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
1. Applicant’s election without traverse of Group II in the reply filed on 2/9/2026 is acknowledged.
Claims 71-84 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 2/9/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
3. The disclosure is objected to because of the following informalities:
The use of trademarked terms, which is a trade name or a mark used in commerce, has been noted in this application on page 19. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
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.
Appropriate correction is required.
Claim Objections
4. Claims 71, 73 are objected to because of the following informalities:
For improved clarity, claim 71 should recite the term in its entirety before abbreviation. In this case, the claim should recite “inverted terminal repeats (ITRs)”.
As to claim 73, for improved clarity, the claim should recite “at least 80% identical”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
5. Claims 73-78, 81 are 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.
See claims 73-78, 81 as submitted 2/9/2026.
As to claim 73, it is not clear what the correlation of the percentages is from SEQ ID NO: 6 to SEQ ID NO: 7. The instant specification teaches wherein SEQ ID NO: 6 encodes human ELP1 protein [0162]. However, the claim only recites nucleic acid with at least “80%” identity thereto but still requires that the protein be at least 95% identical to SEQ ID NO: 7. It is not clear if SEQ ID NO: 6 includes additional components beyond human ELP1 protein or not, or how much of SEQ ID NO: 6 is required to meet the 95% identity of SEQ ID NO: 7. Claims 74-78 depend on this claim.
Further as to claims 77, 78, the claims recite at least 95% identity to AAV2 serotype 2 capsid protein as well as AAV serotype 9 capsid protein. It is not clear what the percent identity numbers are relative to or where position 1 would start to determine percent identity to.
As to claim 81, it is not clear what a “normal” subject is or what makes a subject normal as compared to the subject recited in claim 80. Further, as to claim 81, the method recites “increasing hELP1 expression”, yet (ii) recites exhibiting “reduced expression of ELP1”. It is not clear how increasing expression leads to reduced expression. The claim appears to intend that the subject previously or already has mutant ELP1 or reduced expression of ELP1 or reduced functionality of ELP1 thus needing gene therapy, but the language as currently recited is not clear.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
6. Claims 73-78 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
See claims 73-78 as submitted 2/9/2026.
See also the 35 U.S.C. 112(b) rejection above.
As to claim 73, the claim ultimately depends on claim 71, which only recites that the nucleic acid encode amino acid sequence at least 95% identical to SEQ ID NO: 7. However, claim 73 recites that the nucleic acid encoding the hELP1 protein has a sequence at least 80% identical to the nucleic acid sequence of SEQ ID NO: 6, and also encodes amino acid sequence at least 95% identical to SEQ ID NO: 7. Since the relationship between SEQ ID NO: 6 and SEQ ID NO: 7 is not clear as indicated above, claim 73 appears to further broaden by reciting a lower percent identity (80% identity as opposed to 95% identity) rather than further limit the nucleic acid as recited in claim 71. Claims 74-78 depend on this claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
7. Claims 75-78 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
See claims 75-78 as submitted 2/9/2026.
Claim 75 recites the rAAV virion of claim 74, wherein the promoter sequence
comprises: (i) the nucleic acid sequence of SEQ ID NO: 4, (ii) a sub-sequence from the nucleic acid sequence of SEQ ID NO: 5 that exhibits promoter function in a neuron of the CNS or PNS, or (iii) a sub-sequence within positions 1-206 of the nucleic acid sequence of SEQ ID NO: 5 that exhibits promoter function in a neuron of the CNS or PNS.
Each of the claims is drawn, inherently or explicitly, to any sub-sequence of SEQ ID NO: 5 or sub-sequence within positions 1-206 of SEQ ID NO: 5 that exhibits promoter function in a neuron of the CNS or PNS. Thus, the claims are drawn to compositions comprising a genus of sub-sequences of SEQ ID NO: 5 or sub-sequences within positions 1-206 of SEQ ID NO: 5 having the ability to exhibits promoter function in a neuron of the CNS or PNS.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
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. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the specification teaches: sub-sequence from SEQ ID NO: 5 that exhibits promoter function in a mammalian cell; or a sequence within positions 1-206 of SEQ ID NO: 5 that exhibits promoter function in a mammalian cell [0059, 0167]; SEQ ID NO: 4.
As to the state of the art, the art teaches: promoters can range in length from 100 to 1000 base pairs (See abstract of Le et al. (“Classifying Promoters by Interpreting the Hidden Information of DNA Sequences via Deep Learning and Combination of Continuous FastText N-Grams,” Front Bioeng Biotechnol. 7:305 (2019))(See PTO-892: Notice of References Cited)). It is noted the instant specification teaches wherein SEQ ID NO: 5 is 1277 nucleotides long.
However, while the specification as indicated above identifies recites SEQ ID NO: 5 and positions 1-206 of SEQ ID NO: 5, it does not identify a representative sample of sub-sequences of SEQ ID NO: 5 and fragments within positions 1-206 thereof that exhibit promoter function in a neuron of the CNS or PNS, especially in view of the breadth of the claims. Thus, the application does not identify a representative sample of sub-sequences as claimed clearly within the breadth of the claimed genus.
There is no apparent common conserved structure to the different sub-sequences that distinguishes those that exhibit promoter function in a neuron of the CNS or PNS from those that do not. There is therefore a high level of uncertainty as to which sub-sequences fall within the scope of the indicated genus.
Further, the specification has identified sub-sequences only by function: the ability to exhibits promoter function in a neuron of the CNS or PNS. The specification does not provide a specific structure of any sub-sequence within the genus that correlates with the required function. Because there is no identification of structures common to each sequence, nor sufficient representative examples of the sub-sequences by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of sub-sequences through identification of a structure and function. While the sub-sequences are required to exhibit promoter function in a neuron of the CNS or PNS, this is not alone sufficient structure to correlate with the function. This is because the mere presence of a sub-sequence of SEQ ID NO: 5 or a sub-sequence within positions 1-206 of SEQ ID NO: 5 does not demonstrate that the sequence would be able to exhibit promoter function in a neuron of the CNS or PNS.
For the reasons above, and in view of the uncertainty as to which sub-sequence would be able to exhibits promoter function in a neuron of the CNS or PNS, the application has not provided sufficient written description support for the genus of sub-sequences identified in claim 75. The application therefore fails to provide adequate support for methods of using this genus of sub-sequences.
Conclusion
8. Nucleic acid encoding human ELP1 protein with an amino acid sequence that is at least 95% identical to SEQ ID NO: 7 as recited in claim 71 is free of the prior art of record.
9. Claims 72, 79, 80, 82-84 are objected to for depending on an objected to claim.
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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