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 .
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.
Claim(s) 1-6, 8-10, 12-14 and 19, 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Osborn et al. (US 2020/0187498).
Regarding claims 1, 2, 4-6, 8-10, 12-14 and 19, 22 Osborn discloses nonwoven polyamide structure having antimicrobial properties comprising: nonwoven polyamide fibers comprising less than 4000 ppm zinc dispersed within the nonwoven polyamide fibers; and less than 2000 ppm phosphorus (abstract). The polyamide composition is used to produce antimicrobial molded and processed products having permanent antimicrobial properties (para 0072). In other embodiments, the polyamide composition can be added to form a master batch that is used to form a molded product. Some embodiments relate to a molded and processed product comprising the polyamide composition. In some aspects, the molded and processed products are industrial supplies, various wrappers, consumer supplies or medical supplies, and the molded and processed products can be applied to interior materials such as blinds, wall papers and floor coverings; food related products such as films for wrapping, storage containers (para 0073-0074). Osborn discloses an antimicrobial polyamide composition is used as the polymer for the nonwoven. As used herein, “polyamide composition” and like terminology refers to compositions containing polyamides including copolymers, terpolymers, polymer blends, alloys and derivatives of polyamides. In some aspects, the polyamide is the component present in the greatest amount. For example, a polyamide containing 40 wt. % nylon 6, 30 wt. % polyethylene, and 30 wt. % polypropylene is referred to herein as a polyamide since the nylon 6 component is present in the greatest amount. Additionally, a polyamide containing 20 wt. % nylon 6, 20 wt. % nylon 66, 30 wt. % polyethylene, and 30 wt. % polypropylene is also referred to herein as a polyamide since the nylon 6 and nylon 66 components, in total are the components present in the greatest amount (para 0132). The polyamide comprises nylon 66 or nylon 6/66 (claim 6). A Nylon-6 material can be blended with a nylon copolymer such as a Nylon-6; 66; 6,10 copolymer (para 0144). Osborn discloses for zinc oxide samples, a masterbatch of zinc oxide in nylon 6 was blended with nylon 6,6 flake to achieve the desired zinc amount. For zinc stearate samples, the zinc stearate was added as a powder onto the nylon 6,6 flake and processed through a twinscrew extruder to achieve the desired zinc amount and to distribute the material through the polymer (para 0156).
As Osborn discloses antimicrobial film comprising polyamide composition and zinc dispersed within the polyamide within the film in claimed amount as presently claimed, it therefore would be obvious that an antimicrobial efficacy to Staphylococcus aureus and Escherichia coli log reduction would intrinsically be greater than 2.0, as determined by ISO 22196 (modified), and a slow rate puncture resistance would intrinsically be greater than 1.5 N/um, as measured according to ASTM F1306.
Regarding claim 3, Osborn discloses the film comprising polyamide composition and zinc, however, Osborn does not disclose the claimed film thickness, It would have been obvious to one of ordinary skill in the art at the time of the invention to choose the instantly claimed ranges of less than 0.1 mm through process optimization motivated by the desire to have improved strength and toughness, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (MPEP 2144.05).
As Osborn discloses antimicrobial film comprising polyamide composition and zinc dispersed within the polyamide within the film in claimed amount as presently claimed, it therefore would be obvious that film would intrinsically have the claimed relative viscosity, viscosity number, difference between melt temperature and crystallization temperature, tensile strength, dart drop, glass, haze, clarity and transmission as presently claimed.
Regarding claim 21, Osborn does not explicitly disclose the antimicrobial film requiring the presence of surfactant, coupling agents, lubricants, impact modifiers, plasticizers, colorants or glass, it therefore would be obvious that antimicrobial film contains no aids or additives as claimed.
Regarding claim 3, Osborn discloses the film comprising polyamide composition and zinc, however, Osborn does not disclose the claimed film thickness, It would have been obvious to one of ordinary skill in the art at the time of the invention to choose the instantly claimed ranges of less than 0.1 mm through process optimization motivated by the desire to have improved strength and toughness, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (MPEP 2144.05).
As Osborn discloses antimicrobial film comprising polyamide composition and zinc dispersed within the polyamide within the film in claimed amount as presently claimed, it therefore would be obvious that film would intrinsically have the claimed relative viscosity, viscosity number, difference between melt temperature and crystallization temperature, tensile strength, dart drop, glass, haze, clarity and transmission as presently claimed.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Osborn et al. (US 2020/0187498) as applied to claim 1, further in view of Ono (US 2006/0182812).
Regarding claim 3, Osborn fails to disclose that the film thickness is less than 0.1 mm.
Whereas, Ono discloses improving the processing suitability of an antimicrobial product such as fiber or a film to which is added an antimicrobial composition that includes a silver-based antimicrobial agent such as silver ion-containing tetravalent metal phosphate-based antimicrobial particles (abstract). The antimicrobial film having a film thickness of 10-44 microns (para 0074).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to form film of Osborn having a thickness of 10-44 microns as taught by Ono motivated by the desire to have improved toughness and excellent processability.
Claim(s) 7, 11 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Osborn et al. (US 2020/0187498) as applied to claim 1, further in view of Ray et al. (US 2018/0298144).
Regarding claims 7,11 and 23 Osborn fails to disclose that the film has a MW from 20000 g/mol to 65000 g/mol and film is a cast film, blown film.
Whereas, Ray discloses Nylon6,6 is widely used for injection molding, fiber, extruded profile and film applications. For numerous applications, its rapid crystallization rate and high temperature performance versus other engineering resins (e.g., PET and Nylon6) convey significant advantages (para 0001). The present invention addresses unmet commercial needs by providing access to copolyamides that exhibit an unexpectedly unique combination of thermal, mechanical, and crystallization properties that cannot be achieved with Nylon6, Nylon6,6 or Nylon 6-rich copolyamide solutions, and melt blends thereof, especially when the invention is directed to applications such as cast and blown film. Valued attributes include high melting point (>220° C.), high toughness, a reduced crystallization rate versus Nylon6,6 and a relative viscosity (>60) and/or molecular weight (M.sub.n>18,000 g/mol) that achieves the melt strength required for film applications (para 0007).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to form film of Osborn having a MW of greater than 18000 g/mol as taught by Ray motivated by the desire to have desired melt strength and to form film of Osborn as a cast or blown film as taught by Ray motivated by the desire for end use applications.
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Osborn et al. (US 2020/0187498) in view of Ray et al. (US 2018/0298144).
Regarding claim 24 Osborn discloses nonwoven polyamide structure having antimicrobial properties comprising: nonwoven polyamide fibers comprising less than 4000 ppm zinc dispersed within the nonwoven polyamide fibers; and less than 2000 ppm phosphorus (abstract). The polyamide composition is used to produce antimicrobial molded and processed products having permanent antimicrobial properties (para 0072). In other embodiments, the polyamide composition can be added to form a master batch that is used to form a molded product. Some embodiments relate to a molded and processed product comprising the polyamide composition. In some aspects, the molded and processed products are industrial supplies, various wrappers, consumer supplies or medical supplies, and the molded and processed products can be applied to interior materials such as blinds, wall papers and floor coverings; food related products such as films for wrapping, storage containers (para 0073-0074). Osborn discloses an antimicrobial polyamide composition is used as the polymer for the nonwoven. As used herein, “polyamide composition” and like terminology refers to compositions containing polyamides including copolymers, terpolymers, polymer blends, alloys and derivatives of polyamides. In some aspects, the polyamide is the component present in the greatest amount. For example, a polyamide containing 40 wt. % nylon 6, 30 wt. % polyethylene, and 30 wt. % polypropylene is referred to herein as a polyamide since the nylon 6 component is present in the greatest amount. Additionally, a polyamide containing 20 wt. % nylon 6, 20 wt. % nylon 66, 30 wt. % polyethylene, and 30 wt. % polypropylene is also referred to herein as a polyamide since the nylon 6 and nylon 66 components, in total are the components present in the greatest amount (para 0132). The polyamide comprises nylon 66 or nylon 6/66 (claim 6). A Nylon-6 material can be blended with a nylon copolymer such as a Nylon-6; 66; 6,10 copolymer (para 0144). Osborn discloses for zinc oxide samples, a masterbatch of zinc oxide in nylon 6 was blended with nylon 6,6 flake to achieve the desired zinc amount. For zinc stearate samples, the zinc stearate was added as a powder onto the nylon 6,6 flake and processed through a twinscrew extruder to achieve the desired zinc amount and to distribute the material through the polymer (para 0156).
While it is recognized that the phrase “consisting essentially of” narrows the scope of the claims to the specified materials and those which do not materially affect the basic and novel characteristics of the claimed invention, absent a clear indication of what the basic and novel characteristics are, “consisting essentially of” is construed as equivalent to “comprising”. Further, the burden is on the applicant to show that the additional ingredients in the prior art, would in fact be excluded from the claims and that such ingredients would materially change the characteristics of the applicant’s invention, See MPEP 2111.03.
However, Osborn fails to disclose that the film has a MW from 20000 g/mol to 65000 g/mol.
Whereas, Ray discloses Nylon6,6 is widely used for injection molding, fiber, extruded profile and film applications. For numerous applications, its rapid crystallization rate and high temperature performance versus other engineering resins (e.g., PET and Nylon6) convey significant advantages (para 0001). The present invention addresses unmet commercial needs by providing access to copolyamides that exhibit an unexpectedly unique combination of thermal, mechanical, and crystallization properties that cannot be achieved with Nylon6, Nylon6,6 or Nylon 6-rich copolyamide solutions, and melt blends thereof, especially when the invention is directed to applications such as cast and blown film. Valued attributes include high melting point (>220° C.), high toughness, a reduced crystallization rate versus Nylon6,6 and a relative viscosity (>60) and/or molecular weight (M.sub.n>18,000 g/mol) that achieves the melt strength required for film applications (para 0007).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to form film of Osborn having a MW of greater than 18000 g/mol as taught by Ray motivated by the desire to have desired melt strength.
As Osborn in view of Ray discloses antimicrobial film comprising polyamide composition and zinc dispersed within the polyamide within the film in claimed amount as presently claimed, it therefore would be obvious that an antimicrobial efficacy to Staphylococcus aureus and Escherichia coli log reduction would intrinsically be greater than 2.0, as determined by ISO 22196 (modified), and a slow rate puncture resistance would intrinsically be greater than 1.5 N/um, as measured according to ASTM F1306.
As Osborn in view of Ray discloses antimicrobial film comprising polyamide composition and zinc dispersed within the polyamide within the film in claimed amount as presently claimed, it therefore would be obvious that film would intrinsically have the claimed gloss, haze, clarity and transmission as presently claimed.
Response to Arguments
Applicant’s arguments filed on 07/25/2025 have been fully considered, but they are not persuasive.
Applicant argues that Osborn generally mentions the potential use of a polyamide to form “films for wrapping.” Osborn at paragraph [0074]. Osborn is directed to the production of nonwoven polyamide fibers. In particular, Applicant notes that, while the term “film” appears only once in Osborn, the term “non-woven” appears approximately 200 times and the term “fiber” appears approximately 400 times within the document. Moreover, Osborn provides numerous details on the production of nonwoven fibers, as well as numerous examples in which nonwoven fibers were prepared and tested. However, Osborn does not appear to describe how films might be prepared from the polyamide composition disclosed therein, nor what the properties of such films might be. Furthermore, given the uncertainty in the chemical arts, a POSITA would not assume that a hypothetical film produced from the polyamide composition of Osborn would necessarily possess the same properties as the woven polyamide fibers of Osborn.
However, it should be noted that Osborn does not have to show a process of how the film is made, the claims are directed towards product claim and as long as Osborn teaches that limitation, the claim limitation is met.
Applicant argues that that the properties of the antimicrobial film recited in claim 1 do not “necessarily flow” from the teaching of Osborn. That is, the properties recited in claim 1 would not necessarily be present in each and every embodiment of a polyamide film formed from the polyamide composition of Osborn. This is evidenced by the fact that not even all of the polyamide films described within the present application (which have from 50 wt% to 99.99 wt% of a polyamide composition and from 10 wppm to 6000 wppm of zinc dispersed within the film, as recited in claim 1), are capable of demonstrating the properties recited in claim 1. For example, as indicated in Table 1, Example El-1 is a biaxially oriented polyamide (BOPA) film having the composition recited in claim 1 and demonstrates a log reduction of Staphylococcus aureus and a log reduction of Escherichia coli of less than 2. As also indicated in Table 1, Examples E1-2 and E3-3 are BOPA films having the composition recited in claim 1 and demonstrate a log reduction of Staphylococcus aureus greater than 2, but demonstrate a log reduction of Escherichia coli of less than 2. By way of further example, as indicated in Table 2, Example E2-1 is a blown film having the composition recited in claim 1 and demonstrates a log reduction of Staphylococcus aureus of less than 2. These results demonstrate the uncertainty of the chemical arts, and further, clearly demonstrate that the properties recited in claim 1 cannot “necessarily flow” from the teachings of Osborn to support the inherency position asserted in the Office Action. In the absence of express or inherent disclosure of the properties recited in claim 1, Applicant asserts that Osborn is deficient.
However, the data is not in commensurate in scope with the scope of the present claims, the examples as shown in Table 1 discloses specific polyamide and is formed with a specific process, whereas, claim 1 is open to any polyamide that is known in the art. However, Applicant is requested to file a declaration/Affidavit to show that Osborn’s antimicrobial film comprising polyamide composition and zinc dispersed within the polyamide within the film does not have the claimed log reduction.
However, it is noted that “the arguments of counsel cannot take the place of evidence in the record”, In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). It is the examiner’s position that the arguments provided by the applicant regarding properties recited in claim 1 cannot “necessarily flow” from the teachings of Osborn must be supported by a declaration or affidavit. As set forth in MPEP 716.02(g), “the reason for requiring evidence in a declaration or affidavit form is to obtain the assurances that any statements or representations made are correct, as provided by 35 U.S.C. 24 and 18 U.S.C. 1001”.
Applicant argues that the Office Action cited a portion of Ono in which the document describes forming a vinylidene chloride film from a vinylidene chloride resin containing antimicrobial particles that include phosphate, anatase titanium oxide, and silver. See Ono, paragraph [0074] and Table 2. At least in light of the uncertainty of the chemical arts discussed above, the POSITA would not have been motivated by a reasonable expectation of success in combining the cited teachings of Osborn (which are primarily directed to nonwoven polyamide fibers that contain zinc) with the cited teachings of Ono (which are directed to a vinylidene chloride polymer film containing silver-based antimicrobial particles). The Office Action asserts that “[i]t would have been obvious to one of ordinary skill in the art at the time the application was filed to form film of Osborn having a thickness of 10-44 microns as taught by Ono motivated by the desire to have improved toughness and excellent processability.” Office Action, p. 5.
However, Ono is only used as teaching reference in order to teach film having a thickness of 10-44 microns. It is noted that the "test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference... Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art", In re Keller, 642 F.2d 413,208 USPQ 871,881 (CCPA 1981) and that "combining the teachings of references does not involve an ability to combine their specific structures", In re Nievelt, 482 F.2d 965, 179 USP 224, 226 (CCPA).
Applicant argues that Ray is directed to copolyamide compositions and films, in contrast with the recited antimicrobial polyamide-containing film. Additionally, Ray only mentions Mn average molecular weight once in stating that the copolyamides may provide a Mn average molecular weight of more than 18,000 g/mol. See Ray, paragraph [0007]. As such, Applicant contends that the cited portion of Ray cannot reasonably render obvious all of the infinite range of Mn average molecular weight values greater than 18,000 g/mol. Nothing in Ray would guide the POSITA to particularly select the claimed Mn average molecular weight from 20,000 g/mol to 65,000 g/mol, as recited in claim 7.
However, Ray is only used as teaching reference in order to teach film having a a average molecular weight of more than 18,000 g/mol. It is noted that the "test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference... Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art", In re Keller, 642 F.2d 413,208 USPQ 871,881 (CCPA 1981) and that "combining the teachings of references does not involve an ability to combine their specific structures", In re Nievelt, 482 F.2d 965, 179 USP 224, 226 (CCPA).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONAK C PATEL whose telephone number is (571)270-1142. The examiner can normally be reached M-F 8:30AM-6:30PM (FLEX).
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ALICIA CHEVALIER can be reached on 5712721490. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RONAK C PATEL/Primary Examiner, Art Unit 1788