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 .
Claims Status
Applicant’s election without traverse of Group I, claims 1-8 and 13-14 and the species of: 1) for the API: mixture of nitrofurantoin and NAC; 2) for the structure: wherein the API is loaded, supported and adsorbed; and 3) for the shape: a mixture of substantially spherical and/or spheroidal in the reply filed on 08/29/2025 is acknowledged. The shape is being interpreted as either spherical or spheroidal in view of the election of “and/or”.
Claims 9-12 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/29/2025.
Claims 1-8 and 13-14 are under current examination.
Claim Objections
For claim language consistency, claim 1 at lines 7 and 9 should recite in which said vector or carrier.
Information Disclosure Statements
Information Disclosure Statements (IDS) filed on 04/06/2023 and 07/05/2023 have been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract contains legal phraseology such as “said”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112(b)-indefinite
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 1-8 and 13-14 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.
Claim 1 recites a vector or carrier selected from “the mesoporous nanoparticles comprising pores”. There is insufficient antecedent basis for this limitation in the claim for the recitation of “the” mesoporous nanoparticles because there is no earlier recitation of mesoporous nanoparticles comprising pores, therefore it is unclear what mesoporous nanoparticles comprising pores the claim is referring back to for the selection.
Claim 1 recites improper Markush language of “selected from the group comprising” at line 11 and “including” at line 13 which is synonymous to comprising. It is unclear what other alternatives are intended to be encompassed by the claim in view of the comprising language which enables an open list of alternatives and including language which also enables an open list of alternatives. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022). A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation antimicrobial, and/or antibacterial, and/or bacteriostatic activity, and/or mucolytic activity and/or anti-inflammatory activity, and the claim also recites including at least one antibiotic or vancomycin or NAC or nitrofurantoin which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 1 recites “nitrofurantoin, etc.”. The recitation of “etc.” renders the claim indefinite because it is unclear which active ingredients are intended to be included by the recitation of “etc.” Thus, it is unclear where the claim ends and what actives are encompassed by the claim. Accordingly, the metes and bounds of the claim cannot readily be ascertained. It is suggested that Applicants delete the recitation of “etc.”.
The term “substantially” in claim 4 is a relative term which renders the claim indefinite. The term “substantially” 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. Claim 4 recites that said nanoparticles have a “substantially spherical” shape. The instant specification does not define “substantially” and thus it is unclear to what degree the particles can be spherical to meet a substantially spherical shape. Accordingly, the metes and bounds of claim 4 are indefinite for “substantially spherical”.
The term “substantially comprised of” in claim 5 is a relative term which renders the claim indefinite. The term “substantially” 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. The phrase “substantially comprised” renders the scope of the claim unclear because it is unclear if the values for average volume must be 0.2-4cm3/g, or 0.25-0.35cm3/g or can include other values since the claim recites substantially comprised of. It is unclear to what degree the pores must have the average volume since the claim recites substantially comprised of, thus rendering the metes and bounds of the claim unclear.
Claim 6 recites “(weight/weight)” in parenthesis. It is unclear if the claim requires the weight/weight percent unit for the amount of API because the weight/weight is within parenthesis. It is suggested that Applicants can remove the parenthesis.
Claim 7 recites the system according to claim 1, comprising two or more active principles or pharmacologically active ingredients (API) different from each other, and in which each active principle or pharmacologically active ingredient (API) is loaded in one or more mesoporous nanoparticles different from the nanoparticle or nanoparticles into which the other active principle(s) or pharmacologically active ingredient(s)(API)is loaded or are loaded. There is a lack of antecedent basis for “the other active principle(s) or pharmacologically active ingredients(s)”. It is unclear if the other active principles is referring back to the one more than one or all of the one or more than one active principle and API of claim 1, or this is referring to different APIs and active principles. Furthermore, it is unclear if the recited two or more active principles or pharmaceutically active ingredients is referring to the same at least one active principle or pharmacologically active ingredient (API) already required by claim 1 or if these are additional active principles and APIs to the at least one active principle or API already recited in claim 1 thus further comprise. For purpose of examination, the claim will be interpreted wherein the at least one or more active principle or API of claim 1 comprises two or more active principles or pharmacologically active ingredients that are different to one another.
Claim 14 recites “the antibiofilm activity specifically of eradication”. There is insufficient antecedent basis for this limitation in the claim. It’s unclear if the antibiofilm activity specifically of eradication is referring to the eradication of an infection caused by bacterial biofilm and/or biofilm of a microorganism, the eradication of contamination caused by bacterial biofilm and/or biofilm of a microorganism or both eradication of an infection caused by bacterial biofilm and/or biofilm of a microorganism, and the eradication of contamination caused by bacterial biofilm and/or biofilm of a microorganism. Furthermore, the claim recites “supporting process”. It is unclear how supporting process modifies the loading of the API, and the specification does not clarify what is meant by a supporting process, thus the metes and bounds of the claim cannot readily be ascertained.
The term “in proximity” and “near” in claim 14 are relative terminology which renders the claim indefinite. 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 unclear how close the mesoporous zirconia nanoparticles must be relative to the biofilm to achieve the eradication required by the 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.
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) 1-7 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sponchia et al. (United States Patent 10501331) in view of Brinker et al. (United States Patent Publication 2019/0262469) and O’Neil et al. (United States Patent Publication 2012/0328671).
Claim 1 recites: A system for the administration and delivery of at least one active principle for the eradication of an infection or contamination by bacterial biofilm and/or of other microorganism, comprising: - a vector or carrier selected from the mesoporous nanoparticles comprising pores; - at least one active principle or pharmacologically active ingredient (API) comprising at least one substance with antibacterial, and/or bacteriostatic and/or bactericidal and/or mucolytic and/or anti-inflammatory activity, loaded into said pores of said vector and/or supported by and/or adsorbed in said vector: in which said vector is constituted by mesoporous zirconia nanoparticles (MZN) and in which said at least one active principle or pharmacologically active ingredient (API) is selected from the group comprising at least one molecule with antimicrobial, and/or antibacterial, and/or bacteriostatic activity, and/or mucolytic and/or anti-inflammatory including at least one antibiotic, or vancomycin, or N-acetyl-L-cysteine (NAC), or nitrofurantoin, etc., and/or combinations thereof.
The recitation of a system is being interpreted as a composition which contains a vector constituted of mesoporous zirconia nanoparticles and at least one API. The elected species for the at least one API is nitrofurantoin and N-acetyl-L-lysine (NAC). The elected structure is APIs being loaded, supported and adsorbed. The elected shape is substantially spherical and/or spheroidal. For the purpose of examination supported will be interpreted as inclusive of chemically bound.
Sponchia et al. teach novel mesoporous zirconia nanoparticles comprising pores which are distributed throughout the entire nanoparticle volume. The nanoparticles have the advantage of being non-cytotoxic and present a high surface area making it suitable for drug delivery, see abstract and column 4, lines 35-68. The specific surface area of the particles can comprise 200m2/g. The pore size can comprise from 2-50nm, or an average diameter from 2-10nm, see column 1, lines 39-40 and claims 1 and 3. The pores can be internal, see column 3, lines 39-40. The zirconium oxide nanoparticles have a substantially spherical shape, see claim 5. The pores can have a uniform pore distribution distributed throughout the entire volume of said particle. Compounds which include drugs can be functionalized with or bound to or adsorbed on the particles, see claims 6-7 and 10. The bio nano-system can comprise compounds which include at least one compound such as drugs chemically bound or adsorbed onto one or more particles or are loaded into the pores of said one or more particles, see column 7, lines 62-67 and Example 3. Example 6 demonstrates loading of two drugs. According to Sponchia et al., the sol-gel technique in creation of the nanoparticles allows the synthesis and purification of zirconium nanoparticles with an improved purity and grade and which allows for control over the structure such as the shape and dimension of said nanoparticles, the pores shape and the pore distribution, see column 4, lines 44-55 and claims 12 and 21.
Although Sponchia et al. generically teaches loading of comounds such as drugs, Sponchia et al. do not expressly teach loading an antibiotic nitrofurantoin in combination with N-acetyl-L-cysteine (NAC), the loading weight % of the drugs from 5-20%, the pore volume, or that the particles can be inclusive of a spheroidal shape.
Brinker et al. teach antimicrobial protocell compositions comprising mesoporous metal oxide nanoparticles loaded with antibiotics, see paragraph [0003]. The term “protocell” refers to nanoparticle which is inclusive of zirconia, see paragraph [0165]. The nanoparticles can comprise a delivery system, see paragraph [0206] and [0266]. In one embodiment the nanoparticle contains a multimodal pore size distribution wherein the diameter is 25nm,, see paragraph [0095]. In another embodiment the diameter can comprise from 0.01-50nm in size, see paragraph [0096]. The nanoparticle can be spherical or ellipsoidal (meeting spheroidal), see paragraphs [0095], [0208], [0300], [0366] and [0436]. The protocell can comprise a surface area of from 50m2/g to about 1500 m2/g, see paragraphs [0053], [0075], [0090], [0454] and claims 8 and 21. The protocells which are the nanoparticles can comprise from about 0.01-70% by weight with cargo, see paragraph [0251],[0318], and claim 13. Examples of the cargo include antibiotic agents such as nitrofurantoin, see claim 13, and paragraphs [0088], [0317], [0380], [0517], and entire document. The pores can be on the surface and internal, see paragraph [0067]. The active agents (i.e. cargo) can be adsorbed or loaded into the pores and be included on the surface, see paragraph [0203] and [0296] and [0175].The optimal pore volume is from 0.5-1.1 cubic centimeters per gram (cm3/g), see paragraphs [0252] and [0319], and [0389] rendering obvious the claimed average volume in the range form 0.2-0.4 cm3/g or between 0.25-0.35cm3/g.
Brinker et al. teach mesoporous zirconia which can comprise nitrofurantoin however Blinker et al. do not expressly teach that the antibiotic which includes nitrofurantoin can be combined with N-acetyl-L-cysteine (NAC).
O’Neil et al. tech combinations of antibiotic with N-acetylcysteine surprisingly overcomes the antibiotic resistance of bacterial strains and that a combination of antibiotic agent and dispersant or anti-adhesive increases antibacterial action synergistically. The dispersant or anti-adhesive agent can comprise N-acetyl-cysteine.
It would have been prima facie obvious to load a combination of nitrofurantoin with NAC into the zirconia mesopores of Sponchia et al.
One of ordinary skill in the art would have been motivated to do so in order to treat bacterial infections. One of ordinary skill in the art would have been motivated to combine NAC with nitrofurantoin since per the teachings of O’Neil, the combination of NAC with antibiotic results in synergism against bacterial resistant trains. There would have been a reasonable expectation of success because Sponchia et al. teach that drugs can be loaded with the mesoporous nanoparticles for drug delivery application with non-cytotoxicity.
It would have additionally been obvious to provide nitrofurantoin and NAC drugs in amounts inclusive of 0.01-70% by weight loading because Brinker teaches loading of drugs including nitrofurantoin in these amounts into protocells which are inclusive of mesoporous zirconia. In addition, the optical pore volume for protocells is taught to be from 0.5-1.1 cubic centimeters per gram. One or ordinary skill in the art would have been motivated to provide the pore volume of Sponchia et al. in these optimal ranges as Brinker teaches that such mesoporous protocells are efficient in delivery of antibiotics including nitrofurantoin. Furthermore, per the teachings of Sponchia et al., shape and size of nanoparticles as well as shape and size of the pores can be advantageously altered or consolidated by varying the temperature and duration of a solvo-thermal treatment, see column 10, lines 21-25.
It would have been obvious to adjust the shape of the particles to be spheroidal and/or spherical. One of ordinary skill in the art would have been motivated to do so because Sponchia et al. teach that the sol-gel technique in creation of the nanoparticles allows for control over the structure such as the shape and dimension of said nanoparticles. Furthermore, Brinker et al. teach that mesoporous nanoparticles can be created to have two or more shapes inclusive of both a spherical and spheroidal shape and that the shapes depend on the processing conditions, see paragraph [0208].
The recitation of “for the eradication of an infection or contamination by bacterial biofilm and or other microorganism” and “for use in the eradication of an infection or contamination caused by a bacterial biofilm and/or a biofilm of a microorganism” in claims 1 and 14 is being interpreted as an intended use of the claim. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since Sponchia et al. in view of Brinker et al. and O’Neil et al. arrives at mesoporous zirconia nanoparticles which contain NAC and nitrofurantoin, wherein O’Neil teaches synergism between antibiotics inclusive of nitrofurantoin and NAC, with the composition being effective in prevention of biofilm (paragraph [0011]), the prior art structure is capable of performing the intended use. The fact that the antibiofilm activity is enhanced by loading of the mesoporous zirconia nanoparticles would be the natural result of combining nitrofurantoin and NAC since O’Neil suggests synergism and that the combination provides prevention of biofilm formation.
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.
Claim(s) 1-7 and 13-14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10501331 in view of Brinker et al. (United States Patent Publication 2019/0262469) and O’Neil et al. (United States Patent Publication 2012/0328671).
Claim(s) 1-7 and 13-14 are directed to an invention not patentably distinct from claims 1-11 of U.S. Patent No. 10501331.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Patent ‘331 are directed to mesoporous vector nanoparticles having active agents (i.e. drugs) within. The diameter of the pores in both the instant claims and that of Patent ‘331 includes 2-10nm. The shape of both the instant claims and that of Patent ‘331 includes substantially spherical nanoparticles with an overlapping surface area that is greater than 200m2/g.
The difference between the instant claims and that of Patent ‘331 is the loading of the drugs nitrofurantoin with NAC, the loading capacity (% wt.), and the pore volume amount.
Brinker et al. teach antimicrobial protocell compositions comprising mesoporous metal oxide nanoparticles loaded with antibiotics, see paragraph [0003]. The term “protocell” refers to nanoparticle which is inclusive of zirconia, see paragraph [0165]. The nanoparticles can comprise a delivery system, see paragraph [0206] and [0266]. In one embodiment the nanoparticle contains a multimodal pore size distribution wherein the diameter is 25nm,, see paragraph [0095]. In another embodiment the diameter can comprise from 0.01-50nm in size, see paragraph [0096]. The nanoparticle can be spherical or ellipsoidal (meeting spheroidal), see paragraphs [0095], [0208], [0300], [0366] and [0436]. The protocell can comprise a surface area of from 50m2/g to about 1500 m2/g, see paragraphs [0053], [0075], [0090], [0454] and claims 8 and 21. The protocells which are the nanoparticles can comprise from about 0.01-70% by weight with cargo, see paragraph [0251],[0318], and claim 13. Examples of the cargo include antibiotic agents such as nitrofurantoin, see claim 13, and paragraphs [0088], [0317], [0380], [0517], and entire document. The pores can be on the surface and internal, see paragraph [0067]. The active agents (i.e. cargo) can be adsorbed or loaded into the pores and be included on the surface, see paragraph [0203] and [0296] and [0175].The optimal pore volume is from 0.5-1.1 cubic centimeters per gram (cm3/g), see paragraphs [0252] and [0319], and [0389] rendering obvious the claimed average volume in the range form 0.2-0.4 cm3/g or between 0.25-0.35cm3/g.
O’Neil et al. tech combinations of antibiotic with N-acetylcysteine surprisingly overcomes the antibiotic resistance of bacterial strains and that a combination of antibiotic agent and dispersant or anti-adhesive increases antibacterial action synergistically. The dispersant or anti-adhesive agent can comprise N-acetyl-cysteine.
It would have been prima facie obvious to load a combination of nitrofurantoin with NAC into the zirconia mesopores of Patent ‘331.
One would have been motivated to do so in order to treat bacterial infections. One of ordinary skill in the art would have been motivated to combine NAC with nitrofurantoin since the combination of NAC with antibiotic results in synergism against bacterial resistant trains. There would have been a reasonable expectation of success because Patent ‘331 teaches that drugs can be loaded with the mesoporous nanoparticles for drug delivery application with non-cytotoxicity.
It would have been obvious to provide nitrofurantoin and NAC drugs in amounts inclusive of 0.01-70% by weight as the drugs of Patent ‘331 because Brinker teaches loading of drugs including nitrofurantoin in these amounts into protocells which are inclusive of mesoporous zirconia. In addition, the optical pore volume for protocells is taught to be from 0.5-1.1 cubic centimeters per gram. One or ordinary skill in the art would have been motivated to provide the pore volume of Patent ‘331 in these optimal ranges as Brinker teaches that such mesoporous protocells are efficient in delivery of antibiotics including nitrofurantoin. Furthermore, per the teachings of Patent ‘331 shape and size of nanoparticles as well as shape and size of the pores can be advantageously altered or consolidated by varying the temperature and duration of a solvo-thermal treatment, see column 10, lines 21-25.
It would have additionally been obvious to adjust the shape of the particles to be spheroidal and/or spherical. One of ordinary skill in the art would have been motivated to do so because Patent ‘331 teaches that the sol-gel technique in creation of the nanoparticles allows for control over the structure such as the shape and dimension of said nanoparticles. Furthermore, Brinker et al. teach that mesoporous nanoparticles can be created to have two or more shapes inclusive of both a spherical and spheroidal shape and that the shapes depend on the processing conditions, see paragraph [0208].
Since Sponchia et al. in view of Brinker et al. and O’Neil et al. arrives at mesoporous zirconia nanoparticles which contain NAC and nitrofurantoin, wherein O’Neil teaches synergism between antibiotics inclusive of nitrofurantoin and NAC, with the composition being effective in prevention of biofilm (paragraph [0011]), thus the structure of the mesoporous zirconia is capable of performing the use of “for the eradication of an infection or contamination by bacterial biofilm and or other microorganism” and “for use in the eradication of an infection or contamination caused by a bacterial biofilm and/or a biofilm of a microorganism” in. The fact that the antibiofilm activity is enhanced by loading of the mesoporous zirconia nanoparticles would be the natural result of combining nitrofurantoin and NAC since O’Neil suggests synergism and that the combination provides prevention of biofilm formation.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). U.S. Patent No. 10501331 discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Conclusion
Currently, no claims are allowed and all claims are rejected.
Correspondence
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619