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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/9/2026 has been entered.
Notice of Amendment
In response to the amendment filed on 2/9/2026, amended claims 1-6 are acknowledged. Claims 1-8 remain pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 as amended recites the limitation “the base including a translations assembly, the translation assembly comprising a pinion and a slider, the slider coupleable to a linear slide and the pinion engageable against a rack to cause linear movement of the guidewire controller cassette relative to the base”, and claim 6 similarly recites the limitation “providing a translation assembly coupled to the base and exteriorly of the cartridge, the translation assembly comprising a pinion and a slider, the slider coupleable to a linear slide and the pinion engageable against a rack to cause linear movement of the guidewire controller cassette”. These limitation do not appear to be described by the specification as originally filed, nor has Applicant pointed out where such support for the amendments exists. In particular, the specification appears to lack any relationship between the claimed pinion, slider, and rack and the newly recited base. Figures 7A-G and [0062]-[0064] describe a base 304, whereas Figures 9A-B and [0116]-[0118] describe the translation assembly including pinon 814, slider 816, and rack 820. However, there is no description or explanation of the translation assembly and its subcomponents being a part of base 302 or having any relationship to base 302 such that one skilled in the art would reasonably understand that the inventor had possession of the invention as now claimed.
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.
Claim 1 recites the limitation "the guidewire controller cassette" in line 16. Based on the amendments to the preamble of claim 1, there is now insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “the rotating axis” in line 3. There is insufficient antecedent basis for this limitation in the claim. This limitation should be amended to recite “the rotational axis” to agree with the terminology now recited in independent claim 1.
Claim 6 recites the limitation "the guidewire controller cassette" in lines 22-23. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-5 and 7-8 are further rejection based on their dependence from claims 1 and 6.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharon et al. (US Patent No. 11,213,362 B2) (previously cited), further in view of Yi et al. (US Publication No. 2018/0168751 A1).
Regarding claim 1 as best understood, Sharon et al. discloses a guidewire controller for moving a guidewire (2101, 2405, 2502) having a proximal end, the guidewire controller comprising:
a housing (2402) having an interior space (see Figure 24);
a translational module (2105, 2503) received within the interior space and having an entry side, an opposed exit side and a lateral wall being disposed therebetween (see Figure 24), the translational module comprising a first guidewire path (see Figure 21C) extending between the entry side and the exit side and configured to move the guidewire translationally along the first guidewire path relative to the housing (see Figures 21A, 24, and 25 and col. 43, lines 1-8 and col. 47, lines 31-38); and
a rotational module (2107, 2404, 2501) received within the interior space and mounted at the lateral wall, the rotational module comprising an opening (2404) for receiving the proximal end of the guidewire, a rotational axis allowing the proximal end of the guidewire being rotated thereabout, and a second guidewire path which is a loop path (2411, 2413) extending out from the opening to the entry side (see Figures 21A, 24, and 25 and col. 43, lines 9-46 and col. 47, lines 31-38).
It is noted Sharon et al. does not specifically teach a base, the housing located over the base, the base including a translations assembly, the translation assembly comprising a pinion and a slider, the slider coupleable to a linear slide and the pinion engageable against a rack to cause linear movement of the guidewire controller cassette relative to the base. However, Yi et al. teaches a base (310), the housing (200) located over the base (see Figures 10-11), the base including a translations assembly (300), the translation assembly comprising a pinion (355) and a slider (360), the slider coupleable to a linear slide and the pinion engageable against a rack (350) to cause linear movement of the guidewire controller cassette relative to the base (see Figures 10-11 and [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire controller of Sharon et al. to include a base, the housing located over the base, the base including a translations assembly, the translation assembly comprising a pinion and a slider, the slider coupleable to a linear slide and the pinion engageable against a rack to cause linear movement of the guidewire controller cassette relative to the base, as disclosed in Yi et al., so as to transfer the housing, translational module, and rotational module in the longitudinal direction relative to the base (see Yi et al.:[0084]).
Regarding claim 2, Sharon et al. discloses the translational module comprises at least a pair of rollers (2103, 2505), each roller being disposed to face one another along the first guidewire path, and each roller having an outer circumferential surface, at least a portion of which grips the guidewire extending between the pair of rollers (see Figures 21A, 21C and 25 and col. 43, lines 1-8, col. 44, lines 5-16, and col. 47, lines 31-38).
Regarding claim 3, Sharon et al. discloses the rotational module further comprises a rotation axis extending longitudinally therethrough and a guidewire connector (2121, 2404, 2501) disposed along the rotating axis and having a collet received within the opening in the rotational module and having an opening for receiving the proximal end of the guidewire (see Figures 21A, 24, and 25 and col. 43, lines 17-30 and col. 46, line 65-col. 47, line 14).
Regarding claim 4, Sharon et al. discloses the rotational module further comprises a first gear assembly (2109) disposed at a proximal end of the guidewire controller, a second gear assembly (2111, 2113) engaged to the first gear assembly along a perpendicular direction of the rotational axis (see Figures 21A-B and col. 43, lines 9-16 and lines 57-62).
Regarding claim 5, Sharon et al. discloses the second gear assembly has a rotational shaft (2119, 2127) extending along the perpendicular direction of the rotational axis (see Figures 21A-B and col. 43, line 47-col. 44, line 4).
Regarding claim 6, Sharon et al. discloses a method for moving a guidewire, comprising:
providing a guidewire (2405) having a proximal end (see col. 47, lines 2-3);
providing a guidewire controller comprising:
a cartridge (2402) having an interior space (see Figure 24); a translational module (2105, 2503) received within the interior space and having an entry side, an opposed exit side and a lateral wall being disposed therebetween (see Figure 24), the translational module comprising a first guidewire path (see Figure 21C) extending between the entry side and the exit side and configured to move the guidewire translationally along the first guidewire path with respect to the cartridge (see Figures 21A, 24, and 25 and col. 43, lines 1-8 and col. 47, lines 31-38);
a rotational module (2107, 2404, 2501) received within the interior space and mounted at the lateral wall, the rotational module comprising an opening (2404) for receiving the proximal end of the guidewire and a longitudinal axis allowing the proximal end of the guidewire being rotated thereabout, and a second guidewire path which is a loop path (2411, 2413) extending out from the opening to the entry side (see Figures 21A, 24, and 25 and col. 43, lines 9-46 and col. 47, lines 31-38);
engaging the guidewire to the rotational module and the translational module along the first guidewire path and the second guidewire path (see Figures 21A-C, 24, and 25 and col. 43, lines 1-8); and
moving the guidewire translationally or rotationally along the first guidewire path and the second guidewire path in response to a control signal of the guidewire controller (see col. 7, lines 1-15 and col. 47, lines 39-41).
It is noted Sharon et al. does not specifically teach providing a base, providing a translation assembly coupled to the base and exteriorly of the cartridge, the translation assembly comprising a pinion and a slider, the slider coupleable to a linear slide and the pinion engageable against a rack to cause linear movement of the guidewire controller cassette; and rotating the pinion and moving the guidewire controller cassette linearly to move the guidewire linearly independently of operation of the translational module. However, Yi et al. teaches providing a base (310), providing a translation assembly (300) coupled to the base and exteriorly of the cartridge (200) (see Figures 10-11), the translation assembly comprising a pinion (355) and a slider (360), the slider coupleable to a linear slide and the pinion engageable against a rack (350) to cause linear movement of the guidewire controller cassette; and rotating the pinion and moving the guidewire controller cassette linearly to move the guidewire linearly independently of operation of the translational module (210) (see Figures 10-11 and [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sharon et al. to include providing a base, providing a translation assembly coupled to the base and exteriorly of the cartridge, the translation assembly comprising a pinion and a slider, the slider coupleable to a linear slide and the pinion engageable against a rack to cause linear movement of the guidewire controller cassette; and rotating the pinion and moving the guidewire controller cassette linearly to move the guidewire linearly independently of operation of the translational module, as disclosed in Yi et al., so as to transfer the housing, translational module, and rotational module in the longitudinal direction relative to the base (see Yi et al.:[0084]).
Regarding claim 7, Sharon et al. discloses the translational module comprises at least a pair of rollers (2103, 2505), each roller being disposed to face one another along the first guidewire path, and each roller having an outer circumferential surface, at least a portion of which grips the guidewire extending between the pair of rollers (see Figures 21A, 21C and 25 and col. 43, lines 1-8, col. 44, lines 5-16, and col. 47, lines 31-38).
Regarding claim 8, Sharon et al. discloses the guidewire is engaged to form a loop along the second guidewire path (see Figures 21A, 24, and 25 and col. 46, lines 51-64).
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
Instead, Applicant’s arguments are directed to the newly added subject matter of the amended claims, which is addressed in the new grounds of rejection as outlined above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791