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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 13 July 2026 has been entered.
Status of the Claims Claims 2, 3, 7, and 10 have been cancelled.
Claims 1, 4-6, 8, 9 and 11-18 are presented for examination on the merits.
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, 4-6, 8, 9 and 11-18 stand rejected under 35 U.S.C. 103 as being unpatentable over documents cited by Applicant in IDS filed 9/29/22, such as Zal et al. (US2003/0181358) and Henderson et al. (2004) in view of Tsai et al. (2012).
Zal et al. (2014) describes the oxygen-transporting capacity of the annelid haemoglobins (e.g., Arenicola marina).
Henderson et al. (2004) evaluated whether a cross-linked and polymerised bovine haemoglobin is an alternative to donor blood for extracorporeal oxygenation in a pig model of ARDS. HBOC-201 appears to be an effective alternative for extracorporeal membrane oxygenation, offering the advantages of rapid availability and reduced exposure to donor blood cells.
Tsai et al. disclosing that a molecular Hb oxygen transporter of the marine invertebrate Arenicola marina is a natural extracellular respiratory pigment of high molecular weight (~3600 kDa) that does not require chemical modification.
This material named Hemarina-M101, is purified from extracellular hemoglobin of Arenicola marina and used to produce HEMOXYCarrier® (Hemarina S.A., France), a
product being developed as an oxygen carrying therapeutic.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to employ hemoglobin from annelids (e.g., Arenicola marina) in treating ARDS, as it was previously done with bovine hemoglobin. Given the well-established superior oxygen binding capacity of annelid hemoglobin one would be motivated to substitute Arenicola marina Hb (e.g., M101) for bovine Hb to treat ARDS.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
Accordingly, the instant claims, in the range of proportions where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Response to Arguments
The claims have been amended to included the language “wherein said haemoglobin is formulated in a composition comprising a buffer solution or is formulated in a composition in powder form”. However, such use of commonly-employed forms of administration are well within the purview of the skilled practitioner and are deemed routine practice.
Applicant asserts that one of ordinary skill in the art would recognize that M101 could not be substituted for HBOC and provide similar results. Indeed, it was unexpected/surprising that a much bigger molecule (3.6 MDa for M101 as compared to 250 kDa for HBOC) would be effective. Thus, it is clearly inventive and would be a "big stretch" for one of ordinary skill in the art to use M101 to treat ARDS starting from the prior art.
This is unpersuasive, since the superior oxygen transporting capacity of the Annelid hemoglobin was known in the prior art, it would well within the purview of one of ordinary skill in the art to use the superior choice. Since annelid hemoglobins (such as M101) are already known in the art to be superior oxygen carriers, it would have been well within the purview of the skilled practitioner to substitute them for the bovine Hb to treat ARDS as taught by Henderson. As stated previously, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
Furthermore, with respect to such unexpected results, please note that in KSR, the Court also reaffirmed that evidence of unexpected results may overcome an examiner's prima facie case of obviousness. KSR, 550 U.S. at 416 ("The fact that the elements worked together in an unexpected and fruitful manner supported the conclusion that Adams' design was not obvious to those skilled in the art" - discussing United States v. Adams, 383 U.S. 39). However, "any superior property must be unexpected to be considered as evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). Thus, "[m]ere improvement in properties does not always suffice to show unexpected results ....[W]hen an applicant demonstrates substantially improved results.., and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary." In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). Moreover, in order to establish unexpected results for claimed invention, objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support. In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978). Please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
Accordingly, the instant claims, where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655
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