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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 31OCT2025 has been entered.
Response to Arguments
Applicant’s arguments, see page 6, filed 06OCT2025, with respect to the rejection(s) of claim(s) 1, 3-15, 17, and 19-21 under 35 U.S.C. § 102 and 103 have been fully considered and are moot in view of new grounds of rejection prompted by Applicant’s amendment to claims. A new ground(s) of rejection is made in view of Cox in view of Kulessa.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Claim(s) 1, 4, 5, 8, 10-15, 17, and 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20030023190 A1 (Cox) in view of US 20040260249 A1 (Kulessa).
Regarding Claim 1, Cox teaches a shunt (Cox teaching a plurality of medical devices for fluid removal and therefore considered equivalent [Abstract], Cox further noting the use of any insertable medical device [0025]) comprising:
a catheter body (52) (Fig. 7) having a plurality of discrete holes (58) in fluid communication with a lumen (56) therein [0029].
In the embodiment of Fig. 7, Cox fails to explicitly teach a plurality of discrete coatings.
Cox teaches a plurality of embodiments which may be combined or have features substituted [0034], as well as the ability to have the holes extend through the catheter body [0010]. Cox further teaches a plurality of discrete coverings (the coatings being discrete and non-continuous [0030]), wherein each discrete covering of the plurality of discrete coverings covers only one or more discrete holes of the plurality of discrete holes (as described in [0030], and shown in Fig. 8), the plurality of discrete coverings are within the plurality of discrete holes and protruding outwardly from within the plurality of discrete holes (as seen in Fig. 8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cox to incorporate the features of multiple embodiments as Cox teaches the combination or substitution of features from various embodiments [0034].
Cox fails to explicitly teach the plurality of discrete coverings are each bioresorbable or biodegradable and are configured for passive resorption in vivo over time.
Kulessa teaches a shunt (10) comprising a catheter body (12, 14, and 16) having a plurality of discrete holes (20) in fluid communication with a lumen (18) therein wherein the plurality of discrete coverings are each bioresorbable or biodegradable (PLA and PGA being biodegradable) [0025, 0033] and are configured for passive resorption in vivo over time [0025].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating of Cox with the degradable coating of Kulessa to allow for the coatings to degrade over time, thereby allowing continued flow as holes are fouled by ingrowth [Kulessa 0024].
Regarding Claim 4, Cox further teaches at least two of the plurality of discrete holes have different amounts of the plurality of discrete coverings applied (as seen in Fig. 8).
“[V]arying a cerebrospinal fluid entry capacity through at least two of the plurality of holes” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claim 5, Cox fails to teach at least two of the plurality of discrete holes include at least two of the plurality of discrete coverings with different resorption rates, varying a cerebrospinal fluid entry capacity through at least two of the plurality of discrete holes.
Kulessa further teaches at least two of the plurality of discrete holes (20) include at least two of the plurality of discrete coverings (28) with different resorption rates, varying a cerebrospinal fluid entry capacity through at least two of the plurality of discrete holes [0033].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating of Cox in view of Kulessa with the selectively removable/decaying coatings of Kulessa to allow continued flow through the device as blockages occur [Kulessa 0033].
“[V]arying a cerebrospinal fluid entry capacity through at least two of the plurality of discrete holes” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding claim 8, Cox in view of Kulessa fails to teach at least two of the plurality of discrete holes are sized differently, varying a cerebrospinal fluid entry capacity through at least two of the plurality of discrete holes.
Kulessa further teaches at least two of the plurality of discrete holes (20) are sized differently [0022], varying a cerebrospinal fluid entry capacity through at least two of the plurality of discrete holes.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the holes of Cox in view of Kulessa to vary in size as taught by Kulessa to ensure sufficient flow [Kulessa 0022].
“[V]arying a cerebrospinal fluid entry capacity through at least two of the plurality of discrete holes” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claim 10, Cox further teaches the plurality of discrete coverings (54) are further applied to an inner wall of the catheter body (52) (as seen in Fig. 7).
Regarding Claim 11, Cox further teaches the coating fills into at least some of the holes [0010], and therefore does not fill all the holes. Cox is therefore considered to teach the plurality of discrete coverings are not applied to at least a third discrete hole of the plurality of discrete holes near a distal end of the catheter body.
Regarding claims 12 and 13, Cox further teaches the coating fills into at least some of the holes [0010], and therefore does not fill all the holes. While any grouping of holes may be assigned to create the claimed first and second subsets, Cox fails to explicitly teach the claimed relationship.
Kulessa further teaches the plurality of discrete holes (20a-20h) comprises a first subset (20a) of the plurality of discrete holes positioned near a distal end of the catheter body (16) (Figs. 1 and 2) and a second subset (20b) of the plurality of discrete holes positioned proximally to the first subset of the plurality of discrete holes, the plurality of discrete coverings being only applied to the second subset of the plurality of discrete holes [0024].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the holes of Cox in view of Kulessa to allow for holes to be opened in stages [Kulessa 0024], thereby controlling flow as holes become obstructed by ingrowth.
Regarding claims 14 and 15, Cox in view of Kulessa fails to teach a third subset of holes.
Kulessa further teaches the plurality of discrete holes (20a-20h) further comprises a third subset (20c) of the plurality of discrete holes positioned proximally to the second subset of the plurality of discrete holes (Fig. 2), wherein the plurality of discrete coverings are only applied to the second subset of the plurality of discrete holes and the third subset of the plurality of discrete holes [0024].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the holes of Cox in view of Kulessa to allow for holes to be opened in stages [Kulessa 0024], thereby controlling flow as holes become obstructed by ingrowth.
Regarding Claim 17, Cox further teaches the plurality of discrete coverings (54) project radially inwardly from at least one of the plurality of discrete holes (58) (as seen in Fig. 7).
Regarding Claim 19, Cox teaches a shunt (Cox teaching a plurality of medical devices for fluid removal and therefore considered equivalent [Abstract], Cox further noting the use of any insertable medical device [0025]) comprising:
a catheter (52) (Fig. 7);
a plurality of discrete holes (58) in fluid communication with a lumen (56) of the catheter [0029]; and
In the embodiment of Fig. 7, Cox fails to explicitly teach a plurality of discrete coatings.
Cox teaches a plurality of embodiments which may be combined or have features substituted [0034], as well as the ability to have the holes extend through the catheter body [0010]. Cox further teaches a plurality of discrete coverings (the coatings being discrete and non-continuous [0030]), wherein each discrete covering of the plurality of discrete coverings covers only one or more discrete holes of the plurality of discrete holes (as described in [0030], and shown in Fig. 8), the plurality of discrete coverings are within the plurality of discrete holes and protruding outwardly from within the plurality of discrete holes (as seen in Fig. 8).
Kulessa teaches a shunt (10) comprising a catheter body (12, 14, and 16) having a plurality of discrete holes (20) in fluid communication with a lumen (18) therein wherein the plurality of discrete coverings are each bioresorbable or biodegradable (PLA and PGA being biodegradable) [0025, 0033] and are configured for passive resorption in vivo over time [0025].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating of Cox with the degradable coating of Kulessa to allow for the coatings to degrade over time, thereby allowing continued flow as holes are fouled by ingrowth [Kulessa 0024].
Regarding Claim 20, Cox teaches a shunt (Cox teaching a plurality of medical devices for fluid removal and therefore considered equivalent [Abstract], Cox further noting the use of any insertable medical device [0025]) comprising:
a catheter body (52) (Fig. 7) having a plurality of slits (58) in fluid communication with a lumen (56) of the catheter body [0029].
In the embodiment of Fig. 7, Cox fails to explicitly teach a plurality of discrete coverings for preventing cerebrospinal fluid accumulation on the catheter body, wherein the coverings are biodegradable or bioresorbable.
Cox teaches a plurality of embodiments which may be combined or have features substituted [0034], as well as the ability to have the slits extend through the catheter body [0010]. Cox further teaches a plurality of discrete coverings (the coatings being discrete and non-continuous [0030]), wherein each discrete covering of the plurality of discrete coverings covers only one or more discrete slits of the plurality of discrete slits (as described in [0030], and shown in Fig. 8), the plurality of discrete coverings are within the plurality of discrete slits and protruding outwardly from within the plurality of discrete slits (as seen in Fig. 8).
Kulessa teaches a shunt (10) comprising a catheter body (12, 14, and 16) having a plurality of discrete slits (20) in fluid communication with a lumen (18) therein wherein the plurality of discrete coverings are each bioresorbable or biodegradable (PLA and PGA being biodegradable) [0025, 0033] and are configured for passive resorption in vivo over time [0025], preventing cerebrospinal fluid accumulation on the catheter body [0026].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating of Cox with the degradable coating of Kulessa to allow for the coatings to degrade over time, thereby allowing continued flow as holes are fouled by ingrowth [Kulessa 0024].
“[C]overing means for preventing cerebrospinal fluid accumulation on the catheter body” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claim 21, Cox further teaches the plurality of discrete coverings forms a membrane covering only one of the plurality of discrete holes (as seen in Fig. 8 where each covering 64 covers a single hole) [0030].
Regarding Claim 22, Cox further teaches the coating being flush with the outer surface [0030, 0032], as well as the ability to extend the coating inwardly from the holes and thereby forming a smooth surface with any chosen internal diameter [0029], but fails to explicitly teach at least one of the plurality of discrete coverings is flush within and with a plane along an inner wall of one or more discrete holes of the plurality of discrete holes.
By combining the teachings of Cox, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one of the plurality of discrete coverings to be flush within and with a plane along an inner wall of one or more discrete holes of the plurality of discrete holes as Cox teaches scenarios involving coatings flush with the outer surface, coatings on the inner surface, and the ability to choose the depth the which coatings extend into the device interior.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox in view of Kulessa and further in view of US 20120130467 A1 (Selden et al.).
Regarding Claim 3, Cox in view of Kulessa fails to teach the plurality of discrete coatings each comprise polyalpha-hydroxy-acid or polyesteramide.
Selden teaches a cerebrospinal fluid stent (Fig. 4A) which utilizes polyalpha-hydroxy-acid [0061] as a bioabsorbable material.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bioresorbable or biodegradable coating of Cox in view of Kulessa with the material selection of Selden as a simple substitution of one known biodegradable material for another to predictably control the degradation rate of the biodegradable material MPEP 2143 I.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox in view of Kulessa and further in view of US 20090048667 A1 (Mochizuki et al.).
Regarding Claims 6 and 7, Cox in view of Kulessa fails to teach the plurality of discrete coatings comprise a plasma protein adsorption suppressant such as poly 2-methoxyethylacrylate.
Mochizuki teaches a biodegradable coating for a stent [0014], said coating comprising Poly 2-methoxyethylacrylate [0113], a plasma protein adsorption suppressant.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating material of Cox in view of Kulessa with the material selection of Mochizuki as a simple substitution of one biodegradable coating material for another to ensure compatibility of the biodegradable coating with any drug used in the coating [Mochizuki 0111] MPEP 2143 I.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox in view of Kulessa and further in view of US 20060074388 A1 (Dextradeur et al.).
Regarding Claim 9, Cox teaches the use of anti-infective substances and while an antibacterial agent is an anti-infective, Cox fails to explicitly teach the plurality of discrete coverings comprise an antibacterial coating.
Dextradeur teaches the use of an antimicrobial agents to combat bacteria [0044] in the coating, and is therefore considered to teach an antibacterial coating. Dextradeur further teaches said coating may applied to the inside of the device [0052].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating of Cox in view of Kulessa with the antibacterial coating location of Dextradeur to improve protection again colonization of bacteria [Dextradeur 0002].
Conclusion
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/HANS KALIHER/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781