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 .
Drawings
The drawings are objected to because it appears that in fig. 5 the inlet connector is labeled with “7” and the outlet connector is labeled with “6” and this should be vise-versa. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities:
change claim 1 line 3 accordingly: “filtered liquid;”
change claim 1 line 9 accordingly: “said at least one filtering hydrophilic membrane”
change claim 1 line 10 accordingly: “said at least one interspace”
change claim 1 line 11 accordingly: “said internal channels”
change claim 1 line 12 accordingly: “said at least one interspace”
change claim 1 line 13 accordingly: “[[membranes, ;]] membranes;”
change claim 5 line 3 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 1-5 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.
The term “plate-like element” in claim 1 is a relative term which renders the claim indefinite. The term “plate-like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is thought one of ordinary skill would understand this term to be the structure of a plate or a structure similar (MPEP 2173.05(b) III. C.) to a plate. Examiner could not find any examples that explain the scope of plate-like in applicant disclosure. Further, the term as used in applicant disclosure appears to diverge from the dictionary definition and examples in the prior art. For example “plate-like” can be interpreted as “resembling a plate especially in smooth flat form” (Merriam-Webster online). In contrast applicant fig. 5 shows that the plate-like element 8 appears to have raised edges at the perimeter and thus appears to resemble more of a baking pan or saucer. In addition one example of plate-like in the prior art is US 4211239 col. 5, ll. 55-60 and claim 5, bottom. The plate-like member with opposing sides 50-51 is shown in fig. 5.
The term “box-like structure” in claim 1 is a relative term which renders the claim indefinite. The term “box-like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Initially it was thought by examiner that the scope of claim 1 term “box-like structure” would be understood by one of ordinary skill in light of applicant specification. For example, the box-like body is explained as being formed “by a pair of half-shells” (page 3, ll. 25-30) such body having an internal volume containing a plate-like element (p. 1, ll. 10-15). However at page 7, ll. 20-25 the box-like structure comprises only one of the half-shells (see half-shell 2 in fig. 6). It does not appear that the half-shell 2 resembles a box. Thus it is thought the public would not understand how to avoid infringing the claim.
Claim 1 recites the limitation "the external" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the communication" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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 3 recites “a chamber formed in said plate-like element”. The metes and bounds of this claim is unclear in light of applicant specification. For example applicant disclosure at p. 5, ll. 30-35 states “a chamber 15 formed between a substantially dome-like part 16 of the wall 2 and the corresponding surface of the plate-like element”. One of ordinary skill in the art would understand “formed in” to communicate for example a cavity formed in for example by machining the surface of the plate-like element. However the specification does not discuss this and the corresponding drawing does not show a cavity or chamber formed in the surface (see chamber 15 in fig. 2 wherein annular relief 22 is said to be located inside the chamber rather than forming the chamber: “Inside the chamber 15 there is provided for an annular relief 22”, see p. 6, ll. 1-5).
Claim 5 recites the limitation "the other side" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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 box-like body 104 having an inlet connector 114 for a liquid to be filtered and an outlet connector 108 for the filtered liquid;
said box-like body 104 receiving (see par. 102, top and fig. 6) a plate-like element (see element by way of shading in annotated figures below; such plate-like element can be that in annotated figs. 5 and 6 and can also include a portion at 150b shown in annotated fig. 3 shading; this can be similar to a grid plate, see pertinent prior art infra), said plate-like 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 plate like element) said plate-like element (see annotated figure below), said at least one filtering hydrophilic membrane 140,142 separating said channels from at least one internal interspace 122,124 (see par. 97, middle), said at least one interspace 122,124 being placed in communication (see fig. 3; interspaces 122,124 are “fresh” dialysis fluid passageways and thus are in communication with the inlet connector 114) with the inlet connector 114 and said internal channels 144 being placed in communication (via space 146; see fig. 6) with the outlet connector 108, and said at least one interspace 122,124 being further placed in communication with the external through hydrophobic membranes 152 (see par. 105); and
wherein an overpressure (this valve 150a closes in response from pressure from “used” dialysis fluid backflowing through outlet 108 and the filter 100 flowing from left to right in fig. 3 as shown by dashed line; this permits the used fluid to bypass the membranes 140,142 so the membranes do not become clogged, see par. 99; this is consistent with applicant specification p. 5, ll. 25-30) valve (150a or 150b; wherein valve 150b permits used dialysis fluid to exit at outlet connector after passing through bypass passage, see annotated figures below and par. 104) is operatively associated (see fig. 3) to said outlet connector 108.
It is thought one of ordinary skill would understand Norman’s hydrophobic vent 152 to comprise a hydrophobic membrane 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 vent of Norman does not include a hydrophobic membrane.
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 the 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).
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Regarding claim 2, Norman discloses wherein said overpressure valve 150a is incorporated within (see fig. 3) the box-like body 102 of the filter 100.
Regarding claim 3, Norman discloses wherein said overpressure valve (150a or 150b) comprises a chamber (see annotated figures above) formed in said plate-like element (see annotated figures above) and containing an obturator (at 150a or 150b) which controls the communication (the obturator permits fresh dialysis fluid to pass through the membranes from the inlet connector to the outlet connector and prevents used fluid from passing through the membranes in the opposite direction; see par. 104) between said outlet connector 108 and said inlet connector 114.
Regarding claim 4, Norman discloses (see figs. 4-6) wherein said obturator (at 150a) consists of (there is only the duckbill flexible material) an elastic membrane (see par. 98).
Regarding claim 5, Norman discloses wherein said chamber (e.g., chamber at 150b in annotated figures above) is connected - on one side - to said outlet connector through (see annotated fig. 3 above) a by-pass passage (see annotated figures above) and - on the other side - to said at least one interspace 122,124 (the downstream side, with respect to the flow through the bypass passage is connected to said interspaces through structures at 118 and 116 and is fluidly connected to said interspaces for example via fresh dialysis fluid shown by the dashed arrow at 116 in annotated fig. 3 above).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
“grid plate” 18: US 3876067;
valves related to IV structures: US 20020123715 20220096758;
bypass valves: US 3677242 4413990 5186431 7217357;
filters relating to IV lines: US 4066556 4615694 5100376 5252222 5827429 20210046243 20220313903 WO 2019215516;
duckbill valve has elastic membrane: US 5820600 (col. 8, ll. 50-55); and
valve assembly within filter housing: US 4614581 4854277.
Conclusion
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.
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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
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