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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5 June 2026 has been entered.
The Examiner acknowledges the amendments to claim 1. Claims 1-2, 4-7, 9-10, and 12-13 are pending.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 1, 10, and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryu (US-20170112478-A1, previously presented) in view of Conner (US-4648867-A, previously presented).
Regarding claim 1, Ryu teaches
A device for collection of a bodily sample from an anatomical cavity in a body, 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 flange positioned at the proximal end of the sheath [see flange portion formed by the latter part 110 and the tight band 140 positioned in circumference of the latter part 110; 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, Figs. 1-2)],
wherein the flange does not hinder a movement of the user [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 flange to not hinder a movement of the user], and
wherein the flange comprises an impermeable material [Ryu ¶0048], 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)].
However, while Ryu discloses a flange and wherein the device comprises impermeable material [Ryu ¶0048, Figs. 1-2], Ryu fails to explicitly disclose wherein the flange is a pad, wherein the pad comprises a first surface and a second surface, the pad being configured such that the first surface faces the anatomical cavity and the second surface faces away from the anatomical cavity, wherein the pad is configured to act as a shield between the user's hand and the body, the pad having dimensions so as to prevent substantial direct contact between the user's hand and the body, and so as to prevent contact between the finger of the user and the anatomical cavity; wherein the second surface comprises an impermeable layer.
Conner discloses devices for insertion into an anatomical cavity using a user’s hand, wherein Hooi discloses an impermeable sheath arranged and configured to receive a finger of a user [a protective sheath 2… In FIG. 5, the tampon is fully inserted, and the sheath and finger have passed fully through the clear opening in the broad-collared ring 7 (semi-transparent in these drawings but which may preferably be opaque) (Conner Col 3:11-13, 22-24)] and a pad positioned at the proximal end of the sheath, wherein the pad comprises a first surface and a second surface, the pad being configured such that the first surface faces the anatomical cavity and the second surface faces away from the anatomical cavity, wherein the pad is configured to act as a shield between the user's hand and the body, the pad having dimensions so as to prevent substantial direct contact between the user's hand and the body, and so as to prevent contact between the finger of the user and the anatomical cavity [see broad collared ring 7 (Conner Figs. 4-6); As shown in FIGS. 4 and 5, during insertion the ring can reduce or eliminate contact between the outside of the body and the hand… the inserting finger has made no contact with the body orifice (Conner Col 3:19-22, 33-34)], and wherein the pad does not hinder a movement of the user [The system also permits sanitary, one-handed direct insertion of the tampon (Conner Col 2:32-34, Figs. 3-7), wherein the device being configured to be operable one-handed is considered read on not hindering movement]; wherein the second surface comprises an impermeable layer [the sheath, the ring and the closure in combination constitute a sanitary, impermeable package for the tampon (Conner Col 6:3-5)].
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 wherein the flange is a pad, wherein the pad comprises a first surface and a second surface, the pad being configured such that the first surface faces the anatomical cavity and the second surface faces away from the anatomical cavity, wherein the pad is configured to act as a shield between the user's hand and the body, the pad having dimensions so as to prevent substantial direct contact between the user's hand and the body, and so as to prevent contact between the finger of the user and the anatomical cavity; wherein the second surface comprises an impermeable layer, so as to reduce or eliminate contact between the outside of the body and the user’s hand during operation of the device to maintain sanitary conditions of the device.
Regarding claim 10, Ryu in view of Conner teaches
The device according to claim 1, further comprising a removal string coupled to the distal end of the sheath [pull string 310 (Ryu Fig. 6)].
Regarding claim 12, Ryu in view of Conner teaches
The method according to claim 13, wherein the anatomical cavity is the vaginal cavity [Ryu ¶0043, Fig. 1], the rectal cavity, or the buccal cavity.
Regarding claim 13, Ryu in view of Conner teaches
A method for collecting a bodily sample from an anatomical cavity comprising the steps of collecting a sample from said anatomical cavity using the device according to claim 10 [the apparatus for self-collecting intravaginal sample 10 (Ryu ¶0043)],
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, Fig. 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, Fig. 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, Figs. 4-5)].
Claim(s) 2 and 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryu in view of Conner, as applied to claim 1 above, in further view of McDonald (US-5193684-A, previously presented).
Regarding claim 2, Ryu in view of Conner teaches
The device according to claim 1.
However, while Ryu provides exemplary embodiments of the flange being sealed via adhesive [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 in view of Conner as presently modified 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 Figs. 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 3:38-41, Fig. 3)], said first surface comprising an adhesive layer [double coated tape 44 (McDonald Figures 2-5); 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 4:3-9, Fig. 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 Conner to employ an adhesive layer to comprise the first surface, so as to enable closure of the contaminated portion of the device after use, and 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 Conner and McDonald teaches
The device according to claim 2, wherein the adhesive is a pressure-sensitive adhesive [See § 103 modification of claim 2 above; McDonald Col 4:3-9].
Regarding claim 5, Ryu in view of Conner and McDonald teaches
The device according to claim 2.
However, Ryu in view of Conner and McDonald as presently modified fails to explicitly disclose wherein the adhesive is a reseal adhesive.
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 3:14-16); 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 3:49-52, Fig. 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 Conner and McDonald to employ wherein the adhesive is a reseal adhesive, as this modification would amount to mere simple substitution of one known element for another with similar expected results [provide an adhesive seal] [MPEP § 2143(I)(B)].
Regarding claim 6, Ryu in view of Conner and McDonald teaches
The device according to claim 2.
However, Ryu in view of Conner and McDonald as presently modified fails to explicitly disclose wherein the adhesive layer is covered by a removable film.
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 3:49-52, Fig. 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 Conner and McDonald to employ wherein the adhesive layer is covered by a removable film, so as to make the device tamper-proof prior to removal of the film.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryu in view of Conner and McDonald, as applied to claim 6 above, and further in view of Hooi (US-20160184143-A1, previously presented).
Regarding claim 7, Ryu in view of Conner and McDonald teaches
The device according to claim 6.
However, Ryu in view of Conner and McDonald fails to 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, wherein Hooi discloses positioning an absorbent layer towards 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); 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, Fig. 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 Conner and McDonald to employ an absorbent layer facing the cavity, so as to absorb any bodily fluids that may exit the anatomical cavity.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryu in view of Conner, as applied to claim 1 above, and further in view of Hooi (US-20160184143-A1, previously presented).
Regarding claim 9, Ryu in view of Conner teaches
The device according to claim 1.
However, Ryu in view of Conner fails to explicitly disclose wherein the pad comprises an absorbent layer.
Hooi discloses devices for insertion into an anatomical cavity, wherein Hooi discloses positioning an absorbent layer towards the anatomical cavity [Hooi ¶0024, 0067, Fig. 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 Conner to employ an absorbent layer facing the cavity, so as to absorb any bodily fluids that may exit the anatomical cavity.
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 4-7, filed 5 June 2026, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ryu (US-20170112478-A1, previously presented) in view of Conner (US-4648867-A, previously presented).
The Applicant asserts that the previously applied Ryu reference does not teach or suggest the amended feature wherein “the pad is configured to act as a shield between the user's hand and the body, the pad having dimensions so as to prevent substantial direct contact between the user's hand and the body”, as the Applicant notes that one of ordinary skill in the art would understand that the flange portion of part 110 near the tight band 140 of tube 100 in Ryu is not a pad as amended. The Applicant further argues that Ryu teaches away from the feature as recited in amended claim 1, as the Applicant notes that the tight band 140 in Ryu is designed only to keep the tube on the finger, not to act as a shield [Ryu ¶¶0046, 0083], and further points out that in Fig. 10 of Ryu, the user’s hand is clearly and easily capable of contacting the body into which the finger is inserted. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Ryu is further modified by Conner to employ a pad with structure and functionality as claimed [see broad collared ring 7 (Conner Figs. 4-6); As shown in FIGS. 4 and 5, during insertion the ring can reduce or eliminate contact between the outside of the body and the hand… the inserting finger has made no contact with the body orifice (Conner Col 3:19-22, 33-34)].
The Applicant additionally cites ¶0044 of Ryu as characterizing the open end part 110 as merely a tube opening, not a laterally-extending pad. The Applicant also particularly points out the amended claim language “dimensions so as to prevent substantial direct contact between the user’s hand and the body” as not being an intended-use recitation and instead being a structural requirement specifying that the pad must have physical dimensions large enough to act as a barrier between the user’s hand and the body; wherein the Applicant further notes that Ryu’s open end part 110 as being structurally incapable of the claimed function and notes that the identified portion of Ryu is not a broad pad or shield and that one of ordinary skill in the art would understand that a structure must have substantial lateral extent, akin to the pad described in the Applicant’s Specification to perform the claimed function. However, the Examiner notes that in response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “a laterally-extending pad”, “broad pad or shield”, “a structure must have substantial lateral extent, akin to the pad described in the Applicant’s Specification”) 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). Furthermore, based on the present modification of Ryu in view of Conner, the pad as modified [Conner Col 3:19-22, 33-34, Figs. 4-6] is considered to read on the argued features that are not recited in the rejected claims.
The Applicant asserts that the additionally cited references of McDonald, Conner, or Hooi, taken alone or in combination with Ryu, do not teach or suggest the argued amended feature. However, the Examiner disagrees with the Applicant’s argument for reasons as noted above with respect to the disclosure of Conner that is considered to read on the amended pad. The Examiner further notes that Hooi and McDonald are still considered to be relevant and analogous prior art references, as each of Ryu, Conner, McDonald, and Hooi are directed towards devices for insertion into an anatomical cavity.
The Applicant further asserts that there is no articulated rationale for modifying Ryu’s narrow tube rim into a broad pad with shielding dimensions, as modifying Ryu such that the open end part 110 is enlarged into a broad pad that remains outside the body to shield the user’s hand would fundamentally alter Ryu’s design and intended operation, because Ryu’s tube is meant to be fully inserted and then inverted by pulling a string, not to have a large external pad remaining outside the cavity after insertion into said cavity. However, the Examiner disagrees with the Applicant’s argument that any modification [that is not considered to be required as noted above] would fundamentally alter Ryu’s design and operation as argued, as the Examiner notes that Figs. 3-5 of Ryu explicitly depict operation of the device of Ryu, wherein the portion of open end part 110 taken to read on claimed pad remains outside of the cavity after insertion, through sample collection, and finally removal of the device from the cavity. As such, the modification by Conner is considered to be applicable.
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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