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 .
Election/Restrictions
Applicant’s election of Invention II in the response filed March 23rd, 2026 with traverse has been considered, however, the examiner does not find them persuasive with the arguments stating that the inventive groups disclosed are directed to the same overall inventive concept, such that examination of the elected invention II, would substantially overlap the search and examination required for non-elected inventions 1, 3, and 4. This general statement does not seem to address any error in the restriction requirement mailed on February 3rd, 2026 wherein the examiner clearly laid out the search/examination burden present between the different classes of invention. Simply stating that they are the same overall inventive concept, with no further remarks is not found persuasive and the restriction requirement is herein made final.
Claim Status
The amendment submitted on March 23rd, 2026 has been entered. Claims 21-40 are herein pending and under consideration.
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.
Claim 21-40 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.
Claims 21 and 32 recite the limitations of "external" and “disposed externally”. It is unclear as to what the scope of these limitation are as the term “external” requires the element to be placed in an exterior relation with another object, but there is no such relationship defined by the claims and thus it cannot be determined to what structure the object is in external relationship too. For the purpose of examination, the limitations of “external” and “disposed externally” are being interpreted to mean external to a patient when the device is inserted as generally supported by the applicant’s disclosure in Paragraphs [0002] and [0005] defining external and internal sex organs.
The term “substantial” in claim 30 is a relative term which renders the claim indefinite. The term “substantial” 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. The applicant’s specification discloses in ¶0059 that the laser beam penetrates through the wall of the shield without any distortion, but provides no further disclosure as to what degree would be required for a distortion to be considered “substantial”.
Claims 22-29, 31, and 33-40 are rejected as being dependent upon a rejected claim.
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.
Claim(s) 21-22, 29, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kazic et al. (U.S. Publication 2015/0005755) in view of Gillis et al. (U.S. Publication 2007/0043264).
Regarding claim 21-22, Kazic discloses a vaginal laser treatment device (Fig. 1, Fig. 4) comprising: an external housing (7 and 20) of a vaginal laser instrument (¶0017 suitable for treating large diameter body cavities (such as, for example, a vagina)) and a protective shield 16 configured for attachment to the external housing (¶0065 attached to the grip), the protective shield comprising: a tubular body (17; ¶0065 generally cylindrically shaped) extending along a longitudinal axis 10 between a front end 37 and a rear end (end connected to element 20 as seen in Fig. 4), the rear end being open (open such that element 7 is inserted into the interior as seen in Fig. 4); a tubular connector (edge of rear end that attaches to element 20 connects the elements and is in a tubular format due to the tubular shape of element 17) at the rear end, the tubular connector being configured to be connected to the external housing (¶0065 attached to the grip).
Kazic does not expressly disclose a support formation disposed externally at the rear end and surrounding the tubular connector, the support formation having an inverted mushroom shape including an outer edge, wherein the support formation defines an inner cavity opening toward the front end, the inner cavity extending radially between an outer region adjacent the outer edge and an inner region surrounding the tubular connector, and wherein the support formation is configured to engage external female genital tissue to limit insertion of the tubular body beyond a predetermined depth and cover and surround an entrance to a vaginal cavity during laser treatment (Claim 21) or a fluid conduit connected to the protective shelf and configured to place the inner cavity in fluid communication with an air-cooling system of the vaginal laser instrument) (Claim 22).
However, Gillis, in the same field of endeavor of vaginal insertion devices (¶0059 body opening include the vagina, treating different medical condition), teaches a protective shield (Fig. 1) comprising: (i) a tubular body 51 extending along a longitudinal axis 54 between a front end 52 and a rear end (end at which element 53 is position), the rear end being open (Fig. 1 shows opening in center of element 53, Fig. 10 shows hollow nature of element 5) and (iii) a support formation (elements 2,4,6) disposed externally (disposed external to vagina when inserted ¶0031 continuous band section extend radially outwardly away from the passageway to…limit the insertion depth of the insertion portion 1) at the rear end (disposed at end of 53) and surrounding the tubular body (surrounds element 51), the support formation having an inverted mushroom shape (Fig. 3 shows inverted mushroom shape of element 6) including an outer edge (edge of element 6 distal most to longitudinal axis in radial fashion), wherein the support formation defines an inner cavity (cavity formed between opening 61 and vaginal wall and cavity of element 11) opening toward the front end (61 open toward both the front end and the rear end as it opens through element 6; element 11 open at front end as seen in Fig. 1), the inner cavity extending radially between (A) an outer region adjacent the outer edge and (B) an inner region surrounding the tubular body (extends radially from the groove 12 located an inner region 11 outward to edge of 61 located near outer edge of element 6 with element 6 having inner edge defining the inner region 11 and the totality of element 6 surrounding element 5 and 53 thus inner region surrounds its respective portion of element 53), and wherein the support formation is configured to (1) engage external female genital tissue to limit insertion of the tubular body beyond a predetermined depth and cover and surround an entrance to a vaginal cavity (¶0031 extends radially outwardly away from the passage to protect body portions around the opening from contact with surgical instruments and limit the insertion depth of the insertion portion; ¶0049 obturator 5 include a stop, ring or other feature to limit the insertion depth of obturator into the passageway) for the purpose of protecting body portions around the opening from contact with surgical instruments and limiting the insertion depth of the instrument (¶0031 and ¶0049) (Claim 21); and a fluid conduit connected to the protective shield and configured to place the inner cavity in fluid communication with sources of vacuum or irrigation fluid (¶0058).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kazic to have included the support formation as taught by Gillis for the purpose of protecting body portions around the opening from contact with surgical instruments and limiting the insertion depth of the instrument (¶0031 and ¶0049 of Gillis).
While Gillis does not expressly teach the fluid conduit being in fluid communication with an air-cooling system of the vaginal laser instrument, the limitation of “configured to place the inner cavity in fluid communication with an air-cooling system of the vaginal laser instrument” is considered functional language as the language simply requires the fluid conduit being capable of fluid communication with an air-cooling system and therefore does not positively claim the air-cooling system itself. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the current functional claim language, only requires structure capable of fluid communication and attachment to a fluid delivering device and does not require the structure of the fluid delivering device itself. The structure taught by Gillis of a fluid conduit used to evacuate fluids from an opening or provide a source of irrigation and including a connection point to facilitate attachment of tubes or other sources of vacuum or irrigation fluid (¶0058 of Gillis) is seen to be capable of performing the function of placing the inner cavity in fluid communication with an air-cooling system of the vaginal laser instrument.
Regarding claim 29, Kazic in view of Gillis suggest the device of claim 21. Kazic in view of Gillis as applied in the rejection of claim 21 do not expressly suggest the tubular body of the protective shield being provided in a plurality of sizes differing in at least one of length and outside diameter, and wherein the protective shield is disposable.
However, Gillis, in the same field of endeavor of vaginal insertion devices (¶0059 body opening include the vagina, treating different medical condition), further teaches the protective shield and a tubular body 5 being provided in a plurality of sizes differing in length and/or outside diameter (¶0053 speculum may be available in various sizes…length of the insertion portion may range from approx.. 7-20 cm, while length of the obturator may range from approx.. 8-20 cm…outside diameter may range from approx.. 1.5-5cm) for the purpose of accommodating differences between patient anatomies (¶0053) and the protective shield being disposable (¶0046 portions of the speculum may be made to be disposable).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kazic in view of Gillis for the protective shield to have an outside diameter selected based on a patient’s vaginal anatomy, wherein the protective shield is provided in a plurality of sizes differing in length and outside diameter as taught by Gillis for the purpose of accommodating differences between patient anatomies (¶0053 of Gillis) and for the protective shield to have been disposable, as taught by Gillis, for the purpose of being able to dispose of the protective shield after use.
Regarding claim 31, Kazic in view of Gillis suggest the device of claim 21. Kazic further discloses the front end being smooth and rounded and configured to slide past vaginal tissue with reduced trauma (¶0065 spherical end portion)
Kazic in view of Gillis do not expressly disclose the front end being configured to slide past vaginal tissue with reduced trauma or the front end including a non-stick or release coating.
However, Gillis, in the same field of endeavor of vaginal insertion devices (¶0059 body opening include the vagina, treating different medical condition), further teaches providing a suitable lubricant along the outside of the device (¶0050).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kazic in view of Gillis to have included a clear lubricant along the outside of the device and thus the front end of the device for the purpose of enhancing visualization (¶0045 of Gillis).
Kazic in view of Gillis do not expressly disclose or suggest the front end being configured to slide past vaginal tissue with reduced trauma or the limitation of “non-stick” or “release”, however these limitations are considered functional as the language is drawn to the functions of reducing trauma and being non-stick or releasing. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the lubricant as taught by Gillis would perform the functions of reducing trauma and being non-stick as the definition of a lubricant is a substance that reduces friction and a reduction in friction would inherently result in reduced trauma during the device being inserted into/slid past vaginal tissue and would be non-stick as it reduces friction whereas sticking would increase friction.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kazic et al. (U.S. Publication 2015/0005755) in view of Gillis et al. (U.S. Publication 2007/0043264) as evidenced by Pestano et al. (U.S. Publication 2013/0171642).
Regarding claim 30, Kazic in view of Gillis suggest the device of claim 21. Kazic further discloses a wall 17 of the tubular body being transparent to laser radiation such that a treatment beam passes through the wall without substantial distortion (¶0029 liquid-tight protective sleeve made of a material being transparent to the laser beam), and wherein the wall is formed from a material that is biocompatible with a vaginal tissue (quartz; evidenced by Pestano ¶0072).
Claim(s) 23, 26, 28, 32-34, 37, 39, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kazic et al. (U.S. Publication 2015/0005755) in view of Gillis et al. (U.S. Publication 2007/0043264) and further in view of Desai (U.S. Publication 2003/0130575).
Regarding claim 23, Kazic in view of Gillis suggest the device of claim 21. Gillis further suggests a vacuum port comprising a connection point configured for connection to a vacuum source to evacuate debris and gases present in the inner cavity as detailed in the above rejection of claim 21 (¶0058 of Gillis).
Kazic in view of Gillis do not expressly suggest the vacuum port having a nozzle connected to the fluid conduit wherein the nozzle is configured for connection to a vacuum source.
However, Desai, in the same field of endeavor of vaginal laser treatment devices, teaches a vacuum port 384 having a nozzle (terminal end of 386 connected to vacuum pump) connected to a fluid conduit 386 configured for connection to a vacuum source 388.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vacuum port of Kazic in view of Gillis to have a nozzle as taught by Desai for the purpose of providing a connection to a separable vacuum source, which would provide the advantage of allowing separation of the vacuum source from the vacuum port.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the vacuum port of Kazic in view of Gillis that performs the function of allowing vacuum to be provided for the vacuum port of Desai since these elements perform the same function of allowing vacuum to be provided. Simply substituting one vacuum connecting means for another would yield the predictable result of allowing a(n) vacuum source to be fluidically connected. See MPEP 2143.
Regarding claim 26, Kazic in view of Gillis and Desai suggest the device of claim 23. Kazic in view of Gillis and Desai further suggests the fluid conduit being configured to connect the nozzle to a suction line of a suction device (suction line of syringe) such that suction in suction line provides evacuation through the nozzle (Gillis suction of debris through fluid conduit by suction source, suction provided by suction source would inherently result in suction through suction line providing evacuation through the nozzle connecting the suction line), however Kazic in view of Gillis and Desai do not expressly disclose or suggest the suction line being an air-suction line of the vaginal laser instrument used to cool a laser generator.
However, while Kazic in view of Gillis and Desai do not expressly suggest the fluid conduit being in fluid communication with an air-cooling system of the vaginal laser instrument, the limitation of “configured to connect the nozzle to an air-suction line of the vaginal laser instrument used to cool a laser generator” is considered functional language as the language simply requires the nozzle being capable of connecting with an air-cooling system and therefore does not positively claim the air-cooling system itself. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the current functional claim language, only requires structure capable of attachment to a fluid suctioning device and does not require the structure of the fluid suctioning device itself. The structure taught by Desai of a nozzle used to fluidly connect a suction source to evacuate fluids from an opening is seen to be capable of performing the function of connecting an air-suction line.
Regarding claim 28, Kazic in view of Gillis and Desai suggest the device of claim 23. Kazic in view of Gillis and Desai as modified in claim 23 do not expressly disclose or suggest the inner cavity being arranged such that gases exiting the vaginal cavity enter the inner cavity before being evacuated through the nozzle.
However, Desai, in the same field of endeavor of vaginal laser treatment devices, teaches positioning the fluid conduit 386 such that suction is provided to a cavity 372 such that gases exiting the vaginal cavity 372 are drawn from the vaginal cavity through an inner cavity formed by a support membrane before being evacuated through the nozzle (see Fig. 21 suction would inherently result in drawing from the vaginal space through the cavity formed by support 380 and into suction line 386.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kazic in view of Gillis and Desai to have arranged the fluid conduit and nozzle such that the inner cavity is arranged such that gases exiting the vaginal cavity enter the inner cavity before being evacuated through the nozzle, as taught by Desai, since this claimed position of nozzle in relation to the inner cavity does not change the vacuums ability to provide suction to the vaginal cavity. Since applicant has not given any criticality to why the position of the nozzle in relation to the inner cavity disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claims 32-34, Kazic discloses a vaginal laser treatment device (Fig. 1, Fig. 4) comprising: an external housing (7 and 20) of a vaginal laser instrument (¶0017 suitable for treating large diameter body cavities (such as, for example, a vagina)) and a protective shield 16 configured for attachment to the external housing (¶0065 attached to the grip), the protective shield comprising: a tubular body (17; ¶0065 generally cylindrically shaped) extending along a longitudinal axis 10 between a front end 37 and a rear end (end connected to element 20 as seen in Fig. 4), the rear end being open (open such that element 7 is inserted into the interior as seen in Fig. 4); a tubular connector (edge of rear end that attaches to element 20 connects the elements and is in a tubular format due to the tubular shape of element 17) at the rear end, the tubular connector being configured to be connected to the external housing (¶0065 attached to the grip).
Kazic does not expressly disclose a support formation disposed externally at the rear end and surrounding the tubular connector, the support formation having an inverted mushroom shape including an outer edge, wherein the support formation defines an inner cavity opening toward the front end, the inner cavity extending radially between an outer region adjacent the outer edge and an inner region surrounding the tubular connector, and wherein the support formation is configured to engage external female genital tissue to limit insertion of the tubular body beyond a predetermined depth and cover and surround an entrance to a vaginal cavity during laser treatment (Claim 21) or a fluid conduit connected to the protective shelf and configured to place the inner cavity in fluid communication with an air-cooling system of the vaginal laser instrument) (Claim 22).
However, Gillis, in the same field of endeavor of vaginal insertion devices (¶0059 body opening include the vagina, treating different medical condition), teaches a protective shield (Fig. 1) comprising: (i) a tubular body 51 extending along a longitudinal axis 54 between a front end 52 and a rear end (end at which element 53 is position), the rear end being open (Fig. 1 shows opening in center of element 53, Fig. 10 shows hollow nature of element 5) and (iii) a support formation (elements 2,4,6) disposed externally (disposed external to vagina when inserted ¶0031 continuous band section extend radially outwardly away from the passageway to…limit the insertion depth of the insertion portion 1) at the rear end (disposed at end of 53) and surrounding the tubular body (surrounds element 51), the support formation having an inverted mushroom shape (Fig. 3 shows inverted mushroom shape of element 6) including an outer edge (edge of element 6 distal most to longitudinal axis in radial fashion), wherein the support formation defines an inner cavity (cavity formed between opening 61 and vaginal wall and cavity of element 11) opening toward the front end (61 open toward both the front end and the rear end as it opens through element 6; element 11 open at front end as seen in Fig. 1), the inner cavity extending radially between (A) an outer region adjacent the outer edge and (B) an inner region surrounding the tubular body (extends radially from the groove 12 located an inner region 11 outward to edge of 61 located near outer edge of element 6 with element 6 having inner edge defining the inner region 11 and the totality of element 6 surrounding element 5 and 53 thus inner region surrounds its respective portion of element 53), and wherein the support formation is configured to (1) engage external female genital tissue to limit insertion of the tubular body beyond a predetermined depth and cover and surround an entrance to a vaginal cavity (¶0031 extends radially outwardly away from the passage to protect body portions around the opening from contact with surgical instruments and limit the insertion depth of the insertion portion; ¶0049 obturator 5 include a stop, ring or other feature to limit the insertion depth of obturator into the passageway) for the purpose of protecting body portions around the opening from contact with surgical instruments and limiting the insertion depth of the instrument (¶0031 and ¶0049) (Claim 21); and a fluid conduit connected to the protective shield and configured to place the inner cavity in fluid communication with sources of vacuum or irrigation fluid (¶0058) to generate suction (vacuum) for evacuation of debris and gases (¶0058).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kazic to have included the support formation as taught by Gillis for the purpose of protecting body portions around the opening from contact with surgical instruments and limiting the insertion depth of the instrument (¶0031 and ¶0049 of Gillis).
While Gillis does not expressly teach the fluid conduit being in fluid communication with an air-cooling system of the vaginal laser instrument, the limitation of “configured to place the inner cavity in fluid communication with an air-cooling system of the vaginal laser instrument” is considered functional language as the language simply requires the fluid conduit being capable of fluid communication with an air-cooling system and therefore does not positively claim the air-cooling system itself. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the current functional claim language, only requires structure capable of fluid communication and attachment to a fluid delivering device and does not require the structure of the fluid delivering device itself. The structure taught by Gillis of a fluid conduit used to evacuate fluids from an opening or provide a source of irrigation and including a connection point to facilitate attachment of tubes or other sources of vacuum or irrigation fluid (¶0058 of Gillis) is seen to be capable of performing the function of placing the inner cavity in fluid communication with an air-cooling system of the vaginal laser instrument.
While Gillis suggests the protective shield comprising a fluid conduit, Kazic in view of Gillis do not expressly suggest a nozzle formed in the support formation and in fluid communication with the inner cavity (Claim 32), the fluid conduit being connected to the nozzle, or the nozzle being configured for connection to the vacuum source
However, Desai, in the same field of endeavor of vaginal laser treatment devices, teaches a vacuum port 384 having a nozzle (terminal end of 386 connected to vacuum pump) connected to a fluid conduit 386 configured for connection to a vacuum source 388 that is .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vacuum port of Kazic in view of Gillis to have a nozzle as taught by Desai for the purpose of providing a connection to a separable vacuum source, which would provide the advantage of allowing separation of the vacuum source from the vacuum port.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the vacuum port of Kazic in view of Gillis that performs the function of allowing vacuum to be provided for the vacuum port of Desai since these elements perform the same function of allowing vacuum to be provided. Simply substituting one vacuum connecting means for another would yield the predictable result of allowing a(n) vacuum source to be fluidically connected. See MPEP 2143.
Regarding claim 37, Kazic in view of Gillis and Desai suggest the device of claim 33. Kazic in view of Gillis and Desai further suggests the fluid conduit being configured to connect the nozzle to a suction line of a suction device (suction line of syringe) such that suction in suction line provides evacuation through the nozzle (Gillis suction of debris through fluid conduit by suction source, suction provided by suction source would inherently result in suction through suction line providing evacuation through the nozzle connecting the suction line), however Kazic in view of Gillis and Desai do not expressly disclose or suggest the suction line being an air-suction line of the vaginal laser instrument used to cool a laser generator.
However, while Kazic in view of Gillis and Desai do not expressly suggest the fluid conduit being in fluid communication with an air-cooling system of the vaginal laser instrument, the limitation of “configured to connect the nozzle to an air-suction line of the vaginal laser instrument used to cool a laser generator” is considered functional language as the language simply requires the nozzle being capable of connecting with an air-cooling system and therefore does not positively claim the air-cooling system itself. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the current functional claim language, only requires structure capable of attachment to a fluid suctioning device and does not require the structure of the fluid suctioning device itself. The structure taught by Desai of a nozzle used to fluidly connect a suction source to evacuate fluids from an opening is seen to be capable of performing the function of connecting an air-suction line.
Regarding claim 39, Kazic in view of Gillis and Desai suggest the device of claim 34. Kazic in view of Gillis and Desai as modified in claim 34 do not expressly disclose or suggest the inner cavity being arranged such that gases exiting the vaginal cavity enter the inner cavity before being evacuated through the nozzle.
However, Desai, in the same field of endeavor of vaginal laser treatment devices, teaches positioning the fluid conduit 386 such that suction is provided to a cavity 372 such that gases exiting the vaginal cavity 372 are drawn from the vaginal cavity through an inner cavity formed by a support membrane before being evacuated through the nozzle (see Fig. 21 suction would inherently result in drawing from the vaginal space through the cavity formed by support 380 and into suction line 386.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kazic in view of Gillis and Desai to have arranged the fluid conduit and nozzle such that the inner cavity is arranged such that gases exiting the vaginal cavity enter the inner cavity before being evacuated through the nozzle, as taught by Desai, since this claimed position of nozzle in relation to the inner cavity does not change the vacuums ability to provide suction to the vaginal cavity. Since applicant has not given any criticality to why the position of the nozzle in relation to the inner cavity disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 40, Kazic in view of Gillis and Desai suggest the device of claim 32. Kazic further discloses the front end being smooth and rounded and configured to slide past vaginal tissue with reduced trauma (¶0065 spherical end portion); a wall 17 of the tubular body being transparent to laser radiation such that a treatment beam passes through the wall without substantial distortion (¶0029 liquid-tight protective sleeve made of a material being transparent to the laser beam), and wherein the wall is formed from a material that is biocompatible with a vaginal tissue (quartz; evidenced by Pestano ¶0072 as seen above).
Kazic in view of Gillis and Desai do not expressly suggest the tubular body of the protective shield being provided in a plurality of sizes differing in at least one of length and outside diameter, wherein the protective shield is disposable; the front end being configured to slide past vaginal tissue with reduced trauma or the front end including a non-stick or release coating.
Regarding the sizing, however, Gillis, in the same field of endeavor of vaginal insertion devices (¶0059 body opening include the vagina, treating different medical condition), further teaches the protective shield and a tubular body 5 being provided in a plurality of sizes differing in length and/or outside diameter (¶0053 speculum may be available in various sizes…length of the insertion portion may range from approx.. 7-20 cm, while length of the obturator may range from approx.. 8-20 cm…outside diameter may range from approx.. 1.5-5cm) for the purpose of accommodating differences between patient anatomies (¶0053) and the protective shield being disposable (¶0046 portions of the speculum may be made to be disposable).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kazic in view of Gillis for the protective shield to have an outside diameter selected based on a patient’s vaginal anatomy, wherein the protective shield is provided in a plurality of sizes differing in length and outside diameter as taught by Gillis for the purpose of accommodating differences between patient anatomies (¶0053 of Gillis) and for the protective shield to have been disposable, as taught by Gillis, for the purpose of being able to dispose of the protective shield after use.
Kazic in view of Gillis do not expressly disclose the front end being configured to slide past vaginal tissue with reduced trauma or the front end including a non-stick or release coating.
Regarding the front end configuration to reduce trauma, however, Gillis, in the same field of endeavor of vaginal insertion devices (¶0059 body opening include the vagina, treating different medical condition), further teaches providing a suitable lubricant along the outside of the device (¶0050).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kazic in view of Gillis to have included a clear lubricant along the outside of the device and thus the front end of the device for the purpose of enhancing visualization (¶0045 of Gillis).
Kazic in view of Gillis do not expressly disclose or suggest the front end being configured to slide past vaginal tissue with reduced trauma or the limitation of “non-stick” or “release”, however these limitations are considered functional as the language is drawn to the functions of reducing trauma and being non-stick or releasing. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the lubricant as taught by Gillis would perform the functions of reducing trauma and being non-stick as the definition of a lubricant is a substance that reduces friction and a reduction in friction would inherently result in reduced trauma during the device being inserted into/slid past vaginal tissue and would be non-stick as it reduces friction whereas sticking would increase friction.
Claim(s) 25 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kazic et al. (U.S. Publication 2015/0005755) in view of Gillis et al. (U.S. Publication 2007/0043264) and Desai (U.S. Publication 2003/0130575) and further in view of Uchida (U.S. Publication 2022/0022916).
Regarding claims 25 and 36, Kazic in view of Gillis and Desai suggest the devices of claims 23 and 34 respectively. Kazic in view of Gillis and Desai do not expressly disclose a backflow check valve configured to inhibit reverse flow of evacuated material from the nozzle into the inner cavity upon interruption of suction.
However, Uchida, in the same field of endeavor of providing suction to internal female anatomy, teaches providing a backflow check valve configured to inhibit reverse flow of evacuated materials for the purpose of preventing fluids from flowing in the optional direction (¶0073 connection tubing includes a directional control valve that allows fluid to flow in one direction and prevents fluid from flowing in the opposite direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kazic in view of Gillis and Desai to have included the backflow check valve as taught by Uchida for the purpose of preventing fluids from flowing in the optional direction (¶0073 connection tubing includes a directional control valve that allows fluid to flow in one direction and prevents fluid from flowing in the opposite direction).
Kazic in view of Gillis, Desai, and Uchida do not expressly disclose the inhibition of reverse flow upon interruption of suction, however, the check valve of Uchida being unidirectional would inherently perform the function of inhibiting reverse flow upon interruption of suction as it is unidirectional and does not permit flow in reverse direction of the suction.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kazic et al. (U.S. Publication 2015/0005755) in view of Gillis et al. (U.S. Publication 2007/0043264) and Desai (U.S. Publication 2003/0130575) and further in view of Efremkin (U.S. Publication 2019/0262031).
Regarding claims 27 and 38, Kazic in view of Gillis and Desai suggest the devices of claims 26 and 37 respectively. Kazic in view of Gillis and Desai do not expressly disclose a filter positioned in-line between the nozzle and the air-suction line.
However, Efremkin, in the same field of endeavor of aspirating debris from a body cavity (¶0076), teaches providing a filter in-line (see Fig. 2) between a suction lumen (lumen of catheter 10) and a vacuum pump 70 for the purpose of providing visual feedback to a user related to the type, quantity, and flow rate of material being removed from a patient (¶0076).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid conduit of Kazic in view of Gillis and Desai to have included an in-line filter, as taught by Efremkin, for the purpose of providing visual feedback to a user related to the type, quantity, and flow rate of material being removed from a patient (¶0076 of Efremkin).
Allowable Subject Matter
Claims 24 and 35 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 24, Kazic in view of Gillis suggest the device of claim 22. Kazic in view of Gillis do not expressly disclose the fluid conduit comprising a filter configured to capture airborne debris generated during vaginal laser treatment, and wherein suction generated by the air-cooling system is communicated through the fluid conduit to the protective shield so as to draw treatment-generated debris into the filter, and air passing through the filter continues into the vaginal laser instrument for cooling.
While prior art disclosures such as Efremkin may teach the provision of filter devices, the examiner does not find the limitations require suction generated by the air-cooling system being communicated through the fluid conduit to the protective shield so as to draw treatment-generated debris into the filter, and air passing through the filter continues into the vaginal laser instrument for cooling to have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as there is no suggestion or motivation in the art for one to provide a device that is fluidically connected to as to both provide a suctioning of debris from a vaginal cavity and then return the suctioned air back to the laser instrument in order to provide cooling to the laser instrument. As such this limitation is found to be allowable over the prior art.
Regarding claim 35, Kazic in view of Gillis and Desai suggest the device of claim 33. Kazic in view of Gillis and Desai do not expressly disclose the fluid conduit comprising a filter configured to capture airborne debris generated during vaginal laser treatment, and wherein suction generated by the air-cooling system is communicated through the fluid conduit to the protective shield so as to draw treatment-generated debris into the filter, and air passing through the filter continues into the vaginal laser instrument for cooling.
While prior art disclosures such as Efremkin may teach the provision of filter devices, the examiner does not find the limitations require suction generated by the air-cooling system being communicated through the fluid conduit to the protective shield so as to draw treatment-generated debris into the filter, and air passing through the filter continues into the vaginal laser instrument for cooling to have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as there is no suggestion or motivation in the art for one to provide a device that is fluidically connected to as to both provide a suctioning of debris from a vaginal cavity and then return the suctioned air back to the laser instrument in order to provide cooling to the laser instrument. As such this limitation is found to be allowable over the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Blanche et al. (U.S. Publication 2018/0296383) discloses a vaginal insertion device with a protective shield and application of vacuum.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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