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
The amendment filed 6/30/2023 is acknowledged.
Claims 1-47, and 56-104, are canceled.
Claims 48-55, and 105-117 will be examined on the merits herein.
The examiner attempted to call an agent, Kathlene Robinson, on 2/3/2026 to request authorization to execute an examiner’s amendment but there was no answer.
Claim Objections
Claim 114 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 113. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 52, 109 are objected to because of the following informalities: the claims do not end with a period. MPEP 608.01(m) states that each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 51-55, and 110 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 51 recites the limitation "culturing the host cell of claim 49" in element a). There is insufficient antecedent basis for this limitation in the claim because there is no host cell in claim 49. Claims 52-55 depend upon claim 51 and do not resolve the ambiguity.
Claim 110 recites the limitation "the anti-CD8 antibody of claim 1," in the preamble. There is insufficient antecedent basis for this limitation in the claim because claim 1 has been cancelled.
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.
Claim 106, 108-109 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claim 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.
Claim 106 recites “wherein the antibody is a chimeric antibody, a humanized antibody, or a human antibody.”, claim 108 recites “wherein the anti-CD8 antibody is a human IgG antibody”, and claim 109 recites “wherein the human IgG antibody is an IgG1 antibody”, however the instant application only discloses humanized antibodies derived from mice not antibodies made by a human immune system.
The instant application states “The murine variable regions of the OKT8 antibody were humanized by grafting the murine CDRs onto a human framework using a human kappa I/VH1 framework. The humanized OKT8 antibody served as the basis in vitro phage display-based affinity maturation experiments to generate variants with improved binding performance.” in paragraph [0230] of the specification.
The instant specification states “"Humanized" forms of non-human (e.g., rodent) antibodies are chimeric antibodies that contain minimal sequence derived from the non-human antibody.” in paragraph [0075]. Whereas a human antibody is as an antibody having variable regions in which both the FRs and CDRs are derived from human germline immunoglobulin sequences. The term human antibody is not intended to include antibodies in which CDR sequences derived from the germline of another mammalian species (e.g., mouse) have been grafted onto human framework sequences.
The specification discloses the structure of only humanized anti-CD8 antibodies, it does not make or disclose human antibodies. Therefore, the instant application has not provided a sufficient description showing possession of the human anti-CD8 antibodies as claimed.
The Court has interpreted 35 U.S.C. § 112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe, Inc., 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002). In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 48 USPQ2d 1398 (Fed Cir. 1997)).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear 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 Vas-Cath, p. 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath, p. 1116).
Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning —i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also ensures that when a patent claims a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3. Note the following Court Decisions regarding the written description of antibodies in the context of the current claims.
The specification does not describe any human antibodies, and therefore claims 106 and 108-109 fail to meet the written description requirement, as a person having ordinary skill in the art would not be able to envision a human antibody having human framework and human CDR regions when the instant claims recite a humanized antibody having mouse CDRs and human framework regions.
Proposed Amendments
The following claims 51-52, 106, 108-110, and 114-116 drafted by the examiner and considered to overcome the examiners objections and rejections, are presented to applicant for consideration:
Claim 51. (Currently amended) A method of making an anti-CD8 antibody, the method comprising: a) culturing the host cell of claim [[49]] 50 under conditions where the antibody is produced; and b) recovering the anti-CD8 antibody produced by the host cell.
Claim 52. (Currently amended) The method of claim 51, wherein the host cell is a eukaryotic cell.
Claim 106 The one or more nucleic acid(s) of claim 48, wherein the antibody is a chimeric antibody, or a humanized antibody
Claim 108 The one or more nucleic acid(s) of claim 48, wherein the anti-CD8 antibody
Claim 109 The one or more nucleic acid(s) of claim 108, wherein the .
Claim 110. (Currently amended) The one or more nucleic acid(s) of claim 48,
Claim 114 (Canceled)
Claim 115 (Currently amended) An expression vector comprising the one or more nucleic acid(s) of claim [[114]] 113.
Claim 116 (Currently amended) A host cell comprising the one or more nucleic acid(s) of claim [[114]] 113.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Claims 48-50, 105, 107, 111-113 and 115-117 are allowable as the prior art does not anticipate the nucleotide sequences of the CDRs described in claim 48.
US Pre Grant Publication No. US20140271462A1, ANTIGEN BINDING CONSTRUCTS TO CD8, 09/18/2014, hereinafter Ho et al. referenced in the IDS filed by the applicant on 06/30/2023 teaches antigen binding constructs to CD8. Ho et al. teach a specific embodiment: a cys-diabody monomer, of SEQ ID NO: 77, which anticipates the heavy CDR sequences of the instant applications SEQ ID NO: 9, 10, and 12 in claim 48 elements a(inherently), b, c, d, e, and g. Ho et al. does not teach the specific CDRs of the corresponding light chains of those elements.
The examiner has provided images of an alignment for element (c) of claim 48 to Ho et al SEQ ID NO: 77 below. Light chain CDRs, followed by heavy chain CDRs respectively.
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498
596
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613
638
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Conclusion
Claims 51-55, 106, 108-110, and 114, are not allowed.
Claims 48-50, 105, 107, 111-113 and 115-117 are allowed.
Inquiry Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUDOLPH E. SLOUP Jr. IV Ph.D. whose telephone number is (571)272-7899. The examiner can normally be reached Monday to Friday, 9am to 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E. Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUDOLPH E. SLOUP Jr. IV Ph.D./
Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645
/YVONNE L EYLER/Director, Technology Center 1600