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 .
This action is on claims 1-9 with heading “Preliminary amendment to the claims”.
Claim Objections
Claims 1-9 are objected to because of the following informalities:
Claims 1-9 lack status identifiers and edit marks. Claims must show status identifiers and edit marks.
Claims 2-3 contain misspelling “nuclei”.
Claim 3 contains extra word “as” in line two. It should be deleted.
Claim 6, part 3, “collect ing” is misspelled.
Appropriate correction is required.
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 2-9 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.
Claim 2 is not clear as to the meaning of “a” nucleic acid having the nucleotide sequences. Is it multiple subsequences or just a subsequence of SEQ ID# 2? “A” can mean less than all the sequence and this is also unclear because of the word sequences. It is suggested that the wording be changed to “the nucleic acid sequence having SEQ ID No: 2”.
Claim 5 is not clear as to the reference to “a 5’ terminal” and “a C terminal”. While this seems like proper antecedent introduction, it should be “the” in the claim as each refers to a specific fragment and each fragment has only one of each terminal. Also, 5’ here refers to a peptide and should be referred to “amino terminal” (5’ is for nucleic acid).
Claim 5 is also not clear as to the reference to amino acid positions in part 1. A general reference sequence (SEQ ID No: ) should be added to the claim to know what relative position the fragments are in the spike sequence.
Claim 6 refers to solutions “A” and “B”. If these are important, then the exact formulas need to be in the claim. If these are in general purification use, then just include what is added to or not included in the other to make them different (“A” and “B”).
Claim 6 also contains the trademark/trade names SEPHADEX and AKTA (referring to ÄKTA PCC tradename). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe purification system and chromatography material and, accordingly, the identification/description is indefinite.
Claim 9, while comprising a “step”, the step is “using” without an active step. The fusion protein is an antigen already. Is it mixed with carrier or adjuvant to form a vaccine composition? Is it formulated for a particular type of administration? It is suggested to add language (a step) that indicates what is done to the antigen to make it a vaccine and removing the word using.
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 8 is 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. The claim(s) contains 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Here, the claim requires all antibodies that bind SEQ ID No: 1.
The Court has indicated in Amgen Inc vs Sanofi ( 2017-1480, Fed Cir, 2017) that the disclosure of a well characterized antigen is insufficient for an adequate written description of the antibody that binds the antigen. The Court stated that “an adequate written description must contain enough information about the actual makeup of the claim products – a precise definition such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other material,” which may be present in “function “terminology “when the art has established a correlation between structure and function” (page 17, 1st paragraph). The Court went on to indicate that knowledge of the chemical structure of an antigen does not tell you anything about the structure of the antibody (Id).
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by 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 genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3).
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
Furthermore The Board in Ex Parte Kubin found that the written description of 35 USC 112 was not met, stating that
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The Board in Ex Parte Kubin further stated on page 16 that
Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
The court in In re Alonso (Fed. Cir. 2008) citing In re Enzo, Enzo, 323 F.3d at 969 stated that
[F]or purposes of satisfying the written description requirement, it is not enough merely to disclose a method of making and identifying compounds capable of being used to practice the claimed invention.
In this case, the specification does not appear to describe all antibodies that bind SEQ ID No: 1. and thus does not satisfy either the Lilly nor Enzo standards.
Thus, the specification does not appear to describe any species within the genus of all antibodies that bind SEQ ID No: 1.. There are insufficient structural features common to all members of the genus of antibodies. The Board in Kubin indicated that possession may not be shown by merely describing how to obtain possession of members of the claimed genus. The antibodies are claimed by function, the ability to bind SEQ ID No: 1. However, the specification does not disclose sufficient information on the structural function relationship to identify the claimed genus of antibodies. One of ordinary skill in the art would not be able to identify the broad claimed genus of antibodies that are capable of binding to SEQ ID No: 1.
Thus, the specification does not provide an adequate written description of the genus of antibodies that bind SEQ ID No: 1 that is required to practice the claimed invention. Applicants have not described the genus of antibodies sufficiently to show they had possession of the claimed genus. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Allowable Subject Matter
SEQ ID No: 1 and 2 are free of the prior art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. CN112920278 (only Google translation of claims provided) claims portions of COVID-19 spike joined together but does not teach or make obvious the fusion of SEQ ID No: 1.
Conclusion
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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