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 without traverse of Group II (claims 15-16, 19-33, and new claims 34-44) in the reply filed on May 26, 2026 is acknowledged. In addition, Applicants canceled all non-elected claims (claims 1-14 and 17-18). Thus, claims 15-16 and 19-44 are pending in this application and are under examination.
Information Disclosure Statement
The Information Disclosure Statements filed May 28, 2024; January 16, 2026; and May 26, 2026 have been considered.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The use of the terms BRIJ at page 28, line 30; page 36, lines 14 and 25; and page 38, line 29 and SOTAX at page 30, line 17 and page 34, line 12; which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 15, 19, 21, and 33 objected to because of the following informalities:
At claim 15, line 1, “CNS” should be changed to “central nervous system (CNS).”
At claim 19, line 3, “PLGA” should be changed to “poly(d, l-lactide-co-glycolide) (PLGA).”
At claim 19, line 5, “PEI” should be changed to “polyethylene imine (PEI).”
At claim 21, line 1, “SMA, ALS” should be changed to “spinal muscular atrophy (SAM), amyotrophic lateral scerlosis (ALS).”
At claim 33, line 1, “another” should be changed to “other.”
Appropriate correction is required.
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.
Claims 15-16 and 19-44 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966; Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
A written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name," of the claimed subject matter sufficient to distinguish it from other materials. Fiers v. Revel, 984 F.2d at 1171,25 USPQA2d, 1601; In re Smyth, 480 F.2d 1376,1383, 178 USPQ 279,284 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is an unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not a sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that, for a generic claim, the genus can be adequately described in the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial Structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed structure, and v. Correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art.
A "representative number of species" means that the species, which are adequately described, are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. This disclosure of only one or a few species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 115; Noelle v. Lederman, 355 F.3d, 1343, 1350, 69 USPO2d 1508, 1514 (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.").
In addition, it has been well known that minor structural differences even among structurally related compounds can result in substantially different biology, expression, and activities. Based on the instant disclosure, one of skill in the art would not know what antisense oligonucleotides would be able to be delivered to the central nervous system (CNS) for the treatment of CNS disorders. Mere idea of function is insufficient for written description.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, 1117 clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed (Vas-Cath at 1116).
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483. In Fiddes v. Baird, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
In the instant case, the claims are drawn to a method of treating a CNS disorder comprising administering a CNS delivery composition comprising a polymeric nanocarrier and an antisense oligonucleotide, which is encapsulated within the polymeric nanocarrier and directly pre-complexed with a cationic molecule. The claims do not recite any particular antisense oligonucleotides that, upon expression after delivery, provides a biological result, but recites only that the antisense oligonucleotide is encapsulated in a polymeric nanocarrier and is pre-complexed with a cationic molecule. The claims further recite that the antisense oligonucleotide can be delivered to a patient by intrathecal injection in order to treat a disease or condition. In the absence of sufficient guidance and direction to the structural and functional analysis, Applicant's reliance on the generic antisense oligonucleotide does not appear to provide sufficient written description for the genus of potential antisense oligonucleotides that are able to be delivered to the CNS of a patient, which indicates that the ordinary artisan could not predict the operability in the invention of any species other than those disclosed, which have the desired activity.
Further, the claims recite only that the CNS delivery composition encapsulates an antisense oligonucleotide that is pre-complexed with a cationic molecule, and do not claim any specific sequences or antisense oligonucleotides that can be delivered to the central nervous system of a patient in order to treat a CNS disorder.
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad genus. It is unquestionable that the claims are broad and generic, with respect to all possible antisense oligonucleotides encompassed by the claims. Given the potential antisense oligonucleotides, the possible sequences are numerous. The claims would encompass virtually limitless antisense oligonucleotides, which might, or might not, have the recited activity, or any activity. Specifically, the specification and claims lack written description because it is clear that experimentation would be required to determine whether any particular antisense oligonucleotide can be present in the CNS delivery composition and would meet the functional ability of being a functional antisense oligonucleotide for the treatment of any disease or condition. Further, the claims lack written description because there is no disclosure of a correlation between any particular antisense oligonuclotide, other than those genuses specifically disclosed in the examples in the specification (i.e., the antisense oligonucleotides of SEQ ID NOS: 1-3). Moreover, the specification lacks sufficient variety of species to reflect this variance in these genuses, especially since the specification discloses only antisense oligonucleotides having SEQ ID NO: 1, SEQ ID NO: 2, or SEQ ID NO: 3. While having a generic written description of the antisense oligonucleotides, the specification does not provide sufficient descriptive support for the myriad of potential antisense oligonucleotides embraced by the claims. Thus, it is not predictable to determine which antisense oligonucleotides will have the biological activity of being able to be delivered to a subject’s central nervous system and being able to potentially treat a CNS disease or condition upon expression and which will not is complex and well outside the realm of routine experimentation.
For example, Juliano (44(14) Nucleic Acids Research 6518-6548 (2016), and cited in the Information Disclosure Statement filed May 28, 2024) includes discussions on how to best deliver oligonucleotides to their intracellular sites of action and notes that this is a major issue (abstract) Juliano further discloses that the blood brain barrier includes tightly linked endothelial cells supported by pericytes and astrocytes and is impervious to small molecules (paragraph bridging pages 6521 and 6522 and page 6522, column 1, first full paragraph). Juliano discloses that, while there are reports purporting to deliver oligonucleotides over the blood brain barrier, such delivery could depend on whether the blood brain barrier was intact at the time of delivery (page 6522, column 1, first full paragraph). Thus, Juliano discloses that delivery of oligonucleotides to the CNS is a largely unresolved challenge (page 6522, column 1, first full paragraph).
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521,222 USPQ 369,372-372 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, it is deemed that the specification fails to provide adequate written description for the entire scope of the claim.
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 22-25 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.
At claims 22-25, lines 1-2 in each claim, it is not clear how the antisense oligonucleotide can be delivered to the CNS (claims 22-23), the cortex (claim 24), or the striatum (claim 25) of the human subject after the administration, since the antisense oligonucleotide is encapsulated in the polymeric carrier (e.g., PLGA). In addition, it is also not clear what administration takes place prior to the administration of the antisense oligonucleotide.
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.
Claim Rejections - 35 USC § 102
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.
Claims 15-16, 34-36, 38, and 40-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Juliano (44(14) Nucleic Acids Research 6518-6548 (2016), and cited in the Information Disclosure Statement filed May 28, 2024).
Regarding claims 15, 19, 28-29, and 31, Juliano discloses methods of treating the central nervous system (e.g., the brain) with a nanoparticle including a cargo molecule (therapeutic agent), a polymer, and a pharmaceutically acceptable excipient (abstract and page 6521, column 2 to page 6522). Juliano discloses that the cargo can be a nucleic acid, which can be encapsulated within the polymer (page 6529 column 2 to page 6530, column 1). Juliano discloses that the cargo molecule can be an antisense oligonucleotide (page 15, line 33 to page 16, line 5). Juliano discloses that the nanoparticle formulation includes a cationic molecule, such as PEI or a cationic peptide (page 6530, column 1, first paragraph).
Regarding claim 16, Juliano discloses that the administration can be intrathecal injection (page 6535, column 2, first full paragraph).
Regarding claims 19, 28, 29, 31, Juliano discloses methods of treating the central nervous system (e.g., the brain) with a nanoparticle including a cargo molecule (therapeutic agent), a polymer, and a pharmaceutically acceptable excipient (abstract and page 6521, column 2 to page 6522). Juliano discloses that the cargo can be a nucleic acid, which can be encapsulated within the polymer (page 6529 column 2 to page 6530, column 1). Juliano discloses that the nanocarrier can be PLGA (page 6530, column 1, first paragraph).
Juliano discloses that the cargo molecule can be an antisense oligonucleotide (page 15, line 33 to page 16, line 5). Juliano discloses that the nanoparticle formulation includes a cationic molecule, such as PEI or a cationic peptide (page 6530, column 1, first paragraph).
Regarding claims 20-21 and 34, Juliano discloses that the CNS disorder can be Huntington’s disease, Alzheimer’s disease, ALS, or Angelman syndrome (paragraph bridging page 6521 and 6522 (page 13, lines 4-21 and page 15, line 42 to page 16, line 5).
Regarding claims 26, 33, and 38, Juliano discloses that the nanoparticle formulation includes a cationic molecule, such as a cationic peptide (page 6530, column 1, first paragraph).
Regarding claims 27, 32, and 41, Juliano discloses that the PEI can be linear or cross-linked (page 6530, column 1, second paragraph)
Regarding claims 35-36, Juliano discloses that the nanocarrier can be PLGA (page 6530, column 1, first paragraph).
Regarding claim 40, Juliano discloses that the nanoparticle formulation includes a cationic molecule, such as PEI or a cationic peptide (page 6530, column 1, first paragraph).
Regarding claim 42-43, Juliano discloses that a co-delivered therapeutic agent can be an siRNA (page 6530, first paragraph).
Regarding claim 44, Juliano discloses that the antisense oligonucleotide can be a gapmer or a splice switching antisense oligonucleotide (abstract and page 6519, column 1, first full paragraph).
Juliano discloses each and every limitation of claims 15-16 and 34-44. Therefore, Juliano anticipates claims 15-16 and 34-44.
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.
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 15-16 and 19-44 are rejected under 35 U.S.C. 103 as being unpatentable over Juliano (44(14) Nucleic Acids Research 6518-6548 (2016), and cited in the Information Disclosure Statement filed May 28, 2024), as applied to claims 15-16 and 34-44 above, and in view of Zhou et al. (U.S. Patent Application Publication No. 2018/0126014, published May 10, 2018, and cited in the Information Disclosure Statement filed May 28, 2024) in view of Kilic et al. .
Regarding claims 15, 19, 28-29, and 31, Juliano discloses methods of treating the central nervous system (e.g., the brain) with a nanoparticle including a cargo molecule (therapeutic agent), a polymer, and a pharmaceutically acceptable excipient (abstract and page 6521, column 2 to page 6522). Juliano discloses that the cargo can be a nucleic acid, which can be encapsulated within the polymer (page 6529 column 2 to page 6530, column 1). Juliano discloses that the cargo molecule can be an antisense oligonucleotide (page 15, line 33 to page 16, line 5). Juliano discloses that the nanoparticle formulation includes a cationic molecule, such as PEI or a cationic peptide (page 6530, column 1, first paragraph).
Regarding claim 16, Juliano discloses that the administration can be intrathecal injection (page 6535, column 2, first full paragraph).
Regarding claims 19, 28, 29, 31, Juliano discloses methods of treating the central nervous system (e.g., the brain) with a nanoparticle including a cargo molecule (therapeutic agent), a polymer, and a pharmaceutically acceptable excipient (abstract and page 6521, column 2 to page 6522). Juliano discloses that the cargo can be a nucleic acid, which can be encapsulated within the polymer (page 6529 column 2 to page 6530, column 1). Juliano discloses that the nanocarrier can be PLGA (page 6530, column 1, first paragraph).
Juliano discloses that the cargo molecule can be an antisense oligonucleotide (page 15, line 33 to page 16, line 5). Juliano discloses that the nanoparticle formulation includes a cationic molecule, such as PEI or a cationic peptide (page 6530, column 1, first paragraph).
Regarding claims 20-21 and 34, Juliano discloses that the CNS disorder can be Huntington’s disease, Alzheimer’s disease, ALS, or Angelman syndrome (paragraph bridging page 6521 and 6522 (page 13, lines 4-21 and page 15, line 42 to page 16, line 5).
Regarding claims 26, 33, and 38, Juliano discloses that the nanoparticle formulation includes a cationic molecule, such as a cationic peptide (page 6530, column 1, first paragraph).
Regarding claims 27, 32, and 41, Juliano discloses that the PEI can be linear or cross-linked (page 6530, column 1, second paragraph)
Regarding claims 35-36, Juliano discloses that the nanocarrier can be PLGA (page 6530, column 1, first paragraph).
Regarding claim 40, Juliano discloses that the nanoparticle formulation includes a cationic molecule, such as PEI or a cationic peptide (page 6530, column 1, first paragraph).
Regarding claim 42-43, Juliano discloses that a co-delivered therapeutic agent can be an siRNA (page 6530, first paragraph).
Regarding claim 44, Juliano discloses that the antisense oligonucleotide can be a gapmer or a splice switching antisense oligonucleotide (abstract and page 6519, column 1, first full paragraph).
Juliano fails to disclose or suggest the ratio of lactic acid:glycolic acid in the PLGA. Juliano fails to disclose administration at of the antisense oligonucleotide at different times. Juliano fails to disclose or suggest that the composition is an aqueous composition. Juliano fails to disclose or suggest the location of the intrathecal injection.
Regarding claim 19, 28-29 and 31, Zhou discloses nanocarriers for active agents to target and cross the blood brain barrier (abstract). Zhou discloses that the nanocarrier can be PLGA (paragraph [0029]). Zhou discloses that the active agent can be an antisense oligonucleotide (paragraph [0151]). Zhou discloses that the composition can be an aqueous composition (paragraph [0230]).
Regarding claim 30, Zhou discloses that the administration can be to the striatum (paragraph [0310]).
Regarding claim 39, Zhou discloses the use of chitosan, which can enhance delivery (paragraph [0236]).
Regarding claims 19, 28-29, 31, and 37, Kilic discloses treatment of central nervous system diseases using antisense oligonucleotides (abstract). Kilic discloses that the composition comprises PLGA (abstract). Kilic discloses that the ratio of lactic acid: glycolic acid in the PLGA is 50:50 copolymer (page 635, first paragraph).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to formulate the composition of Juliano for the treatment of CNS diseases using the PLGA of Zhou and Kilic because, when desiring administering a composition across the blood brain barrier, using the components disclosed by each of Juliano, Zhou, and Kilic, including as an aqueous composition, because this will allow for administration directly to the brain or central nervous system, such as Zhou’s striatum. Because the blood brain barrier carries difficulties in direct administration, the use of the PLGA disclosed by Juliano, Zhou, and Kilic, in the ration of Kilic’s PLGA, allows for the intrathecal administration directly to the brain and parts thereof.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to administer the composition at various times in order to treat a CNS disease because additional administrations of the composition disclosed and suggested by Juliano, Zhao, and Kilic will provide further and continued treatments of the CNS diseases.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Karp et al. (PCT Patent Application Publication No. WO 2020/056323, published March 19, 2020, and cited in the Information Disclosure Statement filed May 28, 2024) disclose methods of treating the central nervous system (e.g., the brain) with a nanoparticle including a cargo molecule (therapeutic agent), a polymer, and a pharmaceutically acceptable excipient (abstract, page 1, lines 29-35). Karp discloses that the cargo can be an antisense oligonucleotide (page 6519, column 1, first full paragraph). Karp discloses that the oligonucleotide can be encapsulated within a PLGA nanoparticle (page 6530, column 1, first paragraph). Karp discloses that the nanoparticle formulation includes a cationic lipid (Page 6530).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636
Prosecution Insights