DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/25/26 has been entered.
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’s Comments
The examiner has cited particular columns and line numbers, paragraphs, or figures in the references as applied to the claims for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant, in preparing the responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: “the inner diameter” of the internal lumen should be rewritten as “an inner diameter”. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: “a first polymeric solution comprising PVDF-HFP” should be rewritten as “a first polymeric solution comprising the PVDF-HFP”. 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.
Claim 21 is 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.
Claim 21 recites “said concentric layered electrospun microfiber is formed by co-axial electrospinning of a first polymeric solution comprising PVDF-HFP, a second polymeric solution and a third polymeric solution each independently comprising the water-soluble polymer and an aqueous solution comprising cells.” There is no support in the specification to claim that first polymeric solution, second polymeric solution, and a third polymeric solution all comprises of water-soluble polymer and an aqueous solution comprising cells.
Claims 1, 3-5, 7-9, and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for organic-soluble polymer for the listed materials in claims 8-9 does not reasonably provide enablement for organic-soluble polymer, broadly.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The test of enablement is whether one skilled in the art could make and use the claimed invention coupled with information known in the art without undue experimentation (See United States v. Theketronic Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is required is not based upon a single factor but rather a conclusion reached by weighing many factors (See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400 and MPEP 2164.01.). These factors are:
(A) The breadth of the claims;
The pending claims (at least the independent claim 1) are broad. There are millions and millions of possible compositions that would potentially read on the claimed breadth, given the lack of specific material compositions claimed for the organic-soluble polymer.
(B) The nature of the invention;
At the time of Applicants’ invention, a microfiber comprising an organic-soluble polymer are not an excessively difficult invention, per se, as this class of microfiber have been known for many years. However, there are many different formulations for to use as an organic-soluble polymer and the Examiner notes that chemical variations and different type of organic polymers do not always yield predictable results.
(C) The state of the prior art;
The prior art recognizes that some specific organic polymers can be use in a microfiber. However, the The present disclosed invention supports all of this common, but the present claims do not distinguish how any type of organic polymers is suitable. Producing all possible organic polymers composition to make a microtube covered by the breadth of the claim would require undue experimentation to a skilled artisan.
(D) The level of one of ordinary skill;
The level of ordinary skill in the art is probably a research chemist or material engineer having a minimum of two or three years of experience.
(E) The level of predictability in the art;
Chemical arts, in most aspects, are relatively predictable when dealing with a relatively small number of composition and/or well-established structures. However, as the number of possible composition increases or the lack of previous knowledge increases, the ability to easily formulate these compounds or specific organic polymers becomes more difficult and non-trivial. The present specification does not provide any illumination to this question other than examples.
(F) The amount of direction provided by the inventor;
As noted above, there is almost no direction provided by the inventor as to how to produce some of the millions and millions of possible compounds covered by at least the independent claim. The specification only recites a few examples, which only uses PVDF-HFP, which are directed to a very limited subset of the embodiments as compared to the breadth covered by at least the independent claim.
(G) The existence of working examples; and
The specification provides only a limited number of examples (all of which utilize only PVDF-HFP), where these examples have a very limited structure as compared to the full breadth disclosed in at least the independent claims. The specification provides no clear comparative analysis on how one would synthesize the different embodiments; e.g. ones where all type of organic polymer materials are used.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Potentially, a very large number of experiments are required in order to determine what will and will not work when considering the impact of choosing suitable organic polymers. The Examiner deems that the breadth of the claim scope is immense relative to what is taught in the as-filed specification.
Given the above analysis of the factors, which courts have determined, are critical in asserting whether a claimed invention is enabled, it must be considered that a skilled artisan would have to conduct undue and excessive experimentation in order to practice the claimed invention. Applicant is advised to positively set forth specific structural limitations or to present specific arguments on the record as to why a POSITA would view the claimed limitations as enabling.
This rejection can be overcome by amending the claims to positively recite the materials as recited in claims 8-9.
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, 3-9, and 21 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 recites “(i) an exterior polymeric layer consists of… and optionally further of a water-soluble polymer… said intermediate polymeric layer consists of a water-soluble polymer… said water-soluble polymer is selected from the group consisting of a polysaccharide…”. It is unclear to the examiner if the specific materials of the water-soluble polymer refer to the optional water-soluble polymer in the exterior polymeric layer or the intermediate polymeric layer, or both. Clarification is needed.
Claim 21 recites “internal lumen consists of … optionally of a water-soluble material… (iii) internal layer consisting of a water-soluble polymer… said intermediate polymeric layer consists of the water-soluble polymer”. It is unclear to the examiner which “the water-soluble polymer” of the intermediate polymeric layer is referring to. Clarification is needed if the water-soluble polymer refers to internal lumen, internal layer, or both. If the intention that all of the water-soluble polymer in internal lumen, internal layer, and intermediate polymeric layer is all of the same material, clarification is needed on why the interlayer layer consisting of “a water-soluble polymer”.
Additionally, claim 21 recites “the water-soluble polymer is selected from the group consisting of a polysaccharide…”. It is unclear to the examiner if the specific materials of the water-soluble polymer refer to the optional water-soluble polymer in the internal lumen, internal layer, intermediate polymeric layer, or all the components. Clarification is needed.
Furthermore, claim 21 recites “said concentric layered electrospun microfiber is formed by co-axial electrospinning of a first polymeric solution comprising PVDF-HFP, a second polymeric solution and a third polymeric solution each independently comprising the water-soluble polymer and an aqueous solution comprising cells.” Clarification is needed on how it is possible for each and every polymeric solution comprises water-soluble polymer and an aqueous solution comprising cells, wherein some of the layers comprises of an optional water-soluble material and only the internal lumen consists of the immobilized cells. Clarification is also needed if cells in the aqueous solution is the same or different cells of the immobilized cells in the internal lumen.
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.
Claims 1, 3-5, 7-9, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ben Dror et al. (WO 2014/006621). The Examiner notes that US 2015/0183661 is the English language equivalent of WO 2014/006621 and all citations will refer to US 2015/0183661.
Regarding claims 1, 9, and 21, Ben Dror discloses a microfiber comprising immobilized cells encapsulated within a concentric layered microfiber [0155], wherein the immobilized cells are viable cells capable of proliferations [0162] and are located and filled in an internal lumen of the microfiber [0162-0165], the concentric layered microfiber consists of a PVDF-HFP exterior polymeric layer and a PVD [0018] intermediate polymeric layer and/or other materials as claimed [0089, 0104: coat on the internal surface of the shell]. Although Ben Dror discloses hollow fibers during the production of electrospun microtube, Ben Dror explicitly disclose that the immobilized cells are encapsulated and attached or in contact by the intermediate polymeric layer [0155-0157]. Because of the encapsulation and attachment of the immobilized cells, the microfiber is considered to be a non-hollow fiber. Further, given that there is no structural or material distinction between the claimed internal layer and intermediate polymeric layer, the examiner is taking the position that the lower stratum of the intermediate polymeric layer (coat layer on the internal surface of the shell) would corresponds to the claimed internal layer.
Ben Dror fails to explicitly disclose that the exterior polymeric layer and the intermediate polymeric layer each has a thickness of 1-10 µm as presently claimed. However, Ben Dror discloses that the thickness of inner diameter is 50 nm to about 50 µm and an outer diameter is 0.5-100 µm and the thickness of the microfiber is 100 nm – 20 µm [0072-0075], and that all values within the range appears to be functionally equivalent. It would have been obvious to choose any thickness from that ranged based on the desired properties and that choosing thickness values would have rendered the claimed relationship between layer thicknesses obvious in the absence of showing criticality. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the overlapping portion of the ranges disclosed by the reference because overlapping ranges have been held to be a prima facie case of obviousness, In re Malagari, 182 USPQ 549.
Or the alternative, Ben Dror discloses that the mechanical strength dependent on the thickness layers [0083] as well as flow rates [0159]. Thus, the thickness is a result effective variable. A person having ordinary skill in the art before the effective filling date of the invention would have arrived at the claimed invention by general experimentation alone, without exercising any general experimentation.
Additionally, a person having ordinary skill in the art has good reason to pursue known option within his or her technical grasp. It would have been obvious to one or ordinary skill in the art at the time of the invention was made to optimize the thickness of each polymeric layers since it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not invention to discover optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The burden is upon the Applicant to demonstrate that the claimed amount is critical and has unexpected results. In the present invention, one would have been motivate to optimize the thickness of the polymeric layers dependent on what the end use fiber was used for.
Regarding the limitation “electrospun” and “microfiber is formed by…” per claim 21, 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.”, (In re Thorpe, 227 USPQ 964,966). 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 an unobvious different between the claimed product and the prior art product (In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), MPEP 2113). Nevertheless, Ben Dror discloses electrospun fibers.
Regarding claim 3, Ben Dror discloses that the microfiber being a triple-layer microfiber, However, the rate of the solidifying of the polymeric solution is a product by process limitation (please see withdrawn claim 26). 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.”, (In re Thorpe, 227 USPQ 964,966). 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 an unobvious different between the claimed product and the prior art product (In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), MPEP 2113). Nevertheless, Ben Dror discloses a relationship such that the polymeric solution solidifies faster from the exterior of the fiber to the interior of the fiber [0029].
Regarding claim 4, Ben Dror discloses that organic-soluble polymer and also discloses a water-soluble polymer in an amount as claimed (Table 2).
Regarding claim 5, Ben Dror discloses that the layer is substantially porous layers [0120].
Regarding claim 6, please see [0063], [0096].
Regarding claims 7-9, Ben Dror discloses that the materials of the polymers as claimed [0087-0099].
Regarding claim 20, given that Ben Dror discloses that immobilized cells of the internal lumen attaches to the intermediate polymeric layer, Ben Dror discloses the encapsulation as claimed.
Claims 1, 3-5, 7-8, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kuhn et al. (US 2011/0039296).
Regarding claim 1, Kuhn discloses the microfiber as claimed (Please see the annotated figure 3A-3B below).
PNG
media_image1.png
540
990
media_image1.png
Greyscale
Annotated Figs. 3A-3B
Kuhn discloses the material of the exterior polymeric layer as claimed [0079-0090], the material of the intermediate polymeric layer as claimed [0091], and the material of the internal lumen as claimed, which are filled by cells ([0065], [0184]). Alternatively, Kuhn also discloses a coat over an internal surface of the shell [0011], which would correspond to the claimed intermediate polymeric layer as claimed. Furthermore, because Kuhn discloses the encapsulation and attachment of the immobilized cells, the microfiber is considered to be a non-hollow fiber.
Kuhn fails to explicitly disclose that the exterior polymeric layer and the intermediate polymeric layer each has a thickness of about 1-10 µm as presently claimed. However, Kuhn discloses that the thickness of inner diameter is 50 nm to about 50 µm and an outer diameter is 0.5-100 µm and the thickness of the microfiber is 100 nm – 20 µm [0051-0053], and that all values within the range appears to be functionally equivalent. It would have been obvious to choose any thickness from that ranged based on the desired properties and that choosing thickness values would have rendered the claimed relationship between layer thicknesses obvious in the absence of showing criticality. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the overlapping portion of the ranges disclosed by the reference because overlapping ranges have been held to be a prima facie case of obviousness, In re Malagari, 182 USPQ 549.
Or the alternative, Kuhn discloses that the mechanical strength dependent on the thickness layers [0074] as well as flow rates [0077]. Thus, the thickness is a result effective variable. A person having ordinary skill in the art before the effective filling date of the invention would have arrived at the claimed invention by general experimentation alone, without exercising any general experimentation.
Additionally, a person having ordinary skill in the art has good reason to pursue known option within his or her technical grasp. It would have been obvious to one or ordinary skill in the art at the time of the invention was made to optimize the thickness of each polymeric layers since it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not invention to discover optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The burden is upon the Applicant to demonstrate that the claimed amount is critical and has unexpected results. In the present invention, one would have been motivate to optimize the thickness of the polymeric layers dependent on what the end use fiber was used for.
Regarding the limitation “electrospun”, 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.”, (In re Thorpe, 227 USPQ 964,966). 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 an unobvious different between the claimed product and the prior art product (In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), MPEP 2113). Nevertheless, Kuhn discloses electrospun fibers.
Regarding claim 3, Kuhn discloses that the microfiber being a triple-layer microfiber, However, the rate of the solidifying of the polymeric solution is a product by process limitation (please see withdrawn claim 26). 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.”, (In re Thorpe, 227 USPQ 964,966). 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 an unobvious different between the claimed product and the prior art product (In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), MPEP 2113). Nevertheless, Kuhn discloses a relationship such that the polymeric solution solidifies faster from the exterior of the fiber to the interior of the fiber (Abstract, [0073]).
Regarding claim 4, please see Table 2.
Regarding claim 5, please see [0032].
Regarding claims 7-8, please see [0078-0083].
Regarding claim 20, please see annotated figure. Alternatively, given that Kuhn discloses that immobilized cells of the internal lumen attaches to the intermediate polymeric layer, Kuhn discloses the encapsulation as claimed.
Regarding claim 21, Kuhn discloses the microfiber as claimed (Please see the annotated figure 3A-3B below).
PNG
media_image1.png
540
990
media_image1.png
Greyscale
Annotated Figs. 3A-3B
Kuhn discloses that the material of the exterior polymeric layer is organic soluble polymer [0079-0090], the material of the intermediate polymeric layer as claimed [0091], and the material of the internal lumen as claimed ([0065], [0184]). Alternatively, Kuhn also discloses a coat over an internal surface of the shell [0011], which would correspond to the claimed intermediate polymeric layer and/or internal layer. Given that there is no material or structural difference between the claimed intermediate polymeric layer and internal layer, the examiner is taking the position that the upper stratum of the coat over corresponds to the claimed intermediate polymeric layer and the bottom stratum of the coat over corresponds to the claimed internal layer. Furthermore, because Kuhn discloses the encapsulation and attachment of the immobilized cells, the microfiber is considered to be a non-hollow fiber.
Kuhn fails to explicitly disclose that the exterior polymeric layer and the intermediate polymeric layer each has a thickness of about 1-10 µm as presently claimed. However, Kuhn discloses that the thickness of inner diameter is 50 nm to about 50 µm and an outer diameter is 0.5-100 µm and the thickness of the microfiber is 100 nm – 20 µm [0051-0053], and that all values within the range appears to be functionally equivalent. It would have been obvious to choose any thickness from that ranged based on the desired properties and that choosing thickness values would have rendered the claimed relationship between layer thicknesses obvious in the absence of showing criticality. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the overlapping portion of the ranges disclosed by the reference because overlapping ranges have been held to be a prima facie case of obviousness, In re Malagari, 182 USPQ 549.
Or the alternative, Kuhn discloses that the mechanical strength dependent on the thickness layers [0074] as well as flow rates [0077]. Thus, the thickness is a result effective variable. A person having ordinary skill in the art before the effective filling date of the invention would have arrived at the claimed invention by general experimentation alone, without exercising any general experimentation.
Additionally, a person having ordinary skill in the art has good reason to pursue known option within his or her technical grasp. It would have been obvious to one or ordinary skill in the art at the time of the invention was made to optimize the thickness of each polymeric layers since it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not invention to discover optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The burden is upon the Applicant to demonstrate that the claimed amount is critical and has unexpected results. In the present invention, one would have been motivated to optimize the thickness of the polymeric layers dependent on what the end use fiber was used for.
Regarding the limitation “microfiber is formed by…”, 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.”, (In re Thorpe, 227 USPQ 964,966). 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 an unobvious different between the claimed product and the prior art product (In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), MPEP 2113). Nevertheless, Kuhn discloses electrospun fibers.
Although Kuhn discloses an organic soluble polymer to be of a copolymer, Kuhn fails to explicitly disclose that it is of PVDF-HFP as presently claimed.
Ben Dror discloses a microfiber comprising immobilized cells encapsulated within a concentric layered microfiber [0155], wherein the immobilized cells are viable cells capable of proliferations [0162] and are located in an internal lumen of the microfiber [0165], the concentric layered microfiber consists of a PVDF-HFP exterior polymeric layer and a PVD [0018] intermediate polymeric layer and/or other materials as claimed [0089, 0104].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuhn’s organic soluble polymer to be of PVDF-HFP, since Ben Dror discloses that this is a suitable polymeric material as an exterior of the microfiber.
Alternatively, Kuhn discloses a microfiber comprising an exterior layer as set forth above, however, fails to explicitly disclose that it comprises of PVDF-HFP. Kuhn discloses the claimed invention except it uses PCL, as one of the examples, instead of PVDF-HFP. Ben Dror shows that PVDF-HFP is an equivalent structure known in the art ([0110], [0095]). Therefore, because these two materials were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute PCL for PVDF-HFP in the invention of Kuhn. Substitution of equivalents requires no express motivation as long as the prior art recognizes the equivalency. In re Fount 213 USPQ 532 (CCPA 1982); In re Siebentritt 152 USPQ 618 (CCPA 1967); Grover Tank & Mfg. Co. Inc V. Linde Air Products Co. 85 USPQ 328 (USSC 1950).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that Ben Dror does not disclose or suggest a concentric layered electrospun microfiber having two distinct polymeric layers together with an internal lumen filled with immobilized cells.
This is because Ben Dror recites in [0083].
PNG
media_image2.png
146
612
media_image2.png
Greyscale
However, the examiner contends that paragraph [0083] discloses the claimed structure. Ben Dror explicitly states that the polymer of the second polymeric solution forms a thin layer on the internal surface of the shell. Essentially, the examiner is taking the position that the thin layer of the internal surface of the shell corresponds to the claimed intermediate polymeric layer, thereby the remaining part of the shell corresponds to the claimed exterior polymeric layer.
Applicant argues that the amended claim 1 recites that the intermediate polymeric layer doesn’t include cells, wherein Applicant argues that Ben Dror discloses that it comprises of cells. Applicant points to paragraph 156 that:
PNG
media_image3.png
114
628
media_image3.png
Greyscale
The examiner respectfully disagrees. Paragraph of 156 of Ben Dror discloses that the cells are attached to the coat polymer, which corresponds to the claimed intermediate polymeric layer. This actually reads upon the claimed “said intermediate polymeric layer consists of a water-soluble polymer and is in contact with the immobilized cells of the internal lumen”. Ben Dror does not state that the coat polymer comprises of cells as argued by the Applicant. The examiner maintains that the attachment of cells to a layer is completely different that cells being within a layer.
Therefore, the examiner maintains that Ben Dror discloses the claimed invention.
Applicant argues that since Kuhn discloses a 2-layered fiber having an exterior water-insoluble layer and an interior soluble layer containing cells., Kuhn fails to disclose the claimed invention. The examiner respectfully disagrees. As annotated in Figure of 3A and 3B set forth above, the upper and lower stratum of the interior soluble layer reads upon the claimed intermediate polymeric layer (please see the small brackets wherein no cells are actually present). With regards to Kuhn’s disclosure of “a coat over the internal surface of the shell”, this also would correspond to the claimed intermediate polymeric layer and/or internal layer. With similar reasoning set forth above, the examiner contends that cells were “attached to said coat over said internal surface of said shell” (claim 16) does not equate that the internal surface of the shell comprise of the cells. This specific attachment would actually reads upon claimed “said intermediate polymeric layer consists of a water-soluble polymer and is in contact with the immobilized cells of the internal lumen”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDA N CHAU whose telephone number is (571)270-5835. The examiner can normally be reached 9AM-5PM EST M-F.
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, Mark Ruthkosky can be reached at (571)272-1291. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Linda Chau
/L.N.C/Examiner, Art Unit 1785
/Holly Rickman/Primary Examiner, Art Unit 1785
Prosecution Insights