DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/13/2026, 08/22/2025, 03/26/2025, 08/07/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Status of the Claims
The response and amendment filed 06/01/2026 is acknowledged.
Claims 1-20 are pending.
Claims 1, 12, and 17 are independent.
The restriction dated 06/01/2026 has been withdrawn after a search and consideration of the prior art.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4, 6, 7, 8, and 11 are rejected under 35 U.S.C. 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Surti, US 20170232141.
Surti teaches a method of treatment comprising inserting a delivery system into the gastrointestinal tract of a patient (Surti, e.g., 0102), wherein the bleeding lesion is the surface of the stomach (Surti, e.g., 0042-0043 and example 1).
The method comprises applying a first composition comprising a hemostatic agent (Surti, e.g., 0021, and 0090).
The method comprises applying a second composition, i.e., a protective covering composition (Surti, e.g., 0021, and 0090). The protective covering composition comprises polymers (Surti, e.g., 0012, 0025, and 0054-0058).
Applicable to claim 3: Surti teaches the hemostatic composition or the protective covering composition may further comprise additional ingredients such as one or more buffering agents (Surti, e.g., 0075), where the buffering agents include, e.g., magnesium hydroxide, sodium bicarbonate and combinations thereof (Surti, e.g., 0080).
Applicable to claim 4: Surti teaches the protective covering comprising a polyester (Surti, e.g., 0060-0062).
Applicable to claim 6: Surti teaches the protective covering composition comprising a polymer comprising polyvinyl alcohol (Surti, e.g., 0011-0012, 0025, 0036), and/or polyethylene oxide (Surti, e.g., 0057).
Applicable to claim 8: Surti teaches the hemostatic composition in the form of a powder (Surti, e.g., 0044-0051, and 0088, and claim 1).
Applicable to claim 11: Surti teaches the protective covering composition in the form of a powder (Suri, e.g., 0044-0051, and 0088, and claim 1) including a pH modifying material in the form of a powder wherein the pH modifying material is calcium carbonate (Surti, e.g., example 2, 0119).
Surti anticipates the subject matter of instant claims 1, 3, 4, 6, 8, and 11.
Claim Rejections - 35 USC § 103
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 of this title, 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.
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, 3-4, 6-8, 10-11 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Surti, US 20170232141 in view of Enestvedt, WO 2019133894 A1.
The teachings of Surti enumerated above apply here. Surti teaches applying the protective covering (second composition as claimed) composition to the target site once active bleeding has stopped or slowed after applying the hemostatic composition (Surti, e.g., 0012).
Surti does not expressly teach applying the time frame of from 1 second to 30 seconds after applying the hemostatic composition.
Enestvedt teaches similar methods for treating gastrointestinal bleeds (Enestvedt, e.g., Abstract, pg. 1). Enestvedt teaches a method comprising applying a hemostatic chitosan dressing to control bleeding, e.g., effective to control a Forrest 1a hemorrhage upon application within 30 seconds to 3 minutes (Enestvedt, e.g., ¶ bridging pp. 3-4).
The time period of within 30 seconds to 3 minutes overlaps with the claimed range. In 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). MPEP 2144.05.
It would have been obvious before the effective filing date of the presently claimed invention to modify the method of Surti by optimizing the time frame for applying the second protective composition within a time frame suggested by the prior art with a reasonable expectation of success. Since Surti suggests practicing the method by applying the second composition after bleeding has stopped or slowed, the skilled artisan would have applied the second composition within known time frames for stopping or controlling similar bleeds with a reasonable expectation of success. Depending on the type of bleed being treated and the amount of hemostatic composition applied the skilled artisan would have optimized the time for applying the second composition to achieve the desired lesion protection suggested by Surti. Since Enestvedt teaches similar methods for treating gastrointestinal bleeds the skilled artisan would have had a reasonable expectation of using the time frame known from Enestvedt as a starting point from which to optimize timing for applying the protective composition in Surti’s method.
Applicable to claim 3: Surti teaches the hemostatic composition or the protective covering composition may further comprise additional ingredients such as one or more buffering agents (Surti, e.g., 0075), where the buffering agents include, e.g., magnesium hydroxide, sodium bicarbonate and combinations thereof (Surti, e.g., 0080).
Applicable to claim 4: Surti teaches the protective covering comprising a polyester (Surti, e.g., 0060-0062).
Applicable to claims 6 and 12: Surti teaches the protective covering composition comprising a polymer comprising polyvinyl alcohol (Surti, e.g., 0011-0012, 0025, 0036), and/or polyethylene oxide (Surti, e.g., 0057).
Applicable to claims 7 and 14: Surti does not exemplify a single embodiment comprising a combination of sodium alginate and a cellulose polymer chosen from hydroxypropylmethylcellulose, methyl cellulose, ethyl cellulose, hydroxylpropylcellulose, hydroxyethylcellulose, or carboxymethylcellulose. However, Surti teaches the protective coating composition comprising mucoadhesive polymers, wherein the mucoadhesive polymers include sodium alginate and cellulose derivatives, e.g., methyl cellulose, carboxymethylcellulose, hydroxypropylmethylcellulose, and hydroxypropylcellulose (Surti, e.g., 0011, 0012, 0036). It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to formulate a protective coating composition comprising sodium alginate and a cellulose derivative, e.g., e.g., methyl cellulose, carboxymethylcellulose, hydroxypropylmethylcellulose, and hydroxypropylcellulose with a reasonable expectation of success. The skilled artisan would have seen this modification as a combination of known mucoadhesive polymers expressly suggested to improve the adhesion of the protective coating to tissue to arrive at a protective coating composition useful for the same purpose. See MPEP 20144.06. The results would have been predictable because each of the polymers named in Surti improve the adhesiveness of the composition to tissue.
Applicable to claims 8 and 15: Surti teaches the hemostatic composition in the form of a powder (Surti, e.g., 0044-0051, and 0088, and claim 1).
Applicable to claim 11: Surti teaches the protective covering composition in the form of a powder (Suri, e.g., 0044-0051, and 0088, and claim 1) including a pH modifying material in the form of a powder wherein the pH modifying material is calcium carbonate (Surti, e.g., example 2, 0119).
Accordingly, the subject matter of claims 1, 3-4, 6-8, 10-11 and 12-15 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Surti, US 20170232141 in view of Enestvedt, WO 2019133894 A1 as applied to claims 1, 3-4, 6-8, 10-11 and 12-15 above, and further in view of Na, WO 2006049463 A1.
The combined teachings of Surti and Enestvedt teach a method according to claim 12 as enumerated above.
Surti teaches the hemostatic composition and/or the protective covering may further comprise at least one therapeutic agent (Surti, e.g., 0083). Surti teaches exemplary agents including, e.g., antibiotics, antiseptic agents, and proton pump inhibitors. Surti does not expressly teach a histamine-2 blocker.
Na teaches methods like those of Surti, comprising applying a hemostatic agent to bleeding lesions in the gastrointestinal tract (Na, e.g., Abstract). Na teaches the method comprising administering an H2 receptor antagonist selected from cimetidine, ranitidine, famotidine, nizatidine and rozatidine (Na, e.g., claim 4). As evident from the present specification these appear to be histamine-2 blockers, e.g., famotidine (Spec, 005).
It would have been obvious before the effective filing date of the presently claimed invention to modify a method suggested by Surti and Enestvedt by applying therapeutic agents known and suggested for treating gastrointestinal bleed such as famotidine suggested by Na with a reasonable expectation of success. The skilled artisan would have seen this modification as a substitution of one known therapeutic agent for another where each were suggested for the same purpose. The skilled artisan would have had a reasonable expectation of success since Na is directed to methods for solving the same problems as Surti.
Accordingly, the subject matter of claim 16 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-4, 6-9, 11, 17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Surti, US 20170232141 in view of Na, WO 2006049463 A1.
The teachings of Surti enumerated with respect to claim 1 above apply here.
Applicable to claim 2: Surti teaches applying hemostatic agent in powder form, wherein the hemostatic agent is chitosan. However, Surti does not expressly teach a chitosan salt.
Applicable to claims 2 and 17: Na teaches methods like those of Surti, comprising applying a hemostatic agent to bleeding lesions in the gastrointestinal tract (Na, e.g., Abstract). Na teaches the method including applying a composition to a lesion of a mucous membrane (Na, e.g., 0029). Na teaches the composition comprising chitosan salt of acetic acid (Na, e.g., 0033).
It would have been obvious before the effective filing date of the presently claimed invention to modify a method suggested by Surti by formulating a chitosan salt as the hemostatic agent with a reasonable expectation of success. The skilled artisan would have seen this modification as a substitution of one chitosan for another where each was separately taught in the prior art as a hemostatic agent for treating gastrointestinal bleeds in a patient. The skilled artisan would have had a reasonable expectation of success since Na was directed to solving the same problem as Surti.
Applicable to claim 3: Surti teaches the hemostatic composition or the protective covering composition may further comprise additional ingredients such as one or more buffering agents (Surti, e.g., 0075), where the buffering agents include, e.g., magnesium hydroxide, sodium bicarbonate and combinations thereof (Surti, e.g., 0080).
Applicable to claim 4: Surti teaches the protective covering comprising a polyester (Surti, e.g., 0060-0062).
Applicable to claim 6: Surti teaches the protective covering composition comprising a polymer comprising polyvinyl alcohol (Surti, e.g., 0011-0012, 0025, 0036), and/or polyethylene oxide (Surti, e.g., 0057).
Applicable to claim 7: Surti does not exemplify a single embodiment comprising a combination of sodium alginate and a cellulose polymer chosen from hydroxypropylmethylcellulose, methyl cellulose, ethyl cellulose, hydroxylpropylcellulose, hydroxyethylcellulose, or carboxymethylcellulose. However, Surti teaches the protective coating composition comprising mucoadhesive polymers, wherein the mucoadhesive polymers include sodium alginate and cellulose derivatives, e.g., methyl cellulose, carboxymethylcellulose, hydroxypropylmethylcellulose, and hydroxypropylcellulose (Surti, e.g., 0011, 0012, 0036). It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to formulate a protective coating composition comprising sodium alginate and a cellulose derivative, e.g., e.g., methyl cellulose, carboxymethylcellulose, hydroxypropylmethylcellulose, and hydroxypropylcellulose with a reasonable expectation of success. The skilled artisan would have seen this modification as a combination of known mucoadhesive polymers expressly suggested to improve the adhesion of the protective coating to tissue to arrive at a protective coating composition useful for the same purpose. See MPEP 20144.06. The results would have been predictable because each of the polymers named in Surti improve the adhesiveness of the composition to tissue.
Applicable to claim 8: Surti teaches the hemostatic composition in the form of a powder (Surti, e.g., 0044-0051, and 0088, and claim 1).
Applicable to claims 9 and 20: Surti teaches the hemostatic composition and/or the protective covering may further comprise at least one therapeutic agent (Surti, e.g., 0083). Surti teaches exemplary agents including, e.g., antibiotics, antiseptic agents, and proton pump inhibitors. Surti does not expressly teach a histamine-2 blocker.
Na teaches methods like those of Surti, comprising applying a hemostatic agent to bleeding lesions in the gastrointestinal tract (Na, e.g., Abstract). Na teaches the method comprising administering an H2 receptor antagonist selected from cimetidine, ranitidine, famotidine, nizatidine and rozatidine (Na, e.g., claim 4). As evident from the present specification these appear to be histamine-2 blockers, e.g., famotidine (Spec, 005).
It would have been obvious before the effective filing date of the presently claimed invention to modify a method suggested by Surti by applying therapeutic agents known and suggested for treating gastrointestinal bleed such as famotidine suggested by Na with a reasonable expectation of success. The skilled artisan would have seen this modification as a substitution of one known therapeutic agent for another where each were suggested for the same purpose. The skilled artisan would have had a reasonable expectation of success since Na is directed to methods for solving the same problems as Surti.
Applicable to claim 11: Surti teaches the protective covering composition in the form of a powder (Suri, e.g., 0044-0051, and 0088, and claim 1) including a pH modifying material in the form of a powder wherein the pH modifying material is calcium carbonate (Surti, e.g., example 2, 0119).
Applicable to claim 17: Na teaches the composition comprising chitosan salt of acetic acid (Na, e.g., 0033). Surti teaches the hemostatic composition, or the protective covering composition, may further comprise additional ingredients such as one or more buffering agents (Surti, e.g., 0075), where the buffering agents include, e.g., magnesium hydroxide, sodium bicarbonate and combinations thereof (Surti, e.g., 0080). It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to further modify the first composition to include a pH agent including magnesium hydroxide, sodium bicarbonate and combinations thereof because Surti expressly teaches this optional feature.
Applicable to claim 19: Surti teaches the protective coating comprising mucoadhesive polymers, e.g., polyethylene glycol and/or polyvinyl alcohol (Surti, e.g., 0036) for improved tissue adhesion to maintain the coating at the tissue site with improved residence time.
Accordingly, the subject matter of claims 1-4, 6-9, 11, 17 and 19-20 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Surti, US 20170232141 in view of Na, WO 2006049463 A1 (cited on Applicant’s IDS dated 08/25/2021) as applied to claims 1-4, 6-9, 11, 17 and 19-20 above, and further in view of Enestvedt, WO 2019133894 A1.
The combined teachings of Surti and Na teach applying the protective covering (second composition as claimed) composition to the target site once active bleeding has stopped or slowed after applying the hemostatic composition (Surti, e.g., 0012).
The combined teachings of Surti and Na do not expressly teach applying the time frame of from 1 second to 30 seconds after applying the hemostatic composition.
Enestvedt teaches similar methods for treating gastrointestinal bleeds (Enestvedt, e.g., Abstract, pg. 1). Enestvedt teaches a method comprising applying a hemostatic chitosan dressing to control bleeding, e.g., effective to control a Forrest 1a hemorrhage upon application within 30 seconds to 3 minutes (Enestvedt, e.g., ¶ bridging pp. 3-4).
The time period of within 30 seconds to 3 minutes overlaps with the claimed range. In 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). MPEP 2144.05.
It would have been obvious before the effective filing date of the presently claimed invention to modify the method of Surti and Na by optimizing the time frame for applying the second protective composition within a time frame suggested by the prior art with a reasonable expectation of success. Since Surti suggests practicing the method by applying the second composition after bleeding has stopped or slowed, the skilled artisan would have applied the second composition within known time frames for stopping or controlling similar bleeds with a reasonable expectation of success. Depending on the type of bleed being treated and the amount of hemostatic composition applied the skilled artisan would have optimized the time for applying the second composition to achieve the desired lesion protection suggested by Surti. Since Enestvedt teaches similar methods for treating gastrointestinal bleeds the skilled artisan would have had a reasonable expectation of using the time frame known from Enestvedt as a starting point from which to optimize timing for applying the protective composition in Surti’s method.
Accordingly, the subject matter of claim 18 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1, 3-8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Surti, US 20170232141 in view of Sawhney, US 6514534.
The teachings of Surti enumerated with respect to claim 1 above apply here.
Applicable to claims 4 and 5: Surti teaches the protective covering comprising a polyester (Surti, e.g., 0060-0062). Surti teaches the protective coating composition should form an adhesive, protective barrier (Surti, e.g., 0023, 0090, claims 11-12). Surti teaches the protective coating should be capable of remaining on the tissue site for a time which allows the tissue site to heal, e.g., 72 hours or longer (Surti, e.g., 0031). Surti does not expressly teach the polymer comprising N-hydroxysuccinimide esters.
Sawhney teaches compositions which form tissue protective coatings and adherent barriers with drug delivery options (Sawhney, e.g., Title, Abstract, claims, and c9:5-14). Sawhney teaches polymers comprising reactive ester groups, e.g., N-hydroxysuccinimide esters (Sawhney, e.g., ¶ spanning c9-c10). Alternatively, polymers containing reactive aldehydes may be used (Sawhney, e.g., c10:6-13). These polymer functional groups are equivalent because they each present electrophilic reactive groups, e.g., ester or aldehyde, which are capable of reacting with nucleophilic groups (Sawhney, e.g., c9:5-c10:43). The reactive polymer compositions may be loaded with drugs including hemostatic agents (Sawhney, e.g., ¶ spanning c11-c12). The reactive groups improve tissue adherence and residence time of the barrier (Sawhney, e.g., c5:4-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a protective coating composition in Surti’s method by incorporating polymers comprising an aldehyde or ester group such as N-hydroxysuccinimide as suggested by Sawhney with a reasonable expectation of success. Since Surti teaches the protective coating composition should form a protective barrier and adhere to tissue and enable drug delivery, the skilled artisan would have adopted polymer selection techniques known from Sawhney to improve the barrier and tissue adherent properties offered by reactive polymers taught in Sawhney. The skilled artisan would have had a reasonable expectation of success since both Sawhney and Surti teach polymer compositions effective to form tissue adherent barriers when delivered to local tissue sites.
Applicable to claim 3: Surti teaches the hemostatic composition or the protective covering composition may further comprise additional ingredients such as one or more buffering agents (Surti, e.g., 0075), where the buffering agents include, e.g., magnesium hydroxide, sodium bicarbonate and combinations thereof (Surti, e.g., 0080).
Applicable to claim 4: Surti teaches the protective covering comprising a polyester (Surti, e.g., 0060-0062).
Applicable to claim 6: Surti teaches the protective covering composition comprising a polymer comprising polyvinyl alcohol (Surti, e.g., 0011-0012, 0025, 0036), and/or polyethylene oxide (Surti, e.g., 0057).
Applicable to claim 7: Surti does not exemplify a single embodiment comprising a combination of sodium alginate and a cellulose polymer chosen from hydroxypropylmethylcellulose, methyl cellulose, ethyl cellulose, hydroxylpropylcellulose, hydroxyethylcellulose, or carboxymethylcellulose. However, Surti teaches the protective coating composition comprising mucoadhesive polymers, wherein the mucoadhesive polymers include sodium alginate and cellulose derivatives, e.g., methyl cellulose, carboxymethylcellulose, hydroxypropylmethylcellulose, and hydroxypropylcellulose (Surti, e.g., 0011, 0012, 0036). It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to formulate a protective coating composition comprising sodium alginate and a cellulose derivative, e.g., e.g., methyl cellulose, carboxymethylcellulose, hydroxypropylmethylcellulose, and hydroxypropylcellulose with a reasonable expectation of success. The skilled artisan would have seen this modification as a combination of known mucoadhesive polymers expressly suggested to improve the adhesion of the protective coating to tissue to arrive at a protective coating composition useful for the same purpose. See MPEP 20144.06. The results would have been predictable because each of the polymers named in Surti improve the adhesiveness of the composition to tissue.
Applicable to claim 8: Surti teaches the hemostatic composition in the form of a powder (Surti, e.g., 0044-0051, and 0088, and claim 1).
Applicable to claim 11: Surti teaches the protective covering composition in the form of a powder (Suri, e.g., 0044-0051, and 0088, and claim 1) including a pH modifying material in the form of a powder wherein the pH modifying material is calcium carbonate (Surti, e.g., example 2, 0119).
Accordingly, the subject matter of claims 1, 3-8, and 11 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-16 of US 12083216 in view of Surti, US 20170232141 and Sawhney, US 6514534.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach methods for treating patients comprising:
introducing a medical device into a gastrointestinal system of a patient;
applying a first composition to a target site of the patient with the medical device, the first composition being in powder form and consisting of at least one hemostatic agent in powder form, wherein the target site includes bleeding stomach tissue; and
applying a second composition comprising at least one pH agent in powder form to the target site from 10 seconds to 30 seconds after applying the first composition to increase a pH of the target site;
wherein the at least one hemostatic agent reduces bleeding of the stomach tissue (claim 1 is representative).
The reference claims teach the method comprising applying a second composition, e.g., comprising at least one pH agent in powder form to the target site from 10 seconds to 30 seconds after applying the first composition to increase a pH of the target site but do not expressly teach the second composition comprising a polymer.
However, the teachings of Surti enumerated above teach including polymers in a second coating so that the composition adheres to tissue and protects the site of treatment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify methods claimed by the reference patent by including polymers in the second composition applied with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to protect the tissue site being treated with a composition which remains at the site for a sustained amount of time to allow the tissue site to heal. The skilled artisan would have had a reasonable expectation of success because Surti teaches the polymer containing composition improves healing of tissue treated with a hemostatic agent like the methods of the reference claims.
The reference claims do not expressly teach the polymers of claims 4-7, 12, 14, or 19.
However, the teachings of Surti and Sawhney enumerated above cure this deficiency.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a method suggested by the reference claims and Sawhney by incorporating polymers comprising an aldehyde or ester, e.g., n-hydroxysuccinimide esters of polyethylene glycol, and/or mucoadhesive polymers including sodium alginate and cellulose derivatives e.g., methyl cellulose, carboxymethylcellulose, hydroxypropylmethylcellulose, and hydroxypropylcellulose with a reasonable expectation of success. The skilled artisan would have been motivated to make these modifications to improve adhesion to the target tissue to keep the covering at the desired site and to improve the residence time of the covering to allow the tissue site time to heal. The skilled artisan would have had a reasonable expectation of success since each of the documents teach materials and methods for tissue treatment and healing.
Accordingly, the subject matter of claims 1-20 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM CRAIGO/Examiner, Art Unit 1615
Prosecution Insights