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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. FR2107086, filed on 06/30/2021.
Election/Restrictions
Applicant's election with traverse of groups A-B in the reply filed on 07/02/2026 is acknowledged. The traversal is on the ground(s) that restriction was improper. The restriction requirement has been withdrawn, and all claims have been examined, details below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-22, and 25-26 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In claim 1, applicant claims "a first cavity set comprising at least one cavity (Fig 8, 20) comprising pancreatic cells." Examiner suggests the following edit: “one cavity configured to accommodate pancreatic cells”
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.
Regarding claim 9, the phrase "preferably " renders the claim indefinite (relative term) because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-9, 12, 15, 17-19, and 23-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flanagan et al US 20180263238 A1, herein referred to as Flanagan.
Regarding claim 1, Flanagan discloses a matrix for receiving pancreatic cells (Flanagan teaches using matrix in conjunction with pancreas islets [0081]) comprising:
a semi-permeable wall at least partly defining an inner volume (the space inside), a porous body (Fig 22 ,14 and 16 [0130) disposed of in the inner volume Fig 22, comprising:
comprising:
• a first cavity set comprising at least one cavity (Fig 8, 20) comprising pancreatic cells ([0081] and [0091]),
• a second cavity set comprising at least one cavity devoid of pancreatic cells (Fig 8, 80; [0091] does not teach inserting cells in reservoir),
• the porous body comprising walls defining the first cavity set and the second cavity set not being fluidly connected to one another other than by a diffusion (limitation directed toward intended use) of a liquid through the walls of the porous body (Fig 8, seams shown).
Regarding claim 2, Flanagan discloses wherein the first set and/or the second set comprises several cavities (Fig 8).
Regarding claim 3, wherein for each two consecutive cavities of the first set taken according to a first direction, a cavity of the second set is disposed between the two consecutive cavities of the first set (Annotated Fig 4 below).
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Regarding claim 4, Flanagan discloses wherein for each two consecutive cavities of the first set taken according to a second direction, a cavity of the second set is disposed between the two consecutive cavities of the first set (Annotated Fig 4 above).
Regarding claim 5, Flanagan discloses wherein a distance between at least one cavity of the second set and at least one directly neighboring cavity of the first set taken from the center of the cavity of the first set to the center of the at least one cavity of the second set is between 0.5mm and 3cm (Fig 8; [0023]; teaches “16-1900 micron” which is the same as 0.016 mm to 1.9 mm; While Flanagan does not teach the specific range, the claimed ranges are with the ranges taught by Flanagan.).
Regarding claim 7, Flanagan discloses, wherein the second set comprises a plurality of interconnected cavities (Fig 8).
Regarding claim 8, Flanagan discloses wherein each cavity of the first set has a transverse cross-section having a smallest dimension substantially greater than the size of the pancreatic cells or of the islets of pancreatic cells (pancreatic islets are known to be 50-500 um in diameter; Flanagan teaches 600 um dimension [0081]).
Regarding claim 9, Flanagan discloses wherein the cavities of the first and of the second set extend according to a direction of principal extension in a manner parallel to each other (Fig 8), over a length substantially greater than or equal to 70%, of the length of the porous body (Fig 22, extends over the entire porous body (14/16).
Regarding claim 12, Flanagan discloses wherein an artificial pancreas device intended to be implanted in the human or animal body and comprising the matrix for receiving pancreatic cells according to claim 1 (intended use; [0081]; fully capable).
Regarding claim 15, Flanagan discloses wherein the fluidic module is fluidly connected to the second cavity set ([0008] and [0006]; Fig 1, 22).
Regarding claim 17, Flanagan discloses wherein the tank comprises at least one out of a nutrient for the pancreatic cells ([0003]) and an anti-inflammatory compound ([0090]).
Regarding claim 18, Flanagan discloses wherein the fluidic module comprises a pump configured to induce a flow of liquid from a liquid outside of the device to inside the cavities of the second set (([0008] and [006] and [0110]).
Regarding claim 19, Flanagan discloses wherein the fluidic module comprises a regulator ([0013] teaches a one-way valve in system) configured to regulate at least one parameter of the formation of the flow by the fluidic module ([0013]).
Regarding claim 23, Flanagan discloses a method for seeding ([0019]) the matrix for receiving pancreatic cells ([0081]), the method comprising:
Providing a matrix capable of forming the reception matrix according to claim 1,
the matrix comprising at least the porous body comprising:
a first cavity set intended to comprise pancreatic cells (Fig 8, 20),
a second cavity set devoid of pancreatic cells (Fig 8, 80; [0091] does not teach inserting cells in reservoir),
the porous body comprising walls defining the first cavity set and the second cavity set (Fig 8), the first cavity set and the second cavity set not being fluidly connected to one another other than by a diffusion of a liquid through the walls and inside of the porous body (limitation directed toward intended use), and
seeding of first cavity set of the matrix with pancreatic cells [0081].
Regarding claim 24, Flanagan discloses a method for delivering insulin ([0003]) comprising the implantation of the artificial pancreas device according to claim 12 ([0084], acts at least in part as an artificial pancreas device), in a human or animal body ([0077]; teaches implantation into a patient).
Regarding claim 25, Flanagan discloses wherein the porous body is monolithic (Fig 8).
Regarding claim 26, Flanagan discloses wherein the semi-permeable wall has a cutoff threshold configured preventing vascularization of the porous body [0071].
Claim(s) 1 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fournier et al. US 5425764 A, herein referred to as Fournier.
Regarding claim 1, Fournier discloses a matrix ([0010]) for receiving pancreatic cells (teaches using matrix in conjunction with pancreas islets [0009-0011]) comprising:
a semi-permeable wall (25) at least partly defining an inner volume ([0010]), a porous body (body formed by the bounds of 25) disposed of in the inner volume (inner component of 25), comprising:
comprising:
• a first cavity set comprising at least one cavity (Figs 3 or 4, cavity between 5 and 20) comprising pancreatic cells ([0010]),
• a second cavity set comprising at least one cavity devoid of pancreatic cells (Figs 3 or 4, 10; [0008]),
• the porous body (Figs 1-4, device 1) comprising walls defining the first cavity set and the second cavity set not being fluidly connected to one another other than by a diffusion (limitation directed toward intended use) of a liquid through the walls of the porous body ([0010-0011]).
Regarding claim 12, Fournier discloses wherein an artificial pancreas device intended to be implanted in the human or animal body and comprising the matrix for receiving pancreatic cells according to claim 1 (intended use; [0021] teaches being used with pancreatic cells).
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.
Claim(s) 6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flanagan.
Regarding claim 6, Flanagan, as discussed in claim 1 above, does not explicitly disclose wherein the first set comprises a plurality of cavities interconnected and fluidly connected to an injection channel.
However, in another embodiment, Flanagan teaches wherein the first set comprises a plurality of cavities interconnected and fluidly connected to an injection channel ([0008] and [006]; Fig 1, 22).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the matrix of Flanagan to incorporate wherein the first set comprises a plurality of cavities interconnected and fluidly connected to an injection channel, as taught and suggested by Flanagan in order inflate the matrix and change its configuration as needed (Flanagan [0038]).
Regarding claim 13, Flanagan, as discussed in claim 12 above, does not explicitly disclose further comprising a fluidic module configured to create a flow of liquid around and/or inside the matrix.
In another embodiment, Flanagan also teaches comprising a fluidic module (Fig 1, 22) configured to create a flow of liquid around and/or inside the matrix ([0008] and [006]; Fig 1, 22; incorporating the fluidic module of Fig 1 would allow the mapped portions of Flanagan from Figs 8 and 22 to change positions as need by pushing fluid around the matrix as claimed).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the matrix of Flanagan further comprising a fluidic module configured to create a flow of liquid around and/or inside the matrix, as taught and suggested by Flanagan in order manipulate the matrix’s position as needed (Flanagan [0038]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flanagan in view of Green et al US 20140014226 A1, herein referred to as Green.
Regarding claim 16, Flanagan discloses wherein the fluidic module comprises a pump (Fig 10, 128; [0110]). Flanagan does not disclose wherein the fluidic module comprises a tank and [a] pump being configured to induce a flow of liquid from the tank to inside the cavities of the second set.
However, Green discloses a similar loading system. Green teaches wherein the fluidic module comprises a tank (40) and [a] pump (Fig 7, 30) being configured to induce a flow of liquid from the tank to inside the cavities of the second set (Fig 16, 80; [0088]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify fluidic system of Flanagan disclose wherein the fluidic module comprises a tank and [a] pump being configured to induce a flow of liquid from the tank to inside the cavities of the second set, as taught and suggested by Flanagan in order manipulate the matrix’s position as needed (Flanagan [0038]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flanagan in view of Manesis US 20210301098 A1, and in further view of Hermsen US 20220257382 A1, herein referred to as Hermsen.
Regarding claim 10, Flanagan does not disclose wherein the porous body is chosen from the group consisting of chitosan, polyacrylamide, aramid nanofibers, polyvinyl alcohol.
However, in the same field of endeavor, Manesis discloses a matrix ([0031]) to be used with cells ([0003]), comprising a porous body (Fig 2). Manesis teaches wherein the porous body is made from chitosan, polyacrylamide, poly(p-phenyl-p-phthalimide), aramid nanofibers, polyvinyl alcohol ([0088], [0140]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Flanagan to incorporate wherein the porous body is made from chitosan, polyacrylamide, poly(p-phenyl-p-phthalimide), aramid nanofibers, polyvinyl alcohol, as taught and suggested by Manesis in order allow semi-open structures (Manesis [0140]).
Yet, Flanagan as modified by Manesis does not disclose wherein the porous body is made of poly (p-phenyl-p-phthalimide).
However, in the same field of invention, Hermsen teaches wherein a porous body (Fig 1, 4) is made of poly(p-phenyl-p-phthalimide) ([0027]; synthesizing as described could yield of poly(p-phenyl-p-phthalimide).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Flanagan as modified by Manesis to incorporate wherein the porous body is made from poly(p-phenyl-p-phthalimide), as taught and suggested by Hermsen in order allow synthesis of the material to be done with advantageous molar masses (Hermsen [0027]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flanagan in view of Manesis and Hermsen, and further in view of Beres et al. US 20200155725 A1, herein referred to as Beres.
Regarding claim 11, Flanagan as modified by Manesis and Hermsen discloses wherein the wall has a cutoff threshold substantially between 5.8kDa and 8kDa ([0127]).
However, Beres teaches discloses wherein the wall has a cutoff threshold substantially between 5.8kDa and 8kDa (While Beres does not teach the specific range, the claimed ranges are with the ranges taught by Beres [0127]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Flanagan as modified by Manesis and Hermsen to incorporate wherein the wall has a cutoff threshold substantially between 5.8kDa and 8k, as taught and suggested by Hermsen in compensate for mass loss over the time the implant is in place (Beres [0027] and [0362]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flanagan in view of Manesis.
Regarding claim 14, Flanagan does not disclose wherein the fluidic module comprises a coating of the matrix, made from an electroactive polymer, the coating being capable of deforming the matrix.
However, Manesis teaches wherein the fluidic module comprises a coating ([0140]) of the matrix, made from an electroactive polymer ([0140]), the coating being capable of deforming the matrix ([0169]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Flanagan to incorporate wherein the fluidic module comprises a coating of the matrix, made from an electroactive polymer, the coating being capable of deforming the matrix, as taught and suggested by Manesis to allow the matrix to form to a wound site (Manesis [0169]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flanagan in view Uhland et al. US 9014799 B2, herein referred to as Uhland.
Regarding claim 20, Flanagan but does not disclose further comprising at least one anode and at least one cathode, a source of electric energy, the anode and the cathode being electrically connected to the source of electric energy, so that in the presence of bodily fluid, a closed electric circuit is formed so as to produce dihydrogen at the cathode and dioxygen at the anode, by electrolysis of the bodily fluid, at least one out of the cathode and the anode being disposed in the inner volume at least partly defined by the wall of the matrix.
Uhland discloses an implant matrix (Col 5, lines 60- Col 6, lines 8). Uhland teaches further comprising at least one anode (Fig 9, 26) and at least one cathode (26),
the anode and the cathode being electrically connected to the source of electric energy (Fig 9, 40; Col 4, lines 26-34), so that in the presence of bodily fluid, a closed electric circuit is formed so as to produce dihydrogen at the cathode and dioxygen at the anode (intended use), by electrolysis of the bodily fluid (intended use), at least one out of the cathode and the anode being disposed in the inner volume at least partly defined by the wall of the matrix (Col 7, 13 – Col 8, lines 2; Col 5, lines 60- Col 6, lines 8 and Col 4, lines 26-34; Teaches using swelling material as housing to allow permeability to bodily fluid from surrounding mucosal tissue in which the device is implanted).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the implantable matrix Flanagan to incorporate at least one anode and at least one cathode, a source of electric energy, the anode and the cathode being electrically connected to the source of electric energy, so that in the presence of bodily fluid, a closed electric circuit is formed so as to produce dihydrogen at the cathode and dioxygen at the anode, by electrolysis of the bodily fluid, at least one out of the cathode and the anode being disposed in the inner volume at least partly defined by the wall of the matrix, as taught and suggested by Uhland to alter cell permeability as need in area around the implant (Uhland Col 7, lines 43-59), as shown to be a challenge in the matrix of Flanagan ([0082])
Claim(s) 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fournier in view Uhland.
Regarding claim 20, Fournier but does not disclose further comprising at least one anode and at least one cathode, a source of electric energy, the anode and the cathode being electrically connected to the source of electric energy, so that in the presence of bodily fluid, a closed electric circuit is formed so as to produce dihydrogen at the cathode and dioxygen at the anode, by electrolysis of the bodily fluid, at least one out of the cathode and the anode being disposed in the inner volume at least partly defined by the wall of the matrix.
Uhland discloses an implant matrix (Col 5, lines 60- Col 6, lines 8). Uhland teaches further comprising at least one anode (Fig 9, 26) and at least one cathode (26),
the anode and the cathode being electrically connected to the source of electric energy (Fig 9, 40; Col 4, lines 26-34), so that in the presence of bodily fluid, a closed electric circuit is formed so as to produce dihydrogen at the cathode and dioxygen at the anode (intended use), by electrolysis of the bodily fluid (intended use), at least one out of the cathode and the anode being disposed in the inner volume at least partly defined by the wall of the matrix (Col 7, 13 – Col 8, lines 2; Col 5, lines 60- Col 6, lines 8 and Col 4, lines 26-34; Teaches using swelling material as housing to allow permeability to bodily fluid from surrounding mucosal tissue in which the device is implanted).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the implantable matrix of Fournier by embedding the electrodes and power source of Uhland in the cell chambers (Figs 3-4, the chamber defined by 20) to incorporate at least one anode and at least one cathode, a source of electric energy, the anode and the cathode being electrically connected to the source of electric energy, so that in the presence of bodily fluid, a closed electric circuit is formed so as to produce dihydrogen at the cathode and dioxygen at the anode, by electrolysis of the bodily fluid, at least one out of the cathode and the anode being disposed in the inner volume at least partly defined by the wall of the matrix, as taught and suggested by Uhland to alter cell permeability as need in area around the implant (Uhland Col 7, lines 43-59), as shown to be a challenge in the matrix of Flanagan ([0082])
Regarding claim 21, the combination as made of Fournier and Uhland in claim 20, teaches wherein at least one out of the cathode and the anode disposed in the porous body of the matrix (the combination as shown in 20 would have exposed the cathodes and anodes as claimed to the porous body matrix).
Regarding claim 22, the combination as made of Fournier and Uhland in claim 20, wherein at least one out of the cathode and the anode is disposed on the porous body of the matrix (the combination as shown in 20 would have exposed the cathodes and anodes as claimed to the porous body matrix, when the electrodes are embedded in 20 of Fournier, shown in Fig 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./Patent Examiner, Art Unit 3774
Matthew DeSanto
/MATTHEW F DESANTO/Primary Examiner, Art Unit 3700
Prosecution Insights