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 1-18 are pending and currently under consideration for patentability.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/11/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
Claim(s) 1-6, 9-10, 13-15, and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erbey (US 20190366039 A1).
Regarding Claim 1, Erbey teaches a urinary catheter product (100) comprising:
a catheter tube (116, paragraph [0228]) having a proximal insertion end (136) and a distal drainage end (D1);
a lumen extending from the proximal insertion end to the distal drainage end (117);
the proximal insertion end having an opening (133) for receiving urine in communication with the lumen (figure 1J, paragraph [0229]);
the distal drainage end having a drainage opening for draining urine from the lumen (paragraph [0438]); and
a biomarker strip within the lumen of the catheter product (paragraph [0426]).
Regarding Claim 2, Erbey teaches the urinary catheter product of claim 1. Erbey further comprising a drainage member at the distal drainage end of the catheter tube that further defines the lumen of the catheter product (paragraph [0438]).
Regarding Claim 3, Erbey teaches the urinary catheter product of claim 2. Erbey further teaches wherein the drainage member is a funnel (paragraph [0028]).
Regarding Claim 4, Erbey teaches the urinary catheter product of claim 2. Erbey further comprising wherein the drainage member comprises a connector (paragraph [0471]).
Regarding Claim 5, Erbey teaches the urinary catheter product of claim 1. Erbey further comprising wherein the biomarker strip is located near the distal drainage end of the catheter tube (paragraph [0426]).
Regarding Claim 6, Erbey teaches the urinary catheter product of claim 1. Erbey further comprising, wherein the biomarker strip is affixed to an inside surface of the catheter tube (paragraph [0426]).
Regarding Claim 9, Erbey teaches the urinary catheter product of claim 1. Erbey further comprising wherein the biomarker strip identifies characteristics of the urine (paragraph [0427]).
Regarding Claim 10, Erbey teaches the urinary catheter product of claim 1. Erbey further comprising, wherein the biomarker strip includes one or more indicators (paragraph [0427]).
Regarding Claim 13, Erbey teaches the urinary catheter product of claim 10. Erbey further teaches wherein the one or more indicators of the biomarker strip comprise color-changing sensors (paragraph [0427]).
Regarding Claim 14, Erbey teaches the urinary catheter product of claim 10. Erbey further teaches wherein the one or more indicators have wireless communication capabilities (paragraph [0427]).
Regarding Claim 15, Erbey teaches the urinary catheter product of claim 14. Erbey further teaches wherein the one or more indicators communicate via RFID, NFC, and/or Bluetooth technology (paragraph [0446]).
Regarding Claim 17, Erbey teaches the urinary catheter product of claim 1. Erbey further teaches, wherein the catheter tube is opaque (paragraph [0236]).
Regarding Claim 18, Erbey teaches the urinary catheter product of claim 1. Erbey further including a hydrophilic coating on an outer surface of the catheter tube, wherein the hydrophilic coating is transparent (paragraph [0237]).
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) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Erbey (US 20190366039 A1) in view of Zhejiang (CN 112304930 A).
Regarding Claim 7, Erbey teaches the urinary catheter product of claim 1. Erbey fails to teach wherein the biomarker strip includes a tab extending out of the lumen of the catheter product. Zhejiang teaches wherein the biomarker strip includes a tab extending out of the lumen of the catheter product (page 7, paragraph 3). 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 Erbey wherein the biomarker strip includes a tab extending out of the lumen of the catheter product, similar to Zhejiang, to create a method to view the biomarker strip.
Regarding Claim 8, Erbey teaches the urinary catheter product of claim 2. Erbey fails to teach wherein the biomarker strip includes a tab extending out of the drainage member, the tab being folded over the drainage member and adhered to an outer surface of the drainage member. Zhejiang teaches wherein the biomarker strip includes a tab extending out of the drainage member, the tab being folded over the drainage member and adhered to an outer surface of the drainage member (page 7, paragraph 3). 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 Erbey wherein the biomarker strip includes a tab extending out of the lumen of the catheter product, similar to Zhejiang, to create a method to view the biomarker strip.
Claim(s) 11-12, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Erbey (US 20190366039 A1) in view of Anderson (WO 2018058077 A1).
Regarding Claim 11, Erbey teaches the urinary catheter product of claim 10. Erbey fails to teach wherein the biomarker strip includes a front surface and a rear surface, the one or more indicators are located on the front surface of the biomarker strip and the rear surface of the biomarker strip being adhered to the inside surface of the catheter tube. Anderson teaches wherein the biomarker strip includes a front surface and a rear surface, the one or more indicators are located on the front surface of the biomarker strip and the rear surface of the biomarker strip being adhered to the inside surface of the catheter tube (paragraph [0038]). 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 Erbey wherein the biomarker strip includes a front surface and a rear surface, the one or more indicators are located on the front surface of the biomarker strip and the rear surface of the biomarker strip being adhered to the inside surface of the catheter tube, similar to Anderson, so the biomarkers are located all around the catheter.
Regarding Claim 12, Erbey teaches the urinary catheter product of claim 10. Erbey fails to teach wherein the biomarker strip includes a front surface and a rear surface, and the one or more indicators are located on the front surface of the biomarker strip and the front surface of the biomarker strip being adhered to the inside surface of the catheter tube. Anderson teaches wherein the biomarker strip includes a front surface and a rear surface, and the one or more indicators are located on the front surface of the biomarker strip and the front surface of the biomarker strip being adhered to the inside surface of the catheter tube (paragraph [0038]). 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 Erbey wherein the biomarker strip includes a front surface and a rear surface, and the one or more indicators are located on the front surface of the biomarker strip and the front surface of the biomarker strip being adhered to the inside surface of the catheter tube, similar to Anderson, so the biomarkers are located all around the catheter.
Regarding Claim 16, Erbey teaches the urinary catheter product of claim 1. Erbey fails to teach wherein the catheter tube is transparent. Anderson teaches wherein the catheter tube is transparent (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 catheter of Erbey to be transparent, similar to Anderson, so that the biomarkers are easy to observe.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20220233812 A1, US 20200016380 A1, US 20220241549 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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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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