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 .
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.
Election/Restrictions
Applicant's election with traverse of Group 1, drawn to a catheter robot of claims 1-4 and 18-21 in the reply filed on 2/17/26 is acknowledged. The traversal is on the ground(s) that Graetzel does not teach the claimed internal mechanism for rotation of the external long flexible medical instrument, synchronized to the rotation of the internal longitudinal translation and rotation mechanism and rotation mechanism. This is not found persuasive because the argument(s) do not appear commensurate in scope with the claim language. For example, there is no “supplementary rotation module” in claim 1. Additionally, the response argues that the same “flexible medical instrument” is driven at both its proximal and distal ends and that Graetzel doesn’t disclose such a feature, but the claims don’t recite that both a proximal module and distal module both drive a single instrument. Instead, claim 1 recites “an external long flexible medical instrument” and “an internal flexible medical instrument” and that the proximal and distal modules drive one of these instruments each. Notwithstanding the above, para [0160] of Graetzel explicitly teaches “…the system may be configured to map the articulation command to one or both of the outer and inner bodies…” (emphasis added) and “…it may be desirable to articulate both of the inner and outer bodies…” (emphasis added).
The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 5-17 and 22 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/17/26.
Claim Objections
Claim 1 is objected to because of the following informalities: “instrument.” (line 10) appears that it should be “instrument;”.
Claim 18 is objected to because of the following informalities: “the internal longitudinal translation and rotation mechanism” (line 3) appears that it should be “the internal longitudinal translation and rotation mechanisms.”
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.
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: “a catheter robot support,” in claim 1, which has no corresponding structure; “a distal module, comprising an internal longitudinal translation and rotation module,” in claim 1, which has no corresponding structure; “a proximal module, comprising an internal longitudinal translation and rotation module,” in claim 1, which has no corresponding structure; and “an internal mechanism for rotation of said external long flexible medical instrument, synchronized to the rotation of said internal longitudinal translation and rotation mechanism for said external long flexible medical instrument of said distal module,” in claim 1, which has no corresponding structure.
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.
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.
Claim(s) 1-4 and 18-21 is/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.
For claim 1, the claim language “a catheter robot support” 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, at the time the application was filed, had possession of the claimed invention. Specifically, this claim language invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. As a result, there is a lack of evidence that Applicant had possession of the claimed subject matter since there is no description of the structure(s) that correspond to the claimed subject matter. The examiner respectfully requests Applicant’s assistance in determining where support may be found or have the subject matter deleted from the claim(s).
For claim 1, the claim language “a distal module, comprising an internal longitudinal translation and rotation module” 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, at the time the application was filed, had possession of the claimed invention. Specifically, this claim language invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. As a result, there is a lack of evidence that Applicant had possession of the claimed subject matter since there is no description of the structure(s) that correspond to the claimed subject matter. The examiner respectfully requests Applicant’s assistance in determining where support may be found or have the subject matter deleted from the claim(s).
For claim 1, the claim language “a proximal module, comprising an internal longitudinal translation and rotation module” 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, at the time the application was filed, had possession of the claimed invention. Specifically, this claim language invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. As a result, there is a lack of evidence that Applicant had possession of the claimed subject matter since there is no description of the structure(s) that correspond to the claimed subject matter. The examiner respectfully requests Applicant’s assistance in determining where support may be found or have the subject matter deleted from the claim(s).
For claim 1, the claim language “an internal mechanism for rotation of said external long flexible medical instrument, synchronized to the rotation of said internal longitudinal translation and rotation mechanism for said external long flexible medical instrument of said distal module” 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, at the time the application was filed, had possession of the claimed invention. Specifically, this claim language invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. As a result, there is a lack of evidence that Applicant had possession of the claimed subject matter since there is no description of the structure(s) that correspond to the claimed subject matter. The examiner respectfully requests Applicant’s assistance in determining where support may be found or have the subject matter deleted from the claim(s).
Dependent claim(s) 2-4 and 18-21 fail to cure the deficiencies of independent claim 1, thus claim(s) 1-4 and 18-21 is/are rejected under 35 U.S.C. 112(a).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-4 and 18-21 is/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.
For claim 1, the claim language “a catheter robot support” is ambiguous. Specifically, this claim language invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. As a result, the metes and bounds of the claim language cannot be ascertained since it is unknown what structure(s) are covered by the claim language and what structure(s) are not. The claim is examined as meaning any structure capable of performing the recited function.
For claim 1, the claim language “a distal module, comprising an internal longitudinal translation and rotation module” is ambiguous. Specifically, this claim language invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. As a result, the metes and bounds of the claim language cannot be ascertained since it is unknown what structure(s) are covered by the claim language and what structure(s) are not. The claim is examined as meaning any structure capable of performing the recited function.
For claim 1, the claim language “a proximal module, comprising an internal longitudinal translation and rotation module” is ambiguous. Specifically, this claim language invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. As a result, the metes and bounds of the claim language cannot be ascertained since it is unknown what structure(s) are covered by the claim language and what structure(s) are not. The claim is examined as meaning any structure capable of performing the recited function.
For claim 1, the claim language “an internal mechanism for rotation of said external long flexible medical instrument, synchronized to the rotation of said internal longitudinal translation and rotation mechanism for said external long flexible medical instrument of said distal module” is ambiguous. Specifically, this claim language invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. As a result, the metes and bounds of the claim language cannot be ascertained since it is unknown what structure(s) are covered by the claim language and what structure(s) are not. The claim is examined as meaning any structure capable of performing the recited function.
For claim 19, the claim term “the other” (line 3) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
Dependent claim(s) 2-4 and 18-21 fail to cure the ambiguity of independent claim 1, thus claim(s) 1-4 and 18-21 is/are rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, and 19-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2020/0352420 to Graetzel et al. (hereinafter “Graetzel”)
For claim 1, Graetzel discloses a catheter robot having a longitudinal axis (Abstract) and comprising:
a catheter robot support (105) (Fig. 16) (para [0110]);
a distal module (115) (Fig. 16) (para [0110]), comprising an internal longitudinal translation and rotation module (para [0112]) for an external long flexible medical instrument (131) (Fig. 16) (para [0113]);
a proximal module (125) (Fig. 16) (para [0110]), comprising an internal longitudinal translation and rotation module (para [0112]) for an internal long flexible medical instrument (133) (Fig. 16) (para [0113]);
said distal module being intended to (Examiner’s Note: functional language/intended use, i.e., capable of) be arranged between the patient and said proximal module (as can be seen in Fig. 1);
said external long flexible medical instrument surrounding, over at least a part of the longitudinal axis, said internal long flexible medical instrument (as can be seen in Figs. 16-17 and 19-20);
wherein:
said proximal module is mobile in longitudinal translation relative to the support and/or relative to said distal module (para [0105] and [0114]);
said proximal module also comprises an internal mechanism for rotation of said external long flexible medical instrument, synchronized to the rotation of said internal longitudinal translation and rotation mechanism for said external long flexible medical instrument of said distal module (para [0160]) (also see more generally para [0161]-[0176] for a discussion of the co-articulation).
For claim 4, Graetzel further discloses wherein said catheter robot comprises a control unit (“one or more processors,” Abstract) configured for (Examiner’s Note: functional language, i.e., capable of) commanding the longitudinal translation of the proximal module by synchronizing it with the longitudinal translation of the external long flexible medical instrument (para [0120]) (also see para [0114]-[0116]), and for controlling the longitudinal translation of the internal long flexible medical instrument by compensating the longitudinal translation of the proximal module so as to keep the internal long flexible medical instrument stationary relative to the support (para [0174]-[0175] and/or [0176]) (also see para [0120]).
For claim 19, Graetzel further discloses wherein said catheter robot does not comprise any deformable guide located around one or the other of the long flexible medical instruments (as can be seen in Fig. 17).
For claim 20, Graetzel further discloses wherein one or more or all of the modules comprise a mobile platform sliding longitudinally in at least one rail (as can be seen in Figs. 1, 3, and 16).
For claim 21, Graetzel further disclose wherein one or more or all of the modules comprise a longitudinally rolling cart (as can be seen in Fig. 2).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graetzel in view of U.S. Patent Application Publication No. 2022/0125520 to Crawford et al. (hereinafter “Crawford”) and U.S. Patent Application Publication No. 2018/0055637 to von Oepen et al. (hereinafter “von Oepen”).
For claim 2, Graetzel does not expressly disclose wherein: said distal module is fixed relative to the support.
However, Crawford teaches wherein: a distal module is fixed relative to a support (para [0066], i.e., motion of the robot arm is prevented).
It would have been obvious to a skilled artisan to modify Graetzel wherein: said distal module is fixed relative to the support, in view of the teachings of Crawford, for the obvious advantage of locking Graetzel’s robot arm in place so that non-intentional movements don’t affect the positioning of the surgical device in Graetzel.
Graetzel and Crawford do not expressly disclose wherein: said external long flexible medical instrument is a guide catheter; said internal long flexible medical instrument is a catheter.
However, Graetzel does teach that the medical instrument may be a steerable catheter (para [0067]).
Additionally, von Oepen teaches that a guide catheter may go over another type of catheter such as a steerable catheter (para [0045] and [0048]-[0049]).
It would have been obvious to a skilled artisan to modify Graetzel wherein: said external long flexible medical instrument is a guide catheter; said internal long flexible medical instrument is a catheter, in view of the teachings of von Oepen, because a guide catheter and catheter are suitable structures for an internal medical instrument and an external medical instrument and Graetzel already teaches the use of a steerable catheter.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graetzel in view of U.S. Patent Application Publication No. 2020/0206511 to Goedeke et al. (hereinafter “Goedeke”).
For claim 3, Graetzel further discloses wherein: said distal module is mobile in longitudinal translation relative to the support (para [0112]); said proximal module is mobile in longitudinal translation relative to the support (para [0112]).
Graetzel does not expressly disclose wherein: said external long flexible medical instrument is a catheter; said internal long flexible medical instrument is a catheter guidewire.
However, Graetzel does teach that the medical instrument may be a steerable catheter (para [0067]).
Additionally, Goedeke teaches that steerable catheters may include a guide catheter as an external instrument and a guidewire as an internal instrument.
It would have been obvious to a skilled artisan to modify Graetzel wherein: said external long flexible medical instrument is a catheter; said internal long flexible medical instrument is a catheter guidewire, in view of the teachings of Goedeke, because a guide catheter and guidewire are suitable structures for an internal medical instrument and an external medical instrument and Graetzel already teaches the use of a steerable catheter.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graetzel in view of U.S. Patent Application Publication No. 2018/0185616 to Deboeuf et al. (hereinafter “Deboeuf”).
For claim 18, Graetzel further discloses wherein: one, several or all of the internal longitudinal translation and rotation mechanisms for a long flexible medical instrument capable of being a guide catheter, a catheter or catheter guidewire (para [0067]).
Graetzel does not expressly disclose two keys being capable of coming together and separating for respectively tightening on or releasing said long flexible medical instrument; said two keys being capable of doing a synchronous longitudinal translation for translating said long flexible medical instrument; said two keys being capable of doing opposite transverse translation for turning said long flexible medical instrument around the longitudinal axis.
However, Deboeuf teaches two keys being capable of coming together (Fig. 4b) and separating (Fig. 4d) for respectively tightening on or releasing said long flexible medical instrument (see Figs. 4a, 4b, 4d, and 4e); said two keys being capable of doing a synchronous longitudinal translation for translating said long flexible medical instrument (as can be seen in Fig. 4c); said two keys being capable of doing opposite transverse translation for turning said long flexible medical instrument around the longitudinal axis (see Figs. 6d, 6e, and/or 6f).
It would have been obvious to a skilled artisan to modify Graetzel to include two keys being capable of coming together and separating for respectively tightening on or releasing said long flexible medical instrument; said two keys being capable of doing a synchronous longitudinal translation for translating said long flexible medical instrument; said two keys being capable of doing opposite transverse translation for turning said long flexible medical instrument around the longitudinal axis, in view of the teachings of Deboeuf, because such a modification provides a suitable mechanism by which to accomplish the predictable result of moving/articulating the medical instrument in Graetzel, which is what Graetzel already wants to do.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791