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(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 20 relies upon Claim 10 and both claims recite identical requirements. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claims 1 and 11 recite a “penis is adapted to be inserted into the check valve” which is directed to the human body by making structural requirements of the penis.
Claims 2-10 and 12-19 are rejected based on their dependency.
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) 1, 3, 5, 6, 9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 3353538 A (Carrigan) in view of US 3916902 A (Lineberger), and US 11413184 B2 (Acosta).
Regarding claims 1 and 11, Carrigan teaches an external catheter system (Figs. 1-3), comprising:
an elongated sheath (12) having an open upper end (at the body of the user, near 14) and an open lower end (at the opposing end, near 26);
an inflatable ring (13) affixed about the open upper end (Fig. 2);
an inflation tube (22) in fluid communication with an interior volume of the inflatable ring (Col. 3: ll. 10-13);
a valve (25) affixed to a distal end of the inflation tube (wherein the valve is configured to operably connect to a pump 25);
whereupon depression of the pump, air is dispensed into the inflatable ring (Col. 3: ll. 14-16);
wherein a diameter of the elongated sheath decreases towards the open lower end (seen to taper in Figs. 1 and 2) defining a drainage tube (31).
Carrigan fails to teach a syringe valve and associated syringe, instead teaching a pump and valve. Carrigan additionally fails to teach a conical-shaped check valve inserted into the elongated sheath; wherein the check valve is disposed before the drainage tube and sits within the elongated sheath; and wherein a user’s penis is adapted to be inserted into the check valve to stop the user’s penis from extending further into the elongated sheath past the stabilized elongated sheath.
Lineberger teaches an external catheter system (10) comprising a syringe valve (26) configured to operably connect to a syringe (Col. 3: ll. 42-45); whereupon depression of a plunger of the syringe, air is dispensed into the inflatable ring (20) (Col. 3: ll. 45-46).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump and valve of Carrigan with the syringe valve and associated syringe of Lineberger as a simple substitution of one known valve type for another with a reasonable expectation of providing an inflation fluid to the ring, thereby retaining the device in the desired position MPEP 2143 I.
Acosta teaches an external catheter system (Fig. 6) comprising a conical-shaped check valve (670) [42] (a flutter valve being a type of check valve) inserted into the elongated sheath (630); wherein the check valve is disposed before the drainage tube (the distal-most portion of 630, which corresponds to Fig. 1 having drainage tube 150) and sits within the elongated sheath (Fig. 6); and wherein a user’s penis is adapted to be inserted into the check valve to stop the user’s penis from extending further into the elongated sheath past the stabilized elongated sheath [42] (as seen in Fig. 6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carrigan in view of Lineberger with the check valve of Acosta to prevent re-entry of urine [Acosta 42].
Regarding claim 3, Carrigan further teaches a urine collection bag (30) removably securable to the open lower end (at fitting 26, Fig. 2).
Regarding claim 5, the device of claim 1 is considered to teach the check valve having a generally conical shape (as seen in Acosta Fig. 6).
Regarding claim 6, Carrigan further teaches the inflation tube (22) is affixed to a lower side of the inflatable ring (13) (the lower side being closer to the body than to the drainage end of the device as seen in Fig. 2).
Regarding claim 9, Carrigan is considered to teach the inflatable ring (13) is affixed about an exterior of the open upper end of the elongated sheath (12) (the inflatable ring surrounding the opening where the penis is inserted into the device).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan in view of Lineberger and Acosta and further in view of US 3905361 A (Hewson et al.).
Regarding claim 2, Carrigan in view of Lineberger and Acosta fails to teach a pilot balloon disposed adjacent to and in fluid communication with the syringe valve.
Hewson teaches a pilot balloon (9) disposed adjacent to and in fluid communication with a syringe valve (11) (Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carrigan in view of Lineberger and Acosta with the pilot balloon of Hewson to provide visual indication of balloon pressure to the user (Hewson Col. 2: ll. 13-15).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan in view of Lineberger and Acosta and further in view of US 20030136415 A1 (Lanton).
Regarding claim 4, Carrigan in view of Lineberger and Acosta fails to teach the inflatable ring comprises a rigid outer portion and an inflatable interior portion.
Lanton teaches a device (100) comprising an inflatable ring (Fig. 1) to secure a penis, the inflatable ring comprising a rigid exterior ring portion (110) and an inflatable interior ring portion (120).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inflatable ring of Carrigan in view of Lineberger and Acosta with the inflatable ring of Lanton to reduce device movement during use [Lanton 0020].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan in view of Lineberger and Acosta and further in view of US 9125752 B2 (Zeller).
Regarding claim 7, Carrigan in view of Lineberger and Acosta fails to teach wherein the syringe valve comprises a two-way check valve.
Zeller teaches a urine collection apparatus which seeks to solve the same problem of urine storage which comprises a two-way check valve (Col. 4: ln 54-56), said check valve being used to equilibrate pressure (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve of Carrigan in view of Lineberger and Acosta to equilibrate pressure (Zeller Abstract) which would allow for a greater degree of control in regulating pressure to prevent injury.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan in view of Lineberger and Acosta and further in view of US 20090216206 A1 (Nishtala et al.).
Regarding claim 8, Carrigan in view of Lineberger and Acosta fails to teach the syringe valve is threaded to engage complementary threading disposed on the syringe, such that the syringe is removably securable to the syringe valve.
Nishtala teaches a device with an inflatable cuff which seeks to solve the same problem of using an inflatable device for retention. Nishtala teaches an inflation port (40) which corresponds to the syringe valve of claim 1 which is threaded to engage complementary threading disposed on the syringe, via a luer connector [0067], such that the syringe is removably securable to the syringe valve [0067].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe valve of Carrigan in view of Lineberger and Acosta with the luer-connector of Nishtala to allow for selective inflation and deflation of the inflatable ring [Nishtala 0067].
Claim(s) 10, 13, 15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan in view of Lineberger and Acosta and further in view of US 20160095479 A1 (Jenkin).
Regarding claim 10, Carrigan in view of Lineberger and Acosta fail to teach the elongated sheath is inserted into a collection bag with an open top and a raised circular base.
Jenkin teaches a urine collection system (Fig. 10) wherein a urine collection device outlet (corresponding to the sheath of claim 1) is inserted into a collection container (300) with an open top (304) and a raised circular base (the base below the handle being circular and raised, i.e., not flat).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carrigan in view of Lineberger and Acosta to use the alternate collection means of Jenkin thereby preventing spillage of the contents [Jenkin 0010].
Regarding claim 13, Carrigan further teaches a urine collection bag (30) removably securable to the open lower end (at fitting 26, Fig. 2).
Regarding claim 15, Carrigan further teaches the inflation tube (22) is affixed to a lower side of the inflatable ring (13) (the lower side being closer to the body than to the drainage end of the device as seen in Fig. 2).
Regarding claim 18, Carrigan further teaches a slot, the interior of (44) which interacts with (43), disposed about a circumference of the inflatable ring along an upper side thereof (Carrigan Annotated Fig.), wherein the slot is dimensioned to frictionally engage the open upper end of the elongated sheath therein (Col. 3: l. 74 – Col. 4: l. 4).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan in view of Lineberger, Acosta, and Jenkin and further in view of Hewson.
Regarding claim 12, Carrigan in view of Lineberger, Acosta and Jenkin fails to teach a pilot balloon disposed adjacent to and in fluid communication with the syringe valve.
Hewson teaches a pilot balloon (9) disposed adjacent to and in fluid communication with a syringe valve (11) (Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carrigan in view of Lineberger, Acosta and Jenkin with the pilot balloon of Hewson to provide visual indication of balloon pressure to the user (Hewson Col. 2: ll. 13-15).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan in view of Lineberger, Acosta, and Jenkin and further in view of Lanton.
Regarding claim 14, Carrigan in view of Lineberger, Acosta and Jenkin fails to teach the inflatable ring comprises a rigid outer portion and an inflatable interior portion.
Lanton teaches a device (100) comprising an inflatable ring (Fig. 1) to secure a penis, the inflatable ring comprising a rigid exterior ring portion (110) and an inflatable interior ring portion (120).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inflatable ring of Carrigan in view of Lineberger, Acosta and Jenkin with the inflatable ring of Lanton to reduce device movement during use [Lanton 0020].
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan in view of Lineberger, Acosta, and Jenkin and further in view of Zeller.
Regarding claim 16, Carrigan in view of Lineberger, Acosta and Jenkin fails to teach wherein the syringe valve comprises a two-way check valve.
Zeller teaches a urine collection apparatus which seeks to solve the same problem of urine storage which comprises a two-way check valve (Col. 4: ln 54-56), said check valve being used to equilibrate pressure (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve of Carrigan in view of Lineberger, Acosta and Jenkin to equilibrate pressure (Zeller Abstract) which would allow for a greater degree of control in regulating pressure to prevent injury.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan in view of Lineberger, Acosta, and Jenkin and further in view of Nishtala.
Regarding claim 17, Carrigan in view of Lineberger, Acosta and Jenkin fails to teach the syringe valve is threaded to engage complementary threading disposed on the syringe, such that the syringe is removably securable to the syringe valve.
Nishtala teaches a device with an inflatable cuff which seeks to solve the same problem of using an inflatable device for retention. Nishtala teaches an inflation port (40) which corresponds to the syringe valve of claim 1 which is threaded to engage complementary threading disposed on the syringe, via a luer connector [0067], such that the syringe is removably securable to the syringe valve [0067].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe valve of Carrigan in view of Lineberger, Acosta and Jenkin with the luer-connector of Nishtala to allow for selective inflation and deflation of the inflatable ring [Nishtala 0067].
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrigan in view of Lineberger, Acosta, and Jenkin and further in view of US 5478334 A (Bernstein).
Regarding claim 19, Carrigan in view of Lineberger, Acosta and Jenkin fails to teach the elongated sheath removably secures to the inflatable ring via inserting the open upper end through a central aperture of the inflatable ring.
Bernstein teaches an external catheter system (Fig. 1), comprising:
a flexible elongated sheath (23) (Col. 4: ll. 13-14) having an open upper end (at 22); a ring (22) removably securable about an exterior of the elongated sheath (Col. 4: ll. 6-9) such that the open upper end extends through an entirety of the ring (Fig. 4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the attachment means of Carrigan in view of Lineberger, Acosta and Jenkin with the elongated sheath removably secured to a ring by insertion through the open upper end as taught by Bernstein to allow the device to be locked together during use, but remain separable when not in use (Bernstein Col. 3: ll. 51-57).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20150320583 A1 discloses an external catheter with inflatable rings.
US 20080091155 A1, US 2699781 A, and US 3511241 A disclose an external catheter with an inflatable ring.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANS KALIHER/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781