Reissue
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Claim Status
Patent claims 1-2 and new claims 3-12 are pending.
Improper Amendment
The amendment filed 13 November 2024 proposes amendments to the specification and claims that do not comply with 37 CFR 1.173(b), which sets forth the manner of making amendments in reissue applications.
All paragraphs which are newly added to the specification of the original patent must be submitted as completely underlined each time they are re-submitted in the reissue application. See MPEP 1453 I. For each new claim added to the reissue by the amendment being submitted (the current amendment), the entire text of the added claim must be presented completely underlined. See MPEP 1453 II.
Consent
This application is objected to under 37 CFR 1.172(a) as lacking the written consent of all assignees owning an undivided interest in the patent. The consent of the assignee must be in compliance with 37 CFR 1.172. See MPEP § 1410.01.
A proper assent of the assignee in compliance with 37 CFR 1.172 and 3.73 is required in reply to this Office action.
The Consent filed 13 November 2024 was signed by Brittany Washington, Intellectual Property Counsel. This person does not have apparent authority to sign and has not been designated as a party authorized to act on behalf of the assignee. One having apparent authority to sign on behalf of the organization under 37 CFR 3.73(d)(2) is an officer (chief executive officer, president, vice-president, secretary, or treasurer). A person having a title (administrator, general counsel) that does not clearly set forth that person as an officer of the assignee is not presumed to have authority to sign the submission on behalf of the assignee. Further, the person signing the consent has not been appointed in a Power of Attorney. See MPEP 325 V.
Recapture
Claims 3-12 are rejected under 35 U.S.C. 251 as being an impermissible recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based.
See Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984).
The reissue application contains claim(s) that are broader than the issued patent claims. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
In Clement, 131 F.3d at 1468-70, 45 USPQ2d at 1164-65, the Court of Appeals for the Federal Circuit set forth a three step test for recapture analysis. In North American Container, 415 F.3d at 1349, 75 USPQ2d at 1556, the court restated this test as follows:
We apply the recapture rule as a three-step process:
(1) first, we determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims;
(2) next, we determine whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution; and
(3) finally, we determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
Analysis
As to STEP 1, new claims 3-5 do not include the following limitations found in original patent claim 1:
“before filtering fluid, passing air and/or gas through the porous filter medium or through a sterilizing grade porous medium arranged upstream of the filter device to produce sterile air and/or sterile gas.”
“allowing the sterile air and/or the sterile gas to pass from the flexible container along the second fluid flow path into the first flow path and through the outlet into the housing of the filter device, and displacing retained filtered fluid along the first fluid flow path into the filtered fluid receiving container.”1
New claims 6-12 do not include the following limitations found in original patent claim 1:
“before filtering fluid, passing air and/or gas through the porous filter medium or through a sterilizing grade porous medium arranged upstream of the filter device to produce sterile air and/or sterile gas.”
“allowing the sterile air and/or the sterile gas to pass from the flexible container along the second fluid flow path into the first flow path and through the outlet into the housing of the filter device, and displacing retained filtered fluid along the first fluid flow path into the filtered fluid receiving container.”
Thus, new claims 3-12 contain within their scope methods and systems which would not have infringed the patent, i.e., methods and systems for recovering filtered fluid not including the limitations above. Accordingly, new claims 3-12 have been broadened compared to the original patent (see MPEP 1412.03).
With respect to STEP 2, if an original patent claim limitation now being omitted or broadened in the present reissue application was originally relied upon by applicant in the original application to make the claims allowable over the art, the omitted limitation relates to subject matter previously surrendered by applicant. The reliance by applicant to define the original patent claims over the art can be by presentation of new/amended claims to define over the art, or an argument/statement by applicant that a limitation of the claim(s) defines over the art.
During prosecution of the application that became U.S. Patent No. 11,498,024, applicant presented new claim limitation (i) above and argued that limitation (ii) defined over the art. In the Remarks filed with the claim amendments of 19 August 2022, arguing that the Gulati reference failed to teach limitation (ii) applicant stated:
Among other deficiencies, Gulati fails to teach "allowing the sterile air and/or the sterile gas to pass from the flexible container along the second fluid flow path into the first flow path and through the outlet into the housing of the filter device, and displacing retained filtered fluid along the first fluid flow path into the filtered fluid receiving container."
Thus, during prosecution of the application that became U.S. Patent No. 11,498,024, limitations (i) and (ii) above were added or argued to make the claims patentable over the art. Any limitation presented, argued or stated to make the claims patentable over the art “generates” the surrender of claimed subject matter that omits that limitation in its entirety, i.e. surrender of any claim whose scope does not contain the limitation.
Although claim 3 retains in broadened form, limitation (ii) argued to overcome the art rejection, the limitation remains a surrender-generating limitation because the step of “allowing the sterile air and/or sterile gas to pass from the flexible container to displace retained filtered fluid along the first fluid flow path into the filtered fluid receiving container,” is known in the prior art as taught by Matkovich (discussed below). See In re Mostafazadeh, 643 F.3d 1353, 1361,98 USPQ2d 1639, 1644 (Fed. Cir. 2011); MPEP 1412.02 II C. Claim 5 recites limitation (i). However, as claim 5 depends from claim 3 it only retains limitation (ii) in broadened form.
Thus, new claims 3-12 relate to subject matter surrendered in the original prosecution.
As to STEP 3, limitations (i) and (ii) have not been materially narrowed such that recapture is avoided.
Accordingly, claims 3-12 are rejected as being improper recapture of broadened claimed subject matter.
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 9-12 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.
Recitation of the “filter system” and the components thereof in lines 14-32 of claim 9 renders the claim vague and indefinite. The fluid processing circuit is recited as being “removably attachable” to the filter system and thus, these are separate components. However, the following components are disclosed to be part of both the fluid processing circuit and the filter system:
“first fluid path” in paragraphs “(a)” and “(c’).”
“a filter device outlet and a filtered fluid receiving container” in paragraphs (“(a)”, “(a’)”, and “(c’).”
“a second fluid flow path” in paragraphs “(c)” and “(d’)”
“a flexible container for containing sterile air and/or sterile gas” in paragraphs “(c)” and “(e).”
It is unclear how the same component can be part of both the fluid processing circuit and the filter system if they are detachable from one another.
Claims 10-12 are likewise rejected as depending from claim 9 and requiring all
the limitations thereof.
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.
Claim(s) 3 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5,863,436 to Matkovich (hereinafter Matkovich).
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With respect to claim 3, Matkovich teaches a method for recovering filtered fluid retained in a filter system 10 including a filter device 14 comprising a housing having an inlet and an outlet defining a filtration flow path between the inlet and the outlet and a porous filter medium2 across the filtration flow path (col.5, lines 49-56), the porous medium having an upstream side and a downstream side; the system also including a filtered fluid receiving container 17 arranged downstream of the outlet; a first fluid flow path 15 between the outlet and the filtered fluid receiving container; a second fluid flow path 36 between the first fluid flow path and a flexible container 35 (col.16, lines 43-47) containing sterile air and/or sterile gas, the second fluid flow path including an associated flow control device (col.16, lines 41-43); wherein the second fluid flow path is connected to the filter system downstream of the filter device; the method comprising: (a) passing fluid to be filtered along the filtration flow path through the filter device and passing filtered fluid along the first fluid flow path into the filtered fluid receiving container, wherein a volume of filtered fluid is retained in the housing between the downstream side of the porous filter medium and the outlet (col.16, lines 17-21); and, (b) allowing the sterile air and/or sterile gas to pass from the flexible container to displace retained filtered fluid along the first fluid flow path into the filtered fluid receiving container (col.16, lines 24-30).
As to claim 6, Matkovich teaches a filter system 10 for filtration of fluid comprising: (a) a filter device 14 (col.5, lines 52-59) comprising a housing having an inlet and an outlet defining a filtration flow path between the inlet and the outlet, and a porous filter medium across the filtration flow path, the porous filter medium having an upstream side and a downstream side; (b) a filtered fluid receiving container 17 arranged downstream of the outlet; (c) a first fluid flow path 15 between the outlet and the filtered fluid receiving container; (d) a flexible container 35 (col.16, lines 43-44) for containing sterile air and/or sterile gas; (e) a second fluid flow path 36 in fluid communication with the flexible container and with the outlet of the filter device, the second fluid flow path including an associated flow control device (col.16, lines 41-43) configured to selectively allow sterile air and/or sterile gas to displace retained filtered fluid along the first fluid flow path into the filtered fluid receiving container. See col.16, lines 24-30.
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.
Claim(s) 4, 5, 7, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matkovich.
With respect to claims 4 and 8, Matkovich teaches that the filter device may “also include a device for destroying biological contaminants” (col.5, lines 52-58). A POSITA would have found it obvious to use a sterilizing grade filter, as fulfilling the functions of both filtration and sterilization.
As to claims 5 and 7, Matkovich discloses that the purge gas may be provided from numerous sources such as, provided from a storage container, or injected aseptically from an outside source that has been sterilized. See col.7, lines 9-18. Container 35 is described as “both a source and repository of gas or air” with gas entering conduit 12 through inlet 13. The gas inlet includes a microporous membrane (col.7, lines 19-20) which does not allow bacteria to pass (a sterilizing grade filter). See col.9, lines 5-11. Thus, as container 35 is disclosed to be both a source and repository of gas or air and as Matkovich discloses passing the gas or air through a sterilizing grade porous filter, one of ordinary skill in the art would have found it obvious to provide the container 35 with air/gas that has been passed through the sterilizing filter when it is functioning as a repository, thereby assuring that only sterile air/gas is ultimately used to purge the filtration fluid path. Note that Matkovich expressly teaches that “the sterility of the system” is not to be compromised. See col.4, lines 7-8.
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matkovich.
With respect to claim 9, Matkovich teaches a fluid processing conduit system comprising: (a) at least one conduit 15 for passage of fluid, wherein the at least one conduit for passage of fluid forms a first fluid flow path between a filter device 14 outlet and a filtered fluid receiving container 17;
(b) at least one connector at 16 for connecting the at least one conduit for passage of fluid between the filter device outlet and a filtered fluid receiving container (“a gas inlet or a gas outlet may be disposed in a conduit having a connector on both ends. In this way, the embodiment may be inserted into a previously existing system”; col.5, lines 15-18)
(c) at least one conduit 36 for passage of sterile air and/or sterile gas, wherein the at least one conduit for passage of sterile air and/or sterile gas forms a second fluid flow path between a flexible container 35 for containing sterile air and/or sterile gas and
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the filter device outlet;
(d) at least one connector for connecting the at least one conduit 36 for passage of sterile air and/or sterile gas between the flexible container 35 for containing sterile air and/or sterile gas and the filter device outlet. As set forth above, gas outlet 16 may be disposed in a conduit having connectors at both ends. Thus, conduits 36 and 15 may each have connectors at both ends. It would have been obvious for a POSITA to do so, as Matkovich discloses that the provision of connectors allows insertion of components, such as the flexible container, into a previously existing system
Further, as set forth above the fluid processing conduit system is removably attachable via connectors to a filter system for filtration of fluid, the filter system for filtration of fluid comprising: (a') a filter device 14 comprising a housing having an inlet and a filter device outlet defining a filtration flow path between the inlet and the filter device outlet, and a porous filter medium across the filtration flow path, the porous filter medium having an upstream side and a downstream side; (b') the filtered fluid receiving container 17 arranged downstream of the filter device outlet; (c') the first fluid flow path 15 between the filter device outlet and the filtered fluid receiving container 17; (d') a second fluid flow path 36 connected to the filter system downstream of the filter device; and (e') the flexible container 35 for containing sterile air and/or sterile gas, the second fluid flow path including an associated flow control device (col.16, lines 24-30); wherein, after filtration is complete, the system is arranged such that opening the associated flow control device allows sterile air and/or sterile gas to displace retained filtered fluid along the first fluid flow path into the filtered fluid receiving container.
As to claim 10, Matkovich discloses embodiments using connectors wherein a plurality of conduits 15B,15B, and gas outlet 16 for passage of fluid are connected by at least one connector 60 in Figure 6C. See also embodiments shown in Figures 6A and 6B.
With respect to claim 11, the gas inlet includes a microporous membrane (col.7, lines 19-20) which does not allow bacteria to pass (a sterilizing grade filter). See col.9, lines 5-11.
As to claim 12, Matkovich teaches that the filter device may “also include a device for destroying biological contaminants” (col.5, lines 52-58). A POSITA would have found it obvious to use a sterilizing grade filter, as fulfilling the functions of both filtration and sterilization.
Allowable Subject Matter
Claims 1 and 2 are allowed.
The following is an examiner’s statement of reasons for allowance: While Matkovich teaches the use of a sterile purge gas to remove fluid from filter 14, the location of gas inlet 13 upstream of the filter indicates that the gas enters the filter on an upstream inlet side, pushing remaining fluid in the filter out through the downstream outlet side. Claim 1 recites “allowing the sterile air and/or the sterile gas to pass from the flexible container along the second fluid flow path into the first flow path and through the outlet into the housing of the filter device, and displacing retained filtered fluid along the first fluid flow path into the filtered fluid receiving container.” Thus, in claim 1 the sterile gas must enter the filter through the downstream outlet side which is neither taught nor suggested by Matkovich.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 11,498,024 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L MCKANE whose telephone number is (571)272-1275. The examiner can normally be reached Mon-Thu 6:30a-4:30p EST.
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, Patricia Engle can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELIZABETH L MCKANE/Specialist, Art Unit 3991
Conferees:
/LEE E SANDERSON/Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
1 Claim 3 recites a broadened version of limitation (ii) and dependent claim 5 recites limitation (i), which is discussed further below.
2 Filters are porous mediums. A leucocyte depletion filter comprises a porous non-woven web.