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 1-5 are 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 1 recites the limitation "the bottom end" in line 20. 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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Kalinoski USPN 5193553 in view of Moyet-Ortiz USPN 5267989.
As to claim 1, Kalinoski teaches a urine collecting device, comprising:
a urine bag 4, including:
an opening 9;
a side surface having a notch 11, wherein the notch 11 extends from the opening 9; and
a bottom edge 31 opposite to the opening 9 (Figure 2),
a girdle 6 with a hook and loop fastener 7,7’ (Figure 2).
Kalinoski teaches a fastening system 13, 13’, 14, and 15 for attaching the urine bag to the girdle 6 (col. 4, lines 42-51). Kalinoski teaches hook and loop fastener strips (col. 2, lines 52-55) instead of a strong clamp. It would have been obvious to one of ordinary skill in the art before the invention was originally filed to provide Kalinoski with a clamp closure since it is old and well known in the art that fastening mechanisms like clamps and hook and loop closure are interchangeable. This modification does not take away any function or characteristic of the package, since the package is disposable and the hook and loop fasteners provide a secure attachment to the girdle as does the clamp closure.
Kalinoski teaches the present invention substantially as claimed, but does not teach a sanitary pad. Moyet-Ortiz teaches a urine collection device comprising a plastic envelope-like member attached to a urine storge bag. The device of Moyet-Ortiz further includes an absorbent pad on the rear sheet of the envelope to trap and retain dribble to draw it away from the user’s skin to prevent rashes or bacterial infections (Moyet-Ortiz, Figure 1, element 14; col. 1, lines 53-56). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to provide an absorbent pad in the invention of Kalinoski for the benefits taught in Moyet-Ortiz.
Kalinoski teaches the urine bag is placed on a body of a user (Figure 1). The limitations directed to aligning a bottom end of the notch with a lower edge of a scrotum of the user and the opening passing through the girdle with the hook and loop fastener from an inside formed by the girdle with the hook and loop fastener surrounding a waist of the user so that the urine bag is fixed on the waist of the user by the girdle with the hook and loop fastener, are directed to an intended use of the article. Regarding the limitations of adapted to and traversing the gluteal fold, these limitations are directed to an intended use of the article. Intended use 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. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The invention of Kalinoski meets the structural limitations of claim 1 as broadly as claimed and is capable of being aligned and fixed on a user with the fastening system of the girdle.
Kalinoski teaches the urine bag 4 is fixed on the girdle 6 with the hook and loop fastener 7,7’ instead of by the strong clamp (see discussion above), and
wherein the sanitary pad is provided at the bottom end, and the bottom end is an end of the notch away from the opening (Moyet-Ortiz Figures 1 and 2, element 14).
As to claim 2, Kalinoski teaches the urine collecting device of claim 1, further comprising a mesh elastic bandage 36 – where Kalinoski teaches the support material 36 is a soft woven stretchable, breathable material (Kalinoski col. 8, lines 16-19), which constitutes a bandage as broadly as claimed, for fixing a portion of the urine bag adjacent to the bottom edge 31 to a calf of the user (Kalinoski Figs. 3 and 4; col. 4, lines 57-67)
As to claim 3, Kalinoski/Moyet-Ortiz teaches the present invention substantially as claimed. Kalinoski/Moyet-Ortiz does not teach a contracted rope for tightening a portion of the urine bag adjacent to the bottom edge. Kalinoski does teach the bottom 32 of envelope 4 is sewn closed with the exception of an opening through which an outlet nipple 32 may protrude for access to drain fluid from the drainage bag 8, supported by the bottom 31 (Kalinoski col. 3, line 68 through col. 4, line 4). Although Kalinoski does not teach a rope, Kalinoski does provide a closure for the bag and the weight of the bag closure and support loops (Kalinoski Figure 2) provides sufficient weight to allow fluid to drain by gravity, thus providing the structure is functionally equivalent to the contracted rope of the present invention (see published application US 2025/0009551, paragraph 0027).
As to claim 4, Kalinoski teaches hook and loop fasteners 38, 39 and a support sleeve 26for fixing the bottom of the bag on the body of the user. Kalinoski teaches hook and loop fastening system instead of the claimed strong clamp. However, The urine collecting device of claim 3, further comprising another strong clamp for fixing the tightened bottom edge on the girdle with the hook and loop fastener or on the body of the user. It would have been obvious to one of ordinary skill in the art before the invention was originally filed to provide Kalinoski with a clamp closure since it is old and well known in the art that fastening mechanisms like clamps and hook and loop closures are interchangeable. This modification does not take away any function or characteristic of the package, since the package is disposable and the hook and loop fasteners provide a secure attachment to the user as does the clamp closure.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kalinoski USPN 5193553 in view of Moyet-Ortiz USPN 5267989 and further in view of Joh US Patent Application Publication 2017/0340475. Kalinoski/Moyet-Ortiz teach a urine bag, but do not teach the urine bag is a high-density polyethylene (HDPE) plastic bag. Joh teaches a urine collection apparatus constructed of flexible and collapsible material including high density polyethylene (HDPE). Joh teaches these material generally remain flat and inconspicuous when the apparatus is worn by a person (Joh paragraph 0037). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to provide a high density polyethylene material for the urine bag for the benefits taught in Joh.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bisbee USPN 6887223, Kulikov US 2002019376, Smith USPN 4813943, and Johnson Jr. et al. USPN 4511358 are cited to show wearable urine collection bags.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781