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 .
CONTINUING DATA
This application is a 371 of PCT/SE2021/050344 04/14/2021
PCT/SE2021/050344 has PRO 63/010,211 04/15/2020
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 30, 2025 has been entered. Claims 32, 34-46, and 50-51 are pending.
All rejections made in the previous office action are withdrawn in view of new rejections made in this office action.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 46, 50-51, 32, and 34-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bansal (US 2010/0087393 A1, 2010) in view of Nilsson (US 2014/0094435 A1, 2014) and Bruce (WO 2016/076780 A1, cited on IDS).
Bansal teaches a method of treating a subject suffering from complement mediated clinical conditions comprising administration of dextran sulfate [0019]. The clinical condition can be ARDS. Paragraphs [0022] and [0105]-[0107]. ARDS is an inflammatory disorder [0104]. The clinical condition can be SIRS [0032], which is also an inflammatory disorder. The molecular weight of dextran sulfate is 1000 to 500,000 Daltons [0020]. Dextran sulfate of molecular weight 5,000 was effective for treating inflammatory disorders in Examples 10b and 11 on pages 24-25. The sulfate content of the dextran sulfate is about 12% to about 18% [0072].
Bansal does not teach that the dextran sulfate has a number average molecular weight of 1850 to 3500 Da as measured by NMR.
Nilsson teaches that dextran sulfate having a molecular weight of 5,000 Da and an average sulfur content in a range of 15 to 20% is used to inhibit IBMIR (an inflammatory disease) in a patient. See claims 1-4 and 17. IBMIR causes significant complement activation [0048]. Dextran sulfate inhibits complement activation in a dose-dependent fashion [0085]. The commercially available LMW-DS had an average molecular weight of 5000 Da and a sulfur content of about 17% [0066].
Bruce teaches a dextran sulfate having a number average molecular weight as measured by NMR spectroscopy within an internal of 1850 and 3500 Da. The average sulfate number per glucose is 2.5 to 3.0. This dextran sulfate has improved biological effects and/or reduced toxicity compared to similar dextran sulfate molecules available on the market. See abstract. The Mn can be 1850 to 2000 Da (page 6, lines 13-17). The dextran sulfate can be the sodium salt (page 6, lines 20-21). The average glucose units is about 5.1. Page 6, end. The average sulfate number per glucose is 2.6 to 2.7. Page 7, lines 1-2. The calculated weight percent of sulfur is about 19% (page 24, second paragraph).
A commercially available dextran sulfate had a molecular weight of 5000 Da and an average sulfur content of 17%, which is equivalent to approximately 2.3 sulfate groups per glucose residue. The Mn measured by NMR was 8600-16900 Da. Page 33, lines 5-10 and page 34, lines 14-16.
The dextran sulfate is used for treating various inflammatory disorders, including MS and IBMIR. Pages 12-13. Administration can be via injection such as intravenous or subcutaneous injection of an aqueous solution. Page 13, lines 7-15.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out Bansal’s method of treatment using Bruce’s dextran sulfate. Bansal employs a commercially available dextran sulfate having a molecular weight of 5000 Da. Bruce teaches that the dextran sulfate having Mn 1850-2000 has superior biological properties and decreased toxicity compared to a commercial product having Mr 5000 Da. The skilled artisan would have used Bruce’s dextran sulfate because it has superior properties compared to a commercial product. The skilled artisan would have had a reasonable expectation of success because Bruce teaches that the dextran sulfate is useful for treating various inflammatory disorders. Bansal teaches treatment of inflammatory disorders. Bruce’s dextran sulfate was more effective than the commercial product in treating or reducing the symptoms of an inflammatory disease (EAE). Page 31, lines 13-17. Thus, Bansal and Bruce both teach treating inflammatory disorders using dextran sulfate so the skilled artisan would have predicted that Bruce’s dextran sulfate would have been effective for Bansal’s treatment.
Response to Arguments
Applicant’s arguments regarding Comper and Wu are moot in view of the new ground of rejection. Applicant argues that Bruce teaches that different dextran sulfates have different properties, so the skilled artisan would not have predicted that Bruce’s dextran sulfate could be substituted for another dextran sulfate for treatment of a given disease. This argument is not persuasive because Bruce generally teaches that the Bruce’s dextran sulfate is superior to the commercial product, not that the dextran sulfate is unsuitable for prior art uses.
Applicant argues that there is no disclosure in Bruce that the dextran sulfate would be useful for treating ARDS or SIRS. This argument is not persuasive because Bruce teaches that the dextran sulfate is superior to prior commercial products, and the prior commercial dextran sulfate MW 5000 is taught to be useful for treating ARDS or SIRS. Bruce also teaches that the dextran sulfate is useful for treating disease which are inflammatory diseases, and Bansal also teaches treatment of inflammatory diseases. Bruce’s product also has a sulfur content (17%) which falls within the guidance given in the prior art for ARDS, SIRS, and another inflammatory disease IBMIR (12-18% or 17%). The prior art as a whole suggests that Bruce’s dextran sulfate should be used instead of the commercial 5000 Da product because it has superior properties, and the skilled artisan would have had a reasonable expectation of success that the treatment would be effective because the prior art references and Bruce all treat inflammatory diseases using a dextran sulfate having the same or similar sulfur content. Absolute predictability is not required.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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, Scarlett Goon can be reached at 571-270-5241. 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.
/LAYLA D BERRY/Primary Examiner, Art Unit 1693