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 .
DETAILED ACTION
The preliminary amendment filed on November 22, 2024 is acknowledged and entered. Claim 1 is amended. Claims 2-20 are new. Claims 1-20 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 11, 2024, May 16, 2024, August 13, 2024, October 23, 2024, November 11, 2024, January 17, 2025, April 18, 2025, June 13, 2025, September 11, 2025 and October 28, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because the unlabeled rectangular boxes in FIGS.7-9 shown in the drawings illustrate overall system and method diagrams and should be provided with descriptive text labels. See MPEP 608. 02(b).II: a reason for objection of the drawings may include that the unlabeled rectangular box(es) shown in the drawings "should be provided with descriptive text labels".
The drawings are further objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “a”, “a1”, and “c3a” in FIG.18A. In the specification [0125] where FIG.18A is disclosed, there is a disclosure in regard to “C3a” being the treatment site. However, as C3 denotes the tissue, and the component “a”, though not disclose in the specification, appears to be a light beam, C3a (upper case C) does not appear to be the treatment site. Perhaps c3a (lower case C) should be the treatment site in the specification? Proper amendment to the specification to correctly denote all the components in FIG.18A is required.
The drawings are further objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "G" (in [0122]) and "c1" (in [0125]) have both been used to designate the “photosensitizer”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In the specification, PG Pub US 2025/0073491 A1, [0034], line 3, the word “the” should be deleted.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 11: the claim limitation of “an applicator device for applying one or more photosensitizers” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “device” coupled with functional language “for applying” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “device”.
Claim 11: the claim limitation of “one or more light devices that are configured to direct one or more pulsed light beams” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “devices” coupled with functional language “to direct” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “devices”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claim 11: “one or more light devices” refers to the specification [0006]: a light source, consisting of one or more light emitting diodes (LEDs), laser diodes, lasers, or related light source including but not exclusively semiconductor light devices; and [0013]: light energy can be delivered from an array of individual light source, for example from an LED array.
The “applicator device” recited in claim 11 does not have structural information disclosed in the specification. [0034] discloses a photosensitizer is administered locally or systemically. [0125] discloses “at least one systemically injected photosensitizer c1”. Neither discloses structural information for the applicator device. Though [0122] discloses FIG.15F shows administration of one or more photosensitizers G into a vein G1, it remains unknown in regard to what structural information refers to the application device. Note that in claim 2, the one or more photosensitizer is activated on a surface of the object, and in claim 3 the one or more photosensitizer is active within the object. Hence it is required for the applicator device to be capable of applying the one or more photosensitizer to the surface of the object and into the tissue. However, there is no structural disclosure for either scenario.
Note that [0124] discloses using a syringe c3 yet it is for injecting an ultrasound contrast solution c2 rather than the one or more photosensitizers. For examination purpose. [0061] also discloses various tools as droplet/aerosol/vapor generation and application. Yet there is no disclosure that any of those are an applicator device for applying the one or more photosensitizers.
For examination purpose, the applicator device is interpreted as a tool that is capable of properly applying the photosensitizer to the target location. If it is within the tissue, it may be for example a syringe with a needle. If it is on the tissue surface, it may be for example a diffuser or a surface spray.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11-20 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, yet neither the claim nor the specification provides the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
As discussed above, the claim limitations below are interpreted under 35 U.S.C. 112 (f).
Claim 11: Claim limitation “an applicator device for applying one or more photosensitizers to an object”.
The specification [0034], [0122] and [0125], as aforementioned, discloses the functions performed by this limitation. N Note that [0124] discloses using a syringe c3 yet it is for injecting an ultrasound contrast solution c2 rather than the one or more photosensitizers. For examination purpose. [0061] also discloses various tools as droplet/aerosol/vapor generation and application. Yet there is no disclosure that any of those are an applicator device for applying the one or more photosensitizers. Hence, one of ordinary skill in the art would not understand the specification, the drawing and the original claims to disclose any particular structure that achieves the disclosed functionality.
This limitation fails to comply with the written description requirement as the limitations are unbound functional imitations which cover all ways of performing the respective functions and inventor has not provided sufficient disclosure to show possession of such an invention. The limitations therefore fails to comply with the written description requirement. See MPEP 2181.II.A.
Further because claims including a 112(f)-invoking term are interpreted as requiring the disclosed corresponding structure for that term, absent the disclosure of any such corresponding structure, the written description is insufficient to show that Applicant was in possession of the invention as claimed at the time of the invention, and such a claim must be rejected under 35 USC 112(a). (MPEP 2181.IV).
The dependent claims of the above rejected claim are rejected due to their dependency.
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.
The following claim limitations invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph:
Claim 11: the limitation of “an applicator device”
A claim with a 112(f)-invoking term must be construed as requiring the corresponding structure for that term, or its equivalents. Consequently, absent the disclosure of such corresponding structure, the metes and bounds of the claim cannot be determined, and the claim must be rejected under 112(b) as being indefinite. (MPEP 2181.III)
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The dependent claims of the above rejected claim are rejected due to their dependency.
Claims 2-5, 12-16 and 18 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 pre-AIA the applicant regards as the invention.
Claims 2 and 3 recite “the one or more acoustic waves causes sonodynamic activation of the one or more photosensitizers”, and claim 5 recites “sonodynamic activation of the one or more photosensitizers caused by the one or more acoustic waves”. Claims 2, 3 and 5 depend on claim 1, and claim 1 recites that the combination of the one or more pulsed light beams and the one or more acoustic waves cause activation of the one or more photosensitizers. It is unclear whether the “activation” of claim 1 and the “sonodynamic activation” of claims 2, 3 and 5 has any relationship and if so what kind of relationship do they have.
Claim 4 recites “photoactivation of the one or more photosensitizers”. Claim 4 depends on claim 1, and claim 1 recites that the combination of the one or more pulsed light beams and the one or more acoustic waves cause activation of the one or more photosensitizers. It is unclear whether the “activation” of claim 1 and the “photoactivation” of claim 4 has any relationship and if so what kind of relationship do they have.
In view of the above, it appears that the one or more pulsed light beams cause photoactivation of the one or more photosensitizers (Claim 4), and the one or more acoustic waves cause sonodynamic activation of the one or more photosensitizers (claims 2, 3 and 5). Yet claim 1 recites the combination of the one or more pulsed light beams and the one or more acoustic waves cause activation of the one or more photosensitizers. Hence it is unclear if the one or more pulsed light beams cause one type of activation (“photoactivation”), the one or more acoustic waves cause another type of activation (“sonodynamic activation”), and the combination of the one or more pulsed light beams and the one or more acoustic waves cause yet another type of activation (“activation”). The scope of claims 2-5 hence is considered indefinite.
The same rejection applies to claims 12-15 for the substantially identical limitations recited in these claims.
Claims 3 and 13 recite “applying the one or more photosensitizers further comprises employing the one or more acoustic waves to cause sonodynamic activation…” that renders the scope of the claims indefinite. The one or more photosensitizers, according to the specification, PG Pub US 2-25/0073491 A1, at least [0028] and [0125] is an injectable formulation, i.e., a material. To apply the one or more photosensitizers is to provide it to the object. However, in order to generate the one or more acoustic waves, it requires light irradiation ([0034]: a photosensitizer is administered locally or systematically, and the activated simultaneously by light absorption; and [0122]: activation of the photosensitizer(s) by the light source A and/or A1). The generated acoustic waves then would subsequently activate the photosensitizer material. It is unclear how by simply applying the one or more photosensitizers would result in the one or more acoustic waves, and further would employ the one or more acoustic waves to cause sonodynamic activation. Clarification with proper amendment is required. For examination purpose, claim 3 is interpreted such that the employing step is an additional step further comprised in the claimed method. In regard to claim 13, since it is an apparatus claim, it may be interpreted similarly but it would raise another ground of indefiniteness rejection that applies to claims 12, 14-16 and 18 (see below).
Claims 12, 14-16 and 18 recite “employing….” that are method steps. Claims 12, 14-16 and 18 however are apparatus claims. It is unclear whether any of the recited components in claim 12 (i.e., an applicator device and one or more light devices) is configured to perform these “employing” method steps. It is unclear how these method steps further limit the structure of the claimed apparatus. The scope of these claims hence is indefinite. Note that claim 13 is not included in this rejection yet the claim language raises another ground of indefiniteness rejection (see above).
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 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.
Claims 1-3, 5, 7-8, 11-13, 15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dai et al., US 2025/0041459 A1, hereinafter Dai, in view of Peyman et al., US 11.419,543 B1, hereinafter Peyman.
Claims 1 and 11. Dai teaches a method and an apparatus, comprising:
an applicator device for applying one or more photosensitizers ([0032]: to provide a use of the fluorescent probe in preparing a formulation for diagnosis or treatment of tumors; and [0037]: this probe can also produce singlet oxygen under the irradiation of laser of ultrasound with a certain intensity) to an object ([0028]: when in use, the fluorescent probe is generally injected into the body by intravenous injection, or can be used through intraperitoneal injection, subcutaneous injection, intramuscular injection, intratumoral injection, surface spraying, perfusion and the like) – since the probe can produce singlet oxygen under the irradiation of laser, it is considered as the “one or more photosensitizers” as claimed. Since Dai teaches that the probe is injected, sprayed or perfused to the object, and the injection, the spray and the perfusion require tools to accomplish, Dai is considered at least implicitly teaching the recited applicator device that is the device required for implementing the injection, the spraying or the perfusion;
one or more light devices that are configured to direct one or more light beams at the object ([0037]: this probe can also produce singlet oxygen under the irradiation of laser of ultrasound with a certain intensity) – the laser is the ”one or more light devices” as claimed, wherein
the one or more light beams cause generation of one or more acoustic waves in the object ([0037]: the probe of the present disclosure can be used for photoacoustic imaging which mainly utilizes strong absorption of the fluorescent probe in the near-infrared region) – photoacoustic imaging is conventionally known to be based on the photoacoustic effect where pulsed laser light is delivered and converted into sound waves; and wherein
the combination of the one or more light beams and the one or more acoustic waves cause activation of the one or more photosensitizers to generate singlet oxygen ([0037]: this probe can also produce singlet oxygen under the irradiation of laser or ultrasound with a certain intensity, so as to be used to photodynamic therapy and sonodynamic therapy of tumors).
Dai does not teach that (1) the one or more light devices that are configured to direct one or more pulsed light beams at the object; (2) the one or more pulsed light beams cause generation of one or more acoustic waves in the object; and (3) the combination of the one or more pulsed light beams and the one or more acoustic waves cause activation of the one or more photosensitizers to generate singlet oxygen.
However, in an analogous photoacoustic activation of photosensitizer-based tumor-targeting treatment and therapy field of endeavor, Peyman teaches
(1) the one or more light devices that are configured to direct one or more pulsed light beams at the object (Col.17, ll.27-46: the thermotherapy is done after intravenous or local administration of…photosensitizers…with laser light that penetrates superficial tissue or tissues…with the thermal energy and measurement of the temperature photoacoustically by combining a pulsed laser fiber optic to induce photoacoustic pulses after the tissue is heated up with the thermally induced laser and measuring the photoacoustic sound from outside the body using a receiver transducer positioned to the skin to listen to the photoacoustic sound generated in the body);
(2) the one or more pulsed light beams cause generation of one or more acoustic waves in the object (Col.17, ll.27-46:…with the thermal energy and measurement of the temperature photoacoustically by combining a pulsed laser fiber optic to induce photoacoustic pulses after the tissue is heated up with the thermally induced laser and measuring the photoacoustic sound from outside the body using a receiver transducer positioned to the skin to listen to the photoacoustic sound generated in the body); and
(3) the combination of the one or more pulsed light beams and the one or more acoustic waves cause activation of the one or more photosensitizers to generate singlet oxygen (Col.13, ll.3-11: a known photosensitizer…is conjugated with antibody coated nanoparticles having a thermosensitive polymeric coating…Upon light activation, the nanoparticles simultaneously release a small amount of photosensitizer and other medications from the polymeric coating. Subsequently, after release of the photo sensitizer, in the presence oxygen and laser application, singlet oxygen and free radicals are created).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method and apparatus of Dai employ such features associated with (1) the one or more light devices that are configured to direct one or more pulsed light beams at the object; (2) the one or more pulsed light beams cause generation of one or more acoustic waves in the object; and (3) the combination of the one or more pulsed light beams and the one or more acoustic waves cause activation of the one or more photosensitizers to generate singlet oxygen as taught in Peyman for the advantage of “early disease detection, diagnosis, and treatment” and “inducing endothelial cell wall damage of the lesion that is induced by the singlet oxygen and free radical formation in a tumor”, as suggested in Peyman, Col.1, ll.44-50, and Col. 13, ll.58-59.
Claims 2 and 12. Dai further teaches
employing the one or more acoustic waves to cause sonodynamic activation of the one or more photosensitizers on a surface of the object ([0028]: when in use, the fluorescent probe is generally injected into the body by intravenous injection, or can be used through intraperitoneal injection, subcutaneous injection, intramuscular injection, intratumoral injection, surface spraying, perfusion and the like; and [0037]: the probe of the present disclosure can be used for photoacoustic imaging which mainly utilizes strong absorption of the fluorescent probe in the near-infrared region…this probe can also produce singlet oxygen under the irradiation of laser of ultrasound with a certain intensity, so as to be used to photodynamic therapy and sonodynamic therapy of tumors).
Claims 3 and 13. Dai further teaches
employing the one or more acoustic waves to cause sonodynamic activation of the one or more photosensitizers within the object ([0028]: when in use, the fluorescent probe is generally injected into the body by intravenous injection, or can be used through intraperitoneal injection, subcutaneous injection, intramuscular injection, intratumoral injection, surface spraying, perfusion and the like; and [0037]: the probe of the present disclosure can be used for photoacoustic imaging which mainly utilizes strong absorption of the fluorescent probe in the near-infrared region…this probe can also produce singlet oxygen under the irradiation of laser of ultrasound with a certain intensity, so as to be used to photodynamic therapy and sonodynamic therapy of tumors).
Claims 5 and 15. Dai and Peymen combined teaches all the limitations of claim 1, including the one or more pulsed light beams (Peyman: Col.17, ll.27-46).
Dai further teaches
employing modification of one or more of an intensity or a frequency of the one or more light beams to adjust sonodynamic activation of the one or more photosensitizers caused by the one or more acoustic waves ([0037]: this probe can also produce singlet oxygen under the irradiation of laser or ultrasound with a certain intensity, so as to be used for photodynamic therapy and sonodynamic therapy of tumors) – the intensity of the light beams needs to be adjusted to be the “certain intensity” in order for the irradiation of laser may be effective for being used for photodynamic therapy and sonodynamic therapy of tumors, i.e., “adjusting the sonodynamic activation of the one or more photosensitizers” as claimed.
Claims 7 and 17. Dai further teaches that
the one or more light beams further comprise one or more non-ionized light beams ([0037]: the probe of the present disclosure can be used for photoacoustic imaging which mainly utilizes strong absorbance of the fluorescent probe in the near-infrared region…this probe can also produce singlet oxygen under the irradiation of laser) – a laser light in the near-IR region is a non-ionized light beam.
Claims 8 and 18. Dai further teaches
employing the one or more acoustic waves to generate ultrasound stimulation within the object ([0034]: the formulation for treatment of tumors comprises…a tumor sonodynamic therapeutic agent; and [0037]: this probe can also produce singlet oxygen under…ultrasound…so as to be used for…sonodynamic therapy of tumors) –sonodynamic therapy is an ultrasound-based stimulation with therapeutic effect.
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Dai et al., US 2025/0041459 A1, hereinafter Dai, in view of Peyman et al., US 11.419,543 B1, hereinafter Peyman, further in view of Hasan et al., US 2011/0112059 A1, hereinafter Hasan.
Claims 4 and 14. Dai and Peyman combined teaches all the limitations of claim 1, including the one or more pulsed light beams (Peyman: Col.17, ll.27-46).
Neither Dai nor Peyman teaches employing modification of one or more of an intensity or a frequency of the one or more light beams to adjust a rate of photoactivation of the one or more photosensitizers.
However, in an analogous photosensitizer activation field of endeavor, Hasan teaches
employing modification of one or more of an intensity or a frequency of the one or more light beams to adjust a rate of photoactivation of the one or more photosensitizers ([0209]: in aspects where treatment is desired, the dosage of photosensitizer composition, and light activating the photosensitizer composition, is administered in an amount sufficient to produce a phototoxic species. For example, where the photosensitizer is chlorine6…the light delivery time is spaced in intervals of about 30 minutes to about 3 days…The light dose administered is in the range of about 2-500 J/cm2…The fluence rate is in the range of about 20 to about 500 mw/cm2. There is a reciprocal relationship between photosensitizer compositions of light dose, thus, determination of suitable wavelength, light intensity, and duration of illumination is within ordinary skill in the art).
When Dai, Peyman and Hasan are combined, the light beam is a pulsed light beam.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method and apparatus of Dai and Peyman combined employ such features associated with employing modification of one or more of an intensity or a frequency of the one or more light beams to adjust a rate of photoactivation of the one or more photosensitizers as taught in Hasan for the advantage of achieving a desired treatment and such an adjustment is within ordinary skill in the art, as suggested in Hasan, [0209].
Claims 6, 9-10, 16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dai et al., US 2025/0041459 A1, hereinafter Dai, in view of Peyman et al., US 11.419,543 B1, hereinafter Peyman, further in view of Buchan et al., US 2024/0206737 A1, hereinafter Buchan.
Claims 6 and 16. Dai and Peyman combined teaches all the limitations of claim 1, including the one or more pulsed light beams (Peyman: Col.17, ll.27-46).
Neither Dai nor Peyman teaches employing a plurality of different wavelengths for the pulsed light beams to generate a plurality of different depths of penetration within the object by the one or more pulsed light beams and the one or more acoustic waves.
However, in an analogous photoacoustic light beam configuration field of endeavor, Buchan teaches
employing a plurality of different wavelengths for the pulsed light beams to generate a plurality of different depths of penetration within the object by the one or more pulsed light beams and the one or more acoustic waves ([0120]: an infrared (IR) light-emitting diode LED may be selected and a short pulse of IR light emitted to illuminate a portion of the target object and generate acoustic wave emissions that are then detected by the receiver system…one or more light sources of different wavelengths may be fired in turn or simultaneously to generate acoustic emissions that may be detected by the ultrasonic receiver. Image data from the ultrasonic receiver that is obtained with light sources of different wavelengths and at different depths into the target object may be combined to determine the location and type of material in the target object…Depth contrast may be obtained with light of different wavelengths and/or intensities at each selected wavelength).
When Dai, Peyman and Buchan are combined, the light beam is a pulsed light beam.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method and apparatus of Dai and Peyman combined employ such features associated with employing a plurality of different wavelengths for the pulsed light beams to generate a plurality of different depths of penetration within the object by the one or more pulsed light beams and the one or more acoustic waves as taught in Buchan for the advantage of “determining the location and type of material in the target object”, as suggested in Buchan, [0120].
Claims 9 and 19. Dai and Peyman combined teaches all the limitations of claim 1.
Dai further teaches that the probe, i.e., the photosensitizer as claimed, can be used for photoacoustic imaging ([0037]).
Neither Dai nor Peyman teaches employing the one or more acoustic waves to generate one or more ultrasound visualizations of an interior of the object.
However, in an analogous photoacoustic imaging configuration field of endeavor, Buchan teaches
employing the one or more acoustic waves to generate one or more ultrasound visualizations of an interior of the object ([0120]: one or more light sources of different wavelengths may be fired in turn or simultaneously to generate acoustic emissions that may be detected by the ultrasonic receiver. Image data from the ultrasonic receiver that is obtained with light sources of different wavelengths and at different depths into the target object may be combined to determine the location and type of material in the target object).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method and apparatus of Dai and Peyman combined employ such features associated with employing the one or more acoustic waves to generate one or more ultrasound visualizations of an interior of the object as taught in Buchan for the advantage of “determining the location and type of material in the target object”, as suggested in Buchan, [0120].
Claims 10 and 20. Dai and Peyman combined teaches all the limitations of claim 1, including the one or more pulsed light beams (Peyman: Col.17, ll.27-46).
Dai further teaches that the one or more pulsed light beams
employing a plurality of wavelengths that range from 800 nanometers to 2,500 nanometers ([0037]: the probe of the present disclosure can be used for photoacoustic imaging which mainly utilizes strong absorbance of the fluorescent probe in the near-infrared region…this probe can also produce singlet oxygen under the irradiation of laser) – wavelength of the near-IR region is from about 750-1400 nm.
Neither Dai nor Peyman teaches the pulsed light beam employing a plurality of frequencies that range from one to ten mega hertz (MHz).
However, in an analogous photoacoustic imaging configuration field of endeavor, Buchan teaches
employing a plurality of frequencies that range from one to ten mega hertz (MHz) ([0120]: an infrared (IR) light-emitting diode LED may be selected and a short pulse of IR light emitted to illuminate a portion of the target object and generate acoustic wave emissions that are then detected by the receiver system; and [0121]: the light source system may be configured for emitting a plurality of light pulses at a pulse repetition frequency between about 1 MHz and about 100 MHz).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method and apparatus of Dai and Peyman combined employ such features associated with employing a plurality of frequencies that range from one to ten mega hertz (MHz) as taught in Buchan for the advantage of “determining the location and type of material in the target object”, as suggested in Buchan, [0120].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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, Pascal M Bui-Pho can be reached at 571-272-2714. 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.
/YI-SHAN YANG/Primary Examiner, Art Unit 3798
Prosecution Insights