DETAILED ACTION
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(a)-(d) and (f) or under 35 U.S.C. 120, 121, 365(a) or (b), or 386(a) is acknowledged. The present application is drawn from PCT/EP2022/055456, filed 3/3/2022; and claims benefit under 35 U.S.C. (119(a)-(d) to foreign application EP21305253.3, filed 3/3/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Claims
Claims 28-47 are pending and are being examined on the merits.
Claim Objections
Claims 28, 32-34 and 47 are objected to because of the following informalities: The claims recite “of sequence(s) SEQ ID No(s).”. This is grammatically awkward, reciting “sequence” and “SEQ ID No.”. The claims should recite either “of the amino acid sequences of SEQ ID NOs:” or simply “of SEQ ID NOs:”. Further, the sequence identification number should be abbreviated in capital letters, (i.e., “NO”, and not “No”), and also have a colon at the end; for example, “SEQ ID NO:” or “SEQ ID NOs:”. Appropriate correction is required.
Claims 30, 33-34, 44 and 47 objected to because of the following informalities: the claims recite “selected in the group consisting of”. The word “in” is the incorrect preposition for selecting from the group consisting of; the proper preposition is selecting “from” the group. Appropriate correction is required.
Claim 36 recites the method of treatment of claim 35 and “wherein the treatment comprises inducing an immune response in the patient”. The method of claim 35 comprises the active steps of the method, including administering the antibody. Claim 36 further limits the method of claim 35 by way of the result of the method. Thus, claim 36 does not “comprise” additional method steps, it limits the method by way of the result, i.e. the properties of the method. Thus, the claim should be amended to recite “wherein the treatment induces an immune response in the patient”; and should omit “comprises”, as the claim does not further comprise additional steps to administering the method.
Claim 37 is objected to because of the following informalities: Claim 37, line 3, recites “cytokines release by macrophages”; which is improper grammar. The claim should recite either “cytokines released by macrophages” in reference to multiple cytokines, or “cytokine release by macrophages” in reference to the general concept of “cytokine release” as a property of macrophages, and which encompasses any number of cytokines. 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.
Claims 30, 32, 37-38 and 41 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 30 contains the trademark/trade name NANOBODY. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe single domain antibodies (sdAb), or VHH antibodies and, accordingly, the identification/description is indefinite.
Claim 32(b), line 1, recites and antibody comprising, or consisting of, a heavy chain variable domain of sequence SEQ ID No. 47 and the three light-chain CDRs of sequences SEQ ID Nos. 12, 13 and 14. Applicants are directed to section 2111.03 of the MPEP regarding transitional phrases. The term “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements; whereas “consisting of” excludes any element not specified in the claim. These terms are distinct alternatives, and encompass different limitations which may be in conflict with each other. That is, an embodiment “consisting of” is more limited than an embodiment “comprising”; and thus a skilled artisan would not know what the required limitations of the claim are. An antibody “comprising” the requisite amino acid sequences may also embody other sequences encoding other components of the antibody, but would then be in conflict with a claim limited to an antibody “consisting of” the amino acid sequences, whereby any additional amino acid sequences are not encompassed in the invention. Thus, an antibody cannot be claimed as both comprising or consisting of a particular amino acid sequence, as these are distinctly different claim limitations regarding the amino acid sequence of the invention. As the metes and bounds of the claim are unclear, claim 32 is rejected as indefinite. Further, the claim is drawn to an antibody with a VH of SEQ ID NO: 47 and the VL CDRs 1-3 of SEQ ID NOs: 12-14. If the claim is drawn to an antibody “consisting of” the VL CDRs 1-3 of SEQ ID NOs: 12-14, it would prevent the inclusion of framework region amino acid sequences in the VL. An antibody consisting of 3 “floating” CDRs, with no framework sequences and no linkers, would not have a functional VL region. Such a claim may invoke 35 U.S.C. 112 issues for descriptive support and/or enablement of use, as an antibody VL domain requires that the CDRs are embedded in the corresponding framework regions; and the “consisting of” language of the claim prohibits the addition of the necessary framework region amino acid sequences necessary to complete the antigen-binding domain of the antibody.
Regarding claim 37, the phrase "notably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 37 recites “wherein the immune response includes polarization of macrophages, notably TAM, to an M1 phenotype”. It is unclear if the claim is limited to TAM macrophages, and thus requires that the macrophages are specifically TAMs, or encompasses alternative macrophages. As the metes and bounds of the claim limitations are unclear, claim 37 is rejected as indefinite.
Regarding claim 38, the phrase “e.g.” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if the hematological cancer is limited to leukemia, lymphoma or myeloma, or encompasses all types of hematological cancers. Thus, the metes and bounds of the claim are unclear and the claim 38 is rejected for indefiniteness.
Claim 41 is rejected under 35 U.S.C. 112(b), because claim 41 is a “use” claim. According to MPEP 2173.05(q), “[a]ttempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which reads: ‘[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon’ was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).”
Claim 41 recites the pharmaceutical composition of claim 40 for simultaneous, separate or sequential use. It is unclear what “simultaneous, separate or sequential use” is relative to. Claim 41 is drawn to a product (i.e., a pharmaceutical composition; claim 39), which may further comprise an immune checkpoint inhibitor (claim 40); whereas the “simultaneous, separate or sequential use” language suggests a method of treating, wherein the method comprises alternative therapies/agents. If so there is no antecedent basis for reference to additional/alternative therapies in the claims. Further, as claim 41 is drawn to a product, no active steps for a “method of using” the pharmaceutical composition are recited, such as administering the pharmaceutical composition to a subject. Is claim 41 referring to the immune checkpoint inhibitor of the pharmaceutical composition of claim 40? If so, the immune checkpoint inhibitor is already in the pharmaceutical composition, and therefore cannot be administered separately or sequentially. The language of “simultaneous, separate or sequential use” is attempting to claim a process of using the pharmaceutical composition of claims 39-40; however the claim does not recite any active, positive steps defining how this use is actually practiced and what the limitations are of the alternative treatment/compositions to which the “use” pharmaceutical composition is “simultaneous, separate or sequential.” Therefore, claim 41 is rejected under 35 U.S.C. 112(b) as a “use” claim and for indefiniteness as to the metes and bounds of the claim limitations.
Claim Rejections - 35 USC § 112(d)
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.
Claim 30 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. 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.
Claim 30 depends from claim 28, whereby claim 28 recites an antibody comprising three heavy chain CDRs and three light chain CDRs to form the antigen binding domain of any fragment of the antibody as claimed. Claim 30 describes types of antibody fragments, including single-domain antibodies (i.e., Nanobody™, sdAb or VHH). It is known in the art that sdAbs are derived from camelids or sharks, and are unique in that they comprise only a heavy chain domain, with the three corresponding heavy chain CDRs. Thus, a sdAb is a unique antibody, and not a fragment of a canonical antibody. Further, sdAbs cannot be human antibodies, as sdAbs are only derived from camelids or shark species. Thus, the inclusion of sdAbs as a “antigen-binding fragment thereof, of claim 28” does not delineate a fragment of the antibody of claim 28; rather, it broadens the scope of the antibody of claim 28 to include non-human, sdAbs derived from alternative species, and which do not comprise a light chain with the requisite light chain CDRs, of claim 28. Therefore, claim 30 is rejected for being an improper dependent claim by failing to include all the limitations of the claim upon which it depends.
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.
Claims 35-37 and 42 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.
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. 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.
Claims 35 and 42 recite a method of treating cancer in a subject by administering the anti-VSIG4 antibody of claim 28. One skilled in the art would readily appreciate that an anti-VSIG4 antibody could be used to treat a VSIG4-expressing cancer; however the claims are drawn to a method of treating any cancer by administering an anti-VSIG4 antibody. Absent empirical determination one skilled in the art would be unable to envision which cancers that do not express VSIG4 could be treated with the claimed anti-VSIG4 antibody. Applicant is informed that this written description issue may be overcome by amending the claims to specifically recite a method of treating VSIG4-expressing cancers/tumors.
Allowable Subject Matter
The monoclonal antibodies of claim 28, wherein the antibody comprises the heavy and light chain CDRs of SEQ ID NOs: 3-8, respectively, or the heavy and light chain CDRs of SEQ ID NOs: 9-14, respectively, have been searched and are free of the art. As claim 28 is currently objected to, all claims that depend from claim 28 are objected to, pending compliance with all formal requirements.
Conclusion
No claims are allowed. Claims 30, 32, 35-38 and 41-42 are rejected; claims 28-29, 31, 33-34, 39-40 and 43-47 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R. MELCHIOR whose telephone number is (703)756-4761. The examiner can normally be reached M-F 8:00-5:00 CST.
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, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAMES RYLAND MELCHIOR/Examiner, Art Unit 1644
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642