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 .
Status of the Claims
Claims 16-23 and 33-37 are currently pending. Claim 16 has been amended. Claims 16-23 and 33-37 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/19/2025, with respect to the rejection(s) of claim(s) 16 over various combinations of Garibaldi (US 6524303 B1) and Garibaldi fig. 6 et al (US 20140052120 A1) have been fully considered and are persuasive, because the amendment introduces the previously unconsidered limitation “a ferromagnetic area or structure located at least at the flat, most distal surface of the distal end”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view an alternative interpretation of Garibaldi (US 6524303 B1) and the embodiment of fig. 6 of Garibaldi.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16, 22-23, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi (US 6524303 B1; hereafter Garibaldi) in view of the embodiment of fig. 6 of Garibaldi.
Regarding claim 16, Garibaldi discloses a flow directed device (fig. 1, col. 4 ln. 55-59, catheter 20) configured to be introduced into a tubular structure of a body (col. 4 ln. 55-59, catheter 20 is adapted to be flow-directed within blood vessels), the flow directed device comprising:
a proximal end (proximal end 24, fig. 1, col. 2 ln. 13-17), a distal end (distal end 26, fig. 1, col. 2 ln. 13-17), and an elongated body in between defining a longitudinal axis (see fig. 1), the distal end comprises a flat; and
a ferromagnetic area or structure located at least at the most distal surface of the distal end configured to deflect the distal end when subjected to an external magnetic field (body 32, fig. 1 shown located at distal end 26 of catheter 20; col. 2 ln. 26-30, body 32 made of a material and with dimensions such as to align the catheter with an applied magnetic field; Examiner notes that since body 32 is entirely made of a magnetic material, then the most distal surface is also ferromagnetic.),
Examiner notes claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function. As the body 32 helps to align the catheter, which may entail deflection of the distal end, the structure can perform the recited function.
Garibaldi is silent to most distal surface defined along a transverse plane transverse relative to the longitudinal axis of the elongated body of the flow directed device. Examiner notes that fig. 1 does show a distal face of the distal end 26 of the body 20 in such a way that it appears to be flat and transverse to the longitudinal axis of the elongated body.
A second embodiment of Garibaldi, directed to a similar embodiment shown in fig. 6, teaches a flat, most distal surface (see noted surface in annotated fig. 6 below) defined along a transverse plane (see dashed double arrow in annotated fig. 6 below) transverse relative to the longitudinal axis (see dotted double arrow in annotated fig. 6 below) of the elongated body of the flow directed device (catheter 200, fig. 6, col. 5 ln. 40-49).
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667
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the embodiment of Garibaldi shown in fig. 1 to have a clearly flat, most distal surface as shown in fig. 6 of Garibaldi, since both figures deal with similar embodiments of magnetically guided catheters. One would have been motivated to make the modification because the flat distal surface, being blunt, is less likely to cause damage to the interior of veins than if the distal surface were pointed.
Regarding claim 22, Garibaldi modified by Garibaldi fig. 6 discloses the flow directed device of claim 16, as described above. Garibaldi discloses further comprising: a drag member (body 32) configured to be pushed by the fluid flow to transport the flow directed device along the tubular structure (fig. 1 shows that body 32 has a wider diameter than the more proximal region 38, so there is a lip formed which could be pushed on by fluid flow in a vessel).
Examiner notes claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function. As the body 32 can be pushed by fluid flow, the structure is capable of performing the claimed function.
Regarding claim 23, Garibaldi modified by Garibaldi fig. 6 discloses the flow directed device of claim 22, as described above. Garibaldi further discloses wherein the ferromagnetic area or structure is disposed within the drag member (col. 2 ln. 21-22, body 32 includes a magnetically responsive material).
Regarding claim 37, Garibaldi modified by Garibaldi fig. 6 discloses the flow directed device of claim 16, including wherein the tubular structure is a blood vessel (Garibaldi: col. 4 ln. 55-59, catheter 20 is adapted to be flow-directed within blood vessels).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi modified by Garibaldi fig. 6 as applied to claim 16 above, and further in view of Egley (US 20170157311 A1; hereafter Egley) and Badawi et al (US 20160287438 A1; hereafter Badawi).
Regarding claim 17, Garibaldi modified by Garibaldi fig. 6 discloses the flow directed device of claim 16, as described above, including the distal end (Garibaldi: distal end 26, fig. 1, col. 2 ln. 13-17).
Garibaldi and Garibaldi fig. 6 are silent to the flexural rigidity.
Egley teaches a medical fluid pumping system comprising a “flow directed device” (catheter) wherein the distal end has an elastic modulus between about 100 kPa and about 10 GPa ([0041] silicone catheter has an elastic modulus of 5E6 Pa, Examiner notes that 5x10[10^6] Pa = 5000 kPa and falls within the claimed range).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the distal end and elongated body of Garibaldi to have the elastic modulus taught by Egley because both pieces of prior art deal with catheters and, as noted in Garibaldi, high flexibility allows passage through small vessel branches (Garibaldi col. 2 ln. 43-44).
Badawi teaches wherein a cross-sectional diameter perpendicular to the longitudinal axis has a dimension between about 500 nm and about 500 μm ([0092] outer diameter of the cannula may be 50 microns).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Garibaldi to have the diameter of 50 microns as taught by Badawi because it would allow the catheter to more easily access smaller vessels ([0005] Schlemm’s canal has a small diameter, 50 microns on the lower end). Furthermore, the smaller diameter vessel would be less likely to cause injury to a patient’s vessel by becoming or pushing against the walls of the vessel.
Flexural rigidity is equal to EI (instant spec [0052]; formula found at Dwivedi. “Flexural Rigidity: Definition, Formula, Derivation, Calculation”, mechical.com, 22 May 2022, https://www.mechical.com/2022/05/flexural-rigidity.html.), where I is the area moment of inertia (mechical.com). The area moment of inertia of a circular cross section about its diameter is I = pi*(diameter^4)/64 (“Area Moment of Inertia – Typical Cross Sections I”, engineeringtoolbox.com, https://www.engineeringtoolbox.com/area-moment-inertia-d_1328.html), or, for this particular modified device with a diameter of 50 microns,
I
=
π
d
4
64
=
π
(
50
-
6
)
4
64
=
3.068
*
10
-
19
m
4
. Since this modified device has an elastic modulus equal to 5000 kPa, or 5000000 Pa, the flexural rigidity is equal to
E
I
=
3.06796
*
10
-
19
*
5000000
=
1.534
*
10
-
12
P
a
*
m
4
.
Therefore, the device of Garibaldi modified by Garibaldi fig. 6, Egley, and Badawi discloses wherein at least the distal end and the elongated body have a flexural rigidity between about 10^(-10) Pa*m^4 and about 10^(-14) Pa*m^4 (
1.534
*
10
-
12
P
a
*
m
4
falls within the claimed range).
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi modified by Garibaldi fig. 6 and further in view of Egley.
Regarding claim 18, Garibaldi modified by Garibaldi fig. 6 discloses the flow directed device of claim 16 as shown in the 103 rejection of claim 16 above, including the distal end (Garibaldi: distal end 26, fig. 1, col. 2 ln. 13-17) and the elongated body (Garibaldi: region 38 shown in fig. 1 defining longitudinal axis).
Garibaldi and Garibaldi fig. 6 are silent to the elastic modulus of the distal end and elongated body.
Egley teaches a medical fluid pumping system comprising a “flow directed device” (catheter) having an elastic modulus between about 100 kPa and about 10 GPa ([0041] silicone catheter has an elastic modulus of 5E6 Pa, Examiner notes that 5x10[10^6] Pa = 5000 kPa and falls within the claimed range).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the distal end and elongated body of Garibaldi to have the elastic modulus taught by Egley because both pieces of prior art deal with catheters and, as noted in Garibaldi, high flexibility allows passage through small vessel branches (Garibaldi col. 2 ln. 43-44).
Regarding claim 19, Garibaldi modified by Garibaldi fig. 6 and Egley, as applied to claim 18 above, discloses the flow directed device of claim 18, wherein the elastic modulus between 500 kPa and 5 GPa (Egley [0041] teaches 5000 kPa elastic modulus which falls within the claimed range).
Claim(s) 20-21 and 33-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi modified by Garibaldi fig. 6 and further in view of Badawi.
Regarding claim 20, Garibaldi modified by Garibaldi fig. 6 discloses the flow directed device of claim 16, as described above, including a longitudinal axis (Garibaldi: fig. 1 show elongated body 38 defining longitudinal axis).
Garibaldi and Garibaldi fig. 6 are silent to a cross-sectional diameter falling within the claimed range.
Badawi teaches an ocular delivery system including a “flow directed device” (elongate member/cannula) wherein a cross-sectional diameter perpendicular to the longitudinal axis has a dimension between about 500 nm and about 500 μm ([0092] outer diameter of the cannula may be 50 microns; 50 microns falls within the claimed range of 500 nm to 500 μm).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Garibaldi to have the diameter of 50 microns as taught by Badawi because it would allow the catheter to more easily access smaller vessels ([0005] Schlemm’s canal has a small diameter, 50 microns on the lower end). Furthermore, the smaller diameter vessel would be less likely to cause injury to a patient’s vessel by pushing against the walls of the vessel.
Regarding claim 21, Garibaldi modified by Garibaldi fig. 6 and Badawi, as applied to claim 20 above, discloses the flow directed device of claim 20, wherein the cross-sectional diameter has a dimension between about 1 μm and about 300 μm ([0092] outer diameter of the cannula may be 50 microns; 50 microns falls within the claimed range of 1 μm and 300 μm).
Regarding claim 33, Garibaldi modified by Garibaldi fig. 6 discloses the flow directed device of claim 16, as described above, including the distal end (Garibaldi: distal end 26, fig. 1, col. 2 ln. 13-17).
Garibaldi and Garibaldi fig. 6 are silent to a width of the distal end falling in a certain range.
Badawi teaches wherein a width of at least the distal end is comprised between about 10 μm to about 500 μm ([0092] outer diameter of the cannula may be 50 microns).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Garibaldi to have the width of 50 microns as taught by Badawi because it would allow the catheter to more easily access smaller vessels ([0005] Schlemm’s canal has a small diameter, 50 microns on the lower end). Furthermore, the smaller diameter vessel would be less likely to cause injury to a patient’s vessel by pushing against the walls of the vessel.
Regarding claim 34, Garibaldi modified by Garibaldi fig. 6 and Badawi as applied to claim 33 above discloses the flow directed device of claim 33, including wherein the width of at least the distal end is between 30 and 300 μm (Badawi [0092] outer diameter of the cannula may be 50 microns).
Regarding claim 35, Garibaldi modified by Garibaldi fig. 6 and Badawi as applied to claim 33 above discloses the flow directed device of claim 33, including wherein the width of at least the distal end is between 50 and 200 μm (Badawi [0092] outer diameter of the cannula may be 50 microns).
Regarding claim 36, Garibaldi modified by Garibaldi fig. 6 and Badawi as applied to claim 33 above discloses the flow directed device of claim 33, including wherein the width of at least the distal end is between 50 and 100 μm (Badawi [0092] outer diameter of the cannula may be 50 microns).
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 ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 02/06/2026