DETAILED ACTION
Notice of Pre-AlA or AIA Status
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. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 15, 2026, has been entered.
Claim Disposition
3. Claims 2-3, 5, 7-9, 11 and 13-17 are cancelled. Claims 1, 4, 6, 10, 12 and 18-35 are pending. Claims 1, 4, 6, 10 and 12 are under examination. Claims 18-35 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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.
4. Claims 1, 4, 6, 10 and 12 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-AlA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention as amended is directed to “a recombinant protein comprising an Fc-binding polypeptide with an N-terminus spacer….wherein the N-terminal spacer comprises an amino acid sequence selected from the group consisting of the more than 10 sequences (see claim 1 in its entirety), however, the claim language has no functional or structural limitation per se. The claimed invention as set forth in claim 1 encompasses a large variable genus of structures and only provides the structure of the spacer but not the fusion partners or the activity of the fusion protein. Having the structure of the spacer does not give an ordinary skilled worker a glimpse of the structure of the recombinant protein or the Fc binding polypeptide. Thus the claim is completely devoid of any structural or functional limitations for the recombinant protein. Therefore, no correlation is made between structure and function. The claim language broadly reads on any recombinant protein from any source and any length with no requirement for activity. Therefore, no correlation is made between structure and function for the protein and claim 1 needs to stand on its own. The claimed invention as a whole encompasses a large variable genus of structures and organisms and lacks functional limitation. The specification discloses E. coli, however the claims encompass a large variable genus of gram negative bacteria. The dependent claims hereto do not rectify the missing information. One of ordinary skill in the art would not have a glimpse of the recombinant polypeptide with just knowing the two amino acids on the N-terminal spacer or that the Fc-binding polypeptide alpha helix has 14-24 amino acids, for example. What is the structure and function of the ‘recombinant protein’ claimed?
The specification fails to provide any additional representative species of the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species which are adequately described are representative of the entire genus. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. In addition, critical information is missing from for example, claim 10 to achieve an alkali-stabilized Fc-binding domain, thus the claimed invention is not adequately described.
The 'written description' requirement.., serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed ....The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The purpose of the written description requirement "is to ensure that the scope of the right to exclude ... does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed. Cir. 2000). The goal of the written description requirement is "to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4 (CCPA 1977) "A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date." In re Glass, 492 F.2d 1228, 1232 (CCPA 1974).
Additionally, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
5. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
6. Claim(s) 1, 4, 6, 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over by (WO2012083425, cited on IDS) in view of GSP:BBG83940 (cited on IDS), Spector (US Patent No. 8592555, April 2009), Wolfe et al. (US Patent No. 9,340,584 (2011)) and EP2532672 (cited on IDS).
The primary reference discloses Ig-binding polypeptide (4 copies of HDS mutant of protein A domain Z) fused at N-terminal to a six amino acid spacer attached to the C-terminal of a Tev cleavage signal (ENLYFQG). The spacer is attached to the N-terminal alpha helix of the Ig-binding protein (4HDS(+)), see page 13, paragraph 63, page 15, paragraph 71, pages 18, paragraph 83, SEQ ID NO:10 and FIG 4). The reference disclose the immobilization of the recombinant protein onto porous beads via a linker. It is also disclosed where the solid support comprises a cross-linked polysaccharide (see page 2, paragraph 7, page paragraph 37-page 7 paragraph 39 and 42, page 9, paragraph 46, page 17, paragraph 79- page 18 paragraph 82 and page 19, paragraphs 87-89). In addition, the primary reference discloses a method for separating an immunoglobulin comprising the use of a separation matrix comprising the Ig-binding polypeptide wherein the separation matrix is contacted with a liquid sample containing an Ig to bind it and then contacting said matrix with an elution liquid to elute the Ig (see page 2 paragraph 8, page 11, paragraph 56 and 57, page 19, paragraph 90-page 20 paragraph 91). The primary reference does not teach the structures recited in claim 1.
The secondary reference GSP:BBG83940, discloses an engineered protein (recombinant polypeptide) with a sequence having 94.74% sequence identity over 19 positions of common overlap with SEQ ID NO:34 of the instant application. Therefore, functional polypeptide in claim 1 is expressed by the corresponding expression vector. Additionally, Spector discloses modified immunoglobulin-binding proteins, for example, Staphylococcus protein A, having improved binding specificity for immunoglobulins and methods of making and using the same and discloses the expressed one of the instant application.
Wolfe et al. discloses thioredoxin-like fold protein domains described as engineered thioredoxin-like fold proteins (ETRXs). These proteins include one or more artificially diversified thioredoxin-like fold protein domains; each domain may be originated from the same or different thioredoxin-like fold protein domains. Features of the invention also include methods for identifying and preparing an enriched composition of target binding, loop-diversified ETRXs with additional sequence variations to improve affinity, stability, selectivity, or solubility. The invention also features compositions of ETRXs substituted with prosthetic groups, polymers, proteins, nucleic acids, carbohydrates, metals, natural or synthetic small molecules and toxins. The N-terminal spacer set forth in SEQ ID NO: 35 of the instant application with 100% sequence identity is taught by the Wolfe et al. (and utilized in the their invention, see paragraph [104] for example). Furthermore, the invention encompasses the sequence of the coupling moiety comprising a cysteine residue and/or a plurality of lysine residues. Such moieties are well known in the art as demonstrated in EP2532672 (see page 16, paragraphs 121 and 122). EP2532672 discloses ligands based on one or more domains of immunoglobulin binding proteins (abstract); with capture and purification of antibodies and Fc-containing proteins (see page 2).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because the combined teaching of the references render the claimed invention as obvious. The primary reference provides the recombinant protein with linkage of a spacer and the secondary reference provides the structural limitations, another property of the protein and the tertiary reference meets the limitation of the coupling moiety. One of ordinary skill in the art would be motivated to combine the teaching of the references as they can be construed as analogous art. Moreover, in KSR v Teleflex (500 US 398 2007) (pages 12-13) " ... the Court has held that a "when a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill."
Response to Arguments
7. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejections of record under 112, first remains for the reasons stated above and has herein been amended to reflect changes made to the claims.
The rejections have been altered to reflect changes made to the claims. Applicant is urged to contact the examiner to discuss the remaining issues.
Conclusion
8. No claims are presently allowable, however, SEQ ID NOs: 16-18, 29-30, 33 and 34 full length are free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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