The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to Applicants’ amendments/remarks received July 21, 2026.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claims 6, 10-11 are canceled. Claims 1-5, 7-9 are under consideration.
Priority: This application is a 371 of PCT/KR2022/021261, filed December 26, 2022, which claims benefit to foreign applications KR 10-2022-0019745, filed February 15, 2022, and KR 10-2022-0035054, filed March 22, 2022. Copies of the foreign priority documents have been received in the instant application on March 9, 2025, and are not in the English language.
Objections and Rejections
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.
Claims 1-5, 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 20150352049; IDS 08.06.24, previous cited) in view of Ali-Mohamad et al. (2021 Endosc Int Open 09: E693-E698; IDS 11.09.25, previously cited) and Schutte et al. (US 20140369991; previously cited). Kim et al. disclose a pharmaceutical composition in powder form for providing wound protection and hemostasis in the gastrointestinal tract, comprising a mucoadhesive polymer (first component) selected from hydroxyethyl cellulose, polyethylene glycol, and a mixture thereof; and a hygroscopic agent (second component) selected from croscarmellose sodium, sodium starch glycolate, crospovidone, and a mixture thereof (at least paragraphs 0008, 0021, 0023). Kim et al. disclose that the pharmaceutical composition further comprises a wound-healing agent for facilitating wounds (e.g. ulcers and/or lesions) in the gastrointestinal tract (at least paragraph 0027). Kim et al. differ from the claimed invention by not reciting thrombin.
Ali-Mohamad et al. disclose self-propelling thrombin powder (SPTP), an agent that is effective in halting hemorrhage from large arterial bleeds, successfully achieves hemostasis and halts bleeding in the gastrointestinal tract (at least p. E693-E694). Ali-Mohamad et al. disclose the SPTP consists of porous calcium carbonate microparticles (i.e. a water-absorbing material) loaded with thrombin (i.e. a hemostatic agent) (at least p. E694).
Schutte et al. also disclose compositions for hemostasis comprising an absorbable carrier of a biocompatible polymer comprising thrombin particles, where the absorbable carrier is flexible and porous (at least p. 18 claims 1, 5-6, 11), the compositions for hemostasis in the gastrointestinal system (at least paragraph 0120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the thrombin of Ali-Mohamad et al./Schutte et al. for the wound-healing agent in the pharmaceutical composition of Kim et al., comprising a mucoadhesive polymer (first component) selected from hydroxyethyl cellulose, polyethylene glycol, and a mixture thereof; and a hygroscopic agent (second component) selected from croscarmellose sodium, sodium starch glycolate, crospovidone, and a mixture thereof, to thereby arrive at the claimed composition (instant claims 1-5, 7-9). The motivation to do so is given by the prior art, which disclose that thrombin is a hemostatic agent (or wound-healing agent) and can be incorporated into compositions comprising water-absorbable materials for the same purpose as the wound-healing agents of Kim et al., i.e. providing wound healing and hemostasis in the gastrointestinal tract. One of ordinary skill would have a reasonable expectation of success because thrombin is a well-known and widely used wound-healing agent for enhancing hemostatic efficiency.
Regarding instant claim 2, Kim et al. disclose the composition comprises the mucoadhesive agent (first component) and the hygroscopic agent (second component) are present in an amount ranging from 70 to 95 wt/wt% and from 5 to 30 wt/wt%, based on the total weight of the composition, respectively (at least paragraphs 0010, 0025).
Regarding instant claims 3-5, it is noted that the instant claims are still product claims drawn to the pharmaceutical composition for hemostasis, regardless of the intended use and/or results to be achieved recited in the wherein clauses. In this instance, Kim et al. in view of Ali-Mohamad et al./Schutte et al. disclose a composition comprising the same materials recited and can be deemed to disclose the composition of instant claims 3-5, regardless of the results to be achieved by the composition.
Regarding instant claim 7, Schutte et al. disclose a thrombin content of about 10 to 20,000 IU/g (at least paragraph 0072).
Regarding instant claim 8, Kim et al. disclose the pharmaceutical composition in powder form for providing wound protection and hemostasis in the gastrointestinal tract further comprises an inorganic material selected from calcium chloride, calcium phosphate, calcium hydroxide, calcium silicate, and calcium sulfate (at least paragraph 0009).
Regarding instant claim 9, as noted above, Kim et al. disclose the pharmaceutical composition in powder form for providing wound protection and hemostasis in the gastrointestinal tract (at least paragraphs 0008, 0021, 0023).
Reply: Applicants’ amendments/remarks have been considered but they are not persuasive.
Applicants assert that Kim et al. expressly rely on a wound-healing agent selected from epidermal growth factor, keratinocyte growth factor, and basic growth factor, and that Kim et al. fail to teach or suggest thrombin.
Applicants’ remarks are not persuasive. The deficiency of Kim et al. to not teach thrombin is remedied by Ali-Mohamad et al. and Schutte et al., which reasonably disclose that thrombin is a wound healing agent that is incorporated into compositions for the same purpose as the wound-healing agents of Kim et al., i.e. to provide wound healing and hemostasis in the gastrointestinal tract. MPEP 2143 notes that it is obvious to substitute a known element for another to obtain predictable results.
As noted above, Kim et al. differ from the claimed composition by not reciting thrombin. However, it would have been obvious to incorporate the thrombin of Ali-Mohamad et al./Schutte et al. for the wound-healing agent in the pharmaceutical composition of Kim et al. comprising a mucoadhesive polymer (first component) selected from hydroxyethyl cellulose, polyethylene glycol, and a mixture thereof; and a hygroscopic agent (second component) selected from croscarmellose sodium, sodium starch glycolate, crospovidone, and a mixture thereof, to thereby arrive at the claimed composition. The motivation to do so is given by the prior art, which disclose that thrombin is a hemostatic agent (or wound-healing agent) and can be incorporated into compositions comprising water-absorbable materials for the same purpose as the wound-healing agents of Kim et al., i.e. providing wound healing and hemostasis in the gastrointestinal tract. One of ordinary skill would have a reasonable expectation of success because thrombin is a well-known and widely used wound-healing agent for enhancing hemostatic efficiency.
Applicants assert that Ali-Mohamad et al. carry thrombin on porous calcium carbonate microparticles (p. E694) and Schutte et al. carry thrombin on an absorbable carrier of a biocompatible, biodegradable polymer ([0013]). Applicants assert that neither Ali-Mohamad et al. nor Schutte et al. teach or suggest combining thrombin with the first component and the second component recited in instant claim 1.
Applicants’ remarks are not persuasive. Ali-Mohamad et al. and Schutte et al. are not being relied upon for the carriers they disclose to carry or deliver thrombin to the gastrointestinal tract. Ali-Mohamad et al. and Schutte et al. are being relied upon for teaching that thrombin is a healing agent or hemostatic agent that can be delivered in carriers for the same purpose as the wound-healing agents to be incorporated with the mucoadhesive polymer (first component) and hygroscopic agent (second component) composition in Kim et al. for providing wound healing and hemostasis in the gastrointestinal tract. Therefore, it would have been obvious to one of ordinary skill that a thrombin as disclosed in Ali-Mohamad et al./Schutte et al. can reasonably be incorporated as the wound-healing agent in the composition comprising a first component and second component of Kim et al. noted above.
Applicants assert that moreover, the specification demonstrates that combining the first component and second component with only a small amount of thrombin achieves a blood clotting time shorter than that of a sample containing thrombin alone (Table 2, Figs. 1-7).
Applicants’ remarks are not persuasive. In this instance, Kim et al. have already disclosed that the composition comprising a first component and second component as noted above have advantageous effects, including providing rapid wound-protection and hemostasis (at least paragraphs 0013, 0023). Therefore, it would be obvious and expected that a wound healing agent, such as thrombin, when combined with the composition comprising a first component and second component, in a small therapeutic amount, achieves a blood clotting time shorter than that of a sample containing the wound healing agent alone.
For at least these reasons, the 103 rejection is maintained.
No claim is allowed.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marsha Tsay whose telephone number is (571)272-2938. The examiner can normally be reached M-F.
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/Marsha Tsay/Primary Examiner, Art Unit 1656
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