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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) 2. because reference character "224" has been used to designate both a seal (see fig. 5 and specification page 15, lines 3, 6 and 8) and a center post (see figs. 36-37 and specification page 14, lines 14-15) of a body/first coupling (200).
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.
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 abstract of the disclosure is objected to because:
The abstract does not fulfill the minimum 50 word requirement.
Correction is required. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The specification uses the reference character "224" to designate both a b. seal (see fig. 5 and specification page 15, lines 1, 4 and 6) and a center post (see figs. 36-37 and specification page 14, lines 12-13) of a body/first coupling (200).
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.
Claim Objections
Claims 9-11 are objected to because of the following informalities:
In claim 9, line 1, the recitation “the rotating the shell” should read --the [[rotating]]rotation of the shell--.
In claim 10, line 1, the recitation “the rotating the shell” should read --the [[rotating]]rotation of the shell--.
In claim 11, line 2, the recitation “the rotating the shell” should read --the [[rotating]]rotation of the shell--.
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 2 and 17 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 2 recites the limitation "metallic-free" in line 2. The term "metallic" is merely descriptive of a characteristic of an element "resembling metal" (as defined by Merriam-Webster); however, the claim is unclear as to what resemblances of metal is being excluded by the phrase "metallic-free", thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). For the purpose of examination, it is assumed that the recitation "metallic-free" in claim 2, line 2, should read –metal
Similarly, claim 17 recites the limitation "metallic-free" in line 2, and is rejected for the same reason as claim 2, above.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 12, 14 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN107883097 (“Zhang”).
Regarding claim 12, Zhang discloses a single-use aseptic fluid coupling assembly defining a longitudinal axis (central longitudinal axis of fluid coupling assembly in fig. 1) and an open fluid flow path (flow path extending through fluid coupling assembly as illustrated in fig. 1) through the fluid coupling assembly along the longitudinal axis, the fluid coupling assembly comprising:
a first coupling (1) comprising:
a first housing (“valve seat body” 111);
a first valve (13); and
a shell (121 and/or 122) that is rotatably coupled to the first housing; and
a second coupling (2) releasably connected to the first coupling and comprising:
a second housing (22); and
a second valve (23), the second valve being translatable along the longitudinal axis,
wherein manual rotation of the shell drives closure of the first and second valves and physical separation of the first and second couplings (by retracting sleeve 122 and rotating to unscrew female thread of inner sleeve 121 from male thread of second housing 22).
Regarding claim 14, Zhang discloses the first coupling (1) further comprises a shuttle (14) disposed about the first valve (13), the shuttle being coupled to the shell (121 and/or 122) such that the shuttle is translatable along the longitudinal axis in response to rotation of the shell (via threaded engagement between male threading of second housing 22 and female threading of inner sleeve 121).
Regarding claim 18, Zhang discloses the first (1) and second (2) couplings cannot be unconnected from each other until both the first valve (13) and the second valve (23) are in closed configurations (since female threading on sleeve 121 extends beyond an end face 132 of the first valve 13, the first and second valves will be closed before the first and second couplings are completely separated from one another).
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.
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 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang, as applied to claim 1 above, in view of Scheiwer.
Regarding claim 16, Zhang discloses the invention as claimed except for a valve gasket compressed between an outer annular face portion of the first valve and an outer annular face portion of the second valve.
Scheiwer teaches (see fig. 2) a valve gasket (60) compressed between an outer annular face portion (interfacing face portion on which gasket 60 is disposed) of a first valve (58) and an outer annular face portion (interfacing face portion which engages abuts first valve 58) of a second valve (18).
It would have been obvious to one having ordinary skill in the art at the time of filing of the invention to modify the invention of Zhang by employing a valve gasket compressed between an outer annular face portion of the first valve and an outer annular face portion of the second valve, as taught by Scheiwer, to allow sealing engagement between the first and second valves, thereby reducing residual fluid within the fluid coupling assembly
Claim 17, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang, as applied to claim 1 above, in view of Burdge.
Regarding claim 17, Zhang discloses the invention as claimed except for the fluid coupling assembly being metallic-free.
Burdge teaches (see paragraph [0017]) a fluid coupling assembly which is metallic-free, to allow for gamma sterilization and because nonmetallic fluid coupling devices exhibit enhanced fatigue-resistance characteristics, minimal installed stress, and enhanced corrosion resistance.
It would have been obvious to one having ordinary skill in the art at the time of filing of the invention to modify Zhang by configuring the fluid coupling assembly to be nonmetallic, as taught by Burdge, to allow for gamma sterilization and because nonmetallic fluid coupling devices exhibit enhanced fatigue-resistance characteristics, minimal installed stress, and enhanced corrosion resistance
Claims 1 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of US2545796 (“Scheiwer”).
Regarding claim 1, Zhang discloses a single-use aseptic fluid coupling assembly defining a longitudinal axis (central longitudinal axis of fluid coupling assembly of fig. 1) and an open fluid flow path (see fluid path extending through coupling assembly of fig. 1) through the fluid coupling assembly along the longitudinal axis, the fluid coupling assembly comprising:
a first coupling (1) comprising:
a first housing (“valve seat body” 111);
a first termination member (11) fixedly coupled to the first housing and including a first termination (male threaded port at housing 11);
a shell (mainly defined by 121 and/or 122) that is rotatably coupled to the first housing;
a first valve (13) that is fixedly coupled to the first termination member; and
a shuttle (14) disposed about the first valve, the shuttle being coupled to the shell such that the shuttle is translatable along the longitudinal axis (between closed position illustrated in fig. 2 and open position illustrated in fig. 1) in response to rotation of the shell;
a valve gasket (see o-ring seal between member 13 and shuttle or sleeve 14) coupled to the first valve; and
a second coupling (2) releasably connected to the first coupling and comprising:
a second housing (22);
a second termination member (21) fixedly coupled to the second housing and including a second termination (male threaded port at left end of member 21, relative to the orientation of fig. 3); and
a second valve (23) movably coupled to the second termination, the second valve being translatable along the longitudinal axis (between closed position illustrated in fig. 3, and open position illustrated in fig. 1) relative to the second termination.
However, Zhang does not disclose a face seal portion of the valve gasket being compressed between a face portion of the first valve and a face portion of the second valve.
Scheiwer teaches (see fig. 2) a valve gasket (60) coupled to a first valve (58), wherein a face seal portion (bottom face of seal 60, relative to the orientation of fig. 1) of the valve gasket is compressed between a face portion (bottom face of first valve 58, relative to the orientation of fig. 1) of the first valve and a face portion (top face, relative to the orientation of fig. 1) of a second valve (18).
It would have been obvious to one having ordinary skill in the art at the time of filing of the invention to modify the invention of Zhang by employing a valve gasket, wherein a face seal portion of the valve gasket is compressed between a face portion of the first valve and a face portion of the second valve, as taught by Scheiwer, to allow sealing engagement between the first and second valves, thereby reducing residual fluid within the fluid coupling assembly.
Regarding claim 6, Zhang discloses one or more movable clips (inclined teeth of ratchet 3) that prevent the shell (mainly defined by 121 and/or 122) from being rotated (once first 1 and second 2 couplings are assembled, ratchet 3 prevents rotation to separate first and second couplings) relative to the first housing (111).
Regarding claim 7, Zhang discloses the first coupling (1) is separable from the second coupling (2) by rotating (sleeve 122 is pulled against force of spring 123 to allow rotation thereby allowing separation of first 1 and second 2 couplings) the shell (mainly defined by 121 and/or 122) and then longitudinally separating the first and second couplings from each other.
Regarding claim 8, Zhang discloses the first (1) and second (2) couplings cannot be separated from each other until: (i) the first valve (13) is in a closed configuration (see closed configuration of fig. 2) relative to the shuttle (14) and (ii) the second valve (23) is in a closed configuration (see closed configuration of fig. 3) relative to the second termination member (21) (since female threading on sleeve 121 extends beyond an end face 132 of the first valve 13, the first and second valves will be closed before the first and second couplings are completely separated from one another).
Regarding claim 9, Zhang discloses the rotating the shell (121 and/or 122) moves the first (13) and second (23) valves to the closed configurations.
Regarding claim 10, Zhang discloses the rotating the shell (121 and/or 122) unlatches the first valve (13) from the second valve (23).
Regarding claim 11, Zhang discloses the shuttle (14) is releasably coupled to the second housing (22), and wherein the rotating the shell (121 and/or 122) uncouples the shuttle from the second housing.
Claim 2, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Scheiwer, as applied to claim 1 above, and further in view of US2018/0296817 (“Burdge”).
Regarding claim 2, the combination of Zhang and Scheiwer discloses the invention as claimed except for the fluid coupling assembly being metallic-free.
Burdge teaches (see paragraph [0017]) a fluid coupling assembly which is metallic-free, to allow for gamma sterilization and because nonmetallic fluid coupling devices exhibit enhanced fatigue-resistance characteristics, minimal installed stress, and enhanced corrosion resistance.
It would have been obvious to one having ordinary skill in the art at the time of filing of the invention to further modify the combination of Zhang and Scheiwer by configuring the fluid coupling assembly to be nonmetallic, as taught by Burdge, to allow for gamma sterilization and because nonmetallic fluid coupling devices exhibit enhanced fatigue-resistance characteristics, minimal installed stress, and enhanced corrosion resistance
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.
Claims 1, 12, 14, 18 are rejected on the ground of nonstatutory double patenting over claims 3, 11 (which by dependency includes the limitations of parent claims 1, 7 and 10), 11 and 11, respectively, of U.S. Patent No. 12140257 (“Patent A”).
The narrower Patent A claim 3 anticipates the broader Application claim 1, see claims listing below.
Application claim 1
Patent A claim 3
Claim 1. A single-use aseptic fluid coupling assembly defining a longitudinal axis and an open fluid flow path through the fluid coupling assembly along the longitudinal axis, the fluid coupling assembly comprising: a first coupling comprising: a first housing; a first termination member fixedly coupled to the first housing and including a first termination; a shell that is rotatably coupled to the first housing; a first valve that is fixedly coupled to the first termination member; and a shuttle disposed about the first valve, the shuttle being coupled to the shell such that the shuttle is translatable along the longitudinal axis in response to rotation of the shell; a valve gasket coupled to the first valve; and a second coupling releasably connected to the first coupling and comprising: a second housing; a second termination member fixedly coupled to the second housing and including a second termination; and a second valve movably coupled to the second termination, the second valve being translatable along the longitudinal axis relative to the second termination, wherein a face seal portion of the valve gasket is compressed between a face portion of the first valve and a face portion of the second valve.
Claim 1. A single-use aseptic fluid coupling assembly defining a longitudinal axis and an open fluid flow path through the fluid coupling assembly along the longitudinal axis, the fluid coupling assembly comprising: a first coupling comprising: a first housing; a first termination member fixedly coupled to the first housing and including a first termination; a shell that is rotatably coupled to the first housing; a first valve that is fixedly coupled to the first termination member; and a shuttle disposed about the first valve, the shuttle being coupled to the shell such that the shuttle is translatable along the longitudinal axis in response to rotation of the shell; and a second coupling releasably connected to the first coupling and comprising: a second housing; a second termination member fixedly coupled to the second housing and including a second termination; and a second valve movably coupled to the second termination, the second valve being translatable along the longitudinal axis relative to the second termination, wherein the first valve is releasably latched to the second valve.
Claim 3. The fluid coupling assembly of claim 1, further comprising a valve gasket compressed between an outer annular face portion of the first valve and an outer annular face portion of the second valve.
Similarly, Patent A claim 11 anticipates the limitations of Application claims 12, 14 and 18.
Claims 1, 2, 4, 5, 7, 8, 9, 10 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 7, 10, 11, 8 and 9, respectively, of Patent A in view of Scheiwer.
Regarding claim 1, Patent A claim 1 discloses all the limitations of Application claim 1 except for a valve gasket coupled to the first valve, wherein a face seal portion of the valve gasket is compressed between a face portion of the first valve and a face portion of the second valve.
However, Scheiwer teaches (see fig. 2) a valve gasket (60) coupled to a first valve (58), wherein a face seal portion (bottom face of seal 60, relative to the orientation of fig. 1) of the valve gasket is compressed between a face portion (bottom face of first valve 58, relative to the orientation of fig. 1) of the first valve and a face portion (top face, relative to the orientation of fig. 1) of a second valve (18).
It would have been obvious to one having ordinary skill in the art at the time of filing of the invention to modify the invention of Patent A claim 1 by employing a valve gasket, wherein a face seal portion of the valve gasket is compressed between a face portion of the first valve and a face portion of the second valve, as taught by Scheiwer, to allow sealing engagement between the first and second valves, thereby reducing residual fluid within the fluid coupling assembly.
In a similar manner as above, claims 2, 4, 5, 7, 8, 9, 10 and 11 are rejected over Patent A claims 2, 4, 5, 7, 10, 11, 8 and 9, respectively, in view of Scheiwer.
Claims 1 and 12 are rejected on the ground of nonstatutory double patenting over claims 3 and 11, respectively, of U.S. Patent No. 12480608 (“Patent B”).
The narrower Patent B claim 3 anticipates the broader Application claim 1, see claims listing below.
Application claim 1
Patent B claim 3
Claim 1. A single-use aseptic fluid coupling assembly defining a longitudinal axis and an open fluid flow path through the fluid coupling assembly along the longitudinal axis, the fluid coupling assembly comprising: a first coupling comprising: a first housing; a first termination member fixedly coupled to the first housing and including a first termination; a shell that is rotatably coupled to the first housing; a first valve that is fixedly coupled to the first termination member; and a shuttle disposed about the first valve, the shuttle being coupled to the shell such that the shuttle is translatable along the longitudinal axis in response to rotation of the shell; a valve gasket coupled to the first valve; and a second coupling releasably connected to the first coupling and comprising: a second housing; a second termination member fixedly coupled to the second housing and including a second termination; and a second valve movably coupled to the second termination, the second valve being translatable along the longitudinal axis relative to the second termination, wherein a face seal portion of the valve gasket is compressed between a face portion of the first valve and a face portion of the second valve.
1. A single-use aseptic fluid coupling assembly defining a longitudinal axis and an open fluid flow path through the single-use aseptic fluid coupling assembly along the longitudinal axis, the single-use aseptic fluid coupling assembly comprising: a first coupling comprising: a first housing; a first termination member fixedly coupled to the first housing and including a first termination; a shell that is rotatably coupled to the first housing; a first valve that is fixedly coupled to the first termination member; and a shuttle disposed about the first valve, the shuttle being coupled to the shell such that the shuttle is translatable along the longitudinal axis in response to rotation of the shell; and a second coupling releasably connected to the first coupling and comprising: a second housing; a second termination member fixedly coupled to the second housing and including a second termination; and a second valve movably coupled to the second termination, the second valve being translatable along the longitudinal axis relative to the second termination, wherein the first housing and the shell comprise a one-way rotation mechanism by which the shell is rotatable relative to the second coupling in only one direction.
3. The single-use aseptic fluid coupling assembly of claim 1, further comprising a valve gasket compressed between an outer annular face portion of the first valve and an outer annular face portion of the second valve.
In a similar manner as above, Patent B claim 11 anticipates the limitations of Application claim 12.
Claims 1, 2, 3, 4, 5, 7, 8, 9 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 7, 8, 11, 12 and 9, respectively, of Patent B in view of Scheiwer.
Regarding claim 1, Patent B claim 1 discloses all the limitations of Application claim 1 except for a valve gasket coupled to the first valve, wherein a face seal portion of the valve gasket is compressed between a face portion of the first valve and a face portion of the second valve.
However, Scheiwer teaches (see fig. 2) a valve gasket (60) coupled to a first valve (58), wherein a face seal portion (bottom face of seal 60, relative to the orientation of fig. 1) of the valve gasket is compressed between a face portion (bottom face of first valve 58, relative to the orientation of fig. 1) of the first valve and a face portion (top face, relative to the orientation of fig. 1) of a second valve (18).
It would have been obvious to one having ordinary skill in the art at the time of filing of the invention to modify the invention of Patent B claim 1 by employing a valve gasket, wherein a face seal portion of the valve gasket is compressed between a face portion of the first valve and a face portion of the second valve, as taught by Scheiwer, to allow sealing engagement between the first and second valves, thereby reducing residual fluid within the fluid coupling assembly.
Similarly, claims 2, 3, 4, 5, 7, 8, 9 and 10 are rejected over Patent B claims 2, 3, 4, 7, 8, 11, 12 and 9, respectively, in view of Scheiwer.
Allowable Subject Matter
Claims 13, 15, 19 and 20 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 3-5 would be allowable if rewritten to overcome the double patenting rejection(s), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, the closest prior art does not disclose or render obvious the fluid coupling assembly, wherein the valve gasket includes an annular portion that provides a seal between the first valve and the shuttle, in combination with the limitations of the base claim.
Regarding claim 4, the closest prior art does not disclose or render obvious the fluid coupling assembly, wherein the shell includes one or more projections that are movably disposed in one or more slots defined by the shuttle, in combination with the limitations of the base claim.
Claim 5 is allowable because it requires all the limitations of an allowable claim.
Regarding claim 13, the closest prior art does not disclose or render obvious the fluid coupling assembly, wherein, once the first and second couplings have been unconnected from each other, the first and second couplings cannot be reconnected to define the open fluid flow path, in combination with the limitations of the base claim.
Regarding claim 15, the closest prior art does not disclose or render obvious the fluid coupling assembly, wherein the shell includes one or more projections that are movably disposed in one or more slots defined by the shuttle, in combination with the limitations of the base claim.
Regarding claim 19, the closest prior art does not disclose or render obvious the fluid coupling assembly, further comprising a removable retainer clip that is releasably coupled to the first coupling and the second coupling, in combination with the limitations of the base claim.
Claim 20 is allowable because it requires all the limitations of an allowable claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Hailey K. Do whose direct telephone number is (571)270-3458 and direct fax number is (571)270-4458. The examiner can normally be reached on Monday-Thursday (8:00AM-5:00PM ET) and Friday (8:00AM-12:00PM ET).
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/HAILEY K. DO/Primary Examiner, Art Unit 3753