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 April 1, 2026, has been received and entered.
Claim Disposition
3. Claims 1-24 and 29-33 are cancelled. Claims 25-28 are pending and are under examination.
Claim objection
4. Claims 25-28 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 25 is amended to read, “An isolated nucleic acid, comprising a nucleotide sequence encoding a mutated arylsulfatase A (ARSA) enzyme, wherein the mutated ARSA enzyme is at least 90% identical to SEQ ID NO: 1 (wild-type human ARSA enzyme), [[and]] wherein the mutated ARSA enzyme amino acid sequence [[when aligned to the sequence of SEQ ID NO: 1]] comprises at least [[one mutation which is a mutation of E424]] amino acid mutations E424R, G, L, W, Y, A or F [[of]] in SEQ ID NO:1, and wherein the mutated ARSA enzyme has an increased protein half-life compared to the wild-type human ARSA enzyme [[of SEQ ID NO: 1]]”. See also claims 26 and 28 with similar language.
For clarity and precision of claim language it is suggested that claims 25-26 and 28 are amended to recite, “…..enzyme, wherein the mutated ARSA enzyme is at least…, [[and]] wherein the mutated ARSA enzyme amino acid sequence…… in [[of]] SEQ ID NO: 1, and wherein the …..”. The dependent claim hereto is also included.
For clarity it is suggested that claim 25 is amended to read, “An isolated nucleic acid comprising a nucleotide sequence encoding a mutated arylsulfatase A (ARSA) enzyme….. comprises at least a mutation of amino acid E424R,G,L,W,Y,A or F in SEQ ID NO:1”.
For clarity and consistency it is suggested that claim 27 is amended to read, “The vector of”, in lieu of ‘The vector according to”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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, 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.
5. 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.
6. Claim(s) 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lukateka et al (Biochemistry, 1998, of record in the application) in view of Von Bulow Rixa et al. (J. of Biological Chemistry, 2002, of record in the application).
Lukateka et al. discloses mutants of ARSA, more particularly human mutant M202V and human mutant M202V/T286L/R291N (see SEQ ID NO:4, example 5, pages 27-28). The primary reference indicates that the higher enzymatic activity can be a consequence of increased conformation flexibility of loop and hinge regions in the polypeptide scaffold. The single mutation and the triple mutation dimmish the stability (see page 27, Example 5).The single mutation and the triple mutation diminish the stability of human ARSA and increase activity of the enzyme. The primary reference mentions that the decline in activity slightly restricts the potency of hyperactive ARSA mutants to hydrolyse sulfatides. The primary reference does not disclose a human ARSA with a mutation at position E424. However, the secondary reference teaches mutations in an ARSA what encompasses E424. The secondary reference discloses mutations in an ARSA such as P426L and states that it is one of the common mutations causing metachromatic leukodystrophy by forming a very instable ARSA in lysosomes. The secondary reference explains that octamerization which depends on protonation of glutamate at position 424 (E424) is impaired in mutant P426L ARSA (see page 9457). Thus the claimed invention is obvious and the cited art meets the broad limitation of a modification at 424.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because the combined teaching of the references renders the claims as obvious. The references are considered to be analogous art, thus motivation to combine exists.
Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Response to Arguments
7. Applicant’s comments have been considered in full. Withdrawn objections and rejections will not be discussed herein as applicant’s comments are moot. Note that the art rejection remains for the reasons stated and herein. Applicant opines that the primary reference and secondary reference does not teach a mutation at position E424. This argument is not persuasive because the secondary reference indicates that the specific position was impaired which means mutated. Applicant argues the resulting effect is not taught, however, the art does not have to report the same activity and having the same physical structure would inherently produce the same results (intended use bears no patentable weight). Applicant has claimed a mutated ARSA and the combined teaching in the art provides that with a mutation at the same position. Therefore, the rejection remains meritorious. The examiner proposed specific language above which would place the application in better form. Applicant is urged to contact the examiner to expedite proceedings.
Conclusion
8. No claims are presently allowable.
9. 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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