Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 07/02/2026 have been fully considered but they are not persuasive.
On page 2, 1st full paragraph Applicant asserts:
“even assuming that Lin generally teaches polymer conjugation, the Office Action still does not explain why a person of ordinary skill in the art would have selected polymer conjugation from among the numerous alternative attachment strategies disclosed in paragraphs [0206]-[0207], and then modified Xie's silica-shell architecture to replace the embedded photosensitizer with a PEG containing polymer coating bearing a covalently conjugated photosensitizer.”
The examiner disagrees since the obviousness assertion in the rejection below reads in part as:
to modify the invention of Xie et al., as taught by Chen et al., to provide the system with conjugating the photosensitive material to the shells/coating of nanoparticles and conjugating cell targeting to the coat/shell in order to provide a known and workable means for providing the scintillating nanoparticle with cell targeting capabilities and photosensitive properties in order to treat tissue (e.g., cancer), and as further taught by Lin, Ph.D. et al., to provide a "photosensitizers coordinatively bonded to a particle surface, where the coordination methods include but are not limited to carboxylate or phosphate coordination (such as via the coordination of a carboxylate or phosphate group on the PS to open metal sites (e.g., Ln.sup.3+, Zn.sup.2+, Al.sup.3+, etc.) on nanoparticles); thiol coordination to nanoparticles, (via PSs containing thiols conjugating to nanoparticles through the coordination of thiol groups to Au (in gold nanoparticles) or, for example, Zn, Cd, in quantum dots); polymer conjugation and surface coating, for example, via covalently conjugating PSs to oligomers or polymers with functional groups (e.g., cyclodextrin, polyethylene glycol (PEG), poly (maleic acid) derivatives, etc.) and conjugating the scintillator particles through coordination of additional functional groups (e.g., carboxylates, thiols, hydroxyls, amines, etc.) to the metals on a particle surface, for example using photosensitizers such, but not limited to, any of those shown in FIGS. 27 and 28, covalently bonding to a MOF ligand, for example via amide conjugation, ester conjugation, thiourea conjugation, "click chemistry", disulfide bond conjugation, etc.; surface modification of porous materials and entrapment, mesoporous silica coating and entrapment, and MOF coating and entrapment, for example with photosensitizers entrapped in the pores of the silica layer" (see [0207]) in order to provide a known and workable manner of coating a nanoparticle and/or nanoparticle core in order to treat cancer.”
Accordingly, Applicant’s argument is unpersuasive.
Next in the same paragraph Applicant asserts “Instead, the rejection reconstructs Applicant's invention by selecting individual features from separate disclosures without identifying a teaching or suggestion in the prior art directing those particular modifications.” This seems to be an assertion of hindsight analysis. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Accordingly, this argument is unpersuasive.
Recall, the test for obviousness is what the combined teachings of the references would have suggested to one of ordinary skill in the art, and all teachings in the prior art must be considered to the extent that they are in analogous arts.
Next, on page 2, 2nd full paragraph Applicant asserts:
“Because the cited references do not teach or suggest the claimed nanoparticle architecture, they likewise do not teach or suggest the nanoparticle composition required by claim 16. The additional method steps of administering the nanoparticle composition and administering electromagnetic radiation, relied upon primarily from Xie, do not remedy the deficiencies discussed above with respect to the claimed nanoparticle architecture.”
Applicant has made a blanket assertion about some alleged deficient or missing nanoparticle architecture or element thereof of the aforementioned architecture and other than the traversal above points out no alleged missing or deficient element. The prior art combination makes obvious the recited limitations of the claimed invention. Again the test for obviousness is what the combined teachings of the references would have suggested to one of ordinary skill in the art, and all teachings in the prior art must be considered to the extent that they are in analogous arts.
Applicant’s arguments are unpersuasive.
Accordingly, this action is made FINAL.
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.
Claims 1-4, 11, 14, 16-19, 21-23, 25-26, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. (U.S. Patent Application Publication 2017 /0209575) in view of Chen et al. (U.S. Patent Application Publication 2007 /0218049) in view of Lin, Ph.D. et al. (U.S. Patent Application Publication 2017 /0231903).
Regarding claims 1, 11, 16, 18-19, 25-26, and 30, Xie et al. disclose a nanoparticle
composition comprising and a PDT method comprising:
a scintillation nanoparticle core (see A) "Scintillation nanoparticles, as used herein, refer to nanoparticles that can absorb ionizing radiation such as X-rays, neutrons, alpha, beta, or gamma-rays" in [0040], and B) abstract, [0005], [0058], [0077], [0084], and claim 3 regarding the core) having:
a coating layer (comprising the first and second shells, see [0057]-[0062] and figure 21 ), and
a photosensitizer coupled to the coating layer ("the photosensitizer can be embedded in the mesoporous material," see abstract, [0008], [003 7], [0056] for example),
wherein the scintillation nanoparticle emits electromagnetic radiation having a first wavelength when irradiated with electromagnetic radiation having a second wavelength (see [0008]), and
wherein the photo sensitizer absorbs electromagnetic radiation of said first wavelength (see [0008]).
Xie et al. further disclose 1) administering to the subject an effective amount of a composition comprising the nan op article composition (see [0071 ]); and administering to the subject electromagnetic radiation having a second wavelength (see [0008]).
Xie et al. also disclose cell targeting moiety in for the invention (see [0063 ]-[0067] and claims 26-27) but fail to explicitly recite:
1) the photosensitizer is conjugated to the coating layer,
2) the cell targeting moiety conjugated to the coating layer,
3) the coating layer a polymer layer that in tum comprises one or more polyethylene glycol (PEG) group, and
4) the photosensitizer from the PEG group is covalently conjugated to the photosensitizer.
Like Xie et al., Chen et al. disclose scintillation nanoparticle for treating cancer having a photosensitizer and a coating and teach providing:
conjugating the photosensitive material to the shells/coating of nanoparticles (see [0 102]), and
conjugating cell targeting to the coat/shell (see [0 122])
as a known and workable means for providing the scintillating nanoparticle with cell targeting capabilities and photosensitive properties in order to treat tissue (e.g., cancer).
Like both Xie et al. and Chen et al., Lin, Ph.D. et al. disclose scintillation nanoparticles comprising gold, a coating and a photosensitizer used to treat cancer and teach providing "Examples of photosensitizers conjugated to X-ray scintillating nanoparticles for use in X-ray induced PDT include, but are not limited to: photosensitizers coordinatively bonded to a particle surface, where the coordination methods include but are not limited to carboxylate or phosphate coordination (such as via the coordination of a carboxylate or phosphate group on the PS to open metal sites (e.g., Ln.sup.3+, Zn.sup.2+, Al.sup.3+, etc.) on nanoparticles); thiol coordination to nanoparticles, (via PSs containing thiols conjugating to nanoparticles through the coordination of thiol groups to Au (in gold nanoparticles) or, for example, Zn, Cd, in quantum dots); polymer conjugation and surface coating, for example, via covalently conjugating PSs to oligomers or polymers with functional groups (e.g., cyclodextrin, polyethylene glycol (PEG), poly (maleic acid) derivatives, etc.) and conjugating the scintillator particles through coordination of additional functional groups (e.g., carboxylates, thiols, hydroxyls, amines, etc.) to the metals on a particle surface, for example using photosensitizers such, but not limited to, any of those shown in FIGS. 27 and 28, covalently bonding to a MOF ligand, for example via amide conjugation, ester conjugation, thiourea conjugation, "click chemistry", disulfide bond conjugation, etc.; surface modification of porous materials and entrapment, mesoporous silica coating and entrapment, and MOF coating and entrapment, for example with photosensitizers entrapped in the pores of the silica layer" (see [0206]-[0207]) in order to provide a known and workable manner of coating a nanoparticle and/or nanoparticle core in order to treat cancer (see [0075], [0077], [0079]-[0080] for example).
In a nutshell, Lin, Ph.D. et al. teach bonding a photosensitizer via polymer conjugation (i.e., covalent conjugation) to a polymer surface coating, wherein the polymer coating comprises an element from a polyethylene glycol (PEG) group.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Xie et al., as taught by Chen et al., to provide the system with conjugating the photosensitive material to the shells/coating of nanoparticles and conjugating cell targeting to the coat/shell in order to provide a known and workable means for providing the scintillating nanoparticle with cell targeting capabilities and photosensitive properties in order to treat tissue (e.g., cancer), and as further taught by Lin, Ph.D. et al., to provide a "photosensitizers coordinatively bonded to a particle surface, where the coordination methods include but are not limited to carboxylate or phosphate coordination (such as via the coordination of a carboxylate or phosphate group on the PS to open metal sites (e.g., Ln.sup.3+, Zn.sup.2+, Al.sup.3+, etc.) on nanoparticles); thiol coordination to nanoparticles, (via PSs containing thiols conjugating to nanoparticles through the coordination of thiol groups to Au (in gold nanoparticles) or, for example, Zn, Cd, in quantum dots); polymer conjugation and surface coating, for example, via covalently conjugating PSs to oligomers or polymers with functional groups (e.g., cyclodextrin, polyethylene glycol (PEG), poly (maleic acid) derivatives, etc.) and conjugating the scintillator particles through coordination of additional functional groups (e.g., carboxylates, thiols, hydroxyls, amines, etc.) to the metals on a particle surface, for example using photosensitizers such, but not limited to, any of those shown in FIGS. 27 and 28, covalently bonding to a MOF ligand, for example via amide conjugation, ester conjugation, thiourea conjugation, "click chemistry", disulfide bond conjugation, etc.; surface modification of porous materials and entrapment, mesoporous silica coating and entrapment, and MOF coating and entrapment, for example with photosensitizers entrapped in the pores of the silica layer" (see [0207]) in order to provide a known and workable manner of coating a nanoparticle and/or nanoparticle core in order to treat cancer.
Regarding claims 2, and 21, Xie et al. disclose the claimed invention, see figure 9b and
[0037].
Regarding claims 3-4 and 22-23, Xie et al. disclose the claimed invention, see [0046],
[0062] and claim 13 for example.
Regarding claim 14, Xie et al. disclose the claimed invention, see [0069].
Regarding claim 17, Xie et al. disclose the claimed invention, see figure 9b and [003 7].
Regarding claim 18, Xie et al. in view of Chen et al. in view of Lin, Ph.D. et al.
disclose the claimed invention including the nanoparticle composition and the
electromagnetic radiation provide the subject a combination therapy where the
therapeutic results are synergistic compared to either electromagnetic radiation or
photodynamic therapy alone, since the delivery of electromagnetic radiation alone – that is without the photodynamic effect the delivery of the photosensitive nanoparticles -
yields nominal electromagnetic radiation influence not tuned to addressing the desired
tissue effects, while delivering the photodynamic photosensitive nanoparticles alone -
that is without the photosensitive activating electromagnetic radiation - yields delivering
nanoparticles having photosensitive properties a that are never activated.
Claims 8 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. (U.S. Patent Application Publication 2017 /0209575) in view of Chen et al. (U.S. Patent Application Publication 2007 /0218049) in view of Lin, Ph.D. et al. (U.S. Patent Application Publication 2017 /0231903) as applied to claims 1 and 16 above, and further in view of Lin et al. (U.S. Patent Application Publication 2018/0153796).
Regarding claims 8, and 27, Xie et al. in view of Chen et al. in view of Lin, Ph.D. et al. disclose ( or make obvious) the invention shown above, but fail to recite the
photosensitizer is Chlorin e6 (Ce6).
Like Xie et al., Chen et al., and Lin, Ph.D. et al., Lin et al. disclose scintillation nanoparticles comprising gold, a coating and a photosensitizer used to treat cancer and teach providing the nanoparticle with "Exemplary photosensitizers for such combination therapy include, but are not limited to: upconversion nanoparticles, such as Na YF.sub.4 (for example, doped at a ratio of Y:Yb:Er=78%:20%:2%), combined with chlorin e6 or MC540" (see [0209]) in order to provide a known and workable photosensitizer for the treatment of cancer with scintillation nanoparticles.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Xie et al. in view of Chen et al. in view of Lin, Ph.D. et al., as taught by Lin et al., to provide the nanoparticle with a photosensitizer in the form of Chlorin e6 (Ce6) in order to provide a known and workable photosensitizer for scintillation nanoparticles used to treat cancer.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON F ROANE/Primary Examiner, Art Unit 3792
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