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 .
Status of Application
Claims 1-20 are under examination.
Specification
The disclosure is objected to because of the following informalities: because the following structures are blurry and difficult to read (pg 6, B107; pg 7, MBC-1, MBC-2, MBC-3; pg 8, CuBC-840, CuBC-725, CuBC-775; pg 19, B107; pg 20, MBC-1 and MBC-2; pg 21, MBC-3 and CuBc-725; pg 22, CuBc-775, CuBc-840).
Appropriate correction is required.
The use of the terms IRDye, Higgins, VEVO, MSOT, InVision, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant specification teaches a method of generating an image by exposing the volume to radiation (line 8).
However, the instant specification does not offer sufficient description of the common identifying characteristics that constitute the radiation encompassed. There is no description of structural elements of radiation that are sufficient to distinguish the claimed radiation from other types of radiation (e.g. nuclear radiation). Furthermore, the instant specification does not indicate that the inventors have possession of the details of the structural elements that would comprise these distinguishing characteristics of all radiation.
A person of ordinary skill in the art would appreciate that there are many different structural elements that would constitute the radiation to facilitate the functions recited in the instant claims. However, the instant specification is silent as to which type of radiation (e.g. wavelength) the inventor has determined to be sufficient to characterize radiation. Therefore, the instant specification does not provide a disclosure of corresponding structure in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how the inventor intended what features constitute the radiation to allow the function recited in the instant claims.
Claim Rejections - 35 USC § 112(b)
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 term “a derivative thereof” in claims 1-6, 9, and 14-15 is a relative term which renders the claim indefinite. The term “a derivative thereof” 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. The chemical structures of the metallobacteriochlorin and metallochlorin are rendered indefinite. A person of ordinary skill in the art could modify the metallobacteriochlorin or metallochlorin through methods known in the art to many other compounds which may include polymers, proteins, metal organic frameworks, etc. Therefore, the term renders the claims indefinite.
The terms “any combination thereof” or “combinations thereof” or “combination thereof” in claims 1-2, 6, 9, and 15 is a relative term which renders the claim indefinite. The terms, terms “any combination thereof” or “combinations thereof” or “combination thereof” 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.
The chemical structures of the metallobacteriochlorin and metallochlorin are rendered indefinite. A person of ordinary skill in the art could conceivably combine the different metallobacteriochlorin or metallochlorin through methods known in the art such that ring fusions, covalent linkages, non-covalent associations, mixtures, etc are contemplated. Therefore, the term renders the claims indefinite.
Claim Interpretation
Claims 1-6, 9, and 14-15 recite the term “a derivative thereof”, “any combination thereof” or “combinations thereof” or “combination thereof”. The examiner notes that the specification provides some guidance for a derivative thereof is a component having an absorption spectrum in the range of 650-1070 nm (pg 3, lines 3-4). Therefore, for the purposes of examination, any prior art which contains a metallobacteriochlorin or metallochlorin or non-metalated derivatives thereof or other derivatives or combinations thereof with an absorption wavelength in the range of 650-1070 nm reads on this claim.
Claim 5 recites “(b) exposing the volume to radiation” (line 8). While there are many types of radiation, the examiner acknowledges that in every instance radiation is used in the specification, radiation describes a wavelength that can be absorbed by the PAI. Therefore, for the purposes of examination, the examiner interprets radiation to mean a wavelength near the range of being absorbed by a PAI considered in this instant application, which includes wavelengths 650-1070 nm, reads on this claim.
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.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prud'homme, R. K.; et al. (US 2016/0082134 A1, as cited in the IDS filed on 08/28/2025) and Chen, C-Y.; et al. Synthesis and Physicochemical Properties of Metallobacteriochlorins, Inorg. Chem. 2012, 51, 9443-9464 (as cited in the IDS filed on 08/28/2025).
Prud'homme, R. K.; et al. (hereafter referred to as Prud'homme) is drawn to nanoparticle photoacoustic imaging agents for imaging which absorb radiation for imaging, diagnostics or delivery (title; abstract). Prud'homme teaches photoacoustic imaging agents which are at least one of bacteriochlorin, chlorin, isobacteriochlorin, and porphyrin (pg 2, para [0013], line 2-3), and absorb wavelengths with a maximum in the range of 700-1100 (abstract, lines 2-3; pg 3, para [0039]), and contain chelated metals (pg 3, para [0039]; para [0060]-[0062]), have targeting capabilities (pg 10, para [0121], lines 14-16) and can be used in ultrasound detection and imaging (pg 10, para [0120]; pg 10, para [0121], lines 2-6).
As to claim 1, Prud’homme teaches photoacoustic imaging contrast agents (abstract; pg 1, para [0002]; pg 1, para [0012], lines 1-4) comprising at least one radiation-absorbing component (pg 1, para [0012], lines 1-4) wherein the radiation-absorbing component is a bacteriochlorin (pg 7, para [0085]; pg 11, para [0124], lines 1-2) and may be complexed to copper (pg 5, para [0061]) or manganese (pg 5; para [0060]).
Prud’homme does not expressly teach a metallobacteriochlorin or metallochlorin.
Chen, C-Y.; et al. (hereafter referred to as Chen) is drawn to synthesis and properties of metallobacteriochlorins (title; abstract). Chen teaches metallobacteriochlorins and metallochlorins (title; abstract; pg 9445, chart 2; pg 9445, col 2, para 3, lines 18-20; pg 9453, Fig 3, structure FbC), complexation to metals (pg 9447, Chart 2, structure I and VI), radiation absorption in the range of 700-900 nm (Fig 4, structures a, and d or e or f or g, and h), and their synthesis (pg 9446, Scheme 1).
Regarding the metallobacteriochlorins and metallochlorins, Chen teaches metallobacteriochlorins and metallochlorins and derivatives thereof (title; abstract; pg 9445, chart 2; pg 9445, col 2, para 3, lines 18-20; pg 9453, Fig 3, structure FbC) where the metallobacteriochlorins and metallochlorins are complexed to copper or manganese (pg 9447, Chart 2, structure I and VI).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the photoacoustic contrast agents of Prud’homme to include the metallobacteriochlorins and metallochlorins as taught by Chen because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the expressed metallobacteriochlorins and metallochlorins.
A person of ordinary skill in the art would have had a reasonable expectation of success in combining the arts to use metallobacteriochlorins or metallochlorins because Prud’homme disclosed using metals complexed to bacteriochlorin photoacoustic agents (pg 5, para [0060]-[0061]). Additional prior art of Chen suggests that metallobacteriochlorins or metallochlorins have similar properties because of the overlap of structural features of the chelators and the known effect of adding metals between the two arts involves wavelength shifting of the bacteriochlorins. Additional teaching of Prud’homme and Chen disclose that the desired wavelengths can be achieved with or without metals. The skilled artisan would have been motivated to combine the teachings of Chen with the teachings of Prud’homme because both are drawn to bacteriochlorins and their derivatives and adding metals allows adjusting the wavelength of the same bacteriochlorin by simply chelating with different metals.
Claim(s) 2-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prud’homme and Chen as applied to claim 1 above, and further in view of Kim, H-J.; et al. (US 2014/0371286 A1, as cited in the IDS filed on 08/28/2025). The teachings of Prud’homme and Chen as applied in the previous rejection are incorporated in this rejection.
As to claim 2, Prud’homme teaches photoacoustic imaging contrast agents (abstract; pg 1, para [0002]; pg 1, para [0012], lines 1-4). Prud’homme teaches a plurality of bacteriochlorins, chlorins, derivatives thereof, or combinations thereof (pg 2, para [0013], lines 2-3; pg 9, para [0114]) and distinct absorbance maxima in the range of 700-1100 nm (abstract; pg 1, para [0009]; pg 1, para [0012], lines 1-4; pg 2, para [0029], lines 1-3; pg 2, para [0030]; pg 9, para [0114]). The claimed range of 650-1070 nm overlaps with the prior art range of 700-1100 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Prud’homme teaches complexation to copper (pg 5, para [0061]) or manganese (pg 5; para [0060]).
Prud’homme does not expressly teach metallobacteriochlorins and metallochlorins.
Regarding the metallobacteriochlorins and metallochlorins, Chen teaches metallobacteriochlorins and metallochlorins and derivatives thereof (title; abstract; pg 9445, chart 2; pg 9445, col 2, para 3, lines 18-20; pg 9453, Fig 3, structure FbC) where the metallobacteriochlorins and metallochlorins are complexed to copper or manganese (pg 9447, Chart 2, structure I and VI).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the photoacoustic contrast agents of Prud’homme to include the metallobacteriochlorins and metallochlorins as taught by Chen because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the expressed metallobacteriochlorins and metallochlorins.
A person of ordinary skill in the art would have had a reasonable expectation of success in combining the arts to use metallobacteriochlorins or metallochlorins because Prud’homme disclosed using metals complexed to bacteriochlorin photoacoustic agents (pg 5, para [0060]-[0061]). Additional prior art of Chen suggests that metallobacteriochlorins or metallochlorins have similar properties because of the overlap of structural features of the chelators and the known effect of adding metals between the two arts involves wavelength shifting of the bacteriochlorins. Additional teaching of Prud’homme and Chen disclose that the desired wavelengths can be achieved with or without metals. The skilled artisan would have been motivated to combine the teachings of Chen with the teachings of Prud’homme because both are drawn to bacteriochlorins and their derivatives and adding metals allows adjusting the wavelength of the same bacteriochlorin by simply chelating with different metals.
Alternatively, Chen teaches metallobacteriochlorins and metallochlorins and derivatives thereof (title; abstract; pg 9445, chart 2; pg 9445, col 2, para 3, lines 18-20; pg 9453, Fig 3, structure FbC) where the metallobacteriochlorins and metallochlroins are complexed to copper or manganese (pg 9447, Chart 2, structure I and VI).
Chen does not expressly teach a plurality of different metallobacteriochlorins or metallochlorins.
Chen does not expressly teach each having a different absorption spectrum in the range of 650-1070 nm.
Kim, H-J.; et al. (hereafter referred to as Kim) is drawn to synthesis of bacteriochlorins and the use as active agents in photodynamic therapy (title; abstract). Kim teaches bacteriochlorins and metallobacteriochlorins (pg 13, para [0216]; pg 13, para [0222]; claim 18 and 24) with radiation absorption around 650-900 nm (pg 13, para [0215], lines 10-11; claim 37), with a variety of metals (pg 9, para [0118], col 2, line 12; pg 10, para [0121], lines 3-7), encapsulating in liposomes (pg 17, para [0274]-[0275]) or nanoparticle (pg 1, para [0012], lines 10-11), targeting with antibodies (pg 1, para [0007]; pg 17, para [0277], lines 5-6), and synthesis of the bacteriochlorins (pg 25, Scheme 1).
Regarding the plurality, Kim teaches a plurality of different metallobacteriochlorins, metallochlorins, derivatives thereof, or combinations thereof (pg 13, para [0216]; pg 13, para [0222]; claim 18 and 24).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the photoacoustic agents of Chen with the plurality of photoacoustic agents of Kim because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a plurality of photoacoustic agents.
A person of ordinary skill in the art would have had a reasonable expectation of success in using a plurality of PAIs because Chen discloses that the overlap of several PAIs can have wavelengths in a range of values (pg 9452, Fig 5). Additional prior art of Kim discloses that more PAIs together achieves a range of wavelengths and still maintains similar behavior and properties. The skilled artisan would have been motivated to increase the range of wavelengths that can be absorbed and converted to therapeutic ultrasound because this decreases the requirement of the irradiating device using a specific wavelength narrow wavelength range to a broader wavelength range increasing applicability in a variety of clinic conditions.
Regarding the absorption spectrum, Kim teaches a plurality of compounds with absorptions in the 650-900 nm. The prior art range of 650-900 nm lies within the claimed range of 650-1070 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). And, Kim teaches that each compound has a unique wavelength between 650 and 900 nm (pg 13, para [0215]).
As to claim 3, Prud’homme teaches a plurality of metallobacteriochlorins, metallochlorins, derivatives thereof, or combinations thereof (pg 2, para [0013], lines 2-3; pg 9, para [0114]) and distinct absorbance maxima in the range of 700-1100 nm (abstract; pg 1, para [0009]; pg 1, para [0012], lines 1-4; pg 2, para [0029], lines 1-3; pg 2, para [0030]; pg 9, para [0114]). The claimed range of 650-950 nm overlaps with the prior art range of 700-1100 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Prud’homme does not expressly teach metallobacteriochlroins or metallochlorins.
Regarding the metallobacteriochlorins and metallochlorins, Chen teaches metallobacteriochlorins and metallochlorins and derivatives thereof (title; abstract; pg 9445, chart 2; pg 9445, col 2, para 3, lines 18-20; pg 9453, Fig 3, structure FbC) where the metallobacteriochlorins and metallochlorins are complexed to copper or manganese (pg 9447, Chart 2, structure I and VI).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the photoacoustic contrast agents of Prud’homme to include the metallobacteriochlorins and metallochlorins as taught by Chen because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the expressed metallobacteriochlorins and metallochlorins.
A person of ordinary skill in the art would have had a reasonable expectation of success in combining the arts to use metallobacteriochlorins or metallochlorins because Prud’homme disclosed using metals complexed to bacteriochlorin photoacoustic agents (pg 5, para [0060]-[0061]). Additional prior art of Chen suggests that metallobacteriochlorins or metallochlorins have similar properties because of the overlap of structural features of the chelators and the known effect of adding metals between the two arts involves wavelength shifting of the bacteriochlorins. Additional teaching of Prud’homme and Chen disclose that the desired wavelengths can be achieved with or without metals. The skilled artisan would have been motivated to combine the teachings of Chen with the teachings of Prud’homme because both are drawn to bacteriochlorins and their derivatives and adding metals allows adjusting the wavelength of the same bacteriochlorin by simply chelating with different metals.
As to claim 4, Kim teaches a plurality of different metallobacteriochlorins, metallochlorins, derivatives thereof, or combinations thereof (pg 13, para [0216]; pg 13, para [0222]; claim 18 and 24) and where they are complexed to zinc and copper and nickel (pg 9, para [0118], col 2, line 12; pg 10, para [0121], lines 3-7).
As to claim 5, Prud’homme teaches a) contacting a volume with a plurality of metallobacteriochlorins, metallochlorins, derivatives thereof, or combinations thereof (pg 2, para [0013], lines 2-3; pg 9, para [0114]; pg 10, para [0123], lines 1-8; pg 9, para [0114]) which can be complexed to copper (pg 5, para [0061]) or manganese (pg 5; para [0060]).
As to b), Prud’homme teaches exposing the volume to radiation (pg 10, para [0123], lines 1-3).
As to c), Prud’homme teaches detecting ultrasonic waves generated in the volume by the radiation (pg 10, para [0123], lines 5-6 and 13-15).
As to d), Prud’homme teaches generating a photoacoustic image of the volume or part thereof containing the contrast agent (pg 10, para [0123], lines 11-19).
Prud’homme does not expressly teach a single embodiment comprising all the features of the claimed product. However, it would be prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments a)-d) taught by Prud’homme as a skilled artisan recognizes that these claim elements are known in the art and could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results or the combination were predictable. See MPEP 2143(I)(A).
As to claim 6, Kim teaches encapsulating the metallobacteriochlorin, the metallochlorin, and/or the derivative thereof in a liposome (pg 17, para [0274]-[0275]) or nanoparticle (pg 1, para [0012], lines 10-11).
As to claim 7, Prud’homme teaches radiation with wavelength of 700-1100 nm nm (abstract; pg 1, para [0009]; pg 1, para [0012], lines 1-4; pg 2, para [0029], lines 1-3; pg 2, para [0030]; pg 9, para [0114]). The claimed range of 650-1070 nm overlaps with the prior art range of 700-1100 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 8, Prud’homme teaches wavelengths of 700-1100 nm (abstract; pg 1, para [0009]; pg 1, para [0012], lines 1-4; pg 2, para [0029], lines 1-3; pg 2, para [0030]; pg 9, para [0114]). The prior art range of 700-1100 nm overlaps with the claimed range of 650-950 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 9, Prud’homme teaches a plurality of metallobacteriochlorins, metallochlorins, derivatives thereof, or combinations thereof (pg 2, para [0013], lines 2-3; pg 9, para [0114]) and distinct absorbance maxima in the range of 700-1100 nm with distinct absorbance maxima (abstract; pg 1, para [0009]; pg 1, para [0012], lines 1-4; pg 2, para [0029], lines 1-3; pg 2, para [0030]; pg 9, para [0114]). The prior art range of 700-1100 nm overlaps with the claimed range of 650-1070 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 10, Prud’homme teaches targeting agent (pg 1, para [0013], lines 4-6; pg 2, para [0023]; pg 5, para [0065]; claim 5).
As to claim 11, Prud’homme teaches targeting moieties that bind to a ligand and/or a target present on a tumor cell or cancer cell (pg 8, para [0101]; pg 10, para [0121], lines 14-16).
Alternatively, Kim teaches targeting moieties that bind to tumor cells or cancer cells (pg 6, para [0076] and [0077], lines 1-18; pg 17, para [0277], lines 1-11).
As to claim 12, Kim teaches tumor-associated antigens (pg 17, para [0277], lines 4-17).
As to claim 13, Prud’homme teaches peptides for targeting (pg 1, para [0007]).
Alternatively, Kim teaches antibodies (which are peptides) against tumor antigens (pg 17, para [0277], lines 5-6).
As to claim 14, Prud’homme teaches a) contacting a volume with a plurality of metallobacteriochlorins, metallochlorins, derivatives thereof, or combinations thereof (pg 2, para [0013], lines 2-3; pg 9, para [0114]; pg 10, para [0123], lines 1-8; pg 9, para [0114]) which can be complexed to copper (pg 5, para [0061]) or manganese (pg 5; para [0060]).
As to b), Prud’homme teaches exposing the volume to radiation (pg 10, para [0123], lines 1-3).
As to c), Prud’homme teaches detecting ultrasonic waves generated in the volume by the radiation (pg 10, para [0123], lines 5-6 and 13-15).
As to d), Prud’homme teaches generating a photoacoustic image of the volume or part thereof containing the contrast agent (pg 10, para [0123], lines 11-19).
Prud’homme does not expressly teach a single embodiment comprising all the features of the claimed product. However, it would be prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments a)-d) taught by Prud’homme as a skilled artisan recognizes that these claim elements are known in the art and could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results or the combination were predictable. See MPEP 2143(I)(A).
As to claim 15, Kim teaches encapsulating the metallobacteriochlorin, the metallochlorin, and/or the derivative thereof in a liposome (pg 17, para [0274]-[0275]) or nanoparticle (pg 1, para [0012], lines 10-11).
As to claim 16, Prud’homme teaches radiation with wavelength of 700-1100 nm nm (abstract; pg 1, para [0009]; pg 1, para [0012], lines 1-4; pg 2, para [0029], lines 1-3; pg 2, para [0030]; pg 9, para [0114]). The claimed range of 650-1070 nm overlaps with the prior art range of 700-1100 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 17, Prud’homme teaches wavelengths of 700-1100 nm (abstract; pg 1, para [0009]; pg 1, para [0012], lines 1-4; pg 2, para [0029], lines 1-3; pg 2, para [0030]; pg 9, para [0114]). The prior art range of 700-1100 nm overlaps with the claimed range of 650-950 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 18, Prud’homme teaches a plurality of metallobacteriochlorins, metallochlorins, derivatives thereof, or combinations thereof (pg 2, para [0013], lines 2-3; pg 9, para [0114]) and distinct absorbance maxima in the range of 700-1100 nm with distinct absorbance maxima (abstract; pg 1, para [0009]; pg 1, para [0012], lines 1-4; pg 2, para [0029], lines 1-3; pg 2, para [0030]; pg 9, para [0114]). The prior art range of 700-1100 nm overlaps with the claimed range of 650-1070 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 19, Prud’homme teaches targeting agent (pg 1, para [0013], lines 4-6; pg 2, para [0023]; pg 5, para [0065]; claim 5).
As to claim 20, Prud’homme teaches targeting moieties that bind to a ligand and/or a target present on a tumor cell or cancer cell (pg 8, para [0101]; pg 10, para [0121], lines 14-16).
Alternatively, Kim teaches targeting moieties that bind to tumor cells or cancer cells (pg 6, para [0076] and [0077], lines 1-18; pg 17, para [0277], lines 1-11).
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7-19 of U.S. Patent No. 11,904,026 in view Chen.
The instant claims are drawn to a photoacoustic imaging contrast agent comprising at least one metallobacteriochlorin, metallochlorin, or derivative thereof complexed to copper or manganese, a plurality of these, where the absorption is in the range of 650-1070 nm and at least 3 different of these with absorption values in the range of 700-950 nm non-overlapping and where at least one is complexed to Cu and at least one compound is complexed with Mn, Zn, Ni, Fe, or Co. The instant claims are also drawn to a method of generating an image of a volume by contacting the volume with the contrast agent, exposing to radiation with a wavelength of 650-1070 nm, detecting ultrasonic waves, and generating an image. The contrast agent can be encapsulated in a liposome, micelle, or nanoparticle, and can have a targeting agent for tumors, cancers, or vascular endothelial cell.
The conflicting claims of U.S. Patent No. 11,904,026 (hereafter referred to as '026) are drawn to photoacoustic imaging contrast agent comprising at least one metallobacteriochlorin complexed to Cu, Mn, Zn, Ni, Fe, or Co and absorb radiation in the range of 650-1070 nm where the maxima are substantially non-overlapping. The claims of '026 are also drawn to a method of generating an image of a volume by contacting the volume with the contrast agent, exposing to radiation with a wavelength of 650-950 nm, detecting ultrasonic waves, and generating an image. The contrast agent can be encapsulated in a liposome, micelle, or nanoparticle, and can have a targeting agent for tumors, cancers, or vascular endothelial cell.
The conflicting claim 1 does not teach metallochlorins.
Regarding the metallochlorins, Chen teaches metallobacteriochlorins and metallochlorins and derivatives thereof (title; abstract; pg 9445, chart 2; pg 9445, col 2, para 3, lines 18-20; pg 9453, Fig 3, structure FbC) where the metallobacteriochlorins and metallochlorins are complexed to copper or manganese (pg 9447, Chart 2, structure I and VI).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the photoacoustic contrast agents of the conflicting claims to include the metallochlorins as taught by Chen because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the expressed metallobacteriochlorins and metallochlorins.
A person of ordinary skill in the art would have had a reasonable expectation of success in combining the arts to use metallochlorins because conflicting claims disclosed using metallobacteriochlorins. The additional prior art of Chen suggests that metallobacteriochlorins or metallochlorins have similar properties because of the overlap of structural features of the between metallobacteriochlorins and metallochlorins. Chen discloses that the desired wavelengths can be achieved with either metallobacteriochlorins or metallobacteriochlorins. The skilled artisan would have been motivated to combine the teachings of Chen with the conflicting claims because both are drawn to metallobacteriochlorins and are concerned with achieving certain properties in a similar wavelength range.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-11 of U.S. Patent No. 12,042,548 in view of Prud’homme, Chen, and Kim.
The instant claims are drawn to a photoacoustic imaging contrast agent comprising at least one metallobacteriochlorin, metallochlorin, or derivative thereof complexed to copper or manganese, a plurality of these, where the absorption is in the range of 650-1070 nm and at least 3 different of these with absoption values in the range of 700-950 nm non-overlapping and where at least one is complexed to Cu and at least one compound is complexed with Mn, Zn, Ni, Fe, or Co. The instant claims are also drawn to a method of generating an image of a volume by contacting the volume with the contrast agent, expsoing to radiation with a wavelength of 650-1070 nm, detecting ultrasonic waves, and generating an image. The contrast agent can be encapsulated in a liposome, micelle, or nanoparticle, and can have a targeting agent for tumors, cancers, or vascular endothelial cell.
The conflicting claims of U.S. Patent No. 12,052,548 (hereafter referred to as '548) are drawn to photoacoustic imaging contrast agent comprising at least one metallobacteriochlorin, targeting agent, and complexed to Cu and Ni, Co, and Fe. The conflicting claims of '548 are drawn to a method of generating an image of a volume by contacting the volume with the contrast agent, exposing to radiation with a wavelength of 650-1070 nm, detecting ultrasonic waves, and generating an image. The contrast agent can be encapsulated in a liposome, micelle, or nanoparticle, and can have a targeting agent for tumors, cancers, or vascular endothelial cell.
The conflicting claims of '548 do not teach PAIs with absorption values in the range of 700-950 nm with non-overlapping wavelengths.
As noted in the current rejections above, the combined teachings of Prud’homme, Chen, and Kim render obvious instant claims 1-20.
Prud’homme teaches distinct absorbance maxima in the range of 700-1100 nm (abstract; pg 1, para [0009]; pg 1, para [0012], lines 1-4; pg 2, para [0029], lines 1-3; pg 2, para [0030]; pg 9, para [0114]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the PAI used in the conflicting claims of ‘548 to include a plurality of PAIs with distinct absorbance maxima as taught by Prud’homme because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a plurality of PAIs with distinct absorbance maxima.
A person of ordinary skill in the art would have had a reasonable expectation of success in using PAIs with distinct absorbance maxima because the prior art already teaches using distinct PAIs together with unique absorbance maxima. The skilled artisan would have been motivated to combine PAIs with distinct absorbance maxima because it broadens the range that the radiation can be absorbed at and broadens applicability for use in clinics.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, and 9 of copending Application No. 18/571,684 in view of Prud’homme, Chen, and Kim.
The conflicting claims of copending application no. 18/571,684 (hereafter referred to as '684) are drawn to a photoacoustic imaging agent where the metallobacteriochlorin is complexed to Cu or Zn.
The conflicting claims of '684 do not teach a plurality of agents.
The conflicting claims of '684 do not teach wavelength absorption ranges.
The conflicting claims of '684 do not teach PAIs with absorption values in the range of 700-950 nm that have substantially non-overlapping wavelengths.
The conflicting claims of '684 do not teach a method of generating an image of a volume by contacting the volume with the contrast agent, exposing to radiation with a wavelength of 650-1070 nm, detecting ultrasonic waves, and generating an image.
The conflicting claims of '684 do not teach the contrast agent can be encapsulated in a liposome, micelle, or nanoparticle.
The conflicting claims of '684 do not teach a targeting agent for tumors, cancers, or vascular endothelial cell.
However, these features are known in the art. As noted in the current rejections, the combined teachings of Prud’homme, Chem, and Kim render obvious claims 1-20.
Regarding a plurality of agents, Prud’homme teaches a plurality of bacteriochlorins, chlorins, derivatives thereof, or combinations thereof (pg 2, para [0013], lines 2-3; pg 9, para [0114]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the metallobacteriochlorin of conflicting claims of ‘684 to include a plurality of photoacoustic agents as taught by Prud’homme because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a plurality of bacteriochlorins.
A person of ordinary skill in the art would have had a reasonable expectation of success in using a plurality of bacteriochlorins because Prud’homme and other known prior art uses a plurality of PAIs with great success. The skilled artisan would have been motivated to use a plurality of PAIs because multiple PAIs with their distinct wavelengths enables broader use in clinic.
Regarding wavelength absorption ranges, Prud’homme teaches distinct absorbance maxima in the range of 700-1100 nm (abstract; pg 1, para [0009]; pg 1, para [0012], lines 1-4; pg 2, para [0029], lines 1-3; pg 2, para [0030]; pg 9, para [0114]). The claimed range of 650-1070 nm overlaps with the prior art range of 700-1100 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding substantially non-overlapping wavelengths, Prud’homme teaches distinct absorbance maxima in the range of 700-1100 nm with distinct absorbance maxima (abstract; pg 1, para [0009]; pg 1, para [0012], lines 1-4; pg 2, para [0029], lines 1-3; pg 2, para [0030]; pg 9, para [0114]). The prior art range of 700-1100 nm overlaps with the claimed range of 650-1070 nm.
Regarding a method of generating an image of a volume by contacting the volume with the contrast agent, exposing to radiation with a wavelength of 650-1070 nm, detecting ultrasonic waves, and generating an image, Prud’homme teaches a) contacting a volume with a plurality of metallobacteriochlorins, metallochlorins, derivatives thereof, or combinations thereof (pg 2, para [0013], lines 2-3; pg 9, para [0114]; pg 10, para [0123], lines 1-8; pg 9, para [0114]) which can be complexed to copper (pg 5, para [0061]) or manganese (pg 5; para [0060]).
As to b), Prud’homme teaches exposing the volume to radiation (pg 10, para [0123], lines 1-3).
As to c), Prud’homme teaches detecting ultrasonic waves generated in the volume by the radiation (pg 10, para [0123], lines 5-6 and 13-15).
As to d), Prud’homme teaches generating a photoacoustic image of the volume or part thereof containing the contrast agent (pg 10, para [0123], lines 11-19).
Prud’homme does not expressly teach a single embodiment comprising all the features of the claimed product. However, it would be prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments a)-d) taught by Prud’homme as a skilled artisan recognizes that these claim elements are known in the art and could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results or the combination were predictable. See MPEP 2143(I)(A).
Regarding contrast agent can be encapsulated in a liposome, micelle, or nanoparticle, Kim teaches encapsulating the metallobacteriochlorin, the metallochlorin, and/or the derivative thereof in a liposome (pg 17, para [0274]-[0275]) or nanoparticle (pg 1, para [0012], lines 10-11).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the PAI of conflicting claims ‘684 to include encapsulation with a liposome as taught by Kim because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of liposomal encapsulated PAIs.
A person of ordinary skill in the art would have had a reasonable expectation of success in encapsulating PAIs because it is established in the teachings of Prud’homme and shown to work. The skilled artisan would have been motivated to encapsulate the PAIs because encapsulation within liposomes or similar nanoparticles improves the in vivo uptake and biocompatibility of the PAIs.
Regarding a targeting agent for tumors, cancers, or vascular endothelial cell, Prud’homme teaches targeting moieties that bind to a ligand and/or a target present on a tumor cell or cancer cell (pg 8, para [0101]; pg 10, para [0121], lines 14-16).
This is a provisional nonstatutory double patenting rejection.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 18/271,010 in view of Prud’homme, Chen, and Kim.
The instant claims are drawn to a photoacoustic imaging contrast agent comprising at least one metallobacteriochlorin, metallochlorin, or derivative thereof complexed to copper or manganese, a plurality of these, where the absorption is in the range of 650-1070 nm and at least 3 different of these with absorption values in the range of 700-950 nm non-overlapping and where at least one is complexed to Cu and at least one compound is complexed with Mn, Zn, Ni, Fe, or Co. The instant claims are also drawn to a method of generating an image of a volume by contacting the volume with the contrast agent, exposing to radiation with a wavelength of 650-1070 nm, detecting ultrasonic waves, and generating an image. The contrast agent can be encapsulated in a liposome, micelle, or nanoparticle, and can have a targeting agent for tumors, cancers, or vascular endothelial cell.
The conflicting claims of copending application no. 18/271,010 (hereafter referred to as '010) are drawn to at least one metallobacteriochlorin, metallochlorin, or derivative thereof complexed to copper, and later to copper or manganese or a plurality of these, where the absorption is in the range of 650-1070 nm and at least 3 different of these with absorption values in the range of 700-950 nm non-overlapping and where at least one is complexed to Cu and at least one compound is complexed with Mn, Zn, Ni, Fe, or Co.
The conflicting claim 1 of '010 does not teach complexation to manganese.
The conflicting claim 1 of ‘010 does not teach a plurality of these.
Regarding complexation to manganese, Prud’homme teaches complexation to manganese (pg 5; para [0060]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to substitute the conflicting claim 1 of ‘010 with manganese as taught by Prud’homme because the prior art contained a composition which differed from the claimed composition by the substitution of copper with manganese. The substituted metals and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known metal for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
A person of ordinary skill in the art would have had a reasonable expectation of success in using a manganese because Prud’homme and other known prior art uses manganese with great success. The skilled artisan would have been motivated to use manganese because changing the metal can alter the wavelength of absorption in a desired direction without changing the chemistry of the complexing ligand.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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