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
Information Disclosure Statement
The information disclosure statements (IDS) filed on 12/10/2024 and 11/05/2024 have been considered here.
Status of Claims
Claims 13-25 are now pending. Claims 1-12 are cancelled.
Claims 13-25 will be examined on the merits herein.
Specification
The disclosure is objected to because of the following informalities: On page 7, lines 7-14 of the instant specification as filed, it reads “debridement toll” which should read, “debridement tool”.
Appropriate correction is required.
The use of the term Pluronic®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 14 is objected to because of the following informalities: “H2O2” should read “H2O2”. Appropriate correction is required.
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 13-25 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.
Claims 13 and 14 recite the limitation "the composition". There is insufficient antecedent basis for this limitation in the claim. For purposes of search and examination, claim 13 is understood as “wherein components a) and b) are kept separate from each other until they are simultaneously mixed to form a composition…”.
Claims 15-25 are indefinite as they depend from an indefinite claim.
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 13-25 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20200222537 A1 (Loupis, 2020) in view of EP 2512402 B1 (Lyngstadaas, 2015).
In regards to claims 13-14, Loupis teaches a composition for the debridement of wounds or skin (see Loupis, paragraph 0021) and treating periodontal disease (see Loupis, paragraphs 0229-0237) comprising hydrogen peroxide in an amount from about 0.01% to about 30%, more specifically from 0.1% to 6% by weight of the total composition (see Loupis, paragraph 0102), which is approximately 0.1 to 6% v/v. The composition comprises a thickening agent as well, such as Pluronic® (i.e., a poloxamer)(see Loupis, paragraph 0114), in an amount of about 0.001% to about 40% w/w (see Loupis, paragraph 0109). It is also taught that the viscosity, flexibility, rigidity, tensile strength, tear strength, elasticity, and adhesiveness can be adjusted by varying the content of the thickening agent (see Loupis, paragraph 0109). 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 regards to the limitation of wherein the composition is a liquid at a temperature of at most 30°C, as the teachings of Loupis would yield an identical composition as instantly claimed, the properties, such as the state of matter at a specific temperature, of the composition would be the same. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art teaches an identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Further, claim 13 claims a future intended use, however the future intended use of a product is not considered to contribute to the overall patentability of the instant invention, particularly when the product itself is claimed and that same product is taught in the prior art. Further, while the teachings of Loupis generally teach that the components of the composition are kept separate, it is taught that the composition comprises chromophores (see Loupis, abstract) and that the thickening agent is selected so that the chromophores remain photoactive in the carrier medium (see Loupis, paragraph 0107). It is specifically taught that the chromophores and peroxide are kept in separate containers (see Loupis, paragraph 0255).
In regards to claim 19, the composition comprises a water-insoluble substrate, such as polymeric netted mesh, among others (see Loupis, paragraph 0119), or collagen (see Loupis, paragraphs 0137-0140), which is taught as a mesh-forming and/or scaffolding component in the specification as filed (see specification as filed, page 18, lines 30-35).
In regards to claim 20, the composition comprises an antimicrobial agent (see Loupis, paragraphs 0120-0136). The specification as filed teaches that antimicrobial molecules are bioactive substances (see specification as filed, paragraph bridging pages 18-19). Further, one with ordinary skill in the art would understand that hydrogen peroxide itself is a bioactive substance, looking at the teachings of the specification (i.e., it is a small molecule and is known to be antimicrobial).
In regards to claims 21-23, it is taught that the composition has its components in different containers, specifically a dual chamber syringe (see Loupis, paragraph 0255). The composition is taught to be in a kit comprising instructions (see Loupis, paragraph 0257), separate containers (i.e., understood as vial using the broadest reasonable interpretation of a vial) of the peroxide and chromophores (i.e., the thickening agent) (see Loupis, paragraph 0255), a syringe (see Loupis, paragraphs 0255 and 0257), instructions for use (see Loupis, paragraph 0257), and a container with an outlet in communication with the chamber for discharging the composition from the container (i.e., a connector device and applicator tip) (see Loupis, paragraph 0258). The kit also comprises a spatula (i.e., a mixing device) (see Loupis, paragraph 0257).
In regards to claims 24-25, the composition is taught to be use to disrupt a biofilm on a wound or for the debriding or disinfecting of a wound (see Loupis, paragraph 0221) as well as treat gingivitis (see Loupis, paragraphs 0225-0228), periodontitis (see Loupis, paragraphs 0233-0237), chronic cutaneous ulcers (see Loupis, paragraph 0212), and mucositis (see Loupis, paragraph 0250). As such, it would be within the purview of one with ordinary skill in the art to understand that the instructions included in the kit (see Loupis, paragraph 0257) would comprise instructions for using the kit in the removal of biofilm from a biological surface or to treat the various conditions mentioned above.
The teachings of Loupis are silent on the composition comprising microparticles, the kit comprising a debridement tool, and the use of poloxamer 407.
In regards to claims 13-15 and 17-18, Lyngstadaas teaches a composition comprising a composition for implant cleaning and debridement of hard surfaces in the oral cavity (i.e., teeth), which comprises nanoparticles of titanium dioxide and hydrogen peroxide (see Lyngstadaas, paragraph 0001). It is taught that the concentration of hydrogen peroxide is at most 7.5% by volume (see Lyngstadaas, paragraphs 0052-0053). The nanoparticles are taught to have a mean particle diameter (d50) of about 100-200µm (see Lyngstadaas, paragraph 0048). The microparticles are taught to be made of titanium oxide, which is inorganic (see Lyngstadaas, paragraph 0048). It is also taught that the microparticles are biodegradable (see Lyngstadaas, paragraph 0058). It is also taught that Pluronic® F-127 (i.e., poloxamer 407) is used as a thickening agent (see Lyngstadaas, example 3).
In regards to claims 13, 16, and 21, it is taught that the composition is used in a kit comprising separate containers for the components, instructions, a device for application of the composition, such as a syringe, as well as a debridement tool (see Lyngstadaas, paragraph 0069). The debridement tool is taught elongated base member formed of at least two wires being twisted with each other, and a plurality of bristles fixed between said twisted wires and extending away from said twisted wires, whereby said bristles are positioned in a cleaning section at a first end of said base member; and that said bristles comprise or consist of titanium and/or a titanium alloy (see Lyngstadaas, paragraph 0075).
In regards to claims 13-25, 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 Loupis and Lyngstadaas as both references teach using similar components in similar amounts using similar kits to achieve the same goal (e.g., debridement of biological tissue and cleaning teeth). "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 add the microparticles and the debridement tool of Lyngstadaas to the composition and kit of Loupis as the solid microparticles and tool would improve mechanical debridement and cleaning ability of the composition/kit (see Lyngstadaas, paragraphs 0001, 0052, 0055, and 0069). It would be obvious to one with ordinary skill in the art to combine microparticles and tool of Lyngstadaas with the teachings of Loupis according to the known method of making a composition comprising microparticles and hydrogen peroxide (see Lyngstadaas, example 1) 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 13-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 7 of U.S. Patent No. 12685749 B2 (the reference patent) in view of US PGPUB 20200222537 A1 (Loupis, 2020) and f EP 2512402 B1 (Lyngstadaas, 2015).
The reference patent teaches an antimicrobial and/or anti-inflammatory composition for cleaning and/or debriding a biological surface and/or a biomaterial surface in situ, consisting of a) hydrogen peroxide at a final concentration of between 0.1-5% v/v, and b) a composite hydrogel formulation comprising poloxamers at a concentration of 10-40% w/v, wherein the ratio of the concentration of component a to component b in the composition is 1:10; and wherein the composition is liquid at a temperature of at the most 30° Celsius (see reference claim 1). Further the reference patent teaches a kit comprising a composition according to claim 1, the kit further comprising h) at least two containers comprising said components a) and b), respectively, i) a syringe and a vial, j) a connector device, k) an applicator tip, l) an instruction leaflet (see reference patent 2), m) a mixing device, and n) a debridement tool (see reference patent, claim 3). The composition is taught to be in a two-chamber syringe (see reference patent, claim 4) and comprise inorganic or organic microparticles with a mean diameter overlapping with the instant claims (see reference patent, claim 7).
The teachings of the reference patent are silent on the structure of the debridement tool, the use of poloxamer 407, at least one mesh-forming and/or scaffolding component, and a bioactive substance.
The teachings of Loupis and Lyngstadaas have been described supra.
In regards to claims 13-25, 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 the reference patent with Loupis and Lyngstadaas as all references teach using similar components using similar kits in similar amounts to achieve the same goal (e.g., removal of biofouling, biofilm and/or necrotic tissue from a biological surface and/or a biomaterial surface in situ, treatment and/or prevention of periimplantitis, gingivitis, mucositis, peri-implant mucositis, periodontitis, and/or chronic and/or infected dermal ulcers). "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 the teachings of the reference patent with the teachings of Loupis and Lyngstadaas according to the known method of making a composition comprising microparticles and hydrogen peroxide (see Lyngstadaas, example 1) 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.
Claims 13-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6-7, 10-13 and 23 of copending Application No. 17939570 (reference application) in view of US PGPUB 20200222537 A1 (Loupis, 2020) and f EP 2512402 B1 (Lyngstadaas, 2015).
The reference application teaches a composition comprising hydrogen peroxide and poloxamer, specifically a composite hydrogel formulation (see reference application claim 4). The concentrations of the poloxamer (10% w/v) and hydrogen peroxide (3.0-7.0% v/v; see reference application claims 1 and 7) overlap in both claim sets. Claim 10 of the reference application has the limitation that both of the components are kept separate until use and claims 11-13 teach the use of at least one bioactive substance or antimicrobial substance.
The teachings of the reference application are silent on the teaching of a kit comprising a debridement tool, among other components.
The teachings of Loupis and Lyngstadaas have been described supra.
In regards to claims 13-25, 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 the reference application with Loupis and Lyngstadaas as all references teach using similar components in similar amounts to achieve the same goal (e.g., oral cleaning). "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 the teachings of the reference application with the teachings of Loupis and Lyngstadaas according to the known method of making a composition comprising microparticles and hydrogen peroxide (see Lyngstadaas, example 1) 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.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611
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