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 is a first action on the merits of the application. Claims 34-53 are pending.
Election/Restrictions
Applicant's election with traverse of invention I, claims 34-48 in the reply filed on April 07, 2026 is acknowledged.
The traversal is on the ground(s) that: the inventions as claimed can be readily evaluated in one search without placing undue burden on the Examiner. That is, all the claims are so interrelated that a search of one group of claims will reveal art to the others. Were restriction to be effected between the claims of Groups I, II, and III, a separate examination of the claims in these three groups would require substantial duplication of work on the part of the U.S. Patent and Trademark Office. Even though some additional consideration would be necessary, the scope of analysis of novelty of all the claims of Groups II and III would have to be as rigorous as when only the claims of Group I, for example, were being considered by themselves. Clearly, this duplication of effort would not be warranted where these claims of different categories are so interrelated. Remarks, pages 8-9, filed 04/07/2026.
In response, Applicant’s argument is not found persuasive because a serious burden for the Examiner does exist because the elected and non-elected inventions would require different fields of subclass search, and because the elected and non-elected inventions are mutually exclusive. For example, claim 1 would require section/class/subclass searching within C07K 16/34+, while claim 49 would require section/class/subclass searching within B01D 15/1894+, and claim 50 would require section/class/subclass searching within G01N 33/50+. Therefore, because different section/class/subclass searches would be necessary, a serious burden for the Examiner does exist if restriction were not required.
In addition, a serious burden for the Examiner does exist because:
(i) Inventions I and II are related as combination and subcombination. In the instant case, the combination as claimed, a separation device, does not require the particulars of the subcombination as claimed, a separation media, because a separation device can be constructed without using a separation media as claimed as taught by HUMPHREYS et al. (ISOLATION AND IMMUNOLOGIC CHARACTERIZATION OF A HUMAN, B-LYMPHOCYTE-SPECIFIC, CELL SURFACE ANTIGEN, THE JOURNAL OF EXPERIMENTAL MEDICINE • VOLUME 144, 1976). (see pages 98-100, Section: Materials and Methods), or as taught by SONTI et al. (Cell Separation Using Protein-A-Coated Magnetic Nanoclusters, JOURNAL OF COLLOID AND INTERFACE SCIENCE 170, 575-585 (1995)). The subcombination, a separation media, has separate utility such as a stand-alone separation media for separating desired/targeted biomolecules from a mixture;
(ii) Inventions I and III are related as product and process of use. In the instant case the process for using the product as claimed can be practiced with another materially different product as taught by HUMPHREYS et al. (ISOLATION AND IMMUNOLOGIC CHARACTERIZATION OF A HUMAN, B-LYMPHOCYTE-SPECIFIC, CELL SURFACE ANTIGEN, THE JOURNAL OF EXPERIMENTAL MEDICINE • VOLUME 144, 1976) (see pages 98-100, Section: Materials and Methods), or as taught by SONTI et al. (Cell Separation Using Protein-A-Coated Magnetic Nanoclusters, JOURNAL OF COLLOID AND INTERFACE SCIENCE 170, 575-585 (1995)); and
(iii) Inventions II and III are related as process and apparatus for its practice. In the instant case the process for using the apparatus as claimed can be practiced with another materially different apparatus comprising a product as taught by HUMPHREYS et al. (ISOLATION AND IMMUNOLOGIC CHARACTERIZATION OF A HUMAN, B-LYMPHOCYTE-SPECIFIC, CELL SURFACE ANTIGEN, THE JOURNAL OF EXPERIMENTAL MEDICINE • VOLUME 144, 1976) (see pages 98-100, Section: Materials and Methods), or comprising a product as taught by SONTI et al. (Cell Separation Using Protein-A-Coated Magnetic Nanoclusters, JOURNAL OF COLLOID AND INTERFACE SCIENCE 170, 575-585 (1995)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 49-53 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
It is noted herein that the examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
Claim Objections
Claims 36, 37, 39, 40, 42 and 44-48 are objected to because of the following informalities:
Claim 36 recites “wherein Sp comprises -C(O)-” in line 1. It is respectfully suggested to amend the limitation to “wherein the Sp comprises -C(O)-” for clarification purposes.
Claim 37 recites “Rp3 and Rp4 comprises RpE” in lines 1-2. It is respectfully suggested to amend the limitation to “the Rp3 and the Rp4 comprises the RpE” for clarification purposes.
Claim 39 recites “wherein SL2” in line 1. It is respectfully suggested to amend the limitation to “wherein the SL2” for clarification purposes.
Claim 40 recites “the separation ligand formula SL or SL1” in lines 1-2 which appears to be a misspelling of “the separation ligand formula SL1 or SL2
Claim 40 recites “wherein X in the Formula” in line 6. It is respectfully suggested to amend the limitation to “wherein X in the Formula (XII) or (XIII)” for clarification purposes.
Claim 40 recites “wherein Y is Y is OH” in line 8 which appears a misspelling of “wherein Y is
Claim 42 recites “the blood type antigen of fragment thereof” in lines 1-2 which appears a misspelling of “the blood type antigen or
Claim 44 recites “the blood type recognizing domain” in line 2. It is respectfully suggested to amend the limitation to “the blood type antigen recognizing domain” for consistent recitation of claim limitation.
Claim 45 recites “the support membrane” in line 4. It is respectfully suggested to amend the limitation to “the support substrate
Claim 46 recites “A separation media comprising two or more of the separation media of claim 34 arranged in a stacked configuration.” It is respectfully suggested to amend the limitation to “A separation media system comprising two or more of the separation media of claim 34 arranged in a stacked configuration” for distinguishing the claimed separation media from the separation media recited in claim 34. The amendment will affect the preamble of claims 47-48, such as “The separation media system of claim 46,”.
Appropriate corrections are required.
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 34-48 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 regard(s) as the invention.
Claim 34 recites “a blood type antigen or a fragment thereof” in line 7. This is considered indefinite for the following reason: It is unclear what “a fragment thereof” refers to. A blood type antigen is a complex oligosaccharide (carbohydrate) chain built onto precursor glycolipids or glycoproteins on the surface of red blood cells and other tissues. Consequently, the limitation “a fragment thereof” is unclear in the context of general definition of a blood type antigen, since it is unclear which part, or portion, or molecule of the blood type antigen is being referred to by the recitation “a fragment thereof”. For examining purposes only, the recitation “a blood type antigen or a fragment thereof” in line 7 is reasonably interpreted as “a molecule” until applicants further specify the limitation, in view of the MPEP 2111 that directs during patent examination, the pending claims must be “given their broadest reasonable interpretation consistent with the interpretation that those skilled in the art would reach.
Claim 34 recites “the reaction product” in line 8 which lacks an antecedent basis.
Claim 34 recites “Rp1, Rp3, and Rp4 each independently comprise the reaction product of any one of RpA, RpB, RpC, RpD, RpE, RpF, RpG, RpH, RpI, RPJ, RpK, or an isomer thereof” in lines 8-9. This is considered indefinite for the following reason: (i) the claim limitation directs that “RpA, RpB, RpC, RpD, RpE, RpF, RpG, RpH, RpI, RPJ, RpK, or an isomer thereof” are precursor of “the reaction”, and it is unclear what is the nature of “reaction product” of any one of RpA, RpB, RpC, RpD, RpE, RpF, RpG, RpH, RpI, RPJ, RpK, or an isomer thereof. One skilled in the art cannot figure out what could be the “reaction product” without reciting the nature of reaction and/or reaction condition(s) using the precursor materials “RpA, RpB, RpC, RpD, RpE, RpF, RpG, RpH, RpI, RPJ, RpK, or an isomer thereof”.
Claims 35-38 are also rejected under 35 U.S. §112 by virtue of its dependence on claim 34.
Claim 35 recites “the alkanediyl or alkenediyl” in lines 1-2 which lacks an antecedent basis.
Claim 38 recites “each U5 is O, each U5 is NH, or one U5 is NH and U5 is O” in lines 1-2. This is considered indefinite for the following reason: In claim 34, there is only one U5, however, claim 38 directs there are multiple U5 in claim 34.
Claim 43 recites “the three terminal saccharide residues of the A-type antigen or the B-type antigen” in lines 2-3 which lacks an antecedent basis.
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 of this title, 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(a) 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 34, 36-38 and 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over Cuatrecasas et al. (Purification of neuraminidases from Vibrio cholerae, Clostridium perfringens and influenza virus by affinity chromatography, BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS, Vol. 44, No. 1, 1971, hereinafter “Cuatrecasas”).
In regard to claims 34 and 36-38, Cuatrecasas discloses an adsorbent (i.e., a separation media) for separating neuraminidases (page 178, Abstract) comprising (pages 178-180; Scheme I):
(i) a support substrate (Agarose beads); and
(ii) a plurality of separation ligands for formula SL1 or SL2 (the tripeptide gly-gly-tyr attached to the agarose bead which meets RPA and RpE of claim 34 with Sp equal to -C(O)- (claim 36) and U0 and U5 are NH),
wherein Z comprises molecule of diazonium derivative of N-(p-aminophenyl) oxamic acid.
Since the adsorbent (i.e., a separation media) taught by Cuatrecasas is used for separating neuraminidases that is heavily glycosylated, with carbohydrates often accounting for up to 40-50% of its molecular, one skilled in the art would have reasonably expected that the adsorbent is also used for isolating a target molecule comprising a blood type antigen recognizing domain as recited.
Moreover, it has long been held that “apparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990); see also Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003) (“An intended use or purpose usually will not limit the scope of the claim because such statements usually do no more than define a context in which the invention operates.”); In re Michlin, 256 F.2d 317, 320 (CCPA 1958) (“It is well settled that patentability of apparatus claims must depend upon structural limitations and not upon statements of function.”).
The adsorbent (i.e., a separation media) taught by Cuatrecasas renders the separation media of claim 34 prima facie obvious.
In regard to claims 46-48, Cuatrecasas discloses affinity chromatography using the adsorbent (i.e., a separation media) for separating neuraminidases (pages 180-182). This directs a stacking of separation media of the same or different identity depending on the target materials to be separated.
Claim Objections
Claims 39-45 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, such as incorporating one or more of dependent claims 39-45 into an independent claim 34 as exemplified below.
Allowable Subject Matters
Claims 39-45 in the instant application are allowed if previously presented objection to claims 36, 37 and 39-48, and 35 U.S.C. 112(b) rejections to claims 34-48 are resolved.
The following is an examiner’s statement of reasons for allowance: A thorough search for pertinent prior art did not locate any prior art that discloses or suggests the invention recited in claims 39-45. The following is a statement of reasons for the indication of allowable subject matter. A thorough search for pertinent prior art did not locate any prior art that discloses or suggests the invention recited in claims 39-45. The concept of a separation media comprising: a support substrate; and a plurality of separation ligands for formula SL1 or SL2 wherein Z is a separation group comprising an affinity group, the affinity group comprising a blood type antigen or a fragment thereof; and Rp1, Rp3, and Rp4 each independently comprise the reaction product of any one of RpA, RpB, RpC, RpD, RpE, RpF, RpG, RpH, RpI, RPJ, RpK, or an isomer thereof, wherein RpA, RpB, RpC, RpD, RpE, RpF, RpG, RpH, RpI, RPJ, RpK are represented by the formula in claim 34, and Sp is a spacer comprising a divalent organic group, and wherein the separation media configured for isolating a target molecule comprising a blood type antigen recognizing domain, and
wherein the separation ligand formula SL1 or SL2 is of formula X, XI, XII, or XIII (claim 40), or
wherein the blood type antigen of fragment thereof comprises an A-type antigen, a B-type antigen, or a fragment thereof (claim 42), is considered novel.
The closest prior art to Cuatrecasas et al. (Purification of neuraminidases from Vibrio cholerae, Clostridium perfringens and influenza virus by affinity chromatography, BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS, Vol. 44, No. 1, 1971) discloses an adsorbent (i.e., a separation media) for separating neuraminidases (page 178, Abstract) comprising (pages 178-180; Scheme I): (i) a support substrate (Agarose beads); and (ii) a plurality of separation ligands for formula SL1 or SL2 (the tripeptide gly-gly-tyr attached to the agarose bead which meets RPA and RpE of claim 34 with Sp equal to -C(O)- (claim 36) and U0 and U5 are NH), wherein Z comprises molecule of diazonium derivative of N-(p-aminophenyl) oxamic acid.
Other pertinent prior art to Ciccotosto et al. (Synthesis and evaluation of N-acetylneuraminic acid-based affinity matrices for the purification of sialic acid-recognizing proteins, Glycoconjugate Journal 15, 663-669 (1998)) discloses epoxy-activated Sepharose 6B affinity adsorbents that is efficient in purifying the sialic acid-recognizing enzyme Vibrio cholerae sialidase, in a one-step process with yields in the order of 60%.
Other pertinent prior art to Knutson et al. (US 2013/0273571 Al) discloses a method/an apparatus of purifying antibodies in a solid phase antibody screening assay, to produce dense functionalized indicator cells which can be used as a component of an assay that will indicate a presence or an absence of antibodies or antigens, comprising: (i) coating a predetermined antigen to an affinity column, said predetermined antigen being one of A, B, AB and MNS antigens; (ii) introducing human plasma into said affinity column, such that antibodies disposed in said human plasma attach to said predetermined antigen; (iii) purifying said antibodies using immunoaffinity chromatography, such that said purified antibodies remain and other undesired antibodies are removed; (iv) exposing said purified antibodies to red blood cells, such that said purified antibodies bind with and coat said red blood cells; and (v) forming indicator cells by exposing said coated red blood cells to additional antibodies that have a specificity for said purified antibodies, such that said additional antibodies attach to said purified antibodies and coat said red blood cells.
Other pertinent prior art to Nilsson (WO 2021/086259 A1) discloses an adsorbent comprising at least two types of covalently bound antigens having the ability to bind at least one component present in a blood flow or blood plasma flow passing through said adsorbent, wherein said at least two types of antigen comprises at least one linear peptide and at least one cyclic peptide, wherein optionally a spacer is provided between the peptide and the adsorbent.
Other pertinent prior art to Zhu (CN 114113639 A) discloses a blood group antibody detection method/apparatus that is characterized by comprising the step of mixing a to-be-detected object with blood group antibody binding protein, wherein the blood group antibody binding protein is Fya, Fyb, S, S or N blood group antibody binding protein, and the blood group antibody binding protein comprises a nucleotide sequence which is similar to the nucleotide sequence shown in SEQ ID NO: 2. 4, 6, 8 or 10 has more than 80% homology or comprises SEQ ID NO: 2. 4, 6, 8 or 10.
The combination of cited prior arts, alone or in a combination, does not provide any guidance which would lead one to manufacture a separation media comprising: a support substrate; and a plurality of separation ligands for formula SL1 or SL2 wherein Z is a separation group comprising an affinity group, the affinity group comprising a blood type antigen or a fragment thereof; and Rp1, Rp3, and Rp4 each independently comprise the reaction product of any one of RpA, RpB, RpC, RpD, RpE, RpF, RpG, RpH, RpI, RPJ, RpK, or an isomer thereof, wherein RpA, RpB, RpC, RpD, RpE, RpF, RpG, RpH, RpI, RPJ, RpK are represented by the formula in claim 34, and Sp is a spacer comprising a divalent organic group, and wherein the separation media configured for isolating a target molecule comprising a blood type antigen recognizing domain, and wherein the separation ligand formula SL1 or SL2 is of formula X, XI, XII, or XIII (claim 40), or wherein the blood type antigen of fragment thereof comprises an A-type antigen, a B-type antigen, or a fragment thereof (claim 42).
Conclusion
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/YOUNGSUL JEONG/Primary Examiner, Art Unit 1772
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