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 12/27/22. Claims 1-16 are pending and under examination.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See for example specification p.36.
Claim Interpretation
The instant use of “preventing” is defined broadly to include reducing severity of a disorder and includes reducing the disease in any aspect such as the biochemistry, histology, or behavioral symptoms (p.39). The term “preventing” has been defined such that the term is not limited to actual prevention, i.e., does not require stopping the disease entirely from ever starting.
Claim Objections
Claim 4 is objected to because of the following informalities: Claim 4 depends from claim 1. Claim 4 recites a list that begins at “d” rather than “a”. The elements in claim 1 use romanettes (i-iii) and so there is no choice represented by “a”, “b”, or “c”. Lists should begin with the first choice (I, i, a, etc.) and proceed in sequential order. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: Claim 6 depends from claim 1. Claim 4 recites a list that begins at “q” rather than “a”. The elements in claim 1 use romanettes (i-iii) and so there is no choice represented by “a”, “b”, or “c”. Lists should begin with the first choice (I, i, a, etc.) and proceed in sequential order. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: only one period is allowed in a claim except for when used with abbreviations (MPEP §608.01(m)). The use of, e.g., “A.” in claim 9 does not appear to be abbreviations for anything and so should not be accompanied by a period. Further, if “A.” is/are in fact abbreviations, it is not a common abbreviation and must be accompanied by the full name of what is being abbreviated at its first recitation. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: “an enzymes” does not conform to proper number agreement; the phrase should be “an enzyme”. 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 1-16 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 claims use phrases including “preferably” and “more preferably”, which are indefinite. Taking claim 1 as an example, the claim sets forth options “i" through “iii”. The claim then notes that “preferably”, “i" through “iii” have different/narrower limitations. In one interpretation, the claims use “preferably” in the same sense as “optionally”, in which case everything after “preferably” is not a claim limitation. However, see MPEP § 2173.05(d) which states that “[d]escription of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim."
In another interpretation, Applicant is using “preferably” to indicate further limitations or a narrowing of the scope, in which case the everything after “preferably” is a claim limitation. However, in that case a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the first set of i-iii are the broad recitation and the second set of i-iii are the narrower statement of the limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In this case, the use of “preferably” does not make clear if the narrower limitations are examples or further limitations. Further, if they are examples then they do not belong in the claim but rather the specification while if they are further limitations, they should be positively recited as required and not optional.
This same reasoning applies to the other uses of “preferably” and dependent claims do not clarify the issue.
Claim 12 is further indefinite for the term “therapeutically effective amount”. See MPEP §2173.05(c)(III), which states that one skilled in the art must be able to determine what this amount is based on the disclosure and may be indefinite when the claim fails to state the function to be achieved and more than one effect may be implied. In this case, the specification lists numerous possible diseases to be treated (p.16-17). The claim fails to recite any purpose of the therapeutic and any of the disclosed diseases could be implied. There is no evidence that a single amount is “effective” to treat all of the disclosed diseases and so the effective amount will vary. Without the claim reciting what the therapeutic effect is, there is no fair way to determine the therapeutically effective amount.
Claim 14 is a method of immunodetection comprising the step of “making the anti-CD70 antibody according to claim 1 in contact with a subject”. The claim is indefinite because the claim does not define who or what must be in contact with the subject/sample while the antibody is being made. Alternately, the antibody must be produced/made while the antibody is in contact with the subject or sample, but this interpretation leads to confusion over whether or not the antibody must already exist as the step of “making the antibody” suggests the antibody does not initially exist, yet the making requires the antibody exist so that it is in contact with the subject while the antibody is being made. Moreover, the step of “making the antibody” does not itself result in any detection or determination, leading to confusion over the scope of the claim and the relevance of the preamble. Finally, the words “making” and “in” may have some intended but unclaimed relationship, such as “making the antibody contact” (omitting “in”) or “placing the antibody in contact” (altering “making”).
Therefore, claims 1-16 are indefinite. For the purpose of prosecution, claim language after “preferably” will be considered as merely an example and not claim limitations as this is the broadest interpretation.
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 7 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.
Claim 7 is directed to any antibody that competes for binding with the antibody of claim 1. As such, the claim is directed to an antibody defined entirely by function (binding). See MPEP §2163(I)(A) which states:
"The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.”
In this case, 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 (CD70) and envisage the combination of six CDRs that will bind that antigen, nor is there a way to infer such a binding sequence when provided with a different antibody (the antibody of claim 1).
First, even highly related CDRs may not bind the same target. See for example Kussie (cited on form 892) who demonstrates that a single amino acid change in the heavy chain of an antibody which binds p-axophenylarsonate (Ars) completely abrogates the ability of the antibody to bind Ars but adds the functionality of binding the structurally related p-azophenylsulfonate (e.g., abstract). Second, even when provided with several related antibodies that bind the desired target, this does not represent the astronomical and potentially unknowable breadth of all possible amino acid sequences which will result in the desired binding properties. This is exemplified by the Court decision in Abbvie (Abbvie v Janssen 759 F.3d 1285 (Fed. Cir. 2014)), where Abbvie developed over 200 antibodies that shared 99.5% identity in the variable regions (p.7) and which bound the target, but in no way allowed one to envisage the unique structure of Centocor’s antibodies which bound the same target but shared only 50% sequence similarity (see table on page 11).
Thus, the art recognizes that the CDRs define the binding properties of an antibody and that even single amino acid changes to this region can completely abrogate the binding specificity of an antibody. As a further example, see Chen (cited on form 892) which demonstrates single amino acid changes in the VH CDR2 sequence can increase binding, decrease binding, destroy binding, or have no effect on binding when compared to the wild-type antibody.
Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions. Moreover, antibodies need not even bind the same epitope in order to compete as an overlapping epitope or even steric hinderance when binding an unrelated epitope can lead to competition. Applicant’s claim to all possible antibodies that might compete with the antibody of claim 1 for any number of reasons in insufficiently described.
Therefore, claim 7 does not meet the written description requirements.
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.
Claim 15 is 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.
Claim 15 depends from claim 1. The only difference is that claim 15 recites a preamble of a “kit”. However, a kit has no particular structure and does not require any particular additional elements. It is reasonable to consider the antibody alone as within the definition of a “kit” and therefore claim 15 does not provide any additional limitations.
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.
Allowable Subject Matter
No prior art rejections have been written in this action. As set forth in the written description rejection, altering even a single amino acid in a CDR of an antibody is highly unpredictable. All of the instant claims depend from claim 1 and so require an antibody with specific CDRs. These CDRs were not discovered in the prior art nor was there explicit motivation to alter an existing antibody to arrive at the instant sequences. As such, the antibodies of claim 1 are non-obvious.
The antibody of claim 7 does not require any particular sequence, only that it competes with the antibody of claim 1. However, the instant specification does not appear to disclose the epitope of the antibodies. The Office is not equipped to make and test products and so the Office cannot determine where or how the instantly claimed antibody binds. While anti-CD70 antibodies are known in the art, there is no “inherent” epitope on CD70 nor any means to determine if a prior art antibody would somehow compete with the instant antibody. Simply binding somewhere on CD70 would not necessarily act to compete with the instant antibody and so an argument regarding an inherent property can not be made. As such, no prior art rejection of claim 7 was made either, though these facts further emphasize the lack of written description for the claimed genus.
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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/Adam Weidner/ Primary Examiner, Art Unit 1675