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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 12/08/2025 is acknowledged. Claims 2-5 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 13/23/2023, 10/07/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claims status
Claims 1-13 are pending with claims 1, 6-9 and 11-13 being examined and claims 2-5 and 10 are considered withdrawn.
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 8-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
As to line 2 of claim 8, the “return device is unclear what Applicant refers to as there is no drawings that illustrate what the return device is.
As to line 4 of claim 9, “a bayonet lock” it is unclear if Applicant is referring to the same bayonet lock recited in line 3 or a different bayonet lock. The limitation will be interpreted as “the bayonet lock” for clarity.
Appropriate action is required.
Claim Rejections - 35 USC § 102
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 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 1, 6-9, 11 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams (US 20110256021 A1; hereinafter “Adams” already of record).
Regarding claim 1, Adams teaches a beta-component (Adams; fig. 1. 100) of a transfer system (Adams; Title) comprising a receiving space (Adams; fig. 3D. 100a), a beta-flange (Adams; fig. 3D and [0055] “beta-flange 101”), a casing (Adams; fig. 3D and [0060] “second side 102”) defining the receiving space (Adams; fig. 3D. 100a), and a beta-closure unit (Adams; fig. 3D. 102 and [0061] “beta cover 102”), wherein the beta-closure unit is detachably attached to the beta-flange for opening and closing the receiving space (Adams; fig. 3D beta-flange 101, and beta cover 102 and [0060] “the beta-flange 101 can be releasably locked to the beta cover 102”), and the beta-flange and the beta-closure unit are configured for coupling to an alpha-flange (Adams; fig. 2C. 11) and an alpha-closure unit (Adams; fig. 2C. 16) of an alpha-port (Adams; fig. 2C. 10 and [0020]-[0029]) of the transfer system (Adams; fig; 5A, 11, 100, 101 and fig; 5C. 10), wherein the beta-component comprises a holding device for holding an object in a defined position and orientation (Adams; fig. 3D. 110) which is arranged on a side of the beta-closure unit facing the receiving space (Adams; fig. 3D. 110).
Regarding claim 6, Adams teaches the beta-component according to claim 1 (see above), wherein the casing of the receiving space of the beta-component is configured to be detachable from the beta-flange (Adams; [0060] “beta cover 102 becomes detached from the beta flange”).
Regarding claim 11, Adams teaches the beta-component according to claim 1 (see above), wherein the object held by the holding device is a filling needle (Adams; fig. 5G. 208).
Regarding claim 7, Adams teaches the beta-component according to claim 11 (see above), wherein the filling needle is connected to a tube which extends out of the receiving space (Adams; fig. 5J. 109, 208).
Regarding claim 8, Adams teaches the beta-component according to claim 7 (see above), wherein the beta- component comprises a return device for the tube (Adams; fig. 4C. 104), which, when the filling needle is moved back into the receiving space, also moves the tube back into the receiving space (Adams; fig. 5H illustrates what appears to be the needle 208 which appears to be movable in and out of second side 102 where the receiving space is).
Regarding claim 9, Adams teaches the beta-component according to claim 1 (see above), wherein the beta-flange of the beta-component (Adams; fig. 4C. 101a) and the alpha-flange of the alpha-port (Adams; fig. 4B, 111b) are configured to be connected to each other with a bayonet lock and the beta-closure unit and the alpha- closure unit are configured to be connected to each other with a bayonet lock (Adams; [0060] “flange bayonets 101a on the first side 101 of the housing are configured to engage bayonet receivers 11b of the docking cover”).
Regarding claim 13, Adams teaches the beta-component according to claim 7 (see above), wherein the tube comprises a sterile connector at an end facing away from the filling needle for connection to a feed tank (Adams; fig. 3B. 105, 109).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (US 20110256021 A1; hereinafter “Adams” already of record) as applied to claim 6 above, and in view of Norton et al. (US 20110209410 A1; hereinafter “Norton”).
Regarding claim 12, Adams teaches the beta-component according to claim 6 (see above), to include a casing (see above).
Adams fails to teach the casing is formed by a flexible plastic bag or is formed by a dimensionally stable sterilizable container.
However, Norton teaches the analogous art of a port assembly (component) for transferring material (Norton; fig. 4. 10 and [0001]), wherein the port assembly includes an annular body (Norton; fig. 4. 12) wherein the port assembly with annular body comprises a casing (Norton; fig. 19. 12, 61 and [0034] “port assembly faces the interior of a container”) wherein the casing is a plastic bag (Norton; [0050] “plastic bag 61”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Adams’ casing to be a plastic bag as taught by Norton because Norton teaches a port assembly (component) for transferring material (Norton; fig. 4. 10 and [0001]) comprising a casing (Norton; fig. 19. 12, 61 and [0034] “port assembly faces the interior of a container”) wherein the casing is a plastic bag (Norton; [0050] “plastic bag 61”).
Using a plastic bag as casing allows for replacement after each use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798