DETAILED ACTION
Citation to the Specification will be in the following format: (S. # : ¶) where # denotes the page number and ¶ denotes the paragraph number of the pregrant publication corresponding to this application, US 2024/0181061. Citation to patent literature will be in the form (Inventor # : LL) where # is the column number and LL is the line number. Citation to the pre-grant publication literature will be in the following format (Inventor # : ¶) where # denotes the page number and ¶ denotes the paragraph number.
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 Application
This office action is in response to the papers as filed 12/5/2023.
Claim(s) 1-18 is/are pending.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on:
5/20/2024 (4 pages)
5/20/2024 (29 pages)
12/19/2024 (5 pages)
12/19/2024 (18 pages)
4/29/2025 (5 pages)
5/29/2025 (5 pages)
6/25/2025 (5 pages)
7/31/2025 (5 pages)
8/28/2025 (5 pages)
9/29/2025 (5 pages)
12/30/2025 (6 pages)
2/24/2026 (5 pages)
3/31/2026 (5 pages)
4/28/2026 (6 pages)
5/28/2026 (6 pages)
are in compliance with the provisions of 37 CFR 1.97-1.98, with the caveats below:
An excessive number of references have been filed, the overwhelming majority of which have little relevance to the pending claims (i.e. it does establish, by itself or in combination with other information, a prima facie case of unpatentability of a claim). For example, the 29 page 5/20/2024 IDS lists an article by Selim, et al. (NPL Cite No. 21) entitled “Hierarchical biocide-free silicon/graphene-silicon carbide nanocomposite coatings for marine antifouling and superhydrophobicity of ship hulls,” dated 5 June 2024. First, this is after both the provisional and non-provisional filing date. It is not prior art. Non-prior art is relevant in very limited circumstances. MPEP 2124. If Applicants believe any of the issues identified in MPEP 2124 are present in this application vis-à-vis the references submitted on the various IDS, they are invited to state so on the record. Second, the Selim article related to coating ship hulls. It is not a “nano-drug delivery method,” composition, or method of forming such a composition. Ship coatings have nothing to do with drug delivery methods. If the Examiner is mistaken, an explanation to that end would be helpful.
Serial non-compliance with the rules is reflected across the various IDS. 37 CFR 1.98 governs the content of Information Disclosure Statements, and is reproduced below:
1.98 Content of information disclosure statement.
(a) Any information disclosure statement filed under § 1.97 shall include the items listed in paragraphs (a)(1), (a)(2) and (a)(3) of this section.
(1) A list of all patents, publications, applications, or other information submitted for consideration by the Office. U.S. patents and U.S. patent application publications must be listed in a section separately from citations of other documents. Each page of the list must include:
(i) The application number of the application in which the information disclosure statement is being submitted;
(ii) A column that provides a space, next to each document to be considered, for the examiner’s initials; and
(iii) A heading that clearly indicates that the list is an information disclosure statement.
(2) A legible copy of:
(i) Each foreign patent;
(ii) Each publication or that portion which caused it to be listed, other than U.S. patents and U.S. patent application publications unless required by the Office;
(iii) For each cited pending unpublished U.S. application, the application specification including the claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion [but see 1287 OG 163 (October 19, 2004) discussed in MPEP § 609.04(a), subsection II]; and
(iv) All other information or that portion which caused it to be listed.
(3)
(i) A concise explanation of the relevance, as it is presently understood by the individual designated in § 1.56(c) most knowledgeable about the content of the information, of each patent, publication, or other information listed that is not in the English language. The concise explanation may be either separate from applicant’s specification or incorporated therein.
(ii) A copy of the translation if a written English-language translation of a non-English-language document, or portion thereof, is within the possession, custody, or control of, or is readily available to any individual designated in § 1.56(c).
(b)
(1) Each U.S. patent listed in an information disclosure statement must be identified by inventor, patent number, and issue date.
(2) Each U.S. patent application publication listed in an information disclosure statement shall be identified by applicant, patent application publication number, and publication date.
(3) Each U.S. application listed in an information disclosure statement must be identified by the inventor, application number, and filing date.
(4) Each foreign patent or published foreign patent application listed in an information disclosure statement must be identified by the country or patent office which issued the patent or published the application, an appropriate document number, and the publication date indicated on the patent or published application.
(5) Each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication.
(c) When the disclosures of two or more patents or publications listed in an information disclosure statement are substantively cumulative, a copy of one of the patents or publications as specified in paragraph (a) of this section may be submitted without copies of the other patents or publications, provided that it is stated that these other patents or publications are cumulative.
(d) A copy of any patent, publication, pending U.S. application or other information, as specified in paragraph (a) of this section, listed in an information disclosure statement is required to be provided, even if the patent, publication, pending U.S. application or other information was previously submitted to, or cited by, the Office in an earlier application, unless:
(1) The earlier application is properly identified in the information disclosure statement and is relied on for an earlier effective filing date under 35 U.S.C. 120; and
(2) The information disclosure statement submitted in the earlier application complies with paragraphs (a) through (c) of this section.
37 C.F.R. 1.98. Note that at least dates are required for publications. 37 C.F.R. 1.98(b)(5). At least the 29 page 5/20/2024 IDS contains multiple references listed without a date. These have been crossed off, and have not been considered.
In other instances, the Applicants have not filed the document they say they have filed on the IDS. For example, on at least the 29 page 5/20/2024 IDS, Applicants cite a reference to Nepal, et al. (NPL Cite No. 1). What was submitted however was not the entire article, as the 29 page 5/20/2024 IDS suggests, but rather the abstract only. The document should match what was submitted. It is Applicant’s responsibility to go “behind the paywall” and get the reference so that a legible copy can be filed. 37 CFR 1.98(a)(2)(ii). Other instances of assorted and sundry non-compliance with the rules are present. For example, note the “firstgraphene.net” website is largely blank. To the extent any discrepancies were overlooked between what was listed and what was actually filed, only what was actually filed was considered. It is ultimately Applicants responsibility to ensure the copy of the reference they want considered is actually in the file.
Limited time is allocated for examination and prosecution of the whole patent application, let alone the Information Disclosure Statements. It is irregular to have this many instances of non-compliance on a form that gives instructions on how to fill the form out. It is unfortunately commonplace to have numerous non-relevant references filed for consideration. As such, Applicants are invited to call out any references they believe are particularly relevant to this application. Similarly, numerous search reports have been filed. As understood, while this is a national filing under 35 U.S.C. 111, an international application (PCT/US23/82535) was filed based on the same provisional document. As understood, no national stage filings exist from this international application. If this is incorrect, please correct the record and identify parallel applications in other jurisdictions/patent granting authorities. Do parallel Paris Convention applications exist? If so, this information would be helpful. It is unclear why so many seemingly irrelevant search reports are provided, so Applicants are invited to call out any search reports they believe are particularly relevant to this application.
Non-English documents have been considered to the extent the translated abstract or other statement of relevance indicates.
Accordingly, the information disclosure statements are being ““considered”” by the Examiner.
To advance prosecution (MPEP 713: “Discussions between an applicant and an examiner are often indispensable to advance the prosecution of a patent application.”), the Examiner requests a telephonic interview prior to Applicants filing additional Information Disclosure Statements, so that the IDS can be discussed in advance.
Claim Rejections - 35 USC § 112
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.
I. Claims 1-20 – or as stated below – is/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 enablement requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The analysis for determining whether a claim is supported by the disclosure is cast in terms of whether “undue experimentation” is necessary to practice the invention. See MPEP 2164.01. In examining the claims in light of the supporting disclosure, the Federal Circuit has provided a non-exclusive list of factors to consider in determining whether a disclosure is enabling. See generally In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). These factors include:
The breadth of the claims;
The nature of the invention;
The state of the prior art;
The level of one of ordinary skill;
The level of predictability in the art;
The amount of direction provided by the inventor;
The existence of working examples; and
The quantity of experimentation needed to make or use the invention based on the content of the disclosure
Id. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” Id. The Examiner has considered all factors in light of all claims rejected makes the following findings of fact:
The breadth of the claims
Three independent claims are pending: Claim 1, Claim 14 and Claim 20. These claims are reproduced below:
A nano-drug delivery method comprising:
preparing a nano-drug delivery component comprising a carbon-based nanomaterial composition and a nano-drug composition attached to the carbon-based nanomaterial composition;
delivering the nano-drug delivery component to a treatment location; and
applying a radio frequency to the nano-drug delivery component at the treatment location, wherein the radio frequency is configured to heat the nano-drug delivery component and cause the nano-drug composition to detach from the carbon-based nanomaterial composition for delivery at the treatment location,
wherein the carbon-based nanomaterial composition comprises: a carbon content of at least about 60% and not greater than about 99%
based on elemental analysis of the graphene composition,
an oxygen content of at least about 1% and not greater than about 35% based on elemental analysis of the graphene composition, and
a nitrogen content of at least about 2% and not greater than 50%.
14. A nano-drug delivery component comprising:
a carbon-based nanomaterial composition and a nano-drug composition attached to the carbon-based nanomaterial composition;
wherein the nano-drug delivery component is configured to be delivered to a treatment location and heated using a radio frequency at the treatment location,
wherein heating the nano-drug delivery component causes the nano-drug composition to detach from the carbon-based nanomaterial composition for delivery at the treatment location,
wherein the carbon-based nanomaterial composition comprises:
a carbon content of at least about 60% and not greater than about 99% based on elemental analysis of the graphene composition,
an oxygen content of at least about 1% and not greater than about 35% based on elemental analysis of the graphene composition, and
a nitrogen content of at least about 2% and not greater than 50%.
20. A method of forming a nano-drug delivery component, wherein the method comprises:
providing a carbon-based nanomaterial composition, and
attaching a nano-drug composition to the carbon-based nanomaterial composition to form the nano-drug delivery component,
wherein the nano-drug delivery component is configured to be delivered to a treatment location and heated using a radio frequency at the treatment location,
wherein heating the nano-drug delivery component causes the nano-drug composition to detach from the carbon-based nanomaterial composition,
wherein the carbon-based nanomaterial composition comprises: a carbon content of at least about 60% and not greater than about 99% based on elemental analysis of the graphene composition,
an oxygen content of at least about 1% and not greater than about 35% based on elemental analysis of the graphene composition, and
a nitrogen content of at least about 2% and not greater than 50%.
While not employing parallel language throughout, the claims are a method of forming a specific “nano-drug delivery component” (Claim 20), the “nano-drug delivery component” (Claim 14) and a method of “nano-drug delivery” that employs a “nano-drug delivery component.”
The claim is broad in the sense that it extends to all “nano-drug composition[s].” The composition itself is broad in that – while there are some ambiguities (discussed below) – it apparently extends to all carbon-based nanomaterial, subject to the carbon, oxygen and nitrogen limitations. The claims are broad in the sense that the “nano-drug composition” can be applied anywhere, and are so “configured.” Claim 1 is broad in the sense that it requires “configur[ing]” radio frequency to heat the nanomaterial. This could be any manner of “configuring.”
The claims do not explicitly require treatment. They only require delivery of the “nano-drug delivery component” to a ““treatment location”” (Claim 1), being ““configured”” to be delivered at a treatment location via a radio frequency (Claim 14, Claim 20). So, stated differently, the “carbon-based nanomaterial” can be ““configured”” to deliver “snake oil” to a cancerous tumor, a scalp experiencing alopecia, etc., with no clinical result (cancer remission, hair growth, etc.) required.
The rejection focuses on the bold-faced language above related to the nano-drug component ““configured”” to be delivered to a specific location, and the
The nature of the invention
According to the Specification: “[t]he present disclosure relates to a nano-drug delivery component including a carbon-based nanomaterial composition, methods of delivering a nano-drug delivery component including a carbon-based nanomaterial composition, and methods of forming the same.” (S. 1: [0002]).
The state of the prior art
Rejinold, et al., Radio frequency responsive nano-biomaterials for cancer therapy, Journal of Controlled Release 2015; 204: 85-97 (hereinafter “Rejinold at __”) was applied in the international application.
First, the Examiner is distinguishing between the methods/materials as claimed and RF ablation with various nanoparticles. RF ablation with nanoparticles is well known. The Rejinold document provides a good summary of the state of the art. (Rejinold 86, col. 1 et seq.). Succinctly stated: the nanoparticles are introduced; RF waves are applied, causing heat; hyperthermia is induced in the cancer cells and the cells die. See generally (Rejinold at 87, col. 1). The claims on the other had involve “configuring” a nano-drug component attached to a carbon-based nanomaterial to be delivered at a treatment location. (Claim 20, Claim 14). The drug is then delivered to the treatment location, RF waves are applied, and the “nano-drug” ““detaches”” from the carbon-based nanomaterial to be delivered to the treatment location. (Claim 1).
Second, notwithstanding any characterizations made in the international application, Rejinold is not understood as teaching delivering the nano-drug to the treatment location and detaching them with radio waves. Rather, as discussed above, the nanoparticles are delivered to the location and heated with radio waves to heat cancer cells. Note that Rejinold teaches that carbon nanostructures like nanotubes heat upon treatment with radio waves. (Rejinold at 90, col. 2). If the nanotubes destroy cancer cells, it stands to reason they would heat up and destroy any “nano-drug” attached to it.
The level of one of ordinary skill
The level of skill is reasonably inferred from the subject matter claimed. As discussed above, the claims brush up against a “method of treatment,” but do not actually require treatment. That said the claims require the ability to – at minimum – attach, “configure” and deliver a “nano-drug” to a specific location. This suggests some level of sophistication in the chemistry of carbon-based nanomaterial. The claims also require delivery at the specific location via radio frequency, so this suggests some knowledge of physics, etc. The level of skill in the art is reasonably inferred to be a PhD level chemist or physicist, likely with some exposure to medicine.
The level of predictability in the art
A determination of the predictability in the art starts with a threshold inquiry of what one is seeking to predict. Here, it is the ability to “configure” nano-drugs to be delivered at a treatment location, the ability to have them detach with radio frequencies that have been “configured” to heat the drug and cause it to detach at a specific treatment location. Insofar as the prior art (and the Specification) does not teach this, the art is understood as unpredictable.
The amount of direction provided by the inventor
Scant direction was provided. First, note that the Specification does not discuss a single “nano-drug” with any degree of specificity beyond the word “nano-drug.” The “Figures” are boxes with generic words in them. For example:
PNG
media_image1.png
364
520
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Greyscale
This does not describe how to attach the ““nano-drug.”” The Specification is equally lacking / generic in its detail. The Specification states:
[0028] Referring to the second step 2020, attaching the nano-drug composition to the carbon-based nanomaterial composition may be through a functional bond between the nano-drug composition and the carbon-based nanomaterial composition or through absorption of the nano-drug composition into the carbon-based nanomaterial. According to still other embodiments, the nano-drug composition may be absorbed within layers of the carbon-based nanomaterial. For example, if the carbon-based nanomaterial has a sheet structure, the nano-drug composition may be absorbed within and bond to layers of the sheet structure. According to other embodiments, if the carbon-based nanomaterial has a nano-onion structure, i.e., a structure that includes layers folded over on themselves such that they resemble an onion shell, the nano-drug composition may be absorbed within and bond to layers of the nano-onion structure.
(S. 3: [0028]) (emphasis added). What is a ““functional bond?”” This is not understood to be an actual chemical term, like an ionic or covalent bond. This is understood to be language that merely describes the result with circular language, i.e. “a bond that ‘functions’ to bond the nano-drug to the carbon-based nanomaterial” is a “functional bond.” Absorption is a real mass transfer phenomena, but this is the only mention of absorption in the Specification.
No guidance was given to ““configure”” either the radio frequence or the nano-drug to achieve the claimed delivery. The Specification merely contains laundry lists of numbers. See (S 2: [0022] et seq.). Many of these frequencies read on broadcast FM radio. The Specification doesn’t address any issues that may arise with that – for example how is a nano-drug ““configured”” to be delivered to a specific location when the subject (in most parts of the world and certainly in America where this patent would be enforced) would be awash in FM radio waves?
Most of the Specification appears to repackage material from another of the Applicant’s applications related to oxygen-doped carbon nanomaterials. See 18/176,558; US 2023/0278865 to Johnson at al. (“Johnson ‘865). Compare (S. Figure 4) with (Johnson ‘865 Figure 2). Note also the same boilerplate. Compare e.g. (S. 4: [0033] et seq.) with (Johnson ‘865 4: [0031] et seq). In this sense, this is a method of making carbon nanostructures masquerading as a pharmaceutical application.
The existence of working examples
No working examples were presented. This is unusual in carbon nano applications. While not dispositive, this is highly probative evidence supporting the conclusion that these compositions and methods have not actually been made. If this is incorrect, citation to the working examples might be persuasive.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure
The only Wands factor supporting a conclusion of enablement is the level of skill in the art, which is high. The factors supporting a conclusion of non-enablement include the breadth of the claims, the state of the prior art (teaching a related but different method), the lack of guidance in the Specification (most of which is devoted to the method of making the nanocarbons from a different application), and the lack of experimental evidence and/or a reduction to practice. With infinite ““nano-drugs,”” infinite treatment locations, and the entire RF spectrum being claimed, infinite and undue experimentation is needed to practice the claimed invention.
If Applicants disagree, an explanation of how to “configure” a nano-drug to be delivered to a specific location with radio frequencies, etc. would be helpful in withdrawing the rejection.
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.
I. Claims 1-20 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 graphene composition.” This lacks antecedent basis.
Claim 14 recites “the graphene composition.” This lacks antecedent basis.
Claim 20 recites “the graphene composition.” This lacks antecedent basis.
Dependent claims not specifically addressed import the issues of the claims from which they depend.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL C. MCCRACKEN whose telephone number is (571) 272-6537. The examiner can normally be reached on Monday-Friday (9-6).
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, Anthony J. Zimmer can be reached on 571-270-3591. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL C. MCCRACKEN/Primary Examiner, Art Unit 1736
Prosecution Insights