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 .
Status of Application/Amendment/Claims
This Office action is in response to the communications filed on August 28, 2025.
Currently, claims 1, 3-10, 12-15, 20-21, and 24-33 are pending in the instant application. Claims 3, 6-10, 21, 24, and 26 are withdrawn from further consideration as being drawn to nonelected inventions/species. It is noted that applicant elected an invention drawn to a nanoligomer comprising a polynucleotide binding domain hybridizing with NLRP3 and a transcription activation domain hybridizing to TATA box-containing promoter with species election of 30 in the reply filed on May 15, 2024. Accordingly, claims 1, 4-5, 12-15, 20, 25, and 27-33 are under examination on the merits in the instant application.
The following rejections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Terminal Disclaimer
The terminal disclaimer filed on August 28, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Application No. 18/137,101 has been reviewed and is accepted. The terminal disclaimer has been recorded.
New Objections/Rejections Necessitated by Amendment
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 63/335,485, 63/344,152, 63/390,909, and 63/409,294, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The aforementioned provisional applications are completely silent regarding SEQ ID NO:3 as well as “SB NI 112” recited in the amended claims. Accordingly, claims 1, 4-5, 12-15, 20, 25, and 27-33 are not entitled to the provisional filing date. The effective filing date for claims 1, 4-5, 12-15, 20, 25, and 27-33 will be the filing date (August 20, 2023) of Application No. 18/137,101.
Claim Objections
Claim 28 is objected to because of the following informalities: “wherein acidic” in line 1 should be “wherein the acidic”. Appropriate correction is required.
Claim 32 is objected to because of the following informalities: “wherein a neurodegenerative” in line 1 should be “wherein the neurodegenerative”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4-5, 12-15, 20, 25, and 27-33 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.
Claims 1, 4-5, 12-15, 20, 25, and 27-33 are now amended to recite “SB NI 112 nanoligomer”. The term/name “SB NI 112” is not defined in the claims or in the specification. It is noted that the specification at best discloses “SB_NI_112”, wherein the term/name is used to describe at least 4 different structures disclosed in Table 1. That is, even if the claims were to recite “SB_NI_112”, the term/name fails to particularly point out which of the four structures disclosed in Table 1 is intended to be claimed. In addition, it is unclear how the term/name in the preamble defines the structure of the instant claims. Most importantly, claim 1, for instance does not comprise all of the structural elements constituting any one of the four structures in Table 1, wherein all four structures require “AEEA” (SEQ ID NO:17), “HHHHH” (SEQ ID NO:18), “Au22”, and “Glutathione 18”. Hence, it is unclear what purpose the mere term/name “SB NI 112” or “SB_NI_112” serves to define the claimed subject matter.
For examination purpose, the newly added term/name in the preamble will not be taken into consideration.
Claims 1, 4-5, 12-15, 20, 25, and 27-33 are now amended to recite “a targeting sequence” comprising SEQ ID NO:3 is capable of hybridizing with SEQ ID NO:5.
It is noted that the nucleotide sequence of SEQ ID NO:3 is 5’-CGGGTGCTTGCCATCTT.
It is also noted that the nucleotide sequence of SEQ ID NO:5 is 5’-CGGGTGCTTGCCATCTT.
As such, SEQ ID NO:3 and SEQ ID NO:5 are 100% identical to each other, which therefore means that SEQ ID NO:3 is incapable of hybridizing with SEQ ID NO:5.
In fact, SEQ ID NO:3 is not complementary to any one of SEQ ID NOs:6 and 8-9 thus is incapable of hybridizing with any one of SEQ ID NOs:6 and 8-9.
Hence, the instant claims recite structurally and functionally conflicting, impossible limitations regarding the targeting sequence of the claimed “SB NI 112 nanoligomer”, thereby rendering the claims indefinite.
Claim 1 recites “the neuroinflammatory protein includes NLRP3”. The term “includes” means that the protein is not necessarily limited to NLRP3. As such, it is unclear how a single sequence of SEQ ID NO:3 can possibly target multiple neuroinflammatory proteins including NLRP3.
Claim 27 recites “further comprising an embodiment for oral or intraperitoneal (IP) administration.” It is unclear what is intended and claimed by this limitation as it is incomprehensible. In particular, it is unclear what is meant by “an embodiment”.
Claim 28 recites “comprises at least 3 amino acids in length including at least 40% - 50% acidic amino acids.” It is noted that 40-50% of a 3-amino acid long peptide amounts to about 1.5 amino acids, wherein a half of an amino acid residue cannot exist. For examination purpose, “at least 40% - 50%” will be interpreted as at least 2 acidic amino acids.
Claim 29 recites “one or more transition metals comprising groups 3 – 12 transition metals on a period table of elements.” This entire limitation is grammatically incorrect and incomprehensible.
Claim 29 recites the limitation "one or more transition metals" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites “a period table”. This limitation is incomprehensible as such term is not recognized in the relevant art.
Claim 30 recites “an Au 22 nanoparticle capped with 18-glutathione molecules”. It is unclear what is meant by “capped”. Note that this term is not even disclosed or defined in the instant specification. As such, it is impossible to clearly determine the metes and bounds of the aforementioned limitation.
Claim 30 recites “configured to maintain spacing”. It is unclear whether “SEQ ID NO: 17” is the structure that provides the recited function “to maintain spacing” or whether other structures are required in order to be “configured” to provide the recited function. For examination purpose, the expressly recited single structure, SEQ ID NO:17, will be interpreted as being the structure that is meant to “maintain spacing”.
Claim 30 recites “peptide nucleic acid (PNA) segments of the polynucleotide binding domain”. It is unclear which of the 17-mer sequence of SEQ ID NO:3 should be the “PNA” segments.
Claim 30 recites the limitation "PNA segment" in in line 9. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether the aforementioned limitation is same as or different from the PNA “segments” recited in line 5.
Claim 30 recites “thereby binding all components together”. It is unclear exactly what is referred to by “all components” as the word “component” or “components” are not recited preceding the aforementioned limitation.
Claims 31-32 recite “configured to decrease microglial and astrocytic inflammation”. However, there is no structural limitation pertaining to the recited function. That is, claims 31-32 fail to particularly point out and distinctly claim what structures of the composition of claim 13 should be required in order to be “configured” to provide the recited function.
Claim 32 recites “(Crohn’s and Colitis)”. It is unclear whether the parenthetical recitation is a required claim limitation or is merely exemplary thus not required.
Claim 33 recites that the exterior of the nanoligomer of claim 1 “is primarily neutral in charge.” It is noted that claim 1 does not recite any structural limitations pertaining to the “exterior” of the nanoligomer. In fact, the term “exterior” is not even recited in claim 1, which does not even differentiate between the “exterior” and interior of the nanoligomer. As such, it is unclear which structural limitations are required to satisfy the “primarily neutral in charge” for the “exterior of the nanoligomer”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 15, and 33 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zhang et al. (US 2022/0354963 A1).
Note that the preamble “SB NI 112” or “SB_NI_112” and the limitation pertaining to SEQ ID NO:3 being capable hybridizing with one of SEQ ID NOs:5-6 and 8-9 are not taken into consideration in view of the §112(b) issues set forth above.
Note that this rejection will be maintained under 35 U.S.C. 102(a)(2) even if applicant perfects the priority benefit to any one of the provisional application filing dates.
Zhang teaches making a nanovesicle covalently linked to an antisense oligonucleotide of SEQ ID NO:104 (5’-GCGGGTGCTTGCCATCTTCA) targeting human NLRP3, wherein Zhang’s SEQ ID NO:104 comprises the entire 17-mer sequence of SEQ ID NO:3 claimed in the instant case. See the underlined sequence. See paragraphs 0113, 0431, 0437-0440; Figure 1A.
Since all structural limitations recited in the claims are fully satisfied by Zhang’s nanovesicle covalently linked to SEQ ID NO:104, it necessarily follows that Zhang’s product inherently possesses the physical properties of claims 15 and 33, absent objective evidence to the contrary.
Note that “[f]rom the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (CCPA 1963).
Accordingly, claims 1, 15, and 33 are described by Zhang et al.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 12-15, 20, and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Saltzman et al. (US 2021/0206879 A1) in view of Zhang et al. (US 2022/0354963 A1).
Note that the preamble “SB NI 112” or “SB_NI_112” and the limitation pertaining to SEQ ID NO:3 being capable hybridizing with one of SEQ ID NOs:5-6 and 8-9 are not taken into consideration in view of the §112(b) issues set forth above.
Saltzman teaches making a composition comprising a gold nanoparticle of “1 nm” or “5 nm” conjugated with “NLRP3 inhibitor” for immunosuppression, wherein target inhibitors can be an antisense molecule. See paragraphs 0014, 0155-0158, 0242, and 0296.
Saltzman does not teach that the antisense molecule that functions as the NLRP3 inhibitor comprises SEQ ID NO:3 claimed in the instant case.
Zhang discloses an antisense oligonucleotide of SEQ ID NO:104 (5’-GCGGGTGCTTGCCATCTTCA) targeting human NLRP3, wherein Zhang’s SEQ ID NO:104 comprises the entire 17-mer sequence of SEQ ID NO:3 claimed in the instant case. See the underlined sequence. See Figure 1A.
It would have been obvious to one of ordinary skill in the art before the effective filing date to use Zhang’s SEQ ID NO:104 for the “NLRP3 inhibitor” conjugated to the gold nanoparticle of Saltzman. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because one of ordinary skill in the art would have readily recognized that Zhang’s SEQ ID NO:104 qualifies as the “NLRP3 inhibitor” that is an “antisense molecule” that is conjugated to a gold nanoparticle of 1 nm or 5 nm.
Since the composition comprising the gold nanoparticle conjugated with the human NLRP3-targeting antisense oligonucleotide of Zhang’ SEQ ID NO:104 fully satisfies all structural limitations set forth in the rejected claims, it necessarily follows that the composition rendered obvious in the instant rejection would inherently possess all of the properties recited in the rejected claims, absent objective evidence to the contrary.
Note that the Office does not have the facilities and resources to provide the factual evidence needed in order to determine and/or compare the specific activities of the instantly claimed composition to the composition rendered obvious in the instant rejection. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed composition is different from the one rendered obvious in the instant rejection, thereby establishing patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ2d 1922(PTO Bd.Pat. App. & Int. 1989).
In view of the foregoing, claims 1, 12-15, 20, and 31-33 taken as a whole would have been prima facie obvious before the effective filing date.
Response to Arguments/Declaration
Applicant's arguments pertaining to the previous §103 rejection filed on August 28, 2025 have been fully considered but they are moot because they do not pertain to the new ground of rejection set forth hereinabove.
It is noted that applicant submitted a §1.132 declaration on August 28, 2025, wherein the declaration appears to have been submitted in response to the previous §103 rejection as evidenced by paragraph 4 stating “the §103 rejection”. As noted above, the instant ground of rejection under §103 is different from the previous ground of §103 rejection. However, for completeness of the record, the examiner will address the declaration.
The declaration under 37 CFR 1.132 filed on August 28, 2025 is insufficient to establish nonobviousness of the amended claims as filed on August 28, 2025 for the following reasons:
The declarant, the sole inventor of this application, states that there are “several points of distinction that demonstrate why my claimed composition is not obvious.” See paragraph 4. The declarant in particular states that the claimed composition provides “results and advantages that would not have been expected” by pointing out 14 references, most of which are post-filing. As an initial matter, it is noted that none of the references cited in the declaration have been cited in the IDS of record, nor has applicant provided a legible copy of each reference for examiner’s full consideration of each of the cited references. Hence, the examiner will solely rely on the reproduced Figures pasted in the declaration.
It appears that none of the Figures in the declaration shows a composition comprising SEQ ID NO:3. Further, it remains unknown whether the compositions in the Figures, which appear to be called “SB_NI_112” and “NI112”, fully satisfy all structural limitations of the claims rejected in the instant §103 rejection. In fact, it appears that “NI112” is intended to target only NF-kB as evidenced by the Figure legend at page 23 of the declaration. Hence, the data included in the declaration do not pertain to the instantly claimed subject matter requiring SEQ ID NO:3 hybridizing with the NLRP3 sequence.
In paragraph 5, the declarant states that the “SB_NI_112” molecule with “specific design” “is the only brain-penetrant molecule” unlike the cited references of record. In response, it is noted that the rejected claims, claims 1, 12-15, 20, and 31-33, in the instant §103 rejection do not appear to have the alleged “specific design”, which appears to pertain to the structure disclosed in Table 1 of the instant application. In addition, the “brain-penetrant” limitation is not claimed or required by the rejected claims, except claims 13 and 31-32, wherein the “brain penetrating” property is deemed inherent to the structural limitations set forth in the claims as explained in the rejection above.
Note that the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” See MPEP §716.02. Further, unexpected results must also be “commensurate in scope with the degree of protection sought by the claimed subject matter.” In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005).
Accordingly, the §1.132 declaration filed on August 28, 2025 is not found sufficient to support the asserted nonobviousness of claims 1, 12-15, 20, and 31-33 rejected in the instant rejection.
Conclusion
No claim is allowed.
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 DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635