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 .
Drawings
The drawings are objected to as failing to adequately use solid black lines. 37 CFR 1.84(a)(1) requires black ink to secure solid black lines and 37 CFR 1.84(l) states that every line must be durable, clean, black, sufficiently dense and dark, and uniformly thick and well-defined.
The drawings are objected to as failing to properly use shading to aid in understanding the
invention. 37 CFR 1.84(m) encourages the use of shading to indicate certain shapes or to show parts in perspective views. However, in the instant case, such as in at least Figs. 7-8 and to a lessor extent in Figs. 2-4, the shading appears unnecessary and detracts from aiding in understanding the invention.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the complementary surfaces of the membrane and piston in claim 6 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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 6 and 41 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 6 recites the surface profile of the membrane is complementary to an inner surface profile of the piston. It is unclear how these two surfaces are “complementary.” It is unclear if such a limitation is defining a type of surface structure or some other type of characteristic. Typical dictionary definitions include making up what is lacking or enhancing strengths, but it is unclear how surface profiles can be complementary in that sense. For examination purposes, if the surfaces of the membrane and piston in the prior art are capable of contacting one another, they will be considered “complementary” given the broadest reasonable interpretation.
Claim 41 recites the piston having a fluid cavity and defining a reservoir. It is unclear if the fluid cavity and the reservoir refer to the same element or separate elements. For examination purposes, both will be considered the same element.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 6, 9-11, 13, 14, 41, and 44-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 2013/0274659 to Imran et al. (“Imran”).
Regarding claim 1, Imran teaches a delivery assembly (Fig. 12A/B) for an ingestible device capable of delivering a fluid preparation ([0066]) into a GI lumen wall or surrounding tissue thereof of a subject, the delivery assembly comprising a housing (260) defining a chamber (chamber of 260), a piston (252/253) movably disposed in the chamber, a needle (40) coupled to the piston, and a membrane (235) coupled to the piston such that the membrane and the piston cooperatively define a reservoir (251) capable of containing the fluid preparation.
Regarding claim 6, Imran teaches the delivery assembly of claim 1 as shown above, Imran further teaching the membrane (235) has a surface profile that is complementary to an inner surface profile of the piston which defines the reservoir (235 is complementary to 250).
Regarding claim 9, Imran teaches the delivery assembly of claim 1 as shown above, Imran further teaching the housing (260) is structured to be coupled to, and disposed in, an expandable member (20).
Regarding claim 10, Imran teaches the delivery assembly of claim 1 as shown above, Imran further teaching the piston is structured to move relative to the housing in response to a pressure applied against the membrane to advance the needle into the GI lumen wall (pressure is applied to the membrane and the piston to move the needle when 810 and 811 mix).
Regarding claim 11, Imran teaches the delivery assembly of claim 1 as shown above, Imran further teaching the membrane comprises a flexible material to allow for deformation of the membrane by a pressure applied against an outer surface of the membrane to expel the fluid preparation from the reservoir into the needle (pressure is applied to the outer surface of 235).
Regarding claim 13, Imran teaches the delivery assembly of claim 1 as shown above, Imran further teaching a fluid preparation ([0066]) disposed in the reservoir, wherein the fluid preparation comprises at least one therapeutic agent ([0099]).
Regarding claim 14, Imran teaches the delivery assembly of claim 13 as shown above, Imran further teaching the at least one therapeutic agent is one or more selected from an immunosuppressive drug, a chemotherapy drug, a central nervous system (CNS) drug, an antidiabetic drug, an enzyme replacement therapy (ERT) drug, an antibody, a hormone, insulin, an incretin or a combination thereof, or an oligonucleotide ([0128]).
Regarding claim 41, Imran teaches a delivery assembly (Figs. 12A/B) for an ingestible device for delivering a fluid preparation ([0066]) into a GI lumen wall or surrounding tissue thereof of a subject, the delivery assembly comprising a housing (260) defining a chamber (chamber of 260), a piston (250/252/253) movably disposed in the chamber, the piston comprising a needle cavity (left portion of 250, Fig. 12A) and a fluid cavity (251), a needle (40) coupled to the piston at the needle cavity, a membrane (235) coupled to the piston at the fluid cavity such that the membrane and the piston cooperatively define a reservoir (251) in the fluid cavity for containing the fluid preparation, and a fluid preparation ([0066]) disposed in the reservoir, the fluid preparation comprising at least one therapeutic agent ([0099]).
Regarding claim 44, Imran the delivery assembly of claim 41 as shown above, Imran further teaching the piston is structured to move relative to the housing in response to a pressure applied against the membrane to advance the needle into the GI lumen wall (pressure is applied to the membrane and the piston to move the needle when 810 and 811 mix).
Regarding claim 45, Imran teaches the delivery assembly of claim 41 as shown above, Imran further teaching the membrane comprises a flexible material to allow for deformation of the membrane by a pressure applied against an outer surface of the membrane to expel the fluid preparation from the reservoir into the needle (pressure is applied to the outer surface of 235).
Regarding claim 46, Imran teaches the delivery assembly of claim 41 as shown above, Imran further teaching the at least one therapeutic agent is one or more selected from an immunosuppressive drug, a chemotherapy drug, a central nervous system (CNS) drug, an antidiabetic drug, an enzyme replacement therapy (ERT) drug, an antibody, a hormone, insulin, an incretin or a combination thereof, or an oligonucleotide ([0128]).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No 2004/0253304 to Gross et al. (“Gross”).
Regarding claim 1, Gross teaches a delivery assembly (Figs. 29A-29B) for an ingestible device for delivering a fluid preparation into a GI lumen wall or surrounding tissue thereof of a subject, the delivery assembly comprising a housing (102) defining a chamber (chamber of 102), a piston (220) movably disposed in the chamber, a needle (Fig. 29B) coupled to the piston, and a membrane (122) coupled to the piston such that the membrane and the piston cooperatively define a reservoir (106) for containing the fluid preparation.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 2009/0043278 to Tanaka et al. (“Tanaka”).
Regarding claim 1, Tanaka teaches a delivery assembly (Figs. 9-10) for an ingestible device capable of delivering a fluid preparation into a GI lumen wall or surrounding tissue thereof of a subject, the delivery assembly comprising a housing (2) defining a chamber (chamber of 2), a piston (12d) movably disposed in the chamber, a needle (41) coupled to the piston (operatively coupled, 12d causes the needle to move), and a membrane (4) coupled to the piston such that the membrane and the piston cooperatively define a reservoir (3) for containing the fluid preparation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of U.S. Patent Publication No. 2013/0226143 to Davies et al. (“Davies”).
Regarding claim 2, Imran teaches the delivery assembly of claim 1 as shown above, but does not teach the needle cavity.
Davies teaches a piston (401, Figs. 4A-4B) defining a needle cavity (Fig. 4B), and wherein a needle (204) is slidably coupled to the piston in the needle cavity (Fig. 4B). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the piston and reservoir configuration of Imran with the configuration of Davies to yield the predictable result of providing fluid for delivery. Both Imran and Davies represent piston-based drug delivery systems, Davies merely showing an alternative piston configuration to accomplish the same result.
Regarding claim 3, Imran and Davies teach the delivery assembly of claim 2 as shown above, Davies further teaching a seal (seal within 401, Fig. 4A) coupled to the piston between the needle cavity and the reservoir to define a substantially fluid-tight seal therebetween.
Regarding claim 4, Imran and Davies teach the delivery assembly of claim 3 as shown above, Imran further teaching the needle including a first end (40) structured to penetrate the GI lumen wall, but does not teach the details of the second end.
Davies teaches a delivery assembly including a needle (Figs. 4A/B) having a first end (bottom of 204) and a second end (204) structured to pierce a seal (seal within 401). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the needle and seal configuration of Imran with the configuration of Davies to yield the predictable result of delivering a fluid preparation. Both Imran and Davies convey fluid using a needle and a membrane-based reservoir, Davies merely showing an alternative configuration to perform the same function. Once combined, the seal would be capable of being pierced in response to a resistance applied to the needle from the GI lumen wall, since rearward movement is necessary to pierce the seal.
Claims 5 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of U.S. Patent Publication No. 2020/0206132 to Imran et al. (“Imran2”).
Regarding claim 5, Imran teaches the delivery assembly of claim 1 as shown above, including the needle (40) being structured to penetrate through the GI lumen wall but does not mention the peritoneal cavity.
Imran2 teaching penetrating into a peritoneum or peritoneal cavity of the subject for discharging the fluid preparation therein ([0006]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have structured the needle of Imran to penetrate into the peritoneal cavity as taught by Imran2 to yield the predictable result of treating various diseases ([0098]).
Regarding claim 42, Imran teaches the delivery assembly of claim 41 as shown above, including the needle (40) being structured to penetrate through the GI lumen wall but does not mention the peritoneal cavity.
Imran2 teaching penetrating into a peritoneum or peritoneal cavity of the subject for discharging the fluid preparation therein ([0006]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have structured the needle of Imran to penetrate into the peritoneal cavity as taught by Imran2 to yield the predictable result of treating various diseases ([0098]).
Claims 7, 8, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of U.S. Patent Publication No. 2012/0038872 to Shimizu et al. (“Shimizu”).
Regarding claim 7, Imran teaches the delivery assembly of claim 1 as shown above, but does not teach the volume.
Shimizu teaches a reservoir defining a volume for containing up to about 250 µl of fluid ([0028]) in an ingestible device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Imran to convey 250 µl of fluid as taught by Shimizu to yield the predictable result of conveying a therapeutic volume of fluid to suit the particular needs of the patient as would be understood by medical practitioner.
Regarding claim 8, Imran teaches the delivery assembly of claim 1 as shown above, but does not teach the volume.
Shimizu teaches a reservoir defining a volume for containing about 50 µl to about 200 µl of fluid ([0028]) in an ingestible device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Imran to convey about 50 µl to about 200 µl of fluid as taught by Shimizu to yield the predictable result of conveying a therapeutic volume of fluid to suit the particular needs of the patient as would be understood by medical practitioner.
Regarding claim 43, Imran teaches the delivery assembly of claim 41 as shown above, but does not teach the volume.
Shimizu teaches a reservoir defining a volume for containing about 50 µl to about 200 µl of fluid ([0028]) in an ingestible device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Imran to convey about 50 µl to about 200 µl of fluid as taught by Shimizu to yield the predictable result of conveying a therapeutic volume of fluid to suit the particular needs of the patient as would be understood by medical practitioner.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of U.S. Patent Publication No. 2022/0039686 to Arrick et al. (“Arrick”).
Regarding claim 12, Imran teaches the delivery assembly of claim 1 as shown above, but does not teach the fill port.
Arrick teaches a piston (513, Fig. 6B) including a fill port (514) for filling the reservoir (510) with the fluid preparation ([0071]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the piston of Imran to include a fill port as taught by Arrick to yield the predictable result of allowing the reservoir to be refilled for prolonged use and convenience to the user as is known in the art.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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