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 .
Election/Restrictions
Newly submitted claims 36-37 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Newly submitted claims 36-37 and currently rejected invention are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed different designs and modes of operation. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants. Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); (d) the prior art applicable to one invention would not likely be applicable to another invention; and (e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 36-37 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 32-33 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. This rejection concerns new matter.
Newly added claims 32-33 recite: 32. The blood separation system of claim 26, wherein the adsorption material comprises polyacrylate-coated beads. 33. The blood separation system of claim 32, wherein said beads are comprised of polyacrylamide. The current remarks urges support therefor may be found in paragraph “00038”. The examiner cannot find support in the specification as originally filed, whereas it is noted the specification as originally filed describes, at best, “An exemplary whole blood adsorption column is the DALI® adsorber made and sold by Fresenius Medical Care, although any suitable whole blood adsorption column may be used.” (¶ 0038). Accordingly, the disclosure as originally filed provided no implicit or explicit support for this limitation. Applicants are reminded that it is their burden to show where the specification and priority document as appropriate supports any amendments to the disclosure.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 26-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (US 2002/0128584) in view of Wang et al. (US 2015/0283318).
Regarding claim 26, Brown et al. teach:
26. A blood separation system comprising:
a processing kit including a whole blood inlet (e.g., donor needle 14), a whole blood adsorption chamber (e.g., first sub-chamber 226; see i.e. For example, where a blood component such as plasma or red blood cell is to be treated with a treating agent or described above, plasma can be separated from red cells in the first “sub-chamber” 226 ¶ 0115) containing an adsorption material (see i.e., [...] a solvent contained in container 64. The solvent is capable of extracting lipids from the plasma. Such solvents are described in, for example, U.S. Pat. Nos. 4,895,558, 5,744,558 and 5,911,698, which are incorporated herein by reference. Examples of solvents are DIPE (di-isopropylether). Of course, other solvents capable of extracting lipids from plasma and known to those of skill in the art may likewise be used. ¶ 0101; Plasma and the solvent may be combined in, for example, [...] inside separator 68. If combined outside of the separator, the plasma and solvent may then be reintroduced into the separator to further separate plasma from the lipid containing solvent. In a preferred embodiment, the separator is a centrifugal separator of the type shown in FIGS. 2-3 and/or FIGS. 13-16. Centrifugal action results in the separation into a two-phase solution, an upper organic phase that includes the solvent and extracted lipid, and a lower lipid-depleted plasma phase. ¶ 0102; container 64 may include the beads or particles. In a preferred embodiment, the beads may be lightweight, simple, hollow (or solid) sphere-like structures. The beads are coated with an affinity material, such as monoclonal antibodies. The beads may have a specific affinity for lipids, sickled cells, immunoglobulins, Factor VIII or other proteins. The beads, preferably, have a density less than the density of plasma. Alternatively, the beads may be of the type described in U.S. Pat. Nos. 5,916,743 and 5,641,622, which are incorporated herein by reference. ¶ 0105) configured to remove certain lipids, proteins, antibodies, and/or fatty acids from whole blood (see ¶ 0101-0102, 0105 for example), and a blood processing container (e.g., second sub-chamber 224), wherein the whole blood adsorption chamber is positioned downstream of the whole blood inlet and upstream of the blood processing container (see i.e., the first sub-chamber 226 can be used to perform a first separation step and the second sub-chamber 224 can be used to perform a second separation step. ¶ 0115 & Fig. 14); and
a separation component including a pump system (e.g., pumping stations ¶ 0054+), a separator (e.g., separation chamber 68) in which the blood processing container is positioned (see Figs. 13-15 for example), and a controller (e.g., internal computer, controller Abstract, ¶ 0057+), wherein the controller is programmed to control the pump system (¶ 0059, 0065-0069+) to convey whole blood from the whole blood inlet to the whole blood adsorption chamber (¶ 0117-0118+), control the pump system to convey the whole blood through the whole blood adsorption chamber (e.g., first separation step ¶ 0115, 0117-0118+) capable of creating purified whole blood by removing certain lipids, proteins, antibodies, and/or fatty acids from the whole blood via adsorption (see ¶ 0101-0102, 0105 for example), control the pump system to convey the purified whole blood from the whole blood adsorption column into the blood processing container (e.g., second separation step ¶ 0115, 0117-0118+) positioned within the separator (see Fig. 16 for example), control the separator capable of separating the purified whole blood in the blood processing container into mononuclear cells and at least one component (¶ 0119-0120; see entire incorporated reference U.S. Pat. No. 5,980,760 Min et al.), and control the pump system to convey the mononuclear cells from the blood processing container for collection (¶ 0119-0120; see entire incorporated reference U.S. Pat. No. 5,980,760 Min et al.).
Regarding the whole blood adsorption column, Brown et al. teach a whole blood adsorption chamber containing an adsorption material (see e.g., first sub-chamber 226 above) resembling a column shape (see Fig. 16). In addition, Brown et al. teach the system comprising a separation column (i.e., In another embodiment, separator 20 may also be a separation column with its own integral chamber [...] ¶ 0058; In another embodiment, one of the separators may be a centrifuge or a drive for a rotating membrane and the other separator can be a filter medium or a separation column. ¶ 0079; The filter medium may be a flat sheet or a packed column of the type described above. In addition, the separation medium (e.g., separator 80) may be used to extract or remove lipids or other compounds (through affinity separation) such as IgG, IgM, Factor VIII, and the like from plasma. ¶ 0106). However, Brown et al. do not explicitly teach the first sub-chamber is a whole blood adsorption column containing an adsorption material configured to remove lipoproteins from whole blood.
Wang et al. teach, among other things, A blood separation system comprising:
a processing kit including a whole blood inlet (e.g., inlet for a patient blood 1), a whole blood adsorption column containing an adsorption material (e.g. direct adsorption of lipoprotein from whole blood (DALI), HELP, LIPOSORBER, Immunoadsorption system with special antilipoprotein(a) column, membrane different filtration (MDF), dextran sulfate cellulose adsorption (DSCA) and etc. ¶ 0133) configured to remove lipoproteins from whole blood (e.g., Lipoprotein removal cartridge such as dextran sulphate cellulose columns and LIPOSORBER System ¶ 0057; DALI, ¶ 0133), and a blood processing container (e.g., centrifugation based device ¶ 0093), wherein the whole blood adsorption column is positioned downstream of the whole blood inlet and upstream of the blood processing container (see i.e., [...] the whole blood first passes through a filtration type CTC removing device and the blocked CTC/other cells then are sent to a centrifugation type blood cell separator. ¶ 0095 for example); and
a separation component including a pump system (e.g., 2), a separator (i.e., Many blood cell separation devices can be used such as varieties of blood cell separator, e.g. cs3000plus blood cell separator, COBEVR Spectra system and the Elutra system (Caridian BCT). ¶ 0087) in which the blood processing container is positioned, and a controller (blood cell separator such as the CS-3000 Plus blood cell separator, CobeVR Spectra system and the Elutra system (¶ 0087) comprises a controller), the pump system is capable of conveying whole blood from the whole blood inlet to the whole blood adsorption column (see Fig. 1 & ¶ 0060 for example), the pump system to is capable of conveying the whole blood through the whole blood adsorption column capable of creating purified whole blood by removing lipoproteins from the whole blood via adsorption (¶ 0057-0058, 0133), the pump system to is capable of conveying the purified whole blood from the whole blood adsorption column into the blood processing container (see ¶ 0095 for example), the separator capable of separating the purified whole blood in the blood processing container into mononuclear cells and at least one component (see ¶ 0065, 0093 for example), and the pump system is capable of conveying the mononuclear cells from the blood processing container for collection (see ¶ 0065, 0093 for example).
wherein the blood processing container comprises a centrifugal separation container (¶ 0093, 0095).
wherein the mononuclear cells comprise at least one of lymphocytes, monocytes, and stem cells (see ¶ 0065, 0093 for example).
wherein the purified whole blood has a lower concentration of proteins, lipids, and/or bilirubin than the whole blood (the claim does not impart any structure).
wherein the pump system is capable of conveying the whole blood directly from the whole blood inlet to the whole blood adsorption column and the pump system is capable of conveying the purified whole blood directly from the whole blood adsorption column into the blood processing container (see ¶ 0093, 0095 for example).
wherein the adsorption material comprises beads (¶ 0054-0058+) coated with polyacrylate (e.g., DALI ¶ 0133. As evidenced by the Applicant, DALI inherently incorporates polyacrylate-coated beads and the removal of lipoproteins from whole blood, 09/05/2025 Remarks pages 7-8).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the adsorption chamber 226 with an adsorption column known in the art, as taught by Wang et al., to selectively remove lipoproteins from whole blood (Wang et al. ¶ 0057-0058, 0133). In addition, the change in configuration of shape of a device is obvious absent persuasive evidence that the particular configuration is significant. Further, the claim is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement. The Court stated that if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Id. at ___, 82 USPQ2d at 1396.
With regard to limitations in claims 26, 28, 29 (e.g., to create [...], to separate the purified whole blood into mononuclear cells and at least one component, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
Regarding claims 27-30, modified Brown et al. teach:
27. The blood separation system of claim 26, wherein the blood processing container comprises a centrifugal separation container (see ¶ 0113 for example).
28. The blood separation system of claim 26, wherein the mononuclear cells comprise at least one of lymphocytes, monocytes, and stem cells (see ¶ 0067 for example).
29. The blood separation system of claim 26, wherein the purified whole blood has a lower concentration of proteins, lipids, and/or bilirubin than the whole blood (the claim does not impart any structure. However, this limitation would be taught as removal of certain contents of whole blood as recited in claim 26 would inherently lower concentration in the whole blood.).
30. The blood separation system of claim 26, wherein the controller is programmed to control the pump system to convey the whole blood directly from the whole blood inlet to the whole blood adsorption column and to control the pump system to convey the purified whole blood directly from the whole blood adsorption column into the blood processing container (see ¶ 0115, 0117-0118+ for example).
Claim(s) 32, 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (US 2002/0128584) in view of Wang et al. (US 2015/0283318) and/or Karumanchi (US 8,969,322 Applicant’s Remarks 09/05/2025 pg. 7).
Regarding claim 32, Brown et al. teach: wherein the adsorption material comprises coated beads (¶ 0104-0105). However, Brown et al. do not explicitly teach: 32. The blood separation system of claim 26, wherein the adsorption material comprises polyacrylate-coated beads.
Wang et al. teach: wherein the adsorption material comprises coated beads (¶ 0054-0058+), wherein the coated beads are coated with polyacrylate (e.g., DALI ¶ 0133. As evidenced by the Applicant, DALI inherently incorporates polyacrylate-coated beads and the removal of lipoproteins from whole blood, 09/05/2025 Remarks pages 7-8).
Karumanchi teaches: a whole blood adsorption column (e.g., DALI) containing an adsorption material configured to remove lipoproteins from whole blood (C13/L27-33), and wherein the adsorption material comprises polyacrylate-coated beads (C13/L27-33).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the polyacrylate coated beads, as taught by Wang et al. (DALI ¶ 0133); and/or Karumanchi (C13/L27-33) for the removal of lipoproteins from whole blood. See also “one of ordinary skill in the art would have been familiar with the structure and operation of the DALI® adsorber, including the nature of its adsorption material and the ability of the adsorption material to remove lipoproteins from whole blood.” (Applicant’s Remarks 09/05/2025 pg. 7). The claim is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement. The Court stated that if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Id. at ___, 82 USPQ2d at 1396.
Regarding claim 33, modified Brown et al. teach: 33. The blood separation system of claim 32, wherein said beads are comprised of polyacrylamide (¶ 0105; see C13/L34-42 of the incorporated reference U.S. Pat. No. 5,916,743; and C13/L24-31 of the incorporated reference U.S. Pat. No. 5,641,622 both of Lake et al.).
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground(s) of rejection.
Applicant is encouraged to amend the claims to include additional structural elements of the system. Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dräger et al. (DALI-the first human whole-blood low-density lipoprotein and lipoprotein (a) apheresis system in clinical use: procedure and clinical results. Eur J Clin Invest. 1998 Dec; 28(12):994-1002. doi: 10.1046/j.1365-2362.1998.00395.x. PMID: 9893010.) teach: “The DALI® adsorber has been in use since at least 1998, as evidenced by an article entitled "DALI - The First Human Whole-Blood Low-Density Lipoprotein And Lipoprotein(a) Apheresis System In Clinical Use: Procedure And Clinical Results" from the European Journal of Clinical Investigation, [...] the name "DALI" stands for "direct adsorption of lipoproteins," with the device functioning to remove lipoproteins from whole blood. [...] The abstract of the article also describes how the DALI adsorber employs polyacrylate-coated polyacrylamide beads to remove lipoproteins from whole blood via adsorption. The Introduction section of the article explains that, before introduction of the DALI® adsorber, it was only known to remove lipoproteins from plasma via adsorption.” Applicant’s Remarks 09/05/2025 pg. 7.
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 DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JILL A. WARDEN can be reached at (571) 272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798