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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 16, 2026 has been entered.
Election/Restrictions
To summarize the current election, the applicant elected Group I, without traverse.
The election is deemed proper and therefore made FINAL
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, 6, and 9-10 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 functionalized 2D TMD simultaneously exhibits intracellular- reactive oxygen species and nitric oxide (NO) scavenging activity.” The scope of the term “simultaneously” in the claim is unclear, given the inconsistent discussion in the disclosure of the reactions that occur between reactive oxygen species (ROS) or NO and the 2D transition metal chalcogenide (TMD). The specification in paragraph 112 states the following:
“The TMDs can be hydroxylated in aqueous solution after ROS scavenging, and the TMDs scavenge ROS in aqueous solution to produce chalcogen-vacant TMDs (XV-MX). The chalcogen-vacant TMDs (XV-MX) further scavenge ROS to produce oxidized TMDs (O-MX). In addition, TMDs react with NO to form nitrosyl-TMD complexes (ON-TMD), followed by dimerization of NO to liberate NO2 as reported in other metal-nitrosyl complexes. Then, the chalcogen-vacant TMDs react with NO2 to form oxidized TMDs (O-MX).”
This text is suggestive of the reactions of ROS and NO with the TMD starting and occurring at the same time because the same TMD material is a reactant for both reactions. Figure 22 shows the following, where MX2 is the TMD (see specification paragraph 44):
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The scheme in figure 22 does not show TMD reacting with NO, as is discussed is the specification. Instead, it shows a chalcogen vacant TMD, represented by XV-MX, reacting with NO. The XV-MX is a product of ROS reacting with TMD which indicates that that TMD does not react with NO without being first acted upon to be converted to a chalcogen vacant TMD. It additionally means that a reaction between a TMD and both NO and ROS would not start at the same time, but could occur concurrently after the ROS reaction has started. This concurrent window could be broadly viewed as a simultaneous period following an asynchronous start. It is not clear which description of the TMD scavenging reactions is correct. Further, if the scheme of figure 22 is correct and “simultaneously” requires a synchronous start, a mixture of TMD and chalcogen vacant TMD would be needed in the composition. There is no discussion of a composition that has a combination of TMD and chalcogen vacant TMD that are both polymer functionalized with the instantly required polymer. Therefore the scope of the claim is unclear in regard to the structure that corresponds to the functional limitations.
For the sake of application of prior art, the limitation “the functionalized 2D TMD simultaneously exhibits intracellular- reactive oxygen species and nitric oxide (NO) scavenging activity,” will be deemed as meet when the recited structure of the claimed product is met. Clarification is still required.
Claims not explicitly elaborated upon are also indefinite because they depend from an indefinite claim and do not add clarity.
Claim Rejections - 35 USC § 102/103
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.
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.
Claim1, 6, and 9 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yim et al. (Small 2018 14(1800026):1-10 - previously cited) as evidenced by Berger et al. (Critical Care Medicine 2007 35[Suppl.]:S584–S590).
Yim et al. disclose 2D transition metal dichalcogenide nanosheets surface functionalized and exfoliated with amphiphilic block copolymers (see abstract and page 3 first column). The block copolymer is made of a PEG block and a PCL block, while the 2D transition metal dichalcogenide is tungsten disulfide, molybdenum diselenide, or tungsten diselenide (see page 3 first column first full paragraph; instant claims 1-3 and 5). The resulting tungsten disulfide functionalized and exfoliated with PCL460-b-PEG5000 has a lateral size of 45 nm and a thickness of 4.41 nm while tungsten disulfide functionalized and exfoliated by PCL2000-b-PEG5000 has a lateral size of 60 nm and a thickness of 8.25 nm 60 nm (see page 3 first column second full paragraph; instant claims 1 and 6). Yim et al. further disclose the intracellular antioxidant properties of the functionalized 2D transition metal dichalcogenides as reactive oxygen species scavengers (see page 9 first column first column first full paragraph and figure 7a-d; instant claim 1). They envision this scavenging capability to be useful in treating or regulating inflammation and oxidative stress (see page 2 first column and page 9 first column last partial paragraph-second column first partial paragraph). Berger et al. detail the utility of antioxidants, including selenium, as treatments for sepsis (see abstract and table 1 page 586 first column).
The composition of Yim et al. has all the claimed components that are present in the claimed configuration. In addition, both Yim et al. and the instant applicant make the 2D transition metal dichalcogenide functionalized and exfoliated with an amphiphilic block copolymer via very similar methods. In both instances 40 mg of a PCL460-b-PEG5000 in solution is combined with about 2 mmol tungsten disulfide, molybdenum diselenide, or tungsten diselenide and sonicated for 1 hour with the same pulse-on/pulse-off regimen (2 mmol in Yim et al. and 2.4 mmol WS2, 2.4 mmol MoSe2, and 2 mmol WSe2 in specification paragraph 79, as calculated by the examiner). The result is centrifuged by both for 1 hour at a lower rate and an additional hour at a higher rate. The precipitate in both instances is then collected and redispersed in nearly the same volume of water and centrifuged again to obtain a supernatant with the functionalized material (see Yim et al. page S3 first paragraph and instant specification paragraph 78). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here the claim recitation “for treating sepsis or septic shock” is an intended use that does not recite or imply additional structure beyond hat already provided by Yim et al. The instant disclosure details 2D tungsten disulfide functionalized with a PCL460-b-PEG5000 as capable of treating sepsis (see specification paragraph 124). Since Yim et al. also disclose 2D tungsten disulfide functionalized with a PCL460-b-PEG5000 made via nearly the same method and have demonstrated impact as antioxidants, they would also have the sepsis/septic shock treating capability (see Berger et al.). While Yim et al. is silent in regard to inflammatory cytokine secretion and reactive nitric oxide scavenging occurring, they teach the same TMD nanosheets functionalized with the same polymer as the applicant. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Also, MPEP 2145II notes that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Thus the product of Yim et al. with its structural alignment with the instantly claimed and exemplified product is sufficient to meet the functional limitations of instant claims 1 and 9-10. Therefore claims 1, 6, and 9-10 are anticipated by or obvious over Yim et al. as evidenced by Berger et al.
Response to Arguments
Applicant's arguments filed March 16, 2026 have been fully considered, but they are not persuasive.
The applicant argues that the instant claims are novel because the prior art does not describe its product to have all the same functional capabilities as that instantly claimed. The applicant highlights the claimed function of simultaneously exhibiting intracellular reactive oxygen species and nitric oxide (NO) scavenging activity as absent from the prior art product description and argue that is not an inevitable feature. The rejection notes that the same materials combined by the applicant are combined in the prior art composition and the outcome has intracellular reactive oxygen species scavenging ability as is also shown by the applicant. The prior art also produces its composition via nearly the same procedure as the applicant, where the only differences are small variations in the amount of TMD for two of the TMD options and a slight difference in the centrifugation speed employed in the centrifugation steps. There is no indication or reason to expect that these small differences in the production procedure would eliminate the nitric oxide scavenging and inflammatory secretion inhibition activity assessed in the applicant’s example of the claimed composition.
The current claims recite the scavenging of NO and ROS as simultaneous and the applicant argues that this feature is not detailed in the prior art. As the rejection notes, the meaning and required structure for this recitation is not clear. Since the term is unclear, it also is not evident that whatever the way in which the instant composition yields simultaneous NO and ROS scavenging is absent from the prior art.
As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). The applicant has not provided any evidence or indicated why the correspondence made between the prior art product and the instant product via composition and production falls short of providing a product with the claimed functions. The applicant’s choice to assess a different suite of capabilities than Yim et al. does not make the functional capabilities of the products different from one another. The rejection does not connect that the product of Yim et al. has NO scavenging and inflammatory cytokine secretion reduction capabilities because it has ROS scavenging ability, as the applicant contends. Instead, the rejection sets forth that the product of Yim et al. is so similar to the instantly exemplified product that was demonstrated to have NO scavenging and inflammatory cytokine secretion reduction capabilities that it would also have NO scavenging and inflammatory cytokine secretion reduction capabilities. As discussed in In re Spada, the structural alignment between the product of Yim et al. and the instantly claimed and exemplified product makes the properties of the instantly claimed and exemplified product inseparable from those of the product of Yim et al.
The applicant further argues that the product of Yim et al. also does not meet the claimed intended use limitation of being for treating sepsis or septic shock. Since a product is being claimed, the prior art need only be capable of performing this function. Yim et al. establish that their polymer modified TMD is an antioxidant that scavenges ROS and envision its medical use. The instant specification details that excessive ROS production is a feature of sepsis which means it can be treated with a ROS scavenger. Thus the composition of Yim et al. is capable of treating sepsis or septic shock, regardless of whether Yim et al. describe it in this way. Berger et al. has been cited as evidence to further support this already evident point. Furthermore, the demonstration by the specification of an embodiment so similar to that of Yim et al. that treats sepsis or septic also supports the contention that Yim et al. is capable of treating sepsis or septic shock.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615