DETAILED ACTION
Acknowledgment and entry of the Amendment submitted on 6/2/26 is made.
Claims 11-14, 16-22 and new claims 23, 26 and 27 read upon the elected species and are currently under examination.
Claim 15 has been amended to depend from non-elected new claim 24 and is hereby withdrawn. Claims 1-10, 15, 19 (recites administered polypeptides, not the elected administration of polynucleotides), 24 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Election by Original Presentation
Newly submitted claims 24 and 25 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 24 and 25 are drawn to a method that does not use the elected invention, e.g., the elected invention being: a method for inducing an antigen specific response in a subject comprising administering the subject a polynucleotide sequence encoding a Gmd polypeptide fragment comprising: the amino acid sequence of SEQ ID NO: 22 (e.g., the nucleic acid sequence of SEQ ID NO:23 and the RNA sequence of SEQ ID NO:24), or an immunogenic variant or fragment thereof. Claim 24 instead is drawn to a different method that solely uses the components listed in original claim 12, that was a dependent claim and these were ‘further comprising’ ingredients.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 24 and 25 (and claim 15 which now depends from claim 24) are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 112-2nd paragraph
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.
Claim 19 is 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 19 lacks antecedent basis for “the administered antigenic polypeptide.” Note: this is a non-elected species solely, e.g., a method of administering a polypeptide. Since claim 19 depends from claim 11, the phrase should be changed to “the administered nucleic acids.” Appropriate correction is required.
Status of Claims
Allowable Subject Matter
Claims 11-13, 16-18, 20-23, 26 and 27 are allowed.
Claim 19 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Applicants should amend claim 19 and cancel non-elected claims 1-10, 15, 24 and 25 to advance the application to allowance.
Reasons for allowance
Structurally, the Specification supplies the precise sequence blueprints necessary to synthesize the required genetic material, explicitly defining the full-length Gmd polypeptide (SEQ ID NO: 19), its optimized DNA template (SEQ ID NO: 20), and its functional mRNA transcript sequence (SEQ ID NO: 21), alongside well-defined functional subunits such as the Gmd R3 domain (SEQ ID NOS: 22-24) and the Gmd catalytic domain (SEQ ID NOS: 25-27). Practicing the invention across mammalian models is explicitly taught through detailed codon- optimization methodologies designed to alter GC content, minimize tandem base runs, lower destructive secondary structure propensity, and modulate native translational kinetics inside host cells. Furthermore, the formulation and delivery of these Gmd-encoding sequences are fully enabled through an explicit, step-by-step empirical protocol. The disclosure details the specific process of executing in vitro mRNA synthesis, verifying product integrity and size via agarose gel electrophoresis, and complexing the resulting polynucleotide with specialized transfection vehicles (e.g., in vivo-jetRNA or lipid nanoparticles) to ensure successful intracellular carriage and functional target protein translation. The Specification also provides robust clinical and animal data demonstrating that these enabled vehicles generate a protective, effective immune response. Efficacy of the Gmd target is clinically established by patient repository correlation data (N=194 patients) from the AOTrauma CPP Bone Infection Registry, where high levels of anti-Gmd IgG antibodies strongly correlated with patients who successfully controlled orthopedic S. aureus infections relative to those experiencing adverse outcomes, identifying anti-Gmd immunity as a vital clinical benchmark. Applicant submits that the Specification clearly demonstrates that administration of the claimed nucleic acid molecules encoding the recited antigenic polypeptides resulted in a robust immune response. For example, the Specification demonstrates that significant IgG antibody levels were detectable 28 days post-immunization following administration of all mRNA nanoparticle vaccines (see Example 2, page 148 of the specification and Figure 3). Specifically, the functional capacity of the enabled nucleic acid vaccine to achieve this protective state is demonstrated by the in vivo murine model graphically illustrated in Figure 3D. Intramuscular injection of a 15 µg dose of the Gmd mRNA nanoparticles on Day 0, followed by a booster on Day 14, successfully stimulated robust, statistically significant, antigen-specific IgG antibody titers by Day 28 and Day 42 compared to unimmunized controls (p < 0.01). This induction satisfies the functional benchmark defined in the specification, which dictates that an effective composition achieves an antigen-specific antibody titer in the blood or serum of greater than 0.2 µg/ml within 30 days post-administration.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached on (571) 270-0684.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 8/7/26
Prosecution Insights