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 .
Status of Claims
The amended claims filed 05/15/2026 are acknowledged and entered.
Claims 59, 63-68 have been amended
Claims 56-58 and 73 have been cancelled
Claims 59-72, 74, and 153-158 are pending and examined on their merits.
Response to Amendment
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Objections
Drawings - Withdrawn
The disclosure was objected to because of the following informalities:
a) The objection for not providing sequence identifiers (SEQ ID numbers) for the amino acid sequences appearing in FIG 1A and FIG. 1B is withdrawn. Applicant has corrected the informalities in the substitute replacement sheets.
Claim Rejections - 35 USC § 112 withdrawn
1. The rejections for claim 57 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in view of claim 57 being cancelled.
New Claim Objections
Claims 59, 61, 62 63, 67, 68 and 74 are objected to because of the following informalities:
Applicant is advised that should claim 59 be found allowable, claim 63 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. 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).
Claim 59 is objected rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the claim recites the term “host cell”. It is unclear if the “host cell” is isolated or is part of a tissue/organ/animal. Clarity is improved by changing the term “host cell” to “isolated host cell”.
Claims 61, 62, 67, 68 and 78 recite the term “about” which is subjective and a relative term. It is unclear the extend of the ranges included in the term “about”. Clarity is improved by removing the term “about”.
Appropriate correction is required.
Rejections Maintained
Claim Rejections - 35 USC § 103 - Maintained
Claims 59-67 69-70, 74, 153 and 155-158 remain rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Zhang (previously cited) and Suffian (previously cited) in view of Lingappa (previously cited).
6. Claims 59, 67, and 68 remain rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Zhang, Suffian, and Lingappa in view of Conner (previously cited) and Malvern (previously cited).
7, Claims 59, 71, 72, and 154 stand rejected as obvious over Zhang and Suffian in view of Kuznetsov (previously cited) and Expert-Bezancon (previously cited).
Applicant’s arguments have been fully considered and are not persuasive. Therefore, the rejections are maintained.
Applicant’s Arguments:
Claim 59 has been amended and recites a method of making a capsid comprising a cargo, which includes reassembling the disassembled endogenous retroviral capsid polypeptide in a reassembly buffer containing less than 500 mOsm/kg salt thereby generating the capsid comprising the cargo.
Zhang does not disclose or suggest the steps of capsid disassembly/reassembly as conceded on page 7 of the Office Action, and relies on Suffian. However, Suffian does not remedy the deficiencies of Zhang.
Suffian teaches the use of 0.1 M CaCl2 in their buffers. However, the molarity of a salt does not directly correlate to the osmolality, as it depends, among other things, on the solute. Therefore, while 0.1 M CaCl2 is disclosed in Suffian, there are instances where a 0.1 M can be greater than 500 mOsm/kg salt. As Suffian does not disclose the osmolality of the reassembly buffer, one skilled in the art would not reach the present invention based on Suffian.
Lingappa, Connor, Malvern, Kuznetov, and Expert-Bezancon, alone or in combination does not remedy the deficiencies of Zhang and Suffian as they do not disclose or suggest a capsid reassembly buffer containing less than 500 mOsm/kg salt.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive.
The amended recitation of claim 59: “the reassembly buffer containing less than 500 mOsm/kg salt” is found obvious in view of the cited prior art as previously discussed in the Non-final Action dated 10/16/2025.
- (a) As mentioned by the applicant, Suffian teaches the use of 0.1 M CaCl2 in their buffers. However, finding the osmolality from the CaCl2 molarity is easy using the established chemical formula for conversion and optimizing such parameters. The theoretical osmolality of 0.1 M of calcium chloride solution (same solute as the solute in the instant invention) so molarity of a salt can directly correlate to the osmolality) is 300 mOsm/kg based on the formula to convert osmolality (osmoles per kilogram of solvent) to osmolarity (osmoles per liter of solution; 1 osmol = 1000mOsm; At dilute concentrations in water, 1 Liter of solution is very close to 1 Kilogram of solvent.:
Osmolality = Osmolality × ρ x 1,000
Where ρ is the density of the solution in kilograms per liter (kg/L). In the case of CaCl2, it completely dissociates into 3 ions (1 Ca²⁺ + 2 Cl⁻), so ρ is 3.
Osmolality = 0.1M x3x1,000 = 300 mOsm/kg, which is less than 500 mOsm/kg and in the range of about 270-330 mOsm/kg of salt (claim 74).
As mentioned in the previous Non Final action, it would further be obvious that the percentages of isolated polypeptides, percentages of polypeptides assembled into capsids, capsid disassembling into polypeptides, purity, salt concentrations, incubation temperatures or other measurements are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Routine optimization will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameters are critical.
In addition, 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). Applicant has not sufficiently described why there is no prima facie case for obviousness. See previous Non Final action for more details regarding the teachings of Zhang ,Suffian, Lingappa, Connor, Malvern, Kuznetov, and Expert-Bezancon, relevant to the rejection under 35 U.S.C. 103 and the motivation to combine these references.
Applicant argues as set forth above. Thus, for the reasons set forth above and the reasons of record, the rejection is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/IMMA BARRERA/
Examiner, Art Unit 1671
/Michael Allen/ Supervisory Patent Examiner, Art Unit 1671
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