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 claims
Claims 1-20 were previously cancelled.
Claim 21 was amended.
New claim 39 was added.
Claims 21-39 are pending.
Restriction Response
Applicant’s election with traverse of Group I (claims 21-23) in the reply filed on 03/23/26 is acknowledged. The traversal is on the ground(s) that Langer et al. (US 2011/0142948 A1 – “Langer”) defeats the patentability of claims 28-38 of the present application. Applicant argues that Langer does not comprise one or more amorphous nanoparticles, a limitation recited in e.g., claim 21 of the present application.
This is not persuasive because even though Langer does not expressly teach amorphous nanoparticles, Langer teaches that nanoparticles are diverse both in their shape and composition ([0017]). All the claimed components of the nanoparticle composition recited in instant claim 21 are taught by Langer, including the photosensitizer and the size of the nanoparticles. Since the same components and the same nanoparticle composition are disclosed by the prior art the same properties of the nanoparticle composition, i.e., amorphous nanoparticles, are necessarily present. Please see MPEP 2112.01(I).
The lack of unity is still deemed proper and is therefore made FINAL.
Claims 24-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 21-23 and 39 are included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/23/26 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement. Please see the attached copy of PTO-1449.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 39 is 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.
Claim 39 is dependent on cancelled claim 1. 35 U.S.C. 112(b) states: “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.” In this case, since claim 39 is dependent on cancelled claim 1, the metes and bounds of claim 39 are literally unknowable. For examination purposes, claim 39 is construed to be dependent on claim 21.
Notice for all US Patent Applications filed on or after March 16, 2013
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.
Claim Rejections - 35 USC § 102
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 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Langer et al. (US 2011/0142948 A1 – “Langer”).
Instant claim 21 is drawn to a nanoparticle composition comprising: one or more amorphous nanoparticles comprising up to 100% by weight of a photosensitizer; wherein the one or more amorphous nanoparticles have a size of 1000 nm or less; and wherein the one or more amorphous nanoparticles are surfactant-free, carrier-free, polymer-free, and lipid-free.
Langer teaches nanoparticulate formulations comprising human serum albumin (HSA) and therapeutically effective amounts of photosensitizer (PS) (Abstract). Preferred HSA-based nanoparticles have a mean size less than 500 nm in diameter ([0057]). The PS includes temoporfin and 5,10,15,20-tetrakis(m-hydroxyphenyl)-porphyrin (mTHPP) ([0059]). TABLE 1 discloses physico-chemical characteristics of mTHPP-loaded HSA nanoparticles wherein the mTHPP loading ranges from 17.3 ± 0.3 µg/mg to 21.6 ± 6.8 µg/mg or 17 µg/mg to 28.4 µg/mg which is calculated to be 1.7% to 2.84%. TABLE 1 also discloses the particle diameter of the nanoparticles ranging from 189.9 ± 0.4 nm to 204.0 ± 5.2 nm. The nanoparticulate formulation taught by Langer does not contain surfactant, carrier, polymer, or lipid.
Regarding instant claim 21, the limitation of a nanoparticle composition is anticipated by the nanoparticulate formulations comprising HSA and therapeutically effective amounts of PS (Abstract), as taught by Langer.
Regarding instant claim 21, the limitation of one or more amorphous nanoparticles is anticipated by the nanoparticles which are diverse both in their shape and composition ([0017]), as taught by Langer. All the claimed components of the nanoparticle composition recited in instant claim 21 are taught by Langer, including the photosensitizer and the size of the nanoparticles. Since the same components and the same nanoparticle composition are disclosed by the prior art the same properties of the nanoparticle composition, i.e., amorphous nanoparticles, are necessarily present. Please see MPEP 2112.01(I).
Regarding instant claim 21, the limitation of one or more amorphous nanoparticles comprising up to 100% by weight of a photosensitizer is anticipated by the mTHPP-loaded HSA nanoparticles wherein the mTHPP loading ranges from 17.3 ± 0.3 µg/mg to 21.6 ± 6.8 µg/mg or 17 µg/mg to 28.4 µg/mg which is calculated to be 1.7% to 2.84% (TABLE 1), as taught by Langer.
Regarding instant claim 21, the limitation of the one or more amorphous nanoparticles having a size of 1000 nm or less is anticipated by the preferred HSA-based nanoparticles having a mean size less than 500 nm in diameter ([0057]), and the particle diameter of the nanoparticles ranging from 189.9 ± 0.4 nm to 204.0 ± 5.2 nm (TABLE 1), as taught by Langer.
Regarding instant claim 21, the limitation of the one or more amorphous nanoparticles being surfactant-free, carrier-free, polymer-free, and lipid-free is anticipated by the nanoparticulate formulation taught by Langer that does not contain surfactant, carrier, polymer, or lipid.
Regarding instant claim 22, the limitation of the photosensitizer that absorbs light in a range of from about 400 nm to about 1200 nm is anticipated by the PS including temoporfin and mTHPP ([0059]), as taught by Langer.
Regarding instant claim 23, the limitation of a porphyrin photosensitizer is anticipated by the PS including temoporfin and mTHPP ([0059]), as taught by Langer.
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 of this title, 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.
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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 39 is rejected under 35 U.S.C. 103 as being unpatentable over Langer et al. (US 2011/0142948 A1 – “Langer”), as applied to claims 21-23 above, in view of An et al. (Materials Letters 122 (2014) 323-326 – “An”).
Instant claim 39 is drawn to the nanoparticle composition of claim 1 (construed to be claim 21), wherein one or more amorphous nanoparticles comprise 100% by weight of a photosensitizer.
The teaching of Langer is discussed above.
Langer does not expressly teach one or more amorphous nanoparticles comprise 100% by weight of a photosensitizer.
An teaches a carrier-free photosensitizer nanocrystal for photodynamic therapy (Title) since poor drug loading requires excessive use of carrier materials which may induce side effects and inhibit their clinical translation (Abstract). An teaches the preparation of pure nanocrystals of hydrophobic mesotetraphenylporphyrin (TPP) photosensitizer (PS) molecules (Abstract, Page 323, Col. 1, 2nd ¶, lines 1-3). “Unlike the traditional nanovehicle-based pharmaceutical formulation, the PS nanocrystals contain no carrier materials and are composed of pure TPP molecules which give rise to an ultra-high drug loading” (Page 324, Col. 1, under section “3. Results and discussion”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare nanoparticulate formulations comprising HSA and therapeutically effective amounts of PS, as taught by Langer, in view of the PS nanocrystals which contain no carrier materials and are composed of pure TPP molecules which give rise to an ultra-high drug loading, as taught by An, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because of the advantages of no side effects and no inhibition of clinical translation as a result of ultra-high drug loading and no carriers (Abstract), as taught by An.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 39, the limitation of 100% by weight of a photosensitizer would have been obvious over the PS nanocrystals which contain no carrier materials and are composed of pure TPP molecules which give rise to an ultra-high drug loading (Title, Abstract, and Page 324, Col. 1, under section “3. Results and discussion”), as taught by An.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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