DETAILED ACTION
The receipt is acknowledged of applicants’ amendment filed 11/17/2025.
Claims 1, 4-6, 8-9, 14-16 and 18-19 previously presented. claims 20-28 are currently added. Claims 1, 4-6, 8-9, 14-16 and 18-28 are pending and subject of this office 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 .
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, 4-6, 8-9, 14-16 and 18-28 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hardy et al. (WO 2012/123728), the article by Bartley (Should chitosan and tranexamic acid be combined for improved hemostasis after sinus surgery?), and Korobov et al. (WO 2016/176186), all the references are of record.
Applicant Claims
Claim 1 is directed to a carrier material comprising a haemostatic composition applied thereto, the haemostatic composition comprising a haemostat agent, a bioadhesive agent and an antifibrinolytic agent,
wherein the haemostat agent comprises a material selected from the group consisting of chitin, chitosan, a chitosan salt, derivatives of chitosan, derivatives of chitin, or any combination thereof; and
wherein the bioadhesive agent comprises one or more selected from the group consisting of: a cross-linked polymer of acrylic acid, the polymer having a molecular weight of 50,000 g/mol to 300,000 g/mol; a carbomer, a high molecular weight acrylic acid polymer cross-linked with divinyl glycol, the salts of polyacrylic acid cross-linked with divinyl glycol, or mixtures thereof, and wherein the antifibrinolytic agent is tranexamic acid.
claim 20 is directed to a carrier material comprising a haemostatic composition applied thereto, the
haemostatic composition comprising a haemostat agent, a bioadhesive agent and an antifibrinolytic
agent,
wherein the haemostat agent comprises a chitosan salt;
wherein the bioadhesive agent comprises a carbomer; and
wherein the antifibrinolytic agent is tranexamic acid.
claim 28 is directed to a carrier material having applied thereon a defined haemostatic composition
consisting essentially of:
a haemostat agent consisting of chitosan lactate;
a bioadhesive agent consisting of a carbomer homopolymer type C corresponding to the
material commercially available as NF980; and
an antifibrinolytic agent consisting of tranexamic acid.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Hardy teaches haemostatic material/composition useful for effectively controlling bleeding with reduced required compression time. The haemostatic material comprises haemostat agent and bioadhesive agent (abstract; page 2, lines 10-17). The haemostat material is applied to a physiological target bleeding site (page 2, lines 18-22). The haemostat agent comprises chitosan. The haemostat agent is preferably a chitosan salt. Good results have been observed wherein the chitosan salt is chitosan succinate (page 3, line 13 till page 4, line 13). The bioadhesive agent exhibits low adhesion to dry surface, and when combined with haemostat agent provides haemostatic material that exhibits no adhesion to dry surfaces. Beneficially, this property of the bioadhesive agent provides a haemostatic material that is both easy to handle and enables the haemostatic material to effectively control bleeding within a reduced compression period (page 5, lines 7-20). The bioadhesive agent may be selected from any of the following either alone or in combination: carbomers, or a high molecular weight acrylic acid polymer cross-linked with divinyl glycol or the salts of polyacrylic acid cross-linked with divinyl glycol. Carbomer can be Carbopol®NF980. Preferably, the bioadhesive agent comprises high molecular weight cross-linked polymers of acrylic acid. By ‘high molecular weight’ it is meant a molecular weight of at least 50,000 g/mol. Preferably, the molecular weight is at least 60,000 g/mol and more preferably from 100,000 to 300,000 g/mol. In such embodiments, the bioadhesive agent may be a homopolymer comprising a polymer of acrylic acid cross-linked with allyl sucrose or allyl pentaerythritol; a copolymer comprising a polymer of acrylic acid and C10-C30 alkyl acrylate cross-linked with allyl pentaerythritol; a carbomer; or mixtures thereof (page 6, line 19 till page 7, line12). The haemostat material further comprises inert material (page 8, lines 12-21). The haemostatic material is applied to a carrier selected from woven, non-woven, flexible substrate, film, foam or sheet gel (page 11, lines 5-9). Hardy teaches method of haemostasis method comprising the steps of applying the haemostatic material to a physiological target site; and applying pressure to the haemostatic material. The haemostatic material used in stemming blood flow from a physiological target site that can be in or on a subject body, and can be surgical wound caused during a surgical procedure (page 2, lines 18-22; page 12, lines 16-22). The reference teaches applying pressure to haemostatic material applied to the target site preferably for less than one minute (page 13, lines 5-7). The reference teaches method of manufacturing the haemostatic material dispensing each ingredient in an inert material in a mixing vessel (page 13, lines 16-20).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Hardy teaches haemostatic material/composition for providing hemostasis to wound in or on a subject body including surgical wound wherein the hemostatic material comprising the chitosan and its salts, and the claimed bioadhesive, the reference however does not teach the claimed antifibrinolytic agent in the composition.
Bartley teaches combination of chitosan and tranexamic acid shows improved hemostasis and better postsurgical outcome after sinus surgery, and the combination has beneficial potential application as improved hemostatic external wound and internal surgical wounds dressing (abstract). Tranexamic acid inhibits fibrinolysis and successfully controls bleeding in anti-coagulated patients during surgery. Chitosan also facilitates transfer of tranexamic acid into tissues of the wound, therefore, facilitates its hemostatic action (page 1037, left column).
Korobov teaches hemostatic composition comprises polysaccharide base, e.g. chitosan acetate, and fibrinolytic inhibitor, e.g. tranexamic acid. Inclusion of fibrinolytic inhibitors is advantageous in improving hemostatic properties of the composition, reducing the risk of re-bleeding for significant long period (abstract; ¶¶ 0003-0004, 0013, 0020-0021, 0026; claim 1). The reference teaches a method of making the composition comprising mixing the ingredients (¶¶ 005, 0037). The mixture is spread on a sheet, i.e. carrier (¶ 0041). The composition is used to arrest bleeding during surgical intervention and other injuries when extensive hemorrhages occur and difficult to arrest by other means (¶¶ 0008, 0055). The composition has a stimulating effect on regenerative processes in the wound, which is reflected in the acceleration of granulation tissue growth, promotion of marginal and insular epithelization, and the facilitation of favorable conditions for epithelial cell migration, vascular invasion and scar-free wound healing (¶ 0010).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide a haemostatic composition comprising chitosan and its salt, and bioadhesive to arrest bleeding in or on subject body including surgical bleeding occur during surgery as taught by Hardy, and add tranexamic acid taught by Bartley or Korobov to the composition. One would have been motivated to do so because Bartley teaches combination of chitosan and tranexamic acid control bleeding in anticoagulated patient and shows improved hemostasis and better postsurgical outcome, and the combination has beneficial potential application as improved hemostasis in external wound and internal surgical wounds, and because Korobov teaches antifibrinolytic agents including tranexamic acid improve hemostatic properties of a composition comprising chitosan, arrest bleeding during surgical intervention and other injuries when extensive hemorrhages occur and difficult to arrest by other means, reduce the risk of re-bleeding for significant long period, and stimulate regenerative processes in the wound. One would reasonably expect formulating improved hemostatic material comprising chitosan, bioadhesive agent and tranexamic acid wherein the composition has improved hemostasis even in anti-coagulated patients during surgery and useful to arrest extensive bleeding.
Regarding hemostats claimed by claims 1, 4-6, 20, 21-23 and 28, Hardy, Bartley and Korobov all teach chitosan and its salts, e.g. chitosan succinate, chitosan lactate.
Regarding the bioadhesive is crosslinked polymer of acrylic aid having molecular weight of 50,000 to 300,000 g/mol claimed by claim 1, Hardy teaches cross-linked polymers of acrylic acid having molecular weight of at least 50000 g/mol; preferably at least 60,000 g/mol, and more preferably from 100,000 to 300,000 g/mol. The molecular weights taught by Hardy fall within the claimed molecular weights. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the acrylic acid polymer claimed by claims 8 and 9, they are taught by Hardy.
Regarding the nominal method of making the carrier material claimed by claims 9 and 14, it is taught by Hardy and Korobov.
Regarding applying pressure to the hemostatic composition as claimed by claim 15, it is taught by Hardy.
Regarding claim 16 that pressure is applied for less than 1 minute, Hardy teaches preferably pressure is applied for less than one minute.
Regarding the carrier material claimed by claims 18 and 27, Hardy and Korobov teach nonwoven material, flexible substrate, foam and sheet.
Regarding use of the carrier material for stemming blood flow from a physiological target site as claimed by claim 19, all the cited references teach stemming of blood flow from bleeding site.
Regarding the carbomer claimed by claims 20, 24-26 and 28, Hardy teaches the claimed NF 980.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claims 1, 4-6, 8-9, 14-16 and 18-28 are rejected under 35 U.S.C. 103 as being unpatentable over Korobov et al. (WO 2016/176186), as evidenced by and also combined with Bartley, and combined with Hardy et al. (WO 2012/123728) and Mershon (US 7,303,759), as evidenced by the article “Carbopol Polymer Product”, all references are of record.
Applicant Claims
Claim 1 is directed to a carrier material comprising a haemostatic composition applied thereto, the haemostatic composition comprising a haemostat agent, a bioadhesive agent and an antifibrinolytic agent,
wherein the haemostat agent comprises a material selected from the group consisting of chitin, chitosan, a chitosan salt, derivatives of chitosan, derivatives of chitin, or any combination thereof; and
wherein the bioadhesive agent comprises one or more selected from the group consisting of: a cross-linked polymer of acrylic acid, the polymer having a molecular weight of 50,000 g/mol to 300,000 g/mol; a carbomer, a high molecular weight acrylic acid polymer cross-linked with divinyl glycol, the salts of polyacrylic acid cross-linked with divinyl glycol, or mixtures thereof, and wherein the antifibrinolytic agent is tranexamic acid.
claim 20 is directed to a carrier material comprising a haemostatic composition applied thereto, the
haemostatic composition comprising a haemostat agent, a bioadhesive agent and an antifibrinolytic
agent,
wherein the haemostat agent comprises a chitosan salt;
wherein the bioadhesive agent comprises a carbomer; and
wherein the antifibrinolytic agent is tranexamic acid.
claim 28 is directed to a carrier material having applied thereon a defined haemostatic composition
consisting essentially of:
a haemostat agent consisting of chitosan lactate;
a bioadhesive agent consisting of a carbomer homopolymer type C corresponding to the
material commercially available as NF980; and
an antifibrinolytic agent consisting of tranexamic acid.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Korobov teaches hemostatic composition comprises polysaccharide base, e.g. chitosan acetate, and fibrinolytic inhibitor, e.g. tranexamic acid. Inclusion of fibrinolytic inhibitors is advantageous in improving hemostatic properties of the composition, reducing the risk of re-bleeding for significant long period (abstract; ¶¶ 0003-0004, 0013, 0020-0021, 0026; claim 1). The reference teaches a method of making the composition comprising mixing the ingredients (¶¶ 005, 0037). The mixture is spread on a sheet, i.e. carrier (¶ 0041). The composition is used to arrest bleeding during surgical intervention and other injuries when extensive hemorrhages occur and difficult to arrest by other means (¶¶ 0008, 0055). The composition has a stimulating effect on regenerative processes in the wound, which is reflected in the acceleration of granulation tissue growth, promotion of marginal and insular epithelization, and the facilitation of favorable conditions for epithelial cell migration, vascular invasion and scar-free wound healing (¶ 0010). Tranexamic acid control bleeding in anti-coagulating patients during surgery as evidenced by Bartley.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Korobov teaches hemostatic composition comprising the claimed hemostatic agent and antifibrinolytic agent to use with extensive bleeding during surgery, the reference however does not teach the claimed bioadhesive agent in the composition as claimed by claim 1.
The element missing from Korobov is taught by Hardy, Bartley and Mershon.
The teachings of Hardy and Bartley are previously discussed in this office action.
Mershon teaches safe and efficient hemostatic composition for stopping bleeding from open wound. The composition comprises polyacrylic acid polymers having molecular weight between 10,000-70,000 that absorbs blood from the open wound and forms an aqueous gel that has sufficient viscosity an adhesiveness to cover and adhere to the open wound so that bleeding is stopped (abstract; col.3, lines 12-30, 46-54; col.8, lines 15-25, 38-43; col.12, lines 1-4). The reference teaches applying pressure on the bleeding site for about 15 second (col.14, lines 1-10, 36-39; example 6, claim 17). The composition is applied to woven or nonwoven carrier (claim 18). Polyacrylic acid polymers taught by Mershon include Carbopol polymer (col.12; examples), that are acrylic acid crosslinked with allyl sucrose or allyl pentaerythritol, acrylic acid and C10-C30 alkyl acrylate crosslinked with allyl pentaerythritol, carbomer homopolymer or copolymer that contains a block copolymer of polyethylene glycol and a long chain alkyl acid ester, as evidenced by the article “Carbopol Polymer Products”.
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide a hemostatic composition comprising chitosan salt and tranexamic acid to arrest severe bleeding that is difficult to control even in anti-coagulated patients as taught by Korobov, evidenced by Bartley, and confidently use tranexamic acid taught by Bartley and add bioadhesive agent such as polyacrylic acid polymer taught by any of Hardy and Mershon to the composition. One would have been motivated to do so because Bartley teaches combination of chitosan and tranexamic acid control bleeding in anticoagulated patient and shows improved hemostasis and better postsurgical outcome, and the combination has beneficial potential application as improved hemostasis in external wound and internal surgical wounds, and one would add bioadhesive because Hardy teaches that such bioadhesive agent exhibits low adhesion to dry surface, and when combined with hemostat agent provides hemostatic material that exhibits no adhesion to dry surfaces and easy to handle, and enables the hemostatic material to effectively control bleeding within a reduced compression period during surgery, and because Mershon teaches such bioadhesive is safe and efficient hemostatic composition for stopping bleeding from open wound with minimal compression, and absorbs blood from the open wound and forms an aqueous gel that has sufficient viscosity an adhesiveness to cover and adhere to the open wound so that bleeding is stopped. One would reasonably expect formulating improved safe efficient hemostatic material that control bleeding even in anti-coagulated patients during surgery comprising chitosan salt, bioadhesive polyacrylic acid polymer, and tranexamic acid wherein the composition has improved, safe, efficient hemostasis and requires minimal compression for very short time.
Regarding hemostats claimed by claims 1, 4-6, 20, 21-23 and 28, Hardy, Bartley and Korobov all teach chitosan and its salts, e.g. chitosan succinate, chitosan lactate.
Regarding the bioadhesives claimed by claims 1, 8 and 9, they are taught by Hardy and Mershon.
Regarding the bioadhesive is crosslinked polymer of acrylic aid having molecular weight of 50,000 to 300,000 g/mol claimed by claim 1, Hardy teaches cross-linked polymers of acrylic acid having molecular weight of at least 50000 g/mol; preferably at least 60,000 g/mol, and more preferably from 100,000 to 300,000 g/mol. Mershon teaches polyacrylic acid polymers having molecular weight between 10,000-70,000. The molecular weights taught by Hardy fall within the claimed molecular weights, and the molecular weights taught by Mershon overlaps with the claimed molecular weights. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the chitosan succinate claimed by claim 6, while it is taught by Hardy, however, applicants failed to show unexpected results obtained from using succinate salts over any other succinate salt.
Regarding the nominal method of making the composition by mixing the ingredients as claimed by claims 13 and 14, it is taught by and Korobov and Hardy.
Regarding applying pressure to the hemostatic composition as claimed by claim 15, it is taught by Hardy and Mershon.
Regarding claim 16 that pressure is applied for less than 1 minute, this is taught by Hardy teaches preferably pressure is applied for less than one minute, and Mershon that teaches 15 seconds.
Regarding the materials of the carrier materials claimed by claims 18 and 27, Hardy teaches all the claimed materials, and Mershon teaches woven and nonwoven carrier material.
Regarding use of the hemostatic composition for stemming blood flow from a physiological target site as claimed by claim 19, all the cited references teach stemming of blood flow from bleeding site.
Regarding the carbomer claimed by claims 20, 24-26 and 28, Hardy teaches the claimed NF 980.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 4-6, 8-9, 14-16 and 18-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,828,389 in view of Hardy et al. (WO 2012/123728) and the article by Bartley (Should chitosan and tranexamic acid be combined for improved hemostasis after sinus surgery?). The pending claims and the issued claims are directed to carrier comprising hemostatic material/composition comprising hemostatic agent chitosan and acrylic based polymers, that are claimed by the issued patent as bonding agent. Claim 9 of the issued patent recites acrylic based material that reads on the instantly claimed bioadhesives claimed by claim 1. However, the present claims recite specific bioadhesive polymers that not claimed by the issued claims. The issued claims do not recite antifibrinolytic agents as instantly claimed by claim 1. The teachings of Hardy and Bartley are previously discussed in this office action. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide a carrier comprising hemostatic material comprising chitosan and acrylic based material as claimed by the issued patent, and use the acrylic based bioadhesive material used by Hardy and further add tranexamic acid taught by Bartley to the hemostatic material. One would have been motivated to do so because Hardy teaches acrylic based bioadhesive having the claimed molecular weight exhibits low adhesion to dry surface, and when combined with haemostat agent provides haemostatic material that exhibits no adhesion to dry surfaces, and beneficially this property of the bioadhesive agent provides a haemostatic material that is both easy to handle and enables the haemostatic material to effectively control bleeding within a reduced compression period. One would have added tranexamic acid taught by Bratley because Bartley teaches combination of chitosan and tranexamic acid shows improved hemostasis and better postsurgical outcome after sinus surgery, and the combination has potential beneficial application as improved external wound and internal surgical wound dressings even in anticoagulated patients. One would reasonably expect formulating improved hemostatic material comprising carrier, chitosan, acrylic based bioadhesive material, and tranexamic acid that effective to control bleeding and easy to handle, and further has better postsurgical outcome and more potential beneficial application for use as hemostatic agent in external and internal surgeries in anticoagulated patients. Therefore the claimed present invention is claimed by the issued claims when combined with Hardy and Bartley.
Claims 1, 4-6, 8-9, 14-16 and 18-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,973,946 in view Hardy and the article by Bartley. The pending claims and the issued claims are directed to carrier comprising hemostatic material/composition comprising hemostatic agent chitosan and acrylic based polymers, that is claimed by the issued patent as bonding agent. Claim 7 of the issued patent recites acrylic based material that reads on the instantly claimed bioadhesives claimed by claim 1. However, the present claims recite specific bioadhesive polymers that not claimed by the issued claims. The issued claims do not recite antifibrinolytic agents as instantly claimed by claim 1. The teachings of Hardy and are previously discussed in this office action. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide a carrier comprising hemostatic material comprising chitosan and acrylic based material as claimed by the issued patent, and use the acrylic based bioadhesive material used by Hardy and further add tranexamic acid taught by Bartley to the hemostatic material. One would have been motivated to do so because Hardy teaches acrylic based bioadhesive having the claimed molecular weight exhibits low adhesion to dry surface, and when combined with haemostat agent provides haemostatic material that exhibits no adhesion to dry surfaces, and beneficially this property of the bioadhesive agent provides a haemostatic material that is both easy to handle and enables the haemostatic material to effectively control bleeding within a reduced compression period. One would have added tranexamic acid taught by Bratley because Bartley teaches combination of chitosan and tranexamic acid shows improved hemostasis and better postsurgical outcome after sinus surgery, and the combination has potential beneficial application as improved external wound and internal surgical wound dressings even in anticoagulated patients. One would reasonably expect formulating improved hemostatic material comprising carrier, chitosan, acrylic based bioadhesive material, and tranexamic acid that effective to control bleeding and easy to handle, and further has better postsurgical outcome and more potential beneficial application for use as hemostatic agent in external and internal surgeries in anticoagulated patients. Therefore the claimed present invention is claimed by the issued claims when combined with Hardy and Bartley.
Response to Arguments
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive.
Double Patenting Rejections
The examiner acknowledges applicant’s intention to file terminal disclaimer once the pending claims are found allowable. Therefore, the double patenting rejections are maintained.
Prior Art Rejections Under 35 U.S.C. §103
The Cited Prior Art
Applicants argue that Hardy is owned by the applicant of the instant application and the haemonstatic material described therein is marketed by the applicant under the trade name Celox Rapid. Under normal conditions, the Celox Rapid haemostat product requires a protocol of care for one minute continuous compression followed by a further one minute compression (if required) to achieve haemostasis. However, in coagulopathic conditions the Celox Rapid requires two minutes continuous compression to achieve haemostasis. The Examiner admits that Hardy does not disclose the addition of an antifibrinolytic agent in the composition. Bartley teaches chitosan, through topical application, facilitates the systemic delivery of analgesic drugs. Theoretically this ability could be used to enhance the local delivery of hemostatic drugs, such as tranexamic acid (TXA), improving chitosan's role as a topical dressing. The only thing that Bartley reliably teaches is that “individually a chitosan-dextran gel and tranexamic acid have been shown to improve hemostasis after endoscopic sinus surgery.” The Examiner cites Bartley only for teaching that the “combination of chitosan and tranexamic acid shows improved hemostasis and better postsurgical outcome after sinus surgery, and the combination has beneficial potential application as improved hemostatic external wound and internal surgical wounds dressing ....”.
In response to the above arguments, as applicants themselves admit, Hardy teaches the claimed dressing comprising chitosan and the claimed bioadhesives, and only missing the anti-fibrinolytic agent that is taught by Bartley, and admit that Bartley teaches the “combination of chitosan and tranexamic acid shows improved hemostasis and better postsurgical outcome after sinus surgery, and the combination has beneficial potential application as improved hemostatic external wound and internal surgical wounds dressing…”. This teaching provides enough motivation to use TXA with chitosan. Further, applicants admits that Hardy teaches one minute compression, and additional compression of one minute is provided if needed. If anti-fibrinolytic agent if added to the hemostatic chitosan and bioadhesives of Hardy, it is obvious and inevitable to have improved hemostasis. Even if Bartley teaches different mechanism of action of the combination of chitosan and TXA, i.e. “facilitates the systemic delivery of analgesic drugs that could be used to enhance the local delivery of hemostatic drugs, such as tranexamic acid, improving chitosan's role as a topical dressing”, one cannot ignore the teaching of Bartley that individually chitosan and TXA have been shown to improve hemostasis after endoscopic sinus surgery. This teaching would have strongly suggested to one skilled in the art to combine chitosan and TXA as hemostatic agents in a single product. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose. See In Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Applicants argue that Korobov discloses a hemostatic composition comprises calcium alginate, a chitosan, epsilon-aminocaproic acid, an acid selected from aminomethylbenzoic acid and tranexamic acid, and tannin.” Korobov also notes that fibrinolytic inhibitors included in the composition improve its hemostatic properties. Korobov does not, however, quantify the benefits in such hemostatic properties.
In response to this argument, it is argued that, as applicants admit, Korobov recognized the hemostatic activity of TXA, and would suggested to one having ordinary skill in the art to use tranexamic acid on a bleeding site, combined with the chitosan. The benefit of the hemostatic properties of the TXA is expected. Korobov teaches composition comprising the antifibrinolytic agent and chitosan used to arrest bleeding during surgical intervention and other injuries. The composition has a stimulating effect on regenerative processes in the wound. Inclusion of fibrinolytic inhibitors is advantageous in improving hemostatic properties of the composition, reducing the risk of re-bleeding for significant long period. These teachings of these benefits are enough motivation to direct one having ordinary skill in the art to use these elements in hemostatic wound dressing of Hardy. One having ordinary skill in the art would be expected to achieve any benefit applicants achieved. The cited references are in the same field of endeavor and seek to solve the same problems as the instant application and claims, and one of skill in the art is free to select components available in the prior art, In re Winslow, 151 USPQ 48 (CCPA, 1966).
Applicants argue that Mershon discloses that haemostasis can occur within 15 seconds in normal conditions when discussing Example 6 (Mershon, col. 23, Il. 55-58), but does not disclose any results in coagulopathic conditions.
In response to this argument, it is argued that Bartley teaches TXA inhibits fibrinolysis and successfully controls bleeding in anti-coagulated patients during surgery. Mershon is relied upon for solely teaching the claimed bioadhesives, and does not need to teach its use for coagulopathic conditions.
Rejection 1
Applicants argue that Bartley does not disclose any actual haemostatic composition containing both chitosan and tranexamic acid (TXA); rather, it merely theorizes that such a combination "could" or "should" improve hemostasis after sinus surgery and "could have" potential applications in wound dressings. Such language is the epitome of conjecture. The Manual of Patent Examining Procedure expressly recognizes that an assertedly anticipating disclosure must actually enable the subject matter in question, and that "mere naming or description of the subject matter is insufficient, if it cannot be produced without undue experimentation." Bartley fits squarely within this prohibited category: it offers no concrete formulation, no guidance on concentrations or ratios, no discussion of compatibility between chitosan and tranexamic acid (let alone with the specific acrylic-acid polymers of the rejected claim), and no indication that a particular dressing composition would actually work. It simply raises the idea that such a combination might be worth investigating. A potential combination, without more, cannot establish that the specific claimed composition was obvious with a reasonable expectation of success. MPEP also makes clear that a prima facie case of obviousness requires not just a motivation to combine but a reasonable expectation of success in doing so.
In response to this argument, as applicants themselves notices, Bartley is relied upon for suggesting a composition containing both chitosan and TXA and the reference is applied in combination of other cited references, and one cannot show un-obviousness by at tacking the references individually wherein obviousness is based on combination of references. Both Hardy and Korobov desired to have a hemostatic composition comprising chitosan, and both Bartley and Korobov suggest the benefit of having chitosan combined with TXA, and one having ordinary skill in the art would have been motivated to use both chitosan and TXA without undue experimentation. The cited references are of the inventor’s endeavor, and reasonably pertinent to the particular problem with which the inventor was concerned, which is hemostatic wound dressings. It is reasonable to be relied upon the cited references as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). Further, the office provided motivation to combine the cited references and reasonable expectation to achieve the present invention. The rationale to modify the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art and the reason to modify the reference may often suggest what the applicant has done. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). Additionally, conclusion of obviousness does not require absolute predictability, only reasonable expectation of success.
Regarding the argument that Bartley reference is not enabling, it is argued that a reference contains an “enabling disclosure” if the public was in possession of the claimed invention before the date of invention. Elan Pharm., Inc. v. Mayo Found. For Med. Educ. & Research, 346 F.3d 1051, 1054, 68 USPQ2d 1373, 1376 (Fed. Cir. 2003).
Applicants argue that scholarly commentary has likewise recognized that much non-patent prior art is "speculative and fanciful," noting that authors often have "no practical idea how to implement" the concepts they describe, and that such literature should not be treated as if it placed enabling embodiments in the public domain. Bartley is a paradigmatic example of this type of speculative publication: it identifies a theoretical possibility but fails to provide the concrete detail necessary for a skilled person to prepare a specific chitosan/TXA/acrylic-polymer haemostatic composition of the type claimed. Bartley's speculative discussion cannot be relied upon to supply the missing antifibrinolytic element of the rejected claim, cannot provide the required reasonable expectation of success in modifying Hardy's chitosan/polymer dressings, and cannot support the Examiner's obviousness rationale under 35 U.S.C. § 103.
In response to this argument, it is reiterated that a reference contains an “enabling disclosure” if the public was in possession of the claimed invention before the date of invention. Elan Pharm., Inc. v. Mayo Found. For Med. Educ. & Research, 346 F.3d 1051, 1054, 68 USPQ2d 1373, 1376 (Fed. Cir. 2003). Further, if Bartley was to teach chitosan/TXA/acrylic-polymer haemostatic composition, the reference would have been considered for anticipation. This is not the case here. Bartley satisfies the purpose for which it was applied in combination with the other references. Again one cannot attack the references individually wherein obviousness is based on combination of references. Bartley provided the missing element from Hardy. All the elements of the claimed invention are taught by combination of the cited references. Motivation to combine the references exists and reasonable expectation to achieve the present invention was presented. It is well established that the claims are given the broadest interpretation during examination. A conclusion of obviousness under 35 U.S.C. 103 (a) does not require absolute predictability, only a reasonable expectation of success; and references are evaluated by what they suggest to one versed in the art, rather than by their specific disclosure. In re Bozek, 163 USPQ 545 (CCPA 1969).
Rejection 2
Applicants argue that Korobov's compositions are designed around polysaccharide gels, not acrylic-acid polymers. They are based on chitosan acetate and similar derivatives that form their own gel matrices. Nothing in Korobov indicates that its chitosan-based haemostats should, or even could, be modified by incorporating cross-linked polyacrylic-acid polymers, carbomers, or other acrylic-acid-based bioadhesives. The Examiner has not identified any disclosure in Korobov that would lead a skilled artisan to incorporate synthetic cross-linked acrylic-acid polymers or carbomers-let alone the specific molecular-weight ranges, crosslinkers, and structural characteristics required by claim 1- into a polysaccharide-based haemostatic composition.
In response to this argument, it is argued that applicants are attacking Korobov reference individually while the rejection is based on combination of references. Korobov combined with Bartley, Hardy and Mershon teaches all the elements of the instantly claimed composition. Motivation to combine the references is drawn from the teachings of the secondary references as set forth in this office action. One having ordinary skill in the art would have add bioadhesive agent such as polyacrylic acid polymer taught by any of Hardy and Mershon to the hemostatic composition taught by Korobov because Hardy teaches that such bioadhesive agent exhibits low adhesion to dry surface, and when combined with hemostat agent provides hemostatic material that exhibits no adhesion to dry surfaces and easy to handle, and enables the hemostatic material to effectively control bleeding within a reduced compression period during surgery, and because Mershon teaches such bioadhesive is safe and efficient hemostatic composition for stopping bleeding from open wound with minimal compression, and absorbs blood from the open wound and forms an aqueous gel that has sufficient viscosity an adhesiveness to cover and adhere to the open wound so that bleeding is stopped. It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. As such, the examiner respectfully submits that there is motivation to combine polyacrylic acid from Hardy or Mershon would have been obvious to achieve the hemostatic composition having the benefits taught by Hardy and Mershon.
Applicants repeats the arguments above regarding Bartley reference, and argue that Bartley provides no disclosure of acrylic-acid polymers, no guidance regarding mixing tranexamic acid with the polysaccharide systems of Korobov, and no instruction that combining the two would result in a composition exhibiting the mechanical, bioadhesive, or haemostatic properties required by claim 1.
In response to this argument, the argument regarding Bartley reference above, is hereby reiterated as set forth in this office action. Further, applicant’s attention is directed to the scope of the present invention that is directed to a product, and all the elements of the claimed invention are taught by combination of the cited references. Motivation to combine the references exists, and reasonable expectation to achieve the claimed invention, absent evidence to the contrary. The combination of the cited references is expected to provide a composition exhibiting the mechanical, bioadhesive, or haemostatic properties achieved by applicants since materials and their properties cannot have mutual exclusive characteristics.
Applicants argue that each reference describes compositions built around fundamentally different design principles. Hardy focuses on minimizing adhesion to dry tissue while maintaining handling and compression properties, and Mershon focuses on synthetic polyacrylic systems designed to form gels upon absorption of blood. Neither reference indicates that such synthetic polymers are compatible with or should be incorporated into, Korobov's polysaccharide matrices.
In response to this argument, it is argued that the present claims are directed to a product, and all the elements of the claimed product are taught by combination of the cited references. It has been decided by the Courts that even in a case where the reference does not teach the same use of the composition, the two different intended uses are not distinguishable in terms of the composition, see In re Thuau, 57 USPQ 324; Ex parte Douros, 163 USPQ 667; and In re Craige, 89 USPQ 393. In the instant case all the cited references are of the inventor’s endeavor, and reasonably pertinent to the particular problem with which the inventor was concerned, which is hemostatic wound dressings, and it is reasonable to be relied upon the cited references as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). Further, the office provided motivation to combine the cited references and reasonable expectation to achieve the present invention.
Applicants argue that the Examiner's reliance on overlapping molecular-weight ranges does not cure these deficiencies, because structural overlap alone is insufficient to establish obviousness unless the prior art suggests combining the materials in the first place. Here, there is no suggestion-explicit or implicit-in any cited reference to mix Korobov's polysaccharide-tranexamic-acid compositions with the acrylic-acid polymers of Hardy or Mershon. Acrylic-acid polymers and polysaccharides differ significantly in chemical behavior, ionic character, swelling behavior, crosslinking mechanisms, and compatibility with amine-containing small molecules such as tranexamic acid. Neither Hardy nor Mershon provides any discussion of the compatibility of tranexamic acid with their acrylic-acid polymer systems, and neither reference suggests that their acrylic polymer gels could be blended with the polysaccharide-based haemostats of Korobov. The Examiner's proposed combination is therefore based on hindsight rather than any articulated reasoning with rational underpinning, as required by Kahn and KSR.
In response to this argument, the examiner respectfully disagrees with the applicants because motivation to combine the cited references has been provided, as set forth in this office action, even if the motivation is different from what applicants had done. It has been held that it is obvious to combine prior art elements according to known methods to yield predictable results. A finding that the prior art included each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference, was held obvious by the court.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case the examiner relied on the teachings of the cited references to construe the rejection, and not relied on applicant’s disclosure as applicants assert. The rejection provided motivation to combine the references and reasonable expectation to achieve the claimed invention, as set forth in this office action.
Applicants argue that the cited art provides no reasonable expectation of success for such a combination. Korobov does not disclose any interactions between tranexamic acid and acrylic acid polymers; Hardy and Mershon do not disclose any interactions between acrylic-acid polymers and tranexamic acid; and Bartley provides nothing more than conjecture regarding a hypothetical combination of chitosan and tranexamic acid. The prior art thus provides neither a motivation nor a technical basis to expect that combining these materials would yield a functioning haemostatic composition, let alone one possessing the haemostatic, bioadhesive, mechanical, and handling properties recited in claim 1.
In response to this argument, applicant’s attention is directed to the scope of the present invention that is directed to product and all the elements of the claimed product are taught by combination of the cited references. Motivation to combine the references exists and reasonable expectation to achieve the present invention has been provided as set forth in this office action. The product taught by combination of the cited reference is expected to provide the properties applicants achieved, absent evidence to the contrary.
Applicants argue that the Carbopol article adds nothing to the Examiner's position. It merely describes the structure and properties of Carbopol polymers; it does not suggest combining Carbopol with polysaccharide-tranexamic systems, nor does it provide any teaching regarding compatibility, formulation strategy, or haemostatic performance when mixed with tranexamic acid or chitosan salts.
In response to this argument, it is argued that the article Carbopol, as applicants noticed, the article is relied upon as an evidentiary reference showing that polyacrylic acid polymers taught by Mershon include those claimed by applicants.
Applicants argue that none of the references suggests, enables, or motivates combining all three actives-polysaccharide, tranexamic acid, and cross-linked acrylic-acid polymer-into a single haemostatic composition applied to a carrier. The Examiner's reasoning improperly uses the present application as a roadmap, without any support in the cited art, and constructs the claimed composition from fragments of unrelated teachings.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as set forth in the current rejections, motivation to combine the references exist, even if different from what applicants had done, and reasonable expectation to achieve the present invention has been presented. The obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. v. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir.1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
New Claims 20 to 28.
Applicants argue that new claims 20 to 28 are fully supported by the unexpected-results evidence presented in the two declarations of inventor Andrew Hoggarth, submitted under 37 C.F.R. § 1.132. When considered together, these Declarations provide compelling and commensurate evidence that the specific haemostatic compositions recited in claims 20 to 28 possess properties that are neither taught nor suggested by the cited prior art. Claims 20 to 28 are directed to a carbomer as the bioadhesive agent, and TXA as the antifibrinolytic agent, with dependent claims further specifying particular chitosan salts and carbomer Type C materials such as NF934, NF974, NF971, and NF980. This formulation precisely matches the compositions evaluated in the First Hoggarth Declaration, which describes a haemostatic dressing constructed from chitosan lactate, a carbomer bioadhesive of the type used in the Celox Rapid product of Hardy, and tranexamic acid. The First Hoggarth Declaration compares this "Celox Rapid TXA" composition against Celox Rapid-the closest prior art and the product protected by Hardy-and therefore provides a highly appropriate comparison for demonstrating unexpected results under MPEP § 716.02(c).
In response to this arguments and to the Hoggarth declarations, it is argued that the carbomers currently claimed by the new claims is taught by Hardy and Mershon. TXA is taught by Bartley, and chitosan taught by Hardy, Bartley and Korobov. Hardy teaches the claimed NF934, NF974, NF971, and NF980 and teaches the claimed chitosan lactate. The combination of the cited references teaches the claimed product, and any properties applicants achieved is expected. Note that the claims do not recite amounts of any ingredients that used by the declaration.
Applicants argue that the data in the First Hoggarth Declaration demonstrate that incorporating tranexamic acid into the chitosan-salt/carbomer framework of Hardy yields dramatic and wholly unexpected performance advantages. These advantages include complete elimination of fluid penetration at dilution levels where the prior-art product fails, significantly increased gauze-to-gauze adhesion that enhances dressing stability, and, most importantly, pronounced improvements in hemostasis in coagulopathic swine, where Celox Rapid TXA achieves hemostasis after short compression times under conditions in which Celox Rapid alone does not. These results represent a qualitative improvement in addressing a well-recognized clinical challenge-achieving rapid hemostasis in coagulopathic trauma patients-and nothing in Hardy, Bartley, Korobov, or Mershon suggests that adding tranexamic acid to a carbomer-based chitosan salt dressing would produce such an effect. Because claims 20 to 28 are limited to the precise three-component combination evaluated in the First Hoggarth Declaration, the unexpected results are fully commensurate with their scope.
In response to this argument, it is argued that the specific elements claimed by the new claims are taught by the cited references, as set forth in this office action. The combination of the cited references teaches the claimed chitosan lactate, TXA and bioadhesive. The claims do not recite any amounts used by the declaration that exhibit the unexpected results. Further, the declaration is not using the claimed product comprising carrier and hemostatic material applied on the carrier as claimed. The declaration does not show how much TXA is included in the article? Hardy achieves hemostasis by compressing for less than one minute on the hemostatic article, and Bartley teaches: “The use of a chitosan/tranexamic acid dressing could have a wide range of potential beneficial applications… and teaches hemostasis in anticoagulated patients.” This is enough teaching to motivate one having ordinary skill in the art to combine both chitosan and tranexamic in any hemostatic article. When TXA is combined with chitosan of Hardy, the produced article is expected to achieve what applicants achieved. If the claimed combination taught by the prior art does not work, then why the same ingredients did work when combined by the applicants? Note that applicants used compression on the hemostatic material to achieve hemostasis as claimed by claim 15.
Applicants argue that the Second Hoggarth Declaration further reinforces the patentability of claims 20 to 28. In response to the Examiner's concern that the initial unexpected results might be limited to a single formulation, the Second Hoggarth Declaration demonstrates that the relevant physical effects-specifically, the softening of the hydrated chitosan-salt gel and the enhancement of gauze to-gauze adhesion-are robust and arise from the claimed structural combination. The Second Hoggarth Declaration shows that these effects occur when tranexamic acid is used with the same classes of chitosan salts and carbomer bioadhesives recited in the claims, including carbomer NF980, and that similar physical behavior is observed across various combinations of antifibrinolytic agents and acrylic-acid-based bioadhesives. Although the claims are limited to tranexamic acid and not to broader antifibrinolytics, the Second Hoggarth Declaration nonetheless confirms that the observed improvements are attributable to the interaction of the claimed components and not to a singular or anomalous formulation. This evidence demonstrates that the mechanism underlying the unexpected performance of Celox Rapid TXA is characteristic of the claimed chitosan-salt/carbomer/TXA system as a whole and not the result of isolated or unrepeatable conditions.
In response to this argument, it is argued that even if the second declaration shows the effect of various anti-fibrinolytic agents and bioadhesives in different combinations, the used anti-fibrinolytic agents and bioadhesives that are known in the art and taught by the cited references to achieve hemostasis. The claimed elements are taught by the cited references and the properties of such elements are inseparable from the elements. Same elements of the prior art and instantly claimed cannot have mutually exclusive characteristics. The discovery of a new action underlying a known process does not make it patentable. MEHL/Biophile, 192 F.3d at 1365, 52 U.S.P.Q.2d at 1303. Also, it is irrelevant that the prior art observers did not recognize the property or function of the disputed claim; if the prior art inherently possessed that characteristic, it anticipates. See Verdeegal Brothers, lnc. v. Union Oil Co. of Cal., 814 F.2d 628, 633, 2 U.S.P.Q.2d 1051, 1054 (Fed. Cir. 1987). This is believed to be applicable here because anticipation is the epitome of obviousness.
Note that Bartley teaches tranexamic acid inhibits fibrinolysis and successfully controls bleeding in anti-coagulated patients during surgery. Anticoagulated patients are patients under similar coagulopathic conditions. Therefore, it was known before the effective filing date of the present invention that TXA controls bleeding in coagulopathic patients during surgery. Hardy seeks hemostasis during surgery. Usually patient undergoing surgery have to discontinue taking anticoagulant drugs to avoid bleeding during surgery. However, Bartley controls bleeding during surgery in patients continue to take anti-coagulant drugs by using TXA. Hardy teaches compression up to a minute, and if needed more time is provided. It is expected that the use of more than hemostatic agents, e.g. chitosan and TXA, would decrease the time required for hemostasis. One having ordinary skill in the art would have used TXA in hemostatic material of Hardy to control bleeding during surgery wherein the patient is in conditions similar to coagulopathic condition. Therefore, the results applicants achieved is not unexpected in view of the cited art. Further, the claims are not directed to hemostasis in coagulopathic patients, the claims are directed to hemostatic material.
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition that is to be used for the very same purpose; the idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 205 USPQ 1069.The cited references show that it was well known in the art at the time of the invention to use the claimed ingredients as hemostatic agents. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. ln re Pinten, 459 F.2d 1053, 173 USPQ 801 (CCPA 1972); ln re Susi, 58 CCPA 1074, 1079-80) 440 F.2d 442, 445; 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21; 279 F.2d 274, 276-277; 126 USPQ 186, 188 (1960). Based on the disclosure by the cited references that these elements are used in hemostatic compositions, an artisan of ordinary skill would have a reasonable expectation that a combination of the elements would also be useful in creating hemostatic compositions. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See ln re Sussman, 1943 C.D. 518; In re Huellmantel 139 USPQ 496; ln re Crockett 126 USPQ 186.
Conclusion
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.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./