DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Disposition of Claims
Claims 1-3, 5-12, 14, 16-20 & 22-24 are pending and rejected.
Claims 4, 13, 15, 21 & 25-31 are canceled.
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 limitations are:
“a grasper drive system… to drive motion of the tissue grasping device” in Claims 1-3, as described in Para. [0028] of Applicant’s specification.
“a control system configured to… control the grasper drive system” in Claims 1 & 5, as described in Para. [0061] of Applicant’s specification.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-9, 12, 16-17 & 22-23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Asherov et al. (hereinafter "Asherov") (US 2023/0355232).
Regarding Claim 1, Asherov discloses a system (Fig. 1A, 100; [0097]) comprising:
an elongate flexible instrument (Fig. 1A, 102; [0098]);
a tissue grasping device (Figs. 1A & 13, 101; [0098]) including a helical needle (Figs. 1E & 13, 116 wherein 116 is helical; [0112] & [0115]) extending from a distal end of the elongate flexible instrument (101 extends from a distal end of 102; see Figs. 1A-B);
a grasper drive system (Fig. 13, 1208; [0114]) coupled to the tissue grasping device ([0114]) to drive motion of the tissue grasping device ([0163]);
a sensor system (Fig. 13, 1302; [0163]) coupled to the tissue grasping device ([0164]); and
a control system (circuitry; [0187]) configured to receive sensor information from the sensor system ([0187]) and control the grasper drive system in response to the received sensor information ([0191] & [0192]).
Regarding Claim 2, Asherov discloses the system of Claim 1. Asherov further discloses wherein controlling the grasper drive system includes providing an actuation signal to the grasper drive system ([0193] & [0194]).
Regarding Claim 3, Asherov discloses the system of Claim 1. Asherov further discloses wherein controlling the grasper drive system includes adjusting a setting of the grasper drive system ([0195]).
Regarding Claim 5, Asherov discloses the system of Claim 1. Asherov further discloses an instrument system (Fig. 12, 1200; [0112]), the instrument system in communication with the control system ([0187] & [0188]).
Regarding Claim 6, Asherov discloses the system of Claim 5. Asherov further discloses wherein the instrument system is at least one of a suturing system, a biopsy system ,a treatment system, or an ablation system (Fig. 12, 1200 is a suturing assembly; [0112]).
Regarding Claim 7, Asherov discloses the system of Claim 5. Asherov further discloses wherein the instrument system is configured to initiate a procedure based on the received sensor information ([0187] & [0188]).
Regarding Claim 8, Asherov discloses the system of Claim 1. Asherov further discloses wherein the elongate flexible instrument includes an endoscopic imaging system ([0107]).
Regarding Claim 9, Asherov discloses the system of Claim 1. Asherov further discloses wherein the tissue grasping device is cannulated (Figs. 7B & 13, 110A of 101 comprises 705 of 700 of 1302; [0164] & [0168]), and a component of the sensor system extends within the tissue grasping device (Fig. 7A, 702; [0168]).
Regarding Claim 12, Asherov discloses the system of Claim 1. Asherov further discloses wherein the sensor system includes a pressure sensor (Figs. 7A & 13, 710 of 700 of 1302; [0164] & [0168]) configured to detect a change in fluid pressure in a lumen extending through the tissue grasping device ([0170]) as the tissue grasping device penetrates tissue ([0171]).
Regarding Claim 16, Asherov discloses the system of Claim 1. Asherov further discloses wherein the sensor system includes an electrical sensor (Figs. 9A & 13, 910 of 1302; [0164] & [0177]).
Regarding Claim 17, Asherov discloses the system of Claim 16. Asherov further discloses wherein the electrical sensor is configured to detect a change in an electrical property as the tissue grasping device penetrates tissue ([0180]).
Regarding Claim 22, Asherov discloses the system of Claim 1. Asherov further discloses wherein the sensor system includes encoders in the grasper drive system (Fig. 1A, 121A; [0109]).
Regarding Claim 23, Asherov discloses the system of Claim 1. Asherov further discloses wherein the tissue grasping device includes a slidable elongated core (Fig. 1E, 115 wherein 115 moves longitudinally; [0125]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10-11 & 24 are rejected under 35 U.S.C. 103 as being unpatentable over Asherov et al. (hereinafter "Asherov") (US 2023/0355232) in view of Romley (US 2014/0343576).
Regarding Claims 10-11 & 24, Asherov discloses the system of Claim 1. Asherov fails to explicitly disclose wherein the helical needle is a first helical needle and the tissue grasping device includes a second helical needle; wherein the tissue grasping device comprises a straight needle and the helical needle is wrapped around an axis of the straight needle; and wherein a slidable sheath extends around the tissue grasping device.
However, Romley teaches a system (Fig. 1, 2; [0087]) comprising:
an elongate flexible instrument (Fig. 1, 16; [0088]);
a tissue grasping device (Fig. 1, 12; [0088]) including a helical needle (Fig. 29, 32 of 6; [0091]) extending from a distal end of the elongate flexible instrument (see Fig. 1);
a grasper drive system (Fig. 1, 50; [0088]) coupled to the tissue grasping device to drive motion of the tissue grasping device ([0095]);
a sensor system (Fig. 1, 41; [0093]) coupled to the tissue grasping device ([0093]);
wherein the helical needle is a first helical needle (Fig. 29, 32 of 6 is helical; [0091]) and the tissue grasping device includes a second helical needle (Fig. 29, 32 of 10; [0091]);
wherein the tissue grasping device comprises a straight needle (Fig. 29, 30 of 60; [0091]) and the helical needle is wrapped around an axis of the straight needle (see Fig. 29); and
wherein a slidable sheath extends around the tissue grasping device (Fig. 4, 58; [0099]).
The advantage of the multiple tissue grasping needles is to provide greater flexibility in which tissues are folded and/or fastened together (Romley; [0115]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the tissue grasping device as disclosed by Asherov, to include the additional tissue grasping needles as taught by Romley, to provide greater flexibility in which tissues are folded and/or fastened together (Romley; [0115]).
Claims 14 & 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Asherov et al. (hereinafter "Asherov") (US 2023/0355232) in view of Duindam et al. (hereinafter "Duindam") (US 2013/0204124).
Regarding Claims 14 & 18-20, Asherov discloses the system of Claim 1. Asherov fails to explicitly disclose wherein the sensor system includes an optical sensor configured to detect a change in a parameter of reflected light as the tissue grasping device penetrates tissue; wherein the sensor system includes an optical fiber sensor; wherein the optical fiber sensor is configured to detect a change in strain as the tissue grasping device penetrates tissue; and wherein the optical fiber sensor is configured to detect a change in shape of the tissue grasping device as the tissue grasping device penetrates tissue.
However, Duindam teaches a system (Fig. 1A, 100; [0030]) comprising:
a needle (Fig. 1A, 110; [0030]);
a sensor system (Fig. 1A, 120; [0032]) coupled to the needle ([0032]);
wherein the sensor system includes an optical fiber sensor ([0046]);
wherein the optical fiber sensor is configured to detect:
a change in a parameter of reflected light as the tissue grasping device penetrates tissue ([0048]);
a change in strain as the tissue grasping device penetrates the tissue ([0048]); and
a change in shape of the tissue grasping device as the tissue grasping device penetrates the tissue ([0047]).
The advantage of the optical shape sensor is to efficiently and effectively control the trajectory of the needle (Duindam; [0011]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the sensor system as disclosed by Asherov, to include the optical shape sensor taught by Duindam, to efficiently and effectively control the trajectory of the needle (Duindam; [0011]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
West et al. (US 2024/0415377) teaches an endoscopic tissue grasping system and method.
Guerrero et al. (US 2024/0156446) teaches a transcatheter device for repairing a leaflet of a heart valve.
Purcell et al. (US 2023/0225865) teaches an apparatus for mitral valve chord repair.
Favreau et al. (US 2021/0068812) teaches a suturing closure scope with alternative needle orientation.
Comee et al. (US 2021/0068811) teaches a suturing device with a sensor-controlled locking mechanism.
Fischell et al. (US 2019/0374220) teaches an apparatus for approximating and securing tissue.
Saadat et al. (US 2014/0350412) teaches an apparatus for delivering a biological compound to an infarcted tissue.
Ream et al. (U.S. 5,972,012) teaches a cutting apparatus having an articulable tip.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN FLOYD LONDON whose telephone number is (571)272-4478. The examiner can normally be reached Monday - Friday: 10:00 am ET - 6:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL CAREY can be reached at (571)270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHEN FLOYD LONDON/Examiner, Art Unit 3795
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