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 .
Response to Amendment
The amendment filed 3/23/2026 has been entered. Claims 1-13 are pending in the application.
The 112(b) rejections previously set forth are withdrawn in view of the amendment.
Response to Arguments
Applicant's arguments filed 3/23/2026 have been fully considered but they are not persuasive.
As an initial matter, examiner notes that the claim language requires the presence of monomers which comprise the various moieties. Given the broadest reasonable interpretation, the use of multiple separate monomers which each include some of the required moieties e.g. the use of PEG-DA to provide polyoxyalkylene and acrylate moieties, and the use of PVA modified with poyvinylamine for the provision of amino moieties (although it may further include modification with MMA and thus further acrylate moieties in at least some embodiments). As such, even if a single monomer is not provided which itself contains all of the necessary moieties alone, the combination of monomers still satisfies the claim requirements, because the claim language is sufficiently broad to be read on such arrangements (“…wherein the hydrophilic monomers comprise…”). If the contention is that certain additives e.g. PVA-PVAm represent polymer additives rather than monomers, they nevertheless are constructed from and contain monomers and are used to modify the membrane. Additionally, at least in the case of claim 1, the claim represents a product-by-process limitation whose scope would be defined by the structure of the final product i.e. the chemical moieties which are modified onto the surface via the electron beam process.
In view of this, the instant claim language is sufficiently broad to be read on the taught membranes absent more specific clarification on the specific species employed for modification or clarification of differences in the required final structure that distinguish over the prior art.
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.
Claims 1-8, 9, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moore et al (EP 3210664 A1).
With respect to claim 1, Moore teaches membranes which include surface modifications with hydrophilic polymers and further hydrophilic additives, where such polymers and additives are cured using high energy irradiation [Abs] e.g. an electron beam [0006, 0008]. The base membrane may be a fluoropolymer such as PTFE, although alternatives such as polyethylene and polyamide are contemplated [0014]. The base membrane is coated with a coating including modified polyvinyl alcohol, with examples such as polyvinalamine-modified PVA being employed [0030] (comprising at least one amino moiety). The further hydrophilic additives may include diacrylates such as polyethylene glycol diacrylate (PEG-DA) (comprising at least one polyoxyalkylene unit and at least one acrylate moiety) [0031-0032].
As best understood, the membrane taught by Moore anticipates the broadest reasonable interpretation of the claimed invention.
With respect to claim 2, as above the membrane may include PEGDA, a polyether.
With respect to claim 3, Moore teaches secondary and/or tertiary amines for the modified PVA, such as PVA-PVAm-MMA, and PVA-PVAm-mal [pg. 6]
With respect to claim 4, as best understood, PVA-PVAm-MMA at least includes three secondary amino moieties [pg. 6].
With respect to claim 5, as best understood, PVA-PVAm-mal includes one tertiary amino moiety [pg. 6].
With respect to claim 6, as above the additive may include a diacrylate i.e. two acrylate moieties. Further moieties may be present on the modified PVA but still within the claimed range e.g. as part of PVA-PVAm-MMA, depending upon the embodiment [pg. 6].
With respect to claim 7, the surface properties would be an inherent result of the coating applied to the membranes which, as discussed above, is anticipated by Moore. The membranes of Moore would necessarily have the appropriate properties.
An alternative grounds of rejection is presented below.
With respect to claim 8, Moore teaches applying a solution containing the relevant monomers to the membrane via standard coating methods and, thereafter, irradiating with an electron beam to cure the coating [0033-0036].
With respect to claim 9, Moore teaches various ranges for irradiation but, in an exemplary teaching, employs 40 kGy [0038].
With respect to claims 11 and 12, Moore teaches washing the membrane for extraction, and then drying [0053].
With respect to claim 13, Moore teaches biomedical applications, water purification, protein purification, and similar applications [0047]. Filtering a liquid i.e. “liquid filtration” is explicitly identified.
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 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Moore et al in view of Charkoudian (US PGPub 2003/0226799 A1).
With respect to claim 7, Moore teaches as above but does not measure IgG adsorption; if the IgG adsorption behavior is not considered an inherent result of the material employed as the membrane and coating, alternatively see Charkoudian, which teaches porous membranes having surface coatings to provide biomolecule resistant properties [Abs] and low extractables. The membrane may be formed from a substrate of polyethylene, PTFE, or similar materials which are then coated with a coating containing hydrophilic monomers [0025] and teaches that, to constitute a biomolecule resistance surface, the IgG should adsorb at a rate of 30 micrograms/cm2 or less [0007].
It would have been obvious to one of ordinary skill in the art to ensure that the surface of the membrane taught by Moore has very low IgG adsorption because, as in Charkoudian, this is a way to measure IgG resistance in an hydrophilically-coated membrane, and further because Moore already contemplates biomedical applications, protein purification, dialysis and the like for which protein adsorption would be a potential factor requiring mitigation.
With respect to claim 10, Moore is silent to the specific configuration of the membrane, however configurations such as flat sheets and hollow fibers are well known in the art as standard configurations for membranes, including coated membranes. See e.g. Charkoudian which teaches such configurations [0098] for a similar article which is coated with a hydrophilic coating for protein resistance or the like. Such a configuration would have been obvious to employ as a typical membrane configuration for the membranes taught by Moore.
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 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/772,572 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites overlapping requirements for substrate, hydrophilic monomers, and the like.
Instant claim 1 is at minimum obvious over reference claim 2 which teaches the monomers and teaches substrates which may include polyethylene (which would at least render obvious the ultra high molecular weight polyethylene recited by the instant invention); examiner notes that, although the reference application employs “actinic radiation” that is not specifically electron beam radiation, the invention of instant claim 1 and reference claim 2 is a product claim, and so the specific scope of process limitations in a product-by-process interpretation are not sufficient to patentably distinguish.
Instant claim 2 corresponds to reference claim 3. Instant claim 6 corresponds to reference claim 5. Instant claim 7 corresponds to reference claim 9. Regarding instant claims 3-5, the reference application in claim 1 recites specific monomers which satisfy instant claims 3-5, i.e. by including e.g. three secondary amino or three tertiary amino structures. See e.g. reference Formula (VII) or Formula (XIV).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,420,239 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patents recites overlapping subject matter for substrate, hydrophilic monomers, and the like.
Instant claim 1 is at minimum obvious over reference claim 2 which teaches the monomers and teaches substrates which may include polyethylene (which would at least render obvious the ultra high molecular weight polyethylene recited by the instant invention). The reference patent employs electron beam radiation for formation of the product.
Instant claim 2 corresponds to reference claim 3. Instant claim 6 corresponds to reference claim 5. Instant claim 7 corresponds to reference claim 6. Regarding instant claims 3-5, the reference application in claim 1 recites specific monomers which satisfy instant claims 3-5, i.e. by including e.g. three secondary amino or three tertiary amino structures. See e.g. reference Formula (VII) or Formula (XIV).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY R SPIES whose telephone number is (571)272-3469. The examiner can normally be reached Mon-Thurs 8AM-4PM.
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, Jennifer Dieterle can be reached at (571)270-7872. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY R SPIES/Primary Examiner, Art Unit 1777
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