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 .
Election/Restrictions
Applicant’s election of SEQ ID NO:1 in the reply filed on July 28, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Claims
Claims 1-20 are currently pending and under examination on the merits in the instant application.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 6, 8, 10, and 15-16 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 6, 8, and 10 each recite “wherein the ASO-based drug or nucleic acid-based drug”. It is noted that claim 1 from which each of claims 6, 8, and 10 depends does not recite “nucleic acid-based drug”. Hence, there is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites “at least one of the sequences”. There is insufficient antecedent basis for “the sequences” in the claim. In addition, it is noted that claim 1 recites “an antisense oligonucleotide (ASO)-based drug.” That is, the ASO is a single sequence, not a plurality of “sequences”. Hence, it is unclear what is meant by “at least one of the sequences”.
Claims 15-16 each recite “which is co-administered with a non-nucleic acid based drug.” It is noted that the claims are drawn to a “composition”, whereas the aforementioned limitation is a method step. As such, it is unclear which subject matter (composition vs. method) is intended to be claimed. For examination purpose, the composition of claims 15-16 will be interpreted as a combination composition.
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.
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chang et al. (WO 2004/091634 A1).
Chang teaches making a pharmaceutical composition comprising an antisense oligonucleotide that “hybridizes to the galectin-3 mRNA and decreases expression of galectin-3”. See page 18; claim 74.
Accordingly, claim 19 is described by Chang et al.
Claims 1, 3, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Le et al. (US 2019/0054192 A1, applicant’s citation).
Le teaches making a pharmaceutical composition comprising a therapeutic antisense oligonucleotide-loaded exosomes derived from red blood cells, wherein the composition is useful for inhibiting the growth of cancer cells, thereby treating cancer, wherein the composition is formulated for “intravenous injection.” See paragraphs 0008, 0010-0011, 0023, and 0025.
Since Le’s pharmaceutical composition fully satisfies the instantly claimed structural limitations thus is structurally indistinguishable from the claimed composition, it necessarily follows that Le’s composition is inherently deemed useful “for the prevention or treatment of lung cancer”, absent objective evidence to the contrary.
“[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mkt. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). That is, “[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).
In addition, note that a “mere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable.” In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969).
Accordingly, claims 1, 3, and 11-12 are described by Le et al.
Claims 1, 3, 5, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (KR 10-2018-0005546 A; English language translation attached following the original document).
Lee teaches making a pharmaceutical composition comprising an antisense oligonucleotide-loaded exosome, wherein the exosome is derived from human embryonic kidney cell line, HEK293T, wherein the composition can be formulated for intravenous administration. See claims 1-6 and paragraph 0027 of the English language translation.
Since Lee’s pharmaceutical composition fully satisfies the instantly claimed structural limitations thus is structurally indistinguishable from the claimed composition, it necessarily follows that Lee’s composition is inherently deemed useful “for the prevention or treatment of lung cancer”, absent objective evidence to the contrary.
Accordingly, claims 1, 3, 5, and 11-12 are described by Lee et al.
Claims 1 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yao et al. (Journal of Nanobiotechnology, published online on June 5, 2021, 19:169).
Yao teaches a composition comprising human umbilical cord mesenchymal stem cell (HUMSC)-derived exosomes comprising an “antagonist” of miR-29a-3p. See page 3.
It is noted that the intended use recitation in the preamble such as “pharmaceutical” and “for the prevention or treatment of cancer” including “lung cancer” does not have patentable weight as the intended use language does not change the structure of the claimed composition.
Note that “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”. See MPEP §2111.02.
Accordingly, claims 1 and 12 are described by Yao et al.
Claims 1, 4, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han et al. (Frontiers in Molecular Biosciences, September 20, 2021, 8:743013).
Applicant cannot rely upon the certified copy of the foreign priority application (KR10-2021-0085716) to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. In addition, this application is a continuation-in-part of PCT/KR2022/009415, which is presumably in non-English language and there is no record of an English language translation of the PCT application. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Han discloses a composition comprising human umbilical cord blood mesenchymal stem-derived exosomes loaded with an antisense oligonucleotide, wherein the composition is useful for treating colorectal cancer. See pages 1-2; Figure 4.
Since Han’s composition fully satisfies the instantly claimed structural limitations thus is structurally indistinguishable from the claimed composition, it necessarily follows that Han’s composition is inherently deemed useful “for the prevention or treatment of lung cancer”, absent objective evidence to the contrary.
Accordingly, claims 1, 4, 12, and 14 are described by Han et al.
Claims 1, 3, 6, and 11-12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Boutin et al. (US 2023/0193274 A1).
Boutin discloses a pharmaceutical composition comprising an antisense oligonucleotide loaded in an exosome that is “derived from a producer cell”, wherein the composition is formulated for “intravenous injection” and can be used for treating cancer including “lung cancer (e.g., non-small lung cancer (NSCLC))”, and the antisense oligonucleotide can comprise 2’-O-methyl modifications. See paragraphs 0008, 0074, 0107, 0777, and 0780.
Accordingly, claims 1, 3, 6, and 11-12 are described by Boutin et al.
Claim Rejections - 35 USC § 103
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 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.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (WO 2004/091634 A1) in view of Lee et al. (KR 10-2018-0005546 A; English language translation attached following the original document), Kim et al. (BBRC, 2017, 493:1102-1108), Kalinski et al. (US 2010/0222409 A1), and Vickers et al. (The Journal of Biological Chemistry, 2003, 278:7108-7118).
Chang teaches making a pharmaceutical composition formulated for oral administration or intravenous injection with a pharmaceutically acceptable carrier, wherein the composition comprises an antisense oligonucleotide that “hybridizes to the galectin-3 mRNA and decreases expression of galectin-3”, wherein the antisense oligonucleotide can be modified with phosphorothioate, wherein “a galectin-3 inhibitor is sufficient to restore chemotherapeutic sensitivity” thus a combination of a galectin-3 inhibitor and chemotherapeutic agents “can be used to improve the efficacy” of the chemotherapeutic agents such as cisplatin for treatment of “lung cancer” by reducing/inhibiting the migration of cancer cells. See pages 5-6, 9, 18, and 23-34.
Chang does not teach that the pharmaceutically acceptable carrier for the galectin-3 mRNA-targeting antisense oligonucleotide is an exosome derived from human umbilical cord blood stem cells.
Lee teaches making a pharmaceutical composition comprising an antisense oligonucleotide-loaded exosome, wherein the exosome is derived from human embryonic kidney cell line, HEK293T, wherein the composition can be formulated for intravenous administration. See claims 1-6 and paragraph 0027 of the English language translation.
Kim teaches that exosomes of 50-150 nm can be obtained from human umbilical cord blood stem cells, wherein exosomes are known to enable “internalization of contents of exosomes by target cells.” See pages 1102-1106.
Kalinski teaches making a pharmaceutical composition comprising an siRNA targeting LGALS3 (galactin 3), wherein the siRNA comprises 5’-GACCCAGAUAACGCAUCAUGG (SEQ ID NO:5310) as an antisense strand sequence, which is reproduced hereinbelow by accessing http://seqdata.uspto.gov as instructed at page 23.
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It is noted that the first 20-mer of Kalinski’s SEQ ID NO:5310 is fully complementary to SEQ ID NO:1 claimed in the instant case.
Vickers teaches that siRNAs and antisense oligonucleotides targeting the same target of a target gene provide target inhibition and that “a significant concordance exists between siRNA and RNase H-dependent oligonucleotide binding sites on targeted RNAs.” See page 7113.
It would have been obvious to one of ordinary skill in the art before the effective filing date to use Lee’s HEK293T cell-derived exosome or Kim’s human umbilical cord blood stem cell-derived exosome as the pharmaceutically acceptable carrier when making Chang’s pharmaceutical composition comprising an antisense oligonucleotide targeting galectin-3 (or LGALS3). One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because an exosome was an art-recognized carrier of a payload molecule that is readily internalized by target cells as evidenced by the teachings of Lee and Kim, wherein the use of an HEK293T cell-derived exosome as a pharmaceutically acceptable carrier for an antisense oligonucleotide was expressly taught by Lee, thereby reasonably suggesting that Kim’s exosome can also be used as a pharmaceutically acceptable carrier for an antisense oligonucleotide. When designing an antisense oligonucleotide that “hybridizes to the galectin-3 mRNA and decreases expression of galectin-3” as taught by Chang, one of ordinary skill in the art would have reasonably obtained an oligonucleotide sequence hybridizing to SEQ ID NO:1 claimed in the instant case because antisense oligonucleotides and siRNA molecules hybridizing to the same target site were known to provide target inhibition as evidenced by Vickers, wherein a galectin-3 (or LGALS3)-targeting siRNA molecule hybridizing to the 20-mer of SEQ ID NO:1 was known to be useful in inhibiting galaectin-3 as taught by Kalinski, thereby providing a reasonable expectation of success that an antisense oligonucleotide hybridizing to the same target site as Kalinski’s galectin-3 (or LGALS3)-targeting siRNA molecule would also decrease expression of galectin-3, thereby inhibiting galectin-3’s function, wherein the inhibition of galectin-3 function “is sufficient to restore chemotherapeutic sensitivity” for lung cancer treatment as taught by Chang.
Accordingly, claims 1-20 taken as a whole would have been prima facie obvious before the effective filing date.
Conclusion
No claim is allowed.
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
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