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 04/24/2026 in response to the Office Action of 02/24/2026 is acknowledged and has been entered.
Applicant has elected Group I, claims 1-7 and 9-15, drawn to an antibody binding specifically to CD55 or an antigen-binding fragment thereof, comprising a heavy chain variable region comprising an HCDR1 region having an amino acid sequence represented by the general formula 1; an HCDR2 region having an amino acid sequence of SEQ ID NO 1; and an HCDR3 region having an amino acid sequence
represented by the general formula 2:
General formula 1
D-R-G-M-X1
General formula 2
N-A-X2-A-G-G-W-H-A-A-Y-I-D-A
wherein X1 is Ala or Val, and X2 is selected from a group consisting of Val, Ala, Ile, Leu,
Phe and Met.
Additionally, the Applicant has elected the species of anti-CD55 antibody wherein X1 is Ala and X2 is Val, as exemplified by SEQ ID NOs: 4 and 5 (EP-10H antibody), an anti-CD20 as species of pharmaceutical ingredient.
3. Claims 1-21 are pending in the application. Claims 8, 12 and 16-21 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 04/24/2026.
4. Claims 1-7, 9-11 and 13-15 are currently under prosecution.
Priority
5. Applicant’s claim under 35 U.S.C. §§ 365(c) for benefit of the earlier filing date of application is acknowledged.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Improper Markush Grouping Rejection
6. Claims 1 and 6 are 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 recited in claims 1 and 6 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 do not share a “single structural similarity”.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
7. 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.
8. 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.
9. Claims 1-7, 9-11 and 13-15 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.
In this instance, claims 1, 4 and 6 are drawn to an anti-CD55 antibody comprising formula 1: D-R-G-M-X1,
formula 2: N-A-X2-A-G-G-W-H-A-A-Y-I-D-A, wherein X1 is Ala or Val, and X2 is selected from a group consisting of Val, Ala, Ile, Leu, Phe and Met; and
formula 3: W-N-X3-K-R-P-S, wherein X3 is Asn or Asp.
Claim 1 recites an amino acid sequence of SEQ ID NO 1. Claim 4 recites an amino acid sequence of SEQ ID NO 2 and an amino acid sequence of SEQ ID NO 3. An amino acid sequence of SEQ ID NO: 1, 2 or 3 includes any fragment of SEQ ID NO: 1, 2 or 3.
The specification only teaches anti-CD55 antibodies: 4-1H, G4-1H, EP-1E, EP-1F, EP-9B, 3R-2-1H and EP-10H; see Examples 1 and 6.
Thus, the claims are broad drawn to a genus of anti-CD55 antibodies comprising formulas 1-3, and any fragment of SEQ ID NO: 1, 2 or 3.
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 formulas 1-3, and any fragment of SEQ ID NO: 1, 2 or 3. Although the Specification teaches anti-CD55 antibodies: 4-1H, G4-1H, EP-1E, EP-1F, EP-9B, 3R-2-1H and EP-10H; however, these antibodies do not represent the claimed a genus of anti-CD55 antibodies comprising formulas 1-3, and any fragment of SEQ ID NO: 1, 2 or 3.
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 anti-CD55 antibodies comprising formulas 1-3, and any fragment of SEQ ID NO: 1, 2 or 3, 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.
Conclusion
10. No claim is allowed.
11. The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure. KR101800774 (published on 11/24/2017, IDS) could be considered as the closest prior art. KR101800774 teaches the instant claimed SEQ ID NOs: 1-3 and formula 1 and 3; however, SEQ ID NO: 7 (NAGAGGWHAAYIDA) of KR101800774 is different with the instant claimed formula 2 (NAX2AGGWHAAYIDA), wherein X2 is selected from a group consisting of Val, Ala, Ile, Leu, Phe and Met.
12. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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