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 .
Summary
Claims 1, 5, 7, and 9-22 are pending. Claims 1, 5, 7, and 9-22 are rejected herein. This is a Non-Final Rejection after the amendment, arguments, and Request for Continued Examination (hereinafter “the Response”) dated 13 Jan 2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “reading cell that is a component of the piercing system” in claims 1, 11, and 21 must be shown or the feature(s) canceled from the claim(s). The drawings must also show the solenoid latch of claims 19 and 22. No new matter should be entered.
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.
Claim Suggestions
Claim 1 already introduces the initials for Laboratory Information System (LIS), therefore it is no necessary to do so again in claim 9.
Claim Objections
Claim(s) 1, 5, and 11 is/are objected to because of the following informalities. Appropriate correction is required.
Regarding claim 1: Change “system- handler” to --system handler-- (remove the hyphen). This same typo appears in claim 11.
Regarding claim 5: Remove the extra hyphen in “rack--holding.”
Regarding claim 18: It appears that “pick-and-place” has two hyphens in each hyphen position.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1, 5, 7, and 9-22 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claims 1, 11, and 22: The Applicant’s disclosure does not enable one skilled in the art to make or use “a reading cell formed within the piercing system.” The Applicant has stated (page 9 of the Response) that support for this limitation is in FIG. 9, which simply has the overall reference character “900” and para. 37 of the specification as published only says, “In FIG. 9, an exemplary piercing system reading cell 900 is illustrated.” There appears to be a test tube in the top lefthand corner of FIG. 9 and perhaps a circuit board in the center. Other than that, there is no indication as to what the components are or how they function. Therefore, this disclosure does not enable one skilled in the art to make or use the invention. The lack of information is especially problematic because this limitation is central to the Applicant’s argument for patentability as set forth on pages 12-13 of the Response dated 19 Sep 2025.
Regarding claims 1, 11, and 22: The Applicant’s disclosure does not allow one skilled in the art to make or use the invention because the disclosure is silent as to the structural relationship between the robot arm, the piercing system, and the reader/reading cell. Are all of these components mounted on the robot arm? Does the robot arm move the sample tube to a piercing station? Is the reader mounted on the robot arm and the reading cell is a location where the robot arm does the reading? Claim 1 recites “a reading cell that is a component of the piercing system.” This does not provide a structural relationship. Claim 1 further recites “a robot arm configured to…using a reader operatively associated with the robotic arm, read an identification (tube ID) on the extracted sample tube.” “Operatively associated” provides no information as to the structural connection. If two structures are “operatively associated” they can merely exist on the same device. The drawings and specification provide no information as to this relationship which is crucial to the functioning and patentability of the invention.
Regarding claims 5, 7, 9, 10, 12-20, and 22: These claims are rejected as lacking enablement due to their dependence.
Claim Rejections - 35 USC § 112(b)
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(s) 1, 5, 7, and 9-22 is/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.
Regarding claims 1, 11, and 21: Claims 1, 11, and 21 are rejected under 35 U.S.C. 112(b) as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structural relationship between the robot arm, the piercing system, and the reader/reading cell. Are all of these components mounted on the robot arm? Does the robot arm move the sample tube to a piercing station? Is the reader mounted on the robot arm and the reading cell is a location where the robot arm does the reading? Claim 1 recites “a reading cell that is a component of the piercing system.” This does not provide a structural relationship. Claim 1 further recites “a robot arm configured to…using a reader operatively associated with the robotic arm, read an identification (tube ID) on the extracted sample tube.” “Operatively associated” provides no information as to the structural connection. If two structures are “operatively associated” they can merely exist on the same device. The drawings and specification provide no information as to this relationship which is crucial to the functioning and patentability of the invention.
Regarding claims 5, 7, 9, 10, 12-20, and 22: These claims are rejected as indefinite for depending from an indefinite claim.
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.
Claim(s) 1, 5, 7, 9-18, 20, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over ACCURSO et al. (US 2017/0176481) in view of SELF et al. (US 2010/012686), LEVY (US 2011/0130740), and DUFRESNE et al. (US 5,745,227).
Regarding claim 1: As best understood, ACCURSO discloses: An analyzer (FIG. 27; abstract) comprising: an analytical unit including a mixing wheel (602 in FIG. 6; para. 117), a piercing system (700 in FIG. 7; para 120), and a reading cell (optical detection system in para. 113); a rack-holding system (400 in FIG. 4; para. 114) configured to receive racks (one rack shown loaded in FIG. 4, but shows enough room for 12 racks) containing sample tubes (FIG. 4 shows 10 sample tubes.) and to lock each received rack (with locking rib 4406; FIG. 44; para. 92) until all tubes in that rack have been evaluated for processing and returned to their original rack positions (This is a statement of intended use and does not structurally limit the analyzer.); a robotic arm (gripper 402 in FIG. 4) configured to: (i) extract a sample tube from any rack position (This is done by gripping robot gripping feature 4208 in FIG. 42. Para. 99 discusses picking up a rack. Moving tubes is discussed in para. 148.), (ii) using a reader operatively associated with the robotic arm (barcode reader in para. 113), read an identification (tube ID) on the extracted sample tube, the reading of the tube ID providing an identified tube, and (iii) after analysis, return the sample tube to its original rack position (This is a statement of intended use. Because the robot arm is capable of picking up and moving the sample tubes, it is capable of putting them back.); a system-handler processor communicatively linking the analytical unit, the rack-holding system, and the robotic arm (computer running software to control the apparatus as discussed in para. 136, 203) and configured to query a Laboratory Integration System (LIS/LIMS in FIG. 62) whether erythrocyte sedimentation rate (ESR) analysis is required for the identified tube and, when the LIS indicates analysis is not required, to control the robotic arm to return the extracted tube to its original rack position; wherein, when the LIS indicates analysis is required, the robotic arm places the extracted tube on the mixing wheel for analysis by the analytical unit (The flow diagram in FIG. 57 shows that after reading the label at 3.0, the sample is either resuspended in the mixing wheel at 4.0 or skipped through 14.0 to incubate at 8.0.), and the analytical unit determines ESR (para. 80; 173), and wherein, after a successful measurement, the mixing wheel positions the measured tube for extraction to enable the robotic arm to return the measured tube to its original rack position (Please note that these method steps are statements of intended use and since the device of ACCURSO is capable of performing these methods as shown in FIG. 57, it meets these limitations.).
It is unclear (see 112 rejections above) what it means for the reading cell to be “a component of the piercing system,” but please note that SELF teaches an automated sample processing system (FIG. 4; abstract) that has a barcode reader (para. 190) and states that such a barcode reader can be located anywhere in the apparatus including stationary location with the barcode being moved past the reader or located on the robot arm, or located in another location with mirrors or optics to permit scanning of the barcodes (para. 190). Therefore placing a barcode reader anywhere in such an apparatus is within the capabilities of one skilled in the art and will be based on the types of tests, equipment, and movement used for the particular analytical setup.
ACCURSO does not disclose a hydraulic system. ACCURSO mentions stepper motors for system movement (para. 119).
LEVY however does teach a hydraulic system (para. 80) to actuate a piercing system (FIG. 4) for use in automated sampling (para. 34). Please note that LEVY also teaches pneumatic actuation (para. 80).
One skilled in the art at the time the application was effectively filed would be motivated to use the hydraulic actuation of LEVY to power the robotics of ACCURSO because hydraulic actuation provides more power in a given amount of volume. Furthermore, since all three actuation systems are known (pneumatic and hydraulic as taught by LEVY and electrical as taught by ACCURSO), the use of one over the other is “Simple Substitution of One Known Element for Another to Obtain Predictable Results” (see MPEP 2143 B). In the present case, the known elements are the different types of robotic actuation and the predictable results are that the robotics system is provided with the controlled movement to carry its automated tasks.
ACCURSO discloses erythrocyte sedimentation rate (ESR) analysis in para. 80 and 173. ACCURSO does not specifically recite what the method is for determining ESR.
DUFRESNE however does specify that ESR is determined by digitally recording optical changes in the reading cell over time (abstract), processes this data into a value expressed in millimeters per hour (mm/hr) (col. 1 lines 13-24).
It would be obvious to one skilled in art at the time the application was effectively filed to optically monitor the reading cell over time and calculate the value in mm/hr because this is the typical Westergren output for the test (col. 1 lines 5-25 of DUFRESNE).
Regarding claim 5: As best understood, ACCURSO discloses: the robotic arm is configured to reach every rack location in the rack-holding system and to extract each tube from any location in each rack while the rack is in a locked position (FIG. 4 shows the robotic arm 402, and FIG. 44 shows that when the racks are in place, they are in the locked position by locking rib 4406.).
Regarding claim 7: As best understood, ACCURSO discloses: the identification is a barcode on each extracted sample tube and wherein the reader comprises a barcode reader (para. 113).
Regarding claim 9: As best understood, ACCURSO discloses: the system handler processor is configured to send the identification to the Laboratory Integration System (LIS) and receive, from the LIS, a response indicating whether analysis is required (The processor is computer from para. 136 and 203 that is running the “Abbott Middleware” at the bottom right which is shown communicatively linked to an LIS/LIMS in FIG. 62. They run the flow diagram shown in FIG. 57 to decide whether analysis is needed.).
Regarding claim 10: As best understood, ACCURSO discloses: the LIS (LIS shown in bottom right of FIG. 62.) is configured to provide information on whether a particular sample tube requires analysis (according to the decision tree shown in FIG. 57).
Regarding claim 11: As best understood, ACCURSO discloses: A method for analyzing samples using an analyzer (FIG. 27, abstract) that includes an analytical unit having a mixing wheel (6023 in FIG. 6; para. 117), a piercing system (700 in FIG. 7; para. 120), a reading cell (optical detection system in para. 113); a rack-holding system (400 in FIG. 4; para. 114); a robotic arm (gripper 402 in FIG. 4); and a system-handler processor that communicatively links the analytical unit, the rack-holding system, and the robotic arm (computer running software to control the apparatus as discussed in para. 136, 203), the method comprising: receiving at least one rack containing sample tubes in the rack-holding system and locking each received rack (with locking rib 4406; FIG. 44; para. 92) until all tubes in that rack have been evaluated for processing and returned to their original rack positions (according to the flow chart in FIG. 57; Movement is done by gripping robot gripping feature 4208 in FIG. 42. Para. 99 discusses picking up a rack. Moving tubes is discussed in para. 148.); extracting, with the robotic arm, a sample tube from any rack position of a locked rack (This is done by gripping robot gripping feature 4208 in FIG. 42. Para. 99 discusses picking up a rack. Moving tubes is discussed in para. 148.) and reading an identification on the extracted sample tube to obtain a tube identification (para. 115); sending the tube ID to a Laboratory Integration System (LIS/LIMS in FIG. 62) to determine whether erythrocyte sedimentation rate analysis is required for the sample associated with the tube ID; when the LIS indicates analysis is not required (The flow diagram in FIG. 57 shows that after reading the label at 3.0, the sample is either resuspended in the mixing wheel at 4.0 or skipped through 14.0 to incubate at 8.0.), returning the extracted sample tube to its original rack position; when the LIS indicates analysis is required, placing the extracted sample tube on the mixing wheel for analysis by the analytical unit (The flow diagram in FIG. 57 shows that after reading the label at 3.0, the sample is either resuspended in the mixing wheel at 4.0 or skipped through 14.0 to incubate at 8.0.; determining ESR (para. 80; 173).
It is unclear (see 112 rejections above) what it means for the reading cell to be “a component of the piercing system,” but please note that SELF teaches an automated sample processing system (FIG. 4; abstract) that has a barcode reader (para. 190) and states that such a barcode reader can be located anywhere in the apparatus including stationary location with the barcode being moved past the reader or located on the robot arm, or located in another location with mirrors or optics to permit scanning of the barcodes (para. 190). Therefore placing a barcode reader anywhere in such an apparatus is within the capabilities of one skilled in the art and will be based on the types of tests, equipment, and movement used for the particular analytical setup.
ACCURSO does not disclose a hydraulic system. ACCURSO mentions stepper motors for system movement (para. 119).
LEVY however does teach a hydraulic system (para. 80) to actuate a piercing system (FIG. 4) for use in automated sampling (para. 34). Please note that LEVY also teaches pneumatic actuation (para. 80).
One skilled in the art at the time the application was effectively filed would be motivated to use the hydraulic actuation of LEVY to power the robotics of ACCURSO because hydraulic actuation provides more power in a given amount of volume. Furthermore, since all three actuation systems are known (pneumatic and hydraulic as taught by LEVY and electrical as taught by ACCURSO), the use of one over the other is “Simple Substitution of One Known Element for Another to Obtain Predictable Results” (see MPEP 2143 B). In the present case, the known elements are the different types of robotic actuation and the predictable results are that the robotics system is provided with the controlled movement to carry its automated tasks.
ACCURSO discloses erythrocyte sedimentation rate (ESR) analysis in para. 80 and 173. ACCURSO does not specifically recite what the method is for determining ESR.
DUFRESNE however does specify that ESR is determined by digitally recording optical changes in the reading cell over time (abstract), processes this data into a value expressed in millimeters per hour (mm/hr) (col. 1 lines 13-24).
It would be obvious to one skilled in art at the time the application was effectively filed to optically monitor the reading cell over time and calculate the value in mm/hr because this is the typical Westergren output for the test (col. 1 lines 5-25 of DUFRESNE).
Regarding claim 12: As best understood, ACCURSO discloses: the identification is performed by a reader operatively associated with the robotic arm (para. 113; 506 in FIG. 5).
Regarding claim 13: As best understood, ACCURSO discloses: determining whether ESR analysis is required includes receiving, from the Laboratory Integration System (LIS), a response indicating whether analysis is required (LIS is shown at bottom right of FIG. 62. Decision of whether to mix or go straight to analysis is handled at 3.0 in FIG. 57.).
Regarding claim 14: As best understood, ACCURSO discloses: the identification is a barcode on the extracted tube (para. 113).
Regarding claim 15: As best understood, ACCURSO discloses: the reader comprises a barcode reader and wherein reading the identification is performed by the barcode reader (para. 113).
Regarding claim 16: As best understood, ACCURSO discloses: receiving two or more racks in the rack-holding system at the same time (FIG. 4 shows a single 10-tube rack and space for 12 racks.); and locking each received rack to prevent removal until all tubes in that rack have been evaluated for processing- and returned to their original rack positions (Racks are locked into place with locking rib 4406 in FIG. 44.).
Regarding claim 17: As best understood, ACCURSO discloses: when the LIS indicates analysis is not required, the extracted tube is immediately returned to its original rack position without being placed on the mixing wheel (The flow chart in FIG. 57 shows that after reading the label at 3.0, the tube is either mixed or replaced for analysis.).
Regarding claim 18: As best understood, ACCURSO discloses: during operation displaying, via a visual indicator, a rack status to a user and notifying the system handler processor which rack is to receive so that pick-and-place coordinates are adjusted accordingly (para. 89-91; 204).
Regarding claim 20: As best understood, ACCURSO discloses: upon completion for a given rack, releasing that rack from the locked state for manual extraction after all tubes in the rack have been evaluated for processing and returned to their original rack positions (The user adding and removing racks is discussed in para. 87, and removing the racks after testing is completed is just the logical end of the analysis process. Otherwise the racks with already-tested samples would stay in the apparatus forever.)
Regarding claim 21: As best understood, ACCURSO discloses: An analyzer system comprising: an analytical unit (FIG. 27; abstract) including a mixing wheel (602 in FIG. 6; para 117), a piercing system (700 in FIG. 7; para. 120), and a reading cell (optical detection system in para. 113); a rack-holding system (400 in FIG. 4; para. 117) configured to receive racks (one rack shown loaded in FIG. 4, but shows enough room for 12 racks) containing sample tubes (FIG. 4 shows 10 sample tubes.) and to lock each received rack (with locking rib 4406; FIG. 44; para. 92) until all tubes in that rack have been evaluated for processing and returned to their original rack positions (This is a statement of intended use and does not structurally limit the analyzer system.); a robotic arm (gripper 402 in FIG. 4) configured to: (i) extract a sample tube from any rack position of a locked rack (This is done by gripping robot gripping feature 4208 in FIG. 42. Para. 99 discusses picking up a rack. Moving tubes is discussed in para. 148.), (ii) using a reader operatively associated with the robotic arm, read an identification on the extracted sample tube (barcode reader in para. 113) and (iii) after analysis, return the identified sample tube to its original rack position (This is a statement of intended use. Because the robot arm is capable of picking up and moving the sample tubes, it is capable of putting them back.); and a system-handler processor communicatively linking the analytical unit, the rack- holding system, and the robotic arm (computer running software to control the apparatus as discussed in para. 136, 203) and configured to query a Laboratory Integration System (LIS/LIMS in FIG. 62) whether erythrocyte sedimentation rate (ESR) analysis is required for the extracted sample tube and, when the LIS indicates analysis is not required, to control the robotic arm to return the extracted tube to its original rack position; wherein, when the LIS indicates analysis is required, the robotic arm places the extracted sample tube on the mixing wheel for analysis by the analytical unit (The flow diagram in FIG. 57 shows that after reading the label at 3.0, the sample is either resuspended in the mixing wheel at 4.0 or skipped through 14.0 to incubate at 8.0.), and the analytical unit determines ESR (para. 80, 173) and wherein, after a successful measurement, the mixing wheel positions the measured tube for extraction to enable the robotic arm to return the measured tube to its original rack position (Please note that these method steps are statements of intended use and since the device of ACCURSO is capable of performing these methods as shown in FIG. 57, it meets these limitations.).
It is unclear (see 112 rejections above) what it means for the reading cell to be “a component of the piercing system,” but please note that SELF teaches an automated sample processing system (FIG. 4; abstract) that has a barcode reader (para. 190) and states that such a barcode reader can be located anywhere in the apparatus including stationary location with the barcode being moved past the reader or located on the robot arm, or located in another location with mirrors or optics to permit scanning of the barcodes (para. 190). Therefore placing a barcode reader anywhere in such an apparatus is within the capabilities of one skilled in the art and will be based on the types of tests, equipment, and movement used for the particular analytical setup.
ACCURSO does not disclose a hydraulic system. ACCURSO mentions stepper motors for system movement (para. 119).
LEVY however does teach a hydraulic system (para. 80) to actuate a piercing system (FIG. 4) for use in automated sampling (para. 34). Please note that LEVY also teaches pneumatic actuation (para. 80).
One skilled in the art at the time the application was effectively filed would be motivated to use the hydraulic actuation of LEVY to power the robotics of ACCURSO because hydraulic actuation provides more power in a given amount of volume. Furthermore, since all three actuation systems are known (pneumatic and hydraulic as taught by LEVY and electrical as taught by ACCURSO), the use of one over the other is “Simple Substitution of One Known Element for Another to Obtain Predictable Results” (see MPEP 2143 B). In the present case, the known elements are the different types of robotic actuation and the predictable results are that the robotics system is provided with the controlled movement to carry its automated tasks.
ACCURSO discloses erythrocyte sedimentation rate (ESR) analysis in para. 80 and 173. ACCURSO does not specifically recite what the method is for determining ESR.
DUFRESNE however does specify that ESR is determined by digitally recording optical changes in the reading cell over time (abstract), processes this data into a value expressed in millimeters per hour (mm/hr) (col. 1 lines 13-24).
It would be obvious to one skilled in art at the time the application was effectively filed to optically monitor the reading cell over time and calculate the value in mm/hr because this is the typical Westergren output for the test (col. 1 lines 5-25 of DUFRESNE).
Claim(s) 19 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over ACCURSO, SELF, LEVY, DUFRESNE, and YAMADA et al. (US 4559201).
Regarding claims 19 and 22: As best understood, ACCURSO does not disclose a solenoid latch.
YAMADA however does teach locking of a rack that comprises actuating a solenoid latch (col. 2 lines 58-68). The invention of YAMADA is for the automatic processing of a rack of containers (abstract FIG. 2).
One skilled in the art at the time the application was effectively filed would be motivated to use the solenoid latch of YAMADA to lock the racks of ACCURSO because it facilitates automation (col. 1 lines 32-38 of YAMADA).
Response to Amendment/Argument
The Applicant has argued (pages 9-10 of the Response) that the objection to the drawings on the basis that they must show “a reading cell formed within the piercing system” has been overcome because the claims have been amended to recite “a reading cell that is a component of the piercing system.” The Applicant has further argued (page 12 of the Response) that this limitation is enabled by the specification. This argument has been fully considered and is not persuasive. The Examiner maintains that this limitation, even in its new form, is not shown in the drawings or enabled by the Applicant’s disclosure. FIG. 1 schematically shows the reading cell 123 and the piercing system 122 as separate and on the analytical unit 120 not the robot arm 110. FIG. 9 and accompanying para. 37 have been relied upon by the Applicant to allegedly show enablement for this limitation, however claim 9 has no reference characters except the global character 900 with the only explanation in the specification being “[0037] In FIG. 9, an exemplary piercing system reading cell 900 is illustrated.” Furthermore, the Applicant has indicated that this is not a background or obvious limitation. The Applicant’s Remarks (dated 19 Sep 2025) state that “the amended claims recite a specific structural integration and coordinated workflow that Accurso, Levy, and Dufresne-alone or in combination-do not teach or suggest. An example of the distinction is that the analyzer (in the presently amended claims) performs time-resolved optical ESR measurement in a reading cell formed within the piercing system while the tube remains coupled to that piercer” (emphasis added). Therefore, the Applicant has indicated that this limitation is what makes claim 1 patentably distinct from the prior art of record. The Applicant explains that this limitation is enabled on page 12 of the Response where it states “FIG. 9 explicitly illustrates this ‘exemplary piercing system reading cell 900,’ depicting key components such as a sample tube holder for secure positioning, a piercing element for sample access, integrated optical detectors for capturing aggregation-induced changes, and hydraulic/mechanical linkages for controlled operation (FIG. 9; spec. at [0037]). None of these structures are labeled in claim 9 and the entirety of para. 37 is quoted above. It does not refer to any of these structures. Therefore the Examiner maintains the enablement rejection of this limitation and the objection to the drawings based on this feature of the invention not being shown.
The Applicant has argued (page 11 of the Response) that:
the amended claims are enabled because the specification provides a clear and comprehensive disclosure that allows one of ordinary skill in the art (e.g., a biomedical engineer familiar with automated laboratory analyzers) to make and use the invention without undue experimentation. The rejection centers on the "reading cell formed within the piercing system," but the amendments rephrase this to "a reading cell that is a component of the piercing system," aligning precisely with the specification's description of the analytical unit 12 comprising integrated elements including the mixing wheel 18, piercing system 20, reading cell 22, and hydraulic system 24 (e.g., spec. at [0014] and [0035]; FIG. 1, FIG. 4). This integration is functionally detailed: the piercing system accesses the sample tube (e.g., via a needle or lance), positions it for optical interrogation in the reading cell, where optical sensors digitize and record variations in light transmission or scatter due to red blood cell aggregation over time.
The Examiner disagrees with this characterization of the specification. It is not functionally detailed as it does give any detail as to how any of the components are arranged or how the actual functions are carried out. For instance, how does the piercing system position the sample tube for optical interrogation and where is the optical reader mounted? The Examiner maintains the position that the Applicant’s original disclosure is so lacking in detail in both the specification and drawings that the claims are indefinite for failing to recite the structural arrangement of the components such that the scope of the claim is understood, and also lacks enablement because one skilled in the art cannot make or use the invention for the same reason. It does not appear that this deficiency can be remedied because any information added at this point would be new matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHANIEL J KOLB whose telephone number is (571)270-7601. The examiner can normally be reached M-F 9-5 EST.
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/NATHANIEL J KOLB/Examiner, Art Unit 2896