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 .
In light of the amendments filed 12/19/2025 in which claims 1, 3, 5, 8, 10, and 15-22 were amended and claim 12 was cancelled, claims 1-11 and 13-34 are pending in the instant application, and in light of the restriction requirement in which claims 6-8 and 31-34 remain withdrawn, claims 1-5, 9-11, and 13-30 are examined on the merits herein.
Priority
The instant application is a 371 of PCT/US2020/067451 filed 12/30/2020 which claims priority to U.S. Provisional application 62,956,767 filed on 01/03/2020.
Claims 1-11 and 13-34 receive priority to the prior-filed application, filed on 01/03/2020.
Election/Restrictions
Claim 15 is allowable. The restriction requirement between species, as set forth in the Office action mailed on 11/05/2024, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 11/05/2024 is partially withdrawn. Claims 23-25, directed to a non-elected species are no longer withdrawn from consideration because the claims requires all the limitations of an allowable claim. However, claims 6-8, directed to the same non-elected species remain withdrawn from consideration because the claims do not require all the limitations of an allowable claim. Further, claims 31-34, directed to a non-elected invention remain withdrawn from consideration because the claims do not require all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Response to Arguments
IDS
The IDSs filed 10/07/2025 and 12/19/2025 remedy the deficiencies of the previous IDSs.
Objections to the Drawings
The objections to the drawings are withdrawn in view of the amendment to the drawings filed 12/19/2025.
Objections to the Claims
The previous objections to the claims are withdrawn in view of the amendments to the claims filed 12/19/2025.
Claim Rejections under 112(a) and 112(b)
The claim rejections under 112(a) and 112(b) are withdrawn in view of the amendments to the claims filed 12/19/2025.
Claim Rejections under 35 U.S.C. 102(a)(1) and 103
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding amended claim 1, the applicant asserts on pg. 9-11 that one of ordinary skill would not be motivated to modify the cap of Davis to comprise a maximum width that is more than a centimeter greater than an opening width of the opening of the cap as the device of Davis requires other elements that are wider than the cap and that this modification may result in a device that is too wide to function as intended.
In response to the applicant’s argument, the examiner respectfully disagrees. First, Davis discloses that the cap can be any suitable shape and/or size capable of collecting fluid (para. 0081) and provides multiple embodiments of the cap in different shapes and sizes (Fig. 22). Davis further discloses that those skilled in the art will readily appreciate that many modifications are possible (e.g. variations in sizes, structures, shapes and proportions of the various elements) (para. 0120). Further, the applicant seems to be arguing that a modification of Davis to have a body width that is greater than the opening width of the opening of the cap would make the cap of Davis unsatisfactory for its intended purpose. The claim is not so narrow to require that the cap have the maximum body width at any specific portion of the body. The only size requirements for the cap of Davis are that the cap is physically able to pass through the urine collection device body (Fig. 1; Fig. 7) and that the cap recess is sized to hold together the ends of the tube, the inner collection core, and the outer collection layer (para. 0081). Davis does not disclose any specific sizes for any of the components of the urine collection device, except for the anchor which the cap does not interact with. There is no suggestion in Davis that modifying the maximum body width or the opening width would not be considered obvious or would make the cap of Davis unsatisfactory for its intended purpose.
The amendments to the claim have necessitated new grounds of rejection.
Regarding amended claim 15, the applicant asserts on pg. 11 that Davis fails to read on the newly added limitations.
In response to the applicant’s argument, the examiner respectfully notes that Davis was not used in the previous Office Action filed 04/08/2025 to read on the newly added limitations; however, the examiner agrees with the applicant that Davis fails to read on the newly added limitations.
All claim rejections to claims 15-30 have been withdrawn.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 recites the limitation “a width of sizing device” in ln. 2. This should read “a width of the sizing device”.
Appropriate correction is required.
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.
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Ex. Fig. 1 of Davis Fig. 7
Claims 1-5, 9-11, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over US/2018/0228642 A1 to Davis.
Regarding claim 1, Davis discloses a sizing device for a urine collection system (Fig. 1, sizing device 28, urine collection system 10; para. 0081), the sizing device comprising:
a body having a distal end and an attachment end spaced from the distal end (Ex. Fig. 1), the attachment end defining an opening (Ex. Fig. 1); and
a recess extending into the body from the opening (Ex. Fig. 1), the recess being sized and dimensioned to receive a portion of a urine collection device and selectively secure the sizing device to the urine collection device (Fig. 5 showing sizing device 28 receiving at least tube 32 of urine collection device 20; Fig. 21B; para. 0081-0082),
wherein the body is sized and dimensioned to interface and/or contact legs and/or gluteal cleft of a user when the sizing device is secured to the urine collection device (Fig. 22 showing exemplary shapes of sizing device 28 for fitting within gluteal folds and perineum, first shape shaped similarly to sizing device 28 in Fig. 1; para. 0081, sizing device 28 is any shape and/or size capable of collecting fluid; para. 0084-0085; para. 0094).
Davis further discloses wherein the sizing device may be any suitable shape and/or size capable of collecting fluid (para. 0081); however, Davis differs from the instantly claimed invention in that Davis fails to explicitly disclose wherein the opening has an opening width of about 1.3-2.5 cm, and wherein the body includes a maximum body width of at least about 3.8 cm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the body of Davis such that the opening has an opening width of about 1.3-2.5 cm, and wherein the body includes a maximum body width of at least about 3.8 cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Davis would not operate differently with the claimed length and width and since the sizing device may be any suitable shape and/or size capable of collecting fluid (para. 0081), the device would function appropriately having the claimed opening and body widths. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the opening and body widths “may” be within the claimed ranges (specification para. 0024-0025).
Regarding claim 2, the cited prior art suggests the invention of claim 1. Davis further discloses wherein the body includes a substantially cylindrical portion positioned between the attachment end and the distal end (Ex. Fig. 1).
Regarding claim 3, the cited prior art suggests the invention of claim 2. Davis further discloses wherein the sizing device may be any suitable shape and/or size capable of collecting fluid (para. 0081); however, Davis differs from the instantly claimed invention in that Davis fails to disclose a substantially frustoconical head having sloped walls tapering a width of the sizing device at least partially between the maximum body width at the cylindrical portion and the opening width of the opening at the attachment end.
It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sizing device of Davis to include a frustoconical head having sloped walls tapering a width of the sizing device at least partially between the cylindrical portion and the opening width of the opening at the attachment end, since a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976).
Regarding claim 4, the cited prior art suggests the invention of claim 2. Davis further discloses a semispherical base tapering at least partially between the cylindrical portion and the distal end (Ex. Fig. 1).
Regarding claim 5, the cited prior art suggests the invention of claim 2. Davis further discloses wherein the sizing device may be any suitable shape and/or size capable of collecting fluid (para. 0081); however, Davis differs from the instantly claimed invention in that Davis fails to disclose wherein the body includes a length from the distal end to the attachment end of at least 5.1 cm and the maximum width of at least about 5.1 cm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the body of Davis to have a length from the distal end to the attachment end of at least 5.1 cm and the maximum width of at least about 5.1 cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Davis would not operate differently with the claimed length and width and since the sizing device may be any suitable shape and/or size capable of collecting fluid (para. 0081), the device would function appropriately having the claimed length and width. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length and width “may” be within the claimed ranges (specification para. 0023-0024).
Regarding claim 9, the cited prior art suggests the invention of claim 1. Davis further discloses wherein the body includes a generally ellipsoid shape (Fig. 22 showing exemplary shapes of sizing device 28 for fitting within gluteal folds and perineum, first shape shaped similarly to sizing device 28 in Fig. 1, first shape generally ellipsoid as generally resembling a squashed sphere; para. 0081, sizing device 28 is any shape and/or size capable of collecting fluid).
Regarding claim 10, the cited prior art suggests the invention of claim 9. Davis further discloses wherein the sizing device may be any suitable shape and/or size capable of collecting fluid (para. 0081); however, Davis differs from the instantly claimed invention in that Davis fails to disclose wherein the body includes the maximum width of at least 6.25 cm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the body of Davis to have a maximum width of at least 6.25 cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Davis would not operate differently with the claimed width and since the sizing device may be any suitable shape and/or size capable of collecting fluid (para. 0081), the device would function appropriately having the claimed width. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the width “may” be within the claimed ranges (specification para. 0024).
Regarding claim 11, the cited prior art suggests the invention of claim 9. Davis further discloses wherein the sizing device may be any suitable shape and/or size capable of collecting fluid (para. 0081); however, Davis differs from the instantly claimed invention in that Davis fails to disclose wherein the body includes a length of about 2.5 cm to about 5 cm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the body of Davis to have a length of about 2.5-5 cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Davis would not operate differently with the claimed length and since the sizing device may be any suitable shape and/or size capable of collecting fluid (para. 0081), the device would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length “may” be within the claimed ranges (specification para. 0023).
Regarding claim 13, the cited prior art suggests the invention of claim 1. Davis further discloses wherein the sizing device may be any suitable shape and/or size capable of collecting fluid (para. 0081); however, Davis differs from the instantly claimed invention in that Davis fails to disclose wherein the recess includes a depth of about 1.25 cm to about 2.5 cm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the recess of Davis to have a depth of about 1.25-2.5 cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Davis would not operate differently with the claimed depth and since the sizing device may be any suitable shape and/or size capable of collecting fluid (para. 0081), the device would function appropriately having the claimed depth. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the depth “may” be within the claimed ranges (specification para. 0027).
Regarding claim 14, the cited prior art suggests the invention of claim 1. Davis further discloses wherein the recess includes a substantially cylindrical portion and a substantially semispherical portion (Ex. Fig. 1, cylindrical and semispherical portions of recess generally in same areas as similarly named areas of body).
Allowable Subject Matter
Claims 15-30 are allowed.
The following is an examiner’s statement of reasons for allowance:
No art on record, alone or in combination, could be found to teach the following limitations from claim 15: “[a] urine collection system, comprising: a urine collection device including a fluid impermeable barrier having a proximal end portion and a closed distal end portion…a sizing device secured or securable to the urine collection device, the sizing device including: a body having a distal end and an attachment end spaced from the distal end, the attachment end defining an opening; and an inner surface defining a recess extending into the body from the opening, the recess being sized and dimensioned to receive the closed distal end portion of the urine collection device and selectively secure the sizing device to the urine collection device with a friction fit between the closed distal end portion and at least a portion of the inner surface of the sizing device, wherein the body is sized and dimensioned to interface and/or contact legs and/or a gluteal cleft of a user when the sizing device is secured to the urine collection device”.
The closest prior art is US/2018/0228642 A1 to Davis, U.S. Patent no. 4,194,508 A to Anderson, and U.S. Patent no. 3,340,876 A to Hill.
In the previous Office Action filed 04/08/2025, the examiner utilized Davis to read on the claims. Davis can no longer read on the amended claim. The sizing device of Davis is a cap that is coupled to a second open end of a urine collection device (Fig. 1, urine collection device 10 comprising sizing device 28 attached to second open end; Fig. 7) to create a water-tight seal and act as a reservoir for diverted fluid which has been collected by the device (para. 0081), and the cap is attached to the open end by tape or shrink wrapping (para. 0082). The newly amended claim requires the sizing device to attach by a friction fit to a closed distal end of the urine collection device. Any modification to Davis to read on the amended claim would make Davis unsatisfactory for its intended purpose.
Anderson discloses a female urinary collection system comprising a removable fastening means for insertion into the vaginal opening (Fig. 1, female urinary collection system comprising removable fastening means 28). The body of the removable fastening means comprises an attachment end at the bottom of the body that is considered to span from the distal end to the proximal end (Fig. 5, fastening means 28 comprising groove 60 at the bottom of the body to connect to female urinary collection system). Further, as the removable fastening means is configured to be inserted into the vaginal opening, the body would not be sized and dimensioned to interface and/or contact legs and/or a gluteal cleft of a user when the removable fastening means is secured to the urine collection device.
Hill discloses a urinary collection system comprising a removable retaining means configured to be held between the legs of a user (Fig. 1, urinary collection system comprising removable retaining means 20; col. 3 ln. 22-25); however, like Davis, the retaining means is connected to an open end of a urine collection device and is configured to act as a reservoir for collected fluid (Fig. 1, removable retaining means 20 connected to end comprising opening 1131; col. 3 ln. 37-47). Any modification to Hill to read on the claim would make Hill unsatisfactory for its intended purpose.
Therefore, these limitations are not taught nor rendered obvious by the prior art stated or otherwise available to one of ordinary skill in the art before the effective filing date of the instant application, because the prior art fails to disclose or suggest the amended claims and any modification to read on the amended claims would make the prior art unsatisfactory for its intended purpose.
Claims 16-30 are allowable for depending upon an allowed base claim.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/PHILIP R WIEST/ Primary Examiner, Art Unit 3781