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 Objections
Claims 10-16 are objected to as being dependent on canceled claims 1-3. For the purpose of examination, claims 10 and 13-16 are interpreted to depend from claim 9, claim 11 is interpreted to depend from claim 10, and claim 12 is interpreted to depend from claim 11. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: Claim 9 recites “the distal end” in line 2 which should read “a distal end”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: Claim 9 recites “the inner face” and “the outer face” in line 5 which should read “an inner face” and “an outer face”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: Claim 9 recites “the smaller diameter” in lines 6-7 which should read “a smaller diameter”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: Claim 9 recites “the inner diameter” in line 8 which should read “an inner diameter”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: Claim 11 recites “the probe” and “the area” in line 3 which should read “the truncated cone” and “an area”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Claim 13 recites “C.” in line 3 which should read “C” and “sterilizable in at least 15 to 20 times” which appears to have grammatical issues. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Claim 14 recites “the cone” in line 2 which should read “the truncated cone”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 9 recites “its dimensions being able to adapt to the different sizes of the vagina” in lines 8-9. It is unclear as to what “its” is referring to. For example, the vaginal probe, the central stem, the truncated cone, the handle and/or some other part.
Claims 11 and 12 recite a “LED-type light lamp”. The addition of the word "type" to the otherwise definite expression "LED light lamp" extends the scope of the expression so as to render it indefinite, see MPEP 2173.05(b), in particular MPEP 2173.05(b)(III)(E).
It is unclear what "type" is intended to convey or cover beyond the term "LED light lamp", as understood by one skilled in the art. In other words, it is unclear how similar to or different from a LED light lamp or how closely resembling a LED light lamp the "LED-type" element may be while still remaining within the metes and bounds of the claim (e.g., be generally a light bulb, etc.). The recitation is not rendered clear in light of the specification because the specification only repeats the term "LED-type" without providing any explanation which would limit the bounds of the term "type" (e.g., see page 8, line 26, none of which define the full scope encompassed by "type"). It is also noted that the term "LED-type" does not appear to be a structural term of art which implicitly or inherently indicates a specific and particular structure in the art.
Claim 11 recites the limitation "the walls" in line 3. There is insufficient antecedent basis for this limitation in the claim.
The term “special luminosity” in claim 11 is a relative term which renders the claim indefinite. The term “special” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Because the specification does not use the term “special” it is unclear of what the metes and bounds of the term defines.
Claim 11 recites the limitation "the distal cylinder" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites “a single material that is compatible” in line 2. It is unclear with respect to what the single material is compatible with. Appropriate clarification is required.
Claims 10 and 14-16 are rejected based on their dependency to rejected claim 9.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9-10 and 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill et al. (US 2015/0351621 A1) in view of Koch (US 6,923,185 B1).
Regarding claim 9, Hill discloses a vaginal probe (illumination member 10; Fig. 6) for performing colpotomies (via colpotomy ring 22), characterised in that it is formed, at least, by a head (distal end 16) at the distal end (Fig. 6), a central stem (elongate member 14) and an ergonomic handle (handle 12), the head (16) having a cylinder at its end and a truncated cone at its junction with the central stem (Fig. 6), being hollow inside (Fig. 6), outer rings (at colpotomy ring 22) on the outer face of the cylinder (Fig. 6), the central stem (14) being a hollow cylinder with an outer diameter similar to the smaller diameter of the truncated cone (Fig. 6) and the handle (14) having a larger diameter (as the diameter of 12 is larger than 14; Fig. 6), said handle (14) being also hollow with an inner diameter similar to the inner diameter of the central stem (Fig. 6), its dimensions being able to adapt to the different sizes of vagina (as the device is placed in the vaginal canal 34).
The claimed phrase “being manufactured in a single piece” is being treated as a product by process limitation; that is the process of making the device as a single piece. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. In the instant case, the structure of the illumination member 10 of Hill appears to be substantially the same as that claimed i.e., comprising a fixed head, central stem and handle, as shown in Fig. 6 and discussed above. Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manufacture the vaginal probe of Hill to be of a single piece, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Hill fails to disclose grooves having approximately a semi-toroidal shape located on the inner face of the head corresponding to the outer rings in relief on the outer face of the cylinder.
However, Koch teaches a cervical cap (rim 10 and shell 12; Figs. 1b and 2) having a rim (10), similar to the colpotomy ring (22) of Hill, with an outer ring (flange 11) in relief on an outer face of the rim (Fig. 1b) and a groove (concave inner wall 20) having approximately a semi-toroidal shape (Fig. 1b) located on an inner face of the rim corresponding to the outer ring (11; Fig. 1b) between ridges (ridges 22, 24). The groove (20) and ridges (22, 24) on the inner surface of the rim are for the purpose of holding the rim firmly in place against the cervix during use (column 5, lines 13-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the head of Hill such that grooves having approximately a semi-toroidal shape are located on the inner face thereof corresponding to the outer rings of Hill in relief on the outer face of the cylinder in light of the teachings of Koch in order to better hold the head firmly in place against the cervix during use.
Regarding claims 10 and 13, Hill modified fails to disclose wherein the vaginal probe is made of a single transparent material to allow the passage of light therethrough, wherein the single material is compatible, resistant to temperatures of up to 1200 C. as well as washable and sterilizable in at least 15 to 20 times.
However, Koch teaches the shell (12, 26) of the cervical cap is formed of a translucent or transparent material e.g., cellulose acetate (column 5, lines 33-37), which is biocompatible (as the device is used in the cervix of a body), resistant to temperatures of up to 120 degrees C (cellulose acetate has a melting point between 230-300 degrees C), as well as washable and sterilizable in at least 15 to 20 times (dependent upon the users manipulation of the device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vaginal probe of modified Hill to be made of cellulose acetate for the purpose of allowing the user to see through the device. Additionally, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manufacture the vaginal probe of Hill to be of a single piece, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claims 14-16, Hill modified fails to explicitly disclose wherein the cylinder of the head has a height of 30 mm, a height of the cone of 30 mm and an inner diameter of the cylinder of 30 mm and exterior of 35 mm, with a relief of the outer rings of 1.5 mm, having three rings separated by 10 mm from each other, wherein the central stem has a length between 180 and 200 mm, an inner diameter of 11 mm and an outer diameter of 16 mm, and wherein the handle has an outer diameter of 40 mm, a length of 100 mm and an inner diameter of 11 mm. However, the device of Hill is used for the same purpose as the claimed device i.e., carrying out colpotomies ([0013]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vaginal probe of modified Hill such that the cylinder of the head has a height of 30 mm, a height of the cone is 30 mm and an inner diameter of the cylinder is 30 mm and exterior is 35 mm, with a relief of the outer rings of 1.5 mm, having three rings separated by 10 mm from each other, wherein the central stem has a length between 180 and 200 mm, an inner diameter of 11 mm and an outer diameter of 16 mm, and wherein the handle has an outer diameter of 40 mm, a length of 100 mm and an inner diameter of 11 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of modified Hill would not operate differently with the claimed diameter and since the device of Hill is used for carrying out colpotomies ([0013]) and vaginas vary in size. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the dimensions of the head “can” be within the claimed range and are “non-limiting” (specification page 4, paragraph 4), the dimensions of the stem “can” have a length between the claimed range (specification page 5, paragraph 4), and the dimensions of the handle “can” be within the claimed range (specification page 6, paragraph 2).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill et al. (US 2015/0351621 A1) in view of Koch (US 6,923,185 B1), as applied to claim 10, and further in view of Wolter (DE 10 2016 120 387 A1).
Regarding claim 11, Hill modified discloses the invention as claimed above, and Hill further discloses an LED light lamp (LED array 18 which may be a circular array; [0031]) to allow the surgeon to effectively see through the tissue to identify the exact location of the head (colpotomy ring 22; [0038]), but fails to disclose wherein a LED-type light lamp is housed in the handle which, using the conductive property of light of the transparent material, illuminates the walls of the probe, with special luminosity in the area of the rings of the distal cylinder of the head.
However, Wolter teaches a uterine manipulator (Figs. 1-3) with a head (portiocap 16), a central stem (shaft 12), and a handle comprising a LED-type light lamp (mobile light source 28 comprising LEDs; page 3, paragraph 7 of the attached English translation) which, illuminates the walls of the probe, with luminosity in the area of a distal cylinder of the head (as shown via the light cone 36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the LED-type light lamp of modified Hill to be housed in the handle as taught by Wolter in order to increase the range in which the light travels to better illuminate the cervix and surrounding area. Further, because the vaginal probe of modified Hill is transparent, the light would inherently illuminate the walls of the probe.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill et al. (US 2015/0351621 A1) in view of Koch (US 6,923,185 B1) in view of Wolter (DE 10 2016 120 387 A1), as applied to claim 11 above, and further in view of Greeley et al. (US 2019/0380805 A1).
Regarding claim 12, Hill modified fails to disclose wherein the LED-type lamp has average warming with a color temperature value of 4500 K.
However, Greeley teaches a handpiece for illuminate a surgical field ([0004]) with a LED-type lamp (light source 124 can comprise one or more LEDs; [0060]). Greeley further teaches may physician users prefer “white light,” which has a typical color temperature range of 2700K to 6500 K, over warmer light with a color temperature in a range of less than 2700 K ([0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the LED-type lamp of modified Hill to have average warming with a color temperature value of 4500 K as taught by Greeley as many physician users prefer white light.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Begg et al. (US 2018/0325575 A1) is noted for teaching a colpotomy cup with grooves/ridges (Figs. 21-23, 24A-24B). Koch (US 5,123,424) and Kohl (US 2,818,856) are noted for teaching a cervical cup with grooves on an inner surface thereof.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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