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 75-94 are pending. Claims 75-84 are for examination. Claims 85-94 are withdrawn.
Applicants’ response of 8/26/2026 against office action of 5/26/2026
is acknowledged. Submission of TDS against the ODP rejection of against office action of 5/26/2026 is considered . However there required NEW ODP rejection as explained bellow.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/26/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the IDS statement.
Claim Rejection
Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The instant Claims 75-84 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 75-84 of US PAT Application NO: 19449850. US PAT Application NO: 19449850 is CON of the instant application. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). Although the conflicting claims are not identical, they are not patentably distinct from each other.
Claims 75-84 of instant application directed to method of subcutaneous administration of a hyaluronidase PH20 enzyme formulation to a subject in need thereof, the method comprising subcutaneously administering to the subject in need thereof about 3 mL to about 50 mL of a formulation comprising recombinant human hyaluronidase PH20 enzyme comprising a sequence having at least 98% amino acid sequence identity to any of an amino acid sequence SEQ ID NO: 1-7 , and having an activity of about 500 U/mL to about 5,000 U/mL. The claims 75-84 of US PAT Application NO: 19449850 are directed method of subcutaneous administration of a hyaluronidase PH20 enzyme formulation to a subject in need thereof, the method comprising subcutaneously administering to the subject about 3 mL to about 50 mL of a formulation comprising recombinant human hyaluronidase PH20 enzyme comprising a sequence having at least 95% amino acid sequence identity to an amino acid sequence selected from any of SEQ ID NO: 1 through 7 and SEQ ID NO: 15, and having an activity of about 500 U/mL to about 5,000 U/mL, wherein the subcutaneous administration occurs at a rate of about 0.10 mL/sec to about 1.0 mL/sec.
Therefore claims 75-84 of instant application are obvious over claims 75-84 of US PAT Application NO: 19449850.
The instant Claims are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-15 of US PAT 12,558,404. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). Although the conflicting claims are not identical, they are not patentably distinct from each other.
The claims 1-15 of US PAT 12,558,404 are directed to method of subcutaneous administration of a hyaluronidase PH20 enzyme formulation to a subject in need thereof, the method comprising subcutaneously administering to the subject in need thereof about 3 mL to about 50 mL of a formulation comprising recombinant human hyaluronidase PH20 enzyme comprising a sequence having at least 98% amino acid sequence identity to an amino acid sequence selected from any of SEQ ID NO: 1 through 7, and having an activity of about 500 U/mL to about 5,000 U/mL.
The Instant claims also are directed to a method of subcutaneous administration of a hyaluronidase PH20 enzyme formulation to a subject in need thereof, the method comprising subcutaneously administering to the subject about 3 mL to about 50 mL of a formulation comprising recombinant human hyaluronidase PH20 enzyme comprising a sequence having at least 98% amino acid sequence identity to an amino acid sequence selected from any of SEQ ID NO: 1 through 7, and having an activity of about 500 U/mL to about 5,000 U/mL, and a therapeutically effective amount of an active ingredient selected from a small molecule, a peptide fragment, a biologic, a nanoparticle, an antibody, an antibody fragment, and a small molecule antiviral, wherein the subcutaneous administration occurs via a high volume autoinjector at a rate of about 0.10 mL/sec to about 1.0 mL/sec. The specification that subcutaneous administration of a hyaluronidase PH20 enzyme formulation to a subject in need thereof, the method comprising subcutaneously administering to the subject in need thereof about 3 mL to about 50 mL of a formulation comprising recombinant human hyaluronidase PH20 enzyme comprising a sequence having at least 98% amino acid sequence identity to an amino acid sequence selected from any of SEQ ID NO: 1 through 7, and having an activity of about 500 U/mL to about 5,000 U/mL claims of that patent can also teach in different embodiment the subcutaneous administration of a hyaluronidase PH20 enzyme formulation to a subject in need thereof the method comprising subcutaneously administering to the subject about 3 mL to about 50 mL of a formulation comprising recombinant human hyaluronidase PH20 enzyme comprising a sequence having at least 95% amino acid sequence identity to an amino acid sequence selected from any of SEQ ID NO: 1 through 7, and having an activity of about 500 U/mL to about 5,000 U/mL, and a therapeutically effective amount of an active ingredient selected from a small molecule, a peptide fragment, a biologic, a nanoparticle, an antibody, an antibody fragment, and a small molecule antiviral, wherein the subcutaneous administration occurs via a high volume autoinjector at a rate of about 0.10 mL/sec to about 1.0 mL/sec in the instant claims of the instant application. It would have been obvious to one of ordinary skill in the art to select this specific embodiment of the genera of subcutaneous administration of a hyaluronidase PH20 enzyme formulation to a subject in need thereof and therapeutic ingredients , the method comprising subcutaneously administering to the subject in need thereof about 3 mL to about 50 mL of a formulation comprising recombinant human hyaluronidase PH20 enzyme comprising a sequence having at least 95% amino acid sequence identity to an amino acid sequence selected from any of SEQ ID NO: 1 through 7, and having an activity of about 500 U/mL to about 5,000 U/mL to use for the method of instant claims. Therefore claims 75-84 of instant application are obvious over claims 1-15 of US PAT 12,558,404.
Td submission will overcome the above rejections.
Conclusion
Claims 75-84 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Mohammad Meah whose telephone number is 571-272-
1261. The examiner can normally be reached on 8:30-5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
supervisor, Robert Mondesi can be reached on 4089187584. The fax phone number
for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMAD Y MEAH/Examiner, Art Unit 1652
