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 .
Information Disclosure Statements
The information disclosure statement(s) (IDSs) submitted on 11/1/24 was/were filed before the mailing date of a first Office Action on the merits. The submission(s) are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have being considered and entered by the examiner.
Status of the Claims
Claims 1-20 are pending in the application.
Reasons for Allowable Subject Matter
Claims 1-20 are considered allowable over the prior art of record, subject to the Obviousness Type Double Patenting rejection presented below. The following is an examiner’s statement of reasons for allowable subject matter: The prior art fails to teach or fairly suggest the present claims of Applicant. The closest prior art of record is Davis (US 2018/0228642 A1).
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As to independent claim 1, Davis teaches a method of making a urine collection device 10; Fig.26-27, [0051]-[0121], comprising: a covering 20 (Fig.26-27;[0052]-[0054]) defining a recessed receptacle (e.g., receptacle within covering 20 holding foam sleeve for shape retaining element 90 Fig.26-27;[0099],ll.14-17);
forming a fluid collection assembly positioned in the recessed receptacle defined by the covering (Fig.26-27;[0051]-[0103]), wherein the fluid collection assembly comprises:
a foam sleeve (foam casing provided within covering 20 Fig.26-27 [0099,ll.14-17]) comprising a bore extending from a first end of the foam sleeve to a second end of the foam sleeve (Fig.26-27 [0099,ll.14-17]); and a tube 92 (as core 92 in the form of a tube within retaining element 90 and attached at one end to cap 28 Fig.27 [0100],ll.5,3-6) extending through the bore of the foam sleeve (Fig.26-27 [0099,ll.14-17]), after forming the covering 20 such that the covering 20 defines the recessed receptacle (Fig.26-27;[0099],ll.14-17), positioning the fluid collection assembly in the recessed receptacle defined by the covering (Fig.26-27;[0051]-[0103]); and
after positioning the fluid collection assembly in the recessed receptacle defined by the covering (Fig.26-27;[0051]-[0103]), coupling a top sheet 40 to the covering 20 with the fluid collection assembly positioned between the top sheet 40 and the covering 20 (Fig.26-27;[0051]-[0103]),
wherein the top sheet 40 and covering 20 define an internal chamber of the urine collection device 10 (as chamber between 40 and 20 Fig.27A; [0098],ll.8-13); wherein the top sheet 40 is configured to draw urine into the internal chamber and toward the fluid collection assembly (Fig.26-27;[0098],ll.8-13).
As to independent claim 11, Davis teaches a method of making a urine collection device 10; Fig.26-27, [0051]-[0121], comprising: forming a covering 20 (Fig.26-27;[0052]-[0054]) such that the covering define a recessed receptacle (e.g., receptacle within covering 20 holding foam sleeve for shape retaining element 90 Fig.26-27;[0099],ll.14-17);
forming a fluid collection assembly (Fig.26-27;[0051]-[0103]), comprising:
a foam sleeve (foam casing provided within covering 20 Fig.26-27 [0099,ll.14-17]) comprising a bore extending from a first end of the foam sleeve to a second end of the foam sleeve (Fig.26-27 [0099,ll.14-17]); and a shape retaining element 90 [0099],ll.2 positioned in the bore of the foam sleeve (Fig.26-27;[0099],ll.16), wherein the shape retaining element 90 is configured to: conform the fluid collection assembly to a curved configuration for placement against a body of a user (Fig.26-27 Abstract,ll.10-12); and maintain the curved configuration of the fluid collection assembly until the curved configuration is adjusted (Fig.26-27 Abstract,ll.10-12); wherein the shape retaining element 90 defines a passage extending from between a distal end of the shape retaining element 90 and a proximal end of the shape retaining element 90 (Fig.26-27;[0063],ll.19-21); and
a tube 92 (as core 92 in the form of a tube within retaining element 90 and attached at one end to cap 28 Fig.27 [0100],ll.5,3-6) extending through the passage defined by the shape retaining element 90 (passage as hollow formed by linking elements 36 of retaining element 90 FIg.26-27 [0100],ll.3-6);
after forming the covering 20 such that the covering 20 defines the recessed receptacle (Fig.26-27;[0099],ll.14-17), positioning the fluid collection assembly in the recessed receptacle defined by the covering (Fig.26-27;[0051]-[0103]); and
after positioning the fluid collection assembly in the recessed receptacle defined by the covering (Fig.26-27;[0051]-[0103]), coupling a top sheet 40 to the covering 20 with the fluid collection assembly positioned between the top sheet 40 and the covering 20 (Fig.26-27;[0051]-[0103]),
wherein the top sheet 40 and covering 20 define an internal chamber of the urine collection device 10 (as chamber between 40 and 20 Fig.27A; [0098],ll.8-13); and wherein the top sheet 40 is configured to draw urine into the internal chamber and toward the fluid collection assembly (Fig.26-27;[0098],ll.8-13)
As to independent claim 15, Davis teaches a method of making a urine collection device 10; Fig.26-27, [0051]-[0121], comprising: forming a covering 20 (Fig.26-27;[0052]-[0054]) defining a recessed receptacle (e.g., receptacle within covering 20 holding foam sleeve for shape retaining element 90 Fig.26-27;[0099],ll.14-17); and comprising a tapered portion at a distal end of the covering 20 (Fig.27A,C as tapered portion of 20 between 22/25 and 50);
forming a fluid collection assembly (Fig.26-27;[0051]-[0103]), comprising:
a tube 92 (as core 92 in the form of a tube within retaining element 90 and attached at one end to cap 28 Fig.27A,C; [0100],ll.5,3-6) having: (i) a first end at the tapered portion of the distal end of the covering 20 (Fig.27A,C tapered portion of 20 between 22/25 and 50); and (ii) a second end that extends proximally of the proximal end of the covering 20 (as opposite end of 20 (Fig.27A,C; [0100],ll.5,3-6); and a porous material (foam casing provided within covering 20 and around shape retaining element 90 (as claimed below) Fig.26-27 [0099,ll.14-17]) that is configured to reduce a contact pressure of the tube 92 on a body of a user, wherein the tube 92 extends through the porous material (foam casing provided within covering 20 and around tube 92 and necessarily capable of reducing contact pressure of tube 92 on user Fig.26-27 [0099,ll.14-17]);
after forming the covering 20 such that the covering 20 defines the recessed receptacle (Fig.26-27;[0099],ll.14-17), positioning the fluid collection assembly in the recessed receptacle defined by the covering (Fig.26-27;[0051]-[0103]); and
after positioning the fluid collection assembly in the recessed receptacle defined by the covering (Fig.26-27;[0051]-[0103]), coupling a top sheet 40 to the covering 20 with the fluid collection assembly positioned between the top sheet 40 and the covering 20 (Fig.26-27;[0051]-[0103]),
wherein the top sheet 40 and covering 20 define an internal chamber of the urine collection device 10 (as chamber between 40 and 20 Fig.27A;C; [0098],ll.8-13), wherein a distal end of the covering 20 defines a distal end of the internal chamber (Fig.27A;C; [0098],ll.8-13) wherein the top sheet 40 extends above the recessed receptacle of the covering 20 such that the top sheet 40 defines a top of the internal chamber (Fig.26-27;[0098],ll.8-13), wherein the top sheet 40 is configured to draw urine into the internal chamber and toward the fluid collection assembly (Fig.26-27;[0098],ll.8-13).
However, as to independent claim(s) 1, 11, and 15, Davis fail(s) to teach or fairly suggest the combination of:
(as per claim 1) wherein the covering defines an upper peripheral edge; and a recessed receptacle extending from the upper peripheral edge; (as per claim 11) wherein the covering comprises a channel that extends from the recessed receptacle to an opening at the proximal end of the covering; and wherein the tube is received in the channel of the covering; and (as per claim 15) wherein the covering defines an upper peripheral edge; and a recessed receptacle extending from the upper peripheral edge.
As further presented on pages 11-12 of the 9/19/23 Amendment (of grand-parent application 17/013822), it would not have been obvious to one of ordinary skill in the art at the time of the invention to modify the collection device of Davis to provide the above combination of elements and features. One of skill would not have been motivated to modify the teachings of Davis to provide the above combination elements and features, where Davis fails to teach or fairly suggest providing all of these elements and features, and does not provide any motivation to do so.
Double Patenting
Non Statutory Obviousness Type 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting over claims 1-20 of US Patent No. 12,133,813 B2 (‘813) (issued from parent application 18/386350).
As to claims 1-20, claims 1-20 of ‘813 teach or suggest the claimed delivery and fluid storage bridge, as follows:
Claim
1
2
3
4
5
6
7
8
9
10
11
‘813
1
2
3
4
5
6
7
8
9
10
11
Claim
12
13
14
15
16
17
18
19
20
‘813
12
13
14
15
16
17
18
19
20
The differences between present claims and the claims of ‘813 claims do not identically recite each element of current claims (e.g., using substantially similar but not identical terms; different elements are in different claims; and/or different combinations of elements, e.g., channel as passage; porous material as foam).
However, the ‘813 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘813 claims to one of ordinary skill in the art at the time of the present invention. A two-way test is not to be applied in the present cases as Applicant could have filed the claims in a single application and there was no administrative delay. In re Berg, 46 USPQ2d 1226 (Fed. Cir. 1998) (“The two-way exception can only apply when the applicant could not avoid separate filings, and even then, only if the PTO controlled the rates of prosecution to cause the later filed species claims to issue before the claims for a genus in an earlier application . . . In Berg’s case, the two applications could have been filed as one, so it is irrelevant to our disposition who actually controlled the respective rates of prosecution.”). In the absence of administrative delay, a one-way test is appropriate. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993). Unless the record clearly shows administrative delay by the Office and that applicant could not have avoided filing separate applications, the examiner may use the one-way obviousness determination and shift the burden to applicant to show why a two-way obviousness determination is required.
One would be motivated to provide each element of the present claims from the ‘813 claims, as they both relate to the same type of device with the same elements for the same purpose and function in the same field of endeavor.
Claims 1-20 are rejected on the ground of nonstatutory double patenting over claims 1-10, 13-14, and 18 of US Patent No. 11,890,221 B2 (‘221) (issued from parent application 17/013822).
As to Claims 1-20, claims 1-10, 13-14, and 18 of ‘221 teach or suggest the claimed delivery and fluid storage bridge, as follows:
Claim
1
2
3
4
5
6
7
8
9
10
11
‘221
1
2
3
4
1,5
6
7
8
9
10
1,13,
18
Claim
12
13
14
15
16
17
18
19
20
‘221
1,13
1,18
18
18
1,14,
18
3
4
6
7
The differences between present claims and the claims of ‘221 claims do not identically recite each element of current claims (e.g., using substantially similar but not identical terms; different elements are in different claims; and/or different combinations of elements, e.g., channel as passage; porous material as foam).
However, the ‘221 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘221 claims to one of ordinary skill in the art at the time of the present invention. A two-way test is not to be applied in the present cases as Applicant could have filed the claims in a single application and there was no administrative delay. In re Berg, 46 USPQ2d 1226 (Fed. Cir. 1998) (“The two-way exception can only apply when the applicant could not avoid separate filings, and even then, only if the PTO controlled the rates of prosecution to cause the later filed species claims to issue before the claims for a genus in an earlier application . . . In Berg’s case, the two applications could have been filed as one, so it is irrelevant to our disposition who actually controlled the respective rates of prosecution.”). In the absence of administrative delay, a one-way test is appropriate. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993). Unless the record clearly shows administrative delay by the Office and that applicant could not have avoided filing separate applications, the examiner may use the one-way obviousness determination and shift the burden to applicant to show why a two-way obviousness determination is required.
One would be motivated to provide each element of the present claims from the ‘221 claims, as they both relate to the same type of device with the same elements for the same purpose and function in the same field of endeavor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NICHOLAS WEISS, can be reached on 571-270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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