DETAILED ACTION
Status of the Claims
Claims 1, 3-6, 8-20, and 23-24 are currently pending.
Claims 18-20 and 23-24 have been withdrawn as being drawn to non-elected subject matter (see below).
Claims 1, 3-6, and 8-17 are examined herein.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Restriction Requirement
Applicant’s election of Group I (claims 1, 3-6, and 8-17) in the reply filed on 03/10/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 18-20 and 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/10/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/10/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Abstract
Applicant is reminded of the proper language, content, and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. In certain patents, particularly those for compounds and compositions, wherein the process for making and/or the use thereof are not obvious, the abstract should set forth a process for making and/or use thereof. If the new technical disclosure involves modifications or alternatives, the abstract should mention by way of example the preferred modification or alternative.
The abstract of the disclosure is objected to because it does not relate enough information about the disclosed invention(s) needed to "…disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details”, as per MPEP 608.01(b). Applicant is instructed to amend the abstract accordingly.
Drawings
The drawings are objected to because the Brief Description of the Drawings for Fig. 6 does not match the Fig. 6 of the drawings. Specifically, the Brief Description of the Drawings for Fig. 6 recites “Figure 6A through Figure 6C” as being representative results of ELISA assays (Fig. 6A), representative results of Biolayer Interferometry assays (Fig. 6B), and a representative list of nanobodies and human protein antigens that were characterized by ELISA (Fig. 6C), however, there are no corresponding Fig. 6A-6C in the drawings, which are instead a series of binding curves. Similarly, the Brief Description of the Drawings states that Fig. 7A and 7B depict a prediction of Binders via Machine Learning Modeling, however, the Fig. 7 looks more like biolayer interferometry or SPR data.
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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 5-6, 13-15, and 17 are rejected under 35 U.S.C. 101 because the claimed invention(s) is/are directed to one or more judicial exceptions (i.e., product of nature, a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is directed to a judicial exception (i.e., a product of nature) without significantly more, and specifically to an isolated antibody or antibody fragment that specifically binds to a target protein or peptide, wherein the target protein or peptide is selected from the group consisting of a secreted protein or peptide and an extracellular protein or peptide. The claim does not include any additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed isolated antibody or fragment encompasses naturally occurring antibodies (e.g., such as anti-IL17A autoantibodies as disclosed by Sioud et al. (Clin. Exp. Immunol., 1994, 98:520-525) as per the Abstract). Since the broadest reasonable interpretation of the claim encompasses products of nature and/or products which are indistinguishable from or not markedly different from naturally occurring products, the claim is patent ineligible.
Claims 5-6 and 13 do not distinguish over the naturally occurring antibodies and therefore do not make the claims patent eligible. Further, claims 14-15 are drawn to nucleic acids which encode for the antibody, which is present in the human genome, and therefore is a product of nature and not patent eligible. Claim 17 is drawn to a cell with the nucleic acid of claim 14, which is also naturally occurring and patent ineligible.
For further information, please see the latest revision of MPEP § 2104-2106 {Patent Subject Matter Eligibility Under 35 U.S.C. 101}, including MPEP § 2106.04 {Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception} and 2106.05 {Eligibility Step 2B: Whether a Claim Amounts to Significantly More}, as well as any additional guidance on Subject Matter Eligibility, provided on the USPTO website at
https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility.
Claim Rejections - 35 USC § 112(a)
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Written Description Rejection
Claims 1, 3-6, and 8-17 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 claims contain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As per MPEP 2163(I), "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Also, as per MPEP 2163.03(V), there is a presumption that an adequate written description of the claimed invention is present in the specification as filed.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Possession may be shown in a variety of ways, for example, possession may be shown by describing an actual reduction to practice of the claimed invention. A specification may describe an actual reduction to practice by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose. Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896, 1901 (Fed. Cir. 1998). See also UMC Elecs. Co. v. United States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987) ("[T]here cannot be a reduction to practice of the invention ... without a physical embodiment which includes all limitations of the claim."); Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1614 (Fed. Cir. 1997) ("[A] reduction to practice does not occur until the inventor has determined that the invention will work for its intended purpose."); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that the invention will work for its intended purpose may require testing depending on the character of the invention and the problem it solves). Alternatively, applicant may present that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it").
Finally, MPEP 2163.04 describes the burden on the examiner with regard to the Written Description requirement, stating that in rejecting a claim, the examiner must set forth express findings of fact which support the lack of written description conclusion. These findings should:
(A) Identify the claim limitation(s) at issue; and
(B) Establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed.
For claim 1, the claim encompasses any isolated antibody or antibody fragment that specifically binds to any secreted or extracellular proteins/peptides and thus covers a very large genus. Notably, the specification at para [0048]-[0049] discloses that such antibodies and antibody fragments include but are not limited to “polyclonal antibodies, monoclonal antibodies, intracellular antibodies (‘intrabodies’), Fv, Fab, Fab′, F(ab)2 and F(ab′)2, as well as single chain antibodies (scFv), heavy chain antibodies, such as camelid antibodies, and humanized antibodies” and “Fab, Fab′, F(ab′)2, and Fv fragments, linear antibodies, sdAb (either VL or VH), camelid VHH domains, scFv antibodies, and multi-specific antibodies formed from antibody fragments.” Further, the claim does not limit the identity of the target protein or peptide, so long as it is secreted or extracellular. From the combination of any antibody or antibody fragment each specific for any secreted or extracellular target protein/peptide, the scope of the claim is unimaginably large.
Claim 3 limits the antibody to be a nanobody, which reduces the scope of the invention a little, but still encompasses any nanobody or nanobody fragment that specifically binds to any secreted or extracellular target protein/peptide.
Claim 4 recites that the nanobody or nanobody fragment have “a predicted binding score of at least 0.5”, but as this is not well defined in the specification, essentially does not reduce the scope in any meaningful way.
Claim 6 merely adds that the antibody or antibody fragment comprises a “therapeutic agent or a detection moiety”, neither of which are defined in the specification, thus doing little or nothing to further limit the claim scope.
Claims 13-17 do not limit the identity of the antibody or antibody fragment or target protein or peptide, but instead disclose the corresponding encoding nucleic acid sequence and in an expression vector and/or a cell.
In contrast, the specification discloses a finite listing of 42,843 amino acid sequences of phage-displayed nanobodies against 1068 yeast-displayed antigens (e.g., as per para [0182]) that were predicted from computationally filtered next-generation sequencing data from a biopanning assay (e.g., as per Example 5). Of these, only 59 were experimentally tested for binding, and only about half of these were found to bind less than five off-targets and have a measured affinity better than 10-6 M (e.g., as per Table 1). So, at most, <0.1% of the disclosed sequences of nanobodies were experimentally validated.
Claim 5 recites a binding of at least 10-6 M, which was only experimentally validated for about 54 of a total of 59 nanobodies tested (e.g., as per Table 1), of which another 22 showed 5 or more off-targets.
Claims 8-9 narrow the list of selected target proteins, but these claims are still not limited to the disclosed sequence-target pairs of the application as filed.
Claim 10 recites that the nanobody comprise a minimum of one of the disclosed CDRs, but allows for essentially any other CDRs and scaffold, thus far exceeding the number of disclosed sequences.
Claim 11 requires CDR1, CDR2, and CDR3 to be from the same SEQ ID NO, but still does not require the complete disclosed scaffold context of the disclosed nanobodies. The specification does not establish that the disclosed CDR sets retain the claimed specific-binding functionality when inserted into the context of the broader range of antibody or antibody fragment structures still encompassed by the claims.
Therefore, the specification fails to provide either a representative number of species commensurate with the scope of the claims or structural features common to the claimed genus that would allow one of ordinary skill in the art to be able to visualize or recognize the full scope of the claimed antibodies or antibody fragments, and therefore fails to provide adequate written description support for the full scope of the claims 1, 3-6, 8-11, and 13-17.
Claim 12 limits the antibody to comprise an amino acid sequence as set forth in any one of SEQ ID NO:1-42,890, which each comprise a nanobody scaffold and CDRs. Importantly, from its dependence on claims 8, 3, and 1, the antibody is a nanobody that “specifically binds to a target protein or peptide” selected from those listed in Table 2. Therefore, the claim requires that every single one of the 42,890 disclosed sequences must be a functional, target-specific binder. As detailed in Example 5 of the disclosure, Applicant started with a 24 billion nanobody variant library, performed multiple selection rounds and fed the next-generation sequencing data through a computational pipeline to “select the highest-confidence nanobodies”, resulting in 42,843 nanobodies against 1038 antigens. It is unclear why this number differs from the 42,890 sequences claimed.
However, despite providing the precise amino acid sequence for each of 42,890 amino acid sequences and having predicted their binding to target based on some indirect sequencing data, such is still not sufficient to satisfy the written description requirement. Namely, as discussed above, only 59 of the sequences (approx. 0.14%) were experimentally tested for binding to their target (e.g., as per Table 1) and of which five did not report quantitative binding and 22 were reported as having 5 or more off- targets (e.g., as per Table 1), so seemingly only one-third to nearly one-half of the tested sequences (representing only about 0.1% of the claimed sequences) were experimentally validated for affinity and specificity. This is not reasonably a representative number of species to allow for the skilled artisan to realize that Applicant was in possession of the full scope of the claim as of the effective filing date.
Such analysis is consistent with the guidance provided in MPEP § 2163, including the citation of Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1337, 2021 USPQ2d 893 (Fed. Cir. 2021), “where the claims are directed to species that bind to various selected targets, it is not fatal that all species are not disclosed as long as the patent provides other means of identifying which species would possess the claimed common structural characteristics or shared traits.”
In conclusion, due to a lack of sufficient actual reduction to practice and/or a showing that the full scope of the invention was “ready for patenting”, there is insufficient written description support for the invention as claimed and the claims are therefore properly rejected under 35 U.S.C. 112(a).
Enablement Rejection
Claims 1, 3-6, and 8-17 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 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.
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988). See also United States v. Telectronics, Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988) ("The test of enablement is whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation.").
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) and MPEP 2164.01(A)) as follows: 1) quantity of experimentation necessary, 2) the amount of direction or guidance presented, 3) the presence and absence of working examples, 4) the nature of the invention, 5) the state of prior art, 6) the relative skill of those in the art, 7) the predictability or unpredictability of the art, and 8) the breath of the claims. While all the above factors have been fully considered and have led the Examiner to conclude that the specification fails to teach how to make and/or use the claimed invention without undue experimentation, only the most relevant factors are addressed in detail below.
(1 and 2) The breadth of the claims and the nature of the invention:
The claimed invention is directed to a vast genus of isolated antibodies or antibody fragments defined primarily by their functional capacity to specifically bind to a target protein/peptide that is secreted or extracellular. Claim 3 limits the antibody to nanobodies. Claims 4-5 further define the functional aspects of predicted and actual binding to the target. Claim 6 adds a “therapeutic agent or a detection moiety”, neither of which are defined in the specification, thus doing little or nothing to further limit the claim scope. Claims 8-9 limit the target protein to one of many human exoproteins. Claims 10-11 limit the selection of CDRs, but not the framework scaffold. Claims 13-17 do not limit the identity of the antibody or antibody fragment or target protein or peptide, but instead disclose the corresponding encoding nucleic acid sequence and in an expression vector and/or a cell. However, despite any of these limiting factors, the complete scope of claimed nanobodies are required to specifically bind to their target protein and therefore the specification must enable a person of ordinary skill in the art to make and use the full functional scope of the claimed genus without undue experimentation. See MPEP § 2164 and also Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023).
(3 and 5) The state of the prior art and the level of predictability in the art:
The field of antibody engineering and selection, particularly the selection and design of single-domain antibodies (nanobodies) that bind to specific targets with high affinity is highly unpredictable. As noted in the specification, “[a]ntibody discovery remains a labor and resource-intensive process involving immunization of animals or use of synthetic libraries with a molecular selection system such as phage display” (e.g., as per para [0002]). Even minor sequence modifications within the hypervariable CDR loops or changes to the flanking scaffold framework sequences can completely disrupt a nanobody’s proper folding, stability, expression, and binding ability.
(4) The level of one or ordinary skill:
The level of skill would be high, most likely at the Ph.D. level or equivalent number of years of experience. However, such persons of ordinary skill in this art, given its unpredictability, would have to engage in undue (non-routine) trial and error experimentation to carry out the invention as claimed.
(6 and 7) The amount of direction or guidance presented and the existence of working examples:
The disclosure as originally filed fails to provide sufficient structure-function correlation or predictable rules to guide one of ordinary skill in the art to the full scope of embodiments in the claimed invention. Instead of validating the entire functional genus, or even a representative number of species therein, the disclosure details the high-throughput HAPPY platform the screens a 24 billion member phage display library against 3088 human exoproteins displayed on yeast. Data from next-generation sequencing of before and after rounds of selection were put through a computational pipeline described by Applicant to select a final listing of 42384 candidate nanobody sequences. However, the specification only experimentally validated a very small fraction (approx. 0.14% or less) using ELISA or Biolayer Interferometry for 59 sequences as per Table 1. For the remaining 42831 sequences, the specification only provides an unverified prediction that they will bind their respective targets.
(8) The quantity of experimentation required to practice the claimed invention based on the teachings of the specification.
Therefore, it is deemed that further research of an unpredictable nature would be necessary to make or use the full scope of the invention as claimed. Thus, due to the inadequacies of the instant disclosure, undue experimentation would be required of one of skill in the art to practice the full scope of the claimed invention.
Claim Rejections - 35 USC § 112(b) -- Indefiniteness
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 8-12 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 pre-AIA the applicant regards as the invention.
Claim 8 currently makes reference to Table 2 in the specification. However, as per MPEP § 2173.05(s), “[w]here possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table ‘is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.’ Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).”
Claims 9-12 depend from claim 8 and are therefore similarly rejected.
As per MPEP 2173: It is of utmost importance that patents issue with definite claims that clearly and precisely inform persons skilled in the art of the boundaries of protected subject matter. Therefore, claims that do not meet this standard must be rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph as indefinite.
Claim Rejections – 35 U.S.C. 102
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 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Beirnaert
Claims 1, 3-6, 8-9, and 13-17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Beirnaert (U.S. PGPub 2010/0297111 A1).
Regarding claim 1, Beirnaert discloses an isolated antibody or antibody fragment that specifically binds to a target protein or peptide, wherein the target protein or peptide is selected from the group consisting of a secreted protein or peptide and an extracellular protein or peptide (e.g., against TNF-alpha as per the Abstract).
Regarding claim 3, Beirnaert discloses the above, wherein the antibody is a single chain antibody, and further wherein the single chain antibody is a nanobody (e.g., against TNF-alpha as per the Abstract).
Regarding claim 4, Beirnaert discloses the above, wherein the nanobody has a predicted binding score of at least 0.5, and further wherein the predicted binding score is determined using a machine learning algorithm wherein the machine learning algorithm comprises a multi-class classifier based on a logistic regression model.
Regarding claim 5, Beirnaert discloses the above, comprising an antibody or binding portion thereof that specifically binds to the secreted or extracellular protein or peptide with an affinity of at least 10-6 M (e.g., as per para [1364]).
Regarding claim 6, Beirnaert discloses the above, wherein the antibody or antibody fragment comprises a therapeutic agent or a detection moiety (e.g., a tag or epitope as per para [1185]).
Regarding claim 8, Beirnaert discloses the above, wherein the secreted or extracellular protein or peptide is selected from the group consisting of a target provided in Table 2 (e.g., against TNF-alpha as per the Abstract).
Regarding claim 9, Beirnaert discloses the above, wherein the extracellular protein or peptide is selected from the group consisting of CCL16, CD302, CD3D, CD3E, CEACAM4, IL10RA, IL13, IL17A, IL1RN, IL21, PROCR, TIGIT, TNF, TNFRSF17, and TNFSF 18 (e.g., against TNF-alpha as per the Abstract).
Regarding claim 13, Beirnaert discloses a composition comprising an antibody or antibody fragment of claim 1 (e.g., against TNF-alpha as per the Abstract).
Regarding claim 14, Beirnaert discloses a nucleic acid molecule comprising a nucleotide sequence encoding an antibody or antibody fragment of claim 1.
Regarding claim 15, Beirnaert discloses a composition comprising a nucleic acid molecule of claim 14 (e.g., a nucleic acid encoding said nanobody as per the Abstract).
Regarding claim 16, Beirnaert discloses an expression vector comprising the nucleic acid molecule of claim 14 (e.g., in an expression vector as per para [1206]).
Regarding claim 17, Beirnaert discloses a host cell comprising the nucleic acid molecule of claim 14 (e.g., a host cell as per the Abstract).
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
U.S. 9,273,134 B2
Claims 1, 3-6, 8, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 9,273,134 B2 (the ‘134 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claims 1, 3-6, 8, and 13, the claims of the ‘134 patent disclose a nanobody that specifically binds to a target secreted or extracellular protein or peptide (e.g., as per claims 1 and 5 of the ‘134 patent).
U.S. 12,533,395 B2
Claims 1, 4-6, 8-9, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12,533,395 B2 (the ‘395 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claims 1, 4-6, 8-9, and 13, the claims of the ‘395 patent disclose a nanobody that specifically binds to a target secreted or extracellular protein or peptide (e.g., anti-TIGIT antibody as per claim 9 of the ‘395 patent).
U.S. 11,311,538 B2
Claims 1, 4-6, 8, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,311,538 B2 (the ‘538 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claims 1, 4-6, 8, and 13, the claims of the ‘538 patent disclose a nanobody that specifically binds to a target secreted or extracellular protein or peptide (e.g., anti-EGF receptor antibody as per claim 6 of the ‘538 patent).
U.S. 11,267,875 B2
Claims 1, 4-6, 8, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,267,875 B2 (the ‘875 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claims 1, 4-6, 8, and 13, the claims of the ‘875 patent disclose a nanobody that specifically binds to a target secreted or extracellular protein or peptide (e.g., anti-DKK2 antibody as per claim 1 of the ‘875 patent).
U.S. 11,203,636 B2
Claims 1, 4-6, 8, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,203,636 B2 (the ‘636 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claims 1, 4-6, 8, and 13, the claims of the ‘636 patent disclose a nanobody that specifically binds to a target secreted or extracellular protein or peptide (e.g., anti-IL6 antibody as per claim 1 of the ‘636 patent).
U.S. 10,895,569 B2
Claims 1, 4-6, 8-9, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,895,569 B2 (the ‘569 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claims 1, 4-6, 8-9, and 13, the claims of the ‘569 patent disclose a nanobody that specifically binds to a target secreted or extracellular protein or peptide (e.g., anti-CD3 antibody as per claim 1 of the ‘569 patent).
U.S. 10,889,649 B2
Claims 1, 4-6, 8, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 10,889,649 B2 (the ‘649 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claims 1, 4-6, 8, and 13, the claims of the ‘649 patent disclose a nanobody that specifically binds to a target secreted or extracellular protein or peptide (e.g., anti-CD20 antibody as per claim 9 of the ‘649 patent).
U.S. 10,835,611 B2
Claims 1, 4-6, 8, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,835,611 B2 (the ‘611 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claims 1, 4-6, 8, and 13, the claims of the ‘611 patent disclose a nanobody that specifically binds to a target secreted or extracellular protein or peptide (e.g., anti-GDNFR-α1 antibody as per claim 1 of the ‘611 patent).
Conclusion
No claims are allowed.
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/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684
Prosecution Insights