DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Applicant’s amendments to the claims of April 16, 2026, in response to the Office Action of October 16, 2026, are acknowledged.
Response to Arguments
In view of Applicant’s amendments to the claims, the rejections under Section 112 and the rejection under Section 102 are withdrawn. Further, the Objection to the Drawings is held in abeyance pending a decision on the Petition to Accept Color Drawings. The rejection under Section 103 is moot in view of the amendments to the claims and the new prior art applied below in an effort to address those amendments.
Applicant has amended the claims to require either a, b, or c, and at least one of (a) through (f). Further, if (b) is selected, a mucoadhesive gel is required to have an additional component.
For example, the claims require sustained release injectable gel having epinephrine and including a degradable polymer. The degradable polymer include one of a-f, which can be about 0.8% to about 5% chitosan.
The previously cited prior art teaches injectable gel formulations comprising epinephrine for treating ulcers, lesions, and other wounds associated with the GI tract. It can further include chitosan and sodium alginates. It does not teach using a claimed concentration of chitosan and xanthan gum. The examiner cites Male and Phillips below, which teach hemostatic gels formulations that comprise a claimed concentration of chitosan.
In a second rejection, the examiner cites Lee for teaching a claimed concentration of chitosan or xanthan gum.
Male et al., (US20210236642) teaches a hemostatic gel composition that is injectable and includes chitosan as the polysaccharide component. See par.’s 66-69. Chitosan is already available in the market in many forms. Se par. 70. It has a preferred concentration in the range of 2% to 10%. See par. 74. In Example 3, chitosan is used in a concentration of 4%.
Phillips et al., (US2017/0035861) teaches flowable hemostatic gel compositions that can include polycationic polymers that form clots , wherein the polymer includes chitosan. See par. 16. Embodiments described the use of 1% chitosan and well as 2-3% chitosan. See par. 22. In one example 2% chitosan is used with 2% sodium alginate. See par. 68. Strong gels were shown to form with both alginate and chitosan. See par. 75. A bioadhesive agent that can be used includes PVP. See prior art claim 9. A bioadhesive can be used in a concentration of about 10% to about 20%. See par. 31. The flowable gel can includes at least one additional active agent. A predetermined release profile can be established, such as an extended release slower rate. For example, thrombin can be released at a predefined profile. See par. 28 and 29. The release rate of the active agent can be tunable by altering hardening time, gel strength, resistance to degradation, etc. See par. 42.
Lee et al., (US20200114047) teaches a composition to repair mucosal tissues during an endoscopic procedure wherein a polysaccharide and an alginic acid salt is used therein. The compositions can be injected submucosally. See Abstract. An amount of alginic acid salt can be used in a concentration of 0.5% to 2%. Further, sodium alginate is used as a polymer that is viscous. A most preferred concentration of 0.05 to 1%. The polysaccharide includes xanthan gum or chitosan in a concentration of 0.01 to 2%. See par. 34.
As such, rejections are set forth below.
Status of the Claims
Claims 2, 5, 11-13, 17, 19, 21-28, 30, 31, 34-40, 45-47, 50, 51, 56-58, 60, 61, and 72-75 are pending. Claims 2, 5, 11-13, 17, 19, 21-28, 30, 31, 34-40, 45-47, 50, and 51 are withdrawn. Claims 56-58, 60, 61, and 72-75 are examined.
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, 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.
Claims 56-58, 60, 61, and 72-75 are rejected under 35 U.S.C. 103 as being unpatentable Surti et al., (US2017/0232141), in view of Male et al., (US20210236642), and in view of Phillips et al., (US2017/0035861).
Surti teaches a method for treating a lesion site in a gastrointestinal tract. See Abstract. Surti also teaches treating tumors and sealing perforations, e.g. See par. 3. These include GI motility, GI infection, GI inflammation, lesions, wounds, endoscopic procedures, polypectomy, and others. See par. 4. Localized delivery to a target site can be through a catheter or injection with a therapeutic agent. See par. 6. The composition can be in the form of a hemostatic gel comprising a coating comprising an adhesion agent, including chitosan and sodium alginates. See par. 11. The adhesive agent can be a mucoadhesive agent. See par. 12. Ulcers and cancer are taught to be treated. See par. 19. The hemostatic composition and a protective coating can be delivered separately. The hemostatic layer can include hemostatic agents, such as epinephrine among a limited list of hemostatic agents. See par.’s 11 and 33. The composition can bind to a mucosal and submucosal layer at a site of a lesion. See par. 35 and 37. As mucoadhesive agents are often hydrophilic they are capable of forming bonds at the site. Mucoadhesive agents include sodium alginates, PVP, and others. Additional therapeutic agents can be incorporated into the composition. See par. 84. These agent include antibiotics, among others. See par. 83. The composition can be applied through endoscopic techniques. See par. 91. The composition can be applied on the lesion itself to ensure the most complete coverage as possible. See par. 28. The mucoadhesive agent can adhere to the hemostatic agent or the mucous membrane by a physical or chemical force. See par. 37.
Male teaches a hemostatic gel composition that is injectable and includes chitosan as the polysaccharide component. See par.’s 66-69. Chitosan is already available in the market in many forms. Se par. 70. It has a preferred concentration in the range of 2% to 10%. See par. 74. In Example 3, chitosan is used in a concentration of 4%.
Phillips teaches flowable hemostatic gel compositions that can include polycationic polymers that form clots , wherein the polymer includes chitosan. See par. 16. Embodiments described the use of 1% chitosan and well as 2-3% chitosan. See par. 22. In one example 2% chitosan is used with 2% sodium alginate. See par. 68. Strong gels were shown to form with both alginate and chitosan. See par. 75. A bioadhesive agent that can be used includes PVP. See prior art claim 9. A bioadhesive can be used in a concentration of about 10% to about 20%. See par. 31. The flowable gel can includes at least one additional active agent. A predetermined release profile can be established, such as an extended release slower rate. For example, thrombin can be released at a predefined profile. See par. 28 and 29. The release rate of the active agent can be tunable by altering hardening time, gel strength, resistance to degradation, etc. See par. 42.
The examiner notes that the use of a viscous agent in a composition will have an effect of providing some level of sustained or slowed release of a therapeutic agent incorporated therein. The slower the degradation of the carrier, the slower the release that would be expected.
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); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
It would have been prima facie obvious to a person of ordinary skill in the art prior art prior to the filing of the instant application to combine the teachings of Surti, Male, and Phillips to arrive at the claimed methods. One would be motivated to do so because the claimed agent epinephrine is known to be combined with biodegradable and mucoadhesive polymers for administration to treat lesions and stop bleeding. Further, such compositions can be in the form of an injectable gel that can be delivered by multiple means including through an endoscopic administration to the GI tract and other organs in combination with additional therapeutic agents. The mucoadhesive agent, including chitosan, can be coated and/or sprayed onto a lesion site. The composition can include a layer that is mucoadhesive and this would be understood to include a coating, e.g., to adhere to the location of a lesion or other area in which a composition is intended to target. Further, an amount of chitosan for inclusion in hemostatic compositions is known to be in a concentration that falls within the claimed range. Thus, a biodegradable gel comprising a hemostatic agent including epinephrine and including a mucoadhesive agent that can be a coating. As such, there is a reasonable and predictable expectation of success in arriving at the claimed methods in view of the cited prior art for the reasons set forth above.
As such, no claim is allowed.
Claims 56-58, 60, 61, and 72-75 are rejected under 35 U.S.C. 103 as being unpatentable Surti et al., (US2017/0232141), in view of Lee et al., (US20200114047).
Surti teaches a method for treating a lesion site in a gastrointestinal tract. See Abstract. Surti also teaches treating tumors and sealing perforations, e.g. See par. 3. These include GI motility, GI infection, GI inflammation, lesions, wounds, endoscopic procedures, polypectomy, and others. See par. 4. Localized delivery to a target site can be through a catheter or injection with a therapeutic agent. See par. 6. The composition can be in the form of a hemostatic gel comprising a coating comprising an adhesion agent, including chitosan and sodium alginates. See par. 11. The adhesive agent can be a mucoadhesive agent. See par. 12. Ulcers and cancer are taught to be treated. See par. 19. The hemostatic composition and a protective coating can be delivered separately. The hemostatic layer can include hemostatic agents, such as epinephrine among a limited list of hemostatic agents. See par.’s 11 and 33. The composition can bind to a mucosal and submucosal layer at a site of a lesion. See par. 35 and 37. As mucoadhesive agents are often hydrophilic they are capable of forming bonds at the site. Additional therapeutic agents can be incorporated into the composition. See par. 84. These agent include antibiotics, among others. See par. 83. The composition can be applied through endoscopic techniques. See par. 91. The composition can be applied on the lesion itself to ensure the most complete coverage as possible. See par. 28. The mucoadhesive agent can adhere to the hemostatic agent or the mucous membrane by a physical or chemical force. See par. 37.
Lee teaches a composition to repair mucosal tissues during an endoscopic procedure wherein a polysaccharide and an alginic acid salt is used therein. The compositions can be injected submucosally. See Abstract. An amount of alginic acid salt can be used in a concentration of 0.5% to 2%. Further, sodium alginate is used as a polymer that is viscous. A most preferred concentration of 0.05 to 1%. The polysaccharide includes xanthan gum or chitosan in a concentration of 0.01 to 2%. See par. 34.
The examiner notes that the use of a viscous agent in a composition will have an effect of providing some level of sustained or slowed release of a therapeutic agent incorporated therein. The slower the degradation of the carrier, the slower the release that would be expected.
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); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
It would have been prima facie obvious to a person of ordinary skill in the art prior art prior to the filing of the instant application to combine the teachings of Surti and Lee to arrive at the claimed methods. One would be motivated to do so because the claimed agent epinephrine is known to be combined with biodegradable and mucoadhesive polymers for administration to treat lesions and stop bleeding. Further, such compositions can be in the form of an injectable gel that can be delivered by multiple means including through an endoscopic administration to the GI tract and other organs in combination with additional therapeutic agents. The mucoadhesive agent, including chitosan, can be coated and/or sprayed onto a lesion site. The composition can include a layer that is mucoadhesive and this would be understood to include a coating, e.g., to adhere to the location of a lesion or other area in which a composition is intended to target. Thus, a biodegradable gel comprising a hemostatic agent including epinephrine and including a mucoadhesive agent that can be a coating. Further, Lee teaches a hemostatic composition comprising an amount of alginic acid salt can be used in a concentration of 0.5% to 2%. Further, sodium alginate is used as a polymer that is viscous. A most preferred concentration of 0.05 to 1%. The polysaccharide includes xanthan gum or chitosan in a concentration of 0.01 to 2%. See par. 34. As such, there is a reasonable and predictable expectation of success in arriving at the claimed methods in view of the cited prior art for the reasons set forth above.
As such, no claim is allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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