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 .
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: "controller…." in claims 23-54. Although the term "controller" is a noun and also known for performing generic function of controlling, no evidence is before the Examiner that the term is recognized in the art to be the name for structure that performs the claimed functions.
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.
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(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 24-34 and 44-54 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Claims 24-34 and 44-54 depend from claim 23 or 43, drawn to structure of a system. Claims 24-34 and 44-54 recite limitations of a target substance or fluid sample. The target substance and fluid sample are not structural elements of the claimed system, but rather an object intended to be worked up by the system. Accordingly, claims 24-34 and 44-54 do not further limit the structure of the system from which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hlavinka et al. (U.S. 2023/0129832; U.S. Pat. No. 12,605,495).
Hlavinka shows the following:
1. A method for determining content of a target substance in a fluid sample using a refractometer including a light source and a light sensor, the method comprising:
calibrating the refractometer by identifying a calibration pixel pattern of first pixels of the light sensor illuminated by light from the light source that has reflected off a sensing surface of a container including a reference fluid having a known reference density (claim 1, first clause);
identifying a fluid pixel pattern of second pixels of the light sensor illuminated by light from the light source that has reflected off the sensing surface when the fluid sample is present in the container (claim 1, second clause);
identifying a pixel shift distance along the light sensor from the calibration pixel pattern to the fluid pixel pattern (claim 1, third clause); and
determining the content of the target substance in the fluid sample based on the pixel shift distance (claim 1, fourth clause).
2. The method of claim 1, wherein the target substance is plasma free hemoglobin (claim 9).
3. The method of claim 1, wherein the target substance is a target anticoagulant (claim 9).
4. The method of claim 1, wherein the target substance is a target saline (claim 9).
5. The method of claim 1, wherein the fluid sample is whole blood (claim 8).
6. The method of claim 1, wherein the fluid sample is a blood component (claim 8).
7. The method of claim 1, wherein the fluid sample is blood plasma (title).
8. The method of claim 1, wherein the target substance is plasma free hemoglobin and the fluid sample is whole blood or a blood component (claim 9).
9. The method of claim 1, wherein the target substance is a target anticoagulant and the fluid sample is whole blood or a blood component (claim 8, 9).
10. The method of claim 1, wherein the target substance is a target saline and the fluid sample is whole blood or a blood component (claim 8, 9).
11. The method of claim 1, wherein the reference fluid is a reference anticoagulant (claim 5).
12. The method of claim 1, wherein the reference fluid is a reference saline (claim 5).
13. The method of claim 1, wherein the container includes a prism including the sensing surface (claim 2).
14. The method of claim 13, wherein the refractometer and the prism are on an upper side of the container such that gravity draws red blood cells of the fluid sample away from the sensing surface (claim 3).
15. The method of claim 13, wherein determining the content of the target substance in the fluid sample is further based on the known reference density of the reference fluid, wavelength of light generated by the light sensor, resolution of the light sensor, and optical properties of the prism (Para. [0107]; these are inherent properties that affect the images and "based on" does not limit how the determination is based on the recited properties).
16. The method of claim 1, further comprising pausing flow of the fluid sample through the container during the identifying of the fluid pixel pattern to allow gravity to draw red blood cells of the fluid sample away from the sensing surface of the container (Para. [0072]).
17. The method of claim 1, wherein the container is a cuvette including an integrated prism, the sensing surface is at the integrated prism (claim 4).
18. The method of claim 1, wherein: the container is connected to an apheresis machine; and the method further includes activating the apheresis machine to separate blood plasma from the fluid sample when the target substance is plasma free hemoglobin and the content of the plasma free hemoglobin is below a first predetermined limit (claim 7).
19. The method of claim 18, wherein the method is performed by a controller of the apheresis machine (Para. [0007]).
20. The method of claim 19, wherein the controller is configured to operate the apheresis machine to not return the fluid sample to a location from which the fluid sample originated when determination of the plasma free hemoglobin content is above a second predetermined limit that is higher than the first predetermined limit (Para. [0089]).
21. The method of claim 1, wherein: the container is connected to an apheresis machine operated by a controller; and the controller is configured to operate the apheresis machine to not return the fluid sample to a location from which the fluid sample originated when content of the target substance is above a predetermined limit (Para. [0089]).
22. The method of claim 1, wherein: the container is connected to an apheresis machine operated by a controller; the controller is configured to stop the apheresis machine when content of the target substance is above a predetermined limit; and the target substance is one of a target anticoagulant and a target saline (Para. [0089]; note that claim only requires the controller to have the ability to stop the machine, not determine when to stop).
23. A system for measuring content of a target substance in a fluid sample, the system comprising:
a light source (claim 10, first clause);
a light sensor (claim 10, second clause);
a container including a prism having a sensing surface (claim 10, third clause);
a support member configured to hold the container relative to the light source and the light sensor such that light generated by the light source reflects off the sensing surface to the light sensor (claim 10, fourth clause); and
a controller configured to (claim 10, fifth clause):
calibrate the system by identifying a calibration pixel pattern of first pixels of the light sensor illuminated by light from the light source that has reflected off the sensing surface when a reference fluid is present in the container supported by the support member, the reference fluid having a known reference density;
identify a fluid pixel pattern of second pixels of the light sensor illuminated by light from the light source that has reflected off the sensing surface when the fluid sample is present in the container;
identify a pixel shift distance along the light sensor from the calibration pixel pattern to the fluid pixel pattern; and
determine the content of the target substance in the fluid sample based on the pixel shift distance.
24. The system of claim 23, wherein the target substance is plasma free hemoglobin (claim 8, 9).
25. The system of claim 23, wherein the target substance is a target anticoagulant (claim 9).
26. The system of claim 23, wherein the target substance is a target saline (claim 9).
27. The system of claim 23, wherein the fluid sample is whole blood (claim 8).
28. The system of claim 23, wherein the fluid sample is a blood component (claim 8, 9).
29. The system of claim 23, wherein the fluid sample is blood plasma (claim 8, 9).
30. The system of claim 23, wherein the target substance is plasma free hemoglobin and the fluid sample is whole blood or a blood component (claim 8, 9).
31. The system of claim 23, wherein the target substance is a target anticoagulant and the fluid sample is whole blood or a blood component (claim 8, 9).
32. The system of claim 23, wherein the target substance is a target saline and the fluid sample is whole blood or a blood component (claim 8, 9).
33. The system of claim 23, wherein the reference fluid is a reference anticoagulant (claim 5).
34. The system of claim 23, wherein the reference fluid is a reference saline (claim 5).
35. The system of claim 23, wherein the controller is further configured to determine the content of the target substance in the fluid sample based on the known reference density of the reference fluid, wavelength of light generated by the light source, resolution of the light sensor, and optical properties of the prism.
36. The system of claim 23, wherein the light source, the light sensor, and the prism are on an upper side of the container such that gravity draws red blood cells of the fluid sample away from the sensing surface (claim 11).
37. The system of claim 23, further comprising an apheresis machine; wherein the controller is configured to activate the apheresis machine to separate plasma from the fluid sample when the target substance is plasma free hemoglobin and the content of the plasma free hemoglobin is below a first predetermined limit.
38. The system of claim 37, wherein the controller is further configured to operate the apheresis machine to not return the fluid sample to a location from which the fluid sample originated when determination of the plasma free hemoglobin content is above a second predetermined limit that is higher than the first predetermined limit (claim 16; note that the claim only requires the controller to have the ability to stop the machine, not determine when to stop).
39. The system of claim 23, further comprising an apheresis machine; wherein the controller is configured to operate the apheresis machine to not return the fluid sample to a location from which the fluid sample originated when the content of the target substance is above a predetermined limit (claim 16; note that the claim only requires the controller to have the ability to stop the machine, not determine when to stop).
40. The system of claim 23, further comprising an apheresis machine operated by the controller; wherein the controller is configured to stop the apheresis machine when content of the target substance is above a predetermined limit, the target substance is one of a target anticoagulant and a target saline (claims 7-9; note that the claim only requires the controller to have the ability to stop the machine, not determine when to stop).
41. An apheresis system comprising:
an apheresis machine configured to separate plasma from a fluid sample (claim 15, first clause);
a refractometer configured to measure content of a target substance in the fluid sample, the refractometer including (claim 15, second clause):
a light source;
a light sensor;
a cuvette including a prism with a sensing surface; and
a support member configured to hold the cuvette relative to the light source and the light sensor such that light generated by the light source reflects off the sensing surface to the light sensor; and
a controller configured to (claim 15, seventh clause):
calibrate the refractometer by identifying a calibration pixel pattern of first pixels of the light sensor illuminated by light from the light source that has reflected off the sensing surface while a reference fluid is present in the cuvette supported by the support member, the reference fluid having a known reference density;
identify a fluid pixel pattern of second pixels of the light sensor illuminated by light from the light source that has reflected off the sensing surface while the fluid sample is present in the cuvette;
identify a pixel shift distance along the light sensor from the calibration pixel pattern to the fluid pixel pattern;
determine content of the target substance in the fluid sample based on the pixel shift distance; and
activate the apheresis machine to separate plasma from the fluid sample when the determined content of the target substance in the fluid sample is below a first predetermined limit.
42. The apheresis system of claim 41, wherein the controller is further configured to operate the apheresis machine to not return the fluid sample to a location from which the fluid sample originated when the determined content of the target substance in the fluid sample is above a second predetermined limit that is higher than the first predetermined limit.
43. The apheresis system of claim 41, wherein the controller is configured to stop the apheresis machine when content of the target substance is above a predetermined limit, the target substance is one of a target anticoagulant and a target saline (claims 7-9; note that the claim only requires the controller to have the ability to stop the machine, not determine when to stop).
44. The apheresis system of claim 41, wherein the target substance is plasma free hemoglobin (claim 9).
45. The apheresis system of claim 41, wherein the target substance is a target anticoagulant (claim 9).
46. The apheresis system of claim 41, wherein the target substance is a target saline (claim 9).
47. The apheresis system of claim 41, wherein the fluid sample is whole blood (claim 8).
48. The apheresis system of claim 41, wherein the fluid sample is a blood component (claim 8).
49. The apheresis system of claim 41, wherein the fluid sample is blood plasma (claim 8).
50. The apheresis system of claim 41, wherein the target substance is plasma free hemoglobin and the fluid sample is whole blood or a blood component (claims 8, 9).
51. The apheresis system of claim 41, wherein the target substance is a target anticoagulant and the fluid sample is whole blood or a blood component (claims 8, 9).
52. The apheresis system of claim 41, wherein the target substance is a target saline and the fluid sample is whole blood or a blood component (claims 8, 9).
53. The apheresis system of claim 41, wherein the reference fluid is a reference anticoagulant (claim 5).
54. The apheresis system of claim 41, wherein the reference fluid is a reference saline (claim 5).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-1 54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,605,495. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are broader than the claims of the reference patent.
1. A method for determining content of a target substance in a fluid sample using a refractometer including a light source and a light sensor, the method comprising:
calibrating the refractometer by identifying a calibration pixel pattern of first pixels of the light sensor illuminated by light from the light source that has reflected off a sensing surface of a container including a reference fluid having a known reference density (claim 1, first clause);
identifying a fluid pixel pattern of second pixels of the light sensor illuminated by light from the light source that has reflected off the sensing surface when the fluid sample is present in the container (claim 1, second clause);
identifying a pixel shift distance along the light sensor from the calibration pixel pattern to the fluid pixel pattern (claim 1, third clause); and
determining the content of the target substance in the fluid sample based on the pixel shift distance (claim 1, fourth clause).
2. The method of claim 1, wherein the target substance is plasma free hemoglobin (claim 9).
3. The method of claim 1, wherein the target substance is a target anticoagulant (claim 9).
4. The method of claim 1, wherein the target substance is a target saline (claim 9).
5. The method of claim 1, wherein the fluid sample is whole blood (claim 8).
6. The method of claim 1, wherein the fluid sample is a blood component (claim 8).
7. The method of claim 1, wherein the fluid sample is blood plasma (claim 9).
8. The method of claim 1, wherein the target substance is plasma free hemoglobin and the fluid sample is whole blood or a blood component (claim 9).
9. The method of claim 1, wherein the target substance is a target anticoagulant and the fluid sample is whole blood or a blood component (claim 9).
10. The method of claim 1, wherein the target substance is a target saline and the fluid sample is whole blood or a blood component (claim 9).
11. The method of claim 1, wherein the reference fluid is a reference anticoagulant (claim 5).
12. The method of claim 1, wherein the reference fluid is a reference saline (claim 5).
13. The method of claim 1, wherein the container includes a prism including the sensing surface (claim 2).
14. The method of claim 13, wherein the refractometer and the prism are on an upper side of the container such that gravity draws red blood cells of the fluid sample away from the sensing surface (claim 3).
15. The method of claim 13, wherein determining the content of the target substance in the fluid sample is further based on the known reference density of the reference fluid, wavelength of light generated by the light sensor, resolution of the light sensor, and optical properties of the prism (these are inherent properties that affect the images and "based on" does not limit how the determination is based on the recited properties).
16. The method of claim 1, further comprising pausing flow of the fluid sample through the container during the identifying of the fluid pixel pattern to allow gravity to draw red blood cells of the fluid sample away from the sensing surface of the container (claim 4).
17. The method of claim 1, wherein the container is a cuvette including an integrated prism, the sensing surface is at the integrated prism (claim 6).
18. The method of claim 1, wherein: the container is connected to an apheresis machine; and the method further includes activating the apheresis machine to separate blood plasma from the fluid sample when the target substance is plasma free hemoglobin and the content of the plasma free hemoglobin is below a first predetermined limit (claim 7).
19. The method of claim 18, wherein the method is performed by a controller of the apheresis machine (the acts performed by the system of claim 10).
20. The method of claim 19, wherein the controller is configured to operate the apheresis machine to not return the fluid sample to a location from which the fluid sample originated when determination of the plasma free hemoglobin content is above a second predetermined limit that is higher than the first predetermined limit (the acts performed by the system of claim 13).
21. The method of claim 1, wherein: the container is connected to an apheresis machine operated by a controller; and the controller is configured to operate the apheresis machine to not return the fluid sample to a location from which the fluid sample originated when content of the target substance is above a predetermined limit (the acts performed by the system of claim 13).
22. The method of claim 1, wherein: the container is connected to an apheresis machine operated by a controller; the controller is configured to stop the apheresis machine when content of the target substance is above a predetermined limit; and the target substance is one of a target anticoagulant and a target saline (the acts performed by the system of claim 17).
23. A system for measuring content of a target substance in a fluid sample, the system comprising:
a light source (claim 10, first clause);
a light sensor (claim 10, second clause);
a container including a prism having a sensing surface (claim 10, third clause);
a support member configured to hold the container relative to the light source and the light sensor such that light generated by the light source reflects off the sensing surface to the light sensor (claim 10, fourth clause); and
a controller configured to (claim 10, fifth clause):
calibrate the system by identifying a calibration pixel pattern of first pixels of the light sensor illuminated by light from the light source that has reflected off the sensing surface when a reference fluid is present in the container supported by the support member, the reference fluid having a known reference density;
identify a fluid pixel pattern of second pixels of the light sensor illuminated by light from the light source that has reflected off the sensing surface when the fluid sample is present in the container;
identify a pixel shift distance along the light sensor from the calibration pixel pattern to the fluid pixel pattern; and
determine the content of the target substance in the fluid sample based on the pixel shift distance.
24. The system of claim 23, wherein the target substance is plasma free hemoglobin (claim 8, 9).
25. The system of claim 23, wherein the target substance is a target anticoagulant (claim 9).
26. The system of claim 23, wherein the target substance is a target saline (claim 9).
27. The system of claim 23, wherein the fluid sample is whole blood (claim 8).
28. The system of claim 23, wherein the fluid sample is a blood component (claim 8, 9).
29. The system of claim 23, wherein the fluid sample is blood plasma (claim 8, 9).
30. The system of claim 23, wherein the target substance is plasma free hemoglobin and the fluid sample is whole blood or a blood component (claim 8, 9).
31. The system of claim 23, wherein the target substance is a target anticoagulant and the fluid sample is whole blood or a blood component (claim 8, 9).
32. The system of claim 23, wherein the target substance is a target saline and the fluid sample is whole blood or a blood component (claim 8, 9).
33. The system of claim 23, wherein the reference fluid is a reference anticoagulant (claim 5).
34. The system of claim 23, wherein the reference fluid is a reference saline (claim 5).
35. The system of claim 23, wherein the controller is further configured to determine the content of the target substance in the fluid sample based on the known reference density of the reference fluid, wavelength of light generated by the light source, resolution of the light sensor, and optical properties of the prism (these are inherent properties that affect the images and "based on" does not limit how the determination is based on the recited properties).
36. The system of claim 23, wherein the light source, the light sensor, and the prism are on an upper side of the container such that gravity draws red blood cells of the fluid sample away from the sensing surface (claim 11).
37. The system of claim 23, further comprising an apheresis machine; wherein the controller is configured to activate the apheresis machine to separate plasma from the fluid sample when the target substance is plasma free hemoglobin and the content of the plasma free hemoglobin is below a first predetermined limit (claim 13).
38. The system of claim 37, wherein the controller is further configured to operate the apheresis machine to not return the fluid sample to a location from which the fluid sample originated when determination of the plasma free hemoglobin content is above a second predetermined limit that is higher than the first predetermined limit (claim 16; note that the claim only requires the controller to have the ability to stop the machine, not determine when to stop/return the fluid sample).
38. The system of claim 37, wherein the controller is further configured to operate the apheresis machine to not return the fluid sample to a location from which the fluid sample originated when determination of the plasma free hemoglobin content is above a second predetermined limit that is higher than the first predetermined limit (claim 16; note that the claim only requires the controller to have the ability to stop the machine, not determine when to stop).
39. The system of claim 23, further comprising an apheresis machine; wherein the controller is configured to operate the apheresis machine to not return the fluid sample to a location from which the fluid sample originated when the content of the target substance is above a predetermined limit (claim 16; note that the claim only requires the controller to have the ability to stop the machine, not determine when to stop).
40. The system of claim 23, further comprising an apheresis machine operated by the controller; wherein the controller is configured to stop the apheresis machine when content of the target substance is above a predetermined limit, the target substance is one of a target anticoagulant and a target saline (claims 7-9; note that the claim only requires the controller to have the ability to stop the machine, not determine when to stop).
41. An apheresis system comprising:
an apheresis machine configured to separate plasma from a fluid sample (claim 15, first clause);
a refractometer configured to measure content of a target substance in the fluid sample, the refractometer including (claim 15, second clause):
a light source;
a light sensor;
a cuvette including a prism with a sensing surface; and
a support member configured to hold the cuvette relative to the light source and the light sensor such that light generated by the light source reflects off the sensing surface to the light sensor; and
a controller configured to (claim 15, seventh clause):
calibrate the refractometer by identifying a calibration pixel pattern of first pixels of the light sensor illuminated by light from the light source that has reflected off the sensing surface while a reference fluid is present in the cuvette supported by the support member, the reference fluid having a known reference density;
identify a fluid pixel pattern of second pixels of the light sensor illuminated by light from the light source that has reflected off the sensing surface while the fluid sample is present in the cuvette;
identify a pixel shift distance along the light sensor from the calibration pixel pattern to the fluid pixel pattern;
determine content of the target substance in the fluid sample based on the pixel shift distance; and
activate the apheresis machine to separate plasma from the fluid sample when the determined content of the target substance in the fluid sample is below a first predetermined limit.
42. The apheresis system of claim 41, wherein the controller is further configured to operate the apheresis machine to not return the fluid sample to a location from which the fluid sample originated when the determined content of the target substance in the fluid sample is above a second predetermined limit that is higher than the first predetermined limit (claim 16; note that the claim only requires the controller to have the ability to stop the machine, not determine when to stop/return the fluid sample).
43. The apheresis system of claim 41, wherein the controller is configured to stop the apheresis machine when content of the target substance is above a predetermined limit, the target substance is one of a target anticoagulant and a target saline (claims 7-9 where the function of the controller flows from the steps of method claims 7-9. The same applies to the dependent claims below; note that the claim only requires the controller to have the ability to stop the machine, not determine when to stop).
44. The apheresis system of claim 41, wherein the target substance is plasma free hemoglobin (claim 9).
45. The apheresis system of claim 41, wherein the target substance is a target anticoagulant (claim 9).
46. The apheresis system of claim 41, wherein the target substance is a target saline (claim 9).
47. The apheresis system of claim 41, wherein the fluid sample is whole blood (claim 8).
48. The apheresis system of claim 41, wherein the fluid sample is a blood component (claim 9).
49. The apheresis system of claim 41, wherein the fluid sample is blood plasma (claim 9).
50. The apheresis system of claim 41, wherein the target substance is plasma free hemoglobin and the fluid sample is whole blood or a blood component (claim 9).
51. The apheresis system of claim 41, wherein the target substance is a target anticoagulant and the fluid sample is whole blood or a blood component (claim 8).
52. The apheresis system of claim 41, wherein the target substance is a target saline and the fluid sample is whole blood or a blood component (claim 8).
53. The apheresis system of claim 41, wherein the reference fluid is a reference anticoagulant (claim 5).
54. The apheresis system of claim 41, wherein the reference fluid is a reference saline (claim 5).
Conclusion
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/Hwa Andrew Lee/Primary Examiner, Art Unit 2877
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