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 .
FINAL ACTION
Response to Amendment
The amendment filed on 12/19/2025 has been received and claims 1-4 and 6-27 are pending.
Election/Restrictions
Claims 15-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/04/2025.
Claim Objections
Claims 1-4 and 6-14 are objected to because of the following informalities:
in line 6 of Claim 1, delete “of” between “cleaning” and “the septum”;
in line 17 of Claim 1, insert --automated-- before “vial”;
in line 4 of Claim 6, delete “by” and insert --with--;
in line 5 of Claim 6, insert --automated-- before “vial”;
in line 6 of Claim 7, insert --at least one-- before “swab”;
in line 9 of Claim 7, insert --at least one-- before “swab”;
in line 10 of Claim 7, insert --at least one-- before “swab”;
in line 11 of Claim 7, insert --at least one-- before “swab”;
in line 12 of Claim 7, insert --at least one-- before “swab”;
in line 13 of Claim 7, insert --at least one-- before “swab”;
in line 14 of Claim 7, insert --at least one-- before “swab”;
in line 4 of Claim 8, delete “vial” and insert --vials--;
in line 3 of Claim 9, delete “vial” and insert --vials--;
in line 4 of Claim 9, delete “constitutes” and insert --is--;
in line 10 of Claim 12, insert --the-- before “UV radiation”;
in line 4 of Claim 13, delete “vial” and insert --vials--.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “imaging apparatus” in claim 1; “vial transferring means” in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. In particular, the corresponding structure for the “imaging apparatus” is one or more cameras, sensors, or other image capture devices (see p. 54 [0423]) and the corresponding structure for the “vial transferring means” is a robotic arm with a gripper at an end or a robotic arm (see p. 49 [0397], p. 60 [0450] of Specification).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 11 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.
In Claim 11, it is not clear whether the limitation “to an ultraviolet (UV) radiation” is attempting to set forth a type of electromagnetic radiation/wave or a UV light source/”source of UV radiation”.
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.
Claim(s) 1 and 6-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mlodzinski (20080199353).
As to Claim 1, Mlodzinski (‘353) discloses an automated vial preparation module (100) that, when in use, prepares vials for being used in pharmaceutical compounding, said preparation of vials capable of comprising at least cleaning a septum of a vial (see entire document, particularly p. 5 [0043] and [0045]-[0048], pp. 10-11 [0087], p. 12 [0105] and [0108]-[0109]), said automated vial preparation module (100) comprising:
a vial preparation zone (i.e. area/region where component(s) such as 300/500/600/1100/1200, 1212 is/are located) in which the automated vial preparation module performs the preparation of the vial (330; 560; 812; 1208) capable of including the cleaning the septum of the vial;
at least one imaging apparatus for imaging a field of view including the vial preparation zone (see entire document, particularly p. 4 [0038]); and
a controller or control circuitry (1000) (see entire document, particularly Figure 10, p. 5 [0044], p. [0066], pp. 9- 10 [0080], p. 10 [0081]-[0085], pp. 10-11 [0087], p. 12 [0102] and [0104]) for:
receive (via 1010 and/or 1025), from the at least one imaging apparatus (see entire document, particularly p. 4 [0038]), images capable of including the septum of the vial (see entire document, particularly Figures 3A-3C and 10, p. 12 [0102]);
process (via 1005) the received images (see entire document, particularly Figure 10, p. 4 [0038], pp. 9- 10 [0080], p. 10 [0081]-[0085], pp. 10-11 [0087], p. 12 [0105]); and
monitor (via 1005, 1010, 1015; 1025), based on said processing, at least the cleaning of the septum of the vial (see entire document, particularly Figures 3A-3C and 10, pp. 4-5 [0041], p. 5 [0044], pp. 9- 10 [0080], p. 10 [0081]-[0085], pp. 10-11 [0087], p. 12 [0105]); and
operate the automated vial preparation module (100) based on feedback generated according to the monitoring (see entire document, particularly Figure 10, pp. 4-5 [0041], p. 5 [0044], pp. 9- 10 [0080], p. 10 [0081]-[0085], pp. 10-11 [0087]).
As to Claim 6, Mlodzinski (‘353) discloses that the automated vial preparation module (100) being configured to perform the cleaning the septum of the vial is capable to wipe the septum of the vial with at least one swab greppable via a manipulator (i.e. robotic arm such as 335) of the automated vial preparation module (100) (see entire document, particularly p. 9 [0076], p. 10 [0087], p. 12 [0102]).
As to Claim 7, the controller or control circuitry (1000) of Mlodzinski (‘353) is capable to/operable to monitor one or more swab related indications based on the images, wherein the one or more swab related indications capable of being at least one of: a pattern of movement of the at least one swab on the septum, a duration of wiping, an accuracy of wiping, a contact between the at least one swab and the septum, a pressure applied by the at least one swab on the septum, a position of the at least one swab, a relative position of the at least one swab and the septum during the wiping, a determination whether the swab is wet or dry, an orientation of the at least one swab with respect to the septum, and a time of initiation of the wiping; and wherein the feedback is capable of being generated according to the one or more swab related indications.
As to Claim 8, Mlodzinski (‘353) discloses that the automated vial preparation module (100) being configured to perform the preparation of the vials is capable/configured to mount a vial adaptor (1202) on the vial (1208), the vial adaptor (1202) greppable by a vial transferring means (i.e. robotic arm such as 335) of the automated vial preparation module (100) (see entire document, particularly p. 9 [0076], p. 10 [0087], p. 12 [0102]); and wherein the controller or control circuitry (1000) is capable to/operable to monitor one or more vial adaptor related indications based on the images, where the one or more vial adaptor related indications is capable of being at least one of: an alignment of the vial adaptor with respect to the vial, an angle of the vial adaptor with respect to the vial, a final position of the vial adaptor on the vial, an expiry date of the vial adaptor, and a determination whether the vial adaptor is genuine; and wherein the feedback is capable of being generated according to the one or more vial adaptor related indications.
As to Claim 9, Mlodzinski (‘353) discloses that the automated vial preparation module being configured to perform the preparation of the vials is configured to place the vial (760; 812) on a vial mount (i.e. holder/gripper/clip 790; 805; 1212) which is a component of the automated vial preparation module (100) (see entire document, particularly p. 5 [0043] – lines 3-4, p. 6 [0054], pp. 6-7 [0055]).
As to Claim 10, the controller or control circuitry (1000) of Mlodzinski (‘353) is capable to/operable to monitor one or more vial related indications based on the images; wherein the one or more vial related indications capable of being at least one of: an alignment of the vial with respect to the vial mount, an orientation of the vial on the vial mount, a position of the septum of the vial, a position of the vial with respect to the vial mount, a position of the vial on the vial mount, an identification of a label of the vial, a height of the vial, a geometry of the vial, a content of the vial, movement of the vial and/or the vial mount, and disinfection of the septum of the vial; and wherein the feedback is capable of being generated according to the one or more vial related indications.
As to Claim 11, Mlodzinski (‘353) discloses that the automated vial preparation module (100) being configured to perform the cleaning of the septum of the vial (see Figures 3A-3C) is configured to expose the septum to an ultraviolet (UV) radiation (305; 510; 820) (see entire document, particularly p. 5 [0043] – lines 1-3 and [0044]-[0048], p. 6 [0051]-[0053], pp. 10-11 [0087], p. 12 [0108]-[0109]).
As to Claim 12, the controller or control circuitry (1000) of Mlodzinski (‘353) is capable to/operable to monitor one or more UV related indications capable of being at least one of: a wavelength of the UV radiation, an intensity of the UV radiation, a duration of exposure, an angle of the exposure, and a distance between the septum and source of the UV radiation; and wherein the feedback is capable of being generated according to the one or more UV related indications.
As to Claim 13, Mlodzinski (‘353) discloses that the automated vial preparation module (100) being configured to perform the preparation of vials is configured to deliver and direct an airflow on the vial (see entire document, particularly pp. 5-6 [0049], p. 9 [0079], p. 11 [0097]).
As to Claim 14, the controller or control circuitry (1000) of Mlodzinski (‘353) is capable to/operable to monitor one or more airflow related indications capable of being at least one of: a laminarity of the airflow, a first contact of the airflow with the vial and/or with a vial adaptor associated with the vial, a velocity of the airflow, a direction of the airflow, a presence of the airflow, and an airflow path; and wherein the feedback is capable of being generated according to the one or more airflow related indications.
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(s) 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Mlodzinski (20080199353) as applied to claim 1 above, and further in view of Tribble (20190307643).
Mlodzinski (‘353) is relied upon for disclosure described in the rejection of claim 1 under 35 U.S.C. 102(a)(1).
As to Claim 2, while Mlodzinski (‘353) discloses that the automated vial preparation module (100) being configured to perform the cleaning the septum of the vial (see Figures 3A-3C), Mlodzinski (‘353) does not appear to specifically teach that the automated vial preparation module is configured to apply a disinfecting solution on the septum of the vial.
It was known in the art before the effective filing date of the claimed invention to provide a disinfecting solution on a surface of a vial. Tribble (‘643) discloses an automated vial preparation module that is configured to apply a disinfecting solution to a vial which intrinsically comprises a septum in order to disinfect an exposed surface of the vial (see entire document, particularly p.6 [0064]). It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a disinfecting solution applying means in the module of Mlodzinski as a known additional component in order to sterilize the vial as shown by Tribble.
As to Claim 3, the control circuitry (1000) of Mlodzinski (‘353) is capable to/operable to monitor one or more disinfecting solution related indications based on the images.
As to Claim 4, in the automated vial preparation module (100) of Mlodzinski (‘353), the one or more disinfecting solution related indications is capable of being at least one of: a volume of the disinfecting solution on the septum of the vial, whether the septum of the vial is wet or dry, and whether the volume of the disinfecting solution on the septum is sufficient or not; and wherein the feedback is capable to be generated according to the one or more disinfecting solution related indications.
Thus, Claims 2-4 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Mlodzinski (‘353) and Tribble (‘643).
Terminal Disclaimer
The terminal disclaimer filed on 12/19/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Number 19/174,365 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4 and 6-14 have been considered but are moot because the new ground of rejection does not rely on the new combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M YOO whose telephone number is (571)272-6690. The examiner can normally be reached Monday - Friday, 9:00 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REGINA M YOO/ Primary Examiner, Art Unit 1758