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
2. Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 2-20, drawn to a method of detecting at least one fragment of a polypeptide in a sample, classified in class 435, subclass 4.
II. Claim 21, drawn to a sample, classified in class 424, subclass 130.1.
The inventions are independent or distinct, each from the other because:
3. Inventions I and II are unrelated. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, the different inventions are not disclosed as capable of use together and they have different designs. The method of Group I is for detection of at least one fragment of a polypeptide and is not for the preparation of the sample in Group II.
4. 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:
- the inventions have acquired a separate status in the art in view of their different classification;
- the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
- the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these 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.
5. During a telephone conversation with Scott Siera on May 28, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 2-20. Affirmation of this election must be made by applicant in replying to this Office action. Claim 21 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
6. Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 6 and 11-16 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 6 is vague because it refers to Table 1 instead of reciting what is in the table to clearly define the metes and bounds of the claim. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (MPEP 2173.05(s)
Claims 11 and 13 are vague because the recitations of “the matrix” lack antecedent support.
Claims 15-17 are vague because the recitations of “the first elution buffer” and “the second elution buffer” lack antecedent support.
9. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
10. Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 already recites detecting the polypeptide and fragments in step (d) so claim 19 does not further limit claim 2. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
11. 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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
12. Claims 2-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,385,238 in view of Johnsen et al (“A critical evaluation of Amicon Ultra centrifugal filters for separating proteins, drugs and nanoparticles in biosamples”, Journal of Pharmaceutical and Biomedical Analysis, 120, 2016, 106-111; herein referred to as Johnsen).
Patent ‘238 claims:
1. A method of detecting at least one fragment of a polypeptide in a sample, comprising:
(a) fractionating the sample, comprising:
a. loading the sample onto a size exclusion chromatographic matrix;
b. applying a volume of a first elution buffer to the matrix, wherein the polypeptide is eluted into a first fraction; and
c. applying a volume of a second elution buffer to the matrix, wherein the at least one fragment is eluted into a second fraction;
(b) treating the first fraction with a proteolytic enzyme, thereby producing a treated first fraction comprising a digest of the polypeptide; and
(c) optionally, combining the treated first fraction with the second fraction, and
(d) detecting the digest of the polypeptide in the treated first fraction and detecting the at least one fragment in the second fraction.
2. The method of claim 1, further comprising after step (a), treating the second fraction with a proteolytic enzyme.
3. The method of claim 2, wherein the proteolytic enzyme comprises trypsin.
4. The method of claim 1, wherein the polypeptide is a therapeutic polypeptide.
5. The method of claim 4, wherein the therapeutic polypeptide comprises an antibody or antigen-binding fragment thereof, a fusion polypeptide.
6. The method of claim 5, wherein the antibody is selected from the group consisting of infliximab, bevacizumab, cetuximab, ranibizumab, palivizumab, abagovomab, abciximab, actoxumab, adalimumab, afelimomab, afutuzumab, alacizumab, alacizumab pegol, ald518, alemtuzumab, alirocumab, altumomab, amatuximab, anatumomab mafenatox, anrukinzumab, apolizumab, arcitumomab, aselizumab, altinumab, atlizumab, atorolimiumab, tocilizumab, bapineuzumab, basiliximab, bavituximab, bectumomab, belimumab, benralizumab, bertilimumab, besilesomab, bevacizumab, bezlotoxumab, biciromab, bivatuzumab, bivatuzumab mertansine, blinatumomab, blosozumab, brentuximab vedotin, briakinumab, brodalumab, canakinumab, cantuzumab mertansine, cantuzumab mertansine, caplacizumab, capromab pendetide, carlumab, catumaxomab, cc49, cedelizumab, certolizumab pegol, cetuximab, citatuzumab bogatox, cixutumumab, clazakizumab, clenoliximab, clivatuzumab tetraxetan, conatumumab, crenezumab, cr6261, dacetuzumab, daclizumab, dalotuzumab, daratumumab, demcizumab, denosumab, detumomab, dorlimomab aritox, drozitumab, duligotumab, dupilumab, ecromeximab, eculizumab, edobacomab, edrecolomab, efalizumab, efungumab, elotuzumab, elsilimomab, enavatuzumab, enlimomab pegol, enokizumab, enoticumab, ensituximab, epitumomab cituxetan, epratuzumab, erenumab, erlizumab, ertumaxomab, etaracizumab, etrolizumab, evolocumab, exbivirumab, fanolesomab, faralimomab, farletuzumab, fasinumab, fbta05, felvizumab, fezakinumab, ficlatuzumab, figitumumab, flanvotumab, fontolizumab, foralumab, foravirumab, fresolimumab, fulranumab, futuximab, galiximab, ganitumab, gantenerumab, gavilimomab, gemtuzumab ozogamicin, gevokizumab, girentuximab, glembatumumab vedotin, golimumab, gomiliximab, gs6624, ibalizumab, ibritumomab tiuxetan, icrucumab, igovomab, imciromab, imgatuzumab, inclacumab, indatuximab ravtansine, infliximab, intetumumab, inolimomab, inotuzumab ozogamicin, ipilimumab, iratumumab, itolizumab, ixekizumab, keliximab, labetuzumab, lebrikizumab, lemalesomab, lerdelimumab, lexatumumab, libivirumab, ligelizumab, lintuzumab, lirilumab, lorvotuzumab mertansine, lucatumumab, lumiliximab, mapatumumab, maslimomab, mavrilimumab, matuzumab, mepolizumab, metelimumab, milatuzumab, minretumomab, mitumomab, mogamulizumab, morolimumab, motavizumab, moxetumomab pasudotox, muromonab-cd3, nacolomab tafenatox, namilumab, naptumomab estafenatox, narnatumab, natalizumab, nebacumab, necitumumab, nerelimomab, nesvacumab, nimotuzumab, nivolumab, nofetumomab merpentan, ocaratuzumab, ocrelizumab, odulimomab, ofatumumab, olaratumab, olokizumab, omalizumab, onartuzumab, oportuzumab monatox, oregovomab, orticumab, otelixizumab, oxelumab, ozanezumab, ozoralizumab, pagibaximab, palivizumab, panitumumab, panobacumab, parsatuzumab, pascolizumab, pateclizumab, patritumab, pemtumomab, perakizumab, pertuzumab, pexelizumab, pidilizumab, pintumomab, placulumab, ponezumab, priliximab, pritumumab, PRO 140, quilizumab, racotumomab, radretumab, rafivirumab, ramucirumab, ranibizumab, raxibacumab, regavirumab, reslizumab, rilotumumab, rituximab, robatumumab, roledumab, romosozumab, rontalizumab, rovelizumab, ruplizumab, samalizumab, sarilumab, satumomab pendetide, secukinumab, sevirumab, sibrotuzumab, sifalimumab, siltuximab, simtuzumab, siplizumab, sirukumab, solanezumab, solitomab, sonepcizumab, sontuzumab, stamulumab, sulesomab, suvizumab, tabalumab, tacatuzumab tetraxetan, tadocizumab, talizumab, tanezumab, taplitumomab paptox, tefibazumab, telimomab aritox, tenatumomab, tefibazumab, teneliximab, teplizumab, teprotumumab, tezepelumab, TGN1412, tremelimumab, ticilimumab, tildrakizumab, tigatuzumab, TNX-650, tocilizumab, toralizumab, tositumomab, tralokinumab, trastuzumab, TRBS07, tregalizumab, tucotuzumab celmoleukin, tuvirumab, ublituximab, urelumab, urtoxazumab, ustekinumab, vapaliximab, vatelizumab, vedolizumab, veltuzumab, vepalimomab, vesencumab, visilizumab, volociximab, vorsetuzumab mafodotin, votumumab, zalutumumab, zanolimumab, zatuximab, ziralimumab, zolimomab aritox, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 1 and a heavy chain comprising SEQ ID NO: 2, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 3 and a heavy chain comprising SEQ ID NO: 4, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 5 and a heavy chain comprising SEQ ID NO: 6, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 7 and a heavy chain comprising SEQ ID NO: 8, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 9 and a heavy chain comprising SEQ ID NO: 10, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 11 and a heavy chain comprising SEQ ID NO: 12, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 13 and a heavy chain comprising SEQ ID NO: 14, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 15 and a heavy chain comprising SEQ ID NO: 16, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 17 and a heavy chain comprising SEQ ID NO: 28, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 19 and a heavy chain comprising SEQ ID NO: 20, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 21 and a heavy chain comprising SEQ ID NO: 22, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 23 and a heavy chain comprising SEQ ID NO: 24, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 25 and a heavy chain comprising SEQ ID NO: 26, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 27 and a heavy chain comprising SEQ ID NO: 28, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 29 and a heavy chain comprising SEQ ID NO: 30, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 31 and a heavy chain comprising SEQ ID NO: 32, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 33 and a heavy chain comprising SEQ ID NO: 34, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 35 and a heavy chain comprising SEQ ID NO: 36, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 37 and a heavy chain comprising SEQ ID NO: 38, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 39 and a heavy chain comprising SEQ ID NO: 40, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 41 and a heavy chain comprising SEQ ID NO: 42, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 43 and a heavy chain comprising SEQ ID NO: 44, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 45 and a heavy chain comprising SEQ ID NO: 46, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 47 and a heavy chain comprising SEQ ID NO: 48 a monoclonal antibody comprising a light chain comprising SEQ ID NO: 49 and a heavy chain comprising SEQ ID NO: 50, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 51 and a heavy chain comprising SEQ ID NO: 52, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 53 and a heavy chain comprising SEQ ID NO: 54, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 55 and a heavy chain comprising SEQ ID NO: 56, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 57 and a heavy chain comprising SEQ ID NO: 58 a monoclonal antibody comprising a light chain comprising SEQ ID NO: 59 and a heavy chain comprising SEQ ID NO: 60, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 61 and a heavy chain comprising SEQ ID NO: 62, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 63 and a heavy chain comprising SEQ ID NO: 64, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 65 and a heavy chain comprising SEQ ID NO: 66, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 67 and a heavy chain comprising SEQ ID NO: 68 a monoclonal antibody comprising a light chain comprising SEQ ID NO: 69 and a heavy chain comprising SEQ ID NO: 70, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 71 and a heavy chain comprising SEQ ID NO: 72, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 73 and a heavy chain comprising SEQ ID NO: 74, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 75 and a heavy chain comprising SEQ ID NO: 76, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 77 and a heavy chain comprising SEQ ID NO: 78 a monoclonal antibody comprising a light chain comprising SEQ ID NO: 79 and a heavy chain comprising SEQ ID NO: 80, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 81 and a heavy chain comprising SEQ ID NO: 82, a monoclonal antibody comprising a light chain comprising SEQ ID NO: 83 and a heavy chain comprising SEQ ID NO: 84, and a monoclonal antibody comprising a light chain comprising SEQ ID NO: 85 and a heavy chain comprising SEQ ID NO: 86.
7. The method of claim 4, wherein the therapeutic polypeptide is a polypeptide selected from the group consisting a glycoprotein, CD polypeptide, a HER receptor polypeptide, a cell adhesion polypeptide, a growth factor polypeptide, an insulin polypeptide, an insulin-related polypeptide, a coagulation polypeptide, a coagulation-related polypeptide, albumin, IgE, a blood group antigen, a colony stimulating factor, a receptor, a neurotrophic factor, an interferon, an interleukin, a viral antigen, a lipoprotein, calcitonin, glucagon, atrial natriuretic factor, lung surfactant, tumor necrosis factor-alpha and -beta, enkephalinase, mouse gonadotropin-associated peptide, DNAse, inhibin, activing, an integrin, protein A, protein D, a rheumatoid factor, an immunotoxin, a bone morphogenetic protein, a superoxide dismutase, a surface membrane polypeptide, a decay accelerating factor, an AIDS envelope, a transport polypeptide, a homing receptor, an addressin, a regulatory polypeptide, an immunoadhesin, a myostatin, a TALL polypeptide, an amyloid polypeptide, a thymic stromal lymphopoietin, a RANK ligand, a c-kit polypeptide, a TNF receptor, and an angiopoietin, and biologically active fragments, analogs or variants thereof.
8. The method of claim 1, wherein the fragments are 0.3 kD to about 50 kD.
9. The method of claim 1, wherein the proteolytic enzyme comprises trypsin.
10. The method of claim 1, wherein the matrix comprises a gel filtration matrix.
11. The method of claim 10, wherein the gel filtration matrix comprises cross-linked dextran.
12. The method of claim 1, wherein the matrix is prepared in a column before performing step (a).
13. The method of claim 12, wherein the column is suitable for gravity flow or centrifugal flow.
14. The method of claim 1, wherein the first elution buffer and the second elution buffer are the same.
15. The method of claim 14, wherein the first elution buffer and the second elution buffer comprise 100 mM Tris and 50 mM methionine, pH 7.5.
16. The method of claim 1, wherein the first elution buffer volume is greater than the second elution buffer volume.
17. The method of claim 1, further comprising, before step (a), performing at least one step selected from the group consisting of polypeptide alkylation, polypeptide reduction, and polypeptide denaturation, or any combination thereof.
18. The method of claim 1, further comprising detecting the polypeptide and fragments.
19. The method of claim 18, wherein the detecting comprises mass spectrometry.
20. The method of claim 1, wherein (d) comprises separately (i) detecting the digest of the polypeptide and (ii) detecting the at least one fragment.
21. The method of claim 1, wherein (d) comprises detecting (i) the digest of the polypeptide and (ii) the at least one fragment, combined.
22. A method of detecting at least one fragment of a glycoprotein in a sample, comprising:
(a) denaturing, reducing, and alkylating the glycoprotein and fragments in the sample;
(b) fractionating the sample, comprising,
a. loading the sample onto a cross-linked dextran gel filtration column, wherein the cross-linked dextran gel has a fractionation range of about 1000- 5000 Da;
b. applying a volume of a first elution buffer comprising 100 mM Tris and 50 mM methionine, pH 7.5 to the column, wherein the glycoprotein is eluted into a first fraction; and
c. applying a volume of second elution buffer comprising 100 mM Tris and 50 mM methionine, pH 7.5 to the column, where the at least one fragment is eluted into the second fraction;
(c) treating the first fraction with trypsin, thereby producing a treated first fraction comprising a digest of the glycoprotein;
(d) combining the treated first fraction with the second fraction; and
(e) detecting the digest of the glycoprotein in the treated first fraction and the at least one fragment in the second fraction.
23. The method of claim 22, further comprising, after step (b), treating the second fraction with trypsin.
The method of patent ‘238 differs from the instant invention in using a size exclusion chromatographic matrix instead of a molecular weight cutoff filter in a centrifugal device as in the instant invention to fractionate a sample.
Johnsen teach using centrifugal molecular weight filters to fractionate proteins in biological samples. Johnsen teaches that centrifugal filters are an alternative to size exclusion chromatography matrix for protein fractionation (page 106).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute centrifugal molecular weight cutoff filters for the size exclusion chromatography matrix in the method of patent ‘238 because Johnsen teaches that centrifugal filters are an alternative to size exclusion chromatography matrix for protein fractionation. A person of ordinary skill in the art reasonably would have expected success because both patent ‘238 and Johnsen are directed to fractionating proteins in biological samples.
Allowable Subject Matter
11. Claims 2-20 are free of the prior art of record because the prior art does not teach a method with the specific limitations of claim 2.
Conclusion
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
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, Bao-Thuy Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
5/29/2026
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