Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
This action is in response to claims filed 4/20/26. Claims 1-6 and 14-20 are pending and under examination.
Withdrawn Rejections
The objection is withdrawn in light of the amendments.
The claim objections are withdrawn in light of the amendments.
The rejection under §112b is withdrawn. Claim 1 no longer depends from itself. Claims 9, 11, and 13 have been canceled.
The double patenting rejections have been withdrawn as the previous rejected claims were canceled.
Maintained Rejections and New Rejections Necessitated by Amendment
Claim Objections
Claims 1 and 2 are objected to because of the following informalities: In the alternative groups in claim 3, the options are listed and include the “and” in each, clearly indicating that both sequences are required when choosing one of the (1), (2), or (3) options. This is not the case for claims 1 and 2. In claims 1 and 2, there is no conjunction. While it is clear from the record that this is meant to be “and” rather than “or”, the word should be included to make this apparent on its face. Appropriate correction is required.
Claims 1-3 are objected to because of the following informalities: The list of options (group consisting of) ends with an “or” in claims 1 and 2 but an “and” in claim 3. While either is acceptable (“and” is preferred), the same term should be used consistently to avoid suggesting the lists are meant to be interpreted differently because of the inconsistent terminology. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: there is only one species of human and so “human CD38 protein” is acceptable. However, “monkey” is a group of species and would better phrased as “a monkey protein”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 and 14-17 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 1 recites the limitation "the CD38 protein" in line 2. There is insufficient antecedent basis for this limitation in the claim. There is no earlier recitation of “a CD38 protein” nor is there inherently only a single CD38 protein for this phrase to refer to.
Therefore, claim 1 is indefinite.
Claims 1-4 and 14 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 1 is “an antibody…binding to the CD38 protein”. The word “binding” is an active verb, suggesting the act of binding. However, the rest of the claim (“an antibody”) suggests this as a composition claim. It is unclear if Applicant intends to claim just the antibody or a method of antibody binding in claim 1.
Dependent claims do not clarify this.
Therefore, claims 1-4 and 14 are indefinite.
Claim 5, 6, and 18 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.
The claims recite “an antibody…when binding to the CD38 protein”.
First, there is insufficient antecedent basis for this limitation in the claim. There is no earlier recitation of “a CD38 protein” nor is there inherently only a single CD38 protein for this phrase to refer to.
Second, “the antibody when binding” could be referring to the act of binding or a property when bound. It is unclear if the claims are directed to 1) an antibody capable of binding residues 60-69 of a human CD38 protein, 2) a requirement that the antibody is bound to residues 60-69 of a human CD38 protein, or 3) the process of the antibody binding residues 60-69 of a human CD38 protein.
Claim 6 is further indefinite. It is unclear what the term “only” is meant to convey. This could mean that the antibody only possesses the capability of binding a peptide consisting of these three groups of residues and lacks the ability to bind any other residues regardless of the conditions or other elements that might be included; for example, this interpretation would mean that the antibody can bind the fragment 60-69 of a human CD38 protein but could not bind a protein comprising residues 59-69 or 60-70 of a human CD38 protein. It might also mean that these residues represent the specific and sufficient epitope for the antibody, e.g., these are the residues that are chemically engaged by the paratope of the antibody, but the antibody could bind these residues in the context of the whole CD38 protein. This might also mean that the antibody binds these residues when binding CD38, but does not limit binding of other proteins.
Therefore, claims 5 and 6 are indefinite. For the purpose of examination, the claim will be treated as the antibody is capable of binding these residues without requiring actual binding to those residues nor the exclusion of the capability of binding other residues.
Claims 16 and 20 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.
Claims 16 and 20 recite “the group comprising”. Per MPEP §2173.05(h): a claim which recites a list of alternatives (a Markush group) is a closed group, i.e., “the selection is made from a group ‘consisting of’ rather than ‘comprising’”. The use of “group comprising” renders the claim indefinite because it is unclear what other elements might be included in the list.
Therefore, claims 16 and 20 are indefinite.
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 5, 6, and 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 5 is directed to any antibody that binds specific residues of CD38. 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 (CD38 or the specific residues of CD38) 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 (previously cited) 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.
The specification discloses three sets of CDRs that result in the claimed binding (claim 1 options 1, 2, and 3). However, as discussed above, without any way to determine how broad the genus of such antibodies is, 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 nor does it allow the skilled artisan to envisage the specific structure of such antibodies. It would not convey possession of even a single other antibody that did not comprises one of the three sets of claimed CDR combinations.
Further note the decision in Amgen v. Sanofi 2017, where the Court supported previous decisions (Centocor 2011; Abbvie 2014) that defining an antibody solely by what it binds does not satisfy the written description requirement, stating that this would allow patentees to “claim antibodies by describing something that is not the invention, i.e., the antigen”. MPEP 2163 states “disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not, without more, provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional”.
Therefore, claims 5-6 and 18 do not meet the written description requirement.
Claims 15-16 and 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating CD38 cancer, does not reasonably provide enablement for preventing said cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: 1) nature of the invention, 2) breadth of claims, 3) amount of direction or guidance by the inventor, 4) relative skill of those in the art, 5) level of predictability in the art, 6) state of the prior art, 7) existence of working examples, and 8) quantity of the experimentation needed to make or use the invention. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
The nature of the invention is administering an antibody to prevent cancer, specifically one of the cancers in claims 16 or 20. Guidance in the specification is that there is no special definition of “prevent” nor any additional context for the term. The term “preventing” is interpreted under an ordinary definition which includes the ability to wholly prevent the cancer from appearing. Guidance in the specification is also such that the antibody was tested in an animal model and failed to cure or prevent the cancer. Figure 6 shows the administration of SG003. While tumor burden was reduced, there are still a significant number of tumors in this group as represented by the coloration. Note that only a grey scale representation has been provided and it appears that every mouse has some degree of antibody binding, which is indicative of the presence of a CD38 tumor. Further, while the survival time of the treated mice is extended, the survival rate of the SG003 treated animals drops to 50% after 30 days (figure 7).
The prior art confirms this. CRI (form 892) teaches that as of 2026 “there is currently no known way to prevent multiple myeloma”.
Cancer is well known in the art as a difficult disease to treat and both the examples and art demonstrate that there is no reasonable expectation of preventing the claimed diseases. It would require undue experimentation for others to determine if or how the instant antibody might be used to prevent these cancers when others have tried but failed.
Therefore, claims 15-16 and 19-20 are not enabled for their full scope.
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 14 and 18 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.
When reading the preamble in the context of the entire claim, the recitation “pharmaceutical composition” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
As such, claim 14 fails to provide a further limitation to claim 1. The antibody of claim 1 is already a composition. The term “pharmaceutical” has no special definition in the specification and does not provide any specific structure or element in addition to the antibody. The pharmaceutically acceptable adjuvant is “optional”, i.e., not required and is also an option for inclusion with the antibody of claim 1. Taken as a whole, claim 14 does not provide any further limitation as required by §112(d).
The same logic applies mutatis mutandis to claim 18 depending from claim 5.
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 5, 6, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11713357. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claim 5 is directed to an antibody that binds CD38 at specific residues. The reference claims (e.g., claim 1) claim an antibody that also binds CD38, though does not claim the specific residues. The residues an antibody binds are defined by its structure. The reference structure (CDRs) is disclosed as binding the same residues in both the instant specification as well as the parent disclosure. Reference claim 6 also includes the pharmaceutical composition and optional adjuvant.
Therefore, the reference claims anticipate the instant claims.
Claims 5, 6, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12304967. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claim 5 is directed to an antibody that binds CD38 at specific residues. The reference claims (e.g., claim 5) claim an antibody that also binds CD38, though does not claim the specific residues. The residues an antibody binds are defined by its structure. The reference structure (CDRs) is disclosed as binding the same residues in both the instant specification as well as the parent disclosure. Reference claim 15 claims a method of treating a subject with the antibody, meeting the criteria of being “pharmaceutical”.
Therefore, the reference claims anticipate the instant claims.
Allowable Subject Matter
Claims 1-4 and 14-17 require the CDRs to have six specific sequences. Applicant has confirmed on the record that the correct interpretation is that the CDRs comprise the whole of the sequences identified by SEQ ID (remarks 4/20/26). As noted before and reiterated in the 112a rejection above, the CDRs are responsible for the binding properties of an antibody and, importantly, are highly unpredictable when altered by even a single amino acid; see, e.g., Kussie. Thus, without disclosure of the exact sequences or a clear motivation to arrive at the claimed sequences, the claimed antibody is non-obvious over the prior art; no prior art disclosing these claimed combinations of six CDRs was discovered.
U.S. Patent No. 11713357 (the parent application-turned-patent) discloses but does not claim the instant antibody. ‘357 discloses SEQ ID NO 17 comprises instant SEQ ID NO: 24-26. SEQ ID NO: 16 comprises instant SEQ ID NOs: 27-29. The reference patent also discloses the specific combination of SEQ ID NO: 16 and 17 as the light and heavy chain, respectively (C12). However, this document does not qualify as prior art (same inventive entity) and does not claim the instant antibody. The reference claims all require SEQ ID NOs: 1-6. While some of these sequences are claimed (e.g., SEQ ID NO: 4), others are different (e.g., reference SEQ ID NO: 5 is not encompassed by any of the instantly claimed sequences. The instant claims which contain sequences and the reference claims are mutually exclusive; there is no antibody that is within the scope of instant claim 1 as well as reference claim 1. As such, claims such as instant claim 1 have not been rejected for double patenting.
Response to Arguments
Applicant’s arguments filed 4/20/26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s arguments are all directed to the amendments addressing the previous rejections or indicating the claims were canceled. The instant rejections were all necessitated by the amendments but are not the same rejections as previously set forth.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Weidner/Primary Examiner, Art Unit 1675
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