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 .
Election/Restriction
Applicant’s election without traverse of Group I, Claims 1-18 in the reply filed on 09 July 2026 is acknowledged. Claims 1-18 are examined on their merits and claims 19-29 are withdrawn from further consideration.
Drawings
The drawings are objected to because in Fig. 5, element “2215” should be revised as “2115” to indicate second coupling 2115 (¶ [0086], In each instance, the buffer bag 2110 may include a second port or opening 2113 and optionally a second coupling 2115 that may be couplable to the apheresis device 100 (for example, via one or more other tube lengths 2252, 2254, 2256) so as to be able to return the modified fluid (e.g., plasma) to the donor or the subject or the patient or the source).
In Fig. 4, second coupling 2115 is properly labeled.
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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 5, 7, 8, 13, 15 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because they do not describe the physical structure, composition or function of the medical system.
Claim 5 calls for “… wherein the first and second tubes are provided as a connectivity set.” This claim does not appear to recite any structural or functional limitation, and instead designates the first and second tubes in a group. This claim appears to describe a strictly mental activity or change in perception.
Claim 7 calls for “… wherein the first, second, and third tubes are provided as a connectivity set.”
Claim 8 calls for “… wherein the second and the third tubes are provided as a connectivity set.”
Claim 13 calls for “… wherein the first flow path and the second flow path are provided as a connectivity set.”
Claim 15 calls for “…wherein the first, second, and third flow paths are provided as a connectivity set.”
Claim 16 calls for “…wherein the second and the third flow paths are provided as a connectivity set.”
Here also, the claims appear to describe a strictly mental activity or change in perception that does not represent a physical structure, composition or function.
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.
Claims 1-10 and 13-16 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.
Claim 1 calls for “…and to return the isolated at least one of the two or more components to the separation device.” The specification describes a system that moves separated components to a post-processing unit (¶ [0081], During use, line 234 of the (first) tubing and bag set 201 may be closed (for example, using one or more valves or clamps) to divert plasma … where the tubing and bag set 2100, as further detailed below, directs the collected plasma … to a post-processing unit).
However, the specification does not describe a system that returns one of the components to the separation device. Instead, the system conducts components from the post-processing unit into a buffer bag and then to the patient (¶ [0081], The tubing and bag set 2100 in turn may be configured so that effluent from the post-processing unit is directed to a waste bag 2170 … or to a buffer or plasma bag 2110 so to be returned to the donor or the subject or the patient or the source. The buffer bag 2110 … assures that the modified or treated component (e.g., plasma) is always available to be returned to the donor or the subject or the patient or the source).
Another embodiment, labeled as prior art, describes a system including a separation device (¶ [0076] FIG. 3 is an illustration of an example disposable set 300 for use in or with apheresis systems).
This prior art embodiment separates material into multiple components (¶ [0077], the disposable set 300 may be used in a centrifuge that rotates processing vessel 304, and as a result of centrifugal forces, separates liquids into one or more components); and
then conducts the components through a post-processing unit (¶ [0079], Components initially separated in the processing vessel 304 may be further separated in the cell separation chamber 308. For example, white blood cells could be separated from plasma and platelets in the buffy coat using the cell separation chamber 308).
However, this prior art embodiment does not return components from the post-processing unit to the separation device, but instead passes the components from the post-processing unit and away from the separation device, towards an outlet (¶ [0079], Plasma and platelets may flow out of the cell separation chamber 308 through outlet 340).
Therefore, claim 1 contradicts the specification and lacks enablement.
Claim 3 calls for “…to return the isolated at least one of the two or more components to the separation device.”
Claim 4 calls for “…to return the isolated at least one of the two or more components to the separation device.”
Claim 12 calls for “…to return the isolated at least one of the two or more components to the separation device.”
These claims likewise contradict the specification, which describes a system that does not return components from a post-processing unit to a separation device, but instead returns components from a post-processing unit to the donor or patient.
Claims 2-10 and 13-16 are rejected for depending on a rejected parent claim.
Claim Interpretation - 35 USC § 112(f)
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.
In claims 1, 11 and 19, the limitations “separation device” and “post-processing unit” have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because they use a generic placeholder “device” or “unit” coupled with functional language without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claims 1, 11 and 19 have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
Claim(s) and
Generic placeholder
Functional language
1, 11, 19
separation device
separation device configured to separate a material received from a source into two or more components
1, 11, 19
post-processing unit
post-processing unit in fluid communication with the separation device and configured to isolate at least one of the two or more components
In claims 9, 10, 17 and 18, the limitation “post-processing unit” has not been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it recites sufficient structure to achieve the function.
Claim(s), generic placeholder and function
Sufficient structure
9, 17
wherein the post-processing unit includes a column.
wherein the post-processing unit includes a column.
10, 18
wherein the post-processing unit includes a filter.
wherein the post-processing unit includes a filter.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 102
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 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 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) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(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; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9 and 11-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Foley; John T. et al. (US 20140291248 A1).
Regarding claim 1, Foley discloses a medical system (¶ [0002], [0010], [0034] FIG. 2 illustrates a disposable flow circuit 12 that may be used in combination with the centrifuge system 10 of FIG. 1 to provide a blood separation system; ¶ [0089] The adsorption device may be variously connected to the blood separation system, such as in what may be referred to a "passive" blood treatment system (FIG. 16) or in what may be referred to as an "active" blood treatment system (FIG. 17));
comprising: a separation device configured to separate a material received from a source into two or more components (¶ [0037], The blood separation chamber 34 separates the blood into its constituent parts; ¶ [0065] As described above, the centrifuge 52 rotates the blood separation chamber 34, thereby centrifugally separating whole blood received from a blood source into component parts, e.g., red blood cells, plasma, and buffy coat comprising platelets and leukocytes);
a post-processing unit in fluid communication with the separation device and configured to isolate at least one of the two or more components (¶ [0091] In a passive system … the mating parts are connected to the adsorption device 170 to fluidly connect the adsorption device or column 170 inline with the downstream and upstream portions of the tubing 42, as shown in FIG. 16; ¶ [0093] The adsorption device 170 receives the separated plasma from the blood separation system and processes it to remove undesirable substances by adsorption; ¶ [0102] In contrast to the adsorption device 170 of FIG. 16, the adsorption device 172 of FIG. 17 includes more than an adsorption column. In the illustrated embodiment, the adsorption device 172 of FIG. 17 includes a component 174 for removing undesirable substances from plasma (typically provided as an adsorption column)); and
a controller configured to manage operation of the separation device (¶ [0064], The sensed pressures are transmitted to a controller of the centrifuge system 10 as part of its overall system monitoring function; ¶ [0077] The interface controller includes a viewing head 156 carried on the yoke 58 (see FIGS. 3 and 13); ¶ [0089], In an active system, the adsorption device 172 includes … a controller 178; ¶ [0102], The controller 178 may be variously provided, but is typically provided as a computer which monitors the various components of the adsorption device 172);
to separate the material received from the source into the two or more components (¶ [0114] During the "build-up" stage (and whenever the controller of the centrifuge system 10 has set or reset the plasma pump flow rate), the controller checks whether the weight of the pre-adsorption reservoir 44 is within a predetermined range, as represented by the top diamond of FIG. 18);
to cause the two or more components to move to the post-processing unit, and to return the isolated at least one of the two or more components to the patient (¶ [0107], The processed plasma may then be returned to the blood source from the post-adsorption reservoir 184 by operation of one or more return or RF ("return fluid") pumps of the centrifuge system 10. In the embodiment of FIG. 17, the lower pump 92 associated with the middle cassette 16a serves as the sole RF pump; ¶ [0126], When the reservoir 184 reaches a threshold weight, the RF pump(s) may begin operating at a RF pump flow rate Qrf).
Foley does not disclose that the components return to the separation device. However, this feature is rejected under 112(a) for contradicting the specification as discussed above.
Regarding claim 11, Foley discloses a therapeutic system (¶ [0002], [0010], [0034] FIG. 2 illustrates a disposable flow circuit 12 that may be used in combination with the centrifuge system 10 of FIG. 1 to provide a blood separation system; ¶ [0089] The adsorption device may be variously connected to the blood separation system, such as in what may be referred to a "passive" blood treatment system (FIG. 16) or in what may be referred to as an "active" blood treatment system (FIG. 17));
comprising: a flow path (¶ [0034], The flow circuit 12 includes a variety of tubing and a number of components; ¶ [0037], The left cassette 16 also includes tubing 32 … cellular blood components are returned to the middle cassette 16a … substantially cell-free plasma is returned to a right cassette 16b);
fluidically connecting a separation device (¶ [0037], The blood separation chamber 34 separates the blood into its constituent parts; ¶ [[0065] As described above, the centrifuge 52 rotates the blood separation chamber 34, thereby centrifugally separating whole blood received from a blood source into component parts, e.g., red blood cells, plasma, and buffy coat comprising platelets and leukocytes); and
a post-processing device (¶ [0091] In a passive system … the mating parts are connected to the adsorption device 170 to fluidly connect the adsorption device or column 170 inline with the downstream and upstream portions of the tubing 42, as shown in FIG. 16; ¶ [0093] The adsorption device 170 receives the separated plasma from the blood separation system and processes it to remove undesirable substances by adsorption; ¶ [0102] In contrast to the adsorption device 170 of FIG. 16, the adsorption device 172 of FIG. 17 includes more than an adsorption column. In the illustrated embodiment, the adsorption device 172 of FIG. 17 includes a component 174 for removing undesirable substances from plasma (typically provided as an adsorption column));
the separation device configured to separate a material received from a source into two or more components (¶ [0037], The blood separation chamber 34 separates the blood into its constituent parts; ¶ [0065] As described above, the centrifuge 52 rotates the blood separation chamber 34, thereby centrifugally separating whole blood received from a blood source into component parts, e.g., red blood cells, plasma, and buffy coat comprising platelets and leukocytes); and
the post-processing device configured to isolate at least one of the two or more components (¶ [0091] In a passive system … the mating parts are connected to the adsorption device 170 to fluidly connect the adsorption device or column 170 inline with the downstream and upstream portions of the tubing 42, as shown in FIG. 16; ¶ [0093] The adsorption device 170 receives the separated plasma from the blood separation system and processes it to remove undesirable substances by adsorption; ¶ [0102], the adsorption device 172 of FIG. 17 includes a component 174 for removing undesirable substances from plasma (typically provided as an adsorption column)).
Regarding claims 2-4, 6, 9, 14 and 17, Foley discloses a medical system wherein the medical system further includes: a tube establishing the fluid communication between the separation device and the post-processing unit (¶ [0037], while substantially cell-free plasma is returned to a right cassette 16b of the flow circuit 12 from the blood separation chamber 34 via tubing 38 … The plasma may be pumped back to the left cassette 16 via tubing 42 for return to the blood source and/or it may be pumped into a container 44 via different tubing 46);
wherein the fluid communication between the separation device and the post-processing unit is a first fluid communication between the separation device and the post-processing unit (¶ [0037], while substantially cell-free plasma is returned to a right cassette 16b of the flow circuit 12 from the blood separation chamber 34 via tubing 38 … The plasma may be pumped back to the left cassette 16 via tubing 42 for return to the blood source and/or it may be pumped into a container 44 via different tubing 46); and
the medical system further includes: a second fluid communication between the post-processing unit and the separation device to return the isolated at least one of the two or more components to the patient (¶ [0035] The illustrated flow circuit 12 is a "two needle" system, which includes a pair of blood source access devices 14 and 14a (e.g., phlebotomy needles); ¶ [0036] The other blood source access device 14a is used to deliver or return blood, a blood component, and/or some other replacement fluid to the blood source);
wherein the tube is a first tube (¶ [0037], cell-free plasma is returned to a right cassette 16b … via tubing 38 … return to the blood source and/or it may be pumped into a container 44 via different tubing 46); and
the medical system further includes: a second tube establishing the second fluid communication between the post-processing unit and the separation device to return the isolated at least one of the two or more components to the separation device (Figs. 17-18 show multiple tubes interconnecting each of left cassette 16, middle cassette 16a and right cassette 16b to each other and to the blood separation chamber 34; ¶ [0101] The adsorption device 172 is provided with connectors 186 which are suitable for fluidly associating the adsorption device 172 with the flow circuit 12);
wherein the medical system further includes: a third tube or flow path establishing fluid communication between the separation device and the source (Figs. 17-18 show multiple tubes interconnecting each of left cassette 16, middle cassette 16a and right cassette 16b to each other, to blood separation chamber 34 and to access devices 14 and 14a);
wherein the post-processing unit includes a column (¶ [0089], In an active system, the adsorption device 172 includes a variety of components, including an adsorption column 174 (or the like) for removing undesirable substances).
Regarding claim 12, Foley discloses a therapeutic system wherein the flow path is a first flow path (¶ [0037], while substantially cell-free plasma is returned to a right cassette 16b of the flow circuit 12 from the blood separation chamber 34 via tubing 38 … The plasma may be pumped back to the left cassette 16 via tubing 42 for return to the blood source and/or it may be pumped into a container 44 via different tubing 46); and
the therapeutic system further includes: a second flow path fluidically connecting the separation device and the post-processing device to return the isolated at least one of the two or more components to the separation device (Figs. 17-18 show multiple tubes interconnecting each of left cassette 16, middle cassette 16a and right cassette 16b to each other and to the blood separation chamber 34; ¶ [0101] The adsorption device 172 is provided with connectors 186 which are suitable for fluidly associating the adsorption device 172 with the flow circuit 12).
Regarding claims 5, 7, 8, 13, 15 and 16, Foley discloses first, second and third tubes or flow paths as discussed above. These claims are rejected under 112(d) for describing purely mental activities and failing to describe physical structures or functions, as discussed above. Foley’s tubes and fluid passages can be reclassified or reassigned to any combination of groups, sets or assemblies.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Foley; John T. et al. (US 20140291248 A1) in view of Lynn, Daniel et al. (US 20010037078 A1).
Regarding claims 10 and 18, Foley does not explicitly disclose a filter. Lynn discloses systems and methods for harvesting plasma (¶ [0002], [0006], [0026] The FIGS. 1 to 13 show various categories of blood collection and storage systems 10); comprising
a separation device (¶ [0027], In use, the transfer container 14 receives a targeted blood component separated during centrifugation in the blood processing container 12); and
a post-processing unit, wherein the post-processing unit includes a filter (¶ [0034], the leukocytes are removed by adsorption using a leukocyte-reduction filter 16 containing a fibrous filtration medium; ¶ [0035] In the illustrated embodiment, the cell-free plasma is obtained by exclusion using a finishing filter 18 that contains a membrane filtration medium; ¶ [0052] As shown in FIG. 3, the finishing filter 18 can be located in transfer tubing 28 in a downstream flow direction; ¶ [0062], The transfer tubing 28 carries an in-line finishing filter 18; ¶ [0063], The transfer tubing 48 carries an in-line leukocyte-reduction filter 16).
Lynn removes red blood cells or leukocytes from a plasma volume in order to comply with storage guidelines (¶ [0005] It is also believed beneficial that plasma used for transfusion or fractionation be as free as possible of cellular blood species, such as leukocytes, red blood cells, platelets). One would be motivated to modify Foley with Lynn’s filter since Foley suggests to incorporate other devices in a post-processing unit (¶ [0087], Methods of selecting a ligand and preparing and using an adsorption device are described in U.S. Pat. No. 5,277,701 to Christie et al., which is incorporated herein by reference; ¶ [0089], In a passive system, the adsorption device consists solely of an adsorption column (or the like) for removing undesirable substances from separated plasma by adsorption). Lynn’s filter removes other undesirable substances, namely RBC’s or leukocytes, from blood by size exclusion. A skilled artisan would have been able to modify Foley with Lynn’s filter by exchanging or supplementing Foley’s column with Lynn’s filter. Therefore, it would have been obvious to modify Foley with Lynn’s filter in order to remove further undesired RBC’s or leukocytes from plasma.
Double Patenting
Igarashi; Masatsugu (US 11752243 B2, US RE50824 E) is relevant to the claimed invention, and claims a medical system comprising: a separation device (claim 13, A biological component sampling system comprising: a separation device configured to separate a biological component from liquid containing at least one biological component);
a controller (claim 15, a control section configured to control the return pump).
However, Igarashi does not claim a post-processing unit or a controller configured to manage operation of the separation device. Therefore, Igarashi is not cited in a double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Corbin, Frank III et al. US 20030173274 A1
Holmes, Brian M. et al. US 20040104182 A1
Min; Kyungyoon et al. US 20090211962 A1
Ragusa; Michael et al. US 20140039373 A1
Abedin; Tanima Jahan et al. US 20160051744 A1
Wenthold; Randy US 20200222615 A1
Kusters; Benjamin E. et al. US 20220409799 A1
Sheriff; Ahmed et al. US 20230090960 A1
Surkov; Kirill et al. US 20230201439 A1
Kusters; Benjamin E. et al. US 20240226396 A1
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application is assigned is 571-273-8300.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights