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 with traverse of Group I in the reply filed on 2/26/2026
The traversal is on the ground(s) that RGN are polypeptides that bind to target nucleotide sequences in a sequence specific manner and that the term RNA-guided nuclease also encompasses nuclease-dead RNA-guided nucleases that are capable of binding to, but not cleaving a targes sequence. As such both the RGN of group I and II have shared function of binding target sequences regardless of their ability to cleave. This is not found persuasive because while the groups I and II both have structures that bind target sequences as a whole the RGN of Group II has a different structure that leads to a different function (i.e. base editing) compared to the RGN structure of group I (i.e. cleaving DNA).
The requirement is still deemed proper and is therefore made FINAL.
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.
(1) Claims 30, 32, 37-39, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 6, and 15 of copending Application No. 19/126,929 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims disclose a species of the instant claims.
Regarding claim 30, copending claim 1 discloses a RGN with 90% sequence identity to SEQ ID NOS: 1-4, 49-162 amongst others. SEQ ID NO:3 has 100% identity to SEQ ID NO:83 of the instant application. SEQ ID NO:51, 33, and 54 have 99% identity to SEQ ID NO:83 of the instant application. SEQ ID NOS:34-38 have 98% identity to SEQ ID NO:83 of the instant application. The scope of the copending claim 1 is narrower because this RGN has is part of fusion protein.
Regarding claim 32, copending claim 2 specifies the sequence is SEQ ID NO:3 among others. Again SEQ ID NO:3 has 100% identity with SEQ ID NO:83 of the instant claim. As such, Copending claim 2 is an anticipatory species of instant claim 32.
Regarding claim 37, copending claim 5 specifies that fusion polypeptide comprises a base-editing polypeptide.
Regarding claim 38, copending claim 15 specifies the nuclease as an inactive nuclease or nickase.
Regarding claim 39, copending claim 6 specifies a deaminase.
Regarding claim 41, copending claim 1 does not specify that the RGN further comprises one or more nuclear localization signals. However, NLS were commonly included for targeting the RGN to the nuclease site of action. As such, instant claim 41 is a obvious variant of copending claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(2) Claims 30, 32 and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 124 of copending Application No. 19/105177 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims disclose a species of the instant claims.
Regarding claim 30 and 32, copending claim 124 discloses an RGN polypeptide with at least 80-100% identity to SEQ ID NOS: 1, 69, 93, and 252. SEQ ID NO:69 has 100% identity to SEQ ID NO:83 of the instant application. Copending claim 124 also states the RGN is comprised in a system. As such, copending claim 124 is an anticipatory species of instant claims 30 and 32.
Regarding claim 41, copending claim 124 does not specify that the RGN further comprises one or more nuclear localization signals. However, NLS were commonly included for targeting the RGN to the nuclease site of action. As such, instant claim 41 is an obvious variant of copending claim 241.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(3) Claims 30, 37-39, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 of copending Application No. 18/628400 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims disclose a species of the instant claims.
Regarding claim 30, copending claim 4 discloses a RGN with at least 95% sequence identity to SEQ ID NOS: 59 amongst others. SEQ ID NO:59 has 99.9% identity to SEQ ID NO:83 of the instant application. The scope of the copending claim 1 is narrower because this RGN has is part of fusion protein.
Regarding claim 37, copending claim 4 specifies that fusion polypeptide comprises a deaminase.
Regarding claim 38, copending claim 4 specifies the nuclease as an inactive nuclease or nickase.
Regarding claim 39, copending claim 4 specifies a deaminase.
Regarding claim 41, copending claim 4 does not specify that the RGN further comprises one or more nuclear localization signals. However, NLS were commonly included for targeting the RGN to the nuclease site of action. As such, instant claim 41 is an obvious variant of copending claim 4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(3) Claims 30, 37-39, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of copending Application No. 18955480 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims disclose a species of the instant claims.
Regarding claim 30, copending claim 20 discloses a RGN with at least 95% sequence identity to SEQ ID NOS: 59 amongst others. SEQ ID NO:59 has 99.9% identity to SEQ ID NO:83 of the instant application. The scope of the copending claim 1 is narrower because this RGN has is part of fusion protein.
Regarding claim 37, copending claim 20 specifies that fusion polypeptide comprises a deaminase.
Regarding claim 38, copending claim 20 specifies the nuclease as an inactive nuclease or nickase.
Regarding claim 39, copending claim 20 specifies a deaminase.
Regarding claim 41, copending claim 20 does not specify that the RGN further comprises one or more nuclear localization signals. However, NLS were commonly included for targeting the RGN to the nuclease site of action. As such, instant claim 41 is an obvious variant of copending claim 20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(5) Claims 30, 37-39, and 41 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 11,981,940. Although the claims at issue are not identical, they are not patentably distinct from each other because patent claims are an anticipatory species of the instant claims.
Regarding claim 30, patent 1 discloses a RGN with at least 95% sequence identity to SEQ ID NOS: 59 amongst others. SEQ ID NO:59 has 99.9% identity to SEQ ID NO:83 of the instant application. The scope of the patent claim 1 is narrower because this RGN has is part of fusion protein.
Regarding claim 37, patent claim 1 specifies that fusion polypeptide comprises a deaminase.
Regarding claim 38, patent claim 1 specifies the nuclease as a nickase.
Regarding claim 39, patent claim 1 specifies a deaminase.
Regarding claim 41, patent claim 3 discloses that the RGN further comprises one or more nuclear localization signals.
(5) Claims 30, 37-39, and 41 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,188,062. Although the claims at issue are not identical, they are not patentably distinct from each other because patent claims are an anticipatory species of the instant claims.
Regarding claim 30, patent 1 discloses a RGN with at least 90% sequence identity to SEQ ID NOS: 59 amongst others. SEQ ID NO:59 has 99.9% identity to SEQ ID NO:83 of the instant application. The scope of the patent claim 1 is narrower because this RGN has is part of fusion protein.
Regarding claim 37, patent claim 1 specifies that fusion polypeptide comprises a deaminase.
Regarding claim 38, patent claim 1 specifies the nuclease as a nickase.
Regarding claim 39, patent claim 1 specifies a deaminase.
Regarding claim 41, patent claim 6 discloses that the RGN further comprises one or more nuclear localization signals.
(6) Claims 30, 37-39, and 41 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,252,718. Although the claims at issue are not identical, they are not patentably distinct from each other because patent claims are an anticipatory species of the instant claims.
Regarding claim 30, patent 1 discloses a RGN with at least 90% sequence identity to SEQ ID NOS: 59 amongst others. SEQ ID NO:59 has 99.9% identity to SEQ ID NO:83 of the instant application. The scope of the patent claim 1 is narrower because this RGN has is part of fusion protein.
Regarding claim 37, patent claim 1 specifies that fusion polypeptide comprises a deaminase.
Regarding claim 38, patent claim 1 specifies the nuclease as a nickase.
Regarding claim 39, patent claim 1 specifies a deaminase.
Regarding claim 41, patent claim 6 discloses that the RGN further comprises one or more nuclear localization signals.
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.
Claim(s) 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nausad (Nausad et al. Front. Microbiol. 7:1990, 2016).
Nausad disclose the polypeptide sequence having Accession No. A0A2T4KGD5 having 99.4% identity with SEQ ID NO:83. Nausad discloses this sequence is RGN found in non-aureus Staph species based upon sequence.
As such the prior art of Nausad anticipates claim 30 because it expressly discloses one of the embodiments of claim 30.
PNG
media_image1.png
420
696
media_image1.png
Greyscale
PNG
media_image2.png
526
738
media_image2.png
Greyscale
PNG
media_image3.png
901
749
media_image3.png
Greyscale
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.
Claim 30 is rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more.
The claim(s) recite(s) “a population of isolated expanded potential stem cells”. According to the 2019 Revised Patent Subject Matter Eligibility Guidelines (2019PEG), the claim is first analyzed to determine if it is directed to one of the acceptable statutory categories of invention (i.e. process, machine, manufacture, or composition of matter). Claim 30 is drawn to a composition of matter comprising a polypeptide sequence. Thus claim 30 meets the requirements for step 1 of the analysis.
Second, the claim is assessed to determine if it is directed to a judicial exception under step 2A. Under 2019PEG, “directed to” is determined via a two-prong inquiry: (1) Does the claim recite a law of nature, a product of nature, a natural phenomenon, or an abstract idea; and (2) Does the claim recite additional element(s) that integrate the judicial exception into a practical application. The phrase, “integration of a practical application”, requires the presence of an additional claim element(s) or a combination thereof to apply, rely on or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception, such that the claim does not monopolize the judicial exception. (See MPEP § 2106.05 for examples of integration of practical application).
Regarding the first prong (1), claim 30 is directed to a “RNA-guided nuclease (RGN) polypeptide, wherein said RGN polypeptide comprising an amino acid sequence having at least 90% sequence identity to SEQ ID NO: 83.”. RGN polypeptides are products of nature found in non-S. aureus species (see Naushad and above anticipation rejection). Thus, the first prong of the inquiry demonstrates that claim 30 does recite a judicial exception because the claim is directed to a product of nature found in non-S. aureus species.
Regarding the second prong (2), claim 30 recites additional structural elements of the RGN polypeptide and does not recite any limitation that would be deem an application. Thus, since the additional element solely provide structural limitations, the claim do not recite any additional elements or a combination thereof that integrates the judicial exception identify in prong 1 as being integrated into a practical application. Further since the claims are not meaningfully limited to any particular practical application, the generic nature of the claim appears to monopolize the claimed polypeptide. Thus, claim 30 meets the requirement of step 2A as being directed to a judicial exception.
Third, if a judicial exception is present in the claim, it is further assessed to determine if the claim recites any additional elements or steps that are sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception. The additional limitations recites are that the polypeptide has at least 90% identity to SEQ ID NO:83. The breadth of the limitation is a sequence that has the same sequence as SEQ ID NO:83 or any number of changes to the sequence that does not change more than 10% of the amino acid sequence composition. As discussed above, Naushad discloses that a wild-type polypeptide sequence that has 99.4% identity to SEQ ID NO:83 is known to exist in non-S. aureus species found in intramammary infections in dairy cattle (see abstract). As such, the breadth of the claims encompass a wild-type RGN polypeptide that is indistinguishable from the claimed 99% identical to SEQ ID NO:83. As such, the claim comprises embodiments that are structurally identical to polypeptides found in nature. Claimed sequences that read on wild-type sequences are merely products of nature and not markedly different from the natural counterpart. As such, claim 30 does meet the requirements of step 2B and in fact comprises embodiments that are a judicial exception and not patent eligible.
In conclusion, the breath of claim 30 encompasses non-patent eligible subject matter because the breadth of the claims encompasses a wild-type sequence found in nature and does not recite additional elements that impart markedly more than the judicial exception.
No claims are allowed.
As discussed above, the claim recites the structural element of “isolated”. It is noted that “isolated” does impart a structural distinction to the claimed cell population because in nature blastomeres are not isolated but rather are found within an embryo surrounded by an outer membrane. However, the claimed isolated ESPC is structurally indistinguishable from the blastomeres because they are naïve or ground state pluripotent cells having the ability to differentiate into trophoblast cells or embryonic proper cells.
Under the holding of Myriad, an isolated but otherwise unchanged nucleic acid was not patent eligible subject matter because it was not different enough from what exists in nature to avoid improperly tying up the future use and study of naturally occurring nucleic acid. The isolated EPSC population of the claim is analogous to the isolated nucleic acid in Myriad. The claimed EPSC population can be interpreted as being an isolated blastomere population that is otherwise an unchanged. Thus, similar to the isolated nucleic acid, the isolated EPSC population is not patent eligible subject matter because it is not different enough from blastomere populations that exists in nature to avoid improperly tying up the future use and study of the naturally occurring blastomere population.
Regarding the recited process by which the claimed isolated EPSC is made, the claims generic recite providing a non-pluripotent cell population and reprogramming the non-pluripotent cell population into a pluripotent cell population. The generic nature of the claimed process means that the non-pluripotent cells can be reprogrammed by any means to arrive at pluripotent cells, including methods that do not impart any additional genetic or structural distinction to the pluripotent cell that would distinguish it from an inner cell mass cell of an embryo. Similarly the culturing step solely requires the culture in a particular medium. It does not require that the cell have any structural component that is different from a pluripotent or totipotent cell, such as a blastomere, found in a naturally occurring embryo. Thus, as a whole, generic nature of the process does not impart any structural or functional distinctions to the claimed EPCS cell population product that would distinguish it from a blastomere cell population found in nature. As such, claim 23 does not meet the requirements of step 2B of the 2019PEG because the isolated nature of the claimed cell population and the method by which the claimed cell population do not impart a significant distinction to the claimed ESPC cell population to distinguish it from its natural blastomere population counterpart.
In conclusion, claim 23 does meet all the requirements of the 2019PEG and therefore deemed patent ineligible.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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, Peter Paras can be reached at 571-272-4517. 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.
MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/ Primary Examiner, Art Unit 1632
Prosecution Insights