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 .
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.
Claim(s) 1-3, 5-9, 12, 13, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoch et al. (US20230120283), hereafter Hoch, in view of Howsam (US20140148740), hereafter Howsam.
Regarding Claim 1, Hoch discloses a dilator (Fig. 1) comprising: a housing (Fig. 33, container 182)
Hoch is silent on the housing comprises of a handle body having a first handle end and a second handle end opposite and spaced apart from the first handle end.
However, Howsam teaches a dilator (Fig. 1), comprising of a housing (Fig. 4 shows a housing), wherein the housing comprises of a handle body (Fig. 4, handle 106) having a first handle end and a second handle end opposite and spaced apart from the first handle end (Fig. 4, a first handle end defined away from element 132, and a second handle end coupled to element 132), and a protrusion (Fig. 4, hollow core 132; element 132 protrudes from the handle and is therefore a protrusion; see Fig. 1, par. 0021 of applicant’s disclosure, element 24 is also a hollow housing protruding from a handle body). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known dilator of Hoch, with the handle body of Howsam, so the dilator can be held by the user as the handle is ergonomically designed to be clasped in hand as taught by Howsam (Howsam, par. 0029).
The modified Hoch further discloses a protrusion (Hoch, Fig. 33, a protrusion is defined by the housing 182, protruding from the handle after the modification; see Fig. 1, par. 0021 of applicant’s disclosure, element 24 is a housing protruding from a handle body) having a first protrusion end coupled to the second handle end (Hoch Fig. 33, rear end 186, after the modification the first protrusion end would be coupled to the second handle end), a second protrusion end opposite and spaced apart from the first protrusion end (Hoch Fig. 33, front end 190), and a protrusion outer surface extending from the first protrusion end to the second protrusion end (Hoch Fig. 33, the outer surface of side wall 194); a coating layer (Hoch Fig. 33, inner body 114) having a first coating end (Hoch Fig. 33, rear end 144) and a second coating end opposite and spaced apart from the first coating end (Hoch Fig. 33, tip end 130), wherein the first coating end defines a coating opening extending toward the second coating end (Hoch, Fig. 33, cavity 180), wherein the coating layer has a coating inner surface defined by the coating opening (Hoch, Fig. 33, inner surface of 114) and a coating outer surface spaced radially outwardly from the coating inner surface (Hoch, Fig. 33, outer surface of 114), wherein the second protrusion end is disposed within the coating opening to couple the coating layer to the housing (See Hoch Fig. 32, the second protrusion end is inserted into the opening created by 114); and a sleeve (Hoch, Fig. 33, outer body 116) having a first sleeve end (Hoch Fig. 33, rear portion 120) and a second sleeve end opposite and spaced apart from the first sleeve end (Hoch Fig 33. front portion 128), wherein the first sleeve end defines a sleeve opening extending toward the second sleeve end (See Hoch Fig. 33, an opening is defined by the first sleeve end), wherein the sleeve has a sleeve inner surface defined by the sleeve opening (Hoch Fig. 33, inner surface of 116) and a sleeve outer surface spaced radially outwardly from the sleeve inner surface (Hoch Fig. 33, outer surface of 116), wherein the second coating end is removably disposable within the sleeve opening to couple the sleeve to the coating layer and the housing (Hoch Fig. 32, par. 0080 shows the sleeve being removable).
Regarding Claim 2, the modified Hoch discloses the dilator of claim 1, further comprising a vibrator motor disposed within the housing, wherein the vibrator motor is configured to cause vibration of a sleeve coupled to the coating layer (Hoch, par. 0080, “the container 182 provides an internal compartment or cavity space 196, which may be used to house electronics related to a vibrating motor”; a vibrating motor as disclosed by the prior art will inherently cause the sleeve to vibrate).
Regarding Claim 3, the modified Hoch discloses the dilator of claim 2, wherein the vibrator motor is disposed within the protrusion of the housing (Hoch Fig. 32, par. 0080, the motor is disposed within the protrusion).
Regarding Claim 5, the modified Hoch discloses the dilator of claim 1, wherein the sleeve comprises silicone (Hoch, par. 0058, “The outer body 116 may be made of silicone rubber”).
Regarding Claim 6, the modified Hoch discloses the dilator of claim 1, wherein the coating layer comprises silicone (Hoch par. 0058, “The inner body 114 may also be made of silicone rubber”).
Regarding Claim 7, the modified Hoch discloses the dilator of claim 1, wherein the sleeve and the coating layer comprise a same material (Hoch par. 0058).
Regarding Claim 8, the modified Hoch discloses the dilator of claim 1, wherein one of the housing outer surface and the coating inner surface defines a circumferentially extending first groove (See Hoch Fig. 32 and 33, the coating inner surface defines a recess 200, par. 0078), and another of the coating inner surface and the housing outer surface includes a circumferentially extending first flange sized to be disposed within the first groove (Hoch Fig. 32, 33, par. 0078, the housing outer surface includes a circumferential rim 188 fits into the recess 200).
Regarding Claim 9, the modified Hoch discloses the dilator of claim 8, but does not specifically disclose wherein the housing outer surface defines the first groove, and the coating inner surface includes the first flange.
However, Howsam further teaches a housing (Fig. 5, interface ring 136), and a coating layer (Fig. 5, sheath cover 130), wherein the housing outer surface defines a first flange (Fig. 5, lip 148), and the coating inner surface includes a first groove (Fig. 5, inner face 146; par. 0034, “An internal collar 144 of the interface ring mechanically engages (at or near the base of the sheath cover) an inner surface 146 of the sheath cover 130. For example, the mechanical engagement may be brought about by an outwardly projecting lip 148 that produces a locking undercut region 150 into which the inner surface of 146 of the sheath cover 130 can bite”). Therefore, it would have been obvious to try, by one of ordinary skill in the art before the effective filing date of the claimed invention, to reverse the position of the groove and the flange between the housing outer surface and the coating inner surface, since there are only a finite number of predictable arrangement for a groove-flange type coupling. Such modification would have yielded predictable results, and one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success, see KSR International Co. v. Teleflex Inc., 550 U.S.398 (2007).
Regarding Claim 12, the modified Hoch discloses the dilator of claim 1, wherein the coating opening is a same size as the protrusion outer surface such that the entire protrusion outer surface contacts the coating inner surface (See Hoch Fig. 32, the protrusion is entirely inserted into the coating opening).
Regarding Claim 13, the modified Hoch discloses the dilator of claim 1, wherein the sleeve opening is a same size as the coating outer surface such that the entire coating outer surface contacts the sleeve inner surface when the second coating end is disposed within the sleeve opening to couple the sleeve to the coating layer (See Hoch Fig. 32, the coating layer is entirely inserted into the sleeve opening).
Regarding Claim 19, the modified Hoch discloses the dilator of claim 1, wherein the sleeve outer surface defines a textured surface (Hoch Fig. 27-29, par. 0077, the sleeve includes ribs to define a textured surface).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoch in view of Howsam, further in view of Nan (US20070129599).
Regarding Claim 4, the modified Hoch discloses the dilator of claim 2, but is silent on further comprising a battery disposed within the housing, wherein the battery is in electrical communication with the vibrator motor.
However, Nan teaches a dilator (Fig. 1), comprising of a housing (Fig. 2, inner casing 16), a coating layer (Fig. 2, hollow outer sleeve 14), and a sleeve (Fig. 2, prosthetic member 12), further comprising of a vibrator motor disposed within the housing to cause the sleeve to vibrate (Fig. 2, a vibratory component 22, par. 0030), and a battery disposed within the housing, wherein the battery is in electrical communication with the vibrator motor (Fig. 2, battery 42, par. 0030). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known dilator of Hoch, with the dilator of Nan, and include batteries in the housing, to provide power to the vibrator motor as taught by Nan (Nan, par. 0030).
Claim(s) 10, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoch in view of Howsam, further in view of Haddock et al. (US20200085681), hereafter Haddock.
Regarding Claim 10, the modified Hoch discloses the dilator of claim 1, but is silent on wherein one of the housing outer surface and the sleeve inner surface defines a circumferentially extending second groove, and another of the sleeve inner surface and the housing outer surface includes a circumferentially extending second flange sized to be disposed within the second groove.
However, Haddock teaches a dilator (Fig. 7B), comprising of a housing (Fig. 7A, shaft chamber 108), a coating layer (Fig. 7A, layer comprising of the roller 104), and a sleeve (Fig. 7A, sheathe 701). Wherein one of the housing outer surface and the sleeve inner surface defines a circumferentially extending groove (Fig. 7A, groove 721, par. 0087), and another of the sleeve inner surface and the housing outer surface includes a circumferentially extending flange sized to be disposed within the second groove (Fig. 7A, protrusion 719). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known dilator of Hoch, with the coupling mechanism of Haddock, to securely hold the sleeve to the housing as taught by Haddock (Haddock, par. 0087, Fig. 7A).
Regarding Claim 11, the modified Hoch discloses the dilator of claim 10, wherein the housing outer surface defines the second groove (See Haddock Fig. 7A, the housing defines the groove 721), and the sleeve inner surface includes the second flange (See Haddock Fig. 7A, the sleeve defines the flange 719).
Claim(s) 14-18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoch in view of Howsam, further in view of Yenko et al. (US20150119636), hereafter Yenko.
Regarding Claim 14, the modified Hoch discloses the dilator of claim 1, but is silent on wherein the sleeve is a first sleeve, further comprising a second sleeve having at least one larger outer dimension than the first sleeve, wherein the second coating end is removably disposable within the sleeve opening of the second sleeve to couple the second sleeve to the coating layer.
However, Yenko discloses a dilator (Fig. 5), with a coating layer (Fig. 5, outer layer of extension 52), and a sleeve (Fig. 5, sleeve 20) having a sleeve opening (Fig. 5, cavity 40). Yenko further discloses wherein the sleeve is a first sleeve, further comprising a second sleeve (See Fig. 6-18, a plurality of sleeves are shown, par. 0005 discloses the sleeves being interchangeable) having at least one larger outer dimension than the first sleeve (par. 0045, “Skilled artisans will appreciate additional embodiments to include 30, 35, 40, 45, 50, 55, 65, 70, 75, 80, 85, 90, 95, or another length in millimeters for the sleeve”; additional sleeves with larger dimension is disclosed), wherein the second coating end is removably disposable within the sleeve opening of the second sleeve to couple the second sleeve to the coating layer (par. 0005). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known dilator of Hoch, with the additional sleeves of Yenko, to allow size customization and provide various stimulation to the user as taught by Yenko (Yenko par. 0052).
Regarding Claim 15, the modified Hoch discloses the dilator of claim 14, wherein the outer dimension is a length as measured from the first sleeve end to the second sleeve end of the respective sleeve (Yenko, par. 0045, “…the sleeve may be approximately 60 millimeters long, between its top end 22 and its bottom end 24. Skilled artisans will appreciate additional embodiments to include 30, 35, 40, 45, 50, 55, 65, 70, 75, 80, 85, 90, 95, or another length in millimeters for the sleeve”; the dimension is between first sleeve end 24 and second sleeve end 22).
Regarding Claim 16, the modified Hoch discloses the dilator of claim 15, wherein the length is in the range of 30 to 95 millimeters (Yenko, par. 0045), but does not explicitly disclose the length is in the range of 10cm-18cm.
It would have been obvious for one of ordinary skilled in the art to modify the range of length of the modified Hoch from 30 to 95 millimeters to 10cm – 18cm, as applicant appears to have placed no criticality on the claimed range (See applicant’s disclosure, par.0010, “in some implementations, the length is in the range of 10cm-18cm”). In this case, the range disclosed by the modified prior art is close to the claimed range. The courts have held a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985), MPEP 2144.05.
Regarding Claim 17, the modified Hoch discloses the dilator of claim 14, wherein the outer dimension is a largest diameter as measured circumferentially around a portion of the sleeve adjacent the first sleeve end of the respective sleeve (Yenko, par. 0045, “The bottom end of this illustrative sleeve may be substantially flat and have a diameter of approximately 16 millimeters. Skilled artisans will appreciate additional embodiments of the bottom end to include a diameter of 5, 10, 12, 13, 14, 15, 17, 18, 19, 20, 22, 25, 30, or another diameter in millimeters”).
Regarding Claim 18, the modified Hoch discloses the dilator of claim 17, wherein the largest diameter is in the range of 5 – 30 millimeters, but does not explicitly disclose wherein the largest diameter is in the range of 20mm-35mm.
It would have been obvious for one of ordinary skilled in the art to modify the range of length of the modified Hoch from 5 - 30 millimeters to 20mm – 30mm, as applicant appears to have placed no criticality on the claimed range (See applicant’s disclosure, par. 0010, “In some implementations, the largest diameter is in the range of 20mm-35mm”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 20, the modified Hoch discloses the dilator of claim 19, but is silent on wherein the textured surface comprises a plurality of bumps.
However, Yenko further teaches the sleeve outer surface defines a textured surface (Fig. 6-18, par. 0053), wherein the textured surface comprises a plurality of bumps (Fig. 16, par. 0064). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known dilator of Hoch, with the textured surface of the sleeve of Yenko, to engage different areas and provide different stimulations through the bumps as taught by Yenko (Yenko, par. 0064).
Conclusion
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/KRIS HANYU GONG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785