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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Jan. 17, 2024. Claims 1-17 are pending and are currently examined.
Claim Objection
The base claims 1-2 are objected to because of the following informalities:
Claims 1-2 list the specific CDR sequences without identifying them by an assigned SEQ ID NO:.
Sequence Compliance:
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) as follows:
The specification does not contain sequence identifiers (SEQ ID NO:) in all locations where sequences are disclosed, see at least the instant claims 1 and 2. To correct this, the CDR sequences in claims 1-2 need to be assigned with a SEQ ID NO:. If the prior filed Sequence Listing does not contain updated sequences, Applicant is also required to submit a replacement Sequence Listing that includes all updated sequences.
Appropriate correction is required.
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.
Claim 11 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 11 is drawn to a host cell comprising or expressing the antibody or antigen-binding fragment. It reads on human organism because such a host cell can be a cell in the body of a human subject, who got infected with the claimed virus.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 13 is directed to “use” of the antibody or antigen-binding fragment for a treatment and/or prevention of a respiratory syncytial virus-related disease or disorder.
"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961) ("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid."
Accordingly, claims 11 and 13 are rejected under 35 U.S.C. 101.
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 1-17 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.
The base claim 1 and claim 2 recite a phrase as “an amino acid sequence of HCDR/LCDR being…”, where the “being” renders the claims indefinite. It is not clear if the “being” means “consist of” or “comprise”.
Claims 3-5 recite a phrase “…sequence set forth in…” that renders the claims indefinite. It is not clear if the sequence “consist of” or “comprise” the claimed SEQ ID NO: sequences.
Claim 11 is directed to the use of the antibody or antigen-binding fragment according to claim 1 in the preparation of a medicament for a treatment and/or prevention of a respiratory syncytial virus-related disease or disorder. The claim is not clear because they do not define how the “use” can be practiced.
Claim 15 recites “preferably” that renders the claim indefinite because it is unclear whether the limitations following the phrase are parts of the claimed invention.
Claim Rejections - 35 USC § 112(a)
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 1 and 3-17 are 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.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings. See MPEP 2163. I.
In Regents of the University of California v. Eli Lilly and Co. 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997), the Court decided that adequate written description of genetic material "requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention." Id. 43 USPQ2d at 1404 (quoting Fiefs, 984 F.2d at 1171, 25 USPQ2d at 1606). In AbbVie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (Court of Appeals, Federal Circuit 2014), the Court ruled that “[W]ith the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that “merely recite a description of the problem to be solved while claiming all solutions to it and . . .cover any compound later actually invented and determined to fall within the claim' s functional boundaries.”).”
Claims 1, 3 and 5-17 are directed to an antibody or antigen-binding fragment that binds to an F protein of a respiratory syncytial virus comprising a heavy chain variable region, wherein HCDR1, HCDR2 and HCDR3 of the heavy chain variable region are selected from the listed sequences as claimed.
The art relating to antibodies recognizes that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity that is characteristic of the parent immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites. As evidence, Janeway (Immunobiology, 5th edition. New York: Garland Science; 2001) describes the structure of a typical antibody molecule and teaches that comprising two identical lights chains and two identical heavy chains, and can be thought of as forming a flexible Y-shaped structure. Each of the four chains has a variable (V) region at its amino terminus, which contributes to the antigen-binding site, and a constant (C) region, which determines the isotype (See page 5). The teachings indicate that the presence of both the heavy and light variable regions, with the indicated CDRs of those regions in the proper conformation, is required for the antigen binding proteins to bind the target antigens. However, the base claim 1 does not have the limitation for a LCDR or light chain variable region or light chain. The instant specification also does not provide information and supported evidence to demonstrate that the claimed antibody or antigen-binding fragment will keep the antigen binding function to RSV F protein without a light chain variable region.
Claims 3 is directed to an antibody or antigen-binding fragment wherein the heavy chain variable region comprises an amino acid sequence having at least 90% sequence identity to the sequence set forth in SEQ ID NO: 4, 6 or 8.
Claim 4 is directed to an antibody or antigen-binding fragment wherein the heavy chain variable region comprises an amino acid sequence having at least 90% sequence identity to SEQ ID NOs: 4, 6 and 8 and a light chain variable region comprises an amino acid sequence having at least 90% sequence identity to SEQ ID NOs: 5, 7 and 9, respectively. However, the specification does not indicate which portions of the claimed SEQ ID NOs are essential to retain the ability to be a functional antibody to bind to an F protein of RSV or which portions of the claimed SEQ ID NOs can be modified or altered up to 10% and still retain the ability of binding to the F protein of RSV. It is a common knowledge in the art that even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function. This can be evidenced by Rudikoff et al. (Proc Natl Acad Sci U S A. 1982 Mar;79(6):1979-83.). Rudikoff teaches that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function. The teachings in the art therefore indicate a single amino acid changes in the CDR can result in the loss or changes of the antibody-antigen binding.
The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.).
As discussed above, the skilled artisan cannot envision the detailed antibody sequence and structure "at least 90% identical” to the claimed SEQ ID NOs. therefore, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
Claim Rejections - 35 USC § 112 (Enablement)
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 13-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to 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.
Claims 13-15 contain subject matter which was not described in the specification in such a way as to 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. Enablement is considered in view of the Wands factors (MPEP 2164.01(a)) (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Claim 13 is directed to the use of the antibody or antigen-binding fragment according to claim 1 in the preparation of a medicament for a treatment and/or prevention of a respiratory syncytial virus-related disease or disorder.
Claims 14-15 are directed to a method for treating and/or preventing respiratory syncytial virus-related diseases or disorders in a subject, comprising administering to a subject a therapeutically effective amount of the antibody or antigen-binding fragment according to claim 1.
The instant specification discloses that “when referring to the treatment or prevention of RSV infection, "therapeutically effective amount" refers to the amount of active compound (such as an antibody) that is sufficient to cause biological or medical response expected by the clinician in a subject, and may also refer to the amount of medicament or drug that is sufficient to achieve or at least partially achieve the expected effect” (See [0076]). However, the instant specification does not provide method and experimental supports for a method to treat or prevent RSV-related disease or disorder in a subject. There are five examples disclosed in the instant specification. However, there is no evidence to support a method for treating/preventing RSV- related disease or disorder in a subject. For example, Example 1 is for Pre-Fusion F protein (RSV) purification (See [[79] to [0081]), Examples 2-4 are for human derived monoclonal antibody isolation and purification, and Examples 5-6 are for the detection of binding performance of the antibody using CM5 chip and the neutralizing activity detection using a flow cytometry staining method (See e.g., [0102]). There is no in vivo evidence to support that a method can be used for treating and/or preventing respiratory syncytial virus-related diseases or disorders in a subject, comprising administering to a subject as claimed.
Accordingly, when all the aforementioned factors are considered in total, it would require undue experimentation for one skilled in the art to practice the full scope of claimed invention as defined by instant claims 13-15.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am to 4:30 pm, EST.
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/RUIXUE WANG/ Examiner, Art Unit 1672
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