DETAILED ACTION
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 with traverse of Group I, claims 1-3, 5, 7 & 14-17 in the reply filed on 3/25/26 is acknowledged. The traversal is on the ground(s) that all claims of the three groups recite a modified RBC with a linked uric acid-degrading polypeptide prepared by a Staphylococcus aureus transpeptidase A variant (mgSrtA), which represents a special technical feature over the prior art. This is not found persuasive because the claims are not limited to that scope and also the art teaches or suggests the RBC as claimed (see below prior art rejections).
The requirement is still deemed proper and is therefore made FINAL.
Note that applicant’s claims are remit with “optional” steps which fails to specifically limit the claims and may be better presented as dependent claims.
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 1-3, 7 & 15-17 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by WO2019183292A1(RUBIUS).
Rubius discloses an RBC that has been linked to a uricase and a by a sortase enzyme to an endogenous membrane protein and pharmaceutical compositions of said RBCs. The linkage is made using one polypeptide containing the acceptor sequence LPXTG or LPXTA with a polypeptide containing the N-terminal donor sequence GGG.
uric acid transporter, wherein the uric acid degrading polypeptide comprises one or more polypeptides selected from a group consisting of: uricase, HIU hydrolase, OHCU decarboxylase, allantoinase and allantoicase; the uric acid transporter comprises one or more polypeptides selected from a group consisting of: URAT1, GLUT9, OAT4, OAT1, OAT3, Gal-9, ABCG2, SLC34A2, MRP4, OAT2, NPT1, NPT4, and MCT9. Rubius further discloses that the exogenous polypeptide can be conjugated to the surface of RBC by transpeptidase reaction mediated by a sortase enzyme to connect one polypeptide containing the acceptor sequence LPXTG or LPXTA with a polypeptide containing the N-terminal donor sequence GGG.D1 further discloses a method of making the engineered RBC.
The reference anticipates the claim subject matter.
Claim Rejections - 35 USC § 103
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 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.
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.
Claims 1-3, 5, 7 & 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over WO2019183292A1(RUBIUS) and WO2016096741(Dulat)
Rubius discloses an RBC that has been linked to a uricase (uric acid degrading polypeptide) and a by a sortase enzyme (SUMMARY OF INVENTION) to an endogenous membrane protein and pharmaceutical compositions of said RBCs. The linkage is made using one polypeptide containing the acceptor sequence LPXTG or LPXTA with a polypeptide containing the N-terminal donor sequence GGG, uric acid transporter. The uric acid transporter comprises one or more polypeptides selected from a group consisting of: URAT1, GLUT9, OAT4, OAT1, OAT3, Gal-9, ABCG2, SLC34A2, MRP4, OAT2, NPT1, NPT4, and MCT9 (page 8). Rubius further discloses that the exogenous polypeptide can be conjugated to the surface of RBC by transpeptidase reaction mediated by a sortase enzyme to connect one polypeptide containing the acceptor sequence LPXTG or LPXTA with a polypeptide containing the N-terminal donor sequence GGG.D1 further discloses a method of making the engineered RBC.
Rubius teaches using a multitude of known sortases, conjugations amd attachment motifs [p 5-10] and as such is suggestive that it would have been obvious to one of ordinary skill in the art at the time the invention was filed any known sortase and corresponding conjugation that said artisan would work like eth enzymes they utilized and it would have been further obvious to use Staphylococcus aureus transpeptidase A variant (mgSrtA), though not taught by Rubius, because Dulat teaches (II. ENZYMATIC CONJUGATION USING SORTASE A) Sortase A (SrtA) is a membrane bound enzyme which attaches proteins covalently to the bacterial cell wall. The specific recognition motif on the SrtA substrate is LPXTG, whereby the enzyme cleaves between the residues threonine and glycine. Sortase A lacking the membrane-spanning region (SrtA; amino acid residues 60-206 of Staphylococcus aureus SrtA) can be used (SEQ ID NO: 21). The recognition motif on the peptidoglycan is a pentaglycine motif. It has been shown that a triglycine and even a diglycine motif on the N-terminus is sufficient to support the SrtA reaction (Clancy, K.W., et al, Peptide science 94 (2010) 385- 396). The reaction proceeds through a thioester acyl-enzyme intermediate, which is resolved by the attack of an amine nucleophile from the oligoglycine, covalently linking peptidoglycan to a protein substrate and regenerating SrtA. SrtA can be used to covalently conjugate chemically synthetized peptides to recombinantly expressed proteins. This peptide cleaving reaction results in a Sortase A- substrate thioester intermediate.
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “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.”
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was filed especially in the absence of evidence
to the contrary.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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, Louise Humphrey can be reached at 571-272-5543. 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.
BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657
Prosecution Insights