DETAILED ACTION
This Action is in response to the amendment filed on 03/23/2026.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-27 are pending.
Claims 23-27 and the non-elected species remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/02/2025.
Claims 1-22 are examined herein, as they read on the elected species.
Improper Markush Group
Claim 1 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the claim includes a Markush grouping of nucleotide sequences identified as SEQ ID Nos: 1-20 and 75; however, each nucleotide sequence is different from the others and there does not appear to be any structural similarity common to all of the nucleotide sequences (i.e., there is not a single structural similarity). Furthermore, it does not appear that all of the alternatives are members of the same recognized physical or chemical class or the same art-recognized class as they appear to be generic nucleotide sequences.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Objections
Claims 2-22 are objected to as being dependent upon a rejected base claim, but would be allowable if claim 1 were amended to overcome the improper Markush group rejection.
Response to Arguments
With respect to the rejection of claims under 35 USC 112(a) (written description), Applicant’s arguments have been fully considered and in view of the amendment to the claims are persuasive. The rejection has been withdrawn.
With respect to the improper Markush group rejection, Applicant's arguments have been fully considered but they are not persuasive. Applicant argues that each compound of the group shares a nucleic acid backbone which satisfies the requirement for structural similarity and refers to a Patent Trial and Appeal Board (PTAB) decision reversing a similar improper Markush rejection (Ex Parte Ren) and each is shown in the application to share a common use as a genomic safe harbor.
Applicant’s arguments have been fully considered but are not persuasive because Ex Parte Ren is a board decision and is not precedential and has no binding effect on examination. Applicant is reminded that each application is examined on its own merits. In addition, a search of the MPEP for determining a proper Markush group does not indicate that this Board decision was cited for patent examination policy regarding Markush groups. Also, there are other cases from the Board that might be considered to indicate that the claims contain an improper Markush group. See Ex Parte Chettier (Appeal No. 2016-003639). In Ex Parte Chettier, the PTAB states:
“The sequences shown in Table 1 do not share any common sequence, and therefore do not share a common structure. For example, the first two sequences shown in Table 1 are ggtgattctgaagacc[A/G]ctgctatatgtcatct and taaaggatgggaactg[A/Claactagaagaccgtca (Spec. 57.4) Although both sequences, like all DNA sequences, are made up of the same four bases, they do not share any significant similarity in the order in which those bases are arranged. Thus, the structures of the DNA molecules represented by the sequences are different. We therefore agree with the Examiner that the 133 DNA sequences shown in the Specification's Table 1 do not make up a proper Markush group.”; and,
“Appellants also argue that similar rejections for improper Markush groups were made in two other applications and subsequently withdrawn. (Appeal Br. 4-5.) What may have happened during prosecution of other applications, however, has no bearing on whether the Examiner's rejection in this case is merited.” (See pages 4-5).
Furthermore, the fact that all of the compounds of the Markush group share a nucleic acid backbone cannot be considered a significant structural element, since it is shared by all nucleic acid sequence molecules. Additionally, although the specification asserts that the claimed sequences all share a common use as a genomic safe harbor (GSH), it is noted that the specification discloses that of the 6 GSH sequences tested only one (GSH-6, which corresponds to SEQ ID NO: 6) promoted long term CAR expression that translated to effective tumor control (e.g., see specification beginning on page 107 through page 109). Thus, one of skill in the art would not recognize the claimed sequences as having a common use wherein each member could be substituted one for the other, with the expectation that the same intended result would be achieved.
In view of the guidelines set forth in MPEP 2117 for Markush claims, the claims are not considered a proper Markush group, and Applicant’s arguments are not persuasive.
Conclusion
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 J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637
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