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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 11/21/25. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
Claim Objections
Claim 1 is objected to because of the following informalities: the recitation of “a measurement of forces that a opposes to an advancement” appears to contain grammatical error, perhaps the “a” is erroneous. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: there appears to be an additional “and” and/or missing recitation in line 4. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-8 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.
Claims 1-8 are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. In light of the Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention required by claims 1-8. One of ordinary skill in the art in light of the Specification would not be apprised of what may be explicitly, implicitly, inherently, and/or otherwise necessarily required or excluded for the scope(s) of claims 1-8. The claims appear to recite processes by which the system and its components operate and/or are disposed, however, this appears to mix statutory classes of invention, i.e. apparatus and process, and/or product-by-process limitations define the majority of the claimed invention such that the scope of the claims are indefinite as to what is explicitly, implicitly, inherently, and/or inferentially required for the system via the process recitations.
For example, apparatus claim 1 positively recites the seeming process steps of “increasing…” and “divided”, that despite the presence of positively recited structures, render the scope of the claim indeterminate. It is unclear with respect to what the “increasing a size of passage hole through a robot actuator to allow not only a thrust of catheters and stens, by even the passage of a hemostatic valves” and/or “divided” process steps occur. While it appears to reference prior endovascular robotic systems and/or applications, this is merely assumed. Depending claims 2-8 inherit and do not remedy the indefiniteness. Further indefinite is introduced in depending claims 2-8 as enumerated below.
Similarly, apparatus claim 2 seemingly recites process steps of “an increase”, “also presenting”, “also adding”, and “allowing the insertion of increased disposables for the passage of catheters”. Similarly, apparatus claim 3 seemingly recites process steps of a plurality of “divided” steps, “presenting”, “present two teeth”, and “then fixed”. Similarly, apparatus claim 4 seemingly recites process steps of “is then fixed”, and “making it possible to read”. Similarly, apparatus claim 5 seemingly recites process steps of “presenting”, “which then runs”, “slipping into the mechanical protection”, “which can be easily inserted and removed”. Similarly, apparatus claim 6 seemingly recites process steps of “while, if you want to bend the tip, just rotate the head of the joystick”. Similarly, apparatus claim 7 seemingly recites process steps of “which can come out both from one end of the carrier”.
Claim 1 positively recites the limitations “the passage of a hemostatic valves” in lines 4-5, “the control system” in line 10. There is insufficient antecedent basis for this limitation in the claim, rendering claim 1 indefinite. Claims 2-8 inherit and do not remedy the indefiniteness of claim 1 for antecedent issue(s). Applicant’s attention is respectfully directed to antecedent basis issues in claims 2-8. Although not all instances of lack of antecedent basis are distinctly pointed out herein, claims 2-8 positively recite and suffer similar deficiencies as those particularly noted in claim 1.
Claim 1 positively recites “a thrust of catheters”, “an advancement of the catheters”, “the catheters”, and “a catheter”. The scope of the claim is indeterminate with respect to the relationship(s) amongst the “a catheter” and the previously recited “the catheters”, rendering the claim indefinite. Claims 2-8 inherit and do not remedy the indefiniteness of claim 1 for antecedent issue(s).
The terms “large diameter” and “standard guides” in claim 1 are relative terms which renders the claim indefinite. The terms are 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. Given the specification, it would be indeterminate to one of ordinary skill in the art how large and/or how standard the catheters and/or guides are required to be. One of ordinary sill in the art in light of the Specification would not be apprised of the scope of the invention in the presence of the relative terminology, rendering claim 1 indefinite. Claims 2-8 inherit and do not remedy the indefiniteness of claim 1 for relative terminology issue(s). Applicant’s attention is respectfully directed to similar relative terminology issues in claims 2-8. Although not all instances of relative terminology are distinctly pointed out herein, claims 2-8 positively recite and suffer similar deficiencies as those particularly noted in claim 1.
The terms “an increase in number of teeth of a central wheel”, “what must be introduced”, “also adding the possible exit” in claim 2 are relative terms which renders the claim indefinite. The terms are 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. Given the specification, it would be indeterminate to one of ordinary skill in the art how many teeth, the introduction element(s), and/or what exit(s) are necessarily required or excluded from the scope of the claim. One of ordinary sill in the art in light of the Specification would not be apprised of the scope of the invention in the presence of the relative terminology, rendering the claim indefinite.
The terms “special cavities”, “while, as can be seen,”, “which, as will become clearer later”, “correct alignment”, “special tube groove”, “final disposable” in claim 3 are relative terms which renders the claim indefinite. The terms are 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. Given the specification, it would be indeterminate to one of ordinary skill in the art how special or the degree of special required for the cavity and/or groove, “what can be seen”, “what is clearer”, and how “correct” the alignment must be to know what is necessarily required or excluded from the scope of the claim. One of ordinary sill in the art in light of the Specification would not be apprised of the scope of the invention in the presence of the relative terminology, rendering the claim indefinite.
Regarding claim 4, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 4 positively recites “the operating table”, “the nut screw”, “the platform mobile”, “the possibility of reading” that lacks antecedent basis, rendering the claim indefinite.
The terms “which usually controls”, “or other equivalent system”, “essential” in claim 4 are relative terms which renders the claim indefinite. The terms are 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. Given the specification, it would be indeterminate to one of ordinary skill in the art what controls, other systems, or the degree of essential-ity are necessarily required or excluded from the scope of the claim. One of ordinary sill in the art in light of the Specification would not be apprised of the scope of the invention in the presence of the relative terminology, rendering the claim indefinite.
Claim 5 positively recites “a catheter” in lines 3 and 16. The scope of the claim is indeterminate with respect to the relationship(s) amongst the “a catheter” and the previously recited multitude of “the catheters” of claim 1, rendering the claim indefinite.
Claim 5 positively recites “a disposable”. The scope of the claim is indeterminate with respect to the relationship(s) amongst the “a disposable” and the previously recited “disposable” of claim 1, rendering the claim indefinite.
The terms “small wedge-shaped”, “smallest lumen”, “small lumen”, “small radius drum”, “special disposable”, “which allows you to pull” or other equivalent system”, “easily inserted”, “specially splined shaft”, and “the same” in claim 5 are relative terms which renders the claim indefinite. The terms are 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. Given the specification, it would be indeterminate to one of ordinary skill in the art what wedge shapes, lumen sizes, drum sizes, disposable, the degree of ease of insertion, degree of special-ness of a splined shaft, and/or if the same is a catheter or valve are necessarily required or excluded from the scope of the claim. One of ordinary sill in the art in light of the Specification would not be apprised of the scope of the invention in the presence of the relative terminology, rendering the claim indefinite.
Claim 6 positively recites “the motorized trolley”, “the nut screw”, “the platform mobile”, “the possibility of reading” that lacks antecedent basis, rendering the claim indefinite.
The terms “if you want to bend the tip”, “small counter-rotation”, “can already be rare on the side of the small lumen”, and “any direction” in claim 6 are relative terms which renders the claim indefinite. The terms are 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. Given the specification, it would be indeterminate to one of ordinary skill in the art what bending, the size of the counter-rotation and lumen, the degree of rare-ness, and what directions are necessarily required or excluded from the scope of the claim. One of ordinary sill in the art in light of the Specification would not be apprised of the scope of the invention in the presence of the relative terminology, rendering the claim indefinite.
Claim 7 positively recites “the internal toothing”, “the desired degrees of control, “the main rotation”, “the desired command” that lack antecedent basis, rendering the claim indefinite.
The terms “certain number of hollow toothed wheels whose number equals the desired degrees of control in addition to the main rotation”, “have, for simplicity, but not necessarily”, and “other pinions” in claim 7 are relative terms which renders the claim indefinite. The terms are 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. Given the specification, it would be indeterminate to one of ordinary skill in the art what number of teeth may be considered certain, what degree of simplicity/necessity, and what pinions are necessarily required or excluded from the scope of the claim. One of ordinary sill in the art in light of the Specification would not be apprised of the scope of the invention in the presence of the relative terminology, rendering the claim indefinite.
The terms “in this case” in claim 8 is relative terms which renders the claim indefinite. The terms are 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. Given the specification, it would be indeterminate to one of ordinary skill in the art what cases are necessarily required or excluded from the scope of the claim. One of ordinary sill in the art in light of the Specification would not be apprised of the scope of the invention in the presence of the relative terminology, rendering the claim indefinite.
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)(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) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Battaglia et al. (WO 2019082224, hereinafter Battaglia) , particularly as best understood by the examiner in light of the indefiniteness issues noted above. The examiner respectfully notes that this prior art rejection is based on features of claim language as best understood in light of the Specification. It is particularly uncertain what may be required by the scope of the claims, however in the interest of compact prosecution the examiner is attempting to reject claimed inventive features.
For claims 1-8, Battaglia discloses a robotic system (Figs 1-14) (Pgs 3-12) for remote control multi- guide and/or multi- catheter bending, prebending, and insertion having a multi-rail track permitting six degrees of freedom control for translations and rotations during insertion (Figs 1-14) (Pgs 3-12), wherein insertion torque/force/rotation/translation control is achieved with multiple controllers with computerized feedback (Figs 1-14) (Pgs 3-12), wherein force sensing ensures facilitating internal patient integrity perforation considerations during cardiac access procedures, wherein catheters of various sizes and diameters are incorporated ((Figs 1-14) (Pgs 3-12), wherein disposable sheaths and barriers are used for sterility and protection (Figs 1-14) (Pgs 3-12), wherein operation includes worm gears, pinions, teeth, gearing, caps, mounts, drums, sprockets, and frames in various configurations (Figs 1-14) (Pgs 3-12).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791