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 .
Preliminary Amendment
The preliminary amendment dated 06/21/2024 has been entered. Claims 1, 8-13, 21-22, 25-33 are pending and under examination.
Information Disclosure Statement
No information disclosure statement (IDS) has been submitted.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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. The earliest possible effective filing date for the instant claims is May 15, 2021 based on the filing date of the application SG10202105095U.
Drawings Objections
The drawings are objected to because of poor resolution in the following figures:
Figs. 1, 3, 4, 6B, 8, 10B, 10C, 13, 14, 15A, 15B are not legible.
Fig. 10: there are color references (red, blue etc.) but the figure is black and white therefore, no such colors can be discerned
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 Objections
Claims 1, 8-13, 21-22, 25-33 are objected to because of the following informalities:.
Claims 1 recites the limitation "An antigen-binding molecule….”. This limitation is unclear because the antigen-binding molecule has six CDRs and therefore it appears to be an antibody. The recitation’s clarity is improved by the following changes: replacing “An antigen-binding molecule” by “An antibody molecule” in the limitation. So, the recitation reads: “An antibody molecule which binds to a sarbecovirus spike protein…….”. Claims 8-13, 21-22, 25-33 are also objected as they do not remedy the situation.
Claim 11 is objected as the term “SARS-CoV-2 is duplicated.
Appropriate corrections are required
Claim Rejections - 35 USC § 112
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.
Claims 13 and 25-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an isolated or purified nucleic acid does not reasonably provide enablement for said non-isolated nucleic acid which reads upon a transgenic animal or a transgene therein. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). See also MPEP § 2164.01(a) and § 2164.04. Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of the invention/Breadth of the claims. Applicant broadly claims a nucleic acid. Under broadest reasonable interpretation, the claims read on a cell within a transgenic animal or a transgene therein, given that the term "isolated" is not denoted in describing the host cell, nucleic acid, or vector.
State of the prior art/Predictability of the art. With respect to the unisolated host cells and/or transgenes as “nucleic acids” or “vectors “of the instant claims discussed above that are not isolated, the state of the art at the time of filing was such that one of skill in the art could not predict the phenotype of transgenics. The art of transgenic animals has for many years stated that the unpredictability lies, in part, with the site or sites of transgene integration into the target genome and that "the position effect" as well as unidentified control elements are recognized to cause aberrant expression of a transgene and possible silencing of host genes, which result in undesirable phenotypes and/or additional health issues in the animal. The elements of the particular construct used to make transgenic animals are also held to be critical, and they must be designed case by case without general rules to obtain good expression of a transgene in the host. Viral vectors, such as Adeno-associated virus (AAV), adenovirus (AdV), and lentiviral/retroviral vectors, can transfer larger amounts of genetic information to a host, but some vectors cannot carry all the required genetic structures for proper expression (e.g. entire gene plus extensive regulatory elements) and certain viral vectors can cause uncontrolled, random integration, which increases the risk of tumorigenesis and inconsistent expression. (See e.g. National Academies of Sciences, Engineering, and Medicine; Division on Earth and Life Studies; Food and Nutrition Board; Board on Agriculture and Natural Resources; Committee on Heritable Genetic Modification in Food Animals. Heritable Genetic Modification in Food Animals. Washington (DC): National Academies Press (US); 2025 Apr 23. 3, Potential Hazards to Animals and Consumers.; Park F. Lentiviral vectors: are they the future of animal transgenesis? Physiol Genomics. 2007 Oct 22;31(2):159-73. Epub 2007 Aug 7.; Shakweer WME, Krivoruchko AY, Dessouki SM, Khattab AA. A review of transgenic animal techniques and their applications. J Genet Eng Biotechnol. 2023 May 9;21(1):55.). Therefore, the field of transgenics was and remains highly unpredictable.
Working examples/Guidance in the Specification. No working example of a transgenic animal is disclosed in the specification. The specification provides guidance towards the generation and use of an isolated/purified nucleic acid
Amount of experimentation necessary. At the time of filing, the phenotype of a transgene and transgenic cell contained within any animal was unpredictable. The claims as written, encompassing a transgene and cell in a transgenic animal, is not adequately described in the specification as to prevent excessive experimentation by the public to generate and use the invention. Applicants can obviate the instant rejection by amending the claim to clarify that the nucleic acid is not within a transgenic animal by utilizing the term "isolated" before the recitation of said nucleic acid (that is removing the term optionally). Applicant may consider using purified in such claims if description is appropriate for such a term and it is not redefined away from standard meaning. Method claims using these products should also carry the appropriate adjectives above.
In view of the lack of the predictability of the art to which the invention pertains as evidenced by the art above, the lack of guidance and direction provided by Applicant, and the absence of working examples, undue experimentation would be required to make and use the transgenes and transgenic animals commensurate in scope with the claimed invention with a reasonable expectation of success. Thus, the claims are rejected here.
For the reasons discussed above, it would require undue experimentation for one skilled in the art to make and/or use the claimed products.
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 11, 21, 22 and 29-33 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.
Claims 11, 22 and 29 recite the terms “….wherein the sarbecovirus is selected from the group comprising SARS-CoV-2,….” The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., > Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term comprising,’ the terms containing’ and mixture’ are open-ended.”).< Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003). MPEP 2111.02. Thus, the claims are indefinite since it is not clear what else is included in the open group. It is recommended to use of the term “consisting of” to clearly define the invention rather than comprising after “group”.
Claim 21 recites; “ A method of treating or preventing a disease caused by infection with a sarbecovirus, comprising administering to a subject a…” The recitation “a disease caused by an infection” is undefined as the disease could be directly or indirectly (for example if the subject is an immunocompromised patient) caused by the infection. Such an immunocompromised patient could suffer secondary infections or other diseases not directly caused by the sarbecovirus. Thus, there are multiple interpretations as to the limit of “disease caused by infection with a sarbecovirus”. The presence of multiple interpretations renders the claim indefinite as well as its dependents.
A clear recitation would be “A method of treating or preventing an infection with a sarbecovirus, comprising administering to a subject a…”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8-11, 26-29 and 31-33 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 8-11 are dependent of claim 1 and the limitations of claims 8-11 (binding to the RBD, inhibiting interactions between spike and ACE2, antigen-binding molecule binds to the receptor binding domain (RBD) of the Sarbecovirus spike protein, inhibits infection of ACE2-expressing cells by a sarbecovirus, sarbecovirus selected from the group) are all inherent properties of the Antibody of claim 1 as defined by their CDRs. Therefore, claims 8-11 do not further limit claim 1.
Claims 26-29 are dependent on claim 13. And the limitations of claims 26-29 ((binding to the RBD, inhibiting interactions between spike and ACE2, antigen-binding molecule binds to the receptor binding domain (RBD) of the Sarbecovirus spike protein, inhibits infection of ACE2-expressing cells by a sarbecovirus, sarbecovirus selected from the group) are all inherent properties of the nucleic acids of claim 13 Therefore, claims 26-29 do not further limit claim 13.
Claims 22, 31-33 are dependent on claim 21. And the limitations of claims 26-29 ((binding to the RBD, inhibiting interactions between spike and ACE2, antigen-binding molecule binds to the receptor binding domain (RBD) of the Sarbecovirus spike protein, inhibits infection of ACE2-expressing cells by a sarbecovirus, sarbecovirus selected from the group) are all inherent properties of the nucleic acids of claim 21 Therefore, 22, 31-33 do not further limit claim 21.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 8-13, 21-22, 25-33, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 27 of copending application No. US 19/141,758 (reference application). The reference is not afforded safe harbor protection under 35 USC 121 because it does not share continuity with much less is it subject to a restriction/speciation with the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US 19/141,758 are drawn to the same antibody as disclosed in this instant application. Please see alignment comparison below for instant SEQ ID NOs: 91 (VH) with reference application SEQ ID NO: 824 and 92 (VL) with reference application SEQ ID NO: 830:
Title: US-18-561-266-91
Perfect score: 641
Sequence: 1 QVQLQESGPGLVKPSETLSL..........YLETGPFEYWGQGTLVTVSS 120
US-19-141-758-824
Sequence 824, US/19141758
GENERAL INFORMATION
APPLICANT: National University of Singapore (en)
TITLE OF INVENTION: SARS-COV-2 SPIKE PROTEIN-BINDING MOLECULES (en)
FILE REFERENCE: M0546.70054US00
CURRENT APPLICATION NUMBER: US/19/141,758
CURRENT FILING DATE: 2025-06-20
NUMBER OF SEQ ID NOS: 855
SEQ ID NO 824
LENGTH: 120
TYPE: PRT
FEATURE:
NAME/KEY: source
LOCATION: 1..120
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 641; Length 120;
Best Local Similarity 100.0%;
Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLQESGPGLVKPSETLSLTCTVSGGFIGPHYWSWVRQPPGKGLEWIGYIYISGSTNYN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLQESGPGLVKPSETLSLTCTVSGGFIGPHYWSWVRQPPGKGLEWIGYIYISGSTNYN 60
Qy 61 PSLKSRLTISVDMSKSQFSLTLSSATAADTAVYYCARGGGYLETGPFEYWGQGTLVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PSLKSRLTISVDMSKSQFSLTLSSATAADTAVYYCARGGGYLETGPFEYWGQGTLVTVSS 120
Title: US-18-561-266-92
Perfect score: 579
Sequence: 1 DIVMTQSPLSLPVTPGEPAS..........CMQSLQIPGTFGQGTRLEIK 112
US-19-141-758-830
Sequence 830, US/19141758
GENERAL INFORMATION
APPLICANT: National University of Singapore (en)
TITLE OF INVENTION: SARS-COV-2 SPIKE PROTEIN-BINDING MOLECULES (en)
FILE REFERENCE: M0546.70054US00
CURRENT APPLICATION NUMBER: US/19/141,758
CURRENT FILING DATE: 2025-06-20
NUMBER OF SEQ ID NOS: 855
SEQ ID NO 830
LENGTH: 112
TYPE: PRT
FEATURE:
NAME/KEY: source
LOCATION: 1..112
QUALIFIERS: mol_type = protein
organism = synthetic construct
Query Match 100.0%; Score 579; Length 112;
Best Local Similarity 100.0%;
Matches 112; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIVMTQSPLSLPVTPGEPASISCRSSQSLLQNNGYNYLAWYLQKPGQSPQLLIYLSSTRA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIVMTQSPLSLPVTPGEPASISCRSSQSLLQNNGYNYLAWYLQKPGQSPQLLIYLSSTRA 60
Qy 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCMQSLQIPGTFGQGTRLEIK 112
||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCMQSLQIPGTFGQGTRLEIK 112
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IMMA BARRERA whose telephone number is (571) 272-0674. The examiner can normally be reached Monday - Friday 9 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached on (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IMMA BARRERA/
Examiner, Art Unit 1671
/Michael Allen/ Supervisory Patent Examiner, Art Unit 1671
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