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 .
Response to Amendment
Amendments to the abstract and claims filed on 8 April 2026 are acknowledged. Claims 1, 10, 26, 41, and 62-64 are amended. Claims 1, 2, 8-10, 14, 17, 26-28, 32, 41-44, and 53-64 are pending and are examined herein on the merits.
In response to the reply filed on April 2026, the objection to the abstract is withdrawn; the objections to the claims are withdrawn; the rejections under 35 U.S.C. 112(a) are withdrawn; the rejections under 35 U.S.C. 112(b) are withdrawn; and the double patenting rejections are maintained with modification.
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, 2, 8-10, 14, 17, 26-28, 32, 41-44, and 53-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 14, and 20 of U.S. Patent No. US 11,796,546 (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1, 26, 41, and 59-64, the patented claims recite the option that the xHA-L-P is contacted with the hyaluronoglucosidase in a pressure cycler (see patented claims 7, 13, and 19) at about 10 KPSI or about 15 KPSI (patented claims 8, 14, and 20) and the option that the oHA-L-P is contacted with the second enzyme in a pressure cycler (see patented claims 7, 13, and 19) at about 40 KPSI or about 45 KPSI (patented claims 8, 14, and 20), which anticipates the recited pressure ranges of the instant independent claims and the recited specific pressures of instant dependent claims 59-62. A specific example that is within a claimed range anticipates the range. See MPEP 2131.03, I.
Regarding instant claims 2 and 42, patented claims 8, 14, and 20 do not explicitly recite that the peptide digest products are between about 2 amino acids and about 100 amino acids in length. However, this is held to be either inherit or obvious over patented claim 20, which recites steps (see patented claim 15) of contacting a sample of the xHA-L-P prodrug formulation with HA lyase EC 4.2.2.1 to generate oligomeric hyaluronic acid-linker-peptide drug (oHA-L-P) and contacting the oHA-L-P with Asp-N to generate peptide digest products of the drug. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454,456, 105 USPQ 233, 235 (CCPA 1955).
Regarding instant claims 8, 27, and 43, patented claims 8, 14, and 20 do not recite that the step of detecting the peptide digest products is performed by a method selected from the group consisting of one or a combination of liquid chromatography-mass spectrometry (LC-MS), liquid chromatography tandem mass spectrometry (LC-MS-MS), liquid chromatography-high resolution mass spectrometry (LC-HRMS), ultraviolet (UV) absorbance and fluorescence detection. The examiner takes official notice that at least one of the recited analytical techniques is conventional for detecting the peptide digest products. The use of a known technique to improve similar methods in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.). For the benefit of selecting a conventional means of detecting the peptide digest products, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the patented claims such that the step of detecting the peptide digest products is performed by a method selected from the group consisting of one or a combination of liquid chromatography-mass spectrometry (LC-MS), liquid chromatography tandem mass spectrometry (LC-MS-MS), liquid chromatography-high resolution mass spectrometry (LC-HRMS), ultraviolet (UV) absorbance and fluorescence detection.
Regarding instant claims 9 and 28, patented claim 20 recites that the hyaluronoglucosidase is hyaluronate (HA) lyase EC 4.2.2.1 (see patented claim 15).
Regarding instant claim 10, patented claims 8 and 14 recite a hyaluronoglucosidase but do not recite that the hyaluronoglucosidase is a HAase that is selected from the group consisting of HAase 1, HAase 2, HAase 3, HAase 4, HAase 5 and HAase 6. The examiner takes official notice that at least one of HAase 1, HAase 2, HAase 3, HAase 4, HAase 5 and HAase 6 is a known example of a hyaluronoglucosidase. Choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, E.).
Regarding instant claim 14, patented claim 14 recites that the oHA-L-P is contacted with an endoproteinase (see patented claim 9).
Regarding instant claims 17, 32, and 44, patented claims 8, 14, and 20 do not recite the use of an internal standard and/or wherein the amount of drug present is determined using a calibration curve. The examiner takes official notice that it is conventional, when determining the amount of an analyte, to use a calibration curve. The use of a known technique to improve similar methods in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.). For the benefit of selecting a conventional means of determining an amount of an analyte, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the patented claims such that the amount of drug present is determined using a calibration curve.
Regarding instant claims 53-58, these claims do not require that the option of the use of an internal standard recited in claims 17, 32, and 44 is mandatory. Accordingly, the difference between instant claims 53-58 and patented claims 8, 14, and 20 is obvious for at least the reason set forth regarding instant claims 17, 32, and 44.
Response to Arguments
Applicant's arguments filed on April 2026 have been considered and are not fully persuasive. With respect to the double patenting rejections, Applicant argues the following:
The subject claims are patentably distinct over the claims of the '546 patent. In particular, none of the claims of the '546 patent require contacting a sample of xHA-L-P prodrug formulation with a hyaluronoglucosidase in a pressure cycler at a pressure between about 5 kilopounds per square inch (KPSI) and about 80 KPSI, or require contacting the oHA-L-P with a second enzyme in a pressure cycler at a pressure between about 35 KPSI and about 80 KPSI, as recited by the subject claims.
In response, the patented claims recite the option that the xHA-L-P is contacted with the hyaluronoglucosidase in a pressure cycler (see patented claims 7, 13, and 19) at about 10 KPSI or about 15 KPSI (patented claims 8, 14, and 20) and the option that the oHA-L-P is contacted with the second enzyme in a pressure cycler (see patented claims 7, 13, and 19) at about 40 KPSI or about 45 KPSI (patented claims 8, 14, and 20). Accordingly, the specific pressures recited in the patented claims fall within the ranges of the instant independent claims. A specific example that is within a claimed range anticipates the range. See MPEP 2131.03, I.
Conclusion
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 MICHELLE ADAMS whose telephone number is (571)270-5043. The examiner can normally be reached M, T, Th, and F, 12-4 P.M.
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, Lyle Alexander can be reached on (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHELLE ADAMS/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
Prosecution Insights