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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/07/2026 has been entered.
Status of Claims
Claims 1-5, 7-11, and 18-20 are currently pending. Claims 1 and 17 are currently amended. Claims 6 and 12-16 are cancelled. No new subject matter is added.
Response to Arguments
Applicant argues that Seelich and Hubbell do not teach a hemostatic, clot-forming composition in dry form. The Examiner agrees, and has set forth a new rejection in view of Herzberg et al. (US 20050272697 A1) below. 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.
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 1-5, 7, 9-11, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Seelich et al. (US 4909251 A), hereinafter referred to as “Seelich” in view of Pines et al. (US 5330974 A), hereinafter referred to as “Pines” in further view of Herzberg et al. (US 20050272697 A1), hereinafter referred to as “Herzberg”.
Regarding Claim 1, Seelich teaches a hemostatic, clot forming composition for treating, inhibiting, arresting or delaying bleeding (a tissue adhesive for seamlessly or seam-supportingly connecting human or animal tissue or organ parts, for sealing wounds, stopping bleeding, see Col 1. ln 4-7), comprising one or more clottable proteins and albumin, wherein the one or more clottable proteins and albumin (a tissue adhesive for seamlessly or seam-supportingly connecting human or animal tissue or organ parts, for sealing wounds, stopping bleeding, stimulating wound healing and the like, in lyophilized form and contain proteins, such as fibronectin and albumin, see Col. 1 ln 4-16; Example 45 and 47) is at a total concentration of at least 90% by total protein weight (an albumin content of up to 1.1 (110% by mass) of the fibrinogen content, see claim 18), wherein the one or more clottable proteins comprise fibrinogen and fibronectin (comprising fibrinogen and fibronectin, see Example 47, Col. 14 ln 29-34), and wherein the albumin to fibrinogen weight ratio is at least 1:15, respectively (see example 47 mass ratio of albumin to fibrinogen is 0.18, see Col. 14 ln 34; wherein 0.18/1 is a ratio of 1:5.56).
However, Seelich does not explicitly disclose an article of manufacture comprising: a hemostatic, clot forming composition in dry form,
wherein
(i) said article of manufacture being a wound dressing, comprising at least one layer of an absorbable woven or knitted fabric, and
(ii) (ii) the absorbable woven or knitted fabric comprises oxidized cellulose (OC), oxidized regenerated cellulose (ORC), or combination thereof.
Ilan teaches an article of manufacture (conventional hemostatic wound dressings, see Paragraph [0023]) comprising: a hemostatic, clot forming composition (oxidized regenerated cellulose that may be used in one embodiment include fabrics utilized as conventional hemostatic wound dressings, see Paragraph [0023]) in dry form (example of preparation of dry oxidized regenerated cellulose samples includes dried first in open air and then in a vacuum oven at room temperature, see Paragraph [0051]),
wherein
(i) said article of manufacture being a wound dressing (wound dressings, see Paragraph [0023]), comprising at least one layer of an absorbable woven or knitted fabric (absorbable hemostat knitted fabrics, see Paragraph [0023]), and
(ii) (ii) the absorbable woven or knitted fabric comprises oxidized cellulose (OC), oxidized regenerated cellulose (ORC), or combination thereof (oxidized regenerated cellulose that may be used in one embodiment include fabrics utilized as conventional adhesion barriers or conventional hemostatic wound dressings, see Paragraph [0023]).
Seelich and Herzberg are analogous art because both teach a composition for reducing pain at a surgical wound site.
Herzberg teaches it would be beneficial to have a composition for reducing pain at a surgical wound site or trauma site comprising oxidized regenerated cellulose (see Paragraph [0010]). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the hemostatic, clot forming composition of Seelich and further include the hemostatic composition to be incorporated in a wound dressing in dry form comprising oxidized regenerated cellulose (ORC), as taught by Herzberg.
However, Seelich and Herzberg do not explicitly disclose the fibronectin being at an amount of less than about 0.5% by total protein weight or being absent.
Pines teaches a hemostatic, clot forming composition for treating, inhibiting, arresting or delaying bleeding (a therapeutic composition effective on contact with thrombin at a site of treatment in a patient as a tissue adhesive, hemostat or sealant, see Abstract), comprising one or more clottable proteins and albumin (therapeutic composition comprising, expressed as percent (w/w) of total protein contained therein, bovine fibrinogen at about 95% and of which about 90% thereof is clottable; serum albumin at about 0.8%, plasma fibronectin at less than 0.5%, see Col. 8 ln 47-52) wherein the one or more clottable proteins comprise fibrinogen and fibronectin (see Col. 8 ln 47-53); and wherein the fibronectin being at an amount of less than about 0.5% by total protein weight or being absent (plasma fibronectin at less than 0.5%, see Col. 8 ln 53).
Seelich, Herzberg, and Pines are analogous art because all teach a therapeutic composition comprising fibrinogen, albumin, and fibronectin for a site of treatment in a patient as a tissue adhesive, hemostat or sealant.
Pines teaches it is beneficial that the small quantities of the copurifying plasma proteins are present, for example, in the highly preferred therapeutic composition defined directly above, are representative of a range of concentrations (preferably from about 1 to about 10%) of copurifying protein (expressed as % w/w of protein) that when present in conjunction with low molecular weight physiologically-compatible solutes (defined and described directly below) facilitate solubilization (reconstitution) of fibrinogen from the lyophilized state without interfering with the polymerization of the fibrinogen (fibrin) lattice (see Col. 9 ln 8-19). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the therapeutic composition of Modified Seelich and further include wherein the fibronectin is at an amount of less than about 0.5% by total protein weight or being absent, as taught by Pines.
Regarding Claim 2, Modified Seelich teaches all of the limitations as discussed above in Claim 1 and Seelich further teaches wherein the clottable proteins comprise a percentage of fibrinogen (a fibrinogen content of 85% by weight and were practically free from albumin and fibronectin, see Col. 11 ln 61-63). However, Modified Seelich does not explicitly disclose wherein the clottable proteins comprise 90% of fibrinogen.
It has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Accordingly, 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 composition of Modified Seelich to comprise 90% of fibrinogen as applicant appears to have placed no criticality on the claimed range (see Paragraph [0074] indicating the composition comprise “about” 90% fibrinogen be within the claimed range).
Regarding Claim 3, Modified Seelich teaches all of the limitations as discussed above in Claim 1 and Pines further teaches wherein the fibronectin is in an amount of 0.05% to 2% fibronectin by weight (plasma fibronectin at less than 0.5%, see Col. 8 ln 53).
However, Modified Seelich does not explicitly disclose wherein the fibronectin is in an amount of 0.3% by weight.
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 composition of Modified Seelich to comprise the fibronectin being at an amount of 0.3% by weight as applicant appears to have placed no criticality on the claimed range (see Paragraph [0081] indicating the composition comprise “about” 0.3% fibronectin be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 4, Modified Seelich teaches all of the limitations as discussed above in Claim 1 and Seelich further teaches wherein the albumin to fibrinogen weight ratio is between 1:1 and 1:15 (see example 47 mass ratio of albumin to fibrinogen is 0.18, see Col. 14 ln 34; wherein 0.18/1 is a ratio of 1:5.56)
Regarding Claim 5, Modified Seelich teaches all of the limitations as discussed above in Claim 1 and Seelich further teaches wherein said albumin content is between about 0.5% and about 55% by weight (20% by weight human albumin solution, see Example 45; Col. 12 ln 24-25).
Regarding Claim 7, Modified Seelich teaches all of the limitations as discussed above in Claim 1. However, Modified Seelich do not explicitly disclose the composition being in a powder form.
Herzberg further teaches the composition being in a powder form (oxidized cellulose is in powder form, see Paragraph [0023]).
Seelich, Herzberg, and Pines are analogous art because all teach a therapeutic composition comprising fibrinogen, albumin, and fibronectin for a site of treatment in a patient as a tissue adhesive, hemostat or sealant.
Herzberg teaches having the composition in powdered form is beneficial because often the drug delivery system is biocompatible and absorbable, which permits it to be used intracorporeally at the surgical wound site or trauma site and then slowly absorbed by the patient's body. One advantage of using an absorbable drug delivery system at the surgical wound site or trauma site is that the site does not have to be re-opened to remove the drug delivery system after depletion of the drug (see Paragraph [0005]). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the composition of Modified Seelich and further include wherein the composition is in a powder form, as taught by Herzberg.
Regarding Claim 9, Modified Seelich teaches all of the limitations as discussed above in Claim 1 and Seelich further teaches further comprising thrombin (the thrombin activity required may be derived from adding thrombin to the tissue adhesive at gluing in the form of a solution containing thrombin and Ca.sup.2+ ions, see Col. 1 ln 23-27).
Regarding Claim 10, Modified Seelich teaches all of the limitations as discussed above in Claim 9 and Seelich further teaches wherein said albumin content is between about 5% and about 43% by weight (20% by weight human albumin solution, see Example 45; Col. 12 ln 24-25).
Regarding Claim 11, Modified Seelich teaches all of the limitations as discussed above in Claim 10 and Pines further teaches comprising less than about 0.5% fibronectin (plasma fibronectin at less than 0.5%, see Col. 8 ln 53).
Regarding Claim 18, Modified Seelich teaches all of the limitations as discussed above in Claim 1 and Seelich further teaches a method for the treating, inhibiting, arresting or delaying bleeding or any disorder associated thereto (a tissue adhesive for seamlessly or seam-supportingly connecting human or animal tissue or organ parts, for sealing wounds, stopping bleeding, stimulating wound healing and the like, see Col. 1 ln 4-16), the method comprising topically administering onto a wounded tissue of a subject in need thereof an effective amount of the composition of claim 1 (such preparations allow for a reliable stopping of bleeding, make for a good adhering capacity of the tissue adhesive to the wound or tissue surfaces, and provide for a high straining capacity of the glued sites or sealed wounds, and a complete absorbability of the tissue adhesive in the course of the wound healing process; and they have properties which stimulate wound healing, see Col., 1 ln 18-35).
Regarding Claim 19, Modified Seelich teaches all of the limitations as discussed above in Claim 18 and Seelich further teaches wherein the bleeding is at least one of injury-induced bleeding, surgery-induced bleeding or trauma-induced bleeding (On the part of the physicians there is the wish for a shortening of the dissolution periods, since particularly in emergency situations involving surgery quick availability may be of decisive importance, Col. 1 ln 44-47)
Regarding Claim 20, Modified Seelich teaches teach all of the limitations as discussed above in Claim 18 and Seelich further teaches wherein the bleeding is during a surgical procedure (On the part of the physicians there is the wish for a shortening of the dissolution periods, since particularly in emergency situations involving surgery quick availability may be of decisive importance, Col. 1 ln 44-47).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Seelich, Herzberg, and Pines, as applied in claim 1, and further in view of Ilan et al. (US 10159720 B2), hereinafter referred to as “Ilan”.
Regarding Claim 8, Modified Seelich teaches all of the limitations as discussed above in Claim 1. However, Modified Seelich does not explicitly disclose a tissue adhesiveness of at least 40N/m as measured by a peel force test.
Ilan teaches a spray-dried thrombin powder comprises albumin (see Abstract, Col. 4 ln 16-17) wherein a matrix comprises the spray-dried thrombin powder in a patch (see Col. 6 ln 64-65; Col. 7 ln 10) characterized by a tissue adhesiveness of at least 40N/m as measured by a peel force test (the characteristics of the fibrin sealant patch were analyzed as shown in Table 14 with a Tissue Peel Test result of 155 N/m, see Col. 26 ln 34).
Seelich, Herzberg, Pines, and Ilan are analogous art because all teach a therapeutic wound mixture formulated to work in combination with human growth factors.
Ilan teaches a fibrin patch comprising such compositions is used, there is a higher thrombin concentration in the formed fibrin clot formed, resulting in more fibrin fibers in the clot, leading to greater clot strength and adhesion to tissue (Col. 15 ln 29-33). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the tissue adhesive composition of Modified Seelich and further include a tissue adhesiveness of at least 40N/m as measured by a peel force test, as taught by Ilan.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Seelich, Herzberg, and Pines, as applied to claim 1 above, and further in view of Ahn et al. (WO 2019094526 A1), hereinafter referred to “Ahn”.
Regarding Claim 17, Modified Seelich teaches all of the limitations as discussed above in Claim 1. However, Modified Seelich does not explicitly disclose wherein the absorbable nonwoven fabric is comprised of aliphatic polyester polymers or copolymers of one or more monomers selected from the group consisting of lactic acid, lactide (including L-, D-, meso and D, L mixtures), glycolic acid, glycolide, e-caprolactone, p-dioxanone and trimethylene carbonate.
Ahn teaches a absorbable nonwoven fabric is comprised of aliphatic polyester polymers or copolymers of one or more monomers selected from the group consisting of lactic acid, lactide (including L-, D-, meso and D, L mixtures), glycolic acid, glycolide, e-caprolactone, p-dioxanone and trimethylene carbonate (the fabrication of polymeric fiber, e.g., micron, submicron or nanometer dimension polymeric fiber, scaffolds comprising polycaprolactone (PCL), see Col. 2 ln 22-24; polycaprolactone being a aliphatic polyester polymer).
Seelich, Herzberg, Pines, and Ahn are analogous art because all deal with a wound dressing comprising an absorbable fabric.
Ahn teaches it is beneficial to have a absorbable nonwoven fabric made from polycaprolactone to have physical and mechanical properties that mimic dermal skin extracellular matrix and that promote and accelerate cutaneous wound closure, promote cutaneous wound healing and/or cutaneous tissue regeneration and reduce fibrosis (see Col. 2 ln 24-26). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the absorbable fabric of Modified Seelich and further include wherein the absorbable nonwoven fabric is comprised of an aliphatic polyester polymer, i.e. polycaprolactone , as taught by Ahn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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.
/ERIC RASSAVONG/ (3/31/2026)Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 1 April 2026
Prosecution Insights