DETAILED ACTION
Claims 43-46 and 51-63 are currently pending and under examination.
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 .
Withdrawn Rejections
The prior rejection of claims 43-44 and 46 under 35 U.S.C. 102(a)(1) as being anticipated by Freyer et al. is withdrawn in light of Applicant’s amendment to specify the thickness of the fiber mat composition that Freyer does not teach.
The prior rejection of claims 43-44 and 46 under 35 U.S.C. 102(a)(1) as being anticipated by Iimura et al. is withdrawn in light of Applicant’s amendment to specify the thickness of the fiber mat composition that Iimura does not teach.
The prior rejection of claims 43 and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grotheer et al. is withdrawn in light of Applicant’s amendment to specify the thickness of the fiber mat composition that Grother does not anticipate.
Examiner’s Note
Applicant's amendments and arguments filed 01/05/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed 01/05/2026, it is noted that claims 43 is amended and claims 51-63 are newly added. No new matter or claims have been added.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments and newly added claims.
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 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.
Claims 43-46 and 51-63 are rejected under 35 U.S.C. 103 as being unpatentable over Grotheer et al. (“The performance of an orthosilicica acid-releasing silica gel fiber fleece in wound healing”, previously applied) in view of Veverková et al. (“Modified Silica Nanofibers with Antibacterial Activity”, previously applied).
Grotheer et al. teaches an inorganic orthosilicic acid-releasing spun fiber fleece (see abstract). Grotheer et al. teaches that the fleeces are a spun silica gel fiber fleeces with a chemical composition of Si(OH)yO2-y/2]n (i.e. a silica fiber mat composition, see page 7317). Grotheer et al. teaches that full-thickness wounds were excised to the subcutaneous fat tissue on the back of the pigs and that the depth of the wounds was approximately 3.5 mm (see page 7317). Grotheer et al. teaches that the spun silica gel fiber fleeces was inserted into the wounds, which then were sterilely covered by a dressing plaster (see page 7317). In Figure 1A, the spun silica gel fiber fleeces are shown to be flush with the skin, thus a person of ordinary skill in the art would reasonably expect that they had a thickness of approximately 3.5 mm (i.e. 0.138 inches).
Grotheer et al. does not teach that the fibers have a diameter of from about 50nm to about 5µm.
Veverková et al. teaches a nanofibrous material with antibacterial activity for wound dressing applications (see abstract). Veverková et al. teaches e nanofibers combining poly(vinyl alcohol) and silica were produced by electrospinning from the sol (see abstract). Veverková et al. teaches electrospinning is a method that produces polymer fibers using electrically driven jet; starting material is polymer solution or melt (see page 1). Veverková et al. teaches the process produces ultrafine fibers (micro- or nanofibers) with high specific surface area with various pore sizes (see page 1). Veverková et al. teaches electrospun nanofibers are widely used for biomedical applications as mentioned tissue engineering involving also wound dressing (see page 1). Veverková et al. teaches silica nanomaterials are a good candidate for medical applications because they are able to meet a number of mentioned strict criteria (low toxicity, high porosity, and relatively suitable surface for subsequent functionalization) and appear to be the ideal material for tissue engineering as well as wound dressing for the treatment of chronic wounds (see page 1 bridging to page 2). Veverková et al. teaches that the initial sol was prepared from TEOS by controlled hydrolysis and polycondensation in ethanol as solvent and HCl as a catalyst (see page 2). Veverková et al. teaches that the nanofibers had a diameter of 100-800nm (see Figure 1).
Regarding claims 43-45, 51-60, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have a fiber diameter of 100-800nm as taught by Veverková et al. in the spun fiber fleece of Grotheer et al. One would be motivated to do so with a reasonable expectation of success as both are drawn to silica fiber materials for wound healing, and Veverková et al. teaches that fibers with a diameter of 100-800nm can be successfully utilized. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). In the instant case the 100-800nm range taught by the prior art overlap on the instantly claimed range of 50nm to 5µm. Further, unless an unobvious structural limitation is provided by the process limitation, patentability of product-by-process claims are based on the product itself (see MPEP 2113). As Grotheer et al. discloses spun silica gel fiber fleeces (i.e. a silica fiber mat composition), the teachings of the prior art appear to meet the limitations recited in the instant claim and Veverková specifically teaches TEOS, ethanol, hydrocholic acid as staring material (2.1). “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. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), emphasis added.
Regarding claim 46, Grotheer et al. teaches that the fleeces are a spun silica gel fiber fleeces with a chemical composition of Si(OH)yO2-y/2]n (i.e. a silica fiber mat composition), thus the composition consists essentially of SiO2 (see page 7317).
Regarding claim 61-62, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). In the instant case, a person of ordinary skill in the art would reasonably expect the 0.138 inch thickness of the mat to have the same properties as one that is at least ½ inch. Alternatively, a person of ordinary skill in the art would be motivated to manipulate the thickness of the mat by routine experimentation, in order to optimize the desired effect of the resultant composition, such as increasing the thickness of the mat to match the depth of the wound to be treated, as Grotheer et al. teaches that the spun silica gel fiber fleeces was inserted into the wounds and the spun silica gel fiber fleeces are shown to be flush with the skin.
Regarding claim 63, Grotheer et al. does not teach the addition of organic polymers (see abstract and whole document generally).
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues Grotheer is different from the soft flexible and fluffy silica fiber mat composition of the instant claims as it appears to be rigid and fracture or break easily (section 3.3).
In response, Applicant is arguing limitations not present in the instant claims. The instant claims are directed to a fiber mat composition with a thickness of at least ¼ and inch. The remaining limitations are directed to process of making said mat. No limitations in the instant claims are directed to the structure of the finished mat.
Applicant argues Grotheer is not an enabling prior art since the process by which it was produced is not disclosed. Besides mere mentioning of the chemical composition of the silica fiber after spinning Grotheer is silent on how the fleece was actually made or prepared.
In response, the instant claims are directed to the product, the finished silica fiber mat. Grotheer teaches the chemical composition of a silica gel fiber fleece in wound healing. It is well established that a reference is presumed to have an enabling disclosure barring evidence to the contrary (see MPEP 2121). It is the burden of the applicant to submit evidence showing that the disclosure of Grotheer is not enabling for how the fleece was made. Applicant arguments are more than allegations that find support neither in technical reasoning nor in evidence of record. The examiner further points to MPEP 2121.01 (II): “Even if a reference discloses an inoperative device, it is prior art for all that it teaches.”
Applicant argues the claims have been amended for the silica fiber mat composition that has a thickness of at least about ¼ an inch and comprise silica fibers prepared by electrospinning a sol-gel with the recited chemical composition and transitioned under the specific conditions including transitioned duration (i.e. at least 2 days, humidity and temperature. The silica fiber mat has beneficial and advantageous properties compared to that prepared by conventional methods. For example, it is soft, flexible and fluffy. See Fig 4, 5A and 5B.
In response, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). In the instant case, a person of ordinary skill in the art would reasonably expect the 0.138 inch thickness of the mat to have the same properties as one that is at least ½ inch. Alternatively, a person of ordinary skill in the art would be motivated to manipulate the thickness of the mat by routine experimentation, in order to optimize the desired effect of the resultant composition, such as increasing the thickness of the mat to match the depth of the wound to be treated, as Grotheer et al. teaches that the spun silica gel fiber fleeces was inserted into the wounds and the spun silica gel fiber fleeces are shown to be flush with the skin.
Additionally, Applicant has disclosed a single method of making the silica fiber mat composition (Example 1). The instant claims do not contain limitations directed to the soft, flexible and fluffy structure of the silica mat nor the properties of collagen biomimetic at the site of tissue injury. Applicant’s single example is not commensurate in scope with the instant claims to demonstrate the full scope of the instant claims would result in the structural features argued. No comparison data is provided. Thus, the rejection is maintained for reasons of record. As Grotheer et al. discloses spun silica gel fiber fleeces (i.e. a silica fiber mat composition), the teachings of the prior art appear to meet the limitations recited in the instant claim. “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. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), emphasis added.
Applicant argues Veverková fails to teach or suggest the specifically recited parameters e.g. mat thickness and preparation conditions as required by the instant claim, nor is there any recognition in Veverková that combined parameters are result effective as convincingly demonstrated in the instant specification.
In response, Applicant’s arguments regarding the method steps are addressed above in regards to Grotheer. Applicant has provided no comparison or evidence to support what is structurally different. Further, the instant claims are drawn to a composition, not to a method of making. Unless an unobvious structural limitation is provided by the process limitation, patentability of product-by-process claims are based on the product itself (see MPEP 2113). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). In the instant case, a person of ordinary skill in the art would reasonably expect the 0.138 inch thickness of the mat to have the same properties as one that is at least ½ inch. Alternatively, a person of ordinary skill in the art would motivated to manipulate the thickness of the mat by routine experimentation, in order to optimize the desired effect of the resultant composition, such as increasing the thickness of the mat to match the depth of the wound to be treated, as Grotheer et al. teaches that the spun silica gel fiber fleeces was inserted into the wounds and the spun silica gel fiber fleeces are shown to be flush with the skin.
Conclusion
No claims are allowed.
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.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613