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 .
Specification
The disclosure is objected to because of the following informalities:
Acronyms such as PVDF-HFP, PVP, PCL, PLA, PGA, PES
At [00140] “tub-like ” should read “tube-like”.
At [00169] “(poly(vinylidene fluoride-hexafluoropropylene)” is missing a parenthesis.
At [00224] “thet” should read “the”.
Appropriate correction is required.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 2, 12, 23, and 30 are objected to because of the following informalities:
Claim 1 recites “electrospun fibers comprising a shell”. This should read “electrospun fibers comprises a shell”.
Claim 2 recites “The fibrous mat of claim 1, the plurality of cells”. Examiner suggests adding “wherein” before “the plurality of cells” for consistency.
Claim 12 recites “wherein water insoluble cellulose derivative”. This should read “wherein the water insoluble cellulose derivative”.
Claim 23 recites “configured for stably adhere”. This should read “configured to stably adhere” or “configured for stably adhering”.
Claim 23 recites the limitation, “the dimension of the target site”. This should be “the dimensions of the target site”.
Claim 30 is missing a conjunction between limitations (i) and (ii).
Claim 30 recites “wherein the container further comprises seal”. This should read “wherein the container further comprises a seal”.
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.
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 3, 5, 10-13, 18-19, 23, and 30-32 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.
Regarding claim 3, claim 3 recites the limitation “the mat”. There is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, this limitation is interpreted to read “the fibrous mat”.
Regarding claim 5, claim 5 recites “cosmeceutical”. The term “cosmeceutical” is not defined in the claims nor the specification. The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). In the instant case, neither the claims nor specification provides an objective definition for “cosmeceutical.” Furthermore, “cosmeceutical” is not a regulated term with any standardized or legal meaning. See FDA (2022). Thus, there is no objective standard for determining the scope of this limitation. For purposes of compact prosecution, the term “cosmeceutical-grade” will be interpreted to be synonymous with “biocompatible”.
Regarding claim 10, this claim recites, “wherein the water insoluble polymer comprises a water insoluble polysaccharide, a fluoropolymer, or PVDF-HFP, including any combination and any copolymer thereof”. The term “including” is synonymous with “comprising”, which is a term of art indicating that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. MPEP 2111.03. Thus, the claim language seemingly indicates that the invention requires both a combination and copolymer thereof. Thus, the claim language listing the water insoluble polysaccharide, a fluoropolymer, or PVDF-HFP in the alternative, indicating that only one of those needs to be present, seems to contradict the subsequent claim language “including”. As a result, it is unclear which elements are required as part of the invention.
Additionally, claims 11 and 12 depend from claim 10 and do not cure the deficiencies of claim 10. Therefore, claims 11 and 12 inherit the deficiencies of parent claim 10.
For purposes of compact prosecution, if the prior art teaches any of the listed elements, it will be considered to read on the claim.
Regarding claim 11, this claim recites, “wherein the water insoluble polysaccharide comprises cellulose, a water insoluble cellulose derivative, including any combination and any copolymer thereof”. The lack of conjunctions such as “and” or “or”, and the use of “comprises” in combination with the phrase “any combination and any copolymer thereof” render the claim indefinite because it is unclear whether all the listed elements are required as part of the claimed invention. "Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. MPEP 2111.03, see Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986). If both a cellulose and water-insoluble cellulose derivative are essential to the instant claim, the recitation of “any combination and any copolymer thereof” would be redundant, since both elements would necessarily be present already. (I.e. in order for “any combination and any copolymer thereof” to have meaning, the claim limitation would need to be capable of being satisfied by the presence of just one element.) As a result, it is unclear if the instant claim limitation would be satisfied if only cellulose or only a water-insoluble cellulose derivative was present.
If the intention is such that the limitation may be satisfied by having only one of the listed elements present, this intent also seems to contradict the subsequent use of the term “including”. The term “including” is synonymous with “comprising” (see MPEP 2111.03 I), indicating that the invention requires both a combination and copolymer thereof. It is also unclear if “including any combination and any copolymer thereof” is intended to modify only “water insoluble cellulose derivative” or both “cellulose” and “water insoluble cellulose derivative”. Since “water insoluble cellulose derivative” embraces a genus of compounds, an interpretation of the instant limitation where “any combination and any copolymer thereof” applies only to the water-insoluble cellulose derivative is plausible.
Additionally, claim 12 depends from claim 11 and does not cure the deficiencies of claim 10. Therefore, claim 12 inherits the deficiencies of parent claim 11. For purposes of compact prosecution, claim 11 is being interpreted to read “wherein the water insoluble polysaccharide comprises cellulose, a water insoluble cellulose derivative, or any copolymer thereof.”
Regarding claim 12, this claim recites “wherein water insoluble cellulose derivative comprises [list of various cellulose derivatives], including any copolymer and any combination thereof”. The term “including” is synonymous with “comprising” (see MPEP 2111.03 I), indicating that the invention requires both a combination and copolymer thereof. Additionally, the use of the transitional phrase “comprises” and lack of any conjunctions seemingly indicates that each and every element in the list is required. As a result, the recitation of “including any copolymer and any combination thereof” is redundant, since all elements are already required to be present, and unclear, since “any” suggests that there may be different combinations, but “comprising” indicates that all elements must be present, thus there can only be one possible combination.
Furthermore, claim 12 recites cellulose derivatives that are water-soluble (e.g. methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose), despite the instant claim categorizing them as water-insoluble. For purposes of compact prosecution, if the prior art teaches any of the listed elements, it will be considered to read on the claim.
Regarding claim 13, this claim recites that the water-soluble polymer may be selected from a list of different cellulose derivatives, ending with “polyether” followed by “including any combination and any copolymer thereof”. The term “including” is synonymous with “comprising”, which is a term of art indicating that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. MPEP 2111.03. Thus, the claim language seemingly indicates that the invention requires both a combination and copolymer thereof. This seems to contradict the language “selected from” which seems to indicate a Markush grouping of alternatively useable members. MPEP 2117. Thus, the selection of a single listed element would seem to contradict the recitation of “including any combination and any copolymer thereof”, which requires both a combination and a copolymer to be present. Furthermore, it is unclear if “any combination and any copolymer thereof” modifies only “polyether” or if it encompasses the entire list of elements. Since polyether refers to a wide class of compound, a reading wherein “any combination and any copolymer thereof” refers only to polyethers would be plausible. For purposes of compact prosecution, the claim will be interpreted to read “wherein the water-soluble polymer is selected from a water-soluble polysaccharide, a polyol, a polyvinyl alcohol, polyalkyleneoxide, PVP, a polyether, or any combination or copolymer thereof.”
Regarding claim 18, claim 18 recites the limitation “the dormant cells”. There is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, this limitation is interpreted to read “the cells”.
Claim 18 also recites the limitation “the mat”. There is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, this limitation is interpreted to read “the fibrous mat”.
Regarding claim 19, claim 19 recites the limitation “the water insoluble cellulose derivative”. There is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, this limitation is interpreted to read “a water insoluble cellulose derivative”.
Claim 19 also recites the limitation “the water soluble polysaccharide”. There is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, this limitation is interpreted to read “a water soluble polysaccharide”.
Claim 19 also recites “wherein the core comprises (i) at least one of a monosaccharide, a di-saccharide, and an oligosaccharide”. The use of “comprises” followed by “at least one…and” renders the claim indefinite. "Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added. MPEP 2111.03. In contrast, “at least one” implies that only one is required, but more can be present if desired. Thus “comprises” and “at least one” contradict each other. For purposes of compact prosecution, the limitation will be interpreted to read “wherein the core comprises (i) at least of one a monosaccharide, a disaccharide, or an oligosaccharide”.
Regarding claim 30, claim 30 recites “sufficient heat transfer capacity”. The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). In the instant case, neither the claims nor specification provide an objective definition for “sufficient heat transfer capacity”. Thus, the scope of the term is not understood when read in light of the specification. For purposes of compact prosecution, any material that will allow for heat exchange will be read on the instant claim.
Regarding claim 30, claim 30 recites the limitation “the water-tight container”. There is insufficient antecedent basis for this limitation in the claim. Claim 30 depends from claim 29, which seems to require only a single wall of the container to be water impermeable, whereas claim 30 seems to imply that the entire container is water impermeable. As a result, the metes and bounds of the claim are unclear. For purposes of compact prosecution, the limitation will be interpreted to read “a water-tight container”.
Regarding claim 31, claim 31 recites the limitation “wherein the activating composition is capable of providing the plurality of cells from a dormant state into an active state.” It is unclear how cells can be provided from a dormant state to an active state.
Regarding claim 32, claim 32 recites the limitation “plant-based”. The term “plant-based” is a relative term which renders these claims indefinite. The term “plant-based” is not defined by these claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how far one can deviate from a compound that is directly extracted from a plant without being so far removed therefrom as to be considered no longer “plant-based”. For example, would acetylsalicylic acid (i.e. aspirin) be considered “plant-based”, since it derives from a precursor found in the bark of the willow tree? Would synthetic substances that also occur naturally in plants be considered “plant-based”?
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.
Claims 1-3, 5, 9-14, 17, 19-20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ben Dror et al. (US 2018/0044817 A1, published 2/15/2018), in view of Singh et al. (US 2013/0196405 A1, published 8/1/2013) and Stojanov et al. (2020).
Examiner would like to note, regarding the limitation “electrospun”, that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." MPEP 2113 I. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. MPEP 2113 III.
Regarding claims 1 and 10-11, Ben Dror teaches electrospun, concentric multi-layered microfibers comprising an exterior layer (i.e. shell), intermediate layer, and interior layer which comprises of living cells and water-soluble polymer (i.e. core) [0006; 0047]. The exterior layer may comprise of poly(vinylidenefluoride) [0013] (reads on fluoropolymer of claim 10), PVDF-HFP [0014] (reads on claim 10), or cellulose [0013] (reads on claims 10-11). Ben Dror does not explicitly state that the polymers comprising the exterior layer are water-insoluble, however, a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. MPEP 2112.01. Thus, the disclosure of poly(vinylidenefluoride), PVDF-HFP, and cellulose reads on water-insoluble polymer. Ben Dror further teaches that the exterior layer may be porous [0112-0114].
Ben Dror does not explicitly teach a fibrous mat wherein cells are present in an amount of up to 1011 CFU/cm2. Ben Dror teaches that in some embodiments, the fibers incorporated viable cells at a concentration of about 1011 cells/ml [0038], indicating that the electrospun fibers are capable of incorporating high concentrations of viable cells [0038]. However, the cell loading limitation of the instant claim is essentially an expression of concentration. Differences in concentration generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05. Stojanov teaches that bacterial cells incorporated into electrospun fibers have been used as probiotics and drug delivery systems [pg. 6], and must be administered in adequate amounts in order to confer health benefits [pg. 6]. Thus, it would be obvious to one of ordinary skill to modify the teachings of Ben Dror and Singh with that of Stojanov to optimize the amounts of cells encapsulated in the electrospun fibers in order to attain a concentration of cells that is effective in conferring the desired benefits.
Ben Dror does not explicitly teach a fibrous mat characterized by a thickness of between 10 and 2000 um. Singh teaches a porous fiber having a core-shell configuration [0008] wherein biological material, including cells [0018], is retained in the encapsulated core [0011]. The fibers of Singh may be gathered to form a membrane (i.e. mat) for a sufficient period of time until a desired membrane thickness is obtained. The thickness of the membrane may be the same as the diameter of the fiber or up to about 300 um [0052]. Individual layers may also be stacked if a thicker membrane is desired [0052]. The disclosed range of mat thickness overlaps with the instantly claimed range, thus a prima facie case of obviousness exists. MPEP 2144.05. Singh further teaches that such fibrous membranes and mats may be adapted for use in a wide range of biosensor applications such as testing of antibiotic effectiveness, immunoassays, and mutagenicity tests [0056]. Thus, it would be obvious to one of ordinary skill in the art, before the effective filing sate of the claimed invention, to modify the teachings of Ben Dror with that of Singh to assemble the porous, layered microfibers of Ben Dror into a mat or membrane configuration in order to broaden the range of commercial applications for which the electrospun fibers can be used [Singh 0003].
Regarding claim 2, Ben Dror teaches that the cells may comprise bacterial and fungal cells [0068].
Regarding claim 3, Ben Dror does not explicitly teach a dry weight concentration of the cells in the fibrous mat. However, as discussed above, differences in concentration generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. MPEP 2144.05.
Regarding claim 5, Ben Dror teaches that the exterior and internal layers of the fiber may each have a thickness of about 5 nm to 10 um, and the internal layer may have a thickness of about 5 nm to 50 um [0025-0028]. This equates to a fiber thickness range of about 0.015 um to 70 um, which overlaps with the instantly claimed range and is prima facie obvious. MPEP 2144.05.
Regarding claim 9, Ben Dror does not explicitly teach electrospun fibers wherein the shell comprises at least 50% by dry weight of water insoluble polymer. However, Ben Dror teaches that the outer layer may comprise of one or more polymers including PVDF-HFP [0013-0014]. Thus, if the if the outer layer comprises of only PVDF-HFP, then the outer layer comprises 100% by dry weight of water insoluble polymer, which reads on the instantly claimed at least 50%. However, as discussed above, differences in concentration generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. MPEP 2144.05. Ben Dror also teaches that the exterior layer may further comprise of water-soluble polymer [0059].
Regarding claim 12, Ben Dror does not explicitly teach the instantly claimed cellulose derivatives. As discussed above, Ben Dror teaches that suitable polymers for the exterior shell include poly(vinylidenefluoride) and PVDF-HFP [0013-0014]. Singh similarly teaches that the polymer comprising the electrospun fibers may include poly(vinylidenefluoride) and PVDF-HFP [0065]. Singh further teaches that an additional equivalent polymer suitable for electrospun nanofibers is cellulose acetate [0065]. Substitution of equivalents known for the same purpose is prima facie obvious. MPEP 2144.06. Furthermore, Singh teaches that methylcellulose, hydroxyethylcellulose, and carboxymethyl may be included in the fiber shell [0076; 0083]. The selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. Thus, it would be obvious to a skilled artisan to modify the teachings of Ben Dror with that of Singh to include the aforementioned cellulose derivatives in the exterior shell of the instantly claimed fibrous material.
Regarding claim 13, Ben Dror teaches that the water-soluble polymer of the interior layer may comprise of polyvinyl alcohol, PVP, polyethylene oxide, and water-soluble polysaccharides [0062-0063].
Regarding claim 14, Ben Dror teaches that the water-soluble polymers of the interior layer may comprise of saccharide oligomers (i.e. oligosaccharides) [claim 15; 0021]
Regarding claim 17, Ben Dror teaches that the cells of the invention may comprise of plant cells, bacteria, and fungi [0068]. Ben Dror does not explicitly teach a plant extract, bacterial metabolite, or fungal metabolite. Under BRI, plant extracts may be interpreted as any substance extracted from plant cells. Thus, the encapsulation of plant cells would necessarily include all the substances contained within the plant cells, reading on the instant limitation of plant extract. Additionally, the fibers of Ben Dror comprise of viable cells [0038]. Experimental data demonstrated that encapsulated yeast remained alive, active, and proliferated inside the fibers [0121]. Thus, the presence of live cells necessarily results in the presence of metabolites resulting from ongoing cellular metabolism, reading on the instant limitation of bacterial or fungal metabolites.
Regarding claim 19, this claim recites limitations that have been previously addressed and made obvious. The analysis for these limitations will not be repeated herein. See rejections for claims 1, 5, 10-11, 13, and 14.
Regarding claim 20, Ben Dror teaches that the water-soluble polysaccharide may comprise of alginate (reads on gum) [0020, claim 15]. Ben Dror also teaches polyethylene glycol (synonymous with polyethylene oxide or PEO) [0060, 0062, claim 15].
Regarding claim 23, Stojanov teaches the application of a nanofiber delivery system comprising S. epidermidis in order to alter skin microbiota to prevent diabetic foot ulcers [pg. 7-8]. ]. Thus, it would be obvious to one of ordinary skill in the art, before the effective filing sate of the claimed invention, to modify the fibrous mat made obvious by Ben Dror and Singh with the teachings of Stojanov and adapt the fibrous mat for topical use on skin. A skilled artisan would be motivated to make this modification in order to broaden the range of commercial applications for which the invention can be used [Stojanov pg. 7-8]. Singh further teaches that fibrous membranes may be cut into a desired size and shape as needed for a given purpose [0119]. It would be obvious to one of ordinary skill to apply the teachings of Stojanov and Singh to the fibrous mat previously made obvious, to arrive at the instantly claimed invention wherein the fibrous mat is in the form of a topical product, configured for application to the skin, wherein the length and/or width of the product is compatible with the dimension of the target site on the skin.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ben Dror et al. (US 2018/0044817 A1, published 2/15/2018), in view of Singh et al. (US 2013/0196405 A1, published 8/1/2013) and Stojanov et al. (2020), as applied to claim 1 above, and further in view of Fadil et al. (2021).
Regarding claim 15, Singh teaches that fibrous membranes may be cut into a desired size and shape as needed for a given purpose [0119] (reads on shapeable). The instant claim also recites the limitation wherein the fibrous mat has a water absorption capability of up to 1000% relative to its dry weight. Ben Dror and Singh do not explicitly address the water absorption capability of the electrospun fibrous material. Fadil teaches electrospun fibrous mats for use as a seed germination substrate [Abstract]. Fadil further teaches that the porous fiber structure of the fibrous substrate has high capillary forces that allow for an excellent ability to absorb and store water [Abstract; pg. 5]. Example D of Fadil was shown to possess a fluid uptake ability (FUA) of about 80% [pg. 6]. FUA was calculated as a percent of water loss per unit weight using the following equation: FUA (in %) = (Ws – Wd)/Ws x 100, wherein Ws is the wet weight of the electrospun fibers, and Wd is the dry weight of the electrospun fibers [pg. 2]. Thus, a fluid uptake ability of 80% equates to a 500% water absorption capability. (Ex: If Ws = 250 and Wd= 50, then (250-50)/250 x 100 = 80%; thus, a wet weight of 250 is a 500% relative increase from a dry weight of 50). Fadil further teaches that altering the fiber diameter and pore size will affect the fluid absorption capability and wettability of the fibrous material [6-7]. Thus, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the teachings of Fadil to the fibrous mat previously made obvious by Ben Dror and Singh, to arrive at the instantly claimed invention. A skilled artisan would be motivated to modify the fiber structure and porosity to achieve a higher water absorption capacity to suit the application of the fibrous mat as needed [pg. 2]. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ben Dror et al. (US 2018/0044817 A1, published 2/15/2018), in view of Singh et al. (US 2013/0196405 A1, published 8/1/2013) and Stojanov et al. (2020) as applied to claim 1 above, and further in view of Salalha et al. (2006).
Regarding claim 18, Ben Dror does not explicitly teach a fibrous mat wherein the moisture content is less than 10%. However, as discussed above, differences in concentration generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. MPEP 2144.05.
Regarding the instantly claimed limitation of maintained cell viability within the fibrous mat for at least 3 months, Ben Dror and Singh do not explicitly address this limitation. Salalha teaches the encapsulation of bacteria in electrospun fibers [Abstract], wherein the electrospun fibers were collected into a macroscopic ribbon and subsequently desiccated (i.e. inactivated) through the application of vacuum and heating at about 40°C for 4 hours [4677]. The fibrous ribbons were found to contain 7% water by weight. Salalha further teaches that their technique allowed encapsulated organisms to retain their viability for at least 3 months [4680]. It would be obvious to one of ordinary skill, before the effective filing date of the claimed invention, to modify the fibrous mat previously made obvious with the teachings of Salalha, and modify the moisture content to the instantly claimed range, in order to allow for convenient and efficient storage of microorganisms in dry form while maintaining their viability [Abstract; 4680].
Claims 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Ben Dror et al. (US 2018/0044817 A1, published 2/15/2018), in view of Singh et al. (US 2013/0196405 A1, published 8/1/2013) and Stojanov et al. (2020), as applied to claim 1 above, and further in view of Caldwell (US 2016/0053218 A1, published 2/25/2016), as evidenced by LB Broth Specification Sheet (2024).
Regarding claims 29-31, Caldwell teaches a kit comprising a first container containing a dormant bacterial inoculant [0008, claim 2] and a second, sealed container containing an activating medium [0006]. The containers are separated by a dividing member that is capable of being disrupted, allowing the microbes and media to be combined [claim 1]. The dividing member may comprise a movable dividing member that can be moved to open the two chambers to each other (reads on valve) [0080]. The addition of the media to the dormant microbes serves to activate the microbes [Fig. 1]. Caldwell further teaches that the container may comprise of materials such as various plastics, polymers, glass, and stainless steel (reads on stable at up to 60°C and has sufficient heat transfer capacity) [0087], and that materials may be selected according to desired properties such as reaction inertness and durability [0088]. Example 1 of Caldwell discloses the use of a plastic chamber with a 20% headspace of ambient air [0103], attached to a second chamber containing mineral water, reading on the instant limitations of water impermeable and substantially oxygen impermeable. The invention of Caldwell provides for a kit system that is protected from external contamination [0043], has enhanced storage capabilities [0045], and provides an unskilled user with the convenient, on-demand ability to activate dormant microbial inoculants [0043]. It would be obvious to one of ordinary skill in the art to apply the teachings of Caldwell to the fibrous mat made obvious by Ben Dror and Singh, to package the fibrous mat in a kit as taught by Caldwell for the aforementioned benefits.
Regarding claim 32, Caldwell teaches that the type of media used in the kit will depend on the microbe itself and its nutrient needs [0068]. Examples include LB and nutrient broth [0015]. LB broth has a pH of 6.7 to 7.2 [LB Broth Specification Sheet], which overlaps with the instant claimed pH of between 3 and 10, and is therefore prima facie obvious. It would be obvious to one of ordinary skill in the art to apply the teachings of Caldwell to the instantly claimed invention, and select LB broth (or any other nutrient broth) as the activating composition in order to meet the nutrient needs of the specific microbes that are encapsulated in the fibrous material.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-3, 5, 9-14, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 16, and 18 of copending Application No. 19/141,667 (reference application, hereinafter ‘667).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and those of Application No. 19/141,667 encompass a fibrous material comprising electrospun, polymeric fibers, wherein the fiber comprises a water-insoluble, porous polymer shell [‘667 claim 9] and a core comprising a water-soluble polymer and a plurality of cells [‘667 claim 1].The fibrous material of both applications have an average fiber cross section of between 1 and 500 um [‘667 claim 1] and overlapping claimed ranges of mat thickness [‘667 claim 5]. The water-insoluble polymer shell of both applications may comprise of cellulose, water-insoluble cellulose-derivative, and combinations and copolymers thereof [‘667 claim 2]. The water-soluble polymer core of both applications may comprise of water-soluble polysaccharide, water-soluble gym, polyol, polyvinyl alcohol, polyether, and combinations and copolymers thereof [‘667 claim 3]. The core of both inventions can further comprise a monosaccharide, disaccharide, oligosaccharide, or combination thereof [‘667 claim 18]. Both applications claim various amounts/ratios of polymeric materials [‘667 claims 4, 8, 10, 16] and cells [‘667 claim 7]. However, differences in concentration will not support the patentability of subject matter unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, claims 6 and 11 of the reference application recite properties that are inseparable from the claimed composition. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. MPEP 2112.01.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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