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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/2/2025 has been entered.
Response to Amendment
The amendment filed on 12/2/2025 has been entered. Claim(s) 1-19, 21-23, 25, 27-30, 32-33 and 37 have been cancelled. Claims 20 and 24 are amended. Claim(s) 20, 24, 26, 31 and 34-36 is/are pending and is/are under examination in this office action.
Response to Arguments
Applicant's argument filed on 12/2/2025, with respect to 103 rejection has been fully considered but is not persuasive.
Applicant argued that Gruening's gel-forming mechanism is fundamentally different. If one were to incorporate the claimed amounts of lithium magnesium sodium silicate nanoparticles in the composition of Gruening, as required by the Examiner's obviousness rejection, the house of cards structure would likely not be formed since its formation is very sensitive to various factors, such as the appropriate environment solvent amount, and the concentrations of each reagent. This is the particularly the case if one were to modify Gruening's gels, based on poly(N-vinyl lactam) which contain carboxylic acid (negatively charged) and would repel the lithium magnesium sodium silicate nanoparticles and not be able to form a stable house-of-card structure (since the surface in is negatively charged and the surface charge is the most dominant in sodium silicate nanoparticles). Therefore, Gruening would not be able to obtain the same viscosity, shear-thinning properties and stability as in the instant gel formulation.
In response, the claim recites the house-of-cards structure to the lithium magnesium sodium silicate nanoparticles, not to the gel. Neither the claims nor the specification discloses the gel having the house-of-cards structure. Since the prior art teaches the same lithium magnesium sodium silicate nanoparticles, this house-of-cards structure is expected to be present. Moreover, applicant did not provide any evidence to show that the lithium magnesium sodium silicate nanoparticles from the prior art cannot form house-of-cards structure. Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965), MPEP 716.01(c).
Applicant argued that as shown in Shi et al. (2017), which is being submitted herewith via an Information Disclosure Statement, combining poly(N-vinyl lactam) and Laponite causes the formation of unstable Pickering emulsions unless a polymerization reaction is conducted under the irradiation of UV light to form the hydrogel. As shown in FIG. 1 of Shi, Pickering emulsions are formed from VCL monomers dispersed in the Laponite clay aqueous solution. While Shi discloses careful UV light irradiation to facilitate polymerization, such special processing techniques are not disclosed, contemplated, or practical in the method of Gruening. This is because one of ordinary skill in the art would not be motivated to incorporate Laponite in the poly(N-vinyl lactam)-based gels of Gruening in the first place, and if they did in the amounts claimed here, they would have to account for the Pickering emulsions and would not achieve the instantly claimed house-of-cards structure.
In response, Shi (2017) reference does not disclose “combining poly(N-vinyl lactam) and Laponite causes the formation of unstable Pickering emulsions”. Shi teaches Pickering emulsions formed from VCL monomer droplets dispersed in the Laponite clay aqueous solution; and stable PVCL is formed when UV-light irradiation is applied [Figure 1]. Therefore, contrary to the applicant’s interpretation, PVCL is stable in the presence of Laponite. One of ordinary skill in the art would not be discouraged to combine poly(N-vinyl lactam) and Laponite based on Shi’s teaching.
Claim Objections
Claim 31 objected to because of the following informalities: Claim 31 recites “The sealant according to claim 30”. However, claim 30 is canceled. Appropriate correction is required.
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) 20, 24, 26, 31 and 34-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gruening et al (US 20050191270 A1) in view of Karandikar (US 20150313912 A1), Scholz et al (US 20090005339 A1), and Thompson et al (Journal of Colloid and Interface Science, Vol. 151, No. 1, June 1992).
Regarding claim 20, Gruening teaches a sealant for prevention of infection of mammalian body cavity or opening such as ear canal and teat canal comprising a hydrogel composition [0017, 0054]. The mammalian body cavity or opening reads on the claimed duct in a body of a mammal. The hydrogel is fully reversible due to its hydrogen bond nature [0034]. Therefore, the hydrogel is a physically reversible gel.
The hydrogel comprises up to 10 wt% of consistency modifying and/or performance modifying agent including polyethylenoxide [0036-0037]. This reads on the claimed 0.5-10 wt% of hydrophilic polymer.
Gruening does not teach the claimed molecular weight of the polyethylenoxide.
In the same field of endeavor, Karandikar teaches an antimicrobial hydrogel composition that can be used as a bioadhesive [abstract, 0233]. The hydrogel composition comprises polyethylene oxide polymers with molecular weights up to 5,000,000 [0042].
It would have been obvious to one of ordinary skill in the art at the time of the invention to form a hydrogel according to Gruening including polyethylene oxide having molecular weights up to 5,000,000, as Karandikar demonstrates this range to be suitable for similar polyethylene oxide used in similar hydrogel. This represents the use of a suitable range of polyethylene oxide molecular weight in a hydrogel which is compositionally similar to those of Karandikar and which is used in similar application. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416-21 (2007). See MPEP 2141.
The polyethylene oxide having molecular weights up to 5,000,000 (5,000 kDa) overlaps the claimed from about 1 kDa to about 10,000 kDa. A prima facie case of obviousness exists where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" (MPEP 2144.05.I).
The hydrogel comprises glycerin (equivalent to the claimed glycerol) as a humectant [0040], which is a therapeutic performance enhancing agent [0045]. Gruening teaches that the glycerol concentration can be 3-20 wt% [0044], falling within the claimed range of 1 to 80 wt%.
Gruening teaches that the water content can be up to 90 wt% [0031], falling within the claimed range of up to 100 wt%.
Gruening does not teach lithium magnesium sodium silicate nanoparticles, having a size from 1 nm to 500 nm. However, Gruening teaches using consistency modifying agent [0035].
In the same field of endeavor, Scholz teaches a hydrophilic gel used for prevention of infection of the internal spaces such as the middle ear and/or Eustachian tube as well as the external ear canal [0062, 0098]. The hydrophilic gel comprises hydrophilic components such as polyethylene glycols (PEG), random or block copolymers of ethylene oxide, and hydroxypropyl cellulose as well as water [0099]. The hydrophilic gel also comprises a thickener such as laponite in order to achieve high viscosities [0217, 0249, 0250].
It would have been obvious to one of ordinary skill in the art at the time of filing to add laponite as the consistency modifying agent in Gruening’s hydrogel to achieve high viscosities. Consistency modifying agents are art recognized as thickeners. As evidenced by the applicant, laponite reads on the lithium magnesium sodium silicate nanoparticles [P4L25 spec.].
The recited “forming a three dimensional house-of-cards structure” is a property of the laponite. “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 laponite product as the current invention, the recited “forming a three dimensional house-of-cards structure” is expected to be present.
Scholz teaches that the total concentration of the thickener is preferably 1-8 wt% based on the total weight of the ready to use composition [0249], meeting the claimed range of 1-15 wt%.
Scholz is silent about the particle size of the laponite.
In the same field of endeavor, Thompson teaches Laponite as a thickening agent used in aqueous dispersions [p. 236 under “Introduction”], having average particle size of 20 nm [abstract].
It would have been obvious to one of ordinary skill in the art at the time of the invention to form a sealant composition according to Gruening including lithium magnesium sodium silicate nanoparticles having average particle size of 20 nm, as Thompson demonstrates this particle size to be suitable for laponite for similar application. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416-21 (2007). See MPEP 2141.
The average particle size of 20 nm meets the claimed 1-500 nm.
The optional limitations need not to be addressed.
Gruening teaches that the product is a hydrogel as stated above, meeting the limitation of “in the form of a gel”.
The recited pH and density are properties 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.
Regarding claim 24, Scholz teaches that the total concentration of the thickener is preferably 1-8 wt% based on the total weight of the ready to use composition [0249], overlapping the claimed range of 8-15 wt%.
Regarding claim 26, the recited “gelation of the gel is reversed upon addition of a salt” is a property of the product. “Products of identical chemical composition can not 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. 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.
Regarding claim 31, Gruening in view of Scholz teaches the claimed lithium magnesium sodium silicate nanoparticles as stated above.
Regarding claims 34-36, Gruening teaches that the composition comprises antibiotics [0045] and dye [0051], meeting the claimed drug or agent.
Conclusion
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/JIANGTIAN XU/Examiner, Art Unit 1762
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