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 Amendment
This Office action is responsive to the Amendment/Response to Office Action filed June 25, 2025. The Examiner acknowledges the amendments to Claim 1. Claims 1-4, 6-20 and 33 are pending.
Response to Arguments
Applicant’s arguments, see page 6 of the Remarks, filed June 25, 2025, with respect to the objection to claim 1 have been fully considered and are persuasive. The claim objection of claim 1 has been withdrawn.
Applicant’s arguments with respect to the rejections claims 1-4, 6-20 and 33 have been considered but are moot because the new ground of rejections does not rely on any reference as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 15 is objected to because of the following informalities: at line 4, --to-- should be inserted before “receive”. 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.
Claims 1-4, 6, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehead (US 2009/0082695) in view of Decker et al. (US 7,413,551).
Regarding claim 1, Whitehead teaches a device capable of use for self-collection of a biological sample. The device (1) comprises an enclosure (4, 6) configured to be gripped in one hand of a user and inserted into the user's vaginal canal ([0042]-[0043]), said enclosure having an opening at a distal end thereof; an elongate retractable biopsy or surgical device (RBSD, [0043]) having a proximal end and a distal end with a sample-collecting head; a translational actuator (32) coupled to the proximal end of the RBSD and configured to advance the sample-collecting head through the opening proximate a cervical os of the user; and a rotational actuator (58) configured to rotate the sample-collecting head, wherein the rotational actuator is coupled to the proximal end of the RBSD and is disposed on an exterior of the enclosure (see at least Figure 1).
While Whitehead teaches the RSBD may be a swab, spatula or other suitable biopsy/surgical device ([0043]), Whitehead does not expressly disclose that the elongate RBSD has a shaft, stem, and sample-collecting head, where the distal end of the stem is coupled to the sample-collecting head and the proximal end of the stem is coupled to the distal end of the elongate shaft of the RBSD.
Decker et al. teach a endocervical/exocervical sampling device and cell transport/preservation system. The device includes a shaft (6), stem (16), and sample-collecting head (18), where the distal end of the stem is coupled to the sample-collecting head (17) and the proximal end of the stem is coupled to the distal end of the elongate shaft of the RBSD (at collar 15).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to use a sampling device similar to that taught by Decker et al. with a stem and sample-collecting head as the RBSD in the device of Whitehead with predictable results of effectively obtaining a biological sample from the vaginal canal while allowing the head to be easily separated from the RBSD for collection, containment and transport of the cervical material sample.
Regarding claim 2, Whitehead teaches a distal region of the enclosure tapers to a distal tip (see figure 2).
Regarding claim 3, Whitehead teaches the distal region of the enclosure conforms to a vaginal anatomy (see [0042]-[0043]).
Regarding claim 4, Whitehead teaches the opening in the enclosure is at the distal tip (see at least Fig. 1).
Regarding claim 6, Decker et al. teaches the sample-collecting head comprises a plurality of protrusions (9).
Regarding claim 13, Whitehead teaches an insertion stop disposed on an exterior of the enclosure at a location spaced proximally of the distal end (taper at connection of 4 and 6).
Regarding claim 14, Whitehead teaches the rotational actuator comprises a knob disposed at a proximal end of the enclosure (see Fig. 1, enclosure defined above as 4 and 6).
Regarding claim 15, Whitehead teaches all of the limitations of the claim except for a collection receptacle having an aperture configured to receive the distal end of the enclosure to allow the sample-collecting head to be advanced through the opening of the enclosure and into an interior volume of the collection receptacle; and a cover configured to be sealed over the aperture of the collection receptacle. Decker et al. teaches a system of containment and transport of a biological sample including a collection receptacle (2) having an aperture configured to receive the distal end of the enclosure to allow the sample-collecting head to be advanced through the opening of the enclosure and into an interior volume of the collection receptacle (see Figs. 1 and 12-15); and a cover (1) configured to be sealed over the aperture of the collection receptacle. It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to use a collection receptacle and cover similar to those taught by Decker et al. to receive the enclosure and RBSD of Whitehead with predictable results of effectively obtaining a biological sample from the vaginal canal while allowing the head to be easily separated from the RBSD for collection, containment and transport of the cervical material sample.
Regarding claim 16, the aperture of Decker et al. is configured to seal about an exterior of the enclosure of the device for self-collection.
Regarding claim 17, the collection receptacle of Decker et al. includes a horizontal opening (4), where the lower end of the conical sidewall effectively forms a cutter by contacting the sampling head when rotated 90 degrees and severing the removable head from the shaft upon pulling upward on the shaft (see Figs. 13-15 and column 4, lines 46-54).
Regarding claim 18, Whitehead, as modified with Decker et al. hereinabove, teaches a method for self-collection of a cervical sample by a user, wherein the method comprises gripping the enclosure of the device of claim 1; inserting the distal end of the enclosure into the user's vaginal canal; advancing the sample-collecting head from an interior of the enclosure through the opening to position the sample-collecting head proximate the user's cervix; rotating the sample-collecting head while the enclosure remains in the user's vaginal canal to collect the cervical sample from the cervical os or a surrounding tissue; retracting the sample-collecting head back into the enclosure; and withdrawing the distal end of the enclosure from the user's vaginal canal after the sample-collecting head has been retracted back into the enclosure, wherein the steps may be performed by the user.
Regarding claim 19, Whitehead, as modified with Decker et al. hereinabove, teaches that gripping the enclosure and inserting the distal end of the enclosure into the vaginal canal is performed using one hand.
Regarding claim 20, Whitehead, as modified with Decker et al. hereinabove, teaches advancing the RBSD sample-collecting head is accomplished by the user using the one hand or another hand to advance the translational actuator.
Claims 7 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehead (US 2009/0082695) in view of Decker et al. (US 7,413,551), as applied to claims 1 and 6 above, and further in view of Ching et al. (US 2015/0297196 A1).
Regarding claims 7 and 33, Whitehead, as modified with Decker et al. teaches all of the limitations of claim 1. Decker et al. further teach that different shapes or numbers of protrusions and shapes of sample collecting heads may be employed (column 4, lines 32-36). The combination does not teach the sample-collecting head comprises an ovoid sponge. Ching et al. teaches a sample-collecting head may be an ovoid shape (See Fig. 11) or be formed of sponge ([0103]). It would have been obvious to one of ordinary skill in the art at the effective filing date of the claimed invention to make the sample-collecting head of Decker et al, in the combination of Whitehead and Decker et al. be formed of a sponge material and/or have an ovoid shape as taught by Ching et al. with predictable results as both sponge materials and various shapes of collection heads are known to be effective for biological sampling of vaginal or cervical tissue while causing minimal discomfort to the subject.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehead (US 2009/0082695) in view of Decker et al. (US 7,413,551), as applied to claim 1 above, and further in view of alternate embodiments of Whitehead.
Whitehead, as applied to claim 1, above teaches that trigger 36 forms a translational actuator configured to extend and retract the RBSD. However, in alternate embodiments of Whitehead (see for example Figs. 9-10, the translational actuator may comprise a slidable carriage (see proximal end of Fig. 10) within the enclosure, wherein the slidable carriage is coupled to both the sample-collecting head and the translational actuator so that advancing and retracting the translational actuator advances and retracts the sample-collecting head (See Fig. 10). The translational actuator of Whitehead may further include a slider having a thumb button (90, 92) and a coupling arm (100) which attaches the thumb button to the slidable carriage, wherein the coupling arm is slidably received in an axial slot (94) in a wall of the enclosure.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to use translation actuators having the slots, thumb buttons and carriage of the embodiment of Figs. 9-10 of Whitehead as the translation actuator of the combination of Whitehead and Decker et al. with predictable results of effectively extending and retracting the RBSD.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Whitehead (US 2009/0082695) in view of Decker et al. (US 7,413,551), as applied to claim 9 above, and further in view of Bagaoisan et al. (WO 2012/096816).
Regarding Claim 10, Whitehead and Decker et al. teach all of the limitations of the claim except that the axial slot has ratchets along an axial edge thereof, wherein the coupling arm is biased to engage the ratchets to immobilize the slider and the slidable carriage when the thumb button is released and to disengage the ratchets when the thumb button is depressed to advance and retract the slider and the slidable carriage.
Bagaoisan et al. teaches a device having a slot with ratchets along an axial edge thereof that allow a coupling arm to extend therethrough with indica at the ratchets (see Figs. 9A-9B) so as to inform a user of the relative positioning of the components of the device and maintain those relative positions for a desired time period.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to provide the slots of a translation actuator similar to that of Figs. 9-10 of Whitehead with ratchet notches and indicia similar to those taught by Bagaoisan et al. as the translation actuator of the combination of Whitehead in order to inform a user of the relative positioning of the RBSD and maintain that relative positioning for a desired time period.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehead (US 2009/0082695) in view of Decker et al. (US 7,413,551), as applied to claim 9 above, and further in view of Moore et al. (US 8,672,860).
Whitehead and Decker et al. teach all of the limitations of the claim except that the rotational actuator is coupled to the sample-collecting head and to the shaft by a rotatable barrel, wherein the rotatable barrel, which is coupled to a gear train configured to rotate the barrel from four to 12 times for each rotation of the rotational actuator.
Moore et al. teach a rotational actuator for a sample-collection device including an actuation mechanism (60) coupled to the shaft (shaft 50) by the rotatable barrel (80) which is coupled to a gear train (Fig 25). Moore et al. is directed toward a tissue sampling device. It would have been obvious to one of ordinary skill in the art at the effective filing date of the claimed invention to incorporate the gear train of Moore et al. into the rotational actuator of Whitehead, as modified with Decker et al. hereinabove. to provide a way for the RBSD to rotate effectively, by making the rotation more efficient and automatic. The addition of the gear train would provide the capability of rotating the barrel and sample collecting head 4-5 times per rotation by the actuator.
Conclusion
The foreign prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Charles A Marmor, II whose telephone number is (571)272-4730. The examiner can normally be reached Monday-Friday 9AM-5PM.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791