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 Claims
Claims 1-20 are pending.
Priority
Claims 1-20 are a 371 of PCT/EP 2022/085962 filed on December 14, 2022, which has priority to EP 21214769.8 which was filed on December 15, 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on June 13, 2024, was filed before the mailing of the First Office Action on June 20, 2026. The Non-Patent Literature is in compliance with the provisions of 37 CFR 1.97 and are being considered by the examiner.
Claim Objections
Claim 14 is objected to for the following informalities:
Claim 14 recites “an adino-associated virus (AAV)” should read as “an [[adino]] adeno-associated virus (AAV)”. Appropriate correction is required.
Drawings
The drawings are objected to because of the following informalities:
There is description of color in the Specification in Figures 5 and 6 on pgs. 5-6, and the various colors cannot be distinguished from each other given the figures are in black and white.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites the limitation "The vector" in Line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not contain a limitation for a vector.
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.
Claims 1-20 are rejected under 35 U.S.C. §102(a)(1) as being anticipated by Wood et al. [WO 2020 176896 A1].
Regarding claim 1, Wood et al. teaches a nucleic acid molecule [¶ 5] for use in the treatment of laminopathy in a subject [¶ 4], comprising a nucleic acid sequence encoding Lamin A [¶ 5].
Regarding claim 2, Wood et al. teaches the nucleic acid molecule according to claim 1, wherein the nucleic acid molecule further comprising a nucleic acid sequence encoding a promoter [¶ 18 Fig. 1].
Regarding claim 3, Wood et al. teaches the nucleic acid molecule according to claim 2, wherein the promoter is a constitutive promoter or a tissue-specific promoter [¶ 18 Fig. 1].
Regarding claim 4, Wood et al. teaches the nucleic acid molecule according to claim 1, wherein the Lamin A is wild-type Lamin A [¶ 7].
Regarding claim 5, Wood et al. teaches the nucleic acid molecule according to claim 1, wherein the nucleic acid molecule encodes an amino acid sequence that is at least 70% identical to the amino acid sequence according to SEQ ID NO: 1 [Para starting with “embodiments, the nucleotide sequence comprises the introns corresponding”, Table 2 SEQ ID NO: 12 is 100% identical to Applicant’s SEQ ID NO: 1].
Regarding claim 6, Wood et al. teaches the nucleic acid molecule according to claim 1, wherein the laminopathy is caused by one or more mutations of the LMNA gene [¶ 16].
Regarding claim 7, Wood et al. teaches the nucleic acid molecule according to claim 6, wherein the one or more mutations of the LMNA gene causes haploinsufficiency for Lamin A or wherein the one or more mutations of the LMNA gene causes a dominant-negative Lamin A [¶ 16].
Regarding claim 8, Wood et al. teaches the nucleic acid molecule according to claim 1, wherein the laminopathy that affects the striated muscle and is selected from the group consisting of cardiomyopathy or muscular dystrophy [¶ 16, Para starting with “missassembly of the Lamin polypeptide].
Regarding claim 9, Wood et al. teaches the nucleic acid molecule according to claim 8, wherein the laminopathy is dilated cardiomyopathy 1A [Id.].
Regarding claim 10, Wood et al. teaches a vector comprising the nucleic acid molecule of claim 1 for use in treatment of laminopathy in a subject [¶ 4].
Regarding claim 11, Wood et al. teaches the vector according to claim 10, wherein the vector is an expression vector comprising a nucleic acid molecule [Para starting with “In certain embodiments, the viral vector comprises a nucleotide sequence further”] further comprising a nucleic acid sequence encoding a promoter [¶ 18 Fig. 1], wherein the promoter is operably linked to the nucleic acid sequence encoding Lamin A [Para starting with “embodiments, the nucleotide sequence is at least 95% identical to the nucleotide sequence of SEQ ID NO: 3” and ¶ 137], resulting in expression of Lamin A in cells contacted with the vector when the promoter is active [¶ 15].
Regarding claim 12, Wood et al. teaches the vector according to claim 1, wherein the expression of Lamin A from the vector increases the overall expression level of Lamin A in cells affected by laminopathy contacted with the vector to at least 50% of the wild-type expression level [Para starting with “80 fold, 60-70 fold 70-90 fold”].
Regarding claim 13, where the expression of Lamin A from the vector increases the absolute force produced by cardiomyocytes affected by laminopathy contacted with the vector by 5% to 200% compared to cardiomyocytes affected by laminopathy not contacted with the vector. Wood et al. does not expressly teach that absolute force produced by cardiomyocytes affected by laminopathy contacted with the vector increases by 5% to 200% compared to cardiomyocytes affected by laminopathy not contacted with the vector. Although, Wood et al. does not expressly quantify an increase in absolute force of 5% to 200% in reference to cardiomyocytes treated with the nucleic acid construct, the claimed functional improvement would be considered an inherent property in practicing the disclosed gene therapy method given that administering a functional LMNA construct to LMNA-deficient cardiomyocytes necessarily restores Lamin A function which would improve absolute force, e.g. contractility of the cardiomyocytes. "[I]n order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis – the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art." Id. at 1195-96, 112 USPQ2d at 1952. But see, Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements." (emphasis in original). Here, Wood et al. teaches the same gene construct to cardiomyocytes affected by laminopathy for restoration of Lamin A expression and improvement in cellular function.
Regarding claim 14, Wood et al. teaches an adeno-associated virus (AAV) for use in the treatment of laminopathy in a subject comprising a vector of claim 10 [Para starting with “In certain embodiments, the viral vector comprises”].
Regarding claim 15, Wood et al. teaches a pharmaceutical composition for use in the treatment of laminopathy in a subject comprising the vector of claim 10 and a pharmaceutically acceptable carrier [¶ 112].
Regarding claim 16, Wood et al. teaches a method of treating laminopathy in a human or non-human subject in need thereof [¶ 191], the method comprising administering to the subject a nucleic acid comprising a sequence encoding a Lamin A polypeptide [¶ 13].
Regarding claim 17, Wood et al. teaches the method of claim 16, wherein the sequence further encodes a promoter [¶ 18 Fig. 1].
Regarding claim 18, Wood et al. teaches the method according to claim 17, wherein the promoter is a constitutive promoter or a tissue-specific promoter [Id.].
Regarding claim 19, Wood et al. teaches the method according to claim 16, wherein the Lamin A is wild-type Lamin A [¶ 5, 191].
Regarding claim 20, Wood et al. teaches the method according to claim 16, wherein the sequence encodes an amino acid sequence that is at least 70% identical to the amino acid sequence according to SEQ ID NO: 1 [Para starting with “embodiments, the nucleotide sequence comprises the introns corresponding”, Table 2 SEQ ID NO: 12 is 100% identical to Applicant’s SEQ ID NO: 1].
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN DAVID MOORE whose telephone number is (703)756-1887. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached on 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN DAVID MOORE/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
Prosecution Insights