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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 15, 2025 has been entered.
Response to Arguments
I. Claim Objections
Applicant’s amendment has overcome the previous objection of claim 42. That objection is withdrawn.
II. Claim Rejections under 35 U.S.C. § 103
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 42 is rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0224584 A1 to Pryor et al. (hereinafter “Pryor”).
Regarding Claim 42, Pryor teaches a method for treating pelvic pain (see “pain in the vaginal canal” in Para. 3 and “vaginal pain” in Para. 11), comprising:
providing a source (104; see FIG. 1) of laser energy (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) capable of emitting laser energy to vaginal 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 an outer surface (see FIG. 1, particularly the portion indicated as “102”);
inserting said probe into a vagina of a patient, such that at least a portion of said probe outer surface is in physical contact with a portion of said vaginal tissue (see e.g. “the protuberance 102 executes rubbing and kneading massage to the vaginal tissue” in Para. 11; also see Paras. 14, 15);
activating said source of laser energy thereby causing laser energy to be emitted by said probe, wherein said laser energy illuminates said vaginal tissue, creating a probe treatment surface 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);
massaging said probe treatment surface area while illuminating said probe treatment surface area with said laser energy (see Paras. 11, 14 and 15), said massaging performed by continuously translating said probe in a back and forth motion at a rate of motion along a longitudinal axis of said probe while said probe emits said laser energy (see Para. 11),
Pryor fails to specifically teach the following numerical treatment parameters:
said rate of motion being between 2.5 and 60 millimeters per second, said translation being defined by a total distance of travel; and administering between 200-600 joules per linear centimeter of vaginal tissue.
Pryor does, however, teach 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)).
Claims 42-44, 46-47 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Pryor in view of US 2009/0319008 A1 to Mayer (hereinafter “Mayer”).
Regarding Claim 42, Pryor alone is considered to render this claim obvious as discussed above. However, as further evidence of the obviousness of the dosage parameters recited by Applicant, 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 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 43, Pryor teaches the method of claim 42 as discussed above but fails to teach that the laser energy is continuous. 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) in which the illumination can either be continuous or pulsed (Paras. 16, 33, 37, 42, 43, 58, 60, 92). 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 use continuous laser energy, as taught by Mayer, because Mayer teaches that both continuous and pulsed energy may be effective for treatment, and thus it would have been obvious to select from among the finite (i.e. two) possible solutions to providing laser energy for this kind of treatment. Additionally/alternatively, one skilled in the art would have found it obvious to select from between pulsed and continuous emission modes depending on the given situation, e.g. the particular patient, particular condition being treated, other laser parameters, etc.
Regarding Claim 44, Pryor further teaches:
wherein said probe is further defined as having a shape consisting of a sphere (see FIG. 1 which illustrates portion 102, shown to be a cross-section of a sphere; the Examiner notes that especially in this context of treating sensitive body cavities such as the vagina, the circular shape shown in FIG. 1 is undoubtedly meant to convey the cross-section of a sphere even though Pryor fails to show a full 3-dimensional view of the probe) that is capable of emitting said laser energy in a 120 degree to 360 degree spherical pattern along a longitudinal axis of said probe (see directions of therapeutic light 106 in FIG. 1); and
wherein said step of continuously translating is performed without rotation of the probe within the vagina (see e.g. Para. 11: there is no discussion of rotation being used);
Pryor fails to specifically teach that the sphere has a diameter between 1.5 and 4.0 cm. However, as discussed above, Pryor explicitly teaches that the spherical portion (102) is suitably sized for treating the vagina. As explained in MPEP § 2144.05(I), a prima facie case of obviousness exists where claimed ranges and prior art ranges overlap or are otherwise close enough that one skilled in the art would expect them to have the same properties. Here, since Pryor’s device is sized and shaped for insertion into the vagina to illuminate and massage tissues therein, i.e. the same purpose as Applicant’s device, it logically follows that Pryor’s device size is at least close enough to Applicant’s claimed size such that one skilled in the art would expect Pryor’s device size to generally yield the same properties, effects etc. as Applicant’s claimed device size, and thus Pryor renders obvious Applicant’s claimed range of diameter.
Furthermore, mere changes in size/scale are generally not patentable advances on their own absent some kind of criticality or unexpected result. See MPEP § 2144.04(IV)(A).
Still furthermore, 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 diameter for the spherical probe, e.g. based on the size of the particular body cavity being treated, 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)).
Regarding Claims 46, 47 and 51, 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 probe velocity and the ratio of power density to probe velocity 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)).
Claims 53-56 are rejected under 35 U.S.C. 103 as being unpatentable over Pryor in view of Mayer as applied to claim 42 above, and further in view of US 2012/0253204 A1 to Ben-Yehuda (hereinafter “Ben-Yehuda”)
Regarding Claim 53, Pryor in view of Mayer teaches the method of claim 42 as discussed above but fails to specifically teach the step of providing markings on said probe to indicate the linear distance the probe has been translated during said continuous movement, said markings visible from outside said vagina when said probe is inserted into said vagina.
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 in view of Mayer to provide markings on the probe to indicate the linear distance the probe has been translated during said continuous movement, said markings visible from outside said vagina when said probe is inserted into said vagina, 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.
Regarding Claim 54, as discussed above, Pryor in view of Mayer and Ben-Yehuda renders obvious a method including the step of providing markers on the probe. As also discussed above, Ben-Yehuda specifically teaches that the markings may indicate depth measured in units of length “such as centimeters and/or inches” in Para. 114. Although Ben-Yehuda fails to specifically teach that the distance between each marking is exactly one centimeter, it would nevertheless 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 spacing between each marker. 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)). Here, given Ben-Yehuda’s teaching in Para. 114, a variety of spacing intervals such as 1 cm intervals or 1 inch intervals between markings would be equally obvious, particularly given that length indicators typically include individual units of the chosen unit type (e.g. rulers and measuring tapes which are in units of centimeters include 1 centimeter intervals).
Regarding Claims 55 and 56, Pryor as modified above fails to specifically teach the step of providing a source of laser energy as that is operable to provide auditory or visual cues facilitating the continuous movement to be performed at a predetermined rate and wherein said auditory or visual cues rely upon input information, said input selected from the group consisting of providing probe diameter and or power density, accelerometer information, probe treatment surface area, and temperature information; and further comprising the step of processing said input to determine the timing of said auditory or visual cues.
However, Ben-Yehuda teaches a similar device in the analogous art of phototherapy of body cavities (see title, abstract) specifically the step of providing a source of laser energy as that is operable to provide auditory or visual cues facilitating the continuous movement to be performed at a predetermined rate (indication is provided to the physician based on the detected speed, delivered dose etc. see Paras. 79-80, 127-128 and 137-141) and wherein said auditory or visual cues rely upon input information, said input selected from the group consisting of providing probe diameter or surface area information and or power density, accelerometer information, probe treatment surface area, and temperature information (the indication is based at least on the speed and power density and the treatment surface area; see Paras. 79-80, 127-128 and 137-141); and further comprising the step of processing said input to determine the timing of said auditory or visual cues (see again Paras. 79-80, 127-128 and 137-141). 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 in view of Mayer and Ben-Yehuda to include the step of providing a source of laser energy as that is operable to provide auditory or visual cues facilitating the continuous movement to be performed at a predetermined rate, wherein said auditory or visual cues rely upon input information, said input selected from the group consisting of providing probe diameter and or power density, accelerometer information, probe treatment surface area, and temperature information; and further comprising the step of processing said input to determine the timing of said auditory or visual cues, as taught by Ben-Yehuda, because it would assist the physician/operator in delivering the correct dose to the patient.
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]).
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NIKETA PATEL can be reached at (571)-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792