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 .
Response to Arguments
Applicant's arguments filed 7/17/2026 have been fully considered but they are not persuasive. Claim 1 recites the first and second barrier line or rim are adapted to sealingly engage the skin of a user which is contemplated by Marsan (US 3712304 A, see column 7 lines 16-19: “The gel ring 22 and the tapes 41 will be pressed against the skin around the stoma making sealing engagement with the skin.”). In response to applicant's argument that the Marsan fails to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., similar barriers or rims creating substantially uniform and coordinated skin seals) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 (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 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(s) 1-4, 7-17, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peck (US 4706676 A) in view of Marsan (US 3712304 A), and in further view of Cheng et al. (US 20040176731 A1).
Regarding claim 1, Peck discloses a system for collecting, for diagnostic and/or treatment purposes, samples of urine or body fluids exuding from a skin of a user (abstract), comprising a base part (7, fig. 3) of a pliable material adapted to be draped on the skin of a user closely following contours of a predetermined body part of the user (column 6 lines 56-65) and having an inner side facing the skin of the user (figs. 1-3), and a urine or fluid collecting part (3) provided on the inner side of the base part (figs. 2 and 3).
However, Peck fails to disclose wherein the base part, on its inner side, comprises at least an area defined by at least one second barrier line or rim encircling at least a part of the urine or fluid collecting part exposed to a user, and at least a first barrier line or rim at its circumference encircling at least one second barrier line or rim, and wherein the first barrier line or rim and the at least one second barrier line or rim are adapted to sealingly engage the skin of a user, thereby preventing intrusion of any contaminations into the area surrounding the urine or fluid collecting part and leakage of urine or body fluids therefrom.
Marsan teaches a bodily fluid collection device wherein the base part (38), on its inner side (figs. 7-9), comprises at least an area defined by at least one second barrier line or rim (22) encircling at least a part of the urine or fluid collecting part (42, fig. 9) exposed to a user, and at least a first barrier line or rim (41) at its circumference encircling at least one second barrier line or rim (fig. 8), and wherein the first barrier line or rim (41) and the at least one second barrier line or rim (22) are adapted to sealingly engage the skin of a user (column 7 lines 4-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Peck and incorporate the first and second barriers of Marsan to enhance the sealing effects of the device to the user (column 7 lines 4-19).
However, Marsan fails to expressly disclose “thereby preventing intrusion of any contaminations into the area surrounding the urine or fluid collecting part and leakage of urine or body fluids therefrom.” While features of an apparatus may be recited either structurally or functionally, claims directed to a device must be distinguished from the prior art in terms of structure rather than function, because device claims cover what a device is, not what a device does (MPEP 2114). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. In this case, the device/apparatus of Marsan is capable of performing the claimed function because the double peripheral seal is to increase adhesion to the skin of the user and preventing leaks so as much as it keeps fluid in, it would keep incoming fluid or contaminants out.
However, the combination of Peck and Marsan fails to disclose a capillary structure which is at least partly enclosed by a polymer film wrapping or bag adapted to receive and contain urine or fluids excreted by a user.
Cheng teaches a bodily fluid collection device with a capillary structure (211) adapted to receive and adsorb urine or fluids excreted by a user (para. [0047, 0116, 0117]). Additionally, Peck teaches a polymer film wrapping (occlusive cover 2, column 5 lines 50-51) or bag.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Peck and Marsan and incorporate the capillary material as shown in Cheng to enhance wicking of the fluid away from the user towards the collection device (para. [0022, 0116, 0117]).
Regarding claims 2-4, the combination of Peck, Marsan, and Cheng discloses the system of claim 1. However, Peck fails to disclose:
(Claim 2) wherein the first barrier line or rim and the at least one second barrier line or rim have a shape of one of a raised area, a film, a printed area or line or any structure adapted to effect hermetically sealing against the skin of a user;
(Claim 3) wherein the first barrier line or rim and the at least one second barrier line or rim have adhesive characteristics on a surface providing efficient adhesion to the skin of the user and an easy peel-off characteristic;
(Claim 4) wherein the first barrier line or rim and the at least one second barrier line or rim comprise flexible and/or cushioning material able to closely follow contours of the skin of the user.
Cheng teaches:
(Claim 2) wherein the first barrier line or rim (41) and the at least one second barrier line or rim (22) have a shape of one of a raised area (see side profile fig. 9), a film, a printed area or line or any structure adapted to effect hermetically sealing against the skin of a user;
(Claim 3) wherein the first barrier line or rim (41) and the at least one second barrier line or rim (22) have adhesive characteristics on a surface providing efficient adhesion to the skin of the user and an easy peel-off characteristic (column 7 lines 4-19);
(Claim 4) wherein the first barrier line or rim (41) and the at least one second barrier line or rim (22) comprise flexible and/or cushioning material (claim 1 states the sealing means has elasticity, flexibility, and compressibility) able to closely follow contours of the skin of the user (fig. 5, 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Peck and incorporate the first and second barriers of Marsan to enhance the sealing effects of the device to the user (column 7 lines 4-19).
Regarding claim 7, the combination of Peck, Marsan, and Cheng discloses the system of claim 1. Peck further discloses wherein the base part (7) is made of a textile or textile based pliable material (column 5 lines 51-67).
Regarding claim 8, the combination of Peck, Marsan, and Cheng discloses the system of claim 7. Peck further discloses wherein the textile or textile based material is coated on one or both of its sides with a waterproof (column 5 lines 51-67) or water repellent inert material.
Regarding claim 9, the combination of Peck, Marsan, and Cheng discloses the system of claim 1. Peck further discloses wherein the base part (7) is made of a waterproof or water repellent material (column 5 lines 51-67).
Regarding claims 10 and 12-13, the combination of Peck, Marsan, and Cheng discloses the system of claim 1. However, Peck fails to disclose:
(Claim 10) wherein the base part is shaped to surround and cover a genital area of the user, leaving the user's anus area uncovered;
(Claim 12) wherein the base part has at least one or two laterally protruding parts;
(Claim 13) wherein the urine or body fluid collecting part is extending from a barrier-defined waterproof or water repellent area on the inner side of the base part to an outer side of the base part and that it comprises at least one inner end part located within the area and capable of receiving urine or body fluids, and an outer part protruding from the base part.
Cheng teaches:
(Claim 10) wherein the base part (21) is shaped to surround and cover a genital area of the user, leaving the user's anus area uncovered (fig. 3B, para. [0116, 0117]);
(Claim 12) wherein the base part (21) has at least one or two laterally protruding parts (lateral wings seen in fig. 4A, 4B).
(Claim 13) wherein the urine or body fluid collecting part (22) is extending from a barrier-defined waterproof or water repellent area (210) on the inner side of the base part (21, fig. 4A) to an outer side of the base part (fig. 4B) and that it comprises at least one inner end part located within the area and capable of receiving urine or body fluids, and an outer part protruding from the base part (para. [0116-0118]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid collection system of Peck and apply it to urine collection as shown by Cheng because collecting urine samples is a common practice and Cheng similarly teaches a device that is flush to the skin of the user to collect the bodily exudate (para. [0116-0118]).
Regarding claim 11, the combination of Peck, Marsan, and Cheng discloses the system of claim 1. Peck further discloses wherein the base part (7) has rounded edges or corners (fig. 1).
Regarding claims 14-15, the combination of Peck, Marsan, and Cheng discloses the system of claim 13. However, Peck fails to disclose:
(Claim 14) wherein the outer part of the urine or body fluid collecting part is covered by a protective cover made of an opaque or a transparent material;
(Claim 15) wherein the protective cover is detachably connected to the base part.
Cheng teaches:
(Claim 14) wherein the outer part of the urine or body fluid collecting part is covered by a protective cover (224) made of an opaque or a transparent material (fig. 4B, para. [0120]);
(Claim 15) wherein the protective cover (224) is detachably connected to the base part (para. [0049] states that the device can detached from the connection with the conduit so the cover (213) is detachably connected to the base part as the entire conduit is disconnected).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Peck and incorporate the protective cover on the collecting part of Cheng to further waterproof the conduit (para. [0120]).
Regarding claims 16-17, the combination of Peck, Marsan, and Cheng discloses the system of claim 14. However, Peck fails to disclose:
(Claim 16) wherein the outer part of the urine or body fluid collecting part is at least partly extending underneath the least one inner end part of the body fluid collecting part either parallel to a center line of the base part or enclosing an angle therewith;
(Claim 17) wherein the urine or body fluid collecting part is extending through an opening in the base part and that a sealing means is provided adjacent the opening on the inner side and/or outer side of the base part.
Cheng teaches:
(Claim 16) wherein the outer part of the urine or body fluid collecting part (22) is at least partly extending underneath the least one inner end part of the latter either parallel to a center line of the base part (fig. 4B, para. [0118]) or enclosing an angle therewith;
(Claim 17) wherein the urine or body fluid collecting part is extending through an opening in the base part (fig. 4B, para. [0116]) and that sealing means (226, para. [0118-0119]) are provided adjacent the opening on the inner side and/or outer side of the base part (fig. 4B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Peck and incorporate the urine or body fluid collecting part to remove incoming bodily fluid via a conduit through the bottom of the device (para. [0118-0119]).
Regarding claim 20, the combination of Peck, Marsan, and Cheng discloses the system of claim 2. However, Peck fails to disclose wherein the first barrier line or rim and the at least one second barrier line or rim have adhesive characteristics on a surface providing efficient adhesion to the skin of the user and an easy peel-off characteristic.
Marsan teaches wherein the first barrier line or rim (41) and the at least one second barrier line or rim (22) have adhesive characteristics on a surface providing efficient adhesion to the skin of the user and an easy peel-off characteristic (column 7 lines 4-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Peck and incorporate the first and second barriers of Marsan to enhance the sealing effects of the device to the user (column 7 lines 4-19).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peck (US 4706676 A) in view of Marsan (US 3712304 A), Cheng et al. (US 20040176731 A1), and in further view of Lee (US 20230172748 A1).
Regarding claim 5, the combination of Peck, Marsan, and Cheng discloses the system of claim 1, but fails to disclose wherein on a surface of the area of the inner side of the base part between the first barrier line or rim and the at least one second barrier line or rim protruding dots and or rims are provided having the same height as the first barrier line or rim and the at least one second barrier line or rim.
Lee teaches a skin contacting fluid absorption device with protruding dots (para. [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Peck and incorporate the protruding dots of Lee to create areas of distance from the skin surface to the substrate (para. [0028]). Further, it would have been obvious for the dots to be the same height as the barrier rims because if they are taller than the adhesive rim would not fit as securely and if they are shorter than they are not contacting the skin.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peck (US 4706676 A) in view of Marsan (US 3712304 A), Cheng et al. (US 20040176731 A1), and in further view of Stoll et al. (US 20220355290 A1).
Regarding claim 6, the combination of Peck, Marsan, and Cheng discloses the system of claim 1, but fails to disclose wherein the area of the base part is coated with an inert material unable to influence essential characteristics of urine or body fluids received in this area.
Stoll teaches a urine sampling device with an inert material unable to influence essential characteristics of urine or body fluids received in this area (para. [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Peck and incorporate the inert material of Stoll to not alter the collected sample and impact the analysis (para. [0058]).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peck (US 4706676 A) in view of Marsan (US 3712304 A), Cheng et al. (US 20040176731 A1), and in further view of Mayer (US 4360015 A).
Regarding claims 18-19, the combination of Peck, Marsan, and Cheng discloses the system of claim 1, but fails to disclose:
(Claim 18) wherein the capillary structure of the urine or body fluid collecting part comprises a fabric in the form of one of a single sheet, a double or multiple folded sheet, or a material having similar characteristics with one or more end part;
(Claim 19) wherein the capillary structure of the urine or body fluid collecting part comprises one of synthetic yarns, multifilament yarns, fibers, and porous material having a cellular structure.
Mayer teaches an absorbent structure:
(Claim 18) wherein the capillary structure of the urine or body fluid collecting part comprises a fabric in the form of one of a single sheet, a double or multiple folded sheet, or a material having similar characteristics with one or more end part (column 4 lines 48-63);
(Claim 19) wherein the capillary structure of the urine or body fluid collecting part comprises one of synthetic yarns, multifilament yarns, fibers, and porous material having a cellular structure (column 4 lines 48-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Peck and incorporate the capillary structure of Mayer with predictable results namely, wicking material to pull incoming fluid away from the skin (column 4 lines 48-63).
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 ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (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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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 8 September 2026
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