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 .
Drawings
The drawings are objected to because Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g).
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
The objection to the drawings will not be held in abeyance.
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.
Claim 5 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The limitation “…responsive to the irradiating…” is unclear given that irradiation of the administered nanoparticles is said to generate heat. It would seem that the tumor must logically be response to the heat, not the irradiation (of the nanoparticle photosensitizer) per se.
Clarification is in order.
Claim 6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Note that claim language that merely states a problem to be solved or a result obtained “…causes a porosity of the tumor to increase…”, without setting forth well-defined boundaries of the claimed scope (i.e. by not specifying any way to achieve the desired results), is unclear. Typically no patentable distinction (no limit on the claim scope) is made by a recitation of an intended use or result unless some structural difference is imposed by the use or result on the structure or material recited in the claim, or some manipulative difference is imposed by the use or result on the action recited in the claim. Note the discussion at MPEP 2173.05(g).
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, 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. In the present instance, the claim fails to further limit the subject matter of the claim upon which it depends. Claim 1, the claim from which claim 13 immediately depends, explicitly teaches “…injecting nanoparticles into a target site in or adjacent to an eye…”. Claim 13 then teaches “… injecting the nanoparticles comprises targeted injection.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirement.
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 1, 2, 13, 14, 16-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Colloids and Surfaces A (2019), 579, 123706 (7 pages).
The reference teaches a photodynamic therapy method for targeted therapy comprising injecting photosensitizing nanoparticles (spherical) into a target site in or adjacent to the eye (manually, under the conjunctiva) and then irradiating the target site with a light source (IR) in order to activate the nanoparticle (which generates singlet oxygen from molecular oxygen) (abstract; page 3, column 2, 4.4 BDPY treat corneal neovascularization as photodynamic therapy; page 4, column 1, 6. Results and discussion; page 5, column 1, text line 20). The method, a treatment of corneal neovascularization, has an application as a treatment for tumors of the eye (page 4, column 2, text line 17).
Claims 1, 2, 4, 7, 9-14, 16-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Molecular Pharmaceutics (2019), 16, pp. 4045-4058.
The reference teaches a combined, targeted chemo- and photodynamic therapy method (520-680 nm) for the treatment of retinoblastoma by injecting lipid polymer nanoparticles (spherical), which encapsulate both beta-lapachone (a drug with both anti-cancer and anti-angiogenic properties) and m-THPC (a photosensitizer which generates ROS such as singlet oxygen from molecular oxygen), utilizing a single (manual) intravitreal injection (abstract; page 4045, column 2, text line 9; page 4049, column 1, 2.2.6.3. Cytotoxicity and Phototoxicity Experiments on RB cells and column 2, 3.1. Experimental Conditions Influencing Nanoparticle Characteristics; page 4055, column 1, 4. Conclusions).
Claims 1-3, 7-11, 13, 14 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Small (2019), 15, 1903880 (13 pages).
The reference teaches the synergistic chemotherapy and photodynamic therapy (650 nm) of endophthalmitis (a bacterial infection of the aqueous and vitreous humors) by (manual) injection into the eye of zeolitic imidazolate framework nanoparticles (spherical) which have been loaded with methylene blue (a broad-spectrum photosensitizer antibacterial agent), coated with Ag/PDPA and coated again with vancomycin/PEG (abstract; page 2 of 13, Scheme 1; page 9 of 13, column 1, text line 7; page 10 of 13, column 2, 3. Conclusions).
Allowable Subject Matter
Claims 15 and 19 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 8/16/2026
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