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 .
Applicant' s arguments, filed 3/9/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 3/9/2026.
Claims 1-8 and 10-21 are the currently pending claims hereby under examination. Claim 9 has been canceled and claim 21 newly added.
Information Disclosure Statement
The information disclosure statement filed 06/16/2023 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered. Specifically, under the Foreign Patent Documents section, citation number 2 (“3022147 FR Al 2015-12-18 ROBOCATH”) and citation number 3 (“3037269 FR Al 2016-12-16 ROBOCATH”) are not in the English language, were not accompanied by an English translation, were not accompanied by an English Abstract, and were not accompanied by a concise explanation of their relevance. These references have not been considered.
Claim Objections
Claims 3 and 21 are objected to because of the following informalities:
in claim 3, lines 18-19: "each catheter translation modules” uses the singular “each”, but the plural “modules” and should be “each catheter translation module”; and
in claim 21, lines 29-31, “which first and second catheter translation modules are longitudinally spaced apart from each other” uses the term “which”, resulting in an improper relative clause and should be amended to read “the first and second catheter translation modules being longitudinally spaced apart from each other”, or the like.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 and 10-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 (lines 16-19) and 8 (lines 19-22) recite “respective groups of crossing tracks of both catheter translation modules are facing each other so that a given flexible elongated medical element which translates within a crossing track of one group also translates within a crossing track of the other group" has the phrase “facing each other” which is unclear because it may suggest that the two track groups are merely positioned opposite one another rather than that the corresponding crossing tracks form continuous, longitudinally aligned passages through both modules. In contrast, the specification indicates that each crossing track of the first module is the same crossing track of the second module (Instant Application, FIG. 1), so that the same flexible elongated medical element passes through both modules along the same track. Thus, there appears to be a contradiction between the claim language and the written description that causes confusion as to the meaning of the claim language in light of the specification. To better reflect the intended relationship from the specification, the claim may be amended to clarify that each crossing track is a continuous structural passage extending through both catheter translation modules.
Claims 2-7 and 14-20 are rejected by virtue of their dependence from claim 1.
Claims 10-13 are rejected by virtue of their dependence from claim 8.
Allowable Subject Matter
Claims 1-8 and 10-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action .
Claim 21 would be allowable if rewritten to overcome the above objection.
Prior art by Bencteux et al. (US 2020/0297434 A1), hereto referred as Bencteux, and Fournier et al. (US 2018/0353250 A1), hereto referred as Fournier, and Deboeuf et al. (US 2017/0151024 A1), hereto referred as Deboeuf, do not fully anticipate or make obvious these claims.
Claim 1 is directed to a catheter robot comprising a base and at least two catheter translation modules supported by the base. Each catheter translation module comprises (i) only one set of movable parts so as to translate longitudinally at a time only one flexible elongated medical element, (ii) a group of several crossing tracks within which several corresponding flexible elongated medical elements can translate through the catheter translation module, and (iii) a switch to direct said single set of movable parts in any of said crossing tracks so as to then translate longitudinally said corresponding flexible elongated medical element. Claim 1 further requires that the first and second catheter translation modules are longitudinally spaced apart from each other such that respective groups of crossing tracks of both catheter translation modules are facing each other so that a given flexible elongated medical element which translates within a crossing track of one group also translates within a crossing track of the other group.
Bencteux
Bencteux discloses a catheter insertion robot having a base, a rail, and a drive module for advancing a catheter and guide into a patient. The drive module is mounted on the rail and is configured to grip and translate elongate flexible medical elements along a longitudinal axis. Thus, Bencteux teaches a robotic catheter system with a base and at least one translation module for elongate flexible medical elements. For example, Bencteux describes that "a robot for insertion of an elongate flexible medical instrument into a patient includes drive modules for driving the elongate flexible medical instrument in this patient" (Bencteux, US 2020/0297434 A1, Abstract) and that the system comprises "an elongate flexible medical instrument (1)," and "an elongate flexible medical instrument drive module (3) whose movement causes movement of the elongate flexible medical instrument (1)" (Bencteux, US 2020/0297434 A1, ¶[0616]-[0620]).
However, Bencteux does not disclose or suggest the following limitations of claim 1:
“a group of several crossing tracks within which several corresponding flexible elongated medical elements can translate through said catheter translation module”;
“only one set of movable parts so as to translate longitudinally at a time only one flexible elongated medical element” that is shared among multiple tracks; and
“a switch to direct said single set of movable parts in any of said crossing tracks so as to then translate longitudinally said corresponding flexible elongated medical element”; together with
“said first and second catheter translation modules being longitudinally spaced apart from each other so that respective groups of crossing tracks of both catheter translation modules are facing each other so that a given flexible elongated medical element which translates within a crossing track of one group also translates within a crossing track of the other group".
In Bencteux, each drive module effectively provides a single drive path for the instruments it handles and does not disclose a shared actuator that is routed between multiple distinct crossing tracks, nor aligned groups of crossing tracks across two spaced modules.
Fournier
Fournier discloses a robotic drive module for an elongate flexible medical member, including a base and pairs of drive members (pads) that at least partly face each other and clamp a flexible member between drive surfaces to translate the member longitudinally. In particular, Fournier explains that "[t]he drive module 131 comprises a base 132 and at least one drive member 24 movably mounted relative to the base 132" and that a second drive member 24' is provided so that "[d]rive member 24 ... and second drive member 24' ... together form a pair of drive members 33" which "cooperate to generate a movement of the elongate flexible medical member relative to the base 132" (Fournier, US 2018/0353250 A1, ¶[0097]-[0099]). Fournier therefore teaches a catheter translation module with a set of movable drive members (pads) that clamp and translate a flexible elongated element along a longitudinal axis.
However, Fournier does not disclose or suggest:
a catheter translation module having “a group of several crossing tracks within which several corresponding flexible elongated medical elements can translate through said catheter translation module”;
that there is “only one set of movable parts so as to translate longitudinally at a time only one flexible elongated medical element” which is then switched among multiple crossing tracks via a switch as recited in claim 1; or
a catheter robot having two catheter translation modules being longitudinally spaced apart such that their “respective groups of crossing tracks of both catheter translation modules are facing each other so that a given flexible elongated medical element which translates within a crossing track of one group also translates within a crossing track of the other group".
Instead, Fournier presents the drive module as providing a single drive path for a given elongate member, without internal multi-track routing or facing track groups in spaced modules.
Deboeuf
Deboeuf likewise discloses a robotic drive module for an elongated flexible medical device, including a base and one or more pairs of drive members configured to clamp the device between facing surfaces and translate the device along a drive axis. Deboeuf teaches "a robotic drive module for an elongate flexible medical device" comprising "a base" and "a pair of drive members each having a drive surface," where the pair "[is] placeable in a drive configuration in which the drive surfaces ... engage with the elongate flexible medical device" and is "movably mounted relative to the base" with a control member that drives the device relative to the base (Deboeuf, US 2017/0151024 A1, ¶[0014]-[0018]; see also ¶[0096]-[0100]). Deboeuf shows the general concept of a translation module having movable drive members that engage a single flexible elongated medical element.
Deboeuf, however, does not disclose or suggest:
“a group of several crossing tracks within which several corresponding flexible elongated medical elements can translate through said catheter translation module”;
“only one set of movable parts so as to translate longitudinally at a time only one flexible elongated medical element” shared among multiple tracks; or
“a switch to direct said single set of movable parts in any of said crossing tracks so as to then translate longitudinally said corresponding flexible elongated medical element”; nor
a system having “said first and second catheter translation modules being longitudinally spaced apart from each other so that respective groups of crossing tracks of both catheter translation modules are facing each other so that a given flexible elongated medical element which translates within a crossing track of one group also translates within a crossing track of the other group".
Deboeuf’s module is configured to drive an elongate device along a single drive passage, not to multiplex a shared actuator among multiple crossing tracks nor to coordinate facing track groups between spaced modules.
Allowable feature(s) for claim 1
Accordingly, while Bencteux, Fournier, and Deboeuf collectively show catheter robots and drive modules capable of translating flexible elongated medical elements, none of the prior art of record teaches or suggests the combination of:
“a group of several crossing tracks within which several corresponding flexible elongated medical elements can translate through said catheter translation module”;
“only one set of movable parts so as to translate longitudinally at a time only one flexible elongated medical element”; and
“a switch to direct said single set of movable parts in any of said crossing tracks so as to then translate longitudinally said corresponding flexible elongated medical element,” with
“said first and second catheter translation modules being longitudinally spaced apart from each other so that respective groups of crossing tracks of both catheter translation modules are facing each other so that a given flexible elongated medical element which translates within a crossing track of one group also translates within a crossing track of the other group.”
This specific architecture of multi-track catheter translation modules with a shared actuator switched among crossing tracks, deployed in two spaced modules having facing track groups for the same flexible element, appears to be neither taught nor suggested by the prior art of record, and is considered to be the feature(s) which support the patentability of independent claim 1.
However, claims 1-7 and 14-20 are rejected under 35 U.S.C. 112(b).
Dependent Claims – Allowability by Virtue of Dependency to Claim 1
Dependent claims 2-7 and 14-20 recite further limitations such as specific structures or operations for the catheter translation modules, clamping devices, or track configurations beyond those recited in the respective independent claims.
No prior art of record has been identified that, under a broadest reasonable interpretation, teaches or renders obvious the particular combinations of limitations recited in these dependent claims in addition to the allowable subject matter of claim 1 discussed above.
Accordingly, these dependent claims would be allowable over the prior art of record by virtue of their dependency from claim 1, provided that they are amended to overcome the objections and 35 U.S.C. 112 rejections set forth in this Office action and to maintain proper dependency and clarity. As discussed in the “Objections” and “35 U.S.C. 112” sections of this Office action: Claims 1-7 and 14-20 are rejected under 35 U.S.C. 112(b) and Objections have been raised for claims 4, 6, and 17.
Prior art by Bencteux et al. (US 2020/0297434 A1), hereto referred as Bencteux, and Fournier et al. (US 2018/0353250 A1), hereto referred as Fournier, and Deboeuf et al. (US 2017/0151024 A1), hereto referred as Deboeuf, do not fully anticipate or make obvious these claims.
Claim 8 recites a catheter robot having at least two catheter translation modules, each module comprising:
“only one set of two pairs of movable pads: said pads of a same pair at least partly facing each other,”;
the ability for each of the two pairs to alternatingly clamp a flexible elongated medical element so as to translate it longitudinally;
“a group of several crossing tracks within which several corresponding flexible elongated medical elements can translate through said catheter translation module,”;
“a switch to direct said single set of two pairs of movable pads in any of said crossing tracks so as to then translate longitudinally said corresponding flexible elongated medical element,”; and
two longitudinally spaced catheter translation modules whose respective groups of crossing tracks face each other, and wherein “both switches of said first and second catheter translation modules are synchronized together so as not to direct their respective sets of two pairs of movable pads in crossing tracks of said first and second groups which face each other.”
Independent claim 8 therefore recites an integrated multi-track, shared-actuator switching architecture involving two modules, each having only one set of two alternating pad pairs that must be switched among multiple crossing tracks, and further requires inter-module synchronization such that neither module directs its pad set into crossing tracks that face each other.
Bencteux
Bencteux teaches a catheter insertion robot comprising a base and one or more drive modules that grip and translate elongate flexible medical instruments. For example, Bencteux describes:
“a robot for insertion of an elongate flexible medical instrument into a patient includes drive modules for driving the elongate flexible medical instrument in this patient” (Bencteux, Abstract), and
an “elongate flexible medical instrument (1)” and a “drive module (3) whose movement causes movement of the elongate flexible medical instrument (1)” (Bencteux, ¶[0616]–[0618]).
Thus, Bencteux teaches a robotic catheter system including a base and translation/drive modules for advancing flexible medical elements.
However, Bencteux does not disclose:
two pairs of movable pads in any translation module;
only one set of two pairs for the entire module;
a group of several crossing tracks within each translation module;
switching the single set of two pad pairs among multiple crossing tracks; or
synchronized switching between two spaced modules such that neither module directs its pads into facing tracks.
Bencteux provides only single-path drive modules without multi-track routing, pad-pair architecture, shared-actuator switching, or inter-module coordination of track occupation.
Fournier
Fournier discloses a robotic drive module comprising a base and two pairs of drive members (pads) arranged so that each pair clamps and drives an elongate flexible member. Fournier further teaches alternating “drive” and “free” configurations and coordinated operation of the two pairs:
The drive module “comprises a base 132 and at least one drive member 24 movably mounted relative to the base 132,” and a second drive member 24' such that these together “form a pair of drive members 33” for generating longitudinal movement (Fournier, ¶[0097]–[0099]).
Each pair “can be placed in a free configuration” or a “drive configuration” to alternately engage the elongate member (Fournier, ¶[0102]).
Their operations may be controlled “in a cyclic repeated manner” and “in a synchronized manner” (Fournier, ¶[0103]; claims 19–20).
Accordingly, Fournier teaches two pairs of pads capable of alternating clamping and translation of a flexible elongated element.
However, Fournier does not disclose or suggest:
a group of several crossing tracks within the module;
only one set of two pairs of pads shared among multiple crossing tracks;
a switch that directs the set of two pad pairs into selected crossing tracks; or
two longitudinally spaced modules with facing track groups, and synchronized switching preventing both from directing their pad sets into facing tracks.
In Fournier, pad synchronization concerns a single drive path, not multi-track routing or inter-module track-occupation avoidance.
Deboeuf
Deboeuf also teaches a drive module with one or more pairs of drive members that alternately clamp a flexible device between facing drive surfaces and translate it along a drive axis. For example:
A pair of drive members is “placeable in the drive configuration” and “in the free configuration” (Deboeuf, ¶[0020]–[0022]).
Movement of the drive members is controlled “in a repeated cyclical manner” while alternating between configurations.
Deboeuf further teaches arrangements including a second base and second pair of drive members (Deboeuf, ¶[0017]–[0021]).
Thus, Deboeuf teaches alternating clamping pairs similar to the two pairs recited in claim 8.
However, Deboeuf does not teach or suggest:
a group of several crossing tracks within each translation module;
a single set of two pad pairs that is shared among multiple tracks via switching;
a switch that selects which crossing track the shared actuator is directed into; or
two spaced modules whose switches are synchronized to avoid directing pad sets into facing tracks.
Deboeuf’s teachings concern coordinated clamping for a single drive path, not multiplexed shared-actuator routing nor inter-module synchronized switching.
Allowable feature(s) for independent claim 8
None of the three strongest comparators (Bencteux, Fournier, or Deboeuf) discloses or suggests the specific architecture recited in claim 8, including:
Only one set of two pairs of movable pads within each catheter translation module;
Alternating clamping between the two pairs to translate a flexible elongated element;
A group of several crossing tracks within each module;
A switch for directing the single set of two pad pairs into any selected crossing track;
Two catheter translation modules spaced longitudinally such that their track groups face each other; and
Synchronized switching such that neither module’s pad set is directed into a crossing track that faces the track selected in the other module.
These combined requirements define a shared-actuator, multi-track catheter translation system with inter-module coordination, a configuration that is not taught or suggested in any of the cited references.
Accordingly, subject to correction of the 35 U.S.C. 112 objections and rejections noted elsewhere in this Office action, independent claim 8 is considered allowable over the prior art of record.
However, claim 8 is objected to and claims 8-13 are also rejected under 35 U.S.C. 112(b).
Dependent Claims – Allowability by Virtue of Dependency to Claim 8
The dependent claims 9-13 recite further limitations such as specific structures or operations for the catheter translation modules, clamping devices, or track configurations beyond those recited in the respective independent claims.
No prior art of record has been identified that, under a broadest reasonable interpretation, teaches or renders obvious the particular combinations of limitations recited in these dependent claims in addition to the allowable subject matter of claim 8 discussed above. Accordingly, these dependent claims would be allowable over the prior art of record by virtue of their dependency from claims 1 or 8, provided that they are amended to overcome the objections and 35 U.S.C. 112 rejections set forth in this Office action and to maintain proper dependency and clarity.
As discussed in the “Objections” and “35 U.S.C. 112” sections of this Office action: Claims 8-13are rejected under 35 U.S.C. 112(b), claim 9 is rejected under 35 U.S.C. 112(d), and Objections have been raised for claims 8 and 13.
Prior art by Bencteux et al. (US 2020/0297434 A1), hereto referred as Bencteux, and Fournier et al. (US 2018/0353250 A1), hereto referred as Fournier, and Deboeuf et al. (US 2017/0151024 A1), hereto referred as Deboeuf, do not fully anticipate or make obvious these claims.
Claim 21 is directed to a catheter robot comprising a base and at least two catheter translation modules supported by the base. Each catheter translation module comprises (i) only one set of movable parts so as to translate longitudinally at a time only one flexible elongated medical element, (ii) a group of several crossing tracks within which several corresponding flexible elongated medical elements can translate through the catheter translation module, and (iii) a switch to direct said single set of movable parts in any of said crossing tracks so as to then translate longitudinally said corresponding flexible elongated medical element. Claim 21 further requires that the first and second catheter translation modules are longitudinally spaced apart from each other such that respective groups of crossing tracks of both catheter translation modules are facing each other so that a given flexible elongated medical element which translates within a crossing track of one group also translates within a crossing track of the other group, and additionally recites that each crossing track is a passage extending successively through first catheter translation module and through second catheter translation module, which first and second catheter translation modules are longitudinally spaced apart from each other.
Bencteux
Bencteux discloses a catheter insertion robot having a base, a rail, and a drive module for advancing a catheter and guide into a patient. The drive module is mounted on the rail and is configured to grip and translate elongate flexible medical elements along a longitudinal axis. Thus, Bencteux teaches a robotic catheter system with a base and at least one translation module for elongate flexible medical elements. For example, Bencteux describes that "a robot for insertion of an elongate flexible medical instrument into a patient includes drive modules for driving the elongate flexible medical instrument in this patient" (Bencteux, US 2020/0297434 A1, Abstract) and that the system comprises "an elongate flexible medical instrument (1)," and "an elongate flexible medical instrument drive module (3) whose movement causes movement of the elongate flexible medical instrument (1)" (Bencteux, US 2020/0297434 A1, [0616]-[0620]).
However, Bencteux does not disclose or suggest the following limitations of claim 21:
"a group of several crossing tracks within which several corresponding flexible elongated medical elements can translate through said catheter translation module”;
"only one set of movable parts so as to translate longitudinally at a time only one flexible elongated medical element" that is shared among multiple tracks; and
"a switch to direct said single set of movable parts in any of said crossing tracks so as to then translate longitudinally said corresponding flexible elongated medical element"; together with
"said first and second catheter translation modules being longitudinally spaced apart from each other so that respective groups of crossing tracks of both catheter translation modules are facing each other so that a given flexible elongated medical element which translates within a crossing track of one group also translates within a crossing track of the other group," and additionally
"each crossing track is a passage extending successively through first catheter translation module and through second catheter translation module, which first and second catheter translation modules are longitudinally spaced apart from each other."
In Bencteux, each drive module effectively provides a single drive path for the instruments it handles and does not disclose a shared actuator that is routed between multiple distinct crossing tracks, nor aligned groups of crossing tracks across two spaced modules, nor the added requirement that each crossing track is a passage extending successively through both catheter translation modules.
Fournier
Fournier discloses a robotic drive module for an elongate flexible medical member, including a base and pairs of drive members (pads) that at least partly face each other and clamp a flexible member between drive surfaces to translate the member longitudinally. In particular, Fournier explains that "[t]he drive module 131 comprises a base 132 and at least one drive member 24 movably mounted relative to the base 132" and that a second drive member 24' is provided so that "[d]rive member 24... and second drive member 24'... together form a pair of drive members 33" which "cooperate to generate a movement of the elongate flexible medical member relative to the base 132" (Fournier, US 2018/0353250 A1, [0097]-[0099]). Fournier therefore teaches a catheter translation module with a set of movable drive members (pads) that clamp and translate a flexible elongated element along a longitudinal axis.
However, Fournier does not disclose or suggest:
a catheter translation module having "a group of several crossing tracks within which several corresponding flexible elongated medical elements can translate through said catheter translation module”;
that there is "only one set of movable parts so as to translate longitudinally at a time only one flexible elongated medical element" which is then switched among multiple crossing tracks via a switch as recited in claim 21; or
a catheter robot having two catheter translation modules being longitudinally spaced apart such that their "respective groups of crossing tracks of both catheter translation modules are facing each other so that a given flexible elongated medical element which translates within a crossing track of one group also translates within a crossing track of the other group," where additionally "each crossing track is a passage extending successively through first catheter translation module and through second catheter translation module."
Instead, Fournier presents the drive module as providing a single drive path for a given elongate member, without internal multi-track routing, without facing track groups in spaced modules, and without the added continuous successive passage relationship now expressly recited in claim 21.
Deboeuf
Deboeuf likewise discloses a robotic drive module for an elongated flexible medical device, including a base and one or more pairs of drive members configured to clamp the device between facing surfaces and translate the device along a drive axis. Deboeuf teaches "a robotic drive module for an elongate flexible medical device" comprising "a base" and "a pair of drive members each having a drive surface," where the pair "[is] placeable in a drive configuration in which the drive surfaces engage with the elongate flexible medical device" and is "movably mounted relative to the base" with a control member that drives the device relative to the base (Deboeuf, US 2017/0151024 A1, [0014]-[0018]; see also [0096]-[0100]). Deboeuf shows the general concept of a translation module having movable drive members that engage a single flexible elongated medical element.
Deboeuf, however, does not disclose or suggest:
"a group of several crossing tracks within which several corresponding flexible elongated medical elements can translate through said catheter translation module”;
"only one set of movable parts so as to translate longitudinally at a time only one flexible elongated medical element" shared among multiple tracks; or
"a switch to direct said single set of movable parts in any of said crossing tracks so as to then translate longitudinally said corresponding flexible elongated medical element"; nor
a system having "said first and second catheter translation modules being longitudinally spaced apart from each other so that respective groups of crossing tracks of both catheter translation modules are facing each other so that a given flexible elongated medical element which translates within a crossing track of one group also translates within a crossing track of the other group," where additionally "each crossing track is a passage extending successively through first catheter translation module and through second catheter translation module."
Deboeuf's module is configured to drive an elongate device along a single drive passage, not to multiplex a shared actuator among multiple crossing tracks, not to coordinate facing track groups between spaced modules, and not to provide the expressly recited successive passage of each crossing track through both modules.
Allowable feature(s) for claim 21
Accordingly, while Bencteux, Fournier, and Deboeuf collectively show catheter robots and drive modules capable of translating flexible elongated medical elements, none of the prior art of record teaches or suggests the combination of:
"a group of several crossing tracks within which several corresponding flexible elongated medical elements can translate through said catheter translation module”;
"only one set of movable parts so as to translate longitudinally at a time only one flexible elongated medical element"; and
"a switch to direct said single set of movable parts in any of said crossing tracks so as to then translate longitudinally said corresponding flexible elongated medical element," with
"said first and second catheter translation modules being longitudinally spaced apart from each other so that respective groups of crossing tracks of both catheter translation modules are facing each other so that a given flexible elongated medical element which translates within a crossing track of one group also translates within a crossing track of the other group," and further with
"each crossing track is a passage extending successively through first catheter translation module and through second catheter translation module, which first and second catheter translation modules are longitudinally spaced apart from each other."
This specific architecture of multi-track catheter translation modules with a shared actuator switched among crossing tracks, deployed in two spaced modules having facing track groups for the same flexible element, and further requiring that each crossing track is a passage extending successively through both catheter translation modules, appears to be neither taught nor suggested by the prior art of record, and is considered to be the feature(s) which support the patentability of independent claim 21.
Response to Arguments
Objections
Applicant's arguments filed 3/9/2026, page 15, regarding the previous Objections of claims 4, 6, 8, and 13 have been fully considered and are persuasive. The previous Objections have been withdrawn. However, there are new objections as shown above.
35 U.S.C. §112(b)
Applicant's arguments filed 3/9/2026, pages 15-17, regarding the previous 112(b) Rejections of claims 3, 7, 10, and 17 have been fully considered and are persuasive. The previous 112(b) rejections of claims 3, 7, 10, and 17 have been withdrawn. However, the arguments regarding the previous 112(b) Rejections of claims 1 and 8 (and their dependents) have been fully considered and are not persuasive.
Applicant's Argument: Applicant contends that the phrase "respective groups of crossing tracks of both catheter translation modules are facing each other so that a given flexible elongated medical element which translates within a crossing track of one group also translates within a crossing track of the other group" is definite when read together with the recitation that the first and second catheter translation modules are "longitudinally spaced apart from each other" and with the earlier limitation "to translate longitudinally at a time only one flexible elongated medical element." Applicant further relies on Figure 1 and asserts that the modules are "in the extension of each other" such that a flexible elongated medical element passes first through one module and then through the other, so that each crossing track successively extends through both modules. Applicant also points to newly added claim 21, which expressly recites that "each crossing track is a passage extending successively through first catheter translation module and through second catheter translation module, which first and second catheter translation modules are longitudinally spaced apart from each other”, and requests withdrawal of the § 112(b) rejection of claims 1–20.
Examiner's Response: Applicant's arguments have been fully considered but are not persuasive with respect to independent claims 1 and 8. As set forth in the prior Office action, the phrase "facing each other" remains unclear because, as written, it may reasonably be interpreted as merely placing the two groups of crossing tracks opposite one another, rather than requiring that corresponding crossing tracks form continuous, longitudinally aligned passages through both catheter translation modules. The prior Office action explained that the specification, including Figure 1, indicates that each crossing track of the first module corresponds to the same crossing track of the second module such that a single flexible elongated medical element passes through both modules along the same track, and indicated that the claim could be amended to clarify that each crossing track is a continuous structural passage extending through both catheter translation modules.
Applicant's present arguments do not resolve that ambiguity because claims 1 and 8 still do not expressly recite that each crossing track is a passage extending successively through both catheter translation modules. Instead, the arguments seek to import that requirement from surrounding language and the drawings. The claims, however, must themselves particularly point out and distinctly claim the subject matter regarded as the invention. Even when read together with the limitations regarding longitudinal spacing and translation of a given flexible elongated medical element through tracks of both groups, the phrase "facing each other" does not require that corresponding crossing tracks form a continuous passage extending successively through both catheter translation modules. The explanation provided may reflect the intended configuration, but that configuration is not clearly set forth in the claim language as presently written.
The addition of new claim 21 further confirms that claims 1 and 8 lack this express clarification. Claim 21 now recites that "each crossing track is a passage extending successively through first catheter translation module and through second catheter translation module, which first and second catheter translation modules are longitudinally spaced apart from each other," thereby directly addressing the ambiguity identified in the prior Office action and aligning with the disclosure relied upon by applicant. The inclusion of this express language in claim 21, while it is absent from claims 1 and 8, supports the conclusion that claims 1 and 8 remain indefinite.
Accordingly, the rejection of claims 1 and 8 under 35 U.S.C. 112(b) is maintained.
Applicant's Argument: Applicant did not address the information disclosure statement deficiency identified in the prior Office action and nevertheless asserted that the application is in condition for allowance.
Examiner's Response: This assertion is not persuasive because the IDS deficiency remains outstanding. As previously indicated, the information disclosure statement filed 06/16/2023 failed to comply with 37 CFR 1.98(a)(3)(i) because foreign patent document citation number 2 ("3022147 FR AL 2015-12-18 ROBOCATH") and citation number 3 ("3037269 FR AL 2016-12-16 ROBOCATH") are not in the English language and were not accompanied by an English translation, an English abstract, or a concise explanation of their relevance. These references have therefore been placed in the application file but have not been considered, and applicant has not cured the deficiency in the present response.
With respect to new claim 21, the added limitation that "each crossing track is a passage extending successively through first catheter translation module and through second catheter translation module, which first and second catheter translation modules are longitudinally spaced apart from each other" appears to overcome the specific indefiniteness issue previously raised against claims 1 and 8 by expressly reciting the continuous successive passage relationship that was previously missing. The added limitation in claim 21 is supported by the original disclosure and, in the absence of newly discovered prior art, claim 21 places the application in condition for allowance over the prior art of record, while claims 1 and 8 remain subject to the § 112(b) rejection set forth above.
35 U.S.C. §112(d)
Applicant's arguments filed 3/9/2026, page 17, regarding the previous 112(d) Rejections of claim 9 have been fully considered but are moot since claim 9 has been canceled.
Conclusion
THIS ACTION IS MADE FINAL. 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 AARON MERRIAM whose telephone number is (703) 756-
5938. The examiner can normally be reached M-F 8:00 am - 5:00 pm.
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, Jason Sims can be reached on (571)272-4867. The fax phone number for the
organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained
from Patent Center. Unpublished application information in Patent Center is available to
registered users. To file and manage patent submissions in Patent Center, visit:
https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for
more information about Patent Center and https://www.uspto.gov/patents/docx for
information about filing in DOCX format. For additional questions, contact the Electronic
Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO
Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
Prosecution Insights