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 .
Information Disclosure Statement
The information disclosure statements filed October 10, 2025 and October 28, 2028 have been received and made of record. Note the acknowledged PTO-1449 forms enclosed herewith.
Specification
The disclosure is objected to because of the following informalities: para.[0047], lines 2, “did failed” should read --failed--. Appropriate correction is required.
Claim Objections
Claims 11, 17 and 20 is objected to because of the following informalities: claim 11, “a clot time” should read --the clot time--; claim 17, “1 ug/cm2 to 300ug/cm2” should read --1 µg/cm2 to 300 µg/cm2--; and claim 20 should be rewritten as follows “20. The device of claim 1, wherein the device has at least one log reduction in bacterial growth compared to [the] an untreated control (no antimicrobial agent)…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 16, 17, 20, and 21 are 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.
Regarding claim 4, the recitation “(preferably chlorhexidine diacetate or chlorhexidine dichloride) is indefinite in that it is unclear if Applicants are claiming the subjected matter following “preferably”.
Regarding claim 16, the recitation “preferably polyester-rayon” is indefinite in that it is unclear if Applicants are claiming the subjected matter following “preferably”.
Regarding claim 17, the recitation “preferably 1 to 75, and most preferably 1 to 30” is indefinite in that it is unclear if Applicants are claiming the subjected matter following “preferably” and “most preferably”.
Regarding claim 20, the recitation “the untreated controls” lacks proper antecedent basis. Further the recitation,” preferably greater than 2 log and most preferably greater than 4 log reduction in bacterial growth compared to an untreated (no antimicrobial agent) control” is indefinite in that it is unclear if Applicants are claiming the subjected matter following “preferably” and “most preferably”.
Regarding claim 21, “the medical device” lacks proper antecedent basis.
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.
Claim(s) 1-4, 15, 17-19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 8,114,433 (“hereinafter “Huey”) in view of U.S. Patent Application Publication No. 2015/0283286 (hereinafter “Eastwood”).
Regarding claim 1, Huey discloses clay-based hemostatic agents and devices for the delivery thereof that substantially discloses Applicants’ claimed invention. More specifically, Huey discloses an antimicrobial hemostatic device, comprising: a substrate (gauze, see the abstract) configured to be in contact with a bleed (see the abstract), said substrate comprising: a hemostatic agent (clay, see the abstract which discloses ‘[w]hen the device is used to treat a bleeding wound, at least a portion of the clay material comes into contact with blood emanating from the wound to cause the clotting” and col. 5, lines 11-12 which discloses in “one preferred embodiment of the present invention, the claimed material is kaolin”), an antimicrobial agent (see col. 5, lines 42-48 which discloses “…materials may be mixed with, or incorporated into the kaolin…such as …antimicrobial agents” ), and a binder configured to maintain the hemostatic agent with the substrate (see col. 8, lines 26-27 which discloses “the kaolin may be attached to the gauze substrate using a binder”).
Huey fails to disclose the antimicrobial agent is a biguanide based antimicrobial agent, or a pharmaceutically acceptable salt thereof. However, Eastwood in the disclosure of analogous hemostatic compositions and dressings for bleeding teaches it is known to provide a hemostatic dressing incorporating at least kaolin (abstract) and an antimicrobial agent such as chlorhexidine (see para. [0067]), which is a known biguanide.
In view of Eastwood, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have used chlorhexidine as the antimicrobial agent in the hemostatic device of Huey since it is a broad spectrum antimicrobial agent that is commonly used provide protection against bacteria and viruses.
Regarding claim 2, modified Huey discloses the device of claim 1, wherein the binder is glycerin (note col. 8, lines 26-31 and 59-66, which disclose binder is a polyol and wherein the polyol may be glycerin).
Regarding claim 3, modified Huey discloses the device of claim 1, wherein the hemostatic agent is kaolin (note the disclosure of kaolin, see col. 4, lines 60-61, col. 5, lines 11-13 and the rejection of claim 1 above).
Regarding claim 4, modified Huey discloses the device of claim 1, wherein the biguanide based antimicrobial agent is chlorhexidine (preferably chlorhexidine diacetate or chlorhexidine dichloride) or polyhexamethylene biguanide (PHMB) (note the rejection of claim 1 above, which discloses the antimicrobial agent is chlorhexidine).
Regarding claim 15, modified Huey discloses the device of claim 1, wherein the substrate is a textile (see col. 7, lines 39-43, which discloses the gauze may be constructed from cotton, polyester, silk, etc.; these are textile materials).
Regarding claim 17, modified Huey discloses the device of claim 1, except wherein the biguanide based antimicrobial agent is present in an amount of 1 g/cm2 to 300 µg/cm2, preferably 1 to 75, and most preferably 1 to 30. However, Everwood in para. [0065] discloses the “amount of additional therapeutic agent present in the compositions of this invention will typically be no more than the amount that would normally be administered in a composition comprising that therapeutic agent as the only active agent. In certain embodiments, the amount of additional therapeutic agent in the inventive compositions will range from about 50% to 100% of the amount normally present in a composition comprising that agent as the only therapeutically active agent”.
In view of Everwood, it would have been obvious to one having ordinary skill in the art, through routine experimentation, to have provided the biguanide, chlorhexidine, in an amount of 1 g/cm2 to 300 µg/m2 in order to provide a broad spectrum, long lasting antimicrobial barrier that kills bacteria, viruses and fungi to reduce the risk of infections at the wound site.
Regarding claim 18, modified Huey discloses the device of claim 1, wherein the substrate consists essentially of the hemostatic agent, the biguanide based antimicrobial agent, and the binder (see col. 8, line 59-col. 9, line 4, which discloses the substrate consists essentially of the hemostatic agent kaolin, the binder, and as can be read from col. 5, lines 42-48, an antimicrobial may be mixed with the kaolin to maintain an antiseptic environment).
Regarding claim 19, modified Huey discloses the device of claim 1, wherein the substrate consists of the hemostatic agent, the biguanide based antimicrobial agent, and the binder (see also col. 8, line 59-col. 9, line 4, which discloses the substrate consists essentially of the hemostatic agent kaolin, the binder, and as can be read from col. 5, lines 42-48, an antimicrobial may be mixed with the kaolin to maintain an antiseptic environment; note the rejection of claim 1 above which discloses the antimicrobial agent is a biguanide).
Regarding claim 21, modified Huey discloses the method of controlling or lessening the severity of bleeding, comprising contacting the substrate of the medical device of claim 1 with a bleed (note the abstract which discloses “[w]hen the device is used to treat a bleeding wound, at least a portion of the clay material comes into contact with blood emanating from the wound to cause the clotting”; thus the device of modified claim 1 discloses a method of lessening the severity of bleeding by causing clotting, and method comprises contacting a bleeding wound with the gauze substrate).
Claim(s) 5-8 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Huey in view of Eastwood as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2020/0254139 (hereinafter “Phillips”).
Regarding claim 5, modified Huey discloses the device of claim 1, except wherein said substrate further comprises an effective amount of a silver-based antimicrobial. However, Phillips in the disclosure of an analogous device teaches that it is known to provide a hemostatic device with hemostats such as kaolin (see para. [0164] and a combination of antimicrobials such as biguanides and disinfectants such as silver derivatives including silver oxide, silver nitrate, silver acetate and silver chloride, for the inherent purpose of targeting distinct antimicrobial spectrums.
In view of Phillips, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have provided the gauze substrate with an additional antimicrobial agent such as silver nitrate in order target distinct antimicrobial spectrums not covered by the biguanide antimicrobial agent.
Regarding claim 6, modified Huey discloses the device of claim 1, wherein the silver-based antimicrobial is colloidal silver, silver chloride, silver sulfadiazine, or silver nitrate (note the rejection of claim 5 above).
Regarding claim 7, modified Huey discloses the device of claim 1, except wherein said substrate further comprises an effective amount of an antimicrobial iodine compound.
However, Phillips in the disclosure of an analogous device teaches that it is known to provide a hemostatic device with hemostats such as kaolin (see para. [0164] and a combination of antimicrobials such as biguanides and disinfectants such as silver derivatives including silver oxide, silver nitrate, silver acetate and silver chloride (see para. [0162], which discloses combination materials). Phillips also discloses disinfectants such as iodine, e.g., povidone iodine (see para. [0163]) for the inherent purpose of targeting distinct antimicrobial spectrums.
In view of Phillips, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have provided the gauze substrate with an additional antimicrobial agent such iodine, e.g., povidone iodine, in order target distinct antimicrobial spectrums not covered by the biguanide antimicrobial agent.
Regarding claim 8, modified Huey discloses the device of claim 7, wherein the antimicrobial iodine compound is povidone-iodine or cadexomer iodine (note the rejection of claim 7 above).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huey in view of Eastwood as applied to claim 1, and further in view of In-vitro Analysis of Hemostatic Cotton Khadi Dressing with Kaolin/Chitosan-based Composition and Its Application as Prospective Wound Dressing (hereinafter “Raval”).
Regarding claim 9, modified Huey discloses the device of claim 1, except wherein a clot time for the device is less than 180 seconds. However, Raval discloses that average clotting time is calculated after 30 µl of blood comes into contact with the gauze to the time is fully clotted. The comparative analysis shows that the standard cotton gauze requires an average of 132.9 seconds for complete clotting; thus, cotton gauze with an added hemostat agent will clot at an average time less than standard cotton gauze. The standard cotton gauze does not have a hemostatic agent.
In view of Raval, it would have been obvious to one having ordinary skill in the art that since standard cotton gauze requires an average of 132.9 seconds for complete clotting, cotton gauze with an added hemostat will clot at a time less and 132.9 seconds on average, which is less than 180 seconds.
Regarding claim 10, modified Huey discloses device of claim 9, wherein the clot time for the device is less than 150 seconds (note the rejection of claim 9 above).
Regarding claim 11, modified Huey discloses the device of claim 9, except wherein a clot time for the device is between 100 and 150 seconds. However, depending upon the size of the wound and the amount of kaolin that is provided in and on the gauze, will determine the clot time.
However, it has been held that “[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP §2144.05).
Therefore, it would have been obvious to one of ordinary skill in the art at before the filing of the claimed invention, to optimize the amount of kaolin based on the size of a wound, such that clot time is between 100 seconds and 150 seconds in order to provide expedient clotting in order to prevent excessive blood loss.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huey in view of Eastwood as applied to claim 15 above, and further in view of EP 0504715 A2 (hereinafter “Weaver”).
Regarding claim 16, modified Huey discloses the device of claim 15, except wherein the textile is a gauze, preferably polyester-rayon (interpreted as the textile is a polyester-rayon gauze). However, Weaver in the disclosure of an analogous gauze used in wound treatment, teaches is it is known to construct gauze from a rayon polyester blend (see col. 7, lines 36-42).
Applicant is reminded that it has been held that the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have constructed the gauze of modified Huey from a polyester rayon blend, as taught by Weaver, since the blend reduces linting and are less likely to adhere to wounds compared to cotton gauze.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huey in view of Eastwood as applied to claim 1 above, and further in view of U.S. Patent No. 2011/0086078 (“hereinafter Gooch”).
Regarding claim 20, modified Huey discloses the device of claim 1, except wherein the device has at least one log reduction in bacterial growth (as interpreted) compared to an untreated (no bacterial agent) control (as interpreted), preferably greater than 2 log and most preferably greater than 4 log reduction in bacterial growth compared to an untreated (no antimicrobial agent) control.
However, Gooch in the disclosure of an analogous antimicrobial dressing comprising a biguanide (see the abstract) teaches it is known to obtain approximately Log-6 to Log reduction in bacteria (see Table 3 and para. [0121]).
In view of Gooch, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the amount of antimicrobial agents in the modified gauze substrate of Huey such that there is enhanced antimicrobial activity, wherein the gauze has a between log 6 to log 8 reduction of bacteria in order to increase the rate of wound healing.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huey in view of Eastwood as applied to claim 1 above, and further in view of U.S. Patent Application No. 2013/0029030 (hereinafter “Larsen”).
Regarding claim 22, modified Huey discloses a method of preparing a device of claim 1, comprising: combining the hemostatic agent, an antimicrobial agent (see col. 5, lines 42-48 which discloses mixing an antimicrobial with the kaolin), and binder in a liquid carrier to form a composition (as can be read from col. 8, lines 59-65 discloses mixing kaolin (hemostatic agent) with glycerol (binder) and depositing the mixture on the gauze substrate by any suitable method); dipping or spraying the substrate in the composition (col. 8, line 66-col. 9, line 4 discloses spraying); and drying the substrate after the dipping or spraying (see Example 3 in col. 12 which discloses the saturated gauze is dried).
Modified Huey fails to explicitly disclose mixing the biguanide antimicrobial agent with kaolin. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have, during manufacturing of the modified gauze of Huey, mix the biguanide antimicrobial agent with the kaolin since Huey discloses mixing and antimicrobial agent with the kaolin.
Modified Huey further fails to disclose drying is at a temperature less than 80 degrees C. However, Larsen in the disclosure of an analogous hemostatic devices teaches it is known to spray hemostatic devices with pharmaceutical compositions (see the abstract, para. [0002] and para. [0270]) and then dry them in an oven preferably 45 degrees C (see para. [0300]-[0304]). However the devices may be dry from the 15 degrees C to 60 degrees C (see para.[0305]), which is less than 80 degrees C, in order to prevent the device from changing its physico-chemical properties (see para. [0038]).
In view of Larsen, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have dried the modified hemostatic device of Huey at a temperature less than 80 degrees in order to prevent the device from changing its physico-chemical properties.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huey in view of Everwood and Larsen as applied to claim 22 above, and further in view of U.S. Patent 4,292,972 (hereinafter “Pawelchak”).
Regarding claim 23, modified Huey discloses the method of claim 22, except that the method further comprises the step of sterilizing the substrate after drying with gamma radiation. However, Pawelchak in its disclosure of an analogous hemostatic dressing (see the abstract, which discloses the invention is a foam sponge product having medically useful hemostat and adhesive properties) that is sterilized by gamma radiation after it is dried (see col. 4 line 57-col. 5, line 8).
In view of Pawelchak, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have sterilized the final product (modified gauzed substrate) after drying, in order to ensure the device, when placed on a wound, is sterile to reduce the risk of infection and to promote faster healing.
Allowable Subject Matter
Claims 12-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach or fairly suggest to one alone or in combination the weight ratios of biguanide antimicrobial agents to the hemostatic agents. Specifically, the prior fails to teach the device of claim 1, wherein a weight ratio of the biguanide based antimicrobial agent to the hemostatic agent is less than 0.04, as recited in claim 12, or device of claim 12, wherein the weight ratio is between 0.04 and 0.001, or the
device of claim 13, wherein the weight ratio is between 0.02 and 0.001.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIM M LEWIS whose telephone number is (571)272-4796. The examiner can normally be reached Monday -Friday 5:30 am -11:30 am.
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/KIM M LEWIS/Primary Examiner, Art Unit 3786