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 .
Claim Status
Claims 1-19 have been considered on their merits.
Claim Objections
Claims 1 and 3-4 objected to because of the following informalities: The term “RNA Booster” should not be presented in italics. 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 1-19 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 claims are drawn to a method of treating skin and/or skin appendages in a subject in need thereof, comprising administering to the subject a ribonucleic acid (RNA) molecule comprising, from 5' to 3': an RNA Booster sequence comprising or consisting of the following ribonucleic acid sequence: mmsknkkkm, wherein: "m" indicates an adenine (a) or cytosine (c); "s" indicates a guanine (g) or a cytosine (c); "k" indicates a guanine (g) or a uracyl (u); "n" indicates any nucleotide; and a sequence of interest (claim 1). Accordingly, the claims encompass using and “RNA Booster” sequence which meets the broad structural limitations of the mmsknkkkm sequence which is narrowed slightly by the ribonucleic acid sequences of claim 3. Additionally, the claims disclose the RNA booster sequence “comprises” a ribonucleic acid sequence as claimed. Due to the use of transitional phrase having the open-ended language, the scope of the claimed RNA booster is not limited to 9-mer. Thus, any RNA molecule regardless of its size would be considered as RNA boosters at least if those 9-mers is present in the sequence. Simply assembling an RNA molecule comprising a 9-mer sequence as well as a sequence of interest would not necessarily have any function following administration. The specification fails to provide any other RNA booster having the size other than 9-mer, and thus, the specification fails to provide sufficient written description for the claimed RNA booster comprising the sequence of the 9-mer as claimed.
Claim 12 lists five optional components of the RNA molecule, it is not clear if only including the 5’ ITR, as an example, the RNA booster sequence and the sequence of interest would result in a treatment of a skin and/or skin appendage in a subject in need thereof. It is not clear what other components would be required which would result in a successful skin treatment.
The application discloses nine specific RNA Booster sequences, identified as RNA Booster 1, RNA Booster 2, RNA Booster 3, RNA Booster 4, RNA Booster 5, RNA Booster 6, RNA Booster 7, RNA Booster 8, and RNA Booster 9 (claim 4). The specification at paragraph [0243] and Figure 5, provides evidence of enhanced proliferation of Human hair follicle dermal papilla cells by contacting and transducing the cells with an RNA vector derived from lentivirus (with a mutated D110E reverse transcriptase) expressing FGF9 with RNA Booster 8. After transduction, the cells were treated with 300 nM of cortisol (which has a negative effect on proliferation). A control with or without VEGP (which inhibits the cortisol effect) was performed. Cell proliferation was measured through BrdU (5-bromo-2’-deoxyuridine) incorporation. However, there is no evidence that any other sequence which meets the structural limitations of the broad claims would provide a therapeutic treatment when combined with a sequence of interest. The limited disclosure of nine specific oligonucleotide sequences which improve transgene expression does not adequately describe the entire genus of sequences encompassed by the claims because it is unclear which other sequences which meet the structural limitations of the claims would have RNA Booster function and which ones would not. That is, the claims encompass a genus of oligonucleotide sequences identified as RNA Booster sequences, but only provides evidence of one specific oligonucleotide which have RNA Booster activity and further experimentation would be required in order to determine which other oligonucleotide sequences which meet the structural limitations of the claims would be functional.
“Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, 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.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
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, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is 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 sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163.
The court and the Board have repeatedly held (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,18 USPQ2d 1016 (CA FC, 1991); Fiers v. Revel, 25 USPQ2d 1601 (CA FC 1993); Fiddes v. Baird, 30 USPQ2d 1481 (BPAI 1993) and Regents of the Univ. Calif. v. Eli Lilly & Co., 43 USPQ2d 1398 (CA FC, 1997)) that an adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it, irrespective of the complexity or simplicity of the method; what is required is a description of the nucleic acid itself.
The specification provides evidence for nine specific oligonucleotide sequences which have RNA Booster activity (Fig. 1), but further experimentation would be required to identify the other oligonucleotide sequences which meet the structural limitations of the claims that have RNA Booster activity. Without the additional experimentation, one of skill in the art would not be able to distinguish the functional sequences of the recited structural genus from the non-functional members. Thus, one of skill at the time of the invention could not have concluded that Applicant was in possession of the entire genus of RNA Booster sequences encompassed by the claims and that are required to practice the claimed method.
It is noted that limiting the claims to any of the nine specific RNA Booster sequences identified as RNA Booster 1, RNA Booster 2, RNA Booster 3, RNA Booster 4, RNA Booster 5, RNA Booster 6, RNA Booster 7, RNA Booster 8, and RNA Booster 9 (such as indicated in claim 3), would obviate this rejection.
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 1-19 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.
The term “RNA Booster” in claims 1 and 3-4 are used by the claim, however, the term’s meaning is not particularly defined in the specification and the prior art does not define the term. The specification merely discloses that an artificial 9-nucleotide sequence was named as “RNA booster”. The language of a claim must make it clear what subject matter the claim encompasses to adequately delineate its "metes and bounds". See, e.g., the following decisions: In re Hammack, 427 F 2d. 1378, 1382, 166 USPQ 204, 208 (CCPA 1970); In re Venezia 530 F 2d. 956, 958, 189 USPQ 149, 151 (CCPA 1976); In re Goffe, 526 F 2d. 1393, 1397, 188 USPQ 131, 135 (CCPA 1975); In re Watson, 517 F 2d. 465, 477, 186 USPQ 11, 20 (CCPA 1975); In re Knowlton 481 F 2d. 1357, 1366, 178 USPQ 486, 492 (CCPA 1973). Furthermore, it is not clear what is boosted by the “RNA booster”. Applicant is advised to delete “Booster” from “RNA Booster sequence”. The term is indefinite because the specification does not clearly define the term.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2 and 5-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation.
The claim(s) recite(s) a method of treating skin or skin appendage in any subject in need thereof comprising administering to the subject an RNA molecule comprising an RNA Booster sequence and any sequence of interest. This judicial exception is not integrated into a practical application because the method of treating a subject, which is considered administering a natural product and the RNA molecule is a nature-based product. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
In regard to Step 1, the claimed invention is directed to a statutory class of invention, i.e., a process of nature.
In regard to Step 2A, prong one, instant claims are directed a method of treating skin or skin appendage in any subject in need thereof comprising administering to the subject an RNA molecule comprising an RNA Booster sequence and any sequence of interest. As evidenced by Bentwich (GenBank: AY882337.1, 2007). Specifically, Bentwich discloses a human microRNA HIV-MIR-RG-1 which is 100% identical to the disclosed sequence formula in claim 1. The sequence is disclosed in sequence search results file: 20250520_153515_us-17-818-493-seq1.max100.rge, result 433, see alignment below:
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The limitation “RNA Booster” is undefined by the specification and the prior art, the term is interpreted as a gene regulating element. The sequence is described as part of a novel HIV microRNA sequence, gctaactagg gaacccac. MicroRNAs (miRNAs) are short, non-coding RNA molecules, which play a crucial role in regulating gene expression and would be found in the genome. Therefore, the miRNA disclosed by Bentwich reads on the RNA Booster sequence formula of claim 1, absent evidence to the contrary. The sequence of interest required by claim 1 is extremely broad to encompass any sequence of any length, which includes the ACCCAC sequence following the disclosed sequence AACTAGGGA corresponding to the alignment above.
The claimed RNA molecule has no different functional characteristics, i.e., the sequence of Bentwich comprises the sequence of the claim, which is found in the HIV virus, thus a natural gene. Additionally, the HIV virus is known to naturally infect humans which would necessarily result in an immune response. The resulting immune response would be considered to fall under the scope of a method of treating, as this is broadly claimed in instant claim 1. Accordingly, the claim is directed to an exception (Step 2A, prong one: YES).
In regard to Step 2A, prong two, instant claims are directed to said RNA molecule in a recombinant vector. With respect to Step 2A, prong two, limitations that may be enough to qualify as additional elements that integrate the judicial exception into a practical application include:
Improvements to another technology or technical field.
Improvements to the functioning of the computer itself.
Applying the judicial exception with, or by use of, a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application.
Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
With respect to Step 2A, prong two, limitations that were found not to be enough to qualify as additional elements that integrate the judicial exception into a practical application include:
Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer
Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well understood, routine and conventional activities previously known to the industry
Adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea
Generally linking the use of the judicial exception to a particular technological environment or field of use.
In regard to Step 2A, prong two, instant claims do not recite additional elements or a combination of elements in the claims other than the natural product itself. Specifically, claims 1 and 13-14, recite additional nature-based elements. Claims 6-12 recite vector elements, placing nucleic acids in a “vector” is claimed with such a high degree of generality it encompasses expression systems of a natural host cell.
Finally, in regard to Step 2B, does the claim recite additional elements that amount to significantly more than the judicial exception. In instant case, claim 2 recites numerous maladies to be treated with the RNA molecule which could be addressed by a nature based product, such as treating skin with collagen; claim 5 broadly recites a non-viral vector which could comprise nature-based products; claims 6-10 recite species of RNA virus vectors, to include HIV which the sequence in question is comprised in the HIV genome; claim 11 recites a RT-defective Group IV RNA virus vector which are not nature-based products, however, these vectors were well-understood, routine and conventional in the art at the time of the invention. Claims 15-19 recite intended uses of said RNA molecule, therefore, do not add significantly more than the judicial exception. Viewed as a whole, these additional claim elements do not provide meaningful limitations to transform the natural product into a patent eligible composition. Nevertheless, claims 3-4 recite species of sequences which appear to not be nature-based products of instant Application are NOT rejected because it adds significantly more to the RNA molecule by including sequences not identified as nature-based products and combining a specific non-naturally occurring structural element.
Therefore, claims 1-2, 5-19 add no additional elements that integrate the judicial exception into a practical application than the “process of nature” itself. Thus, instant claims do not amount to significantly more than the judicial exception itself and do not qualify as patent eligible subject matter under 35 U.S.C. § 101.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bentwich, (GenBank: AY882337.1, 2007) as evidenced by Economou et al. (Atherosclerosis 241, published 2015).
Bentwich discloses a human microRNA HIV-MIR-RG-1, disclosed in sequence search results file: 20250520_153515_us-17-818-493-seq1.max100.rge, result 433, see alignment below:
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The limitation “RNA Booster” is undefined by the specification and the prior art, the term is interpreted as a gene regulating element. The sequence is described as part of a novel HIV microRNA sequence, gctaactagg gaacccac. MicroRNAs (miRNAs) are short, non-coding RNA molecules, which play a crucial role in regulating gene expression (Economou et al., Abstract). Therefore, the miRNA disclosed by Bentwich reads on the RNA Booster sequence formula of claim 1, absent evidence to the contrary. The sequence of interest required by claim 1 is extremely broad to encompass any sequence of any length, which includes the ACCCAC sequence following the disclosed sequence AACTAGGGA corresponding to the alignment above.
Thus, the reference anticipates the subject matter of claim 1.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19/102,165 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending claims anticipate the instant claims.
Claims 1-8 are clearly anticipated by copending claims 1-8.
Claim 9 is anticipated by copending claim 7.
Claim 10 is anticipated by copending claim 8.
Claim 11 is anticipated by copending claim 9.
Claim 12 is anticipated by copending claim 10.
Claim 13 is anticipated by copending claim 11.
Claim 14 is anticipated by copending claim 12.
Claims 15 and 16 are anticipated by copending claim 12.
Claims 17 and 18 are anticipated by copending claim 13.
Claim 19 is anticipated by copending claim 14.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 19/102,219 in view of Sarkis et al. (WO 2013/060819, IDS ref.).
Although the claims at issue are not identical, they are not patentably distinct from each
other because the patented claims render obvious the instant claims.
Regarding claims 1-2 and 15-16, copending claim 1 recites a ribonucleic acid (RNA) molecule comprising: an RNA Booster sequence comprising or consisting of the ribonucleic acid sequence mmsknkkkm, wherein: "m" indicates an adenine (a) or cytosine (c); "s" indicates a guanine (g) or a cytosine (c); "k" indicates a guanine (g) or a uracyl (u); "n" indicates any nucleotide; and a sequence of interest. Copending claim 1 is silent to a method of treating skin and/or skin appendages in a subject in need thereof, comprising administering to the subject the above-named RNA molecule.
However, the copending specification discloses uses and applications of the RNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition, for use in skin and/or skin appendages (such as hair, nails or skin glands) treatment; or a method of treating skin and/or skin appendages (such as hair, nails or skin glands) in a subject in need thereof against, comprising administering to the subject in need thereof the RNA molecule or DNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition (para. [0192]). The copending specification discloses examples of treatments of skin and/or skin appendages, in particular of non-therapeutic treatments, include for instance any or several of induction of hair growth, prevention of hair loss, induction of hair removal, hair coloring or bleaching, prevention of hair graying, promotion of hair thickening, promotion of or prevention of hair curling, promotion of skin healing, promotion of skin repairing, promoting skin appearance, prevention of wrinkle formation, improvement of skin elasticity, induction of skin tone homogenization, and reduction of sebum secretion (para. [0196]) (claims 15-16). Therefore, the copending claims in light of the copending specification teach the limitations of instant claims 1 and 2. The MPEP states “…the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”.
Additionally, Sarkis et al. teach reverse transcriptase deficient vector capable of transient expression of an RNA sequence of interest in a cell (Abstract). Sarkis et al. teach a method wherein conventional techniques of chemistry, molecular biology, microbiology, recombinant DNA technology, chemical methods, pharmaceutical formulations and delivery and treatment of patients (p. 8, lines 7-9). Therefore, it would have been obvious to one of ordinary skill in the art to use the vector of Sarkis et al. with the RNA molecule of the copending application to treat skin in a subject in need thereof with a reasonable expectation of success because Sarkis et al. teach such vectors, using conventional techniques are suitable for the treatment of patients.
Copending claim 2 disclose all of the limitation of instant claims 3 and 4.
Copending claim 3 disclose all of the limitations of instant claim 5.
Copending claim 4 disclose all of the limitations of instant claims 6 and 7.
Copending claim 6 disclose all of the limitations of instant claim 8.
Copending claim 5 disclose all of the limitations of instant claims 9 and 10.
Copending claim 7 disclose all of the limitations of instant claim 11.
Copending claim 8 disclose all of the limitations of instant claim 12.
Regarding claims 13-14, the copending specification discloses in some embodiments, the sequence of interest is FGF9 (para. [0099]) (claims 13 and 14).
Regarding claims 17 and 18, the copending specification discloses, in some embodiments, the RNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition, is to be administered topically, in particular cutaneously or transdermally (para. [0202]) (claims 17 and 18).
Regarding claim 19, the copending specification discloses, in some embodiments, the RNA molecule or DNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition, is to be administered topically after collagen induction therapy (CIT) (para. [0203]) (claim 19).
This is a provisional nonstatutory double patenting rejection.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19/102,140 in view of Sarkis et al. (WO 2013/060819, IDS ref.).
Although the claims at issue are not identical, they are not patentably distinct from each
other because the patented claims render obvious the instant claims.
Regarding claims 1-2 and 15-16, copending claim 1 recites a ribonucleic acid (RNA) molecule comprising: an RNA Booster sequence comprising or consisting of the ribonucleic acid sequence mmsknkkkm, wherein: "m" indicates an adenine (a) or cytosine (c); "s" indicates a guanine (g) or a cytosine (c); "k" indicates a guanine (g) or a uracyl (u); "n" indicates any nucleotide; and a sequence of interest. Copending claim 1 is silent to a method of treating skin and/or skin appendages in a subject in need thereof, comprising administering to the subject the above-named RNA molecule.
However, the copending specification discloses uses and applications of the RNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition, for use in skin and/or skin appendages (such as hair, nails or skin glands) treatment; or a method of treating skin and/or skin appendages (such as hair, nails or skin glands) in a subject in need thereof against, comprising administering to the subject in need thereof the RNA molecule or DNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition (para. [0189]). The copending specification discloses examples of treatments of skin and/or skin appendages, in particular of non-therapeutic treatments, include for instance any or several of induction of hair growth, prevention of hair loss, induction of hair removal, hair coloring or bleaching, prevention of hair graying, promotion of hair thickening, promotion of or prevention of hair curling, promotion of skin healing, promotion of skin repairing, promoting skin appearance, prevention of wrinkle formation, improvement of skin elasticity, induction of skin tone homogenization, and reduction of sebum secretion (para. [0193]) (claims 15-16). Therefore, the copending claims in light of the copending specification teach the limitations of instant claims 1 and 2. The MPEP states “…the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”.
Additionally, Sarkis et al. teach reverse transcriptase deficient vector capable of transient expression of an RNA sequence of interest in a cell (Abstract). Sarkis et al. teach a method wherein conventional techniques of chemistry, molecular biology, microbiology, recombinant DNA technology, chemical methods, pharmaceutical formulations and delivery and treatment of patients (p. 8, lines 7-9). Therefore, it would have been obvious to one of ordinary skill in the art to use the vector of Sarkis et al. with the RNA molecule of the copending application to treat skin in a subject in need thereof with a reasonable expectation of success because Sarkis et al. teach such vectors, using conventional techniques are suitable for the treatment of patients.
Copending claim 2 disclose all of the limitation of instant claim 3.
Copending claim 3 disclose all of the limitation of instant claim 4.
Copending claim 4 disclose all of the limitation of instant claim 5.
Copending claim 5 disclose all of the limitations of instant claims 6 and 7.
Copending claim 7 disclose all of the limitations of instant claim 8.
Copending claim 6 disclose all of the limitations of instant claims 9 and 10.
Copending claim 8 disclose all of the limitations of instant claim 11.
Copending claim 9 disclose all of the limitations of instant claim 12.
Regarding claims 13-14, the copending specification discloses inducing hair growth and/or promoting skin healing can be achieved using the RNA molecule, in particular the retroviral vector, of the invention, in particular wherein the sequence of interest encodes the glia-activating factor (aka FGF9) (para. [0195]) (claims 13 and 14).
Regarding claims 17 and 18, the copending specification discloses, in some embodiments, the RNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition, is to be administered topically, in particular cutaneously or transdermally (para. [0199]) (claims 17 and 18).
Regarding claim 19, the copending specification discloses, in some embodiments, the RNA molecule or DNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition, is to be administered topically after collagen induction therapy (CIT) (para. [0200]) (claim 19).
This is a provisional nonstatutory double patenting rejection.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/102,177 in view of Sarkis et al. (WO 2013/060819, IDS ref.).
Although the claims at issue are not identical, they are not patentably distinct from each
other because the patented claims render obvious the instant claims.
Regarding claims 1-2 and 15-16, copending claim 1 recites a ribonucleic acid (RNA) molecule comprising: an RNA Booster sequence comprising or consisting of the ribonucleic acid sequence mmsknkkkm, wherein: "m" indicates an adenine (a) or cytosine (c); "s" indicates a guanine (g) or a cytosine (c); "k" indicates a guanine (g) or a uracyl (u); "n" indicates any nucleotide; and a sequence of interest. Copending claim 1 is silent to a method of treating skin and/or skin appendages in a subject in need thereof, comprising administering to the subject the above-named RNA molecule.
However, the copending specification discloses uses and applications of the RNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition, for use in skin and/or skin appendages (such as hair, nails or skin glands) treatment; or a method of treating skin and/or skin appendages (such as hair, nails or skin glands) in a subject in need thereof against, comprising administering to the subject in need thereof the RNA molecule or DNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition (para. [0190]). The copending specification discloses examples of treatments of skin and/or skin appendages, in particular of non-therapeutic treatments, include for instance any or several of induction of hair growth, prevention of hair loss, induction of hair removal, hair coloring or bleaching, prevention of hair graying, promotion of hair thickening, promotion of or prevention of hair curling, promotion of skin healing, promotion of skin repairing, promoting skin appearance, prevention of wrinkle formation, improvement of skin elasticity, induction of skin tone homogenization, and reduction of sebum secretion (para. [0194]) (claims 15-16). Therefore, the copending claims in light of the copending specification teach the limitations of instant claims 1 and 2. The MPEP states “…the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”.
Additionally, Sarkis et al. teach reverse transcriptase deficient vector capable of transient expression of an RNA sequence of interest in a cell (Abstract). Sarkis et al. teach a method wherein conventional techniques of chemistry, molecular biology, microbiology, recombinant DNA technology, chemical methods, pharmaceutical formulations and delivery and treatment of patients (p. 8, lines 7-9). Therefore, it would have been obvious to one of ordinary skill in the art to use the vector of Sarkis et al. with the RNA molecule of the copending application to treat skin in a subject in need thereof with a reasonable expectation of success because Sarkis et al. teach such vectors, using conventional techniques are suitable for the treatment of patients.
Copending claim 2 disclose all of the limitation of instant claim 3.
Copending claim 3 disclose all of the limitation of instant claim 4.
Copending claim 4 disclose all of the limitation of instant claim 5.
Copending claim 5 disclose all of the limitations of instant claims 6 and 7.
Copending claim 7 disclose all of the limitations of instant claim 8.
Copending claim 6 disclose all of the limitations of instant claims 9 and 10.
Copending claim 8 disclose all of the limitations of instant claim 11.
Copending claim 9 disclose all of the limitations of instant claim 12.
Regarding claims 13-14, the copending specification discloses inducing hair growth and/or promoting skin healing can be achieved using the RNA molecule, in particular the retroviral vector, of the invention, in particular wherein the sequence of interest encodes the glia-activating factor (aka FGF9) (para. [0196]) (claims 13 and 14).
Regarding claims 17 and 18, the copending specification discloses, in some embodiments, the RNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition, is to be administered topically, in particular cutaneously or transdermally (para. [0200]) (claims 17 and 18).
Regarding claim 19, the copending specification discloses, in some embodiments, the RNA molecule or DNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition, is to be administered topically after collagen induction therapy (CIT) (para. [0201]) (claim 19).
This is a provisional nonstatutory double patenting rejection.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/818,483 in view of Sarkis et al. (WO 2013/060819, IDS ref).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Regarding claims 1-2 and 15-16, copending claim 1 recites a ribonucleic acid (RNA) molecule comprising: an RNA Booster sequence comprising or consisting of the ribonucleic acid sequence mmsknkkkm, wherein: "m" indicates an adenine (a) or cytosine (c); "s" indicates a guanine (g) or a cytosine (c); "k" indicates a guanine (g) or a uracyl (u); "n" indicates any nucleotide; and a sequence of interest. Copending claim 1 is silent to a method of treating skin and/or skin appendages in a subject in need thereof, comprising administering to the subject the above-named RNA molecule.
However, the copending specification discloses uses and applications is the RNA molecule, or the non-viral vector or viral vector, in particular the retroviral vector, or the composition, for use in skin and/or skin appendages (such as hair, nails or skin glands) treatment; or a method of treating skin and/or skin appendages (such as hair, nails or skin glands) in a subject in need thereof against, comprising administering to the subject in need thereof the RNA molecule, or the non-viral vector or viral vector, in particular the retroviral vector, or the composition (para. [0148]). The copending specification discloses examples skin and/or skin appendages, in particular of non-therapeutic treatments, include for instance any or several of induction of hair growth, prevention of hair loss, induction of hair removal, hair coloring or bleaching, prevention of hair graying, promotion of hair thickening, promotion of or prevention of hair curling, promotion of skin healing, prevention of wrinkle formation, improvement of skin elasticity, induction of skin tone homogenization, and reduction of sebum secretion. (para. [0150]) (claims 15-16). Therefore, the copending claims in light of the copending specification teach the limitations of instant claims 1 and 2. The MPEP states “…the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”.
Additionally, Sarkis et al. teach reverse transcriptase deficient vector capable of transient expression of an RNA sequence of interest in a cell (Abstract). Sarkis et al. teach a method wherein conventional techniques of chemistry, molecular biology, microbiology, recombinant DNA technology, chemical methods, pharmaceutical formulations and delivery and treatment of patients (p. 8, lines 7-9). Therefore, it would have been obvious to one of ordinary skill in the art to use the vector of Sarkis et al. with the RNA molecule of the copending application to treat skin in a subject in need thereof with a reasonable expectation of success because Sarkis et al. teach such vectors, using conventional techniques are suitable for the treatment of patients.
Copending claim 2 disclose all of the limitation of instant claim 3.
Copending claim 3 disclose all of the limitations of instant claim 4.
Copending claim 4 disclose all of the limitations of instant claim 5.
Copending claim 5 disclose all of the limitations of instant claim 6.
Copending claim 6 disclose all of the limitations of instant claim 7.
Copending claim 7 disclose all of the limitations of instant claim 8.
Regarding claim 9 and 10, the copending specification discloses in some embodiments, the Retroviridae vector is selected from the group consisting of human immunodeficiency viruses (HIV), simian immunodeficiency viruses (SIV), feline immunodeficiency virus (FIV), bovine immunodeficiency virus (BIV), puma lentivirus (PLV), equine infectious anemia virus (EIA V), caprine arthritis encephalitis virus (CAEV), Visna-maedi virus, Jembrana disease virus (para. [0013]) (claims 9 and 10).
Copending claim 8 disclose all of the limitations of instant claim 11.
Copending claim 9 disclose all of the limitations of instant claim 12.
Regarding claims 13-14, the copending specification discloses in some embodiments, the sequence of interest is FGF9 (para. [0057]) (claims 13 and 14).
Regarding claims 17 and 18, the copending specification discloses, in some embodiments, the RNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition, is to be administered topically, in particular cutaneously or transdermally (para. [0154]) (claims 17 and 18).
Regarding claim 19, the copending specification discloses, in some embodiments, the RNA molecule or DNA molecule or the non-viral vector or viral vector, in particular the retroviral vector, or the composition, is to be administered topically after collagen induction therapy (CIT) (para. [0155]) (claim 19).
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/N.A.H./Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631