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
Applicant’s claim amendments have successfully overcome all previous claim objections and § 112 rejections. Those objections and rejections are now withdrawn.
Concerning the § 103 rejections, Applicant’s remarks have been fully considered but are not persuasive.
Concerning claim 1, Applicant argues that Zhang fails to teach that the laser probe is translated to the most distal point of the outer sheath. While the Examiner agrees concerning Zhang alone, this limitation is rendered obvious in view of Zipper which teaches translating the probe back-and-forth to a most distal position in the vaginal cavity which would correspond with Zhang’s most distal point in the outer sheath (see interior end 115 in FIG. 1 of Zhang, and compare to distal-most position “E” in FIG. 7 of Zipper).
Applicant further argues that Zhang “does not teach the user interface having a display, upon which a graphical representation of to display symptom improvement or worsening as claimed in the amended claims 1, 5, and 12 - 18, collecting such data, storing such data and transmitting such data to a remote data base.” The Examiner agrees; however, the rejections do not rely on Zhang for these limitations. The rejection of claim 1 has been updated to address the amendment.
Concerning Lundahl, Applicant’s remarks are moot because Lundahl is not used in the rejection to address the “outer sheath.” Rather, Lundahl is used merely to show the “protective sheath.”
Concerning Zhu, Applicant argues that Zhu fails to teach that input observations result in alteration or maintenance of dosing. This argument is moot because Zhu was not asserted to teach this in the rejection. This limitation was only recited (and is still only recited) in claim 5. The rejection of claim 5 relies on the Esch reference for this limitation.
Finally, concerning claims 8-11, Applicant argues that Zhang demonstrates why routine experimentation would not be adequate to discover the optimal treatment parameters here. The Examiner respectfully disagrees. Zhang’s teaching that LLLT will “generally not be prescribed by a medical healthcare provider” does not lead to the conclusion that the claimed parameters are nonobvious. The considerations and standards for obviousness are entirely different to the considerations and standards for whether a therapy will actually be prescribed by a provider. For instance, the requirements to show consistent safe and effective results to be approved for regular medical use on actual patients is far more stringent and burdensome than the requirements to show obviousness. Furthermore, Zhang demonstrates that it was known how to evaluate the efficacy and safety of such parameters, and thus one skilled in the art would understand how to experiment with different parameters to discover optimal value(s)/range(s), especially since the combination of at least the Zhang and Zipper references illustrates that the general conditions of the claim were known.
Claim Objections
Claims 5 and 12-13 objected to because of the following informalities: claim 5 recites “a user interface” which is in improper antecedent form since claim 1 already recites a user interface. Similarly, claim 12 recites “a laser user interface” which has the same issue.
Additionally, both claims 12 and 13 recites the term “laser user interface” whereas other claims, such as 1 and 5, recite just a “user interface.” To be in proper antecedent form, the same terminology should be used throughout. Appropriate correction is required.
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 1-4 and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0008837 A1 to Zhang (hereinafter “Zhang”) in view of US Patent No. 4,998,930 to Lundahl (hereinafter “Lundahl”) in view of US 2017/0172658 A1 to Zipper (hereinafter “Zipper”).
Regarding Claim 1, Zhang teaches a method for reshaping transmucosal energy delivery to pelvic tissue (see e.g. the title, abstract and the background section in Paras. 3-9), said method comprising:
a first step of providing an outer sheath (“insert” 110 and/or 200 and/or 300 in FIGS. 1-3 respectively) with an inner diameter sufficient to allow insertion of a laser fiber probe (135 and/or 205 and/or 305 in FIGS. 1-3 respectively);
followed by a second step of inserting said tubular sheath into a patient body cavity potential space such as a vagina or rectum (see e.g. FIG. 1):
followed by a third step of providing a laser fiber probe (135 and/or 205 and/or 305 in FIGS. 1-3 respectively) composed of a laser fiber (135 and/or 205 and/or 305 in FIGS. 1-3 respectively) (130 in FIGS. 1 and 3; “dosed light source” in FIGS. 2A-C);
followed by the fourth step of inserting said laser fiber probe into the outer sheath until the laser emitting portion of said laser fiber is within said body cavity (see e.g. FIGS. 1-3):
followed by a fifth step of activating said laser energy and transmitting said laser energy through said protective sheath and outer sheath (see e.g. FIGS. 1-3 and Paras. 72 and 77) wherein said laser source is in communication with a laser processor (see e.g. Para. 63: “The dosage is dispensed, and optionally can be monitored by, the controller that is in operational engagement with the light source, thereby making it a “dosed light source.” The controller is generally a microprocessor operated component, that can have firmware engaged therewith, or that can enable software instructions to be incorporated therewith, as are known.”);
followed by a sixth step of translating said laser fiber probe distal end (see e.g. FIGS. 1-3):
followed by a seventh step of deactivating said laser energy and removing said outer sheath and laser fiber probe from body cavity (this necessarily occurs at some point after the conclusion of a treatment session as Zhang’s device is not a permanent implant).
Concerning the order of the steps, Zhang doesn’t appear to specify whether the laser fiber probe is inserted into the outer sheath after the outer sheath has already been inserted into the patient’s body cavity. However, there would only be two possible options here: either the probe is inserted into the sheath prior to the sheath being inserted into the patient’s body cavity, or the probe is inserted into the sheath after the sheath is inserted into the patient’s body cavity. Given only these options, both of which would yield only predictable results, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to consider and experiment with both options to see which one was preferable in a given situation, particularly since it does not appear that either option would significantly impact the resulting therapy on the patient since the desired end result requires that both objects be inserted into the body cavity, and either option would yield that result. As such, both options would be equally obvious to one skilled in the art.
Zhang fails to explicitly teach (1) that the fiber is enclosed in a protective sheath, (2) wherein said laser fiber is capable of emitting laser energy from an area in its distal 4 cm, (3) the translating of the fiber is a “back and forth” motion to “the most distal outer sheath point,” and (4) wherein the laser processor is in communication with a user interface having a display.
Concerning (1), it is remarkably common and well known for optical fibers to be enclosed in a protective sheath (which may be referred to by various names, such as a “jacket” or “outer jacket” among others). As such, as an initial matter, it is the Examiner’s position that this explicit disclosure is simply omitted from Zhang because it is so common. However, as one example providing an explicit disclosure of this limitation, attention is directed to Lundahl which teaches a similar phototherapy device including an optical fiber; Lundahl teaches that it was known to provide such a protective sheath around the fiber (see “However, it will typically have known cladding and an outer ensheathing jacket or coating (not illustrated).”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Zhang (provided that Zhang doesn’t already include this) to enclose the fiber in a protective sheath because it was extraordinarily well known and common to do this for optical fibers, and doing so would predictably help protect the fiber.
Concerning (2) and (3), another reference, Zipper, teaches an extremely similar device for treatment of body cavities including a tip that can emit light from its distal 4 cm (see “4.0 cm” throughout Zipper’s claims, e.g. in claim 3; the sphere emits energy in a spherical pattern and has a diameter of up to 4 cm, and thus emits energy in an area in the distal 4 cm) and which can include back-and-forth translation (see the phrase “back and forth” in Paras. 11, 46-47, 51 and 53 and claims 1, 21 and 42) to a distal-most position of the vaginal cavity (see e.g. position “E” in FIG. 7). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Zhang to provide a distal tip that emits energy in its distal 4cm, and to provide a back-and-forth translation to the most distal position of the vaginal cavity, because it would increase the amount and/or uniformity of the emitted light to the tissue of the surrounding body cavity and would allow sufficient treatment to all tissues throughout the entire vaginal cavity. It would have been additionally obvious to select the back-and-forth motion in combination with the tip shape seen in Zipper because it would predictably enhance Zhang by allowing the addition of Zipper’s disclosed massaging function in combination with the laser energy emission, thereby yielding an enhanced therapeutic result. It is noted that in this combination, by comparing Zipper’s position E in FIG. 7 with Zhang’s most distal end 115 in FIG. 1, that incorporating Zipper’s motion would include reaching Zhang’s most distal end 115 since that position corresponds to Zipper’s most distal treatment position “E.”
Concerning (4), Zipper teaches a similar device including a processor (see e.g. Para. 31) in communication with a user interface having a display (see e.g. the phrase “visual cues” throughout Zipper, such as in Para. 50: “Auditory and or visual cues may be provided by the energy source user interface and or other hardware to facilitate the movement of the probe at the prescribed rate.”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Zhang to include a user interface having a display in communication with the processor because it would advantageously provide useful information to the operator in a convenient format, such as to help in delivering the correct treatment parameters.
Regarding Claim 2, see e.g. Para. 44 and 73 of Zhang discussing multiple wavelengths failing within Applicant’s claimed range.
Regarding Claim 3, see e.g. FIGS. 1-3 and the abstract of Zhang (Zhang is directed toward treatment of the vaginal cavity).
Regarding Claim 4, Zhang is silent as to treating the rectum. However, Zipper discloses a similar invention for treating a variety of body cavity conditions, including both the vagina and the rectum (see e.g. the title, Para. 5, FIG. 9). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Zhang to treat the rectum because it would predictably and advantageously allow condition(s) of that body cavity to be treated, as taught by Zipper.
Regarding Claim 6, see the rejection of claim 1 above; the “back and forth” motion incorporated from Zipper is specifically a distal and proximal motion (see e.g. Para. 46 of Zhang: “in a back and forth fashion, over a treatment length L between proximal position D and distal position E”).
Regarding Claim 7, Zhang teaches that treatment can be done for a time span of at least one minute (see e.g. Paras. 79-80). Additionally, 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 duration of treatment) 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, risk factors associated with the treatment 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 8-11, 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 irradiance and energy output) 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, risk factors associated with the treatment 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)).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Lundahl and Zipper as applied to claim 1 above, and further in view of US 2007/0050000 A1 to Esch et al. (hereinafter “Esch”).
Regarding Claim 5, Zhang as modified above teaches the method of claim 1, but fails to teach “wherein the user observes markings on outer sheath, protective sheath, fiber cladding, or other fiber covering such marking conveying information on a length of area and or surface area to be treated, user inputs said observations into a user interface of said laser energy source, said input observations resulting in alteration or maintenance of dosing based on dosing information maintained in laser physical storage media that is in communication with the laser processor.” Zipper teaches that the laser fiber probe may include markings (e.g. marking 202; see the term “markings” throughout Zipper) to indicate the depth of insertion to help facilitate the proper delivery of energy to the tissue. Furthermore, the Esch reference teaches an analogous device for treatment of a hollow anatomical structure which includes spaced apart index markings which the surgeon can input into a controller so that the controller can alter or maintain the dosing of the therapy based on information maintained in memory (see e.g. Paras. 454, 456, 460, 463). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Zhang to provide markings (as taught by Zipper and Esch) on the laser fiber probe and to allow a user to input observations of those markings into the laser controller for dosage control (as taught by Esch) because doing so would predictably and advantageously help ensure that the proper dosage is being delivered at each region of tissue.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Lundahl and Zipper as applied to claims 2 and 11 above, and further in view of US 2016/0136442 A1 to Zhu (hereinafter “Zhu”).
Regarding Claims 12-15, Zhang as modified above fails to teach that the user inputs diagnostic or symptom information into a user interface prior to or after activating the laser, and generating graphical data to display symptom improvement or worsening on the user interface. Another reference, Zhu, teaches a therapeutic system which includes a user interface for receiving user input related to symptom or diagnostic information both before and after treatment (see e.g. Paras. 14, 44) and in which the interface can display symptom improvement or worsening (see e.g. Paras. 47 and 89). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Zhang to provide that the user inputs diagnostic or symptom information into a user interface prior to and after activating the laser, because doing so would predictably and advantageously help ensure that the proper therapy is delivered, and to generate graphical data to display symptom improvement or worsening on the user interface, because doing so would predictably and advantageously help provide the user and/or operator with intuitive and easy-to-understand feedback concerning the effectiveness of the therapy, thereby helping to allow them to make any needed adjustments to the therapy.
Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Lundahl and Zipper as applied to claims 1 and 11 above, and further in view of US 2017/0000946 A1 to Boyle et al. (hereinafter “Boyle”).
Regarding Claims 16 and 18, Zhang as modified above fails to specifically teach transmitting data to a database not located within the laser, specifically usage information used to maintain procedure related inventory. Another reference, Boyle, teaches a medical device which gathers usage data and transmits it to a remotely located database in order to maintain inventory (see e.g. Para. 82). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Zhang to transmit usage data to a remote database for maintaining inventory, as seen in Boyle, because doing so would predictably and advantageously help ensure that suitable inventory levels of various system components are maintained, which would help ensure that no lapses in treatment capability occur.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Lundahl and Zipper and Zhu as applied to claim 12 above, and further in view of Boyle.
Regarding Claim 17, Zhang as modified above fails to specifically teach transmitting data to a database not located within the laser. Another reference, Boyle, teaches a medical device which gathers usage data and transmits it to a remotely located database in order to maintain inventory (see e.g. Para. 82). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Zhang to transmit usage data to a remote database for maintaining inventory, as seen in Boyle, because doing so would predictably and advantageously help ensure that suitable inventory levels of various system components are maintained, which would help ensure that no lapses in treatment capability occur.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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
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