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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “a member” in claims 7-9 and 11.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
The term “a member” will be interpreted as a male penis.
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.
Claims 1, 3, 6-8 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (KR 20220167093 A, as mapped by translated copy attached).
Regarding Claim 1, Kim teaches a urine collection device (men urine bag 10, see Abstract; Figure 5-7), comprising:
a portable collection chamber (second container 200); and
a penis receptacle (first container 100) fitted into a first wall of the portable collection chamber (the first container 100 allows the penis to enter the flow space 110 formed inside the first container 100; the inner circumferential ends of the first inlet 101 and the second inlet 201 are fitted into each other, see Figure 7).
Regarding Claim 3, Kim further teaches wherein the first wall of the portable collection chamber comprises a waterproof polymer (the second container 200 is made of a synthetic resin material, see pg. 4 paragraph 5).
Regarding Claim 6, Kim further teaches a one of a semi-airtight zipper or a flap type closure disposed on a second wall of the portable collection chamber (the second container 200 can be selectively opened and closed by installing a second sealing means 220 at the upper entrance of the inner space 210; the sealing means 220 being a zipper, see Figure 5; pg. 4 paragraph 8 and 10).
Regarding Claim 7, Kim further teaches wherein an edge of the penis receptacle (the inner circumferential ends of the first inlet 101) comprises an elastomeric material (annular guide means 150 is applied as a sponge having a cushion and a plurality of incisions 153 formed in the inner hole 151 formed in the center, this allows the inner diameter of the inner hole 151 to be elastically widened by the incision 153, see pg. 4 second to last paragraph) configured to contract about a member present in the penis receptacle (to be elastically widened by the incision 153, so that it can be applied according to various body conditions, see pg. 4 second to last paragraph).
Regarding Claim 8, Kim teaches all of the limitation as discussed above in claim 7 and Kim further teaches wherein the elastomeric material expands or contracts in correspondence with a change of a dimension of the member at the penis receptacle (to be elastically widened by the incision 153, so that it can be applied according to various body conditions, see pg. 4 second to last paragraph).
Regarding Claim 10, Kim further teaches wherein the portable collection chamber (200) further comprises a hole (see below) configured to receive a portion of a catheter from outside of the portable collection chamber (see below).
Regarding Claim 11, Kim further teaches wherein the elastomeric material is in direct contact with less than 5% of a surface area of the member (annular guide means 150 contacts a small surface area of the penis, see Figure 5).
Claims 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zimmermann (EP 3949917 A1, as mapped by translated copy attached).
Regarding Claim 12, Kim teaches a system (700) of holding a catheter (urinal condom 710 and connecting hose 720, see Figure 7) in place with respect to a penis (see Figures 2 and 7), comprising:
an elastomeric O ring coupled to the catheter (a fastening means 240), wherein the O ring is configured to contract around a penis and to restrict a movement of the penis away from the O ring (attachment means 240 may comprise a mechanical compression means. The mechanical compression means can include a locking clamp and/or a rubber cord with a locking clamp, an infinitely adjustable elastic cord with locking clamp and selectable rubber elasticity allows optimal adaptation to different anatomical conditions, see pg. 6 paragraph 8).
Regarding Claim 13, Kim further teaches wherein the O ring forms a fluidic seal about the penis, thereby preventing leaking of urine from the catheter (fastening means 240 allows the system to be used in a leak-proof manner for the user, see Figure 2 and 7; pg. 6 paragraph 6).
Regarding Claim 14, Kim further teaches wherein the O ring expands or contracts in correspondence with a change of a dimension of the penis at the penis receptacle (attachment means 240 may comprise a mechanical compression means. The mechanical compression means can include a locking clamp and/or a rubber cord with a locking clamp. an infinitely adjustable elastic cord with locking clamp and selectable rubber elasticity allows optimal adaptation to different anatomical conditions, see pg. 6 paragraph 8).
Regarding Claim 15, Kim further teaches wherein the O ring is in direct contact with less than 5% of a surface area of the member (attachment means 240 contacts a small portion of the penis, see Figure 2).
Regarding Claim 16, Kim further teaches wherein the catheter (710) further comprises a hole configured to receive a portion of a Foley catheter (urinal condom 710 having through holes allow catheter 770 into urinary bladder 760 of the user, see Figure 7).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 20220167093 A) in view of Raynie (US 5662630 A).
Regarding Claim 2, Kim teaches all of the limitations as discussed above in claim 1. However, Kim does not explicitly disclose wherein the portable collection chamber or the penis receptacle is at least 90% biodegradable, either alone or in combination.
Raynie teaches a urine collection device (10) comprising a portable collection chamber (16) and a penis receptacle (male engagement member 12b) wherein the portable collection chamber or the penis receptacle is at least 90% biodegradable, either alone or in combination (the urine collection device should be 100% biodegradable, see Col. 1 ln 43-44).
Kim and Raynie are analogous art because both teach a urine collection device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the urine collection device of Kim and further include wherein the portable collection chamber and penis receptacle are at least 90% biodegradable, as taught by Raynie. Raynie teaches given the current concern for the huge amount of waste products produced by our society--for example the enormous load that disposable diapers puts on land fills--the need for a biodegradable urine collection device would also appear to be important (see Col. 1 ln 16-20).
Claims 4-5 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 20220167093 A) in view of Chauhan (GB 2462267 A).
Regarding Claim 4, Kim teaches all of the limitations as discussed above in claim 1. However, Kim does not explicitly disclose an absorbent pad disposed within the portable collection chamber, wherein one of a deodorant crystal or a deodorant compound is disposed at an edge of the absorbent pad.
Chauhan teaches a urine collection device (see Abstract) comprising: a portable collection chamber (a male incontinence sheath B) and an absorbent pad disposed within the portable collection chamber (the end of the sheath is filled with absorbent cellulose fibers C, see Col. 1 ln Paragraph 2), wherein one of a deodorant crystal or a deodorant compound is disposed at an edge of the absorbent pad (the absorbent material may be cellulose fibers and may contain microcrystalline silver having anti-odor properties, see Abstract).
Kim and Chauhan are analogous art because both teach a urine collection device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the portable collection chamber of Kim and further include an absorbent pad with a deodorant compound within the portable collection chamber, as taught by Chauhan. Chauhan teaches the absorbent pad would provide sufficient absorption for several hours wear without discomfort to the patient (see Col. 1 paragraph 2).
Regarding Claim 5, Kim teaches all of the limitations as discussed above in claim 1. However, Kim does not explicitly disclose 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.
Chauhan teaches a urine collection device (see Abstract) comprising portable collection chamber (a male incontinence sheath B) and an absorbent pad disposed within the portable collection chamber (the end of the sheath is filled with absorbent cellulose fibers C, see Col. 1 ln Paragraph 2), wherein one of an antiseptic crystal or an antiseptic compound is disposed at an edge of the absorbent pad (the absorbent material may be cellulose fibers and may contain microcrystalline silver having anti-bacterial properties, see Abstract).
Kim and Chauhan are analogous art because both teach a urine collection device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the portable collection chamber of Kim and further include an absorbent pad with an antiseptic compound as taught by Chauhan. Chauhan teaches the absorbent pad would provide sufficient absorption for several hours wear without discomfort to the patient (see Col. 1 paragraph 2).
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 20220167093 A) in view of Wang (US 20200375787 A1).
Regarding Claim 9, Kim teaches all of the limitations as discussed above in claim 7. However, Kim does not explicitly disclose wherein the elastomeric material forms a fluidic seal about the member present in the penis receptacle, thereby preventing leaking of fluid from the portable collection chamber.
Wang teaches a urine collection device comprising: a penis receptacle (urine sheath (1), wherein an edge of the penis receptacle comprises an elastomeric material (leaking-stop ring 2 is an integrated flexible foil with a wrap opening 21 in its center, surrounded with a collar 22, the collar can be tightly combined with the concave ring groove 14 inside the flange ring 13, see Figure 5; Paragraph [0022]), and wherein the elastomeric material forms a fluidic seal about the member present in the penis receptacle, thereby preventing leaking of fluid from the portable collection chamber (leaking-stop ring 2 is flexible, made of medical silica gel or other waterproof materials, so that the urine will not leak out, see Paragraph [0023]).
Kim and Wang are analogous art because both teach a urine collection device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the elastomeric material of Kim and further include herein the elastomeric material forms a fluidic seal about the member present in the penis receptacle, thereby preventing leaking of fluid from the portable collection chamber, as taught by Wang. Wang teaches whenever the user lies down, turns over or stands, the urine will not leak out during urination due to the isolation of leaking-stop ring, such sanitary problems as soaking pollution and odor spilling are prevented effectively (see Paragraph [0025]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bernstein (US 5478334 A) teaches a urine collection device (standard pouch 10), comprising: a portable collection chamber (standard pouch 10); and a penis receptacle (condom 23) fitted into a first wall of the portable collection chamber (see Figure 4-5).
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/E.R./ (10/28/2025)Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781