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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 23, 2026 has been entered.
Response to Amendment
This Office action is responsive to the amendment filed with the request noted above. As directed by the amendment, claims 8, 12 and 15 have been amended, claim 14 has been cancelled and claims 18-20 have been added. Thus, claims 1-12 and 15-20 are presently pending, with claims 1-7 being previously withdrawn from further consideration.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the term/phrase “generally 21 megaHertz” in regards to frequency of the photoacoustic acoustic imaging unit lacks antecedence basis in the specification.
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.
Claims 8-12 and 15-17 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.
Claim 8 recite the limitations "the embedding" in in the last stanza. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend to “the embedded gold nanoparticles into the liposomes facilitates …” to be consistent with the prior recitation.
Claim 8 further recites in part “the photoacoustic imaging of a release of the anti-tumor drug” in the last stanza. There is insufficient antecedent basis for this limitation in the claim and the photoacoustic imaging is not intended to release any medication, but rather the heating step previously recited. For examination purposes, it will be presumed that this limitation reads “…and facilitates t
Claims 9-12 and 15-17 are likewise rejected, only because they include all limitations and deficiencies of claim 8.
Claim 12 recite in part “generally 21 megaHertz”, the term “generally” is a relative term which render the claim indefinite. The term “generally” 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.
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.
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 8, 10 and 14-15 is rejected under 35 U.S.C. 103 as being unpatentable over previous cited Peyman US 20190091350 A1 , in view of Peyman US 20150157713 A1 (Peyman 15') as evidence by previously cited Emelianov et al., US 20120253180 A1 hereinafter "Emelianov".
Regarding claim 8, Peyman discloses a cancer treatment method using nanoparticle-mediated thermal therapy and photoacoustic imaging (e.g., [abstract], [0037], [0040]), the method comprising the steps of: administering a plurality of nanoparticles to a tissue at a site of a tumor in a patient ([abstract], [0035]), the plurality of nanoparticles administered to the tissue at the site of the tumor in the patient comprising gold nanoparticles ([0028]) embedded in liposomes, the liposomes containing an anti-tumor medication ([0036] “the nanoparticles are incorporated in liposomes. In this embodiment, they may contain medications that, upon attainment of a specific tumor temperature, are released”),
heating the tissue and at least some of the plurality of nanoparticles at the site of the tumor using a thermal energy source ([0045]), note, the phrase “so as to generate photoacoustic signal, damage one or more tumor cell membranes, and release antigenic material in vivo that activates and stimulates an immunogenic response of the patient at the site of the tumor” are effects of the heating step on the nanoparticles that are expected based on the teachings e.g., in [0045], [0047] and/or [0051]), in a plurality of heating stages ([0040] increasing temperature of the nanoparticles to 42-43oC to release anticancer medications or inhibitory genes, and further increasing the temperature to 45-50oC to kill the suspected tumor to which the nanoparticle is attached);
performing photoacoustic imaging with a photoacoustic imaging unit so as to acquire photoacoustic signals ([0005], [0034-0035], [0037], [0040], illustration Fig. 1); and
determining, by using the photoacoustic imaging unit, a temperature of the heated tissue at the site of the tumor from the photoacoustic signals ([0040], [0050] “… the photoacoustic or thermoacoustic sound is recorded as a temperature profile of the site of the nanoparticle/cell membrane imaged” i.e., the temperature profile will reflect temperature of heated tissue at the site of the tumor),
wherein the step of heating the tissue and the at least some of the plurality of nanoparticles further comprises heating at least some of the gold nanoparticles at the site of the tumor, the heating of the gold nanoparticles resulting in an increased temperature rise at the site of the tumor that is five to seven times greater than a temperature rise achieved without the administration of gold nanoparticles ([0028] regarding gold nanoparticles, as such, the heating step encompasses heating some of the gold nanoparticles at the site of tumor; in regards to “the heating of the gold nanoparticles resulting in an increased temperature rise at the site of tumor that is five to seven times greater than a temperature rise achieved without the administration of gold nanoparticles” this limitation is directed to a result of the method step that is expected (i.e., inherent because the gold nanoparticles allows for the rise of temperature, see also as evidenced by Emelianov in [0009] “… gold nanostructures ( shells, particles, rods, and cages) emerged as useful agents for photothermal therapy after they were shown to have strong absorption in the NIR region (four to five times higher than conventional photo-absorbing dyes) as well as tunable optical resonances. The strong absorption enables effective laser therapy at relatively low laser energies, rendering such therapy methods minimally invasive”, the gold nanoparticles are expected to increase five times fold absorption the absorption would result with an increase in temperature) when the gold nanoparticles are heated in view of [0040] which is similar to temperature rise of tissue in instant application,.)
Peyman does not explicitly disclose the thermal energy source operating near an absorption peak of the gold nanoparticles.
However, Peyman 15’ discloses wherein the gold nanoparticles have an absorption that corresponds with a laser to enhance image or temperature ([0153]). In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified the method of Peyman to include staged heating of the nanoparticles using a laser operating near an absorption peak of the gold nanoparticles, for a more enhanced image or temperature for monitoring the tissue during heating as taught by Peyman 15’.
In regards to and wherein the embedded gold nanoparticles into the liposomes facilitates photoacoustic imaging of accumulated ones of the liposomes at the site of the tumor and facilitates release of the anti-tumor medication at the site of tumor. Examiner notes that this is an inherent property of the gold nanoparticles embedded in liposomes of Peyman in view of the teachings of Emelianov in [0009],the superior absorption of the gold nanoparticles would facilitate photoacoustic imaging and release of an the anti-tumor medication).
Regarding claim 10, see Peyman [0051] and/or [0060].
Regarding claim 15, see Peyman [0132] regarding the anti-tumor medication comprising doxorubicin.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Peyman 15’ as evidenced by Emelianov as applied to claim 8 above, and further in view of previous cited Knight et al., US 20120052560 A1 hereinafter "Knight".
Regarding claim 9, Peyman in view of Peyman 15’ discloses the invention of claim 8 as discussed above, Peyman further discloses a temperature controller/processor that is operatively coupled to the thermal energy source and the photoacoustic imaging unit ([0040]”… the temperature of the functionalized nanoparticles is increased, by the thermal delivery unit via a processor under the control of the photoacoustic or thermoacoustic imaging unit …”Examiner note: the processor is a temperature controller); and the step of heating as discussed in claim 8 comprises controlling the thermal energy source using the temperature controller based on temperature determined by photoacoustic imaging unit, in order to heat the tissue and the at least some of the plurality of nanoparticles to a prescribed temperature, so as to provide real-time temperature control of the nanoparticle-mediated thermal therapy (continued from [0040] cited above “… to image the temperature and control it to 45° C.-47° C., to 47° C., or to 50° C. to kill the suspected tumor to which the antibody coated nanoparticles are attached”).
Peyman differs with the claimed invention in terminology only, in that in the claimed invention, an analogous temperature controller is labelled as a proportional-integral-derivative (PID) controller. However, a PID controller is a known type of temperature controller as exemplified in [0285] of Knight. As such, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have replaced the temperature controller/processor of Peyman with a PID controller, to predicable perform the same function of temperature control.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Peyman 15’ as evidenced by Emelianov as applied to claim 8 above, and further in view of previously cited Emelianov.
Regarding claims 11-12, Peyman in view of Peyman 15’ discloses the method of claim 8 as discussed above, the photoacoustic imaging unit is disclosed as comprising an ultrasound transducer and an excitation laser (see illustration Fig. 1), however, Peyman does not explicitly disclose that the excitation laser is a nanosecond laser, and wherein the ultrasound transducer operates at a frequency of approximately 21 MHz and the nanosecond laser operates in a wavelength range of about 680-930 nm.
Emelianov in the same field of endeavor of imaging gold nanoparticles using photoacoustic imaging ([title], [0082]) teaches that it was known in the prior art to use a Vevo® 2100 ultrasound system that is interfaced with a 21 MHz center frequency linear array, an ND:YAG pump laser with a nominal pulse with of 5 ns and imaging at 800, 900 and 1064 nm for photoacoustic imaging ([0072]) and teaches in [0174-0175] that PA images obtained at 1064 nm and 800 nm qualitatively showed an increase in PA signal.
In view of these teachings, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the photoacoustic imaging unit of Peyman with a nanosecond excitation laser wherein the ultrasound transducer operates at a frequency of approximately 21 MHz and the nanosecond laser operates at a wavelength of 800 nm, to enhance photoacoustic signal generation.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Peyman 15’ as evidenced by Emelianov as applied to claim 8 above, and further in view of previously cited Almutairi et al., US 20140358068 A1 hereinafter "Almutairi".
Regarding claim 17, Peyman in view of Peyman 15’ discloses the method of claim 8 as discussed above, but does not explicitly disclose wherein the thermal energy source has a power output of up to 15 watts. However, Almutairi in the same field of endeavor of laser thermotherapy of cancer with use of gold nanoparticles ([0010]) that a laser with power of up to 15 watts is suitable to excite gold nanoparticles (claim 9). In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have specified a power output of up to 15 watts for the thermal energy source in Peyman, because Almutairi exemplifies that such a power output is suitable for targeting gold nanoparticles.
Response to Arguments
Applicant’s arguments directed to the rejections of claims 8-12 and 14-15 have been fully considered but are moot in light of new ground of rejection as detailed in the rejection section above.
Applicant’s arguments directed to 16 have been fully considered and is persuasive. The prior art rejection of claim 16 is hereby withdrawn.
Allowable Subject Matter
Claim 16 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.
Claims 18-20 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797