DETAILED ACTION
Claims 38-51 were pending, claim 38 has been amended.
Claims 38-51 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/9/2025 has been entered.
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 .
Priority
The instant application, filed 11/5/2018 is a national stage entry of PCT/EP2017/060579, with an International Filing Date of 5/3/2017. The application claims foreign priority to 16168476.6, filed 5/5/2016.
Claim Rejections - 35 USC § 112(a)
(Written Description)
(MAINTAINED)
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 38-51 are 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.
Claim 38 is directed to a “composition comprising a polydisperse mixture of particles derived from a dendrimer and a photoactivatable compound, wherein at least one photoactivatable compound is covalently bonded and/or non-covalently associated to the dendrimer, and wherein the particles have a dimension within a size distribution range between 1 nm and 500 nm.” Implied in the specification is a function of the composition of matter that self-assembles into nano-particles, this function is provided by some disclosed structure, however the Applicant has not shown written description/possession of the invention as claimed in such broad terms. Applicant has not described the structure/function relationship to take a molecular structure (functionalized dendrimer) to arrive at a nanoparticle (particle with a size distribution range between 1 nm and 500 nm). As such the scope of claim 38 is not described/possessed by Applicant.
The scientific literature states that “self-assembly” is defined as the process of association of individual units of a material into highly arranged/ordered structures/patterns. It imparts unique properties to both inorganic and organic structures, so generated, via non-covalent interactions.
Claim 38 requires two limitations/structures, (1) nano-particles; and (2) the nano-particles derived from dendrimers having a photoactivatable compound covalently or non-covalently bound to the dendrimer thereof. Therefore the claim is directed towards all types of secondary structure; micelles, liposomes, polymeric micelles, and polymersomes. Moreover, the secondary structure must be “nano,” as Applicant limits the size to particles having dimensions in the range 1 to 500 nm.
The Applicant has only shown examples of PAMAM dendrimers of the Generation 3, 4, and 5. With peripheral loading (covalently) of an average of zinc phthalocyanine between 1 and 8. This covers a very small portion of the claimed subject matter. To using all known dendrimers, which is an immense amount of chemical space. See Dendrimer Chemistry Chapter 4, 2009 and Abbasi et al. “Dendrimers: synthesis, applications, and properties,” Nanoscale Research Letters 2014, 9:247. Given the fact that Applicant has self-assembles a small set of nano-particles with a very limited showing of example, and has claimed any nano-particle comprised of any dendrimer with any photoactive group on the periphery, the invention as claimed does not have proper written description based on the disclosure provided.
Response to Arguments: Applicant’s claims are directed to the structure of “a mixture of particles” and they are claimed to be “derived from a dendrimer and a photoactivatable compound.” The claims are also using comprising language and are therefore open ended. Given these facts, the only non-functional limitation requires particles in a size range, derived from a dendrimer and a photoactivatable compound, wherein at least one photoactivatable compound is covalently bonded and/or non-covalently associated to the dendrimer. The scope of claim 38 is not described by Applicant in the Specification as the claims encompass all dendrimers (having any chemical structure) in combination with all photoactivatable compound (of any chemical structure) to achieve a certain size. Simply put Applicant has not shown possession of the scope of the claims. See Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2010) (En Banc Decision).
Although many original claims will satisfy the written description requirement, certain claims may not. For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.
Applicant’s claims are generic and to a vast genus and do not demonstrate possession, as the species taught in the Specification are not sufficient. Applicant has provided 19 examples of dendrimers meeting the generic limitations in claim 38. The scope of these examples in narrow.
The dendrimers taught:
Example 1, Covalent 4-carbomethoxy pyrrolidone G3 - PAMAM Dendrimer - ZnPc (TT1) Nano - System , having an Average of 1.0 ZnPc ( TT1 ) Molecules.
Example 2, Covalent 4-carbomethoxy pyrrolidone G3 - PA MAM Dendrimer - ZnPc (TT1) Nano - System, having an Average of 1.4 ZnPc ( TT1 ) Molecules.
Example 3, Covalent Carboxylate/TRIS G3 - PAMAM Dendrimer - ZnPc (TT1) Nano - System, Having an Average of 1.0 ZnPc ( TT1 ) Molecules Per Dendrimer.
Example 4, Covalent Carboxylate/TRIS G3 - PAMAM Dendrimer - ZnPc (TT1) Nano - System, Having an Average of 1.4 ZnPc ( TT1 ) Molecules Per Dendrimer.
Example 5, Covalent 4-carbomethoxy pyrrolidone G4- PAMAM Dendrimer - ZnPc (TT1) Nano - System , Having an Average of 3 ZnPc (TT1) Molecules Per Dendrimer
Example 6, Covalent Carboxylate /TRIS G4 - PAMAM Dendrimer - ZnPc ( TT1 ) Nano - System, Having an Average of 3 ZnPc (TT1) Molecules Per Dendrimer.
Example 7, Covalent Carboxylate / TRIS G5 - PAMAM Dendrimer - ZnPc ( TT1 ) Nano - System, Having an Average of 8 ZnPc (TT1) Molecules Per Dendrimer.
Example 8, Covalent 4-carbomethoxy pyrrolidone G4 - PAMAM Dendrimer-ZnPc (TT1) Nano - System, having an Average of 2 ZnPc ( TT1 ) Molecules Per Dendrimer.
Example 9, Covalent 4-carbomethoxy pyrrolidone G5 - PAMAM Dendrimer - ZnPc (TT1 ) Nano - System, having an Average of 4 ZnPc ( TT1 ) Molecule.
Example 10, Covalent Amine G3 - PAMAM Dendrimer - ZnPc ( TT1 ) Nano - System, Having an Average of 1.4 ZnPc ( TT1 ) Molecules Per Dendrimer.
Example 11, Non-Covalent 4-carbomethoxy pyrrolidone G4-PAMAM Dendrimer ZnPc ( TT1) Nano - System , Having an Average of 2 ZnPc ( TT1 ) Molecules Per Dendrimer.
Example 12, Non-Covalent 4-carbomethoxy Pyrrolidone G4 -PAMAM Dendrimer - ZnPc ( TT1 ) Nano-System , Having an Average of 2 ZnPc ( TT1 ) Molecules Per Dendrimer.
Example 13, Non-Covalent 4-carbomethoxy pyrrolidone G3-PAMAM Dendrimer -ZnPc ( TT1 ) Nano -System , Having an Average of 0.5 ZnPc ( TT1 ) Molecules Per Dendrimer.
Example 14, Non -Covalent 4-carbomethoxy pyrrolidone G4-PAMAM Dendrimer - ZnPc ( TT1 ) Nano - System , having an Average of 4 ZnPc ( TT1 ) Molecules Per Dendrimer.
Example 15, Non - Covalent 4 -carbomethoxy pyrrolidone G5-PAMAM Dendrimer - ZnPc ( TT1 ) Nano - System , Having an Average of 2.3 ZnPc ( TT1 ) Molecules Per Dendrimer.
Example 16, Non-Covalent Carboxylate / TRIS G4 -PAMAM Dendrimer - ZnPc ( TT1 ) Nano - System, Having an Average of 3 ZnPc ( TT1 ) Molecules Per Dendrimer.
Example 17, Non-Covalent Carboxylate / TRIS G5 - PAMAM Dendrimer - ZnPc ( TT1 ) Nano - System , Having an Average of 7 ZnPc ( TT1 ) Molecules Per Dendrimer.
Example 18, 0266 ] Non - Covalent Amine G4 - PAMAM dendrimer ZnPc ( TT1 ) Nano – System, Having an Average of 2 ZnPc ( TT1 ) Molecules Per Dendrimer.
Example 19, Mixed Covalent and Non-Covalent 4-carbomethoxy pyrrolidone G5 - PAMAM Dendrimer - ZnPc ( TT1 ) Nano - System , Having an Average of 4 ZnPc ( TT1 ) Molecules Per Dendrimer Covalently Linked and 2 ZnPc ( TT1 ) Molecules Per Dendrimer Non-Covalently Linked.
These teaching are all PAMAM dendrimers,
the generations are G3-G5;
the surface is modified with either 4-carbomethoxy pyrrolidone or TRIS;
the photoactive group is zinc phthalocyanine (ZnPc) or a modified ZcPc (see instant claim 48);
the ZnPc is covalently or non-covalently bound from 0.5 to 7 Molecules Per Dendrimer.
Applicant has taught this scope (above), and continues to claim any dendrimer structure, any generation, any photoactive group, and while Applicant doesn’t require a surface modification but with comprising language is capturing the scope of any surface modification with the FUNCTION/PROPERTY of being a polydisperse particles derived from a dendrimer and a photoactivatable compound, and wherein the particles have a dimension within a size distribution range between 1 nm and 500 nm. All this scope is claimed by function, meanwhile Applicant has not taught how to obtain the structure from the function/property. There is not a sufficient teaching of a structure property relationship to believe Applicant is in possession of the scope claimed.
Applicant also doesn’t understand why all the claims are rejected for written description, arguing that the dependent claims with structure should be sufficient to show written description at some point. This is not the case. As Applicant has not narrowed the claims at any point to what is described. While Applicant appears to be inventive in the photoactive group, when the zinc phthalocyanine (ZnPc) is a modified ZcPc structure (instant claim 48), Applicant has not shown any dendrimer structure, any generation, and while Applicant doesn’t require a surface modification but with comprising language is capturing the scope of any surface modification with the FUNCTION/PROPERTY of being a polydisperse particles derived from a dendrimer and a photoactivatable compound, and wherein the particles have a dimension within a size distribution range between 1 nm and 500 nm with these modified ZcPc structures. The problem is the combination. As such all the claims lack written description.
Claim Rejections - 35 USC § 102
(MAINTAINED)
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 38-41, 44-47, and 49-51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spyropoulos-Antonakakis et al. Nanoscale Research Letters (2015) 10:210 published May 7, 2015.
Spyropoulos teaches zinc phthalocyanine (ZnPc) conjugated to a G0 PAMAM dendrimer (1,4-diaminobutane core, carbomethoxy pyrolidinone terminated, GEN 0.0, C48H76N10O16) solutions meeting all the limitations of the claims rejected in the header. ZnPc is photoactivatable.
Response to Arguments: Applicant argues the limitation in claim 38 to "...a mixture of particles ... [having] a dimension within a size distribution range between 1 nm and 500 nm," is not taught by the reference having these physically measurable attributes. While the reference doesn’t measure the size, the size of the structure described by the reference inherently has the properties as they are inherent to the structure. As such the limitation is met. Applicant could show that the art is not the same by providing evidence via comparison.
Claim Rejections - 35 USC § 102
(MAINTAINED)
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 38-40, 42-47, and 49-51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neuberger et al. WO 2006/007261 A1 published January 17, 2008.
Neuberger teaches a therapeutic molecule delivery complex, comprising: a dendrimer molecule; multiple therapeutically active molecules (AM); and multiple photosensitizer molecules connected to a periphery of said dendrimer molecule (claim 1). The photosensitizer is phthalocyanines (claim 4). Neuberger teaches a method of medicinal therapy comprising the steps of: applying therapeutic dendrimer complexes of claim 1 to a treatment area; and irradiating said treatment area with radiation having a wavelength suitable to activate said photosensitizers and release said therapeutically active molecules from said dendrimer (claim 20). Neuberger teaches generation 3 (G3) complexes of polypropylamine (PPI), see Figure 2.
Response to Arguments: Applicant argues the limitation in claim 38 to "...a mixture of particles ... [having] a dimension within a size distribution range between 1 nm and 500 nm," is not taught by the reference having these physically measurable attributes. While the reference doesn’t measure the size, the size of the structure described by the reference inherently has the properties as they are inherent to the structure. As such the limitation is met. Applicant could show that the art is not the same by providing evidence via comparison.
Claim Rejections - 35 USC § 102
(MAINTAINED)
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 38-47 and 49-51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hovig et al. WO 2008/007073 A2 published January 17, 2008.
Hovig teaches a method for introducing an siRNA molecule into the cytosol of a cell, said method comprising i) contacting said cell with an siRNA molecule, a carrier and a
photosensitising agent, and ii) irradiating the cell with light of a wavelength effective to activate the photosensitising agent, wherein said carrier comprises a cationic polyamine selected from…
(d) an amine group containing dendrimer…(claim 1).
Hovig states dendrimers can also be defined with reference to their generation, and as such the dendrimer (e.g. the PAMAM dendrimer) is preferably of generation 0, 1, 2, 3, 4, 5,
6, 7, 8, 9 or 10, particularly generation 2-6.
Hovig teaches classes of suitable photosensitising agents which may be mentioned thus include porphyrins, phthalocyanines, purpurins, chlorins, (particularly chlorin derivatives of the prophyrins described below) benzoporphyrins, lysomotropic weak bases, naphthalocyanines, cationic dyes ap.d tetracyclines or derivatives thereof (Berg et al., (1997), J. Photochemistry and Photobiology, 65, 403-409). See claim 28.
Hovig at page 29 states, in order to target the siRNA molecule and/or the photosensitizing agent to specific cells (e.g. cancer cells) or tissues, the siRNA molecule and/or the photosensitizer and/or the carrier may be associated or conjugated to specific targeting molecules that will promote the specific cellular uptake of the siRNA molecule into desired
cells or tissues.
Response to Arguments: Applicant argues the limitation in claim 38 to "...a mixture of particles ... [having] a dimension within a size distribution range between 1 nm and 500 nm," is not taught by the reference having these physically measurable attributes. While the reference doesn’t measure the size, the size of the structure described by the reference inherently has the properties as they are inherent to the structure. As such the limitation is met. Applicant could show that the art is not the same by providing evidence via comparison.
Conclusion
No claims allowed.
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/MICHAEL J SCHMITT/ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629