DETAILED ACTION
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 .
Response to Amendment
The amendment filed on 10/20/2025 has been entered. Claim(s) 1 is/are currently amended. Claim(s) 1-7 is/are pending and is/are under examination in this office action.
Response to Arguments
The Declaration under 37 CFR 1.132 filed 10/20/2025 is insufficient to overcome the rejection of claims 1-7 based upon 35 USC 112(b) and 35 USC 103 as set forth in the last Office action because:
The Declarant argued that the structural and composition differences between what is disclosed in the cited prior art references and what is claimed here accomplish the goal of treating respiratory infections and cancers by inhalation, which none of the cited references (whether alone or in combination) is designed to achieve, and thus, the recited claim elements are not merely “intended use” limitations.
In response, the recited “in the presence of visible light, the water based polymer generating therapeutically useful quantities of singlet oxygen for treatment, by inhalation thereof, of respiratory infections and cancers” is an intended use limitation that imparts no additional structure beyond the claimed photosensitizer and need not be taught by the prior art to read on the claimed invention. See MPEP 2111.02(III). Nevertheless, Wilson teaches that the materials “produce singlet oxygen with antimicrobial activity when exposed to ambient light or when illuminated in a surgical or other environment” [abstract], suggesting that the photosensitizer can generate therapeutically useful quantities of singlet oxygen for treatment.
The Declarant argued that a person of ordinary skill in the art would not combine Appeaning—which is limited to topical applications—with the mask of Tong in view of Wilson’s composition, which is also limited to topical applications.
In response, as stated in the 103 rejection, Tong teaches surgical masks having antimicrobial activity. Wilson teaches an antimicrobial polymer material for surgical drapes and face masks. Therefore, Tong and Wilson are in the same field of endeavor. Appeaning teaches light-activated antimicrobial articles for medical and surgical use. One of ordinary skill in the art would be able to relate the articles for medical and surgical use to surgical masks, because surgical masks belong to articles for medical and surgical use. Therefore, Tong, Wilson and Appeaning are in the same field of endeavor.
The Declarant argued that a photosensitizer, such as that claimed in the present invention, would be undesirable for application in Tong’s mask due to impeded air flow. In [0035], Tong concedes as follows: “In general, the N95 respirator is inferior to the surgical/medical mask in terms of its breathability. It is relatively comfortable to wear surgical/medical masks when compared with N95 respirators, which provide high levels of protection at the expense of breathability.” In [0137], Tong discusses differential pressure across his mask for inhalation and exhalation, according to 2 NIOSH test procedures. His best values for both were 9.3 and 9.9 mm H20. (See [0138]). This pressure differential shows that air flow is still impeded. Thus, Tong’s mask would not have the desired air flow through the fabric or mask substrate for Singlet Oxygen (SO) to be inhaled in order to treat respiratory infections or even lung cancer. SO appears to have a collisional deactivation mechanism, with lifetime of the excited state inversely proportional to the particle density of the medium (liquid, air, vacuum). In contrast, the substrate of the claimed invention does not function as a filter of particles. Instead, it serves as a fixed bed catalytic reactor, utilizing light to catalyze formation of SO, which is inhaled from the substrate. High, minimally impeded air flow, facilitated by a porous substrate such as a fabric mask, is desirable. Thus, multiple layers of Tong’s mask would make undesirable barriers to the SO passing through the layers, thereby reducing, if not, eliminating, any therapeutically-effective yield of SO.
In response, the combination of Tong and Wilson is for the light-activated antimicrobial material only, not for the fabric or mask substrate. Tong teaches surgical masks having antimicrobial activity, but does not teach that the antimicrobial activity is from light-activated antimicrobial material. In the same field of endeavor, Wilson teaches the light-activated antimicrobial material for surgical masks. It would have been obvious to one of ordinary skill in the art at the time of filing to select the light-activated antimicrobial material for Tong’s surgical masks.
The Declarant argued that Wilson’s teachings are limited to topical applications. “Inhalation” is never mentioned. Treating respiratory infections or lung cancer through inhalation is not mentioned or even contemplated by Wilson.
In response, Wilson teaches surgical drapes and face masks as stated in the 103 rejection.
The Declarant argued that Appeaning is also limited to topical applications. Appeaning teaches a light source, a light-activated antimicrobial article comprising a photosensitizer and a viscoelastic material such as a pressure sensitive adhesive adapted to receive light from the light source. There is no teaching or suggestion of inhalation or long range transport of singlet oxygen from nose to lungs in Appeaning.
In response, Appeanng teaches light-activated antimicrobial articles for medical and surgical use, as stated in the 103 rejection. Articles for medical and surgical use cover surgical masks.
The Declarant argued that the presently claimed face masks exhibit unexpected results. As shown in the specification of the pending application, the face masks—through inhalation by the user of therapeutically useful quantities of singlet oxygen—have been effective for treatment of respiratory infections and cancers. See [0057] —[0063].
In response, whether unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980); MPEP 716.02(d). In the instant case, the examples are not commensurate in scope with the claims. For instance, claim 1 recites a porous substrate “having an outer layer, the outer layer being treated with a water-based polymer containing at least one photosensitizer in sufficient quantity to impart a characteristic color, and in the presence of visible light, the water based polymer generating therapeutically useful quantities of singlet oxygen for treatment, by inhalation thereof, of respiratory infections and cancers”. This covers a wide variety of porous substrates with different substrate material and pore sizes, treated with a wide variety of water-based polymer. However, the examples only employ one nonwoven polyester fabric. It is not known if other substrate material (e.g., cellulose based) will give the same result. The examples only employ one water- based, anionic, cross linkable solution polymer [0051 PGPUB] and an anionic core-shell emulsion polymer [0054 PGPUB.]. It is not known if other water-based polymers (e.g., nonionic polymers, cationic polymers, polyacrylates, polyurethanes, …) will give the same results. Claim 1 recites “at least one photosensitizer”, which covers a wide variety of photosensitizers. However, the examples only employ curcumin, Rose Bengal, and Methylene Blue [e.g., 0055 PBPUB]. It is not known if other photosensitizers (e.g., porfimer sodium, verteporfin, …) will give the same result. Since the examples are not reasonably commensurate with the full scope of claimed materials, and the Applicant has not provided any additional information that would allow one skilled in the art to extend the results associated with the data to the full scope of the claim, the examples cannot be relied upon to establish non-obviousness of the claimed invention.
The Declarant argued that with respect to the claim term “characteristic color,” this term is defined in the claim language itself (i.e., as imparted by the photosensitizer used: “at least one photosensitizer in sufficient quantity to impart a characteristic color’), and it is described in the specification. If the photosensitizer used is derived from Rose Bengal dye, then the “characteristic color” is pink. See e.g., paragraph [0031]. If the photosensitizer used is derived from Methylene Blue, then the “characteristic color’ is blue. See e.g., paragraphs [0053] and [0054].
In response, the phrase “at least one photosensitizer in sufficient quantity to impart a characteristic color” is not a definition of “characteristic color”. Paragraph [0031], [0053] and [0054] of PGPUB do not mention the term “characteristic color” at all.
The Declarant argued that as stated in the specification, other embodiments may include the use of anionic dyes and cationic dyes that are capable of generating singlet oxygen, and the dyes may be used alone or in combination. See paragraph [0043]. A person of ordinary skill in the art, such as myself, would be reasonably apprised of the scope of the invention including what this “characteristic color” is based on what is in the specification and claims. “Characteristic color” is a term referring to the color of the substrate containing the chromaphore Rose Bengal (or other dyes such as Methylene Blue).
In response, these paragraphs give examples of the characteristic colors, but do not give definition of this term. It is not known if other colors not included in the examples meet this limitation.
The Declarant argued that based on what is disclosed in the specification, “exhausted onto the substrate” can be interpreted as “applied” onto the substrate. The specification provides, in one embodiment, that “[i]f the water- based polymer is anionic, a cationic photosensitizer may also be applied to the fabric substrate by ionic attraction to the polymer.” See paragraph [0046]; see also paragraph [0047], which describes another embodiment: “Thus, curcumin may be applied to fabric from a turmeric dispersion, bonded by an anionic water-based polymer containing a photosensitizer, and a cationic photosensitizer may be exhausted onto the substrate by ionic attraction to the polymer. Thus, 3 photosensitizers may be applied to the fabric.” A person of ordinary skill in the art, such as myself, would be reasonably apprised of the scope of the invention including what “applied onto the substrate” means based on what is in the specification and as it is used in the claims. Moreover, one skilled in the art of would be familiar with “Exhaust Dyeing”. The department head at Gaston Community College Textile Dept (presumably one of ordinary skill in the art) was of assistance in dyeing 10 yard segments of fabric and used this term several times: The exhaust dyeing process involves the gradual, slow transfer of dye from a dye bath to a textile material within the same vessel until the dye is "exhausted" or absorbed from the bath by the material. This is also known as batch dyeing. The process requires controlled conditions, including specific dyes (like reactive or disperse dyes), chemicals such as electrolytes, and : parameters like temperature, time, and pH to achieve the desired color on fabrics such as cotton and cotton blends.” The cationic methylene blue dye in solution is drawn to the anionic Rose Bengal affixed to the substrate, and is held in place by ionic attraction. This migration from solution to substrate is commonly referred to as “exhausted” onto the substrate. Thus, a person of ordinary skill in the art would be reasonably apprised of the scope of the invention including what “applied onto the substrate” means.
In response, this argument is persuasive. The 112(b) rejection on “exhausted onto the substrate” is withdrawn.
Applicant's argument filed on 2/8/2023, with respect to 112(b) rejection and 103 rejection are the same as the Declaration, and are addressed above.
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 1-7 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.
The term “characteristic color” in claim 1 is a relative term which renders the claim indefinite. The term “characteristic color” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what color is characteristic. For the purpose of further examination, based on the broadest reasonable interpretation, any color derived from the product will be considered meeting this limitation.
Claims 2-7 are rejected as depending on claim 1.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tong et al (US 20160174631 A1) in view of Wilson et al (WO 9949823 A1) and Appeaning et al (US 20120100039 A1).
Regarding claims 1 and 3-4, Tong teaches a protective mask comprising a microfibrous substrate [abstract]. As seen from Fig. 7-11, the substrate is porous. The protective mask can be surgical mask [0073]. The substrate forms an outer layer [claim 21]. The outer layer has antimicrobial activity [0042].
Tong does not teach that the antimicrobial activity is from light-activated antimicrobial material.
In the same field of endeavor, Wilson teaches an antimicrobial polymer material for surgical drapes and face masks [abstract]. The polymer is incorporated with a singlet- oxygen generating amount of photosensitizer that is excited by light absorption and which generates singlet-oxygen by energy transfer from the excited photosensitizer [P2L2-4]. The photosensitizer includes rose Bengal and methylene blue [P2L32-34].
It would have been obvious to one of ordinary skill in the art at the time of filing to use light-activated antimicrobial material as the sole antimicrobial material in Tong’s composition, as it is expressly disclosed by Wilson as being useful in this capacity. It has been established that selection of a known material based on its suitability for its intended use is prima facie obvious (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). See MPEP 2144.07.
Wilson does not teach that the polymer is water-based polymer. However, the term “water-based polymer” is a product-by-process limitation. According to the specification, the polymer was applied from an aqueous solution before being dried and cured [Example 1, 0050 spec.]. Thus, the final product has no water. Product-by-process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps. If the product in a product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the product was made by a different process. See MPEP 2113(1). The product obtained through this process is a dried polymer. The same product could be achieved through a different process, for example by using a commercially available dry polymer.
Wilson’s photosensitizer is physically mixed and uniformly dispersed in the polymeric material [P3L21-25], rather than chemically bonded to the polymer chain.
In the same field of endeavor, Appeaning teaches light-activated antimicrobial articles for medical and surgical use [0112, 0124], comprising a photosensitizer and a viscoelastic material. The photosensitizer includes rose Bengal and Methylene blue [0074]. The viscoelastic material includes at least one polymer [0048]. The polymer includes acrylic polymers containing (meth)acrylic acid unit [0049-0052], which are widely made by emulsion polymerization and are art recognized as water-based. The photosensitizer may be covalently bonded to the polymer – the polymer may have pendant photosensitizer groups. The polymer having a covalently bound photosensitizer may comprise polystyrene/divinylbenzene copolymer having pendant rose Bengal groups [0077].
It would have been obvious to one of ordinary skill in the art at the time of filing to use the polymer having a covalently bound rose Bengal as the sole antimicrobial material in Tong in view of Wilson’s composition, as it is expressly disclosed by Appeaning as being useful in this capacity. It has been established that selection of a known material based on its suitability for its intended use is prima facie obvious (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). See MPEP 2144.07.
Wilson teaches that the material has “light-violet color” [P8L24], meeting the claimed “impart a characteristic color”, and suggesting that the photosensitizer is in sufficient quantity.
The recited “in the presence of visible light, the water based polymer generating therapeutically useful quantities of singlet oxygen for treatment, by inhalation thereof, of respiratory infections and cancers” is an intended use limitation that imparts no additional structure beyond the claimed photosensitizer and need not be taught by the prior art to read on the claimed invention. See MPEP 2111.02(III). Nevertheless, Wilson teaches that the materials “produce singlet oxygen with antimicrobial activity when exposed to ambient light or when illuminated in a surgical or other environment” [abstract], suggesting that the photosensitizer can generate therapeutically useful quantities of singlet oxygen for treatment.
Regarding claim 2, the recited “the characteristic color fades due to photodegradation, the color fading being indicative of the amount of singlet oxygen generated being insufficient for effective treatment of respiratory infection or cancer” is a physical property of the product. “Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). See MPEP 2112.01. Since the prior art teaches the same product containing the same photosensitizer as the current invention, the recited property is expected to be present.
Regarding claim 6, the prior art teaches the same rose Bengal and polymer composition as the instant application. The polymer contains (meth)acrylic acid unit as stated above. Therefore, the polymer is expected to be anionic. Since the photosensitizer is incorporated into the substrate, the cationic Methylene Blue is expected to be exhausted onto the substrate.
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tong in view of Wilson and Appeaning as applied to claim 1 above, further in view of Baumler et al (US 20190111168 A1).
Regarding claim 5, Tong in view of Wilson and Appeaning teaches the face mask in claim 1. Tong, Wilson or Appeaning does not teach a dispersion of turmeric, the turmeric containing a curcumin, the curcumin being the photosensitizer.
In the same field of endeavor, Baumler teaches a photosensitizer-containing dispersion for surgical use [0001, 0271-0272]. The photosensitizer includes curcumin [0060].
It would have been obvious to one of ordinary skill in the art at the time of filing to add a curcumin dispersion in the face mask of modified Tong, as it is expressly disclosed as being useful in this capacity. It has been established that selection of a known material based on its suitability for its intended use is prima facie obvious (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). See MPEP 2144.07.
The prior art teaches the same rose Bengal and polymer composition as the instant application. The polymer contains (meth)acrylic acid unit as stated above. Therefore, the polymer is expected to be anionic.
Regarding claim 7, since the photosensitizer is incorporated into the substrate, the cationic Methylene Blue is expected to be exhausted onto the substrate.
The recited “resulting in nonionic, anionic and cationic photosensitizers being attached to the substrate, the nonionic, anionic and cationic photosensitizers each a different color and having different absorbance maxima in the visible light spectrum” is a property of the product. “Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). See MPEP 2112.01. Since the prior art teaches the same product as the current invention, the recited property is expected to be present.
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 extension fee 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 date of this final action.
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/JIANGTIAN XU/Primary Examiner, Art Unit 1762