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 of Group I in the reply filed on 5 January 2026 is acknowledged. Upon cursory search, there is no burden in searching the species of instant claims 1 and 2. Therefore, the species election requirement, has been withdrawn and all species of claims 1-2 have been searched.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 5,6 and 8-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions/species, there being no allowable generic or linking claim.
Claims 1-4 and 7 are examined upon their merits in this Office action.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims the benefit of US Provisional Application No. 63/353,308 filed on 17 June 2022.
Claims 1-4 and 7 have an effective US filing date of 17 June 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 20 September 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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 3-4 and 7 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.
Claim 3 is indefinite because it recites a product (the mutant PF4 protein of claim 1) and process in the same claim (elected “selectively binds the HIT antibody compared to a non-HIT antibody”). MPEP 2173.05(p)(II) states: “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112, second paragraph.” See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). In Katz, a claim directed to “A system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. In re Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.2d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); < Ex parteLyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph).
The case law applies to instant Claim 3 which recites a mutant platelet factor 4 protein and the process of using it to selectively bind one antibody over another. There is confusion as to whether direct infringement occurs upon anticipation of the material product itself, or if assessment of selective binding is required for infringement. This affects the scope of all depending claims, Claims 4 and 7.
Claims 4 and 7 are further indefinite wherein they fail to further limit the material/structure of the PF4 protein product of the invention of Claim 1 (see MPEP 2111.02), but rather limit the elected antibody (PF4-H+NH-) that is selectively bound by the process of Claim 3. MPEP 2112.01 states: “When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Since structures cannot be separated from their properties, then the mutant PF4 protein of Claim 1 has all of the selective binding properties of Claims 3-4 and 7. Claims 3-4 and 7 will be anticipated by prior art products that are identical or substantially identical in structure to the protein of Claim 1.
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 1-4 and 7 are rejected under 35 U.S.C. 102(a)(1), or in the alternative under 1-2(a)(2), as being anticipated by WO 2006055959 (hereafter the WO’959 publication), published 26 May 2006.
Regarding claim 1, the WO’959 publication teaches a mutant Platelet Factor 4 (PF4) comprising a mutation at position H23. Specifically the prior art teaches pharmacophores with mutations within the heparan sulfate binding domain and specifically at residues His 23 (see Figure 2A).
Regarding claim 2, the WO’959 publication teaches the mutant PF4 comprising the H23A mutation (see pg. 6, line 23 and pg. 74, lines 14-15).
Regarding claims 3-4 and 7, as stated above, structures cannot be separated from their properties. Thus, the mutant PF4 protein(s) of Claim 1 inherently possesses the selective binding properties of Claims 3-4 and 7 and these claims are anticipated by the structure of Claim 1.
The prior art products are identical or substantially identical in structure to the protein product of the invention, and Claims 1-4 and 7 are rejected.
Claims 1-4 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ziporen, et al., Blood (1998), 92(9), 3250-3259 (hereafter Ziporen).
Regarding claim 1, the Ziporen publication teaches mutant Platelet Factor 4 (PF4) proteins comprising a mutation at positions K62, K65 and K66 (see paragraph bridging pgs. 3253-54 and Figure 2A).
Regarding claim 2, the Ziporen publication teaches the mutant PF4 proteins comprising K62A, K65A and K66A (see pg. 3253, paragraph subtitled “Lysine to alanine substitutions in the C-terminus of PF4” and Figure 2A).
Regarding claims 3-4 and 7, as stated above, structures cannot be separated from their properties. Thus, the mutant PF4 protein(s) of Claim 1 inherently possesses the selective binding properties of Claims 3-4 and 7 and these claims are anticipated by the same structure as anticipates Claim 1.
The prior art products are identical or substantially identical in structure to the protein product of the invention, and Claims 1-4 and 7 are rejected.
Claims 1, 3-4 and 7 are rejected under 35 U.S.C. 102(a)(1), or alternatively under 102(a)(2), as being anticipated by WO 2011012585 (hereafter the WO’585 publication).
Regarding claim 1, the WO’585 publication teaches mutant Platelet Factor 4 (PF4) proteins comprising a mutation at positions 66 and 67. Specifically, the prior art discloses a mutant comprising K66E (pg. 1, last line).
Regarding claims 3-4 and 7, as stated above, structures cannot be separated from their properties. Thus, the mutant PF4 protein(s) of Claim 1 inherently possesses the selective binding properties of Claims 3-4 and 7 and these claims are anticipated by the same structure as anticipates Claim 1.
The prior art products are identical or substantially identical in structure to the protein product of the invention, and Claims 1-4 and 7 are rejected.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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/STACEY N MACFARLANE/Examiner, Art Unit 1675