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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 14 July 2025 (and the species of antibody hC11a in the reply filed on 05 November 2025) is acknowledged. The traversal is on the ground(s) that there is substantial commonality of the subject matter of all the claims and no substantial burden is therefore seen in consideration of these groups in a single application. This is not found persuasive because the claims were restricted based on 371 practice and burden of search is not a consideration for the propriety of the holding of Lack of Unity.
Applicant also argues that with regard to the election of species requirement, “Applicants are entitled to claim the subject matter which the applicant regards as his invention”. Applicant asserts that “the objectives of streamlined examination and compact prosecution would be promoted if a search were conducted simultaneously for all of the species”. Applicant’s arguments and concerns are noted, but these arguments and concerns are not directed to whether or not the species election requirement was proper or improper. The various species were determined to lack unity of invention for the reasons of record and Applicant has not pointed out why such determination is improper or in error.
The requirement is still deemed proper and is therefore made FINAL.
Claims 4, 8, 12-14 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 14 July 2025.
Claim 8 does not read on the elected species as it is directed to an antibody/fragment which binds to the same epitope as the elected antibody, competes for binding with the elected antibody or competitively inhibits binding of the elected antibody. Therefore, it is not the same antibody and therefore does not read on the elected invention. Claims 19 and 20 depend from claim 8, therefore they are also non-elected as not encompassing the elected species.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The information disclosure statements (IDS) submitted on 22 June 2022 and 10 July 2024 have been considered by the examiner.
Drawings
The drawings are objected to because they do not comply with 37 CFR 1.84 (a)(1), (l), (p)(1) and (u)(1).
37 CFR 1.84 (a)(1) – Black ink. Black and white drawings are normally required. India ink, or its equivalent that secures solid black lines, must be used for drawings.
37 CFR 1.84(l) - Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined.
37 CFR 1.84(p) -Numbers, letters, and reference characters. (1) Reference characters (numerals are preferred), sheet numbers, and view numbers must be plain and legible, and must not be used in association with brackets or inverted commas, or enclosed within outlines, e.g., encircled. They must be oriented in the same direction as the view so as to avoid having to rotate the sheet.
37 CFR 1.84(u)(1) - Numbering of views. (1) The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG."
Several of the Figures do not utilize black ink that secures solid black lines. The numbers on the X and Y axis of Figures 2-4 and 6 do not meet the requirement.
Figure 5 uses a gray bar to denote 293T-CLDN18.1 but no bars are displayed. It is not clear if this is because there is no data associated with 293T-CLDN18.1 or if the bars are not showing up.
Figures 2-4 and 6 do not meet the requirement of 37 CFR 1.84(l) or (p). Figures 1, 5 and 10 are not labeled in the same direction as the view.
None of the figures with multiple panes is labeled correctly. There are several pages with multiple panels which only have one letter and the letter is not associated with the figure number. There are two pages which are labeled as Figure 1B, which is does not appear to meet the requirement of the rule.
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.
Specification
The disclosure is objected to because of the following informalities:
The Brief Description of the Drawings is objected to because it does not comply with 37 CFR 1.84(u)(1). A figure which has multiple panels and parts A-C must be referred to by both the Figure number and the letter; e.g. Figure 3A-3C.
Appropriate correction is required.
The use of the terms Tween®, ATCC®, SIGMAFAST™, FACSAria™, FACSCalibur™, which are trade names or marks used in commerce, have been noted in this application. The term(s) should be accompanied by the generic terminology; furthermore the term(s) should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicant should carefully review the specification for any other instances of trade names/marks which have not be appropriately indicated and assure all terms be accompanied by the generic terminology.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “CLDN18.2”. When an abbreviation is used, it is customary to recite the full name that the abbreviation corresponds to at the first instance of use. Appropriate correction is required.
Claims 1-2 are objected to because of the following informalities: the claims recite “An antibody or fragment thereof binding to CLDN18.2”. It would appear that the claims intend to claim the antibody/fragment and not the antibody/fragment which is already bound to CLDN18.2. However, as the claims are currently drafted, the claims are directed to an antibody/fragment which is bound to CLDN18.2. It is suggested that the claims be amended to recite “An antibody or antigen binding fragment thereof which binds to CLDN18.2”. The claim is currently interpreted as being bound to CLDN18.2 because “binding” is an active verb, therefore, it is actively binding. Appropriate correction is required.
Claim 15 is objected to for reciting a non-elected invention. Claim 15 includes the administration of “a nucleic acid encoding the antibody, a vector comprising the nucleic acid, or a host cell comprising the nucleic acid”. The method of treatment by administration of a nucleic acid/vector/host cell was found to have Lack of Unity with the elected invention and is no subject to rejoinder. This invention should be canceled from the claim.
Claim Rejections - 35 USC § 112
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 1-2, 5, 7, 9-11, 15-18 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 1 is directed to an antibody or fragment thereof which binds CLDN18.2 and binds to CLDN18.2 in tumor tissue preferentially compared to CLDN18.2 expressed in healthy tissue. Claim 2 recites that the antibody/fragment comprises 6 CDRs wherein the amino acid sequences are SEQ ID NO:21-26, respectively. The amino acid sequences in claim 2 include variable amino acids in 13 different positions (1 in HCDR1, 5 in HCDR2, 1 in HCDR3, 2 in LCDR1, 3 in LCDR2 and 1 in LCDR3). Claim 5 recites an antibody/fragment which has a VH and VL chain sequence with some degree of percent identity to a given amino acid sequence with no requirement of any particular portion/structure being retained or unmodified. Claim 7 recites an antibody/fragment which has a heavy and light chain sequence with some degree of percent identity to a given amino acid sequence with no requirement of any particular portion/structure being retained or unmodified. Claims 9 and 16 recites that the antibody/fragment has a particular form or properties, but do not provide any structure for the claimed antibody/fragment. Claims 10-11 and 17-18 recite characteristics of the antibody/fragment but do not provide any structure for the claimed antibody/fragment or which provide for the recited characteristics.
However, the claims fail to provide an adequate written description for the claimed antibodies/fragments antibodies for a number of reasons. Claims 1, 9-11 fail to provide any structure at all for the claimed antibody and only define what the antibody binds or what properties are to be possessed by the antibody/fragment. Claim 2 recites CDR consensus sequences which include 13 variable positions which mix and match CDRs from different antibodies. While claims 5 and 7 recite amino acid sequences for heavy/light chains of the antibody/fragment, they include percent identity language without any recitation that the necessary portions of the heavy/light chain regions are preserved and therefore, encompass variation in the CDR regions. Claims 9 and 16 encompasses antibody forms which are single domain (embodiment (a) which only recites a VL or a VH).
The claims as currently presented do not require the antibody/fragment to possess any particular structure or have a full complement of CDRs from a particular recited antibody or have two variable domains (heavy and light chain) from a particular antibody. The elected species of antibody, hCl1a, has heavy and light chain CDRs with the amino acid sequences of SEQ ID NO: 1, 15, and 3-6 (respectively) and heavy/light chain variable regions with the amino acid sequences of SEQ ID NO: 33 and 38 (heavy and light chains have the amino acid sequences of SEQ ID NO: 46 and 51). An antibody with these structures (all 6 recited CDRs or both heavy/light chains) of CDRs has written description. However, the instant specification does not describe antibodies which lack a full complement of CDRs or mix and match CDRs from different antibodies (as encompassed by the consensus sequences of SEQ ID NO:21-26) or which have amino acid sequence variations from the disclosed CDR amino acid sequences which also have the ability to bind their respective target. The instant specification does not teach antibodies with less than a complete complement of CDRs from the same antibody as having the ability to bind their stated target. Additionally, the specification does not teach a genus of antibodies which bind to CLDN18.2 with preferential binding to CLDN18.2 in tumor tissue compared to healthy tissue.
The specification fails to provide a written description of the genus of antibodies which bind to CLDN18.2 with preferential binding to CLDN18.2 in tumor tissue compared to healthy tissue which lack the recited 6 CDRs identified above in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. The instant specification fails to describe any antibodies which mix and match CDRs and/or heavy/light variable chains or the full scope of antibodies which only recite functionality of binding to the target, and there is no direction provided in the instant specification as to what additional structure would be required in order to obtain an antibody with the necessary binding characteristics and functional characteristics required by the claims. While the specification contemplates mixing and matching CDRs from different antibodies, the specification does not make such antibodies or demonstrate that such constructs would bind their respective target and have the required functional activities of the claims. The instant specification may contemplate such antibodies but the specification fails to provide an adequate written description for such as no antibodies meeting these structural criteria have been provided or described.
The structures of the antibodies claimed are not adequately described. In AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., Ill USPQ2d 1780 (Fed. Cir. 2014) AbbVie had claims to functionally claimed antibodies and Centocor presented evidence that the antibodies described in AbbVie's patents were not representative of other members of the functionally claimed genus. The decision states, “When a patent claims a genus using functional language to define a desired result, ‘the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.’ Id. at 1349. We have held that 'a sufficient description of a genus ... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus.’ Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). Here, the claimed invention is a class of fully human antibodies that are defined by their high affinity and neutralizing activity to human IL-12, a known antigen. AbbVie's expert conceded that the '128 and '485 patents do not disclose structural features common to the members of the claimed genus.”
The AbbVie decision considers how large of a genus is involved and what species of the genus are described in the patent. With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that “merely recite a description of the problem to be solved while claiming all solutions to it and ... cover any compound later actually invented and determined to fall within the claim's functional boundaries.”).
In the instant application, the specification and claims draw a fence around a perceived genus but the genus is not adequately described. The specification exemplifies an antibody comprising 6 CDRs having the amino acid sequences of SEQ ID NO: 1, 15, 3-6 and with a VH and VL of SEQ ID NO: 22 and 38 as well as a heavy chain amino acid sequence of SEQ ID NO:46 and a light chain amino acid sequence of SEQ ID NO:51; however, the claims are not so limited and the structural variability of the claimed genus is very large. No reasonable structure-function correlation has been established that is commensurate in scope with the claims. The specification does not describe representative examples to support the full scope of the claims.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states 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, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). A review of the language of the claim indicates that these claims are drawn to antibodies which have specific functional characteristics.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(1), the court states, “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.”
Thus, given the level of skill and knowledge and predictability in the art, those of skill in the art would not conclude that the applicant was in possession of the claimed genera of antibodies which bind CLDN18.2 and preferentially bind to CLDN18.2 in tumor tissue compare to healthy tissue based on disclosures set forth above. "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly.
Further, it is not sufficient to define the genus solely by its principal biological property, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. Per the Enzo court's example, (Enzo Biochem, Inc. v. Gen-Probe Inc., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched "in terms of its function of lessening inflammation of tissues" which, the court stated, "fails to distinguish any steroid from others having the same activity or function" and the expression "an antibiotic penicillin" fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Similarly, the function of the variant as claimed does not distinguish a particular variant from others having the same activity or function and as such, fails to satisfy the written-description requirement. Applicant has not disclosed any relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the claimed genus. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. (Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406).
In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus, which are antibodies/fragments which bind CLDN18.2 and preferentially bind to CLDN18.2 in tumor tissue compare to healthy tissue and which vary from the disclosed antibody hCL1a with the recited structures identified above. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus. 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 at page 1116).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Claim 15 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 15 is directed to a method of treatment of a subject suffering from or at risk of developing and/or being diagnosed for a neoplastic condition by administering the antibody or fragment thereof of claim 1. The claim has been rejected above for lack of written description with respect to the antibody/fragment recited in the claim. Claim 15 is also not enable for treating a subject (1) at risk of developing a neoplastic condition as well as (2) treating any and all neoplastic conditions.
First, the instant application does not enable method of preventing or treating a subject at risk of developing a neoplastic condition. There is no evidence of record that would suggest that administration of an antibody which binds CLDN18.2 would have the ability to prevent neoplasms. In fact, the antibody/fragment recited in the claim “exhibits increased binding to tumor tissue expressing CLDN18.2 over healthy tissue expressing CLDN18.2”. Therefore, in order for the antibody recited in the claims to bind to CLDN18.2, the tissue would need to be tumor tissue and not healthy tissue and therefore, the subject would be suffering from a neoplasm and not “at risk of developing” a neoplastic disease. Therefore, the claim is not enabled for a method of treating a subject at risk of developing a neoplastic disease.
Secondly, the claims are not enabled for treatment of “neoplastic disease”. The antibody/fragment recited in the claim binds to CLDN18.2 and if the tumor does not express this protein, the antibody/fragment would not bind to the target. While the prior art teaches that CLDN18.2 is a tight-junction protein highly expressed in gastric mucosa and is frequently activated in stomach and gtastroesophageal junction cancers, this does not mean that CLDN18.2 is a protein that is expressed in all neoplastic disease and the specification does not teach how to treat neoplastic disease which does not express CLDN18.2 with the antibody/fragment of the claim. Additionally, while the instant specification teaches that the antibody/fragment of claim 1 binds to CLDN18.2 and preferentially binds to CLDN18.2 expressed in tumor cells compared to healthy tissue, there is no evidence in the instant specification that administration of an antibody of claim 1 will treat neoplastic disease. While the antibody to which the instant antibody was compared (zolbetuximab/IMAB362) has the ability to bind CLDN18.2 and induce cancer cell death, the instant specification fails to teach that the antibody of claim 1 has this same ability. The instant antibody clearly does not bind to the same antigenic region as that of IMAB362 based on the fact that IMAB362 binds CLDN18.2 in healthy tissues to the same degree as tumor tissue expressing CLDN18.2 while the antibody of claim 1 does not. One of ordinary skill in the art would have no reasonable expectation of success in treating a neoplastic disease by administering the antibody/fragment of claim 1 to a subject if the antibody/fragment does not evoke some physiologic process that would result in the inhibition of the neoplastic cell to which the antibody binds. The ability of an antibody/fragment to bind to a specific target does not necessarily mean that the antibody/fragment will illicit a particular biological effect on the cell in which the target is expressed. In the absence of some teaching that the antibody/fragment of the instant claim has the ability to induce cancer cell death or in some way inhibit the neoplastic cell expressing CLDN18.2, the instant claims are not enabled for treatment of a subject suffering from or being diagnosed for a neoplastic disease.
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 5, 7 and 15 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.
Regarding claims 5 and 7, the phrase "preferably comprising" renders the claim indefinite because it is unclear if the claims are limited to those embodiments following the phrase or not.
Claim 15 recites a method for treatment of a subject (a) “suffering from” and (c) “being diagnosed for”. However, the claim is unclear with regard to the distinction of embodiment (a) versus embodiment (c) because in order to be treated for a particular condition, the subject would necessarily need to be diagnosed with the condition. Additionally, if the subject is diagnosed with a particular condition, the subject would also be suffering from the condition. Therefore, the distinction which is to be made between (a) and (c) is not clear and the scope of the claim is indefinite.
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.
Claims 10, 16 and 17 are 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 10 recites the limitation “wherein the increased binding to tumor tissue expressing CLDN18.2 over healthy tissue expressing CLDN18.2 is measured by flow cytometry or by immunohistochemistry”. However, this limitation does not limit the subject matter of the claim which is an “antibody or fragment thereof of claim 1”. The means by which the binding is measured does not place any material limitation on the antibody/fragment which is doing the binding.
Claim 16 recites wherein the antibody or fragment thereof is VL or VH. These embodiments do not include all the limitations of the claim from which they depend from (claim 2) which requires the 6 CDRs from the VH and VL. If the antibody/fragment only comprises the VL or the VH, it will not include all the limitations from claim 2.
Claim 17 recites that the antibody/fragment exhibits increased binding to tumor tissue expressing CLDN18.2 over healthy tissue expressing CLDN18.2 however, this limitation is already possessed by the antibody/fragment of claim 2. Claim 17 also recites the limitation “wherein the increased binding to tumor tissue expressing CLDN18.2 over healthy tissue expressing CLDN18.2 is measured by flow cytometry or by immunohistochemistry”. However, this limitation does not limit the subject matter of the claim which is an “antibody or fragment thereof of claim 2”. The means by which the binding is measured does not place any material limitation on the antibody/fragment which is doing the binding.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-7, 9-11 and 16-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 13, 15-18 of copending Application No. 18/269,240 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over claims of ‘240.
‘240 is directed to an antibody drug conjugate wherein the antibody binds CLDN18.2. Claim 1 of ‘240 recites that the antibody comprises the amino acid sequences of SEQ ID NO:21-26 (6 CDRs) which are identical to those recited in instant claim 2. Claim 11 of ‘240 recites that the CDR amino acid sequences of the CLDN18.2 antibody are SEQ ID NO:1, 15, 3-6 which are identical to those of instant claim 3. Claim 13 of ‘240 recites that the VH and VL amino acid sequences are SEQ ID NO:33 and 38 and that the heavy and light chains have the amino acid sequences of SEQ ID NO:46 and 51, which are identical to those amino acid sequences of instant claims 5-7. The claimed antibodies are obvious over the antibodies conjugated to a drug as claimed in ‘240 because one of ordinary skill in the art could use the antibody of the claims of ‘240 in the absence of the drug which is conjugated to the antibody. The antibodies are fully disclosed in ‘240. While instant claims 1, 10-11 and 17-18 recite particular characteristics of the antibody, these characteristics are possessed by the antibodies of ‘240 because the antibodies have the identical amino acid sequence structure (a compound and its properties are inseparable). Instant claims 9 and 16 recite that the antibody/fragment is in a particular form or has particular properties however, the antibodies of ‘240 meet the limitations of these claims as the antibody having the amino acid sequences noted above are from a humanized antibody which does not bind to CLDN18.1, is less susceptible to posttranslational deamidation than IMAB362 and is isolated. Therefore, the instant claims are not patentably distinct from the claims of ‘240.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 5-6, 10-11, 16-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of copending Application No. 18/573,397 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the claim of ‘397.
‘397 is directed to an immunocytokine which is a conjugate that comprises a cytokine domain and an antibody. Claim 15 of ‘397 recites that the antibody comprises the amino acid sequences of SEQ ID NO:33 and 38 which are identical to those amino acid sequences of instant claims 5-6. The claimed antibodies are obvious over the antibodies conjugated to an immunocytokine as claimed in ‘397 because one of ordinary skill in the art could use the antibody of the claims of ‘397 in the absence of the cytokine which is conjugated to the antibody. The antibody/fragment is fully disclosed in ‘397. While instant claims 1, 10-11 and 17-18 recite particular characteristics of the antibody, these characteristics are possessed by the antibody of ‘397because the antibodies have the identical amino acid sequence structure (a compound and its properties are inseparable). Instant claims 9 and 16 recite that the antibody/fragment is in a particular form or has particular properties however, the antibody of ‘240 meets the limitations of these claims as the antibody having the amino acid sequences noted above is from a humanized antibody which does not bind to CLDN18.1, is less susceptible to posttranslational deamidation than IMAB362 and is isolated. Therefore, the instant claims are not patentably distinct from the claim of ‘397.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/Christine J Saoud/Primary Examiner, Art Unit 1645