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 .
The examiner notes that per MPEP Section 714(II)(C)) “ A) Status Identifiers: The current status of all of the claims in the application, including any previously canceled or withdrawn claims, must be given. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers: (original), (currently amended), (previously presented), (canceled), (withdrawn), (new), or (not entered). The status identifier (withdrawn – currently amended) is also acceptable for a withdrawn claim that is being currently amended.” The examiner notes that the most recently updated claim set filed 03/01/2024 contains amendments but fails to include status identifiers. The examiner notes that, in an effort to achieve compact prosecution, the claims are still examined hereafter, as the examiner was able to determine the status identifiers for all the claims. Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "102" and "106" have both been used to designate the drainage opening. The examiner notes that repeatedly in the specification and as seen in figure 1, the drainage opening is referred to a reference number 106. However in figure 2, the drainage eyelet in step 202 is reference number 102. The examiner understands that per the specification the drainage inlet/eyelet may be described interchangeably, but reference number 102 refers to a different component entirely, that being the catheter shaft (see page 5 of the spec and figure 1). 102 is also referred to as the shaft in step 208 of figure 2. Appropriate correction is required.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6,10 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 requires a thread for coupling to the stylet. However, claim 6 is dependent from claim 1, which does not require a stylet. Rather, a stylet is not introduced into the claims until claim 5. Therefore the stylet of claim 6 lacks antecedent basis. As such it is interpreted that claim 6 depends from claim 5, as this is when the stylet is first required by the claims.
Claim 10 requires the stylet. However, claim 10 is dependent from claim 7, which does not require a stylet. Rather, a stylet is not introduced into the claims until claim 9. Therefore the stylet of claim 10 lacks antecedent basis. As such it is interpreted that claim 10 depends from claim 9, as this is when the stylet is first required by the claims.
Claim Interpretation
The examiner notes that the term check eyelet is interpreted to be an eyelet/opening on a catheter that is more proximally (further from the tip) located than another hole. Said check eyelet is associated with a structure (a balloon) to ensure that the structure is implemented in the intended location (i.e. as the check inlet is more proximal than the balloon, when the check eyelet is properly draining, the user knows the balloon is in place). For the purpose of examination, an eyelet that meets the above interpretation reads to the claimed 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.
(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) 1-4,7-8 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by El Maoued et al. US 5769818, hereafter El Maoued .
Regarding Claim 1, El Maoued discloses a device (Fig. 1) comprising: a catheter shaft (12) comprising: one or more check eyelets (Fig. 4,5, drainage portal (36)) adapted to drip urine accumulated in a bladder of a user (see figure 1, column 2 lines 29-33), wherein the one or more check eyelets (104) drips the urine when the one or more check eyelets reaches inside the bladder upon insertion of the catheter shaft in the bladder of the user (see column 4, lines 31-57, specifically 51-57).
Regarding Claim 2, El Maoued discloses the device as claimed in claim 1, wherein the catheter shaft further comprising an outlet adapted to drain the urine from the bladder of the user when the urine drips from the one or more check eyelets (figure 1, proximate end (14), seen extending outside the user, and per column 3 lines 24-27 may be configured to connect to a urine collector).
Regarding Claim 3, El Maoued discloses the device as claimed in claim 1, further comprising:
a drainage eyelet (figure 4, second drainage portal (38); and a balloon (Figure 1-4, balloon (32)) disposed between the one or more check eyelets (36) and the drainage eyelet (38) (see figure 2 where opening (36) is seen on the opposite side of the balloon from opening (38). El Maoued further discloses wherein the insertion of the balloon inside the bladder is confirmed when the urine drips from the one or more check eyelets. The examiner notes that as seen in figure 2, for the opening (36) to allow fluid to pass through, the balloon must be in the bladder. This is also seen in column 4 lines 44-46, where the balloon inflates around the opening but does not block the opening. Therefore it is interpreted that the opening would only be in the bladder is the balloon is in the bladder, since the balloon surrounds the opening.
Regarding Claim 4, El Maoued discloses the device as claimed in claim 3, further comprising a bulb inflation port (Fig. 1, distension tube (28) connected to inflation channel (26) seen in figure 4)) such that upon insertion of the balloon inside the bladder, the bulb inflation port is adapted to inflate the balloon to hold the device inside the bladder of the user (column 3, lines 34-44).
Regarding Claim 7, El Maoued discloses a method for draining urine from a bladder of a user (column 2, lines 20-33), the method comprising: inserting (column 2, lines 20-22), a device (figure 1-4) that is provided with a catheter shaft (12) having one or more check eyelets (Fig. 4,5, drainage portal (36), inside the bladder of the user (see figure 1, column 2 lines 29-33); confirming (204) that the one or more check eyelets (104) reaches inside the bladder by observing a flow of the urine that is accumulated inside the bladder (see column 4, lines 31-57, specifically 51-57) through an outlet of
the catheter shaft (figure 1, proximate end (14), seen extending outside the user, and per column 3 lines 24-27 may be configured to connect to a urine collector) that further confirms insertion of a balloon (Figure 1-4, balloon (32)) of the device inside the bladder (fig. 1); and inflating (column 2, lines 23-25), the balloon by way of a bulb inflation port (Fig. 1, distension tube (28) connected to inflation channel (26) seen in figure 4)) of the device (column 2, lines 23-25, see also column 3, lines 34-44). The examiner notes that as seen in figure 2, for the opening (36) to allow fluid to pass through, the balloon must be in the bladder. This is also seen in column 4 lines 44-46, where the balloon inflates around the opening but does not block the opening. Therefore it is interpreted that the opening would only be in the bladder is the balloon is in the bladder, since the balloon surrounds the opening. El Maoued further teaches that that upon inflation, the balloon holds the device inside the bladder of the user (column 3, lines 50-53). Should applicant disagree with this interpretation of El Maoued, the examiner points to MPEP section 2112.02 I, where “if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.” The examiner notes that as El Maoued discloses a urinary catheter comprising a balloon and (interpreted) check outlet for drainage, where said catheter is inserted and drains fluid, it is interpreted that El Maoued performs the claimed method, as El Maoued, in its normal and usual operation, would necessarily perform the method claimed.
Regarding Claim 8, El Maoued discloses the method (200) as claimed in claim 7, further comprising draining, the urine when the urine drips from the one or more check eyelets (104), by way of the outlet of the device (Column 2, lines 30-34). The examiner notes that as detailed under the rejection of claim 7, the examiner points to MPEP section 2112.02 I, where “if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.” The examiner notes that as El Maoued discloses a urinary catheter comprising a balloon and (interpreted) check outlet for drainage, where said catheter is inserted and drains fluid, it is interpreted that El Maoued performs the claimed method, as El Maoued, in its normal and usual operation, would necessarily perform the method claimed.
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) 5,9 is/are rejected under 35 U.S.C. 103 as being unpatentable over El Maoued in view of Olson et al. US 2013/0204208, hereafter Olson.
Regarding Claim 5, El Maoued discloses the device as claimed in claim 3, but fails to discloses the device further comprising a stylet that is adapted to block the drainage eyelet to prevent inadvertent inflation of the balloon inside the bladder prior to insertion of the balloon inside the bladder.
Olson teaches a catheter device and is thus considered analogous to the claimed invention. Olson teaches that the catheter device comprises openings (see figures 6a-b, openings (620)), where said device further comprises a stylet (610) configured to block at least some of the openings in an effort to enable fluid flashback (para. 0037). The configuration seen in figures 6a-b allow the most distal holes to be blocked while still allowing fluid to flow through later holes, as indicated by arrows (640). The examiner further notes that per para. 0036 fluid flashback is fluid flow which indicates that the proper area for the catheter has been reached. Afterwards, (para. 0036) the stylet is removed. Therefore, as a means to ensure that the device of El Maoued is positioned properly, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a styler that only blocks the most distal hole of the catheter. Doing so would merely involve the use of known technique (stylets to enable fluid flashback) to improve similar devices (catheters) in the same way (covering the distal most holes to ensure proper location), and as such a prima facie case of obviousness exists.
Regarding Claim 9, El Maoued discloses the method as claimed in claim 7, but fails to teach a stylet and thus fails to teach the limitation of prior to inserting the balloon inside the bladder, the method further comprising blocking, a drainage eyelet of the device by way of a stylet of the device such that blocking of the drainage eyelet prevents inadvertent inflation of the balloon . El Maoued does disclose a drainage eyelet (figure 4, second drainage portal (38)).
Olson teaches a catheter device and is thus considered analogous to the claimed invention. Olson teaches that the catheter device comprises openings (see figures 6a-b, openings (620)), where said device further comprises a stylet (610) configured to block at least some of the openings in an effort to enable fluid flashback (para. 0037). The configuration seen in figures 6a-b allow the most distal holes to be blocked while still allowing fluid to flow through later holes, as indicated by arrows (640). The examiner further notes that per para. 0036 fluid flashback is fluid flow which indicates that the proper area for the catheter has been reached. Afterwards, (para. 0036) the stylet is removed. Therefore, as a means to ensure that the device of El Maoued is positioned properly, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a styler that only blocks the most distal hole of the catheter. Doing so would merely involve the use of known technique (stylets to enable fluid flashback) to improve similar devices (catheters) in the same way (covering the distal most holes to ensure proper location), and as such a prima facie case of obviousness exists. The examiner notes that as the stylet is configured to block fluid flowing into the distal most openings upon insertion, it is interpreted that the stylet is entered into the catheter prior to insertion and thus reads to the claimed limitation.
Should applicant disagree that the device of the prior art combination prevent inadvertent inflation of the balloon, per MPEP section 2112.02 I, where “When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.” Therefore as the combination of El Maoued and Olson teach a catheter device with distal and (defined) check eyelet, and a balloon between, where a stylet is introduced to block the distal most (drainage) eyelet, the prior art device is understood to be the same as the device in the specification for carrying out the claimed method. As such the prior art device is interpreted to inherently perform the claimed process.
Claim(s) 6,10 is/are rejected under 35 U.S.C. 103 as being unpatentable over El Maoued in view of Olson and further in view of Hakim et al. US 2017/0136222, hereafter Hakim.
Regarding Claim 6, El Maoued and Olson teach the device as claimed in claim 5, as interpreted under the 112b rejection. Olson further teaches that stylet comprises a shaft (210) which may be made from metal, metal alloy, hard polymer, or other biocompatible material (para. 0028). However no disclosure of a thread is taught. The examiner does note that as detailed under the rejection of claim 5, the stylet is configured to block the distal most hole and is removed when the device is in a proper position to allow drainage through all holes (para. 0036 of Olson).
Hakim teaches a catheter device and is thus considered analogous to the claimed invention. Hakim teaches a catheter system (figure 4a-c, system 131)) comprising a catheter (130) and a stylet (160) seen to be within the catheter body. Hakim teaches that as a means to maneuver the stylet within the catheter and/or to control/limit the extent at which the stylet may be pulled out, a string (139) is attached to the stylet (para. 0077). Therefore as a means to control within and control the pull out of the stylet within the catheter of El Maoued and Olson, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a string that extends externally and through the catheter (As seen in figure 4b of Hakim) to achieve this function. Doing so would merely involve combining prior art elements (catheter stylets with a string for catheter stylets) according to known methods to yield predictable results (that being control of the stylet), and as such a prima facie case of obviousness exists.
Regarding Claim 10, El Maoued discloses the method (200) as claimed in claim 9 (per 11b interpretation), wherein, upon inserting the balloon inside the bladder, the method further comprising unblocking the drainage eyelet by pulling the stylet of the device (para. 0036 of Olson, previously cited in rejection of claim 9) . The examiner further notes that per para. 0036 fluid flashback is fluid flow which indicates that the proper area for the catheter has been reached. Afterwards, (para. 0036) the stylet is removed), wherein the unblocking of the drainage eyelet (106) facilitates dripping of the urine from at least one of the one or more check eyelets (104) and the drainage eyelet (106) to drain the urine from the bladder. As such, removal of the stylet would let fluid enter the device from both the check and drainage eyelet, and thus the prior art combination reads to this limitations.
However the prior art fails to teach that the stylet is removed by way of a thread (112). Olson further teaches that styler comprises a shaft (210) which may be made from metal, metal alloy, hard polymer, or other biocompatible material (para. 0028). However no disclosure of a thread is taught.
Hakim teaches a catheter device and is thus considered analogous to the claimed invention. Hakim teaches a catheter system (figure 4a-c, system 131)) comprising a catheter (130) and a stylet (160) seen to be within the catheter body. Hakim teaches that as a means to maneuver the stylet within the catheter and/or to control/limit the extent at which the stylet may be pulled out, a string (139) is attached to the stylet (para. 0077). Therefore as a means to control within and control the pull out of the stylet within the catheter of El Maoued and Olson, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a string that extends externally and through the catheter (As seen in figure 4b of Hakim) to achieve this function. Doing so would merely involve combining prior art elements (catheter stylets with a string for catheter stylets) according to known methods to yield predictable results (that being control of the stylet), and as such a prima facie case of obviousness exists. Therefore, as a result of the obviousness combination, removal of the stylet may be done using a thread.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Hakim.
Regarding Claim 11, Olson discloses a device (Fig. 6a-b) comprising a catheter shaft a catheter shaft (600) comprising: one or more check eyelets (side holes 620,622 [not blocked by stylet)) adapted to drip urine accumulated in a bladder of a user (flow arrows 640, see para. 0037, where paragraph 0049 discloses use of the catheter in various locations including for urinary drainage), wherein the check eyelet drips the urine when the check eyelet reaches inside the bladder upon insertion of the catheter shaft in the bladder of the user (para. 0037).
Olson further discloses a drainage eyelet (opening blocked by stylet, best seen by reference number 615 in figure 6a and 655 in figure 6b)), a stylet (612) that is adapted to block the drainage eyelet (see figure 6a-b), and where , removal of the stylet is adapted to unblock the drainage eyelet wherein when the drainage eyelet is unblocked at least one of the one or more check eyelets and the drainage eyelet drips the urine to drain the urine from the bladder (para. 0036-0037, where the stylet is removed where paragraph 0049 discloses use of the catheter in various locations including for urinary drainage). The examiner further notes that per para. 0036 fluid flashback is fluid flow which indicates that the proper area for the catheter has been reached. Afterwards, (para. 0036) the stylet is removed.
Olson further teaches that styler comprises a shaft (210) which may be made from metal, metal alloy, hard polymer, or other biocompatible material (para. 0028). However no disclosure of a thread is taught. However, Olson fails to teach a thread is coupled to the stylet and passes through the catheter shaft such that the thread, upon being pulled, removes the stylet.
Hakim teaches a catheter device and is thus considered analogous to the claimed invention. Hakim teaches a catheter system (figure 4a-c, system 131)) comprising a catheter (130) and a stylet (160) seen to be within the catheter body. Hakim teaches that as a means to maneuver the stylet within the catheter and/or to control/limit the extent at which the stylet may be pulled out, a string (139) is attached to the stylet (para. 0077). Therefore as a means to control within and control the pull out of the stylet within the catheter Olson, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a string that extends externally and through the catheter (As seen in figure 4b of Hakim) to achieve this function. Doing so would merely involve combining prior art elements (catheter stylets with a string for catheter stylets) according to known methods to yield predictable results (that being control of the stylet), and as such a prima facie case of obviousness exists.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kashintsev US 20230037101, disclosing a balloon catheter with multiple sets of openings, Vazales US 20150343182, disclosing a balloon catheter with openings on either side of the balloon, Pinchuk WO 2015184357 discloses a catheter comprising a closure device connected with a string for preventing inflation/deflation of balloons, JP 2011512942, specifically figure 10, showing a balloon catheter with an opening on either side of the balloon, Patterson US 20090318870, disclosing a movable obturator in a catheter, Mroncz DE 102005038291, disclosing a string pulled closure device for the lumen of a balloon catheter, and Engel US 6167886, disclosing a ballon catheter with multiple openings.
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