DETAILED ACTION
This action is responsive to the Amendment under 37 C.F.R. § 1.111 filed 22 October 2025. The Examiner acknowledges the amendments to the Specification and the amendments to claims 1 and 7. Claims 1-2, 4-7, 9-10, and 12-13 are pending.
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 .
Claim Interpretation
Examiner Notes: the previously presented claim interpretations invoked under § 112(f) on p. 5-6 of the Non-Final Rejection dated 22 April 2025 are maintained; the previously presented interpretations in light of intended use limitations on p. 7 of the Non-Final Rejection dated 22 April 2025 are maintained.
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.
Claim(s) 1, 10, and 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryu (US-20170112478-A1, previously presented).
Regarding claim 1, Ryu teaches
A device for collection of a bodily sample from an anatomical cavity, the device comprising:
an impermeable sheath [tube 100 (Ryu Figures 1-3)] arranged and configured to receive a finger of a user [The tube 100 has an open end part 110 and a closed end part 120, and provides an inner space where a finger may enter (Ryu ¶0044, Figure 3)], said sheath comprising a distal end [closed end part 120 (Ryu Figures 1-3)] and a proximal end [open end part 110 (Ryu Figures 1-3)];
a sample collecting means [collecting part 200 (Ryu Figures 1-3)] positioned at the distal end of the sheath [The collecting part 200 may be provided as a pad form that attaches to the outer surface of the closed end part 120 of the tube 100 (Ryu ¶0049)]; and
a pad [wherein the flange portion formed by the latter part 110 and the tight band 140 positioned in circumference of the latter part 110 is considered to form the hermetically closable pad; Like FIG. 6, (the sealing step) prevents contaminating the sample by sealing the open end part 110 of the tube 100 after the turnover step (Ryu ¶0054)] positioned at the proximal end of the sheath [Ryu Figures 1-2],
wherein the pad comprises a first surface and a second surface [see Annotated Figure 1 below], and wherein, in use, the first surface faces the anatomical cavity and the second surface faces away from the anatomical cavity so as to prevent contact between the finger of the user and the anatomical cavity [wherein as noted in the Claim Interpretation section above, the limitation “wherein, in use,…” is considered to be an intended use of the claimed device, and is not specifically required to be taught by the applied art; however, in order to advance prosecution, the Examiner notes that as depicted in Figure 3 of Ryu, the pad (flange portion formed by the latter part 110 and the tight band 140 positioned in circumference of the latter part 110 as depicted in Figures 1-2) is depicted as preventing contact between the finger of the user and the anatomical cavity] and wherein the pad does not hinder a movement of the user [wherein as noted in the Claim Interpretation section above, the limitation “wherein, in use,…” is considered to be an intended use of the claimed device, and is not specifically required to be taught by the applied art; however, in order to advance prosecution, the Examiner cites the following portion of Ryu: Meanwhile, the tube 100 may be composed of at least one of a natural rubber, synthetic rubber, or silicon. For example, the tube 100 of the embodiment is provided with a silicon material (Ryu ¶0048), wherein the flexibility of the material to be manipulated with a finger and inverted (Ryu Figures 4-5) is considered to define a material property of the pad to not hinder a movement of the user],
wherein the pad comprises a line of weakness about which the pad can be folded [Ryu ¶0048, wherein the device comprising a flexible material (rubber, silicon), any line along the portion of the flange portion formed by the latter part 110 and the tight band 140 positioned in circumference of the latter part 110, considered to read on the claimed pad, may be considered to read on the claimed “line of weakness” as the entire device being flexible is considered to allow the pad to be folded along said any line], and
wherein the second surface comprises an impermeable layer [Ryu ¶0048, wherein the device comprising an impermeable material (rubber, silicon), the portion of the flange portion formed by the latter part 110 and the tight band 140 positioned in circumference of the latter part 110, considered to read on the claimed pad, facing away from the cavity as depicted in Figures 11-12 of Ryu is considered to comprise an impermeable layer], and
wherein the sheath comprises a material that is flexible [Like FIGS. 4 and 5, the turnover step turns over inside out of the tube 100 by pulling the pull string 310 of the turner 300 after taking out the finger from the tube, wherein the tube 100 is inserted inside of the woman's vaginal (Ryu ¶0053), wherein the tube 100 being made of a material that is foldable and invertible (see Ryu ¶0084) is considered to define a material that is flexible based on the BRI of flexible referring to being capable to bend (https://www.merriam-webster.com/dictionary/flex#h1)].
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Annotated Figure 1. Figure 2 of Ryu is considered to depict wherein the pad comprises a first surface and a second surface as defined by the flange portion formed by the latter part 110, wherein the surface portion of the flange portion facing the anatomical cavity (as depicted in Figure 3 of Ryu) is considered to read on the claimed first surface, and the surface portion facing away from the anatomical cavity (as depicted in Figure 3 of Ryu) is considered to read on the claimed second surface.
Regarding claim 10, Ryu teaches
The device according to claim 1, further comprising a removal string [pull string 310 (Ryu Figure 6)] coupled to the distal end of the sheath [Ryu Figure 6].
Regarding claim 13, Ryu teaches
A method for collecting a bodily sample from an anatomical cavity comprising the steps of collecting a sample from said anatomical cavity using a device according to claim 10 [the apparatus for self-collecting intravaginal sample 10 (Ryu ¶0043); see § 102 rejection of claim 10 above],
wherein, during said method, a user positions their finger at the distal end of the sheath and inserts their finger into the sheath so as to push the sample collecting means towards the proximal end of the sheath, and the device is then placed into the anatomical cavity [(The inserting step) like FIG. 3, a user places her finger inside the tube 300 and inserts the tube 100 inside of her cervix through her intravaginal 1 (Ryu ¶0053, Figure 3)] and the sample collecting means is exposed and positioned at a target area where it can collect fluids [(The collecting step) when the closed end part 120 of the tube 100 enters a cervix 2, the woman may collect a sample of the intravaginal to the collecting part 200 using her fingertip, wherein the collecting part 200 is attached at the outer surface of the closed end of the tube 100 (Ryu ¶0053, Figure 4)], and
wherein once the sample has been collected the user draws the sample collecting means out of the anatomical cavity and back inside the sheath by pulling on the string [(The turnover step) To prevent contaminating the collecting part 200 from outside contaminants, the collecting part 200 is placed inside of the tube 100 by turning over inside out of the tube 100, wherein the collecting part 200 comprises a collected intravaginal sample. Like FIGS. 4 and 5, the turnover step turns over inside out of the tube 100 by pulling the pull string 310 of the turner 300 after taking out the finger from the tube, wherein the tube 100 is inserted inside of the woman's vaginal (Ryu ¶0053, Figures 4-5)].
Regarding claim 12, Ryu teaches
The method according to claim 13, wherein the anatomical cavity is the vaginal cavity [the apparatus for self-collecting intravaginal sample 10 (Ryu ¶0043, Figure 1)], the rectal cavity, or the buccal cavity.
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.
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) 2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryu, as applied to claim 1 above, and further in view of McDonald (US-5193684-A, previously presented).
Regarding claim 2, Ryu teaches
The device according to claim 1.
However, while Ryu provides exemplary embodiments of the pad [the sealed member 130 may be provided with different sealed structures such as adhesively sealing the open end part 110 by applying glue at the outer surface of the open end part when the tube 100 is turned over or as zip locking the open end part 110 (Ryu ¶0047)], Ryu fails to explicitly disclose wherein said first surface comprising an adhesive layer.
McDonald discloses systems for receiving a device from an anatomical cavity [McDonald abstract], wherein McDonald discloses a pad comprising a first surface facing [back sheet 16 (McDonald Figures 2-3, 5)], in use, the cavity [The device 10 minus the towel 18 is then disposed, as a unit, flatly against the surface of the user's body with the central openings and slits generally centrally disposed over the cavity containing the tampon (McDonald Col 3, lines 38-41, Figure 3)], said first surface comprising an adhesive layer [double coated tape 44 (McDonald Figures 2-5)].
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 device of Ryu to employ an adhesive layer to comprise the first surface, as this modification would amount to mere simple substitution of one sealing structure [sealed member 130 of Ryu] for another [back sheet 16 and double coated tape 44 of McDonald], with the similar expected result of sealing the claimed sheath [MPEP § 2143(I)(B)].
Regarding claim 4, Ryu in view of McDonald teaches
The device according to claim 2.
However, Ryu fails to explicitly disclose wherein the adhesive is a pressure-sensitive adhesive.
McDonald discloses a sealable pad comprising a pressure-sensitive adhesive [With the bag extended fully to its forward position, as illustrated by FIG. 3, and projecting forwardly of the front sheet 12, the major or axis end portions of the sheets are grasped and pulled in a toward each other so that the double coated tape 44 seals with the opposite major axis end flat portion of the sheet 16 to close the opening 32 (McDonald Col 4, lines 3-9, Figure 4, wherein pressing the double coated tape 44 to seal the sheet 16 is considered to read on the adhesive being a pressure-sensitive adhesive].
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 device of Ryu in view of McDonald to employ a pressure-sensitive adhesive, as this modification would amount to mere simple substitution of one adhesive [adhesive seal of Ryu] for another adhesive [double coated tape 44 of McDonald] with the similar expected result of sealing the claimed pad [MPEP § 2143(I)(B)].
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryu in view of McDonald as applied to claim 2 above, and further in view of Conner (US-4648867-A, previously presented).
Regarding claim 5, Ryu in view of McDonald teaches
The device according to claim 2.
However, Ryu in view of McDonald fails to explicitly disclose wherein the adhesive is a reseal adhesive.
Conner discloses systems for sealing a device for insertion into an anatomical cavity [Connor abstract], wherein Conner discloses the use of reseal adhesives [Reference numeral 5 refers to the combination of the broad-collared ring 7 and the removable closure 6 with its tab 8 (Conner Col 3, lines 14-16); The closure may be made of paper, foil, or other similar material, and is removably secured to the ring by use of a peelable adhesive or other securing means (Conner Col 3, lines 49-52, Figure 3)].
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 device of Ryu in view of McDonald to employ a reseal adhesive, as this modification would amount to mere simple substitution of one kind of adhesive [double coated tape 44 of McDonald based on the previous 103 rejection of claim 2 above] for another [peelable adhesive of Conner], with the similar expected result of providing an adhesive seal [McDonald Col 3, lines 38-41; Conner Col 3, lines 49-52] [MPEP § 2143(I)(B)].
Regarding claim 6, Ryu in view of McDonald teaches
The device according to claim 2.
However, Ryu in view of McDonald fails to explicitly disclose wherein the adhesive layer is covered by a removable film.
Conner discloses systems for sealing a device for insertion into an anatomical cavity, wherein Conner discloses covering an adhesive layer by a removable film [removable closure 6 (Conner Figure 3)] [The closure may be made of paper, foil, or other similar material, and is removably secured to the ring by use of a peelable adhesive or other securing means (Conner Col 3, lines 49-52, Figure 3)].
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 device of Ryu in view of McDonald to employ a removable film to cover the adhesive layer, to make the device tamper-proof prior to removal of the film [if the closure is made of a properly selected material, such as foil, the package can be made tamper proof (Conner Col 3, lines 55-57)].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryu in view of McDonald and Conner as applied to claim 6 above, and further in view of Hooi (US-20160184143-A1, previously presented).
Regarding claim 7, Ryu in view of McDonald and Conner teaches
The device according to claim 6.
However, the combination of Ryu in view of McDonald and Conner fails top explicitly disclose wherein the surface of the removable film facing, in use, the cavity, comprises an absorbent layer.
Hooi discloses devices for insertion into an anatomical cavity [Hooi abstract], wherein Hooi discloses positioning an absorbent layer towards the anatomical cavity [The pad 3 has an absorbent layer on the inward side 7 and a liquid impermeable layer on the outward side 8. In this embodiment, the absorbent layer is made from compressed cotton and the liquid impermeable layer is made from a polymeric material (Hooi ¶0067, Figure 1)].
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 device of Ryu in view of McDonald and Conner to employ an absorbent layer facing the cavity, so as to absorb any bodily fluids that may exit the anatomical cavity [Another important function of the anchor element is to recover any fluid rejected by the cavity. Preferably, the anchor element comprises an absorbent layer. Because of the nature and functions of the vaginal and rectal cavities, body fluids (and also some composition mixed with the body fluids) can be rejected by the cavity and soil the wearer's clothes. Preferably, the anchor element comprises a liquid impermeable layer, such as a liquid impermeable backing sheet so that any fluid rejected by the cavity and/or absorbed by the absorbent layer does not soil the wearer's clothes (Hooi ¶0024)].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryu as applied to claim 1 above, and further in view of Hooi.
Regarding claim 9, Ryu teaches
The device according to claim 1.
However, Ryu fails to explicitly disclose wherein the pad comprises an absorbent layer.
Hooi discloses devices for insertion into an anatomical cavity [Hooi abstract], wherein Hooi discloses positioning an absorbent layer towards the anatomical cavity [The pad 3 has an absorbent layer on the inward side 7 and a liquid impermeable layer on the outward side 8. In this embodiment, the absorbent layer is made from compressed cotton and the liquid impermeable layer is made from a polymeric material (Hooi ¶0067, Figure 1)].
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 device of Ryu to employ an absorbent layer, so as to absorb any bodily fluids that may exit the anatomical cavity [Another important function of the anchor element is to recover any fluid rejected by the cavity. Preferably, the anchor element comprises an absorbent layer. Because of the nature and functions of the vaginal and rectal cavities, body fluids (and also some composition mixed with the body fluids) can be rejected by the cavity and soil the wearer's clothes. Preferably, the anchor element comprises a liquid impermeable layer, such as a liquid impermeable backing sheet so that any fluid rejected by the cavity and/or absorbed by the absorbent layer does not soil the wearer's clothes (Hooi ¶0024)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 5, filed 22 October 2025, with respect to the previously presented Specification Objections have been fully considered and are persuasive. The specification objection has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 5, with respect to the previously presented Claim Objections have been fully considered and are persuasive. The claim objection of claim 7 has been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 5-7, with respect to the previously applied Claim Rejections under § 102 and § 103 have been fully considered but they are not persuasive.
The Applicant asserts that Ryu fails to teach or suggest the amended limitation “the sheath comprises a material that is flexible”, wherein the Applicant argues that the tube 100 of Ryu is “rigid” as exemplified in Fig. 2 of Ryu depicting the tube 100 as not collapsing and maintaining a relatively constant diameter when the tight band 140 is placed around it. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that Ryu discloses the use of a material that is capable of being foldable and being inverted [Ryu ¶¶0053, 0084], wherein the Examiner notes that the material of Ryu is considered to read on the broadest reasonable interpretation of “a material that is flexible” [flexible is defined as being capable of bending (https://www.merriam-webster.com/dictionary/flex#h1)]. The Examiner further notes that the tube 100 as depicted in Fig. 2 of Ryu is not considered to be in use and is described as being a “plan view”, as opposed to Figs. 4-5 of Ryu, which are considered to depict the tube 100 as being invertible.
The Applicant asserts that Ryu fails to teach or suggest (i) “a pad positioned at the proximal end of the sheath”, wherein the Applicant directs attention to element 200 of Ryu, which is defined as a pad positioned at the distal end of the tube, and also argues that the “so-called ‘flange portion’” would not be considered a “pad” by one of ordinary skill in the art. However, the Examiner disagrees with the Applicant’s arguments, as the Examiner notes that element 200 of Ryu is not cited as the claimed pad, such that the specific argument regarding element 200 being in the wrong position to be considered the claimed pad is not considered applicable. Furthermore the Examiner notes that the claimed pad lacks sufficient particular structure to prevent the flange portion of Ryu from read on the broadest reasonable interpretation of a “pad” [wherein a pad is defined as a thin flat mat or cushion: such as (1) a guard worn to shield body parts against impact; (4) a piece of usually folded absorbent material (such as gauze) used as a surgical dressing or protective covering (https://www.merriam-webster.com/dictionary/pad), wherein the flange portion is considered to be defined as a relatively flat element along a 2D plane perpendicular to a longitudinal axis defined by a length of pull string 310 as depicted in at least Ryu Fig. 2].
The Applicant further asserts that Ryu fails to teach or suggest (iii) “wherein, in use, the first surface faces the anatomical cavity and the second surface faces away from the anatomical cavity so as to prevent substantial direct contact between a user and the anatomical cavity”, wherein the Applicant argues that the end part 110 and tight band 140 cannot effectively “prevent substantial direct contact between a user and the anatomical cavity” since the end part 110 and tight band 140 are not in the form of a pad and do not cover any significant lateral area so as to prevent contact. However, the Examiner disagrees with the Applicant’s argument regarding the pad for reasons discussed in the Examiner’s Response to Arguments above and further notes that as depicted in Figure 3 of Ryu, the pad [flange portion formed by the latter part 110 and the tight band 140 positioned in circumference of the latter part 110 as depicted in Figs. 1-2] is depicted as preventing contact between the finger of the user and the anatomical cavity [wherein as noted in the Claim Interpretation section above, the limitation “wherein, in use,…” (lines 7-10) is considered to be an intended use of the claimed device, and is not specifically required to be taught by the applied art, but is still considered to be taught by Ryu as noted above for the sake of compact prosecution].
The Applicant also asserts that Ryu fails to teach or suggest (v) “wherein the second surface comprises an impermeable layer”. The Examiner notes that Applicant’s arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. The Examiner disagrees with the Applicant’s argument, as the Examiner notes that as the device of Ryu comprises an impermeable material [rubber, silicon], the portion of the flange portion formed by the latter part 110 and the tight band 140 positioned in circumference of the latter part 110, is considered to comprise an impermeable layer.
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.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/S.P.L./Examiner, Art Unit 3791