DETAILED OFFICIAL 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 .
Examiner Note
It is noted that all references hereinafter to Applicant’s specification (“spec”) are to the published application US 2024/0101794, unless stated otherwise. Further, any italicized text utilized hereinafter is to be interpreted as emphasis placed thereupon.
Election/Restrictions
Applicant’s election of the invention of Group I, claims 1-4, 9, 11-12, 14, 16-18, and 23-27 in the reply filed on 02 April 2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Additionally, it is noted that claims 28-30 and 34 (invention of Group II) have been canceled.
Claim Status
Claims 1-4, 9, 11-12, 14, 16-18, and 23-27 are pending and under consideration on the merits.
Information Disclosure Statement
The information disclosure statements filed 06 December 2023 and 31 May 2024 are in compliance with 37 CFR 1.97 and 1.98 and have been considered.
Third Party Submission
The Third-Party Submission under 37 CFR 1.290 filed 13 September 2024 has been considered.
Claim Objections
Claims 4 and 25 are objected to because of the following informalities.
[claim 4] recites “comprises at least one of: carrageenan, agar, alginate, fucoidan or a combination thereof” – the phrases “at least one of” and “or a combination thereof” utilized together are redundant and inhibit the readability of the claim
the following amendment is respectfully suggested in order to overcome the issue: “comprises at least one of: carrageenan, agar, alginate, and fucoidan
[claim 25] recites “…wherein said bioplastic product is in the form of in film”– the phrase “in film” constitutes a typographical error
It is believed that Applicant intended to recite “…in the form of thin film”, in accordance with the spec [0115, 0117-0119, 0140, 0169]
However, the phrase “thin film” could present an indefiniteness issue – specifically “thin” constitutes a relative term of degree (MPEP 2173.05(b)(I)), if Applicant were to alter the dependency of claim 25
In view of the totality of the foregoing, it is respectfully suggested to amend claim 25 in accordance with the following, of which also constitutes the interpretation of claim 25 for examination on the merits: “wherein said bioplastic product is in the form of a film”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 9, 11-12, 14, 17-18, 24-27 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention.
Regarding claims 9, 11-12, 14, 17-18, and 26-27, the phrase “selected from the list comprising…” constitutes improper Markush group language which renders each claim indefinite. It is unclear what additional alternative materials/species are intended to be encompassed by each list. See MPEP 2173.05(h)(I) – “If a Markush group requires a material selected from an open list of alternatives (e.g., selected from the group “comprising” or “consisting essentially of” the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.” Additionally, see MPEP 2117.
In order to overcome the indefiniteness issue, it is respectfully suggested to amend claims 9, 11-12, 14, 17-18, and 26-27 in accordance with the following (i) and (ii):
(i) “is selected from the list consisting of:…”, in addition to adding “and” between the penultimate and last species in each list
(ii) addition of the word “and” between the penultimate and last species recited in each list, e.g. “…diacetin, and triacetin.” (claim 9),
Regarding claim 12, the term “inorganic salt” of the phrase “wherein said inorganic salt” lacks sufficient antecedent basis. There is no prior recitation/introduction of an inorganic salt in claim 12 or claim 1 (upon which claim 12 is directly dependent) – as such, it is unclear (i) whether the inorganic salt is one of the four additives recited in claim 1, and if so, which of the four additives; (ii) whether the inorganic salt is a component of the composition separate/distinct from the seaweed extract, water, and the four additives; or (iii) if Applicant intended for claim 12 to be dependent upon a claim other than claim 1, such as claim 11 or claim 14 (each of which recite “inorganic salt”). The metes and bounds of the claimed invention are not clear and cannot be readily determined.
For examination on the merits, claim 12 is interpreted as if it were dependent upon claim 11 rather than claim 1, i.e. to read as “Composition according to claim [[1]]11, wherein said inorganic salt”. The interpretation is directly supported by, and in accordance with Applicant’s spec [0084-0086]. The aforesaid interpretation, presented in marked-up format, is respectfully suggested as an amendment to overcome the indefiniteness issue.
Regarding claim 24, the phrase “preferably between 0.01 mm and 0.15 mm” constitutes a preferential, narrower range which renders the claim indefinite, as it is unclear whether the phrase constitutes a limitation of the claimed invention. See MPEP 2173.05(d) – “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b)…should be made.”
For examination on the merits, claim 24 is interpreted in accordance with the following amendment, of which is respectfully suggested in order to overcome the indefiniteness issue: “wherein it has a thickness comprised between 0.01 mm and 5 mm
Claims 25-26 are indefinite and rejected under 112(b) as they are directly dependent upon claim 24, respectively, and therefore include, and do not remedy the indefiniteness issues identified above.
Appropriate action is required.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-4, 9, 11-12, 14, 17-18, and 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Dundar Field (US 2023/0323095; “Dundar Field”).
Regarding claim 1, Dundar Field discloses a biodegradable composition (“composite material”) comprising the following components (each relative to total weight of composition, i.e. 100 wt.%):
(a) seaweed extract, in an amount of 30-70 wt.% [0017, 0019, 0060-0061, 0077] (at least one seaweed extract),
(b) water, 1-20 wt.% [0017, 0079] (water),
(c) biodegradable filler, 5-60 wt.% [0017, 0021, 0064, 0067, 0070, 0078] (at least one adjuvant),
(d) glycerol, 0.1-40 wt.% [0022, 0073-0074, 0076] (at least one plasticizer),
(e) alkali metal salt that is, inter alia potassium chloride, 0.1-5 wt.% [0074-0075] (at least one antimicrobial agent), and, inter alia
(f) a salt that is, inter alia calcium chloride or sodium chloride (“table salt”) (alternatively, calcium carbonate) [0074] (gelling agent),
wherein the total amount of (d), (e), and (f) relative to the total weight of the composition is 40 wt.% or less [0022, 0073]. See MPEP 2131.02(II), MPEP 2144.06(I), and MPEP 2144.07. Regarding (e) potassium chloride (antimicrobial agent), see claims 11-12 and Applicant’s spec [0084-0085]. Regarding (f) calcium or sodium chloride (gelling agent), see claim 14 and the spec [0090-0091].
The amount of (a) seaweed extract (30-70 wt.%) is within and/or overlaps with the claimed range of between 30 and 80 wt.% seaweed extract, thereby rendering the range prima facie obvious (MPEP 2144.05(I), MPEP 2131.03). The amount of (b) water (1-20 wt.%) is within and/or overlaps with the claimed range of between 1 and 30 wt.% water, thereby rendering the range prima facie obvious (MPEP 2144.05(I), MPEP 2131.03).
The (c) biodegradable filler (adjuvant), and the (d) glycerol (plasticizer), (e) potassium chloride (antimicrobial agent), and (f) inorganic salt (gelling agent), in total (c+d+e+f), may define up to 69 wt.% of the composition (e.g. about 5 wt.% or greater, up to 69 wt.%), given that required amounts of (a) seaweed extract (30 wt.%) and (b) water (1 wt.%) define a minimum total of 31 wt.% of the composition. That is, Dundar Field implicitly and reasonably discloses that (c), (d), (e), and (f), in total, define from greater than about 5 wt.%, up to 69 wt.% of the biodegradable composition. The aforesaid range overlaps with, and thereby renders prima facie obvious the claimed range of the at least four additives of between 20 and 70 wt.% (see MPEP 2144.05(I)).
The biodegradable composition of Dundar Field, set forth/cited above, reads on the bioplastic composition defined by each and every limitation of claim 1.
Regarding claim 2, the rejection of claim 1 above reads on the composition defined by claim 2. The amount of (a) seaweed extract (30-70 wt.%) encompasses and thereby renders prima facie obvious the claimed range of between 40 and 70 wt.% seaweed extract (MPEP 2144.05(I)). The amount of (b) water (1-20 wt.%) overlaps with the claimed range of between 5 and 25 wt.% water, thereby rendering the range obvious (MPEP 2144.05(I)). The implicit range of about 5 up to 69 wt.% of the total of (c), (d), (e), and (f) encompasses, and thereby renders prima facie obvious the claimed range of between 30 and 50 wt.% said four additives (MPEP 2144.05(I)).
Regarding claim 3, as set forth in the rejection of claim 1 above, the combined total of (c) filler (adjuvant), (d) glycerol (plasticizer), (e) potassium chloride (antimicrobial agent), and (f) calcium or sodium chloride (gelling agent) defines from greater than about 5 wt.%, up to 69 wt.% of the composition, wherein relative to the composition, (c) may be included in an amount of 5-60 wt.%, (d) may be included in an amount of 0.1-40 wt.%, (e) may be included in an amount of 0.1-5 wt.%, with (f) defining a non-zero remaining amount.
In view of the foregoing, the individual amounts of (c), (d), (e), and (f) relative to the combined total thereof can be calculated. That is, (i) assuming 100 parts (mass) total composition, (ii) utilizing (max. amounts) 70 parts (a) seaweed extract and 20 parts (b) water, and (iii) utilizing (min. amounts) 5 parts (c) filler, 0.1 parts (d) plasticizer, 0.1 parts (e) antimicrobial, and (remainder amount) 4.8 parts (f) gelling agent, the total amount of (c+d+e+f) is 10 parts. Through calculation, relative to the total weight (10 parts) of (c), (d), (e), and (f), the (c) filler constitutes 50 wt.%, the (d) plasticizer constitutes 1 wt.%, the (e) antimicrobial agent constitutes 1 wt.%, and the (f) gelling agent constitutes 48 wt.%. In this calculated embodiment, the plasticizer, gelling agent, and filler (adjuvant) are outside of the corresponding claimed ranges (50-95 wt.%, 0.01-30 wt.%, 0.01-30 wt.%, respectively).
However, in view of the foregoing, the disclosure of Dundar Field also reasonably encompasses embodiment(s) of the composition (again, assuming 100 parts total) formed from 30 parts (a) and 1 part (b) (min. amounts), 5 parts (c) (min.), 40 parts (d) (max.), 5 parts (e) (max.), and 19 parts (f) (remainder), wherein the total of (c+d+e+f) is 69 parts. Through calculation, relative to the total weight (69 parts) of (c), (d), (e), and (f), the (c) filler (adjuvant) constitutes 7.25 wt.%, the (d) plasticizer constitutes 58 wt.%, the (e) antimicrobial agent constitutes 7.25 wt.%, and the (f) gelling agent constitutes 27.5 wt.%, each of which are within the corresponding claimed ranges (claim 3, 0.01-30 wt.% adjuvant, 50-95 wt.% plasticizer, 0.01-30 wt.% antimicrobial agent, and 0.01-30 wt.% gelling agent).
Additional calculable embodiments are encompassed within the disclosure of Dundar Field, e.g. wherein the amount of (c) filler is increased and the amount(s) of (e) antimicrobial agent and/or (f) gelling agent are decreased (not provided herewith).
In view of the totality of the foregoing – inclusive of the calculated embodiment of the composition of Dundar Field wherein the wt.% of each of the (c) filler (adjuvant), (d) glycerol (plasticizer), (e) potassium chloride (antimicrobial agent), and (f) calcium or sodium chloride (gelling agent), relative to the total weight of (c+d+e+f), is within the respective/corresponding range defined by claim 3 – it is clear that the disclosure/teachings of Dundar Field reasonably encompass embodiments of the composition wherein the respective amounts of (c), (d), (e), and (f) are within, or encompass/overlap, and thereby render prima facie obvious, the respective ranges defined by claim 3 (MPEP 2144.05(I)). Additionally/alternatively, see MPEP 2144.05(II).
The composition(s) of Dundar Field, exemplified/indicated above and/or encompassed within the disclosure thereof, read on the composition defined by claim 3.
Regarding claim 4, in view of the rejection of claim 1 above, Dundar Field discloses that the (a) seaweed extract is one or more of carrageenan, agar, and alginate, preferably kappa carrageenan [0019, 0060-0061, 0068] (carrageenan, agar, alginate).
Regarding claim 9, the rejection of claim 1 above reads on the composition defined by claim 9 – the composition of Dundar Field includes (d) glycerol (plasticizer selected from the list consisting of…glycerol).
Regarding claims 11-12, the rejection of claim 1 above reads on each composition defined by claims 11-12 (see rejection of claim 12 under 112(b) above) – the composition of Dundar Field includes (e) potassium chloride (claim 11, antimicrobial agent selected from the list consisting of…an inorganic salt; claim 12, wherein said inorganic salt is selected from the list consisting of…chloride of an alkaline or alkaline earth metal).
Regarding claim 14, the rejection of claim 1 above reads on the composition defined by claim 14 – the composition of Dundar Field includes (f) calcium chloride or sodium chloride (gelling agent selected from the list consisting of…an inorganic salt).
Regarding claims 17-18, as set forth above in the rejection of claim 1, the composition includes (c) biodegradable filler (claim 17, adjuvant is selected from the list consisting of…filler), wherein Dundar Field discloses that the biodegradable filler is suitably, inter alia hemp fiber [0015, 0021, 0064, 0067, 0070, 0078] (MPEP 2131.02(II), MPEP 2144.07) (claim 18, adjuvant is selected from the list consisting of…hemp fiber).
Regarding claim 23, in view of the rejection of claim 1 above, Dundar Field discloses that the composition is formed into one or more products, including shaped articles such as a sheet or film, three-dimensionally (3D) shaped articles, and/or food packaging containers [0029, 0088-0089] (bioplastic product comprising at least one composition according to claim 1).
Regarding claims 24-25, in view of the rejection of claim 23 above, Dundar Field discloses that the thickness of the product, e.g. sheet/film, 3D-shaped product, and/or packaging container, is suitably from 0.1 mm to 10 mm, such as a thickness of at most, inter alia 5 mm [0088-0089]. The aforesaid film thickness range encompasses, and thereby renders prima facie obvious the claimed thickness range of between 0.01 and 5 mm (MPEP 2144.05(I)) (claim 24, thickness range; claim 25, wherein said bioplastic product is in the form of a film).
Regarding claim 26, in view of the rejection of claim 24 above (product thickness range), Dundar Field discloses that the 3D shaped product may exhibit the shape(s) of a planar/flat sheet, and/or a regular or irregular: sphere/spheroid, cube or cuboid, ellipsoid, cylinder, cone, prism, pyramid, or a combination thereof [0029, 0088-0089] (wherein said product has a shape selected from the list consisting of: plane, flat sheet, sphere, spheroid, cube, cuboid, ellipse, ellipsoid, cylinder, cone, prism, pyramid, and a combination thereof).
Regarding claim 27, as set forth above in the rejection of claim 23, Dundar Field discloses that the product formed from the composition may be, inter alia a film, sheet, and/or food packaging container, as well as a packaging material, tube, (drinking) straw, cup, or tray [Abstract; 0001, 0088-0090] (wherein said product is selected from the list consisting of: food container, packaging material, film, sheet, straw, tube, dish, tray).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Dundar Field as applied to claim 1 above, further in view of Salumäe et al. (US 2022/0144517; “Salumäe”) and Edwards et al. (US 2016/0023826; “Edwards”), optionally in view of and/or evidenced by 21 CFR § 184.1207 (copy provided herewith) and 21 CFR § 170.3(o)(28) (copy provided herewith).
Regarding claim 16, as set forth above in the rejection of claim 1, the composition of Dundar Field includes (f) a salt that is, inter alia calcium chloride or sodium chloride [0074] (gelling agent), wherein calcium carbonate is also named [0074]. Further, Dundar Field discloses that the films formed therefrom desirably exhibit temperature-dependent water-solubility, and may be moisture absorbent in relation to certain foods packaged within the film or other products formed from the composition [0081-0082, 0086, 0093, 0124-0125].
Dundar Field is silent regarding the (f) salt being calcium lactate, as claimed (claim 16, wherein said gelling agent is calcium lactate).
Salumäe, directed to biodegradable film-forming compositions and films formed therefrom suitable for use as food packaging materials [Abstract; 0014, 0017, 0019, 0033, 0048, 0059-0060], teaches that calcium chloride and calcium lactate are suitable solubility reducers (additives which reduce/retard solubility) which function to adjust the dissolution (solubility) of film-forming agents including agar, carrageenan, and alginate [0044, 0097-0101, 0104-0106] in liquids (e.g. cold, cool, warm, and hot water), thereby resulting in easier film formation (from the composition) and the ability to control/tune the solubility characteristics of the resultant film based on desired/predetermined end-uses (e.g. food moisture content, environmental conditions, water temperature) [0067, 0109-0110, 0125-0126, 0145; Table 1]. In view of and addition to the foregoing, Salumäe reasonably teaches that calcium lactate is a functionally equivalent alternative to calcium chloride for the aforesaid use/purpose as an additive to seaweed extract-based film forming compositions (MPEP 2144.06(II)).
Edwards – directed to biodegradable films/vessels for encasing edible materials, wherein the films/vessels are formed from hydrocolloid polymers such as, inter alia alginate, agar, and/or carrageenan [Abstract; 0002, 0004, 0007, 0010, 0023, 0043, 0046] – teaches that calcium chloride and calcium lactate function as gelling agents for (e.g.) alginate through electrostatic crosslinking (Ca ions replace the Na ions of alginate), allowing for easy gel formation [0047, 0066]. Additionally, Edwards teaches that calcium chloride, calcium lactate, and calcium carbonate are recognized as stabilizers – which impart body to, or improve consistency of, the compositions/solutions to which they are added, or aid in formation of films therefrom – suitable for use with (i.e. addition to) said hydrocolloid film-forming polymers [0068-0069]. See MPEP 2144.06(II), MPEP 2144.07.
Title 21 of the Code of Federal Regulations, specifically 21 CFR § 184.1207 [p. 518], unchanged since 03 January 2017, teaches/evidences that calcium lactate is used/recognized as a stabilizer and thickener [p. 518–p. 519] in accordance with 21 CFR § 170.3(o)(28). 21 CFR § 170.3(o)(28) [pp. 8–10], unchanged since 03 January 2017, defines “stabilizers and thickeners” as substances used to produce viscous solutions or dispersions, to impart body, improve consistency, or stabilize emulsions, including suspending and bodying agents, setting agents, jellying agents, and bulking agents, etc. [p. 10].
Dundar Field, Salumäe, and Edwards each constitute prior art which is directly analogous to the claimed invention – seaweed extract-based film-forming compositions, and the resultant films/packaging materials formed therefrom. The aforecited sections of CFR Title 21 constitute evidence, and/or prior art directly analogous to the claimed invention.
In view of the combined teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the composition of Dundar Field by having utilized calcium lactate in place of, or in addition to, calcium chloride as the (f) salt (gelling agent), as calcium lactate would have been readily recognized as a functionally equivalent alternative to calcium chloride for use as a thickener/stabilizer, gelation agent, and/or film-forming additive allowing for easier film formation (from the agar, alginate, or carrageenan-based composition) and/or control/tuning of the solubility characteristics (e.g. water temperature dependence) of the resultant film. See MPEP 2144.06(II) – an express suggestion to substitute one equivalent component for another is not necessary to render such substitution obvious. See MPEP 2144.07 – the selection of a known material based on its suitability for its intended use has been held prima facie obvious by the Courts.
In accordance with the foregoing modification, the (f) salt (gelling agent) of the composition of Dundar Field would have been calcium lactate (instead of calcium chloride) – the resultant composition reads on the composition defined by claim 16 (wherein said gelling agent is calcium lactate).
Pertinent Prior Art
The following constitutes a list of prior art which are not relied upon herein, but are considered pertinent to the claimed invention and/or written description thereof. The prior art are purposely made of record hereinafter to facilitate compact/expedient prosecution, and consideration thereof is respectfully suggested.
US 2020/0047927 to Paslier et al. – discloses/teaches/evidences that, inter alia calcium chloride, calcium lactate, calcium lactate gluconate, and calcium gluconate are known/recognized stabilizers for alginate-based film forming compositions [Abstract; 0001-0006, 0008-0012, 0028-0029, 0033, 0054-0057, 0061]
US 2015/0167249 to Ono et al. – teaches/evidences that salts of inorganic acids, such as calcium chloride, and salts of organic acids, such as calcium lactate, are bulking agents/extenders and moisture absorbents [0068]
US 2019/0128815 to Alshatwi et al. – discloses biofilms formed from alginate and cellulose nanofibrils, said biofilms suitable for use as food packaging materials [Abstract; 0003-0006, 0012, 0015, 0019]
US 2023/0080039 to Paslier et al. – discloses food packaging laminates comprising a substrate and coated layer formed thereon, said layer formed from a crosslinked, naturally-derived polysaccharide and a polyphenol [Abstract; 0010-0013, 0020-0022], and optionally other compounds such as, inter alia agar, carrageenan, sorbitol, glycerol, calcium lactate, and/or potassium hydroxide [0017-0019, 0023-0037]
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Michael C. Romanowski whose telephone number is (571)270-1387. The Examiner can normally be reached M-F, 09:30-17:30.
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, Aaron Austin can be reached at (571) 272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL C. ROMANOWSKI/Primary Examiner, Art Unit 1782
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