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
The amendment of 05/25/2026 has been entered. Claims 1, 6-8, 14-15, 45, 47-52, and 54-58 are currently pending in this US patent application and were examined on their merits.
Withdrawn Rejections
The rejections of the claims under 35 U.S.C. 103 as being unpatentable over Liu in view of Frost and on the ground of nonstatutory double patenting as set forth in the previous Office action are withdrawn in light of the amendment of 05/25/2026, which amended claims 1, 45, and 52 to recite that the administration of hyaluronidase is a subcutaneous administration. Applicant’s argument that the previously cited combination of references did not teach or suggest the subcutaneous administration of hyaluronidase for the treatment of vascular occlusion has been found persuasive.
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, 6-8, 14-15, 45, 47-52, and 54-58 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over DeLorenzi, Aesthetic Surgery Journal 34(4): 584-600 (2014), in view of US patent application publication 2009/0311237 filed by Frost, published 12/17/2009.
DeLorenzi teaches that accidental intravascular injection may occur when administering dermal fillers, resulting in local and/or distant ischemic necrosis from the partial or complete vascular compromise that arises from the filler injection into the arterial system (see entire document, including page 585, left column, paragraph 2). The treatment mainstay for these types of filler-induced occlusions is hyaluronidase, an enzyme that catalyzes hyaluronic acid hydrolysis. The dosage of the enzyme should be titrated to clinical effect. The treatment is accomplished with the diffuse injection of hyaluronidase into the tissues affected by ischemia. It is for the most part unnecessary to get the hyaluronidase into the vessel, as it appears effective by diffusion. As soon as hyaluronidase has been injected into the subcutaneous tissues, it tends to diffuse widely, particularly with external compression (page 595, left column, paragraph 3, to right column, paragraph 2; cf. claims 1, 14-15, 45, 50-52, and 57-58). It is important to keep the material where the obstruction is (page 595, right column, paragraph 2). DeLorenzi reports multiple cases in which filler embolisms in the face were treated with hyaluronidase injections in the affected areas (see, for example, Figures 5-6).
However, DeLorenzi does not teach the concentrations of hyaluronidase recited in instant claims 1, 6-8, 45, 47-49, 52, and 54-56 or explicitly recite the injection location in a dermal portion of a skin region as recited in instant claims 1, 45, and 52.
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 DeLorenzi 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 DeLorenzi because DeLorenzi teaches that the dosage of the enzyme should be titrated to clinical effect and because Frost teaches that concentrations of up to 5000000 U/mL of hyaluronidase can be administered to patients through injection. While DeLorenzi does not explicitly teach that the subcutaneous administration of the hyaluronidase composition is made 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 DeLorenzi. As discussed above, DeLorenzi also teaches that the hyaluronidase administration should be made in the region where the obstruction is. One of ordinary skill in the art would have a reasonable expectation that subcutaneously administering a hyaluronidase composition, as taught by DeLorenzi, containing the concentration taught by Frost to the face of a patient experiencing vascular occlusion following hyaluronic acid administration as taught by DeLorenzi 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, 6-8, 14-15, 45, 47-52, and 54-58 are rendered obvious by DeLorenzi 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 newly rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11878051 in view of DeLorenzi, Aesthetic Surgery Journal 34(4): 584-600 (2014). 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. The claims of ‘051 do not recite subcutaneous administration, as recited in the instant claims. However, this administration is rendered obvious by DeLorenzi, as discussed extensively above. As such, the instant claims are ‘rendered obvious by the cited claims of ‘051 in view of DeLorenzi and are rejected on the ground of nonstatutory double patenting.
Claims 1, 6-8, 14-15, 45, 47-52, and 54-58 are newly rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11890331 in view of DeLorenzi, Aesthetic Surgery Journal 34(4): 584-600 (2014). 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. The claims of ‘331 do not recite subcutaneous administration, as recited in the instant claims. However, this administration is rendered obvious by DeLorenzi, as discussed extensively above. As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘331 in view of DeLorenzi and are rejected on the ground of nonstatutory double patenting.
Claims 1, 6-8, 14-15, 45, 47-52, and 54-58 are newly provisionally rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/392498 in view of DeLorenzi, Aesthetic Surgery Journal 34(4): 584-600 (2014). 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. The claims of ‘498 do not recite subcutaneous administration, as recited in the instant claims. However, this administration is rendered obvious by DeLorenzi, as discussed extensively above. As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘498 in view of DeLorenzi and are provisionally rejected on the ground of nonstatutory double patenting.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 08/20/2026
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