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 DIV of 18/056,301 11/17/2022 PAT 12076337
18/056,301 is a DIV of 16/644,575 03/05/2020 PAT 11534457
16/644,575 is a 371 of PCT/SE2018/050898 09/07/2018
PCT/SE2018/050898 has PRO 62/555,848 09/08/2017
Claims 1-15 are pending.
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) 1-8, 11, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruce (WO 2016/076780 A1, cited on IDS) in view of Mizushima (JP 2016132619 A, machine translation, cited on IDS) and Zhan (Curr Alzheimer Res. Author manuscript; available in PMC: 2015 Mar 1).
Bruce teaches a dextran sulfate having a molecular weight 1850-3500 Da and 2.5-3.0 average sulfate number per glucose unit. The dextran sulfate has improved biological effects and/or reduced toxicity compared to similar dextran sulfates. See abstract. Preferably, the molecular weight is 1850-2000 Da. Pages 6-7. Preferably, the dextran sulfate has an average of 5.1 glucose units and an average sulfate number per glucose within an interval of 2.6 and 2.7. Page 7. The dextran sulfate is used for treating various demyelinating diseases and CNS neuropathies. Page 12. The dextran sulfate is preferably administered by intravenous or subcutaneous injection. Page 13.
Bruce does not teach treatment of Alzheimer’s disease.
Mizushima teaches that dextran sulfate is useful for treating Alzheimer’s disease. See abstract. Dextran sulfate acts as a binding inhibitor between amyloid beta oligomer and normal prion protein. See claims.
Zhan teaches that myelin disruption is an important feature of Alzheimer’s disease. See abstract.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat Alzheimer’s disease using Bruce’s dextran sulfate. Dextran sulfate is used to treat Alzheimer’s disease, and Bruce provides a dextran sulfate which has improved properties. Bruce’s dextran sulfate is also taught to be useful for treating demyelinating disorders, and Alzheimer’s disease is a demyelinating disorder, so the skilled artisan would have predicted that Bruce’s dextran sulfate would be effective for treating Alzheimer’s disease.
Claim(s) 1-8, 9-10, 12, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waas (WO 2015/190989 A1, cited on IDS) in view of Bruce (WO 2016/076780 A1, cited on IDS).
Waas teaches dextran sulfate having a molecular weight below 10,000 Da for treating a subject suffering from ischemia. See abstract. Dextran sulfate is administered as i.v. or s.c. injection. Page 11, first paragraph. Treatment is suitable for treating or preventing ALS, ischemic brain injury, and traumatic brain injury. Page 13. Hemorrhagic stroke, including bleeding of blood vessels into the subarachnoid space surrounding brain tissue, may be treated. Paragraph bridging pages 16-17.
Waas does not teach use of the dextran sulfate recited in current claim 1.
Bruce teaches a dextran sulfate having a molecular weight 1850-3500 Da and 2.5-3.0 average sulfate number per glucose unit. The dextran sulfate has improved biological effects and/or reduced toxicity compared to similar dextran sulfates. See abstract. Preferably, the molecular weight is 1850-2000 Da. Pages 6-7. Preferably, the dextran sulfate has an average of 5.1 glucose units and an average sulfate number per glucose within an interval of 2.6 and 2.7. Page 7. The dextran sulfate is used for treating various demyelinating diseases and CNS neuropathies. Page 12. The dextran sulfate is preferably administered by intravenous or subcutaneous injection. Page 13.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to use Bruce’s dextran sulfate to treat the disorders taught by Waas. Waas teaches that DS having a molecular weight of less than 10,000 is useful for treating ALS, TBI, and SAH. Bruce’s dextran sulfate has a molecular weight less than 10,000 and is taught to have superior properties compared to other dextran sulfates on the market. The skilled artisan would have predicted that Bruce’s DS would be effective because it has the required molecular weight, and the skilled artisan would have administered Bruce’s DS because it has superior properties.
Claim(s) 1-8, 13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruce (WO 2016/076780 A1, cited on IDS) in view of Dean (PLoS ONE 11(10): e0163774).
Bruce teaches a dextran sulfate having a molecular weight 1850-3500 Da and 2.5-3.0 average sulfate number per glucose unit. The dextran sulfate has improved biological effects and/or reduced toxicity compared to similar dextran sulfates. See abstract. Preferably, the molecular weight is 1850-2000 Da. Pages 6-7. Preferably, the dextran sulfate has an average of 5.1 glucose units and an average sulfate number per glucose within an interval of 2.6 and 2.7. Page 7. The dextran sulfate is used for treating various demyelinating diseases and CNS neuropathies. Page 12. The dextran sulfate is preferably administered by intravenous or subcutaneous injection. Page 13.
Bruce does not teach treatment of Parkinsons’s disease.
Dean teaches that Parkinsons’s disease involves changes in myelin content in the brain. See abstract.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat Parkinson’s disease using Bruce’s dextran sulfate because Bruce teaches that demyelinating diseases can be treated and Parkinson’s disease involves demyelination.
Claim(s) 1-8, 14, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruce (WO 2016/076780 A1, cited on IDS) in view of UCLA (UCLA Research Implicates Myelin in Early Evolution of Huntington’s Disease, internet article dated 2007, https://www.uclahealth.org/news/release/ucla-research-implicates-myelin-in-early-evolution-of-huntington-s-disease).
Bruce teaches a dextran sulfate having a molecular weight 1850-3500 Da and 2.5-3.0 average sulfate number per glucose unit. The dextran sulfate has improved biological effects and/or reduced toxicity compared to similar dextran sulfates. See abstract. Preferably, the molecular weight is 1850-2000 Da. Pages 6-7. Preferably, the dextran sulfate has an average of 5.1 glucose units and an average sulfate number per glucose within an interval of 2.6 and 2.7. Page 7. The dextran sulfate is used for treating various demyelinating diseases and CNS neuropathies. Page 12. The dextran sulfate is preferably administered by intravenous or subcutaneous injection. Page 13.
Bruce does not teach treatment of Huntington’s disease.
UCLA teaches that breakdown of myelin is characteristic of Huntington’s disease. See entire article.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat Huntington’s disease using Bruce’s dextran sulfate because Bruce teaches that demyelinating diseases can be treated and Huntington’s disease involves demyelination.
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 1-9 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11534457. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘457 patent claims treatment of ALS and neuroinflammation using the same dextran sulfate which has a molecular weight of 1850-3500 Da. See all claims. The dextran sulfate has on average 5.1 glucose units and an average sulfate number per glucose unit of 2.6 to 2.7. Claim 16. Administration is intravenous or subcutaneous. Claim 17. The ‘457 claims anticipate current claims 1-9 and 15.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11534457 in view of Schimmel (Brain Circ 2017;3:135-42).
The ‘457 patent claims treatment of neuroinflammation using the same dextran sulfate recited in the current claims, as set forth above. The ‘457 patent does not claim treatment of TBI.
Schimmel teaches that a hallmark of TBI is neuroinflammation. See abstract.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat TBI using the dextran sulfate recited in the ‘457 claims because the ‘457 patent claims treatment of neuroinflammation and neuroinflammation is a hallmark of TBI.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11534457 in view of Wang (Transl Neurodegener. 2015 Oct 12;4:19).
The ‘457 patent claims treatment of neuroinflammation using the same dextran sulfate recited in the current claims, as set forth above. The ‘457 patent does not claim treatment of PD.
Wang teaches that chronic neuroinflammation is one of the hallmarks of PD pathophysiology. See abstract.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat PD using the dextran sulfate recited in the ‘457 claims because the ‘457 patent claims treatment of neuroinflammation and neuroinflammation is a hallmark of PD.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11534457 in view of Miller (BioMed Research International Volume 2014, Article ID 384342).
The ‘457 patent claims treatment of neuroinflammation using the same dextran sulfate recited in the current claims, as set forth above. The ‘457 patent does not claim treatment of SAH.
Miller teaches that inflammation is the driving force behind the pathology of SAH. See abstract.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat SAH using the dextran sulfate recited in the ‘457 claims because the ‘457 patent claims treatment of neuroinflammation and neuroinflammation is a driving force behind the pathology of SAH.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11534457 in view of Heneka (Lancet Neurol 2015; 14:388-405).
The ‘457 patent claims treatment of neuroinflammation using the same dextran sulfate recited in the current claims, as set forth above. The ‘457 patent does not claim treatment of AD.
Heneka teaches that in AD, neuroinflammation contributes to pathogenesis. See abstract.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat AD using the dextran sulfate recited in the ‘457 claims because the ‘457 patent claims treatment of neuroinflammation and neuroinflammation contributes to the pathogenesis of AD.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11534457 in view of Crotti (Trends Immunol. 2015 May 20;36(6):364–373).
The ‘457 patent claims treatment of neuroinflammation using the same dextran sulfate recited in the current claims, as set forth above. The ‘457 patent does not claim treatment of HD.
Crotti teaches that neuroinflammation is a strong component of HD pathogenesis. See page 16, last paragraph.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat HD using the dextran sulfate recited in the ‘457 claims because the ‘457 patent claims treatment of neuroinflammation and neuroinflammation is a hallmark of HD pathogenesis.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693
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