DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 objected to because of the following informalities:
Change claim 1 line 18 accordingly: “said at least one interspace”
Appropriate correction is required.
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 3-5 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.
Claim 3 line 2 recites “a chamber”. It is unclear whether the claim 3 instant chamber (1) refers to the claim 1 line 15 “a chamber”, or (2) is a different chamber. It is noted that “chamber” is also recited in claim 5 that depends upon claim 3. The claim is interpreted regarding scenario (1) for purposes of compact prosecution.
Claim 3 recites “obturator”. Referring to the flow chart in MPEP 2111.01 V. it does not appear that term obturator has a clear ordinary and customary definition in the art. For example, an obturator can be interpreted as being a different element than a membrane (for example see US 20160051806 par. 756). Applicant has not discussed in applicant disclosure what is meant by an obturator. For purposes of compact prosecution the term obturator is interpreted as “something … that closes or blocks up an opening” (Merriam-Webster online).
Claim 4 line 2 recites “an elastic membrane”. It is unclear whether the claim 4 instant membrane (1) refers to the claim 1 line 16 “an elastic membrane”, or (2) is a different elastic membrane. The claim is interpreted regarding scenario (1) for purposes of compact prosecution.
Claims dependent thereon are rejected for the same reasons.
Claim Rejections - 35 USC § 102/103
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.
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Pub No. US 2020/0086028 A1 (Norman) or, in the alternative, under 35 U.S.C. 103 as obvious over Norman in view of US 2014/0190876 A1 (Meyer).
Regarding claim 1, Norman discloses (see figs. 1 and 3-6) filter 100 for medical infusion lines 86,88,50 comprising;
a body 104,106,112 having an inlet connector 114 for a liquid to be filtered and an outlet connector 108 for the filtered liquid;
said body 104,106,112 receiving (see par. 102, top and fig. 6) a central element (see element by way of shading in annotated figures below; such central element can be that in annotated figs. 3, 5 and 6), said central element comprising opposite faces (see example face in annotated figure below; face can be interpreted as “surface”, Merriam-Webster online) and having ribs 136 formed (see annotated figure below) on at least one (the face opposite of the annotated face) of said opposite faces, said ribs 136 defining internal channels 144 extending parallel (see fig. 6) between said inlet connector 114 and said outlet connector 108;
at least one filtering hydrophilic membrane 140,142 arranged on (see annotated fig. 5 below; the membranes 140,142 are arranged on portions of the central element) said central element (see annotated figure below), said at least one filtering hydrophilic membrane 140,142 separating (membranes 140,142 separate interspace portions 122,124 from said internal channels, see par. 106; for example “upper membrane 140 filters fresh dialysis fluid flowing downwardly through first … [interspace] 122” and “fresh dialysis fluid flows downwardly from first, upper … [interspace] 122 through multiple generally parallel passageways created by a first filter membrane and an inner grid into an interior region 126”1 wherein such region 126 comprises the internal channels 144 as shown in fig. 6) said internal channels from at least one internal interspace (annotated “interspace” in annotated figure 3 below and 122,124; the claimed at least one interspace is not required to be continuous), said at least one interspace in communication (interspace portions 122,124 are “fresh” dialysis fluid passageways and thus are in communication with the inlet connector 114; also annotated interspace portion coincides with the inlet connector 114; see annotated figures below) with the inlet connector 114 and said internal channels 144 in communication (via space 146; see fig. 6) with the outlet connector 108, and said at least one interspace (annotated “interspace” annotated figure 3 below and 122,124) in communication with an exterior through hydrophobic membranes 152 (see par. 105); and
an overpressure (valve portion membrane 150b opens in response from pressure from “used” dialysis fluid backflowing through outlet 108 flowing from left to right in fig. 3 as shown by dashed arrowed line; this permits the used fluid to bypass the hydrophilic membranes 140,142 so such membranes do not become clogged, see par. 99; this is consistent with applicant specification p. 5, ll. 25-30) valve (the claimed valve can include the annotated chamber and the elastic membrane 150b; such valve permits “new” fluid to enter interspace portions 122,124 and prevents the “new” fluid from entering passage 118 by way of the elastic membrane 150b duckbill aperture not opening in response to the new fluid entering inlet connector 114; see par. 98; for example, elastic membrane “150b is oriented such that it opens under negative pressure of the used dialysis fluid pulled through used dialysis fluid pathway 118 by pumping cassette 42” and elastic membrane “150b is closed under positive pressure from pumping cassette 42 pushing fresh dialysis fluid into filter 100 via second port 114”, see par. 100) is operatively associated (see fig. 3 wherein part of the operation of the filter 100 includes backflowing via passage 118 used dialysis fluid to membrane 105b from outlet connector 108; see par. 100) to said outlet connector 108,
said overpressure valve comprising a chamber (see annotated figures below) bounded (see annotated figure 3 below) by said central element (see annotated figures below), an internal surface (see annotated figure 3 below) of a dome shaped portion (see annotated shading of dome shape in annotated figure 3 below) of a wall of said body and an elastic membrane (at 150b; see par. 98) connected to (via the structures of filter 100) said central element and configured to allow a flow (see par. 100) past said elastic membrane 150b from the outlet connector 108 to said chamber (see annotated figures below) and to said at least one interspace (annotated interspace portion in fig. 3 below) to bypass said at least one filtering hydrophilic membrane 140,142 when a pressure in a passage 118 in fluid communication (see fig. 3) with the outlet connector 108 is higher than a predetermined threshold value (the value of the “negative pressure” discussed in par. 100, top), the passage 118 on a same side of the elastic membrane 150b as the outlet connector 108 and on an opposite side (see annotated figure below) of the elastic membrane relative to the chamber (see annotated figures below).
It is thought one of ordinary skill would understand Norman’s hydrophobic vents 152 to comprise a hydrophobic membranes regarding the 102 discussion above. However in the alternative in the event one of ordinary skill in the art would not make such an understanding, then it can be said the hydrophobic vents of Norman do not include hydrophobic membranes.
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Meyer teaches structures related to kidney dialysis (and thus is similar to Norman regarding Norman par. 4) and further teaches in par. 258 a hydrophobic membrane for a hydrophobic vent. It is further noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 at 1395 (U.S. 2007) (MPEP 2143 I.B.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute the hydrophobic membrane porous material of Meyer for porous material (of each hydrophobic vent) of Norman for the purpose of substituting one known element for another in order to provide the expected result of providing a vent of gasses of Norman in view of Meyer (this is consistent with Norman par. 42).
Regarding claim 2, Norman discloses wherein said overpressure valve (the claimed valve can include the annotated chamber and the elastic membrane 150b; such valve permits “new” fluid to enter interspace portions 122,124 and prevents the “new” fluid from entering passage 118 by way of the elastic membrane 150b duckbill aperture not opening in response to the new fluid entering inlet connector 114; see par. 98; for example, elastic membrane “150b is oriented such that it opens under negative pressure of the used dialysis fluid pulled through used dialysis fluid pathway 118 by pumping cassette 42” and elastic membrane “150b is closed under positive pressure from pumping cassette 42 pushing fresh dialysis fluid into filter 100 via second port 114”, see par. 100) is incorporated within (see fig. 3) the body 104,106,112 of the filter 100.
Regarding claim 3, Norman discloses said overpressure valve comprises a chamber (see annotated figures above) bounded (see annotated figures above) by said central element (see annotated figures above) and containing an obturator 150b which controls a communication (see par. 99) between said outlet connector 108 and said inlet connector 114.
Regarding claim 4, Norman discloses (see fig. 3) wherein said obturator 150b consists of an elastic membrane 150b.
Regarding claim 5, Norman discloses wherein said chamber (see annotated figure above) is connected (fluidly connected via elastic membrane 150b and structurally connected via walls of structure 104 portion of the body) - on one side (the upstream side with respect to the direction of flow through passage 118 in fig. 3) - to said outlet connector 114 through a by-pass passage (see annotated figures above) and - on another side – (the downstream side) to said at least one interspace (portion of at least one interspace shown in annotated figure 3 above).
Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive. Applicant argues at page 6 middle that claim 3 has been removed and thus the 112 rejection thereof is moot. In response there appears to still be a claim 3.
Applicant argues that Norman does not disclose or teach “an overpressure valve having a chamber bounded by a central element, a dome shaped portion and an elastic membrane connected to the central element, the elastic membrane configured to allow a flow thereby from an outlet connector to such a chamber to an interspace to bypass a filtering membrane when a pressure in a passage in fluid communication with the outlet connector is higher than a predetermined threshold value where the passage is on a same side of the elastic membrane as the outlet connector and on an opposite side of the elastic membrane relative to the chamber”. Applicant refers to the Norman valves as valves 150a,150b. However the BRI of a valve may include more than just the valve element such as elastic membrane 150b. For example the BRI of a valve may include a chamber to receive fluid exiting the valve elastic membrane 150b. In this context Norman discloses the instant quoted limitations.
Because the new limitations cite different portions of Norman compared to the non-final office action the claim mapping to Norman is presented here for applicant convenience regarding the instant quoted recitation wherein Norman discloses an overpressure (valve portion membrane 150b opens in response from pressure from “used” dialysis fluid backflowing through outlet 108 flowing from left to right in fig. 3 as shown by dashed arrowed line; this permits the used fluid to bypass the hydrophilic membranes 140,142 so such membranes do not become clogged, see par. 99; this is consistent with applicant specification p. 5, ll. 25-30) valve (the claimed valve can include the annotated chamber and the elastic membrane 150b; such valve permits “new” fluid to enter interspace portions 122,124 and prevents the “new” fluid from entering passage 118 by way of the elastic membrane 150b duckbill aperture not opening in response to the new fluid entering inlet connector 114; see par. 98; for example, elastic membrane “150b is oriented such that it opens under negative pressure of the used dialysis fluid pulled through used dialysis fluid pathway 118 by pumping cassette 42” and elastic membrane “150b is closed under positive pressure from pumping cassette 42 pushing fresh dialysis fluid into filter 100 via second port 114”, see par. 100) is operatively associated (see fig. 3 wherein part of the operation of the filter 100 includes backflowing via passage 118 used dialysis fluid to membrane 105b from outlet connector 108; see par. 100) to said outlet connector 108,
said overpressure valve comprising a chamber (see annotated figures below) bounded (see annotated figure 3 below) by said central element (see annotated figures below), an internal surface (see annotated figure 3 below) of a dome shaped portion (see annotated shading of dome shape in annotated figure 3 below) of a wall of said body and an elastic membrane (at 150b; see par. 98) connected to (via the structures of filter 100) said central element and configured to allow a flow (see par. 100) past said elastic membrane 150b from the outlet connector 108 to said chamber (see annotated figures below) and to said at least one interspace (annotated interspace portion in fig. 3 below) to bypass said at least one filtering hydrophilic membrane 140,142 when a pressure in a passage 118 in fluid communication (see fig. 3) with the outlet connector 108 is higher than a predetermined threshold value (the value of the “negative pressure” discussed in par. 100, top), the passage 118 on a same side of the elastic membrane 150b as the outlet connector 108 and on an opposite side (see annotated figure below) of the elastic membrane relative to the chamber (see annotated figures below).
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The annotated chamber above may extend upward to location 116 wherein the chamber direction bounds the central element. It is thought that it is reasonable that the Norman chamber include the instant upper portion at location 116 because fluid is shown flowing in both directions (i.e. the new fluid flowing into the central element for filtering and the used fluid exiting passage 118) and valve elastic membrane 150b plays a role in each of the instant both directions. For example, “valve 150b is oriented such that it opens under negative pressure of the used dialysis fluid pulled through used dialysis fluid pathway 118 by pumping cassette 42” and “valve 150b is closed under positive pressure from pumping cassette 42 pushing fresh dialysis fluid into filter 100 via second port 114” (see par. 100).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “valve structures … configured to protect a hydrophilic membrane from backflow pressure damage”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally it is noted that the protected hydrophilic membranes 140,142 from damage because backflow from the patient is permitted to bypass such membranes 140,142 via passage 118 (see Norman fig. 3): “used dialysis fluid is prevented from entering fresh dialysis fluid pathway 120 and contacting the filter membranes, which is desirable since filtering used dialysis fluid could… clog the filter membrane” (see par 99) and thus could prevent damage.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARC J AMAR whose telephone number is (571)272-9948. The examiner can normally be reached M-F 9:00-6:00.
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, Devon Kramer can be reached at (571) 272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARC AMAR/Examiner, Art Unit 3741 /DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741
1 See par. 97.
Prosecution Insights