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 amendments to the claims filed on 08/14/2025 in which claims 1-3, 6-9, and 11-18 were cancelled and claims 19-33 were added, claims 19-33 are pending in the instant application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/06/2025 has been entered.
Priority
The instant application claims priority to U.S. Provisional Application no. 62/908,326 filed on 09/30/2019.
Priority is given for all claims to the filing date of the provisional application, 09/30/2019.
Election/Restrictions
Newly submitted claims 26-33 are directed to an invention that is independent or distinct from the elected invention for the following reasons: these claims are directed towards a method for rapidly collecting accumulated blood from a subject.
Claims 26-33 are therefore withdrawn, and claims 19-25 are examined on the merits herein.
Response to Affidavit
The affidavit under 37 CFR 1.132 filed 08/06/2025 is insufficient to overcome the rejection of claims 1-3, 6-7, and 15-18 based upon the 35 U.S.C. 103 rejections as set forth in the last Office action because: the affidavit fails to set forth facts showing unexpected results. It should be noted that the applicant has since cancelled claims 1-3, 6-7, and 15-18, and the examiner is responding to the affidavit in view of the newly added claims 19-25.
In the showing of unexpected results, the examiner respectfully notes that there is a problem of relevance of the result to the currently claimed invention. It is unclear from the study cited in the Corrales Declaration filed 08/06/2025 what part of the invention as claimed in the newly added claims is the cause of the improved speed. Thus, there is no showing that the objective evidence of nonobviousness is commensurate in scope with the claims as further discussed below. As stated in MPEP §716.01(b), “To be given substantial weight in the determination of obviousness or nonobviousness, evidence of secondary considerations must be relevant to the subject matter as claimed, and therefore the examiner must determine whether there is a nexus between the merits of the claimed invention and the evidence of secondary considerations”. While the Corrales Declaration discloses a single experiment wherein a fluid flowed through their blood container faster than through a Fresenius Kabi Fenwal Transfer Pack® container, the Corrales Declaration does not provide any evidence suggesting why the speed increases with the use of their claimed invention. In other words, the Corrales Declaration does not provide evidence to the secondary considerations of an improved flow rate being a ‘direct result’ of the unique characteristics of the container. See MPEP §716.01(b), "To the contrary, the patent owner is still afforded an opportunity to prove nexus by showing that the evidence of secondary considerations is the 'direct result of the unique characteristics of the claimed invention.'" Id. at 1373-74 (quoting In re Huang, 100 F.3d 135, 140, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996))”.
From the previous Corrales Declaration filed 01/22/2025 and para. 3 of the current Corrales Declaration, it seems that the applicant is trying to show unexpected results in view of the diameter of the infusion and transfusion ports. As noted above, it is unclear what part of the invention as claimed in the newly added claims is the cause of the improved speed. The diameter of the ports is not claimed; therefore, there is no nexus between the Corrales Declarations and the newly added claims.
Further, in the showing of unexpected results, the burden on the applicant is to establish that their results are unexpected and significant in the form of direct or indirect comparison of the claimed invention with the closest prior art that is commensurate in scope with the claims, as explained in MPEP 716.02(b). The applicant’s affidavit seems to disclose that the unexpected results are the speed by which their autotransfusion device drains blood into and out of the apparatus (para. 0018). MPEP 716.02(d) states, “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).” Applicant is trying to show that an increased inner diameter of the infusion and transfusion ports causes an unexpected result; however, the applicant hasn’t compared any specific diameter with diameters inside and outside of the previously claimed range and has not even reported the diameter of the infusion and transfusion ports of the Fresenius container which they compared their invention against. The applicant has also reported only a single test done between the Fresenius container and their container, which is not considered a sufficient number of tests to determine a conclusion. The applicant’s specification also shows no criticality to the inner diameter of the infusion and transfusion ports as explained in the previous Office Action, allowing for inner diameters of 3-25 mm. The applicant’s affidavit has not met the burden for establishing unexpected results. Further, it is well-known that making a diameter of a tube larger would positively affect the flow rate of a fluid through the tube if all other variables are maintained. This can clearly be seen with Poiseuille’s equation for laminar flow of a fluid through a cylindrical tube:
Q
=
∆
P
π
r
4
8
η
L
wherein Q is flow rate, P is pressure, r is radius of the tube, η is viscosity of the fluid, and L is the length of the tube. If the radius of the tube is increased, the flow rate of the fluid increases; therefore, increased speed in view of increased diameter infusion and transfusion ports would not be considered unexpected.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Response to Arguments
Request for Rejoinder
Applicant’s request that the examiner not withdraw the restriction requirement at this time is noted.
Applicant’s request for rejoinder is not persuasive for at least the same reasons as disclosed in the Requirement for Restriction filed on 07/19/2022.
Claim Rejections under 35 U.S.C. 112(b)
The previous rejections under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims filed 08/14/2025.
Claim Rejections under 35 U.S.C. 103
Applicant's arguments filed 08/14/2025 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding claim 1, the applicant argues on pg. 12-15 against the examiner’s interpretations of Dyer in the previous Office Action filed 05/09/2025.
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding new claim 19, the applicant argues on pg. 28-36 that the prior art to Dyer, Poitras, Blake, Brookman, Ingram and Alam fail to disclose the newly added limitations in the newly added claim.
In response to the applicant’s argument, the examiner notes that none of the prior art were utilized in the previous Office Action filed 05/09/2025 to read on the newly added claim.
Regarding the Corrales Declaration filed 01/22/2025, the applicant argues against the examiner’s determination that the applicant has failed to show evidence of long-felt unmet need.
In response to the applicant’s argument, the examiner notes that the determination is maintained in view of the applicant’s arguments. MPEP 716.04 states, “Establishing long-felt need requires objective evidence that an art recognized problem existed in the art for a long period of time without solution. The relevance of long-felt need and the failure of others to the issue of obviousness depends on several factors. First, the need must have been a persistent one that was recognized by those of ordinary skill in the art…Second, the long-felt need must not have been satisfied by another before the invention by the inventor.. Third, the invention must in fact satisfy the long-felt need...Long-felt need is analyzed as of the date the problem is identified and articulated, and there is evidence of efforts to solve that problem, not as of the date of the most pertinent prior art references.” While the applicant has provided evidence of Atrium brand autotransfusion bags that seem to have expired in January 2020 and a general allegation that it appears that no more of these bags are being manufactured, this still does not meet the threshold for long-felt unmet need. The applicant further notes that Fresenius Kabi has on current offering a Continuous Autotransfusion system, seemingly showing that the need of an autotransfusion system in the market is currently being fulfilled.
The examiner previously argued in the Office Action filed 05/09/2025 that the mere fact that there was a commercially available autotransfusion bag indicates that the problem has been solved. The applicant asserts that since there has been no single container that does both collection and reinfusion equivalent to the Atrium 2450 bag since at least 2020, a more accurate assessment is that there was a solution that was discontinued and is no longer commercially available. As noted in the MPEP section above, long-felt need is analyzed as of the date the problem is identified and articulated, not as of the date of the most pertinent prior art references. The applicant has only provided evidence of long-felt need in the absence of the Atrium 2450 bag, and not in the absence of any solution for autotransfusion.
Regarding claim 19, applicant asserts on pg. 41-44 that the evidence of secondary considerations showing unexpected results show that the claims are patentable over the prior art.
In response to the applicant’s arguments, the examiner points to the response to affidavit above. The evidence of secondary considerations fail to outweigh the evidence of obviousness.
Claim Objections
Claims 19-20 and 22-23 are objected to because of the following informalities: The “sterile flexible blood container” is referred to throughout the claims as “the sterile blood container”, “the flexible blood container”, and “the blood container”. These references should be amended to be the same throughout the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 20 is 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.
Claim 20 recites the limitation “a. wherein spatial arrangement of a chest drainage device is configured to be at a lower height than the body cavity of the subject and the blood collection and autotransfusion container to be at a lower height than the chest drainage device in order to generate the gravitational force; and b. wherein spatial arrangement of the blood container is configured to be at a higher height than the subcutaneous transfusion site on the subject for transfusion of the blood through the transfusion member by the gravitational force.” in ln. 2-8. This limitation is indefinite in that it is unclear how or if the blood container is configured to be in said spatial arrangements at the same time. As this would be an impossibility, the examiner is treating the claim as though the spatial arrangements occur at different times during a procedure.
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.
Claims 19-21 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent no. 5,695,489 A to Japuntich in view of U.S. Patent no. 4,198,972 A to Herb.
Regarding claim 19, Japuntich discloses a device comprising a sterile flexible blood container oriented so that an infusion member comprising an infusion port is located on a top surface of the container and a transfusion member comprising a transfusion port is located on a bottom surface of the container (Fig. 1, device for reinfusion of patient’s blood 10 comprising flexible blood container 12 comprising inlet port 14 on the top surface and outlet ports 16 on the bottom surface; col. 3 ln. 42-47, filter material 30 is formed from sterilizable nylon, container 12 is formed from PVC which is sterilizable), the sterile flexible blood container configured for rapid collection of an accumulation of sterile whole blood and for rapid transfusion of the sterile whole blood to the subject in a sterile environment with minimal processing (col. 2 ln. 38-67 and col. 3 ln. 1-4; col. 3 ln. 45-60), the device comprising:
a drainage component comprising a first tube member comprising a first end and a second end, the first end of the first tube member configured for inflow of accumulated whole blood and the second end in fluid connection with the infusion port of the flexible blood container (Fig. 1, transfer tube 26 may be considered drainage component as a first tube member; col. 2 ln. 54-61);
the infusion port comprising an infusion passageway configured to channel blood flow from the infusion port into the sterile flexible blood container, wherein the inner compartment of the infusion port is contiguous with the interior of the flexible blood container (Fig. 1; col. 2 ln. 54-61);
wherein blood flow from the chest cavity into the flexible blood container comprises passage of the sterile accumulated whole blood through the first sterile tube member of the collection component into the infusion port located on the top surface of the flexible blood container, through the infusion passageway, and into the sterile interior of the flexible blood container (col. 2 ln. 54-61);
a transfusion component configured for rapid outflow of blood from the sterile blood container comprising a second tube member comprising a first end configured for fluid connection with a second end, the first end attached to and configured for fluid connection with the transfusion port of the sterile flexible blood container and the second end of the second tube member configured for fluid connection with a subcutaneous transfusion site configured for fluid connection with a blood vessel of the subject via an administration set (Fig. 1, output ports 54/56 may be considered transfusion components as second tube members; col. 2 ln. 62-67 and col. 3 ln. 1-4; col. 3 ln. 58-60);
the transfusion port comprising a transfusion passageway configured to channel blood flow from the transfusion port out of the sterile flexible blood container and into a blood vessel of the subject via the peripheral venous transfusion catheter or subcutaneous transfusion site, wherein the inner compartment of the transfusion port is contiguous with the interior of the flexible blood container (Fig. 1; col. 2 ln. 62-67 and col. 3 ln. 1-4);
wherein blood flow for transfusion comprises passage of the sterile whole blood from the interior compartment of the flexible blood container through the transfusion port located on the bottom surface of the sterile flexible blood container through the transfusion passageway into the second tube member and out of the sterile flexible blood container via the subcutaneous transfusion site into the blood vessel of the subject at high blood flow (col. 2 ln. 62-67 and col. 3 ln. 1-4; col. 3 ln. 58-60).
Japuntich differs from the instantly claimed invention in that Japuntich fails to disclose wherein the drainage component is sealed to occlude fluid communication in or out of the infusion port until unsealed and comprising a first penetrable sterile member and wherein the transfusion component is sealed to occlude fluid communication in or out of the transfusion port until unsealed and comprising a second sterile member.
Herb teaches a blood bag comprising sealable input and output components each comprising sterile tube members to ensure complete sterilization and seal of the tubes as well as decreased risk of germs falling into the ports before or during use and the input sterile tube comprising a secondary penetrable seal to prevent back-flow of material through the tube (Fig. 1, sealable sheets 13/13’ surrounding input tube 17 and output tube 18; Fig. 1, input tube 17 comprising puncturable membrane 22; col. 3 ln. 67-68 and col. 4 ln. 1-5; col. 4 ln. 54-60).
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 system of Japuntich with the sealable components and penetrable membranes of Herb, because Herb teaches that their sealable components ensure complete sterilization of the input and output tubes and that the penetrable seal of the input tube prevents back-flow (col. 3 ln. 67-68 and col. 4 ln. 1-5; col. 4 ln. 54-60).
The limitations of “configured for rapid collection of an accumulation of sterile whole blood in a chest cavity of a subject due to an injury under trauma conditions and for rapid transfusion of the sterile whole blood to the subject in a sterile environment with minimal processing” and “wherein blood flow for transfusion comprises passage of the sterile whole blood from the interior compartment of the flexible blood container through the transfusion port located on the bottom surface of the sterile flexible blood container through the transfusion passageway into the second tube member and out of the sterile flexible blood container via the subcutaneous transfusion site into the blood vessel of the subject at high blood flow by the gravitational force” are considered to be functional language (in view of the specific use cases claimed). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Japuntich discloses all the structure of the unsealed container as claimed, is further used in autotransfusion with an upstream container that may either drain patient’s blood or suction it (col. 2 ln. 38-67 and col. 3 ln. 1-4; col. 3 ln. 45-60), and does not provide any structure for connection of suction to the container (Fig. 1). As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning to collect and rapidly transfuse blood from a chest cavity of a subject under trauma conditions under gravitational force).
Further, regarding the limitation “wherein blood flow into the flexible blood container through the infusion port and out of the flexible blood container through the transfusion port of the flexible blood container to the blood vessel of the patient occurs within minutes of collection of the accumulated whole blood from the chest of the subject, with minimal damage to the living blood cells in the blood despite the high blood flow rate” as that the invention of Japuntich discloses substantially identical structure to the claimed prior art for performing the infusion and transfusion, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Regarding claim 20, the cited prior art suggests the invention of claim 19. Japuntich further discloses an upstream collection container that is connected to the blood container (col. 2 ln. 54-59).
The limitation of “a. wherein spatial arrangement of a chest drainage device is configured to be at a lower height than the body cavity of the subject and the blood collection and autotransfusion container to be at a lower height than the chest drainage device in order to generate the gravitational force; and b. wherein spatial arrangement of the blood container is configured to be at a higher height than the subcutaneous transfusion site on the subject for transfusion of the blood through the transfusion member by the gravitational force” is considered to be functional language (in view of the use case of the device as utilizing gravity to infuse and transfuse blood from the container). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Japuntich discloses all the structure of the unsealed container and further discloses an upstream device that may either drain a patient’s blood or suction it (col. 2 ln. 38-67 and col. 3 ln. 1-4; col. 3 ln. 45-60), and does not provide any structure for connection of suction to the container (Fig. 1). As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning to collect and rapidly transfuse blood from a chest cavity of a subject under gravitational force).
Regarding claim 21, the cited prior art suggests the invention of claim 19.
The limitation of “(i) wherein the injury comprises a blunt or sharp injury to the chest; (ii) wherein the injury comprising a hemothorax comprises collection of blood in the space between the chest wall and the lung (pleural cavity); and (iii) wherein the injury under trauma conditions comprise blood loss greater than 150 ml/min with hemodynamic instability” is considered to be functional language (in view of the specific use cases claimed). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Japuntich discloses all the structure of the unsealed container and further discloses an upstream device that may either drain a patient’s blood or suction it (col. 2 ln. 38-67 and col. 3 ln. 1-4; col. 3 ln. 45-60). As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning to collect and rapidly transfuse blood from an injury to the chest cavity of a subject under gravitational force).
Regarding claim 23, the cited prior art suggests the invention of claim 19. Japuntich further discloses wherein the sterile blood container is disposable (Fig. 1, container 12 fully capable of being disposed of by proper disposal procedures).
Regarding claims 24-25, the cited prior art suggests the invention of claim 19.
Regarding the limitation “[Claim 24] wherein the device reduces risk of transfusion complications including multiple transfusions of component blood products, and allogeneic blood transfusion…[Claim 25] wherein component blood products include a plasma blood product, a red blood cell product, a white blood cell product comprising granulocytes, a blood platelet product and a cryoprecipitate blood product” as that the invention of Japuntich discloses substantially identical structure to the claimed prior art for performing the infusion and transfusion, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Claims 22 are rejected under 35 U.S.C. 103 as being unpatentable over Japuntich and Herb as applied above, and further in view of U.S. Patent no. 2,848,995 A to Ryan.
Regarding claim 22, the cited prior art suggests the invention of claim 19; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein capacity of the sterile blood container device is at least one unit of blood.
Ryan teaches a blood container device comprising a capacity of 600 cc which is considered a preferable capacity in that it is greater than the volume of blood generally transfused in an ordinary transfusion (Fig. 9; col. 2 ln. 6-8).
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 container of the cited prior art to have a capacity of at least one unit of blood as taught by Ryan, because Ryan teaches that it is preferable to provide a capacity of the bag that is greater than the volume of blood generally transfused (col. 2 ln. 6-8).
Conclusion
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 on (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
5 March 2026