DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Application, Amendments and/or Claims
The amendment, filed 16 January 2024, has been entered in full. The amendment, filed 01 May 2024, has been entered in full. Claims 1-15 are canceled. New claims 16-34 are added. Claims 16-34 are under examination.
Information Disclosure Statement
The information disclosure statement(s)(IDS) (filed 16 January 2024) was received. It has been placed in the application file and the information referred to therein has been considered as to the merits.
It is noted that some of the references fail to comply with the provisions of 37 CFR §§1.97, 1.98 and MPEP § 609. MPEP 609.05 [R-3] states that information disclosure statements will be reviewed for compliance with the requirements of 37 CFR 1.97 and 37 CFR 1.98 as discussed in MPEP 609.04(a) and MPEP 609.04(b). The references will be lined through and not considered by the Examiner.
References: The references should include the name of the author, title of the article, name of the item (i.e. book, magazine, Journal, symposium, catalog, etc.), the volume-issue number, the pages, and date.
The following references not considered by the Examiner for the following reasons: The Emrick, Hinton and Zhang references are not being considered by the Examiner because they are missing the titles.
Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 18-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10.689,447.
The instant claims are drawn to a heteromultimeric protein prepared by the process of claim 16. The claims recite that the heteromultimeric protein has substitution modifications on a first Fc region and/or a second Fc region at positions (a) F241R and F243S or (b) F241S and F243R. The claims further recite that the heteromultimeric protein has substitution modifications at T366W, T366S, L368A and/or Y407V. The claims further recite that the heteromultimeric protein is an IgG antibody. The claims further recite that the Fc region of the heteromultimeric protein or the IgG antibody is an IgG1 region.
The claims of U.S. Patent No. 10.689,447 teach a heteromultimeric protein or an IgG antibody, wherein the heteromultimeric protein or the IgG antibody each comprises an Fc region comprising substitution mutations at residues 241 and 243 on at least one heavy chain, wherein said substitution mutations are selected from the group consisting of (a) F241R and F243 S and (b) F241S and F243R. The claims further teach that the heteromultimeric protein or the IgG antibody has substitution modifications at T366W, T366S, L368A and/or Y407V. The claims further teach that the Fc region of the heteromultimeric protein or the IgG antibody is an IgG1 Fc region.
The claims of U.S. Patent No. 10.689,447 further teach an isolated heteromultimeric protein or an isolated IgG antibody produced by culturing a prokaryotic host cell comprising an expression vector encoding the heteromultimeric protein or the IgG antibody, and recovering the heteromultimeric protein or the IgG antibody from the cell culture, wherein the heteromultimeric protein or the IgG antibody each comprises an Fc region comprising substitution mutations at residues 241 and 243 on at least one heavy chain, wherein said substitution mutations are selected from the group consisting of (a) F241R and F243S and (b) F241S and F243R. The claims further teach that the heteromultimeric protein or the IgG antibody has substitution modifications at T366W, T366S, L368A and/or Y407V. The claims further teach that the Fc region of the heteromultimeric protein or the IgG antibody is an IgG1 Fc region.
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The examined claims recite a product that is made from a method comprising the steps of providing a purified first polypeptide comprising the first Fc region with the first heterodimerization domain; providing a purified second polypeptide comprising the second Fc region with the second heterodimerization domain; combining the first and second polypeptides; refolding the first polypeptide with the second polypeptide to form the heteromultimeric protein and then purifying the heteromultimeric protein.
MPEP 2113 teaches: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”
In the instant case, the heteromultimeric protein recited in the examined claims is generic to the species of heteromultimeric protein or IgG1 antibody products taught in the claims of U.S. Patent No. 10.689,447. The species of recited in the claims of claims of U.S. Patent No. 10.689,447 anticipates the claimed genus in the examined application.
See below the MPEP 2113 teaches regarding Product-by-Process
MPEP 2113 [R-1] Product-by-Process Claims. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate.
The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.).
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979) (holding “interbonded by interfusion” to limit structure of the claimed composite and noting that terms such as “welded,” “intermixed,” “ground in place,” “press fitted,” and “etched” are capable of construction as structural limitations.)
ONCE A PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS
FOUND AND A 35 U.S.C. 102 /103 REJECTION MADE, THE BURDEN
SHIFTS TO THE APPLICANT TO SHOW AN UNOBVIOUS DIFFERENCE
“The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983) (The claims were directed to a zeolite manufactured by mixing together various inorganic materials in solution and heating the resultant gel to form a crystalline metal silicate essentially free of alkali metal. The prior art described a process of making a zeolite which, after ion exchange to remove alkali metal, appeared to be “essentially free of alkali metal.” The court upheld the rejection because the applicant had not come forward with any evidence that the prior art was not “essentially free of alkali metal” and therefore a different and unobvious product.).
Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989) (The prior art
disclosed human nerve growth factor (b-NGF) isolated from human placental tissue. The claim was directed to b-NGF produced through genetic engineering techniques. The factor produced seemed to be substantially the same whether isolated from tissue or produced through genetic engineering. While the applicant questioned the purity of the prior art factor, no concrete evidence of an unobvious difference was presented. The Board stated that the dispositive issue is whether the claimed factor exhibits any unexpected properties compared with the factor disclosed by the prior art. The Board further stated that the applicant should have made some comparison between the two factors to establish unexpected properties since the materials appeared to be identical or only slightly different.).
THE USE OF 35 U.S.C. 102 /103 REJECTIONS FOR PRODUCT-BY-PROCESS CLAIMS HAS BEEN APPROVED BY THE COURTS
“[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
CLOSEST PRIOR ART:
Lazar et al. (US Patent 7,317,091; published January 8, 2008) teach heteromultimeric proteins comprising substitution mutations made in the Fc region wherein the substitution mutations comprise F241R and/or F243R.
Lazar et al. do not teach heteromultimeric protein comprising substitution mutations made in the Fc region wherein the substitution mutations comprise
(F241R and F243S) or (F241S and F243R).
ALLOWABLE SUBJECT MATTER:
Claims 16 and 17 are allowed.
Conclusion
Claims 18-34 are rejected.
Claims 16 and 17 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M DEBERRY whose telephone number is (571)272-0882. The examiner can normally be reached M-F 9:00-6:30 pm (alt Fri).
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/R.M.D/Examiner, Art Unit 1647 6/12/2026
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647 /YVONNE L EYLER/Director, Technology Center 1600
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