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 .
The request for participation in the Patent Prosecution Highway (PPH) pilot program filed on 03/25/25 has been denied on 05/15/25.
Receipt is also acknowledged of Amendments and Remarks filed on 08/07/25. Claims 1, 5, 16, 20-21, 23 and 26 have been amended, no claims have been canceled and new claims 27-29 have been added. Accordingly, claims 1, 4-6, 9-10, 16-17 and 20-29 are pending and under examination on the merits.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Objections
Claim 1 is objected to because of the following informalities: the term “are” is missing between -that- and -capable- in line 1.
Objections to the Specification
The specification is objected to as failing to provide proper antecedent basis for
the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o).
Correction of the following is required:
Claim 4 is objected for reciting a reduction potential of from about 0.05 V to about -2 V. The Specification does not contain this limitation.
Claim 16 is objected for lacking support for the recitation of “persulfide- and/or polysulfide-producing effective amount”. The Specification fails to provide any guidance on the claimed amount.
Claim 17 is objected for lacking support in the Specification. There is no disclosure of osmolality, isotonic with blood or the osmolality values of the aqueous formulation in the Specification.
Claim 20 is objected for lacking support in the Specification. The entire claimed method is absent from the Specification.
Claim 20 is objected for requiring an oxidizing effective amount of one or more concentrated nitric acid…. There is no disclosure on what this effective amount is.
Claim 21 is objected for lacking this step in the Specification.
Claim 24 is objected for lacking support for (iii) contacting is to be repeated a plurality of times.
The claims as filed in the original specification are part of the disclosure and therefore, if an application as originally filed contains a claim disclosing material not disclosed in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985). See MPEP § 2163.06(III) and MPEP § 608.01(o).
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.
Claims 1, 4-6, 9-10, 16-17 and 20-29 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 is indefinite for reciting that the oxidized-carbon nanoparticles (are) capable of forming a dispersion in water even when free from an exogenously-supplied functionalized solubilizing agent… . The recitation of -even when- renders the claim indefinite because it is not clear if the solubilizing agent is present or excluded. Additionally, the term “capable” is not a positive recitation and does not require the formation of a dispersion.
Claims 9-10, 20 and 25-26 are indefinite because directly or indirectly they depend on claim 1 which has the limitation of “free from an exogenously-supplied functionalized solubilizing agent”. However, claims 9-10 and 25-26 require oxidized carbon nanoparticles being functionalized with a solubilizing agent.
Claim 16 is indefinite for reciting oxidized-carbon nanoparticles… dissolved or dispersed” “in water. Claim 16 depends on claim 1 which limits the oxidized-carbon nanoparticles being dispersed in water.
Claim 17 recites the limitation "diluent" in the composition of claim 16. There is insufficient antecedent basis for this limitation in the claim. Amendments to claim 16 have deleted the limitation of diluent.
Claim 20 is also indefinite for including two steps of -d)-.
Claims 27 and 28 are drawn to an effective amount of concentration of about 0.1 to about 10 mg/L, and 2 mg/kg of the oxidized-carbon nanoparticles of claim 1. This is indefinite because it is not what the basis for the said concentration is. That is, it is not clear what “L” in mg/L, or ‘kg” in mg/kg are referring to. The claim is further indefinite for reciting a range in mg/L and another one in mg/kg.
Remeining claims are rejected for depending on claim 1.
Claim Interpretation
Claims 23-26 and 28 are drawn to the oxidizing-carbon nanoparticles of claim 1, with the recitation of “for use….”. The said phrase is an intended use limitation and does not materially affect the scope of the claimed nanoparticles. These limitations are thus, not given examination or patentable weight.
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, 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.
Claims 1, 4-6, 9-10, 16-17 and 20-29 are rejected under 35 U.S.C. 103 as being unpatentable over Tour et al (US 20140120081) in view of CN 105832767 and CN 108310392.
Tour et al teach a therapeutic composition comprising a carbon nanomaterial with anti-oxidant activity. The said therapeutic composition comprises a carbon nanomaterial with anti-oxidant activity, said anti-oxidant activity of the carbon nanomaterial corresponds to oxygen radical absorbance capacity (ORAC) values between about 200 to about 15,000. The said carbon nanomaterials include at least one of single-walled nanotubes, double-walled nanotubes, graphene, graphene nanoribbons, graphite, graphite oxide nanoribbons, carbon black, oxidized carbon black, hydrophilic carbon clusters, and combinations thereof. The said carbon nanomaterial may be an ultra-short single-walled nanotube that is functionalized with a plurality of solubilizing groups, including a polyethylene glycol functionalized hydrophilic carbon cluster (PEG-HCC) (See abstract).
The said HCCs can include oxidized carbon nanoparticles that are about 30 nm to about 60 nm long, and approximately 1-2 nm wide (See [0059]).
The said PEG-HCCs were prepared and sterile filtered using a 0.20 μm pore size membrane (See [0130]).
It is disclosed that the said carbon nanomaterials may be modified in various ways, including being oxidized. The said carbon nanomaterials may be functionalized with one or more molecules, polymers, chemical moieties, solubilizing groups, functional groups, such as ketones, alcohols, epoxides, carboxylic acids, and combinations thereof (See [0053]).
The said carbon nanomaterials may be functionalized with a plurality of solubilizing groups including at least one of polyethylene glycols (PEGs), polypropylene glycol (PPG), poly(p-phenylene oxide) (PPOs), polyethylene imines (PEI), poly(vinyl alcohol) (PVA), poly(acrylic acid) (PAA) and combinations thereof. In particular, the carbon nanomaterials can include PEG-functionalized HCCs (i.e., PEG-HCCs) (See [0054]).
It is disclosed that the said carbon nanomaterials may also be associated with one or more transporter moieties such as amantadine, memantine, rimantadine, dopamantin, tromantadine, vildagliptin, karmantadin, and combinations thereof. The said transporter moiety may also include a cannibinoid molecule or a cannibinoid derivative, including cannabigerol, cannabigerol monomethyl ether, cannabinerolic acid A, cannabigerovarin, cannabigerolic acid A, cannabigerolic acid A monomethyl ether, cannabigerovarinic acid A, cannabichromene, cannabichromenic acid A, cannabivarichromene, cannabichromevarin, cannabichromevarinic acid A, cannabidiol, cannabidiol momomethyl ether, cannabidiol-C4, cannabidivarin, cannabidiorcol, cannabidiolic acid, cannabidivarinic acid, cannabinodiol, cannabinodivarin, cannabivarin, cannabicitran, HU-210 and combinations thereof (See [0056]-[0057]).
It is disclosed that “US-SWNTs (i.e., HCCs) may be produced by reacting SWNTs in fuming sulfuric acid with nitric acid to produce a shortened carbon nanotube characterized by opening of the nanotube ends” (See [0060]).
Tour et al teach that “PEG-HCCs were prepared as previously described and sterile filtered using a 0.20 μm pore size membrane. …. These PEG-HCCs can be loaded with hydrophobic drugs, and when mixed with an antibody, a noncovalent formulation capable of targeted drug delivery in vitro is formed” (See [0130]).
Tour et al lack a specific disclosure on the carbon nanoparticle dispersion, nanoparticle dimensions, carbonyl groups or nitric acid. These are known in the art as taught by CN ‘767 and CN ‘392.
CN ‘767 teach applications of active carbon nanoparticles or graphene in resisting an HPV virus. The particle size of the active carbon nanoparticles is 1-100 nm, the active carbon nanoparticles are dissolved by deionized water, so that a suspension is formed, the mass concentration of the active carbon nanoparticles in the suspension is smaller than or equal to 1%, and carbonyl functional groups are modified on the surfaces of the active carbon nanoparticles; the sheet thickness of grapheme is 0.5-5 nm (See abstract).
It is disclosed that carboxyl functional group is loaded on graphene oxide: compound concentration is the graphene oxide suspension of 0.1-2 mg/L, nitric acid is added in the ratio stirring that graphene oxide and nitric acid solid-to-liquid ratio are 1mg:1-10mL, ultrasonic reaction 0.5-2 hour under the conditions of 20-50˚C (See Page 3, para 13).
CN ‘392 teach a preparation method of a medical graphene oxide antibacterial agent. A graphene oxide dispersion was prepared, mixed with the reaction solution, reacted at 50-80 °C, dialyzed and freeze-dried to obtain medical graphene oxide antibacterial agent (See abstract).
Disclosed is that the dispersing graphene oxide is added into absolute ethanol to obtain a graphene oxide dispersion with a concentration of 1.2 mg/mL (See pages 3 and 4, Examples 2 and 4 and claim 1).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of CN ‘767 and CN ‘392 with that of Tour et al to arrive at the instant invention. It would have been obvious to do so because Tour et al teach oxidized carbon nanomaterials functionalized with variety of compounds including one or more molecules, polymers, chemical moieties, solubilizing groups, functional groups, particularly, PEG and one or more transporter moieties. CN ‘767 teaches active carbon nanoparticles or graphene with a particle size of 1-100 nm, with carbonyl functional groups and a thickness of grapheme is 0.5-5 nm and wherein the graphene oxide suspension has a concentration of 0.1-2 mg/L. CN ‘392 teach dispersing graphene oxide is added into absolute ethanol to obtain a graphene oxide dispersion with a concentration of 1.2 mg/mL.
In other words, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claims 1, 4-6, 9-10, 16-17 and 20-29 are rejected under 35 U.S.C. 103 as being unpatentable over Tour et al (US 20140120081) in view of CN 105832767, CN 108310392 and Bandosz (On the adsorption/oxidation of hydrogen sulfide on activated carbons at ambient temperatures).
Teachings of Tour et al, CN ‘767 and CN ‘392 are delineated above and incorporated herein.
The combined teachings lack a disclosure on the method of preparing persulfide or polysulfide from hydrogen sulfide and the oxidized carbon nanoparticles. This is known in the art as taught by Bandosz.
Bandosz teach that activated carbons of various origins (bituminous coal, wood, coconut shells, and peat) were studied as adsorbents of hydrogen sulfide. Before the experiments the surface of the adsorbents was characterized by using the sorption of nitrogen. The adsorbents were chosen to differ in their surface areas, pore volumes, and surface acidities (See abstract).
It is stated that “Based on the results it is clearly seen that the carbons studied differ in surface chemistry. Wood-based carbons have the highest number of acidic groups, and coconut-shell- and coal-based carbons have the lowest. Moreover, the latter groups of carbons have notable numbers of basic groups on the surfaces” (See Page 6, 2nd col. 2nd para).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Bandosz, CN ‘767 and CN ‘392 with that of Tour et al to arrive at the instant invention. It would have been obvious to do so because Tour et al teach oxidized carbon nanomaterials functionalized with variety of compounds including one or more molecules, polymers, chemical moieties, solubilizing groups, functional groups, particularly, PEG and one or more transporter moieties. CN ‘767 teaches active carbon nanoparticles or graphene with a particle size of 1-100 nm, with carbonyl functional groups and a thickness of grapheme is 0.5-5 nm and wherein the graphene oxide suspension has a concentration of 0.1-2 mg/L. Cn ‘392 teach dispersing graphene oxide is added into absolute ethanol to obtain a graphene oxide dispersion with a concentration of 1.2 mg/mL. Bandosz teach using activated carbons of various origins including coal, wood, coconut shells, as adsorbents of hydrogen sulfide. Thus, one of ordinary skill in the art is motivated to functionalize carbon and use the activated carbons as absorbents of hydrogen sulfide for treating patients.
In other words, the claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Response to Arguments
Applicant's arguments filed 08/07/25 have been fully considered but they are not persuasive.
Applicant’s arguments are mainly regarding the teachings of Tour reference. Applicant argues that the claimed nanoparticles are different in structure and function compared to particles disclosed in Tour reference.
Specifically, Applicant argues that “The claimed invention is directed to oxidized-carbon nanoparticles (OACs). In contrast, Tour and the other cited references appear to be directed to hydrophilic carbon clusters (HCCs), particularly (PEG-HCCs). As explained in the present application, the OAC of the claimed invention is compositionally distinct from the material discussed in Tour (PEG-HCCs). OACs are intrinsically soluble in both water and phosphate-buffered saline and require no additional solubilizing agent in the solution or covalently appended solubilizing agent such as poly(ethylene glycol) amine, whereas PEG-HCCs are HCCs conjugated to poly(ethylene glycol) amine. … .Therefore, because OACs are soluble even when free of any additional solubilizer, they are compositionally distinct from PEG-HCCs, and because they are soluble in water (see e.g., Fig. 6 in the present application) without additional stabilizer, they are functionally distinct from PEG- HCCs (see e.g., Table 1). Thus, OACs are clearly different than the PEG-HCCs of Tour” (See remarks, page 10).
The above arguments are not persuasive. Contrary to Applicant’s interpretation, Tour reference, while for most part teaching HCCs, they also disclose oxidized-carbon nanoparticles. Tour reference discloses a therapeutic composition comprising a carbon nanomaterial with anti-oxidant activity. It is stated that, -In some embodiments, the administered carbon nanomaterials include at least one of single-walled nanotubes, … ultra-short nanotubes, graphene, graphene nanoribbons, graphite, carbon black, oxidized carbon black, hydrophilic carbon clusters, and combinations thereof (See abstract, [0005], [0053] and [0059]).
It is noted tat claims and prior art are given their broadest reasonable interpretation. Also, a reference is relied upon for all that it discloses and is not limited to preferred embodiments. Thus, Tour reference discloses nanomaterial that reads on nanoparticles and that the said nanoparticles may be oxidized carbon.
Furthermore, Tour discloses that HCCs can include oxidized carbon nanoparticles. The instant claims are drawn to the nanoparticles, but there is no limitation that exclude them from being part of a cluster.
Additionally, Applicant’s arguments regarding the claimed nanoparticles being soluble without the need for a solubilizing agent is not commensurate with the scope of claims because, claim 1 is directed to nanoparticles dispersed in water wherein functionalized solubilizing agents may or may not be present. In fact, dependent claims require the presence of exogenously-supplied functionalized solubilizing agents including polyethylene glycol.
Next argument is that the claimed nanoparticles have a different geometry, i.e. particles diameter, thickness and shape (See remarks, page 10).
While Tour reference does not teach the claimed geometry of the nanoparticles, this limitation would have been known to one of ordinary skill in the art, especially in view of the teachings in the art including CN ‘767, which teach active carbon nanoparticles or graphene having a particle size of 1-100 nm and a thickness of 0.5-5 nm, meeting the claimed ranges.
The other argument is regarding the limitation of claim 1, wherein the oxidized-carbon nanoparticles pass through a 0.22 nm pore size filter. Applicant argues that “In contrast, HCCs such as in Tour remain on top of a .22 um pore size polyethersulfone (PES) filter membrane. See e.g., [0033]-[0034] in the present application. As explained in [0144], those particles that pass through a 0.22 um filter, display both antioxidant, enhancement of generation of persulfides and/or polysulfides, and electron transfer shuttling properties in solution, in cells and in vivo. This is clearly different, advantageous, and not disclosed or suggested in Tour” (See remarks, page 11).
This argument is also not found convincing. Tour reference clearly teach that the nanomaterial are “sterile filtered using a 0.20 μm pore size membrane” (See [0130] and [0214]). By stating that the preparation is filtered, one can only assume that the nanomaterials were filtered through the said pore size membrane and not remain on top, as argued.
Applicant’s next argument is that “HCCs are most likely somewhat protonated in water. Therefore, there is the possibility that more interparticle hydrogen bonds form between HCC particles than between OACs. Hydrogen bonding is most likely the cause of the aggregation …. Therefore, the structure of the particles is an important factor in distinguishing these particles from previous particles and is believed to be one aspect that makes their use nonobvious” (See remarks, page 11).
This argument has been given full consideration and is found unconvincing as well. While the statement regarding the difference between HCCs and claimed nanoparticles may be correct, the argument is not sufficient to overcome the rejection because the rejection did not contemplate that HCCs and claimed oxidized nanoparticles are the same, rather it is based on the idea that Tour reference teach the claimed oxidized nanoparticles. That is, the disclosed oxidized nanoparticles may or may not be in a cluster structure and as such the embodiments teaching such nanoparticles on their own, meet the claimed nanoparticles.
Claims 1, 4-6, 9-10, 16-17 and 20-29 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616