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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 22, 2024, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China (202210293369.0) on March 24, 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 11 – 20 are examined here-in.
Specification
The disclosure is objected to because of the following informalities:
The abstract exceed 150 words in length. According to MPEP 608.01(b), the abstract should not exceed 150 words in length.
Paragraphs should be numbered with at least four numerals enclosed in square brackets, including leading zeros (e.g., [0001]) according to MPEP 608.01.
Appropriate correction is required.
Claim Objections
Various informalities appear throughout the claim set and Applicant is requested to carefully review and revise the claims as appropriate.
Claims 11 – 20 are objected to because of the following informalities:
In claim 11, “microneedle-matrix solution” should be “a microneedle-matrix solution” for clarity.
Claims 15 and 16 recite “wherein in the CCPCA nanoparticles”. The preposition “in” should be changed to “for” so the phrase is “wherein for the CCPCA nanoparticles”, which is more clear, if appropriate.
In claim 19, “located at the patch” should be “located on the patch”.
Appropriate correction is required.
Claim Interpretation
The recitation “for enhancing accumulation of PpIX in a solid tumor” in claims 11 - 18 does not further limit the active method steps defined by independent claim 11, which recites “dissolving”, “adding”, “loading CAT and 5-ALA”, “loading the CCPCA nanoparticles”, “vacuum drying”, “demolding”, and “obtaining”. According to MPEP 2111.02(II), if the preamble merely states the purpose or intended use of the invention, rather than any distinct definition or any of the claimed invention’s limitations, then it is not considered a limitation and is of no significance to claim construction. In this case, the description that the microneedle patch made according to method claims 11 – 18 is “for enhancing accumulation of PpIX in a solid tumor” does not add any distinct definition to the claimed invention’s limitations. In other words, the intended use of the microneedle patch does not inform the artisan of how the active method steps of “dissolving”, “adding”, “loading CAT and 5-ALA”, “loading the CCPCA nanoparticles”, “vacuum drying”, “demolding”, and “obtaining” are performed, therefore the recitation “for enhancing accumulation of PpIX in a solid tumor” is not interpreted to be limiting.
Similarly in claims 19 and 20, the recitation “for enhancing accumulation of PpIX in a solid tumor” appears to state the intended use of the microneedle patch that is claimed. As discussed above, according to MPEP 2111.02(II), if the preamble merely states the purpose or intended use of the invention, rather than any distinct definition or any of the claimed invention’s limitations, then it is not considered a limitation and is of no significance to claim construction. Therefore, the recitation “for enhancing accumulation of PpIX in a solid tumor” is not interpreted to be limiting.
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.
Claims 15, 16, 18, and 20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 15, which depends on claim 11, recites the mass ratio of CAT to CCP nanoparticles is 0 to 0.1 and the mass ratio of 5-ALA to CCP nanoparticles is 0 to 0.1. A mass ratio of 0 to 0.1 implies that the first component, in this case CAT, is required to be in an amount of 0. In other words, a mass ratio of 0 implies that the component in the numerator position of this ratio is not required. As such, the recitation of claim 15 suggests that CAT and 5-ALA may be in an amount of 0, which is in conflict with independent claim 11’s recitation that CAT and 5-ALA are required. The recitation for a mass ratio of 0 to 0.1 renders the claim indefinite because it is not clear if the first component (i.e. CAT or 5-ALA) is required or not.
Claim 16, which depends on claim 11, recites drug loading of CAT is 0 to 7.9% and drug loading for 5-ALA is 0 to 6.8% with regards to the CCPCA nanoparticles. The lower limit of these ranges, i.e. 0%, suggests that CAT and 5-ALA may be required in an amount of 0%, which conflicts with the definition of CCPCA nanoparticles, which necessarily includes CAT and 5-ALA. The recitation for drug loading of 0 to 7.9% CAT and 0 to 6.8% 5-ALA renders the claim indefinite because it is not clear CAT and 5-ALA are required or not. In claim 16 it is also unclear if the percent is by weight, by volume, by molarity, etc. Appropriate correction is required.
The term “superactive” in claims 18 and 20 is a relative term which renders the claim indefinite. The term “superactive” 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. It is unclear what distinguishes “superactive” hyaluronic acid from any other form of hyaluronic acid.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15 and 16 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15, which depends on claim 11, recites the mass ratio of CAT to CCP nanoparticles is 0 to 0.1 and the mass ratio of 5-ALA to CCP nanoparticles is 0 to 0.1. A mass ratio of 0 to 0.1 implies that the first component, in this case CAT, is required to be in an amount of 0. In other words, a mass ratio of 0 implies that the component in the numerator position of this ratio is not required. As such, the recitation of claim 15 suggests that CAT and 5-ALA may be in an amount of 0, which is in conflict with independent claim 11’s recitation that CAT and 5-ALA are required. The recitation for a mass ratio of 0 to 0.1 broadens the scope of independent claim 11 because it suggests CAT and 5-ALA are not necessarily required. In other words, a mass ratio of 0 (CAT and/or 5-ALA in an amount of 0) fails to include all the limitations of claim 11, upon which claim 15 depends.
Claim 16, which depends on claim 11, recites drug loading of CAT is 0 to 7.9% and drug loading for 5-ALA is 0 to 6.8% with regards to the CCPCA nanoparticles. The lower limit of these ranges, i.e. 0%, suggests that CAT and 5-ALA may be required in an amount of 0%, which conflicts with the definition of CCPCA nanoparticles, which necessarily includes CAT and 5-ALA, and conflicts with the recitation of independent claim 11 which recites that CAT and 5-ALA are required. Drug loading of CAT in an amount of 0 to 7.9% and drug loading for 5-ALA in an amount of 0 to 6.8% broadens the scope of independent claim 11 because it suggests CAT and 5-ALA are not necessarily required. In other words, a drug loading percent of 0 (CAT and/or 5-ALA in an amount of 0) fails to include all the limitations of claim 11, upon which claim 16 depends.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
Closest Prior Art
[AltContent: textbox (Left: dithiocarbamate
Right: carbodiimide)]Skrott (US 2020/0276124 A1) teaches a nanoparticle form of a dithiocarbamate-metal complex with a blood serum protein, wherein the metal is copper and the blood serum protein is albumin, and a method for in-situ self-assembly (abstract, paragraphs 0009 – 0011, 0019, 0025, 0055, 0059, 0066). Skrott’s teachings overlap with the instant application because albumin and copper undergo in-situ self-assembly to form nanoparticles. Skrott’s teachings differ from the instant application because Skrott uses dithiocarbamate, whereas the instant application requires carbodiimide coupling. Dithiocarbamate and carbodiimide have different functional groups and structures (shown below), and thus modulate chemical reactions differently.
Skrott’s teachings also differ from the instant application because Skrott does not teach or suggest the inclusion of calcium in the dithiocarbamate-metal complex blood serum protein nanoparticles.
Jiang (CN111297830 B, citations to translation by EspaceNet) teaches 5-aminolevulinic acid (5-ALA) is a common photosensitizer, and teaches the inclusion of 5-ALA and CAT inside PLGA-HA nanoparticles (page 3 line 17, page 5 lines 3 - 6). Jiang does not teach or suggest 5-ALA and CAT with copper calcium phosphate nanoparticles, as described in the instant application.
The closest prior art of Skrott and Jiang do not fairly teach or suggest a method for making albumin-templated copper calcium phosphate nanoparticles via in-situ self-assembly with 5-ALA and CAT for inclusion in a microneedle patch.
Conclusion
The claims require revision and correction as appropriate. The closest prior art is discussed above. At present, no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
