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 .
Response to Amendment
The amendment filed on 08/31/26 has been entered in the case. Claims 1-8 are pending for examination and claims 9-20 are withdrawn.
Drawings
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 limitation “first area being comprised of a more rigid elastic material and the second area being comprised of a less rigid elastic material” of claim 1; the limitation “a rate-controlling porous or non-porous membrane disposed in the reservoir” in claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Note: Applicant is requested to show that which areas are being designated for “first area” and “second area”.
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 lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim 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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pauley et al. (US 6,060,640).
Regarding claim 1, Pauley discloses a device for delivering one or more therapeutic agents subcutaneously to a mammal in need thereof, the device comprising:
A port 15 for receiving one or more the therapeutic agents that is to be delivered to a mammal subcutaneously, the port 15 having a stem 15, see Figs. 2A-3A;
A reservoir 12 in fluid communication with the stem 15 and comprised of at least two areas (regions 18, 20, 22), the first area 22 being comprised a more rigid elastic material (e.g., materials listed in col. 8, lines 47-59) and the second area 20 being comprised of a less rigid elastic material (e.g., materials listed in col. 7, lines 29-38.
Note: The first area 22 comprises EVOH (Ethylene Vinyl Alcohol) and Cellulose Acetate, ceramic, while the second area 20 comprises PTFE. In fact, EVOH (Ethylene Vinyl Alcohol) and Cellulose Acetate, ceramic is more rigid and structurally stiff than PTFE, while PTFE acts as a softer, more pliable, and waxy material that easily deforms under load.
In addition, the first area 22 is made of a different material than the second area 20. These two different materials provide different levels of rigidity and elasticity. Consequently, either the first area 20 or the second area 22 comprises a more rigid or elastic material relative to the other.
The reservoir being capable of being inserted subcutaneously into a mammal in need of the one or more therapeutic agents and filled or refilled (via syringe and tube 17) to contain the therapeutic agents that are to be delivered to the mammal subcutaneously while at least the reservoir 12 of the device is inserted subcutaneously in the mammal in need of one or more therapeutic agents; and
A rate-controlling porous 18 disposed in the reservoir that allows the one or more therapeutic agents to be delivered to the mammal at a controlled rate. Note: the layer 18 is a permeable material and has plurality of pores to allow the therapeutic agents releasing slowly in a desired or at a controlled rate.
wherein at least the reservoir portion of the device is capable of being inserted subcutaneously into the body of the mammal in need of one or more therapeutic agents and the one or more therapeutic agents can be removed from the reservoir of the device or filled or refilled into the reservoir of the device (via a syringe and tube 17) without the device being removed from the body of the mammal in need of the one or more therapeutic agents, col. 5, lines 25-32.
Note: the first area, second area, and rate-controlling porous layers can be swapped label. For example: the first area can be named as element 18, the second area can be named as element 20, and the rate-controlling porous can be named as element 22, and so on...
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.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Pauley et al. (US 6,060,640) in view of Jamiolkowski et al. (US 2005/0113938).
Regarding claim 2, Pauley discloses all the claimed subject matter as required in the claimed invention except for the limitation that a reinforcement or composite membrane located between the more rigid elastic material and the less rigid elastic material of the reservoir.
Jamiolkowski discloses a biocompatible tissue implant comprising: a porous membrane; a reinforcement 14 is located in between the porous membrane to provide the rigidity and strength in the porous membrane.
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 device of Jamiolkowski with providing a reinforcement layer being inserted into the porous membrane, as taught by Jamiolkowski, in order to provide the rigidity and strength in the porous membrane.
Note: The reinforcement 14 (as modified by Jamiolkowski) can be located anywhere between the porous membranes 18, 20, and 22 in Pauley's device 10’, which is considered a rearrangement of parts. Therefore, the reinforcement 14 is located between the more rigid and less rigid elastic materials of the reservoir.
Regarding claim 3, Pauley in view of Jamiolkowski discloses all the claimed subject matter as required in the claimed invention. Pauley in view of Jamiolkowski discloses that wherein the reinforcement 14 or composite membrane is cladded on both sides of the reinforcement or composite membrane with the more rigid elastic material or the less rigid elastic material and the more rigid material and the less rigid material overlap at least a portion of the reinforcement or composite membrane and create a heat seal (via ultrasonic welding, col. 4, lines 40-42 in Pauley) with the reinforcement membrane in the reservoir.
Regarding claim 4, Pauley in view of Jamiolkowski discloses all the claimed subject matter as required in the claimed invention. Pauley in view of Jamiolkowski discloses that wherein the more rigid elastic material and the less rigid elastic material sufficiently overlap the reinforcement or composite membrane and create a heat sealed (via ultrasonic welding, col. 4, lines 40-42 in Pauley) joint of the more rigid elastic material, the less rigid elastic material and the reinforcement or composite membrane at least at the outer edges of the reservoir.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over D’Amour et al. (US 2019/0328934).
Regarding claim 1, D’mour discloses a device, in Figs. 1-2D, for delivering one or more therapeutic agents subcutaneously to a mammal in need thereof, the device comprising:
Note: Examiner uses Figs. 1B & 2A for mapping out the claimed invention.
a port 85 for receiving one or more therapeutic agents that is to be delivered to a mammal subcutaneously, the port having a stem 85;
a reservoir 86 is in fluid communication with the stem 85 and comprises at least two areas: a first area composed of a more rigid elastic material (such as the PTFE layers 59 and 68) and a second area composed of a less rigid elastic material (such as the film layers 60/63/64/67, which are less rigid than the non-woven PTFE or polyester material, see noted below).
Note: the claimed invention does not specify particular materials for the first and second areas. In this case, Paragraph [0097] states that the layer 59/68 is a non-woven fabric formed of PTFE or polyester material. Notably, the PTFE or polyester material is characterized as being relatively soft and flexible, yet possessing high structural rigidity. Meanwhile, the film ring 60/63/64/67 serves as a film layer or film weld. According to Paragraph [0094], this film acts as a binding or adhesive layer within the weld to help adhere and bond two or more layers together. Because it is well-known in the art to use a fused joint or a thin bonding layer to connect layers of thin polymer films, a person skilled in the art would recognize that the non-woven fabric (i.e., the PTFE or polyester material) is more rigid than the film weld. In addition, the non-woven fabric 59/68 is made of a different material than the film layer 60/63/64/67. These two different materials provide different levels of rigidity and elasticity. Consequently, one of either the non-woven fabric or the film weld layer comprises a more rigid or elastic material relative to the other. Therefore, under the broadest reasonable interpretation, the Examiner properly assumes that the non-woven PTFE layer 59/68 is more rigid than the thin film or film weld layer 60/63/64/67.
the reservoir being capable of being inserted subcutaneously into a mammal in need of the one or more therapeutic agents and filled (via stem 85) or refilled (via stem 85) to contain the therapeutic agents that are to be delivered to the mammal subcutaneously while at least the reservoir of the device is inserted subcutaneously in the mammal in need of one or more therapeutic agents; and
a rate-controlling porous or non-porous membrane 62/65 disposed in the reservoir that allows the one or more therapeutic agents to be delivered to the mammal at a controlled rate;
wherein at least the reservoir portion of the device is capable of being inserted subcutaneously into the body of the mammal in need of one or more therapeutic agents and the one or more therapeutic agents can be removed from the reservoir of the device or filled or refilled into the reservoir of the device without the device being removed from the body of the mammal in need of the one or more therapeutic agents, para [0088].
Regarding claim 2, wherein the reservoir is further comprised of a reinforcement 61 or composite membrane 61 located between the more rigid elastic material 59/68 and the less rigid elastic material 63/64 of the reservoir, see Fig. 1B.
Regarding claim 3, as seen in Fig. 1B, the reinforcement or composite membrane 61/66 is located in between the non-woven fabric-rigid material layer 59/68, and less rigid material layers 60/63/64/67. Therefore, the reinforcement or composite membrane 61 is cladded on both sides of the reinforcement or composite membrane with the more rigid elastic material or the less rigid elastic material and the more rigid material and the less rigid material overlap at least a portion of the reinforcement or composite membrane and create a heat seal (at weld) with the reinforcement membrane in the reservoir, see Figs 1B & 2A.
Regarding claim 4, wherein the more rigid elastic material and the less rigid elastic material sufficiently overlap the reinforcement or composite membrane and create a heat sealed joint (at weld area) of the more rigid elastic material, the less rigid elastic material and the reinforcement or composite membrane at least at the outer edges of the reservoir, see Fig. 2A.
Regarding claim 5, wherein at least a substantial portion of both ends (e.g. weld area is at peripheral of the reservoir, see Fig. 2A) of the reservoir are comprised of the more rigid elastic material and at least a substantial portion of the middle of the reservoir is comprised of the less rigid elastic material, see Fig. 2A.
Regarding claim 6, as seen in Fig. 2A, wherein the device does not have a sleeve covering the reservoir, the reservoir is tapered from at least the reservoir to the stem and the largest diameter of the device when the reservoir does not contain any therapeutic agents is the diameter of the port or the stem allowing for easy removal of the device from the mammal in need of one or more therapeutic agents.
Note: the device is expanded device when filled of therapeutic agent, therefore, an interior space or volume space in the device is expanded and larger in diameter in vertical direction, see Fig. 9. When the device is emptied, the device is deflated, see Fig. 2A-2D, and therefore the larges diameter (or the length of the device), at this point, the device is allowing for removal easily.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over D’Amour et al. (US 2019/0328934) in view of Joseph et al. (US 6,471,689).
Regarding claim 7, D’Amour discloses all the claimed subject matter as required in the claimed invention except for the limitation that a multi-lumen tube that is in fluid communication with at least the stem of the device.
Joseph discloses a drug delivery device comprising: a port 12 for receiving one or more therapeutic agents that is to be delivered to a mammal subcutaneously, a multi-lumen tube 34 & 36 that is in fluid communication with at least the stem 14 of the device, see Fig. 3.
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 device of D’Amour with providing a multi-lumen tube that is in fluid communication with at least the stem of the device, as taught by Joseph, in order to introduce one or more therapeutic agents in the device at the same time.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over D’Amour et al. (US 2019/0328934) in view of Kharul et al. (US 2005/0006302).
Regarding claim 8, D’Amour discloses all the claimed subject matter as required in the claimed invention. D’Amour discloses the rate-controlling membrane has porous but does not disclose the limitation that the device further comprises one or more chemical stabilizers or plasticizers to keep the pores of the rate-controlling membrane open.
Kharul discloses a pours membrane includes one or more chemical stabilizers or plasticizers (e.g., glycerol, water, poly vinyl pyrolidone, polyethylene glycol, and polyethylene oxide, see claim 10 in Kharul).
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 device of D’Amour with providing one or more chemical stabilizers or plasticizers, as taught by Kharul, in order to provide viscosity in the pores, having excellent combination of high-water fluid and solute rejection and also to keep the pores of rate-controlling membrane open.
Response to Arguments
Applicant's arguments filed 08/31/26 have been fully considered but they are not persuasive.
1) Applicant argues that no teaching of “first area being comprised of a more rigid elastic material and the second area being comprised of a less rigid elastic material.
In response, the claimed invention does not specify particular materials for the first and second areas. In this case, Paragraph [0097] states that the layer 59/68 is a non-woven fabric formed of PTFE or polyester material. Notably, the PTFE or polyester material is characterized as being relatively soft and flexible, yet possessing high structural rigidity. Meanwhile, the film ring 60/63/64/67 serves as a film layer or film weld. According to Paragraph [0094], this film acts as a binding or adhesive layer within the weld to help adhere and bond two or more layers together. Because it is well-known in the art to use a fused joint or a thin bonding layer to connect layers of thin polymer films, a person skilled in the art would recognize that the non-woven fabric (i.e., the PTFE or polyester material) is more rigid than the film weld. In addition, the non-woven fabric 59/68 is made of a different material than the film layer 60/63/64/67. These two different materials provide different levels of rigidity and elasticity. Consequently, one of either the non-woven fabric or the film weld layer comprises a more rigid or elastic material relative to the other. Therefore, under the broadest reasonable interpretation, the Examiner properly assumes that the non-woven PTFE layer 59/68 is more rigid than the thin film or film weld layer 60/63/64/67.
2) Applicant argues that no teaching of “rate-controlling porous or non-porous membrane disposed in the reservoir that allows the one or more therapeutic agents to be delivered to the mammal at a controlled rate.
In response, the cell-excluding membrane 62/65 is perforated, para [0118] and Figs. 1B & 2A-B. As seen in Fig. 1B, the porous membrane 62/65 (or rate-controlling porous) disposed in the reservoir and allows the one or more therapeutic agent to be delivered the drug (via the porous or perforations) at aa desired rate (or control rate).
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above 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 that, in preparing responses, the applicant 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
