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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 32, 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hooven et al. (US 4601724 A, hereafter “Hooven”).
Regarding claim 1, Hooven discloses a ventricular catheter portion of a hydrocephalus shunt comprising:
a proximal end portion (52) and a distal end portion (51);
wherein the proximal end portion (52), which is comprised of fluoropolymer tubing terminating in a proximal tip (fig. 4), is comprised of a first material selected from the group consisting of a fluoropolymer, a perfluoropolymer, and combinations thereof (column 4 lines 1-13);
wherein the distal end portion (51) is comprised of tubing that is comprised of a second material selected from the group consisting of a non-fluorinated polymer, non-perfluorinated polymer, silicone elastomer, fluorosilicone elastomer, or perfluorosilicone elastomer (elastomeric tubing 51 is a silicone rubber tubing, column 6 lines 29-30); and
wherein the fluoropolymer tubing of the proximal end portion and the tubing of the distal end portion have a lumen with an open end of the lumen distal to the proximal tip (see longitudinal hollow lumen of both 51 and 52 in fig. 4).
Regarding claim 2, Hooven discloses the catheter of claim 1 and further discloses wherein the first material comprises one or more of: PFA, PTFE, FEP, ePTFE, EFEP, ETFE, PVDF, VF2/HFP, VF2/tetrafluoro ethylene/HFP terpolymer, a fluoroelastomer, and/or a perfluoroelastomer (column 5 lines 19-23).
Regarding claim 32, Hooven discloses the catheter of claim 1 and further discloses a hydrocephalus shunt (22) comprising a ventricular catheter portion of claim 1 (column 2 lines 54-69, column 3 lines 1-6).
Regarding claim 36, Hooven discloses the catheter of claim 1 and further discloses a method of treatment comprising implanting the hydrocephalus shunt of claim 32 in an animal (fig. 1, column 2 lines 54-69, column 3 lines 1-6).
Claim Rejections - 35 USC § 103
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) 3, 5-6, 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hooven (US 4601724 A) in view of Heilman et al. (US 20160136398 A1, hereafter “Heilman”).
Regarding claim 3, Hooven discloses the catheter of claim 1. However, Hooven fails to disclose wherein the first material is a porous fluoropolymer, a porous perfluoropolymer, or a porous fluoropolymer-perfluoropolymer combination.
Heilman teaches a similar device in the same field of endeavor wherein the first material is a porous fluoropolymer, a porous perfluoropolymer, or a porous fluoropolymer-perfluoropolymer combination (para. [0138, 0173]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluoropolymer of Hooven to be porous to allow for fluid communication into the lumen of the shunt (para. [0138, 0173]).
Regarding claim 5, the combination of Hooven and Heilman discloses the catheter of claim 3. Hooven further discloses wherein the second material of the catheter comprises an elastomer (elastomeric tubing 51), silicone, fluorosilicone, perfluorosilicone, or polyurethane.
Regarding claim 6, the combination of Hooven and Heilman discloses the catheter of claim 5. However, Hooven fails to expressly disclose wherein the section where the fluoropolymer tubing and the tubing of the distal end portion join or overlap extends from 0 to 1 cm, from 1 cm to 2 cm, from 2 cm to 3 cm, from 3 cm to 4 cm, from 4 cm to 5 cm, from 5 cm to 6 cm, from 6 cm to 7 cm, from 7 cm to 8 cm, from 8 cm to 9 cm, from 9 cm to 10 cm, from 10 cm to 11 cm, from 11 cm to 12 cm, from 12 cm to 13 cm, or from 13 cm to 14 cm.
While Hooven’s figures may not be to scale, one skilled in the art would still find it obvious to first follow the dimensions as suggested by the figures in order to create the intended article. By doing so, one is likely to arrive at a workable overlapping region that falls within the claimed range through routine experimentation because the claim effectively requires a length of the fluoropolymer tubing to be between 0 and 14 cm, and figure 1 demonstrates a useable length that would fall within that broad claimed range.
Regarding claim 26, Hooven discloses the catheter of claim 1. However, Hooven fails to disclose its specific method of making the device; specifically, the method comprising preparing all or part of the proximal end portion or the distal end portion by one or more of: machining away excess material, drilling, laser cutting, laser drilling, extrusion, co-extrusion, injection molding, compression molding, melt spinning, electrospinning, dip coating, blowing, foaming, over- molding, and chemical vapor deposition.
Heilman teaches the method comprising preparing all or part of the proximal end portion or the distal end portion by one or more of: machining away excess material, drilling, laser cutting (para. [0262]), laser drilling, extrusion (para. [0253]), co-extrusion, injection molding, compression molding, melt spinning, electrospinning, dip coating, blowing, foaming, over- molding, and chemical vapor deposition. Heilman teaches a similar medical device including hydrocephalus shunts and catheters that are made of the same materials as the claimed invention and Hooven—a fluoropolymer-based elastic material for an implant to drain cerebrospinal fluid (para. [0252]); therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the laser cutting and/or extrusion methods of Heilman to produce the device of Hooven with predictable results namely, a flexible fluoropolymer-based shunt with a lumen for drainage.
Regarding claim 27, the combination of Hooven and Heilman discloses the method of claim 26. However, Hooven fails to disclose wherein the proximal portion and/or distal end portion comprise a fluoropolymer and/or perfluoropolymer present on at least a portion of their exterior surfaces, wherein the fluoropolymer or perfluoropolymer containing exterior surface is formed by a method selected from the group consisting of: extrusion, co-extrusion, injection molding, compression molding, melt spinning, electrospinning, dip coating, blowing, and/or foaming.
Heilman teaches wherein the proximal portion and/or distal end portion comprise a fluoropolymer and/or perfluoropolymer present on at least a portion of their exterior surfaces, wherein the fluoropolymer or perfluoropolymer containing exterior surface is formed by a method selected from the group consisting of: extrusion, co-extrusion, injection molding, compression molding, melt spinning, electrospinning, dip coating, blowing, and/or foaming (gas or liquid dispersion, para. [0252, 0254]).
Heilman teaches a similar medical device including hydrocephalus shunts and catheters that are made of the same materials as the claimed invention and Hooven—a fluoropolymer-based elastic material for an implant to drain cerebrospinal fluid (para. [0252]); therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the laser cutting and/or extrusion methods of Heilman to produce the device of Hooven with predictable results namely, a flexible fluoropolymer-based shunt with a lumen for drainage.
Regarding claim 28, the combination of Hooven and Heilman discloses the method of claim 26. Hooven teaches a ventricular catheter portion of a hydrocephalus shunt (fig. 1, column 3 lines 1-6) and it would been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the method of claim 26, explained above, to produce the device of Hooven with predictable results namely, a flexible fluoropolymer-based shunt with a lumen for drainage.
Claim(s) 4, 8, 20-25, 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hooven (US 4601724 A) in view of Jones et al. (WO 2020077161 A1, hereafter “Jones”).
Regarding claim 4, Hooven discloses the catheter of claim 1 but fails to disclose wherein the first material comprises ePTFE.
Jones teaches a similar device in the same field of endeavor comprising ePTFE (para. [0030]).
Hooven discloses PTFE, not ePTFE and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used ePTFE as shown in Jones with predictable results, namely, a flexible and porous material commonly used for medical implants.
Regarding claim 8, Hooven discloses the catheter of claim 1 and further discloses wherein the distal end portion (51) comprises a tube comprised of a silicone elastomer (elastomeric tubing 51 is a silicone rubber tubing, column 6 lines 29-30), fluorosilicone elastomer, and/or perfluorosilicone elastomer; and wherein the tubing of the distal end portion (51) is mechanically attached to the fluoropolymer tubing (52) to create a ventricular catheter portion having a continuous lumen (see figs. 5-7, column 4 lines 42-50).
However, Hooven fails to disclose the fluoropolymer tubing of the proximal end portion is comprised of ePTFE.
Jones teaches ePTFE (para. [0030).
Hooven discloses PTFE, not ePTFE and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used ePTFE as shown in Jones with predictable results, namely, a flexible and porous material commonly used for medical implants.
Regarding claim 20, Hooven discloses the catheter of claim 1. However, Hooven fails to disclose wherein at least a portion of a surface of the proximal end portion, or a portion of a surface of both the proximal end portion and the distal end portion is coated with one or more fluorinated liquids, one or more perfluorinated liquids, or a combination of one or more fluorinated liquids and/or one or more perfluorinated liquids.
Jones teaches wherein the medical device is coated with one or more fluorinated liquids, one or more perfluorinated liquids, or a combination of one or more fluorinated liquids and/or one or more perfluorinated liquids (para. [0027, 0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the liquid coating as shown in Jones to prevent thrombus formation, cell adhesion, and biofilm adhesion/growth (para. [0040]).
Regarding claim 21, the combination of Hooven and Jones discloses the catheter of claim 20. However, Hooven fails to disclose wherein the fluorinated liquid, the perfluorinated liquid, or the combination of one or more fluorinated liquids and/or one or more perfluorinated liquids comprises a fluoroalkane or perfluoroalkane.
Jones teaches wherein the fluorinated liquid, the perfluorinated liquid, or the combination of one or more fluorinated liquids and/or one or more perfluorinated liquids comprises a fluoroalkane or perfluoroalkane (para. [0027, 0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the liquid coating as shown in Jones to prevent thrombus formation, cell adhesion, and biofilm adhesion/growth (para. [0040]).
Regarding claim 22, the combination of Hooven and Jones discloses the catheter of claim 20. However, Hooven fails to disclose wherein greater than 50%, 75%, 80%, or 90%, or 100%, of an exterior surface of the proximal end portion, the distal end portion, or both the proximal end portion and the distal end portion is comprised of a fluoropolymer and/or perfluorinated polymer and is coated with the fluorinated liquid, perfluorinated liquid, or a combination of one or more fluorinated liquids and/or perfluorinated liquids.
Jones teaches wherein greater than 50%, 75%, 80%, or 90%, or 100%, of an exterior surface of the proximal end portion, the distal end portion, or both the proximal end portion and the distal end portion is comprised of a fluoropolymer and/or perfluorinated polymer and is coated with the fluorinated liquid, perfluorinated liquid, or a combination of one or more fluorinated liquids and/or perfluorinated liquids (para. [0027, 0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the liquid coating as shown in Jones to prevent thrombus formation, cell adhesion, and biofilm adhesion/growth (para. [0040]).
Regarding claim 23, the combination of Hooven and Jones discloses the catheter of claim 20. However, Hooven fails to disclose wherein the one or more fluorinated liquids, the one or more perfluorinated liquids, or the combination of one or more fluorinated liquids and/or perfluorinated liquids comprises, consists essentially of, or consists of one or more perfluorinated liquids.
Jones teaches wherein the one or more fluorinated liquids, the one or more perfluorinated liquids, or the combination of one or more fluorinated liquids and/or perfluorinated liquids comprises, consists essentially of, or consists of one or more perfluorinated liquids (para. [0027, 0030, 0033]).
Regarding claim 24, the combination of Hooven and Jones discloses the catheter of claim 20. However, Hooven fails to disclose wherein the one or more fluorinated liquids, the one or more perfluorinated liquids, or the combination of one or more fluorinated liquids and/or one or more perfluorinated liquids comprises greater than:
(i) 50%, 60%, 70%, 80%, 90%, 95%, or 98% of one or two fluorinated and/or perfluorinated compounds on a weight basis;
(ii) 50%, 60%, 70%, 80%, 90%, 95%, or 98% of fluorinated compounds on a weight basis;
(iii) 50%, 60%, 70%, 80%, 90%, 95%, or 98% of perfluorinated compounds on a weight basis; or
(iv) 50%, 60%, 70%, 80%, 90%, 95%, or 98% of fluorinated and/or perfluorinated compounds on a weight basis.
Jones teaches a variety of fluorinated and/or perfluorinated liquids, their potential compounds, and that a combination can be used (para. [0033]), but does not expressly disclose percentages by weight of the various compounds. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the liquid of Jones to have a composition as any of the many options listed above as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05.
Regarding claim 25, the combination of Hooven and Jones discloses the catheter of claim 20. However, Hooven fails to disclose wherein the one or more fluorinated liquids, the one or more perfluorinated liquids, or the combination of one or more fluorinated liquids and/or one or more perfluorinated liquids comprises: perfluoropropane, perfluorobutane, perfluoropentane, perfluorohexane, perfluorooctane, perfluorodecalin, perfluoroperhydrophenanthrene, perfluorooctylbromide, perfluoro tributyl amine, perfluorotripentyl amine, poly(hexa)fluoropropylene oxide, or combinations thereof.
Jones teaches wherein the one or more fluorinated liquids, the one or more perfluorinated liquids, or the combination of one or more fluorinated liquids and/or one or more perfluorinated liquids comprises: perfluoropropane, perfluorobutane, perfluoropentane, perfluorohexane, perfluorooctane, perfluorodecalin, perfluoroperhydrophenanthrene, perfluorooctylbromide, perfluoro tributyl amine, perfluorotripentyl amine, poly(hexa)fluoropropylene oxide, or combinations thereof (para. [0033]).
Regarding claim 29, Hooven discloses the catheter of claim 1. However, Hooven fails to disclose wherein the catheter is packaged in a sterile nonporous container coated with one or more fluorinated liquids, one or more perfluorinated liquids, or a combination of one or more fluorinated liquids and/or one or more perfluorinated liquids.
Jones teaches a medical device packaged in a sterile nonporous (liquid tight seal cover, para. [0012]) container coated with one or more fluorinated liquids, one or more perfluorinated liquids, or a combination of one or more fluorinated liquids and/or one or more perfluorinated liquids (para. [0012, 0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the packaging of Jones for the device of Hooven to maintain sterility of the device and prevent thrombus formation, cell adhesion, and biofilm adhesion/growth (para. [0040]).
Regarding claim 30, Hooven discloses the catheter of claim 1. However, Hooven fails to disclose wherein the catheter is packaged in a sterile nonporous container in the absence of one or more fluorinated liquids, one or more perfluorinated liquids, or a combination of one or more fluorinated liquids and/or one or more perfluorinated liquids; where the package either further comprises or is accompanied by a sterile aliquot of the one or more fluorinated liquids, one or more perfluorinated liquids, or the combination of one or more fluorinated liquids and/or one or more perfluorinated liquids.
Jones teaches a medical device packaged in a sterile nonporous (liquid tight seal cover, para. [0012]) container in the absence of one or more fluorinated liquids, one or more perfluorinated liquids, or a combination of one or more fluorinated liquids and/or one or more perfluorinated liquids (para. [0007-0008, 0012]); where the package either further comprises or is accompanied by a sterile aliquot of the one or more fluorinated liquids, one or more perfluorinated liquids, or the combination of one or more fluorinated liquids and/or one or more perfluorinated liquids (para. [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the packaging of Jones for the device of Hooven to maintain sterility of the device and prevent thrombus formation, cell adhesion, and biofilm adhesion/growth (para. [0040]).
Conclusion
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 27 February 2026