DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's election with traverse of the invention of Group I and the Species of factor H in the reply filed on 12/26/2025 is acknowledged.
This is unpersuasive, because search burden is not a consideration in national stage applications submitted under 35 USC 371, which are evaluated for unity of invention under 37 CFR 1.499 and 37 CFR 1.475.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 39-40 are withdrawn from further consideration by the Examiner under 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1-4, 7, 10-12, 14, 16-17, 21-24, 27, 31, 33-34 and 38 are presently under consideration.
3. 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.
4. Claims 1-4, 7, 10-12, 14, 16-17, 21-24, 27, 31, 33-34 and 38 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claims 1, 17 and 24 are indefinite as being in improper Markush format. The Office recommends the use of the phrase "selected from the group consisting of ..." with the use of the conjunction "and" rather than "or" in listing the species. See MPEP 803.02.
(ii) Claims 1 and 17 are further indefinite in the recitation of “factor H (FH), CD55, CD46, CD59, and CR1, or a functional fragment thereof,” because it is unclear whether the claim is limited to functional fragments of CR1, or encompasses functional fragments of all listed proteins.
Likewise, claim 1 is indefinite in the recitation of “an IgG Fc domain and a human serum albumin, or a functional fragment thereof,” because it is unclear whether the claim is limited to functional fragments of human serum albumin, or also encompasses functional fragments of an IgG Fc domain.
Similarly, claim 24 is indefinite in the recitation of “CD59 and CD55, or a functional fragment thereof,” because it is unclear whether the claim is limited to functional fragments of CD55, or also encompasses functional fragments of CD59.
(iii) Claims 1, 17 and 24 are further indefinite in the recitation of “functional” fragments of the respective proteins, because it is unknown which function(s) are encompassed by the claims.
(iv) Claim 16, and claims 17, 21-24, 27, 31, 33-34 and 38 dependent thereon, are indefinite as being dependent on canceled claims. Accordingly, claims 16-17, 21-24, 27, 31, 33-34 and 38 are not been further examined on the merits.
(v) Claims 2-4, 7, 10-12, 14, 16-17, 21-24, 27, 31, 33-34 and 38 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
5. 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.
6. Claims 1-4, 7, 11 and 14 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Bao et al. (US 20190071477).
Bao teaches a fusion protein comprising complement Factor H (CFH) fused to an IgG Fc domain (e.g. claims 1 and 6-8). Additional amino acid sequences are fused to the CFH-Ig fusion protein, including CRIg and serum albumin (e.g. [0046]). Accordingly, the fusion proteins taught by Bao are within the scope of instant claim 1.
Claim 2 is included in the rejection, because SEQ ID NO: 6 is the amino acid sequence of CRIg extracellular domain, and as such is inherently present in in Bao’s fusion protein.
Claims 3, 4 and 11 are included, because they encompass all possible orders of the respective domains.
Claim 7 is included, because SEQ ID NO: 8 is the amino acid sequence of factor H, and as such is inherently present in in Bao’s fusion protein.
Claim 14 is included, because Bao teaches that the IgG Fc domain is from IgG1 or IgG4 (e.g. [0038]).
7. The following prior art references, cited of record but not presently relied upon, teach various embodiments or features of the present invention:
US 20160326231 (cited in the previous office action)
US 20220220169
US 20070190054
US 20220233756
US 20220009979
Cserhalmi et al. (2016) In vitro evaluation of a CRIg-factor H hybrid complement inhibitor. Immunobiology, Vol. 221, p. 1176. Abstract #101 (cited on IDS)
Hu et al. (2018) Complement Inhibitor CRIg/FH Ameliorates Renal Ischemia Reperfusion Injury via Activation of PI3K/AKT Signaling. Journal of immunology 201: 3717-3730.
8. Conclusion: no claim is allowed.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644