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 .
DETAILED ACTION
Status of Claims
The amendments and arguments filed on 07/28/2026 are acknowledged and have been fully considered. Claims 1-8 are now pending. Claims 9-10 are canceled; claim 1 is amended; claims 6-8 are withdrawn.
Claims 1-5 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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, and constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 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 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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20070292459 A1 (Cooper, 2007) in view of CN 110790698 (Wang, 2020; machine translation provided by PE2E via FIT), and Biddeci (2022).
Cooper teaches a wound-healing bandage or dressing (i.e., a hemostatic material) (see Cooper, paragraph 0061) comprising halloysite microtubules (see Cooper, paragraph 0039) and nanotubes (see Cooper, paragraphs 0044 and 0046). It is taught that halloysite tubules filled with an active agent such as an antibacterial is known in the art (see Cooper, paragraphs 0156, 0161, 0170). It is also taught that the composition comprises 2% of the halloysite microtubes being filled with the active (i.e., moisturizer in the specific embodiment) (see Cooper, paragraph 0164). This would be a ratio of 2:100 of the active to the halloysite. 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).
Cooper is silent on the use of aggregation-induced emission (AIE) nanoparticles and the hydroxylation of the halloysite.
Wang teaches an antibacterial composition comprising TTPy of the same structure as instantly claimed (see Wang, machine translation page 3; page 2, paragraphs 3-5; page 13, final paragraph; original document page 6, formula (III)).
Biddeci teaches a composition comprising halloysite nanotubes that have hydroxyl groups on the surface used for biomedical applications (see Biddeci, introduction; 2. Halloysite nanotubes).
In regard to claims 1-2, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Cooper with Wang and Biddeci as Cooper teaches that the halloysite tubules filled with an active agent, such as an antibacterial (see Cooper, paragraphs 0156, 0161, and 0170) like the TTPy of Wang, are known in the art. Further, Biddeci teaches that halloysite nanotubes can be modified with the intercalation of small organic molecules to increase the surface between the layers increased loading or adsorption (see Biddeci, page 3, first paragraph). It is also taught that the halloysite nanotubes are able to be functionalized and used as delivery vehicles of drugs (see Biddeci, page 9, first paragraph). Further, as the language of the claims recites that the “structure formula of the AIE nanoparticles is TTPy” as shown in claim 1, the compound of Wang meets the requirements of the AIE nanoparticles. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Also, Cooper teaches that the composition comprises 2% of the halloysite microtubes being filled with the active (i.e., moisturizer in the specific embodiment) (see Cooper, paragraph 0164). This would be a ratio of 2:100 of the active to the halloysite. 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). It would be within the purview of one with ordinary skill in the art to use the same amount of active as taught, while using the antibacterial composition taught in Wang. It would be obvious to one with ordinary skill in the art to combine antibacterial of Wang and the hydroxylated halloysite nanotubes with the dressing of Cooper according to known methods of formulating a halloysite dressing with an antibacterial (see Cooper, paragraphs 0156, 0161, and 0170) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
In regard to claims 3-5, a product-by-process claim drawn to a composition directed towards the halloysite-based composite hemostatic material, the patentability of a product does not depend on its method of production. The combination of Cooper, Wang, and Biddeci teach the instantly claimed composition. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). "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 a nonobvious difference between the claimed product and the prior art product. The teachings of Cooper, Wang, and Biddeci teach the composition as instantly claimed, thus the burden shifts to the applicant to come forward with evidence showing that the process of making the composition as instantly claimed produces a materially different product than the composition of Cooper, Wang, and Biddeci.
Response to Arguments
Applicant's arguments filed 07/28/2026 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regard to applicant’s argument that the art does not teach the claimed ratio of instant claims, however it is noted that Cooper teaches that the composition comprises 2% of the halloysite microtubes being filled with the active (i.e., moisturizer in the specific embodiment) (see Cooper, paragraph 0164). This would be a ratio of 2:100 of the active to the halloysite. 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). It would be within the purview of one with ordinary skill in the art to use the same amount of active as taught, while using the antibacterial composition taught in Wang.
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, Cooper teaches that halloysite microtubes/nanotubes are known to be filled with antibacterials known in the art, a category in which the TTPy of Wang falls under. Further, Biddeci teaches that halloysite nanotubes can be modified with the intercalation of small organic molecules to increase the surface between the layers increased loading or adsorption (see Biddeci, page 3, first paragraph). It is also taught that the halloysite nanotubes are able to be functionalized and used as delivery vehicles of drugs (see Biddeci, page 9, first paragraph). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would be obvious to one with ordinary skill in the art to combine antibacterial of Wang and the hydroxylated halloysite nanotubes with the dressing of Cooper according to known methods of formulating a halloysite dressing with an antibacterial (see Cooper, paragraphs 0156, 0161, and 0170) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Applicant is reminded that whether the 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 other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). In the instant case, no data is presented to support the claim of unexpected results. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."). "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). Further, if applicant believes the ratio of the AIE nanoparticles to halloysite is critical to the composition, this must be established as well using data. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
As such, claims 1-5 remain rejected as discussed above.
Conclusion
No claims 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
