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 .
Priority
The instant application has priority going back to the provisional filed March 19, 2014.
Response to Amendment
The amendments filled prior to examination have been entered. Claims 2-21 are currently pending.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Per claim 1: the porous material forming one or more of the lateral edges of the channel is not found in the specification; however, it appears fig 32 supports this limitation as the porous material (or permeable member 1630) surrounds the tube (1621) which can be defined as a channel.
Of note the porous material is a narrower embodiment of the permeable support per applicant’s specification [0058]
Per claim 7: while the figures support “top and bottom surface” of the fluid impermeable layer the terms are NOT found in the specification.
Per claim 9: “the fluid permeable inner layer” is not found in the specification it appears to be a distinct structure form the fluid permeable membrane and porous material (or permeable support). Per [0052] the permeable support is between the permeable membrane and fluid reservoir (suggesting only two layers and not 3 porous/ permeable layers as suggested by claim 9)
Per claim 10: “the fluid permeable inner layer” is not found in the specification it appears to be a distinct structure form the fluid permeable membrane
Per claim 13 the term “semi-spherical” is not found in the specification; however, the figure (32) supports this
Per claim 16: while the figures support “top and bottom surface” of the fluid impermeable layer the terms are NOT found in the specification.
Per claim 19 and 20: “the fluid permeable inner layer” is not found in the specification it appears to be a distinct structure form the fluid permeable membrane
Per claim 21: while the figures support “top and bottom surface” of the fluid impermeable layer the terms are NOT found in the specification.
Per claim 21: “the fluid permeable inner layer” is not found in the specification it appears to be a distinct structure form the fluid permeable membrane
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The term fluid permeable inner layer is not found in the originally filed specification, claims, or figures. While the applicant appears to use porous material interchangeably with permeable support and have support for a permeable membrane there is NO support for a third porous or permeable inner layer material as required by claim 9. Furthermore there is no mention of the fluid permeable membrane extending around a circumference of a fluid permeable inner layer.
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 4, 12-13, 15, and 21 are 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 4 and 5 lack antecedent bases for the term “the fluid permeable membrane” since Claim 1 used the term “porous material” it is unclear if the terms are the same.
Of note claim 9 uses both terms so it is really unclear and the terms are interchangeable as the fluid permeable membrane appears to be different from the permeable support otherwise known as the porous material.
Claim 4 depends from claim 3 which already requires a fluid reservoir; therefore, another fluid reservoir is required or “the fluid reservoir” should be used instead of “a fluid reservoir”.
Claim 11 depends from claim 10 which has a fluid impermeable layer, however in claim 11 “the fluid impermeable barrier” is found. The examiner understands the term to be referring to the fluid impermeable layer of claim 10 since the term barrier is not found in the specification.
Depending claims 12, 13, and 15 also have the “the fluid impermeable barrier” appropriate correction is needed.
Claim 21 requires a fluid impermeable layer in line 2 and then switches to the term” fluid impermeable barrier”. The examiner understands the term to be referring to the fluid impermeable layer since the term barrier is not found in the specification.
Claim Rejections - 35 USC § 102
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.
Claim(s) 2-5, 7-8, 10-14, 16, and 18-21 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Keane US 3349768.
Regarding claim 2, Keane discloses a urine collecting apparatus (abstract), comprising:
a fluid impermeable layer at least partially defining an interior volume, a fluid outlet, and at least one opening (Col 3 lines 67-68 and Col 1 lines 65-70 which notes the material for the head is rubber or a thermoplastic and col 1 lines 20-25 notes the device is use to convey urine and therefore being able to hold liquid and see annotated figure below); and
at least one porous material disposed within the fluid impermeable layer and extending across the at least one opening (or mesh/ plastic insert 35 designed to support a porous material while allowing urine to pass to the channel below Col 4 lines 1-16 and see annotated figure below), the at least one porous material including a proximal end and a distal end longitudinally spaced from the proximal end, the at least one porous material defining a channel extending through the at least one porous material from the proximal end to the distal end thereof, the at least one porous material forms all of one or more lateral edges of the channel ((Col. 4 lines 53-55 and annotated figure below which shows the porous material forming one lateral edge of the channel).
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Regarding claim 3, Keane discloses wherein the fluid impermeable barrier at least partially defines a fluid reservoir (see annotated figure above).
Regarding claim 4, Keane discloses the distal end of the fluid permeable membrane and an adjacent portion of the fluid impermeable barrier at least partially directly define a fluid reservoir (see annotated figure above).
Regarding claim 5, Keane discloses a discharge line extending through the fluid outlet and into the channel, the discharge line extending past the distal end of the fluid permeable membrane, an inlet of the discharge line disposed in the fluid reservoir (see annotated figure above).
Regarding claim 7, Keane discloses wherein the fluid impermeable layer includes a top surface and a bottom surface opposite the top surface, wherein substantially all of the top surface contacts at least one of a vaginal region, perineum, or anal region of the user after positioning the urine collecting apparatus, the top surface exhibiting a convex curvature extending around a longitudinal axis of the fluid impermeable barrier, and wherein the convex curvature is relative to an exterior of the urine collecting apparatus (annotated figure below, figure 4 and Col 1 lines 65-68 which notes the contact of the device to the female).
Regarding claim 8, Keane discloses wherein the at least one porous material exhibits a generally cylindrical shape (the device as seen above in generally cylindrical in shape and as such the porous material will be too).
Regarding claim 10, Keane discloses a fluid impermeable layer at least partially defining an interior volume, a fluid outlet, and at least one opening (Col 3 lines 67-68 and Col 1 lines 65-70 which notes the material for the head is rubber or a thermoplastic and col 1 lines 20-25 notes the device is use to convey urine and therefore being able to hold liquid and see annotated figure below);
a fluid permeable inner layer (35) disposed within the fluid impermeable layer, the fluid permeable inner layer including a proximal end and a distal end longitudinally spaced from the proximal end, the fluid permeable inner layer defining a channel extending through the fluid permeable inner layer from the proximal end to the distal end thereof, the fluid permeable inner layer forms all of one or more lateral edges of the channel (see annotated figure below and Col 3 line 75- Col 4 line 16); and
a fluid permeable membrane (11) covering the portion of the fluid permeable inner layer that extends across the at least one opening to maintain the fluid permeable membrane against or near the urethral opening of the user during use (see annotated figure below and Col 3 line 75- Col 4 line 16).
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Regarding claim 11, Keane discloses wherein the fluid impermeable barrier at least partially defines a fluid reservoir (see annotated figure above).
Regarding claim 12, Keane discloses wherein the distal end of the fluid permeable membrane and an adjacent portion of the fluid impermeable barrier at least partially directly define the fluid reservoir (see annotated figure above).
Regarding claim 13, Keane discloses wherein at least a portion of the fluid impermeable barrier defining the fluid reservoir exhibits a generally semi-spherical shape the shape is generally “c” like and therefore semi-spherical).
Regarding claim 14, Keane discloses a discharge line extending through the fluid outlet and into the channel, the discharge line extending past the distal end of the fluid permeable membrane, an inlet of the discharge line disposed in the fluid reservoir (see annotated figure above).
Regarding claim 16, Keane discloses wherein the fluid impermeable layer includes a top surface and a bottom surface opposite the top surface, wherein substantially all of the top surface contacts at least one of a vaginal region, perineum, or anal region of the user after positioning the urine collecting apparatus, the top surface exhibiting a convex curvature extending around a longitudinal axis of the fluid impermeable barrier, and wherein the convex curvature is relative to an exterior of the urine collecting apparatus (annotated figure below, figure 4 and Col 1 lines 65-68 which notes the contact of the device to the female).
Regarding claim 18, Keane discloses wherein the fluid impermeable layer exhibits a generally cylindrical shape (the device as seen above in generally cylindrical in shape and as such the porous material will be too).
Regarding claim 19, Keane discloses wherein the fluid permeable inner layer exhibits a generally cylindrical shape (the device as seen above in generally cylindrical in shape and as such the permeable material will be too).
Regarding claim 20, Keane discloses wherein the fluid permeable membrane extends around a circumference of the fluid permeable inner layer (the two layers are layered and therefor extends around part of each other).
Regarding claim 21, Keane discloses a fluid impermeable layer at least partially defining an interior volume, a fluid outlet, and at least one opening (Col 3 lines 67-68 and Col 1 lines 65-70 which notes the material for the head is rubber or a thermoplastic and col 1 lines 20-25 notes the device is use to convey urine and therefore being able to hold liquid and see annotated figure below), the at least one opening configured to be positioned adjacent to a urethral opening of a user (Col 1 lines 65-68 which notes the contact of the device to the female), the fluid impermeable layer includes a top surface and a bottom surface opposite the top surface, wherein substantially all of the top surface contacts at least one of a vaginal region, perineum, or anal region of the user after positioning the urine collecting apparatus, the top surface exhibiting a convex curvature extending around a longitudinal axis of the fluid impermeable barrier, and wherein the convex curvature is relative to an exterior of the urine collecting apparatus (annotated figure below, figure 4 and Col 1 lines 65-68 which notes the contact of the device to the female).
a fluid permeable inner layer (35) that is generally cylindrical and disposed within the fluid impermeable layer, the fluid permeable inner layer including a proximal end and a distal end longitudinally spaced from the proximal end, the fluid permeable inner layer defining a channel extending through the fluid permeable inner layer from the proximal end to the distal end thereof, the fluid permeable inner layer forms all of one or more lateral edges of the channel (see annotated figure below and Col 3 line 75- Col 4 line 16);
a fluid permeable membrane (11) covering the portion of the fluid permeable inner layer that extends across the at least one opening to maintain the fluid permeable membrane against or near the urethral opening of the user during use (see annotated figure below and Col 3 line 75- Col 4 line 16); and
a discharge line extending through the fluid outlet and into the channel, the discharge line extending past the distal end of the fluid permeable membrane, an inlet of the discharge line disposed in the fluid reservoir (see annotated figure above).
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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.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Keane US 3349768 in view of Suzuki US 2012/0253303 A1.
Regarding claim 17, Keane fails to disclose wherein the fluid permeable support includes a spine, the spine dividing an inner volume of the permeable support into at least a first channel and a second channel.
Suzuki disclose a urine collection apparatus ( fig 1-4 and [0048]) with a divided inner volume to create multiple channel for the collection of urine ([0050-53]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added the spine to divide the inner volume to allow for better flow dynamics incase the device was partially crushed in use.
Allowable Subject Matter
Claims 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record on the IDS fails to disclose the fluid impermeable layer or body is a two-part system having a body and a cap. No other prior art of record that is eligible as prior art was found to teach this feature.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim see below rejected on the ground of nonstatutory double patenting as being unpatentable over claims see below of U.S. Patent No. see list below. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant case is broader the patents listed below and thus species anticipates genus. (Applicant is advised some could have been missed due to the sheer volume of applications- see applicant submitted IDS.)
The instant application independent claim 2 has three main elements:
- fluid impermeable layer defining a volume or reservoir with an opening and fluid outlet
- porous material within the fluid impermeable layer
Dependent claims 3-4 further define the reservoir
Dependent claim 5 introduces a discharge line
Dependent claim 6 further specifies the impermeable layer has two parts a body
and cap
Dependent claims 7-8 further define the orientation and curvature and shape of the device relative to the user
Dependent claim 9 added two more permeable layers
The instant application independent claim 10 has four main elements:
- fluid impermeable layer defining a volume or reservoir with an opening and fluid outlet
- two permeable layers within the fluid impermeable layer
Dependent claims 11-12 further define the reservoir
Dependent claim 14 introduces a discharge line
Dependent claim 15 further specifies the impermeable layer has two parts a body
and cap
Dependent claim 13, 16, 18-19 further define the orientation and curvature and shape of the device relative to the user
Dependent claim 17 adds a spine
Dependent claim 20 further specifies the permeable layer
The instant application independent claim 21 is almost a combination of claim 10, 16 and 14
Instant Application claims
Patented Case
Patented case claims
2-5, 7-14, 16, 18-21
12622803
1-7
2-4,7-8, 10-12,18-19
12594062
1, 14
2-4,7-8, 10-12,18-19
12589022
1-4
2-4,7-8, 10-13,18-19
12575961
1-9, 17-19
2, 10
12569364
1
2, 10, 21
12569365
1
2, 10, 21
12551385
1, 13
2, 10, 21
12551366
1
2, 10
12521272
1, 10
2
12478499
1, 19
2
12465515
1, 16
2
12465514
1
2
12440370
1
2
12419778
1
2
12350190
1
2
12329364
1
2
12324767
1, 13
2
12274638
1
2,10, 17
12245967
1,3, 6
2, 10
12208031
2, 4
2
12138195
1
2
12048643
1, 13
2
12042423
1
2
11944740
1, 10
2
11938053
1
2
10973678
1
2, 10, 17
10952889
1-17
2, 10
10390989
7
2, 10, 21
10226376
1, 4, 9, 11-14
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA E BURNETTE whose telephone number is (571)272-9574. The examiner can normally be reached M-S: 0830-1900 EST.
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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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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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