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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1 and 7 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of Zhou ‘189; Tingtao et al. (US 12128189 B2) in view of Su; Tsung-chow (US 20130253479 A1).
Regarding pending claim 1, Zhou ‘189 claims substantially all limitations in patented claim 1, namely a device having a urine flow direction, the device comprising: a plurality of protuberances on an interior surface of the device (claim 1, An article comprising a fluidic channel having a flow direction, the article comprising: a plurality of protuberances on an interior surface of the fluidic channel);
a base length of each of a plurality of protuberances being less than one half a distance between vertices of adjacent protuberances (claim 1, the base length of each of the plurality of protuberances being less than one fourth the distance between vertices of adjacent protuberances).
Zhou ‘189 describes the device’s other features with language identical to pending claim 1.
Zhou ‘189 does not explicitly claim a catheter. Su discloses modified urinary catheters and having improved liquid flow (¶ [0002], [0007], [0031], [0032] Referring to FIGS. 1 and 17, examples of a catheter (1) are shown);
comprising a catheter having a urine flow direction (¶ [0034] Typically, a catheter (1) includes an elongate body (5) defining a continuous enclosed liquid flow channel; ¶ [0035] The elongate body (5) may define an inner wall and in one embodiment, as shown in FIG. 2); and
a plurality of protuberances on an interior surface of the catheter (¶ [0035], The elongate body (5) may include at least a first fin (25) extending radially inward from the inner wall, portions of the at least first fin (25) including at least one of the first and second surfaces (FIG. 3)).
Su demonstrates that a tube or channel with protuberances on its interior surface is suitable as a catheter. One would be motivated to modify Zhou ‘189’s claims by constructing or configuring the article as a catheter, according to Su’s example. Zhou ‘189 claims a fluidic channel and flow direction (claim 1, a fluidic channel having a flow direction), which suggests that the article can be adapted for a specific role as a catheter. Therefore, it would have been obvious to modify Zhou ‘189’s claims into a catheter according to Su in order to specialize the article for a desired role.
Regarding pending claim 7, Zhou ‘189 claims substantially all limitations in patented claim 1. Zhou ‘189 does not explicitly claim a method of making a catheter and instead claims an article. Su discloses a catheter having a urine flow direction and protuberances as discussed for claim 1 above. Regarding the rationale and motivation to modify Zhou ‘189’s claim into an article according to Su, see the discussion of claim 1 above.
Regarding the method of method of making a catheter, pending claim 7 recites only the general steps “providing a catheter tube with an inner channel; providing a plurality of protuberances.” This claim does not recite specific manufacturing techniques. Zhou ‘189’s claims imply that the article has been constructed at some time, since it forms a coherent article. The steps of “providing” a tube and protuberances therefore do not distinguish pending claim 7 from Zhou ‘189’s patented claim 1.
Claims 1-12 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7 of Zhou ‘539; Tingtao et al. (US 12220539 B2).
Regarding pending claim 1, Zhou ‘539 claims substantially all limitations in patented claim 1, namely a catheter having a urine flow direction (claim 1, A method of making a catheter having a urine flow direction, the method comprising: providing a catheter tube with an inner channel; providing a plurality of protuberances on an interior surface of the inner channel … the base length of each of the plurality of protuberances being less than one half the distance between vertices of adjacent protuberances).
Zhou ‘539 does not explicitly claim a catheter, and instead claims a method of making a catheter. However, Zhou ‘539’s method will result in the catheter of pending claim 1. Also, Zhou ‘539’s manufacturing steps are broad and consist of “providing a catheter tube … providing a plurality of protuberances.” Zhou ‘539 does not describe any manufacturing techniques that distinguish Zhou ‘539’s patented claim 1 from pending claim 1.
Regarding pending claim 6, Zhou ‘539 does not explicitly claim values for a catheter inner diameter, a base-to-base inter-obstacle distance, a base width (L), a height (h) or an s-parameter.
However, Zhou ‘539 claims that the geometric parameters are optimized by an automated model (claim 1, wherein the providing the plurality of protuberances comprises optimizing geometry parameters of the plurality of protuberances by a geometric Fourier neural operator model; claim 7, wherein the geometric Fourier neural operator model is trained as a surrogate model for a forward fluid and particle dynamics simulation that maps the geometry parameters to a bacteria population function). This model appears to automatically generate a set of geometric parameters based on minimizing bacterial adhesion to the catheter’s lumen. A skilled artisan would have been able to modify Zhou ‘539’s claim 1 by optimizing the protuberances’ geometric parameters according to the geometric Fourier neural operator model.
Alternatively, optimizing these parameters would have been obvious in order to reduce bacterial adhesion and to minimize flow resistance.
Regarding pending claim 7, Zhou ‘539 claims all limitations in patented claim 1. Zhou ‘539 recites additional steps including optimizing geometry parameters (claim 1, wherein the providing the plurality of protuberances comprises optimizing geometry parameters of the plurality of protuberances by a geometric Fourier neural operator model). However, Zhou ‘539’s claim 1 includes all features of pending claim 1, therefore Zhou ‘539’s claim 1 anticipates pending claim 1.
Regarding pending claims 2-5 and 8-12, Zhou ‘539 claims all limitations in patented claims 1-6 as shown in table 1.
Table 1: Zhou ‘539 double patenting
Pending claim
Zhou ‘539
Pending claim
Zhou ‘539
Pending claim
Zhou ‘539
2
1, 2
5
1, 6
10
1, 3, 4
3
1, 3
8
1, 2
11
1, 5
4
1, 3, 4
9
1, 3
12
1, 6
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Spath, Bernd US 20050003146 A1
Kuhlein, Georg et al. US 20050010169 A1
Scholz; Hans et al. US 20080172121 A1
Bommarito; G. Marco et al. US 20130211310 A1
Gulliver; Laurence et al. US 20160220775 A1
Dye; Philip J. US 20170021130 A1
Lackey; John et al. US 20220362516 A1
Johnston; Raymond P. et al. US 20230390991 A1
Ali; Mahfuza B. et al. US 20240114905 A1
Jones; Vivian W. et al. US 20250033319 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
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