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 .
Election/Restrictions
Applicant’s election of Group II (Claims 4-5; drawn to an ex vivo or in vitro method for increasing the likelihood of a fertilized oocyte or preimplantation embryo to become implanted during in vitro fertilization) in the reply filed on January 5, 2026, is acknowledged.
Claims 1-3 and 6-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Groups II and III), there being no allowable generic or linking claim.
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)).
Applicant further elected the following species:
a. proteins/peptide structures
DETAILED ACTION
The amended claims filed on January 5, 2026, have been acknowledged. Claims 1-14 are pending. In light of the Applicant’s elected species, claims 1-3 and 6-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 4-5 are pending and examined on the merits.
Priority
The applicant claims foreign priority from EP19205450.0 filed on October 10, 2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, received April 25, 2022. Claims 4-5 find support in foreign application EP19205450.0 filed on October 10, 2019.
Information Disclosure Statement
The information disclosure statements (IDS) filed on April 25, 2022, September 10, 2024, September 12, 2024, and May 28, 2025, have been considered.
Claim Rejections - 35 USC § 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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fuzzi et al. (Eur. J. Immunol. 32: 311–315. 2002), as evidenced by Uniprot (P17693 · HLAG_HUMAN) and Jurisicova et al. (Proc. Natl. Acad. Sci. USA 93: 161-165. 1996).
As an initial matter, the only active method steps of claim 4 are considered to be culturing an isolated oocyte or preimplantation embryo in the presence of an HLA protein or peptide as defined in claim 1. The limitation “increasing the likelihood of a fertilized oocyte or preimplantation embryo to become implanted during in vitro fertilization of a female” does not require that the fertilized oocyte or embryo is transferred for implantation nor does it require that undergoes the fertilized oocyte or embryo undergoes implantation. Furthermore, the claim does not require that the HLA protein/peptide is responsible for the increased likelihood.
As such, claim 4 broadly encompasses culturing an isolated oocyte or preimplantation embryo that expresses an HLA protein or peptide as defined in claim 1.
Fuzzi teaches that they collected unfertilized oocytes, performed IVF or ICSI, and cultured the fertilized oocytes to generate blastocysts. Fuzzi identified the presence of sHLA-G molecules in culture supernatants of early embryos obtained by in vitro fertilization (IVF) before transfer and positive embryo implantations occurred only in women showing sHLA-G molecules in culture supernatants (Abstract and page 312, column 1, paragraph 2-page 314, column 2, paragraph 2).
Uniprot (P17693 · HLAG_HUMAN) evidences that the consensus wild type sequence for human soluble HLA-G (also known as HLA-G1 sol or HLA-G5) is 93.2% similar to SEQ ID NO: 11 and would fall within the limitations of the claim (page 11).
Therefore, Fuzzi teaches culturing preimplantation blastocysts that express and release soluble HLA-G into the culture media and that this expression is considered to increase the likelihood of implantation.
Regarding claim 5, Fuzzi identifies that they did not detect soluble HLA-G expression from unfertilized oocytes. Fuzzi does not teach examining soluble HLA-G expression from fertilized oocytes, only from early embryos.
However, Jurisicova teaches that they cultured unfertilized embryos and blastocysts and found that they expressed HLA-G (Whole document).
Uniprot (P17693 · HLAG_HUMAN) evidences that the consensus wild type sequence for human HLA-G (also known as HLA-G1) is 99.1% similar to SEQ ID NO: 11 and would fall within the limitations of the claim (page 11).
Therefore, the oocytes of Fuzzi would express HLA-G and , as identified above, post-fertilization expression of soluble HLA-G (an isoform of HLA-G1) increases the rate of implantation.
Conclusion
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/KEENAN A BATES/Examiner, Art Unit 1631