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 .
In light of the preliminary amendment filed 04/24/2025 in which claims 8 and 21-22 were amended and claims 9-18 and 24-30 were cancelled, claims 1-8 and 19-23 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a continuation of PCT/US2023/036332 filed 10/31/2023 which claims priority to U.S. Provisional App. no. 63/431,329 filed on 12/09/2022.
Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112(a) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. V. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/431,329, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed application does not provide support in the specification for the limitations of claims 1-8 and 19-23 in the instant application. Regarding independent claim 1, Application no. '329 does not provide support for the tortuous path filter. Claims 7-8 and 19-23 do not receive priority by depending upon a claim that does not receive priority.
Claims 1-8 and 19-23 receive priority to the prior-filed application ‘332, filed on 10/31/2023.
Claim Objections
Claim 22 is objected to because of the following informalities:
Claim 22 recites the limitation “wherein blood bag” in ln. 1. This should read “wherein the blood bag.”
Appropriate correction is required.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 4-7 are rejected 35 U.S.C. 103 as being unpatentable over US/2023/0293798 A1 to Lyden.
Regarding claim 1, Lyden discloses a tortuous path filter for filtering plasma (Fig. 1, filter device 1a; Fig. 3, screen 16 for use in filter 4a; para. 0174-0177; para. 0174, filter device 1a further includes a filter, such as one of the filters 4a-e; para. 0215; Applicant’s specification describes a tortuous path filter being made from a woven filter: para. 0050-0051), the filter comprising at least two layers of fibers, single-layer filters, or beads (para. 0176-0177; Fig. 3, screen 16 comprising two or more woven partial-layers for use in filter 4a), wherein the filter lacks or substantially lacks pores defining a lumen having a diameter larger than 100 microns along a straight path through the filter (para. 0177, filtering blood plasma requires filtering mesh 16 smaller in size than equal to or less than 15 microns, 2 microns, 1 micron, 0.2 micron, 0.1 micron, 1-100 nanometers).
Lyden differs from the instantly claimed invention in that Lyden fails to explicitly disclose the filter for filtering “reconstituted plasma”; however, this limitation is considered to be a preamble statement reciting intended use. As recited in MPEP 2111.02, “statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art.” As explained above, Lyden discloses all of the structure as claimed. Lyden further discloses that their invention can be used for filtering plasma (see para. 0215). Therefore, Lyden is structured to filter reconstituted plasma.
Regarding claim 4, the cited prior art suggests the invention of claim 1. Lyden further discloses wherein the filter is configured for attachment in a blood product collection or storage device (Fig. 30, filter device 1 attached in a blood product collection device; para. 0154; para. 0162).
Regarding claims 5-7, the cited prior art suggests the invention of claim 1. Lyden further discloses wherein the filter lacks or substantially lacks pores defining a lumen having a diameter larger than
(Claim 5) 50 microns along a straight path of the filter (para. 0177, filtering blood plasma requires filtering mesh smaller in size than equal to or less than 15 microns, 2 microns, 1 micron, 0.2 micron, 0.1 micron, 1-100 nanometers);
(Claim 6) 25 microns along a straight path of the filter (para. 0177, filtering blood plasma requires filtering mesh smaller in size than equal to or less than 15 microns, 2 microns, 1 micron, 0.2 micron, 0.1 micron, 1-100 nanometers);
(Claim 7) 10 microns along a straight path of the filter (para. 0177, filtering blood plasma requires filtering mesh smaller in size than equal to or less than 15 microns, 2 microns, 1 micron, 0.2 micron, 0.1 micron, 1-100 nanometers).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lyden as applied above, and further in view of US/2004/0242857 A to Nilsson.
Regarding claim 2, the cited prior art suggests the invention of claim 1. The cited prior art differs from the instantly claimed invention in that the cited prior art fails to disclose wherein said fibers, single-layer filters, or beads are coated with at least one blood group antigen.
Nilsson teaches a filter coated with at least one blood group antigen to prevent blood group incompatibility problems when the filtered blood is used in a donor transfusion (para. 0001; para. 0004-0007; para. 0019).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the fibers of Lyden to comprise at least one blood group antigen as taught by Nilsson, because Nilsson teaches that this prevents blood group incompatibility problems when the filtered blood is used in a donor transfusion (para. 0001; para. 0004-0007; para. 0019).
Claims 3 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Lyden as applied above, and further in view of U.S. Patent no. 11,975,274 B2 to Liu.
Regarding claim 3, the cited prior art suggests the invention of claim 1. The cited prior art differs from the instantly claimed invention in that the cited prior art fails to disclose wherein the reconstituted plasma is reconstituted from freeze dried plasma.
Liu teaches a method for producing transfusion-ready plasma comprising: reconstituting dried plasma to produce reconstituted plasma; and passing said reconstituted plasma through a filter to produce transfusion-ready plasma (Fig. 49; col. 19:21-20:11). Liu teaches that freeze dried plasma has applications in the military, mass-casualty events, and in the treatment of certain disorders (para. 0002-0003).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to use the filter of Lyden in the method of Liu, because Liu teaches that freeze dried plasma has applications in the military, mass-casualty events, and in the treatment of certain disorders (para. 0002-0003).
Regarding claim 23, the cited prior art suggests the invention of claim 1.
Lyden discloses a method for producing transfusion-ready plasma comprising: passing plasma through the tortuous path filter of claim 1 to produce transfusion-ready plasma (Fig. 30; para. 0162).
The cited prior art differs from the instantly claimed invention in that the cited prior art fails to disclose a method for producing transfusion-ready plasma comprising: reconstituting dried plasma to produce reconstituted plasma; and passing said reconstituted plasma through the tortuous path filter of claim 1 to produce transfusion-ready plasma.
Liu teaches a method for producing transfusion-ready plasma comprising: reconstituting dried plasma to produce reconstituted plasma; and passing said reconstituted plasma through a filter to produce transfusion-ready plasma (Fig. 49; col. 19:21-20:11). Liu teaches that freeze dried plasma has applications in the military, mass-casualty events, and in the treatment of certain disorders (para. 0002-0003).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to use the filter of Lyden in the method of Liu, because Liu teaches that freeze dried plasma has applications in the military, mass-casualty events, and in the treatment of certain disorders (para. 0002-0003).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lyden as applied above, and further in view of U.S. Patent 5,234,593 to Kuroki.
Regarding claim 8, the cited prior art suggests the invention of claim 1. The cited prior art differs from the instantly claimed invention in that the cited prior art fails to disclose wherein the straight path is less than about 10 centimeters in length, or is less than about 5 centimeters in length, or is less than about 1 centimeter in length, or is less than about 500 millimeters in length, or is less than about 100 millimeters in length, or less than about 1 millimeter in length, or is less than about 500 microns in length, or is less than about 100 microns in length, or is less than about 50 microns in length, or is less than about 10 microns in length.
Kuroki teaches a device for purification of platelets in leucocyte containing platelet rich plasma (Fig. 1, filter 1 comprising porous filter body 5; col. 5:29-52) comprising a thickness greater than 0.3 mm and less than 10.0 mm (col. 4:57-68). Kuroki teaches that the thickness must be greater than 0.3 mm to ensure that the filter will seize leucocytes and that the thickness must be less than 10 mm to ensure that the filtration layer does not have a depth so large as to add appreciably to the time required for the operation of the filter (col. 4:57-68). Kuroki further teaches that leucocytes induce fever and other similar secondary effects after the transfusion of platelets (col. 1:29-39), such that one of ordinary skill in the art would be motivated to remove leucocytes from platelet rich plasma in donor transfusion.
Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Lyden device to have a straight path length within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lyden by making the straight path length as claimed as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP 2144.05.
Further still, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lyden to have the straight path length as claimed since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” See MPEP 2144.04. It appears that applicant places no criticality on the range claimed, indicating simply that the straight path length is as claimed (Applicant’s specification: para. 00049).
Claim 19 is rejected 35 U.S.C. 103 as being unpatentable over US/2023/0293798 A1 to Lyden, as evidenced by NPL U (USP 788 Standard) and NPL V (ANSI/AAMI BF7 Standard).
Regarding claim 19, the cited prior art suggests the invention of claim 1.
Lyden differs from the instantly claimed invention in that Lyden fails to explicitly disclose wherein the filter meets a standard selected from the group consisting of a United States Pharmacopeia (USP) 788 standard and American National Standards Institute (ANSI)/ Association for the Advancement of Medical Instrumentation (AAMI) BF7 standard. These standards, as indicated by NPL U and NPL V, are drawn to ensuring that particulate matter is not infused to a patient, ensuring patient safety.
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to make the filter of Lyden meet the claimed established standards in order to ensure patient safety. The USP 788 standard (most recently revised in 2025) is for the determination of particulate matter in injections or infusions and the ANSI/AAMI BF7 standard (most recently revised in 2012) is for the safety and performance requirements of blood transfusion micro-filters.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Lyden as applied above, and further in view of U.S. Patent no. 5,871,459 to Muller.
Regarding claims 20-21, the cited prior art suggests the invention of claim 1.
Lyden further discloses a medical device comprising the tortuous path filter of claim 1, said filter in line with a first tubing to an inlet port and a second tubing to an outlet port, wherein said outlet port further comprising a needle for intravenous injection, and a blood bag (Fig. 30, filter 1 in line with tubing 7 to blood bag 95 and tubing 7 to 8b needle for intravenous injection; para. 0154; para. 0162).
The cited prior art differs from the instantly claimed invention in that the cited prior art fails to disclose
(Claim 20) wherein the inlet port comprises a spike; and
(Claim 21) wherein the blood bag comprising a port injectable with the spike of the tortuous path filter.
Muller teaches an apparatus for treating blood comprising a blood filter in line with a first tubing to an inlet port comprising a spike and a blood bag comprising a port injectable with the spike to ensure that the blood bag is sterile (Fig. 1, blood filter 26 in line with tubing comprising spike 7 insertable into rubber plug 4 as a port of blood bag 2; col. 2:33-41).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Lyden to comprise the spike and port injectable with the spike as taught by Muller, because Muller teaches that a spikeable port ensures that the blood bag is sterile (col. 2:33-41).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Lyden and Muller as applied above, and further in view of US/2023/0040306 A1 to Brebant.
Regarding claim 22, the cited prior art suggests the invention of claim 21. The cited prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the blood bag comprises a blood bag with an internal surface, said internal surface coated with one or more blood group antigens.
Brebant teaches a blood bag with an internal surface, said internal surface coating with one or more blood group antigens to make the blood compatible with patients of any blood type (Fig. 1, blood bag 2 with internal surface coating of particles 5 having an affinity for a target substance; para. 0002; para. 0020-0022; para. 0032; para. 0042-0043; para. 0056-0058; para. 0068-0070).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the blood bag of Lyden, as modified by Muller, to comprise a blood group antigen coating as taught by Brebant, because Brebant teaches that an internal coating with one or more blood group antigens makes the blood compatible with patients of any blood type for donor transfusion (para. 0020-0022).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent no. 4,453,927 A to Sinko discloses a microporous blood inline filter. U.S. Patent no. 4,056,476 A to Mouwen discloses a porous blood filter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 29 September 2026
