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 Claims
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on June 24, 2026 has been entered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is in response to the papers filed on October 30, 2025. Claims 56, 70, 71, 72, 97 – 98, and 100 - 106 are currently pending. Claims 56, 70, 97, and 98 have been amended, and claims 1, 8, 67, 68, 69, 73, 76 – 80, 83, 87 – 89, 91 – 92, 95 – 96, and 99 have been canceled in the response filed June 24, 2026. Claims 100 – 106 have been newly added in the response filed June 24, 2026.
Applicant's election without traverse, in the reply filed 27 June, 2025 of Group III, claims 56, 67 – 73, 75, and 95, drawn to a CD8 targeting molecule; and the following election of Species, without traverse, is acknowledged:
Species (A): the ankyrin repeat protein comprises a sequence selected from the group consisting of Seq ID Nos. 1 – 28 (instant claim 72); and
Species (B): the target molecule comprises a lipid or lipid like component (instant claim 75).
Claims 1, 8, 76– 80, 83, 85, 87 – 89, 96, 91, 92 and 96 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claim 67, 68, 69, 73, and 95 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
The restriction requirement was still deemed proper and is therefore made FINAL.
The claims will be examined insofar as they read on the elected species.
Therefore, claims 56, 70, 71, 72, 97 – 98, and 100 - 106 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed 1 June, 2022, is a 35 U.S.C. 371 national stage filing of International Application No. PCT/EP2020/087627, filed 22 December, 2022, which claims the benefit of PCT/EP2019087110, filed 27 December, 2019. A Certified translated copy of the PCT/EP2019087110 filed on 06/01/2022 is acknowledged.
Therefore, the earliest priority date is 27 December, 2019.
Withdrawn Objections/Rejections
Claim Rejection - 35 USC § 103
The rejection of claim 56, 70 – 71, and 97 - 100 is withdrawn, under 35 U.S.C. 103 as being unpatentable over Zhou et al. (hereinafter referred to as “Zhou”) (Zhou Q et al. T-cell receptor gene transfer exclusively to human CD8(+) cells enhances tumor cell killing. Blood. 2012 Nov 22;120(22):4334-42. doi: 10.1182/blood-2012-02-412973. Epub 2012 Aug 16. PMID: 22898597.), Munch et al. (hereinafter referred to as “Munch”) (Münch RC et al. DARPins: an efficient targeting domain for lentiviral vectors. Mol Ther. 2011 Apr;19(4):686-93. doi: 10.1038/mt.2010.298. Epub 2011 Jan 11. PMID: 21224833; PMCID: PMC3070099.), and in further view of Tamaskovic et al. (Tamaskovic et al. Designed Ankyrin Repeat Proteins (DARPins): From Research to Therapy. Methods in Enzymology, Volume 503, Chapter 5. 2012 Elsevier).
Claim 56 has been amended to recite that the ankyrin repeat protein is attached on the surface of the cationic lipid or the PEG lipid. Zhou, Munch, and Tamaskovic do not teach this limitation. Additionally, the Examiner agrees that Zhou, Munch, and Tamaskovic teaches that the CD8 binding molecule is conjugated to the PEG, but these references do not teach that the CD8 binding molecule is conjugated to the PEG-lipid.
In view of the withdrawn rejection, Applicant’s arguments are moot.
New Objections/Rejections
Claim Rejections - 35 USC § 112(a) – New Matter
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 56, 70 – 72, 97 – 98, and 100 - 106 are 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 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, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection. This rejection is necessitated by the response filed June 24, 2026.
MPEP § 2163.II.A.3.(b) states, “when filing an amendment an applicant should show support in the original disclosure for new or amended claims” and “[i]f the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112, para. 1, as lacking adequate written description”. According to MPEP § 2163.I.B, “While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure” and “The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117”.
The claim contains subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art (hereafter the Artisan), that the inventor(s), at the time the application was filed, had possession of the claimed invention. 37 CFR §1.118 (a) states that "No amendment shall introduce new matter into the disclosure of an application after the filing date of the application".
Claim 56 has been amended to recite that “the ankyrin repeat protein is attached on the surface of the at least one cationic lipid or PEG-lipid” in lines 3 – 4. Upon review of the instant as-Filed Specification, support was not found for the “the ankyrin repeat protein is attached on the surface of the at least one cationic lipid or PEG-lipid”. The instant as-Filed specification teaches that the “particle is functionalized with the ankyrin repeat protein on its surface” (Paragraph [0084]), wherein the particles comprising the nucleic acid and a targeting molecule for targeting the immune effector cells, wherein the targeting molecule is a designed ankyrin repeat protein (DARPin) (Abstract). Thus, the as-Filed Specification teaches that the particles comprise a nucleic acid and a functionalized ankyrin repeat protein on the surface. The disclosure does not teach that “the ankyrin repeat protein is attached on the surface of the at least one cationic lipid or PEG-lipid.”
Additionally, support was not found for “at least one cationic lipid or PEG lipid comprises a nucleic acid” of newly added claim 101. The as-Filed Specification teaches that the particles comprise a nucleic acid and a targeting molecule for targeting the immune effector cells, wherein the targeting molecule is a designed ankyrin repeat protein (DARPin) (Abstract), and that the particle comprises a nucleic acid encoding a CAR or TCR (Paragraph [0081]). The disclosure does not teach that “the one cationic lipid or PEG lipid comprises a nucleic acid.
A claim by claim analysis and for dependents of claim 56, and a method step by method step analysis regarding where support can be found in the originally filed specification is respectfully suggested. See MPEP § 2163 particularly § 2163.06.
Claims 56, 70 – 72, 97 – 98, and 100 - 106 will remain rejected until Applicant cancels all new matter.
Claim Rejection - 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.
Claims 56, 70 – 72, 97 – 98, and 100 – 106 are newly 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. This rejection is necessitated by the response filed June 24, 2026.
Claim 56 is indefinite for the recitation of “CD8 binding molecule comprising an ankyrin repeat protein targeting CD8+ T cells, wherein the CD8-binding molecule is conjugated to at least on cationic lipid or PEG lipid, wherein the ankyrin repeat protein is attached on the surface of the at least one cationic lipid or PEG-lipid” in lines 1 – 4. It is unclear whether the CD8 binding molecule is bound to the cationic lipid or PEG lipid, or whether the ankyrin repeat protein is bound to the cationic lipid or PEG lipid. Further, it is unclear whether the ankyrin repat is attached to the surface of the PEF or the surface of the lipid. Thus, the metes and bounds of the claim cannot be determined.
Claim 101 is indefinite for the recitation of “PEG lipid comprises a nucleic acid” in line 2. The as-Filed Specification teaches that the particles comprise a nucleic acid and a targeting molecule for targeting the immune effector cells, wherein the targeting molecule is a designed ankyrin repeat protein (DARPin) (Abstract). It is not clear how a lipid can comprise a nucleic acid, and thus, the metes and bounds of the claim cannot be determined. The disclosure teaches that the particle comprises a nucleic acid encoding a CAR or TCR (Paragraph [0081]), and that the particles comprise the nucleic acid and a targeting molecule for targeting the immune effector cells (Abstract). For compact prosecution, the PEG lipid is being referred to as the CD8 binding molecule (aka the particle) that comprises a nucleic acid.
Claim 106 is indefinite for the recitation of “wherein the ankyrin repeat protein comprises at least one consensus repeat module…..are present in a repeat domain” in lines 1 – 4. It is unclear if repeat modules 1, 2, and 3 all comprise Seq ID Nos: 1 – 28, or whether all three repeat modules together comprise Seq ID Nos: 1 – 28. Thus, the metes and bounds of the claim cannot be determined.
Claims 70 – 72, 97 – 98, and 100 - 106 are indefinite insofar as they ultimately depend on claim 56.
Conclusion
Claims 56, 70 – 72, 97 – 98, and 100 - 106 remain rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYOMA SHAILESH THAKKER whose telephone number is (571)272-2954. The examiner can normally be reached M-F 8:30 - 5:30 EST.
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/VYOMA SHUBHAM TIWARI/Examiner, Art Unit 1634
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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