DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-23 are pending.
Applicant’s amendment to the claims filed 06/30/2026 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Election
Applicant’s election without traverse of
Group I, claims 1-20, drawn to the technical feature of a modified transposase, comprising a core piggyBac transposase lacking one or more of the N-terminal 74 amino acids, having a duplication of the C-terminal 53 amino acids, or a combination thereof, and a modified transposase, comprising a core of piggyBat transposase with the following point mutations: S8 to A, S24 to A, S32 to A, S37 to A and having a duplication of the C-terminal 81 amino acids, and
Species A1) the modified transposase of claims 1-4, comprising a core piggyBac transposase lacking one or more of the N-terminal 74 amino acids, having a duplication of the C-terminal 53 amino acids, or a combination thereof, wherein the core piggyBac transposase comprises the amino acid sequence of SEQ ID NO: 1, wherein the piggyBac transposase comprises the formula [Xa - SEQ ID NO: 2], wherein Xa is 0 to 70 aa of the amino acid sequence of SEQ ID NO: 3, and wherein the piggyBac transposase comprises the amino acid sequence of SEQ ID NO: 4, or a variant thereof having at least 65% to 100% sequence identity to SEQ ID NO: 4
in the reply filed 06/30/2026 is acknowledged.
Claims 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/30/2026.
Claims 5-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/30/2026.
Claims 1-4 are being examined on the merits only to the extent they read on the elected subject matter.
Priority
The instant application is a national stage filing under 35 U.S.C. 371 of international application PCT/US2022/082217 filed 12/22/2022, which claims domestic priority to U.S. Application No. 63/292,821 filed 12/22/2021.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) submitted on 06/14/2024, 03/25/2025, 03/25/2025 and 08/12/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs have been considered by the examiner.
Foreign Patent Documents 1-4 of the IDS filed 03/25/2025 have been lined through because there is no copy of these references in the application file.
Objections to Specification
The disclosure is objected to because of the following informalities.
The Sequence Listing must be referenced by a statement in the specification identifying (i) the name of the file; (ii) the date of creation; and (iii) the size of the file in bytes (37 CFR 1.834.c.1), however the specification filed on 06/14/2024 does not state the size of the file in bytes.
The use of the terms pAdEasy-1, EXPI293F, ORBITRAPM, SEQUEST, PROTEOMELAB XL-I, LIPOFECTAMINE, RNEASY, ILLUMINA, Q5, MISEQ, NOVASEQ, NEBNEXT, AMPURE, and TAPESTATION which are trade names or marks used in commerce, have been noted in this application in paragraphs 0117, 0120, 0124, 0126, and 0140. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in para 0142. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Objections to Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show any green color in Figure 1B as described in para 0042 of the specification, and any blue color in Figure 2C as described in para 0154 of the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
The drawings are objected to because Figures 1A, 1B, 8A, 9 and 10A show nucleic acid and amino acid sequences without the use of a sequence identifier such as “SEQ ID NO” according to 37 CFR 1.831.c and MPEP 2412.04. It is noted that MPEP 2412.06 states “Pursuant to 37 CFR 1.83(a), sequences that are included in the "Sequence Listing XML" should not be duplicated in the drawings.”
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
The objection to the drawings will not be held in abeyance.
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.
Claims 1-4 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 (claims 2-4 dependent therefrom) is indefinite for the phrase “comprising a core piggyBac transposase lacking one or more of the N-terminal 74 amino acids, having a duplication of the C-terminal 53 amino acids, or a combination thereof”. As the “core piggyBac transposase” is not structurally defined by the claim, the N-terminal and C-terminal amino acids referenced by the claim are similarly undefined, and it is entirely unclear as to the amino acid sequence of the claimed transposase.
Claim 2 (claims 3-4 dependent therefrom) is indefinite for the phrase “wherein the piggyBac transposase comprises the amino acid sequence SEQ ID NO: 1”. As written, it is unclear whether the “wherein” clause limiting the core piggyBac transposase to comprise SEQ ID NO: 1 is intended to replace the limitations of the core piggyBac transposase “lacking one or more of the N-terminal 74 amino acids, having a duplication of the C-terminal 53 amino acids, or a combination thereof” as recited in claim 1, or is intended to further limit the piggyBac transposase to have the amino acid of SEQ ID NO: 1 in addition to “lacking one or more of the N-terminal 74 amino acids, having a duplication of the C-terminal 53 amino acids, or a combination thereof”.
Claim 4 is indefinite for the phrase “The modified transposase of claim 3, wherein the piggyBac transposase comprises … a variant having at least 65%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% … sequence identity to SEQ ID NO: 4”. Claim 3 (from which claim 4 depends) recites the transposase comprises the formula Xa – SEQ ID NO: 2, wherein Xa is 0 to 70 aa of the amino acid sequence of SEQ ID NO: 3, which encompasses a transposase comprising SEQ ID NO: 2 and 0 aa of SEQ ID NO: 3. As SEQ ID NO: 4 shares 100% identity with SEQ ID NO: 2, the limitations in claim 4 of the transposase comprising a variant having less than 100% identity to SEQ ID NO: 4 cannot also comprise SEQ ID NO: 2 as set forth by claim 3. Put another way, the limitation above in claim 4 is a broader limitation than the limitation in claim 3 according to MPEP 2173.05(c).
Claim Rejections - 35 USC § 112(a)
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.
Claim interpretation: Claim 1 is drawn to a modified transposase, comprising a core piggyBac transposase lacking one or more of the N-terminal 74 amino acids, having a duplication of the C-terminal 53 amino acids, or a combination thereof. As the claim recites no structural limitations of the core piggyBac transposase, the claimed transposase is considered to be structurally unlimited, and therefore drawn to a genus of polypeptides that is considered widely variant with respect to sequence.
A. Claim 1 is rejected under 35 U.S.C. 112(a) 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 at the time the application was filed, had possession of the claimed invention.
MPEP 2163.II.A.2.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
According to MPEP 2163.II.A.3.(a).ii), [s]atisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’"
The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163.
The claims recite (in relevant part) a genus of polypeptides comprising a core piggyBac transposase lacking one or more of the N-terminal 74 amino acids, having a duplication of the C-terminal 53 amino acids, or a combination thereof. As stated above, the amino acid sequence of the core piggyBac transposase is unlimited. Also, the function of the genus of modified transposases of claim 1 is unlimited. In this case, the genus of recited polypeptides encompasses species that are considered to be widely variant with respect to sequence and function.
The specification discloses the following representative species of the genus of recited transposase polypeptides: SEQ ID NOs: 1-2, 4, 6, 11, 13, 18, 21, 23, 25-27, and 33.
Regarding the level of skill and knowledge in the art of amino acid modification, the reference of Singh et al. (Curr. Protein Pept. Sci. 18:1-11, 2017; cited on the attached Form PTO-892) reviews various protein engineering methods and discloses that despite the availability of an ever-growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see p. 7, column 1, top). Also, the unpredictability associated with residue substitution is exemplified by the reference of Zhang et al. (Structure 26:1474-1485, 2018; cited on the attached Form PTO-892), which discloses that even a substitution of a surface residue that was predicted to be benign caused significant structural changes and unexpected effects on the function of a polypeptide (p. 1475, column 1).
In view of the high level of unpredictability in the art of amino acid modification, because the genus non-naturally occurring polypeptides and coronavirus spike proteins is widely variant with respect to both structure and function, and the specification discloses the actual reduction to practice of only seventeen representative species among a widely variant genus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the recited genus of non-naturally occurring polypeptides. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
B. Claim 1 is rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a transposase comprising any one of the amino acid sequences of SEQ ID NOs: 1-2, 4, 6, 11, 13, 18, 21, 23, 25-27, and 33, does not reasonably provide enablement for all modified transposases as encompassed by the claim. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with the claim.
“The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue.” In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976). Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)) as follows: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.01(a). The Factors considered to be most relevant to the instant rejection are addressed in detail below.
The nature of the invention: According to the specification at para 0007, “Disclosed herein is a rationally engineered hyperactive piggyBac transposase that can transposition a transposon with LE/LE configuration (shortened inverted repeats (IR) from left end (LE) sequences on both ends)”. The object of the invention is therefore to provide an engineered piggyBac transposase.
The breadth of the claims: The claims recite (in relevant part) a modified transposase, comprising a core piggyBac transposase lacking one or more of the N-terminal 74 amino acids, having a duplication of the C-terminal 53 amino acids, or a combination thereof. As stated above, the claim recites no structural limitations of the core piggyBac transposase, and therefore the claimed transposase is considered to be structurally unlimited. Also, the function of the modified transposase of claim 1 is unlimited.
The state of the prior art; The level of one of ordinary skill; and The level of predictability in the art: According to MPEP 2164.03, “…what is known in the art provides evidence as to the question of predictability” and “[I]f one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art.”
As noted above, the amino acid sequence of the recited transposase is unlimited. The reference of Singh (supra) reviews various protein engineering methods and discloses that despite the availability of an ever-growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see p. 7, column 1, top).
The unpredictability associated with amino acid modification is exemplified by the reference of Zhang (supra) which discloses that even a mutation that was predicted to be benign caused significant structural changes and unexpected effects on the function of a polypeptide (p. 1475, column 1).
As such, one of skill in the art would recognize a high level of unpredictability that all polypeptides as encompassed by the claims would maintain the desired activity/utility.
The amount of direction provided by the inventor and The existence of working examples: The specification discloses the following working examples of the recited transposase – a transposase comprising any one of the amino acid sequences of SEQ ID NOs: 1-2, 4, 6, 11, 13, 18, 21, 23, 25-27, and 33.
Other than these working examples, the specification fails to disclose any other modified transposases. Also, the specification fails to provide guidance for using modified transposases that are non-functional or have activity other than the expected transposase activity.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: While methods of modifying the amino acid sequence of a polypeptide were known at the time of the invention, it was not routine in the art to make and determine a use for all polypeptides as recited by the claims.
In view of the overly broad scope of the claims, the lack of guidance and working examples provided in the specification, the high level of unpredictability, and the state of the prior art, undue experimentation would be necessary for a skilled artisan to make and use the entire scope of the claimed invention. Applicants have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Applicant’s attention is directed to the "Guidance for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products”, released on December 16, 2014.
Claim Interpretation: As amended, claims 1-4 are drawn to a modified transposase, comprising a core piggyBac transposase lacking one or more of the N-terminal 74 amino acids, having a duplication of the C-terminal 53 amino acids, or a combination thereof. As the core piggyBac transposase recited by claim 1 is structurally unlimited, the claimed transposase is not defined by any amino acid sequence and encompasses polypeptides such as the naturally occurring DDE_Tnp_1_7 domain-containing protein of Trichoplusia ni disclosed by UniProt Accession No. Q27027_TRINI (1 page, 01 Nov 1996; cited on the attached Form PTO-892; herein UNI1).
Claim 2 limits the core piggyBac transposase to comprise SEQ ID NO: 1, and in view of the indefiniteness of the limitation on the piggyBac core sequence, the claim is being interpreted such that the modified transposon of claim 1 is being limited to only comprise the amino acid sequence of the core piggyBac sequence of SEQ ID NO: 1. In view of this interpretation, the polypeptide of UNI1 shares 100% sequence identity with SEQ ID NO: 1 [see Appendix B], and is therefore considered to have a piggyBac core comprising SEQ ID NO: 1.
Claim 3 limits the piggyBac transposase to comprise the formula Xa – SEQ ID NO: 2, wherein Xa is 0 to 70 aa of the amino acid sequence SEQ ID NO: 3. The claim encompasses an embodiment without any amino acids from SEQ ID NO: 3, and therefore a piggyBac transposase comprising SEQ ID NO: 2. As SEQ ID NO: 2 shares 100% identity with SEQ ID NO: 4 [see Appendix C], the polypeptide of UNI1 is considered to comprise SEQ ID NO: 2 as recited in claim 3.
Claim 4 limits the amino acid sequence of the claimed transposase to comprise SEQ ID NO: 4, or a variant comprising at least 65% identity to SEQ ID NO: 4, wherein the polypeptide of UNI1 shares 99.8% sequence identity (100% local similarity) with SEQ ID NO: 4 [see Appendix A]. Therefore the polypeptide of UNI1 is considered to comprise SEQ ID NO: 4, or a variant comprising at least 65% identity to SEQ ID NO: 4.
Given a broadest reasonable interpretation, claims 1-4 are directed to a naturally-occurring polypeptide.
Patent Eligibility Analysis Step 1: The claims are drawn to a composition of matter, which is one of the statutory categories of invention.
Patent Eligibility Analysis Step 2A Prong 1: The claims recite a naturally occurring polypeptide, which is considered to be a law of nature or natural phenomena (a natural product). Accordingly, claims 1-4 are directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2: There are no additional elements recited in the claims beyond the judicial exception.
Patent Eligibility Analysis Step 2B: The claims only recite the product of nature, without more and do not include any additional elements that could add significantly more to the judicial exception.
As such, the claims do not qualify as eligible subject matter. For these reasons the claim is rejected under section 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by UniProt Accession No. Q27027_TRINI (1 page, 01 Nov 1996; cited on the attached Form PTO-892; herein UNI1).
Claim 1 is drawn to a modified transposase, comprising a core piggyBac transposase lacking one or more of the N-terminal 74 amino acids, having a duplication of the C-terminal 53 amino acids, or a combination thereof.
Claim 2 is drawn to the modified transposase of claim 1, wherein the core piggyBac transposase comprises the amino acid sequence SEQ ID NO:1.
Claim 3 is drawn to the modified transposase of claim 2, wherein the piggyBac transposase comprises the formula: Xa- SEQ ID NO:2, wherein Xa is 0 to 70 aa of the amino acid sequence SEQ ID NO:3.
Claim 4 is drawn to the modified transposase of claim 3, wherein the piggyBac transposase comprises the amino acid sequence SEQ ID NO:4, or a variant thereof having at least 65%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% sequence identity to SEQ ID NO:4.
The claims recite the terms “core piggyBac transposase”, “modified transposase”, and “piggyBac transposase” without any distinction or special definitions disclosed in the specification. For the sake of compact prosecution, the terms “modified transposase” and “piggyBac transposase” are being interpreted as corresponding to the full length transposase being claimed, and the term “core piggyBac transposase” is being interpreted to correspond to a portion of which the full length transposase is comprised
Regarding claim 1, the recited transposase is only structurally defined as comprising a core piggyBac transposase lacking one or more of the 74 N-terminal amino acids, having a duplication of the C-terminal 53 amino acids, or a combination thereof. As the core piggyBac transposase is structurally undefined by the claim and the instant specification, the claimed transposase encompasses a polypeptide having any amino acid sequence as discussed in the rejections above. In view of the indefiniteness of the structure of the claimed transposase, UNI1 discloses a DDE_Tnp_1_7 domain-containing protein of Trichoplusia ni resulting from analysis of transposon insertions which satisfies the structural limitations of the claimed transposase.
Regarding claim 2, in view of the indefiniteness of the limitation on the piggyBac core sequence, the claim is being interpreted such that the modified transposon of claim 1 is being limited to only comprise the amino acid sequence of the core piggyBac sequence of SEQ ID NO: 1. In view of this interpretation, the polypeptide of UNI1 shares 100% sequence identity with SEQ ID NO: 1 [see Appendix B], and is therefore considered to have a piggyBac core comprising SEQ ID NO: 1.
Regarding claims 3-4, the polypeptide of UNI1 shares 99.8% sequence identity (100% local similarity) with SEQ ID NO: 4 [see Appendix A], and as such is considered to satisfy the limitation of claim 4 of “the piggyBac transposase comprises the amino acid sequence SEQ ID NO: 4” and “the piggyBac transposase comprises a variant thereof having at least 99% sequence identity to SEQ ID NO: 4”. As the transposase of claim 4 is encompassed by the structural limitations of claim 1, the polypeptide is considered to be a transposase, as the associated transposase activity is understood to be inherent to the structure of the polypeptide (see MPEP 2112.01(I)). Additionally, SEQ ID NO: 2 shares 100% identity with SEQ ID NO: 4 [see Appendix C], and therefore the polypeptide of UNI1 satisfies the limitation in claim 3 reciting “the piggyBac transposase comprises the formula Xa – SEQ ID NO: 2” when Xa is 0 aa from SEQ ID NO: 3.
For these reasons, UNI1 anticipates claims 1-4.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,252,693. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Regarding instant claim 1, claim 1 of the patent recites a plasmid comprising a nucleic acid sequence encoding a transposase. As the instantly claimed transposase is only structurally defined as comprising a core piggyBac transposase lacking one or more of the 74 N-terminal amino acids, having a duplication of the C-terminal 53 amino acids, or a combination thereof. As the core piggyBac transposase is structurally undefined by the instant claim and the instant specification, the instantly claimed transposase encompasses a polypeptide having any amino acid sequence as discussed in the rejections above, and as such the transposase recited by the patent satisfies the structural limitations of the instantly claimed transposase.
Claims 2-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,252,693 in view of UNI1.
The claims of the patent as applied to instant claim 1 are above. The claims of the patent do not recite the core piggyBac transposase comprises the amino acid sequence of SEQ ID NO: 1.
Regarding instant claims 2-4, in view of the indefiniteness of the limitation on the piggyBac core sequence, the instant claim is being interpreted such that the modified transposon of instant claim 1 is being limited to only comprise the amino acid sequence of the core piggyBac sequence of SEQ ID NO: 1. In view of this interpretation, the polypeptide of UNI1 shares 100% sequence identity with SEQ ID NO: 1, and is therefore considered to have a piggyBac core comprising SEQ ID NO: 1 recited in instant claim 2. The polypeptide of UNI1 also shares 99.8% sequence identity (100% local similarity) with SEQ ID NO: 4 [see Appendix A], and as such is considered to satisfy the limitations of instant claim 4 of “the piggyBac transposase comprises the amino acid sequence SEQ ID NO: 4” and “the piggyBac transposase comprises a variant thereof having at least 99% sequence identity to SEQ ID NO: 4”. As the transposase of instant claim 4 is encompassed by the structural limitations of instant claim 1, the polypeptide is considered to be a transposase, as the associated transposase activity is understood to be inherent to the structure of the polypeptide (see MPEP 2112.01(I)). Additionally, SEQ ID NO: 2 shares 100% identity with SEQ ID NO: 4 [see Appendix C], and therefore the polypeptide of UNI1 satisfies the limitation in claim 3 reciting “the piggyBac transposase comprises the formula Xa – SEQ ID NO: 2” when Xa is 0 aa from SEQ ID NO: 3.
In view of UNI1, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify the claims of the patent by using the transposase of UNI1 to arrive at the claimed invention, since the simple substitution of one known element for another results in a predictable result. One of ordinary skill in the art would have recognized the transposase of the patent and the polypeptide of UNI1 are both transposases, and as such both are capable of being incorporated into such plasmids as described by the patent. Thus it would have been obvious to one of ordinary skill in the art to replace the transposase of the patent with the polypeptide of UNI1, as one of ordinary skill in the art would have been able to carry out such a substitution with a reasonable expectation of success because both the patent and UNI1 relate to transposases.
Conclusion
Status of the Application:
Claims 1-23 are pending.
Claims 5-23 are withdrawn.
Claims 1-4 are rejected.
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH SPANGLER whose telephone number is (571)270-0314. The examiner can normally be reached M-F 7:30 am - 4:30 pm.
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/JOSEPH R SPANGLER/
Examiner
Art Unit 1656
/David Steadman/Primary Examiner, Art Unit 1656
APPENDIX A
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216
572
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Sequence alignment of SEQ ID NO: 4 with UNI1.
APPENDIX B
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203
567
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Sequence alignment of SEQ ID NO: 1 with UNI1.
APPENDIX C
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203
566
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Sequence alignment of SEQ ID NO: 2 with SEQ ID NO: 4.
Prosecution Insights