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 .
DETAILED ACTION
2. The election without traverse filed 03/03/2026 in response to the Office Action of 01/14/2026 is acknowledged and has been entered.
Applicant has elected Group I, claims 1-2, 4-5, 7-12, 22-24 and 27, drawn to an antibody or an antigen-binding fragment specifically binding to CD5, wherein the antibody or the antigen-binding fragment comprises a CDR1, a CDR2, and a CDR3; the CDR1, the CDR2, and the CDR3 comprise an HCDR1, an HCDR2, and an HCDR3
selected from a VHH domain set forth in any one of SEQ ID NOs: 6-16; or the CDR1, the CDR2, and/or the CDR3 comprise amino acid sequences having at most 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 mutation on the HCDR1, the HCDR2 and/or the HCDR3; the mutation may be selected from an insertion, a deletion, and/or a substitution; the substitution is preferably a substitution of conserved amino acids.
Additionally, Applicant has elected SEQ ID NO: 8 as species of VHH, wherein the HCDR1, the HCDR2, and the HCDR3 have amino acid sequences set forth in SEO ID NOs: 38-40.
Upon review and reconsideration, SEQ ID NOs: 6-7 and 9-16 will be rejoined with SEQ ID NO: 8 for examination.
3. Claims 1-2, 4-5, 7-12, 15-19, 22-24 and 27-28 are pending in the application. Claims 15-19 and 28 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/03/2026.
4. Claims 1-2, 4-5, 7-12, 22-24 and 27 are currently under prosecution.
Priority
5. Applicant’s claim under 35 U.S.C. §§ 365(c) for benefit of the earlier filing date of applications, is acknowledged.
6. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Objections
7. Claim 2 is objected to because claim recites, “the HCDR1, the HCDR2, and the HCDR3 are selected from Table 3”. Claims must, under modern claim practice, stand alone to define invention, and incorporation into claims by express reference to specification and/or drawings is not permitted except in very limited circumstances. See Ex parte Fressola, 27 USPQ2d 1608 (BPAI, 1993). See M.P.E.P. § 2173.05(s), which states:
“Where 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).
Appropriate correction is required.
Improper Markush Grouping Rejection
8. Claim 2 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 706.03(y).
The Markush grouping of antibodies or the antigen-binding fragments (SEQ ID NOs recited in claim 2) is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: because the antibodies or the antigen-binding fragments do not share a “single structural similarity”.
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.
10. 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, 7, 9, 10, 12 and 24 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.
1) Claims 1, 9, 10 and 12 recite the phrase "preferably" or “more preferably”, the phrase "preferably" or “more preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05.
Regarding claims 12 and 24, the phrase "may be" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "may be"), thereby rendering the scope of the claim(s) unascertainable.
2) Claim 7 recites the limitation "the single-domain antibody" in line 2. There is insufficient antecedent basis for this limitation in the claim.
12. 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.
13. 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.
14. Claims 1-2, 4-5, 7-12, 22-24 and 27 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a “written description” rejection.
The considerations that are made in determining whether a claimed invention is supported by an adequate written description are outlined by the published Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, para. 1, ``Written Description'' Requirement (Federal Register; Vol. 66, No. 4, January 5, 2001; The 2015 Written Description Workshop materials; hereinafter “Guidelines”).
These guidelines state that rejection of a claim for lack of written description, where the claim recites the language of an original claim should be rare. Nevertheless, these guidelines further state, “the issue of a lack of written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant has possession of the claimed invention” (Id. at 1105). The “Guidelines” continue:
The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art. This problem may arise 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 lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.
With further regard to the proposition that, as original claims, the claims themselves provide in haec verba support sufficient to satisfy the written description requirement, the Federal Circuit has explained that in ipsis verbis support for the claims in the specification does not per se establish compliance with the written description requirement:
Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). See also: University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 1892 (CA FC 2004).
Thus, an original claim may provide written description for itself, but it must still be an adequate written description, which establishes that the inventor was in possession of the invention.
1) In this instance, claims 1, 4-5 and 7 are drawn to an antibody comprising CDR1-3 comprise amino acid sequences having at most 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 mutation on the HCDR1, the HCDR2 and/or the HCDR3 of SEQ ID NOs: 6-16; or a single-domain antibody comprises a sequence having at most 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 mutation compared with the FR region in the VHH domain set forth in any one of SEQ ID NOs: 6-16, or a sequence having at least 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% identity to SEQ ID NOs: 6-16.
Thus, the claims are drawn to a genus of antibodies or a single-domain antibody comprising mutations on the HCDR1, the HCDR2 and/or the HCDR3 of SEQ ID NOs: 6-16, or a sequence having at least 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% identity to SEQ ID NOs: 6-16.
Claim 2 is drawn to the antibody or the antigen-binding fragment according to claim 1 comprises HCDR1-3 comprising SEQ ID NOs: 17-106.
Thus, the claim 2 is drawn to a genus of antibodies or antigen-binding fragments comprising a miss-matched CDRs.
Additionally, claims 1-2 and 4 include an antibody or an antigen-binding fragment only comprising CDR1, CDR2 or CDR3.
It is well known in the art that 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 et al (Proc. Natl. Acad. Sci. USA, 79(6):1979-1983, March 1982). Rudikoff et al. teach 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. Colman P. M. (Research in Immunology, 145:33-36, 1994) teaches that even a very conservative substitution may abolish binding or may have very little effect on the binding affinity (see pg. 35, top of left column and pg. 33, right column).
Applicant is reminded that “generalized language may not suffice if it does not convey the detailed identity of an invention.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1892 (CAFC 2004).
In this instance, there is no language that adequately describes with any of the requisite clarity or particularity the claimed genus of antibodies comprising mutations on the HCDR1, the HCDR2 and/or the HCDR3 of SEQ ID NOs: 6-16, or 80%-99% identity to SEQ ID NOs: 6-16, or a miss-matched CDRs, or only comprising CDR1, CDR2 or CDR3.
While the written description requirement can by satisfied without an actual reduction to practice, the disclosure of a catalog of potentially effective substances that might be found to be useful in practicing the claimed invention does not fulfill the written description requirement.
Finally, Guidelines states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was ‘ready for patenting’ such as by 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” (Id. at 1104). “Guidelines” further states, “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus” (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. Moreover, because the claims encompass a genus of antibodies comprising mutations on the HCDR1, the HCDR2 and/or the HCDR3 of SEQ ID NOs: 6-16, or 80%-99% identity to SEQ ID NOs: 6-16, or a miss-matched CDRs, or only comprising CDR1, CDR2 or CDR3; but which otherwise vary materially, structurally and/or functionally, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. In this instance, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; Applicant has not shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; and Applicant has not described distinguishing identifying characteristics sufficient to show that Applicant was in possession of the claimed invention at the time the application was filed.
2) Turning to another issue, claim 8 is drawn to the antibody is a fully human antibody.
The specification teaches generation Vicugna pacos antibody (see Example 1), the specification does not teach generation a human antibody. Thus, claim 8 is broadly drawn to a human antibody, because the Vicugna pacos antibodies do not have human sequences. It is submitted that one cannot make a human antibody using CDRs derived from a Vicugna pacos antibody. One could make a chimeric or humanized antibody having the requisite structure but not a "human" antibody. The structures of the claimed human antibody cannot be readily envisioned without actually possessing the antibody. Thus, even if undue experimentation might not be required in order to obtain the human antibody, the Applicants cannot be considered described until they actually have been obtained. See also two CAFC decisions on this issue, for example, Centocor Ortho Biotech v. Abbott Labs, 97 USPQ2d 1870 (Fed. Cir. 2011), and AbbVie Deutschland GmbH v. Janssen Biotech, 111 USPQ2d 1780 (Fed. Cir. 2014).
3) Turning to a different issue, claim 24 is drawn to a method for treating a disease in a subject, wherein the disease is cancer or autoimmune disease. However, the specification does not provide any data for treating a subject with a disease, wherein the disease is cancer or autoimmune disease.
One ordinarily skilled in the art knows that each disease is an etiologically and/or pathologically distinct disease. Thus, there is no one particularly identifying etiologically and/or pathologically feature that is shared by the members of the genus of disease and any one particularly identifying etiologically and/or pathologically feature that is also shared by at least most of its members, which might permit the skilled artisan to immediately envision, recognize or distinguish at least a substantial number of the disease to which the claim refers.
It is well known that therapeutic art for treating a subject with a disease is highly unpredictable. Given the unpredictability of therapeutic art and the teachings of the specification, it is clear that it is not possible to predictably extrapolate the claimed invention. Therefore, it is submitted that the claimed treating a subject with a disease is not adequately described with the requisite clarity and particularity to reasonably convey to the skilled artisan that Applicant had possession of the claimed invention as of the filing date of the application.
The Federal Circuit has decided that a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated. See Noelle v. Lederman, 69 USPQ2d 1508 1514 (CA FC 2004) (citing Enzo Biochem II, 323 F.3d at 965; Regents, 119 F.3d at 1568).
Thus, it is submitted that the instant claims, and the disclosure describing the claimed subject matter, fails to satisfy the written description requirement set forth under 35 U.S.C. § 112, first paragraph.
Conclusion
15. No claim is allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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