DETAILED NON-FINAL REISSUE ACTION
Notice of Pre-AIA or AIA Status
The present application claims priority to 14 February 2013 and therefore is being examined under the pre-AIA first to invent provisions.
Reissue Applications
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 10,293,289 is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely appraise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1422.01, and 1442.04.
Priority
Application number 15/434,180 which matured into United States Patent No. 10,293,289 (hereafter “the ‘289 Patent”) was filed on 16 February 2017 and is a continuation of application number 14/000,981 which was filed on 14 February 2013.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 12/28/2023, 9/11/2025, and 2/10/2026 have been considered by the Examiner.
Claim Status
The following is the status of the claims:
Claims 21-60 are pending all of which are new.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 35, 36, and 57 are rejected under 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention.
Claims 35 and 57 recite “the ion exchange medium has a protein static binding capacity greater than 40 mg/g” which encompasses embodiments in which the protein static binding capacity is any value greater than 40 mg/g. It is noted that at page 15 of the Applicant Arguments/Remarks filed 28 December 2023 Applicant asserts that support for the claimed protein static binding capacity range can be found at col. 18, line 43 through col. 19, line 51 and Table 2 of the ‘289 Patent. However, the only disclosure of protein static binding capacity values is found in Table 2 (column 19 lines 52-60) which discloses a single component nanofiber felt having a protein static binding capacity of 40 mg/g and a hybrid nanofiber felt having a protein static binding capacity of 168 mg/g. As such, the ‘289 Patent only reasonably provides sufficient written description support for an ion exchange medium having a protein static binding capacity of up to 168 mg/g.
Claim 36 recites “a peclet number of at least about 45 per layer of said felt” which encompasses embodiments in which the ion exchange medium has any peclet number which is 45 or greater. It is noted that at page 15 of the Applicant Arguments/Remarks Applicant asserts that support for the limitation can be found at col. 20 line 40 through col. 21 line 5 and Table 4 of the ‘289 Patent.
However, the only disclosure of peclet values is found in Table 4 (column 21 lines 6-21) which discloses a single nanofiber felt having a peclet number that is greater than about 45. More specifically, the example comprising one layer of nanofiber felt is disclosed as having a peclet number value of 45.2 which is the only example which has a peclet number that is greater than about 45. As such, there is insufficient written description support for any peclet value greater than about 45.2 per layer of felt.
Appropriate action is required.
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 29, 30, 32, 39, 43, 44, 51, 54 and 60 are rejected under 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 Applicant regards as the invention.
Claims 29 and 30 recite “the non-cellulose based polymer”. There is insufficient antecedent basis for the term “non-cellulose based polymer” as claim 28 from which claims 29 and 30 depend does not introduce a non-cellulose based polymer. It is noted that claim 28 does recite “a non-cellulose polymer” however it is unclear if the non-cellulose based polymer recited in claims 29 and 30 is the same polymer as the non-cellulose polymer recited in claim 29. Appropriate correction is required.
Claim 32 recites “the non-cellulose polymer”. There is insufficient antecedent basis for the term “non-cellulose polymer” as none of claims 21 or 31 introduce a non-cellulose polymer. As such, one of ordinary skill in the art would not be reasonably apprised of what component of the claimed ion exchange medium corresponds to the claimed non-cellulose polymer. Appropriate correction is required.
Claim 43 recites the limitation "flowing the fluid" in 43. Similarly, claim 44 recites “recovering the fluid”. There is insufficient antecedent basis for the term “the fluid” as neither claim 43 nor claim 44 nor any of the claims from which these claims depend introduces a fluid. As such, one of ordinary skill in the art would not be reasonably apprised of which fluid is being referred to or where said fluid is coming from. Appropriate correction is required. For the purpose of examination, any fluid that is collected from a nanofiber felt which meets the limitation of claim 40 will be interpreted as reading on the claimed fluid.
Claim 54 recites the phrase “the non-cellulose polymer”. Similarly, Claims 39, 51 and 60 recite the phrase “the non-cellulose based polymer”. There is insufficient antecedent basis for claimed non-cellulose based polymer as none of the claims from which claims 39, 51, 54 and 60 depend(s) introduces a non-cellulose polymer or a non-cellulose based polymer. As such, one of ordinary skill in the art would not be reasonably apprised of what component of the claimed nanofiber felt corresponds to the claimed non-cellulose or non-cellulose based polymer. For the purpose of examination, any non-cellulose based polymer present in an ion exchange medium comprising a nanofiber felt comprising cellulose will be interpreted as reading on the claimed non-cellulose based polymer.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 33 and 55 are rejected under pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 33 and 55 both recite “wherein the nanofiber are non-woven nanofibers”. However, per the definitions provided in ‘289, the nanofibers in the electrospun nanofiber felt recited in independent claims 1 and 40 are nonwoven. At col 4 lines 46-48, the ‘289 Patent defines the term “felt” as referring to a non-woven or randomly overlaid collection of fibers. Further, at lines 49-52 of column 4 the ‘298 Patent defines the term “nanofiber felt” as referring to a collection of nanofibers in a substantially planar array”. From these definitions, it is clear that the nanofiber felt recited in independent claims 21 and 40 is a substantially planar array of non-woven nanofibers. As such, claims 33 and 55 fail to further limit the scope of independent claims 21 and 40, respectively.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21, 22, 24-26, 28-34, 37-43, 45, 47, 48, 50-56, and 58-60 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bracewell et al., US 2014/0296464 (“Bracewell”) in view of Zhang et al., Fabrication and bioseparation studies of adsorptive membranes/felts made from electrospun cellulose acetate nanofibers, Journal of Membrane Science, 319 (2008), 176-184 (“Zhang”)(copy provided herewith).
Regarding claim 21, Bracewell discloses an ion exchange medium formed from electrospun cellulose acetate fibers having a diameter of from 300 nm to 400 nm [abstract, 0001, 0018, 0020, 0021, 0023, 0027, claims 1 and 8]. The ion exchange medium may be in the form of a layered membrane formed from nonwoven nanofibers (i.e., a nanofiber felt) [0018-0020, 0024]. Bracewell teaches that the medium can readily be functionalized to interact with target molecules [0027].
Bracewell does not expressly teach the membrane comprising a surface having an ion exchange group attached thereto.
Zhang discloses an ion exchange medium which is an adsorptive felt formed from electrospun cellulose acetate nanofibers (abstract). The cellulose acetate nanofibers are surface functionalized with a diethylaminoethyl (DEAE) anion exchange ligand (abstract, page 178, 1st column, 1st full paragraph). Zhang teaches that felts made of electrospun polymer nanofibers offer a unique capability to control pore size among the nanofibers (page 177, 2nd column, 2nd full paragraph).
Bracewell and Zhang are both directed towards ion exchange media which are formed from electrospun cellulose acetate nanofibers. It would have been obvious to one of ordinary skill in the art at the time the instant invention was made to have functionalized the surface of the cellulose acetate fibers of the ion exchange medium of Bracewell with DEAE in order to render the medium an anionic exchange medium as taught by Zhang. The ion exchange medium of modified Bracewell would have been a felt formed from electrospun nanofibers comprising cellulose as claimed. The surface of the nanofibers would have been functionalized with DEAE which reads on the claimed nanofiber felt comprising a surface having an ion exchange group attached thereto. The nanofibers in the felt would have had a diameter of from 300 nm to 400 nm which falls within the range recited in claim 21.
Regarding claim 22, the DEAE taught by Zhang reads on the claimed ion exchange group comprising a base.
Regarding claim 24, Zhang teaches functionalizing nanocellulose fibers with DEAE by reacting nanocellulose fibers with 2-(diethylamino) ethyl chloride hydrochloride under alkali conditions (page 178, 1st column, 1st full paragraph) which corresponds to the claimed chemical modification.
Regarding claims 25 and 26, the DEAE functionalization taught by modified Bracewell reads on the anion exchange group recited in claim 25 and the diethylaminoethyl recited in claim 26.
Regarding claims 28-32, Bracewell teaches that the disclosed ion exchange medium may comprise a combination of electrospun cellulose acetate fibers and electrospun polyacrylonitrile fibers [0018, 0021]. The electrospun polyacrylonitrile fibers correspond to the non-cellulose polymer recited in claim 28, the thermoplastic copolymer recited in claim 29, the polyacrylonitrile recited in claims 30 and 32, and the non-cellulose-based nanofiber recited in claim 31.
Regarding claim 33, Bracewell teaches non-woven nanofibers such as electrospun nanofibers [0019, 0020].
Regarding claim 34, Bracewell teaches that the disclosed ion exchange medium comprises pores [0018]. Zhang also teaches that nanofiber felts comprise pores (page 177, 2nd column, 2nd full paragraph).
Regarding claim 37 and 38, Bracewell discloses nanofibers having a diameter of from 300 nm to 400 nm [0023, 0054].
Regarding claim 39, Bracewell does not teach or suggest that the disclosed ion exchange medium is required to comprise a mixture of different polymer fibers. As such, modified Bracewell reasonably teaches an embodiment in which all of the fibers are formed from cellulose acetate which meets the limitation of the claim.
Regarding claims 40 and 41, Bracewell teaches using the disclosed ion exchange medium to separate proteins [0059-0062, 0074] which intrinsically requires contacting proteins with the exchange medium.
Regarding claim 42, Bracewell teaches eluting (i.e., recovering) a protein from the disclosed ion exchange medium [0059, 0060, 0068].
Regarding claim 43, as is noted above, Bracewell teaches contacting and eluting proteins with/from the exchange medium. Bracewell is silent regarding flowing a fluid through a second nanofiber felt, however it is noted that MPEP 2144.04(VI)(B) establishes that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In the instant case, it is noted that Bracewell teaches contacting proteins with the disclosed ion exchange medium and then eluting proteins from the ion exchange medium [0059-0062, 0068, 0074]. Thus, unless a new and unexpected result is produced, duplicating the contacting proteins with the disclosed ion exchange medium step taught by Bracewell is viewed as having no patentable significance.
Regarding claims 45, 47, and 48, the DEAE functionalization taught by modified Bracewell reads on the ion exchange group comprising a base recited in claim 45, the anion exchange group recited in claim 47, and the diethylaminoethyl recited in claim 48.
Regarding claims 50-54, Bracewell teaches that the disclosed ion exchange medium may comprise a combination of electrospun cellulose acetate fibers and electrospun polyacrylonitrile fibers [0018, 0021]. The electrospun polyacrylonitrile fibers correspond to the non-cellulose polymer recited in claim 50, the thermoplastic copolymer recited in claim 51, the polyacrylonitrile recited in claims 52 and 54, and the non-cellulose-based nanofiber recited in claim 53.
Regarding claim 55, Bracewell teaches non-woven nanofibers, such as electrospun nanofibers [0019, 0020].
Regarding claim 56, Bracewell teaches that the disclosed ion exchange medium comprises pores [0018]. Zhang also teaches that nanofiber felts comprise pores (page 177, 2nd column, 2nd full paragraph).
Regarding claim 58 and 59, Bracewell discloses nanofibers having a diameter of from 300 nm to 400 nm [0023, 0054].
Regarding claim 60, Bracewell does not teach or suggest that the disclosed ion exchange medium is required to comprise a mixture of different polymer fibers. As such, modified Bracewell reasonably teaches an embodiment in which all of the fibers are formed from cellulose acetate which meets the limitation of the claim.
Claims 21-25, 27-34, 37-43, 45, 46, 49-56, and 58-60 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bracewell in view of Margarit-Purit et al., US 2006/0093820 (“Margarit-Purit”).
Regarding claims 21, 37, and 38, Bracewell discloses an ion exchange medium formed from electrospun cellulose acetate fibers having a diameter of from 300 nm to 400 nm [abstract, 0001, 0018, 0020, 0021, 0023, 0027, claims 1 and 8]. The ion exchange medium may be a layered membrane formed from nonwoven nanofibers (i.e., a nanofiber felt) [0018-0020, 0024]. Bracewell teaches that the medium can readily be functionalized to interact with target molecules [0027].
Bracewell does not expressly teach the membrane comprising a surface having an ion exchange group attached thereto.
Margarit-Purit discloses a separation medium comprising a functionalized nonwoven material formed from fibers having ionic groups covalently bonded to the surface (i.e., an ion exchange medium) wherein the functionalized nonwoven material exhibits excellent separation effects [abstract, 0002, 0012, 0017, 0077, 0079]. The nonwoven fibers may be produced via electrostatic spinning and may comprise cellulose [0026, 0035]. The fibers may be nanofibers [0029].
Bracewell and Margarit-Purit are both directed towards separation media which are formed from fibers, such as electrospun cellulose nanofibers. In light of the teachings of Margarit-Purit it would have been obvious to one of ordinary skill in the art at the time the instant invention was made to have covalently bonded ionic groups onto the surface of the electrospun cellulose nanofibers of the ion exchange medium of Bracewell with the expectation of producing an ion exchange material that exhibits excellent separation effects.
The ion exchange medium of modified Bracewell would have been a felt formed from electrospun nanofibers comprising cellulose as claimed. The surface of the nanofibers would have been functionalized with ionic groups which reads on the claimed nanofiber felt comprising a surface having an ion exchange group attached thereto. The nanofibers in the felt would have had a diameter of from 300 nm to 400 nm which falls within the range recited in claims 21, 37, and 38.
Regarding claims 22, 23, and 27, Margarit-Purit teaches that the anionic group may be a carboxylic acid [0020, 0038, 0047, 0048, Claim 12] which reads on the acid of claim 22, the strong or weak acid of claim 23, and the carboxylic acid of claim 27.
Regarding claim 24, the covalent bonding of the anionic group to the surface of the fibers read on at least the claimed chemical modification.
Regarding claim 25, the anionic group taught by Margarit-Purit reads on the claimed cation exchange ligand.
Regarding claims 28-32, Bracewell teaches that the disclosed ion exchange medium may comprise a combination of electrospun cellulose acetate fibers and electrospun polyacrylonitrile fibers [0018, 0021]. The electrospun polyacrylonitrile fibers correspond to the non-cellulose polymer recited in claim 28, the thermoplastic copolymer recited in claim 29, the polyacrylonitrile recited in claims 30 and 32, and the non-cellulose-based nanofiber recited in claim 31.
Regarding claim 33, Bracewell teaches non-woven nanofibers, such as electrospun nanofibers [0019, 0020].
Regarding claim 34, Bracewell teaches that the disclosed ion exchange medium comprises pores [0018].
Regarding claim 39, Bracewell does not teach or suggest that the disclosed ion exchange medium is required to comprise a mixture of different polymer fibers. As such, modified Bracewell reasonably teaches an embodiment in which all of the fibers are formed from cellulose acetate which meets the limitation of the claim.
Regarding claims 40 and 41, Bracewell teaches using the disclosed ion exchange medium to separate proteins [0059-0062, 0074] which intrinsically requires contacting proteins with the exchange medium.
Regarding claim 42, Bracewell teaches eluting (i.e., recovering) a protein from the disclosed ion exchange medium [0059, 0060, 0068].
Regarding claim 43, as is noted above, Bracewell teaches contacting and eluting proteins with/from the exchange medium. While Bracewell is silent regarding flowing a fluid through a second nanofiber felt, it is noted that MPEP 2144.04(VI)(B) establishes that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In the instant case, it is noted that Bracewell teaches contacting proteins with the disclosed ion exchange medium and then eluting proteins from the ion exchange medium [0059-0062, 0068, 0074]. Thus, unless a new and unexpected result is produced, duplicating the contacting proteins with the disclosed ion exchange medium step taught by Bracewell is viewed as having no patentable significance.
Regarding claims 45, 46, and 49, Margarit-Purit teaches that the ionic groups may be a carboxylic acid [0020, 0038, 0047, 0048, Claim 12] which reads on the acid of claim 45, the strong or weak acid of claim 46, and the carboxylic acid recited in claim 49.
Regarding claims 50-54, Bracewell teaches that the disclosed ion exchange medium may comprise a combination of electrospun cellulose acetate fibers and electrospun polyacrylonitrile fibers [0018, 0021]. The electrospun polyacrylonitrile fibers correspond to the non-cellulose polymer recited in claim 50, the thermoplastic copolymer recited in claim 51, the polyacrylonitrile recited in claims 52 and 54, and the non-cellulose-based nanofiber recited in claim 53.
Regarding claim 55, Bracewell teaches non-woven nanofibers [0019].
Regarding claim 56, Bracewell teaches that the disclosed ion exchange medium comprises pores [0018]. Zhang also teaches that nanofiber felts comprise pores (page 177, 2nd column, 2nd full paragraph).
Regarding claim 58 and 59, Bracewell discloses that the nanofibers have a diameter of from 300 nm to 400 nm [0023, 0054].
Regarding claim 60, Bracewell does not teach or suggest that the disclosed ion exchange medium is required to comprise a mixture of different polymer fibers. As such, modified Bracewell reasonably teaches an embodiment in which all of the fibers are formed from cellulose acetate which meets the limitation of the claim.
Claims 43 and 44 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bracewell in view of either Zhang or Margarit-Purit as applied to claims 40-42 above and further in view of Skudas, US 2013/0280788 (“Skudas”)
Regarding claim 43, as is described above, Bracewell in view of either Zhang or Margarit-Purit teaches a method of separating or purifying proteins using a nanofiber felt (i.e., biological molecules) which meets all the limitations of claim 40.
Modified Bracewell is silent regarding the method comprising a step of flowing a fluid through a second nanofiber felt.
Skudas discloses a method of separating biological molecules which allows for high operational velocity while maintaining high binding capacities [abstract, 0002, 0053-0057, 0083, 0084]. The method is applicable to ion exchange chromatography applications and is suitable for separating proteins [0012, 0053-0057, 0083, 0084]. The method comprises providing at least three separation units comprising the same chromatographic matrix wherein the separation units are connected so that liquid can at least flow from one separation unit to the subsequent one [0151-0165, claim 1 – step a]. The method further comprises feeding a sample on a first separation unit which is in fluid connection with a second separation unit such that the target molecules not bound to the first separation unit can bind the second separation unit [0151-0165, claim 1 – step b].
Modified Bracewell and Skudas are directed towards the method for separating proteins using ion exchange media. In light of the teachings of Skudas, it would have been obvious to one of ordinary skill in the art at the time the instant invention was effectively filed to have modified the method taught by modified Bracewell by providing at least three separation units comprising the disclosed nanofiber felt ion exchange medium wherein the separation units are connected so that liquid can at least flow from one separation unit to the subsequent one and then feeding a sample to a first separation unit which is in fluid connection with a second separation unit such that the target molecules not bound to the first separation unit can bind the second separation unit with the expectation providing a means of separating biological molecules with high operational velocity while maintaining high binding capacities. The resulting method would have comprised a step in which a sample carrying fluid is flowed through a first nanofiber felt containing separation unit to a second nanofiber felt containing separation unit. As such, the resulting method would have met the limitations of claim 43.
Regarding claim 44, Skudas further teaches collecting (i.e., recovering) a fluid which pass through the separation units in a collecting tank [0153-0159].
Conclusion
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/LEE E SANDERSON/Patent Reexamination Specialist, Art Unit 3991
Conferees:
/Kevin S Orwig/Patent Reexamination Specialist, Art Unit 3991
