DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 02/25/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments with respect to the instant claims 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.
Examiner’s Note
The Examiner notes the present rejection, which is a second nonfinal rejection, in order to clarify the Examiner’s position.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 29-49 are rejected under 35 U.S.C. 103 as being unpatentable over Heras et al (Green Chemistry, 2/6/2020), in view both of Janvikul et al (The Journal of Applied Polymer Science, 102, 445-451, 2006) and Lee et al (US 2005/0287193 A1).
Heras taught sponge-like scaffolds (SLS) [page 7, section 2.2] comprising SPI (soy protein isolate, page 4 and last paragraph), 30 % chitin (CH), and glycerol as a plasticizer [page 6, last paragraph bridging to page 7 first paragraph; page 7, section 2.2, 1st paragraph].The swelling of Heras’ SLS in aqueous media was desirable for pathologies such as wounds, where a high swelling capacity was interesting, due to the absorption of the wound exudate [page 21, 2nd paragraph]. Heras was useful as a system for biomedical applications [abstract]. In vivo applications were taught [see section 2.9].
Although Heras taught, as desirable and interesting, sponges with a high swelling capacity for absorption in wounds, Heras was not specific promoting hemostasis, as recited in claim 29.
However, Janvikul taught that chitin is hemostatic; significantly decreases whole blood clotting time; and, significantly accelerates coagulation [title, abstract and page 450 at the 1st paragraph].
And, Lee taught sponge wound dressings made from chitin [abstract and title], where chitin is known in the art as a wound-healing material [0008] to promote hemostasis [0013].
Since Heras generally taught sponges comprised of SPI and chitin, where, as desirable and interesting, were sponges with a high swelling capacity for absorption in wounds, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Heras, the promotion of hemostasis, as taught by Lee. The ordinarily skilled artisan would have been motivated to decrease clotting time and accelerate coagulation, as taught by Janvikul [title, abstract and page 450 at the 1st paragraph].
Heras, in view of Lee and Janvikul, reads on claims 29, 39 and 49.
Claim 30 is rendered prima facie obvious because Heras taught porosity values between 80-90 % [page 20, last paragraph]; the pore sizes were from less than 0.3 mm up to 3 mm [page 21, 1st paragraph].
The instant claim 30 recites a porosity between 70 % and 80 %, and a pore size between 0.5 mm and 1.5 mm.
Heras taught porosity of 80-90 % and pore sizes of less than 0.3 mm up to 3 mm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Claim 31 is rendered prima facie obvious because Heras taught 30 % CH with respect to dry SPI [page 7, section 2.2, 1st paragraph].
Claims 32-33 and 42 are rendered prima facie obvious because Heras taught an average degree of acetylation of 95.9 % [page 7, line 5].
The instant claims 32 and 42 recite at least 75 % acetylation degree.
Heras taught an average degree of acetylation of 95.9 %. A prima facie case of obviousness exists because of overlap, as discussed above.
Further regarding claim 33, the claim requires an acetylation degree of at least 97 %. Heras taught an average degree of acetylation of 95.9 %. The ordinarily skilled artisan would have been motivated to have modified this to have been at least 97 %, as claimed. Where 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. See MPEP 2144.05(II)(A). In this case, the general condition of forming a CH/SPI sponge-like scaffold, desirable for pathologies such as wounds, has been taught by the prior art (Heras et al); as such, it would not have been inventive for the skilled artisan to have discovered the optimum acetylation degree of the CH via routine experimentation.
Claims 34-35 and 43 are rendered prima facie obvious because Heras taught CH extracted from squid pens, washed with water and treated with NaOH [page 6 and last paragraph, section 2.1].
Claim 36 is rendered prima facie obvious because Heras taught β-chitin [page 5 paragraph bridging to page 6 and also at page 6, last paragraph].
Claims 37 and 46 are rendered prima facie obvious because Heras taught Glu (17.92 %); Asp (11.59 %); Leu (9.1 %); Ser (7.06 %); Gly (7.93 %); Ala (6.16 %); and, Pro (6.01 %).
The instant claims 37 and 46 recite at least 6 % of each amino acid residue.
Heras taught amino acid residues at 6.01 % to 17.92 %. A prima facie case of obviousness exists because of overlap, as discussed above.
Claims 38 and 47 are rendered prima facie obvious because Heras taught the sulphur content in SPI as ~ 0.89 % [page 15, last paragraph].
The instant claims 38 and 47 recite less than 2 % sulphur content. Heras taught 0.89 % sulphur content. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 40 is rendered prima facie obvious because Heras taught 30 % glycerol, based on SPI dry basis [page 7, section 2.2, 1st paragraph].
Claim 41 is rendered prima facie obvious because Heras taught mixing (stirring) SPI with CH and water to form a solution; the pH of the solution was adjusted to 10 with NaOH; glycerol was added; a homogeneous blend was obtained; the blend was poured into molds, frozen and freeze-dried to obtain the SLS [page 7, last paragraph].
Claims 44-45 are rendered prima facie obvious because Heras taught washing squid pens with water, then treating with NaOH (1M) in a relation of 1:20 (w/v) at room temperature under continuous stirring during 24 h. Afterwards, samples were filtered and the solid fraction (CH) was washed with distilled water until neutral pH [page 6 last paragraph bridging to page 7].
Claim 48 is rendered prima facie obvious because Heras taught lyophilized SLS [page 7, penultimate sentence].
Claim(s) 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over Heras et al (Green Chemistry, 2/6/2020), in view of Janvikul et al (The Journal of Applied Polymer Science, 102, 445-451, 2006) and Lee et al (US 2005/0287193 A1), and further in view of Harkamp et al (US 2013/0096082 A1).
The 35 U.S.C. 103 rejection over Heras, in view of Janvikul and Lee, was previously discussed.
Although the combined teachings of Heras, Janvikul and Lee taught hemostatic sponges, the combined teachings of the prior art were not specific a hemorrhage, as recited in claims 50-51.
Harkamp taught hemostatic compositions comprising chitin, for use in the treatment of hemorrhage (i.e., the genus of which reads on the species of nasal hemorrhage), as a barrier against bleeding and rebleeding processes [claims 1 and 7-8; ¶s 0035 and 0056].
Since the combined teachings of the prior art taught chitin for use in hemostasis, it would have been prima facie obvious to one of ordinary skill in the art to include, within the combined teachings of the art, hemorrhage, as taught by Harkamp. The ordinarily skilled artisan would have been motivated to control bleeding, as taught by Harkamp [claims 1 and 7-8; ¶s 0035 and 0056].
Claim(s) 52-55 are rejected under 35 U.S.C. 103 as being unpatentable over Heras et al (Green Chemistry, 2/6/2020), in view of Janvikul et al (The Journal of Applied Polymer Science, 102, 445-451, 2006) and Lee et al (US 2005/0287193 A1) and further in view of McCarthy et al (US 2011/0034410 A1).
The 35 U.S.C. 103 rejection over Heras, in view of Janvikul and Lee, was previously discussed.
Although the combined teachings of Heras, Janvikul and Lee taught hemostatic scaffolds (sponges), the combined teachings of the art were not specific the sponge scaffolds immobilized in a support, as recited in claims 52-55.
McCarthy taught hemorrhage control wound dressings formed of chitosan, where the chitosan was converted to chitin, in order to control severe, life-threating bleeding that is typically not capable of being stanched when a conventional gauze is applied to a subject wound [abstract; see also ¶ 0208]. The wound dressings were composite sponges that comprised a backing support layer (e.g., reads on immobilized in a support) [0025, 0109], with adhesion to the wound site (including adhesion to dermis) [0026, 0078, 0111, 0118, 0143]. The compressed composite sponge was capable of forming an adhesive material in combination with blood flowing from said wound at a wound dressing-blood interface, Preferably, the adhesive material was a chitosan adhesive material [0026-0028]. The sponges further comprised non-woven mesh or mats, or woven mats as matrices (e.g., reads on gauze), which were compatible with the sponge compression process, and less likely to cause tearing in the sponge [0021, 0041-0042, 0105].
The wound dressing preferably included a supplemental traction surface which was particularly useful for the application of the wound dressing to a wound site which included a significant amount of surface blood. The supplemental traction surface comprised at least one outer surface that gripped the wound site to avoid slipping of wound dressing (e.g., reads on at least part of the support does not contain the immobilized sponge-like scaffold), typically in a direction away from the wound site, during use [0113].
Since the combined teachings of Heras, Janvikul and Lee taught hemostatic sponges, it would have been prima facie obvious to one of ordinary skill in the art to include, within the combined teachings of the art, sponge scaffolds immobilized in a support, as taught by McCarthy. The ordinarily skilled artisan would have been motivated to control severe, life-threating bleeding that is typically not capable of being stanched when a conventional gauze is applied to a subject wound, as taught by McCarthy [abstract].
It would have been prima facie obvious to one of ordinary skill in the art to include, within the combined teachings of the prior art, nonwoven mesh or mats, or woven mats (e.g., reads on gauze), as taught by McCarthy. The ordinarily skilled artisan would have been motivated to form hemorrhage control wound dressings, where nonwoven mesh or mats, or woven mats are compatible with the sponge compression process and less likely to cause tearing in the sponge, as taught by McCarthy [0021, 0041-0042, 0105, 0113].
It would have been prima facie obvious to one of ordinary skill in the art to include, within the combined teachings of Heras, Janvikul and Lee, an adhesive material, as taught by McCarthy. The ordinarily skilled artisan would have been motivated to adhere the dressing to the wound site, and control bleeding, as taught by McCarthy [abstract, 0026, 0021, 0041-0042, 0105].
Conclusion
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/CELESTE A RONEY/ Primary Examiner, Art Unit 1612
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