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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, corresponding to claims 1 to 17, 19 and 20 in the reply filed on 03/09/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/10/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 13 is 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 13:
The Claim recites the limitation " wherein the at least one filling needle of the number of filling needles is transferred individually from the first needle carrier, arranged in the second position, to the third needle carrier". There is insufficient antecedent basis for this limitation in the claim, a third needle carrier has not been defined in the claim. The Examiner is considering it a typo and that the Applicant meant --second needle carrier--.
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.
Claims 1 to 14, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koike (US 2016/0136052).
Regarding Claims 1, 3, 4 and 17:
Kike discloses a method for transferring at least one filling needle of a number of filling needles into an isolator which has a transfer lock (Figure 2, Figure 16, co-infusion apparatus 1 will be considered the isolator, needle 11c of injector 11 will be considered the filling needle and a single filing needle, the combination of medicine loading section 200 with door 201 and tray insertion port 114 will be considered a transfer lock), the method having the following steps:
providing of a first needle carrier within the transfer lock, said needle carrier carrying the number of filling needles (Figure 54, paragraph 0616, Figure 5 shows tray 101 with object placing member 102 where the injection needles 11c are provided while needles 11c have a cap 11e; alternatively, cap 11e and object placing member 102 can both be considered as a first needle carrier);
providing of a second needle carrier in a first position within the isolator (Paragraph 0597, Figure 48 shows needle 11c, connected to injector 11, that will be considered the second needle carrier supported on holding member 26 in position to fill a vial bottle 10);
robot-assisted transferring of the at least one filling needle of the number of filling needles from the first needle carrier to the second needle carrier (Paragraph 0208, Figures 7, 8, 16 and 47, gripping clicks 25a of holding members 25 place needle 11c, including cap 10e into Injection Needle Attaching and Detaching Device 43, to insert or replace needle 11c on injector 11, supported on holding member 26, detaching cap 11c); and
robot-assisted placing of the at least one filling needle of the number of filling needles in the second needle carrier, wherein the at least one filling needle of the number of filling needles is held directly during the robot-assisted placing (As mentioned above, needle 11c is directly supported on cap 11c and on injector 11 during the placing).
Being that only one needle is being transferred it can be considered that it is being transferred “collectively” or “individually”.
Regarding Claim 2:
Kike discloses that the second needle carrier is in a filling station in which objects are filled with a fluid by means of the at least one filling needle of the number of filling needles (Paragraph 0597, Figure 48 shows needle 11c, connected to injector 11, that will be considered the second needle carrier supported on holding member 26 in position to fill a vial bottle 10 forming a filling station).
Regarding Claim 5 and 7 to 10:
Kike discloses that the step of robot-assisted transferring of the at least one filling needle of the number of filling needles from the first needle carrier to the second needle carrier comprises the following steps:
first robot-assisted transferring of the at least one filling needle of the number of filling needles from the first needle carrier to a third needle carrier, which is arranged in a second position within the isolator, wherein the second position is spaced apart from the first position; robot-assisted placing of the at least one filling needle of the number of filling needles in the third needle carrier (Figures 15 and 16, considering object placing member 102 as a first needle carrier, paragraph 0227, the second control section 500 allows the injection needle attaching and detaching device 43 to rotate the cap to remove the injection needle 11c from the injector 11, Paragraph 0228, the second control section 500 allows the first robot arm 21 to set the injection needle 11c having the syringe filter on the injection needle attaching and detaching device 43, that will be considered a third needle carrier, Then, the second control section 500 allows the second robot arm 22 to transfer the injector 11 to the injection needle attaching and detaching device 43 to attach the injection needle 11c to the injector 11, that is considered the second needle carrier), and
wherein the step of robot-assisted placing of the at least one filling needle of the number of filling needles in the second needle carrier comprises the following step: second robot-assisted transferring of the at least one filling needle of the number of filling needles from the third needle carrier to the second needle carrier, wherein the at least one filling needle of the number of filling needles is held directly during the second robot-assisted transferring (As indicated above, the second robot arm 22 transfer the injector 11 to the detaching device 43 to couple it to the needle 11c that is held directly during the second robot-assisted transferring),
Being that only one needle is being transferred it can be considered that it is being transferred “collectively” or “individually”.
Regarding Claim 6:
Kike discloses that the third needle carrier is an intermediate carrier in which the at least one filling needle is carried before it is transferred to the second needle carrier (As indicated above, detaching device 43 carries needle 11c before transferring to the injector 11).
Regarding Claim 11 to 13:
Kike discloses the step of robot-assisted transferring of the at least one filling needle of the number of filling needles from the first needle carrier to the second needle carrier (As discussed for Claim 1, in this alternative cap 11e will be considered the first needle carrier and injector 11 will be considered the second needle carrier) comprises the following steps:
first robot-assisted transferring of the first needle carrier together with the number of filling needles from the transfer lock to a second position within the isolator, the second position being spaced apart from the first position (Figures 15 and 16, Paragraph 0228, the second control section 500 allows the first robot arm 21 to set the injection needle 11c from the object placing member 102, a first position, to the injection needle attaching and detaching device 43, that will be considered a second position being spaced apart from the first position, Then, the second control section 500 allows the second robot arm 22 to transfer the injector 11 to the injection needle attaching and detaching device 43 to attach the injection needle 11c to the injector 11, that is considered the second needle carrier);
robot-assisted placing of the first needle carrier in the second position (first robot arm 21 is executing the step); and
wherein the step of robot-assisted placing of the at least one filling needle of the number of filling needles in the second needle carrier comprises the following step:
second robot-assisted transferring of the at least one filling needle of the number of filling needles from the first needle carrier to the second needle carrier (Paragraph 0228, the second control section 500 allows the second robot arm 22 to transfer the injector 11 to the injection needle attaching and detaching device 43 to attach the injection needle 11c to the injector 11, that is considered the second needle carrier) , wherein the at least one filling needle of the number of filling needles is held directly during the second robot-assisted transferring (As indicated above, the second robot arm 22 transfer the injector 11 to the detaching device 43 to couple it to the needle 11c that is held directly during the second robot-assisted transferring),
Being that only one needle is being transferred it can be considered that it is being transferred “collectively” or “individually”.
Regarding Claim 14:
Kike discloses that the first needle carrier has a base body for carrying the number of filling needles, and at least one projection, the at least one projection extending from the base body and having a circular cylindrical shape, each of the at least one projection is shaped in such a way that a robot gripper of a robot end effector, which is configured to grip a single filling needle of the number of filling needles can receive said projection (Cap 11e considered the first needle carrier is a regular needle cap as can be seen in the Figure 56 bellow showing the needle 11c, received on cap 11e and coupled to injector 11 just before being separated the needle 11c from the cap, the cap has a base body carrying the needle and a projection extending from the base body and having a circular cylindrical shape that are received in the pair of gripping clicks 25a of arm 22).
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Regarding Claim 19:
Koike discloses a transfer system for transferring at least one filling needle of a number of filling needles into an isolator (Figure 2, Figure 16, co-infusion apparatus 1 will be considered the isolator, needle 11c of injector 11 will be considered the filling needle), the transfer system comprising:
the isolator, which has a transfer lock (Figure 2, the combination of medicine loading section 200 with door 201 and tray insertion port 114 will be considered a transfer lock), wherein a first needle carrier, which carries the number of filling needles, is provided within the transfer lock (Figure 54, paragraph 0616, Figure 5 shows tray 101 with object placing member 102 where the injection needles 11c are provided by tray insertion port 114 of medicine loading section 200, while needles 11c have a cap 11e; alternatively, both cap 11e and object placing member 102 can be considered as a first needle carrier), and
wherein a second needle carrier is provided in a first position within the isolator (Paragraph 0597, Figure 48 shows needle 11c, connected to injector 11, that will be considered the second needle carrier); at least one robot with a robot end effector which is arranged within the isolator (Figure 9, first robot arm 21 and second robot arm 22 with holding member 25 and the holding member 26 respectively); and
a controller which is configured in such a way that the following steps are carried out (Paragraph 0124, co-infusion control device 100 includes first control section 400 and a second control section 500, second control section 500 is provided on the side of the co-infusion process section 300 controlling the robots and the co-infusion process):
robot-assisted transferring of the at least one filling needle of the number of filling needles from the first needle carrier to the second needle carrier; and robot-assisted placing of the at least one filling needle of the number of filling needles in the second needle carrier (Paragraph 0208, Figures 7, 8, 16 and 47, gripping clicks 25a of holding members 25 of arm 21 place needle 11c, including cap 10e into Injection Needle Attaching and Detaching Device 43, to insert or replace needle 11c on injector 11, supported on holding member 26 of arm 22, detaching cap 11c),
wherein the at least one filling needle of the number of filling needles is held directly by the robot end effector during the robot-assisted placing (As mentioned above, needle 11c is directly supported on cap 11c and on injector 11 during the placing).
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 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Koike (US 2016/0136052) in view of Immerzeel (US 2016/0346777).
Regarding Claims 15 and 20:
As discussed for Claims1 and 19 above, Koike discloses the invention as claimed.
Koike does not disclose wherein the number of filling needles are fluidically connected, by means of a number of tubes, to a source container and/or to a conveying means for conveying the fluid.
Immerzeel teaches filling container inside a controlled environment enclosure, that can be considered an isolator, by feeding a filling needle by means of a number of tubes connected to a source container.
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to Koike the teachings of Immerzeel and feed the needle from a source container by tubes as an alternative to using the tank of the injector.
Allowable Subject Matter
Claim 16 is 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.
Reasons for the indication of Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Claim 16 include the following limitations which, in combination with the other limitations of the claims, are what make the subject matter allowable over the prior art, as the subject matter of claim is neither taught or suggested by the prior art:
“wherein the number of tubes cross through a wall of the transfer lock in a sterile manner".
No reference on the record, that can be considered "prior art" teaches filling needles that are fluidically connected, by means of a number of tubes, to a source container and/or to a conveying means for conveying the fluid, wherein the number of tubes cross through a wall of the transfer lock in a sterile manner.
In particular Py (US 2014/0026520), ZIMMERMANN (DE 102019204439), Broadbent (US 10781002), IMMERZEEL (US 20160346777), Smith (US 5562882) and Adams (US 2010/0084045) disclose feeding tubes for filling needles crossing a wall of an isolator in a sterile manner; but no reference teach crossing a wall of the transfer lock of an isolator or provides a motivation to modify a reference in such way.
Note that on amendment the claim could maybe be rejected under Double Patenting over the Claims of patent US 12552053.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. In particular, Giribona (US 2012/0048419) and Umeno (US 2015/0210410) teach relevant methods and devices including first and second needle carriers that can be used for a proper rejection at least of the independent claims, while MAURISCHAT (DE 102019202726) teach a similar device with more than one filling needle and first, second and third needle carriers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDUARDO R FERRERO whose telephone number is (571)272-9946. The examiner can normally be reached M-F 9:30-7:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SHELLEY SELF can be reached at 571-272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EDUARDO R FERRERO/Examiner, Art Unit 3731
/ROBERT F LONG/Primary Examiner, Art Unit 3731
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