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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26, 2025 has been entered.
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
3. Applicant’s amendment filed June 26, 2025 is acknowledged. Claims 2-3 and 8-9 are cancelled. Claims 1 and 7 are amended. Claims 1, 4-7 and 10-13 are pending in this application. Claims 11-13 are withdrawn without traverse (filed 08/22/2024) from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 22, 2024.
4. Claims 1, 4-7 and 10 are under examination with respect to SEQ ID NO:2 in this office action.
5. Applicant’s arguments filed on June 26, 2025 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections/Objections Withdrawn
6. The rejection of claim 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in response to Applicant’s amendment to the claim.
Claim Rejections/Objections Maintained
In view of the amendment filed on June 26, 2025, the following rejections are maintained.
Claim Objections
7. Claim 1 stands objected to because the limitation “the” before the limitation “group’ in line 3 of the claim is missing. Appropriate correction is required.
Claim Rejections - 35 USC § 112
8. 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 1, 4-7 and 10 stand 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. The rejection is maintained of record and the reasons set forth below.
Claims 1, 4-7 and 10 as amended are drawn to a nucleic acid construct encoding a fusion polypeptide including an intracellular domain of Trk having an amino acid sequence selected from the group consisting of SEQ NOs: 2, 6, 9, 12 and 14; and a membrane localization sequence that induces lipid modification of an amino acid; wherein the fusion polypeptide does not include an extracellular domain of any type of tyrosine kinase inhibitor.
The claims encompass a genus of nucleic acid constructs encoding a genus of fusion polypeptide comprising an intracellular domain of Trk having an amino acid sequence of SEQ ID NOs: 2, 6, 9, 12 or 14, and a genus of membrane localization sequence that induces lipid modification of a genus of an amino acid, wherein the fusion polypeptide does not include a genus of extracellular domain of a genus of tyrosine kinase inhibitor.
Note that the limitation “having an amino acid sequence selected from group of SEQ ID NO:2, 6, 9, 12 and 14” include fragments within SEQ ID NOs: 2, 6, 9, 12 or 14.
Applicant has not disclosed sufficient species for the broad genus of nucleic acid construct encoding the broad genus of fusion polypeptide including an intracellular domain of Trk having an amino acid sequence selected from the group consisting of SEQ NOs: 2, 6, 9, 12 and 14; and a membrane localization sequence that induces lipid modification of an amino acid; wherein the fusion polypeptide does not include an extracellular domain of any type of tyrosine kinase inhibitor.
The specification fails to teach the detailed structures and sequences and characteristics for the claimed genus of nucleic acid construct encoding the claimed genus of fusion polypeptide which comprises an intracellular domain of Trk having an amino acid sequence of recited SEQ ID NOs:, and a membrane localization sequence that induces lipid modification and wherein the fusion protein does not include an extracellular domain of any type of tyrosine kinase inhibitor.
Response to Arguments
On p. 5-6 of the response, Applicant argues that the rejection has been overcome in view of amendment to claim 1 by reciting “an intracellular domain of Trk having an amino acid sequence selected from group consisting of SEQ ID NO:2, 6, 9, 12 and 14”. Applicant argues that localizing the N-terminal of the fusion polypeptide on a membrane using a myristoylation sequence enables the fusion polypeptide to function as supported by the reference: “Molecular Therapy Vol.31 No.3 March 2023” (Nishijima et al. Mol. Thera. 2023;31:810-824).
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2163, MPEP §§2163.01-2163.03, the specification fails to provide sufficient description or information or evidence to demonstrate that Applicant is in possession of the claimed genus of nucleic acid construct encoding a genus of fusion polypeptide comprising an intracellular domain of Trk having an amino acid sequence selected from SEQ ID NOs: 2, 6, 9, 12 and 14 and a membrane localization sequence that induces lipid modification on an amino acid, and wherein the fusion polypeptide does not include an extracellular domain of any type of tyrosine kinase inhibitor because:
i. The specification provides no well-established structural and functional relationship or correlation between the claimed genus of nucleic acid construct and the nucleic acid construct of CA-TrkB/AAV-CA-TrkB (SEQ ID NO:4), iSH-TrkB (SEQ ID NO: 5), CA-TrkA/AAV-CA-TrkA (SEQ ID NO: 8) or CA-TrkC/AAV-CA-TrkC (SEQ ID NO:11) shown paragraphs [0111]-[0152], Examples 1-6.
The limitation “an intracellular domain of Trk having an amino acid sequence selected from group of SEQ ID NO:2, 6, 9, 12 and 14” include fragments within SEQ ID NO: 2, 6, 9, 12 or 14. There is no structural and functional relationship between the fragment within SEQ ID NO: 2, 6, 9, 12 or 14 and the intracellular domain of SEQ ID NO:2, 6, 9, 12 or 14.
The limitation “a membrane localization sequence that induces lipid modification at an amino acid” is not limited to a farnesylation sequence or a N-myristoylation sequence shown in paragraph [0035] of the specification or the cited reference but also encompass structurally and functionally undefined sequences.
The specification provides no well-established structural and functional relationship between the claimed genus of the claimed membrane localization sequence that induces lipid modification of an amino acid and the farnesylation signal sequence of SEQ ID NO: 1 that causes a protein to be localized on a membrane as shown in paragraph [0113]. The specification fails to teach what specific sequences and structures are required for the claimed genus of membrane localization sequence that induces lipid modification at an amino acid.
ii. The specification fails to teach the detailed structures and sequences and characteristics for the claimed genus of nucleic acid construct encoding the claimed genus of fusion polypeptide comprising a genus of intracellular domain of Trk having an amino acid sequence selected from SEQ ID NO: 2, 6, 9, 12 or 14 including fragments and a genus of membrane localization sequence that induces lipid modification on an amino acid, and wherein the fusion polypeptide does not include a genus of extracellular domain of a genus of any type of tyrosine kinase inhibitor.
It is not known what the structure of the claimed extracellular domain of any type of tyrosine kinase inhibitor is and what sequences are excluded by the claimed fusion polypeptide.
There is no well-established structural and functional relationship or correlation between the claimed genus of nucleic acid construct and the nucleic acid construct of CA-TrkB/AAV-CA-TrkB (SEQ ID NO:4), iSH-TrkB (SEQ ID NO: 5), CA-TrkA/AAV-CA-TrkA (SEQ ID NO: 8) or CA-TrkC/AAV-CA-TrkC (SEQ ID NO:11) shown paragraphs [0111]-[0152], Examples 1-6.
There is no information regarding the relation of the structure of other structurally and functionally undefined intracellular domains of Trk including fragments within recited SEQ ID NO: to the function of SEQ ID NO:2 (the intracellular domain of TrkB in CA-TrkB/AAV-CA-TrkB), SEQ ID NO:6 (the intracellular domain of TrkA in CA-TrkA/AAV-CA-TrkA) or SEQ ID NO:9 (the intracellular domain of TrkC in CA-TrkC/AAV-CA-TrkC).
There is also no information regarding the relation of structure of other structurally and functionally undefined membrane localization sequences that induce lipid modification of an amino acid to the function of SEQ ID NO: 1 (the farnesylation signal sequence for causing a protein to be localized at a membrane).
There is no well-established structural and functional relationship or correlation between the claimed genus of fusion polypeptide that does not include an extracellular domain of any type of tyrosine kinase inhibitor and the fusion protein encoded by CA-TrkB/AAV-CA-TrkB (SEQ ID NO:4), iSH-TrkB (SEQ ID NO: 5), CA-TrkA/AAV-CA-TrkA (SEQ ID NO: 8) or CA-TrkC/AAV-CA-TrkC (SEQ ID NO:11).
The specification fails to teach what other structures/amino acid sequences can or cannot be included/changed in the claimed fusion polypeptide, the claimed intracellular domain of Trk and the claimed membrane localization sequence. The instant specification fails to provide sufficient descriptive information, such as definitive structural or functional features of the claimed genus of nucleic acid construct, the claimed genus of fusion polypeptide, the claimed genus of intracellular domain of Trk and the claimed genus of membrane localization sequence that induces lipid modification of an amino acid in order to preserve the activity of CA-TrkB/AAV-CA-TrkB (SEQ ID NO:4), iSH-TrkB (SEQ ID NO: 5), CA-TrkA/AAV-CA-TrkA (SEQ ID NO: 8) or CA-TrkC/AAV-CA-TrkC (SEQ ID NO:11).
Since the common characteristics/features of other nucleic acid constructs, other fusion polypeptides, other intracellular domains of Trk including fragments within recited SEQ ID NOs: and other membrane localization sequences are unknown, a skilled artisan cannot envision the functional correlations of the claimed genus with the claimed invention. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of nucleic acid constructs, fusion polypeptides, intracellular domains of Trk and membrane localization sequences inducing lipid modification of an amino acid.
Based on MPEP § 2161.01 and §2163, “to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116”.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
Therefore, the claimed nucleic acid construct, the claimed pharmaceutical composition and the claimed neural cells transfected with the claimed nucleic acid constructs have not met the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115). Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement. See MPEP § 2161.01 and 2163.
Accordingly, the rejection of claims 1, 4-7 and 10 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 is maintained.
Claim Rejections - 35 USC § 103
9. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-7 and 10 stand rejected under 35 U.S.C. 103 as being unpatentable over Qi et al. (WO2017/123559; issued as US9856497) in view of Mujica et al. (US20190159436). The rejection is maintained of record and the reasons set forth below.
Claims 1, 4-7 and 10 as amended are drawn to a nucleic acid construct encoding a fusion polypeptide including an intracellular domain of Trk having an amino acid sequence selected from the group consisting of SEQ NOs: 2, 6, 9, 12 and 14; and a membrane localization sequence that induces lipid modification of an amino acid; wherein the fusion polypeptide does not include an extracellular domain of any type of tyrosine kinase inhibitor.
Response to Arguments
On p. 6-8 of the response, Applicant argues that Qi does not teach the claimed nucleic acid construct. Applicant argues that while Qi teaches the chimeric receptor polypeptide comprising at least an intracellular domain of RTK, there is no description that the chimeric receptor polypeptide does not comprise an extracellular domain of RTK because the chimeric receptor polypeptide of Qi requires binding to the antigen/ligand (paragraphs [00146], [00149]), which cannot have a feature of not comprising an extracellular domain as recited in amended claim 1.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2141, MPEP2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. Note that the claimed fusion polypeptide encoded by the claimed nucleic acid construct as recited in amended claim 1 comprises: 1) an intracellular domain of Trk having an amino acid sequence selected from the group consisting of SEQ NOs: 2, 6, 9, 12 and 14 including any fragments within recited SEQ ID NOs:; 2) a membrane localization sequence that induces lipid modification of an amino acid, including any sequences that induce lipid modification; and 3) does not include an extracellular domain of any type of tyrosine kinase inhibitor.
The claimed fusion protein recited in amended claim 1 does not exclude an extracellular domain of Trk because “an extracellular domain of any type of tyrosine kinase inhibitor” recited in claim 1 is different from “an extracellular domain of Trk (i.e. a tyrosine kinase receptor for NGF”
The chimeric receptor polypeptide (i.e. fusion polypeptide) encoded by a nucleic acid construct disclosed by Qi includes 1) an intracellular domain of a receptor including Trk and 2) a membrane localization sequence/membrane targeting sequence comprising a membrane targeting peptide and directing a polypeptide to a plasma membrane or membrane of a cellular organelle (see paragraphs [00409]-[00412]; [00100]-[00107]), and 3) does not include an extracellular domain of any type of tyrosine kinase inhibitor, regardless whether the chimeric receptor polypeptide of Qi requires binding to a ligand/antigen.
ii. In this case, Qi teaches a nucleic acid construct encoding a chimeric receptor polypeptide (i.e. fusion polypeptide), wherein the chimeric receptor polypeptide includes an intracellular domain of a receptor including Trk and a membrane localization sequence/membrane targeting sequence comprising a membrane targeting peptide and directs a polypeptide to a plasma membrane or membrane of a cellular organelle (see paragraphs [00409]-[00412]; [00100]-[00107]), wherein the membrane localization sequence induces lipid modification of an amino acid, and wherein the lipid modification of an amino acid includes fatty-acylation, prenylation, myristoylation, palmitoylation, farnesylation, geranylgeranylation, and also teaches a farnesylation sequence: CAAX motif (see paragraphs [00211]-[00213]). Qi teaches a vector including an adeno-associated virus vector in claims 5-6 (see paragraphs [00106]; [00362]-[00364]); a pharmaceutical composition comprising the claimed nucleic acid construct as in claim 7 (see paragraphs [00260]; [00416] [00382]-[00383]; [00390]-[00393]); and a neural cell transfected with the claimed nucleic acid construct in an expressible manner as in claim 10 (see paragraphs [00257]; [00262]; [00102]-[00107]).
While Qi does not teach that the intracellular domain of Trk is a polypeptide having an amino acid sequence of SEQ ID NO: 2 (elected) in claim 1, Mujica et al. (US20190159436) teach that the intracellular domain of TrkB having the amino acid sequence of SEQ ID NO:62, which is 100% identical to the amino acid sequence of instant SEQ ID NO:2 (see the sequence alignment; p. 22, table 1; Example 1, paragraph [0207]).
A person of ordinary skill in the art would have recognized that selecting and applying the known sequence of SEQ ID NO:2 as the intracellular domain of TrkB and the known technique disclosed by Mujica to the Qi’s nucleic acid construct encoding a chimeric receptor polypeptide (i.e. fusion polypeptide) would have yielded the predictable result of the claimed nucleic acid construct encoding a chimeric receptor polypeptide/fusion polypeptide comprising an intracellular domain of Trk and a membrane localization sequence/membrane targeting sequence, wherein the intracellular domain of Trk has the amino acid sequence of instant SEQ ID NO:2, and resulted in an improved product.
Using the known sequence of SEQ ID NO:2 as the intracellular domain of TrkB in the nucleic acid construct encoding a chimeric receptor polypeptide (i.e. fusion polypeptide) would expand application of the Qi’s nucleic acid construct encoding a chimeric receptor polypeptide (i.e. fusion polypeptide) in targeting and regulating specific gene expression in specific intracellular compartments for therapeutic and pharmaceutical purposes, and would increase patient’s satisfaction with treatment of gene therapy using a nucleic acid construct encoding a chimeric receptor polypeptide (i.e. fusion polypeptide) in targeting and regulating specific gene expression in specific intracellular compartments.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known sequence of SEQ ID NO:2 as the intracellular domain of TrkB and the known technique disclosed by Mujica to the Qi’s nucleic acid construct encoding a chimeric receptor polypeptide (i.e. fusion polypeptide), and yield the predictable result of the claimed nucleic construct encoding a fusion polypeptide including an intracellular domain of Trk and a membrane localization sequence, wherein the intracellular domain of Trk has the amino acid sequence of instant SEQ ID NO:2.
Accordingly, the rejection of claims 1, 4-7 and 10 under 35 U.S.C. 103 as being unpatentable over Qi et al. (WO2017/123559; issued as US9856497) in view of Mujica et al. (US20190159436) is maintained.
New Grounds of Rejection Necessitated by the Amendment
The following rejections are new grounds of rejections necessitated by the amendment filed on January 13, 2020.
Claim Rejections - 35 USC § 112
10. Claims 1, 4-7 and 10 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.
Claims 1, 4-7 and 10 as amended are drawn to a nucleic acid construct encoding a fusion polypeptide including an intracellular domain of Trk having an amino acid sequence selected from the group consisting of SEQ NOs: 2, 6, 9, 12 and 14; and a membrane localization sequence that induces lipid modification of an amino acid; wherein the fusion polypeptide does not include an extracellular domain of any type of tyrosine kinase inhibitor.
The instant claims now recite new limitations “a nucleic acid construct encoding a fusion polypeptide including an intracellular domain of Trk…and a membrane localization sequence…...wherein the fusion polypeptide does not include an extracellular domain of any type of tyrosine kinase inhibitor”, which were not clearly disclosed in the specification and claims as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in the present claims, which did not appear in the specification or original claims, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C. 112.
The specification fails to disclose the new imitations “a nucleic acid construct encoding a fusion polypeptide including an intracellular domain of Trk…and a membrane localization sequence…...wherein the fusion polypeptide does not include an extracellular domain of any type of tyrosine kinase inhibitor”. The specification only discloses “the fusion polypeptide does not include the extracellular domain of Trk and/or the transmembrane domain. In a more preferable example, the fusion polypeptide includes neither the extracellular domain of Trk nor the transmembrane domain” (see para. [0061]; [0112] of the published Application). Applicant provides no guidance as to what is encompassed in the claimed “wherein the fusion polypeptide does not include an extracellular domain of any type of tyrosine kinase inhibitor” or “a nucleic acid construct encoding a fusion polypeptide including an intracellular domain of Trk…and a membrane localization sequence…...wherein the fusion polypeptide does not include an extracellular domain of any type of tyrosine kinase inhibitor”. Accordingly, in the absence of sufficient recitation for “wherein the fusion polypeptide does not include an extracellular domain of any type of tyrosine kinase inhibitor” or a nucleic acid construct encoding a fusion polypeptide including an intracellular domain of Trk…and a membrane localization sequence…...wherein the fusion polypeptide does not include an extracellular domain of any type of tyrosine kinase inhibitor”, the specification does not provide adequate written description to support the new limitations recited in claim 1. Support is not found for the new limitation as disclosed in the original specification and thus the recitation constitutes new matter absent evidence for their support. Applicant is required to cancel the new matter in the reply to this office action. Alternatively, Applicant is invited to clearly point out the written support for the instant limitations.
Conclusion
11. NO CLAIM IS ALLOWED.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANG-YU WANG whose telephone number is (571)272-4521. The examiner can normally be reached Monday-Thursday, 7:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Chang-Yu Wang
March 20, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675