DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
Claim Objections
Claim 1 objected to because of the following informalities: Claim 1 reads “wherein the the aspiration device” and should read “wherein the aspiration device”. Appropriate correction is required.
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, 7, 8, 9, 13, 16, 17, 30 and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 3,796,211 to Kohl.
Regarding Claims 1 and 30, Kohl discloses a medical device comprising inter alia:
a tubular body (pipette 12 including plastic tube 48) having a proximal end (col. 3, lines 43-44 “The tube projects forwardly from the distal end 50 of the barrel…”) and a distal end (col. 3, lines 44-45 “…terminates at the proximal end 51…”), wherein the tubular body is rigid (col. 3, line 42 “…"memory" capability…”) and comprises a hollow channel (through plastic tube 48 to pipette 12, col. 3, lines 60-61 “…specimen is then withdrawn into the pipette… );
a scraping attachment (sheath 4 including spatula 32) received/attached on the distal end wherein the distal end and the scraping attachment are configured to be received into an endocervical canal and is configured to collect cells from the endocervical canal (col. 3, lines 3-8 “…an aspirator tube or pipette 12 which is slidably engaged in the sheath, to be extended from the tip 8 into the endocervical canal 14 and/or uterine cavity of the patient, or alternately to be retracted into sheath 4 from the canal, while the tip 8 is engaged with the cervix.”) (col. 2, col. 4 “…spatula sampling tip…”) (col. 2, line 67 to col. 3, line 2 “…spatulated sampling tip 8 … adapted to engage the cervix 10 of the patient…”) and wherein the scraping attachment has a planar wing that extends laterally relative to the tubular body (col. 3, lines 25-26 “…tip 8 comprises a flat, generally heart-shaped spatula 32…”); and
an aspiration device received on the proximal end wherein the aspiration device interfaces with the tubular body to create a force through the tubular body (col. 3, lines 47-48 “The coupling 52 is threaded for attachment to an aspirator (not shown)…”).
Regarding Claim 7, Kohl discloses the medical device of claim 1, wherein the scraping attachment includes a receiving passage (cylindrical bore 40) configured to receive the distal end of the tubular body there through (col. 3, lines 31-33 “…a smooth cylindrical bore 40 which extends forwardly from the nipple 30 through the spatula 32 and the nose 34…”) (see FIG. 3).
Regarding Claims 8 and 9, Kohl discloses the medical device of claim 7, wherein the receiving passage (cylindrical bore 40) extends through an entire length of the scraping attachment, having a first opening on a first end and a second opening on a second end, and wherein the distal end of the tubular body extends into the first opening, through the length of the scraping attachment, and at least a portion of the distal end of the tubular body extends out of the second opening when the scraping attachment is attached to the tubular body where at least one aperture is located on a portion of the distal end that extends through the scraping attachment and a second opening when the scraping attachment is attached to the tubular body (col. 3, lines 31-33 “…a smooth cylindrical bore 40 which extends forwardly from the nipple 30 through the spatula 32 and the nose 34…”) (see FIG. 3) (col. 3, lines 3-8 “…an aspirator tube or pipette 12 which is slidably engaged in the sheath, to be extended from the tip 8 into the endocervical canal 14 and/or uterine cavity Hi of the patient, or alternately to be retracted into sheath 4 from the canal, while the tip 8 is engaged with the cervix.”).
Regarding Claim 13, Kohl discloses the medical device of claim 1, wherein the tubular body is configured to aspirate bodily tissues (col. 4, lines 3-7 “… all four quadrants of the cavity are sampled in this fashion, and if desired, the device may also be employed to sample the endocervical canal, and/or the portio vaginalis…”).
Regarding Claim 16, Kohl discloses the medical device of claim 1, wherein the body cavity is an endocervical canal (col. 4, lines 3-7 “… all four quadrants of the cavity are sampled in this fashion, and if desired, the device may also be employed to sample the endocervical canal, and/or the portio vaginalis…”).
Regarding Claim 17, Kohl discloses the medical device of claim 1, wherein the tubular body comprises plastic (plastic tube 48).
Regarding Claim 34, Kohl discloses the medical device of claim 1, wherein the medical device is configured to perform a Papanicolau test (the device of Kohl is capable of being used to perform a Papanicolau test because Kohl is an aspirating cervical sampling that collects cellular material and would allow one to discharge a specimen onto a repository).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kohl in view of US Patent No. 6,086,546 to Morris et al. (hereinafter, Morris).
Kohl discloses the medical device of claim 1 as set forth and cited above, and further discloses where the distal end of the tubular body further comprises at least one aperture at the distal end fluidly connected to the hollow channel of the distal end of tubular body (col. 5, lines 12-14 “…opening in said distal end of the tube…”) when the scraping attachment is attached to the tubular body (FIG. 1)
Kohl does not expressly disclose where the aperture has a first opening through an outer wall of the distal end tubular body and a second opening through an inner wall and fluidly connected to the hollow channel of the distal end of tubular body (Examiner notes such limitation is essentially claiming side/lateral apertures in the tubular body) when the scraping attachment is attached to the tubular body. However, Morris teaches an endometrial sampler that has an opening through an outer wall of the distal end of the tubular body (opening 12) and also includes two further side/lateral openings (side openings 13 and 14) (col. 2, lines 1-9) (FIG. 3). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the distal end of the tubular body and opening in the distal end of the tube of Kohl to also include the side/lateral apertures in the tubular body as set forth in Morris, as Morris teaches that the addition of the side/lateral openings would have increased the effectiveness in loosing cells and would also helped reduce the damage to the cells (col. 3, lines 19-31). Such modification would also yield side/lateral apertures when the scraping attachment is attached to the tubular body.
Claim(s) 10, 11, 27 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kohl in view of US 4620548 A to Hasselbrack.
Kohl discloses the medical device of claim 1 as set forth and cited above and/or discloses all the limitations in Claim 27 (except for the following). Kohl does not expressly disclose wherein the aspiration device is a syringe or wherein aspiration device is a depressible bulb configured to be squeezed, and wherein the force through the tubular body is suction. However, Hasselbrack teaches an endocervical sampling device that includes collecting cells via a squeeze bulb or a syringe (Abstract). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the aspiration device of Kohl to interface with the squeeze bulb or syringe of Hasselbrack as Hasselbrack teaches at col. 6, line 63 to col. 7, line 7 that such devices would have concentrated suction in the endocervical canal for collection of cells.
Claim(s) 28 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kohl in view of Hasselbrack and further in view of US Patent No. 6,086,546 to Morris et al. (hereinafter, Morris).
Kohl in view of Hasselbrack teach where the scraping attachment comprises a planar wing extending laterally from the tubular body (Kohl: col. 3, lines 25-26 “…tip 8 comprises a flat, generally heart-shaped spatula 32…”). Kohl in view of Hasselbrack do not expressly teach wherein the distal end comprises at least one aperture, the at least one aperture having a first opening through an outer wall of the distal end and a second opening through an inner wall of the hollow channel of the tubular body. However, Morris teaches an endometrial sampler that has an opening through an outer wall of the distal end of the tubular body (opening 12) and also includes two further side/lateral openings (side openings 13 and 14) (col. 2, lines 1-9) (FIG. 3). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the distal end of the tubular body and opening in the distal end of the tube of Kohl to also include the side/lateral apertures in the tubular body as set forth in Morris, as Morris teaches that the addition of the side/lateral openings would have increased the effectiveness in loosing cells and would also helped reduce the damage to the cells (col. 3, lines 19-31). Such modification would also yield side/lateral apertures when the scraping attachment is attached to the tubular body.
Claim(s) 32 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kohl in view of US 20120289858 A1 to Ouyang et al. (hereinafter, Ouyang).
Kohl discloses the medical device of claim 1. Kohl does not expressly disclose a light source and a camera. However, Ouyang teaches an integrated apparatus for examining uterine tissues ([0033]) which includes a light source (illuminated device A108B, paragraph [0159]) and a camera (imaging module A108, paragraph [0159]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the device of Kohl to include the light source and camera of Ouyang as Ouyang teaches at paragraph [0034] that this would have improved diagnostic accuracy and at paragraph [0037] states this would have improved visual inspect and reduced debris.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kohl in view of US 20160331357 A1 to Czarnecki et al. (hereinafter, Czarnecki)
Regarding Claim 35, Kohl discloses the medical device of claim 1. Kohl does not expressly disclose wherein the medical device is substantially 12 centimeter in total length as measured from the proximal end to the distal end. However, Czarnecki teaches a sample collection device that is a total of 12 centimeters in length (paragraph [0099]. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the device of Kohl to be the 12 centimeters in length as Czarnecki teaches at paragraph [0099] that the length of a sample collection device can vary or be chosen based upon a desired sample collection area.
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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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791