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 Claims
Claims 1-11 and 16-22 are pending and currently under consideration for patentability.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/24/2024 and 01/20/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claim 21 objected to because of the following informalities: “Holder” should be corrected to “The Holder”. Appropriate correction is required.
Claim 21-23 are objected to under 37 CFR 1.75(c) as being in improper form because claim 21 refers to both 8 and 2 and claims should refer to other claims in the alternative only in a multiple dependent claim. See MPEP § 608.01(n). Accordingly, claim 21-23 has not been further treated on the merits.
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 3 recites the limitation "the absorbent pad" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 contains the trademark/trade name “Velcro”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a hook and loop fastner and, accordingly, the identification/description is indefinite.
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)(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.
Claim(s) 1-2, 6, 8-11, and 16-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pierson (US 20180098877 A1).
Regarding Claim 1, Pierson teaches a urine collection device (paragraph [0055]) (FIGS. 1A-D), comprising:
a portable collection chamber (105)(paragraph [0055]); and
a urinary meatus (external urethral orifice) receptacle fitted into first wall of the portable collection chamber (paragraph [0060]); and
a holder (120 and 125) that holds the collection chamber and meatus receptacle securely in place.
Regarding Claim 2, Pierson teaches the device of claim 1. Pierson teaches wherein all the walls of the portable collection chamber comprises a waterproof polymer (paragraph [0056]).
Regarding Claim 6, Pierson teaches the device of claim 2. Pierson further teaches further comprising a one of a semi-airtight zipper or a flap type closure [0010] disposed on a second wall of the portable collection chamber [0010].
Regarding Claim 8, Pierson teaches the device of claim 1. Pierson further teaches wherein a female meatus receptacle (external urethral orifice) is fused into the collection chamber as a urine port
(paragraph [0060]).
Regarding Claim 9, Pierson teaches the device of claim 8. Pierson further teaches wherein an edge of the meatus receptacle is molded in one piece incorporating an elastomeric strap [0066].
Regarding Claim 10, Pierson teaches the device of claim 8. Pierson further teaches wherein the strap of the receptacle has high strength fabric or polymer backing in order to support a perforation that receives a fastening device such as button, eye, hook, eyelet, grommlete or a snap (paragraph [0091]).
Regarding Claim 11, Pierson teaches the device of claim 8. Pierson further teaches wherein a perforation is created on the strap in order to receive a fastening device such as a button, eye, hook, eyelet, grommlete or a snap (paragraph [0091].
Regarding Claim 16, Pierson teaches the device of claim 8. Pierson further teaches wherein the strap of the receptacle is fitted with Velcro type fastener (paragraph [0088]).
Regarding Claim 17, Pierson teaches the device of claim 8. Pierson further teaches wherein an edge of the meatus receptacle contains a protruding placeholder flap (paragraph [0085-0086]).
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.
Claim(s) 3-4, 7 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pierson (US 20180098877 A1) in view of Joseph (US 20220305191 A1).
Regarding Claim 3, Pierson teaches the device of claim 1. Pierson fails to teach wherein the absorbent pad disposed within the portable collection chamber as well as the collection chamber itself is at least, optionally, 90% biodegradable, either alone or in combination. Joseph teaches wherein the absorbent pad disposed within the portable collection chamber as well as the collection chamber itself (paragraph [0028]) is at least, optionally, 90% biodegradable, either alone or in combination (paragraph [0029: completely biodegradable would be at least 90%]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Pierson so the absorbent is in the collection container to act as an indicator as so when the container should be replaced (as motivated by Joseph, paragraph [0028]).
Regarding Claim 4, Pierson teaches the device of claim 2. Pierson fails to teach further comprising an absorbent pad disposed within the portable collection chamber. Joseph teaches an absorbent pad disposed within the portable collection chamber (paragraph [0028]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Pierson so the absorbent is in the collection container to act as an indicator as so when the container should be replaced (as motivated by Joseph, paragraph [0028]).
Regarding Claim 7 and 20, Pierson teaches the device of claim 2 and 8. Pierson fails to teach wherein the collection chamber further comprises a hole configured to receive a portion of an indwelling foley catheter. Joseph teaches wherein the collection chamber further comprises a hole configured to receive a portion of an indwelling foley catheter (paragraph [0037]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Pierson, to have a hole that receives a foley catheter, similar to Joseph, to create an external fluid seal for the urine (as motivated by Pierson, paragraph [0037]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pierson (US 20180098877 A1) in view of Grandolfo (US 20150025468 A1).
Regarding Claim 5, Pierson teaches the device of claim 2. Pierson fails to teach comprising an absorbent pad disposed within the portable collection chamber, wherein one of an antiseptic crystal or an antiseptic compound is disposed at an edge of the absorbent pad. Grandolfo teaches an external end device for permanent catheters absorbent pad disposed within the portable collection chamber, wherein one of an antiseptic crystal or an antiseptic compound is disposed at an edge (Claim language does not require just edge, can be throughout) of the absorbent pad (paragraph [0002][0027]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the absorbent pad of Pierson to have an antiseptic component, similar to Grandolfo, to protect the absorbent from external bacteria (as motivated by Grandolfo, paragraph [0002]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Pierson (US 20180098877 A1) in view of Berg (US 20210353397 A1).
Regarding Claim 18, Pierson teaches the device of claim 8. Pierson further teaches wherein the body facing side of meatus receptacle is covered with silicone (paragraph [0009]), however fails to teach that the silicone is silicone mesh. Berg teaches an implantable device that could be placed in the urethra, wherein the body facing side of meatus receptacle is covered with silicone mesh (paragraph [100]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the silicon meatus of Pierson, so the silicone is mesh, similar to Berg to prevent unintended growth (as motivated by Berg, paragraph [0100]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Pierson (US 20180098877 A1) in view of Drew (US 20220134077 A1).
Regarding Claim 19, Pierson teaches the holder in claim 8. Pierson fails to teach wherein the body facing side of meatus receptacle is covered with a mesh compromised of antimicrobial doped material. Drew teaches an implantable access port wherein the body facing side of meatus receptacle is covered with a mesh compromised of antimicrobial doped material (paragraph [0005]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter of Pierson to have an antimicrobial mesh, to prevent bacterial growth and infection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 5049144 A, US 20040098794 A1, US 20120035577 A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781