DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/25/2026 has been entered.
Status of the Claims
The response filed 02/25/2026 is acknowledged.
Claims 34-47 and 50-53 are pending.
Claim 53 is new.
Claims 34-46 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/26/2025.
Claims 47 and 50-53 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Response to Arguments
Applicant's arguments filed 07/17/2025 have been fully considered but they are not persuasive.
Applicant argues the instant claim 47 recites inducing hemostasis in a wound by applying to the wound an antimicrobial amphiphilic hydrogel composition comprising a hydrogel comprising a proline arginine-rich end leucine-rich repeat protein, PRELP, derived antimicrobial peptide, wherein the antimicrobial peptide is RRP9W4N having the sequence RRPRPRPRPWWWW-NH2, and a cross-linked amphiphilic component being a lyotropic liquid crystal and having an ordered nanostructure of hydrophobic and hydrophilic domains to cause coagulation of blood at the wound. Applicant argues it is the specific combination of the PRELP and the hydrogel that leads to the observed hemostatic effect to induce coagulation and blood clotting. Applicant argues the reference patent merely relates to antimicrobial properties and does not disclose the use of RRP9W4N in inducing hemostasis. Applicant argues that because the present claims recite a method of treating a wound via application of the antimicrobial amphiphilic hydrogel composition to the wound to cause coagulation of blood at the wound, the instant claims are not obvious variants of the claims of the reference patent in view of Salamone.
These arguments are unpersuasive. The reference claims are directed to a hydrogel composition having all of the features required by the hydrogel used in the current method. For example, the hydrogel combination comprising RRP9W4N combination is a specifically claimed embodiment of the reference claims (claim 5). Further, the reference claims suggest the combination may be used for treating wounds, e.g., wound dressing. Since the claimed combination which results in blood coagulation is also claimed by the reference patent, the properties of blood coagulation are latent properties of the hydrogel composition claimed by the reference patent.
Campos (WO 2019193202 A1) teaches applying hydrogels to wounds for the purpose of controlling bleeding and hemostasis. Hemostasis may be achieved by the hemostatic properties of the hydrogel itself and may be combined with other hemostatic techniques, e.g., applying compression with the hydrogel application. Thus, the skilled artisan would have had a reasonable expectation of successfully inducing hemostasis by applying a hydrogel comprising RRP9W4N as claimed by the reference patent to a wound. The hemostatic properties of the hydrogel claimed by the reference patent would have naturally flowed from practicing the method suggested by Campos using a hydrogel comprising RRP9W4N as claimed by the reference patent which is suggested for wound care.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 47 and 50-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-21 of US 11235021 in view of WO 2019193202 A1 (Campos) and Salamone, US 20160303281.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claims of the reference patent teach 1. A solid antimicrobial hydrogel comprising a first cross-linked amphiphilic component, said first amphiphilic component being a chemically cross-linked lyotropic liquid crystal and having an ordered nanostructure of hydrophobic and hydrophilic domains, the hydrogel comprising an antimicrobial agent covalently attached to the hydrophilic and/or hydrophobic domains. 2. The antimicrobial hydrogel according to claim 1, wherein the antimicrobial agent is a substantially amphiphilic antimicrobial agent covalently immobilized on the hydrophilic domains and, optionally, hydrophobic domains of the first amphiphilic component. 3. The antimicrobial hydrogel according to claim 2, wherein the antimicrobial agent is an antimicrobial peptide. 4. The antimicrobial hydrogel according to claim 3, wherein the antimicrobial agent is an antimicrobial peptide comprising a stretch of at least one hydrophobic amino acid(s) forming a hydrophobic region for interaction with the hydrophobic regions of the hydrogel. 5. The antimicrobial hydrogel according to claim 3, wherein the antimicrobial peptide is RRP9W4N. 6. The antimicrobial hydrogel according to claim 1, wherein the amphiphilic molecule is a co-polymer. 7. The antimicrobial hydrogel according to claim 6, wherein the co-polymer is a diacrylate derivative of a triblock co-polymer. 8. The antimicrobial hydrogel according to claim 1, wherein the ordered nanostructure is an ordered and repeating nanostructure of micellar, hexagonal, cubic or lamellar morphology. 9. The antimicrobial hydrogel according to claim 1, wherein the antimicrobial agent is also physically absorbed in to the hydrogel, such that a portion of the antimicrobial agent present in the hydrogel is physically absorbed and a portion is covalently attached. 10. The antimicrobial hydrogel according to claim 1, wherein a therapeutic agent, in addition to the antimicrobial agent, is covalently attached or physically absorbed to the hydrophilic and/or hydrophobic domains of the first amphiphilic component. 11. The antimicrobial hydrogel according to claim 1, wherein the first amphiphilic component is chemically cross-linked via reactive groups present on the first amphiphilic component. 12. The antimicrobial hydrogel according to claim 1, wherein the hydrogel is substantially non-degrading in physiological conditions. 13. A device comprising a first antimicrobial hydrogel according to claim 1. 14. The device according to claim 13, wherein the first antimicrobial hydrogel is applied on a substrate. 15. The device according to claim 13, wherein the first antimicrobial hydrogel forms a first antimicrobial hydrogel layer, wherein the substrate has an increased mechanical strength relative to the first antimicrobial hydrogel layer. 17. The antimicrobial hydrogel according to claim 1, or a device comprising the antimicrobial hydrogel for use in the prevention and/or treatment of burns, scars, bacterial infections, viral infections, and/or fungal infections. 18. A method of producing an antimicrobial hydrogel according to claim 1, comprising: providing a first cross-linkable amphiphilic component, cross-linking the first amphiphilic component to form a three-dimensional solid and chemically cross-linked lyotropic liquid crystal from the first amphiphilic component, and, attaching, covalently, an antimicrobial agent to the hydrogel. 19. The method according to claim 18, wherein the antimicrobial agent is substantially localized to the surface of the hydrogel, and wherein the attaching of the antimicrobial agent is performed via surface application of a solution comprising an antimicrobial agent. 20. The method according to claim 19, wherein the antimicrobial agent is an antimicrobial peptide (AMP) and the surface application is achieved via spraying a solution having a concentration of AMP greater than about 50 μM, such as greater than about 200 μM, to the surface of the hydrogel. 21. The antimicrobial hydrogel according to claim 7, wherein the co-polymer is a derivative of poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) (PEO-PPO-PEO).
The claims of the reference patent suggest the hydrogel can be applied to a wound, i.e., as part of a bandage or wound dressing (claim 16), but do not expressly teach the hydrogel used in a method to induce hemostasis comprising applying the hydrogel a wound.
However, Campos teaches practicing methods for controlling bleeding comprising applying a hydrogel composition to a wound (Campos, e.g., Abstract, pg. 5:8-19, c6:13-23, pg. 9:28-30, c11:28-30, claims 1-8). For example, hydrogels containing hemostatic agents, e.g., fibrinogen may be used for hemostasis in the treatment of traumatic wounds (Campos, e.g., pg. 5:8-19). Inducing hemostasis reads on controlling bleeding. Thus, to the extent that inducing hemostasis encompasses controlling bleeding, Campos teaches methods which induce hemostasis by applying a hydrogel to a site of bleeding, such as a wound, so that the bleeding is controlled or stopped (hemostasis).
It would have been obvious before the effective filing date of the presently claimed invention to employ the hydrogel of the reference claims in a method for controlling bleeding which method comprises applying the hydrogel to a wound as understood from Campos with a reasonable expectation of success. Since the reference claims teach the hydrogel material may be used as a wound dressing or bandage, the skilled artisan would have been motivated to apply the hydrogel to wounds for the purpose of controlling bleeding as related by Campos with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success because the reference claims suggest the hydrogel may be used in wound care, and since Campos teaches hydrogels useful in wound care may be applied to bleeding wounds to control bleeding.
The combined teachings of the reference claims and Campos teach practicing a method for inducing hemostasis comprising applying the hydrogel to a wound but do not expressly teach the method comprising spraying the hydrogel in the form of a particles in a dispersion on the wound.
However, applicable to claims 51-53, the teachings of Salamone teach similar antimicrobial hydrogels may be formulated as a dispersion of particles and sprayed onto wounds to fill wound voids or form a coating that is conformable to surrounding tissues and filling wound space to reduce infection and promote healing (Salamone, e.g., 0047). Applicable to claim 53: Salamone teaches particle sizes within the claimed range, e.g., ranging from 10-1000 microns, 5-500 microns, or 75-250 microns (Salamone, e.g., 0103 and 0218). Particle sizes may be optimized within these ranges for a desired dispersion viscosity (Salamone, e.g., 0225).
It would have been obvious before the effective filing date of the presently claimed invention to practice a method for controlling bleeding comprising applying an antimicrobial hydrogel to a wound as suggested by the reference patent claims and Campos modified using techniques known from Salamone, e.g., by spraying a dispersion of microgel particles incorporating the antimicrobial agent to improve the method in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to apply the hydrogel by spraying a dispersion of hydrogel particles on the wound to fill wound voids or form a coating that is conformable to surrounding tissues, thereby filling wound space to reduce infection and promote healing in the same way suggested by Salamone with a reasonable expectation of success. Skilled artisan would have had a reasonable expectation of success because Salamone suggests practicing methods for treating wounds using the presently claimed steps with similar biocompatible antimicrobial hydrogels.
Accordingly, the subject matter of claims 47 and 50-53 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615