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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 08/03/2023.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 01/13/2026, 12/20/2023 and 08/03/2023 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
Election/Restrictions
Applicant’s election without traverse of Group I and the species of ACD-A as the anticoagulant in the reply filed on 04/24/2026 is acknowledged.
Claims 19-24, 27-28 and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/24/2026.
Claims 1-5, 10-13 and 17 are being examined on the merits.
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 3 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 3 recites “wherein the anticoagulant is selected from a group consisting of: ACD-A (Anticoagulant Citrate Dextrose, Solution A), EDTA (ethylenediaminetetraacetic Acid), EGTA (ethylene glycol tetraacetic acid), a citrate, Heparin and oxalate, and wherein said one or more coagulation agents or anti-anticoagulating agents are selected from: Kaolin, Ca2+ (e.g. in the form of calcium salts such as Calcium Gluconate), Mg2+, negatively charged phospholipid (PL) and protamine sulfate.”, and it is unclear how the claim is to be interpreted as currently written. The claim uses consisting of language for a group of components to be selected from for the anticoagulant and then recites another list of components which can be selected from for the coagulation agents or anticoagulation agents which renders the claim indefinite because how can the group of anticoagulants be opened to yet another group of components to be selected from when the first limitation restricts the list to the first group? Additionally, the parentheses and what is inside is confusing because it is unclear whether the limitations following the parentheses are part of the claimed invention or merely suggestive. Another issue with the claim at line 4, is the issue of proper antecedent basis. The claim recites “and wherein said one or more coagulation agents or anti-anti coagulation agents” and there is no option for more than one “one or more” of these components in the claim from which it is based. Also, is the term anti-anticoagulation a typo or does the applicant intended the limitation to be a double negative in the sense that the term refers only to a coagulation agent?
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alon Kushnir and Igal Kushnir (From IDS filed on 12/20/2023, WO2019150355).
Regarding claims 1-2, Kushnir discloses “ A wound dressing assembly, comprising a clotting mold device comprising a cavity defined by concave walls surrounded by lips configured for attachment to skin in a fluid tight manner, and a device for introducing blood into the cavity after it is fixed over a wound to permit the blood to clot over the wound within said cavity (see claim 22) and discloses adding a blood-coagulation initiator (see claim 24).
Kushnir discloses “the blood clot that is formed and used according to this disclosure is typically formed from blood of the same subject whose wound is to be dressed by the teaching of this disclosure, withdrawn from the subject in any manner acceptable in medical practice for blood withdrawal” (see 2nd para. of General Description). This would teach i) withdrawing whole blood from a subject, ii) mixing with a coagulation agent, iii) prior to complete coagulation of the blood, introducing the blood with the coagulation agent into the hollowed space and iv) permitting the blood to coagulate in the hollowed space.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1-2, 4-5 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Antoine Turzi (CN105998067A).
Regarding claims 1-2 and 4-5, Turzi teaches the invention provides an autologous wound restoration composition for tissue repairing of hemorrhaging (see last line of page 4 or abstract) and teaches wherein whole blood from the same patient (see 2nd para., page 5) is collected in a container of anticoagulant and then centrifuged (see claim 1). Here Turzi teaches that the composition is intended for treatment of a fistula closer (see page 29, 4th para. from bottom), wounds that are fistulas and lacerated wounds, and to act as tissue and wound sealants (see page 10, last para. or page 4, 2nd para.). Turzi teaches the composition to be mixed before being applied to the wound (see example 2, last para. page 45, see example 5, 2nd para. page 47).
Turzi teaches “In one aspect, the present invention provides a method for preparing a completely autologous in situ wound repair agent or tissue repair agent composition. All the blood components of the autologous wound repairing agent or tissue repairing agent composition come from a single patient (the same patient) who is about to apply the autologous wound repairing agent or tissue repairing agent” (see summary of the invention, para. 2).
Turzi also teaches “the formation of grumeleuse (clumping- presumably meaning coagulation) is a multi-step process or chain of events, and the most several steps need to use calcium ion. By removing the calcium ion in whole blood, as gathered the effect of blood in citrate, it is possible to prevent blood to form solidifying block. Calcium chelating agent is the chemicals that a kind of and in blood calcium reacts, so that calcium is inoperative in coagulation process. The most normal chelating agent be citrate because it is minimum to the side effect of blood coagulation system component. By blood collection to containing calcium in the medium of chelating agent, such as citrate, can carry out sampling and the sample containing citrate being entered in the most several hours row preparation further. Preferably calcium chelating agent is sodium citrate” (see after step C) page 15).
In another aspect, the present invention provides an isolated platelet concentrate composition comprising: a) plasma; b) Platelets with a concentration of at least 300X109 cells/liter; c) White blood cells with a concentration of at least 7X109 cells/liter; d) Fibrinogen with a concentration of at least 3mg/L; and red blood cells with a concentration below 0.6X1012 cells/L. (here this would indicate “whole blood” although enriched in platelets) which can be introduced into/at the wound (see bottom of page 15, middle of page 18, page 22, page 25-26 etc.).
Turzi teaches using anticoagulant acid-citrate-dextrose (see last para. page 42).
Regarding claim 10, Turzi teaches wherein the composition can be the viscous kind which can be applied through injection (see 3rd to last para. of page 4, 4th para. page 16, 7th para. page 21, after part F) page 22, para. 6 page 29, etc.).
Regarding claim 11, Turzi teaches that the composition can promote skin regeneration (see 1st para. page 31) and to be applied to wounds of skin (see last para. example 2, page 45, see example 4 page 47) and to experimenter or skin (see page 56, claim 22). These would indicate external surfaces of the body.
Regarding claim 12, Turzi teaches wherein the composition can be applied for anal incontinence and for gastrointestinal and plastic surgery (see 1st para. page 29) and for the treatment of fistula closure (as done by bicycle rider) (see 4th to last para. page 29).
Turzi does not specifically describe that prior to complete coagulation of the blood, introducing the blood with the coagulation agent into said hollowed space; However Turzi teaches that calcium chelating agent is the chemical that reacts with blood, so that calcium is inoperative in coagulation process. The most normal chelating agent is citrate because it has minimum side effects of blood coagulation systems. By collecting blood containing calcium in the medium and chelating agent, such as citrate, sampling can be carried out for several hours before coagulation can occur in the body.
Therefore it is obvious to persons having ordinary skill in the art to mix the whole blood with the anticoagulation agents and to then administer the composition prior to complete coagulation. Also if one were to administer after complete coagulation the method would not presume to operate efficiently as there would no longer be expected excretion of fibrinogen activators and cytokines from platelets. It is also obvious to administer the method comprising applying a seal as the composition is taught to act as a seal for wounds. Applying the composition/method to anal fistulas is also an obvious limitation as Truzi teaches applying the method/composition to treat fistulas and for controlling anal incontinence the nexus for treating an anal fistula would have been prima facie obvious as the composition is already known for treating fistulas.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Antoine Turzi (CN105998067A) as applied to claims 1-2, 4-5 and 10-12 above, and further in view of Zimmer Bionet (https://www.zimmerbiomet.com/content/dam/zb-corporate/en/products/products/pharmaceuticals/acd-a-anticoagulant-citrate-dextrose-solution-solution-a/ACD-A-FL9350-0120.pdf) hereinafter Zimmer.
Truzi teaches the instant method steps however is silent on the anticoagulant being ACD-A.
Zimmer teaches that “Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P. (ACD-A), is intended for use as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP)’ (see page 1).
Turzi teaches that the wound restoration agent preparation method of composition that Figure 16 show containing hyaluronic acid and platelet rich plasma (PRP) (see bottom of page 16 and top page 17) and “on the other hand, the present invention provides a kind of containing hyaluronic acid with the pipe of PRP. On the other hand, the present invention provides one Plant the pipe selecting colloid containing hyaluronic acid, PRP and cell” (see page 17, 6th para. from bottom).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to use ACD-A as discussed by Zimmer, because it is a known anticoagulant to be used in the extracorporeal blood processing with Autologous PRP Systems and Truzi indeed teaches of extracorporeal blood processing with Autologous PRP Systems.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Antoine Turzi (CN105998067A) as applied to claims 1-2, 4-5 and 10-12 above, and further in view of Andre Hood III (JP H11-502435-A).
Truzi teaches the instant method steps however is silent on the method being useful for sinuses.
Hood teaches of “plasma-buffy coat concentrates containing plasma, platelets at a concentration of 1.0 × 10 9 cells / ml and fibrinogen at a concentration of 5 mg / ml or more are described. The plasma-buffy coat concentrate can be combined with a fibrinogen activator to form a platelet glue wound sealant” (see abstract). Hood teaches “when the wound sealing material of the present invention is applied to the sinus fossa after endoscopic sinus surgery In this case, it was found that the regeneration of the mucous membrane was faster and more uniform than the conventional treatment method” (see middle of page 5).
Therefore it would have been obvious to persons having ordinary skill in the art to administer the composition taught by Hood along with the composition taught by Truzi or in the alternative optimize the platelets and fibrinogen components of Truzi’s composition to be in the concentration taught by Hood, for being able to be applied to a sinus and for successful regeneration.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Antoine Turzi (CN105998067A) as applied to claims 1-2, 4-5 and 10-12 above, and further in view of Mussivand Tofy and Gill Inderjit (JP H10-127772A).
Truzi teaches the instant method steps however is silent on the method comprising the step of bringing an inflatable/deflatable element in its deflated state adjacent to one of the openings and inflating it to seal the opening to thereby allow maintaining of the blood in the hollowed space when it is introduced thereto via a non-sealed opening and deflating the inflatable/deflatable element following sufficient coagulation of the blood within the hollowed space and retrieving the inflatable/deflatable element, prior to step iii).
Tofy teaches of catheters for closing blood flow (see abstract) and teaches “A first elongate tubular member, first and second inflatable balloons spaced apart from each other along the first elongate tubular member, and the first and second inflatable balloons. A second elongate tubular member in communication with the inflatable balloon for inflating the balloon; A method of using a blood flow closing catheter, comprising: when the catheter is inserted into an artery through an incision, the first and second balloons are arranged on both sides of the incision; And stopping blood flow at the same time as securing blood flow through said first elongated tubular member” (see claim 8).
Therefore it would have been obvious to persons having ordinary skill in the art to use an inflatable/deflatable element such as the balloon catheter taught by Tofy for stopping blood flow and securing the flow of blood before complete coagulation, in the method taught by Truzi because this would help control the timing and placement of the composition within the hollowed space.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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