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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/574,412, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed application fails to disclose any of the features of the upper blade/angular adjustment mechanism. Accordingly, the claims receive an effective filing date of 11/1/2017, which is the filing date of 62/574,969.
Claim Rejections - 35 USC § 102
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 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) 2-10, 13, 14, 18, 22-30is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krauter et al. (Pat. No. US 8,376,942 B2).
Regarding claim 2, Krauter et al. discloses a speculum 200 comprising: a lower member 208/210 comprising a handle 210 and a lower blade 208 extending from the handle; an upper member 204 comprising an upper blade 204; and an angular adjustment mechanism connecting the upper member to the lower member, the angular adjustment mechanism comprising: a guiding arm 212; a lever 216 connected to the upper blade 204, the lever 216 being configured to move relative to the guiding arm 212 in a first direction to increase an angle between the upper and lower blades and to move relative to the guiding arm 212 in a second direction to decrease the angle between the upper and lower blades (figure (col. 9, lines 43-65); and a locking member 218 movable between (i) a locked position in which the lever is prevented from moving relative to the guiding arm in the second direction (figure 8) and (ii) an unlocked position in which the lever 216 is free to move relative to the guiding arm 212 in the second direction (col. 10, lines 15-20), wherein the angular adjustment mechanism is configured such that the locking member 218 can be moved from the locked position to the unlocked position without moving the guiding arm 212 (figure 8; col. 10, lines 15-20).
Regarding claim 3, the angular adjustment mechanism is configured to automatically fix the lever 216 relative to the guiding arm 212 along any position on the guiding arm (col. 9, lines 58-65).
Regarding claim 4, the lever 216 is configured to move relative to the guiding arm 212 between a first position corresponding to a closed state of the upper and lower blades and a second position corresponding to an open state of the upper and lower blades (figure 3 and 8; col. 9, line 23-col. 10, line 20).
Regarding claim 5, the lever 216 is configured to be locked relative to the guiding arm 212 at any position within a range from the first position to the second position (col. 9, lines 58-65).
Regarding claim 6, the upper and lower blades are positioned with a maximum operable angle therebetween when the lever 216 is in the second position (when the lever is pressed as close as possible to the guiding arm 212, the upper and lower blades will be at their maximum angle, figure 3).
Regarding claim 7, the guiding arm 212 is free of ratchet teeth (figure 3).
Regarding claim 8, movement of the lever 216 in the first direction causes the angle between the upper and lower blades to increase in a continuous manner (figure 3; col. 9, lines 58-65).
Regarding claim 9, movement of the lever 216 in the first and second directions relative to the guiding arm 212 is click-free (col. 9, lines 58-65).
Regarding claim 10, the speculum further comprises a spring that biases the locking member toward the locked position (the resilient material that the locking member 218/240 is made of biases it toward the locked position).
Regarding claim 13, engagement between the lever 216 and the guiding arm 212 is maintained when the locking member 218/240 is in the locked position and when the locking member 218/240 is in the unlocked position (figure 3 and 8).
Regarding claim 14, the guiding arm 212 extends from the lower member 210 and the lever 216 extends from a proximal end of the upper blade 204 (figure 8).
Regarding claim 18, the speculum further comprises an illumination assembly 154 comprising at least one light source disposed adjacent to the lower blade, at least one battery provided in the handle, and a battery ejection mechanism for removal of the at least one battery from the handle (the illumination assembly 154 inherently comprises a light source in order to illuminate, and a battery in order to power the light source. The battery ejection mechanism is the enlarged end region which can be grasped by a user to eject the illumination assembly, figure 3).
Regarding claim 22, when the locking member 218/240 is in the unlocked position, the lever 216 is free to move relative to the guiding arm 212 in the first direction and in the second direction (figure 8)
Regarding claim 23, the adjustment mechanism is configured to allow a continuous adjustment of the angle between the upper and lower blades (figure 8; col. 9, lines 58-65).
Regarding claim 24, the lower blade 208 extends integrally from the handle 210 (figures 3 and 8), and the upper blade 204 extends integrally from the lever 216 (figures 3 and 8).
Regarding claim 26, Krauter et al. discloses a speculum comprising: a lower member 208/210 comprising a handle 210 and a lower blade 208 extending from the handle 210; an upper member 204 /216 comprising an upper blade 204; and an angular adjustment mechanism connecting the upper member to the lower member, the angular adjustment mechanism comprising a lever 216 for adjusting an angle between the upper and lower blades 204, 208; and a rocker 218 pivotably mounted on the lever 216, the rocker 218 being pivotable between a locked position that locks the lever and a positional relationship between the upper and lower blades 204, 208 and an unlocked position that unlocks the lever 216 and releases a locked positional relationship between the upper and lower blades (figure 3 and 8; col. 9, line 23-col. 10, line 20).
Regarding claim 27, the rocker 218 is biased to the locked position and is configured to be moved to the unlocked position (col. 9, lines 58-65).
Regarding claim 28, the speculum further comprises an illumination assembly 154 comprising at least one light source disposed adjacent to the lower blade, at least one battery provided in the handle, and a battery ejection mechanism for removing the at least one battery from the handle (the illumination assembly 154 inherently comprises a light source in order to illuminate, and a battery in order to power the light source. The battery ejection mechanism is the enlarged end region which can be grasped by a user to eject the illumination assembly, figure 3).
Regarding claim 29, the angular adjustment mechanism comprises a guiding arm 212 that is free of ratchet teeth (figure 8), wherein the lever 216 is configured to move relative to the guiding arm 212 in a first direction to increase the angle between the upper and lower blades and to move relative to the guiding arm 212 in a second direction to decrease the angle between the upper and lower blades (figures 3 and 8).
Regarding claim 30, movement of the lever 216 in the first direction causes the angle between the upper and lower blades to increase in a continuous manner (col. 9, lines 58-65).
Regarding claim 31, the angular adjustment mechanism comprises a guiding arm 212, wherein the lever 216 is configured to move relative to the guiding arm 212 in a first direction to increase the angle between the upper and lower blades and to move relative to the guiding arm 212 in a second direction to decrease the angle between the upper and lower blades, and wherein movement of the lever in the first and second directions relative to the guiding arm is click-free (figures 3 and 8; col. 9, lines 58-65).
Claim(s) 2 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buchok et al. (Pat. No. US 8,096,945 B2).
Regarding claim 2, Buchok et al. discloses a speculum 100 comprising: a lower member 130 comprising a handle 131 and a lower blade 132 extending from the handle (figure 4A); an upper member 120 comprising an upper blade 122; and an angular adjustment mechanism 128/157 connecting the upper member to the lower member, the angular adjustment mechanism 128/157 comprising: a guiding arm 157 (figure 7); a lever 128 connected to the upper blade 122 (figure 4A), the lever 128 being configured to move relative to the guiding arm 157 in a first direction to increase an angle between the upper and lower blades and to move relative to the guiding arm in a second direction to decrease the angle between the upper and lower blades (figure 1A); and a locking member 166 movable between (i) a locked position in which the lever 128 is prevented from moving relative to the guiding arm in the second direction and (ii) an unlocked position in which the lever is free to move relative to the guiding arm in the second direction (as the locking member 166 is moved toward the free end of the guiding arm, the lever is free to move in the second direction, figure 1A), wherein the angular adjustment mechanism is configured such that the locking member 166 can be moved from the locked position to the unlocked position without moving the guiding arm (figure 1A).
Regarding claim 15, the speculum further comprises a linear support member 154 slidably engaged with the handle and hingedly engaged with the upper blade 122 (figures 8A and 8B), wherein the linear support member 154 is configured to allow linear adjustment of a distance between the upper blade 122 and the lower blade 132 (figure 1A), and the guiding arm 157 extends from the linear support member 154 (figure 7).
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) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buchok et al. (Pat. No. US 8,096,945 in view of Nieto (Pat. No. US 6,595,917 B2).
Regarding claims 16 and 17, Buchok et al. discloses the claimed invention, including wherein the handle and linear support member are engaged with one another via a ratchet mechanism 155/137 (figure 4A and figure 9), but fails to disclose wherein the handle comprises a plurality of teeth, and the linear support member comprises a locking projection configured to engage with the plurality of teeth, the plurality of teeth defining corresponding fixed open states and a closed state for linear adjustment of the distance between the upper blade and the lower blade; wherein the plurality of teeth are formed on an inner surface of the handle and a portion of the linear support member is disposed inside the handle so that the locking projection engages with the plurality of teeth.
Nieto teaches wherein the handle 23 comprises a plurality of teeth 24, and the linear support member 5 comprises a locking projection 6 configured to engage with the plurality of teeth 24 (figures 6, 8, and 10), the plurality of teeth 24 defining corresponding fixed open states and a closed state for linear adjustment of the distance between the upper blade and the lower blade (figure 6); wherein the plurality of teeth 24 are formed on an inner surface of the handle 23 and a portion of the linear support member 5 is disposed inside the handle so that the locking projection 6 engages with the plurality of teeth 24 (figure 6), in order to provide a ratcheting vertical adjustment mechanism between the upper and lower blades (figure 6).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the ratchet mechanism between the upper and lower blades of the speculum of Buchok et al. such that the handle comprises a plurality of teeth, and the linear support member comprises a locking projection configured to engage with the plurality of teeth, the plurality of teeth defining corresponding fixed open states and a closed state for linear adjustment of the distance between the upper blade and the lower blade; wherein the plurality of teeth are formed on an inner surface of the handle and a portion of the linear support member is disposed inside the handle so that the locking projection engages with the plurality of teeth, as taught by Nieto, in order to achieve the predictable result of providing a ratcheting vertical adjustment mechanism between the upper and lower blades. Additionally, providing the ratcheting teeth on the interior of the handle allows for a lower profile/reduced thickness handle)
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krauter et al. (Pat. No. US 8,376,942 B2) in view of Frumovitz et al. (Pub. No. US 2003/0105387 A1).
Regarding claim 25, Krauter et al. discloses the claimed invention, but is silent regarding the angle between the handle and the lower member being between 95-120 degrees.
Frumovitz et al. teaches wherein an angle between handle 401 and lower member 403 is preferably 110 degrees for the purpose of eliminating contact with the patient's pubis during use (paragraph 0033; figure 6).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the angle between the handle and the lower member to be 110 degrees as taught by Frumovitz et al., for the purpose of eliminating contact with the patient's pubis during use (paragraph 0033).
Allowable Subject Matter
Claims 11, 12, and 19-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: Regarding claims 11 and 12, the closest prior art, Krauter, fails to disclose nor suggest the features of the rocker mechanism and its engagement with the guiding arm. Regarding claims 19-21, the closest prior art, Krauter, fails to disclose at least the battery ejection mechanism configured to be operated by a user to cause the housing to transition from a retained battery state to an ejected battery state.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO form 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynnsy Summitt whose telephone number is (571)270-78567856. The examiner can normally be reached on Monday through Thursday from 8am until 5pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNNSY M SUMMITT/Primary Examiner, Art Unit 3773
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