DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on May 12, 2026, has been received and entered.
Claim Disposition
3. Claims 1-18, 20-21 and 32 have been cancelled. Claims 19, 22-31 and 33-40 are pending. Claims 19 and 22-30 are under examination. Claims 31 and 33-40 are withdrawn from consideration as directed to a non-elected invention.
Claim objection
4. Claims 19 and 22-30 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 19 is amended to recite “a nucleic acid molecule encoding a [[functional]] chimeric lysosomal acid lipase (LAL) protein, comprising a heterologous signal peptide moiety and a [[functional]] LAL moiety, wherein the signal peptide consists of SEQ ID NO: 5, [[and]] wherein the [[functional]] LAL moiety is a human LAL moiety devoid of its natural signal peptide and [[comprising]] comprises SEQ ID NO: 9 or comprises a sequence that is at least 90% identical to SEQ ID NO: 9 [[having at least 75% sequence identity to]], and wherein the [[said functional]] chimeric LAL protein has enzymatic activity of at least 50% [[as]] compared to [[the]] wild-type human LAL protein set forth in [[of]] SEQ ID NO: 9”. The dependent claims hereto are also included.
For clarity it is suggested that claim 22 is amended to read, “…combination of :
a nucleotide sequence encoding the signal peptide moiety selected from the group consisting of……and a nucleotide sequence encoding the LAL moiety selected from the group consisting of….”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
5. Claims 19 and 22-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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.
The claimed invention is directed to “a nucleic acid molecule encoding a functional chimeric LAL protein comprising a heterologous signal peptide moiety and a functional LAL moiety….wherein the functional LAL moiety is a human LAL moiety devoid of its natural signal peptide… or having at least 75% sequence identity to SEQ ID NO: 9 …..” (see claim 19 in its entirety). The art generally discloses references with a protein at least 75% identical to SEQ ID NO: 9.
The claimed invention also encompasses a LAL moiety that is at least 75% identical to SEQ ID NO: 9 and a functional signal peptide that can have deletion, insertion or substitutions, fragments, derivatives, analogs with this language. The recitation of this language “functional” does not actually endow activity. There are few references in the art with 75% sequence identity to SEQ ID NO: 9, and they do not assert the activity to align with the expressed one claimed. The invention encompasses a lot of variability with no asserted/recited activity specially aligned to protein with 75% and encompassed unlimited variability with the open language. The claimed invention also encompasses a large variable genus of cells wherein the protein is optimized in vivo, that are not adequately described. Further, the invention does not define the chimeric LAL in terms of origin and appears to retain natural parts, thus not adequately described (especially since disclosure in the specification is more geared towards foreign portions making up the chimeric LAL protein.
The claimed invention is not commensurate in scope with the disclosure and no correlation is made between structure and function (as a large variable genus of products with modifications are encompassed and not adequately described). The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
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, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, 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. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "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). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
6. Claims 19 and 22-30 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.
Claim 19 lacks clear antecedent basis for the recitation of “the wild-type human LAL protein”. The dependent claims hereto are also included.
Response to Arguments
7. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicants comments are moot. Note that the rejection under 112, first and second paragraph remains but has been altered to reflect changes made to the claims.
Applicant traverses the rejection stating that claim 19 has been amended, however, the amendment raises new issues under written description, for example the recitation of “75%” and several issues raised were not addressed, thus the rejection remains.
Note that the rejection under 112, second paragraph is instituted based on amendments made to the claims.
Conclusion
8. No claims are presently allowable, however, SEQ ID NO: 21 is free of the art.
9. Applicant’s amendment necessitated the new/modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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