DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 12/23/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 103 (Maintained)
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.
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 1-5, 7-10, and 15-16 are rejected under 35 U.S.C. 103 as being as being obvious over Abe et al. (US 2006/0178339 A1) in view of Willard et al. (US 2020/0281980 A1) and Landolina (US 2014/0287061 A1) and as evidenced by Univar Solutions (CASTOR OIL NO 1 IMPORTED, Technical Grade, Liquid, Bulk).
Note: The Examiner is interpreting “non-volatile hydrophobic solvent” to refer to a hydrophobic solvent having a boiling point of 50°C or higher as defined in the instant specification at paragraph [0036].
Regarding claim 1, Abe discloses a hemostatic material to be applied to the surface of an organism [0001] with the polysaccharide, dextran [0016],[0027], where the polysaccharide has a reactive ester group [0016] introduced by N-hydroxysuccinimide [0099] to form a crosslinked structure (abstract, [0012]-[0013]). The active ester group reacts with active hydrogen-containing groups such as amino groups [0114]. Abe discloses the polysaccharide, such as crosslinked dextran, [0027] [0112] is in the form of a particle [0120]. Abe discloses that the material can be in the form of a film, flexible material and/or liquid [0001] [0032] [0067] [0158] and that plasticizers are known additives [0143].
Abe does not disclose a non-volatile hydrophobic solvent or that crosslinked dextran is modified with an aminoalkyl group.
Willard discloses a hemostatic composition (abstract, [0034]) in the form of a flexible film and/or liquid [0036] [0044] [0057] where the composition includes an oil, such as castor oil in an amount of 1-70 wt.% [0041]. Willard teaches castor oil is included as a plasticizer to impart flexibility to the film and to hinder flaking of the film from the skin [0041] and as a suitable application material for application to an external treatment site [0078] [0012].
Since Abe generally teaches a hemostatic material to be applied to the surface of an organism, it would have been prima facie obvious to one of ordinary skill in the art to include an oil, such as castor oil, in an amount of 1-70 wt.%, within the teachings of Abe, because Willard teaches this amount of oil in a hemostatic material to be applied to the skin. An ordinarily skilled artisan would be motivated to use this amount of castor oil to impart the desired flexibility to the composition, hinder flaking of the composition from the skin [0041], and as an application material for application to an external treatment site [0078] [0012]. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
The combined teachings of the prior art do not disclose that crosslinked dextran is modified with an aminoalkyl group.
Landolina teaches a hemostatic composition to be used for external wound healing [abstract] [0013] [0045] with diethylaminoethyl (DEAE) dextran [abstract] [0041]. Landolina teaches that DEAE-dextran speeds up hemostasis without the need for applying pressure and speeds up blood clotting [abstract] [0015].
Since Abe generally teaches a hemostatic composition to be applied to the surface of an organism with dextran, it would have been prima facie obvious to one of ordinary skill in the art to include DEAE-dextran, within the teachings of Abe, because Landolina teaches DEAE-dextran in a hemostatic composition for external wound healing. An ordinarily skilled artisan would be motivated to use DEAE-dextran because Landolina teaches that DEAE-dextran speeds up hemostasis without the need for applying pressure and speeds up blood clotting [abstract] [0015].
Further regarding claim 1, while it would have been prima facie obvious to include castor oil, as taught by Willard, within the teachings of Abe, as previously discussed, Willard does not explicitly disclose that castor oil is non-volatile.
As evidenced by Univer Solutions, castor oil has a boiling point greater than 300°C (pg. 3, top) and is therefore, non-volatile.
Claims 2-3 are rendered prima facie obvious because Abe discloses the reactive group is an N-hydroxysuccinimide ester group [0016] [0099].
Claim 4 is rendered prima facie obvious because Abe discloses the polysaccharide dextran [0027].
Regarding claim 5, Abe discloses the polysaccharide having the active ester group introduced thereinto, is units of monosaccharide structure [0078]. Abe teaches it is possible to control the amount of active ester group to be introduced into the carboxy group of the starting polysaccharide for active esterification so that the desired polysaccharide derivative is obtained [0103]-[0104] and the addition condition satisfying 0.1<Y/X<100 is preferably used where Y/X is the number of mols of the electrophilic group introducing agent (such as N-hydroxysuccinimide [0042]-[0043]) to the number of moles of total carboxy group in the polysaccharide [0105].
Abe does not specifically disclose the moles of reactive group relative to the moles of the polysaccharide in the obtained hemostatic material based on the taught reaction conditions.
It would have been prima facie obvious to a person having ordinary skill in the art to optimize the conditions, following the teachings of Abe, to provide a composition having the desired properties such as the desired amount of active ester group required for the intended use of the crosslinked polysaccharide composition. It is noted that “[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.” See MPEP 2144.05.II.A.
Claim 7 is rendered prima facie obvious because Abe discloses a weight-average molecular weight of the polysaccharide of 5,000 to 2,500,000 [0079].
A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 8 is rendered prima facie obvious because it would have been prima facie obvious to use the vegetable oil, castor oil, as taught by Willard, as previously discussed.
Regarding claim 9, although the combined teachings of Abe and Willard taught castor oil, the combined teachings of the prior art do not disclose the kinematic viscosity of castor oil at 25°C.
As evidenced by Univar Solutions, the kinematic viscosity of castor oil at 25°C is 600-800 mm2/sec at 25°C (pg. 3). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 10 is rendered prima facie obvious because it would have been obvious to include an oil, such as castor oil, in an amount of 1-70 wt.%, within the teachings of Abe, as taught by Willard, as previously discussed. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 15 is rendered prima facie obvious because it would have been obvious to include DEAE-dextran, within the teachings of Abe, as taught by Landolina, as previously discussed.
Claim 16 is rendered prima facie obvious because Abe discloses the polysaccharide can be a particle with a size of tens of nanometers to hundreds of micrometers [0120].
A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 6 is rejected under 35 U.S.C. 103 as being as being obvious over Abe et al. (US 2006/0178339 A1) in view of Willard et al. (US 2020/0281980 A1) and Landolina (US 2014/0287061 A1) as evidenced by Univar Solutions (CASTOR OIL NO 1 IMPORTED, Technical Grade, Liquid, Bulk) and as further evidenced by Jung et al. (Anal. Chem., 2007, 79, 5703-5710).
The 35 U.S.C. 103 rejection over Abe in view of Willard and Landolina and as evidenced by Univar Solutions was previously discussed. Additionally, Abe discloses reacting polysaccharides (such as dextran, [0084]) having a carboxy group with an electrophilic group-introducing reagent (N-hydroxysuccinimide (NHS) [0041]-[0042]) in the presence of a dehydrating-condensing agent (1-ethyl-3-dimethyaminopropylcarbodiimide hydrochloride (EDC), [0043],[0100]) thereby converting at least part of said carboxy groups into active esters [0035]-[0036].
Abe does not disclose the linkage is the presently claimed “L”
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in which the integer n is 1, as recited in claim 6.
As evidenced by Jung (see the below pictorial), CM-dextran (dextran having a carboxy group) reacts with NHS and EDC in the formation of NHS-dextran, forming the instantly claimed linkage, “L” (Figure 1, pg. 5705).
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Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
Applicant argues at pg. 8-10 that the DEAE-dextran of Landolina is used as a polycationic component in an in-situ crosslinkable gel system, not as a pre-crosslinked dextran particle component; that is Landolina’s DEAE-dextran is a crosslinking participant in situ not a component that is itself disclosed as crosslinked dextran provided as pre-formed particles. Accordingly, applicant argues, Landolina does not teach or suggest the claimed crosslinked particle containing crosslinked dextran modified with an amino alkyl group.
The Examiner disagrees. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See MPEP 2145 IV. Abe discloses crosslinked dextran particles within a hemostatic material and it would have been prima facie obvious to use DEAE-dextran taught by Landolina, within the particles of Abe because Landolina teaches that DEAE-dextran speeds up hemostasis without the need for applying pressure and speeds up blood clotting [abstract] [0015].
Applicant argues at pg. 10-11 that the limitation of claim 1 of “a polysaccharide having a reactive group that reacts with a protein to form a crosslinking structure” is a limitation which defines a chemical property of the polysaccharide itself – that the polysaccharide possesses a reactive group that is capable of reacting with a protein to form a crosslinking structure and that the limitation does not require that such a reaction actually be carried out.
The Examiner agrees with the applicant’s assertion that the limitation defines a chemical property of the polysaccharide itself (capable of reacting with a protein); however, this limitation is met by Abe who discloses the polysaccharide has a reactive ester group [0016] and the active ester group reacts with active hydrogen-containing groups such as amino groups [0114], as discussed above. Therefore, the polysaccharide possesses a reactive group that is capable of reacting with a protein to form a crosslinking structure, as required by claim 1.
Applicant argues at pg. 11-13 that the combination of Abe and Landolina lacks a persuasive motivation and reasonable expectation of success with respect to the claimed crosslinked particle structure because Landolina’s disclosure of DEAE-dextran is presented in the context of a different in-situ matrix formation system and the proposed modification represents hindsight reasoning.
The Examiner disagrees. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See MPEP 2145.X.A. Landolina teaches that DEAE-dextran speeds up hemostasis without the need for applying pressure and speeds up blood clotting [abstract] [0015], and therefore, one would have motivation to include it within the hemostatic material of Abe. There would be a reasonable expectation of success in including DEAE-dextran within the particles of Abe, because Abe teaches that the particles include dextran [0027].
Applicant argues at pg. 13-15 that the requirements and handling characteristics of a self-supporting hemostatic sheet or film or a particle-containing composition such as those taught in Abe are materially different from those of a film formed from an applied liquid bandage such as those taught by Willard.
The Examiner disagrees and maintains that Abe discloses that the additives to the composition are not specifically restricted and include plasticizers, solvents, and carriers [0143]. As Willard teaches castor oil as a plasticizer [0041] and application material [0078] and Abe teaches that plasticizers, solvents, and carriers are known additives to the compositions of the disclosure [0143], it would be reasonably expected for castor oil to be successfully included within the compositions of Abe. Abe does not require the composition to be a dried, solid sheet, and teaches that the composition may have the form of a flexible material and/or applicable liquid [0067] [0158].
Applicant also argues that stating that the hemostatic composition of Abe “may be in the form of a flexible material and/or liquid” overgeneralizes Abe’s disclosure.
The Examiner disagrees. Patents are relevant as prior art for all that they contain and nonpreferred or alternative embodiments constitute prior art. See MPEP 2123. Therefore, although Abe has many teachings, the number of teachings does not detract from paragraphs [0067] and [0158] which state that the composition may be in the form of a flexible material and/or liquid.
Applicant also argues that the cited art does not provide a specific reason to select Willard’s castor oil for incorporation into Abe’s hemostatic material.
The Examiner disagrees. An ordinarily skilled artisan would be motivated to use castor oil to impart the desired flexibility to the composition, hinder flaking of the composition from the skin [0041], and as an application material for application to an external treatment site [0078] [0012] as taught by Willard.
Applicant argues that the evidentiary references Univar Solutions and Jung fail to remedy the fundamental deficiencies of the cited prior art combination.
The Examiner disagrees because the cited prior art combination is not fundamentally deficient, as discussed above.
Terminal Disclaimer
The terminal disclaimer filed on 06/19/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 18/062,577 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEE E WERTZ/Examiner , Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612