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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/13/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The disclosure is objected to because of the following informalities:
Page 5 line 14: “Figure 4D is is a view…”
Page 5 line 20: “Figure 5C isa view…”
Page 7 line 6: “…with an internal tooth 31.1 or 31.2…”
31.2 should be 32.1
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The recitation, in claim 1, of “a first end segment provided with means for
connecting it to the tube” has been interpreted as structurally being elements external projection 23 and collar 24 for the means for connecting it to the tube (page 6, lines 3-7).
The recitation, in claim 2, of “locking means for locking the body” has been interpreted as structurally being elements detent rings 28.1, 28.2, 28.3, and blades 31 and 32 for the means for locking the body in the projecting and flush position (see page 7, lines 18-30).
The recitation, in claim 3, of “pre-coupling and coupling means for engaging another coupling device” has been interpreted as structurally being elements locking tab 26 and first and second opening 37.1, 37.2 for the means for engaging another coupling device (page 10, line 36 – page 11, line 8).
Claim Rejections - 35 USC § 103
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 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 1, 2, 5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Py (United States Patent Application No. US 2011/0240158 A1) and further in view of Nishikawa (United States Patent No. 5,697,652 ), Tenczar (United States Patent No. 4,030,494), Williams et al. (United States Patent No. US 8,491,016 B2; herein, Williams), and Bonnal et al. (United States Patent Application Publication No. US 2012/0192968 A1; herein, Bonnal).
Regarding claim 1, Py discloses an aseptic coupling device (female connector 12) for a tube characterized in that it comprises:
a tubular insert (FIG.1, tubular surface on first valve 12 that surrounds first fluid passageway 14) defining a channel (first fluid passageway 14); and
an annular body (FIG. 1, female connector housing 48) comprising both a first end segment mounted on the second end segment of the insert (FIG. 1, female connector housing 48 attaches to the tubular surface on first valve 12 that surrounds first fluid passageway 14) and also a second end segment projecting axially from the second end segment of the insert (FIG. 1, female connector housing 48 extends axially away from the attachment point), an annular sealing element (first engaging portion 20) that is deformable (FIG. 3, engaging portions 20 and 32 are in fully deflected positions) between a first state (FIG. 1, [0040], non-deflected position) in which the sealing element defines a fluid flow section greater than the cross section of the rod and a second state (FIG. 3, [0040], fully deflected position) in which the sealing element tightly surrounds the rod, the sealing element being arranged to be taken from its first state to its second state under the effect of axial compression (FIG. 2A-2E, engaging portions 20 and 32 enter into fully deflected positions); and in that:
the sealing element has a front face projecting from the second segment of the annular body (FIG. 1); and
a projecting position (FIG. 1, [0040], non-deflected position) in which it projects axially from the insert and in which the sealing element is in its first state, and a flush position (FIG. 3, [0040], fully deflected position) in which it is flush with the insert and in which the sealing element is compressed axially sufficiently to be in its second state.
Py does not disclose the tubular insert having both a first end segment provided with means for connecting it to the tube and also a second end segment for extending outside the tube. However, Nishikawa teaches a tubular insert having both a first end segment provided with means for connecting it to the tube (Fig. 1, cylindrical portion 20A) and also a second end segment for extending outside the tube (Fig. 1, body portion 20B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular surface as disclosed in FIG. 1 of Py to have distinguished first and second portions as taught by Nishikawa in order that there be a defined separation between where an outside tube can attach and where a second element, such as the female connector housing of Py, can lock into.
Py in view of Nishikawa still does not disclose the tubular insert being provided with a cantilevered rod extending axially inside the channel so as to have a free end portion projecting out from the second end segment of the insert and the second end segment of the body defining a housing in register with the free end portion of the rod. However, Tenczar teaches the tubular insert being provided with a cantilevered rod extending axially inside the channel (FIG. 7 and FIG. 8, female coupler element 75) so as to have a free end portion projecting out (FIG. 7) from the second end segment of the insert and the second end segment of the body defining a housing in register with the free end portion of the rod (FIG. 7, inside portion of housing 68 including openable end 70). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular surface as disclosed in FIG. 1 of Py to incorporate a female coupler element enveloped in a housing as taught by Tenczar in order to serve the purpose of allowing fluid flow between two separate connector devices when compressed together, and the housing giving space for the sealing mechanisms to fill in around the fluid flow devices.
Py in view of Nishikawa and Tenczar still does not disclose the annular sealing element is placed between a front face of the second end segment of the insert and an internal lip of the second segment of the annular body and a protective film removably fastened thereto, the film having a pull-tongue folded down thereon with a first end connected to an edge of the protective film and a second end projecting from the edge of the film that is opposite from the first end of the pull-tongue. However, Williams teaches a protective film removably fastened (FIG. 8, membrane 204, 206) thereto, the film having a pull-tongue folded down (FIG. 8, handle portions 520, 552) thereon with a first end connected to an edge of the protective film (FIG. 5, handle portion 520 is coupled to the end of membrane 204) and a second end projecting from the edge of the film that is opposite from the first end of the pull-tongue (FIG. 5). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector disclosed by Py to include the membrane and coupled handle as taught by Williams in order for the connector devices to retain the aseptic characteristic and the handles allow for reduce risk of contamination when removing the films.
While Williams teaches a seal member positioned in a window formed by the inner member and membrane (col. 4 lines 43-49), Williams does not explicitly teach the annular sealing element is placed between a front face of the second end segment of the insert and an internal lip of the second segment of the annular body. However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to add the lip component on the membrane side of the connector in the Williams device because the Applicant has not disclosed that the placement of the sealing element between a front face of the second end segment of the insert and an internal lip of the second segment of the annular body provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Williams’ seal member placement and Applicant’s annular sealing element placement to perform equally well because both mechanisms perform the same function of creating a sterile flow path between two aseptic devices. The shape of the Applicant’s annular sealing element in Fig. 1 requires the claimed placement, as the sealing element eventually compresses downward towards the cantilevered rod as seen in Fig. 5B and 5C. On the other hand, the Williams’ seal member does not compress downward and instead compresses into another seal member, and hence would not require the internal lip. Therefore, it would have been prima facie obvious to modify Williams to obtain the invention as specified by the Applicant because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired sterile flow path and thus fails to patentably distinguish over the prior art of Williams. With that said, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector disclosed by Py to include the placement of the seal member as taught by Williams in order to create the desired sterile flow path.
Py in view of Nishikawa, Tenczar, and Williams still does not disclose the first end segment of the body is mounted on the insert so as to be movable axially. However, Bonnal teaches the first end segment of the body is mounted on the insert so as to be movable axially (FIG. 8, clutch mechanism allows for axial movement between body 22 and collar 54). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the female connector housing and tubular surface disclosed by Py to have the connection with the ability for axial movement as taught by Bonnal in order that the device be have a security mechanism from the outside when going from one position to the next during compression, which allows the user visual confirmation of correct attachment.
Regarding claim 2, in the modified device of Py, Py discloses locking means for locking the body in its projecting position and in its flush position (FIG. 1, locking junction seen between tubular surface and female housing connector 48).
Regarding claim 5, in the modified device of Py, Py discloses a coupling assembly for coupling together two tubes (connector 10), the coupling assembly comprising two coupling devices (FIG. 1, female connector 12 and male connector 24).
Regarding claim 7, in the modified device of Py, Williams teaches a method of connecting together two tubes by means of a coupling assembly (col. 5 line 58 – col. 6 line 22), the method comprising the following steps:
placing the devices to face each other axially (FIG. 8, col. 5 line 61-63);
moving the devices towards each other until the pull-tongues are in contact with each other and the protective films are pressed against the front faces of the bodies (FIG. 4, col. 6 line 3-5);
removing the protective films by pulling simultaneously on the pull-tongues (FIG. 4, col. 6 line 5-11, force in direction 559); and
moving the devices towards each other again until the bodies are pressed against each other (FIG. 7, col. 6 lines 12-22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connectors disclosed by Py to work in a manner of placing the devices to face each other axially; moving the devices towards each other until the pull-tongues are in contact with each other and the protective films are pressed against the front faces of the bodies; removing the protective films by pulling simultaneously on the pull-tongues; and moving the devices towards each other again until the bodies are pressed against each other as taught by Williams in order to properly seal and remove the film, preserving the aseptic characteristic of the connectors.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Py in view of Nishikawa, Tenczar, Williams, and Bonnal as applied to claim 1 above, and further in view of Chavakula (United States Patent Application Publication No. US 2019/0081426 A1).
Regarding claim 3, in the modified device of Py, Py does not disclose pre-coupling and coupling means for engaging another coupling device. However, Chavakula teaches pre-coupling (Fig. 5, audio plugs 4,5,6) and coupling (Fig. 5, ports 9,10,11) means for engaging another coupling device. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector disclosed in Py to contain pre-coupling and coupling means such as the plugs and ports taught by Chavakula in order that one individual connector not be reliant on “gender” or specific connecting ports of another device, and have the ability to both be the locking device and lock a device into place.
Regarding claim 4, in the modified device of Py, Py does not disclose wherein the pre-coupling and coupling means comprise at least one locking tab projecting axially from a front face of the body and including at least two serrations at a free end for co- operating with an edge of the other coupling device. However, Chavakula teaches wherein the pre-coupling and coupling means comprise at least one locking tab (audio plugs 4,5,6) projecting axially from a front face of the body (Fig. 5) and including at least two serrations at a free end for co-operating with an edge of the other coupling device (Fig. 3, serrations on the audio plugs and how each connects with a port). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connectors disclosed in Py to contain pre-coupling means, such as the plugs taught by Chavakula, that extend axially from the face of the device and which fit into a designed coupling means, such as the ports taught by Chavakula, in order that one individual connector securely mate with another with little room for unplanned movement.
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Py in view of Nishikawa, Tenczar, Williams, and Bonnal as applied to claim 5 above, and further in view of Quick (United States Patent Application Publication No. US 2015/0260325 A1).
Regarding claim 6, in the modified device of Py, Py does not disclose the two coupling devices are identical. However, Quick teaches the two coupling devices are identical (FIG. 7, [0077], coupling devices are substantially identical). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connectors disclosed in Py to be identical as taught by Quick in order to eradicate the need for “gendered” connections, simplifying ease of use conditions for users.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/645,468 in view of Tenczar (United States Patent No. 4,030,494), Py (United States Patent Application No. US 2011/0240158 A1), and Williams et al. (United States Patent No. US 8,491,016 B2; herein, Williams). At the time of this office action, the copending application has been granted a Notice of Allowability, but no patent number had been assigned yet. The claims of the instant application being compared here are those that will appear in the patent publication. The claims of the instant application and the claims of the copending application are compared in the table below.
This is a provisional nonstatutory double patenting rejection.
Instant Application 18/257,200
Copending Application 18/645,468
An aseptic coupling device for a tube characterized in that it comprises:
a tubular insert defining a channel and having both a first end segment provided with means for connecting it to the tube and also a second end segment for extending outside the tube, the tubular insert being provided with a cantilevered rod extending axially inside the channel so as to have a free end portion projecting out from the second end segment of the insert; and
an annular body comprising both a first end segment mounted on the second end segment of the insert and also a second end segment projecting axially from the second end segment of the insert so as to co-operate therewith to define a housing in register with the free end portion of the rod for receiving an annular sealing element that is placed between a front face of the second end segment of the insert and an internal lip of the second segment of the annular body and that is deformable between a first state in which the sealing element defines a fluid flow section greater than the cross section of the rod and a second state in which the sealing element tightly surrounds the rod, the sealing element being arranged to be taken from its first state to its second state under the effect of axial compression; and in that:
the sealing element has a front face projecting from the second segment of the annular body with a protective film removably fastened thereto, the film having a pull-tongue folded down thereon with a first end connected to an edge of the protective film and a second end projecting from the edge of the film that is opposite from the first end of the pull-tongue; and
the first end segment of the body is mounted on the insert so as to be movable axially between a projecting position in which it projects axially from the insert and in which the sealing element is in its first state, and a flush position in which it is flush with the insert and in which the sealing element is compressed axially sufficiently to be in its second state.
An aseptic junction device for a tube, comprising:
a tubular insert defining a channel and having a first end segment provided with means for connecting it to the tube and a second end segment which is intended to extend outside the tube;
an annular body comprising a first end segment mounted on the second end segment of the insert, and also a second end segment projecting axially from the second end segment of the insert to define therewith a housing;
an annular sealing element that is disposed in the housing between a front face of the second end segment of the insert and an internal step of the second segment of the annular body and that is deformable from a first state in which the sealing element delimits a fluid flow section and a second state in which the sealing element completely obstructs the channel, the sealing element being arranged to be brought from its first state to its second state under the effect of an axial compression; and
means for coupling to another junction device,
the first end segment of the body being mounted on the insert so as to be movable axially between an axially projecting position of the insert and in which the sealing element is in its first state, and a flush position with the insert in which the sealing element is sufficiently axially compressed to be in its second state, wherein:
a maneuvering sleeve is rotatably mounted on the body between a connection position and a disconnection position, and is coupled to the insert so that a rotation of the sleeve from the connection position to the disconnection position leads an axial movement of the body from the projecting position to the flush position; and
the means for coupling means are arranged to allow decoupling of the junction device and the other another junction device, only when the sleeve is in the disconnection position.
Claim 1 of the copending application recites all the limitations of claim 20 of the instant application except “the tubular insert being provided with a cantilevered rod extending axially inside the channel so as to have a free end portion projecting out from the second end segment of the insert”, “housing in register with the free end portion of the rod”, “greater than the cross section of the rod”, and “the sealing element has a front face projecting from the second segment of the annular body with a protective film removably fastened thereto, the film having a pull-tongue folded down thereon with a first end connected to an edge of the protective film and a second end projecting from the edge of the film that is opposite”.
However, Tenczar teaches the tubular insert being provided with a cantilevered rod extending axially inside the channel (FIG. 7 and FIG. 8, female coupler element 75) so as to have a free end portion projecting out from the second end segment of the insert (FIG. 7), housing in register with the free end portion of the rod (FIG. 7, openable end 70 surrounds female coupler element 75), greater than the cross section of the rod (openable end 70 encapsulates the female coupler element 75). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aseptic junction device of the copending application to incorporate a female coupler element enveloped in a housing as taught by Tenczar in order to serve the purpose of allowing fluid flow between two separate connector devices when compressed together, and the housing giving space for the sealing mechanisms to fill in around the fluid flow devices.
The copending application in view of Tenczar still does not disclose the sealing element has a front face projecting from the second segment of the annular body. However, Py teaches the sealing element has a front face projecting from the second segment of the annular body (FIG. 1). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aseptic junction device of the copending application to contain a projecting front face as taught by Py in order to provide a mating surface with room for the sealing components to compress.
The copending application in view of Tenczar and Py still does not disclose a protective film removably fastened thereto, the film having a pull-tongue folded down thereon with a first end connected to an edge of the protective film and a second end projecting from the edge of the film that is opposite. However, Williams teaches a protective film removably fastened (FIG. 8, membrane 204, 206) thereto, the film having a pull-tongue folded down (FIG. 8, handle portions 520, 552) thereon with a first end connected to an edge of the protective film (FIG. 5, handle portion 520 is coupled to the end of membrane 204) and a second end projecting from the edge of the film that is opposite from the first end of the pull-tongue (FIG. 5). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aseptic junction device of the copending application to include the membrane and coupled handle as taught by Williams in order for the connector devices to retain the aseptic characteristic and the handles allow for reduce risk of contamination when removing the films.HH
Conclusion
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/ Supervisory Patent Examiner, Art Unit 3783