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 .
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.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/23/2026 has been entered.
Status of Claims
Claims 1-11 and 14-20 are pending. Claim 19 is withdrawn. Claims 12-13 are canceled. Claims 1-11, 14-18 and 20 are currently under examination.
Withdrawn Objection
In view of the amendments, the objection to claim 8 is hereby withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11, 14-18 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163.
MPEP § 2163 further states that, for a claimed genus, the written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus:
Claims 1 and 9 are drawn to a method of preparing a universal blood product comprising: obtaining a blood product wherein the blood product comprises whole blood or plasma; and contacting the blood product with (i) hydroxyapatite, wherein the hydroxyapatite is a sphere and the sphere consists essentially of hydroxyapatite; (ii) a carbonaceous material comprising at least a mixture of a first carbon particle having macroporous size α and a second carbon particle having macroporous size β, wherein one macroporous size β is twice the size of macroporous size α; and (iii) at least one support matrix chemically associated with an antigenic determinant.
Similarly, claim 20 is drawn to a method of preparing a universal blood product comprising: obtaining a blood product wherein the blood product comprises whole blood or plasma; contacting the blood product with (i) hydroxyapatite, wherein the hydroxyapatite is a sphere and the sphere consists essentially of hydroxyapatite; (ii) a carbonaceous material comprising at least a mixture of a first carbon particle having macroporous size α and a second carbon particle having macroporous size β, wherein macroporous size α identifies a first range of sizes and macroporous size β identifies a second range of sizes and wherein the first range of sizes and the second range of sizes is different; and (iii) at least one support matrix chemically associated with an antigenic determinant wherein at least one of the hydroxyapatite, carbonaceous material and support matrix is functionalized.
The claims as a whole cover a large genus of possible antigenic determinants that are chemical association to a support matrix; a genus in which includes the antigenic determinants and three elements (i) hydroxyapatite, (ii) carbonaceous material, and (iii) support matrix to produce a universal blood product. Implicit in the claims is that such antigenic determinants and said (i)-(iii) elements possess certain functional characteristics; namely, to produce a universal blood product with antigenic determinants. In other words, the general structures of antigenic determinants chemically associated to a support matrix and in the presence of hydroxyapatite and carbonaceous material as a whole must provide the function of providing the blood product to be universal.
The claims read on any combination of the general antigenic determinants with the claimed support matrix and in the presence of hydroxyapatite and carbonaceous material to provide the function of a universal blood product. Additionally, in claim 20, it recites general functionalization would possess the necessary function. The written description in this instant case does not set forth the broadly claimed structures to produce a universal blood product.
Meanwhile, the instant application only discloses the preparation of trisaccharide conjugated to the claimed support matrix, hydroxyapatite, or carbonaceous to produce a universal blood product. In particular, prior art recognizes structures, binding of saccharides, and positioning of said structures impact binding ability.
Navarra et al. (“Carbohydrate-Lectin Interactions: An unexpected Contribution to Affinity”, ChemBioChem, vol. 18, pgs. 539-544, published 2017, 892 dated 05/19/2025) teach tetrasaccharide 1 and general mechanism for modulating carbohydrate-protein interactions based on non-binding regions of the ligand (see abstract). Navarra further teaches that elongation of 1 (i.e., tetrasaccharide) at its nonreducing terminus with the disaccharide led to substantially improved affinity, although no affinity was found for disaccharide Neu5Acα(2-3)Galβ on its own. Furthermore, analysis of the structure of PapGII co-crystalized with 2 (i.e., Neu5Acα(2-3)Galβ) provided no evidence for a direct interaction of the additional Neu5Acα(2-3)Galβ moiety with the protein (see pg. 543, left col., para. 1 of Conclusion). Additionally, Rempfer et al. (WO2013/020964A1, published 02/14/2013, IDS submitted on 06/20/2022, cite no. 3) disclose that a matrix immobilizes saccharide ligands is based on selective functional moieties between the matrix and the saccharide moiety structure to form separation materials that show good properties in binding and removing e.g. blood antibodies, there is still a desire to provide new materials enabling an enhancement of the performance (see abstract, Figure 3, and pgs. 1-2, background of the invention).
In particular, the skilled artisans recognize structures of saccharides and positionally of said structures would affect binding ability in blood product. Therefore, the skilled artisan would not be able to envision or predict any chemical association between a generic antigenic determinants and support matrix to produce said universal blood product as claimed.
Meanwhile, the specification does not provide sufficient or enough guidance as to the correlation between the structure and function of generic antigenic determinants with the claimed support matrix, hydroxyapatite, and carbonaceous material to produce the claimed universal blood product. Additionally, there is insufficient guidance of the undefined chemical structures of the support matrix, hydroxyapatite and carbonaceous material to place applicant in possession of the claimed genus to chemically associate or functionalized with any antigenic determinants to produce the claimed universal blood product.
“A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus.” See AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69.
Vas-Cath Inc. V Mahurkar, 19 U5PQ2d 1111, clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116). Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 115).
The skilled artisan cannot envision the general structures as claimed to provide the structure and function relationship of a universal blood product. Therefore, conception is not achieved until a representative number of species has reduced to practice, regardless of the simplicity of a method. Adequate written description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it.
Here, Applicants’ claims include generic structures, but does not describe the structure-identifying information to associate the generic antigenic determinants with the support matrix, hydroxyapatite, and carbonaceous material (e.g., see claims 9 and 20) to produce a universal blood product and does not provide a representative number of species falling with the scope of the claimed genus or common structures to the members of the claimed genus so the skilled artisan can visualize or recognize the member of the genus of the chemical structures of the cleansing product. In particular, Navarra teaches that altering the chemical structures of a saccharide to form a different saccharide affects binding affinity. Also, Rempfer et al. teaches that selective functional moieties between the matrix and the saccharide moiety structure are important to produce a specific positioning for the separation material that removes blood antibodies and provide performance (see above).
With the exception of trisaccharide antigen determinants chemically associated with the claimed support, at the time the application was filed, Applicants do not seem to be in possession of generic chemical structures of the antigen determinants to produce the universal blood product.
The instant disclosure, including the claims fail to disclose a representative number of species falling with the scope of the genus and/or structural common to the members of the genus so the skilled artisan can visualize or recognize the members of the genus of chemical structures. A skilled artisan cannot, as one can do with a fully described genus, visualize, predict, or recognize the identity of the members to exhibit the functional property of producing a universal blood product. The specification does not provide evidence of possession of generic antigenic determinant associated with elements (i-iii) which fall within the large genus. Consequently, Applicant was not in possession of the instant claimed invention.
The full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
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 1-8, 15-16 and 18 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.
Claims 1-8 and 18 are rejected for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted element is (iii) a support matrix chemically associated with an antigenic determinant. As stated in the current Remarks (page 9) that the instant Application at [0014] states that (i), (ii), and (iii) are present to produce the cleansing formulation for universal product. Therefore, element (iii) is an essential element to produce such cleansing formulation for the process of retrieving a universal blood product. Claims 2-8 and 18 are rejected as being dependent from claim 1.
With respect to claim 15, the claim recites “the support matrix” is unclear because it lacks antecedent basis as claim 1 does not recite a support matrix. Claim 16 is rejected as being dependent from claim 15.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-11, 14-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ichitsuka et al. (DE3722102, published 01/14/1988, IDS submitted on 06/20/2022, cite no. 1), Rempfer et al. (WO2013/020964A1, published 02/14/2013, IDS submitted on 06/20/2022, cite no. 3) and Tennison et al. (US2013/0072845A1, published 03/21/2013, IDS submitted on 06/20/2022, cite no. 5).
With regard to claim 1, Ichitsuka teaches blood treatment (page 1, para. 1) and a filler material comprising a calcium phosphate-based compound which is in the form of spherical granules of uniform size (page 2, paras. 2-3). Ichitsuka teaches calcium phosphate-based compound which are suitable for preparing the column packing material according to the invention include Ca10(PO4)6(OH)2 (page 2, para. 5; and page 4, para. 2, Example 1), which reads on hydroxyapatite. Ichitsuka further teaches beads of a material such as polyester, polystyrenes, polyacrylic acids, carbon, silica alumina as a spherical substrate (page 2, para. 6), which would read on carbonaceous material with macroporous sizes. Ichitsuka teaches the particles of the filler material according to the invention are preferably adjusted so as to have a size (diameter) in the range of 1 to 100µm (page 3, para. 2). Ichitsuka teaches the filler material consisted of 35.2 µm diameter particles with a 2.6 µm thick hydroxyapatite coating (page 5, para. 3). Ichitsuka teaches produce liquid chromatography fillers from hydroxyapatite, which is closely related to the living body (page 1, para. 3 under Description). Ichitsuka teaches hydroxyapatite coating was formed on the surface of each silica sphere bead (see Example 3). Because Ichitsuka teaches the column is a blood treatment column, it would read on contracting the blood product with the cleaning formulate, and recovering, subsequent to contacting the blood product.
With respect to the carbonaceous material is formed in the presence of a pore-former, see claims 1 and 20, these limitations are directed to product-by-process. Because the carbon particles or pores do not contain the pore-formers after being produced, it is product-by-process limitation to produce the carbon particles. If the prior art references read on the claimed carbon particles having macroporous sizes, then the prior art reference reads on the claimed. In this particular case, Ichitsuka does teach beads of a material such as polyester, polystyrenes, polyacrylic acids, and carbon as spherical substrates (i.e., carbon particles). Meanwhile, MPEP 2113 states:
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. at 1370 ("a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim"). MPEP 2113.
Ichitsuka does not explicitly teach the (ii) macroporous size β is at least twice macroporous α (claim 1).
Rempfer teaches a separation material comprising a saccharide that is bound via a linker to a matrix for enabling the separation of substances from a liquid that selectively bind to saccharide moieties (abstract). Rempfer teaches the material is designed to remove anti-A and/or anti-B antibodies from whole blood or plasma (page 2, lines 10-15). Rempfer teaches a polymer matrix that is in form of beads (page 30, lines 2-25). Rempfer teaches the matrix used has an average particle size range of 100-300 µm (page 31, lines 25-35). Rempfer teaches the median pore diameter is between 40- 60 nm (page 31, lines 25-30). Rempfer teaches the removal of blood A and/or blood group B antibodies from blood, blood plasma, or any other blood product and the removal of blood group A and / or blood group B antibodies is needed to minimize the problem of blood group incompatibility between donor and recipient (page 35, lines 25-35). Rempfer teaches the membrane should have a pore diameter on the selective separation layer in the range of 0.1 to 1 µm and that lower average pore diameters are disadvantageous due to incomplete passage of total plasma proteins through the porous structure (page 33, lines 16-20). Noted that the instant specification discloses that “macropores” refer to pores with diameters larger than 50 nm (see page 7, para. [0021], as filed).
Tennison teaches whole blood is treated extracorporeally to remove substances contrary to health using mesoporous/microporous or macroporous/microporous carbon in the form of beads or carbon monolith wherein the carbon monolith with a pore structure tailored to remove molecules and protein bound uremic toxins, or with a similar removal; system based on small carbon beads, and may provide toxin removal and result in improved patient outcome (abstract; see para. [0019]). Tennison teaches carbonising a mesoporous or macroporous phenolic resin (see abstract). Tennison teaches the term macropore refers to pores with diameters larger than 50 nm [0033]. Tennison teaches Table 3 of carbons 1-4 with bead diameter 250-500 µm with different mean pore diameters such as 70 nm, 80 nm, 120 nm, 30 nm. In particular, Tennison teaches in para. [0079] that FIG. 3 shows that the carbon monolith had pores in the mesopore range of 200-500 nm in size and also a larger population of macropores in the 10000-20000 nm range. Tennison teaches small carbon beads may provide toxin removal and may result in improved patient outcome, and enhanced quality of life, and a reduction in complications (see para. [0019]).
Tennison teaches resin particles with macropore sizes of 4-10 µm, see para. [0061] and resin is carbon composite, see para. [0056]. Tennison teaches the concentration of IL-8 remaining in spiked plasma incubated with carbon 1 TE1/20, and mes-macroporous carbons 2 (TE9/16) and 3 (TE7/20). All of the carbons removed significant amounts of IL-8 and in particular, carbon 2 and 3 removed all detectable IL8 by the first 30 minute time point (see para. [0081]). Tennison further teaches TNF molecule has a larger molecular weight than IL-8 and IL-6 and its removal is dependent on the presence of the larger meso-macropores [0081] and [0082]. Similarly, Tennison teaches that the large mesoporous (TE5) and meso-macroporous carbon (TE9) showed good removal of SEA (Staphylococcal exterotoxin) from plasma over time (see para. [0095]). Tennison teaches a finely controlled multiparous and surface structure activated carbon material can be used for the direct and effective removal of biological active molecules from blood without prior separation of the blood into cells and plasma [0011]. Tennison teaches extracorporeal treatment of whole blood to remove contrary substances and provide treated blood returnable to the body [0012].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have employed the process of blood treatment comprising hydroxyapatite particles and carbon sphere particles of Ichitsuka with the additional carbon particles having selective pore sizes of Rempfer and Tennison because Tennison teaches that effective pore sizes would remove certain targeted molecules of a particular molecular weight and Rempfer teaches that the pore sizes area selective to complete passage of total plasma proteins through the porous structure. Therefore, it would have been obvious to have particles with selective macroporous sizes for blood purification to remove certain molecular weighed toxins. In addition, it would have been obvious to have combined together the materials of Ichitsuka, Rempfer and Tennison in blood product purification because these are well recognized elements to separate unwanted substances for blood treatments.
Additionally, the person would have been motivated to employ the process of blood treatment comprising spherical hydroxyapatite of Ichitsuka with additional carbon particles having different macropore sizes as taught by Tennison (Tables 3-4) because it would have been desirable and well recognized by Tennison to enhance separation and remove unwanted toxins of various sizes through different macropore sizes having mean pore diameters such as 70 nm, 80 nm, 120 nm, 30 nm, as it would improve the patient’s outcome, and enhanced quality of life, and reduce complications, as taught by Tennison.
The person would reasonably expected success using together the spherical shell of hydroxyapatite, porous carbonaceous materials, and functionalized matrix beads for blood treatments because it has been well understood in the art to use hydroxyapatite, porous carbonaceous materials, and functionalized matrix beads in blood treatments.
With regard to claim 2, Ichitsuka teaches calcium phosphate-based compound which are suitable for preparing the column packing material according to the invention include Ca10(PO4)6(OH)2 (page 2, para. 5; and page 4, para. 2, Example 1), which would read on naturally-occurring or synthetic hydroxyapatite.
Regarding claims 3-5, Ichitsuka teaches the particles of the filler material according to the invention are preferably adjusted so as to have a size (diameter) in the range of 1 to 100µm (page 3, para. 2). Even though Ichitsuka does not specifically teach surface area of from about 200 m2 /g to about 3000 m2 /g or having a particle size of from about 300 µm to about 1000 µm or a pore size ranging about 2 nm to greater than about 1000 nm, it is settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum ratio for a result effective variable in capturing specific molecular weight molecules in blood treatment. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation" Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” It would have been obvious for one of ordinary skill to discover the optimum workable sizes and surface areas of the spherical hydroxyapatite particle based from specific affinity of the unwanted substances.
Regarding claims 6-7, Ichitsuka does not explicitly teach macroporous size ranges from about 125 nm to 250 nm or 250 nm to 500 nm. Tennison teaches pore size 2-500 nm within the carbon matrix. It would have been obvious to have used the carbon matrix with a pore size of Tennison because Tennison teaches that effective pore sizes would remove certain molecules of a particular molecular weight. Additionally, it is settled to be no more than routine experimentation for one of ordinary skill in the art to discover optimum pore sizes for a result effective variable to effectively capture particular molecular weight. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation" Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” It would have been obvious for one of ordinary skill to discover the optimum workable pore sizes to capture unwanted substances.
Regarding claim 8, Ichitsuka does not explicitly teach micropores having a pore size range of from about 2 nm to 50 nm. Rempfer teaches the median pore diameter is 40 nm (page 31, lines 25-30). It would have been obvious to have used the carbon particle with pore diameter of 40 nm because Rempfer teaches that the pore sizes area selective to complete passage of total plasma proteins through the porous structure.
Regarding claims 9-11 and 20, Ichitsuka does not teach (iii) at least one support matrix chemically associated with an antigenic determinant; a blood group A determinant or blood group B determinant (claim 9); and the support matrix is polyvinyl acetate. Rempfer teaches polyvinyl acetate (PVA) (page 27). Rempfer teaches the claimed trisaccharide structures of the blood group determinants A and B (page 25, lines 1-5) and further teaches trisaccharide (Examples 1 and 17). Rempfer teaches the claimed blood group determinants A and B trisaccharides (page 25, lines 1-4, page 60, lines 25-28, and Example 1). It would have been obvious to have enhanced blood purification by functionalizing the matrix beads with PVA of Rempfer for blood group determinants A and B trisaccharides because Rempfer teaches that the removal of blood group A and/or blood group B antibodies through covalent bonds would minimize the problem of blood group incompatibility between donors and recipients.
Regarding claims 14-15, Ichitsuka does not teach the claimed support matrix and linker. Rempfer teaches functionalized beads with a linker (page 28, lines 14-15; and Fig. 3). It would have been obvious to have enhanced blood purification by using the functionalized beads of Rempfer because Rempfer teaches that the removal of blood group A and/or blood group B antibodies would minimize the problem of blood group incompatibility between donors and recipients.
Regarding claim 16, Ichitsuka does not teach an amino acid. Rempfer teaches a peptide matrix (page 26, line 20). It would have been obvious to have enhanced blood purification by functionalizing the beads with peptides of Rempfer because Rempfer teaches that the removal of blood group A and/or blood group B antibodies would minimize the problem of blood group incompatibility between donors and recipients.
Regarding claim 17, Ichitsuka does not teach IL-6 or IL8. Tennison teaches in Figure 7 that IL6, IL8, and TNF are reduced by 10% to 50%. It would have been obvious to have removed IL-6 or IL-8 because Tennison teaches that effective pore sizes would remove certain targeted molecules of a particular molecular weight.
Regarding claim 18, Ichitsuka does not teach the blood product is obtained at least two subjects. Tennison teaches the sample is from a human plasma and whole blood [0080]. It would have been obvious to have used multiply subjects in the filtration process because the process would remove similar unwanted substances.
Regarding claim 20, Ichitsuka does not teach (iii) at least one support matrix chemically associated with an antigenic determinant wherein at least the support matrix is functionalized; a blood group A determinant or blood group B determinant (claim 9); and the support matrix is polyvinyl acetate. Rempfer teaches polyvinyl acetate (PVA) (page 27). Rempfer teaches the claimed trisaccharide structures of the blood group determinants A and B (page 25, lines 1-5) and further teaches trisaccharide (Examples 1 and 17). Rempfer teaches the claimed blood group determinants A and B trisaccharides (page 25, lines 1-4, page 60, lines 25-28, and Example 1). It would have been obvious to have enhanced blood purification by functionalizing the matrix beads with PVA of Rempfer for blood group determinants A and B trisaccharides because Rempfer teaches that the removal of blood group A and/or blood group B antibodies through covalent bonds would minimize the problem of blood group incompatibility between donors and recipients.
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.
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Claims 1-11, 14-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11253794B2 (‘794) (of record).
With respect to claim 1, claim 1 of Patent No. ‘794 recites a method of preparing a universal blood product comprising: obtaining a blood product wherein the blood product comprises whole blood or plasma; contacting the blood product with (i) hydroxyapatite, (ii) a carbonaceous material comprising at least a mixture of a first carbon particle comprising pores having a macroporous size α of about 70 nm to about 200 nm and a second carbon particle comprising pores having a macroporous size β of about 70 nm to about 200 nm, wherein macroporous size β is at least twice macroporous size α, (iii) at least one support matrix, and (iv) trisaccharide antigenic determinants to form a cleansed product, wherein the hydroxyapatite, carbonaceous material and support matrix are functionalized with one or more amino acids or peptides; and recovering the cleansed product. Patent claim 4 recites the hydroxyapatite is in the form of beads having a particle size of from about 300 μm to about 1000 μm. Although the claims at issue are not identical, they are not patentably distinct from each other because the Patent claim is a process that obtain the universal blood product through (i), (ii), and (iii).
With respect to the carbonaceous material is formed in the presence of a pore-former, see claim 1, these limitations are directed to product-by-process. Because the carbon particles or pores do not contain the pore-formers after being produced, it is product-by-process limitation to produce the carbon particles. If the prior art references read on the claimed carbon particles having macroporous sizes, then the prior art reference reads on the claimed.
In this particular case, the Patent does recite a carbonaceous material comprising at least a mixture of a first carbon particle comprising pores having a macroporous size α of about 70 nm to about 200 nm and a second carbon particle comprising pores having a macroporous size β of about 70 nm to about 200 nm, wherein macroporous size β is at least twice macroporous size α, (iii) at least one support matrix.
With respect to instant claim 2, the Patent claim 2 recites the hydroxyapatite is naturally-occurring, synthetic, or combinations thereof.
With respect to instant claim 3, the Patent claim 3 recites the hydroxyapatite has a Brunauer Emmett Teller surface area of from about 200 m2/g to about 3000 m2/g.
With respect to instant claim 4, the Patent claim 4 recites the hydroxyapatite is in the form of beads having a particle size of from about 300 μm to about 1000 μm.
With respect to instant claim 5, Patent claim 5 recites the hydroxyapatite has a unimodal pore size distribution with a pore size ranging from about 2 nm to greater than about 1000 nm.
With respect to instant claims 6-7, Patent claim 1 recite the α and β sizes are about 70 nm to 200 nm but fails to recite the claimed range. Because the sizes overlap, it would have been obvious to have produced the claimed ranges.
With respect to instant claim 8, Patent claim 6 recites the carbonaceous material further comprises a pore size range of from about 2 nm to about 50 nm.
With respect to instant claim 9, Patent claim 7 recites the trisaccharide antigenic determinant comprises a Blood Group A determinant, a Blood Group B determinant, or combinations thereof, and wherein the trisaccharide antigenic determinant is covalently immobilized on a substrate. Patent claim 10 recites the at least one support matrix and the trisaccharide antigenic determinant is covalently immobilized on a substrate of polyethylene (PE). Patent claim 21 recites the support matrix further comprises polysaccharides chemically associated with the polyvinyl alcohol via amino acids or peptides.
With respect to instant claim 10, Patent claim 8 recites the Blood Group A determinant comprises A-trisaccharides [Ga1NAcalpha1-3(Fucalpha1-2)Ga1].
With respect to instant claim 11, Patent claim 9 recites the Blood Group B determinant comprises B-trisaccharides [Ga1alpha1-3(Fucalpha1-2)Ga1].
With respect to instant claim 14, Patent claim 12 recites at least one support matrix is in the form of a bead, a sheet, or a hollow fiber membrane.
With respect to instant claim 15, Patent claim 13 recites a linker group coupled with the at least one support matrix.
With respect to instant claim 16, Patent claim 1 recites functionalized with one or more amino acides.
With respect to instant claim 17, Patent claim 14 recites the cleansed product has an amount of at least one molecule selected from the group consisting of TNF-α, IL-1 β, IL-4, IL-6, IL-8, IL-10, IFN-γ, and TGF-β that is reduced by from about 10% to about 50% when compared to the amount present in the blood product.
With respect to instant claim 18, Patent claim 16 recites the blood product is obtained from at least two subjects.
With respect to instant claim 20, Patent claim 17 A method of preparing a universal blood product comprising: obtaining a blood product wherein the blood product comprises whole blood or plasma; contacting the blood product with (i) hydroxyapatite, (ii) a carbonaceous material comprising at least a mixture of a first carbon particle comprising pores having a macroporous size a of about 70 nm to about 200 nm and a second carbon particle comprising pores having a macroporous size β of about 70 nm to about 200 nm, wherein macroporous size β is at least twice macroporous size α; (iii) at least one support matrix, and (iv) trisaccharide antigenic determinants to form a cleansed product; wherein the hydroxyapatite, carbonaceous material and support matrix are functionalized with one or more amino acids or peptides. Patent claim 10 recites the at least one support matrix and the trisaccharide antigenic determinant is covalently immobilized on a substrate of polyethylene (PE). Patent claim 21 recites the support matrix further comprises polysaccharides chemically associated with the polyvinyl alcohol via amino acids or peptides. Although the claims at issue are not identical, they are not patentably distinct from each other because the Patent claim is a process that obtain the universal blood product through (i), (ii), and (iii).
With respect to the carbonaceous material is formed in the presence of a pore-former, see claim 20, these limitations are directed to product-by-process. Because the carbon particles or pores do not contain the pore-formers after being produced, it is product-by-process limitation to produce the carbon particles. If the prior art references read on the claimed carbon particles having macroporous sizes, then the prior art reference reads on the claimed.
In this particular case, the Patent does recite a carbonaceous material comprising at least a mixture of a first carbon particle comprising pores having a macroporous size α of about 70 nm to about 200 nm and a second carbon particle comprising pores having a macroporous size β of about 70 nm to about 200 nm, wherein macroporous size β is at least twice macroporous size α, (iii) at least one support matrix.
Response to Arguments
Applicant's arguments filed 02/23/2026 have been fully considered but they are not persuasive with respect to the written description rejection, 103 rejection and nonstatutory double patenting rejection.
35 U.S.C. 112(a) written description rejection:
Applicant argues on page 12 of the Remarks that the amendments have comply with 35 U.S.C. 112(a) and the claims are not indefinite.
The arguments are not found persuasive for the following reasons. The rejection stated under 35 U.S.C. 112 written description is not based on indefiniteness but rather the instant disclosure fails to disclose a representative number of species falling with the scope of the genus and/or structural common to the members of the genus so the skilled artisan can visualize or recognize the members of the genus of chemical structures. A skilled artisan cannot, as one can do with a fully described genus, visualize, predict, or recognize the identity of the members to exhibit the functional property of retrieving a universal blood product.
35 U.S.C. 103 rejection:
Applicant argues on page 14 of Remarks that the previous Office Action does not cite the current amendments. Therefore, Applicant contends a prima facie case of obviousness has not been made for the amendments.
The arguments are not found persuasive for the following reasons. With respect to the carbonaceous material is formed in the presence of a pore-former, see claims 1 and 20, these limitations are directed to product-by-process. Because the carbon particles or pores do not contain the pore-formers after being produced, it is product-by-process limitation to produce the carbon particles. If the prior art references read on the claimed carbon particles having macroporous sizes, then the prior art reference reads on the claimed. In this particular case, Ichitsuka does teach beads of a material such as polyester, polystyrenes, polyacrylic acids, and carbon as spherical substrates (i.e., carbon particles). Meanwhile, MPEP 2113 states: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”
With respect to the nonstatutory double patenting rejection, no argument was made or a terminal disclaimer has been filed. For the reasons above, the rejection is maintained.
Conclusion
No claim is allowed.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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