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 .
Claim Status
This action is in response to the papers filed on 4/13/2026. Claims 1-16, 18, 20 and 22-27 are currently pending. Claims 12 and 20 have been amended and claims 1-11, 14, 16, 18, 26, and 27 have been withdrawn by Applicants’ amendment filed on 4/13/2026.
Applicant's election with traverse of claims 12 – 13, 15, 20 and 22 – 25 in the reply filed on April 13, 2026, is acknowledged. The traversal is on the ground(s) that the restriction requirement be reconsidered because the Office Action has not shown that a serious burden would be required to examine all of the claims. This is not found persuasive because the claims do not share a special technical feature and are directed to multiple products and multiple methods.
Moreover, Applicants traverse that the combined teachings of Chen and Georgiou would not have been obvious as the “invention is not merely the fusion protein. Rather, the inventive concept lies in the use of an oncolytic virus to locally express a highly cytotoxic Fe-active PD-Ll targeting fusion protein in tumors, thereby overcoming the toxicity barrier that prevented such constructs from being used systemically.” This is not found persuasive. As set forth at pages 4-5 of the restriction requirement filed on 2/13/2026, the combined teachings of Chen and Georgiou render obvious to use the hybrid IgG/IgA Fe domain of Georgiou et al. in the PD-I fusion protein of Chen et al. in order to make a binding molecule with the advantageous binding properties disclosed by Georgiou et al.. Because claim 12 is rendered obvious by Chen and Georgiou, the remaining claims lack the same or corresponding special technical feature and as such, lack unity. The expression “special technical features” means those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. The requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features.
The requirement for restriction between Groups I – IV is still deemed proper and is therefore made FINAL.
Claims 1 – 11, 14, 16, 18, 26 and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on April 13, 2026.
Therefore, claims 12 – 13, 15, 20 and 22 – 25 are currently under examination to which the following grounds of rejection are applicable. Claims 12 and 20 are independent claims.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/FI2022/050070, filed February 4, 2022.
This application is claiming the benefit under 35 U.S.C. 119(e) of prior-filed Finland applications FI20215115 filing date 02/04/2021.
However, there is no record of the certified priority document(s) for the Finland publications on file for this application.
Thus, the earliest possible priority for the instant application is February 4, 2021.
Claim Rejections - 35 USC § 112
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.
Claims 15, 20, 22 and 23 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.
Claims 15, 22 and 23 recite the term “and/or” in lines 4, 5, and 6, respectively. Markush groups using the conjunction “or” and “and” is confusing. The metes and bounds of the claims are indefinite.
Claim 15 is indefinite in its recitation of “the vector is a viral vector, wherein a virus of the viral vector” in line 2 as it is unclear how a virus is contained or is part of a viral vector. As such the metes and bounds of the claim are indefinite.
Claim 20 is indefinite in the recitation of “to be expressed to said cross-hybrid Fc-fusion polypeptide in a cell” since the phrase “to be expressed” refers to a latent ability, and it is unknown whether the ability is expressed or observed in the invention. Additionally, the recitation of “said cross-hybrid Fc-fusion polypeptide” in this context is unclear. Appropriate correction is requested.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 12, 13, 15, 20 and 22 – 25 are rejected under 35 U.S.C. 103 as being unpatentable over Krajewska et al. (Analysis of soluble high-affinity PD1 variants, 1 May 2020 (2020-05-01); cited on IDS, hereinafter Krajewska) in view of Borrok et al. (Enhancement of antibody-dependent cell-mediated cytotoxicity (ADCC) by endowing IgG with Fc[alpha]RI (CD89) binding, MABS, vol. 7, no. 4, 4 July 2015; cited on IDS, hereinafter Borrok) as evidenced by Pecker et al. (W.O. Patent Application No. 2020/012485 A1; hereinafter Pecker) .
Regarding claims 12, 13, 15 and 20, Krajewska discloses an adenovirus engineered (p. 29, 2.15. Adenoviral vector…) to express soluble PD1 as a fusion protein in frame with the hinge, CH2, and CH3 domains of human IgG1 (p.47, para. 1; Fig. 3.1.1). Krajewska further discloses that the ability to mediate ADCC and complement-dependent cytotoxicity (CDC) makes IgG1-Fc desirable in oncological therapies which selectively target tumor cells for destruction and therefore may increase the effectiveness of this soluble construct as a therapeutic (p. 59, par. 2).
Krajewska does not disclose a construct that comprises the constant (biologically active) region of IgG or IgA.
However, Borrok discloses the construction of IgG1/IgA2 tandem antibodies (Fig. 1) in order to promote antibody-dependent cell-mediated cytotoxicity (ADCC). Amino acids 221 to 441 of IgA2-Fc are genetically fused to the IgG1 C-terminus with the IgA2 hinge (221 – 229) serving as a linker between the two Fc domains. To prevent dimerization, the cysteine tailpiece of IgA was not included (p. 744, right-hand column, par. 2 – p. 745, left-hand column, par. 1). The cross-hybrid molecules based on IgG1 and IgA can offer advantages in the treatment of cancer, by enhancing and broadening the effector function over each of IgG1 and IgA. Regarding claim 20, Krajewska discloses using mesenchymal stem cells (Abstract) as an alternative drug delivery method for delivering the treatment (construct) to the pancreas.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to improve the cytotoxic effect of the soluble PD1 fusion polypeptide of Krajewska, by combining/modifying the construct with the hybrid tandem IgG1/IgA molecules of Borrok. The motivation in doing so would be to enhance antibody-dependent cell-mediated cytotoxicity, as recognized by Borrok.
Regarding claims 22 and 23, Pecker discloses a polynucleotide encoding the region of PD-1, SEQ ID NO:146, which is an 81.2% query match to SEQ ID NO: 7 of instant claims 22 and 23.
Regarding claims 24 and 25, Although, Krajewska and Borrok do not explicitly disclose a pharmaceutical composition comprising the polynucleotide or the vector of claims 12 and 13, respectively; Borrok does disclose improving antibody-based immunotherapy (p. 749, left-hand column, par. 2) as the end goal for the invention. Furthermore, as stated above, Krajewska suggests and provides motivation by disclosing that the ability to mediate ADCC and complement-dependent cytotoxicity (CDC) makes IgG1-Fc desirable in oncological therapies (p. 59, par. 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the combined invention of Krajewska and Borrok as a pharmaceutical composition. Doing so would improve antibody-based immunotherapy and oncological therapies, as recognized by Borrok and Krajewska, respectively.
Allowable Subject Matter
The sequence searches for SEQ ID NOs: 6, 8, and 9 did not register a match, within the limitations, for each component of claims 22 and 23; thereby marking the sequences free of the art.
Conclusion
Claims 12 – 13, 15, 20 and 22 – 25 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WALTER JACKSON III/Examiner, Art Unit 1638
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
Prosecution Insights