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 .
Disposition of Claims
Claims 1-8, 11-12 and 14 are pending in the application. Claims 9-10 and 13 have been cancelled. Claims 1-7 are withdrawn from consideration due to Applicant’s elections.
Amendments to claims 8, 11-12 and 14, filed on 9/16/2025, have been entered in the above-identified application.
Claim Objections
Claims 8, 11-12 and 14 are objected to because of the following informalities:
Claim 8 recites the limitations “A nonwoven hydrogen material” (line 1) and “wherein the nonwoven hydrogen material” (the second to last line). Appropriate correction is required.
Claim 8 recites the limitation “vitamins selected from vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, vitamins, peptone…” This should be “….vitamin E and vitamin K, peptone....” Appropriate correction is required.
Claim 8 recites the limitation “wherein the production of the nonwoven hydrogel material of bacterial nanocellulose comprising the steps of.” Appropriate correction is required.
Claims 11-12 and 14 each recite the limitation “The nonwoven hydrogen material.” Appropriate correction is required.
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.
Claims 8, 11-12 and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification does not provide support for the claim 8 limitation “wherein the nonwoven hydrogen material has a content of impurities of 0.01 % by weight to 2% by weight.” Paragraph [0031] of the published application, US 2023/0041020 A1, (or page 6, lines 16-18 as-filed) discloses that the impurities have a content of 0.05% by weight to 1% by weight. Claim 10 as originally filed states “The nonwoven material made of a hydrogel according to claim 9, characterized in that the impurities have a content of 0.01 % by weight to 2% by weight.” However, these sections do not disclose what the claimed weight percentages are with respect to. Claims 11-12 and 14 are rejected due to their dependence on claim 8.
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 8, 11-12 and 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 8 recites the limitation “A nonwoven hydrogen material of bacterial nanocellulose with a water content of between 80% by weight and 99.5% by weight, and a cellulose content of between 0.5% by weight and 20% by weight.” As claimed, it is unclear if the nonwoven hydrogen (hydrogel) material or the bacterial nanocellulose has the claimed water content and cellulose content. The claim further recites the limitation “the nonwoven hydrogel material has a foreign matter content of between 0.01 % by weight and 15% by weight.” The examiner notes that if the nonwoven hydrogel material has a water content of 99.5% by weight, the sum of the water content, the cellulose content and the foreign matter content in the nonwoven hydrogel material would be more than 100%, which would render the claim indefinite. Claims 11-12 and 14 are rejected due to their dependence on claim 8.
Claims 11 and 12 each recite the limitation “the impurities have a content…” It is unclear what the claimed content is with respect to.
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.
Claim(s) 8, 11-12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luukko (WO 2018/109275 A1, attached 9/23/2024).
Regarding claims 8, 11-12 and 14, Luukko teaches a medical hydrogel (a nonwoven hydrogel material) comprising nanofibrillar cellulose, wherein the hydrogel has a viscosity in the range of 2500-9000 Paꞏs and a water retention value in the range of 30-100 g/g (Abstract). The "g/g" refers to grams of water to a gram of hydrogel (page 18, lines 33-36). Therefore the nanofibrillar hydrogel may contain up to 100 grams of water per one gram of dry hydrogel, which is generally not possible for conventional gel forming materials (page 18, lines 33-36).
As calculated by the examiner, the water content would range from about 96.8% to about 99% by weight (e.g., 30/31 = 0.968). The hydrogels may be also provided or called as medical hydrogels or medical products (page 6, lines 17-18). In one embodiment the hydrogel is provided as such (as medical hydrogels or medical products), preferably containing only or substantially only nanofibrillar cellulose and water, such as a product containing 99% (w/w) of nanofibrillar cellulose and water, or more, such as 99.5% (w/w) or 99.9% (w/w), up to 100% (page 6, lines 18-22). In such embodiments, as calculated by the examiner, the content of cellulose in the hydrogel would be 3.2% by weight or less (i.e., 100 - 96.8 = 3.2), and the content of material other than cellulose and water would range from 0% to 1% by weight (e.g., 100 - 99 = 1).
In embodiments, Luukko teaches that a medical product comprising a therapeutic agent may be provided, wherein the hydrogel comprising nanofibrillar cellulose contain(s) one or more therapeutic agent(s), such as a bioactive agent, a medicament or a drug (page 21 lines 23-25). Examples of therapeutic or bioactive agents which may be administered by using the medical products described include (in addition to others) vitamins, such as B12 or cyanocobalamin (impurities as claimed) (page 22 lines 22-23). The content of the therapeutic agent in the product may be for example in the range of 0.01-20% (w/w), such as 0.05-10% (w/w) (p. 21, lines 34-35). In one embodiment the content of the therapeutic agent in the product is in the range of 0.1-5% (w/w), such as 0.1-3% (w/w), 0.5-3.5% (w/w) or 0.5-5% (pp. 21-22, lines 35-1).
A medical product may also be suitable for example for cosmetic purposes, so it may be used also as a cosmetic product (page 8, lines 34--36). The examiner notes that Luukko teaches cosmetic agents such as lactic acid, pigments, plant extracts, fragrances, hyaluronic acid, and vitamins A, C and E, and Luukko teaches that the content of a cosmetic agent in a cosmetic product may be for example in the range of 0.01-20% (w/w), such as 0.05-10% (w/w) (loads as claimed) (see pages 27-28 lines 27-33, and page 6, lines 34-36). In one embodiment the content of the cosmetic agent in the product is in the range of 0.1-5% (w/w), such as 0.1-3% (w/w), or 0.5-5% (w/w) (p. 28, lines 1-3).
Luukko does not explicitly disclose the claimed cellulose content and the claimed foreign matter content in the same embodiment.
However, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to have included the therapeutic agents (impurities) and the cosmetic agents (loads) in the hydrogel each in amounts of 0.01 wt% or more and less than 1 wt%, and totaling up to 1 wt%, in embodiments in which the hydrogel is provided as a medical hydrogel or medical product preferably containing only or substantially only nanofibrillar cellulose and water, such as a product containing 99% (w/w) or more of nanofibrillar cellulose and water (page 6 lines 18-22).
In this event, the foreign matter content (the total amount of impurities and loads) would overlap with the claimed range of 0.01 % by weight and 15% by weight.
With regard to the claimed limitation “a nonwoven hydrogel material,” Luukko teaches that it (nanofibrillar cellulose) forms a self-assembled hydrogel network even at low concentrations (page 7 lines 12-13). The gel is formed already at relatively low concentrations of, for example, 0.05-0.2% (w/w) by dispersed and hydrated entangled fibrils (page 9 lines 22-25). It was found out that a hydrogel comprising nanofibrillar cellulose and having certain physical properties at specific ranges was especially suitable for medical purposes, especially as a medical product, such as a dressing, a patch or a filter (page 2 lines 19-26 and page 26 lines 23-25). When applied to a skin, especially to a wound, the hydrogel exhibited properties such as solidity, low stickiness, sufficient fracture toughness expressed as compression work, formability, and good removability or detachability (col. 2, lines 22-25). A (cosmetic) product may be provided in various shapes, for example a mask may be designed to fit onto face, for example below eye or onto chin, nose or forehead (page 27, lines 27-32). Therefore, the examiner notes that the hydrogel disclosed by Luukko would meet the claimed limitation “a nonwoven material made of a hydrogel.” In the alternative, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to have provided the hydrogel in the form of a web or sheet in order to obtain the medical products taught by Luukko, such as a dressing, a patch or a mask.
The examiner notes that claim 8 includes product-by-process limitations. The product being claimed appears to be the same as or obvious over the prior art product, in which case differences in process are not considered to impart patentability. Further, Luukko teaches that the raw material may be derived from certain bacterial fermentation processes (page 7, lines 21-22). Thus, the burden is shifted to Applicant to show that any differences in process would result in an unobvious difference between the claimed product and the prior art product.
Response to Arguments
Applicant's arguments filed 9/16/2025 have been fully considered but they are not persuasive.
Applicant contends the following “However, Luukko does not disclose an example in which the sum of all components is less than 100% by weight. Therefore, in view of Luukko it would not be obvious to one skilled in the art that the hydrogel could contain any other components. Luukko does not teach that there are ingredients other than hydrogel, water, and therapeutic or cosmetic active ingredients. Specifically, Luukko does not teach that impurities are included that are unintended components and are largely removed from the nonwoven fabric during the washing process. Furthermore, Luukko does not teach a cleaning process.”
Regarding these contentions, as applied above, Luukko teaches medical hydrogels or medical products that preferably contain only or substantially only nanofibrillar cellulose and water, such as a product containing 99% (w/w) of nanofibrillar cellulose and water, or more, such as 99.5% (w/w) or 99.9% (w/w), up to 100% (page 6, lines 18-22). In embodiments, Luukko teaches that a medical product comprising a therapeutic agent (impurities as claimed) may be provided, and the content of the therapeutic agent in the product may be for example in the range of 0.01-20% (w/w), such as 0.05-10% (w/w) (p. 21, lines 23-25 and 34-35). A medical product may also be suitable for example for cosmetic purposes, so it may be used also as a cosmetic product (page 8, lines 34--36). Luukko teaches that the content of a cosmetic agent (loads as claimed) in a cosmetic product may be for example in the range of 0.01-20% (w/w), such as 0.05-10% (w/w) (see pages 27-28 lines 27-33, and page 6, lines 34-36). As applied above, it would have been obvious to one having ordinary skill to have included the therapeutic agent and the cosmetic agents in a medical hydrogel within the ranges disclosed by Luukko and in amounts totaling up to 1 wt% when the medical hydrogel or medical product preferably contains only or substantially only nanofibrillar cellulose, such as 99% (w/w) of nanofibrillar cellulose and water or more.
With regard to the claimed impurities, Luukko’s disclosure of therapeutic agents such as B12 or cyanocobalamin vitamins meets the claimed “impurities” limitation. In addition, Luukko’s disclosure of cosmetic agents such as lactic acid, pigments, plant extracts, fragrances, hyaluronic acid, and vitamins A, C and E meets the claimed “loads” limitation (see p. 22, lines 22-23, pp. 27-28, lines 27-33, and p. 6, lines 34-36). The examiner notes that the source of the claimed materials is not given patentable weight. In addition, although Luukko does not teach the claimed process step of washing or cleaning a hydrogel, Luukko teaches the claimed materials being present in the hydrogel in the claimed amounts. Therefore, it is unclear how any differences in process between that claimed and that taught by Luukko would result in an unobvious difference between the claimed product and the prior art product.
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 Kevin Worrell whose telephone number is (571)270-7728. The examiner can normally be reached Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marla McConnell can be reached on 571-270-7692. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kevin Worrell/Examiner, Art Unit 1789
/MARLA D MCCONNELL/Supervisory Patent Examiner, Art Unit 1789