Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restriction
2. Applicant’s election of species without traverse in the reply filed on 28 January 2026 is acknowledged. Claims 4 and 18 have been withdrawn. The election of species is as follows:
CDRH1-CDRH3 and CDRL1-CDRL-3: SEQ ID NO: 32, 35, 5, and 9-11, respectively.
VH and VL: SEQ ID NO: 37 and 8, respectively.
IAV subtype: H3N2 A/Hong Kong/68
One mutation or combination of mutations that extends in vivo half-life: M252Y/S254T/T256E (YTE)
One set of mutations that enhance binding to a FcγR: S239D/I332E
Claims 1-3, 6, 8, 19-20, 36, 65-67, 69, 71-74, 76-77, 82-83, 91-92, 94, 97, and 99 are under consideration.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 16 October 2025 was filed after the mailing date of the Instant Application on 17 May 2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Specification
4. Applicant is reminded of the proper language 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 in length. 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.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
5. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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://, www., or other browser-executable code. See MPEP § 608.01. See Page 24, line 21 and page 56, line 29 of the Instant Specification
6. The use of the term Per. C6 on page 57, line 15, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Note that Per. C6 is merely an example and all improper uses of trademarks in the specification should be identified by Applicant and properly addressed.
Claim Objections
7. Claims 1-2 and 19 are objected to because of the following informalities:
Regarding claims 1 and 19, the flanking commas around “or antigen-binding fragment thereof” should be removed. Examiner is interpreting these claims without those flanking commas.
Regarding claim 1, the SEQ ID NO for CDRH3 appears to be a typo as it does not match the species election. Examiner is interpreting “SEQ ID NO: 8” to mean “SEQ ID NO: 5” for purposes of prior art.
Regarding claim 2, there is a missing “)”.
Appropriate correction is required.
Claim Interpretation
8. In accordance with the Instant Specification, “about” can be up to +/- 20% unless otherwise indicated (Page 8, line 5); “a” or “an” refer to “one or more” (Page 8, lines 8-9); “or” can include one, both, or any combination (Page 8, line 10); “include”, “have”, and “comprise” are used synonymously (Page 7, lines 11-12); and the CDRs are in accordance with any known numbering system (Page 25, lines 13-16).
Claim Rejections - 35 USC § 112
9. 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.
11. Claims 1-3, 6, 8, 19-20, 36, 65-67, 69, 71-74, 76-77, 82-83, 91-92, 94, 97, and 99 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, “An antibody or antigen-binding fragment thereof comprising” can be interpreted to mean both polyclonal and monoclonal antibodies. Therefore, the claim has multiple structural interpretations. In the polyclonal embodiment, one interpretation is that the VH and VL are on the same molecule while a second interpretation is that they are on two separate molecules and the presence of multiple structural interpretations renders the claims indefinite.
Claims 2-3, 6, 8, 36, 65-67, 69, 71-74, 76-77, 82-83, 91-92, 94, 97, and 99, which are dependent on claim 1, are similarly rejected.
Examiner suggests adding “monoclonal” before “antibody” to all of the claims.
Regarding claim 19, there are no defined CDRs and no CDR labeling system, thus rendering the claim indefinite. The claims could read on Kabat, IMGT, or Chothia CDRs, for example, giving multiple structural interpretations. The claims could also read on composite CDRs such as those including both Kabat and IMGT CDRs. The claim may also allow mixing and matching from multiple labeling systems, some from Kabat, some from IMGT, etc. The presence of so many different interpretations renders the claim indefinite.
Similarly, regarding claim 20, the antibody or antigen-binding fragment is structurally indefinite as it is unclear if only one numbering system is being used or if CDRs according to IMGT can include composite CDRs such as those containing Kabat and IMGT CDRs for example. The same is true for any combination of labeling systems for composite CDR generation. The presence of so many different interpretations renders the claim indefinite.
Regarding claim 36, is it unclear if (1)-(14) are alternatives or all required and therefore, there are multiple interpretations.
Regarding claim 67, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Since the phase could be interpreted as an example or a requirement, there are multiple structural interpretations. It is also unclear if the antibody or antigen-binding fragment is human or humanized/chimeric, as it cannot be both.
Regarding claims 73 and 76, it is unclear which Fc amino acid residues are numbered according to the EU numbering system. This limitation could be interpreted to be one Fc amino acid residues, all Fc amino acid residues, or just a portion. Therefore, there are multiple interpretations present. Examiner suggests adding “all” before “Fc amino acid”.
Regarding claim 94, it is unclear if “pharmaceutically” is modifying “excipient” or all 3 items in the list. Since this provides multiple interpretations, the claim is indefinite.
See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
12. 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.
13. Claims 1-3, 6, 8, 36, 65-67, 69, 71-74, 76-77, 82-83, 91-92, 94, 97, and 99 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. This is a new matter rejection.
Claim 6 recites that “the VL comprises or consists of an amino acid sequence having at least 80% identity to the amino acid sequence of SEQ ID NO: 8”. Claim 1 on which it depends defines CDRH3 as SEQ ID NO: 8, which is 109 amino acids and too long to be a CDR. Both the CDRH3 and the VL cannot be defined as SEQ ID NO: 8 and the original claims and original specification do not support this definition/function.
In view of the fact that the examples provided do not demonstrate possession of an antibody with SEQ ID NO: 8 being both the CDRH3 and the VL, and one of ordinary skill in the art at the time of filing would not have recognized the possession of such an antibody, there is insufficient written description support for this antibody.
14. Claim 36 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the 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 36(14) recites that the antibody or antigen-binding fragment binds to H5 HA and/or to H7 HA with a KD, but does not define a lower limit. Therefore, even with six complete CDRs, there will always be an embodiment that is not possessed by Applicant.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the 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. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP § 2163.04.
An applicant may show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613.
MPEP § 2163 states that 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, 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. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, as here in which the antibodies claimed can have any CDR set, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615. “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” One of skill in this art cannot envision the structure of any antibodies that will have an infinitely small KD. The figures provided by Applicant also does not show an infinitely small KD. Therefore, since no species are provided to represent these genera, the claim clearly fails the written description requirement.
15. Claims 1-3, 6, 8, 19-20, 36, 65-67, 69, 71-74, 76-77, 82-83, 91-92, 94, 97, and 99 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 monoclonal antibody comprising a full set of parental CDRs, does not reasonably provide enablement for any antibody molecule with fewer than all parental CDRs or mutated/truncated CDRs. 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.
In making a determination as to whether an application has met the requirements forenablement under 35 U.S.C. 112 ¶ 1, the courts have put forth a series of factors. See, In reWands, 8 USPQ2d 1400, at 1404 (CAFC 1988). The factors considered include: (1) the breadth of the claims, (2) the nature of the invention, (3) the relative skill of those in the art, (4) the amount of direction or guidance provided, (5) the presence of absence of working examples, (6) the state of the prior art, (7) the level of predictability in the art, and (8) the quantity of experimentation necessary.
Claim 1 is drawn to “an” antibody or antigen-binding fragment thereof for binding IAV HA, in which “an” is defined as “one or more”, as discussed above. The antibody or antigen-binding fragment thereof binds to CDRH1-H3 with SEQ ID NOs: 32, 35, and 8, respectively, and CDRL1-3 with SEQ ID NOs: 9-11, respectively. In addition, SEQ ID NO: 8 is not a CDR. Claim 19 is drawn to “an” antibody or antigen-binding fragment for binding IAV HA which binds to the VH and VL with SEQ ID NOs: 37 and 8, respectively. Both of these claims and the Instant Specification do not list a specific CDR numbering system. Claim 20 lists multiple options for CDR numbering systems. Claim 1 appears to be IMGT CDRs, and thus any other numbering system would read on mutated IMGTs. Claim 67 reads on the antibody or antigen-binding fragment being human or humanized/chimeric.
The nature of the invention is an anti-IAV HA antibody, as well as products and methods for making the same.
The level of skill of one of ordinary skill in this art is high.
The specification provides working examples for producing and sequencing an antibody with a full set of parental CDRs from mice, but does not provide working examples for any antibody molecule with fewer than all parental CDRs or mutated/truncated CDRs. In addition, most antibodies within the full breadth of the claims are highly unpredictable in function and would require an undue amount of experimentation in order to reproduce and use as discussed infra.
The instant claims read on a monoclonal or polyclonal antibody that have the CDR sequences claimed. The polyclonal embodiment can have three or six CDRs per molecule and so each antibody molecule need not be defined by a full set (six) parental CDRs. Antibodies defined by fewer than all parental CDRs, in this case six, are not enabled. The minimal enabled antibody structure of a claim includes six complete parental CDRs.
In addition, claims that do not recite the sequences of each CDR by full sequence identifier are not enabled. This is owed to the fact that not all CDR labeling systems provide complete, functional CDRs for antigen binding as discussed infra.
16. The state of the prior art is such that it is well established in the art that the formation of an intact antigen-binding site of antibodies generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs or hypervariable regions, which provide the majority of the contact residues for the binding of the antibody to its target epitope (Paul, Fundamental Immunology, 3rd Edition, 1993, pp. 292-295, under the heading “Fv Structure and Diversity in Three Dimensions”). The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity, which is characteristic of the immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites (Paul, page 293, first column, lines 3-8 and line 31 to column 2, line 9 and lines 27-30).
Additionally, Bendig (Methods: A Companion to Methods in Enzymology, 1995, 8: 83-93) reviews that the general strategy for “humanizing” antibodies involves the substitution of all six CDRs from a rodent antibody that binds an antigen of interest, and that all six CDRs are involved in antigen binding (see entire document, but especially Figures 1-3). It is noted that Bendig used Kabat CDRs in their humanization process (Pg. 86, Column 2, Paragraph, second). Similarly, the skilled artisan recognized a “chimeric” antibody to be an antibody in which both the heavy chain variable region (which comprises the three heavy chain CDRs) and the light chain variable region (which comprises the three light chain CDRs) of a rodent antibody are recombined with constant region sequences from a human antibody of a desired isotype (see entire document, but especially Figures 1-3). Therefore, the instant antibody or antigen-binding fragment in claim 67 cannot be both humanized/chimeric and human.
Thus, the state of the art recognized that it would be highly unpredictable that a specific antibody comprising less than all six parental CDRs would have antigen binding function. The minimal structure which the skilled artisan would consider predictive of the function of binding the antigen of a murine or humanized antibody includes six CDRs (three from the heavy chain variable region and three from the light chain variable region) in the context of framework sequences which maintain their correct spatial orientation and have the requisite binding function. One of skill in the art would neither expect nor predict the appropriate functioning of the antibody fragments and mutated antibodies of the instant claims as broadly as claimed.
In the case of antibodies, it is especially important to disclose which residues are permissive to mutation. Even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function as evidenced by Rudikoff (Proc. Natl. Acad. Sci. USA, 1982, 79: 1979-1983). Rudikoff teaches that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function (Abstract).
Not knowing, absent further experimentation, which modifications function and which do not, when, as set forth above, even a single change of an encoded amino acid can unpredictably affect antibody structure and function, leads to one having no predictability or expectation of success for the function of any given antibody modification. Such random experimentation to identify at a later time what structure or fragment or modification is or is not functional and is embraced by Applicant’s claims is undue experimentation.
Moreover, claims not containing elements critical or essential to the practice of the invention, such as antibodies or antibody fragments not having all of the relevant functional complementarity determining regions (CDRs) in the proper site on an appropriate antibody heavy or light chain framework, are not enabled by the disclosure. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). Note that an enabling disclosure for the preparation and use of only a few analogs of a product does not enable all possible analogs where the characteristics of the analogs are unpredictable. See Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ 2d 1027 (CAFC 1991).
Examiner suggests the term "monoclonal" be added before the recitation of "antibody". Method claims using these products should also carry the appropriate adjectives.
17. Furthermore, even if all claims recited monoclonal antibodies and both the antibody and antigen binding fragment required all currently recited CDRs, would not be enabled when they do not provide six Kabat or IMGT CDRs by sequence. It is not clear that just any of the CDR sets of claim 20 or just any CDR encompassed by claim 19 is based on a CDR labeling system that yields CDRs that can be used, for example in humanization, to make a functional antibody with a new framework. As mentioned above in the works of Bendig, Kabat CDRs can be moved to a different framework, such as during humanization, and confer antigen binding. IMGT CDRs have been used to define antibodies in US patents and so are considered enabled also. Generic CDRs or those of other labeling systems encompass or amount to no more than mutated Kabat or IMGT CDRs.
Therefore, even a monoclonal antibody comprising the CDRs of claims 1 (which lacks all six CDR sequences owed to SEQ ID NO. 8) and 19-20 are not enabled. Barring experimental evidence, such mutated CDRs would be insufficient to confer antigen binding function. See the work of Rudikoff supra. Applicant is requested to explain how they arrived at the instant CDR set. It is noted that Kabat CDRs and IMGT CDRs have been used in US patents to define antibodies. It is not clear that either of these systems applies to the instant CDRs, however. Also, ¶ [0085] of the PGPub of the Instant Application US20240317841 teaches CDRs refer to sequences of amino acids within antibody variable regions, which, in general, together confer the antigen specificity and/or binding affinity of the antibody. Therefore, if the CDRs of instant claims with sequence identifiers thereof are IMGT CDRs, Applicant has defined them as necessary for antigen binding and therefore logically, no other CDR system should be used to define the antibody CDRs. Other systems would lack one or more IMGT CDR residues defined to be required for antigen binding here.
In view of the lack of the predictability of the art to which the invention pertains as evidenced by the art above, the lack of guidance and direction provided by applicant, and the absence of working examples, undue experimentation would be required to make and use functional antibody molecules comprising fewer than all six complete parental CDRs with a reasonable expectation of success, absent a specific and detailed description in applicant’s specification of how to effectively practice this and absent working examples providing evidence which is reasonably predictive that the claimed antibodies are functional, commensurate in scope with the claimed invention.
As a final point, in claim 67, only human or humanized and chimeric are enabled but not both. Humanized and chimeric antibodies have non-human CDRs. Human antibodies have human CDRs. Therefore, the antbidoy of claim 1 cannot have both human and non-human CDRs. The recited antibody appears to have human CDRs based on example 1. Appropriate correction is required.
18. Claims 91-92 and 97 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 isolated vectors and cells, does not reasonably provide enablement for unisolated vectors and cells. 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/or use the invention commensurate in scope with these claims.
The claims recite a vector or a host cells, which include includes transgenes and transgenic animals respectively since neither is isolated.
The nature of the invention are products and methods for making an antibody.
The level of skill of one of ordinary skill in this art is high.
The specification gives definitions for “isolated”, but does not indicate that the vectors and host cells are isolated. Therefore, these words will be given their broadest reasonable interpretation to one of ordinary skill in the art as discussed above. With respect to transgenes within animals and transgenic animals themselves, none were made here.
With respect to the unisolated host cells and vectors as transgenes, the state of the art at the time of filing was such that one of skill could not predict the phenotype of transgenics. The art of transgenic animals has for many years stated that the unpredictability lies, in part, with the site or sites of transgene integration into the target genome and that "the position effect" as well as unidentified control elements are recognized to cause aberrant expression of a transgene (Wall et Al., Theriogenology, 1996, 45: 57-68).
The elements of the particular construct used to make transgenic animals are also held to be critical, and they must be designed case by case without general rules to obtain good expression of a transgene; e.g., specific promoters, presence or absence of introns, etc. (Houdebine et Al., J. Biotechnol., 1994, 34: 269- 287). Furthermore, transgenic animals are regarded to have within their cells, cellular mechanisms that prevent expression of the transgene, such as methylation or deletion from the genome (Kappell et Al., Current Opinions in Biotechnology, 1992, 3: 548-553). Houdebine (Comparative Immunology, Microbiology, and Infectious Diseases, 2009, 32: 107-121) teaches progress has been made in the field of transgenic animals for production of foreign proteins (Abstract); however, constructing an efficient expression vector to produce a therapeutic protein is not a standard operation (Pg. 116, Paragraph, second). Therefore, undue experimentation is required to make and use a transgene and transgenic animal to produce the antibody and antibody fragments of the instant claims.
The Examiner notes here, in addition to these issues, even assuming arguendo PHOSITA could make a host organism with functional transgene that encodes the instantly recited antibody, there is no predictability that the host will survive its expression. The transgene depends on the host for function and harm to the host, including death, renders the transgene nonfunctional and thus not enabled.
The art is well-aware of side effects caused by therapeutic antibodies such as the one instantly recited. In a transgenic cell or animal that expresses the same, the antibody will exert any possible side effect it can. It is not administered but chronically present and so such side effects are chronic and potentially more serious than any from an administered antibody. Hansel (Nat. Rev. Drug. Discov., 2010, 9: 325-337) teaches in their table 1 on page 328 numerous exemplary side effects from licensed monoclonal antibodies to include: increased bleeding risk, infection, heart failure, cancer, thyroid disorder, autoimmune reactions, and cytokine release syndrome (CRS) to name only a few. One or more such effects, or similar, may occur with the therapeutic antibody instantly recited when administered and indeed be exacerbated by chronic exposure due to internal expression. The instantly encoded antibody may very well target related or unrelated proteins in the transgenic host, leading to such side effects. For all these reasons, transgenes in transgenic animals and the animals themselves are not enabled.
At the time of filing, the phenotype of a transgene and transgenic cell contained within any animal was unpredictable. The claims as written, encompassing a transgene and cell in a transgenic animal, is not adequately described in the specification as to prevent excessive experimentation by the public to generate and use the invention. Applicants can obviate the instant rejection by amending the claim to recite the term "isolated" before the recitation "host cell" and by amending the vector and polynucleotide claims to specify they are not in a transgenic animal using, for example, “isolated”. Applicant may consider using purified in such claims if description is appropriate for such a term and it is not redefined away from standard meaning. Method claims using these products should also carry the appropriate adjectives above.
In view of the lack of the predictability of the art to which the invention pertains as evidenced by the art above, the lack of guidance and direction provided by Applicant, and the absence of working examples, undue experimentation would be required to make and use functional transgenes and transgenic animals encompassed by the instant claims.
Double Patenting
19. 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.
20. Claims 1-3, 6, 8, 19-20, 36, 65-67, 69, 71-74, 76-77, 82-83, 91-92, 94, 97, and 99 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 13 of copending Application No. 18/253,386 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 10 of ‘386 is drawn to an anti-IAV HA antibody or antigen-binding fragment with a VH and VL that has a 100% identity to the elected VH and VL of the Instant Application:
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302
624
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VH sequence SEQ ID NO: 37 for both applications.
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232
633
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VL sequence SEQ ID NO: 8 for both applications.
Claim 13 of ‘386 reads on the elected CDRH1-3 and CDRL1-3 of the Instant Application:
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140
626
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CDRH1 sequence SEQ ID NO: 32 for both applications
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145
628
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CDRH2 sequence SEQ ID NO: 35 for both applications.
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148
622
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CDRH3 sequence SEQ ID NO: 5 for both applications.
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148
622
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CDRL1 sequence SEQ ID NO: 9 for both applications.
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145
618
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CDRL2 sequence SEQ ID NO: 10 for both applications.
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147
617
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CDRL3 sequence SEQ ID NO: 11 for both applications.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Art-Free Subject Matter
21. A monoclonal antibody comprising CDRH1-3 with SEQ ID NOs: 32, 35, and 5, respectively and CDRL1-3 with SEQ ID NOs: 9-11, respectively is currently free of the prior art.
Conclusion
22. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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