DETAILED ACTION
Applicants’ arguments, filed 26 January 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification – Amendment Entered
The amendment to the specification submitted on 26 January 2026 has been entered as it appears to be a correction of an obvious error.
Office Action is NON-FINAL
This office action includes newly applied rejections that are not necessitated by amendment or by the filing of an information disclosure statement. As such, this office action has been made NON-FINAL.
More details regarding this issue are provided later in the office action.
Withdrawn Prior Art Rejections Due to 1.130 Declaration
The examiner previously rejected the instant claims as having been anticipated by and obvious over Gabriele et al. (Pharmaceutics, Vol. 13, 2021, pages 1-13). These rejections have been withdrawn in view of the declaration under 37 C.F.R. 1.130 provided with applicant’s response on 26 January 2026.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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.
Claims 1-3 and 5-10 are 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.
Claim 1 recites the term “sugar.” The meaning of the term “sugar” is unclear, thereby resulting in the claim being indefinite. The examiner presents the following rationale in support of this position.
Terms used contrary to their ordinary meaning must be clearly redefined in the written description. See MPEP 2173.05(a)(III). In this case, it is unclear as to whether the term “sugar” was clearly redefined in the written description and is being used contrary to its ordinary meaning. The examiner presents the following rationale in support of this position.
The instant specification indicates that both glucose and glutamine are sugars. See the instant specification on pages 4-5, paragraph 0021. However, the skilled artisan would have understood that glutamine does not fall within the ordinary definition of the term “sugar.” This is because glutamine is an amino acid rather than a sugar. In support of this position, the examiner cites Muenchen (https://www.cup.uni-muenchen.de/ch/compchem/tink/as.html accessed 18 February 2026, 3 printed pages), which teaches the following, as of page 1, relevant text reproduced below with annotation by the examiner.
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As such, the skilled artisan would have understood glutamine to have been an amino acid rather than a sugar, according to the ordinary definition of the terms “amino acid” and “sugar.”
Consequently, it is unclear as to whether applicant has redefined the term “sugar” in the specification. Therefore, it is therefore unclear as to what the scope of the term “sugar” actually is. Terms used contrary to their ordinary meaning must be clearly redefined in the specification; however, in this case, it is unclear if the applicant has redefined the term “sugar” in the specification. See MPEP 2173.05(a)(III).
This rejection also applies to claim 2 because, as glutamine would have ordinarily been understood to have been an amino acid, it is unclear whether glutamine is actually within the claim scope.
For the purposes of examination under prior art, the examiner will examine claim 1 with the understanding that the term “sugar” has its ordinary definition and excludes polysaccharides. For the purposes of examination under prior art, the examiner understands claim 2 to be limited to glucose. The examiner will not understand glutamine to be within the scope of the required sugar.
In the previous office action, the examiner made an error by having failed to present this rejection. As such, this rejection is not understood to have been necessitated by amendment, and this office action has been made NON-FINAL.
Note Regarding Abbreviations
Claim 5 recites “VM-M3”, “A375” and “HeLa.” The examiner understands these abbreviations to refer to well-known cell lines. Claim 6 recites “IR light.” The skilled artisan would have understood the abbreviation “IR” to have referred to “infrared.”
Claim Rejections - 35 USC § 103 – Obviousness
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.
The factual inquiries 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 as of the effective filing date of the claimed invention(s) 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 as of the effective filing date of the later invention 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(s) 1-3 and 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cuzzubbo et al. (Cancers, Vol. 13, 2021, pages 1-15) in view of Gianneschi et al. (US 2020/0113934 A1).
Cuzzubbo et al. (hereafter referred to as Cuzzubbo) is drawn to melanin nanoparticles for cancer therapy, as of Cuzzubbo, page 1, title and abstract. Cuzzubbo teaches photothermal therapy with melanin nanoparticles, as of Cuzzubbo, page 2, figure reproduced below.
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Cuzzubbo teaches a particle diameter of from 20 nm to 200 nm, as of Cuzzubbo, page 7, bottom paragraph.
Cuzzubbo does not teach a coating.
Gianneschi et al. (hereafter referred to as Gianneschi) is drawn to melanin nanoparticles, as of Gianneschi, title and abstract. Gianneschi teaches administering said melanin nanoparticles parenterally in glucose, as of Gianneschi, paragraph 0248, reproduced below.
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Gianneschi is not anticipatory because the primary purpose of Gianneschi is not for photothermal therapy and therefore does not appear to anticipate the “illuminating” step of claim 1.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the melanin nanoparticles of Cuzzubbo with the glucose of Gianneschi. Cuzzubbo is drawn to administering melanin nanoparticles for treatment of metastatic cells by photothermal therapy. Gianneschi teaches the use of glucose as a diluent for administration of melanin nanoparticles. As such, the skilled artisan would have been motivated to have combined the melanin nanoparticles of Cuzzubbo with the glucose of Gianneschi in order to have predictably administered the melanin nanoparticles safely with a reasonable expectation of success.
As to the first step of claim 1, the skilled artisan would have expected that the steps of combining melanin nanoparticles with glucose, as of Gianneschi, would have resulted in the formation of a coating with a thickness of about 10 to 30 nm even though this was not explicitly disclosed by Gianneschi. Something which is old (e.g. a method of combining melanin nanoparticles with glucose) does not become patentable upon the discovery of a new property (that the glucose coats the melanin with a coating having a particular thickness), and this feature need not have been recognized at the time of filing. Additionally, the USPTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same. See MPEP 2112(V). The examiner notes that the examiner must provide evidence or reasoning to shift the burden to applicant in accordance with MPEP 2112(V). In this case, the examiner’s reasoning is that the instant specification appears to disclose that mixing melanin nanoparticles with sugar results in the formation of sugar-coated melanin nanoparticles, as of at least the instant specification on page 7, paragraph 0032, relevant text reproduced below.
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As such, the skilled artisan would have expected that mixing melanin nanoparticles with sugar would have resulted in the formation of a sugar coating on the melanin nanoparticles with a diameter of about 10 nm to 30 nm thick. Gianneschi teaches combining melanin nanoparticles with glucose; as such, it would have been reasonable to have expected that this would have resulted in the formation of melanin nanoparticles with a diameter of about 10 nm to 30 nm thick. The examiner takes the position that, in view of this fact pattern, there is sufficient support to shift the burden to applicant in accordance with MPEP 2112(V).
As to the second and third steps of claim 1, Cuzzobbo teaches the following on page 10, section 5.2, relevant text reproduced below.
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As such, the skilled artisan would have been motivated to have administered melanin to cancer (i.e. metastatic) cells and to have administered light to create heat, thereby killing cancer; see both the above-reproduced text as well as the entirety of Cuzzubbo, pages 10-11, section 5.2.
As to claim 2, Cuzzubbo teaches glucose, as of the figure in the abstract.
As to claim 3, Cuzzubbo teaches particle diameters of between 20 nm and 200 nm, as of Cuzzubbo, page 7, bottom paragraph. This overlaps with the claimed size range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 6, Cuzzubbo teaches near infrared laser for achievement of the photothermal effect, as of Cuzzubbo, page 10, last paragraph.
As to claim 7, Cuzzubbo teaches intravenous injection, as of page 7, end of first paragraph.
As to claims 8-9, Cuzzubbo teaches near infrared laser for achievement of the photothermal effect, as of Cuzzubbo, page 10, last paragraph. The skilled artisan would have been motivated to have placed this near the skin near the site of the tumor. As there are blood vessels under the skin, this would have resulted in direct exposure of blood vessel near the skin.
As to claim 10, the skilled artisan would have been motivated to have placed the near infrared laser at the wrist if the cancer were at that location.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cuzzubbo et al. (Cancers, Vol. 13, 2021, pages 1-15) in view of Gianneschi et al. (US 2020/0113934 A1), the combination further in view of Wang et al. (US 2020/0085931 A1).
Cuzzubbo is drawn to melanin nanoparticles for cancer treatment via a photothermal method. Gianneschi teaches melanin nanoparticles and teaches treating various cancers, including melanoma, as of Gianneschi, at least paragraph 0113.
Neither Cuzzubbo nor Gianneschi teach A375 derived from melanoma.
Wang et al. (hereafter referred to as Wang) is drawn to nanoparticles for cancer immunotherapy, as of Wang, title and abstract. Wang teaches that A375 is a human melanoma cell line, as of Wang, paragraph 0085.
Wang does not teach melanin nanoparticles.
It would have been prima facie obvious for one of ordinary skill in the art to have used the A375 cells of Wang in experimental testing of the method of Cuzzubo in view of Gianneschi. The method of Cuzzubbo in view of Gianneschi is used for treating cancer, as of Cuzzubbo, page 1, abstract, and Gianneschi, at least paragraph 0113, which teaches melanoma. As such, the skilled artisan would have been motivated to have used the A375 cell line of Wang in order to have predictably tested the method of Cuzzubbo in view of Gianneschi for treating cancer with a reasonable expectation of success.
Response to Arguments
The above prior art rejections are understood to be new rejections not necessitated by amendment. As such, this office action has been made NON-FINAL.
The arguments presented in applicant’s response on 26 January 2026 appear to be moot as these arguments address rejections which have been withdrawn. As such, applicant’s arguments have not been addressed substantively by the examiner.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612