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
Claims 1-13 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8, and the species of SEQ ID NO: 1 in the reply filed on 6/18/2026 is acknowledged. Note that Applicant elected “the sequence in which N terminal amino acid deleted by cleavage before the amino acid residue N37 in a human wild typePH20 having the amino acid sequence of SEQ ID NO: 1” in the response to the requirement for restriction. However, the requirement for restriction only required election from SEQ ID NO: 1-10 and did not require election of the specific fragment of SEQ ID NO: 1.
Claims 9-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/18/2026.
Claims 1-8 are examined herein.
Drawings
The drawings are objected to because the figures are too low resolution for printing. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See line 21 on page 6. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claims 2 and 6-8 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 2 is indefinite for the parenthetical limitations “(an) N-terminal amino acid residue(s)” in parts (a)-(d) as it is unclear whether the claim requires the deletion of a single amino acid residue, the deletion of more than one amino acid residues, or the deletion of one or more amino acid residues.
Claims 6-8 are indefinite for reciting amino acid residue “F468” of SEQ ID NO: 1. The residue at position 468 of SEQ ID NO: 1 is not phenylalanine. Thus, it is unclear whether 468 is the intended position.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries 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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Park (US 2021/0155913 A1).
“Mature animal wild-type PH20” is interpreted as an animal wild-type PH20 lacking the signal peptide (see specification lines 16-20 on page 8). For example, the mature human PH20 lacks amino acids 1 to 35 of SEQ ID NO: 1, which are the signal peptide (specification line 5 on page 14). Thus, the recombinant PH20 polypeptide comprising a sequence starting at N37 in the amino acid sequence of SEQ ID NO: 1 has one amino acid deleted from the N-terminus of mature human wild-type PH20 (the residue at position 36) because mature human wild-type PH20 has no signal sequence (residues 1 to 35).
Park teaches SEQ IDN O: 1, which is identical to the instant SEQ ID NO: 1 (OA Appendix A). Park teaches that mature wild-type PH20 means a protein consisting of amino acid residues L36 to S490 of SEQ ID NO: 1, which lack M1 to T35, which form a signal peptide, and A491 to L509, which are not related to the substantial enzymatic function of PH20, in the amino acid sequence of wild-type PH20 having the sequence of SEQ ID NO: 1 ([0085]). Park teaches that PH20 variants maintained enzymatic activities even when the N-terminal amino acids of PH20 variants lacking the signal peptide were deleted up to five amino acid residues ([0116]). However, Park teaches that the residue P41 is important for catalytic function ([0116]).
Park does not teach deleting 5 amino acid residues from the N-terminus of mature, wild-type PH20. Rather, Park teaches deleting 5 amino acid residues from the N-terminus of mature PH20 variants (lacking the signal peptide) comprising at least one amino acid substitution.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to truncate the N-terminus of SEQ ID NO: 1 (wild-type PH20) by cleavage before F38 of SEQ ID NO; 1. In other words, it would have been obvious to truncate two amino acid residues from the N-terminus of mature (lacking residues 1-35), wild-type PH20.
Regarding claim 1, deletion of 2 amino acid from the N-terminus of mature wild-type PH20 (i.e. cleavage before F38) is within the claimed range of 1 to 7 amino acids.
Regarding claim 2, this rejection applies to embodiment (a).
Regarding claims 3-4, this rejection applies to the embodiment in which the sequence starts at F38.
Regarding claims 5-8, Park does not teach deleting at least one amino acid residue at the C-terminus by cleavage after the amino acid residue Y482 of SEQ ID NO: 1 (claims 5-8).
Park demonstrates that PH20 variant fragments in which the residues before F38 and after Y482 (variant HM49) are deleted have higher expression levels than the PH20 variant truncated before L36 and after S490 (variant HM10) (Figure 12B). Park also teaches that the HM49 variant has a higher specific activity compared to HM10 (Figure 14A). The HM10 and HM49 variants contain the same 14 amino acid substitutions and only differ in the number of truncated amino acids (Table 5 on page 8).
It would have been further obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to truncate the C-terminus by cleavage after Y482 based on the teachings of Park. The person of ordinary skill in the art would have recognized, based on Park’s teachings, that the truncated C-terminal and N-terminal residues are not required for the enzymatic activity. The person of ordinary skill in the art would have been motivated to increase protein expression of the PH20. The person of ordinary skill in the art would have had a reasonable expectation of success given that Park teaches that a PH20 variant fragment of SEQ ID NO: 1 with N-terminal truncation before position 38 and C-terminal truncation after position 482 has increased expression relative to the same variant without these truncations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571)272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
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