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 .
DETAILED ACTION
Applicant’s response filed on 12/11/2025 is duly acknowledged.
Claims 1-15 as presented are pending in this application.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-7; directed to “A method for preparing a multifunctional hydrogel…”) in the reply filed on 12/11/2025 (see REM, p. 6-9) is acknowledged. The traversal is mainly on the ground(s) that “…examination of all pending claims would not be a burden, much less a "serious burden," on the Examiner…”, and that claim 1 recites steps that are common to all groups of invention, specifically “…claim 8-15, which include similar elements”, and therefore “…does not require significant additional examination resources for repeated searches or analysis, fully aligning with the MPEP's principle of avoiding unnecessary restrictions…”. Applicants also appear to argue that “…the hydrogel product necessarily obtained by this method is novel per se… Consequently, the method, product, and use claims are interrelated under a single general inventive concept of "preparing a multifunctional porous hydrogel utilizing yeast fermentation," complying with the statutory requirement for unity of invention…Therefore, the feature in claim 1 is not disclosed by Madsen” (see REM, p. 7-9). Applicant’s arguments are duly noted and considered. However, they are not found persuasive because- first, “search burden” on the examiner per se is not one of the prerequisites for the restriction requirements for applications filed under 371 (i.e. under national stage entry). Second, the common technical feature of the groups I-III as presented by the applicants pertains to the product-by-process claim 8 in the form of a “multifunctional hydrogel”, which as already noted in the previous office action (see paper dated 10/17/2025, p. 4) has been disclosed by Madsen et al, albeit using the mixture of agar and gelatin, wherein the resulting hydrogel would be deemed to be structurally same, unless structural-functional features distinguishing the two products are brought into the product of claim 8. In the absence of such distinguishing structural features, the hydrogel product disclosed in the cited prior art of Madsen et al is deemed to be essentially the same product, and therefore, the inventions of groups I-III, as presented, lack unity a posteriori.
Additionally, since applicants have elected the method claims of group I for examination (and not the product of group II), the request for re-joinder (see REM, p. 9) is duly noted and considered, but is not deemed to be persuasive. The requirement is still deemed proper and is therefore made FINAL.
Claims 8-15 (non-elected inventions of Groups II and III) have been withdrawn from further considerations.
Claims 1-7 (elected invention of Group I with traverse; directed to “A method for preparing a multifunctional hydrogel…”) have been examined on their merits in this action hereinafter.
Priority
This application is a 371 of PCT/CN2022/113331 (filed on 08/18/2022), which claims foreign priority from a Chinese application CN 202111038363.0 filed on 09/06/2021.
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.
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 1-7 (as presented) 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 1 as presented is reproduced below:
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Claim 1 recite multiple limitations that end with a period within the claim. For example, the limitations for temperature in line 1 as “(1) activating yeast in 30 0C. warm water…”. Similar recitations are also presented in steps (2) and (3), which render the claimed process indefinite because a claim must be presented as a single sentence with a single period at the end. The recitation of multiple periods within the claim body makes the recitation ambiguous and confusing because it is unclear if the recitation of limitations following the period are part of the claimed invention, or not. The metes and bounds of the claim is therefore not properly defined.
Similar issues are also noted in dependent claim 4 (line 7), claim 5 (step 1, lines 4 and 5); and step 2, line 5), and claim 6 (line 3), which should be recited for the temperature unit as “0C”, i.e. without the period after “C” (see MPEP 608.01(M) for more guidance).
In addition, claim 1 as presented does not recite any conjunction (“and”, for instance) between the last two steps (i.e. between step (2) and step (3) as recited), which makes the claimed process ambiguous. Similar ambiguity (of missing a conjunction “and’, for instance) is noted in instant claim 5 (see recitation of steps (1) and (2), in particular). Appropriate correction is required.
Claim 2 recites the limitations “wherein in step (1), the yeast liquid has a concentration of 0.2 g/mL to 0.45 g/mL”, which is ambiguous because step (1) of claim 1 (from which claim 2 directly depends from) recites limitations of “activating yeast in 30 0C. warm water to obtain a yeast liquid”, and therefore it not clear as to what exactly is the component(s) for which the “concentration of 0.2 g/mL to 0.45 g/mL” refers to ?...an activating factor(s), or the yeast itself ? From “Example 1” of the instant disclosure of record (see SPEC, p. 5, for instance), it appears that no other “activating” component(s) has been used, other than dissolving “yeast powder” in deionized water at 30 0C, and therefore, applicants are suggested to recite “wherein in step (1), the yeast liquid has a concentration of yeast at 0.2 g/mL to 0.45 g/mL”, if that is what is being intended by the applicants (as being treated hereinafter for the instant office action purposes). Appropriate correction and/or explanation is required.
Claim 5 (in step 1, line 8) recites the limitation “washing with water to neutral”, which is ambiguous recitation of the method step as it is unclear what exactly is being encompassed by the end point of being “neutral”. Does it refer to the neutral pH, neutral reactivity, or any other physical and/or chemical property per se? It is noted that the Example 4 (see SPEC, p. 7, step (1), as presented) also recites the same without providing a reasonable basis/explanation for said limitation, and therefore, it is not clear as to what exactly the term “neutral” encompasses. Appropriate correction and/or explanation is required.
Claim 7 (directly depends from claim 6) recites the limitations of “wherein the saline solution is an ammonium sulfate or sodium citrate solution”, which is ambiguous and confusing because- first, the term “saline” has not been specifically defined by the applicants (see SPEC, p. 3, 5th paragraph; p. 6, Example 3, for instance); and second, to an artisan in the pertinent art, the term “saline” solution would normally mean to encompass a solution of sodium chloride salt in water. However, claim 6 (from which claim 7 depends from) recites the step “…soaked in a mixed solution of a saline solution and glycerol for 12 hours” (see claim 6, line 3) that to an artisan would not mean to encompass “an ammonium sulfate or sodium citrate solution” per se. It appears that applicants intend to recite a “salt solution” in place of “saline solution” in claims 6 and 7, that would be appropriate as per instant disclosure (see Example 3 on p.6, for instance).
Claim 7 also recites the further limitations “the saline solution has a concentration of 10 wt % to 30 wt %”, which is ambiguous recitation because it is not clear as to what exact component has the recited “concentration of 10 wt % to 30 wt %” ? A saline solution is normally known to contain 0.9 wt% sodium chloride in water, and therefore, the recitation appears to be confusing, unless applicants intend to refer to “a salt solution”, and the concentration referred is for a particular salt or salts, or combination thereof. Appropriate amendment and/or correction is required.
NOTE: 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-7 (as presented) are rejected under 35 U.S.C. 103 as being unpatentable over BAO et al (CN 111939326 A; published on 11/17/2020; PTO English machine translation attached, and cited herein as ref. [U] on PTO 892 form) in view of NUSSINOVITCH (US 6,589,328 B1; cited as ref [A] on PTO 892 form) and FU et al (CN 104098860 A; published on 10/15/2014; PTO English machine translation attached; cited herein as ref. [V] on PTO 892 form).
Claim 1 is reproduced as follows:
“1. (Original) A method for preparing a multifunctional hydrogel by yeast fermentation, comprising the following steps:
(1) activating yeast in 30 0C. warm water to obtain a yeast liquid;
(2) weighing plate count agar (PCA) and dissolving in deionized water at 100 0C. for 20 minutes, then cooling to 50 0C. to obtain a PCA solution; adding gelatin (Gel) to the PCA solution with stirring in a 50 0C. bath for 30 minutes; and then adding glucose, conducting the stirring continuously for dissolution to obtain a Gel-PCA-glucose mixed solution, and lowering the temperature of the Gel-PCA-glucose mixed solution to 30 0C.;
(3) subjecting the yeast liquid in step (1) and the Gel-PCA-glucose mixed solution in step (2) to uniform mixing to obtain a first mixture, pouring the first mixture into a first mold for fermentation in a 30 0C. water bath for 30 minutes, and then placing at 4 0C. for 10 minutes to obtain a Gel-PCA-yeast multifunctional hydrogel.”
See also limitations of dependent claims 2-7 as presented (see also 112b rejections discussed above; the term “plate count agar” has not been specifically defined by the applicants, and has been taken herein as “agar”, a polysaccharide preparation, normally used in the microbiology art).
Bao et al (2020; citations as per translation attached) disclose a method for preparing a conductive biomineralized hydrogel (regarding instant claim 1) comprising agar, gelatin and graphene (see Title, Abstract, section “Contents of the Invention”, Embodiment 1, and Claims, for instance); wherein the method comprises the steps as reproduced below:
“S1: configuring 0.167 mol/L of calcium nitrate solution, adding 2 to 5 % (w/v) of agar into the mixed solution and stirring at high temperature of 95 ° C for 30min.
S2: cooling the solution configured in S1 to 60 ° C, then adding 0 to 3 % (w/v) gelatin, stirring for 30min.
S3: continuously stirring the solution configured in S1 at 60 ° C, adding 0 to 0.5mg/ml of graphene oxide, stirring for 30min, then quickly cooling to 5 ° C in the ice water mixture to obtain the chelated calcium ion-agar/gelatin/graphene oxide hydrogel.
S4: the hydrogel obtained in S3 is 0.05 ~ 0.2 mol/L (NH4) 2HPO4 solution, and using ammonia water to adjust the pH value at 10 ~ 11, the reaction system at 37 degrees centigrade biological mineralization reaction for 2 ~ 7 days.
S5: slicing the material obtained in S4; the slice thickness is 1 ~ 2mm, the outermost layer is marked as L 1, the second layer is marked as L2, and so on to obtain several slices, freezing and drying the slice; using scanning electron microscope (SEM), transmission electron microscope (TEM), Fourier transform infrared instrument (FTIR), Raman spectrum analysis material.”
Bao et al also disclose that “the graphene, can be oxidized graphene, reducing graphene oxide, carboxylated graphene, aminated graphene and other graphene derivatives, wherein the graphene oxide is oxidized graphite prepared by Hummers method, putting in aqueous solution for ultrasonic dispersion and peeling” (see section “Contents of the Invention”, for instance); wherein “the hydrogel is composed of agar, gelatin and graphene derivative, wherein the hydrogel, graphene derivative mass fraction is 0 to 2 %”; and wherein graphene-reinforced hydrogel shows mechanical strength, electrical conductivity, and therefore has variety of applications in tissue interface engineering, specifically in bone/cartilage bionic integrated stent preparation technology, and for tissue/cartilage repair and reconstruction fields (see Abstract and section “Technical Field”, for instance).
However, a method for preparing a hydrogel- wherein yeast fermentation is employed in the presence of glucose as nutrient (see steps 1 and 3 of instant claim 1), and wherein the reduced graphene oxide (PrGO) is prepared with the steps involving oxidation with potassium permanganate and hydrogen peroxide, followed by reduction with dopamine hydrochloride (as recited in instant claim 5), have not been explicitly disclosed by the cited prior art reference of Bao et al (though, Bao et al disclose the fact that oxidized graphene was prepared by Hummers method; see section “Contents of the Invention”, for instance).
Nussinovitch (2003), while teaching sponges of hydrocolloids (see Title, Abstract, and Example 8, claim 10, for instance), disclose the process of making sponges from hydrocolloid materials by incorporating fermenting microorganisms such as yeast cells (culture of Saccharomyces cerevisiae; see col. 7, Table 1, Example 8, for instance) into the gel materials; wherein “Gels were placed in sucrose, glucose, fructose or other sugar solutions. Sugar diffused into the gels, and carbon dioxide bubbles were formed and trapped within the gel matrix. Gas bubbles content was a function of yeast and sugar contents, temperature of diffusion, gel dimension, etc. Different gel textures were achieved by changing the percentage of yeast, 103 to 109 cells per gram, changing sugar type and content (0.2-30%) or changing temperature” (see col. 4, 2nd paragraph, for instance); wherein “Gels consisting of one hydrocolloid such as agar, carrageenan, gelatin, alginate, starch, pectin, gellan, kunjak mannan, two hydrocolloids such as Xanthan gum plus locust bean gum, or three or more gelling agents were used, in most cases containing one or more further constituents. Hydrocolloid concentrations were up to about 5% (except in the case of gelatin which can be used in concentrations of up to about 20%)” (see col. 3, lines 46-54. For instance); and wherein sponges having predetermined characteristics of water absorption, biodegradability and pore size and structure could be produced (see col. 18, claim 1, for instance).
Thus, given the beneficial disclosure for incorporation of fermenting microbes such as yeast cells with nutrients (such as suitable sugar including sucrose, glucose, etc.; see teachings above) into gels (including agar, alginate, or gelatin, etc.) in order to prepare hydrogels that have desired predetermined characteristics of water absorption, biodegradability and pore size, as specifically taught by Nussinovitch, it would have been obvious to an artisan of ordinary skill in the art to incorporate such advantageous step in method of making hydrogels that comprise agar, gelatin, and reduced graphene oxide as specifically taught by Bao et al in order to obtain superior hydrogel with desired porous, water absorbing, and mechanical as well as electrical conductive properties desired for various downstream applications, as taught by both cited references of Bao et al and Nussinovitch discussed above. Since, the same components of hydrogels or hydrocolloids including agar and gelatin have been used by Bao et al, and has been incorporated with reduced graphene oxide, the specific parameters of temperatures and time periods for dissolving agar and gelatin, mixing the components in a suitable mold, cooling, etc., would have been obvious and fully contemplated and/or optimized as result-effective variables by an artisan of ordinary skill in the hydrogel/hydrocolloid art.
However, the method wherein the reduced graphene oxide (PrGO) is prepared with the steps involving oxidation with potassium permanganate and hydrogen peroxide, followed by reduction with dopamine hydrochloride (as recited in instant claim 5), have not been explicitly disclosed by the cited prior art reference of Bao et al taken with Nussinovitch, as discussed above.
Fu et al (2014; citations as per translation attached) disclose method to prepare graphene oxide by Hummers oxidation method (see Abstract, entire section of “MODE-FOR-INVENTION”, and Claims) and reducing it by treatment with dopamine hydrochloride; wherein the oxidation step involves treatment with suitable amounts of potassium permanganate and 30% hydrogen peroxide followed with neutralization with water and ultrasonic dispersion; wherein the oxidized graphene oxide was further treated with dopamine hydrochloride in order to obtain reduced graphene oxide (i.e. PrGO; see instant claims 4-5), albeit for making nano-composite material coated with dopamine.
Therefore, since Bao et al already disclose the suitability of reduced graphene oxide, and disclose that oxidized graphene was produced using the method of Hummers, which has been fully disclosed by Fu et al, along with preparation of reduced graphene oxide (PrGO), an artisan of ordinary skill in the art would have had a reasonable expectation of success in preparing and employing reduced graphene oxide in making the hydrogel composition that employs yeast fermentation step, as taught and explicitly suggested by the combined teachings from Bao et al and Nussinovitch, as discussed above. Since, the step of freezing, slicing, drying, and biomineralization using suitable ammonium salt solutions, have already been disclosed by Bao et al, as discussed above, the limitations of instant claims 6 and 7 would have been obvious to an artisan of ordinary skill in the art given the combined disclosure provided by the cited prior art references of Bao et al when taken with Nussinovitch and Fu et al, as discussed above. Unless evidence provided on record to the contrary, such variations in salt solutions, or use of glycerol (see 0-20% glycerol acting as a plasticizer, for instance; see Nussinovitch, col. 3, lines 57-58, claim 6, for instance), would have been obvious to an artisan of ordinary skill in the art depending on the specific requirement(s) for the downstream applications, as desired.
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657