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 .
Response to Election/Restriction filed on January 22, 2026 is acknowledged.
Claims 1-20 are pending in this application.
Restriction
Applicant’s election without traverse of January 22, 2026 of the following species: erythrocruorin and 5-methyltetrahydrofolate and 5-formyltetrahydrofolate and 5,6,7,8-tetrahydrobiopterin as the composition component, liquid as the formulation, and annelid as the erythrocruorin in the reply filed on January 22, 2026 is acknowledged. Applicant indicates that claims 1-2, 13-14, 17 and 20 read on the elected species. Claims 1-20 are examined on the merits in this office action.
Objections
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Rejections
35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites, “
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”. The metes and bounds of the claim is unclear. There is no amounts of each component, no recitation of solvent or any other components involved in the method steps are recited.
Thus, claims 2, 6, 10 and 14 are indefinite, since the claim 1 does not recite the solvent or solution the composition is being combined in. Additionally, claims 2, 6, 10 and 14 are not active method steps. The recitation of “stored as a liquid” is not in an active method form. Applicant is recommended to amend the claims to recite, for example, “…wherein the method comprises mixing erythrocruorin, 5-methyltetrahydrofolate solutions…, wherein the composition in a liquid form.”
Claims 3, 7, 11, and 15 recite, “…wherein the composition is reduced to a paste.” It is unclear how the composition is in a paste form when it appears that each component is in a power form. For example, the purified erythrocruorin, 5-methyltetrahydrofolate, 5-formyltetrahydrofolate and 5,6,7,8-tetrahydrobiopterin are all in power forms, as evidenced by Medchemexpress.com (https://medchemexpress.com, pp. 1-3, accessed 2/10/2026), lifeseasons (https://lifeseasons.com, pp. 1-9, accessed 2/10/2026) and ThermoFisherscientific (https://www.thermofisher.com, pp. 1-4, accessed 2/10/2026). It is unclear how the combination of mixtures of solid components can be in a paste form. Therefore, the metes and bounds of the claims is unclear. Applicant is recommended to amend the claims to recite, “…wherein the method comprises reducing the combination to a paste.”
Claims 4, 8, 12 and 16 recite, “…wherein the composition is lyophilized to a powder.” The claims do not recite any active method steps. Applicant is recommended to amend the claims to recite, “…wherein the method comprises lyophilizing the combination to a powder.”
Claim 5 recites, “…wherein the purified erythrocruorin is combined with 0.001 to 500 mmol/L 5-methyltetrahydrofolate…” Claim 9 recites, “…wherein the purified erythrocruorin is combined with 0.001 to 500 mmol/L 5-formyltetrahydrofolate…” Claim 13 recites, “…wherein the purified erythrocruorin is combined with 0.001 to 500 mmol/L 5-methyltetrahydrofolate, 0.001 to 500 mmol/L 5-formyltetrahydrofolate and 0.001 to 500 mmol/L 5,6,7,8-tetrahydrobiopterin.” It is unclear what the volume of the concentration is referring to.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,472,183. Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of US Patent claims, and vice versa.
Instant application is a CON of US Patent No. 12,472,183, therefore, the double patenting rejection is proper. Additionally, the method of preparing was not claimed in the parent application (issued as US Patent No. 12,472,183). Instant method was NOT under restriction requirement in the parent application.
Instant claims are drawn to:
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US Patent claims are drawn to:
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Instant claims are drawn to a method of preparing the composition of US Patent claims. Because the instant claims share the same components involved in the US Patent claims, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of US Patent claims, and vice versa.
CLOSEST ART OF INTEREST
Dutheil (US 2014/0113274, filed with IDS) teach a composition comprising at least one globin, one globin promoter or one extracellular hemoglobin of annelids, a stabilizing solution and/or a clinically used organ preservation solution. Dutheil et al teach hemoglobin of annelids throughout the reference (e.g., paragraphs [0007]-[0009], [0015], [0017]-[0020], [0024]-[0027], [0029], [0059], [0071], [0073], [0076]). As evidenced by Weber et al, “The term erythrocruorin used in the older literature for all extracellular Hbs and some cytoplasmic invertebrate Hbs is no longer employed” (see p. 570, left column, 2nd full paragraph). Weber et al teach different sources of Hbs (erythrocruorin). Weber et al teach that Hb is encountered in all five kingdoms of organisms…in the phyla Platyhelminthes, Nemertea, Nematoda, Annelida, Vestimentifera, Pogonophora, Echniodermata, and Chordata (see p. 570, left column, 1st paragraph).
Schmid et al (WO 01/56551, filed with IDS) teach a composition and methods useful for preventing or treating vasoconstriction in organs and tissues, such as in connection with the preservation and reperfusion of transplanted organs in mammals, including man. Schmid et al teach a composition comprising a synergistic combinations of tetrahydrobiopterin (BH4) or its precursors together with membrane-permeable analogs og cGMP, such as 8-Br-cGMP (see p. 1, 1st paragraph).
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
2/12/2026
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