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, claims 1, 3, 6 and 9 in the reply filed on 5/19/2026 is acknowledged. 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)).
During a telephone call received from the Examiner on 6/9/2026, Attorney Lotta Kiuru-Ribar was made aware that the response to the election/restriction filed on 5/19/2026 was incomplete because the species election was missing from that response. Accordingly, Attorney Kiuru-Ribar confirmed and further elected: species (i): a coating comprising a poly(vinyl alcohol) and a biological molecule covalently attached to the poly(vinyl alcohol). Hence, claims 1, and 11-14 are under consideration.
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 1, and 11-14 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.
As to claim 1, it is unclear whether the porous substrate is the same or different than the porous membrane.
As to claim 14, the limitation of the poly(vinyl alcohol) having a hydrolyzation rate of 99% or greater was already described in parent claim. Appropriate correction is required.
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.
(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.
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, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2009/0188857 to Moore et al. (hereinafter “Moore”).
Moore discloses a coated membrane comprising a porous base membrane and a hydrophilic coating provided on the porous base membrane (abstract). The porous base membrane comprises ePTFE having an average pore diameter of 1 to 50 microns, and a thickness of 100 microns to 1 mm (paragraphs 24, 27, 50 and 74). The hydrophilic coating comprises methyl methacrylate (MMA) and superhydrolyzed poly(vinyl alcohol) (PVA) (Selvol 165 from Celanese Ltd). (examples 1 and 2).
The snapshot below taken from Selvol™ sales specification is relied upon as evidence indicating that the Selvol 165 superhydrolyzed PVA has a hydrolyzation rate of 99.65% for your convenience.
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As to claim 12, Moore discloses that the porous base membrane comprises ePTFE having an average pore diameter of 1 to 50 microns (paragraphs 24, 27, 50 and 74).
As to claim 13, Moore discloses that the coated membrane has a permeability of 75 mL/min/cm2 or 1.25 cm3/s/cm2 (figure 3). This is within the claimed range.
As to claim 14, Moore discloses that the Selvol 165 superhydrolyzed PVA has a hydrolyzation rate of 99.65% within the claimed range.
Claims 1, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0162723 to Dutta et al. (hereinafter “Dutta”) and further in view of Moore.
As to claims 1 and 14, Dutta discloses a composite material comprising an ePTFE substrate, an interlayer comprising a reactive functionality over the ePTFE substrate, and a functional layer attached to the interlayer wherein the functional layer has functional sites with a density of at least 50 nanomoles/cm2.
Dutta discloses that the ePTFE substrate has a thickness of 5 to 250 microns (paragraph 32). In particular, the ePTFE substrate has a thickness of 152 microns (paragraph 144). The interlayer comprises PVA while the functional layer comprises organosilane (paragraph 13).
Dutta does not explicitly disclose the PVA having a hydrolyzation rate of 99% or greater.
Moore, however, discloses a coated membrane comprising a porous base membrane and a hydrophilic coating provided on the porous base membrane (abstract). The porous base membrane comprises ePTFE having an average pore diameter of 1 to 50 microns, and a thickness of 100 microns to 1 mm (paragraphs 24, 27, 50 and 74). The hydrophilic coating comprises methyl methacrylate (MMA) and superhydrolyzed poly(vinyl alcohol) (PVA) (Selvol 165 from Celanese Ltd). (examples 1 and 2).
The snapshot below taken from Selvol™ sales specification is relied upon as evidence indicating that the Selvol 165 superhydrolyzed PVA has a hydrolyzation rate of 99.65% for your convenience.
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the PVA disclosed in Dutta having a hydrolyzation rate of 99.85% disclosed in Moore, motivated by the desire to provide better mechanical strength and biocompatibility.
As to claim 11, Dutta discloses that the functional chemistry of the functional layer reacts with the functionality of the PVA interlayer to create functional sites which are covalently bound to the biomolecules including nucleic acids, proteins, and peptides (paragraph 57; example 2). As functional sites are part of the PVA interlayer, it is not seen that the biomolecules could not be covalently attached to the PVA interlayer.
As to claim 12, Dutta discloses the pores must be small enough to inhibit lateral spreading of the solution during spotting process. On the other hand, the pores must be large enough to enable the biomolecules to enter the pores freely during washing processes (paragraph 29). The porous substrate has the bubble point of at least 10 psi (paragraph 30).
Dutta does not explicitly disclose the porous substrate having an average pore size in a range of 1 to 100 microns.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the porous substrate disclosed in Dutta having an average pore size in the range instantly claimed, motivated by the desire to provide a good balance of avoiding lateral spreading of the solution during spotting process and allowing the biomolecules to enter the pores freely during washing processes.
As to claim 13, Dutta does not explicitly disclose the composite material has a permeability of 0.1 cm3/s/cm2 or greater at 125 Pa.
However, it appears that the combined disclosures of Dutta and Moore result in a composite material meeting all structural limitations and chemistry required by the claims. The resulting composite material comprises an ePTFE substrate, an interlayer comprising a reactive functionality over the ePTFE substrate, and a functional layer attached to the interlayer wherein the functional layer has functional sites with a density of at least 50 nanomoles/cm2. The ePTFE substrate has a thickness of 152 microns. The interlayer comprises PVA while the functional layer comprises organosilane. The
modified PVA has a hydrolyzation rate of 99.65%. The porous substrate has the bubble point of at least 10 psi. The functional chemistry of the functional layer reacts with the functionality of the PVA interlayer to create functional sites which are covalently bound to the biomolecules including nucleic acids, proteins, and peptides. The biomolecules are covalently bound to the functional sites and thus to the PVA interlayer because the functional sites are part of the PVA interlayer.
Therefore, the examiner takes the position that the permeability of 0.1 cm3/s/cm2 or greater at 125 Pa would inherently be present as like material has like property. This is in line with In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) which holds that if the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the claimed properties or functions will be presumed to be inherent. The burden is shifted to the applicant to show unobvious differences between the claimed product and the prior art product.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Hai Vo whose telephone number is (571)272-1485. The examiner can normally be reached M-F: 9:00 am - 6:00 pm with every other Friday off.
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/Hai Vo/
Primary Examiner
Art Unit 1788
Prosecution Insights