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 .
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.
Claims 1-5 and 7-19 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The NVR of less than about 0.2 mg/g appears to be new matter, since the only disclosure is for membrane A (inventive) at 0.15 and membrane B (commercial) at 0.26. These data points do not translate to a range of “less than about 0.2mg/g.” In any case, applicant did not have this data or information for the claimed generic membrane.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1-5 and 7-19 are rejected under 35 U.S.C. 102(a1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kelly et al (US 2002/0011450), with evidence from TH Meltzer, MW Jornitz - American Pharmaceutical Review, 2003 - researchgate.net (Meltzer.) and Charkoudian et al (US 2003/0077435)
Claims 1, 3-5, 7-9, 11 and 12: Kelly teaches the disclosed membrane A and the claimed membrane in filter #8, table III. The bubble point is a measure for pore size, and since pore size is within claimed range, the bubble point also would be in the claimed range. Wetting surface tension would have been inherent (see below) – same membrane. The amide density would be the same because the membrane has the same monomers. Similarly, the amid moiety per monomer also would be the same.
Kelly is silent regarding the amide density. Applicant defines amide density as “as AD = (number of amide moieties per monomeric unit per molecular weight of the monomeric unit)” – see Spec. @[0028.] That is, it appears to the examiner that monomers are chosen based on the amide density; the amide density is not calculated based on the resulting polymer. Kelly uses in example 8 (Table III), DMAm, MBAm and APMAm. By applicant’s definition, DMAm has one amide unit in one monomer unit with a molecular weight of 99. Therefore, the amide density of DMAm is 1/99 = 0.01. Similarly, MBAm has 2/154 = 0.013, and APMAm has 1/28 = 0.008. Therefore, the amide density in Kelly falls within the claimed range.
Extractable residue by IPA (NVR): Kelly does not teach this element. However, the membrane (filter #8) is the same or has the same formulation. Therefore, the NVR value also should be inherently the same.
The “about 0.2” means more or less 0.2. The commercial membrane (Cobetter Hydrophilic PTFE) has an NVR value of 0.26, which is not very far from the “less than about 0.2” range. Applicant provides no information on the chemistry and structure of this membrane for apple to apple comparison. The examiner assumes that the Cobetter Hydrophilic PTFE is not hydrophilized using the applicant’s inventive membrane formulation. This fact and the fact that Kelly teaches same membrane in filter 8, the NVR of Kelly’s filter 8 also should be inherently within the range claimed.
Further evidence that this type of membrane has very low NVR or TOC extractables is provided by Charkoudian – see [0058] and Table 4 showing same crosslinking agents as in applicant’s inventive membrane A, but support of PVdF instead of PTFE. Note that less than about 2 or less than about 1 values are in micrograms per cm2, compared to applicant’s milligram/g. The examiner believes that when translated to the same units, the Charkoudian membrane would have NVR significantly less than 0.2mg/g.
Claim 2: flow time for 500 ml would be inherently the same since the membrane is the same.
Claim 10: Since MBAm is a crosslinker, the proportion would be ideally stoichiometric to have a complete crosslinking, and thus this ratio would have been obvious to one of ordinary skill in the art, or one would optimize this ratio to obtain the desired cross-linking.
For process claim 13-19: The intended purpose of the filter of Kelly is to filter particles from liquids. See [0037]. Particles listed include organelles, DNA aggregates, etc., which would indicate the filter is intended for filtering particles including bacteria and viruses. Therefore, while the reference is silent on non-aqueous liquids, filtering such liquids would have been obvious to one of ordinary skill in the art, and is not patentable, unless otherwise shown. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). MPEP 2112.02.
The pore size range taught by Kelly also supports bacteria filters, as evidenced by Meltzer. Therefore, claim 13-19 are obvious if not anticipated.
Inherency, inherent property: MPEP 2112: "[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." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. See also MPEP § 2112.01 with regard to inherency and product-by-process claims
Response to Arguments
Applicant's arguments filed 1/21/26 have been fully considered but they are not persuasive.
Regarding the amide density, the office action had clearly shown how Kelly meets this element of the claim using applicant’s definition.
Regarding the arguments traversing inherency/inherent property: MPEP 21112: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Arguments citing Kelly’s general teaching are unpersuasive, when the rejection cites Kelly’s specific teaching. MPEP 2131.02: A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990)
Conclusion
Even though, the Charkoudian is a 35 USC 102(a1)/103 reference because it teaches PTFE among others as the membrane to be hydrophilized with the formulations in Table 4 (uses PVdF), it was not directly applied in rejecting the claims to reduce the number of issues.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISHNAN S MENON whose telephone number is (571)272-1143. The examiner can normally be reached Flexible, but generally Monday-Friday: 8:00AM-4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Prem C Singh can be reached at 571-272-6381. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISHNAN S MENON/ Primary Examiner, Art Unit 1777
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