DETAILED ACTION
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 Amendments
Applicant's amendments filed 3/06/2026 to claims 1, 2, and 5 have been entered. Claims 1-20 remain pending, of which claims 1-12 are being considered on their merits. Claims 13-20 remain withdrawn from consideration. References not included with this Office action can be found in a prior action. Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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.
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.
Claims 1-6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sowemimo-Coker (WO 2017/205590; cite number 436 as provided in the IDS dated 9/06/2022).
This rejection addresses the embodiment of utilizing the psoralen-based INTERCEPT® system to reduce S-303 to a concentration of less than 1 nmol/L in 6 hours or less for claim 1 when read in light of the specification (see ¶0004 and Example 11 of the specification). Therefore, a teaching in the prior art towards the psoralen-based INTERCEPT® system to reduce pathogens in a blood product is reasonably presumed to inherently reduce S-303 to a concentration of less than 1 nmol/L in 6 hours or less absent any showing to the contrary. See M.P.E.P. § 2112.02, when the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).
Sowemimo-Coker teaches a method for pathogen reduction of a leukoreduced and packed red blood product comprising: removing oxygen from a blood product to prepare an oxygen reduced blood product; and reducing blood pathogens from the oxygen reduced blood product to prepare an oxygen-reduced, pathogen reduced blood product comprising: adding amustaline (i.e. S-303) to a final concentration of 0.2 millimolar (mM), and adding glutathione (GSH) to a concentration of 2-20 mM under oxygen-reduced (e.g. anaerobic) conditions overnight and with AS3 additive solution (Example 10; further see Example 2 for oxygen depletion and anaerobic storage), reading in-part on claim 1, 2, 4, and the embodiment of AS-3 for claim 6. Sowemimo-Coker teaches combining the methods for pathogen reduction in a blood product with other known methods of pathogen reduction in a blood product such as the psoralen-based INTERCEPT® system (¶0004, ¶0050, ¶0064, and ¶0076), reading in-part on the reducing step of claim 1. Sowemimo-Coker teaches reducing the carbon dioxide from the blood product (Example 3), which reduces hemolysis of the blood product by about 30% (¶0070), reading on claim 3. Sowemimo-Coker teaches further centrifuging whole blood obtained from subjects to prepare packed red blood cells and/or leukoreduced red blood cells (¶0057; see Example 10 for the centrifugation being before any application of S-303), reading on claim 5. Sowemimo-Coker teaches reduction of blood pathogens between 60-100% (¶0099), reading on claim 8. Sowemimo-Coker teaches removing oxygen and reducing blood pathogens at the same time wherein the blood pathogens are reduced by adding S-303 (¶0052), reading on claims 9 and 11. Sowemimo-Coker teaches reducing microparticles greater than 10% at least one week after storage (¶0097), reading on claim 10. Sowemimo-Coker teaches removing oxygen prior to reducing blood pathogens (¶0052), reading on claim 12.
Regarding claim 1, combining separate steps taught as useful in a method into a singular method must be held as prima facie obvious, as each step is taught separately useful for the same purpose. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In this case, Sowemimo-Coker teaches a method for pathogen reduction comprising adding S-303 and GSH to an oxygen-reduced blood product and separately teaches a method for pathogen reduction comprising utilizing the utilizing the psoralen-based INTERCEPT® system. Therefore, combining the separate steps of Sowemimo-Coker for pathogen reduction in a blood product into a singular method must be held prima facie obvious absent any showing of nonobviousness to the contrary.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sowemimo-Coker as applied to claims 1 and 5 above, and further in view of Henschler et al. (Transfus Med Hemother 2011;38:33–42; cite number 571 as provided in the IDS dated 9/06/2022).
The teachings of Sowemimo-Coker are relied upon as set forth above.
Regarding claim 7, Sowemimo-Coker does not additive solution-5 (i.e. AS5 or AS-5).
Henschler teaches a method of reducing pathogens in a blood product comprising contacting the blood product with a composition comprising S-303, GSH, and AS-5 (i.e. Optisol, and the “second generation” process) (Table 1), reading on claim 7.
A person of ordinary skill in the art would have had a reasonable expectation of success in substituting AS-5 composition of Henschler for AS-3 composition of Sowemimo-Coker because both AS-5 and AS-3 are both explicitly taught as being useful for THE SAME PURPOSE as additive solutions in methods of reducing pathogens in a blood product comprising contacting the blood product with a composition comprising S-303 and GSH. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 13-21, and 24 of U.S. Patent No. 10,583,192 in view of Sowemimo-Coker (WO 2017/205590; cite number 436 as provided in the IDS dated 9/06/2022).
This rejection addresses the embodiment of utilizing the psoralen-based INTERCEPT® system to reduce S-303 to a concentration of less than 1 nmol/L in 6 hours or less for claim 1 when read in light of the specification (see ¶0004 and Example 11 of the specification). Therefore, a teaching in the prior art towards the psoralen-based INTERCEPT® system to reduce pathogens in a blood product is reasonably presumed to inherently reduce S-303 to a concentration of less than 1 nmol/L in 6 hours or less absent any showing to the contrary. See M.P.E.P. § 2112.02, when the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).
Claims 1 and 13 of the ‘562 patent are directed towards removing oxygen from a blood product to prepare an oxygen reduced blood product, reducing blood pathogens from said blood product comprising, adding amustaline (S-303) to a final concentration of between 0.1 and 0.5 millimolar (mM), adding glutathione (GSH) to a final concentration of between 2 to 20 mM; and incubating said oxygen reduced blood product comprising said S-303 and GSH under oxygen reduced conditions for up to 9 hours; whereby residual pathogens are reduced between 60 and 100%, said S-303 level is reduced to a non-toxic level, and the level of microparticle formation is reduced compared to a blood product treated with S-303 under non-oxygen reduced conditions, reading in-part on claim 1 and reading on claim 8.
Claims 2-6 of the ‘583 patent read on instant claims 2-7. Claims 14-16 of the ‘583 patent also read on instant claims 2-4. Claims 18 and 19 of the ‘583 patent read on instant claims 9 and 11. Claim 17 of the ‘583 patent reads on instant claim 10. Claims 20 and 21 of the ‘583 patent read on instant claim 12. Claim 24 of the ‘583 patent reads in-part on reducing S-303 to less than 1 nM of instant claim 1.
The ’583 patent does not claim reducing S-303 to less than 1 nM of instant claim 1.
Sowemimo-Coker teaches a method for pathogen reduction of a leukoreduced and packed red blood product comprising: removing oxygen from a blood product to prepare an oxygen reduced blood product; and reducing blood pathogens from the oxygen reduced blood product to prepare an oxygen-reduced, pathogen reduced blood product comprising: adding amustaline (i.e. S-303) to a final concentration of 0.2 millimolar (mM), and adding glutathione (GSH) to a concentration of 2-20 mM under oxygen-reduced (e.g. anaerobic) conditions overnight and with AS3 additive solution (Example 10; further see Example 2 for oxygen depletion and anaerobic storage), reading in-part on claim 1, 2, 4, and the embodiment of AS-3 for claim 6. Sowemimo-Coker teaches combining the methods for pathogen reduction in a blood product with other known methods of pathogen reduction in a blood product such as the psoralen-based INTERCEPT® system (¶0004, ¶0050, ¶0064, and ¶0076), reading in-part on the reducing step of claim 1. Sowemimo-Coker teaches reducing the carbon dioxide from the blood product (Example 3), which reduces hemolysis of the blood product by about 30% (¶0070), reading on claim 3. Sowemimo-Coker teaches further centrifuging whole blood obtained from subjects to prepare packed red blood cells and/or leukoreduced red blood cells (¶0057; see Example 10 for the centrifugation being before any application of S-303), reading on claim 5. Sowemimo-Coker teaches reduction of blood pathogens between 60-100% (¶0099), reading on claim 8. Sowemimo-Coker teaches removing oxygen and reducing blood pathogens at the same time wherein the blood pathogens are reduced by adding S-303 (¶0052), reading on claims 9 and 11. Sowemimo-Coker teaches reducing microparticles greater than 10% at least one week after storage (¶0097), reading on claim 10. Sowemimo-Coker teaches removing oxygen prior to reducing blood pathogens (¶0052), reading on claim 12.
Regarding claim 1, combining separate steps taught as useful in a method into a singular method must be held as prima facie obvious, as each step is taught separately useful for the same purpose. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In this case, both the ‘583 patent and Sowemimo-Coker teaches a method for pathogen reduction comprising adding S-303 and GSH to an oxygen-reduced blood product and separately teaches a method for pathogen reduction comprising utilizing the utilizing the psoralen-based INTERCEPT® system. Therefore, combining the separate steps of the ‘583 patent and Sowemimo-Coker for pathogen reduction in a blood product into a singular method must be held prima facie obvious absent any showing of nonobviousness to the contrary.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 6-16 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
On pages 7-8 of the reply, Applicant alleges that Sowemimo-Coker does not teach every element of claim 1. This is not found persuasive of error because Sowemimo-Coker is not applied as anticipatory 35 U.S.C. § 102, but under 35 U.S.C. § 103 for obviousness, and the claimed invention becomes obvious when the reference is considered as a whole.
On pages 8-9 of the reply, Applicant alleges Sowemimo-Coker is deficient because the claims do not require UV light, irradiation, photosensitizer, psoralen, and amotosalen. This argument is not persuasive because Sowemimo-Coker was not and is not currently cited for any such limitations, so it is unclear to the examiner what deficiencies Applicant is attempting to articulate with respect to the obviousness rejection of record over Sowemimo-Coker. It is noted that the preamble of claim 1 recites the open-ended transitional phrase “comprising”, and so does not exclude additional, unrecited elements or methods steps; see M.P.E.P. § 2111.03.
On pages 9-10 of the reply, Applicant alleges that the INTERCEPT® system taught by Sowemimo-Coker is deficient as it does not include amustaline (i.e. S-303) and glutathione (i.e. GSH). This argument is not found persuasive and appears to misunderstand the examiner’s reliance on inherency; the rejection of independent claim 1 and it’s dependent claims addresses the embodiment of utilizing the psoralen-based INTERCEPT® system to reduce S-303 to a concentration of less than 1 nmol/L in 6 hours or less for claim 1 when read in light of the specification (see ¶0004 and Example 11 of the specification). Therefore, a teaching in the prior art towards the psoralen-based INTERCEPT® system to reduce pathogens in a blood product is reasonably presumed to inherently reduce S-303 to a concentration of less than 1 nmol/L in 6 hours or less absent any showing to the contrary, and Applicant did not present any new evidence for the examiner’s consideration that would otherwise show by a preponderance of evidence that INTERCEPT® system is not capable of reducing the S-303 to a concentration of less than 1 nmol/L in 6 hours or less; see M.P.E.P. § 716.07 and 2121(I)). Sowemimo-Coker teaches a method for pathogen reduction of blood product comprising in-part adding amustaline (i.e. S-303) and glutathione (i.e. GSH) as cited above, and combining the separate embodiments of Sowemimo-Coker into a single embodiment is the basis for the obviousness rejection of record under 35 U.S.C. § 103 instead of an anticipation rejection under 35 U.S.C. § 102.
On pages 10-11 of the reply, Applicant alleges that there would be no reasonable expectation to combine the separate embodiments of Sowemimo-Coker into a single embodiment as claimed. This is not found persuasive of error because Applicant’s arguments appear to ignore the evidentiary teachings that the INTERCEPT® system taught by Sowemimo-Coker is reasonably construed as capable of and would reduce S-303 to a concentration of less than 1 nmol/L in 6 hours or less when claim 1 is read in light of the specification. Arguments alleging inoperability of the prior art must be factually supported by an appropriate affidavit or declaration, and arguments presented by Applicant cannot take the place of evidence in the record; see M.P.E.P. § 716.01(c).
On pages 11-12 of the reply, Applicant alleges that the claimed methods produce an unexpected result. This is not found persuasive of error for several reasons. First, Applicant’s argument rely on the alleged inoperability of Sowemimo-Coker and which is fully addressed in the preceding paragraph. Second, Applicant’s arguments establish operability of the claimed methods but this is not germane for considerations of nonobviousness under 35 U.S.C. § 103, and the cited portion of the specification does not particularly set forth any improvement such as the exemplary showings at M.P.E.P. § 716.02(a). Third, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Hemanext Oxygen Reduction Bag) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). However, Sowemimo-Coker teaches an oxygen-reduction bag at ¶00134 and Table 3 and so adding this limitation to claim 1, by itself, would not likely be persuasive of nonobviousness.
On pages 12-15 of the reply, Applicants rely on the arguments traversing the above rejection of claim 1 as obvious over Sowemimo-Coker to traverse the rejection of claim 7 further in view of Henschler. Therefore, the response set forth above to the arguments also applies to this rejection.
Conclusion
No claims are allowed. No claims are free of the art.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (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, Sharmila Landau can be reached at 571-272-0614. 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.
/Sean C. Barron/Primary Examiner, Art Unit 1653