Office Action Predictor
Application No. 17/627,007

METHOD FOR SELECTING HYBRIDOMA CELLS FROM A PLURALITY OF HYBRIDOMA CELLS BY MEANS OF A BIRA EXPRESSION VECTOR

Non-Final OA §102§103§112§DP
Filed
Jan 13, 2022
Examiner
WILSON, MICHAEL C
Art Unit
1638
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
New/Era/Mabs GMBH
OA Round
1 (Non-Final)
42%
Grant Probability
Moderate
1-2
OA Rounds
3y 9m
To Grant
53%
With Interview

Examiner Intelligence

42%
Career Allow Rate
384 granted / 919 resolved
Without
With
+10.8%
Interview Lift
avg trend
3y 9m
Avg Prosecution
77 pending
996
Total Applications
career history

Statute-Specific Performance

§101
5.1%
-34.9% vs TC avg
§103
25.3%
-14.7% vs TC avg
§102
20.7%
-19.3% vs TC avg
§112
36.5%
-3.5% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§102 §103 §112 §DP
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 . Claims 1-15 are pending. Election/Restrictions Applicant's election with traverse of Group I, claims 1-8, in the reply filed on 8-28-25 is acknowledged. It appears that DSM 32960 “cell line” containing SEQ ID NO: 18 is actually just a plasmid deposited with the DSM as 32960 (pg 6, para 44); it is not a cell line as claimed. Upon reconsideration, the restriction is as follows: I. Claims 1-13, 15, drawn to a hybridoma cell whose genome comprises a nucleic acid sequence encoding a biotin protein ligase (BPL), a method of making the cell, and a method of using the cell. Cell lines DMS ACC 3343 and 3344 in claim 12 are encompassed by the cell of claim 1. II. Claim 14, drawn to a plasmid that has the nucleic acid sequences of SEQ ID NO: 18 deposited as DSM 34960. Claim 14 has been withdrawn. Claims 1-13, 15 are under consideration. 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 1-13, 15 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 specification lacks written description for any species of hybridoma in vivo or in vitro as broadly encompassed by claim 1 other than an isolated mammalian hybridoma. Claim 1 is drawn to a hybridoma containing at least one polynucleotide encoding biotin protein ligase [BPL] stably integrated into the genome after its transformation. The claim encompasses a hybridoma in vitro or in vivo. The phrase “after its transformation” makes the claim a product-by-process, i.e. a hybridoma that has been transformed. However, the process, transformation, does not bear patentable weight in distinguishing the structure or function of the hybridoma or the structure of the exogenous sequence encoding BPL after it has been stably integrated into the genome of the hybridoma. Any hybridoma with exogenous sequence encoding BPL after it has been stably integrated into its genome by electroporation, transduction, microinjection, etc. has the same structure/function as one made by “transformation”. The specification is limited to an isolated mammalian hybridoma whose genome comprises an exogenous nucleic acid sequence encoding BPL. The specification does not correlate making/using isolated mammalian hybridomas to any species of invertebrate, insect, fish, amphibian, reptile, or bird hybridomas or to hybridomas made/used in vivo. Accordingly, claim 1 should be limited to an isolated mammalian hybridoma. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1-13, 15 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. The phrase “after its transformation” in claim 1 makes the claim indefinite. Claim 1 is drawn to a hybridoma containing at least one polynucleotide encoding biotin protein ligase [BPL] stably integrated into the genome after its transformation. However, cells express endogenous BPL which is an enzyme essential for cellular life. It is unclear whether the claim is limited to a hybridoma comprising an exogenous nucleic acid sequence encoding BPL or if it encompasses any hybridoma that has been transformed (with anything) that expresses endogenous BPL. Moreover, the phrase “after its transformation” makes the claim a product-by-process, but there is nothing in the claim that distinguishes the product claimed from any other hybridoma (which inherently MUST expresses endogenous BPL for survival). Nor is there anything in the claim that distinguishes the product claimed from a hybridoma that has been transformed with anything (which inherently MUST expresses endogenous BPL for survival). The metes and bounds of when a polynucleotide is “stably” integrated into the genome of a hybridoma cannot be determined as required in claim 2. A polynucleotide is either integrated into the genome or it is not. The specification does not teach when integration of an exogenous polynucleotide is “stable”. The phrase “in particular selected from the group consisting of SEQ ID NO: 1…” in claim 3 makes the claim indefinite. It is unclear whether applicants are attempting use the phrase as “for example”. The phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Or perhaps applicants are using the phrase as “such as”. However, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Or perhaps applicants are using the phrase as “or the like”. However, the phrase "or the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Claim 3 is indefinite because it appears that the sequences listed are limited to biotinylation peptides; however, the claim reads as though the “surface protein” + “biotinylation peptide” fusion protein is selected from SEQ ID NO: 1, 2, or 3. To the contrary, only the “biotinylation peptide” is selected from SEQ ID NO: 1, 2, or 3. Therefore, the wording of claim 3 is indefinite because SEQ ID NO: 1-3 cannot encode the fusion protein. Claim 4 is indefinite because it says the polynucleotide encoding the PBL is contained in an expression vector, but it is unclear whether the expression vector encoding the PBL is integrated into the genome of the hybridoma or if just the polynucleotide encoding the PBL is integrated into genome. Claim 5 is indefinite because it says the polynucleotide encoding the “surface protein” is contained in an expression vector, but it is unclear whether the expression vector encoding the “surface protein” is integrated into the genome of the hybridoma or if just the polynucleotide encoding the “surface protein” is integrated into genome. Claim 7 is indefinite because the sequences listed include amino acid sequences, and a vector cannot comprise amino acid sequences. A vector is limited to nucleic acid sequence. Claims 10, 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The claims do not have any steps for making hybridomas. Such steps could include transfecting cells with vectors encoding the “surface protein” and the PBL and fusing the cells such that hybridomas are obtained. If those are the steps, then the specific reagents and the order of the transfections and fusions cannot be determined. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. A) Claims 1, 2, 4-6, 9-11 are rejected under 35 U.S.C. 102a1 as being anticipated by Kimura (“Novel ELISA using intracellularly biotinylated antigen for detection of antibody following DNA immunization”, Japanese journal of infectious diseases, 2010, Vol. 63, No. 1, pp. 41-48). Kimura taught an isolated mammal hybridoma whose genome comprises a polynucleotide encoding a surface protein which contains a biotinylation peptide and a polynucleotide coding for BirA (pg 41-42, “Plasmids” & “Retroviral transduction of HuBirA in human 293T cell”; pg 43, 1st 2 paragraphs; pg 43-44, “Screening of mAb-producing hybridomas by biotinylation-mediated ELISA”). The proteins with the biotinylation peptides described by Kimura are “surface proteins” as required in claim 2 because they are presented on the surface of cells. The vectors encoding the surface protein and BirA were in a plasmid or retrovirus (pg 41-42) which is equivalent to an “expression vector” in claim 4. Claim 5 has been included because the vector encoding the protein that contains a biotinylation pepetide and the vector encoding BirA contained promoters (pg 41-42). Claim 6 has been included because the BirA is released intracellularly and biotinylation occurs intracellularly (Results). Claim 9 has been included because there are no active steps and because Kimura taught making the hybridoma using the steps claimed (Methods). Claim 10 has been included because there are no active steps and because Kimura taught making the hybridoma using the steps claimed (Methods). Kimura using the hybridoma to make antibodies as required in claim 11 (Results). B) Claims 1, 2, 4-6, 9-11 are rejected under 35 U.S.C. 102a1 as being anticipated by Predonzani (BMC Biotech. Biomed. Cntral LTD, 2008, Vol. 8, No. 1, pg 41). Predonzani taught an isolated mammal hybridoma whose genome comprises a polynucleotide encoding a surface protein which contains a biotinylation peptide and a polynucleotide coding for BirA (abstract). PNG media_image1.png 422 804 media_image1.png Greyscale The scFV, t-sigE, t-mLIgE, and αD1D2 are “surface proteins” as required in claim 2. The vectors encoding the surface protein and BirA were in a plasmid (pg 3, 2nd para) which is equivalent to an “expression vector” in claim 4. Claim 5 has been included because vectors encoding the surface protein and BirA contained promoters to control expression (Fig. 1). Claim 6 has been included because the BirA is released intracellularly and biotinylation occurs intracellularly (Results). Claim 9 has been included because there are no active steps and because Predonzani taught making the hybridoma using the steps claimed (Methods). Claim 10 has been included because there are no active steps and because Predonzani taught making the hybridoma using the steps claimed (Methods). Predonzani using the hybridoma to make antibodies as required in claim 11 (Results). C) Claims 1, 4-6, 9-11 are rejected under 35 U.S.C. 102a1 as being anticipated by Polic (WO 2012164320). Polic taught isolated mammalian hybridoma cells whose genome comprises a polynucleotide encoding BirA, a biotin protein ligase (pg 4, 3rd & 5th para; pg 5, description of Fig. 1; pg 7, description of Fig. 7; pg 11, “The BirA positive transfectants (BirA-SP2/O) were further tested for their capability as fusion partners”; pg 11, last para; claim 2). This is equivalent to the hybridoma whose genome comprises a sequence encoding a biotin protein ligase as required in claim 1. The sequence encoding BirA was in a plasmid (pg 5, description of Fig. 1; pg 6, description of Fig. 5) which is equivalent to an “expression vector” in claim 4. Claim 5 has been included because “the integrated polynucleotide encoding… surface protein” lacks antecedent basis. Claim 6 has been included because BirA is release intracellularly and because the phrase “the biotinylation peptide” lacks antecedent basis. Claim 9 has been included because there are no active steps and because Polic taught making a hybridoma whose comprises a sequence encoding a biotin peptide ligase. Claim 10 has been included because there are no active steps other than making a hybridoma whose comprises a sequence encoding a biotin peptide ligase. Polic using the hybridoma to make antibodies as required in claim 11 (see citations above). Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. A) Claims 1-6, 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kimura (“Novel ELISA using intracellularly biotinylated antigen for detection of antibody following DNA immunization”, Japanese journal of infectious diseases, 2010, Vol. 63, No. 1, pp. 41-48) in view of Watzele (20060046285). Kimura taught isolated mammalian hybridoma cells whose genomes comprise a polynucleotide encoding BirA and a polynucleotide encoding a surface protein with a biotinylation peptide as required in claims 1, 2, 4-6, 9-11 (see rejection above). Kimura did not teach the biotinylation peptide had the amino acid sequence of SEQ ID NO: 1 as required in claim 3. However, Watzele taught SEQ ID NO: 7 which encodes a biotinylation peptide that is 100% identical to the amino acid sequence of SEQ ID NO: 1 as required in claim 3. PNG media_image2.png 734 784 media_image2.png Greyscale Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make a hybridoma cell encoding BirA and a surface protein comprising a biotinylation peptide as described by Kimura wherein the biotinylation peptide had the amino acid sequence of SEQ ID NO: 1 as described by Watzele. Those of ordinary skill in the art at the time of filing would have been motivated to use the biotinylation peptide of Watzele as a matter of design choice. Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary. B) Claims 1, 2, 4-7, 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kimura (“Novel ELISA using intracellularly biotinylated antigen for detection of antibody following DNA immunization”, Japanese journal of infectious diseases, 2010, Vol. 63, No. 1, pp. 41-48) in view of Bian (CN103374068). Kimura taught isolated mammalian hybridoma cells whose genomes comprise a polynucleotide encoding BirA and a polynucleotide encoding a surface protein with a biotinylation peptide as required in claims 1, 2, 4-6, 9-11 (see rejection above). Kimura did not teach the biotin protein ligase comprised the nucleic acid sequence of SEQ ID NO: 7 as required in claim 7. However, Bian taught SEQ ID NO: 9 which encodes a biotin protein ligase comprised the nucleic acid sequence of SEQ ID NO: 7 as required in claim 7. PNG media_image3.png 736 598 media_image3.png Greyscale Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make a hybridoma cell encoding BirA and a surface protein comprising a biotinylation peptide as described by Kimura wherein the sequence encoding BirA had the nucleic acid sequence of SEQ ID NO: 7 as described by Bian. Those of ordinary skill in the art at the time of filing would have been motivated to use the sequence of Bian as a matter of design choice to tag BirA. Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary. C) Claims 1-6, 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Predonzani (BMC Biotech. Biomed. Cntral LTD, 2008, Vol. 8, No. 1, pg 41) in view of Watzele (20060046285). Predonzani taught isolated mammalian hybridoma cells whose genomes comprise a polynucleotide encoding BirA and a polynucleotide encoding a surface protein with a biotinylation peptide as required in claims 1, 2, 4-6, 9-11 (see rejection above). Predonzani did not teach the biotinylation peptide had the amino acid sequence of SEQ ID NO: 1 as required in claim 3. However, Watzele taught SEQ ID NO: 7 which encodes a biotinylation peptide that is 100% identical to the amino acid sequence of SEQ ID NO: 1 as required in claim 3. PNG media_image2.png 734 784 media_image2.png Greyscale Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make a hybridoma cell encoding BirA and a surface protein comprising a biotinylation peptide as described by Predonzani wherein the biotinylation peptide had the amino acid sequence of SEQ ID NO: 1 as described by Watzele. Those of ordinary skill in the art at the time of filing would have been motivated to use the biotinylation peptide of Watzele as a matter of design choice. Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary. D) Claims 1, 2, 4-7, 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Predonzani (BMC Biotech. Biomed. Cntral LTD, 2008, Vol. 8, No. 1, pg 41) in view of Bian (CN103374068). Predonzani taught isolated mammalian hybridoma cells whose genomes comprise a polynucleotide encoding BirA and a polynucleotide encoding a surface protein with a biotinylation peptide as required in claims 1, 2, 4-6, 9-11 (see rejection above). Predonzani did not teach the biotin protein ligase comprised the nucleic acid sequence of SEQ ID NO: 7 as required in claim 7. However, Bian taught SEQ ID NO: 9 which encodes a biotin protein ligase comprised the nucleic acid sequence of SEQ ID NO: 7 as required in claim 7. PNG media_image3.png 736 598 media_image3.png Greyscale Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make a hybridoma cell encoding BirA and a surface protein comprising a biotinylation peptide as described by Predonzani wherein the sequence encoding BirA had the nucleic acid sequence of SEQ ID NO: 7 as described by Bian. Those of ordinary skill in the art at the time of filing would have been motivated to use the sequence of Bian as a matter of design choice to tag BirA. Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary. E) Claims 1, 2, 4-6, 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Listek (WO 2015161835) and Polic (WO 2012164320). Listek taught an isolated mammalian hybridoma whose genome comprises a polynucleotide encoding a surface protein that contains a biotinylation peptide. This surface protein is biotinylated using exogenous BirA ligase (claims 1-15; paragraph [0010] - paragraph [0019]; paragraph [0036] - paragraph [0041]; pg 24, para 142 of translation). Listek did not teach the genome of the hybridoma cell contained an exogenous sequence encoding a biotin protein ligase as required in claim 1. However, Polic taught isolated mammalian hybridoma cells whose genome comprises a polynucleotide encoding BirA, a biotin protein ligase (pg 4, 3rd & 5th para; pg 5, description of Fig. 1; pg 7, description of Fig. 7; pg 11, “The BirA positive transfectants (BirA-SP2/O) were further tested for their capability as fusion partners”; pg 11, last para; claim 2). Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make an isolated mammalian hybridoma whose genome comprises a polynucleotide encoding a surface protein that contains a biotinylation peptide as described by Listek and introducing an exogenous sequence encoding BirA into the genome of the cell as described by Polic. Those of ordinary skill in the art at the time of filing would have been motivated to introducing an exogenous sequence encoding BirA into the genome of the cell described by Listek to allow it to biotinylate its own biotinylation peptide. In the reverse, Polic taught isolated mammalian hybridoma cells whose genome comprises a polynucleotide encoding BirA, a biotin protein ligase, but did not teach introducing an exogenous sequence encoding a surface protein comprising a biotinylation peptide into the genome of the hybridoma as required in claim 2. However, doing so was taught by Listek. Those of ordinary skill in the art at the time of filing would have been motivated to introduce an exogenous sequence encoding a surface protein comprising a biotinylation peptide into the genome of the hybridoma to the hybridoma of Polic in order to have a self-contained system for biotinylating surface peptides with biotinylation peptide. The sequence encoding BirA was in a plasmid (pg 5, description of Fig. 1; pg 6, description of Fig. 5) which is equivalent to an “expression vector” in claim 4. Claim 5 has been included because “the integrated polynucleotide encoding… surface protein” lacks antecedent basis. Claim 6 has been included because BirA is release intracellularly and because the phrase “the biotinylation peptide” lacks antecedent basis. Claim 9 has been included because there are no active steps and because Polic taught making a hybridoma whose comprises a sequence encoding a biotin peptide ligase. Claim 10 has been included because there are no active steps other than making a hybridoma whose comprises a sequence encoding a biotin peptide ligase. Polic using the hybridoma to make antibodies as required in claim 11 (see citations above). Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary. F) Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Listek (WO 2015161835) and Polic (WO 2012164320) as applied to claims 1, 2, 4-6, 9-11 further in view of Watzele (20060046285). The combined teachings of Listek and Polic taught isolated mammalian hybridoma cells whose genome comprises a polynucleotide encoding BirA and a polynucleotide encoding a surface protein with a biotinylation peptide (see rejection above). The combined teachings of Listek and Polic did not teach the biotinylation peptide had the amino acid sequence of SEQ ID NO: 1 as required in claim 3. However, Watzele taught SEQ ID NO: 7 which encodes a biotinylation peptide that is 100% identical to the amino acid sequence of SEQ ID NO: 1 as required in claim 3. PNG media_image2.png 734 784 media_image2.png Greyscale Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make a hybridoma cell encoding BirA and a surface protein comprising a biotinylation peptide as described by the combined teachings of Listek and Polic wherein the biotinylation peptide had the amino acid sequence of SEQ ID NO: 1 as described by Watzele. Those of ordinary skill in the art at the time of filing would have been motivated to use the biotinylation peptide of Watzele as a matter of design choice. Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary. G) Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Listek (WO 2015161835) and Polic (WO 2012164320) as applied to claims 1, 2, 4-6, 9-11 further in view of Bian (CN103374068). The combined teachings of Listek and Polic taught isolated mammalian hybridoma cells whose genome comprises a polynucleotide encoding BirA and a polynucleotide encoding a surface protein with a biotinylation peptide (see rejection above). The combined teachings of Listek and Polic did not teach the biotin protein ligase comprised the nucleic acid sequence of SEQ ID NO: 1 as required in claim 7. However, Bian taught SEQ ID NO: 9 which encodes a biotin protein ligase comprised the nucleic acid sequence of SEQ ID NO: 7 as required in claim 7. PNG media_image3.png 736 598 media_image3.png Greyscale Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make a hybridoma cell encoding BirA and a surface protein comprising a biotinylation peptide as described by the combined teachings of Listek and Polic wherein the sequence encoding BirA had the nucleic acid sequence of SEQ ID NO: 7 as described by Bian. Those of ordinary skill in the art at the time of filing would have been motivated to use the sequence of Bian as a matter of design choice to tag BirA. Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary. Double Patenting Claims 12, 13, 15 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 8. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The cell lines ACC 3343 and 3344 have defined structures and functions that are frozen. Saying the have a polynucleotide encoding PBL in claim 13 or 15 does nothing to further limit claim 12 because they too have a polynucleotide encoding PBL. Conclusion No claim is allowed. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Helman (WO 2012085911) taught the same thing as Predonzani (abstract; page 2, line 7 - line 9; page 2, line 26 - line 28; page 3, line 14 - line 17; page 4, line 9 - line 11; page 8, line 30 - page 9, line 10; page 12, line 3 - line 6; claims 1-42). Inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C. Wilson who can normally be reached at the office on Monday through Friday from 9:30 am to 6:00 pm at 571-272-0738. Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public. For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199. If attempts to reach the examiner are unsuccessful, the examiner's supervisor, Tracy Vivlemore, can be reached on 571-272-2914. The official fax number for this Group is (571) 273-8300. Michael C. Wilson /MICHAEL C WILSON/ Primary Examiner, Art Unit 1638
Read full office action

Prosecution Timeline

Jan 13, 2022
Application Filed
Sep 30, 2025
Non-Final Rejection — §102, §103, §112
Apr 04, 2026
Response after Non-Final Action

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Prosecution Projections

1-2
Expected OA Rounds
42%
Grant Probability
53%
With Interview (+10.8%)
3y 9m
Median Time to Grant
Low
PTA Risk
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