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.
Claim 13 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 13 recites the limitation "the catheter” in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the catheter” is interpreted to be the catheter tube component.
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.
Claim(s) 1-6, 8-11, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Erbey, II (Publication No. US 2018/0264226 A1) in view of Tierney et al. (Publication No. US 2019/0143078 A1).
Regarding claim 1, Erbey, II teaches a catheter system for urine extraction (Abstract; Figure 13-14) comprising: an operational tube connected to said adapter base (posts 26 of section 6; Figure 13);
a base unit, connected to said operational tube, and comprising an electric pump and a controller (unit 412/410/414/420/416/422 has an electric pump 410 and controller 414 and connected to posts 26 of section 6 through section 8 of tube 12; Figure 14; Paragraph 0157-0158);
at least one control interface for commanding said controller (control panel 418; Figure 15A-15B; Paragraph 0161);
a catheter tube having a first end for insertion into said base unit and having a second end for insertion into said operational tube (tube 12 has a first end with a connector 54 to connect to unit 412/410/414/420/416/422 and second end that is inserted into posts 26 of section 6; Figure 13; Paragraph 0113). Erbey, II does not teach a genital adapter configured to fit a genitalia; an adapter base connected to said genital adapter.
However, Tierney teaches a genital adapter configured to fit a genitalia (tissue engaging member 122; Figure 1A-1B; Paragraph 0035); an adapter base connected to said genital adapter (handling portion 120 that connects to tissue engaging member 122; Figure 1A-1B; Paragraph 0035).
Erbey, II and Tierney are considered to be analogous to the claimed invention because they are in the same field of urinary catheter devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Erbey, II to incorporate the teachings of Tierney and have the catheter system of Erbey, II to have the genital adapter and the adapter base of Tierney connected over the operational tube and catheter tube of Erbey, II. This allows for the user to have a gripping surface to insert the device onto the genitalia, without direct contact onto the skin (Tierney; Paragraph 0035).
The combination of Erbey, II in view of Tierney further teaches the operational tube connected to said adapter base (see combination above); wherein said second end of said catheter tube is configured to extend through said genital adapter to the urinal bladder and to extract urine from said urinal bladder by said electric pump (Erbey II; tip 40 of tube 12 extends through the device to extract urine from the bladder using pump; Paragraph 0113; see combination above).
Regarding claim 2, Erbey, II in view of Tierney teaches the system of claim 1. Erbey, II further teaches where the system further comprises a detachable container (fluid collection container 412 – obvious that container is detachable from the system since the catheter 10 has a connector 54 that disconnects/connects from external unit; Figure 13-14; Paragraph 0151-0153).
Regarding claim 3, Erbey, II in view of Tierney teaches the system of claim 1. Erbey, II further teaches where the system further comprises at least one of the following sensors: a temperature sensor, a humidity sensor, a mechanical resistance sensor, an electrical resistance sensor, or a pressure sensor (sensors 52 can be a temperature sensor; Paragraph 0149-0150).
Regarding claim 4, Erbey, II in view of Tierney teaches the system of claim 3. Erbey, II further teaches where the sensor monitors at least one of the following conditions around the catheter tube: electrical resistance, mechanical resistance, temperature, pressure, or humidity (Paragraph 0149-150).
Regarding claim 5, Erbey, II in view of Tierney teaches the system of claim 1. Erbey, II further teaches where the genital adapter and/or the catheter tube, and/or the adapter base are disposable single-use items (disposable catheter devices; Paragraph 0110).
Regarding claim 6, Erbey, II in view of Tierney teaches the system of claim 1. Erbey, II further teaches where the system further comprises controls for the insertion and retraction of catheter tube into or out from the urethra (feedback device 420 has a user interface that allows user to turn off pump 410 before removal of catheter out of urethra; Paragraph 0158)).
Regarding claim 8, Erbey, II in view of Tierney teaches the system of claim 1. Erbey, II further teaches where the system further comprises controls for the extraction of the urine out from the bladder (feedback device 420 has a user interface that allows user to adjust pressure for urine extraction; Paragraph 0158).
Regarding claim 9, Erbey, II in view of Tierney teaches the system of claim 1. Erbey, II further teaches where the system automatically controls the extraction of the urine out from the bladder (Paragraph 0153).
Regarding claim 10, Erbey, II in view of Tierney teaches the system of claim 1. The combination of Erbey, II in view of Tierney does not teach where the genital adapter is a male genital adapter.
However, Tierney teaches where the genital adapter is a male genital adapter (adapter 1122’; Paragraph 0076 and 0079; Figure 12E).
Since the prior art of Tierney recognizes a male genital adapter as a type of genital adapter and is analogous to the claimed invention in the field of urinary catheter systems, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the male genital adapter as the genital adapter, as taught by Tierney, as it is merely the selection of functionally equivalent genital adapters recognized in the art, with the function of facilitating the insertion of the urinary catheter into the urethra, and one of ordinary skill in the art would have a reasonable expectation of doing so. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 - 97 (2007) (see MPEP § 2143, B.).
Regarding claim 11, Erbey, II in view of Tierney teaches the system of claim 1. The combination of Erbey, II in view of Tierney does not teach where the genital adapter is a female genital adapter.
However, Tierney teaches where the genital adapter is a female genital adapter (adapter 1122; Paragraph 0076 and 0079; Figure 12F).
Since the prior art of Tierney recognizes a male genital adapter as a type of genital adapter and is analogous to the claimed invention in the field of urinary catheter systems, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the female genital adapter as the genital adapter, as taught by Tierney, as it is merely the selection of functionally equivalent genital adapters recognized in the art, with the function of facilitating the insertion of the urinary catheter into the urethra, and one of ordinary skill in the art would have a reasonable expectation of doing so. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 - 97 (2007) (see MPEP § 2143, B.).
Regarding claim 13, Erbey, II in view of Tierney teaches the system of claim 1. The combination of Erbey, II in view of Tierney does not teach where the catheter is held in a capsule.
However, Tierney teaches where the catheter is held in a capsule (outer tube 334 holds inner tube 304 with a slider mechanism; Paragraph 0046-0047; Figure 4E).
Erbey, II and Tierney are considered to be analogous to the claimed invention because they are in the same field of urinary catheter devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Erbey, II to incorporate the teachings of Tierney and have the catheter system of Erbey, II to have the capsule/outer tube of Tierney over the catheter tube of Erbey, II in view of Tierney with the slider mechanism of Tierney. This allows for the catheter to be in a retracted position before and after use (Tierney; Paragraph 0045-0046).
Regarding claim 15, Erbey, II teaches a method for urine extraction (Abstract; Figure 13-14) comprising:
providing an operational tube (posts 26 of section 6; Figure 13);
providing a base unit, connected to said operational tube, and comprising a pump (unit 412/410/414/420/416/422 has an electric pump 410 and controller 414 and connected to posts 26 of section 6 through section 8 of tube 12; Figure 14; Paragraph 0157-0158);
providing a catheter tube (tube 12; Figure 13; Paragraph 0113);
inserting a first end of said catheter tube into said base unit (tube 12 has a first end with a connector 54 to connect to unit 412/410/414/420/416/422; Figure 13; Paragraph 0113);
inserting a second end of said catheter tube into said genital adapter (tube 12 has a second end that is inserted into posts 26 of section 6; Figure 13; Paragraph 0113);
extending said second end of said catheter tube to the urinal bladder (tip of tube 12 is extended into the bladder of the patient; Figure 14; Paragraph 0153); and
extracting urine from said urinal bladder, using said catheter, by said pump (Figure 14; Paragraph 0153). Erbey, II does not teach providing a genital adapter configured to fit a genitalia; providing an adapter base connected to said genital adapter.
However, Tierney teaches providing a genital adapter configured to fit a genitalia (tissue engaging member 122; Figure 1A-1B; Paragraph 0035); providing an adapter base connected to said genital adapter (handling portion 120 that connects to tissue engaging member 122; Figure 1A-1B; Paragraph 0035).
Erbey, II and Tierney are considered to be analogous to the claimed invention because they are in the same field of urinary catheter devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Erbey, II to incorporate the teachings of Tierney and have the catheter system of Erbey, II to have the genital adapter and the adapter base of Tierney connected over the operational tube and catheter tube of Erbey, II. This allows for the user to have a gripping surface to insert the device onto the genitalia, without direct contact onto the skin (Tierney; Paragraph 0035).
The combination of Erbey, II in view of Tierney further teaches the operational tube connected to said adapter base (see combination above); extending said second end of said catheter tube through said genital adapter to the urinal bladder (Erbey II; tip 40 of tube 12 extends through the device to extract urine from the bladder using pump; Paragraph 0113; see combination above).
Claim(s) 7, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Erbey, II (Publication No. US 2018/0264226 A1) in view of Tierney et al. (Publication No. US 2019/0143078 A1), as applied to claim 1 above, and further in view of Bogusky et al. (Publication No. US 2020/0030575 A1).
Regarding claim 7, Erbey, II in view of Tierney teaches the system of claim 1. The combination of Erbey, II in view of Tierney does not teach where the system automatically controls the insertion and retraction of catheter tube into or out from the urethra.
However, Bogusky teaches where the system automatically controls the insertion and retraction of catheter tube into or out from the urethra (device 202 with variable stiffness automatically navigates and advances through the anatomy of the urinary tract, including the urethra, during operation through the control of the driving unit; Figures 2C, 7A, 8A-8B; Paragraph 0067, 0114, and 0117-0119).
Erbey, II in view of Tierney and Bogusky are considered to be analogous to the claimed invention because they are in the same field of medical catheter systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Erbey, II in view of Tierney to incorporate the teachings of Bogusky and have the catheter system of Erbey, II in view of Tierney to have the variable stiffness of Bogusky in the catheter tube of Erbey, II in view of Tierney with the controller of Erbey, II in view of Tierney to having the drive unit of Bogusky. This allows for the catheter to automatically navigate and advance along the tortuous anatomy of the urinary tract (Bogusky; Paragraph 0117-0119).
Regarding claim 12, Erbey, II in view of Tierney teaches the system of claim 1. The combination of Erbey, II in view of Tierney does not teach where the system further comprises an actuator for pushing the second end of the catheter tube through the genital adapter and forward into the urethra.
However, Bogusky teaches where the system further comprises an actuator for pushing the second end of the catheter tube forward into the urethra (device 202 with variable stiffness automatically navigates and advances through the anatomy of the urinary tract, including the urethra, during operation through the control of the driving unit/actuator; Figures 2C, 7A, 8A-8B; Paragraph 0067, 0114, and 0117-0119).
Erbey, II in view of Tierney and Bogusky are considered to be analogous to the claimed invention because they are in the same field of medical catheter systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Erbey, II in view of Tierney to incorporate the teachings of Bogusky and have the catheter system of Erbey, II in view of Tierney to have the variable stiffness of Bogusky in the catheter tube of Erbey, II in view of Tierney with the controller of Erbey, II in view of Tierney to having the drive unit/actuator of Bogusky. This allows for the catheter to automatically navigate and advance along the tortuous anatomy of the urinary tract (Bogusky; Paragraph 0117-0119).
The combination of Erbey, II in view of Tierney and Bogusky further teaches the actuator for pushing the second end of the catheter tube through the genital adapter and forward into the urethra (obvious that actuator of Bogusky advances the catheter tube of Erbey, II through the urethra and past the genital adapter of Tierney; see combination above).
Regarding claim 14, Erbey, II in view of Tierney teaches the system of claim 13. The combination of Erbey, II in view of Tierney does not teach where the system further comprises a motor for pushing the second end of the catheter tube, in the capsule, through the genital adapter and forward into the urethra.
However, Bogusky teaches where the system further comprises a motor for pushing the second end of the catheter tube forward into the urethra (device 202 with variable stiffness automatically navigates and advances through the anatomy of the urinary tract, including the urethra, during operation through the control of the driving unit/actuator; Figures 2C, 7A, 8A-8B; Paragraph 0067, 0114, and 0117-0119).
Erbey, II in view of Tierney and Bogusky are considered to be analogous to the claimed invention because they are in the same field of medical catheter systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Erbey, II in view of Tierney to incorporate the teachings of Bogusky and have the catheter system of Erbey, II in view of Tierney to have the variable stiffness of Bogusky in the catheter tube of Erbey, II in view of Tierney with the controller of Erbey, II in view of Tierney to having the drive unit/motor of Bogusky. This allows for the catheter to automatically navigate and advance along the tortuous anatomy of the urinary tract (Bogusky; Paragraph 0117-0119).
The combination of Erbey, II in view of Tierney and Bogusky further teaches where the system further comprises a motor for pushing the second end of the catheter tube, in the capsule, through the genital adapter and forward into the urethra (see combination above; obvious that actuator of Bogusky advances the catheter tube of Erbey, II through the urethra and past the capsule and genital adapter of Tierney).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781