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 .
This case has been transferred to Examiner Constantina Stavrou.
Status of the Claims
Claims 1-3, 5 and 8-11 are currently pending.
Claims 1-3 are amended.
Claims 5 and 8-11 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 6-7 are cancelled.
Claims 1-3 have been considered on the merits.
Withdrawn Rejections
The objections made onto claims 1-3 are withdrawn in view of the clarifying amendments presented by applicant in the reply filled on 03/23/2026.
The objections made onto the specification are withdrawn in light of the amendments made onto the specification in the reply filled on 03/23/2026.
The rejections made onto claim 4 under 35 U.S.C. 112(b) are withdrawn due to the cancellation of claim 4 in the reply filled on 03/23/2026.
The rejections made onto claims 1 and 3-4 under 35 U.S.C. 102 are withdrawn due to the inclusion of the phrase “in the form of an erythrocyte concentrate” into independent claim 1 in the reply filled on 03/23/2026.
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 1-3 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 requires step (a) providing blood plasma from group A, B, O, or a mixture of two or more blood plasmas of blood group A, B, and O; step (b) providing erythrocytes from blood groups A, B, and/or AB; and step (c) of obtaining a blood plasma depleted in anti-A and/or anti-B antibodies compared to the blood plasma from step (a), which is indefinite. It is unclear if the intended result of obtaining a blood plasma depleted in anti-A and/or anti-B as compared to the blood plasma of step (a) is capable of happening if the blood plasma of step (a) is provided from group A and the erythrocytes of step (b) are also provided grom group A, which the claim language currently allows. In other words, if the samples provided in steps (a) and (b) are chosen from the same blood group, could the method still result in a blood plasma depleted of any antibodies? It is recommended to amend the claim to require that the blood group of step (a) and step (b) must not be the identical blood group, or similar. Appropriate clarification is required. Claims 2-3 are included in this rejection due to dependency from independent claim 1.
Claim 1 requires step (b) “providing erythrocytes of blood group A and/or erythrocytes of blood group B and/or erythrocytes of blood group AB in the form of an erythrocyte concentrate”, which is indefinite. The scope of claim 1 is rendered unclear because it is uncertain whether the claim requires erythrocytes from blood group A, B, AB, all three blood groups, or an alternative combination in the form of an erythrocyte concentration due to multiple recitations of “and/or”. Accordingly, the metes and bounds of the claim cannot be determined with reasonable certainly. Appropriate clarification is required.
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.
Claims 1 and 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Marguerre et al (US20110008459A1), in view of Karger (Transfusion Medicine and Hemotherapy, 2009, “RBC Concentrates”).
Regarding claim 1, Marguerre teaches a method for preparing blood plasma depleted in anti-A and anti-B antibodies comprising a step of pooling blood plasma and blood, which contains erythrocytes, of blood group A and B as required by steps (a) and (b) of claim 1 ([0004]). Marguerre teaches that by mixing appropriate amounts of blood/blood plasma the anti-A and anti-B antibodies of subclasses IgM and IgG are neutralized by binding the free A and B antigens which are subsequently removed (i.e. removing the plasma supernatant from the cell sediment) as required by step (c) of claim 1 ([0013]-[0015]). Marguerre teaches that the titer of the anti-A and anti-B antibodies is less than 1:8 for IgM and less than 1:32 for IgG which overlaps with the range of a maximum titer of 1:4 as required by step (c) of claim 1 ([0012] /[[0019]). Marguerre teaches the removal of the blood plasma from any residual erythrocytes as required by step (d) of claim 1 ([0016]). Marguerre teaches the method is an in vitro method as required by claim 3 ([0019]). Marguerre teaches the blood and blood plasma are defined by human blood grouping and refer to blood plasma stored in blood banks in hospitals used for operations and severe bleeding, which meets the limitations of the blood plasma or whole blood sample coming from a mammal as required by claim 4 ([0002]-[0003]).
Marguerre does not teach that the step of providing erythrocytes of blood group A and/or erythrocytes of blood group B and/or blood group AB is in the form of an erythrocyte concentrate as required by step (b) of claim 1.
It is pertinent to the rejection that Marguerre does teach the step of providing erythrocytes of blood group A, B, and/or AB in the form of blood/whole blood as stated above ([0013]-[0015]).
Additionally, Karger teaches about erythrocyte (RBC) concentrates. Karger teaches that RBC concentrates can be made using fresh whole blood and that “the active constituents of RBC concentrates are morphologically and functionally intact erythrocytes” (pg. 363, col 1, para 1 and col. 2 para 3). Karger also teaches that erythrocyte concentrates may differ in the contants of plasma, platelets, anticoagulants, and additive solutions depending on the method of making the concentrate but that these factors do not effect the therapeutic efficacy of the RBC concentrates (pg. 363, col. 2, para 3) which is being interpreted to mean that the specific erythrocyte concentrate composition does not materially alter the functionality of the RBCs in the concentrates.
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the method of Marguerre with the RBC concentrates described by Karger to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Marguerre describes the application of whole blood and Karger describes that RBC concentrates do not materially alter the functionality of the intact RBC/erythrocytes; the combination of Marguerre and Karger amounts to no more than a difference in the concentration of RBCs used at step b of claim 1. The MPEP states under 2144.05 (II) A that ‘In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.’)” (See MPEP 2144.05 (II) A). Thus, Karger demonstrates that an erythrocyte concentrate is essentially a more concentrated form of RBC/erythrocytes, and based on this the substitution of the whole blood used in Margeurre with an erythrocyte concentrate amounts to no more than a substitution of equivalents. One of ordinary skill in the art would have a reasonable expectation of success when combining Marguerre with Karger because Marguerre teaches the necessary steps of preforming the method and Karger demonstrates that concentrating erythrocytes does not functionally alter the RBCs in the concentrate.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Marguerre et al (US20110008459A1) and Karger (Transfusion Medicine and Hemotherapy, 2009, “RBC Concentrates”), in view of Huet et al (High-Throughput, 2018).
Regarding claim 2, Marguerre and Karger teach the limitations of the independent claim 1 above. Marguerre teaches that by mixing appropriate amounts of blood/blood plasma the anti-A and anti-B antibodies of subclasses IgM and IgG are neutralized by binding the free A and B antigens which are subsequently removed as required by step (c1) and (c3) of claim 2 ([0013]-[0015]).
Marguerre is silent as to how long the mixture must be incubated. Marguerre does not teach incubating the mixture obtained according to (c1) for at least 10 min as required by claim 2.
However, Huet teaches about real time agglutination of blood. Huet teaches that in undiluted blood with a large amount of RBCs the agglutination process slows and that “with undiluted blood samples, the stabilization of the agglutination indicator occurred only after around 10 minutes”, whereas less time was required for diluted blood samples as required by step (c2) of claim 2 (pg. 7, last para).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the method of Marguerre with the incubation length taught by Huet to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Huet teaches that “with undiluted blood samples, the stabilization of the agglutination indicator occurred only after around 10 minutes” (pg. 7, last para). One of ordinary skill in the art would have a reasonable expectation of success when combining Marguerre with Huet because Marguerre teaches the necessary steps of preforming the method and Huet teaches the required time for agglutination to occur which is the underlying mechanism of the method of Marguerre.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments, see Remarks, pg. 8-12, filed 03/23/2026, with respect to the rejection(s) of claim(s) 1-4 under 35 U.S.C 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Marguerre et al (US20110008459A1) and Karger (Transfusion Medicine and Hemotherapy, 2009, “RBC Concentrates”).
Applicant's arguments filed 03/23/2026 have been fully considered but they are not persuasive with regards to the rejection under 35 U.S.C. 112(b).
Applicant provides arguments (pg. 6-8) regarding the rejection of claim 1 under 35 U.S.C. 112(b). Applicant argues that claim 1 is not indefinite because although the claim is broad enough to encompass combinations of blood plasma types from step a and erythrocytes types from step B which would not result in the claimed result of “obtain[ing] a blood plasma depleted of anti-A antibodies and/or anti-B antibodies compared to the blood plasma according to (a)”, a person or ordinary skill in the art “would therefore understand with reasonable certainty that selecting the same blood group for both steps (a) and (b) would not achieve the claimed depletion result”.
In response, the argument is not found persuasive. Although the concept of blood type coagulation is well known in the art, the claim is broad enough to encompass the combination of blood plasma and erythrocyte types which do not produce the claimed result, which is explicitly recognized by Applicant in the response provided. This discrepancy produced indefiniteness within claim 1. As described in the presented rejection, It is recommended to amend the claim to require that the blood group of step (a) and step (b) must not be from the identical blood group, or similar language desired by Applicant. Thus, the argument is not found persuasive.
Applicant argues with respect to the 35 U.S.C. 103 rejection employing Marguerre in view of Huet that Huet does not remedy the deficiencies of Marguerre regarding the newly amended phrase of claim 1 requiring that the erythrocytes are provided in a erythrocyte concentrate. Huet and Marguerre are not relied upon to teach this limitation. Applicant also argues that there is no motivation to combine Marguerre with Huet, (pg. 15, para 2-3) this argument is addressed below.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the method of Marguerre with the incubation length taught by Huet to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Huet teaches that “with undiluted blood samples, the stabilization of the agglutination indicator occurred only after around 10 minutes” (pg. 7, last para). One of ordinary skill in the art would have a reasonable expectation of success when combining Marguerre with Huet because Marguerre teaches the necessary steps of preforming the method and Huet teaches the required time for agglutination to occur which is the underlying mechanism of the method of Marguerre. Thus, the argument is not found persuasive.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
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