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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
This action is in response to claim amendments filed 6/19/23. Claims 1-17, 23-39, 59 and 67 are pending and under examination.
Drawings
The drawings are objected to because:
Figure 2: The eight sub-figures are largely illegible.
2A uses the same shade of grey for all four groups. The numbers on the x and y axes are illegible.
2B appears to duplicate shapes for some groups, e.g., 176 and 190 both appear to be downward grey triangles and 204/22 both appear to be open squares.
2C has illegible numbers on the x and y axes.
2D the group names in the legend are illegible. The same shapes appear to identify multiple groups. The size of the figure means only one group can be reliably distinguished on the graph, though it is unclear which group this is because it is some form of grey (which is used for multiple groups) and the shape cannot be determined (it variously appears to be closed circles, upwards triangles, or a diamond).
2F the subscript of “OD” is illegible.
2G shapes are duplicated, e.g., M30, M31, and M32 all appear to use a diamond. In the bottom half, it is unclear what the shapes for the groups are in the legend as well as on the graph and so it is unclear which line goes with which group.
2H there appear to be labels on the larger image but these are illegible as they are in a very light grey, making them illegible. The inset provides a structure but is reproduced at a poor quality such that so details can be distinguished.
Fig 2I: none of the labels on any of the axes are legible. The larger labels to the far left are cut off.
Fig3
3A provides text which is blurry and illegible. Some of the letters are in a very light grey, further complicating legibility. The amino acid sequence does not appear to be identified by a SEQ ID in either the image itself or the brief description of that image.
3C there appears to be text on the far right, but it is provided in a very light grey to the point that it is illegible. Further, these labels appear to identify something in the images but the shades of grey are indistinguishable. The labels of each are blurry and difficult to read
Fig 5: the legends are either blurry and difficult to read or in some cases illegible.
Fig 7: 7B uses a scale on the right. This scale uses the same color of grey at both the top and the bottom. The numbers on that scale are illegible.
Fig 12: 12C and 12E have x-axis labels that are illegible.
Fig 13: The text in the top, which appears to identify amino acid ranges, is illegible. The shading on 13A makes the text in those sections illegible.
Fig 14: 14D uses the same color for both groups meaning the graphs themselves cannot be interpreted.
Finally, throughout the brief description of the drawings, the specification makes reference to colors, e.g., “shown in blue” and “shown in green”; however, no color drawings have been provided. As such, the drawings fail to show the details described by the specification.
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.
If Applicant chooses to provide color drawings, Applicant is reminded that color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claim 32 is 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 claim is directed to a hybridoma, i.e., a composition. The claim recites that this hybridoma is one “encoding” the antibody. This describes a property of the cell itself because this refers to having the proper genetic sequence which encodes the antibody rather than an active “encoding” process. However, the claim also recites “producing” the antibody. In one case, this could be interpreted as “capable of producing”, yet as written “producing” is an active step. Adding process steps to a product claim is indefinite as it creates confusion as to when direct infringement occurs; MPEP §2173.05(p)(II). In this case, it is unclear if the claim is infringed only when the cell is actively producing the antibody or if the cell capable of such defined infringement.
Therefore, claim 32 is indefinite.
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 2 and 4 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.
Claim 2 limits the antibody to being a murine, rodent, rabbit, chimeric, humanized, or human antibody. Claim 4 requires the antibody is human.
The specification describes the antibodies of the invention as being generated from rabbits (p.115; paragraph 259).
Antibodies generally share certain characteristics such as Fc regions or hinge regions. However, these structures are not correlated with the binding function of the antibody. The hyper variable regions (HVRs), i.e., complementarity determining regions (CDRs) of an antibody, are well established in the art as the portion of the binding region which imparts the specificity of an antibody. However, there is no way to a priori look at an antigen sequence (LILRB1) and envisage the combination of six CDRs that will bind that antigen. Further, a description of a rabbit antibody does not provide a description of, e.g., a human or murine antibody. The fact that the instant antibody was obtained from a rabbit in no way provides a description of a human which would make that same antibody. In other words, instant SEQ ID NOs: 113-115 and 434-436 are rabbit sequences, whereas a human antibody must contain only human sequences and a murine sequence must contain only mouse sequences.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF' s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. In a similar way, the specification has only provided the rabbit CDRs, which are not a description of the CDRs in other species.
Based on these facts, the required structure of a human, murine, or rodent antibody has not been adequately described. Further, there are no examples of a LILRB1 antibody obtained from a human, mouse, or rodent which comprises the sequences of claim 1.
Therefore, claims 2 and 4 do not meet the written description requirement. The antibody was raised in rabbit and so a rabbit antibody is adequately described. Further, a chimeric and humanized antibody include using the rabbit CDRs and making modifications from other species outside of those regions. Thus, chimeric and humanized antibodies are also considered to meet the written description requirement.
Allowable Subject Matter
Claims 1, 3, 5-17, 23-31, 33-39, 59 and 67 are allowed.
While anti-LILRB1 antibodies existed at the time of filing (e.g., US20180251558 claims 6 and 23; form 892), the specific CDRs instantly claimed were not discovered. CDRs are well-known to be unpredictable when making modifications; see, e.g., Kussie (form 892) where a single amino acid change fully removed binding to the original target and added binding to a different target. Thus, one cannot make arbitrary changes to the CDRs with a reasonable expectation of success. Because of this, absent discovery of the actual claimed sequences or a clear motivation to arrive at the specific instantly claimed sequences, the claims are non-obvious.
Regarding claim 34, the body of the claim is solely “comprising [claim 1]”. However, the preamble requires the composition is a CAR, which implies structures in addition to the antibody/binding fragment portion. As such, this claim is considered to further limit claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Weidner/ Primary Examiner, Art Unit 1675