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 Objections
Claim 1 is objected to because of the following informalities:
In line 8, “the material” should be --a material--,
In line 9, “the reinforcing strip” should be --the two-layer leak-tight reinforcing strip--,
In line 12, “the reinforcing strip” should be --the two-layer leak-tight reinforcing strip--, and
In line 14, “said reinforcing strip” should be --said two-layer leak-tight reinforcing strip--.
Claim 2 is objected to because of the following informalities:
In line 2, “the reinforcing strip” should be --the two-layer leak-tight reinforcing strip--.
Claim 3 is objected to because of the following informalities:
In line 2, “the reinforcing strip” should be --the two-layer leak-tight reinforcing strip--.
Claim 4 is objected to because of the following informalities:
In line 2, “the reinforcing strip” should be --the two-layer leak-tight reinforcing strip--.
Claim 8 is objected to because of the following informalities:
In line 3, “the part” should be --a part--.
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 4 and 9 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.
Regarding claim 4, the language "advantageously" and “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention or whether they are optional.
For the purpose of examination, the two-layer leak-tight reinforcing strip will be considered to have a thickness of between 50 micrometers and 200 micrometers, or between 60 micrometers and 100 micrometers, or 80 micrometers.
Claim 9 recites the limitation “the internal sleeve” in line 3. However, there is insufficient antecedent basis for the limitation in the claims.
For the purpose of examination, the protective ring will be considered to be clipped onto the connection device.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Owen (US 2,687,158 A) in view of Stumpf (US 4,887,912 A), Sheikh (US 2015/0016755 A1) and Murray (US 4,658,434 A).
Regarding claim 1, Owen teaches a leak-tight container comprising a bag (10’’/20’’, 11’’/21’’) formed of a flexible film made of polymer defining an interior volume and a through-opening, and a leak-tight connection device (13’’), said connection device comprising a flange (15’’), said flange delimiting the through-opening of the bag (Fig. 5), wherein the container comprises a two-layer leak-tight reinforcing strip (12’’, 17’’) composed of:
a first layer (12’’) compatible with a material of the flange, and
a second reinforcing layer (17’’) made of a material compatible with that of the bag to allow the two-layer leak-tight reinforcing strip to be directly bonded to the bag,
said two-layer leak-tight reinforcing strip being inserted between the flange and the bag (Fig. 5) such that the first layer is directly adjacent to and in contact with the flange and the second reinforcing layer is bonded to the bag (column 2 line 2-column 5 line 16 and Fig. 1, 5).
Regarding the connection device being intended to engage with a complementary connection device of a sterile chamber so as to ensure leak-tight communication between the interior volume of said container and that of the chamber, it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations and while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function (see MPEP 2114). In this case, the structure of the connection device disclosed by Owen meets the structure claimed and thus, is considered to have the structure necessary to function as claimed.
Owen fails to teach the first layer being directly bonded to the flange such that the flange is bonded to the bag. Stumpf teaches an analogous leak-tight container comprising a bag (12) and a leak-tight connection device (6) comprising a flange (8), wherein the container comprises two reinforcing layers including a first layer (10) of a material compatible with the flange and a second layer (11), wherein the reinforcing layers are inserted between the flange and the bag (FIG. 2) such that the first layer is directly adjacent to and in contact with the flange and the second reinforcing layer is bonded to the bag. Stumpf further teaches that it is known and desirable in the prior art to directly bond the first layer to the flange such that the flange is bonded to the bag in order to ensure a leak-tight connection between the flange and the reinforcing layers and in order to improve torque-resistance (column 1 line 42-column 4 line 14 and FIG. 1, 2).
Accordingly, one having ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify Owen by directly bonding the first layer to the flange such that the flange is bonded to the bag, as taught by Stumpf, in order to ensure a leak-tight connection between the flange and the reinforcing layers and in order to improve torque-resistance.
Owen also fails to teach the first layer being made of polystyrene compatible with the material of the flange, which comprises at least polyphenylene oxide to allow the reinforcing strip to be directly bonded to the flange. Sheikh also teaches an analogous leak-tight container comprising a bag and a leak-tight connection device comprising a flange (22), wherein the container comprises a reinforcing layer (FIG. 3) of a material compatible with the flange, and wherein the reinforcing layer is inserted between the flange and the bag (FIG. 3) such that the reinforcing layer is directly adjacent to and in contact with the flange. Sheikh further teaches that it is known and desirable in the prior art to form the reinforcing layer of polystyrene which comprises at least polyphenylene oxide in order to ensure a water-tight seal between the bag and the connection device (paragraphs 64-73 and FIG. 1-4).
Accordingly, one having ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify Owen by forming the first layer of polystyrene compatible with the material of the flange, which comprises at least polyphenylene oxide to allow the reinforcing strip to be directly bonded to the flange, as taught by Sheikh, in order to ensure a water-tight seal between the bag and the connection device.
Owen also fails to teach the second reinforcing layer being of greater rigidity than the first layer. Murray teaches an analogous leak-tight container comprising a bag (2, 7) and a leak-tight connection device comprising a flange (10), wherein the container comprises reinforcing layers including a first layer (6) of a material compatible with the flange and a second layer (3/4) of a material compatible with the bag (2), wherein the reinforcing layers are inserted between the flange and the bag (FIG. 3, 6) such that the first layer is directly adjacent to and in contact with the flange and the second layer is bonded to the bag. Murray further teaches that it is known and desirable in the prior art to form the second layer of a high density polyethylene in order to provide strength to the reinforcing layers (column 2 lines 31-63 and FIG. 1, 3, 6).
Accordingly, one having ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify Owen by forming the second reinforcing layer of high density polyethylene or other material of greater rigidity than the first layer, as taught or suggested by Murray, in order to provide strength to the reinforcing strip.
Regarding claim 2, Owen as modified by Stumpf, Sheikh and Murray teaches the container of claim 1 above, wherein the two-layer leak-tight reinforcing strip is a strip thermally bonded to the flange (Owen: Fig. 5 and Stumpf: column 1 line 42-column 4 line 14 and FIG. 1, 2).
Regarding claim 3, Owen as modified by Stumpf, Sheikh and Murray teaches the container of claim 1 above, wherein the two-layer leak-tight reinforcing strip is integrated into the bag (Owen: column 4 line 53-column 5 line 9 and FIG. 5).
Regarding claim 4, Owen as modified by Stumpf, Sheikh and Murray teaches the container of claim 1 above, but fails to teach a thickness of the two-layer leak-tight reinforcing strip being between 50 micrometers and 200 micrometers, between 60 micrometers and 100 micrometers, or 80 micrometers. However, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the thickness of the two-layer leak-tight reinforcing strip of Owen as modified by Sheikh and Murray, in order to obtain the thicknesses claimed, as merely changing the size or thickness of a component is insufficient to patentably distinguish over the prior art and is generally recognized as being within the level of ordinary skill in the art absent persuasive evidence that the particular thickness of the claimed reinforcing strip is critical. It is noted that in the instant application, applicant has not disclosed any criticality for the claimed thickness.
Regarding claim 5, Owen as modified by Stumpf, Sheikh and Murray teaches the container of claim 1 above, wherein the second reinforcing layer has a thickness equal to that of the first layer (Owen: column 2 line 2-column 5 line 16 and Fig. 1, 5 and Murray: column 2 lines 31-63 and FIG. 3).
Regarding claim 6, Owen as modified by Stumpf, Sheikh and Murray teaches the container of claim 1 above, wherein the second reinforcing layer is made of polyethylene (Murray: column 2 lines 32-34).
Regarding claim 7, Owen as modified by Stumpf, Sheikh and Murray teaches the container of claim 1 above, but fails to teach the bag being formed form a single or multi-layer film comprising polyethylene.
Owen, however, teaches that bag can be formed from a multi-layer film (10, 11) comprising a thermoplastic material and Murray teaches that analogous bags can be formed from a film comprising polyethylene (2) (Owen: column 2 lines 32-38 and Murray: column 2 lines 31-36).
Accordingly, one having ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify Owen by forming the bag from a single or multi-layer film comprising polyethylene, as taught by Murray, as it has been shown in the prior art to be a well-known and common material for forming analogous bags and as it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. It is noted that in the instant application, applicant has not disclosed any criticality for the claimed material.
Regarding claim 8, Owen as modified by Stumpf, Sheikh and Murray teaches the container of claim 1 above, wherein the container further comprises a protective ring (16’’) encircling a part of the flange on which the bag is mounted, the bag being engaged between said protective ring and the flange (Owen: Fig. 5).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Owen in view of Stumpf, Sheikh and Murray, as applied to claim 8 above, in view of Pham et al. (US 7,967,166 B2, hereinafter Pham).
Regarding claim 9, Owen as modified by Stumpf, Sheikh and Murray teaches the container of claim 8 above, but fails to teach the protective ring being clipped onto the connection device. Pham teaches an analogous leak-tight container comprising a bag and a connection device comprising a flange (12) and a protective ring (80), wherein the protective ring encircles a part of the flange on which the bag is mounted such that the bag is engaged between the protective ring and the flange (FIG. 5). Pham further teaches that it is well-known and common in the art to configure the protective ring to be clipped on the connection device (column 5 lines 47-66).
Accordingly, one having ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify Owen by alternatively configuring the protective ring to be clipped onto the connection device, as taught or suggested by Pham, as the substitution of one known connection structure for an alternative known connection structure to achieve the equivalent result of clamping the bag between the connection device and the protective ring would have been obvious and would have yielded predictable results to one skilled in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NINA KAY ATTEL whose telephone number is (571)270-3972. The examiner can normally be reached Monday-Friday 7AM-4PM EST.
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/NINA K ATTEL/Examiner, Art Unit 3734
/NATHAN J NEWHOUSE/Supervisory Patent Examiner, Art Unit 3734
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