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
To expedite the compact prosecution, the Examiner is pursuing the amended claims dated 24 July 2024, in which applicant; amended claims 1, 3, 6, 13, 21, 27, 29, 31, 45, 55, 59, 66, and 67; canceled claims 2, 4-5, 8-12, 14-20, 23-26, 28, 30, 32-44, 46-54, 60-64, 68-71.
Therefore, claims 1, 3, 6, 13, 21, 27, 29, 31, 45, 55, 59, 66, and 67 are pending in the application.
Priority
This application was filed 07/24/2024 and is a 371 application PCT/CN2023/073420 filed on 01/20/2023, which claims benefit to the foreign application foreign priority to 202210081981.1, filed 01/24/2022; PCT/CN2022/089074, filed 04/25/2022 and PCT/CN2022/129376, filed 11/02/2022.
Filing of a certified untranslated copy of the 202210081981.1, PCT/CN2022/089074 and PCT/CN2022/129376 filed 07/24/2024 is acknowledged. MPEP 2304.01(c) states: Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action, 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is 01/20/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/26/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and the signed and initialed PTO Forms 1449 are mailed with this action.
Abstract Objection
The abstract of the disclosure filed 07/24/2024 is objected to because the abstract is only 26 words in length, and it is not submitted as a single paragraph on a separate sheet as required. Therefore, submitted abstract is considered non-compliant.
The instant application is a 371 application of PCT/US2021/032108, filed on 01/20/2023 is acknowledged. The abstract of the instant application appears on the front page of the PCT publication (see MPEP § 1893.03(e)). However, MPEP §608.01(b)(I) also sets forth guidelines for the abstract. MPEP § 608.01(b)(I)(C) states that “the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.”
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Therefore, appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 31 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 31 is recited “a functional domain.” The term “functional” in the claim is a relative term which renders the claim indefinite. The term “functional” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Furthermore, claim 31 is also unclear because it doesn’t disclose the Markush group of the functional domain or specific type of functional domain. The rejection may be obviated by amending the claim 31 including the specific or Markush group of functional domain.
Claim Rejections - 35 USC § 112(a)
Written Description
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim 67 is 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 claims contain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As per MPEP 2163(I), "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Also, as per MPEP 2163.03(V), there is a presumption that an adequate written description of the claimed invention is present in the specification as filed.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Possession may be shown in a variety of ways, for example, possession may be shown by describing an actual reduction to practice of the claimed invention. A specification may describe an actual reduction to practice by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose. Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896, 1901 (Fed. Cir. 1998). See also UMC Elecs. Co. v. United States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987) ("[T]here cannot be a reduction to practice of the invention ... without a physical embodiment which includes all limitations of the claim."); Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1614 (Fed. Cir. 1997) ("[A] reduction to practice does not occur until the inventor has determined that the invention will work for its intended purpose."); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that the invention will work for its intended purpose may require testing depending on the character of the invention and the problem it solves). Alternatively, applicant may present that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it").
Finally, MPEP 2163.04 describes the burden on the examiner with regard to the Written Description requirement, stating that in rejecting a claim, the examiner must set forth express findings of fact which support the lack of written description conclusion. These findings should:
(A) Identify the claim limitation(s) at issue; and
(B) Establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed.
Claim 67 generally recites a method for diagnosing, preventing, or treating a disease or disorder in a subject. The broadest reasonable interpretation of this claim includes not only the use of a system (or composition) comprising Cas12i polypeptide to treating any disease or disorder, but also diagnosing and preventing the disease or disorder.
Instant specification discloses “the disclosure provides a method for diagnosing, preventing, or treating a disease or disorder in a subject, comprising administering to the subject (e.g., an effective amount of) the system of the disclosure, the cell or progeny thereof of the disclosure, or the composition of the disclosure. [0087] The disease or disorder is a TTR-associated disease or disorder, e.g., ATTR and/or the disease or disorder is a PCSK9-associated disease or disorder.” ([0086], [0088-0089], [0372]-[0373] of US20250101394A1). Therefore, the specification fails to identify the broadest reasonable interpretation of this claim includes not only the use of Cas12i polypeptide to treating any disease or disorder but also diagnosing and preventing the disease or disorder.
The disclosure as originally filed shows a clear reduction to practice of the invention (e.g., as per the Examples and Figures) for insect comprising Anopheles gambiae. In example 11, the disease or disorder is associated with an aberration of a target dsDNA in the subject [0368]. More specifically, Example 11 demonstrates that the CRISPR-Cas12i system of the disclosure has very promising prospects for the treatment of TTR-related amyloid diseases, such as ATTR (e.g., ATTRwt or ATTRm) ([0624] of US20250101394A1). Therefore, it is apparent that Applicant was in possession of only treatment of TTR-related amyloid diseases, such as ATTR (e.g., ATTRwt or ATTRm) using specific Cas12i polypeptide as of the effective filing date.
However, as detailed in MPEP § 2163, besides an actual reduction to practice, Applicant may prove possession of the claimed invention by a showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention. Further, as per MPEP § 2163, “[f]or some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement.”
In the present case, the specification discloses specifically the treatment (without disclosing diagnosing or preventing) of TTR-related amyloid diseases, such as ATTR (e.g., ATTRwt or ATTRm) using specific Cas12i polypeptide. However, it is noted, in the prior art Zhang et al. (Nature structural & molecular biology, 27(11), pp.1069-1076), 2020; cited in IDS filed 12/26/2024; hereinafter “Zhang”) discloses that the mechanisms for target recognition and cleavage by the Cas12i RNA-guided endonuclease for genome editing with high specificity and diagnostic applications (abstract and p. 1075 3rd ¶). Separately, Wu et al. (Advances in CRISPR/Cas-based gene therapy in human genetic diseases. Theranostics, 10(10), p.4374, 2020, cited in PTO892; hereinafter “WU”) disclose a variety of CRISPR/Cas-based therapeutics are being investigated in clinical trials. Among many new findings that have advanced the field, we highlight a few recent advances that are relevant to CRISPR/Cas-based (e.g., Cas 9 and Cas12) gene therapies for monogenic human genetic diseases (abstract, Table 2 and 3). Therefore, Zhang and Wu describe treating of specific disease using CRISPR-Cas base gene therapies. Therefore, it is obvious that prior art does not support to identify the use of Cas12i polypeptide to treating any disease or disorder and also not supporting to diagnosing and preventing the disease or disorder.
Accordingly, it concludes that the treating the claimed genus of the generic disease or disorder, more specifically diagnosing and preventing the disease or disorder comprising administrating Cas12i polypeptide composition doesn't have an adequate written description. It concludes that a skilled artisan would find the specification inadequately described. Therefore, the Applicant did not sufficiently possess the broader invention as claimed in claim 67.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 3, 13, 27, 31, 45, 55, 59, 66, and 67 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 14-16, 20, 32, 35-37 of copending application no. 18859842 (US20250283063A1). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The subject matter claimed in the instant application is disclosed in the reference claims as follows:
Competing claim 1 would anticipate the instant claims 1, 3, directed to Cas12i polypeptide comprising an amino acid substitution at E336, V880, G883, D892, and/or M923 of SEQ ID NO: 458 thereto, furthermore, NCBI Blast search report shows that competing SEQ ID NO: 458 is 99.9% is identical to instant SEQ ID NO:1 (see the NCBI report), if it were available as prior art. Since it is not, the claims are patentably indistinct. Competing claims 14-16 anticipates the instant claims 27, 28, 31 because it discloses the Cas12i polypeptide is further engineered to be a nickase and having substantially no spacer sequence-specific dsDNA cleavage activity. Since competing copending application is not available as prior art, the claims are patentably indistinct. Competing claims 20, 32, 35-37 would anticipate the instant claims 45, 55, 59, 66 and 67 directed to a system comprising the Cas12i polypeptide of claim 1, a modified cell and method for diagnosing, preventing, or treating a disease in a subject in need thereof using the system. Since competing copending application is not available as prior art, the claims are patentably indistinct.
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is 571-272-0196. The examiner can normally be reached M-F 8-5 (EST).
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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