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 without traverse of Group I, clams 1-5, 8,10-21 and species of SEQ ID NOs:64-66, SEQ ID NOs: 81-83, SEQ ID NO:6, SEQ ID NO:13 and SEQ ID NO:18, in the reply filed on 8/27/2025 is acknowledged.
Claims 10, 12-13 and 22-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/27/2025.
Claims 1-3, 5, 11 and 14-21 are under consideration in the instant Office Action.
Withdrawn Objections and Rejections
The objection to the disclosure is withdrawn in view of the amended specification submitted on 12/30/2025.
The rejection of claims 1-3, 5, 11 and 14-21 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of newly amended claim 1 which now only requires one specific antibody disclosed by the CDR sequences set forth in instant claim 1.
Information Disclosure Statement
The information disclosure statement filed 1/26/2027 fails to fully comply with 37 CFR 1.98(a)(3) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each patent listed that is not in the English language. The citation has therefore been lined through and has not been considered.
The information disclosure statements filed 1/26/2026 fail to fully comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because no copies for non-patent literature cited in the IDS were provided and the citations have therefore been lined through. 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). All references listed in the IDS that are not provided are lined through and not considered.
Maintained Rejection
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 1-3, 5, 11 and 14-21 are rejected under 35 U.S.C. 103 as being unpatentable over Cha US2016/0376350 (IDS, 10/6/2022) in view of Bazan US2013/0316354 (9/30/2025 PTO-892).
Cha teaches a fusion protein construct comprising: (a) an antigen binding fragment (Fab) comprising a heavy chain and a light chain; and (b) a granulocyte colony-stimulating factor (GCSF), wherein the heavy chain comprises a heavy chain variable domain and a heavy chain constant 1 domain (CH1 domain) and the light chain comprises a light chain variable domain and a light chain constant domain (see paragraphs [0008], [0013], [0061]-[0062]) as in instant claims 1, 3, 14. In addition, Cha teaches that the heavy chain variable domain comprises heavy chain CDR1, CDR2, CDR3 comprising the amino acid sequence of SEQ ID NOs: 13-15 (identical to instant SEQ ID NOs: 64-66 of the present invention), and the light chain variable domain comprises light chain CDR1, CDR2, CDR3 comprising the amino acid sequence of SEQ ID NOs: 16-18 (identical to instant SEQ ID NOs: 81-83 of the present invention) (see paragraph [0013]) as in instant claim 1. Cha teaches SEQ ID NO: 6 which is the same as instant SEQ ID NO:6 and Cha’s SE ID NO: 61 encompasses instant SEQ ID NO: 13 (see pages 19 and 30) as in instant claim 5. Cha teaches using in a fusion construct with a peptide linker with up to 20 amino acids (see paragraphs [0016], [0062], [0075]) as in instant claims 2 and 15. Cha teaches methods of producing expression vectors and the host cell to produce the fusion construct with nucleic acids (see paragraph [0010], [0017]) as in instant claims 16-18. Cha teaches pharmaceutical composition of the fusion construct (see abstract and paragraph [0024]) as in instant claims 19-20.
Claim 1 differs from Cha in that a GCSF, a heavy chain constant 1 domain and a light chain constant domain are derived from a feline. However, concerning the difference, Bazan teaches a feline GCSF as a therapeutic agent and that it can be bound by a linker to affect drug targeting (see paragraphs [0100], [0101]). Bazan teaches feline GCSF as SEQ ID NO: 7 (see Table 2) which is the same as instant SEQ ID NO: 18 of instant claim 11. Considering this, it would be easily expected that a person skilled in the art would replace the GCSF of Cha with the feline GCSF of Bazan to derive the technical feature of the claim 1, and the effect therefrom is readily obvious with a reasonable expectation of success. Finally Bazan teaches using kit for compositions for diagnostics and treatment (see paragraphs [0135], [0152]) as in instant claim 21 and one of ordinary skill would be motivated to make kits for the claimed invention. Therefore, the instant claims are obvious over Cha in view of Bazan.
Response to Arguments
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive. Applicant argues that the instantly claimed product is not obvious over Cha and Bazan because Cha only teaches the fusion product with the claimed antibody and human GCSF but Cha fails to teach using feline GCSF rather than the human GCSF. Applicant argues that Bazan only teaches the feline GCSF but does not teach the fusion protein and therefore, does not provide motivation to switch the human GCSF with feline GCSF. This is not found persuasive because all of the required components for the claimed fusion product are taught in the prior art. Cha’s teaching already shows that this type of fusion product of GCSF and antibody are capable of being produced and provided a reasonable expectation of success of using other species such as the feline GCSF since it is already disclosed in the prior art by Bazan and one of ordinary skill in the art would have a reasonable expectation of success. Absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. “Good science and useful contributions do not necessarily result in patentability.” PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (Fed. Cir. 2007).
Applicant is reminded that the test for obviousness is not whether the features of the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981). Applicant’s arguments do not show how the combined teachings of the cited references and the knowledge/skills contained therein cannot render the rejected claims obvious.
The assertion that one of ordinary skill in the art would have had no expectation of success for replacing the human GCSF with the feline GCSF and fusing it to the disclosed antibody since Cha does not show that the claimed antibody is capable of binding a feline target cannot be accepted since the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). There is no evidence of record that supports this assertion.
Further, applicant argues that their feline fusion has remarkable and unpredictable effects, or as such “unexpected results”.
See MPEP 716.02(c).II, which states: “Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness… In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (Evidence of improved feed efficiency in steers was not sufficient to rebut prima facie case of obviousness based on prior art which specifically taught the use of compound X537A to enhance weight gain in animals because the evidence did not show that a significant aspect of the claimed invention would have been unexpected.).”
MPEP 716.02 (b) teaches that the burden is on applicant to establish their results are unexpected and significant. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."). Applicant is merely concluding that their results are superior without showing statistical and practical significance.
The evidence of unexpected results must be commensurate in scope with the claimed invention (see MPEP §716.02(d)). Evidence pertaining to secondary considerations must be taken into account whenever present; however, it does not necessarily control the obviousness conclusion. See, e.g., Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372, 82 USPQ2d 1321, 1339 (fed. Cir. 2007) (see MPEP §2145). Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977). The prior art teaches all of the required components of the fusion protein and therefore, would produce the same results since it is the same product modified to accommodate mammalian species specificity.
It is pointed out that the claims are towards a product and not a method. The product would produce the same results since prior art teaches all of the claimed components and one of ordinary skill in the art would find it obvious to use the protein of the animal species, such as the feline, to improve the function of the product composition.
See MPEP 2112 (I), which states, “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.” Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). See also Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 633 (Fed. Cir. 1987) which states "Congress has not seen fit to permit the patenting of an old [composition], known to others…, by one who has discovered its…useful properties."
See MPEP 2112 (I), which states, “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). The Federal Circuit has stated that ("Congress has not seen fit to permit the patenting of an old [composition], known to others…, by one who has discovered its…useful properties.") See Titanium Metals Corp., 778 F.2d at 782; Verdegaal Bros., 814 F.2d at 628,631 (fed. Cir. 1987). Given that the composition contains the same sequences as claimed, the prior art compositions would inherently have the claimed dissociation constants, as a product and its properties are inseparable (see MPEP § 2112(I)).
Therefore, applicant’s arguments are not found persuasive and the rejection is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Advisory Information
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675