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
Regarding the claim objections, applicant’s amendments and remarks have resolved most, but not all, of the issues. Specifically, the objection to claims 11, 14 and 15 (if claims 1, 6 and 7 are found to be allowable) is maintained. As explained in the previous NF, while these claims are worded slightly different, the scope is the exact same. Applicant’s amendments and/or arguments do not address this issues; therefore the objection is maintained. Additionally, claims 9 and 10 are objected for similar reasons as claim 1 and 11; see explanation below.
Regarding the 112b indefiniteness rejections, applicant’s amendments and related remarks are considered persuasive in overcoming most of the previous rejections which are hereby withdrawn. Applicant’s amendments/remarks do not address the 112b for claim 9, specifically the lack of antecedent basis for “the rate of reduction of fluorescence”. Therefore, the previous 112b for claim 9 is maintained, all other 112b rejections are hereby withdrawn.
Regarding the 102 rejection to Hisataka, applicant’s amendments and related arguments are considered persuasive in overcoming the anticipatory rejection, as Hisataka fails to the fluorescent monitoring, as now claimed in the independent claim.
Regarding the 103 rejection to Hisatak and Fraval, applicant’s amendments and related arguments are not considered persuasive. The current amendments to claim 1 are extremely similar to previously presented claims 6-7. The previous NF has already explained the examiner’s position as to why these steps are obvious in view of Fraval. It is emphasized that applicant’s remarks in no way address the previous 103 rejection, therefore it is being maintained. Applicant’s only remarks regarding the previous rejection of claim 6, i.e. the Fraval reference, are “since independent claim 1 patentably distinguishes over the prior art and is allowable, claims 3, 6, 7, 14 and 15 are at least allowable therewith as depending from an allowable base claim”. It is noted that while the 102/anticipation rejection of Hisataka is overcome, this does not make the claims allowable, as purported by applicant in their remarks. Therefore, applicant’s amendments have necessitated a new grounds of rejection for claim 1; however, this new grounds of rejection is substantially the same as the 103 of Hisataka in view of Fraval for previously presented claims 6-7.
Claim Interpretation
For clarity, it is noted that the limitations recited in claims 9 and 10 are interpreted as inherent characteristics/properties of phthalocyanine dyes, i.e. statement of facts. These claims do not require additional method steps, therefore any prior art rejection that teaches/suggests the method of claim 1, also rejects claims 9 and 10; see MPEP 2112. This claim interpretation has been made clear in the previous NF and is repeated herein.
Claim Objections
Claims 9 and 10 are objected to because of the following informalities: “the fluorescent agent that uses the phthalocyanine dye” should be written the fluorescent agent comprising the phthalocyanine dye or just the phthalocyanine dye. Appropriate correction is required.
Applicant is advised that should claims 1, 6-7 be found allowable, claims 11, 14 and 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claims 1 and 11, although worded slightly different, encompass the exact same scope. The only difference is that claim 11 uses passive language “to which a photosensitizing agent is administered” versus the active language in claim 1 “administering a photosensitizing agent”. Regardless of the active versus passive language, the scope of each of these method claims is the same, as both require administration of a photosensitizing agent. Claim 6 is a duplicate of claim 14 with slightly different wording, i.e. synonyms; claim 7 is a duplicate of claim 15.
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 9 is 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.
[Claim 9] The claim recites the limitation "the rate of reduction of fluorescence". There is insufficient antecedent basis for this limitation in the claim. Furthermore, it’s unclear if/how this further limits the method claim, as this appears to be a statement of fact, i.e. an inherent property or characteristic of the previously defined steps. It’s unclear if an additional step is required to meet this limitation. For claim interpretation purposes, if the prior art teaches the previous method steps, then this claim limitation is met, as this limitation refers solely to an inherent property or characteristic of the previously recited method steps.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 6, 7, 9-11, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hisataka as applied to claim 1 above, and further in view of US 2006/0106435 to Fraval.
[Claims 1, 2, 6, 11 and 14] Hisataka discloses a method for irradiating cells with light, the method comprising:
administering a fluorescence agent comprising a phthalocyanine dye, which is a fluorescent dye, to cells (“A molecule that uses a target-specific photosensitizer based on IR700, a near-infrared (NIR) phthalocyanine dye conjugated to a monoclonal antibody (MAb) that targets cell surface receptors. Targeted therapy. In one example, the cell surface receptor is a cell surface receptor found among cancer cells, such as HER1, HER2, or PSMA, and thus PIT can be used to kill such cells. Cell death of the cells occurs when antibody-IR700 molecules bind to the cells and these cells are irradiated with NIR”); and
irradiating the cells with predetermined light with a light intensity of more than 0 mW/cm2 and 50 mW/cm2 or less (“In an in vitro experiment, cell death was induced by NIR light having a power density of 2.2 mW/cm2”, “at least 20 mW/cm2”, 32 or 33 mW/cm2; pg. 21 of the English translation) up to at least 1 J/cm2 (“In general, a suitable dose after administration of the antibody -IR700 at least 1 J/cm2 at a wavelength of 660～740Nm, for example, at least 10 J/cm2 at a wavelength of 660～740Nm least 50 J/cm2 at a wavelength of 660～740Nm, or at least 100 J/cm2 at a wavelength of 660～740Nm, for example, a 1～500J/cm2 at a wavelength of 660～740Nm. In some examples, the wavelength is 660-710 nm.”)
Furthermore, it is clear from applicant’s own specification that Hisataka discloses the claimed method steps, specifically Hisataka discloses using the same photosensitizing agent (IRDye 700; Par 0005 of applicant’s specification) at the same energy density (at least 1 J/cm2; Pars 0006 and 0033 of applicant’s specification).
Hisataka is discussed above, but fails to teach monitoring fluorescence during treatment to determine if the treatment should be continued or stopped. However, in the same field of endeavor, specifically photodynamic therapy to treat cancer, Fraval discloses measuring the intensity of fluorescence during treatment and determining whether or not to continue or stop treatment based on the rate of reduction (Pars 0127-130). Fraval discloses “during the course of treatment, the filter wheels 12 and 24 can be selectively controlled to go back to application of UV light and the spectrum analyser used to determine if any fluorescence is detected from the treatment area. If no fluorescence is detected before the timer 104 runs down, the lamp 10 can be shut off my rotating the wheel 12 to bring the element 20 into alignment with the wheel, as the lack of fluorescence is indicative of the fact that treatment has been completed and the unwanted cells destroyed, thereby indicating that it is not necessary to continue for the full time previously set by the timer 104”. The examiner contends that if no fluorescence is detected, the rate of reduction, i.e. percentage of attenuation, of the fluorescence is 100%, as it has been reduced from its highest/starting value to 0, i.e. 100% reduction. Furthermore, it is implied/inherent that treatment continues for all other values (0% to 99% reduction), as treatment is only stopped when the rate of reduction is 100%. Therefore, it would have been obvious to one of ordinary skill in the art to modify the method of Hisataka with the fluorescence measurement and determination taught by Fraval, as a known way to monitor the progress of similar PDT treatments and provide a safe and effective treatment by ending the treatment when all of the unwanted cells are destroyed.
[Claims 7 and 15] It’s clear in Hisataka that the light delivery of at least 1 J/cm2 is a dose (at least Abstract). It’s inherent (or at the very least obvious) that by virtue of defining this light as a dose, i.e. the measured quantity of a therapeutic agent to be taken at one time, the light delivery is continued until the dose is met, i.e. when the light delivery is stopped, as this meets the definition of a dose. If applicant disagrees, the examiner contends that such a method step is obvious in view of the state of the prior art, and the medical field as a whole, as a dose is a specific quantity, i.e. maximum amount, of a therapeutic agent. Therefore, it would be common sense/known to stop delivering light only when the dose is met.
“Administration of a therapeutically effective amount of an antibody-IR700 molecule followed by irradiation with a therapeutically effective dose and administration of one or more therapeutic agents can selectively kill tumor cells in vivo; It is possible to reduce the weight or volume of a tumor in vivo. Selective killing of tumor cells compared to normal cells means that the method is more effective than normal cells, such as cells that do not express cell surface proteins that specifically bind to the administered antibody. It can be killed”.
The examiner takes the position that based on this teaching, it would be inherent and/or obvious to continue the delivery of light until the therapeutically effective dose of light is met, at which point the delivery is stopped, as it is no longer necessary/effective.
[Claims 9 and 10] As discussed above, these claims relate solely to inherent properties or characteristics of the photosensitizing agent and/or the previously recited method steps. It is emphasized that Hisataka uses the same photosensitizing agent as disclosed by applicant, specifically IRDye 700 (IR700); See MPEP 2112.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hisataka and Fraval, as applied to claim 1 above, and further in view of US 2012/0041523 to Solomon.
Hisataka and Fraval are discussed above, but fail to explicitly teach notifying that the cells are irradiated with the predetermined light. However, in the same field of endeavor, specifically light therapy devices, Solomon discloses an alarm that notifies a user of the end of a treatment session (Par 0052), where a treatment session is defined by a particular fluence delivered (Pars 0012 and 0061). Therefore, it would have been obvious to one of ordinary skill in the art to modify the method taught by Hisataka and Fraval with the step of notifying a user when a certain amount of light has been delivered, as taught by Solomon, as this is combining prior art elements according to known methods to yield predictable results, so that a user is aware when the treatment is finished.
Conclusion
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 Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796