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 .
Response to Amendment
The amendment filed 4/16/2026 has been entered: Claims 1-5 and 6-20 remain pending in the present application. Claims 1, 6, and 20 have been amended.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Hickmott remains as the primary reference in rejecting the present claims, for disclosing a majority of the claimed invention. However, Fig. 14 is no longer relied upon. Instead, a new grounds of rejection is made in view of a new interpretation of Fig. 9 of Hickmott is made in light of Applicant’s amendments.
Further, Applicant notes that the claims recite the catheter comprising the funnel being part of the connector as in Hickmott, while Applicant’s invention also includes a distal holder part as separate from the catheter. While Examiner appreciates the distinction as the invention is represented in Applicant’s specification as a whole, the term “comprising” is broad and would encompass elements which are connected to one another.
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant further argues Hickmott teaches an opposite arrangement of being expanded in a storage configuration, while Applicant’s invention is compacted in its storage configuration. In the instant case, the sleeve of Hickmott being collapsible and expandable meets the limitations of the claims while the limitation of being collapsed specifically for “storage” does not appear to provide further distinction and does not specify any degree of collapse.
Further, this relates to the intended use of the invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant may claim relevant structures to this configurations, such as more details regarding the outward protrusions (223) corresponding to the proximal end of the inner surface of the distal holder part.
Applicant further argues the handle and connector of Hickmott are not “holder parts”. However, this term is highly broad and it would appear the handle and connector of Hickmott are capable of being held. Thus, they are interpreted as being “holder parts”. As above, while Examiner appreciates the functions and concepts of Applicant’s invention as described in the specification may be distinct from Hickmott. However, Hickmott appears capable of meeting the functions as presently claimed.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are the “holder parts” in claim 1, where “holder” is the function and “part” is the generic place holder. Further, limitations of “distal”, “proximal” or the holder parts being connected to other elements do not provide structure to said “parts” as they instead define their location.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
The holder parts are interpreted as a short tube, as described in paragraphs 18 and 19 of Applicant’s invention.
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.
Claims 1-4, 6, 9-16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hickmott et al. (US 2020/0345977 A1).
Regarding claim 1, Hickmott teaches an intermittent urinary catheter assembly (Fig. 1; Abstract) comprising:
a catheter having a proximal insertion end (insertion end 3) and a distal end opposite to the proximal insertion end (distal end at outlet 4), the catheter having a lumen extending from a drainage opening at or near the proximal insertion end to a discharge opening at or near the distal end (Fig. 1 shows an inner lumen between eyelets 6 and outlet 4; also see ¶ 27), the catheter comprising a funnel integrated with the distal end of the catheter shaft (handle 8 in Fig. 8 is interpreted as being funnel shaped; page 6, left column under Claim 2 also recites the drain being funnel-shaped), said funnel defining a discharge opening (within outer thread 15), wherein the distal holder part is connected to the funnel (see annotated Fig. 9 below); and
a protective sleeve arrangement (sleeve 7) having a proximal holder part (handle 8) and a distal holder part (connector 9) and a compactable sleeve connected to the proximal holder part and the distal holder part (sleeve 7), the sleeve having a compacted storage configuration and being expandable into an expanded configuration (¶s 2 and 21 describe how the sleeve is slidable and extendable into an extended configuration),
wherein the distal holder part is connected to the catheter at the distal end (annotated Fig. 8 below) and the proximal holder part and the distal holder part are releasably connected to each other (Figs. 6 and 10 shows how they connect to one another via snap fit or via screw, via the funnel; ¶ 69).
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Regarding claim 2, Hickmott further discloses that the distal holder part and proximal holder parts are made of a more rigid material than the sleeve (¶s 43 and 54 describe the connector 8 and handle 9 as rigid while ¶s 2 and 44 describe the sleeve as flexible).
Regarding claim 3, Hickmott further discloses that the sleeve is made of a flexible, collapsible material (¶s 2 and 44 describe the sleeve as collapsible, slidable, and flexible).
Regarding claim 4, Hickmott further discloses that the proximal holder part and distal holder part both have a greater wall thickness than the sleeve (Fig. 1 shows how the sleeve 7 is substantially thinner than either handle 8 or connector 9).
Regarding claim 6, Hickmott further discloses that the compactable sleeve is extendable towards the proximal insertion end (¶s 2, 21-22 describe how the sleeve is extendable), and wherein the compact bull sleeve, in its expanded configuration, is arranged to cover more than 50% of the length of the catheter shaft (Figs. 1-3 show sleeve 7 covering a majority of the catheter shaft; ¶ 77).
Regarding claim 9, the limitations of the compactable sleeve is “extendable to a length between L-5 to L+5, where L is a length of the catheter shaft” is considered functional language. 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, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Hickmott has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the sleeve would be expected to be extendable to a length as claimed).
Regarding claim 10, Hickmott further discloses that the distal holder part is connected to the catheter by a snap lock attachment (¶s 39-40 describe how the connector and handle have snap fitting means, which would also allow the distal connector 9 to connect to the proximal end of the catheter via proximal holder 8).
Regarding claim 11, Hickmott further discloses that the distal holder part and the proximal holder part are connected to each other by a snap lock (¶s 39-40 and 69 describe how the holder and connector having complementary snap fit means).
Regarding claim 12, Hickmott further discloses that the proximal holder part comprises a protruding part extending radially outward (Fig. 9 shows how proximal handle 8 comprises outer material 18 which protrudes and extends radially outward; also see snap fit means 11 in Figs. 6-8).
Regarding claim 13, Hickmott further discloses that the protruding part is a flange extending radially outwardly (outer material 18 is interpreted as a flange; also see snap fit means 11 in Figs. 6-8).
Regarding claim 14, Hickmott further discloses that the protruding part is arranged at a proximal end of the proximal holder part (Figs. 9 and 10 show how the protruding part is on the proximal end; also see snap fit means 11 in Figs. 6-8).
Regarding claim 15, Hickmott further discloses that the proximal holder part is arranged to be inserted into the distal holder part (Figs. 6-8 show how snap fit means is intended to be inserted into connector 9; ¶ 69).
Regarding claim 16, the limitations of the compactable sleeve “in the compacted storage configuration, is primarily arranged over the proximal holder part” is considered functional language. 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, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Hickmott has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the sleeve would be expected to be capable of being primarily arranged over the proximal holder part when in a compacted storage configuration).
Regarding claim 18, Hickmott further discloses that the compactable sleeve is arranged outside the proximal and distal holder parts (Fig. 1 shows how the sleeve is attached to the ends of holder 8 and connector 9, and thus is outside said elements, and would continue to be when in a compacted storage configuration).
Regarding claim 19, Hickmott further discloses an outer sleeve arranged outside the compactable sleeve (storage packet 22; said storage pack would be usable even when the sleeve is in the compacted storage configuration).
Regarding claim 20, Hickmott further discloses that the catheter shaft of the catheter is provided with a hydrophilic outer surface (¶s 2 and 30).
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hickmott, as applied to claim 6 above.
Regarding claim 7, Hickmott does not explicitly teach that the compactable sleeve, in its expanded configuration, is arranged to cover more than 90% of the length of the catheter shaft.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Hickmott to have the compactable sleeve, in its expanded configuration, be arranged to cover more than 90% the length of the catheter shaft, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hickmott would not operate differently with the claimed coverage (Figs. 1-3 appear to show the sleeve covering a large majority of the catheter length). Further, applicant places no criticality on the range claimed (¶ 23 of Applicant’s specification only indicates these ranges as preferable).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Hickmott, as applied to claim 1 above.
Regarding claim 17, Hickmott does not explicitly disclose that the proximal holder part has an axial length greater than the distal holder part.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Hickmott to have the proximal holder part has an excellent greater than the distal holder part, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hickmott would not operate differently with the claimed lengths. Further, applicant places no criticality on the range claimed (¶s 35-36 of Applicant specification indicates that either holder part may be longer than the other).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hickmott, as applied to claim 1 above, and further in view of Matthison-Hansen (US 2008/0208314 A1), hereinafter Matthison.
Regarding claim 8, Hickmott does not explicitly teach that the compactable sleeve is folded in the compacted storage configuration, with concertina or accordion fold, to form an accordion or concertina pleated configuration.
However, Matthison teaches a sleeved urinary catheter (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a compactable sleeve with a concertina fold to form a concertina pleated configuration (Fig. 3 shows the compacted, pleated configuration; Fig. 4 shows the expanded configuration).
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 sleeve of Hickmott to comprise the concertina fold configuration of Matthison. Doing so would be advantageous in allowing for sleeve materials without particular demands for flexibility (¶ 22 of Matthison).
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 ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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