DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
2. This Office Action is in response to the amendment filed 10 April 2026, wherein claims 1-3 and 5-15 were amended; claims 16-21 were added; and claim 4 was canceled.
Claims 1-3 and 5-21 are under consideration.
Priority
3. Receipt is acknowledged of certified copies of papers required by 35 CFR 1.55. Should Applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CRF 41.154(b) and 41.202(e). Therefore, the effective filing date for purposes of applying prior art is 16 November 2021.
Failure to provide a certified translation may result in no benefit being accorded for the non-English translation.
Claim Interpretation
4. The plasmid pGagPol-RRE-NES-cINT is being interpreted in light of the specification as a construct made by inserting the GagPol and Rev genes into an pcDNA5 base plasmid (Page 7, L17-21). In addition, in accordance with MPEP 2111.03.IV, the word ‘has’ is open to interpretation in light of the specification. As the specification does not define this term, Examiner is interpreting ‘has’ in claims 3 and 4 to be open claim language. The indefinite article ‘a’ allows for the interpretation of reading upon the full-length sequence or a fragment thereof. Therefore, Examiner is interpreting the sequences in claims 3 and 4 read upon the full-length or fragment thereof and may include additional amino acids/nucleotides not disclosed in the claimed SEQ ID NO’s.
It is noted that any interpretation of the claims set forth does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office Action.
Rejections Withdrawn
Claim Rejections - 35 USC § 112
5. The rejections of claims 5-9 and 12-15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite are withdrawn in view of Applicant’s amendments.
Rejections Maintained
6. 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 Rejections - 35 USC § 103
7. It is noted that Applicant amended the claims but reproduced claim scope that was present in at
the time of the Non-Final Office Action mailed 12 January 2026.
8. Claims 1, 5, 10-11, 14, and 19 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20190211358 A1; Published 11 July 2019) (See IDS filed 28 November 2023) in view of Milani (EMBO Mol. Med., 23 August 2017, 9(11): 1558-1573) (See PTO-892 mailed 12 January 2026), Reiser (Addgene plasmid #18659; http://n2t.net/addgene:18659; RRID:Addgene_18659; Published 2005, Accessed 02 January 2026) (See PTO-892 mailed 12 January 2026), Weinburg1 (Addgene plasmid #8454; http://n2t.net/addgene:8454; RRID:Addgene_8454; Published 2003, Accessed 02 January 2026) (See PTO-892 mailed 12 January 2026), and Weinburg2 (Addgene plasmid #8455; http://n2t.net/addgene:8455; RRID:Addgene_8455; Published 2003, Accessed 02 January 2026) (See PTO-892 mailed 12 January 2026).
Regarding claims 1 and 5, Stewart teaches a stable cell line where HEK293T cells are transfected with a pPuro-coTeR plasmid (¶ [0366] and ¶ [0374]). Stewart also teaches a specific example with three separate plasmids for the GagPol, VSV-G, and Rev genes being transfected into the HEK293T-TeR cells (Example 5; ¶ [0371] and ¶ [0374]), but also teaches various plasmid constructions, with Figure 5 and Table 1 showing a set of plasmids with GagPol and Rev on one plasmid and VSV-G on another. Stewart also teaches that it is advantageous to codon optimize the vectors (¶ [0215]-[0217]). Stewart does not teach the GagPol and Rev genes on an pcDNA5 plasmid, as claimed.
However, Milani discloses GagPol and Rev on two separate pcDNA5/TO plasmids (Plasmid Construction). Therefore, it would have been obvious to one of ordinary skill before the time of filing to take the genes and methods for lentivirus production of Stewart and further use the base plasmid of Milani with the GagPol and Rev genes on said one plasmid to arrive at the three plasmids. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02). One of ordinary skill in the art would have had a reasonable expectation of success for combining known lentivirus production and packaging genes into various common plasmid bases. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Neither Stewart nor Milani teaches the specific sequences for the plasmids described. However, Resier teaches a pNL-EGFP/TREPittdU3 lentivirus plasmid, which contains a TetR gene and partially matches SEQ ID NO: 5 of the Instant Application:
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The sequence alignment has been omitted due to its long length.
Weinburg1 teaches a pCMV-VSV-G lentivirus envelope plasmid, which partially matches SEQ ID NO: 6 of the Instant Application, that is to be used in conjunction with a transfer plasmid (such as pCMV-dR8.2 dvpr below):
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The sequence alignment has been omitted due to its long length.
Weinburg2 is part of the same study as Weinburg1 and teaches a pCMV-dR8.2 dvpr lentivirus packaging plasmid with GagPol and Rev that is meant to be used in conjunction with the pCMV-VSV-G envelope plasmid above:
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The sequence alignment has been omitted due to its long length.
Therefore, it would have been obvious to one of ordinary skill at the time of filing to take the methods of Stewart and Milani and further use the specific plasmid sequences as taught in Resier, Weinburg1, and Weinburg2. They meet the structural and functional requirements of the related sequences in the other references supra. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02). One of ordinary skill in the art would have had a reasonable expectation of success for combining known vector components and genes. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claim 10, Stewart further teaches “In accordance with the present invention, and by way of example, some vectors used in recombinant nucleic acid techniques allow entities, such as a segment of nucleic acid (e.g. a heterologous DNA segment, such as a heterologous cDNA segment), to be transferred into and expressed by a target cell. The vector may facilitate the integration of the nucleic acid/nucleotide of interest (NOI) to maintain the NOI and its expression within the target cell.” (¶ [0113]). Therefore, it would have been further obvious to transfect the lentivirus packaging cell line with a plasmid carrying a nucleotide of interest.
Regarding claims 11, 14, and 19, Stewart further teaches that doxycycline can be used to induce lentivirus production post-transfection at a concentration of 1 μg/mL (¶ [0376]) and “Therefore, it is likely that with further optimisation the lentiviral vector yields could be improved. Parameters which may be optimised include: seeding densities, modular construct transfection amounts, transfection reagent amounts, harvest timings and induction timings.” (¶ [0350]). The concentration of the inducing agent and the time administered are both result-effective parameters that one of ordinary skill would routinely optimize. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art.
9. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart (Supra), Milani (Supra), Reiser (Supra), Weinburg1 (Supra), and Weinburg2 (Supra) as applied to claims 1, 5, 10-11, 14, and 19 above, and further in view of Johnson (US 20170145388 A1; Published 25 May 2017) (See IDS filed 28 November 2023).
Regarding claim 2, Stewart, Milani, Reiser, Weinburg1, and Weinburg2 make the limitations of claim 1 obvious as discussed supra. All discussions thereon incorporated here. Stewart further teaches the GagPol, VSV-G, and Rev plasmids having two tetracycline operator sequences (¶ [0374]), each expression cassette having its own polyA region (¶ [0119]), as well as some common retroviral vector elements that can be included, such as CMV and SV40 promoters (¶ [0230]) and puromycin, bleomycin (part of Zeocin™), and hygromycin resistance genes (¶ [0279]). Stewart does not teach the chimeric intron, cPPT/CTS element, and RRE elements.
However, Johnson teaches a retroviral producer cell (Abstract), and that the nucleic acid vector can include a chimeric intron (¶ [0045]), cPPT sequence (¶ [0072]), and RRE sequence (¶ [0078]).
Therefore, it would have been obvious to one of ordinary skill at the time of filing to take the known vector element options of Stewart and Johnson and combine them. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02). One of ordinary skill in the art would have had a reasonable expectation of success for combining known vector components and genes. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
10. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart (Supra), Milani (Supra), Reiser (Supra), Weinburg1 (Supra), Weinburg2 (Supra), and Johnson (Supra), as applied to claim 2 above, and further in view of Bhinder (GB 2540786 A; published 1 February 2017) (See PTO-892 mailed 12 January 2026), Ohlmann (US 20190055288 A1; Priority to 20 October 2015) (See PTO-892 mailed 12 January 2026), Cawood (WO 2019058108 A1; Published 28 March 2019) (See PTO-892 mailed 12 January 2026), and Nie (CN 105602935 A; Published 25 May 2016) (See PTO-892 mailed 12 January 2026).
Regarding claim 3, Stewart, Milani, Reiser, Weinburg1, and Weinburg2 make the limitations of claim 1 obvious as discussed supra. All discussions thereon incorporated here. None of the references teach the specific SEQ ID NOs for the genes used in the plasmids.
However, Bhinder teaches SEQ ID NO: 3 (‘Db’), a codon optimized TetR sequence, which matches SEQ ID NO: 1 of the Instant Application (‘Qy’):
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The sequence alignment has been omitted due to its long length.
Ohlmann teaches SEQ ID NO: 28, a VSVG protein sequence, which matches SEQ ID NO: 2 of the Instant Application:
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The sequence alignment has been omitted due to its long length.
Cawood teaches SEQ ID NO: 5 (‘Db’), a HIV GagPol gene, which matches SEQ ID NO: 3 of the Instant Application (‘Qy’):
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The sequence alignment has been omitted due to its long length.
Nie teaches SEQ ID NO: 5 (‘Db’), a HIV 1 Rev gene, which matches SEQ ID NO: 4 of the Instant Application (‘Qy’):
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Although all the sequences are from different references, one of ordinary skill before the time of filing would have been able to insert these genes into the respective plasmids arrived at by the combined teachings of Stewart, Milani, Reiser, Weinburg1, and Weinburg2 as described in claims 1. It is standard and known within the art to insert and optimize gene sequences into base plasmids. This combination of genes is also well-known in the art to be used together for lentivirus packaging cell lines. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02). One of ordinary skill in the art would have had a reasonable expectation of success for combining known vector components and genes. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
11. Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (Supra), Milani (Supra), Reiser (Supra), Weinburg1 (Supra), Weinburg2 (Supra), Johnson (Supra), Bhinder (Supra), Ohlmann (Supra), Cawood (Supra), and Nie (Supra), as applied to claim 3 above, and further in view of ThermoScientific (2012, Fast Simultaneous Plasmid Vector Linearization and Dephosphorylation) and ThermoFisher (Zeocin Protocol, Wayback Machine to 22 April 2019) (See PTO-892 mailed 12 January 2026).
Regarding claim 6, Stewart further teaches that the HEK293T-TeR cells were made by transfecting linearized pPuro-coTeR plasmid and then using puromycin media (0.6 μg/ml) to select for the transfectants (¶ [0366]). The HEK293T-TeR cells were then transfected with linearized GagPol, Rev, and VSV-G plasmids, and the appropriate antibiotics were used to select for the transfectants (¶ [0368]). Stewart does not specifically teach plasmid linearization using enzymes or the pPuro-coTeR and pVSVG plasmids being transfected at the same time with the same antibiotic resistance gene.
However, ThermoScientific teaches plasmid vector linearization by adding plasmid DNA, buffer, restriction enzyme, alkaline phosphatase, and water (Step 1 table). Therefore, it would have been obvious to one of ordinary skill to take the method of Stewart and apply the linearization method of ThermoScientific. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
In addition, using the same antibiotic resistance gene for both the pPuro-coTeR and pVSVG genes, while not ideal, would predictably produce some cells with both plasmids. Furthermore, doing the first transfection with or without pVSVG are both equally obvious as changing the order of steps is obvious as the only thing it would affect is the combination of antibiotics in each media. This is supported by Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In reGibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
In summary, it would have been obvious to one of ordinary skill before the effective filing date to linearize the plasmids with enzymes, co-transfect the cells with the linearized pPuro-coTeR and pVSVG using one antibiotic for screening, then transfect the cells with the linearized plasmid with GagPol and Rev with a different antibiotic for screening.
Regarding claim 9, Stewart, Milani, Reiser, Weinburg1, Weinburg2, Johnson, and ThermoScientific make the limitations of claim 6 obvious, as discussed supra. All discussions thereon incorporated here. Stewart further teaches using a puromycin concentration of 0.6 μg/mL (¶ [0366]) and Zeocin™ (¶ [0368]), but does not specify the concentration. However, ThermoFisher teaches that Zeocin™ is part of the bleomycin/phleomycin family (Overview) and can be used in mammalian cell selection, wherein the concentration ranges from 50 to 1000 μg/mL, with the average concentration being 250 to 400 μg/mL (Zeocin™ Selection in Mammalian Cells, Introduction). This average concentration range is fully within the 300-500 μg/mL of bleomycin that is claimed.
Antibiotic concentrations in the media for screening are result-effective and the claimed range can be achieved through routine optimization. It would further be obvious that the amount of puromycin used in the screening media is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art.
Therefore, it would be obvious to one of ordinary skill at the time of filing to take the methods of Stewart and Milani and further optimize the concentration of puromycin to select for the HEK293-TetR cells, then use the recommended concentration of Zeocin™ from ThermoFisher to select for the packaging cell lines.
12. Claims 7-8, 12-13, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (Supra), Milani (Supra), Reiser (Supra), Weinburg1 (Supra), Weinburg2 (Supra), Johnson (Supra), Bhinder (Supra), Ohlmann (Supra), Cawood (Supra), Nie (Supra), ThermoScientific (Supra), and ThermoFisher (Supra), as applied to claims 6 and 9 above, and further in view of Tang (Oncol Lett., 7 November 2014, 9(1): 55-62) (See PTO-892 mailed 12 January 2026).
Regarding claims 7-8, 12-13, and 16-18, Stewart, Milani, Reiser, Weinburg1, Weinburg2, and ThermoScientific make the limitations of claims 6 and 10 obvious, as discussed supra. All discussions thereon incorporated here. Stewart further teaches that PEI can be used during the transfection process
(¶ [0323]). Stewart nor Milani teaches the specific ratios of plasmids to cells or plasmids to PEI.
However, Tang teaches optimizing the plasmid DNA concentration for PEI-mediated lentivirus production, which did not result a significant difference in lentivirus titer (Optimization of DNA quality for PEI-mediated LvV production).
It would further be obvious that the ratio of plasmids to cells and plasmids to PEI are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize.
It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art.
13. Claims 15 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (Supra), Milani (Supra), Reiser (Supra), Weinburg1 (Supra), Weinburg2 (Supra), Johnson (Supra), Bhinder (Supra), Ohlmann (Supra), Cawood (Supra), Nie (Supra), ThermoScientific (Supra), ThermoFisher (Supra), and Tang (Supra), as applied to claims 7-8, 12-13, and 16-18 above, and further in view of Cribbs (BMC Biotechnol., 12 November 2013, 13:98) (See PTO-892 mailed 12 January 2026).
Regarding claims 15 and 20-21, Stewart, Milani, Reiser, Weinburg1, and Weinburg2 make the limitations of claim 1 obvious, as discussed supra. Stewart further teaches that sodium butyrate was added post-transfection (¶ [0373]) but does not discuss the importance of adding it. However, Cribbs teaches that sodium butyrate has been shown to function as an enhancer of mammalian cell transfection efficiency (Results and Discussion, ¶ 1). Therefore, one of ordinary skill at the time of filing would have known to add sodium butyrate to the teachings of Stewart and Milani in order to enhance lentiviral expression.
The concentration of sodium butyrate, time for collecting the lentiviruses, the time in which the enhancing agent is added, and the time period in which the enhancing agent is changed are all result-effective parameters that are routinely optimized. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art.
Response to Traversal
14. Examiner has fully considered the arguments made on pages 10-13 of Applicant’s response filed 10 April 2026. Regarding the argument of unexpected results of the claimed lentivirus packing cell line, the figures and data shown do not show statistical significance. In addition, mere fact that the lentiviral cell line is stable does not demonstrate unpredictable results as the lentiviral cell lines of the prior art are also stable. Unexpected results must be shown compared to the closest prior art. Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See MPEP § 2129 and § 2144.03 for a discussion of admissions as prior art. http://rdms-mpep-vip.uspto.gov/RDMS/custom/images/icon_note.png. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). If Applicant believes that the specific stable lentiviral cell line as claimed is exceptional, then a biological deposit should be considered.
Additionally, the arguments focus on attacking the references individually and fail to consider the combination of Stewart and Milani as being nonobvious. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
New Objections
Claim Objections
15. Claims 1-2, 5-8, 11-13, and 17-18 are objected to because of the following informalities:
Regarding claims 1-2, 6-7, claims should only have one period. Examiner suggests changing “pPuro.coTetR” to “pPuro-coTetR” or something similar.
Regarding claim 5, a comma should be added after “HT1080”.
Regarding claims 7, 12-13, and 17, “2-5:1”, “(1-8):1”, and the like should be rewritten in the format of “2:1 to 5:1” or “1:1 to 1:8” for clarity.
Regarding claim 11, “transfecting the stable lentivirus packaging cell line with the target plasmid; and” is repeated from claim 10 and should be deleted.
Regarding claims 13 and 18, “stable lentivirus packaging cell line” should be rewritten as either “cells of the stable lentivirus packaging cell line” or “stable lentivirus packaging cell line cells”.
Appropriate correction is required.
New Rejections
Claim Rejections - 35 USC § 112(b)
16. Claims 1-3 and 5-21 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.
Regarding claims 1 and 3, it is unclear if “comprises a sequence shown in” requires the sequences to be the full length or fragment thereof, and if the sequences can have additional amino acids or not. Examiner is interpreting this limitation to read as “comprising”, such that the sequences can be the full length or fragment thereof and can have additional amino acids. Examiner suggests changing this limitation to “the sequence of” for clarity.
Claims 2-3 and 5-21, which depend on claim 1, are similarly rejected.
The term “about” in claims 8-9, 13-15, and 18-21, is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 21, it is unclear if “changed at a time period…” means that the enhancing agent is changed every 6 to 8 hours or just once. Therefore, there are multiple interpretations for the steps required by the claims.
See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
Conclusion
17. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KRISTINA E. LY/Examiner, Art Unit 1671
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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