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 .
Response to Amendment
Applicant's amendment and argument filed 09/03/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-5, 10-12, 17, 19-24, 26-28, 31 are pending of which claims 19-24, 26-28, 31 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/24/2026.
Claims 1-5, 10-12, 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” and there is no required anticoagulant of claim 1 which means there is no proper antecedent basis.
Claim 3 recites “anti-anti-coagulation agents” and this is not a recognized term of the art. The phrasing is confusing for the use of a double negative and indefinite.
Response to Arguments
Applicant's arguments filed 09/03/2026 have been fully considered but they are not persuasive. The applicant argues that amended claim three now depends from claim 2. The current set of claims do not reflect this, and the claim is still improper for antecedent basis.
The applicant argues that an anti-anticoagulation agent is one that counteracts the activity of an anticoagulation agent. This term is still confusing because it is not a typical term of the art and the applicant does not define the term in their specifications.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. These are new rejections based on the amendments filed on 09/03/2026.
Claims 1 and 4-5 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Alon Kushnir and Igal Kushnir (From IDS filed on 08/03/2023, WO2019058373A1) and further in view of Arvind Srinivasan and Shahriar Alizadegan (Venous insufficiency, lymphocutaneous fistula, and use of autologous blood, J Vasc Surg Cases Innov Tech, 2020 Oct 30:7(1):61-63).
Regarding claims 1, 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.
Kushnir teaches wherein the components may be introduced into the mold space through injection (see page 5, first para., see page 9, claim 17, page 10, claim 29).
Kushnir teaches applying medical dressings (see page 6, line 6, page 7, line 6, etc.).
Kushnir does not specifically teach the method is for a hollowed space which is an anal fistula, a sinus, a pilonidal sinus or a stoma resulting from a stoma surgery.
Shrinivasan teaches “Lymphocutaneous fistulas are an uncommon occurrence that can present after surgical intervention in lymphatic-rich areas. A spontaneous lymphatic leak can occur in conjunction with lymphedema or in the vicinity of venous stasis ulcers. However, spontaneous lymphocutaneous fistulas are extremely rare. Traditional treatments have included surgical ligation, negative pressure therapy, and embolization. We present the case of a lymphocutaneous fistula secondary to chronic venous stasis, which was treated via injection of autologous blood and subsequent thrombosis. In the present case report, we have demonstrated successful embolization of a lymphatic vessel via autologous blood injection, a nontraditional technique that, nonetheless, yielded positive and lasting results” (see abstract).
Therefore, it would have been obvious to persons having ordinary skill in the art before the effective filing date to use Kushnir’s method on an anal fistula or a stoma space formed in a result of a stoma surgery because as Srinivasan teaches the using the patient’s own autologous blood for treating fistulas that are difficult to treat. Although the fistula was spontaneous and not the result of surgery Kushnir’s method would be expected to be effective on anal fistulas and stomas resulting from surgery as the invention does not appear to be limited to specific wounds. Additionally, Shrinivasan teaches that use of autologous whole blood can help heal fistulas that are difficult to treat. There would have been a great expectation of success in using Kushnir’s invention on an anal fistula or stoma which formed from surgery. Applying the method to a hollowed space with two or more openings would have also been obvious as the number of hollowed spaces does not seem to be limited to just one. Creating a sinus by sealing one of the hollowed spaces would make the delivery via injection to the non-closed off hollowed space easier to treat.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Alon Kushnir and Igal Kushnir (WO2019058373A1) and further in view of Arvind Srinivasan and Shahriar Alizadegan (Venous insufficiency, lymphocutaneous fistula, and use of autologous blood, J Vasc Surg Cases Innov Tech, 2020 Oct 30:7(1):61-63) as applied to claims 1 and 4-5 and 10-12above, and further in view of Richard Carroll et. al. (DE69321770T2).
Kushnir and Srinivasan teach the instantly claimed method however is silent on withdrawing whole blood from the subject and mixing it with anticoagulation agent Anticoagulant Citrate Dextrose, Solution A.
Carroll’s disclosure is to “an anticoagulant solution of sodium citrate for use in blood chemistry-related techniques and apparatus is disclosed” (see abstract).
Carroll teaches that “In particular, citrate is commonly used as an anticoagulant in three types of solutions. The first type of solution is called buffered sodium citrate. The second type of solution is usually called CPD solution or citrate phosphate dextrose. The third type is called ACD or acid citrate dextrose. The citrate ion concentration in these solutions is usually greater than that required to provide anticoagulant function. required concentration. Examples of currently available citrate-based anticoagulant solutions are given in the table below. CITRATE-BASED ANTICLOTANT FORMULATIONS” (see page 7, para. 3).
“Accordingly, the present invention provides an improved sodium citrate-based anticoagulant solution for use in techniques and devices related to blood chemistry, particularly devices for collecting and/or separating blood” (see page 3, para. 7).
Therefore, it would have been obvious to people who have ordinary skill in the art before the effective filing date to use ACD-A to control for coagulation in the process taught by Kushnir. Anticoagulant citrate dextrose solution is commonly known in the art for such purposes particularly for collecting whole blood and for preventing clotting and would have been prima facie obvious to use as such.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Alon Kushnir and Igal Kushnir (WO2019058373A1) and further in view of Arvind Srinivasan and Shahriar Alizadegan (Venous insufficiency, lymphocutaneous fistula, and use of autologous blood, J Vasc Surg Cases Innov Tech, 2020 Oct 30:7(1):61-63) as applied to claims 1, 4-5 and 10-12 above, and further in view of Mussivand Tofy and Gill Inderjit (JP H10-127772A).
Kushnir and Srinivasan 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 Kushnir and Srinivasan because this would help control the timing and placement of the composition within the hollowed space.
Response to Arguments
Applicant's arguments filed 09/03/2026 have been fully considered but they are not persuasive. The applicant’s arguments pertaining to Kushnir state that Kushnir does not anticipate the claims as amended because Kushnir does not particularly teach the method to be applied to a sinus, or anal fistula. The Office has articulated reasons to apply the method to anal fistulas based on the knowledge of those skilled in the art and based on Srinivasan’s art.
The Office has dropped the prior art pertaining to Turiz and so the applicant’s arguments to Turiz are moot.
Conclusion
Currently no claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
