DETAILED ACTION
Claim Status
Claim(s) 1, 4, 6-8, 10-14, 17, 19-20 is/are pending.
Claim(s) 1, 4, 6-8, 10-14, 17, 19-20 is/are rejected.
Claim(s) 2-3, 5, 9, 15-16, 18 is/are cancelled by Applicant.
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 .
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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1, 4, 6-8, 10-14, 17, 19-20 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for: (I) a limited range of oxygen barrier coatings; does not reasonably provide enablement for the entire encompassed compositional range of the oxygen barrier coating. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The propriety of a rejection based upon the scope of a claim relative to the scope of the enablement concerns (1) how broad the claim is with respect to the disclosure and (2) whether one skilled in the art could make and use the entire scope of the claimed invention without undue experimentation. See MPEP 2164.08. The disclosure as originally filed does not enable one of ordinary skill in the art to make oxygen barrier packaging material which exhibits the recited physical properties: (A) light transmission (claims 1, 14); (B) bendability and stretchability (claims 1, 14) and (C) antimicrobial activity against Escherichia coli and Staphylococcus aureus (claims 1, 14); and optionally (D) reduction in oxygen transmission rate (claim 8); at thicknesses of 3 microns or less, over the entire scope of the present claims.
MPEP 2164.01(a) Undue Experimentation Factors [R-08.2012]
PNG
media_image1.png
18
19
media_image1.png
Greyscale
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(A) The breadth of the claims;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(B) The nature of the invention;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(C) The state of the prior art;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(D) The level of one of ordinary skill;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(E) The level of predictability in the art;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(F) The amount of direction provided by the inventor;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(G) The existence of working examples; and
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(H) The quantity of experimentation needed to make or use the invention based on the
content of the disclosure.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (reversing the PTO’s determination that claims directed to methods for detection of hepatitis B surface antigens did not satisfy the enablement requirement). In Wands, the court noted that there was no disagreement as to the facts, but merely a disagreement as to the interpretation of the data and the conclusion to be made from the facts. In re Wands, 858 F.2d at 736-40, 8 USPQ2d at 1403-07. The Court held that the specification was enabling with respect to the claims at issue and found that "there was considerable direction and guidance" in the specification; there was "a high level of skill in the art at the time the application was filed;" and "all of the methods needed to practice the invention were well known." 858 F.2d at 740, 8 USPQ2d at 1406. After considering all the factors related to the enablement issue, the court concluded that "it would not require undue experimentation to obtain antibodies needed to practice the claimed invention." Id., 8 USPQ2d at 1407.
In particular, with respect to Wand factor (A) the claims are relatively broad -- for example, but not limited to:
• the claims do not contain any limitations on the minimum individual amounts and/or ratio of chitosan and polyvinyl alcohol (PVOH) in the coating polymer;
• the claims do not contain any limitations on the minimum individual amounts of chitosan and PVOH in the oxygen barrier coating as a whole;
• the claims do not contain any limitations on the physical structure (i.e., aspect ratio, shape, etc.) of the nanoparticles in the oxygen barrier coating as a whole;
• the majority of the claims claims do not contain limitations on the type of plasticizer in the oxygen barrier coating as a whole;
• the claims do not contain any restrictions on the type(s) and amount(s) of other components (e.g., other types of thermoplastic and/or thermosetting resins; non-polymeric components such as various organic or inorganic compounds, such as fillers, pigments, and/or other additives; etc.) in the light transmissive, oxygen barrier coating as a whole, as long as the recited four components -- i.e., (1) coating polymer containing both the specified chitosan and PVOH; (2) nanoparticles; (3) plasticizer; (4) crosslinking agent -- are each present in the recited amounts.
etc.
With respect to Wand factor (B), Applicant asserts that the claimed light transmissive oxygen barrier coating provides “unexpected technical effects” with respect to at least light transmission combined with antimicrobial behavior.
With respect to Wand factor (C), the prior art does not specifically disclose or suggest how to produce light transmissive oxygen barrier coatings containing components (1)-(4) above in the recited amounts which exhibit the required physical properties (A) and (B) and (C) (claims 1, 14), and optionally (D) (claim 8), at thicknesses of 3 microns or less (claim 1).
With respect to Wand factor (D)-(E), in view of Applicant’s assertions of “unexpected technical effects” from the claimed oxygen barrier coating, it is the Examiner’s position that the disclosure as originally filed does not provide adequate guidance that permits one of ordinary skill in the art to produce oxygen barrier films capable of simultaneously satisfy the recited combination of properties (A)-(C) (claims 1, 14), optionally (D) (claim 8), using coating compositions which satisfy the broad compositional limitations on the oxygen barrier coating composition, but which deviate materially from Applicant’s working Examples, using mere routine experimentation, since it is not readily apparent or readily predictable how differences in oxygen barrier coating composition will affect a film’s ability to simultaneously satisfy recited properties (A)-(C) (claim 1, 14), and optionally (D) (claim 8).
With respect to Wand factor (F)-(G), the disclosure as originally filed does not provide provides guidance how to produce a film capable of simultaneously satisfying recited properties (A)-(C) (claim 1, 14), and optionally (D) (claim 8), using a single coating composition. In particular: (i) experimental data on property (A) light transmission is only provided for Examples 1A-2A, but not for Example 3A; (ii) data or information on property (B) bendability and stretchability is not provided for Examples 1A-3A; (iii) information of property (C) antimicrobial activity is only provided for Example 3A, but not for Examples 1A-2A.
With respect to Wand factor (H), in view of: (i) the relative broadness of the present claims; (ii) the absence of inventive Examples which simultaneously exhibit recited properties (A)-(C) (claims 1, 14) and optionally (D) (claim 8); and (iii) Applicant’s assertions of “unexpected technical effects”; it is the Examiner’s position that undue experimentation would be required to produce an oxygen barrier packaging material capable of simultaneously satisfying recited properties (A)-(C) (claims 1, 14), and optionally (D) (claim 8), using oxygen barrier coating compositions -- in particular, (1) coating polymer compositions, and/or (2) type of nanoparticles -- which are encompassed by the present claims, but which deviate materially from those used in the inventive Examples in the specification -- for example, but not limited to:
----------------------------------------------
• the individual relative amounts of chitosan and PVOH in component (1) coating polymer -- the inventive examples only utilize a component (1) coating polymer containing:
• (1a) chitosan - 0.6 parts by weight (i.e., about 19.4 wt%).
• (1b) PVOH - 2.5 parts by weight (i.e., about 80.6 wt%);
However, as noted above, the present claims contain no limitations on the relative or absolute individual amounts of chitosan and PVOH in component (1) coating polymer, as long as both the chitosan and PVOH are present in any non-zero amount. It is reasonable to believe that the use of a coating component (1) containing very small amounts of PVOH and very large amounts of chitosan may adversely affect the elasticity of an oxygen barrier coating (e.g., since chitosan is generally known as a relatively brittle polymer due to its relatively stiff polymer backbone and the presence of a high degree of intramolecular bonding forces). Similarly, use of a coating component (1) containing very small amounts of chitosan and very large amounts of PVOH may adversely affect the antimicrobial characteristics of an oxygen barrier coating (e.g., since chitosan is known to exhibit antimicrobial activity, while PVOH does not have inherent antimicrobial properties).
Therefore, the Examiner has reason to believe that the relative amounts of chitosan and PVOH in component (1) coating polymer would materially affect the ability to produce an oxygen barrier packaging (claim 1) or oxygen barrier coating composition (claim 14) capable of simultaneously satisfying recited properties (A)-(C) (claims 1, 14), and optionally (D) (claim 8).
Applicant has not provided adequate guidance to one of ordinary skill in the art as to how to produce an oxygen barrier packaging (claim 1) or oxygen barrier coating composition (claim 14) which exhibit the above recited properties (A)-(C) (claims 1, 14), and optionally (D) (claim 8), without undue experimentation using a component (1) coating polymer which deviates materially from the single coating polymer formulation used in the working Examples 1A-3A.
----------------------------------------------
• the type of nanoparticle in component (2) nanoparticle -- Example 3A (which is the only inventive Example which provides objective data on antimicrobial activity against Escherichia coli and Staphylococcus aureus) utilizes a component (2) nanoparticle containing an unspecified amount of zinc oxide, which is disclosed in the specification as having particular antimicrobial activity against pathogenic bacteria.
In comparison, Examples 1A-2A only contain nanoclay as nanoparticles, and it is unclear whether the use of nanoclay alone (or silicon dioxide alone) is sufficient to provide the recited property (C) antimicrobial activity, or whether other modifications (e.g., increasing the amount of chitosan and/or nanoparticles, etc.) are necessary in order to provide the recited property (C) antimicrobial activity.
Similarly, since Example 3A fails to specify the individual amount of zinc oxide nanoparticles present in the oxygen barrier coating, it is unclear whether how much zinc oxide particles are sufficient to provide the recited property (C) antimicrobial activity, or whether other modifications (e.g., increasing the amount of chitosan and/or other nanoparticles, etc.) are necessary in order to provide the recited property (C) antimicrobial activity.
Therefore, the Examiner has reason to believe that the type of component (2) nanoparticle would materially affect the ability to produce an oxygen barrier packaging (claim 1) or oxygen barrier coating composition (claim 14) capable of simultaneously satisfying recited properties (A)-(C) (claims 1, 14), and optionally (D) (claim 8).
Applicant has not provided adequate guidance to one of ordinary skill in the art as to how to produce an oxygen barrier packaging (claim 1) or oxygen barrier coating composition (claim 14) which exhibit the above recited properties (A)-(C) (claims 1, 14), and optionally (D) (claim 8), without undue experimentation using a component (2) nanoparticle which does not contain zinc oxide and/or contains only very small amounts of zinc oxide.
----------------------------------------------
• the individual amounts of components (1a)-(1b) and (2)-(4) in the oxygen barrier layer as a whole -- Example 3A (which is the only inventive Example which provides objective data on antimicrobial activity against Escherichia coli and Staphylococcus aureus) utilizes a coating composition which is composed (by dry weight) entirely of:
• (1a) chitosan - 0.6 parts by weight (i.e., about 3.4 wt%).
• (1b) PVOH - 2.5 parts by weight (i.e., about 14.3 wt%);
• (2) nanoclay / zinc oxide nanoparticles - 0.55 parts by weight
(i.e., about 3.2 wt%), of which zinc oxide represents an unspecified amount;
• (3) glycerol plasticizer - 12.5 parts by weight (i.e., about 71.6 wt%);
• (4) citric acid crosslinker - 1.3 parts by weight (i.e., about 7.4 wt%).
There is reason to believe that the relative amounts of various components in the oxygen barrier coating as a whole materially affects one or more of recited properties (A)- (C), or optionally (D), as previously discussed in detail.
For example, relatively low amounts of plasticizer (e.g., 40 wt%) and relatively high amounts of (2) nanoparticles (e.g., 5 wt%) and relatively high amounts of (4) crosslinking agent (e.g., 20 wt%) may be reasonably expected to negatively affect the ability of the oxygen barrier film to exhibit the recited property (B) bendability and stretchability.
Similarly, as discussed above, the absence or very low amounts (e.g., 0.0 wt% or 0.01 wt% or 0.02 wt% or 0.05 wt%, or 0.1 wt% etc.) of zinc oxide nanoparticles and/or relatively low amounts of non-zinc oxide nanoparticles (e.g., 0.1 wt% or 0.2 wt% or 0.5 wt%, etc.) of silicon dioxide and/or nanoclays may be reasonably expected to negatively affect the ability of the oxygen barrier film to exhibit the recited property (C) antimicrobial activity against Escherichia coli and Staphylococcus aureus.
Therefore, the Examiner has reason to believe that the individual amounts of components (1a)(1b) and (2)-(4) in the oxygen barrier composition as a whole would materially affect the ability to produce an oxygen barrier packaging (claim 1) or oxygen barrier coating composition (claim 14) capable of simultaneously satisfying recited properties (A)-(C) (claims 1, 14), and optionally (D) (claim 8).
Applicant has not provided adequate guidance to one of ordinary skill in the art as to how to produce an oxygen barrier packaging (claim 1) or oxygen barrier coating composition (claim 14) which exhibit the above recited properties (A)-(C) (claims 1, 14), and optionally (D) (claim 8), without undue experimentation using oxygen barrier coating compositions which deviate materially from the single working Example 3A.
----------------------------------------------
Therefore, in view of the above, the disclosure as originally filed does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the oxygen barrier packaging (claim 1) or oxygen barrier coating composition (claim 14) which exhibit the above recited properties (A)-(C) (claims 1, 14), and optionally (D) (claim 8), commensurate in scope with the present claims without undue experimentation,
Claim Rejections - 35 USC § 103 (AIA )
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 rejections under 35 U.S.C. 103 based on SAYAKA ET AL (US 5,942,298) in the previous Office Action mailed 03/11/2026 has been withdrawn in view of the Claim Amendments filed 06/08/2026.
Response to Arguments
Applicant's arguments filed 06/08/2026 have been considered but deemed moot in view of the new grounds of rejection necessitated by the Claim Amendments filed 06/08/2026.
The Examiner notes that objective evidence (e.g., additional experimental data, etc.) presented and relied upon in Applicant's arguments should be presented and made of record in the form of a proper Declaration. See MPEP 716.01(c)(II)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
DENG ET AL (US 2006/0222845) and ZISCHKA ET AL (US 2016/0017166) disclose barrier coatings containing a mixture of PVOH and CS.
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 Vivian Chen (Vivian.chen@uspto.gov) whose telephone number is (571) 272-1506. The examiner can normally be reached on Monday through Thursday from 8:30 AM to 6 PM. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Callie Shosho, can be reached on (571) 272-1123. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
The General Information telephone number for Technology Center 1700 is (571) 272-1700.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
August 18, 2026
/Vivian Chen/
Primary Examiner, Art Unit 1787
Prosecution Insights