DETAILED ACTION
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 .
Claim Status
Claims 1, 4, 6-8, 14-15, and 45-58 are currently pending in this US patent application and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed in this application on 03/07/2025 has been received and considered.
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.
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.
Claims 1, 4, 6-8, 14-15, and 45-58 are rejected under 35 U.S.C. 103 as being unpatentable over Chinese patent application CN 111202842 filed by Liu, published 05/29/2020, in view of US patent application publication 2009/0311237 filed by Frost, published 12/17/2009.
Liu teaches a method of administering a pharmaceutical composition comprising a hyaluronidase and aspirin through intravenous injection to an individual with hyaluronic acid vascular embolism, solving the problems of slow recovery, accelerating retinal embolism or cerebral embolism, bruising, and blurred vision (see entire document, including abstract; paragraphs [0007], [0010], and [0036]; cf. claim 1, 14-15, 45, 50-52, and 57-58). The hyaluronidase composition can be administered for vascular embolism symptoms in the face following facial injection of hyaluronic acid (paragraph [0033]).
However, Liu does not teach the concentrations of hyaluronidase recited in instant claims 1, 6-8, 45, 47-49, 52, and 54-56 or the injection location as recited in instant claims 4, 46, and 53.
Frost teaches the subcutaneous administration of compositions comprising soluble hyaluronidase in a concentration of 10-5000000 U/mL (see entire document, including page 1, paragraph 0008, and page 2, paragraph 0015; cf. claims 1, 4, 6-8, 45-49, and 52-56).
While Liu does not teach the administration of the concentrations of hyaluronidase recited in the instant claims, it would have been obvious to one of ordinary skill in the art to do so in the method of Liu because Frost teaches that concentrations of up to 5000000 U/mL of hyaluronidase can be administered to patients through injection. While Liu does not teach the administration of the hyaluronidase composition to a dermal portion of a skin region, it would have been obvious to one of ordinary skill in the art to administer the composition to any location experiencing vascular occlusion as a result of hyaluronic acid injection, including the dermal region of the face, as taught by Liu. In addition, Frost teaches that hyaluronidase compositions may be injected subcutaneously. One of ordinary skill in the art would have a reasonable expectation that administering a hyaluronidase composition containing the concentration taught by Frost to the face of a patient experiencing vascular occlusion following hyaluronic acid administration as taught by Liu would successfully result in the amelioration of the vascular occlusion and the prevention of further ramifications of said occlusion in the patient.
Therefore, claims 1, 4, 6-8, 14-15, and 45-58 are rendered obvious by Liu in view of Frost and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application 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); 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6-8, 14-15, 45, 47-52, and 54-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11878051. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘051 recite the administration of hyaluronidase to a specific tissue for the treatment of a blood vessel blockage, whereas the cited instant claims recite the administration of hyaluronidase to any tissue to treat a blood vessel blockage. As such, the instant claims are ‘anticipated’ by the cited claims of ‘051 and are rejected on the ground of nonstatutory double patenting.
Claims 1, 6-8, 14-15, 45, 47-52, and 54-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11890331. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘331 recite the administration of hyaluronidase to a specific tissue for the treatment of a blood vessel blockage, whereas the cited instant claims recite the administration of hyaluronidase to any tissue to treat a blood vessel blockage. As such, the instant claims are ‘anticipated’ by the cited claims of ‘331 and are rejected on the ground of nonstatutory double patenting.
Claims 1, 6-8, 14-15, 45, 47-52, and 54-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/392498. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘498 recite the administration of hyaluronidase to a specific tissue for the treatment of a blood vessel blockage, whereas the cited instant claims recite the administration of hyaluronidase to any tissue to treat a blood vessel blockage. As such, the instant claims are ‘anticipated’ by the cited claims of ‘498 and are provisionally rejected on the ground of nonstatutory double patenting.
Conclusion
No claims are allowed.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 02/23/2026