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 Status
Rejected Claims: 1, 4, and 6-9
Cancelled Claims: 2-3 and 5
Response to Amendment
The amendment filed on 01 APRIL 2026 has been entered.
In view of the amendment to the claims, the amendment of claims 1 and 6, the cancellation of claims 2-3 and 5, and the addition of new claims 7-9 have been acknowledged.
In view of the amendment to the specification, the objections to the specification have been withdrawn.
In view of the amendment to claims 1 and 6, the previous objections to the claims have been withdrawn.
In view of the cancellation of claims 2-3 and 5, the previous rejections under 35 U.S.C. 103 have been withdrawn.
In view of the amendment to claim 1, the previous rejections under 35 U.S.C. 102 of claims 1, 4, and 6 have been withdrawn and new grounds of rejection under 35 U.S.C. 102 have been made for claims 1 and 6 and a new grounds of rejection under 35 U.S.C. 103 has been made for claim 4.
Response to Arguments
Applicant’s arguments filed on 01 APRIL 2026 have been fully considered.
Applicant argues that the previously cited prior art Tarnopolosky and Ellis do not disclose or make obvious the newly amended claims 1, 4, and 6 and so claims 1, 4, and 6 are allowable (Arguments filed 01 APRIL 2026, Pages 9 to 15).
Applicant’s arguments with respect to claims 1, 4, and 6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 1 and 6-9 are objected to because of the following informalities:
In Claim 1, “said device” twice in lines 14 and 15 of the claim should read “said chromatography device”.
In Claim 6, the parenthetical designation “(Original)” should read “(Currently Amended)” as there has been an amendment to overcome a previous claim objection.
In Claim 7, “said device” in line 10 of the claim should read “said chromatography device”.
In Claim 8, “said device” in line 10 of the claim should read “said chromatography device”.
In Claim 9, “said device” in line 10 of the claim should read “said chromatography device”.
Appropriate correction is required.
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 and 6-7 are rejected under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by DiLeo et al US Patent Application No. US 20050211615 A1 (hereinafter DiLeo).
Regarding Claim 1, DiLeo discloses porous media useful for chromatography (Abstract) that is incorporated into a filter cartridge (i.e., a chromatography device comprising; Fig. 7; Paragraph 0128)
in which the device is formed of two halves (i.e., a housing having; Fig. 7, #98 and 100) with an inlet (i.e., a fluid inlet and; Fig. 7, #102) and an outlet (i.e., a fluid outlet spaced from said inlet; Fig. 7, #104; Paragraph 0128)
with a series of media layers (i.e., at least first and second membrane; Fig. 7, #90; Paragraph 0128) shown to be inside the two halves of the device (i.e., arranged in said internal volume of said housing in a region between said fluid inlet and said fluid outlet; Fig. 7) in which an area of the media may be coated with material that is useful for protein capture and small volume applications and only in areas where there is active filtration or flow (i.e., said at least first and second membranes each having an active membrane area through which fluid introduced into said fluid inlet can flow; Paragraph 0132)
that are separated by spacers (i.e., at least one spacer arranged between said at least first and second membranes; Fig. 7, #92) that are all liquid tightly sealed around the top and bottom circumferences, shown to have a gap in the center in Fig. 7 (i.e., said at least one spacer having a perimeter defining a continuous opening in fluid communication with said active membrane area that does not impede fluid flow in and through said chromatography device; Fig. 7; Paragraph 0128),
wherein Fig. 7, shown below, demonstrates only a single outlet and liquid tight seals on the circumferential edge of the media layers such that the only liquid path is clearly from the inlet, through each media layer consecutively, and then through the outlet (i.e., wherein said device is configured such that between the first membrane and the second membrane, a fluid only flows from the first membrane to the second membrane; Fig. 7; Paragraph 0128)
wherein Fig. 7, also shown below, demonstrates that the gap in the spacers is located between the adjacent media layers such that flow between such layers is not impeded (i.e. wherein there is a filtration zone within said internal volume defined by said active membrane area of said at least first and second membranes, and wherein said opening of said at least one spacer is arranged within said filtration zone; Fig. 7; Paragraph 0128)
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and where the spacers are described as sealing around the top and bottom circumferences of the series of media layers, which states that the media layers are circular in shape and so the spacers are circular with a circular hole in the center (i.e., wherein said at least one spacer is in the shape of an annulus; Paragraph 0128).
Regarding Claim 6, DiLeo further discloses in Fig. 7, shown below, that the fluid flows consecutively through the inlet, the first media layer, the pacer, the second media layer, and then through the outlet (i.e., wherein said at least first and second membranes and said at least one spacer are arranged in said housing such that, in operation of said chromatography device, fluid enters said fluid inlet, passes consecutively through said first membrane, said at least one spacer, and said second membrane prior to exiting said housing through said fluid outlet; Fig. 7, Paragraph 0128).
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Regarding Claim 7, DiLeo further discloses a third media layer and a second spacer in Fig. 7, shown below (i.e., further comprising a third membrane arranged in said internal volume of said housing in a region between said fluid inlet and said fluid outlet, said third membrane having a third membrane active membrane area through which fluid introduced into said fluid inlet can flow, and a second spacer arranged between said second and third membranes, said second spacer having a perimeter defining a continuous opening in fluid communication with said third membrane active membrane area that does not impede flow in and through said device; Fig. 7, Paragraph 0128).
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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 4 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over DiLeo et al US Patent Application No. US 20050211615 A1 (hereinafter DiLeo).
Regarding Claim 4, DiLeo further discloses that a first media layer is located between the inlet and a second media layer (i.e., wherein said first membrane is arranged upstream, in the direction of fluid flow during operation of said chromatography device, of said second membrane; Fig. 7, #90, 102; Paragraph 0128) .
DiLeo then teaches in another embodiment that porous spacers (Fig. 8, #118 and 120) are adjacent to the inlet and outlet to maintain the media in their place (i.e., said chromatography device further comprising a porous frit arranged between said fluid inlet and said first membrane; Fig. 8; Paragraph 0129).
Regarding Claim 8, DiLeo only explicitly teaches three media layers and two spacers in Fig. 7, rather than the four media layers and three spacers required of instant claim 8. However, DiLeo also teaches that a series of media layers separated each my spacers is included in the variation, which is an unspecific plurality (Paragraph 0128). DiLeo further teaches other embodiments with a much larger stack of membranes (Fig. 8, #116; Paragraph 0129). Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960))(See MPEP 2144.04(VI)(B)). DiLeo discloses the claimed invention except for the duplication of media and spacer stack to a fourth and third duplicate, respectively. It would have been obvious to one of ordinary skill in the art to duplicate media layer and spacer since it has been held that a mere duplication of working parts of a device involves only routine skill in the art. One would have been motivated to duplicate apertures for the purpose of having a greater filtering effect of additional consecutive layers.
Regarding Claim 9, DiLeo only explicitly teaches three media layers and two spacers in Fig. 7, rather than the five media layers and four spacers required of instant claim 9. However, DiLeo also teaches that a series of media layers separated each my spacers is included in the variation, which is an unspecific plurality (Paragraph 0128). DiLeo further teaches other embodiments with a much larger stack of membranes (Fig. 8, #116; Paragraph 0129). Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960))(See MPEP 2144.04(VI)(B)). DiLeo discloses the claimed invention except for the duplication of media and spacer stack to a fifth and fourth duplicate, respectively. It would have been obvious to one of ordinary skill in the art to duplicate media layer and spacer since it has been held that a mere duplication of working parts of a device involves only routine skill in the art. One would have been motivated to duplicate apertures for the purpose of having a greater filtering effect of additional consecutive layers.
Conclusion
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.
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/A.A.G./ Examiner, Art Unit 1777
/Ryan B Huang/ Primary Examiner, Art Unit 1777
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