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 .
This is the first Office action on the merits of the claims.
The Patent Office has transferred this application to a different examiner. Please direct any reply to the examiner now identified on the cover sheet.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Reply filed 11 February 2026, Applicant did not amend the claims. Claims 1-10, as originally filed on 12 June 2023, are pending.
Restriction/Election
The examiner acknowledges both (i) Applicant’s election of Group I, which encompasses claims 1-7, and (ii) Applicant’s election of the composite fiber sponge of claim 1, as the species of substrate. Applicant “traverses the election requirements of the Restriction Requirement to the extent of requesting that claims 8-10 in Group II be considered for rejoinder should the claims of Group I be found allowable, and that the non-elected species be reinstated.” Reply, p. 1. In response, the examiner assures Applicant that any withdrawn claims will be considered for rejoinder at the appropriate time, in accordance with the procedures set forth in MPEP § 821.04. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement or the election requirement, Applicant’s elections have been treated as elections without traverse. MPEP § 818.01(a)-(c).
Pursuant to 37 CFR 1.142(b), the claims directed to non-elected Group II (claims 8-10) are withdrawn from consideration.
Claims 1-7 are considered below.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-7 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventor regards as the invention.
Regarding claim 1, the following clause is unclear: “wherein the composite liquid contains a composite fiber including an extract of a Brassicaceae plant, a polysaccharide, and a carboxymethyl cellulose fiber, the extract of the Brassicaceae plant containing the sulforaphane.” Does the claim require that the composite liquid contains a composite fiber, wherein the composite fiber, itself, has the following three constituents: a carboxymethyl cellulose (CMC) fiber, a polysaccharide, and an extract of the Brassicaceae plant containing the sulforaphane? Alternatively, does the claim require that the composite liquid contains the following three constituents: (1) a composite fiber that includes an extract of a Brassicaceae plant, (2) a polysaccharide, and (3) a CMC fiber. This ambiguity render claim 1 and all claims depending thereon indefinite. As a courtesy, Applicant is referred to Example 2 on pages 16-18 of the specification, which may assist in clarifying claim 1.
Regarding claim 2, the phrase “a polysaccharide” is confusing because a polysaccharide is already introduced in claim 1. Perhaps claim 2 should recite “the polysaccharide”? Alternatively, if the polysaccharide of claim 2 is independent of the polysaccharide of claim 1, perhaps claim 2 should recite “a second polysaccharide”?
Claim Rejections - 35 U.S.C. 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ye (CN 114031807 A) in view of Bahia (US 6,075,177), Vile (US 9,775,917 B2), and Zhang (“Antioxidant therapy and antioxidant-related bionanomaterials in diabetic wound healing.” Frontiers in Bioengineering and Biotechnology 9 (2021): 707479).
Ye, which published in Chinese, is directed to a “composite gel sponge for healing and repairing tissue wounds.” Title. The examiner obtained an English machine translation of Ye using Google Patents. Unless otherwise indicated, all citations refer to that translation, which accompanies this Office action.
Ye discloses that the composite gel sponge is made by: (step S1) “adding sodium chloride into a carboxylated cellulose nanofiber aqueous solution, stirring for 5-15 minutes, adding chitosan quaternary ammonium salt, continuously stirring for 4-6 hours, and standing until bubbles are eliminated to obtain initial hydrogel; (step S2) “dropwise adding tannic acid into the initial hydrogel obtained in the step S1, stirring for 0.5-1.5 hours, dropwise adding copper chloride, and continuously stirring for 5-15 minutes to obtain hydrogel”; and (step S3) “filling the hydrogel obtained in the step S2 into a mold, freezing the mold for 7-9 hours, demolding, and freeze-drying to obtain the cellulose chitosan tannin copper composite gel sponge for healing and repairing the tissue wound.” Page 2/8 at claim 1 (emphasis added). In the interest of clarity, the examiner notes that chitosan qualifies as a polysaccharide.
Ye discloses that “the invention introduces the self-assembly of the carboxylated cellulose nano-fiber and the chitosan quaternary ammonium salt, and enhances the mechanical strength and the stability of the gel through the positive and negative charge crosslinking effect.” Page 3/8 (emphasis added).
Ye discloses that the “composite gel sponge has good mechanical strength, stability, antibacterial property and hemostatic property.” Page 2/8; see also Abstract.
First, although Ye discloses that the composite gel sponge comprises “carboxylated cellulose nanofiber,” Ye does not specify whether or not that nanofiber can be composed of carboxymethyl cellulose.
Second, Ye is silent as to whether the composite gel sponge can also include a composite fiber that comprises sulforaphane.
As explained below, the following three references compensate for those deficiencies: Bahia, Vile, and Zhang.
Bahia is directed to “wound dressings, which term also includes bandages and swabs for application to wounds including wounds consequent upon surgical operations, and to the use of absorbent fibre in dressings.” Column 1, lines 12-15.
Bahia teaches: “According to the present invention, a wound dressing is characterised in that the wound-contacting surface thereof comprises carboxymethyl cellulose filaments capable of absorbing at least 15 times their own weight of 0.9% by weight aqueous saline solution (as measured by the free-swell absorbency test) to form a swollen transparent gel and that the dressing when thus swollen to form a transparent gel retains sufficient fibrous character to be removed as a coherent dressing from a wound. The filaments may be in the form of continuous filaments or cut fibre, for example staple fibre, or of strands or fabrics made therefrom. The strands can be any linear textile material formed from the filaments or fibre, for example a yarn, sliver, roving or rope. The carboxymethyl cellulose filaments can for example be used as a tow or as a fabric.” Column 2, lines 1-17 (emphasis added).
Bahia teaches: “Upon application to the moist surface of a wound, the carboxymethyl cellulose filaments absorb the fluid which is exuding from the wound and form a transparent gel. This gel maintains the surface of the wound in a condition which will encourage the natural healing process of the body, that is the surface of the wound is kept in a moist condition without the presence of excess liquid.” Column 7, lines 30-37 (emphasis added).
Bahia teaches: “Dressings according to the invention are suitable for the treatment of traumatic, surgical and chronic wounds. The preferred application is for wounds which are exuding moderate to high levels of exudate form their surface. Examples of such wounds are venous ulcers, decubitus ulcers, diabetic ulcers, donor graft sites and infected post-operative wounds.” Column 7, lines 44-50 (emphasis added).
Vile is directed to “compositions in nanofiber form including one or more bioactive compounds releasably incorporated thereon.” Abstract.
Vile teaches that the nanofibers can be manufactured from carboxymethyl cellulose (CMC), alginate, and chitosan, among other polymers/polysaccharides, and combinations thereof. Column 7, lines 47-59.
Vile teaches that the bioactive compound can be an enzyme, such as myrosinase, and/or an extract from a plant, such as broccoli. Column 6, lines 24-48.
Vile, in Example 7, teaches a nanofiber that comprises sulforaphane, which is sourced from broccoli and is the product of the reaction involving glucosinolates and the enzyme myrosinase. Column 18, line 40, to column 19, line 15.
Vile teaches: “Further immobilisation of the bioactives/nanofibres on a substrate is also possible which places the bioactives in an immediately usable form e.g. a strip or dressing without further manufacture being necessary.” Column 3, lines 5-8. Additionally, the bioactives/nanofibers can be loaded onto a dressing intended for medical applications, such as wound healing. Column 12, lines 39-50.
Zhang is directed to “Antioxidant Therapy and Antioxidant-Related Bionanomaterials in Diabetic Wound Healing.” Title.
Zhang teaches: “Ulcers are a lower-extremity complication of diabetes with high recurrence rates. Oxidative stress has been identified as a key factor in impaired diabetic wound healing. Hyperglycemia induces an accumulation of intracellular reactive oxygen species (ROS) and advanced glycation end products, activation of intracellular metabolic pathways, such as the polyol pathway, and PKC signaling leading to suppression of antioxidant enzymes and compounds. Excessive and uncontrolled oxidative stress impairs the function of cells involved in the wound healing process, resulting in chronic non-healing wounds. Given the central role of oxidative stress in the pathology of diabetic ulcers, we performed a comprehensive review on the mechanism of oxidative stress in diabetic wound healing, focusing on the progress of antioxidant therapeutics.” Abstract (emphasis added).
Zhang teaches: “Nrf2 is a central regulator of redox mechanisms. Firstly, topical application of Nrf2 activators provides a practical therapeutic intervention in diabetic wound healing. Sulforaphane (SF) and cinnamaldehyde (CA) are two known activators of NRF2 (Wu et al., 2013, 2016; Jiang et al., 2014), shown to be effective in ameliorating diabetic wound healing in a mouse model (Long et al., 2016).” Page 5, right column (emphasis added); see also Figure 1 (page 6) at caption (“Nrf2 activators, such as SF, CA, DMF, RTA408 and genistein, stimulate the Nrf2 pathway and ameliorate oxidative stress.”).
Before the effective filing date of the claimed invention, the teachings of Bahia, Vile, and Zhang would have motivated a person having ordinary skill in the art to modify Ye by (i) selecting the carboxymethyl cellulose (CMC) filaments of Bahia as the carboxylated cellulose nanofiber, in an effort to render Ye’s composite gel sponge more effective in treating diabetic ulcers and other wounds that typically exhibit moderate to high levels of exudate, and (ii) adding a CMC/polysaccharide composite nanofiber that comprises sulforaphane, to render Ye’s composite gel sponge especially suitable for treating diabetic ulcers. Therefore, claims 1-7 are prima facie obvious.
In the interest of compact prosecution, the examiner reminds Applicant that “[e]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.” MPEP § 2113(I); see also MPEP § 2113(II) (“The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in the conventional fashion.”).
Conclusion
Claims 1-7 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
02 May 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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