection”. Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) 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. Such claim limitation(s) is/are: “tensioning mechanism configured to apply tension across the incision during formation of the incision” in claims 62, 65-69, and 71-99.
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 described in the specification as performing the claimed function, and equivalents thereof.
The specification discloses corresponding structures for the “tensioning mechanisms” in [0325], [0326], [0329], [0330], and [0349].
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 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 62 and 65-99 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.
Claim 62 recites the limitation “said tensioning mechanism is configured to apply to sufficient tension to maintain a line-of-sight between an output aperture of said robotic assembly and a base of the incision during formation of the incision while preventing substantial tension-induced scar tissue formation”. The amended portion of this limitation “base of the incision” filed on April 7, 2025 is not supported by the as-filed specification. As-filed, the specification discloses a base of a robotic assembly in ¶[0331] and the word “base” associated with an incision does not appear anywhere else in the specification. The as filed specification does not provide any description of what the base of the incision consists of. As such, the specification does not provide an adequate written description of the amended limitation of “base of the incision.”
Claims 65-99 are dependent on claim 62 and are therefore also rejected for the same reasons as claim 62.
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 62 and 65-99 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 “substantial” in the last two limitations of claim 62 is a relative term which renders the claim indefinite. The term “substantial” 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. The specification defines “the phrase "scar-free", when employed to refer to the formation and/or closure of an incision, means absent of visible scarring when viewed by the unaided eye” (¶[0189]) however does not disclose what “preventing substantial laser-induced scar tissue formation” nor does it disclose what “preventing substantial tension-induced scar tissue formation” encompasses. For the purposes of examination, these limitations will be interpretated as preventing visible scarring when viewed by the unaided eye.
The term “predominantly” in line 14 of claim 62 is a relative term which renders the claim indefinite. The term “predominantly” 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. The basis for the laser pulse absorption by the skin tissue is rendered indefinite by the use of the relative term “predominantly.”
Claim 65 recites the limitation of “in the absence of translation/rotation of said robotic assembly”. It is unclear if the slash indicates “and,” “or”, or “and/or”. For the purposes of examination, the limitation will be interpreted as “in the absence of translation or rotation of said robotic assembly”.
Claim 87 recites the limitation "the initial separation" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the limitation will be interpreted as “an initial separation”.
Claims 88 and 89 recite the limitation "said alignment member" in line 1. There is insufficient antecedent basis for this limitation in the claims. For the purposes of examination, the limitations will be interpreted as “an alignment member”.
The term “substantial” in the last line of claim 97 is a relative term which renders the claim indefinite. The term “substantial” 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. The specification defines “the phrase "scar-free", when employed to refer to the formation and/or closure of an incision, means absent of visible scarring when viewed by the unaided eye” (¶[0189]) however does not disclose what “preventing substantial force-induced scar tissue formation” encompasses. For the purposes of examination, “preventing substantial force-induced scar tissue formation” will be interpretated as preventing visible scarring when viewed by the unaided eye.
Claims 65-99 are dependent on claim 62 and are therefore rejected for the same reason as claim 62. Claim 98 is dependent on claim 97 and is therefore rejected for the same reason as claim 97.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 62, 65, 66, 68, 70, and 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over Barral et al. (US 9833254 B1, published Dec. 5, 2017, hereinafter referred to as “Barral”) in view of Miller et al. (US 20180055690 A1, published Mar. 1, 2018, hereinafter referred to as “Miller”) and Jacques (Applied Optics, May 1, 1993, Vol.32(13)).
Regarding claim 62, Barral teaches a system for forming an incision, the system comprising: a laser system; a robotic assembly (Fig. 1A “robotic surgical system 100” in Col. 8 ln. 58 which can be similar to Fig. 9 robotic surgical system 900 in Col. 26 ln. 14-16) configured to direct the laser pulses onto a skin surface of a subject (Fig. 1A “cut tissues at the intervention site 107 by exposing the tissues to beams of illumination having sufficient energy to ablate the tissue” in Col. 8 ln. 64-66); control and processing circuitry operatively coupled to said robotic assembly (Fig. 9 “Controller 910 may be provided as a computing device that includes one or more processors 911” in Col. 26 ln. 45-46), said control and processing circuitry comprising at least one processor (Fig. 9 “at least one processor 911” Col. 26, ln. 55) and associated memory (Fig. 9 “or other memory or disc storage, which can be integrated in whole or in part with at least one of the one or more processors 911” in Col. 26 ln. 57-59), said memory comprising instructions executable by said at least one processor for controlling said robotic assembly (Fig. 9 “The one or more processors 911 can be configured to execute computer-readable program instructions 914 that are stored in a computer readable data storage 912 and that are executable to provide the functionality of a robotic surgical system 900 as described herein” in Col. 26 ln. 46-51) to scan the laser pulses relative to the skin surface for forming the incision (Fig. 9 “The surgical instrument 902 could include a surgical laser… configured to apply energy to a specified portion of a biological tissue” in Col. 27 ln. 18-21 and “The dissection planning module 916 can include instructions for determining a cut trajectory of the surgical instrument 902 to cut a biological tissue” in Col. 28 ln. 40-42); and a tensioning mechanism (Fig. 1A “retractor 130” in Col. 8 ln. 67 and Fig. 9 “a retractor 906” in Col. 26 ln. 36) configured to apply tension across the incision during formation of the incision ( “The retractor 130 is actuated to apply a force between and/or separate tissues opposite a cut or other hiatus in tissue.” in Col. 9 ln. 1-9); said laser system being configured to generate the laser pulses with a wavelength such that absorption of the laser pulses by skin tissue is predominantly due to excitation of vibrational modes of water within the skin tissue (Fig. 1A “The optical head 110 is configured to cut tissue by applying a controlled beam of illumination having sufficient energy to ablate the tissue along a controlled trajectory… a wavelength of light emitted by the surgical laser could be specified to preferentially heat water, fat, or some other element of tissue such that particular tissues are affected (e.g., ablated) by an emitted beam while other tissues (e.g., neighboring tissues, underlying tissues) are relatively unaffected.” col. 11, ln. 13-28); wherein said tensioning mechanism is configured to apply sufficient tension to maintain a line-of-sight between an output aperture of said robotic assembly and a base of the incision during formation of the incision (“As illustrated in FIG. 1B, skin 106 of the person 105 is being retracted by the retractor 130 to expose underlying tissue. The underlying tissue is being cut along a cut trajectory 160 by a beam of illumination 115 emitted by a surgical laser of the optical head 110.” In Col. 9 ln. 5-9).
Barral does not explicitly teach the use of the tensioning mechanism while preventing substantial tension-induced scar tissue formation.
As discussed above in the U.S.C. 112(b) rejections, the instant spec does not provide detail on what substantial tension-induced scar tissue formation includes. Barral’s retractor device is capable of achieving the same results as it can be tuned to the same structural parameters as the instant spec. Blades of a retractor could apply suction to or otherwise adhere to (e.g., by using a liquid and/or dry adhesive) to portions of tissue (e.g., portions of tissue within or proximate to a cut in the biological tissue) in order to apply separating forces to and/or control a displacement between the portions of tissue (Col. 12, ln. 65 - Col. 13 ln. 3). Further, the blades of the retractor 130 Fig. 1A could be actuated (e.g., by a motor or some other actuator) and a force, distance, rate of separation, or other properties of the separation of tissues by the retractor could be controlled by the robotic surgical system 100 (Col. 13, ln. 18-22).
Barral does not disclose a laser system configured to generate laser pulses; said laser system and said robotic assembly being configured to respectively generate and deliver the laser pulses such that: a pulse duration is shorter than a first time duration required for thermal diffusion out of a laser irradiated volume of skin tissue and shorter than a second time duration required for a thermally driven expansion of the laser irradiated volume of skin tissue; the pulse duration and a pulse fluence result in a peak pulse intensity below a threshold for ionization-driven ablation to occur within the laser irradiated volume of skin tissue; and the pulse fluence is sufficiently high such that the laser irradiated volume of skin tissue is ablated and such that any residual energy is insufficient to induce substantial laser-induced scar tissue formation.
Miller’s invention relates to a laser surgery apparatus for contact laser surgery and to a method of using the laser surgery apparatus (¶[0001]). According to a preferred embodiment of the invention, the pulsed laser source is a picosecond infrared laser (PIRL) source (laser pulses). A PIRL source provides ultrafast laser heating to cut at the lowest possible laser fluence. According to this embodiment, the PIRL source may be configured to generate pulsed IR laser light of a wavelength falling within a range from 1 μm to 20 μm, of a pulse duration falling within a range from 100 fs to 10 ns (¶[0029]). The wavelength, pulse duration and repetition rate will be set to appropriate values falling within these ranges depending on the biological tissue to be cut (¶[0030]). The PIRL laser source may be configured to provide pulsed IR laser light of a wavelength in the range of 1 μm-20 μm, but especially 3 μm for heating H2O and 6 μm for heating connective tissue to be cut (¶[0031]). Due to the reduced fluence, local coagulation of the tissue is achieved and ionization of tissue is avoided (the pulse duration and a pulse fluence result in a peak pulse intensity below a threshold for ionization-driven ablation to occur within the laser irradiated volume of skin tissue – peak pulse intensity is fluence/duration, so a smaller fluence would indicate a smaller peak pulse intensity). This invention reduces the required laser fluence substantially, by up to an order of magnitude in comparison to some laser sources currently in use. This feature alone leads to much less tissue damage (¶[0081]). The addition of mechanical forces simultaneously with the ultrafast laser heating of the water in the tissue collapses the shear forces needed to cut the tissue to near zero and enables cutting at the level of single cell without damage to surrounding tissue (¶[0084]) (pulse fluence is sufficiently high such that the laser irradiated volume of skin tissue is ablated and such that any residual energy is insufficient to induce substantial laser-induced scar tissue formation). Further, the instant specification discloses that PIRL have a pulse duration of that is sufficiently short to drive ablation faster than the timescales associated with thermal and acoustic transport to remove or disrupt tissue in a so-called cold ablation process with respect to surrounding tissue (a pulse duration is shorter than a first time duration required for thermal diffusion out of a laser irradiated volume of skin tissue). The energy above the ablation threshold is fully confined to the targeted tissue, thus avoiding collateral damage due to heat and shock wave formation to surrounding tissue, while also being sufficiently long to avoid the ionizing radiation effects of plasma formation (¶[0179]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a laser system that delivers laser pulses with pulse durations and pulse fluence parameters that have thermal confinement without skin expansion and without ablation-driven ionization that is still able to ablate the skin tissue without causing significant scar tissue formation as taught by Miller in the laser system of Barral in order to produce much less tissue damage. Further, it provides all the benefits of the state of the art PIRL scalpel for scar free cutting of tissue but with greatly reduced laser power and associated costs (¶[0083]).
Barral and Miller do not disclose a pulse duration shorter than a second time duration required for a thermally driven expansion of the laser irradiated volume of skin tissue.
Jacques teaches that short laser pulses can confine thermal energy and/or stress energy within the optical zone, which maximizes photothermal and photomechanical mechanisms of interaction (abstract). Any laser pulse that is shorter than 10 ns at a wavelength selectively absorbed by the melanin of the pigmented retinal epithelium will achieve stress confinement and laser pulses below 10 ns have a lower injury threshold than those expected based on thermal confinement alone. (pg. 2453).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have laser pulses with a pulse duration shorter than the time for thermally driven expansion of the skin tissue as taught by Jacques in the device of Barral and Miller in order to minimize injury and therefore minimize scarring.
Regarding claim 65, modified Barral teaches the incision laser system of claim 62.
In the above embodiment, Barral does not disclose wherein said robotic assembly comprises a scanning mechanism configured to scan the laser pulses relative to the incision in the absence of translation or rotation of said robotic assembly.
The instant disclosure defines the scanning mechanism can include a galvanometer scanner including scanning mirrors and motors, for example (¶[0343]). Barral teaches that in other embodiments, a beam emitted by the surgical laser and a beam emitted by the light source could pass through a lens, actuated mirror, filter, or some other optical element(s) such that the direction of the emitted beams could be controlled in common (Col. 11 ln. 37-41).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include a scanning mechanism configured to scan the laser pulses relative to the incision in the absence of translation or rotation of said robotic assembly as taught by Barral in the device of modified Barral in order to control the direction of the emitted beams.
Regarding claim 66, modified Barral teaches the system of claim 62.
Modified Barral does not explicitly teach wherein control and processing circuitry is configured to control said robotic assembly such that the laser pulses are scanned laterally relative to a tissue surface via translation and/or rotation of said robotic assembly.
Barral teaches the robotic surgical system could perform other determinations and/or operations based on one or more images of the biological tissue. For example, the robotic surgical system could update the information indicative of the desired dissection and/or an initial or other determined trajectory based on one or images of the biological tissue. The robotic surgical system could operate a retractor and/or translate or rotate one or more elements of the robotic surgical system to improve access (e.g., by a surgical instrument, by an imager) to regions of the biological tissue (e.g., to tissues at the base of a cut or other dissection or cleft in the tissue) (Col. 21 ln. 5-16).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to scan laser pulses laterally relative to the tissue surface via translation and rotation of the robotic assembly as taught by Barral in the device of modified Barral. This is because Barral’s device already contains the control and processing circuitry and uses it to scan laser pulses and Barral further elaborates that the robotic system can translate or rotate the system to improve its access and update the trajectory of the dissection.
Regarding claim 68, modified Barral teaches the surgical system of claim 66.
Barral does not disclose wherein said robotic assembly comprises a laser pulse delivery tool having an optical waveguide extending therefrom, said optical waveguide comprising a distal tip, said laser system being in optical communication with said robotic assembly for delivering the laser pulses to said optical waveguide, such that the laser pulses are directed through said optical waveguide to said distal tip, the laser pulses being suitable for ablating skin tissue when said distal tip is contacted with the skin tissue and the laser pulses are delivered to the skin tissue through said distal tip.
Miller teaches that conventional fiber optic laser surgery systems generally fall within one of two broad classes, contact systems and free beam systems. Contact systems, as the name suggests, utilize a contact element (i.e. an optical fiber tip or a lens element), which is placed in contact with a tissue area to be irradiated, and a beam carried by the fiber is delivered to the tissue at the point of contact (¶[0010]). Optical fiber 4 of IR laser radiation transmissive material which terminates at an optical fiber tip 5 (distal tip). The fiber tip 5 comprises an exposed core region that is tapered and has a form of a mechanical blade shape (cf. FIGS. 2A to 3F) and is disposed at a distal end of the scalpel 3 for contacting a tissue to be cut (¶[0055]). In use, the uncoated portion 6 of the contact tip 5 is applied directly to the tissue to be cut. The shaped optical fiber 5 serves both as a means to heat the tissue to be cut and as a mechanical cutting edge to make an incision (¶[0074]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have an optical waveguide at the distal tip for delivering laser pulses directly to the skin tissue for ablation as taught by Miller in the device of Barral since Barral requires a tool for administering laser energy and contact fiber optic laser systems can directly administer the laser pulses to the skin.
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barral in view of Barral (hereinafter referred to as “modified Barral”) as applied to claim 66, in further view of Villegas et al. (US 20120046570 A1, published Feb. 23, 2012, hereinafter referred to as “Villegas”).
Regarding claim 67, modified Barral teaches the surgical system of claim 66. Barral further teaches wherein said robotic assembly comprises a distal head configured to deliver the laser pulses to the skin surface (Fig. 1A “The optical head 110 is configured to optically image tissues at the intervention site 107 and to cut tissues at the intervention site 107 by exposing the tissues to beams of illumination having sufficient energy to ablate the tissue.” Col. 8, ln. 63-66).
Modified Barral does not teach wherein the laser pulses are delivered to the skin surface through free space.
Villegas’s invention relates to methods and devices/systems for real time monitoring of tissue treatment as well as methods and devices/systems for treatments to alter tissue content, such as collagen-containing structures, in a subject (¶[0002]). Although optical fibers provide a convenient way of transporting light into a device, various "free-space" embodiments of the systems are also included in the invention. Such optional free space systems comprise the benefit of avoiding the inevitable losses associated with coupling light into optical fibers (¶[0102]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to deliver the laser pulses through free space as taught by Villegas in the device of modified Barral in order to avoid losses associated with coupling optical fibers.
Regarding claim 70, Barral teaches wherein said tensioning mechanism (Fig. 1A “retractor 130” in Col. 8 ln. 67 and Fig. 9 “a retractor 906” in Col. 26 ln. 36) comprises a plurality of tensioning members (“a retractor could include two self-retaining blades (e.g., mechanical elements having sharp and/or blunted prongs configured to secure a biological tissue) connected to an actuator (e.g., a servo, a motor) configured to apply a separating force force) between the blades” in Col. 7, ln. 13-21) that extend from a distal portion of said robotic assembly, said tensioning mechanism being controllable, by said control and processing circuitry, to apply tension by varying a separation between adjacent tensioning members on opposing sides of the incision (Fig. 1A “The robotic surgical system additionally includes a retractor 130 mounted on a second armature 140. The retractor 130 is actuated to apply a force between and/or separate tissues opposite a cut or other hiatus in tissue” in Col. 8 ln. 67 and “The blades of the retractor 130 could be actuated (e.g., by a motor or some other actuator) and a force, distance, rate of separation, or other properties of the separation of tissues by the retractor could be controlled by the robotic surgical system 100. Such operation could be performed based on one or more images of the tissue” in Col. 13 ln. 4-30).
Regarding claim 72, Barral also teaches the surgical robot system further comprising an imaging device (Fig. 1A “The optical head 110 includes a variety of components configured to image and to cut tissues at the intervention site 107.” in Col. 9 ln. 11-13) positioned relative to said tensioning mechanism such that when the incision is formed and a distal trough of the incision is exposed under application of tension by said tensioning mechanism, the distal trough resides within a field of view of said imaging device (“Manipulation of tissue by the refractor could additionally allow for imaging of tissues at the base and/or along the walls of a dissection or at some other location(s) that are occluded from the view of one or more imagers by other tissues and/or surgical instruments.” Col. 7 ln. 38-43).
Regarding claim 73, Barral teaches wherein said imaging device is provided in a substantially overhead configuration relative to a location associated with formation of the incision (“the robotic surgical system could control an armature or other actuator connected to the camera 705 to position the camera 705 as shown in FIG. 7B to provide a view of the biological tissue on both sides of the initial cut 725” in Col. 23, ln. 36-45), enabling imaging of a center of the incision when the incision is sufficiently tensioned (“Manipulation of tissue by the refractor could additionally allow for imaging of tissues at the base and/or along the walls of a dissection or at some other location(s) that are occluded from the view of one or more imagers by other tissues and/or surgical instruments.” Col. 7 ln. 38-43).
,
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Barral in view of Miller, in even further view of Jacques (hereinafter referred to as “modified Barral”) as applied to claim 66, in further view of Straehnz et al. (US 20110276089 A1, published Nov. 10, 2011, hereinafter referred to as “Straehnz”).
Regarding claim 69, modified Barral discloses the surgical system of claim 66.
Modified Barral does not disclose the system further comprising a guide structure that is removably attachable to the skin surface, said guide structure being configured to receive and guide translation of a distal portion said robotic assembly for forming the incision.
Straehnz’s invention relates to surgical instruments, and more specifically relates to incision guides and wound closure devices. (¶[0002]). Prior to making an incision, the bottom surface 16 in Fig. 1 of the surgical mesh 12 may be positioned against the skin surface of a patient. The bottom surface 16 may have a slight or weak adhesive layer applied thereto for forming a non-permanent and/or repositionable frictional engagement with the skin surface. (¶[0042]). The opposing first and second incision guides 20A, 20B define an elongated incision opening extending therebetween that is preferably used for aligning and guiding a surgical tool, such as a scalpel, for making an incision through the surgical mesh 12 and into the tissue of a patient. In one embodiment, the incision guides 20A, 20B desirably align a cutting tool so that it is substantially perpendicular to the skin surface so as to prevent the formation of an angled or sloped incision in the tissue (¶[0043]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include a guide structure that is removably attached to the skin that can receive and guide the distal portion of the robotic assembly as taught by Straehnz in the surgical system of modified Barral in order to prevent formation of angled or sloped incisions and cut exactly where is desired.
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barral as applied to claim 62, in further view of Shelton et al. (US 20200405414 A1, published Dec. 31, 2020, hereinafter referred to as “Shelton”), and in even further view of Pawlaczyk et al. (Postepy Dermatol Alergol, Oct. 2013, Vol 30(5), pg. 302-6, hereinafter referred to as “Pawlaczyk”).
Regarding claim 71, modified Barral teaches the surgical system of claim 62.
Modified Barral does not disclose wherein said robotic assembly comprises a sensor capable of generating a signal dependent on applied tension, and wherein said control and processing circuitry is configured to process the signal to determine whether the applied tension is likely to result in forces within the incision below an inelastic deformation limit.
Shelton’s invention relates to robotic surgical systems including a central control unit and one or more robotic arms (¶[0001]). In various instances, one or more sensors are attached to each robotic arm of a robotic surgical system. The one or more sensors are configured to sense a force applied to the surrounding tissue during the operation of the robotic arm. Such forces can include, for example, a holding force, a retracting force, and/or a dragging force. The sensor from each robotic arm is configured to communicate the magnitude and direction of the detected force to a control unit of the robotic surgical system. The control unit is configured to analyze the communicated forces and set limits for maximum loads to avoid causing trauma to the tissue in a surgical site. For example, the control unit may minimize the holding force applied by a first robotic arm if the retracting or dragging force applied by a second robotic arm increases (¶[0231]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a sensor that measure applied tension and analyze it with control and processing circuitry as taught by Shelton in the surgical system of modified Barral in order to set limits to avoid causing trauma to the incision tissue.
Modified Barral and Shelton do not teach determining whether the applied tension is likely to result in forces within the incision below an inelastic deformation limit.
Pawlaczyk teaches deformation marks the skin in response to applied forces and is defined as perfectly elastic, if the skin returns to its initial state after the termination of the force. If, after exceeding the elastic limit, the termination of the external force does not permit for the skin to return to its initial shape, the so-called residual deformation occurs. This deformation is related to the change of position of the skin elements and, consequently, its stability (pg. 303).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to determine whether the applied tension is likely to result in forces within the incision below an inelastic deformation limit in the device of modified Barral and Shelton because after exceeding the elastic limit, the skin does not return to its initial shape as taught by Pawlaczyk.
Claim 74 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barral as applied to claim 72, in further view of Shelton, and in even further view of Nazari et al. (IEEE Sensors Journal, Vol. 21, No. 7, April 1, 2021, pg. 8805-8830, hereinafter referred to as “Nazari”).
Regarding claim 74, modified Barral teaches the surgical system of claim 72.
Modified Barral does not disclose wherein said control and processing circuitry is operatively coupled to said imaging device and said tensioning mechanism, and wherein said control and processing circuitry is configured to process images obtained from said imaging device to generate feedback for controlling said tensioning mechanism.
Shelton teaches that in various instances, one or more sensors are attached to each robotic arm of a robotic surgical system. The one or more sensors are configured to sense a force applied to the surrounding tissue during the operation of the robotic arm. Such forces can include, for example, a holding force, a retracting force, and/or a dragging force. The sensor from each robotic arm is configured to communicate the magnitude and direction of the detected force to a control unit of the robotic surgical system. The control unit is configured to analyze the communicated forces and set limits for maximum loads to avoid causing trauma to the tissue in a surgical site. For example, the control unit may minimize the holding force applied by a first robotic arm if the retracting or dragging force applied by a second robotic arm increases (¶[0231]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a sensor that measure applied tension and analyze it with control and processing circuitry as taught by Shelton in the surgical system of modified Barral in order to set limits to avoid causing trauma to the incision tissue.
Modified Barral and Shelton do not disclose processing images obtained from said imaging device to generate feedback for controlling said tensioning mechanism.
Nazari’s paper aims to fill the stated gap by reviewing the recent advances in image-based force estimation in robotic interventions (abstract pg. 8805). It teaches force feedback affects the safety level of human-robot/machine interactions, which is specifically vital in medical interventions (pg. 8811).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to use the images obtained in order to generate feedback for controlling the tensioning mechanism as taught by Nazari in the device of modified Barral and Shelton because the estimated forces are essential to the safety of human-robot interactions and the images can be used to estimate tension.
Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barral in further view of Shelton and Nazari as applied to claim 74, and in even further view of Roux et al. (US 20040225197 A1, published Nov. 11, 2004, hereinafter referred to as “Roux”).
Regarding claim 75, modified Barral, Shelton and Nazari teaches the surgical system of claim 74.
As discussed, modified Barral, Shelton and Nazari discloses control and processing circuitry that processes images and controls the tensioning mechanism. Modified Barral, Shelton and Nazari does not disclose wherein said control and processing circuitry is configured to process the images to determine whether or not the incision has sufficient width, and to provide control signals to said tensioning mechanism to increase the tension when the incision is determined to have insufficient width.
Roux’s invention relates to the general field of surgical accessories and is particularly concerned with a surgical retractor (¶[0002]). It should be understood that although the retractor 10 is disclosed herein as being used in a context of a sternotomy-type surgical intervention, the retractor 10 could be used in any other contexts including other types of thoracic surgeries and surgeries performed on other parts of a human or animal body without departing from the scope of the present invention (¶[0063]). Roux’s device consists of an actuator releasably attached to the tissue blades for selective adjustment of the spacing between the blades (abstract). The retractor is cranked open using a rotatable handle until the two spreader arms abutting against the generally opposed sternum edges force the sternum and rib cage to separate and expand open, thereby giving access to the thoracic cavity, and the internal tissues and body organs therewithin (¶[0007]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to determine if the incision has sufficient width and increase the tension of the tensioning mechanism if the width is insufficient as taught by Roux in the surgical system of modified Barral, Shelton and Nazari since this method is art-recognized and allows opening the surgical incision wider to allow access to the internal tissues.
Claim 76 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barral and Shelton as applied to claim 74, and further view of Amundson et al. (US 20210295504 A1, published Sept. 23, 2021, filed Mar. 4, 2021, hereinafter referred to as “Amundson”), Pawlaczyk, and Roux.
Regarding claim 76, modified Barral and Shelton teaches the surgical system of claim 74.
Modified Barral and Shelton discloses wherein said control and processing circuitry is configured to perform operations comprising: while controlling said tensioning mechanism to vary the tension applied across the incision: controlling said imaging device to acquire images corresponding to different amounts of applied tension;
Modified Barral and Shelton teaches in claim 74 the control and processing circuitry controlling tension applied across the incision and force applied to surrounding tissue. There is nothing preventing this device from capturing images corresponding to different amounts of tension.
Modified Barral and Shelton does not teach processing the images to generate incision measures comprising at least (i) a first measure characterizing a presence or absence of the distal trough of the incision and (ii) a second measure characterizing elasticity of deformation of an exposed internal cutaneous tissue surface in response to the tension; and employing the incision measures to control said tensioning mechanism to apply tension such that the distal trough of the incision is exposed and such that deformation of said exposed internal cutaneous surface by the tension is elastic, thereby preventing or reducing formation deformation-induced generation of scar tissue.
Amundson’s invention relates to computing system and methods configured for applying objective image content analysis processes so as to determine the presence (or absence) of objective image characteristics. Those characteristics may be compared against applicable objective criteria that may be utilized to perform an automated diagnosis and/or identification of characteristics of the image (¶[0004]). As indicated at Block 403 in Fig. 4, the image analysis system 65 is configured to detect individual features relevant for the image analysis that are present within the image. Accordingly, utilizing the image analysis criteria received previously, the image analysis system 65 identifies individual features within the image that are relevant for further analysis. For example, the image analysis criteria may indicate (e.g., within a list, a matrix, a reference table, and/or the like), specific features within an image to be identified, and individual entries within the feature listing may be associated with specific models (e.g., machine-learning based models) utilized for identifying those features within an image (¶[0089]). These measurement distance criteria may comprise one or more thresholds, one or more ranges, and/or the like that may be utilized for classifying the overall image (¶[0110]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to analyze an image to product a first measure characterizing a presence or absence of a feature, in this case the distal trough of the incision as taught by Amundson in the surgical system of modified Barral and Shelton in order to automate the identification of the distal trough.
Modified Barral and Shelton and Amundson do not teach processing the images to generate incision measures comprising at least (ii) a second measure characterizing elasticity of deformation of an exposed internal cutaneous tissue surface in response to the tension; and employing the incision measures to control said tensioning mechanism to apply tension such that the distal trough of the incision is exposed and such that deformation of said exposed internal cutaneous surface by the tension is elastic, thereby preventing or reducing formation deformation-induced generation of scar tissue.
Pawlaczyk teaches deformation marks the skin in response to applied forces and is defined as perfectly elastic, if the skin returns to its initial state after the termination of the force. If, after exceeding the elastic limit, the termination of the external force does not permit for the skin to return to its initial shape, the so-called residual deformation occurs. This deformation is related to the change of position of the skin elements and, consequently, its stability (pg. 303).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to measure elasticity of deformation of an exposed internal cutaneous tissue surface in response to the tension in the system of modified Barral and Shelton and Amundson because after exceeding the elastic limit, the skin does not return to its initial shape as taught by Pawlaczyk so this would be important to monitor.
Modified Barral and Shelton, Amundson and Pawlaczyk do not teach employing the incision measures to control said tensioning mechanism to apply tension such that the distal trough of the incision is exposed and such that deformation of said exposed internal cutaneous surface by the tension is elastic, thereby preventing or reducing formation deformation-induced generation of scar tissue.
Roux’s retractor 10 could be used in any other contexts including other types of thoracic surgeries and surgeries performed on other parts of a human or animal body without departing from the scope of the present invention (¶[0063]). Roux’s device consists of an actuator releasably attached to the tissue blades for selective adjustment of the spacing between the blades (abstract). The retractor is cranked open using a rotatable handle until the two spreader arms abutting against the generally opposed sternum edges force the sternum and rib cage to separate and expand open, thereby giving access to the thoracic cavity, and the internal tissues and body organs therewithin (¶[0007]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to apply tension to the tensioning mechanism to see the exposed incision as taught by Roux in the surgical system of modified Barral and Shelton, Amundson and Pawlaczyk since this method is art-recognized and allows opening the surgical incision wider to allow access to the internal tissues. Further, the device width is capable of being tuned to reduce formation of scar tissue.
Claim 77 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barral as applied to claim 72, and in further view of Shelton, Nazari, and Liao et al. (International Journal of Solids and Structures, Vol. 51, pg. 478-490, available online October 23, 2013, hereinafter referred to as “Liao”).
Regarding claim 77, modified Barral teaches the surgical system of claim 72.
Modified Barral does not disclose wherein said control and processing circuitry is configured to perform operations comprising: while controlling said tensioning mechanism to vary the tension applied across the incision: controlling said imaging device to acquire images corresponding to different amounts of applied tension; processing said images to determine a local deformation measure by performing image registration between a common tissue region within the incision across multiple images; and employing said local deformation measure to determine local strain.
Shelton teaches that in various instances, one or more sensors are attached to each robotic arm of a robotic surgical system. The one or more sensors are configured to sense a force applied to the surrounding tissue during the operation of the robotic arm. Such forces can include, for example, a holding force, a retracting force, and/or a dragging force. The sensor from each robotic arm is configured to communicate the magnitude and direction of the detected force to a control unit of the robotic surgical system. The control unit is configured to analyze the communicated forces and set limits for maximum loads to avoid causing trauma to the tissue in a surgical site. For example, the control unit may minimize the holding force applied by a first robotic arm if the retracting or dragging force applied by a second robotic arm increases (¶[0231]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a sensor that measure applied tension and analyze it with control and processing circuitry as taught by Shelton in the surgical system of modified Barral in order to set limits to avoid causing trauma to the incision tissue. There is nothing preventing this device from analyzing measurements corresponding to different amounts of tension.
Modified Barral and Shelton do not disclose controlling said imaging device to acquire images corresponding to different amounts of applied tension; processing said images to determine a local deformation measure by performing image registration between a common tissue region within the incision across multiple images; and employing said local deformation measure to determine local strain.
Nazari teaches force feedback affects the safety level of human-robot/machine interactions, which is specifically vital in medical interventions (pg. 8811). The aim and contribution of this paper are to fill the stated gap by reviewing the recent advances in image-based force estimation in robotic interventions (abstract pg. 8805).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to controlling said imaging device to acquire images corresponding to different amounts of applied tension as taught by Nazari in the device of modified Barral and Shelton because images can be used to estimate tension and the estimated forces are essential to the safety of human-robot interactions.
Modified Barral and Shelton and Nazri do not disclose processing said images to determine a local deformation measure by performing image registration between a common tissue region within the incision across multiple images; and employing said local deformation measure to determine local strain.
Liao teaches t he optimal local deformation gradient technique is introduced to develop a strain field calculation method for determining the ‘local’ strain in a cellular material (pg. 489). Digital image correlation (DIC) technique based on camera system and image processing system has been used in a considerable number of experimental studies on cellular materials to capture the heterogeneous deformation at the mesoscopic scale (processing said images to determine a local deformation measure by performing image registration across multiple images). Deformation localization is a typical feature of the response of cellular materials, especially in dynamic cases, and obviously it cannot be represented by nominal stress–strain relationship. Due to the cellular nature, the concept of ‘local’ strain should be introduced to characterize the deformation of cells at the mesoscopic scale. Here, the terminology of ‘local’ refers to a small region but not to a mathematical point (pg. 478). Once a local deformation gradient is determined, a local strain tensor is obtained (pg. 479).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to perform image registration to determine a local deformation measure between a common tissue region within the incision across multiple images and use the measurement to determine local strain as taught by Liao in the surgical system of modified Barral and Shelton and Nazri since this is an art-known method of calculating strain and knowing the local strain can help the device moderate structural integrity.
Claim 78 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barral as applied to claim 62, in further view of Belson et al. (US 20160310140 A1, published Oct. 27, 2016, hereinafter referred to as “Belson”) and Roux.
Regarding claim 78, modified Barral teaches the surgical system of claim 62.
Modified Barral does not disclose the system further comprising a device for retraction of the incision, said device comprising: a first elongate member and a second elongate member, said first elongate member and said second elongate member being removably securable relative to a skin surface such that said first elongate member and said second elongate member reside adjacent one another, and such that the incision resides between said first elongate member and said second elongate member; each of said first elongate member and said second elongate member comprising a respective incision edge protection feature located such that when said first elongate member and said second elongate member reside adjacent one another, each incision edge protection feature is insertable into the incision, such that each incision edge protection feature resides adjacent to a respective incision edge; and said device further comprising a retraction mechanism connecting said first elongate member and said second elongate member, said retraction mechanism being operable to increase a separation between said first elongate member and said second elongate member, thereby retracting the incision through application of tension across the skin surface while avoiding substantial deformation of the incision edges by said incision edge protection features.
Belson’s invention relates to medical systems, devices, and methods, in particular to the construction, use, and function of surgical incision closure devices with integrated therapeutic and/or sensor properties (¶[0002]). FIG. 1 shows the layout of a basic wound closure device 100. The wound closure device 100 may comprise a first panel 102 (first elongate member) and a second panel 104 (second elongate member). The first and second panels 102, 104 may be arranged in parallel across the lateral sides of an incision before being drawn laterally together to close the incision and maintain its closure. The adjustable straps 118 may connect the first and second panels 102 and 104 through adjustable strap anchors 112 and the adjustable strap ratchets 120 (retraction mechanism connecting said first elongate member and said second elongate member). For example, an individual adjustable strap 118 may be pulled through the adjustable strap ratchet 120 to draw the panels 102 and 104 together. (¶[0030]). The device also has Fig. 1 element of pressure sensitive skin adhesive 116 for securing the panels which is made of a material particularly suited for long-term wear applications (e.g., up to 14 days) (¶[0031]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include a device for retraction of the incision with a first elongate member and a second elongate member removably securable relative to a skin surface such that the incision resides between the two members, and a retraction mechanism connecting said first elongate member and said second elongate member as taught by Belson in the system of modified Barral in order to maintain the incision closure.
Modified Barral and Belson do not teach each of said first elongate member and said second elongate member comprising a respective incision edge protection feature located such that when said first elongate member and said second elongate member reside adjacent one another, each incision edge protection feature is insertable into the incision, such that each incision edge protection feature resides adjacent to a respective incision edge; and said retraction mechanism being operable to increase a separation between said first elongate member and said second elongate member, thereby retracting the incision through application of tension across the skin surface while avoiding substantial deformation of the incision edges by said incision edge protection features.
In Fig. 1 of Roux’s invention, there is shown a surgical retractor 10 in accordance with an embodiment of the present invention. The retractor 10 is shown being used for retracting a pair of substantially opposed body tissue edges 12 delimiting an incision opening 14. It should be understood that although the retractor 10 is disclosed herein as being used in a context of a sternotomy-type surgical intervention, the retractor 10 could be used in any other contexts including other types of thoracic surgeries and surgeries performed on other parts of a human or animal body without departing from the scope of the present invention (¶[0063]). According to the principle of the present invention, the retractor 10 generally involves a pair of retractor blades 16 coupled to a driving means 18 for driving the blade 16 so as to vary the distance therebetween. Typically, the driving means is a drive mechanism that functions in some manner to urge the opposing blade 16 apart thus forcing the opposite tissue edges 12 open in order to allow surgical access through the incision opening 14 (¶[0064]). In the embodiments shown throughout the figures, each of the blades 16 has a blade first segment 38 for substantially contacting a corresponding tissue edge 12 (incision edge protection feature) and a blade second segment 40 extending therefrom for substantially contacting an exterior surface 42 of the tissue in which the incision 14 is made (¶[0068]). Typically, the driving means or mechanism 18 includes a first and a second arm 24, 26 mounted to a bar or rack 28 for relative movement therebetween along the rack 28 (retraction mechanism). The rack 28 is provided with at least one row of gear teeth 32 (¶[0070-0071]). An actuator releasably attached to the tissue blades for selective adjustment of the spacing between the blades is included (abstract).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include incision edge protection features on each of the respective elongate members that lies adjacent to a respective incision edge, and to increase separation between the elongate members through the application of tension while avoiding substantial deformation of the incision edges as taught by Roux in the system of modified Barral and Belson. This is because these components allow surgical access through the incision opening and is art-recognized so can be applied to this application. Further, Roux’s retractor device is capable of achieving the same results as it can be tuned to the same structural parameters as the instant spec for avoiding deformation of the incision edges by modifying the distance of the incision opening.
Claims 79, 80, and 84 are rejected under 35 U.S.C. 103 as being unpatentable over modified Barral as applied to claim 68, and further view of Cowan (US 20160000458 A1, published Jan. 7, 2016, hereinafter referred to as “Cowan”).
Regarding claim 79, modified Barral teaches the surgical system of claim 68.
Modified Barral does not disclose the surgical system further comprising: a support substrate comprising a first elongate substrate portion and a second elongate substrate portion, said support substrate being configured to be removably attachable to the skin surface such that said first elongate substrate portion and said second elongate substrate portion are provided in a spaced relationship, and such that a skin region is accessible between said first elongate substrate portion and said second elongate substrate portion; and a rigid guide structure configured to be removably and rigidly attachable to said support substrate such that a separation between said first elongate substrate portion and said second elongate substrate portion is fixed by said rigid guide structure, said rigid guide structure being configured to guide translation of said laser pulse delivery tool along a prescribed incision path residing within the skin region between said first elongate substrate portion and said second elongate substrate portion for forming the incision while remaining fixed to said support substrate.
Cowen’s invention relates to medical devices and methods, and more particular relates to surgical devices and methods for causing rapid incisions of pre-set depth, and, in at least some embodiments, rapid closure of the incision. The precision incision device of the present invention includes a cutting member (e.g., a scalpel blade) maintained within a housing member. In an embodiment, the housing member fits onto one or more guiding members, (e.g., tracks), which are affixed to the skin with an adherent suitable for use in surgical procedures (¶[0010]). Referring first to FIG. 1, an embodiment of the precision incision device 100 of the present invention comprises includes a pair of guide rails 105A-105B (first and second elongate substrate portions) (¶[0029]). The guide rails are affixed to the skin, and, in some embodiments, spaced very closely together (removably attachable to the skin surface such that said first elongate substrate portion and said second elongate substrate portion are provided in a spaced relationship) (¶[0046]). The Fig. 1 blade 110 is maintained within a cutting member 115 (rigid guide structure) which is mounted onto the rails 105A-105B and slides along their length (¶[0030]). The cutting member and guide rails have cooperated to cause an incision that is perpendicular and without the variation associated with manual incising (¶[0046]). FIGS. 6A-6B show an embodiment of a closure cover 600 which slides along guide rails, with extrusions 605 similar to the extrusions 310 on the cutting member (shows that the rigid guide structure is also removably and rigidly attachable to said support substrate) (¶[0046]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filling to include a support substrate that has two elongate members and is removably attached to the skin with a skin region between them; and a rigid guide structure that is removably and rigidly attachable to the support substrate and can guide translation of said laser pulse delivery tool along a prescribed incision path as taught by Cowan in the surgical device of modified Barral in order to create an incision that is perpendicular.
Regarding claim 80, Cowan teaches wherein said laser pulse delivery tool comprises first guiding features (Fig. 1 “slight indentation 120A-120B” in ¶[0031]) that engage with corresponding second guide features of said rigid guide structure (Fig. 3A “For those embodiments having indentations in the guide rails for retention of the housing, lateral extrusions 310 can be provided on the side walls to mate with the indentations.” In ¶[0034]) to permit and guide translation of said laser pulse delivery tool relative to said rigid guide structure for forming the incision (“In the embodiment shown in FIG. 1, a slight indentation 120A-120B exists at the lower edge of outer side of each of the rails to permit the cutting member 115 to be retained on the rails as it slides along them.” ¶[0031]).
Regarding claim 84, Cowan teaches wherein said support substrate and said rigid guide structure comprise respective engagement features (Fig. 1 “slight indentation 120A-120B” in ¶[0031] and Fig. 3A “For those embodiments having indentations in the guide rails for retention of the housing, lateral extrusions 310 can be provided on the side walls to mate with the indentations.” In ¶[0034]) such that an intraoperative separation between said first elongate substrate portion and said second elongate substrate portion is enforced by said rigid guide structure (“In the embodiment shown in FIG. 1, a slight indentation 120A-120B exists at the lower edge of outer side of each of the rails to permit the cutting member 115 to be retained on the rails as it slides along them.” ¶[0031]).
Claims 81-83, and 85-87 are rejected under 35 U.S.C. 103 as being unpatentable over modified Barral in view of Cowan as applied to claims 79 and 84, in even further view of Martin (US 20130324980 A1, published Dec. 5, 2013).
Regarding claim 81, modified Barral and Cowan teaches the surgical system of claim 79.
Although Cowan teaches the rigid guide structure and mechanisms for holding a cutting tool, modified Barral and Cowan does not disclose the device further comprising a tool carriage configured to support said laser pulse delivery tool relative to said rigid guide structure and facilitate translation of said laser pulse delivery tool relative to said rigid guide structure, said tool carriage comprising first guiding features that engage with corresponding second guiding features of said rigid guide structure to permit and guide translation of said tool carriage relative to said rigid guide structure.
Martin’s invention relates to an apparatus and method for facilitating access through a patient tissue and, more particularly, to a method and apparatus for facilitating access through a patient skin surface (¶[0002]). The tool carriage 522 is configured to accept at least a chosen one of a plurality of surgical tools 532 for sequential interaction with the access site 212. For example, and as shown in FIGS. 5A-5B, the tool carriage 522 accepts a scalpel 534. As another incising option (not shown), the tool carriage 522 could accept just a blade of a scalpel 534, without the handle, a Bovie knife, a cutting laser, a cutting electrode, or any other incising tool. The tool carriage 522 shown includes a tool grasper 536 which is configured to hold the scalpel 534. The tool grasper 536 may have any desired configuration for holding any desired tool 532, using any desired type of engagement (¶[0032]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include a tool carriage to support the laser pulse delivery tool relative to the rigid guide structure that are engaged with each other as taught by Martin in the surgical system of modified Barral and Cowan in order to hold the tool during use.
Regarding claim 82 and 86, modified Barral and Cowan teaches the surgical system of claims 79 and 84.
Modified Barral and Cowan does not disclose the system further comprising an alignment member for defining an initial spacing between said first elongate substrate portion and said second elongate substrate portion during attachment of said first elongate substrate portion and said second elongate substrate portion to the skin surface, said alignment member being removable after attachment of said first elongate substrate portion and said second elongate substrate portion to the skin surface.
Martin shows a placement jig 314 (alignment member) in Fig.’s 3A-3B according to an embodiment of the present invention. The placement jig 314 shown includes two jig channels 316 spaced a predetermined distance apart by a jig body 318. The placement jig 314 is selectively attachable (directly or indirectly) to the guiding substrates 202 for maintaining a substantially fixed relationship between the guiding substrates at a first spacing distance 320 (¶[0026]). The placement jig 314 can be used to help position the guiding substrates 202 in a relatively precise and desirable manner, as compared to freehand placement (¶[0028]). As shown in FIG. 4, the placement jig can be manipulated to bring the (adhesive) underside of the guiding substrates 202 into contact with the skin surface, and then the placement jig can be removed, leaving the guiding substrates and associated guiding rails fastened to the skin surface in the arrangement (spacing and relative orientation) shown in FIG. 1A. When used, the placement jig 314 can help to place one or more guiding substrates 202 and/or guiding structures into a desired position on the skin surface 204 at a predetermined absolute or relative location, and in a repeatable manner (¶[0029]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include an alignment member for defining the space between the elongate substates as taught by Martin in the surgical system of modified Barral and Cowan in order to ensure correct and repeatable placement of the substrates.
Regarding claim 83, modified Barral and Cowan does not disclose wherein said alignment member is configured such that the initial spacing is selectable prior to attachment of said first elongate substrate portion and said second elongate substrate portion to the skin surface.
Martin teaches a lateral width of the tool carriage 522 may be chosen to exert a force upon the skin surface 204 as desired by the user when the tool carriage and guiding structure 210 are engaged together and the guiding substrate 202 is fastened to the skin surface 204. For example, when the apparatus 100 includes attachment of two guiding rails 210 to the skin surface 204 at the first spacing distance 320 relative to one another, the lateral width of the tool carriage 522 may be chosen to pull the guiding rails 210 closer together than the first spacing distance (i.e., the tool carriage will exert compressive force on the skin surface through engagement between the guiding structure and the following structure 524). Similarly, the lateral width of the tool carriage 522 may be chosen to push the guiding rails 210 further apart than the first spacing distance (i.e., the tool carriage will exert tensile force on the skin surface through engagement between the guiding structure and the following structure 524), to a second spacing distance 538. The latter situation will be more common when the apparatus 100 is being used to guide an incising tool (e.g., a scalpel) along the action path 526 to create an incision in the skin surface 204 (¶[0033]). Further, it is contemplated here that a tool carriage 522 could act as a placement jig 314 and/or a maintenance jig 744, particularly when the tool carriage is not carrying a tool. The width of such a multi-purpose tool carriage could be adjustable (e.g., through the use of a spring-biased width-wise telescoping structure), to assist with providing the various spacing distances described herein (¶[0052]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to select the initial spacing between the two elongate members with the alignment member as taught by Martin in the surgical system of modified Barral and Cowan in order to vary the exerted force applied to the tissue during formation of the incision.
Regarding claim 85, modified Barral and Cowan teaches the surgical system of claim 84.
Modified Barral and Cowan does not disclose wherein said rigid guide structure is configured such that the intraoperative separation between said first elongate substrate portion and said second elongate substrate portion is controllable after attachment of said rigid guide structure to said support substrate, thereby permitting intraoperative tuning of an amount of tension applied to the skin region.
Martin teaches that a tool carriage 522 could act as a placement jig 314 and/or a maintenance jig 744, particularly when the tool carriage is not carrying a tool. The width of such a multi-purpose tool carriage could be adjustable (e.g., through the use of a spring-biased width-wise telescoping structure), to assist with providing the various spacing distances described herein (¶[0052]). Martin also teaches a lateral width of the tool carriage 522 may be chosen to exert a force upon the skin surface 204 as desired by the user when the tool carriage and guiding structure 210 are engaged together and the guiding substrate 202 is fastened to the skin surface 204 (¶[0033]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a rigid guide structure with a controllable width to adjust the tension applied to the skin region as taught by Martin in the surgical system of modified Barral and Cowan since there is nothing precluding the tool from being variable in use in order to vary the tension in the skin during operation.
Regarding claim 87, modified Barral and Cowan does not disclose wherein an initial separation is different from the intraoperative separation, such that a prescribed amount of tension is applied across the skin region after attachment of said rigid guide structure to said support substrate and during formation of the incision.
Martin teaches The placement jig 314 is selectively attachable (directly or indirectly) to the guiding substrates 202 for maintaining a substantially fixed relationship between the guiding substrates at a first spacing distance 320 (¶[0026]). A lateral width of the tool carriage 522 may be chosen to exert a force upon the skin surface 204 as desired by the user when the tool carriage and guiding structure 210 are engaged together and the guiding substrate 202 is fastened to the skin surface 204. the lateral width of the tool carriage 522 may be chosen to push the guiding rails 210 further apart than the first spacing distance (i.e., the tool carriage will exert tensile force on the skin surface through engagement between the guiding structure and the following structure 524), to a second spacing distance 538. The latter situation will be more common when the apparatus 100 is being used to guide an incising tool (e.g., a scalpel) along the action path 526 to create an incision in the skin surface 204 (¶[0033]). When a surgeon is creating a freehand incision in a patient's skin surface 204, the surgeon will manually spread/tension the skin surface with her thumb and fingers so that she is cutting a relatively taut surface. However, such manually applied tension is inherently variable and unrepeatable, both along and perpendicular to the action path 526. Using the apparatus 100, a predetermined and repeatable tension can be applied uniformly to the access site 212 (e.g., by placement of the guiding rails 210 at the second spacing distance 538) to assist the incising tool 532 (carried by the tool carriage 522) in creating a relatively uniform and controlled incision (¶[0034]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have an initial spacing that is different from an intraoperative spacing with a prescribed amount of tension as taught by Martin in the surgical system of modified Barral and Cowan in order to have predetermined and repeatable tension uniformly across the access site while creating the incision.
Claims 88-89 are rejected under 35 U.S.C. 103 as being unpatentable over modified Barral in view of Cowan and Martin as applied to claim 87, in even further view of Pawlaczyk.
Regarding claims 88 and 89, modified Barral, Cowan and Martin teaches the surgical system of claim 87.
Modified Barral, Cowan and Martin does not teach wherein said alignment member and said rigid guide structure are configured such that a difference between the initial separation and the intraoperative separation results in an applied tension, within the incision, during formation of the incision, that is less than an elastic deformation limit of skin.
In claim 87, Martin taught that the applied tension was predetermined. Pawlaczyk teaches deformation marks the skin in response to applied forces and is defined as perfectly elastic, if the skin returns to its initial state after the termination of the force. If, after exceeding the elastic limit, the termination of the external force does not permit for the skin to return to its initial shape, the so-called residual deformation occurs. This deformation is related to the change of position of the skin elements and, consequently, its stability (pg. 303).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to select a tension that is less than an elastic deformation limit of skin in the surgical system of modified Barral in view of Cowan and Martin because after exceeding the elastic limit, the skin does not return to its initial shape as taught by Pawlaczyk and modified Barral in view of Cowan and Martin selects the tension so this would be essential to limiting scarring.
Claims 90, 94, 97, and 98 are rejected under 35 U.S.C. 103 as being unpatentable over modified Barral, Cowan and Martin as applied to claim 86, in even further view of Noonan et al. (Medical Image Computing and Computer-Assisted Intervention – MICCAI 2010. MICCAI 2010. Lecture Notes in Computer Science, vol 6363. Springer, Berlin, hereinafter referred to as “Noonan”).
Regarding claim 90, modified Barral, Cowan and Martin teaches the surgical system of claim 86.
Modified Barral, Cowan and Martin taught wherein said control and processing circuitry is operably coupled to said laser pulse delivery tool in earlier claims.
Cowan further teaches said laser pulse delivery tool comprising a depth control mechanism for controlling a depth of said distal tip relative to the skin surface when said laser pulse delivery tool is engaged with said rigid guide structure.
Cowan teaches the depth of the incision can be critical to avoiding unnecessary trauma to the patient (¶[0004]). It is also important that such incisions are limited in depth, to avoid unnecessary blood loss or other complications, which could be caused by, for example, incising epigastric vessels. While surgeons are typically highly skilled, it is inevitable that some incisions made by a hand-held scalpel will be less perpendicular, less straight, less or more deep, and thus fundamentally less precise than others. In addition, the manual application of stitches typically involves uneven pressure along the incision, creating lumps and bumps of scar tissue as the tissues reattach and heal (¶[0007]). The cutting member or blade 110 in Fig.’s 3B-3C can be directly affixed to the housing 300, or can be affixed to a spring-loaded clamping mechanism 315 which can be adjusted to set the depth of the incision (¶[0036]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a depth control mechanism for controlling the depth of the cutting mechanism as taught by Cowan in the device of modified Barral, Cowan and Martin in order to avoid unnecessary trauma to the patient.
Martin further teaches wherein said alignment member is configured such that the initial separation is selectable prior to attachment of said first elongate substrate portion and said second elongate substrate portion to the skin surface for controlling an amount of tension applied within the skin region during formation of the incision.
Martin teaches a lateral width of the tool carriage 522 may be chosen to exert a force upon the skin surface 204 as desired by the user when the tool carriage and guiding structure 210 are engaged together and the guiding substrate 202 is fastened to the skin surface 204. For example, when the apparatus 100 includes attachment of two guiding rails 210 to the skin surface 204 at the first spacing distance 320 relative to one another, the lateral width of the tool carriage 522 may be chosen to pull the guiding rails 210 closer together than the first spacing distance (i.e., the tool carriage will exert compressive force on the skin surface through engagement between the guiding structure and the following structure 524). Similarly, the lateral width of the tool carriage 522 may be chosen to push the guiding rails 210 further apart than the first spacing distance (i.e., the tool carriage will exert tensile force on the skin surface through engagement between the guiding structure and the following structure 524), to a second spacing distance 538. The latter situation will be more common when the apparatus 100 is being used to guide an incising tool (e.g., a scalpel) along the action path 526 to create an incision in the skin surface 204 (¶[0033]). Further, it is contemplated here that a tool carriage 522 could act as a placement jig 314 and/or a maintenance jig 744, particularly when the tool carriage is not carrying a tool. The width of such a multi-purpose tool carriage could be adjustable (e.g., through the use of a spring-biased width-wise telescoping structure), to assist with providing the various spacing distances described herein (¶[0052]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to select the initial spacing between the two elongate members with the alignment member as taught by Martin in the surgical system of modified Barral, Cowan and Martin in order to vary the exerted force applied to the tissue during formation of the incision.
Modified Barral, Cowan and Martin does not disclose wherein the system is configured to control said depth control mechanism such that contact of said distal tip with skin tissue within the incision is maintained as a depth of the incision increases during formation of the incision.
Noonan’s paper describes a force adaptive multi-spectral imaging system integrated with an articulated robotic endoscope that allows a constant contact force to be maintained between the probe and the tissue as the robot tip is actuated across complex tissue profiles (abstract).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to control the depth control mechanism so that the distal tip of the laser was in constant contact with the skin tissue as taught by Noonan in the surgical system of modified Barral, Cowan and Martin since it is an art-recognized method and avoids unnecessary trauma to the patient.
Regarding claim 94, Noonan teaches the system further comprising a sensor for sensing signals dependent on a force applied to said distal tip by the skin tissue during translation of said laser pulse delivery tool, and wherein said depth control mechanism is controlled, based on the signals, to maintain contact between said distal tip and the skin tissue.
Noonan teaches the force along the centerline of the probe is measured by the force-torque sensor (pg. 248). The device is a force adaptive multi-spectral imaging system integrated with an articulated robotic endoscope that allows a constant contact force to be maintained between the probe and the tissue as the robot tip is actuated across complex tissue profiles (abstract).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include a sensor for sending forces applied to the distal tip during translation to maintain contact between the distal tip and the skin tissue as taught by Noonan in the device of modified Barral, Cowan and Martin since it is an art-recognized method and avoids unnecessary trauma to the patient.
Regarding claim 97, Noonan teaches wherein said depth control mechanism is controlled, based on the signals, to limit the force within a range that is suitable for maintaining contact between said distal tip and the skin tissue while preventing substantial force-induced scar tissue formation (“with this system we can maintain a low but constant force that achieves a sufficient optical signal without applying excessive load to the tissue.” Pg. 249 and “This allows a constant contact force to be maintained between the probe and the tissue as the robot tip is translated across complex tissue profiles.” Pg. 246). This device is capable of preventing substantial force-induced scar tissue as it can be tuned to the same structural parameters as the instant spec.
Regarding claim 98, Noonan teaches wherein said depth control mechanism is controlled, based on the signals, to limit the force within an elastic deformation limit of the skin tissue (“with this system we can maintain a low but constant force that achieves a sufficient optical signal without applying excessive load to the tissue.” Pg. 249). This device is capable of being tuned to limit the amount of force applied and therefore can be tuned to limit the force within an elastic deformation limit of the skin tissue.
Claim 91 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barral in view of Cowan, Martin, and Noonan as applied to claim 90, in even further view of Newton (OptoBlog, Feb. 7, 2017).
Regarding claim 91, modified Barral, Cowan, Martin, and Noonan teaches the surgical system of claim 90.
Modified Barral, Cowan, Martin, and Noonan does not disclose wherein said depth control mechanism is controlled in an open-loop configuration according to control criteria dependent on a number of passes of said laser pulse delivery tool along the prescribed incision path.
Newton explains that process control is performed automatically to help ensure consistent and repeatable results. If a process is controlled only by setpoint commands without any feedback measurement signals, the system is referred to as open loop. The advantage to open-loop systems is that they’re typically pretty cheap, because there’s less computing power built into them.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to control the depth control mechanism in an open-loop configuration dependent on the number of passes of the laser pulse delivery tool as taught by Newton in the surgical system of modified Barral, Cowan, Martin, and Noonan because open-loop systems are cheaper to make and still produce consistent repeatable results.
Claim 92 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barral, Cowan, Martin, and Noonan as applied to claim 90, and further view of Bay et al. (J. Biophotonics Vol.8, pg. 102-111, available online Dec. 17, 2013, hereinafter referred to as “Bay”) and Rastegar et al. (US 20080033410 A1, published Feb. 7, 2008, hereinafter referred to as “Rastegar”).
Regarding claim 92, modified Barral, Cowan, Martin, and Noonan teaches the surgical system of claim 90.
Modified Barral, Cowan, Martin, and Noonan does not disclose wherein at least one of said laser pulse delivery tool and said rigid guide structure comprises a sensor for detecting a number of passes of said laser pulse delivery tool during formation of the incision, wherein said control and processing circuitry is operably coupled to said sensor.
Bay teaches that a lack of sensory feedback during laser surgery prevents surgeons from discerning the exact location of the incision, which increases duration and complexity of the treatment. The proposed method holds promise for delivering high precision real-time feedback during laser surgeries (abstract).
Rastegar’s invention relates generally to automated control of a laser head for treatments on human skin, and more particularly to automated control of a laser head for laser debridement of burns. The physician circumscribes the treatment areas on the touch-screen monitor and enters the operating parameters of the laser, including the number of passes over each region of the treatment areas (¶[0045]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to incorporate a sensor to count the number of passes of the laser pulse during formation of the incision as taught by Bay and Rastegar in the surgical system of modified Barral, Cowan, Martin, and Noonan in order to ensure that the laser passes the prescribed number of times and monitor the real-time depth of the incision.
Claims 93 and 99 are rejected under 35 U.S.C. 103 as being unpatentable over modified Barral, Cowan, Martin, and Noonan as applied to claim 90, and further view of Bruno et al. (US 10265126 B2, Apr. 23, 2019, hereinafter referred to as “Bruno”).
Regarding claims 93 and 99, modified Barral, Cowan, Martin, and Noonan teaches the surgical system of claim 90.
Modified Barral, Cowan, Martin, and Noonan does not disclose the laser pulse delivery tool further comprising a sensor for sensing signals dependent on the depth of the incision (spatial offset, in a depth direction, between said distal tip and a bottom of the incision), and wherein said depth control mechanism is controlled in a closed-loop configuration according to control criteria that employs the signals from said sensor.
Bruno’s invention relates to an automated Computer Assisted and Robot-Guided laser osteotome (CARLO). In the preferred embodiment of the present invention the CARLO features a closed-loop control system to stop the laser sending laser pulses at the hard-soft tissue interface when the bone I fully traversed (Col. 6 ln. 38-41). The closed loop hole depth control system (80) requires an acoustical sensor and (44), a time triggering element which could be a photodiode (38) and an electronic processing unit or computer (61). The central operating console (6) comprises the computer (61) running the dedicated software to control all functions of the CARLO medical device (1) by means of various interface units. Included functions are the robotic arm (2), the Photoablation Laser (31), and the autotracking navigation system (4) (Col. 10 ln. 5-14). This offers the advantage of constant control the depth in the cutting, drilling or grinding of bone and cartilage to minimize or completely avoid damage in vulnerable structures (e.g. vessels and nerves) and the surrounding soft tissue (Col. 4 ln.31-34).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include a sensor for sensing signals dependent on the depth of the incision and control in closed-loop configuration as taught by Bruno in the device of modified Barral, Cowan, Martin, and Noonan in order to minimize damage in vulnerable structures and surrounding soft tissue.
Claim 95 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barral, Cowan, Martin, and Noonan as applied to claims 90 and 94, in even further view of Moll et al. (US 20080218770 A1, published Sept. 11, 2008, hereinafter referred to as “Moll”).
Regarding claim 95, modified Barral teaches the surgical system of claim 94.
Modified Barral, Cowan, Martin, and Noonan does not disclose wherein said sensor is configured such that the signals are dependent on an amount of deflection of said optical waveguide.
Moll’s invention relates generally to medical instruments having multiple jointed devices, including for example telerobotic surgical systems, and more particularly to a method, system, and apparatus for sensing or measuring the position, temperature and/or stress and strain at one or more positions along the multiple jointed device (¶[0002]). By utilizing a kinematic model of an instrument fitted with one or more Bragg fiber sensor(s), and a mechanics model of how the instrument should deflect or strain under load, a comparison may be made between the expected position of the instrument, as determined utilizing the kinematic and/or mechanics relationships, and the actual position of the instrument, determined utilizing the Bragg fiber sensor data. The difference between actual and expected may then be analyzed utilizing the kinematic and/or mechanics relationships to determine what kind of load must have been applied to cause the difference between actual and expected--and thereby the load may be characterized. For example, taking a two-link instrument wherein the distal link is basically a flexible polymeric cylinder; a kinematic model can be used to predict how the cylinder should move relative to the more proximal pieces when actuated, and it should retain its original shape unless it is subjected to an external load; if the Bragg fiber sensor data indicates that the cylinder is bending, then the applied load can be calculated (e.g. a formula relating the bending to the load can be determined, or a lookup table of predetermined empirical data could be used). Thus, by using the Bragg fiber sensor to measure deflections or strains in different parts of the instrument, forces on the instrument and stresses within the instrument may be determined (¶[0037]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to measure the signal based on an amount of deflection of an optical waveguide as taught by Moll in the device of modified Barral, Cowan, Martin, and Noonan because it is an art recognized way to measure force.
Claim 96 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barral, Cowan, Martin, and Noonan as applied to claim 90, and further view of Kang (US 20210307849 A1, published Dec. 7, 2021, filed Jun. 22, 2021, hereinafter referred to as “Kang”).
Regarding claim 96, modified Barral, Cowan, Martin, and Noonan teaches the surgical system of claim 94.
Modified Barral, Cowan, Martin, and Noonan does not disclose wherein said sensor is configured such that the signals are dependent on an amount of pressure applied to said distal tip by the skin tissue.
Kang’s invention relates to a surgical robot system with a manipulator and incision tool (¶[0006]). The control system can also monitor contact/contact force during line haptic guiding via one or more sensors S (e.g., one or more force sensors, force/torque sensors, torque sensors, pressure sensors, optical sensors, or the like) that communicates with the robotic controller 32 (Fig.’s 1-2). If no significant contact/contact force is detected, which means the surgical tool 30 is passing through soft tissue, the control system avoids activating the motor of the surgical tool 30 or other power source (e.g., RF energy, ultrasonic motor, etc.). When contact with bone is detected (e.g., optically, sensed force is above a predefined threshold, etc.), the control system can activate the motor or other power source. Users can also passively feel the contact/contact force and trigger a switch to activate the power source (¶[0052]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to detect the amount of pressure applied to the distal tip as taught by Kang in the device of modified Barral, Cowan, Martin, and Noonan in order to activate the laser at the desired location.
Conclusion
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/E.N.C./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792