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 .
Response to Arguments
Concerning Dr. Zipper’s affidavit, as an initial matter, the Examiner notes that as explained in MPEP 716.01(c)(III), “in assessing the probative value of an expert opinion, the examiner must consider … the interest of the expert in the outcome of the case …” and “an affidavit of an applicant as to the advantages of their claimed invention, while less persuasive than that of a disinterested person, cannot be disregarded for this reason alone.” As such, it must be noted that the affidavit is generally less persuasive as a whole compared to an affidavit of a disinterested party.
Turning to the content of the affidavit, it essentially concludes that after experimentation, the claimed ranges “resulted in clinically significant improvement in the test group’s pelvic pain.” However, nothing in the affidavit sets forth any evidence as to why the claimed ranges yield unexpected results relative to values outside those ranges. As noted in MPEP 716.02(d)(II), “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.” There appears to be nothing in the affidavit or elsewhere in the record that compares a sufficient number of tests both inside and outside the claimed ranges to show that the claimed ranges produce unexpected results. For example, given the claimed range of 13.045-310.546 joules/cm2, there is no evidence that this range in particular yields unexpected results compared to values outside the range, e.g. 10 joules/cm2 or 350 joules/cm2.
Applicant argues that “the prior art was essentially inoperable.” Applicant appears to be arguing that the prior art is not enabled. This argument was addressed on pages 2-3 of the Final Office Action dated 10/28/2021 in parent application 15/452,958. Basically, the prior art would only lack enablement if it would require undue experimentation to produce the prior art inventions. However, as noted in those arguments, the existence of multiple prior art references having various overlapping values with Applicant’s claimed ranges shows that, when considering the state of the art as a whole, one skilled in the art would be able to achieve Applicant’s claimed ranges without undue experimentation. Furthermore, the experimentation process outlined by Applicant here to arrive at the claimed ranges appears to be nothing more than ordinary and routine experimentation.
Regarding Mayer, Applicant argues that Mayer at Paras. 93 and 94 does not recite a total dose as claimed by Applicant in the amended claim. The Examiner respectfully disagrees. As explained on pages 4-6 of the Final Office Action dated 03/19/2021 in parent application 15/452,958, Mayer in these paragraphs teaches both a power density range and a treatment duration range. Knowing both of these allows one to calculate the total energy density (or total “dose”). In the case of Mayer, the Examiner explained how Mayer either teaches a range of 2-3600 J/cm2, or a fraction of that range (depending on the duty cycle), and at virtually all possible duty cycles, Mayer’s range overlaps with Applicant’s range. See both the Response to Arguments section of the Final Office Action dated 03/19/2021 as well as the Response to Arguments section of the Final Office Action dated 10/28/2021, both in parent application 15/452,958. It is further noted here, just as in those actions, that even if Mayer were completely omitted from the rejection, the main reason that the claimed ranges are considered obvious is because one skilled in the art could arrive at these ranges through engaging in routine experimentation (which it appears Applicant did here, based on the affidavit as well as the specification).
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.
Claims 1-7 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0224584 A1 to Pryor et al. (hereinafter “Pryor”) alone, and/or in view of US 2012/0253204 A1 to Ben-Yehuda (hereinafter “Ben-Yehuda”) and US 2009/0319008 A1 to Mayer (hereinafter “Mayer”).
Regarding Claim 1, Pryor teaches a method for treating body tissue (see “pain in the vaginal canal” and “overactive bladder” in Para. 3 and “vaginal pain” in Para. 11), comprising:
providing a source (104; see FIG. 1) of laser energy characterized by a laser power P (see “The apparatus comprises a light source 104 consisting of a plurality of laser diodes, light emitting diodes (LEDs), lamps, or other types of light sources” in Para. 11);
providing a probe (100) having a longitudinal axis capable of emitting laser energy to vaginal tissue or rectal tissue (see Para. 11), said probe in optical communication with said source of laser energy (see FIG. 1, Para. 11), said probe being characterized as having a predetermined outer surface laser energy emitting surface area ESA (see FIG. 1, particularly the portion indicated as “102”);
inserting said probe into a potential space of a vagina or rectum of a patient such that at least a portion of said probe outer surface is in physical contact with a portion of said vaginal or said rectal tissue (see e.g. “the protuberance 102 executes rubbing and kneading massage to the vaginal tissue” in Para. 11; also see Paras. 14, 15);
determining a length of intravaginal or intrarectal probe travel L, wherein movement of said probe along distance L causes laser energy emitting surface area ESA to be translated over distance L, resulting in a total treatment surface area TSA (see e.g. “In the mean time, the therapeutic light 106 that transmits through the protuberance 102 provides phototherapy treatment to the same vaginal tissue” in Para. 11; also see Paras. 14, 15; Pryor’s method necessarily involves translating the device for some length L, and thus results in some total treatment surface area TSA);
determining a total laser ON time T for a pre-determined energy/unit area (J/area) (see e.g. “In the mean time, the therapeutic light 106 that transmits through the protuberance 102 provides phototherapy treatment to the same vaginal tissue” in Para. 11; also see Paras. 14, 15; Pryor’s method necessarily includes some laser ON time T which will necessarily produce some energy/unit area);
inserting said probe into a vagina or a rectum of a patient (see e.g. “the protuberance 102 executes rubbing and kneading massage to the vaginal tissue” in Para. 11; also see Paras. 14, 15);
causing laser energy to be emitted by said probe thru outer surface laser energy emitting surface area ESA, wherein said laser energy illuminates said vaginal tissue in the case in which the probe is inserted into a vagina, or illuminates said rectal tissue in the case in which said probe is inserted into a rectum (see e.g. “In the mean time, the therapeutic light 106 that transmits through the protuberance 102 provides phototherapy treatment to the same vaginal tissue” in Para. 11; also see Paras. 14, 15); and
translating said probe at a rate of translation along said longitudinal axis of said probe for period of time T while said probe emits said laser energy from said laser energy emitting surface area ESA (see e.g. “In the mean time, the therapeutic light 106 that transmits through the protuberance 102 provides phototherapy treatment to the same vaginal tissue” in Para. 11; also see Paras. 14, 15).
Pryor teaches that “the therapeutic light is effectively delivered into the vaginal tissue with desired direction, spread angle, power density, depth, and intensity distribution” (see Para. 14); however, Pryor fails to explicitly teach that the laser ON time T satisfies the exact equation T=(TSA*J/area)/P or is in a range of 13.045-310.546 joules/cm2.
First, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal treatment parameters for each particular patient including total laser ON time and energy/unit area, based upon various factors known and understood to those skilled in the art, such as the patient’s particular condition and severity of the condition, other patient health factors, etc. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). For example, one skilled in the art would readily understand that for a higher power P, the total time required to achieve optimal therapeutic results (and to avoid overdosing and damaging the tissue) would be lower.
Second, Ben-Yehuda, teaches a similar device in the analogous art of phototherapy of body cavities (see title, abstract) in which energy application is ceased after a dosage level is reached for the purpose of avoiding overdosing, the dosage level being calculated based on the rate of movement, and thus the total area of tissue being treated (see Paras. 127-130) and being in joules per area (see Paras. 126, 143). Ben-Yehuda teaches that the correct dosage includes translating the device for a total laser ON time (see Paras. 77-78, 128 and 130). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Pryor to continue said continuous translation until the applied energy has reached a predetermined dosage level, including translating the probe for a total laser ON time T based on laser power and treatment area, to provide the advantage of achieving the optimal dosage to provide optimal therapeutic results to the patient, and avoiding under- or overdosing.
As further evidence of the obviousness of the dosage parameters recited by Applicant, including the energy/unit area (J/area), attention is directed to Mayer who teaches a similar invention for phototherapy of a body cavity such as the vagina, rectum, etc. (Para. 13) using a laser (Paras. 17 and 27 and claim 9) for various treatments such as pain relief (Paras. 4 and 45) including dosage parameters overlapping with and/or substantially close to Applicant’s recited dosage (see Paras. 93 and 94). It would have been obvious to one of ordinary skill in the art as of the filing date of the invention to further modify Pryor to select from among the known dosage parameters taught in the art, such as those taught in Mayer, because those parameters were known to be effective in providing similar relief for similar conditions in body cavities as taught by Mayer.
Regarding Claim 2, Pryor fails to specifically teach that the laser energy emitted in a plane perpendicular to the probe longitudinal axis is non-uniform, and the step of rotating the probe about the longitudinal probe axis.
Another reference, Mayer, teaches a similar invention for phototherapy of a body cavity such as the vagina, rectum, etc. (Para. 13) using a laser (Paras. 17 and 27 and claim 9) for various treatments such as pain relief (Paras. 4 and 45). Mayer teaches an embodiment in which the energy emitted in a plane perpendicular to the probe longitudinal axis is non-uniform, and the step of rotating the probe about the longitudinal probe axis, thereby allowing more complex combinations of therapeutic radiation (e.g. multiple wavelengths) to be evenly delivered to the patient (see Para. 101). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Pryor such that the laser energy emitted in a plane perpendicular to the probe longitudinal axis is non-uniform, and the step of rotating the probe about the longitudinal probe axis, as taught in Mayer, as this would allow more complex phototherapeutic treatments, thereby allowing a wider range of conditions to be treated and/or allow for more optimal treatment results for some patients.
Regarding Claim 3, the total distance L which Pryor’s device travels necessarily includes whatever total distance is accumulated between the vaginal opening and the desired or furthest point of travel.
Regarding Claims 4-5, Pryor teaches the method of claim 3 as discussed above but fails to specifically teach the step of providing gradation markings on said probe to indicate the linear distance the probe has been translated by observing the number of markings that pass through the vaginal opening during translation.
Another reference, Ben-Yehuda, teaches a similar device in the analogous art of phototherapy of body cavities (see title, abstract) in which markings (430) are provided at fixed intervals (e.g. centimeters; see Para. 114) to correspond to different depths of insertion into the body cavity and which are visible from outside the cavity when the probe is inserted (see Paras. 112-114; also see Paras. 159-160 which describe similar markings 630 in FIG. 6B). Accordingly, it would have been obvious to one of ordinary skill in the art as of the filing date of the invention to modify Pryor to provide markings on the probe to indicate the linear distance the probe has been translated, similar to the marks taught by Ben-Yehuda, because it would provide the nurse/doctor or other medical professional with a more specific ability to gauge the current depth of insertion into the body lumen at any point in time, which would assist in a variety of ways such as avoiding excessive penetration, ensuring correct delivery of therapy, and so forth.
Concerning claim 5 specifically, it is noted that the rejections herein rely on the claimed alternative option of vaginal treatment, and thus the limitations which only further limit the rectal treatment option need not be addressed specifically.
Regarding Claims 6-7, Ben-Yehuda teaches a depth-of-insertion measurement sensor (see e.g. Para. 43, 49, 167-169, 177-179) and/or a speed measurement sensor (see e.g. Paras. 51, 79-80, 127-130) for controlling the phototherapy. Ben-Yehuda further teaches that this can be accomplished via an optical sensor (see e.g. Paras. 167-169 and 177-179). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Pryor to incorporate an optical sensor for sensing the distance traveled, as taught in Ben-Yehuda, because doing so would advantageously help ensure that the proper dosage is administered to the patient.
Regarding Claim 10, Pryor teaches that “the therapeutic light is effectively delivered into the vaginal tissue with desired direction, spread angle, power density, depth, and intensity distribution” (see Para. 14). It would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal treatment parameters for each particular patient including rate of motion, total distance of travel, total dose and power density based upon various factors known and understood to those skilled in the art, such as the patient’s particular condition and severity of the condition, other patient health factors, etc. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Furthermore, attention is directed to Mayer who teaches a similar invention for phototherapy of a body cavity such as the vagina, rectum, etc. (Para. 13) using a laser (Paras. 17 and 27 and claim 9) for various treatments such as pain relief (Paras. 4 and 45) including dosage parameters overlapping with and/or substantially close to Applicant’s recited dosage (see Paras. 93 and 94). It would have been obvious to one of ordinary skill in the art as of the filing date of the invention to further modify Pryor to select from among the known dosage parameters taught in the art, such as those taught in Mayer, because those parameters were known to be effective in providing similar relief for similar conditions in body cavities as taught by Mayer.
Regarding Claims 11 and 14, see e.g. Para. 11 of Pryor.
Regarding Claim 12, see e.g. Para. 14 of Pryor: “the therapeutic light is effectively delivered into the vaginal tissue with desired … depth ….” It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to utilize Pryor’s invention to deliver therapy to any desired portion of tissue relevant to a particular patient’s symptoms. Pryor teaches a device and method clearly applicable to any region of vaginal tissue, which would include the vaginal apex.
Regarding Claim 13, the rejections herein rely on the claimed alternative option of vaginal treatment, and thus the limitations which only further limit the rectal treatment option need not be addressed specifically.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Pryor in view of Ben-Yehuda and Mayer as applied to claim 1 above, and further in view of US 2016/0045762 A1 to Gurovich et al. (hereinafter “Gurovich”).
Regarding Claims 8-9, Pryor as modified above teaches the method of claim 1 and further teaches a continuous back-and-forth motion of the prove (see Para. 11) but fails to teach that the rate of translation is determined by a periodic metronome signal that provides a cadence.
Gurovich is another related invention that is pertinent to the problem of controlling the speed of a phototherapy device across target tissue in which a variety of cadence alerts such as audible alerts are generated based on a sensed speed, the possible alert types including a variety of sounds such as beeps etc. (see Para. [0046]). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Pryor to include a metronome signal that provides a cadence, as taught in Gurovich, because it would help ensure that the optimal therapeutic dosage is delivered at the optimal speed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent No. 10,687,894 to Femopase which teaches a vaginal treatment device employing laser energy (see abstract) and is translated at a rate overlapping with Applicant’s claimed rate (see Col. 6 lines 63-64: “withdrawn at a rate of 0.33 cm/s” i.e. 3.3 mm/s);
US Publication No. 2005/0004631 A1 to Benedict which teaches light delivery to the vagina (see Para. [0023]) and teaches that an accumulated energy density (i.e. total dose) in the range of 2.5-20 Joules/cm2 is “an appropriate range for many body components” (see Para. [0039] and claim 19);
US Publication No. 2011/0178584 A1 to Parmer et al. which teaches a vaginal remodeling device (see title) that uses an energy density of 90 J/cm2 (see Para. [0143]);
US Publication No. 2011/0295186 A1 to Klem which teaches an irradiation device for body cavities including the walls of the vagina (see e.g. Para. [0133]) in which the total dose applied from LEDs can range from 10-200 J/cm2 (see Paras. [0048] and [0106]);
US Publication No. 2014/0039322 A1 to Trujillo et al. which teaches a light emitting device inserted into the vagina (see e.g. Para. [0012]), and further teaches that a total dose can be approximately 150 J/cm2 but that “other doses may be appropriate as one of ordinary skill in the art can easily determine” (see Para. [0222]).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792