Office Action Predictor
Application No. 17/775,244

SYSTEM AND PROCESS FOR MANUFACTURING LASER MARKED ELASTOMER COMPONENTS

Final Rejection §103
Filed
May 06, 2022
Examiner
BARTLETT, VICTORIA
Art Unit
1744
Tech Center
1700 — Chemical & Materials Engineering
Assignee
West Pharmaceutical Services, INC.
OA Round
5 (Final)
50%
Grant Probability
Moderate
6-7
OA Rounds
3y 2m
To Grant
82%
With Interview

Examiner Intelligence

50%
Career Allow Rate
89 granted / 177 resolved
Without
With
+31.3%
Interview Lift
avg trend
3y 2m
Avg Prosecution
53 pending
230
Total Applications
career history

Statute-Specific Performance

§101
0.9%
-39.1% vs TC avg
§103
54.4%
+14.4% vs TC avg
§102
15.5%
-24.5% vs TC avg
§112
27.2%
-12.8% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§103
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 . Response to Arguments Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive. Regarding claim 1, Applicant argues that the recitation of “automatically” and “robot” in the claims would be understood by a person of ordinary skill in the art to include enabling software and as such the relevant claim limitations should not be interpreted as intended use but rather as computer implemented functional language. Examiner disagrees. Both the term “robot” and an automated machine or a machine that performs a task “automatically” predate computers and software. As per Merriam-Webster, a robot is “a machine that resembles a living creature in being capable of moving independently (as by walking or rolling on wheels) and performing complex actions (such as grasping and moving objects)” or alternatively, “a device that automatically performs complicated, often repetitive tasks (as in an industrial assembly line),” see attached copy. Software is not required to perform a complex task automatically or to move. Since the broadest reasonable interpretation of “robot” and “automatically” do not necessarily include a computer, the claim does not necessarily include computer-implemented function language. Examiner also notes that Rao does describe a robotic system which does perform these limitations specifically, irrespective of intended use, see rejection below. Claim Interpretation Claims 1-2, 7-9, 21, 23, and 26-27 contain limitations that are indicative of the intended use of the apparatus rather than the structural limitations of the apparatus. The manner of operating an apparatus does not differentiate the apparatus claim from the prior art, see MPEP §2114 (II). Such limitations include that the system itself broadly, the molding station, marking station, mixing station, cooling station, robot, or cameras are “configured to” perform a certain task. The apparatus in the prior art must be capable of performing the prior task to teach the claim limitations, for example, a molding station is capable of receiving an elastomeric pad if it is capable of receiving other molding material even if it is not explicitly disclosed in the reference, see MPEP §2114 (II). Claims such as claims 20-23 which specifically disclose a processor configured for performing a task are interpreted as computer implemented functional language, see MPEP 2114(IV). 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1, 3-4, 6-9, 20, 22-23, 26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Krizan (WO2019118983) as modified by Hager (US 2006/0092013), Rao (US 2016/0074865), and Parnell (US 5,895,192). Regarding claim 1, Krizan meets the claimed, A system for manufacturing elastomeric components, (Krizan [0048] and Figure 1 disclose a system for manufacturing an elastomeric article) the system comprising: a molding station comprising a mold, the molding station being configured to receive an elastomeric material, (Krizan [0048] describes a first mold 14 molding an elastomer sheet 44, see also MPEP §2114(II) and 2115) form a pad comprising a plurality of untrimmed elastomeric components, (Krizan Figure 1 and [0053] shows a sheet 44 and film layers 16/46 forming a pad which is then formed into untrimmed elastomeric piston 11 bodies via mold 14) and cure the pad untrimmed elastomeric components; (Krizan [0057]-[0058] discloses curing or vulcanizing, see MPEP 2114(II)). Krizan does not disclose a system for marking the elastomeric components, however, it is known in the art to mark components using a laser. Krizan [0060] discloses the elastomeric article is a piston, stopper, or closure. Hager [0032] discloses a container closure article has images 18 on it made via laser printing. It would have been obvious to a person of ordinary skill in the art before the filing date to have marked the components of Krizan as discussed in Hager in order to provide an indicia for verifying the contents and destination of the container without having to perform additional analytical analysis, see Hager [0036]. Hager [0032] discloses laser printing but does not explicitly disclose an automated marking station or an inspection station and does not meet the claimed, and an automated marking station comprising a robot and a laser, the automated marking station being configured to remove the cured pad untrimmed elastomeric components from the molding station, to present the cured pad untrimmed elastomeric components to the laser to form a mark on each of the untrimmed elastomeric components, and to present the cured pad untrimmed elastomeric components to an inspection station comprising a camera to capture an image of each mark and identify any defects in the elastomeric components. Rao discloses a system for marking tubes and other similar articles to Krizan and Hager with a laser and meets the claimed, and an automated marking station comprising a robot and a laser, (Rao [0070]-[0071] describe a robotic laser marking system controlled via a controller), being configured to automatically present the cured pad of untrimmed elastomeric components to the laser to form a mark on each of the untrimmed elastomeric components, (Rao [0067] describes a robotics system capable of moving marked tubes to the laser, moving the pad to the laser is the intended use of the system, see MPEP §2114 and Rao [0065] also describes a robot system loading a set of fresh tubes into a laser marking system) and present the cured pad of untrimmed elastomeric components to an inspection station (Rao [0067] describes a robotics system capable of moving marked tubes and transporting them to other locations, the transportation of the components is intended use, Rao [0065] describes a robot loading a set of fresh tubes into a laser marking system and [0069] and [0072] describe a camera inspection occurs at the laser marking system) comprising a camera to capture an image of each mark and identify any defects in the elastomeric components (Rao [0072] describes using a camera capable of taking an image of the laser marks to check for defects.) It would have been obvious to a person of ordinary skill in the art before the filing date to substitute the laser printer disclosed in Krizan as modified by Hager with the marking station and inspection station as described in Rao in order to provide an automated method of marking the articles which would save time, see Rao [0052] and defect detection to prevent errors, see Rao [0072]. Krizan [0058] discloses the removal of the articles from the mold but does not disclose a marking system. Rao discloses the robotics system is capable of moving the tubes and also discloses that the articles were molded, see Rao [0032], but does not explicitly disclose it is capable of removing the pad from the molding station and does not meet the claimed, the automated marking station configured to automatically remove the cured pad from the molding station. Like Krizan, Parnell discloses molding of articles and then transferring to a later processing step. Parnell meets the claimed, the automated marking station configured to automatically remove the cured pad of untrimmed elastomeric components from the molding station (Parnell col. 4 lines 6-13 describe an apparatus which removes articles from a mold after having been molded and transporting them to a further locale.) It would have been obvious to a person of ordinary skill in the art before the filing date to use the robot disclosed in Krizan as modified by Rao to remove the articles from the mold as disclosed in Parnell in order to quickly remove the articles from the mold without any shocks or vibrations, see Parnell col. 4 lines 6-13. Regarding claim 3, Krizan meets the claimed, The system of claim 1, wherein the molding station comprises a plurality of compression molds. Krizan [0048] describes compression molding. While Krizan does not explicitly disclose a plurality of compression molds, duplication of parts has no patentable significance unless an unexpected result is produced, see MPEP §2144.04(VI)(B). It would have been obvious to a person of ordinary skill in the art before the filing date to simply duplicate the number of compression molds in Krizan in order to mold more components at a faster rate. Regarding claim 4, Hager discloses codes but does not specify a data matrix code. Rao meets the claimed, The system of claim 1, wherein the mark is a data matrix code (Rao [0051] describes a data matrix code.) The courts have held that substituting one known prior art element for another according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143. It would have been obvious to a person of ordinary skill in the art before the filing date to substitute the code described in Krizan as modified by Hager with the data matrix code as described in Rao because a data matrix code is a known indicia for labeling tubes and closures, see Rao [0051]. Regarding claim 6, Krizan does not describe a mark. Rao meets the claimed, The system of claim 1, wherein the camera is connected to a processor configured to decode each mark and record a unique identifier associated with each mark (Rao [0074] describes software which retrieves identifying data from the laser-marked tubes.) It would have been obvious to a person of ordinary skill in the art before the filing date to further modify the system of Krizan such that a processor can identify each mark as described in Rao in order to properly move and mark the tubes, see Rao [0074]. Regarding claim 7, Krizan does not disclose a cooling station. Rao meets the claimed, The system of claim 1. further comprising a cooling station configured to receive the cured pad following application of the mark to each untrimmed elastomeric component (Rao [0074] describes allowing the tubes to air-dry which would allow them to cool. The location in which they are air-dried is considered the “cooling station” and is capable of receiving the cured pad at any time.) It would have been obvious to a person of ordinary skill in the art before the filing date to combine the system of Krizan with the cooling station of Rao in order to allow the laser mark to dry on the tubes, see Rao [0074]. Regarding claim 8, Rao further meets the claimed, The system of claim 7, further comprising a second robot configured to remove the cured pad from the cooling station and to deliver the cured pad (Rao [0067] describes a robotics system which is capable of picking the marked tubes up and moving them around, Rao does not disclose a second system, however, mere duplication of parts has no patentable significance unless a new and unexpected result is produced, see MPEP 2144.04(VI)(B)) to at least one of a trimming station, a washing station, or a packing station (Rao [0075] describes packaging occurs, the area in which the packaging occurs is the “packing station.”) It would have been obvious to a person of ordinary skill in the art before the filing date to further combine the system of Krizan with the cooling station and the packing station of Rao in order to automate the process and increase efficiency. Regarding claim 9, Krizan does not disclose a camera. Rao further meets the claimed, The system of claim 8. further comprising camera configured to capture a second image of the mark of at least one of the elastomeric components following processing by at least one of the trimming station or the washing station (Rao [0072] describes a camera taking an image of the mark, the camera is capable of doing this at any time including after the tubes are in the air filtration (washing station), see [0073].) Rao does not explicitly disclose a second camera and instead uses only one camera, however, absent unexpected results, simply duplicating the camera which already is capable of performing the claimed function would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2144.04 Section VI (B).) Regarding claim 20, Krizan does not disclose a processor for located the mark. Rao meets the claimed, The system of claim 1, wherein the inspection station further comprises a processor configured to determine the location of each mark on the elastomeric components (Rao [0072], [0081], and [0087] describes a camera/processor capable of locating the marker on the tubes.) It would have been obvious to a person of ordinary skill in the art before the filing date to combine the apparatus of modified Krizan with the processor locating the mark as disclosed in Rao in order to identify and analyze the tube marks for any defects, see Rao [0072]. Regarding claim 22, Krizan does not disclose a processor determining readability. Rao meets the claimed, The system of claim 1, wherein the inspection station further comprises a processor configured to determine whether each mark on the elastomeric components is readable (Rao [0072] describes software connected to the camera which determines if the mark has defects or not.) It would have been obvious to a person of ordinary skill in the art before the filing date to combine the apparatus of modified Krizan with the processor locating the mark as disclosed in Rao in order to identify and analyze the tube marks for any defects, see Rao [0072]. Regarding claim 23, Krizan does not disclose a processor for reading the marks. Rao further meets the claimed, The system of claim 22, wherein the processor is configured to determine that the mark on one of the elastomeric components cannot be read, and the system is configured to reject the one elastomeric component based on the determination that the mark on the one elastomeric component cannot be read (Rao [0072] describes software connected to the camera which determines if the mark has defects or not.) It would have been obvious to a person of ordinary skill in the art before the filing date to combine the apparatus of modified Krizan with the processor locating the mark as disclosed in Rao in order to identify and analyze the tube marks for any defects, see Rao [0072]. Regarding claim 26, Krizan does not disclose trimming. Rao meets the claimed, The system of claim 1, further comprising a trimming station configured to trim the pad to separate the elastomeric components after the image is captured (Rao [0057] discloses a die cut for cutting plastic film components down to size. Cutting a particular component is the intended use of the apparatus. The die cutter would be capable of also cutting apart other elastomeric components.) It would have been obvious to a person of ordinary skill in the art before the filing date to combine the apparatus of Krizan with the die cutter of Rao in order to trim the components down to the appropriate size, see Rao [0057]. Regarding claim 28, Parnell further meets the claimed, The system of claim 1, wherein the robot is configured to remove the cured pad of untrimmed elastomeric components from the molding station (Parnell col. 4 lines 6-13 describe a high speed automated manufacturing system (robot) which removes articles from a mold after having been molded and transporting them to a further locale.) Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over Krizan as modified by Hager and Rao as applied to claim 1 and in further view of Nakai (US 2020/0405918). Regarding claim 2, Krizan does not describe a mixing station and does not meet the claimed, The system of claim 1. further comprising a mixing station configured to compound the elastomeric material and deliver the elastomeric material to the molding station. Analogous in the field of manufacturing tubular medical equipment, Nakai describes a process for molding an tubular endoscope and meets the claimed, The system of claim 1. further comprising a mixing station configured to compound the elastomeric material and deliver the elastomeric material to the molding station (Nakai [0148] describes mixing a resin composition together in a kneader prior to being ejected into compression mold.) The courts have held that combining prior art elements, such as the molding station of Krizan and the kneader of Nakai, according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143. It would have been obvious to a person of ordinary skill in the art before the filing date to combine the molding station of Krizan with the kneader of Nakai in order to mix the resin compositions in the appropriate amounts prior to molding, see Nakai [0148]. Allowable Subject Matter Claim 27 is allowed. Claim 21 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. The following is a statement of reasons for the indication of allowable subject matter: Claim 21 requires all the limitations of claim 1 and claim 20 and further specifies that a processor is configured to determine if the mark is not outside of a target area and if the mark is not outside of that target area, the system is configured to reject that elastomeric component. None of the cited references meet this claim. Krizan generally discloses a mold for molding elastomeric components but does not disclose any marks. Hager, while disclosing marks, does not disclose a processor configured to identify the location of the marks. Rao discloses a system for marking and a camera configured to scan the mark (thereby locating it) and detect defects. Although Rao teaches destroying a tube with a defective marking, Rao does not specify that the defect is not being outside of a target area. None of the other cited references describe a processor capable of determining the location of the mark as not being in the target area and rejecting if the mark is not outside of the target area. Therefore, claim 21 contains allowable subject matter. Claim 27 contains almost identical limitations to claim 21 and therefore is allowed for the same reasons as described above. 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 VICTORIA BARTLETT whose telephone number is (571)272-4953. The examiner can normally be reached Monday - Friday 9:00 am-5:00 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sam Zhao can be reached on 571-270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /V.B./Examiner, Art Unit 1744 /XIAO S ZHAO/Supervisory Patent Examiner, Art Unit 1744
Read full office action

Prosecution Timeline

May 06, 2022
Application Filed
May 06, 2022
Response after Non-Final Action
Jun 04, 2024
Non-Final Rejection — §103
Aug 30, 2024
Response Filed
Nov 06, 2024
Non-Final Rejection — §103
Feb 06, 2025
Response Filed
Feb 24, 2025
Final Rejection — §103
Mar 14, 2025
Examiner Interview Summary
Mar 14, 2025
Applicant Interview (Telephonic)
May 05, 2025
Response after Non-Final Action
Jun 30, 2025
Request for Continued Examination
Jul 02, 2025
Response after Non-Final Action
Aug 05, 2025
Non-Final Rejection — §103
Dec 11, 2025
Response Filed
Jan 28, 2026
Final Rejection — §103
Apr 07, 2026
Response after Non-Final Action

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Prosecution Projections

6-7
Expected OA Rounds
50%
Grant Probability
82%
With Interview (+31.3%)
3y 2m
Median Time to Grant
High
PTA Risk
Based on 177 resolved cases by this examiner