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 without traverse of Group II, claims 21-22 and newly added claims 24-38 and species clone #16, Light and heavy chain variable domains SEQ ID NOs: 22-27, six CDRS SEQ ID NOs: 23, 24, 25, 28, 29, 30 and a means for binding to human iRhom2 in the reply filed on 10/2/2025 is acknowledged.
Claims 21-22 and newly added claims 24-38 are under consideration in the instant Office Action.
Priority
Foreign Filing License
A request for retroactive foreign filing license was first filed on 4/3/2025 and the Office considered and dismissed the request on 4/15/2025. See Petition decision on 4/15/2025 for reason why this was dismissed. A new request for retroactive foreign filing license has been filed on 10/9/2025. See MPEP § 140 and 35 U.S.C. 182, 184 and 185.
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 statement filed 12/29/2023 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. The citation has therefore been lined through and has not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See page 37. 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, like www. See MPEP § 608.01.
Claim Objections
Claims 21, 29 and 32 are objected to because of the following informalities: “iRhom2” is an acronym which stands for “Inactive Rhomboid family member 2” ; “ADAM17” is an acronym which stands for “ADAM metallopeptidase domain 17”; “TACE” is an acronym which stands for “tumor necrosis factor-a-converting enzyme”; “HB-EGF” is an acronym which stands for “Heparin-binding EGF-like growth factor” and needs to be spelled out in the claims, at least once in the first occurrence. Appropriate correction is required.
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 21-22, 24-32 and 35-38 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..
Claims 21-22, 24-32 and 35-38 are directed to a method for treating or preventing an inflammatory condition in a subject by administering any antibody that specifically binds within a region of Loop 1 of human iRhom2. 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 (region of Loop 1 of human iRhom2 or SEQ ID NO: 181 and envisage the combination of six CDRs that will bind that antigen. First, even highly related CDRs may not bind the same target. See for example Kussie (in instant PTO-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 et al., 1995 (in instant PTO-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.
The instant specification discloses 18 pairs of heavy and light chains and CDRs starting at page 140 of the instant specification. However, as discussed above, without any way to determine how broad the genus of such antibodies are, there is no way to determine if these antibodies represent the full breadth of what is claimed. The disclosure of these specific antibodies would not convey to the artisan that Applicant was in possession of the full genus of all antibodies which possess the required functions required to treat or prevent any inflammatory disease nor does it allow the skilled artisan to envisage the specific structure of such antibodies.
Instant claims 35-37 recite heavy and light chain variable region sequences with 90% identity to the VH and VL sequences. In addition to the claim not being self-containing, there is no limitation or exclusion in the claim language that prevents the modifications from occurring within the CDR region due to the claim language of “having at least 90% sequence identity”, which widens the scope of the claim to encompass an immense number of unknown molecules that share 90% identity to the claimed sequence and can bind to the claimed antigen. Applicant has not demonstrated that they are in possession of all the molecules that fall within the immense scope of the claim that are able to achieve the claimed function.
Further, it is well-known in the art that specificity of an antibody stems from the interaction of six CDRs. Moreover, CDRs are not generally recognized as interchangeable, such that using one CDR from one antibody would not be reasonably expected to confer the same binding properties or even the same binding target when combined with two to five CDRs from other antibodies. For example, WO 2008068048 (in instant PTO-892) discloses an antibody with a heavy chain comprising three CDRs (SEQ ID NO: 2) that binds secreted aspartyl protease from Candida sp. US 20170355756 (in instant PTO-892) describes the same three CDRs in the heavy chain (C10-VH3) combined with a different light chain that binds human TDP-43. The instant claims fail to specify what specific sequences constitute the six CDRs of the antibody capable of binding to the target antigen.
As such, the disclosure of a large list of unknown CDRs does not convey possession of all the potential antibodies that would arise from this combination as claimed and have the same binding properties; possession of the precisely defined sequences of the six CDRs is required. As such, the specification fails to set forth a structure-function correlation sufficient to claim all possible antibodies defined by function and one-three CDRs or alterations thereof.
With respect to products in method claims 21-22, 24-32, 35-38, it is recognized that information which is well known in the art need not be described in detail in the specification (MPEP §2163(II)(A)(2)). See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. MPEP §2163(II)(A)(3)(a) also discusses Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004), where a method of using a PGHS-2 inhibitor did not meet the written description as the inhibitor itself was not sufficiently described, clearly indicating that written description of the compound is still required in a method of using that compound. In this case, it is clear from the specification that the invention is in a new antibody, or at the least disclosure of a new antibody that could not have been envisaged from the prior art indicates that the prior art was not in possession of all “region of Loop 1 of human iRhom2” antibodies. Thus, the prior art cannot provide sufficient written description of this genus of compounds and the specification as filed, does not sufficiently describe the genus either as there is an unknown amount of structurally distinct antibodies in this genus (see Amgen and Centocor decisions discussed above).
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., Vas-Cath, Inc., v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. 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. An antibody described only by functional characteristic, such as antibody that binds to a region of Loop 1 of human iRhom2, without any known or disclosed correlation between that function and the structure of the sequence, is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the biomolecule of interest. In re Bell, 991 F.2d 781, 26 U.S.P.Q.2d 1529 (Fed. Cir. 1993). In re Deuel, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995). In the instant case, the specification provides insufficient direction or guidance concerning the relationship between the structure of the possible antibody to demonstrate possession of the breadth of the genus of human iRhom2 antibodies encompassed by the instant claims, especially in view of the unpredictability of such an endeavor. The prior art as evidenced by Edwards et al., 2003 (in instant PTO-892) teaches there is a substantially huge antibody diversity produced to one single antigen target. Edwards provides evidence that over 1000 antibodies, all different amino acid sequences, were generated towards one single protein antigen target (see abstract). Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
Without this guidance or direction the skilled artisan would not consider applicant to be in possession of the claimed genus of antibodies because the skilled artisan recognizes that even seemingly minor changes made without guidance or direction as to the relationship between the particular amino acid sequence of the instantly claimed antibody and its ability to bind antigen, can dramatically affect antigen-antibody binding.
Applicant has not described the claimed invention sufficiently to show they had possession of the claimed genus of antibodies that binds to human iRhom2. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 69 USPQ2d 1886 (Fed. Cir. 2004).
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. 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.
To provide adequate written description and evidence of possession of the claimed genus, the specification must provide sufficient distinguishing identifying 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. In the instant case, the only factors present in the claims are a recitation of one generic, broad genus that encompassed a diverse and huge number of possible antibodies that bind the disclosed epitope. The specification does not provide a consistent structure for all of the possible antibodies and fails to provide a representative number of species for the claimed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly 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 is, for purposes of the 'written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that they invented what is claimed.” (See Vas-Cath at page 1116).
With the exception of specifically disclosed antibodies with specific CDR sequences and heavy and light chain variable sequence pairs, the skilled artisan cannot envision the detailed chemical structure of all of the potential encompassed combination of antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
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. 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).
Therefore, claims 21-22, 24-32 and 35-38 do not meet the written description requirement.
Claim Rejections - 35 USC § 112
Claims 21-22 and 24-38 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 a method treating rheumatoid arthritis (RA) with the disclosed antibodies against iRhom2 in instant claims 33 and 34 , does not reasonably provide enablement for method for treating or preventing an inflammatory condition in a subject, the method comprising administering to the subject any antibody or fragment thereof specifically binding within a region of Loop 1 of human iRhom2. 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.
The factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and, (8) the breadth of the claims. In re Wands, 8 USPQ2d, 1400 (CAFC 1988).
The instant claims call for a method of treating an any inflammatory condition in a patient using any antibody that specifically binding within a region of Loop 1 of human iRhom2 that requires no specific structure and the dependent claims that describe the antibody or call for undisclosed modifications to the disclosed structure does not alleviate the burden on unpredictability on how to perform this method successfully to the full conclusion of prevention. The dependent claims call for undisclosed modifications or differentiations with up to 10% difference in any of the VH and VL and CDRs of the claimed antibody. The patient population is only narrowed in instant claim 22 to RA but is never narrowed in the other dependent claims. The instant claims are broad and generic while what is enabled is narrow and specific. The instant specification only provides examples of reducing effects of inflammation such as TNFa-shedding but fails to show any prevention of these effects in in vitro culture assays or even in a subject (see Example 37, pages 133-135 of instant specification). This treatment is targeted towards someone with an inflammatory condition which is a very broad subject pool. While the treatment with specifically disclosed antibodies shows positive results in cell cultures, it still fails to prevent these types of inflammatory conditions and the diseases it encompasses from occurring and therefore does not provide evidence that any inflammatory condition, let alone RA, is prevented or treated with non-specific antibodies. The instant specification does not provide any examples or evidence that this type of treatment would provide a benefit to RA subjects with unknown and undisclosed antibodies. Further, the instant specification fails to teach any other possible antibodies that have the instantly claimed function and able prevent any inflammatory disease or RA in a patient population. There is no support provided in the instant specification or in the prior or instant art that teaches or supports the ability prevent any inflammatory disease let alone RA.
The term “preventing” is generally understood in the art to encompass a total protection form disease or injury. Thus, given the high level of required effect, a high level of evidence showing prevention is also required. As noted above, however, there are no working examples in the instant specification demonstrating any therapy using the claimed antibody, nor any examples directed to the palliative, preventative, or curative treatment of any inflammatory disease including RA. Therefore, the instant specification does not provide evidence or substantial guidance commensurate in scope with the broadly claimed method in how to use the method to prevent of any inflammatory disease, including RA.
Both at the time of filing and now, effective therapy for the prevention of any inflammatory disease including RA, have eluded researchers. The instant specification itself does not teach any method of prevention of any inflammatory disease including RA. The prior art by Issuree et al., US 2015/0241429 (IDS, 12/23/2024), as discussed below, teaches treating inflammatory diseases such as RA with anti-human iRhom2 antibodies but does not support the scope of preventing any inflammatory disease including RA. Thus, the relevant art recognizes the unpredictability of methods directed to preventing any inflammatory disease including RA. The disclosure is not considered fully enabling for the claimed invention of prevention, since the state of the art teaches that prevention of any inflammatory disease including RA with any agent is not currently possible.
Claims 21 and 35-37 encompasses an antibody with unknown modifications to prevent any inflammatory disease including RA. The nature of the invention is clinical medicine comprising physiological modulation with an antibody for a medical disorder of the immune system, and is therefore of the highest complexity due to the complex nature of the immune system. The art does not provide compensatory teachings. The art teaches a limited amount of possible treatments to produce the limited result of treating RA but does not teach the prevention of these diseases or any other immunological disease. Therefore, the prior art does not compensate for the failing of the instant specification. This speaks to the fact that while the art has observed possible antibodies that match the functional criteria of instant claims 33-34 that they have not yet identified all of the possible antibodies that read on the instant claims. There is still a lot of unknown in the art of what are all the possible antibodies that are functionally capable of meeting the functional imitations of the instant claims and would still require undue experimentation to determine what these antibodies are to prevent any immunological disease. One of ordinary skill would also have to take into account what type of immunological disease this antibody is being administered to, to be able to determine if the antibody meets the required function of the instantly claimed antibody and prevent these diseases. This would require undue experimentation. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without such guidance, the changes which can be made and still maintain activity/utility is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Int. 1986).
As set forth above, inadequate guidance is presented in the specification to overcome the obstacles in practicing the claimed invention in its full scope. The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. Given the tremendous breath of scope involving the instant claims, it would require undue experimentation for one of skill in the art to practice the claimed invention in its full scope. Therefore, the specification fails to provide enough guidance for one skilled in the art on how to practice the full scope of the instantly claimed method, thereby requiring trial and error experimentation to identify compounds meeting the functional limitations of the claims. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. One of skill in the art would neither expect nor predict the appropriate methods of treating all neurodegenerative conditions in the manner claimed. Therefore, in view of the lack of guidance in the specification and in view of the discussion above, undue experimentation would indeed be required to make and use the invention commensurate with the scope of the claims.
The scope of the claims must bear a reasonable correlation with the scope of enablement. In re Fisher, 166 USPQ 18(CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
Undue experimentation would be required to produce the invention commensurate with the breadth of the claims based on the disclosure of the instant specification and the knowledge in the art. Reasonable correlation must exist between the scope of the claims and scope of enablement set forth. In view of the quantity of experimentation necessary, the limited working examples, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breadth of the claims, it would take undue trial and error to practice full scope of the claimed invention.
In conclusion, the instant claims encompass an invention of tremendous breadth, and essentially call for trial and error by the skilled artisan to begin discovering how to make the claimed invention without assisting the skilled artisan in such an endeavor, which amounts to undue experimentation and is therefore insufficient to constitute adequate enablement.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-22, 24-32 and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Issuree et al., US 2015/0241429 (IDS, 12/23/2024).
Issuree discloses methods for treating a subject with a Complement-mediated disease (e.g., rheumatoid arthritis, an inflammatory joint disease) by modulating the interaction between iRhom2 and TACE and/or inhibiting the biological activity of iRhom2 (see [0005], [0007]) and reads on instant claims 21-22 and 29. Issuree teaches a method for treating a subject with a Complement-mediated disease that comprises administering an effective amount of a composition comprising an antibody or antigen-binding fragment thereof that binds to the extracellular loop of human iRhom2 (e.g., NP_078875.4 and [0036], which corresponds to instant SEQ ID NO: 181), decreases the biological activity of iRhom2 and modulates formation of a complex between iRhom2 and TACE ( see [0006-0007]; [0027]; [0036-0037]; [0058]; [0060-0061]) and reads on instant claims 21-22, 24-25 and 29. Issuree additionally teaches a method of identifying an agent for the treatment of a Complement-mediated disease, comprising assessing the quantity of TNF-α release under suitable conditions, wherein diminished TNF-α release in the presence of the test agent indicates that the test agent is useful for treating the Complement-mediated disease (see [0011-0013]) and reads on instant claim 30. Issuree discloses that the antibodies encompass monoclonal and polyclonal antibodies and that it encompasses IgG antibodies and antibody fragments like Fv, Fab, Fab’ and F(ab’)2 fragments and humanized antibodies (see [0052-0054]) and reads on instant claims 26-28. Issuree discloses the subject as human (see [0063]) and reads on instant claim 38. While Issuree is silent of the indented results of reducing IL6-AR shedding and HB-EGF shedding of claims 31-32, it is clear that the same patient population treated with the same antibodies would have the same characteristics as the instantly claimed method since there is no evidence to the contrary. Note that rejections for anticipation are appropriate when the prior art discloses a method (or product) that appears to be identical except that the art is silent as to an inherent property; see MPEP § 2112(III). In such situations, the burden is on applicant to provide evidence that the prior art product (or method) is not the same or an obvious variant; see MPEP § 2112(V).
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 21-22 and 24-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/284,782. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘782 claim a method for treating or preventing an inflammatory condition, comprising administering to a human subject an effective amount of a means for binding, comprising a protein binder, that binds at least within a region of Loop 1 of human iRhom2 (SEQ ID NO: 181, which shares 100% identity to instant SEQ ID NO: 181). Said means for binding inhibits or reduces TACE/ADAM17 activity and inhibits or reduces TNF-a shedding, IL-6 shedding and HB-EGF shedding. ‘782 recites that the inhibition or reduction of TACE/ADAM17 activity is caused by interference with iRhom2-mediated TACE/ADAM17 activation. ‘782 recite that the means for binding is a monoclonal antibody or target-binding fragment thereof, and that the antibody is selected from IgG, scFv, Fab, or (Fab)2. ‘782 claims methods comprising administering an effective amount of a means for binding to human iRhom2 to a human subject for reducing or inhibiting TACE/ADAM17 activity. ‘782 claims the same means for binding iRhom2 is an antibody comprising a combination of heavy chain and light chain CDRs and/or a combination of a heavy chain variable region (VH) and a light chain variable region (VL) which are the same VH and VL SEQ ID NOs; 22 and 27 and CDR SEQ ID NOs: 23-25 and 28-30.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 21-22, 24-32 and 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-36, 45-46 of copending Application No. 17/602,183. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘183 recite a means for binding to human iRhom2, comprising a protein binder, that binds at least within a region of Loop 1 thereof of human iRhom2, inhibits and/or reduces TACE/ADAM17 activity when bound human iRhom2, and reduces or inhibits induced TNF-a shedding. The human iRhom2 comprising the amino acid sequence set forth in SEQ ID NO: 181 shares 100% sequence identity to the amino acid sequence of human iRhom2 set forth in instant SEQ ID NO: 16 in claim 32. ‘182 claims means for binding to human iRhom2 is a monoclonal antibody. 182 claims a method for treating or preventing an inflammatory condition that comprises administering to a human subject the means for binding to human iRhom2 of the co-pending invention. 182 claims recites that the inhibition or reduction of TACE/ADAM17 activity is caused by interference with iRhom2-mediated TACE/ADAM17 activation. As evidenced by the instant specification, the residues spanning positions 431-459 of human iRhom2 correspond to the domain section of the large extracellular loop 1 of human iRhom2, adjacent to TMD1, relevant to claim 32. Thus, the epitope recited in the instant claims is within the scope of “within a region of Loop 1” of human iRhom2 recited in the co-pending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Advisory Information
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675