DETAILED ACTION
Status of Application
The amendments and response and eTerminal disclaimer filed 28 May 2026 are acknowledged and have been considered in their entireties. Claims 39-40 and 43-52 are cancelled; thus, claims 33-37 and 41-42 remain pending; Claims 35-40 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 33-34 and 41-42 remain subject to examination on the merits.
Terminal Disclaimer
The terminal disclaimer filed on 28 May 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patents: 8399643, 9546382, 10287559, 11485959, 10131885 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawal of Previous Objections/Rejections
Claim Objections
The objection to claim 33 for two typographical errors with withdrawn in view of the amendments to correct the spelling of “proline” in lines 8 and 17.
The rejection of claims 41 and 42 under 35 U.S.C. 112(b) for being unclear whether or not substitutions at all three positions 30, 165 and 282 are required or only one of the three is withdrawn in view of the amendments to clarify all three are being substituted.
The non-provisional, non-statutory double patenting rejections over US Patents 8399643, 9546382, 10287559, 11485959, 10131885 are withdrawn in view of the terminal disclaimer as noted above.
Maintained 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 33-34 and 41-42 area rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-10 of U.S. Patent No. 10329543. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims to the ‘543 patent render obvious/anticipate the instant claims.
The instant claims in their broadest are drawn to: a hyperactive transposase protein comprising an amino acid sequence having at least 90% amino acid sequence identity to the protein encoded by the nucleotide sequence of SEQ ID NO: 1 and comprising at least one of the following amino acid substitutions as compared to the protein encoded by the nucleotide sequence of SEQ ID NO: 1: an asparagine for the serine at position 3; a valine for the isoleucine at position 30; a serine for the alanine at position 46; a threonine for the alanine at position 46; a tryptophan for the isoleucine at position 82; a proline for the serine at position 103; a pro line for the arginine at position 119; an alanine for the cysteine at position 125; a leucine for the cysteine at position 125; a serine for the glycine at position 165; a lysine for the tyrosine at position 177; a histidine for the tyrosine at position 177; a leucine for the phenylalanine at position 180; an isoleucine for the phenylalanine at position 180; a valine for the phenylalanine at position 180; a leucine for the methionine at position 185; a glycine for the alanine at position 187; a tryptophan for the phenylalanine at position 200; a proline for the valine at position 207; a phenylalanine for the valine at position 209; a phenylalanine for the methionine at position 226; an arginine for the leucine at position 235; a lysine for the valine at position 240; a leucine for the phenylalanine at position 241; a lysine for the pro line at position 243; a serine for the asparagine at position 258; a glutamine for the methionine at position 282; a tryptophan for the leucine at position 296; a tyrosine for the leucine at position 296; a phenylalanine for the leucine at position 296; a leucine for the methionine at position 298; an alanine for the methionine at position 298; a valine for the methionine at position 298; an isoleucine for the proline at position 311; a valine for the proline at position 311; a lysine for the arginine at position 315; a glycine for the threonine at position 319; an arginine for the tyrosine at position 327; a valine for the tyrosine at position 328; a glycine for the cysteine at position 340; a leucine for the cysteine at position 340; a histidine for the aspartic acid at position 421; an isoleucine for the valine at position 436; a tyrosine for the methionine at position 456; a phenylalanine for the leucine at position 470; a lysine for the serine at position 486; a leucine for the methionine at position 503; an isoleucine for the methionine at position 503; a lysine for the valine at position 552; a threonine for the alanine at position 570; a proline for the glutamine at position 591; or an arginine for the glutamine at position 591. Dependent claim 41 recites the hyperactive piggybac transposase of claim 33, comprises an amino acid substitution at positions 30, 165, 282, wherein the substitution at position 30 is a substitution of a Valine for an Isoleucine (I30V), and wherein the substitution at position 165 is a substitution of a Serine for a Glycine (G165S). Dependent claim 42 recites the hyperactive piggbac transposase of claim 41, wherein the substitution at position 282 is a substitution of any amino acid (X) for a Methionine (M282X), the amino acid (X) selected from the group consisting of a Leucine (L), an Isoleucine (I), a Valine (V), and an Alanine (A).
The claims to the ‘543 patent in their broadest are drawn to methods of producing a plurality of expanded modified T cells (claim 1) by utilizing a transposase, specifically a hyperactive piggybac transposes comprising SEQ ID NO: 4 which has substitutions at positions 30, 165, 282 and 538 of SEQ ID NO: 4 (Dependent claims 4-7); specifically: an I30V substitution (Dependent claim 8); a G165S substitution (Dependent claim 9); a M282V substitution (Dependent claim 10); all of which are recited instant claims 33 and 41-42.
It is noted, instant SEQ ID NO: 2 and SEQ ID NO: 4 of the ‘543 patent have 100% sequence identity with one another – See Supplemental Content, file 20250827_112244_us-18-051-109a-2.minpct90.rai, Duplicates for Result #1.
Thus, the difference between the claims is the claims of the ‘543 patent are drawn to methods of using the same/overlapping hyperactive piggybac transposes which have the same substitutions as claimed in claims 33 and 41-42. An additional difference is the ‘543 patent claims does not define any nucleic acid encoding the hyperactive piggybac transposase. However, the claims are not drawn to nucleic acids and therefore not limited by SEQ ID NO: 1, rather they are drawn to and limited to the encoded hyperactive transposase protein comprising SEQ ID NO: 2 or sequences having 90% identity thereto along with the requisite substitutions. Thus, claims 1 and 6-8 of the ‘959 would render obvious the instant claims when claims 33, 41 and 42 are combined.
It is noted, instant SEQ ID NO: 1 encodes a protein having 99.8% sequence identity to SEQ ID NO: 4 of the ‘543 patent, there being a single mismatch at amino acid 303 - See Supplemental Content, file 20260122_085950_us-18-051-109a-1.rai, Duplicates for Result #6, there being a Tyr at this position. In SEQ ID NO: 2, position 303 is a Tyr. It is noted, however, the codon “ACC” does not encode Tyr, instead it encodes Thr. This seems to be a peristent inconsistency/error throughout the family of patents.
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Instant SEQ ID NO: 1 supposedly encodes instant SEQ ID NO: 2, but there is Tyr at instant amino acid 303 (throughout the entire patent family for SEQ ID NO: 2) and not a Thr.
Nonetheless, even with a Tyr at position 303 instead of Thr, the encoded amino acid sequence of the instant claims has 99.8% sequence identity with SEQ ID NO: 2 of the ‘543 patent.
Applicant’s Response and Examiner’s Rebuttal:
Applicant’s traverse the rejection of record and state that the rejection is not a proper rejection because the ‘543 patent does not qualify as a reference for the purpose non-statutory double patenting rejection, because of the patent term filing dates and the decisions made in Ex parte Baurin (PTAB November 2024, and 2025) which relies heavily upon In re Allergen (Fed Circ., 2024) and the merits of the Patent Trial Appeal Board decision.
Applicant’s suggest that the claims to the ‘543 patent are somehow patentably distinct from the instant claims but do not point out how. As noted in the rejection above, the claims in the ‘543 patent actually would anticipate the instant claims. Just because the two patent lineages differ and the great-grandparent published before the ‘543 patent, does not render them distinct (See Remarks, last paragraph, p. 8).
It should be noted, are two separate justifications for double patenting. See In re Hubbell, 709 F. 3d 1140 (Fed. Cir. 2013) (“There are two justifications for obviousness-type double patenting. The first is ‘to prevent unjustified timewise extension of the right to exclude granted by a patent no matter how the extension is brought about.’ … The second rationale is to prevent multiple infringement suits by different assignees asserting essentially the same patented invention … this court reaffirmed the multiple assignee harassment rationale and applied it to a situation where, as here, the patents were related to the application only by way of a common inventor … ."). See also MPEP 804(II)(B) (“A rejection based on nonstatutory double patenting is based on a judicially created doctrine grounded in public policy so as to prevent the unjustified or improper timewise extension of the right to exclude granted by a patent … A double patenting rejection also serves public policy interests by preventing the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982).”). So even assuming arguendo there is not an extension of patent rights as argued by Applicant’s, there still is the consideration of harassment by multiple owners.
In addition, the decisions in In re Allergen and Ex parte Baurin relied upon the fact that the application being considered was “the first patent ever” to issue for a specific invention. Clearly, the instant application is not the first patent ever to issue for the claimed invention, nor could the ‘543 patent be considered as such. In Allergan, the court held that claims to the first patent ever to be filed covering a particular drug compound are not subject to nonstatutory double patenting over claims issued in a subsequently filed patent that shares a priority date with the first patent, even where those claims would expire later than the subsequently filed patent. Allergan, 111 F.4th at 1371. The court explained that is so because the first filed patent does not extend or prolong the monopoly beyond the period allowed by law; put differently it is not a “second, later expiring patent for the same invention.” Id. (citing Miller v. Eagle Mfg. Co., 151 U.S. 186, 198 (1894), and Abbvie, 764 F.3d at 1373). The Allergan court noted that “[a]s the first-filed, first-issued patent in its family, it is the patent that sets the maximum period of exclusivity for the claimed subject matter and any patentably indistinct variants.” Id. The Board in Baurin went further, however, and stipulated that it did not have to actually issue from the same family at all.
For these reasons, the rejection of record is maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 21 July 2026
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