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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 01/20/2026 has/have been considered by the Examiner.
Status of the Claims
Claims 1-4 and 6-18 are currently pending. Claims 1-4 and 6 are currently rejected. Claims 7-18 are currently withdrawn.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/16/2026, with respect to the rejection(s) of claim(s) claim 1 as amended under 35 U.S.C. 102(a)(1)/(a)(2) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a further embodiment of Bommarito.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 line 2 recites “plurality of features of comprises”. This should read “plurality of features .
Appropriate correction is required.
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) 1-4 and 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bihlmaier et al (US 20200121911 A1; hereafter Bihlmaier) in view of Bommarito et al (US 20130211310 A1; hereafter Bommarito).
Regarding claim 1, Bihlmaier discloses a catheter assembly (PIVC 400, fig. 4, [0038] FIG. 4 illustrates an embodiment of a PIVC 400), comprising:
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a catheter adapter (catheter adapter 401, fig. 4, [0038]), comprising a distal end (see annotated fig. 4 above), a proximal end (see annotated fig. 4 above), an inner surface (see annotated fig. 4 above) extending through the distal end and the proximal end and forming a lumen (see annotated fig. 4 above), and a side port (side port 404, fig. 4, [0038]) forming a side port pathway (see annotated fig. 4 above) through a sidewall (see annotated fig. 4 above) of the catheter adapter (401) and in fluid communication with the lumen (fig. 4 shows fluid flow from side port 404 into lumen of catheter adapter 401);
a catheter (catheter 402, fig. 4, [0038]) extending distally from the distal end of the catheter adapter (401) (see annotated fig. 4 above which shows catheter 402 extending distally from the noted distal end of catheter adapter 401);
a septum (septum 403, fig. 4, [0038]) disposed within the lumen proximal to the side port pathway (see fig. 4 which shows septum 403 located on the proximal side of the side port pathway), wherein a portion of the inner surface proximal to the catheter and distal to the septum comprises a textured surface (protrusion 410, fig. 4, [0038] PIVC 400 includes a flow diverting feature in the form of a protrusion 410 from the sidewall of catheter adapter 401).
Bihlmaier is silent to wherein the textured surface includes a plurality of features arranged in one or more staggered rows.
Bommarito, in the art of engineered surfaces for reducing bacterial adhesion, teaches wherein a textured surface (engineered surface 700, fig. 7d, [0084] engineered surface 700 comprises a plurality of unit cells 740) includes a plurality of features (unit cells 740, fig. 7d, [0084] Each unit cell 740 of the plurality of unit cells 730…contains one microstructure) arranged in one or more staggered rows (see staggered rows in fig. 7d, [0089] the arrangement of unit cells resembles a tessellation as depicted in FIG. 7d, with adjacent unit cells offset or alternating in one dimension).
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 textured surface of Bihlmaier to, instead of being a single protrusion inside the lumen, be multiple protrusions or depressions taught by Bommarito covering the fluid facing interior surface of the catheter assembly, since Bihlmaier and Bommarito both deal with surface modifications on the interior of catheters (see Bihlmaier fig. 4, [0038]; see Bommarito [0046] engineered surface 110 is meant for contact with a fluid, engineered surface 110 defines a portion of the interior surface of a medical article 100, medical article 100 may be a blood stream catheter; [0084] engineered surface 700 as shown in figs. 7a-f are meant to disrupt biofilm formation). One would have been motivated to make the modification because, as noted by Bommarito [0048] and [0084], the engineered structures beneficially reduce microorganism adhesion.
Regarding claim 2, Bihlmaier as modified by Bommarito discloses the catheter assembly of claim 1, as described above, including wherein the textured surface is rough (see fig. 7d, [0084] each unit cell 740…is at least partially defined by a dimension at least approximating the pitch, and contains a microstructure; the engineered surface includes microstructures and is thus rough as it is not flat/smooth).
Regarding claim 3, Bihlmaier as modified by Bommarito discloses the catheter assembly of claim 1, as described above, including wherein each of the plurality of features of comprises a depression or a protrusion ([0084] As can be appreciated by reference to FIGS. 7a-f, the arrangement of engineered structures 710 on at least a portion of the engineered surface 700 comprises a plurality of unit cells 740…Each unit cell 740…contains one microstructure; see fig. 7a which shows that each microstructure is, for example, a cylindrical protrusion).
Regarding claim 4, Bihlmaier modified by Bommarito discloses the catheter assembly of claim 3, as described above.
Bihlmaier is silent to wherein each of the plurality of depressions or protrusions are dome shaped.
Bommarito, in another embodiment, specifically teaches wherein each of the plurality of depressions or protrusions are dome shaped (Bommarito: [0047] fig. 1 shows the engineered structures 120 depicted as dome-shaped features projecting or protruding from the engineered surface 110).
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 plurality of protrusions of Bihlmaier as currently modified by Bommarito further in view of Bommarito fig. 1 since both embodiments of Bommarito deal with engineered surfaces for reducing bacterial adhesion in medical applications. Furthermore, this modification would be obvious since this limitation represents only a change in size/proportion, and since it has been held that mere changes in size/proportion involve only routine skill in the art (MPEP 2144.04(IV)(A)). One would have been motivated to make the modification from cylindrical to domed since the domed structures, as shown in fig. 1 and described in [0049] of Bommarito, allow for smoother addition of nanofeatures 140, without having to turn a corner as would be necessary with the cylinders.
Regarding claim 6, Bihlmaier as modified by Bommarito discloses the catheter assembly of claim 1, as described above.
Bihlmaier is silent to wherein the textured surface extends into the side port pathway.
Bommarito, in another embodiment, teaches wherein a textured surface (engineered surface 110 or engineered surface 210, fig. 1 or fig. 2 respectively, [0047]) comprises a plurality of depressions (engineered structures 220, fig. 2) or protrusions (engineered structures 120, fig. 1) ([0047] fig. 1 shows the engineered structures 120 depicted as dome-shaped features projecting or protruding from the engineered surface 110; fig. 2 shows the engineered structures 220 projected into the engineered surface 210 at creating a series of disconnected or discrete recesses) and covers the interior, fluid facing surface, of a medical device such as a catheter (see [0046]).
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 textured surface of Bihlmaier modified by Bommarito to include the multiple protrusions or depressions taught by Bommarito covering the fluid facing interior surface of the catheter assembly, since Bihlmaier and Bommarito both deal with surface modifications on the interior of catheters (see Bihlmaier fig. 4, [0038]; see Bommarito [0046] engineered surface 110 is meant for contact with a fluid, engineered surface 110 defines a portion of the interior surface of a medical article 100, medical article 100 may be a blood stream catheter). One would have been motivated to make the modification because, as noted by Bommarito [0048] the engineered structures beneficially reduce microorganism adhesion. Thus, it would be obvious to have the textured surface cover the entire fluid facing surface, since this would beneficially inhibit microorganism adhesion throughout the catheter system.
Claim(s) 1-4 and 6 are alternatively rejected under 35 U.S.C. 103 as being obvious over Devgon et al (US 20200100716 A1; hereafter Devgon) in view of Bommarito.
Alternatively, regarding claim 1, Devgon discloses a catheter assembly (access device 270, fig. 4, [0059]), comprising:
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a catheter adapter (hub 271, fig. 4, [0059]), comprising a distal end (see annotated fig. 4 above), a proximal end (see annotated fig. 4 above, note [0059] proximal port 273 is at the proximal end of the catheter adaptor 271), an inner surface extending through the distal end and the proximal end and forming a lumen (lumen 275, fig. 4, [0059] catheter adapter/hub 271 defines a lumen 275 extending from catheter 272 to proximal port 273), and a side port (side port 276, fig. 4, [0059]) forming a side port pathway through a sidewall (see annotated fig. 4 above) of the catheter adapter (271) and in fluid communication with the lumen (275) ([0062] As shown in FIGS. 3 and 4, the side port 276 is in fluid communication with the lumen 275 of the hub 271);
a catheter (catheter 272, fig. 4, [0059]) extending distally from the distal end of the catheter adapter (271) (see annotated fig. 4 above which shows catheter 272 extending distally from the noted distal end of catheter adapter 271);
a septum (seal 274, fig. 4, [0060] seal 274 disposed in the proximal port 273 of the hub 271 can be a septum) disposed within the lumen proximal to the side port pathway (see fig. 4 which shows septum 274 located on the proximal side of the side port pathway),
Devgon is silent to wherein a portion of the inner surface proximal to the catheter (272) and distal to the septum (274) comprises a textured surface.
Bommarito, in the art of engineered surfaces for reducing bacterial adhesion, teaches wherein a textured surface (engineered surface 110, fig. 1, [0047]) includes a plurality of features (engineered structures 120, fig. 1) ([0047] fig. 1 shows the engineered structures 120 depicted as dome-shaped features projecting or protruding from the engineered surface 110) and covers the interior, fluid facing surface, of a medical device such as a catheter (see [0046]).
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 inner surface proximal to the catheter 272 and distal to the septum 274 of Devgon include the textured surface with multiple protrusions or depressions taught by Bommarito covering the fluid facing interior surface of the catheter assembly, since Devgon and Bommarito both deal with delivery of medical fluid through a catheter (see Devgon [0061] fluid may be delivered to patient through side port 276; see Bommarito [0046] engineered surface 110 is meant for contact with a fluid, engineered surface 110 defines a portion of the interior surface of a medical article 100, medical article 100 may be a blood stream catheter). One would have been motivated to make the modification over the interior of the lumen 275 and the side port pathway of side port 276 because, as noted by Bommarito [0048] the engineered structures beneficially reduce microorganism adhesion. Thus, it would be obvious to have the textured surface cover the entire fluid facing surface, since this would beneficially inhibit microorganism adhesion throughout the catheter system and increase patient safety.
Devgon as modified by Bommarito is silent to wherein the plurality of features are arranged in one or more staggered row.
Bommarito, in another embodiment, teaches , teaches wherein a textured surface (engineered surface 700, fig. 7d, [0084] engineered surface 700 comprises a plurality of unit cells 740) includes a plurality of features (unit cells 740, fig. 7d, [0084] Each unit cell 740 of the plurality of unit cells 730…contains one microstructure) arranged in one or more staggered rows (see staggered rows in fig. 7d, [0089] the arrangement of unit cells resembles a tessellation as depicted in FIG. 7d, with adjacent unit cells offset or alternating in one dimension).
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 textured surface of Bihlmaier as modified by Bommarito, to further include multiple staggered rows as taught by Bommarito fig. 7d in view of [0084] “engineered surface 700 as shown in figs. 7a-f are meant to disrupt biofilm formation”. It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to arrange multiple features in the staggered rows since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). One would have been motivated to make the modification because, as noted by Bommarito [0048] and [0084], the engineered structures beneficially reduce microorganism adhesion, and staggering the rows allows the structures to be placed closer together and prevents the formation of channels between rows of structures which may create undesirable fluid flow paths.
Alternatively, regarding claim 2, Devgon modified by Bommarito discloses the catheter assembly of claim 1, as described above, including wherein the textured surface is rough (see Bommarito fig. 1 and fig. 2 which show multiple protrusions/depressions covering the surface, therefore making the surface rough).
Alternatively, regarding claim 3, Devgon modified by Bommarito discloses the catheter assembly of claim 1, as described above, including wherein each of the plurality of features of comprises a depression or a protrusion (Bommarito: fig. 1) (Bommarito: [0047] fig. 1 shows the engineered structures 120 depicted as dome-shaped features projecting or protruding from the engineered surface 110).
Alternatively, regarding claim 4, Devgon modified by Bommarito discloses the catheter assembly of claim 3, as described above, including wherein each of the plurality of depressions or protrusions are dome shaped (Bommarito: [0047] fig. 1 shows the engineered structures 120 depicted as dome-shaped features projecting or protruding from the engineered surface 110).
Alternatively, regarding claim 6, Devgon modified by Bommarito discloses the catheter assembly of claim 1, as described above, including wherein the textured surface (see Bommarito figs. 1 and 2) extends into the side port pathway (see Devgon fig. 4) (note rejection of claim 1 under Devgon modified by Bommarito above which notes that all fluid facing surfaces of the catheter assembly of Devgon, which includes the lumen 275 and the interior surface of the side port 276 which are fluidically connected, are covered in the textured surface of Bommarito).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Harding et al (US 20080027400 A1) - fig. 6 and [0034] “layer 48 discourages adhesion of a pathogen to the layer 48 in order to repress pathogenic activity. As shown in FIG. 7, a section of the layer 48 is shown in close-up view to reveal an irregular surface. The irregular surface is a microsurface of peaks 50 and valleys 52 that are strategically spaced in order to repress pathogenic activity.”
Klein (US 5762631 A) - fig. 5 and col. 8 ln. 38-50 “A central lumen 46 is provided for receiving the balloon or other catheter, which lumen 46 includes the V-shaped peaks 48 of the present invention”
Ramos et al (US-20150366462 A1) - fig. 5 and [0055] “With regard to FIG. 5, to improve urine drainage through the catheter 10 and reduce urine surface tension on the lumen walls of catheter 10, the drainage lumen 40 of catheter 10 is preferably coated with a hydrophobic coating or treatment, and/or formed to include a patterned microstructure surface design, such as superhydrophobic patterned surface 48.”
Kuhlein et al (US 20050010169 A1) - figs 1-2 and [0019] “Knob-like bumps 4, which can be produced in an optional manner, are provided on the inside wall 3 of line 2 which comes in contact with the fluid. These knob-like bumps are distributed either in a regular arrangement or an irregular arrangement over the complete length of the line”
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 03/05/2026