DETAILED ACTION
The receipt is acknowledged of applicant’s amendment filed 03/05/2026.
Claims 1, 3, 6-9, 14-17, 21, 24, 28, 34, 35, 44, 46, 47, 57 and 61 presented by the preliminary amendment and are subject of this office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 6-9, 14-17, 21, 24, 28, 34, 35, 44, 46, 47, 57 and 61 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 44, the expression “at least about” does not set forth the metes and bounds of the claim. The expression permits two contradicting interpretation of the claims. The term “at least" permits values equal to the value following the term and more than that value with no upper limit to the value, while the term “about” permits values below and above the claimed value, usually 10% unless otherwise defined in the specification. The boundaries of coverage is not imposed by the disclosure. Recourse to the specification does not define the expression. Claims 3, 6-9, 14-17, 21, 24, 28, 34, 35, 46, 47, 57 and 61 are rejected as they depend on rejected claims 1 and 44.
Regarding claim 35 is in improper Markush group format. Proper Markush format to be followed in the claim should have the expression “selected from the group consisting of”, and only the last two members of the Markush group are separated by the connector operator “and” OR “or”. The claim recites four combinations of UHP and PCL, and the last two combinations are not separated by “and” or “or” that should be inserted between the last two members of the group.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 3, 6-9, 14-17, 21, 24, 28, 34, 35, 44, 46, 47, 57, 61 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Koenig et al. (WO 2007/700184, IDS filed 03/13/2024), Harrison et al. (US 2020/0112087, previously cited in PTO 892), and optionally Gibbins et al. (US 2003/0224054, currently recited on PTO 892), as evidenced by the article by Huang et al. as applied to claim 61 (“Tuning the size of poly(lactic-co-glycolic acid) (PLGA) nanoparticles fabricated by nanoprecipitation”, previously provided).
Applicant Claims
Claim 1 is directed to An article comprising:
a substrate; and,
a polymer matrix comprising a hydrogen peroxide releasing compound dispersed within the polymer matrix;
wherein the polymer matrix is in contact with the substrate, and wherein the hydrogen peroxide releasing compound is present in an amount of at least about 50 wt.%, based on the total weight of the polymer matrix.
Claim 44 is directed to a method of forming an article, comprising:
contacting a surface of a substrate with a mixture comprising a hydrogen peroxide releasing compound and a polymer to provide the article, wherein the hydrogen peroxide releasing compound is present in an amount of at least about 50 wt%, based on the total weight of the hydrogen peroxide releasing compound and the polymer.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Koenig teaches antimicrobial article comprising substrate and peroxide releasing compounds that are attached to at least part of the surface of the substrate as a coating or a layer. The substrate is made of polymer, woven or nonwoven material, or metal. The article can be medical device, surgical equipment, face mask, cover gown or glove (abstract; page 3, line 25 till page 4, line 11; page 5, lines 4-10, 24-25; page 6, lines 3-5; page 7, lines 20-22; page 14, lines 18-25; page 15, line 31 till page 16 line 3). Hydrogen peroxide is an effective antimicrobial against bacteria, fungi and viruses. When peroxide is activated in presence of free moisture, such as water or water vapor, the hydrogen peroxide is released from the surface of the article providing effective quick-kill and broad spectrum action (page 5, lines 23-33; page 11, lines 22-27). Hydrogen peroxide can be in the form of salt, e.g. calcium salt, or urea hydrogen peroxide (UHP) provided in water soluble polymer carrier coated on the surface of the substrate (page 9, lines 3-16; page 11, lines 8-12). The reference teaches process of making the article comprising applying peroxide containing compounds onto the surface of the substrate. Application can be done by coating a carrier comprising peroxide releasing compound on a substrate (page 13, lines 14 till page 14, line 4; claim 23).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Koenig teaches incorporating hydrogen peroxide releasing agent in a polymer carrier to be applied to the surface of a substrate as a coting or a layer, the reference does not exemplify or explicitly teach polymer matrix comprising the hydrogen peroxide releasing agent as claimed by claim 1.
Koenig does not teach the ratio of hydrogen peroxide releasing agent based on the polymer as claimed by claims 1 and 44.
Harrison teaches composition to treat infection comprising hydrogen peroxide salts or urea peroxide, and biodegradable polymer. The composition can be in the form of sheet covering medical device, e.g. wound dressing, surgical or paramedic aid. The composition is applied to support material, i.e. substrate. The peroxide can be calcium peroxide or urea peroxide (abstract; ¶¶ 0006-0012, 0029, 0049, 0051). The biodegradable polymer is selected from polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone (PCL), poly(lactic-co-glycolic acid) (PLGA), and polyurethane (¶ 0028). The composition comprises 50 or 70-99% biodegradable polymer and 0.1-30% peroxide (0013-0015, 0029). The reference teaches process of making the composition comprising PLGA and peroxide compound comprising the step of dissolving PLGA and peroxide in methylene chloride (dichloromethane), and cast a film on a surface (¶ 0067).
Gibbins teaches article comprising polymer matrix and hydrogen peroxide for treating compromised tissues, e.g. wounds and ischemic tissues. The article comprises 42.5 g hydrogen peroxide and 3 g polymer (abstract; ¶¶ 0025-0029, 0033, 0136). The teaching of the reference implies that the polymer forms about 6.5% of the composition and peroxide forms about 92% of the composition (as calculated by the examiner).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to formulate an article comprising a substrate coated with a layer of polymer carrier comprising peroxide releasing agent as taught by Koenig, and incorporate the peroxide releasing agent in a biodegradable polymer selected from PGA, PLA, PCL, PLGA, and polyurethane taught by Harrison. One would have been motivated to do so because Harrison teaches suitability of such biodegradable polymers to incorporate peroxide releasing agent as a layer or sheet covering medical or surgical aids to release peroxide to provide anti-infective effect at the site of release. One would reasonably expect formulating an article comprising a substrate coated with a layer of polymer matrix selected from PGA, PLA, PCL, PLGA, and polyurethane and comprising peroxide releasing agent that effectively release peroxide to treat infection at the site of application.
Further, one having ordinary skill in the art would have adjusted the amount of hydrogen peroxide to the polymer to more than 50% of the polymer weight as taught by Gibbins because Gibbins teaches such an amount is suitable to treat compromised tissues including wounds.
Regarding the claimed amount of the hydrogen peroxide releasing composition in the article as claimed by claims 1 and 44, Gibbins teaches more than 50%, i.e. about 92% of hydrogen peroxide, that reads on at least about 50% of the total weight of the polymer matrix in a composition. In any event, one having ordinary skill in the art would have determined the desired amount based on the intended use.
Regarding claim 1, the article comprising a substrate and polymer matrix comprising hydrogen peroxide releasing compound is taught by the combination of the cited references.
Regarding material of substrate as claimed by claims 3, Koenig teaches substrate comprising polymeric, metal, and woven and nonwoven materials.
Regarding claim 6 that the substrate is steel, Koenig teaches metal substrate, and further suggests medical devices and surgical equipment that would have suggested steel because surgical equipment are mostly made of steel. In any event applicants failed to show unexpected results obtained from having a steel substrate versus any metal substrates taught by the reference.
Regarding UHP claimed by claim 7, it is taught by both cited references.
Regarding metal peroxides claimed by claim 8, both references teach the claimed calcium peroxide.
Regarding the biodegradable polymer matrix claimed by claim 9, they are taught by Harrison.
Regarding the ratio of hydrogen peroxide releasing agent and polymer of 1:19 to 19:1 and 1:10 to 15:1 as claimed by claims 14 and 15, respectively, Harrison teaches 50 or 70-99% biodegradable polymer and 0.1-30% peroxide that embrace the claimed ratios.
Regarding claim 16 that the polymer matrix is provides as coating, both references teaches layer coating the substrate.
Regarding 17 that the article is antimicrobial effective against bacteria, fungi and viruses, both reference teach antibacterial effect of peroxide, and Koenig teaches antiviral effect.
Regarding claim 21 that specific diseases caused by specific viruses, this is a known fact that which virus causes which disease. Applicants failed to show unexpected effect of the claimed article against specific virus.
Regarding claim 24 that the hydrogen peroxide is released from hydrogen peroxide releasing compound by moisture, this is taught by Koenig that upon exposure to moisture, the peroxide is released from peroxide containing agent. Regarding the claimed relative humidity at which peroxide is released, the claim recites at least 5%, and the reference teaches aqueous environment causes release of peroxide. In view of the term at least “5%” of the claim, then any amount of water in the aqueous environment taught by Koenig would release peroxide, absent evidence to the contrary. Applicants failed to show criticality of the claimed amount of humidity, and the prior art achieves the ultimate results applicants achieved, i.e. release of peroxide.
Regarding the articles claimed by claim 28, Koenig teaches medical devices, surgical equipment, gloves, etc. that all read on the claimed medical devices and tools, and Harrison teaches surgical and medical devices.
Regarding claim 34 that the peroxide releasing compound is UHP and polymer matrix is PCL and PLGA, combination of the cited references teaches the claimed UHP and the claimed polymers.
Regarding claim 35 that UHP is 92-50% and PCL is 8-50%, this is suggested by Gibbins. In any event, applicants failed to show unexpected results obtained from the claimed amounts.
Regarding the nominal claimed method of making the article as claimed by claim 44, it is taught by Koenig.
Regarding dissolving the polymer and peroxide in a solvent as claimed by claims 46 and 47, this is taught by Harrison.
Regarding the solvent is dichloromethane as claimed by claim 57, Harrison teaches methylene chloride which is the claimed dichloromethane.
Regarding claim 61 to use acetonitrile as a solvent for PLGA, one having ordinary skill in the art would have used acetonitrile because as solvent to PLGA because it is a known in the art as evidenced by the article by Huang that teaches acetonitrile is a stable solvent to PLGA to be used in pharmaceuticals (see entire document, and in particular, abstract and page 8).
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 03/05/2026 have been fully considered but they are not persuasive.
CLAIM REJECTIONS - 35 U.S.C. § 103
Applicants argue that amended independent claims 1 and 44 recite hydrogen peroxide releasing compound is present in an amount of at least about 50 wt%, based on the total weight of the polymer matrix (claim 1) or based on the total weight of the hydrogen peroxide releasing compound and the polymer (claim 44). Koenig is directed to products treated with an antimicrobial formulation including stabilized peroxide compounds (p. 1, lines 4-11). Koenig discloses that "said stabilized peroxide compounds is present in an amount of up to about 20% by weight of the substrate," with a preferred range of "about 4-15% by weight", (claims 7-8). Harrison, relied upon by the official action to modify Koenig, discloses oxygen generating compositions for treating hypoxic tissue comprising "from 50 or 70 to 99 percent by weight of a biodegradable polymer" and "from 0.1 to 30 percent by weight of inorganic peroxide incorporated into the polymer in solid form", (paragraphs [0014]-[0015]. Thus, the maximum peroxide concentration taught by either reference is 30% (Harrison). Because the claimed minimum of at least about 50 wt% does not overlap with the maximum of 30% taught by the cited references, the proposed combination of references does not establish a prima facie case of obviousness.
In response to this argument, the examiner presented a newly cited reference to Gibbins that show that hydrogen peroxide can be included in a composition comprising polymer, and hydrogen peroxide in amount 92%. In any event, the amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant's invention. Applicants failed to show any unexpected results obtained from any amount of the peroxide releasing agent. Note that the claimed amount embraces 50% peroxide releasing agent an 50% polymer, that is 1:1 ratio, and one of ordinary skill in the art would be motivated by common sense to select a 1:1 ratio. Case law holds that "[h]aving established that this knowledge was in the art, the examiner could then properly rely.., on a conclusion of obviousness, 'from common knowledge and common sense of the person of ordinary skill in the art within any specific hint or suggestion in a particular reference.'" In re Bozek, 416 F.2d 1385, 1390, 163 USPQ 545, 549 (CCPA 1969). Given the disclosure of cited references, one having ordinary skill in the art would find it obvious to select quantities of polymer and peroxide releasing agent as claimed based on the desired intended use.
Further, Harrison is relied upon for teaching the claimed polymers in particular that are missing from the teaching of Koenig, and not for teaching amount of peroxide. The newly cited reference to Gibbins suggested the claimed amount of peroxide.
Applicants argue that the cited references do not provide any motivation to modify the composition of Koenig to exceed 30% peroxide. The official action proposes modifying Koenig in view of Harrison to incorporate the peroxide releasing agent in a biodegradable polymer matrix. However, even accepting this proposed modification, as described above, the maximum peroxide amount in any of the references is only 30% peroxide, as disclosed in Harrison. Harrison is directed to "a method of treating hypoxic tissue such as wound tissue" where the composition is used to provide oxygen to enhance cell and tissue survival (paragraph [0006]). The purpose of Harrison's compositions is oxygen generation for tissue survival, not antimicrobial activity. Harrison provides no teaching, suggestion, or motivation to use peroxide concentrations exceeding 30%. A person of ordinary skill in the art would have no reason to modify the combination of Koenig and Harrison to include peroxide concentrations of at least about 50 wt% because neither reference teaches or suggests such high concentrations.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, motivation to combine the references exists as set forth in this office action. One would have been motivated to combine Harrison with Koenig because Harrison teaches suitability of PGA, PLA, PCL, PLGA, and polyurethane that are biodegradable polymers to incorporate peroxide releasing agent as a layer or sheet covering medical or surgical aids to release peroxide to provide anti-infective effect at the site of release. One would reasonably expect formulating the claimed article. It should be noted that motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. As such, the examiner respectfully submits that there is motivation to combine the cited references, and combination is proper.
In response to argument regarding amount of hydrogen peroxide releasing agent, the argument supra concerning amounts is hereby repeated.
Regarding the argument that Koenig is directed to antimicrobial composition and Harrison is directed to enhance cell and tissue survival, it has been decided by the Courts that even in a case where the reference does not teach the same use of the composition, the two different intended uses are not distinguishable in terms of the composition, see In re Thuau, 57 USPQ 324; Ex parte Douros, 163 USPQ 667; and In re Craige, 89 USPQ 393. Further, it is noted that the cited references are analogous art, and are in the field of the inventor’s endeavor, and reasonably pertinent to the particular problem with which the inventor was concerned, which is delivering peroxide to the tissues. Therefore it is proper to be relied upon the cited references as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
Applicants argue that Koenig achieves antimicrobial effect through surface-attached peroxide activated by moisture from microbes, not through high concentrations of peroxide dispersed in a polymer matrix. Koenig Koenig's mechanism relies on surface-activated peroxide release triggered by moisture from microbes, not on high bulk concentrations of peroxide in a polymer matrix. Harrison addresses the problem of treating hypoxic tissue by providing oxygen to enhance cell and tissue survival using different mechanism of action through and is relevant or instructive to selecting a peroxide concentration for use in a surface-activated peroxide release composition for forming antimicrobial substrates.
In response to this argument, applicant’s attention is directed to the scope of the present invention that is directed to a product, and all the elements of the claimed product are taught by combination of the cited references. Motivation to combine the references exists, even different from what applicants had done, as well as reasonable expectation to achieve the present invention. The mechanism of action of the product or composition does not impart patentability to the claims.
Further, the discovery of a new action underlying a known process does not make it patentable. MEHL/Biophile, 192 F.3d at 1365, 52 U.S.P.Q.2d at 1303. Also, it is irrelevant that the prior art observers did not recognize the property or function of the disputed claim; if the prior art inherently possessed that characteristic, it anticipates. See Verdeegal Brothers, lnc. v. Union Oil Co. of Cal., 814 F.2d 628, 633, 2 U.S.P.Q.2d 1051, 1054 (Fed. Cir. 1987). This is believed to be applicable here because anticipation is the epitome of obviousness.
Applicants argue that Huang does not remedy the deficiencies of Koenig and Harrison. Huang is directed to PLGA nanoparticles for drug delivery and is entirely silent on peroxide compounds and antimicrobial applications. Huang provides no teaching regarding peroxide concentrations.
In response to this argument, it is argued that Huang is relied upon for solely teaching acetonitrile is a stable solvent to PLGA and suitable to be used in pharmaceuticals. The reference satisfies the purpose for which it was applied.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G/
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