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 9 is 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 9 recites the limitation "the cylindrical, helically wound braid of the plurality of strips of one or more materials". There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 13, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holt (US 20170354532 A1).
Regarding Claim 1, Holt discloses a urine collection device (male catheter assembly 100, Figs 1-4), comprising:
a tubular shaft having an open end and an inner surface (Figs 1-4, combination of sheath 102 and braided section 108 has an opening 106 and an inner surface), the tubular shaft being adjustable between a first configuration having a first inner circumference sized to receive at least a portion of a penis within the tubular shaft and a second configuration having a second inner circumference smaller than the first inner circumference and sized to contact the penis with the inner surface (¶[0024]Fig 4 shows the first configuration, Fig 3 shows the second configuration), wherein the tubular shaft further includes a wicking material defining at least a portion of the inner surface of the tubular shaft (Figs 1-4 ¶[0020] braided section 108 may include nylon, which has wicking capabilities); and
a receptacle connected to the tubular shaft distal to the open end (Figs 1-4 ¶[0022-0023] space in the end of sheath 102 distal to penis and the space in tube 114 is considered the receptacle and is distal to opening in 106), the receptacle being configured to collect urine discharged from the penis when the penis is positioned within the tubular shaft (Figs 1-4 ¶[0022-0023] space in the end of sheath 102 distal to penis is connected to tube 114 which collects urine and may transport it to a collection bag).
Regarding Claim 2, Holt discloses that the tubular shaft includes a cylindrical, helically wound braid of a plurality of a strips of one or more materials (Figs 1-4 ¶[0021] braided section 108 is formed by a plurality of flat strips or strands 110).
Regarding Claim 13, Holt discloses that the first configuration includes a first longitudinal length and the second configuration includes a second longitudinal length that is greater than the first longitudinal length (first configuration shown in Fig 4 has a shorter longitudinal length than the second configuration shown in Fig 3).
Regarding Claim 14, Holt discloses that the receptacle includes a fluid impermeable layer (Figs 1-4 ¶[0020], sheath portion 102, which includes the receptacle portion, may be formed from silicone) and a suction port (Fig 2 ¶[0022-0023] tube 114 includes connection portion 118, which may be a universal connection, and thus is fully capable of connecting to suction).
Regarding Claim 16, Holt discloses that the receptacle is connected to the tubular shaft with at least one of an ultrasonic weld, a heat weld, or an adhesive (Figs 1-4 ¶[0020] sheath portion 102, which includes the receptacle at the distal end thereof, may be connected to braided section 108 of the tubular shaft by hot melting or adhesive).
Claim Rejections - 35 USC § 103
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.
Claims 3, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Holt (US 20170354532 A1) in view of Broerman (US 3608552 A).
Regarding Claim 3, Holt is silent whether the tubular shaft includes a fluid impermeable layer positioned radially outwardly to the cylindrical, helically wound braid of the plurality of strips of one or more materials.
However, Broerman teaches male urinary device, thus from the same field of endeavor, wherein the tubular shaft includes a fluid impermeable layer positioned radially outwardly to the cylindrical, helically wound braid of the plurality of strips of one or more materials ([abstract] Col 1 ln 55-Col 2 ln 11 Fig 2, a knitted tube 1 is coated and impregnated with a liquid repelling rubber material 5, thus forming a liquid impermeable layer positioned radially outward to the knitted tube 1) to prevent leakage by creating a fluidtight relation of the shaft to the penis ([abstract]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Holt so that the tubular shaft includes a fluid impermeable layer positioned radially outwardly to the cylindrical, helically wound braid of the plurality of strips of one or more materials, as taught by Broerman, to prevent leakage by creating a fluidtight relation of the tubular shaft to the penis (as motivated by Broerman [abstract]).
Regarding Claims 7 and 8, The Examiner recognizes claims 7 and 8 as a "product-by-process" claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
As a product claim, Examiner has determined claims 7 and 8 requires the urine collection device to comprise the following structural elements in addition to those in the claims from which they depend: a hydrophobic coating or fluid impermeable coating applied to the strips of one or more materials of the plurality of strips of one or more materials before or after the cylindrical, helically wound braid of the plurality of strips of one or more materials is formed.
In the prior art rejection in this Office action, Examiner considers claims 7 and 8 to be met when a reference teaches these structural limitations. The fluid impermeable coating applied to the cylindrical, helically wound braid of the plurality of strips of one or more materials is taught by Broerman ([abstract] Col 1 ln 55-Col 2 ln 11 Fig 2, a knitted tube 1 is coated and impregnated with a liquid repelling rubber material 5, thus forming a liquid impermeable layer positioned radially outward to and impregnating the knitted tube 1) to prevent leakage by creating a fluidtight relation of the shaft to the penis ([abstract]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the urine collection device of Holt so that each strip of one or more materials of the plurality of strips of one or more materials is coated on at least an outer surface with at least one of a hydrophobic coating or a fluid impermeable coating before the cylindrical, helically wound braid of the plurality of strips of one or more materials is formed, or the cylindrical, helically wound braid of the plurality of strips of one or more materials is coated with at least one of a hydrophobic coating or a fluid impermeable coating after the cylindrical, helically wound braid of the plurality of strips of one or more materials is formed, as taught by Broerman to prevent leakage by creating a fluidtight relation of the tubular shaft to the penis (as motivated by Broerman [abstract]).
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Holt (US 20170354532 A1) in view of Duperret (US 5695485 A).
Regarding Claim 5, Holt is silent whether the tubular shaft further includes a padded material defining at least a portion of the inner surface of the tubular shaft.
However, Duperret teaches a male incontinence device, thus from the same field of endeavor, wherein the tubular shaft further includes a padded material defining at least a portion of the inner surface of the tubular shaft (Col 4 ln 10-15 Figs 1-2 padded channel 17 defines an inner surface of penis receiving cavity 19) to take into account changing dimensions as well as the frequently retracted state of the penis and wicking into the pouch any moisture excreted from the body (Col 2 ln 53-63).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Holt so that the tubular shaft further includes a padded material defining at least a portion of the inner surface of the tubular shaft, as taught by Duperret to take into account changing dimensions as well as the frequently retracted state of the penis and wicking into the pouch any moisture excreted from the body (as motivated by Duperret Col 2 ln 53-63).
Regarding Claim 15, Holt is silent whether the receptacle further includes a wicking material defining at least a portion of an inner surface of the receptacle and a pad material positioned between the wicking material and the fluid impermeable layer.
However, Duperret teaches a male incontinence device, thus from the same field of endeavor, wherein the receptacle further includes a wicking material defining at least a portion of an inner surface of the receptacle (Fig 1, distal end of penis receiving space 19 is considered the receptacle, and includes an interior, permeable, non-absorbent layer 16) and a pad material positioned between the wicking material and the fluid impermeable layer (Fig 1, multiple layers of absorbent material 14 are disposed between the interior, permeable, nonabsorbent layer 16 and the outer impermeable layer 18) in order to keep the skin of the male dry at all times by protecting the penis from contact with moisture by the permeable, non-absorbent layer (Col 3 ln 33-40).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Holt so that the receptacle further includes a wicking material defining at least a portion of an inner surface of the receptacle and a pad material positioned between the wicking material and the fluid impermeable layer, as taught by Duperret in order to keep the skin of the male dry at all times by protecting the penis from contact with moisture by the permeable, non-absorbent layer (as motivated by Duperret Col 3 ln 33-40).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Holt (US 20170354532 A1) in view of Poidomani (US 3998228 A).
Regarding Claim 6, Holt is silent whether the tubular shaft includes a fluid impermeable layer positioned within the cylindrical, helically wound braid of the plurality of strips of one or more materials and defining at least a portion of the inner surface of the tubular shaft.
However, Poidomani teaches an external male catheter, thus from the same field of endeavor, wherein the tubular shaft includes a fluid impermeable layer positioned within the cylindrical, helically wound braid of the plurality of strips of one or more materials and defining at least a portion of the inner surface of the tubular shaft (Fig 1, sheath 11 includes waterproof liner 15 defining the inner surface positioned within outer case 14 comprising woven flat strips 16) so that the device is unaffected by urine acid and is washable (Col 1 ln 55-59).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Holt so that the tubular shaft includes a fluid impermeable layer positioned within the cylindrical, helically wound braid of the plurality of strips of one or more materials and defining at least a portion of the inner surface of the tubular shaft, as taught by Poidomani so that the device is unaffected by urine acid and is washable (as motivated by Poidomani Col 1 ln 55-59).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Holt (US 20170354532 A1) in view of Bellak (US 4895140 A).
Regarding Claim 9, Holt is silent whether the tubular shaft further includes one or more support wires extending longitudinally through the cylindrical, helically wound braid of the plurality of strips of one or more materials.
However, Bellak teaches a condom reinforcing device, thus from the same field of endeavor, wherein tubular shaft further includes one or more support wires extending longitudinally through the cylindrical, helically wound braid of the plurality of strips of one or more materials (Figs 2-3, sheath 11 may include longitudinal filaments 16 interwoven with filaments 15 and 17) to form an easily rollable structure which is quite stiff when unrolled to its cylindrical configuration, providing reinforcement to the condom (Col 2 ln 49-50, Col 3 ln 12-23).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the device of Holt so that the tubular shaft further includes one or more support wires extending longitudinally through the cylindrical, helically wound braid of the plurality of strips of one or more materials, as taught by Bellak to form an easily rollable structure which is quite stiff when unrolled to its cylindrical configuration, providing reinforcement to the condom (as motivated by Bellak Col 2 ln 49-50, Col 3 ln 12-23).
Regarding Claim 10, Holt is silent whether at least one strip of the plurality of strips of one or more materials includes a longitudinally extending support wire.
However, Bellak teaches a condom reinforcing device, thus from the same field of endeavor, wherein at least one strip of the plurality of strips of one or more materials includes a longitudinally extending support wire (Figs 2-3 helical braid filaments 17 are considered the plurality of strips each comprising a longitudinally extending support wire) in order to stiffen the sheath when tension is applied thereto, while still flexing and shifting as necessary, thus providing condom reinforcement (Col 2 ln 49-50, Col 3 ln 24-38).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Holt so that at least one strip of the plurality of strips of one or more materials includes a longitudinally extending support wire, as taught by Bellak in order to stiffen the sheath when tension is applied thereto, while still flexing and shifting as necessary, thus providing condom reinforcement (as motivated by Bellak Col 2 ln 49-50, Col 3 ln 24-38).
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Holt (US 20170354532 A1) in view of Wheeler (US 5199444 A).
Regarding Claim 17, Holt is silent regarding an annular flange positioned within the urine collection device and a chamber sized to receive a head of the penis when the penis is positioned within the tubular shaft, the chamber being defined at least partially by a portion of the receptacle and a portion of the annular flange.
However, Wheeler teaches a condom device, thus from the same field of endeavor, wherein an annular flange is positioned within the urine collection device and a chamber sized to receive a head of the penis when the penis is positioned within the tubular shaft, the chamber being defined at least partially by a portion of the receptacle and a portion of the annular flange (Fig 7, distal annular sealing element 56 creates a chamber sized to receive the head of the penis in distal end 34, the chamber defined by receptacle 36 and annular sealing element 56) to create an additional barrier to the leakage of fluids (Col 14, ln 23-25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Holt so that an annular flange is positioned within the urine collection device and a chamber sized to receive a head of the penis when the penis is positioned within the tubular shaft, the chamber being defined at least partially by a portion of the receptacle and a portion of the annular flange, as taught by Wheeler to create an additional barrier to the leakage of fluids (as motivated by Wheeler Col 14, ln 23-25).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
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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 571-273-8300.
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/Adam Marcetich/Primary Examiner
Art Unit 3781
TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
Prosecution Insights