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 .
Response to Amendment
The Amendment filed July 1, 2026, in response to the non-final rejection of March 4, 2026 is acknowledged and has been entered.
Claims 131-150 were either amended or previously presented and are currently under consideration.
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/Specification Objections
All prior objections are withdrawn in view of applicants’ amendments thereto. Appropriate corrections are requested.
Rejection Withdrawn
The rejection of Claim 140 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of applicant’s amendment.
Rejection Maintained
Claims 131-150 remain 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 for the reasons of record.
Applicants respond by arguing (Remarks, 07-01-2026, page 15) that the written description requirement is satisfied when the specification reasonably conveys to one of ordinary skill in the art that the inventor had possession of the claimed invention at the time of filing. Applicants reference the Federal Circuit decision in Ariad Pharm., Inc. V. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.Cir. 2010) and argue that Ariad makes clear that possession of a claimed genus may be demonstrated in more than one way. Specifically, applicants argue that the Federal Circuit explained that adequate written description may be shown through disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus such that a person of ordinary skill in the art can visualize or recognize the members of the claimed genus. Here, applicants argue that that the “Office’s analysis focuses almost exclusively on the number of disclosed species and largely overlooks the second pathway recognized in Ariad, namely structural features common to the members of the genus”. Applicants argue that the “conjugation of an oligonucleotide to an antibody or antigen binding fragment” is a “common structural modification” and that this modification imparts the claimed functional characteristics. For example, such conjugation “alters the biodistribution and clearance characteristics of antibodies in vivo” as shown in Figure 1. Similarly, applicants reference Figures 2-4 to present further observations on the claimed functional activities (e.g., binds an antigen to a greater extent or faster or is cleared from blood faster as set forth in the independent claim). Applicants argue that these “results” demonstrate a common structural and functional relationship across multiple antibody contexts.
This argument has been considered but is not found persuasive because applicants are arguing that the act of conjugating an oligonucleotide to an antibody is equivalent to describing structural features common to the members of the genus. However, as set forth previously, it is the structure(s) which are not sufficiently described. For example, as previously stated in paragraph 9 of the action mailed 03-04-2026: the oligonucleotides disclosed [0146] can comprise nucleotides or non-natural, or modified nucleotides, such as nucleotide analogs or nucleotide substitutes. Such nucleotides include a nucleotide that contains a modified base, sugar, or phosphate group, or that incorporates a non-natural moiety in its structure. Examples of non-natural nucleotides include, but are not limited to, dideoxynucleotides, biotinylated, aminated, deaminated, alkylated, benzylated, and fluorophore-labeled nucleotides. The oligonucleotides can comprise DNA, RNA, or both DNA and RNA. Further, the description of Figures 1-4 on page 3 of the specification (and the figures themselves) does not identify the oligo structures that were used and that imparted the functional activity. Without these structures, a person of ordinary skill in art would not know which starting materials to employ and would not understand or grasp the structural features common to the genus that give rise to the claimed functional characteristics.
Applicants further argue that the Office’s concern with describing a representative number of “diseases” that can be treated using the claimed compositions “misapprehends the nature of the claimed subject matter” and that their discovery is not the identification of new disease-specific therapies but an enhanced targeting composition that more quickly and effectively clears the antibody-oligonucleotide from the blood and improves biodistribution. This argument has been considered but is not found persuasive because the written description regarding the genus of diseases to be treated was not made in a vacuum or in total isolation from the genus of targeting compositions. Claim 1 requires a “method of treating a disease” with the genus of antibodies conjugated to oligonucleotides. Without sufficient description of the structural features common to the members of the genus of targeting compositions and that perform the claimed functional activities, the disease(s) to be treated were undefined. The previous action merely pointed out (para 8) that there were no limitations on the claimed diseases to be treated and thus it also constituted a large genus.
Applicants also argue that the Office repeatedly notes that the precise mechanism responsible for the observed enhancement in targeting and clearance was not fully understood and that as explained in Ariad, written description concerns whether the specification demonstrates possession of the claimed invention, not whether the inventors had fully elucidated the biological mechanism responsible for the observed results. This argument has been considered but is not found persuasive. The previous action did not repeatedly discuss the precise mechanism for the observed functional activities, rather paragraph 13 of the action mailed 03-04-2026 discussed the state of the prior art of antibody-oligonucleotide conjugates and the importance of the degree of conjugation (DoC values) in concert with the fact that the specification stated that the mechanism for their unexpected findings was unknown. This added to the high degree of uncertainty that a person of ordinary skill in art would encounter when trying to comprehend whether or not the specification conveys, with reasonable clarity, that, as of the filing date, was the inventor in possession of the invention as claimed.
Thus, Applicant’s arguments have not been found persuasive, and the rejection is maintained for reasons of record and for the reasons set forth herein.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643
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