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 .
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 1 (and 2-10 by virtue of their dependency upon claim 1) recites the limitation "the upper side" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-4 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fifield (US 4,029,099).
With reference to claim 1, Fifield discloses an anti-blockage urine bag (figure 1), comprising:
a urine bag body (11), with a passing hole formed on the upper side thereof and communicated to the interior of the urine bag body (see annotated figure 1 below);
a urethral catheter (10), coupled and communicated to the urine bag body (figure 1), and having a first connection part and a second connection part configured to be opposite to each other (figure 1), the first connection part being provided for connecting to a user's urinary tract (see annotated figure 1 below), and the second connection part being passed into the passing hole of the urine bag body and disposed inside the urine bag body (see annotated figure 1); and
an anti-folding tube (13), communicated between the urine bag body and the urethral catheter (figure 1), and having a plug-in part and a hollow support part (see annotated figure 1 below), a flow hole being formed and penetrating between the plug-in part and the hollow support part (see annotated figure 1 below), wherein the second connection part of the urethral catheter is sheathed (col. 3, lines 2-9) on the plug-in part (17), the flow hole is communicated to the urethral catheter (col. 2, lines 30-37); the hollow support part is contained in the urine bag body as set forth in annotated figure 1 below.
The difference between Fifield and claim 1 is the explicit recitation that the plug-in part keeps the urethral catheter straight, that the hollow support part has an external diameter greater than the external diameter of the plug-in part, and the hollow support part is capable of holding up the interior of the urine bag body.
While Fifield does not explicitly state that the plug-in part keeps the urethral catheter straight, Fifield discloses that the plug-in part is made of rubber or plastic and serves to overcome slippage as set forth in col. 3, lines 25-27.
It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize the plug-in part to keep the catheter straight because Fifield discloses that the entire device is integral (col. 2, lines 35-37), that the plug-in portion is formed of a rigid and inflexible material and that the device should remain firm enough so that it may be pushed entirely through the urethra as taught by Fifield in col. 2, lines 16-18.
Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to provide the device wherein the external diameter of the hollow support part is greater than the external diameter of the plug-in part since it has been held that mere changes in size and/or shape of elements previously disclosed by the prior art is considered to be within the level of ordinary skill in the art.
Finally, the hollow support part is considered to be fully capable of holding up the interior of the urine body bag because it is placed within the urine body bag and therefore would not allow the urine body bag to fully collapse when empty. The hollow support part also serves to support fluid flow as the urine enters which also holds up the interior of the bag as taught by Fifield in col. 2, lines 30-34.
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With reference to claim 2, Fifield discloses an anti-blockage urine bag wherein the hollow support part is in a substantially ellipsoidal shape as set forth in figure 1.
The difference between Fifield and claim 2 is the explicit recitation that the circumferential surface of the hollow support part is provided with a plurality of skeletonized holes, and each skeletonized hole is communicated to the flow hole.
Fifield appears to provide the surface of the hollow support with a plurality of skeletonized holes as shown in annotated figure 1 above.
Alternatively, it would have been obvious to one of ordinary skill in the art at the time of the invention to provide the circumferential surface of the hollow support part with skeletonized holes which communicate to the flow hole because Fifield anticipates an integral device that allows urine to flow throughout the device from the catheter tip to the containment bag as set forth in col. 2, lines 30-37.
As to claim 3, Fifield discloses an anti-blockage urine bag wherein the passing hole of the urine bag body is sealed up by a processing method, and the processing method is capable of fixing the urethral catheter to the urine bag body as set forth in col. 2, lines 27-30.
Regarding claim 4, Fifield teaches the invention substantially as claimed as set forth in the rejection of claims 1 and 3.
The difference between Fifield and claim 4 is the provision that a specific processing method is used.
It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize a welding processing method as desired since the prior art discloses the use of a processing method as set forth in col. 2, lines 27-30 and the substitution of one type of processing method for another is considered to be within the level of ordinary skill in the art.
Regarding claim 8, Fifield discloses an anti-blockage urine bag wherein the anti-folding tube is made of a plastic material and integrally formed as set forth in col. 2, lines 35-37 and in col. 3, lines 25-27.
With respect to claim 9, Fifield teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Fifield and claim 9 is the provision that the plug-in part has portions with different shapes and/or sizes.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the shape and/or size of the plug-in part as desired since it has been held that mere changes in size and/or shape of elements previously disclosed by the prior art is considered to be within the level of ordinary skill in the art.
As to claim 10, Fifield teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Fifield and claim 10 is the provision that each skeletonized hole has a specific shape.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the shape of each skeletonized hole as desired since it has been held that mere changes in size and/or shape of elements previously disclosed by the prior art is considered to be within the level of ordinary skill in the art.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Fifield (US 4,029,099) and further in view of Lowthian (US 4,634,437).
With reference to claim 5, Fifield teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Fifield and claim 5 is the provision that the urine bag body has two fixing holes penetrating through the upper side thereof, the passing hole is formed between the two fixing holes, and the two fixing holes are provided with two positioning strips respectively.
Lowthian teaches an analogous anti-kink flexible urine collector wherein the urine bag has two fixing holes (4) penetrating through the upper side thereof (figure 1) with a passing hole (7) formed between the two fixing holes and wherein the two fixing holes may be provided with two positioning strips as set forth in col. 2, lines 41-44.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the article of Fifield with the fixing holes as taught by Lowthian in order to secure the device to a stationary object as taught by Lowthian in col. 2, lines 41-44.
With reference to claim 6, Fifield teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Fifield and claim 6 is the provision that the anti-blockage urine bag further comprises a urine drainage tube coupled to the middle of the lower side of the urine bag body, and the urine drainage tube is installed with a valve device.
Fifield anticipates the use of a urine drainage bag as set forth in col. 2, lines 24-27.
Lowthian teaches an analogous anti-kink flexible urine collector wherein the urine bag further comprises a urine drainage tube coupled to the middle of the lower side of the urine bag body, and the urine drainage tube is installed with a valve device as set forth in col. 2, lines 49-51.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the bag of Fifield with a urine drainage tube coupled to the middle of the lower side of the urine bag body as taught by Lowthian in order to operate the controlled emptying of the bag with one hand as taught by Lowthian in col. 2, lines 49-51.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Fifield (US 4,029,099) and further in view of Walker (US 3,800,795).
With reference to claim 7, Fifield teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Fifield and claim 7 is the provision that the anti-blockage urine bag body further comprises a plastic sheet disposed between the second connection part of the urethral catheter and the urine bag body.
Walker teaches an analogous urinary drainage system wherein the urine bag further comprises a plastic sheet (17) disposed between the second connection part of the urethral catheter and the urine bag body as set forth in col. 2, lines 39-46 and as shown in figures 1-2.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the bag of Fifield with plastic sheet as taught by Walker in order to provide the device with an arrangement that allows for unidirectional urine collection as taught by Walker in col. 2, lines 39-46.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bear et al. (US 2012/0248111) teaches a container with a kink-resistant connector.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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/MICHELE KIDWELL/Primary Examiner, Art Unit 3781