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 Statement
The information disclosure statement(s) (IDSs) submitted on 10/29/23; 11/22/24; 5/23/25; 10/29/25; 10/30/25; 12/29/25; 3/18/26; 5/7/26; 6/24/26; 7/1/26; 7/15/26; and 7/29/26; are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner, but where the documents in the IDS(s) will be considered in the same manner as other documents in Office search files while conducting a search of the prior art in a proper field of search.
Status of the Claims
Claims 1-21 are pending in the application, with claims 1-13 under consideration and claims 14-21 withdrawn. Election/Restriction Applicant's election without traverse of claims 1-13 in the 7/15/26 Restriction Response is acknowledged. The requirement is deemed proper and is therefore made FINAL.
Claims 14-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. A complete reply to a final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for ‘establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103 and potential 35 U.S.C. 102(a)(2) prior art under 35 U.S.C. 103.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Davis (US 2018/0228642 A1), in view of Sanchez (US 2017/0266031 A1).
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As to independent claim 1, Davis teaches a device 10 for removing urine discharged from a body of a user (10, Fig 26-27; [0098]-[0102]), the device comprising: a frame 50/90 comprising a base region 51a, 51b (Fig 27A;26A; [0086]-[0091] anchor 50 with a base portion made of portions 51a and 51b [0086],ll.18-25) and at least one branch 90 extending from the base region 50 (Fig.26A) along a proximal to distal length of the device (Fig.27A; [0099]-[0100]), wherein the at least one branch 90 is curved to conform to the body of the user (90, Fig 26B; [0099]; shape retaining element 90 extending from the proximal end near the anchor 50 along the length of device to the distal end near cap 28 (Fig.27A) wherein the element 90 is biased to be curved to conform to the body of the user so that the device can be secured properly [0100],ll.7-10); a fluid collection region 20/42a/42b extending distally from the base region 51a,b (Fig 26B;27A; [0098] device 10 with different layers 20, 40, 42a, 42b and cap 28 as fluid collection region), comprising: an inner layer 42b that is permeable to urine (42b, Fig 26B; [0098],ll.13-16; [0059] - inner layer 42b which is permeable to urine); an outer layer 20 that is substantially impermeable to urine (20, Fig 26B; [0098] - fluid impermeable backing layer 20), and a transfer layer 42a disposed between the inner layer and the outer layer (42a, Fig 26B; 27A [0098] - layer 42a between layer 42b and outer impermeable backing layer 20); a first suction conduit 32 extending from a proximal end region of the device and disposed between the inner layer 42b and the outer layer 42a (32, Fig 26A-B, 27A; [0098] as fluid tube 32 extending from proximal end 22 of device 10 and wherein the tube 32 is disposed between one section of layer 42b and layer 20 when the entire structure is made as shown in Fig 26A) and ending in one or more fluid inlets at a distal end region of the fluid collection region (34, Fig 26B; [0098] - tube 32 ending in a distal inlet 34 near cap 28 of the fluid collecting region at the distal end). Davis fails to teach the combination of: wherein the first suction conduit extends along a right side of the fluid collection region between the inner layer and the outer layer and ending in a first fluid inlet at a distal end region of the right side of the fluid collection region; and a second suction conduit extending along a left side of the fluid collection region between the inner layer and the outer layer and ending in a second fluid inlet at the distal end region of the left side of the fluid collection region. However, Sanchez teaches a similar urine collection device (Figs 50A-B; [0172]), further comprising: a first suction conduit 2826A extending along a right side of the fluid collection region between the inner layer and the outer layer and ending in a first fluid inlet at a distal end region of the right side of the fluid collection region (2826A, Fig 50A; [0172] - tube 2826A disposed between the layers of device 2802 and on the right side and wherein the tube terminates in the right side distal end defining a fluid inlet to aspirate the collected urine and further in the combined device of Davis and Sanchez, the tube 32 would be moved to the right side within the layer 42b); and a second suction conduit 2826B extending along a left side of the fluid collection region between the inner layer and the outer layer and ending in a second fluid inlet at the distal end region of the left side of the fluid collection region (2826B, Fig 50A; [0172] - tube 2826B disposed between the layers of device 2802 and on the left side and wherein the tube terminates in the left side distal end defining a fluid inlet to aspirate the collected urine and further in the combined device of Davis and Sanchez, an additional tube 32 would be added and moved to the left side within the layer 42b).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Davis and/or Sanchez to provide the above combination of elements and features, and one of skill would have been motivated to do so, in order to provide the advantage of improving the collection and removal of urine from the 1st and 2nd conduits by providing the conduits in the form of shafts, where the shafts would necessarily improve the flow and removal of urine from the conduits under suction.
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As to claims 2-3, Davis teaches wherein the at least one branch 90 has a variable stiffness along its length and is biased with a spring force to curve to conform to the body of the user (wherein the at least one branch 90 as shape retaining element has a variable stiffness as variable positioning that provides a mechanism to conform to the body of the user (Fig 26B; 27A; [0066],[0099]; e.g., shape memory wires to provide a bias to the device 10 [0099],ll.7-8).
As to claim 4, Davis teaches wherein the device 10 further comprises an overhang layer 40 extending over a periphery of the inner layer 42b Fig.26B, wherein the overhang layer 40 is at least partially unattached where it overlaps the inner layer 42b (Fig.26B; [0098],ll.9-16).
As to claim 5, Davis teaches wherein a transfer layer 42a is disposed between the inner layer 42b and the outer layer 20 of the fluid collection region (Fig.26B; [0098],ll.9-16).
As to claim 6, Davis teaches wherein the device further comprises an adhesive patch (adhesive portion) attached to the base region 50 for attaching to the device to a patient ([0088]).
As to claim 7, Davis in view of Sanchez teaches wherein the device further comprises a suction source tube in fluid communication with the first suction conduit 32 (suction tubing; [0098],ll.17-19) and the second suction conduit (as taught by Sanchez, as presented above. It would have been obvious to provide the suction tube of Davis with the second source tube of Sanchez, and one of skill would have been motivated to do so, in order to provide suction removal of urine from the device as designed, as presented above.
As to claim 8, Davis teaches wherein the inner layer 42b comprises a nonabsorbing, porous, urine- permeable, hydrophobic layer (batting as wicking layer [0098],ll.15).
As to claim 9, Davis teaches wherein the outer layer 20 is breathable, substantially impermeable to urine, non-absorbing, and hydrophobic (covering/outer layer 20 as fluid impermeable [0052],ll.6, hydrophobic and breathable as foam [0053],ll.6-9).
As to claim 10, Davis teaches wherein the inner layer 42b, the outer layer 20, and the transfer layer 42a are air permeable (as providing passage of urine and thus air permeable or where 20 has at least one opening as fenestration [0052],ll.6-8,10, as further presented above).
Allowable Subject Matter
Claims 11-13 are considered allowable over the prior art of record, but are objected to as depending upon a rejected base claim (1); and subject to the Obviousness Type Double Patenting rejection presented below.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record is Davis (US 2018/0228642 A1) and Sanchez (US 2017/0266031 A1).
Davis and Sanchez teach the invention of claim 1, as presented above.
However, as to claim 11, Davis and/or Sanchez does not teach or fairly suggest, in combination, a first gravity activated valve in fluid communication with the first suction conduit and configured to close when the first fluid inlet is held laterally above the second fluid inlet; and a second gravity activated valve in fluid communication with the second suction conduit and configured to close when the second fluid inlet is held laterally above the first fluid inlet.
It would not have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Davis and/or Sanchez to provide the above combination of elements and features, and one of skill would not have been motivated to do so, where Davis and/or Sanchez fail to teach or fairly suggest providing these elements, and do not provide any motivation to do so.
Claims 12-13 are allowable as depending upon an allowable base claim (11).
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 1-13 are rejected on the ground of nonstatutory double patenting over claims 1-5 and 7-9 of US Patent No. 12,076,266 B2 (‘266) (issued from parent application 17/925193).
As to claims 1-13, claims 1-5 and 7-9 of ‘266 teach or suggest the claimed delivery and fluid storage bridge, as follows (with claim dependencies shown in paratheses, e.g., 3 (/2/1), as claim 3 incorporating claims 1 and 2):
Claim
1
2
3
4
5
6
7
8
9
10
‘266
1, 7 (/1)
9 (/7/1)
7 (/1), 9 (/7 /1)
1
1
8 (/7 /1)
1
1, 4 (/1); 5 (/1)
1
1
Claim
11
12
13
‘266
1
2 (/1)
3 (/1)
The differences between present claims and the claims of ‘266 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).
However, the ‘266 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘266 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 ‘266 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.
No Obviousness Type Double Patenting
It is noted that the claims of issued patent US 11,207,206 B2 (issued from grandparent application 17/235853) fail to teach or fairly suggest the present claims of applicants, e.g., where the claims fail to teach or fairly suggest the combination of elements as presented above for the prior art. Thus, the claims of these patents do not render obvious the present claims under Obviousness-Type Double Patenting.
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, including, e.g.: Terauchi (US 4281655 A) (Abstract; Fig.1-2; Col.1-2); Ecklund (US 2019/0247222 A1) (Abstract;Fig.2,8-11; [0073]-[0169]); Suzuki (US 2014/0157499 A1) (Abstract;Figs.1-4; [0033]-[0056]); and Nakamura (US 8196230 B2) (Abstract;Figs.1-3,9,14; Col.3-11).
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, 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. 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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