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 .
Applicants’’ response and amendments of 9/16/2025 have been received and entered into the application file. Claims 1-13, 15-17, 19-20, and 25 remain pending, of which claims 19-20 and 25 remain withdrawn from consideration as being drawn to non-elected claims.
Claim Interpretation
For clarity of record, a complete Claim Interpretation section is hereby set forth:
Claim 1 is drawn to an oxygenation constituent. The preamble states the oxygenation constituent is intended for formulating a finished oxygenation medium. This is understood to mean the claimed oxygenation constituent can go on to be used as part of a finished oxygenation medium. Recitation of a future potential use of the claimed product is an intended use limitation. The intended use only limits the claimed product in so far as the claimed product (the oxygenation constituent) must be physically capable of being formulated into (i.e. used as part of) a finished oxygenation medium.
Lines 2-11 of claim 1 describe the oxygenation constituent as comprising a mixture of a first a second preparation, wherein:
The first preparation is a hemoglobin based oxygen carrier (HBOC) preparation comprising:
HBOC in an amount of from about 1% to about 40% by weight, and
aqueous hemoglobin diluent (to balance).
This is understood to mean that the (i) hemoglobin preparation (i.e. first preparation) consists of (a) HBOC and (b) diluent. The term ‘consists of’ is being chosen because the sum of (a) + (b) = 100% w/w.
The second preparation is a red blood cell preparation comprising:
hemoglobin in an amount of from about 1% to about 40% by weight, and
aqueous red blood cell diluent (to balance).
This is understood to mean that the (ii) red blood cell preparation (i.e. second preparation) consists of (c) hemoglobin, and (d) diluent. The term ‘consists of’ is being chosen because the sum of (c) + (d) = 100% w/w.
HBOC is defined in the specification as “an oxygen carrying hemoglobin derivative wherein the hemoglobin molecule has been modified” (¶00076 of as-filed specification). Examples of modifications are presented, but the examples are non-limiting. The definition serves to differentiate HBOC from naturally occurring hemoglobin. It is appreciated that HBOC can (but does not necessarily) contain a hemoglobin molecule, and thus any hemoglobin present in the HBOC preparation will contribute to overall hemoglobin amount in the final oxygenation constituent.
A mixture of (i) and (ii) would be understood to comprise: (a) HBOC + (b) aqueous hemoglobin diluent + (c) hemoglobin + (d) aqueous red blood cell diluent. It is noted that (b) and (d) can be the same diluent. Thus in its broadest scope, the final oxygenation constituent can comprise HBOC, hemoglobin and a single diluent.
Noting the oxygenation constituent is described as comprising a mixture of (i) and (ii), additional elements may be present, but are not required. As additional elements may be present, the % by weight of the (a) HBOC and (c) hemoglobin in each of the first and second preparations are not limiting to the final mixed product (the oxygenation constituent).
At lines 12-15 of claim 1, it states that ‘the mixture is formed such that the oxygenation constituent comprises an amount of the HBOC preparation comprising from about 10% to about 99% w/w hemoglobin of the oxygenation constituent’. For the reasons set forth below under 35 USC 112(b), this limitation is not clear. However, for purposes of providing compact prosecution, the following interpretation is being used for comparison to prior art: ‘wherein about 10% to about 99% by weight of hemoglobin present in the oxygenation constituent is from the HBOC preparation’.
Lines 16-17 of claim 1 provide further limitations to the finished oxygenation medium. It is noted that the claim is to the oxygenation constituent, not the finished oxygenation medium. The preamble of the claim states the claimed oxygenation constituent can be used to formulate a finished oxygenation medium. The recitations in lines 16-17 regarding function of the finished oxygenation medium are not limiting to the claimed oxygenation constituent.
Dependent claims 2-5 define the percentage by weight of the (a) HBOC in the final oxygenation constituent.
Dependent claims 6-11 define the composition of the HBOC preparation or the red blood cell preparation by % weight of each component of the preparations, but the % by weight of the individual components in the preparations do not limit or affect the final oxygenation constituent. That is, claims 6-11 are defining the compositions of intermediate products used to make the final claimed product, but these limitations do not affect the composition of the final claimed composition.
Dependent claims 12-13, like 6-11, begin with defining the composition of the HBOC preparation and the red blood cell preparations. The % by weight of each component in each preparation is not limiting to the final preparation. However, claims 12-13 conclude with statements that the mixture is formed such that the oxygenation constituent comprises an amount of the HBOC preparation comprising specific % w/w hemoglobin from the hemoglobin preparation. As with claim 1, this limitation renders the claims indefinite. For purposes of compact prosecution, for comparison to the prior art the limitations are being interpreted as:
‘wherein about 40% to about 60% by weight of hemoglobin present in the oxygenation constituent is from the HBOC preparation’ (claim 12), and
‘wherein about 50% by weight of hemoglobin present in the oxygenation constituent is from the HBOC preparation’ (claim 13).
Dependent claims 15 and 16 define the composition of the HBOC preparation, but the composition of the individual components used to make the claimed oxygenation constituent do not limit or affect the final oxygenation constituent. That is, claims 15-16 are defining the compositions of intermediate products used to make the final claimed product, but these limitations do not affect the composition of the final claimed composition.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 1-17 under 35 USC 112(b): The amendments to claim 1 have overcome the previous grounds of rejection. The previous grounds of rejection are withdrawn. However, the amendments have necessitated new grounds of rejection.
RE: Rejection of claims 15-16 under 35 USC 112(d):
The amendments to claims 15 and 16 have overcome the previous grounds of rejection. The previous grounds of rejection are withdrawn. However, the amendments have necessitated new grounds of rejection.
RE: Rejection of claims 1-17 under 35 USC 101:
The amendment to claim 1 now requires that the oxygenation constituent comprises a mixture of HBOC, hemoglobin and at least one diluent. The composition as currently claimed no longer reads on naturally occurring hemoglobin. The rejection is withdrawn.
RE: Rejection of claims 1, 6-11, 14 and 17 under 35 USC 102(a)(1) over Hsia:
The amendment to claim 1 to now require HBOC is effective to differentiate over Hsia. The (oxy)hemoglobin of Hsia does not read on HBOC. The rejection is withdrawn.
RE: Rejection of claims 1, 6-11 and 15-17 under 35 USC 102(a)(1) over Page et al:
Applicants have traversed the rejection on the grounds that Page et al does not teach or suggest an oxygenation constituent for formulating a finished oxygenation medium, wherein the finished oxygenation medium is configured for ex vivo preservation of a tissue or an organ.
The argument has been fully considered, but is not found persuasive. The claim is to the oxygenation constituent, per se. The claim is effectively to an intermediate product that can be used to formulate a final product (the oxygenation medium). The final product (the oxygenation medium) is not the subject matter of the current claims. Applicants are arguing a functional limitation of the final product. The argument does not point out errors or deficiencies between the prior art and the actual claimed product. The rejection is modified to address the amended claims.RE: Rejection of claims 1-11, 14 and 17 under 35 USC 103 over Hsia:
As the base rejection under 35 USC 102(a)(1) is withdrawn for the reasons stated above, the obviousness rejections, too, are withdrawn.
RE: Rejection of claims 1-11 and 15-17 under 35 USC 103 over Page et al: Applicants have reiterated their arguments from the anticipation rejection. For the reasons set forth above, the arguments are not found persuasive. The rejection is modified to address the amended claims.
RE: Rejection of claims 1, 6-11 and 15-17 on grounds of NSDP over claims of US Patent 7267817:
Applicants’ have traversed the rejection on the grounds that the patented claims do not recite or suggest an oxygenation constituent for formulating a finished oxygenation medium, wherein the finished oxygenation medium is configured for ex vivo preservation of a tissue or an organ.
The argument has been fully considered, and is found persuasive. The patented method requires administration of a solution comprising a combination of stored red blood cells and HBOC. The patent claims cannot be considered to render obvious the solution, per se, in a form that can be further formulated into an oxygenation medium. The rejection is withdrawn.
Claim Rejections - 35 USC § 112
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 1-13 and 15-17 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.
Regarding claim 1: Claim 1 is drawn to an oxygenation constituent. At lines 12-15 of claim 1, it states that ‘the mixture is formed such that the oxygenation constituent comprises an amount of the HBOC preparation comprising from about 10% to about 99% by weight hemoglobin of the oxygenation constituent’. The language is not understood. The following interpretations are the best attempts at interpreting the claim:
the oxygenation constituent comprises the HBOC preparation, and the HBOC preparation comprises from about 10% to about 99% by weight hemoglobin
the oxygenation constituent comprises from about 10% to about 99% by weight of the HBOC preparation
the oxygenation constituent comprises the HBOC preparation and the oxygenation constituent comprises from about 10% to about 99% by weight hemoglobin
the proportion of (i) HBOC preparation present in the final oxygenation constituent is such that the HBOC preparation provides about 10% to about 99% of the total hemoglobin final the oxygenation constituent
As the claim is unclear and multiple interpretations are possible, the claim is held as indefinite.
Regarding claims 2-13 and 15-17: All claims depend from claim 1, inherit the deficiency, and thus are rejected on the same basis. Claims 12 and 13 have the same general language, reciting narrower ranges within the ‘about 10% to about 99%’ range. The same issue exists for claims 12 and 13, too.
Regarding claims 15 and 16: Each of these claims permit (or require) presence of hemoglobin in the (i) HBOC preparation. The hemoglobin in these claims is considered to be non-modified hemoglobin, i.e. hemoglobin that is not HBOC. These claims are considered indefinite because parent claim 1 requires the (i) HBOC preparation to contain (a) about 1% to about 40% HBOC, and (b) for the balance to be an aqueous hemoglobin diluent. As the hemoglobin diluent constitutes the balance of the HBOC preparation, then (a) + (b) = 100%. The claim does not permit for inclusion of additional, unrecited elements, such as hemoglobin outside of the (a) HBOC. The scope of the claims is thus unclear.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15-16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 15 and 16 fail to correlate in scope with the claim 1. Parent claim 1 requires the (i) HBOC preparation to contain (a) about 1% to about 40% HBOC, and (b) for the balance to be an aqueous hemoglobin diluent. As the hemoglobin diluent constitutes the balance of the HBOC preparation, then (a) + (b) = 100%. The claim does not permit for inclusion of additional, unrecited elements, such as hemoglobin outside of the (a) HBOC. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6-13 and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Page et al (US 6811778).
Page et al discloses a composition comprising stored red blood cells and a hemoglobin solution (See col. 2, ln 40-43). Page et al exemplifies a composition comprising a mixture of stored red blood cells in PBS and HBOC. The HBOC consists of glutaraldehyde-polymerized, ultrapurified bovine hemoglobin in physiologic solution. In the “stored red blood cell/HBOC 1-1” sample, the quantity of hemoglobin from the stored red blood cells was equal to the amount of hemoglobin from the HBCO (See col. 5, ln 50-col. 6, ln 30).
Regarding claims 1, 12 and 13: The “stored red blood cell/HBOC 1-1” sample reads on the claimed oxygenation constituent. The mixed “stored red blood cell/HBOC 1-1” sample contains (i) HBOC in physiological solution (reads a HBOC preparation comprising (a) HBOC and (b) aqueous hemoglobin diluent), and (ii) stored red blood cells in PBS (reads on a red blood cell preparation comprising (a) hemoglobin, and (d) aqueous red blood cell diluent). The proportions by weight of the HBOC and hemoglobin in the HBOC and stored red blood cell samples, respectively, prior to combination are limitations of intermediate products that do not affect the final claimed composition. The HBOC provides 50% by weight of the hemoglobin to the final oxygenation constituent.
Regarding claims 6-11: For the reasons discussed under Claim Interpretation, claims 6-11 are defining the compositions of intermediate products used to make the final claimed product, but these limitations do not affect the composition of the final claimed composition. As such, claims 6-11 are included in the rejection of claim 1.
Regarding claims 15 and 16: For the reasons discussed under Claim Interpretation, claims 15-16 are defining the compositions of intermediate products used to make the final claimed product, but these limitations do not affect the composition of the final claimed composition. As such, claims 15-16 are included in the rejection of claim 1.
Regarding claim 17: Following the discussion of claim 1, Page et al use PBS as the aqueous red blood cell diluent. PBS is considered a modified form of lactated Ringer’s solution (noting that lactated Ringer’s contains PBS plus additional electrolytes and lactate, the removal of the additional electrolytes and lactate can be considered ‘modifications’).
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.
Claims 1-13 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Page et al (US 6811778).
The teachings of Page et al are set forth above. Page et al anticipates claims 1, 6-13 and 15-17.
Regarding claims 2-5: Claims 2-5 deal with the concentration by weight of HBOC of the overall composition.
Page teaches that the stored red blood cell sample and the HBOC sample were combined at 1:1 ratio based on the hematocrit concentration. There is insufficient information to determine the final % by weight of HBOC, per se, in the final mixed sample (as the amount of PBS and physiologic solution are not known). However, the % by weight of HBOC would depend directly on the amount of diluent (PBS and physiologic solution) present, and could be manipulated by adding/reducing amount of diluent. Manipulation of the % by weight HBOC would directly affect the hematocrit % of the solution. Manipulation of the hematocrit % would have been a matter of routine optimization based on downstream applications. See MPEP 2144.05. Please note generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical or produces unexpected results. "[W]here the general conditions of a claim are disclosed by the prior art it is not inventive to discover the optimum or workable ranges by routine experimentation" See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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/ALLISON M FOX/Primary Examiner, Art Unit 1633