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
Election/Restrictions
Applicant’s election with traverse of Group I, claims 1-11 and 20-21 and species: antibody, IgG, pro-inflammatory agent, ruxolitinib, and anti-PD1 antibody in the reply filed 05/08/2026 is acknowledged. The traversal is on the ground(s) that the present claims encompass “a special technical feature that has not been disclosed in the prior art, so unity is present and the claims satisfy the requirements of 37 § CFR 1.475(b) (3) as they clearly encompass a product, a process specially adapted for the manufacture of the said product and a use of the said product”.
This is found persuasive because the antibody of the instant invention is not found in the prior art and as such, the processes are considered to have unity of invention and thus will be examined. Upon further consideration, the restriction requirement mailed 04/14/2026 is hereby withdrawn and the Examiner is rejoining Groups II-III, claims 12-14, 16-17, 19, and 22.
Claims 1-14, 16-17 and 19-22 are now under consideration in the instant Office Action.
Claim Objections
Claims 1-14, 16-17, and 19-22 are objected to because of the following informalities: the instant claim does not explain the acronyms “VH” and “VL” at their first iteration. The acronym must be fully spelled out prior to its first iteration, after which point it may be used in place of the term it acronymizes. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: The terminology “SEQ ID NO” is missing a colon following “NO”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the claims recite repetitive limitations in the last two lines, written as “wherein the conjugate optionally has the sequence set forth in SEQ ID NO: 76 to interleukin-2, and wherein the conjugate optionally has the sequence forth in SEQ ID NO: 76”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: the grammar of the claim is incorrect as it is missing the article “to” before “the sushi-domain of IL15 Receptor alpha (SD)…” Appropriate correction is required.
Claims 16-17 are objected to because of the following informalities: the grammar of the claim is incorrect as it is missing the word “treating” before “cancer in a patient…” 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 7-11, 19, and 22 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.
Instant claims 7-11 recites the term “optionally”. The phrase “optionally” is interpreted as "for example" which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For the purposes of examination, the instant claims will be interpreted without the optional limitations as they are not required or claimed as necessary to the invention.
Instant claims 8 and 9 recite a “heavy chain is conjugated to interferon gamma, or a variant thereof” and “at its C-terminus to tumor necrosis factor alpha (TNFα) or a variant thereof”, respectively. In the absence of any structural or functional limitations, the definition of “a variant thereof” thus extends to short non-functional fragments of the aforementioned biological compounds as well, rendering the scope of the claims unclear.
Instant claim 19 recites both transitional phrases “comprises” and “consists of” in the claims
to encompass the sequences for an antibody conjugate. The scope of the claim is unclear because both of the terms denote different scopes and cannot be used interchangeably. Applicant is encouraged to select one of the terms and adjust the language claiming the amino acid sequence accordingly.
Instant claim 22 recites the limitation "conjugate according to claim 1" in reference to a method of producing an antibody molecule or conjugate; however, instant claim 1 does not recite a conjugate. There is insufficient antecedent basis for this limitation in the claim.
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 12-14, 16-17 and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating cancers marked by the overexpression of fibroblast activation protein (FAP), does not reasonably provide enablement for treating any cancer using the instantly claimed antibody. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term “undue experimentation,” it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include but are not limited to:
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The breadth of the claims;
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The nature of the invention;
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The state of the prior art;
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The level of one of ordinary skill;
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The level of predictability in the art;
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The amount of direction provided by the inventor;
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The existence of working examples; and
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The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The factors most relevant to this rejection are 1) the existence of working examples and 2) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In the instant case, the existence of working examples disclosed in the specification and the quantity of experimentation needed to make or use the invention, as filed, would not be sufficient to enable the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue experimentation.
The existence of working examples - As stated above, the specification reasonably provides enablement for an antibody or antibody conjugate(s) that bind to tumor or cancer cells that overexpress FAP that can be used in the treatment of cancer in Examples 7, 10, and 12; however, there is no showing in the specification of any means by which one skilled in the art could prepare an antibody that may be used against the broad and unbound range of cancers claimed, let alone treat all cancers encompassed within the claim. Cancers exist on a broad spectrum with different etiologies and different metabolic pathways. Each type of cancer has a different relationship with each specificity claimed, therefore the mechanism of impact on each disease state (e.g., overactivity or overexpression of a protein) differs. Additionally, the specification has not provided specific guidance as to how the claimed antibody will treat every type of cancer. Therefore, one skilled in the art would be subject to undue experimentation to make and practice the instant invention as it is currently claimed.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure – As discussed above, the instantly claimed diseases exist on a broad spectrum with different etiologies and different metabolic pathways. There is no evidence that merely binding to FAP will have any effect on all of the diseases in the broad category of cancers, particularly in the dynamic in vivo environment of a living subject. Applicant has provided no guidance as to how one antibody or antibody conjugate can possess the claimed characteristics of treating all cancers claimed given their diverse natures. Thus, it would be an undue burden on one of ordinary skill in the art to make the claimed invention.
In conclusion upon careful consideration of the Wands factors that are used to determine whether undue experimentation is required to practice an invention, the amount of direction provided by the inventor and the working examples provided, as filed, is not deemed sufficient to enable the skilled artisan to make and/or use the invention commensurate in scope with the instant claims at the time the application was filed without undue experimentation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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