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 .
Status of the Claims
The amendment filed 12/03/2024 has been entered. Claims 1-18 are pending and under consideration.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in GB on 03/21/21022. It is noted, however, that applicant has not filed a certified copy of the GB2203882.2 application as required by 37 CFR 1.55.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "1511c" and "1551c" have both been used to designate side panels. 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 Objections
Claims 11-13 are objected to because of the following informalities:
Claims 11-13 recite “panel/side” which should read “panel and/or side”
Appropriate correction is required.
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.
Claims 4-10 and 18 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 4-10 and 18 recites “wherein the fluid collection bag comprises a front panel, a rear panel” which renders the claim indefinite. For instance it is not clear whether the “front panel” and “rear panel” correspond to the previously recited “two panels” or constitute additional panels of the fluid collection bag. For the purpose of examination, the front and rear panels are treated as the two panels of claim 1.
Claim 18 recites “the fluid collection bag” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation is being interpreted as “a fluid collection bag”
Claims 5-10 are rejected for at least being dependent of claim 4.
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.
Claims 1, 3-13, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hinman (US 4126135 A) in view of view of Kluenenberg et al (US 20200130896 A1).
Regarding claim 1, Hinman substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
a catheter assembly (figures 7-12, 10) comprising;
a fluid collection bag (figure 9, 44) and a catheter (figure 9, 52); the fluid collection bag comprising two panels (annotated figure, front and opposite rear panels) a peripheral bond between the two panels, and an inlet (figure 7 col 4 lines 1-11, inlet system) to receive fluid from the catheter,
wherein the two panels are configured to form a base of the fluid collection bag (figures 7-12 and abstract, front and rear panels are connected to a rectangular support base and configured to form a self-supporting base) distal from the inlet; and the fluid collection bag is configured to stand up on the base (figures 7-12 and abstract, the two panels are configured to provide a self-supporting base when spread).
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Hinman does not expressly teach, a peripheral bond between the two panels.
Kluenenberg teaches an upwardly open side-gusset bag (figures 1-4), which is relatively pertinent to the problem posed by Applicant, namely, providing a construction for a self-standing bag, composing front and rear panels (figure 1, two face panels 1) and a peripheral bond between the two panel (figure 1 [0043] weld 4, 14 and 21 bond panels together)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hinman to incorporate the teachings of Kluenenberg and provide the peripheral bond between the two panels for the purpose of simplifying the manufacturing process while improving its stability, shape retention, and sealing performance, as taught by Kulenenberg ([0007-0017 and 0024-0028]).
Regarding claim 3, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 1.
The combination further teaches wherein the fluid collection bag further comprises a base panel (Hinman; annotated figure and col 4 lines 1-30, rectangular support base) configured to form the base of the fluid collection bag.
Regarding claim 4, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 3.
The combination further teaches wherein the fluid collection bag comprises a front panel, a rear panel and the base panel, and the front and rear panels are joined to opposite sides of the base panel (Hinman; annotated figure, front, rear and base panel, the front and rear panels are joined to opposite sides of the base panel)
Regarding claim 5, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 4.
The combination further teaches wherein the front panel and rear panel are joined by the peripheral bond along an upper edge (Kluenenberg, figure 2b, two face panels 1 are bonded along transverse weld 14 and left and right longitudinal welds 21), a left lateral edge and a right lateral edge of the fluid collection bag.
Regarding claim 6, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 4.
The combination further teaches wherein the fluid collection bag further comprises two side panels (Hinman; annotated figure, side panels), the front and rear panels are joined to opposite sides of each side panel, and the base panel is joined to one side of each side panel (Hinman, the front and real panels are joined to opposite sides of each side panel, and the base panel is joined to bottom side of each side panels).
Regarding claim 7, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 6.
The combination further teaches wherein the base panel is rectangular and each side panel is triangular (Hinman; annotated figure and col 1 lines 50-60, triangle side panels and rectangular support base).
Regarding claim 8, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 6.
The combination further teaches wherein the front panel and rear panel are joined by the peripheral bond along an upper edge of the fluid collection bag (Kluenenberg; Kluenenberg, figure 2b, two face panels are bonded along transverse weld 14).
Regarding claim 9, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 6.
The combination further teaches wherein the two side panels are configured to allow the front and rear panels to separate along a left lateral edge and right lateral edge of the fluid collection bag (Hinman; figure 9 and 12, the side panels allow the front and rear panels to spread along the left and right lateral edges of the fluid collection bag)
Regarding claim 10, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 6.
The combination further teaches wherein the fluid collection bag is wedge-shaped (Hinman; figure 12)
Regarding claim 11, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 3.
The combination further teaches wherein the base panel and/or the side panels comprise a stowed configuration in which the base panel/side panels are configured to reduce the internal volume of the fluid collection bag (Hinman; figure 10 and col 3 lines 55-67, contracted configuration reducing inner volume)
Regarding claim 12, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 11.
The combination further teaches wherein the base panel/side panels are folded in the stowed configuration (Hinman; figure 10 and col 3 lines 55-67, contracted configuration).
Regarding claim 13, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 12.
The combination further teaches wherein the base panel/side panels are configured to unfold as liquid enters the fluid collection bag (Hinman; figure 12 and col 4 lines 25-31, spread configuration).
Regarding claim 16, Hinman teaches a method of manufacturing a catheter assembly comprising the steps of providing a catheter (figures 7-12, tubing 52) having a proximal end (figures 7-12, opposite end of 54) for insertion into the body and a distal end (figure 7, 54) and forming a fluid collection bag (figure 9, 44), the fluid collection bag being formed by providing two panels (annotate figure, front and rear panels),
creating a peripheral bond between the two panels, and
providing an inlet (figure 7 col 4 lines 1-11, inlet system) in the fluid collection bag to receive fluid from the catheter,
wherein: the two panels are configured to form a base of the fluid collection bag distal from the inlet (figures 7-12 and abstract, the front and rear panels are connected to a rectangular support base and configured to form a self-supporting base); and the fluid collection bag is configured to stand up on the base (abstract).
Hinman does not expressly teach the method comprises creating a peripheral bond between the two panels.
Kluenenberg teaches an upwardly open side-gusset bag (figures 1-4), which is relatively pertinent to the problem posed by Applicant, namely a self-standing bag, comprising front and rear panels (figure 1, two face panels 1) and a peripheral bond between the two panel (figure 1 [0043] weld 4, 14 and 21 bond panels together)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hinman to incorporate the teachings of Kluenenberg and provide the peripheral bond between the two panels for the purpose of simplifying manufacturing process while improving its stability, shape retention, and sealing performance, as taught by Kulenenberg ([0007-0017 and 0024-0028]).
Regarding claim 18, Hinman teaches a method of preparing a catheter assembly (figures 7-12, 10) for use, the catheter assembly comprising a catheter (figure 7, 52) and a fluid collection bag (figure 9, 44), the fluid collection bag comprising two panels (annotated figure, front and rear panels), a peripheral bond between the two panels, and an inlet (figure 7 col 4 lines 1-11, inlet system) receive fluid from the catheter, the method comprising
using the two panels to form a base of the fluid collection bag distal from the inlet; and standing the fluid collection bag up on the base (figures 7-12 and abstract, the front and rear panels are connected to a rectangular support base and configured to form a self-supporting base).
Hinman does not expressly teach the fluid collection bag comprising a peripheral bond between the two panels.
Kluenenberg teaches an upwardly open side-gusset bag (figures 1-4), which is relatively pertinent to the problem posed by Applicant, namely, providing a construction for a self-standing bag, composing front and rear panels (figure 1, two face panels 1) and a peripheral bond between the two panel (figure 1 [0043] weld 4, 14 and 21 bond panels together)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hinman to incorporate the teachings of Kluenenberg and provide the peripheral bond between the two panels for the purpose of simplifying the manufacturing process while improving its stability, shape retention, and sealing performance, as taught by Kulenenberg ([0007-0017 and 0024-0028]).
Claims 2, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hinman (US 4126135 A) in view of view of Kluenenberg et al (US 20200130896 A1), and in further view of Hursman et al (US 6004305 A)
Regarding claim 2, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 1.
The combination does not expressly teach wherein the catheter is a male urinary catheter.
In the same field of endeavor, namely a drainage catheter assembly, Hursman teaches a catheter assembly (figure 1, 10) comprising a catheter (figure 1, 12), wherein the catheter is a male urinary catheter (col 4 lines 1-10).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hinman, as modified by Kluenenberg, to incorporate the teachings of Hursman and provide the catheter as claimed, and one of skill in the art motivated to do so, for the purpose of allowing drainage of urine from male patient as taught by Hursman (col 4 lines 1-10).
Regarding claim 14, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 1.
The combination does not teach wherein the catheter comprises a funnel configured to engage the inlet of the fluid collection bag.
In the same field of endeavor, namely a drainage catheter assembly, Hursman teaches wherein the catheter comprises a funnel (figure 1 and col 4 line 10-32, proximal engage member 16 prevent the tubular catheter 12 from being fully extracted and removed from the bag 14) configured to engage the inlet of the fluid collection bag.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hinman, as modified by Kluenenberg, to incorporate the teachings of Hursman and provide the catheter as claimed for the purpose of preventing the catheter removed from the bag as taught by Hursman (col 4 lines 10-32).
Regarding claim 17, Hinman, as modified by Kluenenberg teaches the method of claim 16.
The combination does not teach further comprising providing a funnel at the distal end of the catheter and positioning the funnel inside the fluid collection bag.
In the same field of endeavor, namely a drainage catheter assembly, Hursman teaches comprising providing a funnel at the distal end of the catheter and positioning the funnel inside the fluid collection bag (figure 1 and col 4 line 10-32, proximal engage member 16 prevent the tubular catheter 12 from being fully extracted and removed from the bag 14)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hinman, as modified by Kluenenberg, to incorporate the teachings of Hursman and provide the catheter as claimed for the purpose of preventing the catheter removed from the bag as taught by Hursman (col 4 lines 10-32).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hinman (US 4126135 A) in view of view of Kluenenberg et al (US 20200130896 A1), and in further view of Christensen (US 20100100062 A1)
Regarding claim 15, Hinman, as modified by Kluenenberg, teaches the catheter assembly of claim 1.
The combination does not teach wherein the fluid collection bag comprises a fill level indicator configured to allow the user to visualise fluid within the bag and the fill level indicator is positioned adjacent to the inlet.
In the same field of endeavor, namely a bodily fluid drainage assembly, Christensen teaches the fluid collection bag (figure 1, fluid bag 110) comprises a fill level indicator (figure 1, fluid level indicator 136 and graduations 137) configured to allow the user to visualise fluid within the bag and the fill level indicator is positioned adjacent to the inlet.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hinman, as modified by Kluenenberg, to incorporate the teachings of Christensen and provides the fluid collection bag as claimed for the purpose of determining the volume of the fluid as taught by Christensen (abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hanson (US 20040120613 A1) and Subramanian (US 20170290740 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SETH HAN/Examiner, Art Unit 3781
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