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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/10/25 has been entered.
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.
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.
Claim(s) 1, 4, 5, 7-9 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Dahl et al (US 2018/0064844 hereafter Dahl) in view of Fu et al (Effect of cyclodextrins on the structure and functions of blood in vitro, Journal of Bioactive and Compatible Polymers, vol. 30(5), 541-554, 2015).
Dahl discloses a hemostatic paste comprising a hemostatic components, a light curable components where the hemostatic component is suspended in a non-toxic polyol, glycerin [abstract, 0035]. The hemostatic compound further comprises a flavor including honey [Table 1]. The light-curable components comprise ethoxylated bis phenol A dimethacrylate Mw 1700, urethane dimethacrylate, amorphous glass (silanized), Ethyl 4-dimethylaminobenzoate, camphorquinone (initiator), ethylene glycol dimethacrylate, p-methoxyphenol, glycol methacrylate, butylated hydroxytoluene, titanium dioxide pigment and blue pigment Ci 42090 [Table 2]. The light-curable components with the light emitting device having an output peak wavelength range of 450 nm-470 nm and an output intensity from 1100 mW/cm2 to 1330 mW/cm2 [0037]. The composition is applied in the mouth and specifically to the gum or mucosal surface to maintain a tooth in place [0009-0011]. The viscosity of the composition is such that is does not flow under gravity and requires force to flow [0038, 0044]. The purpose of the composition is to staunch bleeding as quickly as possible [0032].
The reference while disclosing the need for a hemostatic compound, does not disclose the compound to be 2-hydroxypropyl gamma cyclodextrin as in the instant claims. The use of gamma cyclodextrins is known in the art as seen in the Fu study.
Fu discloses the effects of different cyclodextrins on blood components in vitro (abstract). Cyclodextrins often have hydroxyl groups attached [pg. 549]. The Gamma cyclodextrins in tests were found to be safe for in vitro blood use, and maintained cell membrane integrity while effecting fibrinogen collection (conclusion). It would have been obvious to include gamma CD into the formulation of Dahl as it helps solve the problem of bleeding.
It would have been obvious to combine the prior art with an expected result of a stable hemostatic paste formulation useful in slowing and stopping bleeding. It would have been obvious to include the blood safe gamma cyclodextrin of Fu into the formulation of Dahl as it would help with bleeding without destroying blood cells. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of stable paste useful in sealing wounds on mucosal surfaces.
Response to Arguments
Applicant’s arguments with respect to claim(s) ) 1, 4, 5, 7-9 and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618