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 .
Applicants' arguments, filed 01/30/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 102/103--Previous
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
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 and 17 remain rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Krishnan (Electronic Theses and Dissertations, 2018).
Krishnan teaches, “targeted BAR encapsulated poly(lactic-co-glycolic acid; PLGA) nanoparticles (NPs) to increase the efficacy of BAR to inhibit P. gingivalis colonization in a dual species biofilm” (p. vi).
“NPs encapsulating BAR peptide potently inhibited pre-formed P.gingivalis/ S. gordonii biofilm. These results suggest that enhanced inhibition of P. gingivalis was be [sic] obtained with BAR-NPs, identifying a novel therapeutic approach to effectively targeting P. gingivalis colonization of the oral cavity” (p. vii).
The NP’s were synthesized using an oil-in-water technique wherein, “polyvinyl alcohol (PVA)” was included in the emulsion (p. 18, 1st full paragraph).
Accordingly, the NP’s comprised a hydrophobic polymer, PLGA, as well as a hydrophilic polymer, PVA, as per claims 2-4.
BAR is taught to have the following sequence: BAR NH2-LEAAPKKVQDLLKKANITVKGAFQLFS-OH (p. 14, Table 1), as per claim 17.
The prior art is anticipatory insofar as it teaches a composition comprising a BAR polypeptide encapsulated within a nanoparticle, where the nanoparticle is comprised of at least one hydrophobic, i.e. poly lactic acid. Assuming, purely arguendo, that the teaching is not specific enough to rise to the level of anticipation, it would have been obvious to a person having ordinary skill to make a composition comprising a BAR polypeptide encapsulated within a nanoparticle for the purpose of inhibiting pre-formed P.gingivalis/ S. gordonii biofilm, in view of Krishnan.
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.
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.
Previous
1) Claim(s) 5 remains rejected under 35 U.S.C. 103 as being unpatentable over Krishnan (Electronic Theses and Dissertations, 2018) as applied to claim 1 above, and further in view of Teulon et al., (nanomaterials, December 2018).
Krishnan, which is taught above, differs from claim 5 insofar as it does not teach an average diameter range for the nanoparticles.
Teulon et al. teaches, “Nanoparticles are defined as elementary particles with a size between 1 and 100 nm for at least 50% (in number) (Abstract).
“Despite differences in international definitions on nanoparticles (NPs) especially concerning solubility, aggregation, and distribution threshold, current regulatory agencies consider that a primary nanomaterial is a nanoparticle (NP) when at least one of its dimensions is in the range 1–100 nm [1], values below the diffraction-limited resolution of conventional microscopy. In Europe, the 2011/696/EU commission recommendation states that a product containing primary particles for 50% or more of the particles in the number size distribution and one or more external dimension in the size range 1–100 nm is a nanomaterial” (p. 2, Introduction, 1st para.).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to adhere to current regulatory agency standards of what constitutes a nanoparticle by providing the nanoparticles of Krishnan with an average particle size in the range of 1-100 nm.
Since the prior art size restriction is based on toxicology, i.e., “particle toxicology generally assumes that an increase in particle surface leads to increase in toxicity” (p. 2, Introduction, 2nd paragraph), it would behoove the artisan to adhere to regulatory standard to avoid causing harm to the patient. Accordingly, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s invention to provide the nanoparticles of Krishnan within the claimed range of about 50-100 nm.
New by Amendment
2) Claim(s) 1 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krishnan (Electronic Theses and Dissertations, 2018) in view of Akagi et al., (Polymer, 2007).
Krishnan teaches, “For drug delivery, it is often desirable for NPs [nanoparticles] to release the drug upon reaching the appropriate sites and hence, biodegradable formulations can aid in this endeavor. Poly(lactic acid, PLA), poly(lactic-co-glycolic acid, PLGA), polycaprolactone (PLCL) are different biodegradable formulations that have been used for nanoparticle synthesis” (p. 9, 1st paragraph)
Krishnan teaches a specific embodiment of a nanoparticle drug carrier, i.e., “targeted BAR encapsulated poly(lactic-co-glycolic acid; PLGA) nanoparticles (NPs) to increase the efficacy of BAR to inhibit P. gingivalis colonization in a dual species biofilm” (p. vi).
“NPs encapsulating BAR peptide potently inhibited pre-formed P.gingivalis/ S. gordonii biofilm. These results suggest that enhanced inhibition of P. gingivalis was be [sic] obtained with BAR-NPs, identifying a novel therapeutic approach to effectively targeting P. gingivalis colonization of the oral cavity” (p. vii).
The NP’s were synthesized using an oil-in-water technique wherein, “polyvinyl alcohol (PVA)” was included in the emulsion (p. 18, 1st full paragraph).
Accordingly, the NP’s comprised a hydrophobic polymer, PLGA, as well as a hydrophilic polymer, PVA.
BAR is taught to have the following sequence: BAR NH2-LEAAPKKVQDLLKKANITVKGAFQLFS-OH (p. 14, Table 1), as per claim 17.
The prior art teaches a composition comprising a BAR polypeptide encapsulated within a nanoparticle comprising a hydrophobic polymer, i.e., polylactic acid. Accordingly, it would have been obvious to a person having ordinary skill to make a composition comprising a BAR polypeptide encapsulated within a nanoparticle for the purpose of inhibiting pre-formed P.gingivalis/ S. gordonii biofilm, in view of Krishnan.
Since the Poly(lactic acid, PLA) and polycaprolactone (PLCL) are shown in the prior art as equivalent biodegradable polymers with poly(lactic-co-glycolic acid; PLGA) for nanoparticle synthesis. It would have been obvious to replace PLGA of the prior art embodiment with polylactic acid or polycaprolactone, as the hydrophobic polymer.
Generally, it is obvious to replace one component for another equivalent component if it is recognized in the art that two components are equivalent and is not based on the Applicant’s disclosure (see MPEP 2144.06).
Krishnan does not teach at least one hydrophilic polymer selected from claim 1.
For the sake of completion, the Examiner cites Akagi et al., teaching “Nanoparticles consisting of hydrophobic and hydrophilic segments have great potential as multifunctional carriers for pharmaceutical and biomedical applications, such as drug, protein, peptide or DNA delivery systems” (Abstract).
“Amphiphilic block or graft copolymers consisting of hydrophilic and hydrophobic segments are self-assembling materials, and are capable of forming polymeric associates in aqueous solutions” (p. 6730, right column, 3rd paragraph).
“Amphiphilic block copolymers, such as poly(ethylene glycol)-b-polylactic acid) (PEG-b-PLA) or PEG-b-PCL, are very attractive for use as drug delivery applications” (Id.). Note: polyethylene glycol is also polyethylene oxide (PEO).
Here, the prior art teaches use of polyethylene oxide a.k.a. polyethylene glycol as the hydrophilic polymer and PLA or PCL as the hydrophobic polymer.
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to combine the hydrophobic and hydrophilic polymers, i.e., PEO and PCL or PEO and PLLA (polylactic acid) since these combinations are known in the prior art as attractive for use as drug delivery applications. The artisan would have had a reasonable expectation of success with the combination insofar as the poly(lactic-co-glycolic acid of the embodiment is a mixture of hydrophobic polylactic acid and hydrophilic glycolic acid.
3) Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krishnan (Electronic Theses and Dissertations, 2018) in view of Akagi et al., (Polymer, 2007), as applied to claim 1 above, and further in view of Teulon et al., (nanomaterials, December 2018).
The combination of Krishnan and Akagi et al., which is taught above, differs from claim 5 insofar as it does not teach an average diameter range of 50 nm to 100 nm for the nanoparticles.
Teulon et al. teaches, “Nanoparticles are defined as elementary particles with a size between 1 and 100 nm for at least 50% (in number) (Abstract).
“Despite differences in international definitions on nanoparticles (NPs) especially concerning solubility, aggregation, and distribution threshold, current regulatory agencies consider that a primary nanomaterial is a nanoparticle (NP) when at least one of its dimensions is in the range 1–100 nm [1], values below the diffraction-limited resolution of conventional microscopy. In Europe, the 2011/696/EU commission recommendation states that a product containing primary particles for 50% or more of the particles in the number size distribution and one or more external dimension in the size range 1–100 nm is a nanomaterial” (p. 2, Introduction, 1st para.).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to adhere to current regulatory agency standards of what constitutes a nanoparticle by providing the nanoparticles of Krishnan with an average particle size in the range of 1-100 nm.
Since the prior art size restriction is based on toxicology, i.e., “particle toxicology generally assumes that an increase in particle surface leads to increase in toxicity” (p. 2, Introduction, 2nd paragraph), it would behoove the artisan to adhere to regulatory standard to avoid causing harm to the patient. Accordingly, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s invention to provide the nanoparticles of Krishnan within the claimed range of about 50-100 nm.
Response to Arguments
Applicant argues that the Krishnan is not anticipatory or obvious over the instant claims as currently amended insofar as the claims now require specific examples of hydrophobic and hydrophilic polymers.
However, the teaching in Krishnan of the embodiment having poly(lactic co-glycolic acid of Krishnan still reads on the instant claims in an anticipatory manner insofar as it is comprised of polylactic acid, as amended, which is one of the “at least one hydrophobic polymers” recited in the claim.
Conclusion
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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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612