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/EP2020/066799 06/17/2020
FOREIGN APPLICATIONS
UNITED KINGDOM 1908639.6 06/17/2019
This office action is in response to Applicant’s amendment submitted January 6, 2026.
Claims 6-7, 10-12, 14-23 and 25-26 are pending.
The rejection of claims 6-7, 10-12, 14-23 and 25-26 under 35 U.S.C. 101 is withdrawn because “if” was removed from step (iii).
The following rejections of record are maintained.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-3, 6-7, 10-23, and 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dessen (WO 2015/092437 A1, cited on IDS) in view of Stanford (BMC Neurology (2015) 15:35, cited on IDS).
Dessen teaches the use of alginate oligomers as blood anticoagulants. The oligomer has 2-75 monomer residues which do not carry a sulfate group. See abstract. The oligomer can be, for example, a 6- to 22-mer, and molecular weight follows directly from the number of monomers. Page 9. The molecular weight is typically 350 to 15,000 Daltons. Top of page 8. Treatment or prevention in a subject who has venous thrombosis, arterial thrombosis, atherosclerosis, vein graft failure, arterial graft failure, stroke, cardiac infarction, pulmonary embolism or thrombophilia. Claim 12. Additional subjects to be treated include those having sickle-cell disease. Page 26, first paragraph. Additional subjects to be treated include those with or receiving an implantable surgical device. Claim 13. Prevention or inhibition of coagulation includes reduction in the density of a clot. Page 21, first full paragraph. The alginate oligomer may have at least 95% G residues and/or wherein at least 80% of the G residues are arranged in G-blocks. Claims 27-28. The alginate may contain 100% M residues arranged in M blocks. Claims 29-30. The alginate may be one wherein at least 70% and up to 100% of the G and M residues are arranged in MG blocks. Claim 31.
Pharmaceutical interventions which treat or prevent thrombotic disease are available, but are limited and have issues of toxicity, drug interactions, and dosing and restrictions on routes delivery. An alternative having a better safety profile, easier to dose and which fewer restrictions on administration routes is provided. See page 2, last paragraph.
The effective amount was 10 mg/ml or 1% (end of page 41), or the local concentration at the target location will be at least 0.1%, 0.2%, 0.5%, or 10%. Page 30, lines 9-15. Dessen’s effective amount inherently meets the limitations of the current claims. The current specification does not provide a limiting definition for the effective amount, but a 6% solution was used to obtain a final concentration of 0.3%. Page 46. Thus, the claimed effective amount includes at least 6% to obtain a final concentration of 0.3%, and Dessen’s amounts meet this requirement.
Dessen does not teach measuring step (i) or determining step (ii).
Stanford teaches that patients with ischemic stroke have denser and stronger clot structure. See abstract. Fractal dimension df is measured at baseline and after treatment (Figure 1). Abnormal blood clots are composed of compact thin fibrin fibers. See Background. Before treatment, blood clots have more branching points corresponding to a relatively higher df value (Figure 3). Patients had a df of 1.77 plus or minus 0.053. See end of page 3. Incorporating the blood-based biomarker into risk prediction scores can help identify patients at high risk of stroke, or predicting poor outcome in TIA or acute ischaemic stroke. See left column, page 7. Obtaining information about the clot structure and strength will aid in risk prediction and managing patients. See right column, page 7.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to include a step of determining df in Dessen’s patients before treatment. Measurement of df shows a denser and stronger clot structure as taught by Stanford. The skilled artisan would have determined df in order to predict risk and manage patients as taught by Stanford. The skilled artisan would have then treated the patient to achieve anticoagulant effects such as reduction in clot density as taught by Dessen.
Alternatively, the skilled artisan would have carried out Stanford’s process with the modification of using Dessen’s anticoagulant instead of aspirin or in addition to aspirin. Simple substitution of one anticoagulant for another would have resulted in the claimed invention, and the results would have been predictable because Dessen teaches an anticoagulant which is effective and lowers clot density. Dessen also teaches that the anticoagulant can be administered along with aspirin (page 27, lines 8-16), so the skilled artisan would have administered Dessen’s compound along with Stanford’s aspirin with a reasonable expectation of success.
Response to Arguments
Applicant argues that Dessen does not teach that the alginate oligomers directly affect clot density because clot density is only mentioned twice as an explanation of what prevention or inhibition of blood coagulation means. This argument is not persuasive because Dessen teaches that “prevention or inhibition of blood coagulation” encompasses reduction in the density of a clot or a reduction in the rate at which a clot increases in density. Dessen then teaches “prevention or inhibition of blood coagulation” comprising contact with the alginate oligomer (claim 1). Thus, Dessen teaches that the alginate oligomers are used in a method which reduces density of a clot or reduces the rate at which the clot increases in density.
Applicant argues that Dessen is silent about subjects at risk of blood clots which have an abnormally dense microstructure. This argument is not persuasive because Dessen teaches treatment of subjects such as those which have had a stroke, and Stanford teaches that patients with stroke have denser and stronger clot structure. Thus, Dessen does contemplate treatment of subjects which have denser and stronger clot structure.
Applicant argues that the claimed methods normalize clot structure but do not provide a direct thrombolytic effect. This result is not unexpected Dessen teaches that “prevention or inhibition of blood coagulation” does not encompass a thrombolytic effect on a pre-existing clot, but as a reduction in the capacity of a clot to be detrimental to the health or well-being of the subject and includes reduction in clot density. Page 21.
MPEP 716 states that presence of an unexpected property is evidence of non-obviousness, but the properties discussed by Applicant are not unexpected in view of Dessen. Furthermore, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention (MPEP 2145). To the extent that Dessen does not literally mention “normalization” of clot density but only reduction in clot density, Dessen administers alginate oligomers to the same patient population for the same purpose, and “normalization” is a latent property.
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 6-7, 10-23, 14-23, and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 11,712,448 in view of Stanford (BMC Neurology (2015) 15:35, cited on IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘448 patent claims treatment or prevention of disorders associated with blood coagulation using an alginate oligomer containing 2-75 monomer residues. The subject to be treated is one having venous thromboembolism, stroke, cardiac infarction, pulmonary embolism, or a subject receiving an implantable surgical device. Claims 25-27. The alginate can be a 2- to 35-mer (claim 32), or may have at least 70% G residues wherein at least 80% of the G residues are arranged in G-blocks (claims 33-34). The ‘448 patent also claims treatment of subjects using alginates wherein at least 80% of the M residues are arranged in M blocks, or where the alginate has 50-95% G residues or 90-95% G residues (claims 22-24), or where at least 80% of the G and M residues are arranged in MG blocks (claim 17). The ‘448 patent claims prevention or inhibition of blood coagulation (claim 1). The ‘448 specification defines “prevention or inhibition of blood coagulation” to include a reduction in size and/or density of a clot. The specification can be used as a dictionary to learn the meaning of a term in the claim. (MPEP 804).
The ’448 patent does not include claimed steps (i) and (ii) (measuring and determining steps).
Stanford teaches that patients with ischemic stroke have denser and stronger clot structure. See abstract. Fractal dimension df is measured at baseline and after treatment (Figure 1). Abnormal blood clots are composed of compact thin fibrin fibers. See Background. Before treatment, blood clots have more branching points corresponding to a relatively higher df value (Figure 3). Patients had a df of 1.77 plus or minus 0.053. See end of page 3. Incorporating the blood-based biomarker into risk prediction scores can help identify patients at high risk of stroke, or predicting poor outcome in TIA or acute ischaemic stroke. See left column, page 7. Obtaining information about the clot structure and strength will aid in risk prediction and managing patients. See right column, page 7.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to include a step of determining df in the ‘448 patients before treatment. Measurement of df shows a denser and stronger clot structure as taught by Stanford. The skilled artisan would have determined df in order to predict risk and manage patients as taught by Stanford. The skilled artisan would have then treated the patient to achieve anticoagulant effects as recited in the ‘448 claims.
Response to Arguments
Applicant’s arguments are the same as those addressed above.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693