DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Application Status
This action is written in response to applicant’s correspondence received 06/23/2023. Claims 1-17 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or
under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in EP20217026.2 on 12/23/2020.
Drawings
The drawings are objected to because 37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG.” In the current application, the view numbers for FIGs. 1-8 are preceded by the word "Figure." instead of the abbreviation "FIG.". Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 13 and 17 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter recited in 35 U.S.C. 101 (process, machine, manufacture, or composition of matter) because they merely recite a use without any active, positive steps delimiting how the use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). See MPEP §2173.05(q).
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 7-8, 10-11, 13, 17 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 7-8, 10, 17, these dependent claims merely recite intended use without changing the structure of the aptamer recited in the claims they depend from. The recitation of "for use" or “is used for” is an intended-use limitation that does not clearly define the structure of the subject matter of the claims. It is not clear whether the claims require any structures beyond those recited in claims they depend from or the recitation merely states a purpose without proposing additional claim scope. The intended-use does not provide definite boundaries that distinguish the aptamer, thereby the metes and bounds of the claim cannot be determined with reasonable certainty, which renders the claim indefinite.
Regarding claim 9, the mere recitation of “a diagnostic … composition” does not establish the metes and bounds of the claimed “composition”. It is unclear what that requires beyond the composition itself.
Regarding claim 11, it’s not clear whether the claim broadly encompasses the composition itself, or whether the claim is a method claim that requires using the composition in one of the recited assays.
Regarding claims 13 and 17, both are “Use” claims. It is unclear what are the metes and bounds of the broad terms “a medicament” or “a diagnostic reagent”. Also unclear is how the aptamer relates to the recited “manufacture of a medicament or a diagnostic reagent”. see MPEP §2173(q).
Claim 17 recites "the agent" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112 Written Description
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.
Claim 1, 7-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), the first paragraph, for failing to comply with the written description requirement. The claims contain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163.II.A.3.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USP USPQ2d at 1406.
Claim 1 directs to a broad genus, i.e. "An aptamer binding to SARS-CoV-2 spike glycoprotein, ... does not bind to ...RBD nor inhibit the interaction of ... (RBD) ...with... (ACE2)". The recitation of “and/or” and any limitation that follows thereof is not required based on the broadest reasonable interpretation (BRI). Despite the attempt to provide a core structure for the claimed aptamers by offering SEQ ID NO: 1 as a formula, the specification provides examples of aptamers that do not comprise SEQ ID NO: 1 but are shown to exhibit binding affinity for the SARS-CoV-2 spike protein (Figure 4; e.g. SEQ ID NO: 16 and SEQ ID NO: 17, see alignment map below (arrows point to SEQ ID NOs: 16 & 17, which do not comprise SEQ ID NO: 1 due to truncation on the 3’ end). Therefore, the aptamer sequence of SEQ ID NO: 1 is not a core structure for all aptamers that fall within the scope of the limitation: "An aptamer binding to SARS-CoV-2 spike glycoprotein, ... does not bind to ...RBD nor inhibit the interaction of ... (RBD) ...with... (ACE2)". Hence the focus of sequences that comprise SEQ ID NO: 1 in the specification is insufficient representation of the broad genus.
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Prior to the current application, only two research articles described the use of aptamers for the detection or therapeutic applications for SARS-CoV-2 infection, published by Song et al. (Discovery of Aptamers Targeting the Receptor-Binding Domain of the SARS-CoV-2 Spike Glycoprotein", Anal. Chem., 2020, 92, 14, 9895-9900; Hereinafter, Song) and Chen et al. (A DNA Aptamer Based Method for Detection of SARS-CoV-2 Nucleocapsid Protein",5Viroogica Sinica, 2020, 35, 351-354; Hereinafter, Chen). However, these aptamers either bind to the receptor binding domain (RBD) of the SARS-CoV-2 spike protein to interfere with its binding with the cognate receptor ACE2 (Song, 2020; Page 9895, Abstract), or bind to the nucleocapsid (N) protein (Chen, 2020; Page 354, line 3). It is still a nascent developing field of research for SARS-CoV-2 and is still not well understood with unpredictable outcomes. Even the current specification teaches that: “Surprisingly, aptamers could be selected that recognise the SARS-CoV-2 spike glycoprotein with high affinity and specificity, but were shown to neither bind to the receptor-binding domain of the SARS- CoV-2 spike glycoprotein nor to inhibit the interaction of the receptor-binding domain (RBD) of spike glycoprotein with angiotensin-converting enzyme II (ACE2)…”.
The disclosure of insufficient species of a broad genus, the high degree of unpredictability in the art, and the failure to disclose correlation between structure in the specification and the claimed function led to the determination that claim 1 is overly broad with insufficient evidence of possession at the time of filing to one skilled in the art, particularly when no representative example is shown as aptamers with binding affinity to the SARS-CoV-2 spike protein without comprising the claimed SEQ ID NO: 1 in full or in part in the specification (Figure 4; SP6.34 and SP7.32 are shown with binding affinity but comprise SEQ ID NO: 1 with at least 96% sequence match; see alignment map above). Therefore, claims 1 does not meet the written description requirement, and the lack of aptamer working examples not comprising the SEQ ID NO: 1 presented in the specification demonstrate a clear lack of possession of the full genera as claimed.
Claims 7-17 are also rejected for depending from the rejected claims 1 or 9 and failing to remedy the lack of written description therein.
Allowable Subject Matter
Claims 2-6 are objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims because the claimed sequences in claims 2-6 (SEQ ID NOs: 1-20) are free of prior art based on sequence search results received on 12/29/2025.
Relevant Art Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Song Y, et al. Discovery of Aptamers Targeting the Receptor-Binding Domain of the SARS-CoV-2 Spike Glycoprotein. Anal Chem. 2020 Jul 21;92(14):9895-9900.
Chen Z, et al. A DNA Aptamer Based Method for Detection of SARS-CoV-2 Nucleocapsid Protein. Virol Sin. 2020 Jun;35(3):351-354.
Tolley A. WO 2021/255479 A1 (APTAMER DIAGNOSTICS LTD [GB]) 23 December 2021 (2021-12-23).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Delphinus D. Yu whose telephone number (571) 272-1576. The examiner can normally be reached Mon-Thr 7:30am to 4:30pm Fri 10am to 2pm ET. 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, Neil P Hammell can be reached on (571) 270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DELPHINUS DOU YI YU/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636