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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in GB on 03/21/2022. It is noted, however, that applicant has not filed a certified copy of the GB application as required by 37 CFR 1.55.
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 limitation(s) is/are: gripping element in claim 1-19.
Per applicant’s specification page 35, lines 25-31 and page 36, lines 1-16, various embodiments of the gripping element are detailed. The examiner notes that the gripping element “control the position of the sleeve on the catheter and also control the position of the catheter of the pouch”. Applicant further provides examples of the element, including an O-ring with aperture, temporary/frangible attachment such as a spot weld, or a narrow channel in the pouch. Therefore, the gripping element is interpreted as an element that controls the position of the catheter in the pouch, such as an O-ring, spot weld, or narrow channel.
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 18,19 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Palmer US 2019/0255280,hereafter Palmer.
Regarding claim 18, Palmer discloses A method of unpackaging a packaged catheter assembly, the packaged catheter assembly (figure 2)comprising a catheter having a proximal end for insertion into the body (para. 0029, where introducer tip is placed within the urethra and a distal end opposite end of catheter); a pouch (bag 22) comprising a gripping element configured to engage the catheter (figure 1B, narrow channel in the pouch between 40 and 41, where the catheter is seen extending through)); and a fluid reservoir configured to release wetting fluid into the pouch so as to wet the catheter (para. 0028, where a small sachet of water may be provided within the bag to wet the catheter); wherein the catheter and fluid reservoir are arranged within the pouch(sachet in the pouch per para. 0028, catheter seen in the pouch in figure 2); the method comprising the steps of releasing wetting fluid into the pouch so as to wet the catheter (para. 0028); allowing wetting fluid to collect in a wetting region (interpreted as the region of the pouch in which the sachet is located in) of the pouch; and withdrawing the catheter from the pouch (see figure 3a-3b); wherein the gripping element is configured to direct the catheter through the wetting region during withdrawal of the catheter from the pouch. The examiner notes that as seen in figure 3a and 3b, the device is held vertically. Palmer teaches that the bag may comprise a sachet containing water with the bag that is ruptured. The examiner notes that due to the holding of the bag as seen in figure 3a/3b, the water would pool at the bottom of the bag due to gravity. Further, as the catheter is pulled through from the bottom of the bag, withdrawing the catheter would pull the catheter through the wetting region and thus it is interpreted that the method of the claim is read to by the prior art.
Regarding claim 19, Palmer discloses the catheter assembly of claim 18 comprising passing the catheter through the wetting region before it reaches the gripping element. The examiner notes that as the wetting region is at the defined bottom of the and the catheter passes through this region before passing through the defined gripping element, Palmer reads to the claimed limitation.
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) 1-4,6-15,17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palmer in view of Jenco et al. US 2022/0176069, hereafter Jenco.
Regarding claim 1, Palmer discloses a packaged catheter assembly (figure 2) comprising; a catheter having a proximal end for insertion into the body (para. 0029, where introducer tip is placed within the urethra) and a distal end (opposite end of catheter); a pouch (bag 22) comprising a gripping element configured to engage the catheter (figure 1B, narrow channel in the pouch between 40 and 41, where the catheter is seen extending through)); and a fluid reservoir configured to release wetting fluid into the pouch so as to wet the catheter (para. 0028, where a small sachet of water may be provided within the bag to wet the catheter);wherein: the catheter and fluid reservoir are arranged within the pouch (sachet in the pouch per para. 0028, catheter seen in the pouch in figure 2); the pouch is configured to provide an opening through which the catheter may be withdrawn (outlet hub 26);the pouch comprises a wetting region in which wetting fluid preferentially collects (interpreted as the area of the pouch containing the water sachet).
However, Palmer fails to specifically disclose that the wetting region is distal the opening.
Jenco teaches a catheter assembly and is thus considered analogous to the claimed invention. Jenco teaches that the assembly comprises a catheter (20), wetting sachet (10) and an opening means for the package (40, see figure 4)). The examiner notes that as seen in figure 4, the sachet is ruptured and the resulting wetting region is located distal (at the bottom end of the package) from the opening. Said water pools within the bag (abstract, 0012). Therefore, as Jenco teaches that a wetting sachet and resulting wetting region may be located at a distal end of a catheter packaging, and still suitably wet the catheter, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to place the sachet and resulting wetting region of Palmer distal to the opening.
The examiner notes that the gripping element (As defined above) is configured to direct the catheter through the bag, as seen in figures 1B,3A-3B. As the wetting region is located within the bag, withdrawal of the catheter through the bag would direct the catheter through wetting region during withdrawal of the catheter from the pouch. Should applicant disagree with this interpretation, MPEP Section 2114 II states "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, as Palmer and Jenco teach a catheter bag comprising a gripping element, catheter, opening, and wetting sachet (located distal to the opening), where the catheter is removed from the bag through the gripping element, and it is interpreted that the directing of the catheter through the wetting region is functional language, the prior art reads to the claimed limitation.
Regarding claim 2, Palmer and Jenco teach the catheter assembly of claim 1 wherein the catheter is a male urinary catheter (suitable for men per para. 0029).
Regarding claim 3, Palmer and Jenco teach the catheter assembly of claim 1 wherein the catheter is longer than the pouch (para. 0021, where the bag “generally shorter than the catheter”).
Regarding claim 4, Palmer and Jenco teach the catheter assembly of claim 1 wherein the catheter is curved between the gripping element and the wetting region (see figure 1B,2, where the catheter curves between the gripping element (channel between 40 and 41) and the distal end of the bag (opposite end of opening 26), previously defined as the wetting region).
Regarding claim 5, Palmer discloses the catheter assembly of claim 1, wherein the catheter is arranged within the pouch in a coiled configuration (para. 0021). The examiner notes that per paragraph 0021, the catheter may be curled or coiled within the bag.
Regarding claim 6, Palmer and Jenco teach the catheter assembly of claim 1 wherein the catheter is drawn through the gripping element during withdrawal of the catheter from the pouch (figure 1b, 3A,3B).
Regarding claim 7, Palmer and Jenco teach the catheter assembly of claim 1 wherein the gripping element restricts the direction of an axis of the catheter (as seen in figure 1b,3b). The examiner notes that as seen in figure 1b,3B, the gripping element provides a straight channel and straightens the catheter (Seen in figure 3b specifically), thus is interpreted to restrict the direction of the axis of the catheter.
Regarding claim 8, Palmer and Jenco teach the catheter assembly of claim 7 wherein the axis of the catheter is restricted to within 20 degrees of an axis of the gripping element. The examiner notes that as seen in the figures (figure 1b,3b), the catheter is straightened (or at least aligned with the channel through the gripping element, and thus it is interpreted that the element straightens the catheter, thus restricts the axis of the catheter to within 20 degrees of an axis of the gripping element.
Regarding claim 9, Palmer and Jenco teach the catheter assembly of claim 1 wherein an axis of the gripping element is directed towards the wetting region. The examiner notes that as seen in figure 1b, the defined gripping element extends longitudinally (along a length of the bag) and thus is interpreted to be “directed towards” the wetting region (located as a bottom of the bag)
Regarding claim 10, Palmer and Jenco teach the catheter assembly of claim 1 wherein the gripping element is located outside the wetting region. The examiner notes that as the gripping element is located not at the bottom of the bag (where the wetting region is) it is interpreted as being located outside the wetting region.
Regarding claim 11, Palmer and Jenco teach the catheter assembly of claim 10 wherein the catheter is configured such that during withdrawal of the catheter from the pouch it passes through the wetting region before it reaches the gripping element. The examiner notes that as the catheter rests at the bottom of the bag (See figure 1b) and is withdrawn out the opposite end of the bag (figure 3b), it is interpreted that the withdrawal of the catheter passes it through the defined wetting area at the bottom of the bag.
Regarding claim 12, Palmer and Jenco teach the catheter assembly of claim 1 wherein the catheter is configured to be withdrawn from the pouch in a direction parallel to the axis of the gripping element (see figure 3b).
Regarding claim 13, Palmer and Jenco teach the catheter assembly of claim 1 wherein the wetting region is configured to collect a pool of wetting fluid. The examiner notes that the combination of Palmer and Jenco teach, per the claim 1 rejection a sachet containing water that is burst, or otherwise opened, to allow water into the bag of the device and pool within the bag.
Regarding claim 14, Palmer and Jenco teach the catheter assembly of claim 1 wherein the catheter is resiliently biased into a straight configuration (figure 3a, 3b). The examiner notes that that as seen in figures 3a and 3b, the catheter is moved from a bent to a straight configuration and therefore is interpreted to be resilient and biased into a straight configuration.
Regarding claim 15, Palmer and Jenco teach the catheter assembly of claim 14 wherein the catheter has a threshold rigidity that ensures it passes through the wetting region. The examiner notes that the catheter has a degree of rigidity as the structure is able to retain its shape (See figure 1b), and as detailed above under the rejection of claims 14 and 1 passes through the wetting region. As such, it is interpreted that the device of the prior art reads to the claimed limitation.
Regarding claim 17, Palmer and Jenco teach the catheter assembly of claim 1 wherein the gripping element is positioned in an upper half of the pouch and the wetting region is adjacent a base of the pouch. The examiner notes that as the defined gripping element is located more than halfway from the bottom of the assembly (see figure 3a), Palmer reads to the claimed limitation. Further, it was found obvious to locate the wetting region, and thus the sachet at the bottom of the assembly, and thus said wetting region would be adjacent a base of the pouch,
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palmer and Jenco, and further in view of Vazales et al. US 2014/0150782.
Regarding claim 16, Palmer and Jenco teach the catheter assembly of claim 15 but fails to teach wherein the threshold rigidity of the catheter is such that the tangent of the catheter resists changing by more than 20 degrees over a length equivalent to the distance between the gripping element and wetting region.
Vazales teaches a catheter device and is thus considered analogous to the claimed invention. Per para. 0237, Vazales teaches “suction catheter 1505 can comprise one or more rigid or semi-rigid, stiff, substantially stiff, flexible and/or substantially flexible materials. These materials include, but are not limited to, PEEK, TPE, polyethylene, polypropylene, PET, PETG, silicone, latex, KRATON polymers and/or any other natural or synthetic materials. The varying degrees of rigidity, stiffness and flexibility of the suction catheter 1505 can be provided by materials selected to aid in steerability and angulation of the distal end. The main body of the suction catheter 1505 can comprise one or more stiff or substantially stiff materials. In some embodiments, the distal end 1502 of the suction catheter 1505 can comprise one or more pre-curved and/or flexible materials. For example, the distal end 1502 of the suction catheter 1505 can comprise one or more flexible materials that aid in the steerability of the catheter 1505.”
The examiner notes that therefore the rigidity of a catheter is disclosed to be a result effective variable in that changing the materials changes the degree of rigidity. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Palmer, as it involves only adjusting materials disclosed to require adjustment, in that changing the materials is desired for different outcomes in flexibility and steering. Further, the instant applicant lacks criticality in the threshold rigidity in that it may resist changing “more than 10…or 80 degrees” (page 14 lines 3-8). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Palmer by using a material for the catheter that is sufficiently rigid, resisting change by more than 20 degrees 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20060293642 A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca 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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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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