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 .
Claims 2-17 are cancelled.
Claims 18-33 are new.
Claims 1 and 18-33 are being examined in this Office Action.
Specification
The disclosure is objected to because of the following informalities.
Page 4 Line 21 “oesophagus” is believed to say esophagus.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 18, 19, 26, 28-31 and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hashim et al. (Pub. No. US 20200289620 A1, herein Hashim).
Regarding Claim 1, Hashim discloses a drug delivery device (Figs. 20a-h) comprising:
a first body part (all components between 160 and 130 in Fig. 20d);
an attachment part (first right side of multiple delivery assemblies 178) attached to the first body part (Fig. 20d);
a second body part (capsule 120p’’, Figs. 20a-b);
an aperture (163) in the first body part and/or the second body part (Fig. 20b);
an actuator mechanism (160) configured to store energy and convert the stored energy to kinetic energy via movement of the first body part or the second body part (“the inflated size (e.g., diameter) of one or more of balloons 130, 160 and 172, can be larger than capsule 120 so as to cause the capsule to come apart from the force of inflation, (e.g., due to hoop stress).” – Paragraph [0177]); and
a locking system (120 and 150) configured to prevent the actuator mechanism from converting the stored energy to the kinetic energy, the locking system comprising:
a locking member (150, Fig. 20b) configured to be releasably retained in the aperture and prevent movement of the first body part with respect to the second body part (“Tube 163 will typically include a degradable separation valve or other separation means 150 which separates the contents of balloon 130, (e.g., water 158) from those of balloon 160 (e.g., reactants 165) until the valve degrades.” – Paragraph [0183], valve preventing balloon from inflating and causing first body part to move relative to the second body part); and
a biodegradable cover (120, Fig. 20a) configured to prevent translation of the locking member out of the aperture (“The capsule can be fabricated from various biodegradable gelatin materials known in the pharmaceutical arts, but can also include various enteric coatings 120c, configured to protect the cap from degradation in the stomach (due to acids etc.), and then subsequently degrade in the in higher pH's found in the small intestine or other area of the intestinal tract.” – Paragraph [0171], capsule preventing valve from degrading until in appropriate location).
Regarding Claim 18, Hashim discloses the drug delivery device of claim 1 wherein converting the stored energy to the kinetic energy is configured to translate the locking member out of the aperture (“Tube 163 will typically include a degradable separation valve or other separation means 150 which separates the contents of balloon 130, (e.g., water 158) from those of balloon 160 (e.g., reactants 165) until the valve degrades.” – Paragraph [0183], as valve 150 degrades, it translates out of tube 163 to allow fluid to enter to expand balloon).
Regarding Claim 19, Hashim discloses the drug delivery device of claim 1, wherein upon weakening of the biodegradable cover (Fig. 20b), the actuator mechanism is configured to convert the energy to the kinetic energy and translate the locking member out of the aperture (valve 150 degrades from tube 163 allowing fluid to enter tubing to expand balloons, Paragraph [0183]).
Regarding Claim 26, Hashim discloses the drug delivery device of claim 1, wherein the biodegradable cover surrounds an entirety of the drug delivery device (Fig. 20a).
Regarding Claim 28, Hashim discloses the drug delivery device of claim 1, wherein the biodegradable cover comprises a first section (120p’) in connection with a second section (120p’’, Fig. 20a, Paragraph [0171]).
Regarding Claim 29, Hashim discloses the drug delivery device of claim 1, wherein an entirety of the biodegradable cover is biodegradable (“The capsule can be fabricated from various biodegradable gelatin materials known in the pharmaceutical arts, but can also include various enteric coatings 120c, configured to protect the cap from degradation in the stomach (due to acids etc.), and then subsequently degrade in the in higher pH's found in the small intestine or other area of the intestinal tract.” – Paragraph [0171]).
Regarding Claim 30, Hashim discloses the drug delivery device of claim 1, wherein the biodegradable cover comprises a biodegradable section (“the capsule 120 can be formed from multiple portions one or more of which may be biodegradable. In many embodiments, capsule 120 can be formed from two portions 120p such as a body portion 120p″ (herein body 120p″) and a cap portion 120p′ (herein cap 120p), where the cap fits onto the body, e.g., by sliding over or under the body (with other arrangements also contemplated).” – Paragraph [0171), and wherein degradation of the biodegradable section releases the biodegradable cover from the first body part and/or the second body part (degradation of either 120p’ or 120p’’ causes cap 120p’ to release as seen in Fig. 20b).
Regarding Claim 31, Hashim discloses the drug delivery device of claim 1, further comprising a second attachment part attached to the second body part (second left side of multiple delivery assemblies 178 in Fig. 20d still attached to body portion 120p’’).
Regarding Claim 33, Hashim discloses the drug delivery device of claim 1, wherein the biodegradable cover is a biodegradable capsule (“the capsule 120 can be formed from multiple portions one or more of which may be biodegradable.” – Paragraph [0171], Fig. 20a).
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.
Claim(s) 18, 20-25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashim.
Regarding Claim 18, Hashim discloses the drug delivery device of claim 1.
Hashim does not expressly disclose wherein converting the stored energy to the kinetic energy is configured to translate the locking member out of the aperture.
However, in a differing embodiment, Hashim teaches wherein the locking member can be made of a variety of structures (“Various embodiments of the invention provide a number of structures for a separation valve 150, for example, a beam like structure (where the valve comprises a beam that presses down on tube 163 and/or connecting section 136), or collar type structure (where the valve comprise a collar lying over tube 163 and/or connecting section 136). Still other valve structures are also contemplated.” – Paragraph [0183]) and degradation of the valve allows water to enter the balloon in order to convert potential energy to kinetic energy (Paragraph [0184]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device disclosed by Hashim wherein converting the stored energy to the kinetic energy is configured to translate the locking member out of the aperture as taught by Hashim so that the valve is able to be displaced after some degree of degradation in order to allow fluid to enter the balloon and expand (Paragraph, [0183])
Regarding Claim 20, Hashim discloses the drug delivery device of claim 1.
Hashim does not expressly disclose wherein the locking member is pyramid shaped.
However, Hashim teaches wherein the locking member can be made of a variety of structures (“Various embodiments of the invention provide a number of structures for a separation valve 150, for example, a beam like structure (where the valve comprises a beam that presses down on tube 163 and/or connecting section 136), or collar type structure (where the valve comprise a collar lying over tube 163 and/or connecting section 136). Still other valve structures are also contemplated.” – Paragraph [0183]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device disclosed by Hashim wherein the locking member is pyramid shaped as taught by Hashim so that the valve is able to degrade at desirable rates and at desirable locations, such as within the digestive tract (Paragraph [0183]).
Regarding Claim 21, Hashim discloses the drug delivery device of claim 1.
Hashim does not expressly disclose wherein the locking member is diamond shaped.
However, Hashim teaches wherein the locking member can be made of a variety of structures (“Various embodiments of the invention provide a number of structures for a separation valve 150, for example, a beam like structure (where the valve comprises a beam that presses down on tube 163 and/or connecting section 136), or collar type structure (where the valve comprise a collar lying over tube 163 and/or connecting section 136). Still other valve structures are also contemplated.” – Paragraph [0183]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device disclosed by Hashim wherein the locking member is diamond shaped as taught by Hashim so that the valve is able to degrade at desirable rates and at desirable locations, such as within the digestive tract (Paragraph [0183]).
Regarding Claim 22, Hashim discloses the drug delivery device of claim 1.
Hashim does not expressly disclose wherein the locking member is ball shaped.
However, Hashim teaches wherein the locking member can be made of a variety of structures (“Various embodiments of the invention provide a number of structures for a separation valve 150, for example, a beam like structure (where the valve comprises a beam that presses down on tube 163 and/or connecting section 136), or collar type structure (where the valve comprise a collar lying over tube 163 and/or connecting section 136). Still other valve structures are also contemplated.” – Paragraph [0183]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device disclosed by Hashim wherein the locking member is ball shaped as taught by Hashim so that the valve is able to degrade at desirable rates and at desirable locations, such as within the digestive tract (Paragraph [0183]).
Regarding Claim 23, Hashim discloses the drug delivery device of claim 1.
Hashim does not expressly disclose wherein the locking member is cone shaped.
However, Hashim teaches wherein the locking member can be made of a variety of structures (“Various embodiments of the invention provide a number of structures for a separation valve 150, for example, a beam like structure (where the valve comprises a beam that presses down on tube 163 and/or connecting section 136), or collar type structure (where the valve comprise a collar lying over tube 163 and/or connecting section 136). Still other valve structures are also contemplated.” – Paragraph [0183]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device disclosed by Hashim wherein the locking member is cone shaped as taught by Hashim so that the valve is able to degrade at desirable rates and at desirable locations, such as within the digestive tract (Paragraph [0183]).
Regarding Claim 24, Hashim discloses the drug delivery device of claim 1.
Hashim does not expressly disclose wherein the locking member is wedge shaped.
However, Hashim teaches wherein the locking member can be made of a variety of structures (“Various embodiments of the invention provide a number of structures for a separation valve 150, for example, a beam like structure (where the valve comprises a beam that presses down on tube 163 and/or connecting section 136), or collar type structure (where the valve comprise a collar lying over tube 163 and/or connecting section 136). Still other valve structures are also contemplated.” – Paragraph [0183]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device disclosed by Hashim wherein the locking member is wedge shaped as taught by Hashim so that the valve is able to degrade at desirable rates and at desirable locations, such as within the digestive tract (Paragraph [0183]).
Regarding Claim 25, Hashim discloses the drug delivery device of claim 1.
Hashim does not expressly disclose wherein the locking member is not biodegradable.
However, Hashim teaches of a valve (155) which is made to resist a burst pressure from the inflating balloon (Paragraph [0180]), the release pressure of the valve can be controlled through the selection of its material (“The release pressure of valve 155 can be controlled through selection of one or more of the size and shape of section 156 as well as the selection of material 157 (e.g., for properties such as adhesive strength, shear strength etc.)” - Paragraph [0180]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device disclosed by Hashim wherein the locking member is not biodegradable as taught by Hashim so that the locking member does not degrade within the intestinal tract preventing the drug delivery device from deploying.
Regarding Claim 27, Hashim discloses the drug delivery device of claim 1.
Hashim does not expressly disclose wherein the biodegradable cover does not cover the attachment part.
However, Hashim teaches where the capsule can include a coating in order to prevent degradation until in a desirable location and can be made in multiple portions (“The capsule can be fabricated from various biodegradable gelatin materials known in the pharmaceutical arts, but can also include various enteric coatings 120c, configured to protect the cap from degradation in the stomach (due to acids etc.), and then subsequently degrade in the in higher pH's found in the small intestine or other area of the intestinal tract. In various embodiments, the capsule 120 can be formed from multiple portions one or more of which may be biodegradable” – Paragraph [0171]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device disclosed by Hashim wherein the biodegradable cover does not cover the attachment part as taught by Hashim so that the attachment part is not prevented by the cover from attaching to the intestinal tract.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashim in view of Shimizu et al (WO 2020106754 A1, herein Shimizu).
Regarding Claim 32, Hashim discloses the drug delivery device of claim 1.
Hashim does not expressly disclose wherein the actuator mechanism is configured to convert the stored energy to the kinetic energy by rotating at least one of the first body part or the second body part with respect to one another.
Shimizu teaches wherein the actuator mechanism (910) is configured to convert the stored energy to the kinetic energy by rotating at least one of the first body part or the second body part with respect to one another (Figs. 9A-B, “the pressure of the drive force generator 910 and the drive coupling 912 is applied to the dispensable substance 904, forcing the cap to move to expose openings 908. As shown in FIG.9B, the housing part 902B has a slot 903 into which a portion of housing part 902A fits such that the motion of the housing part 902A is both axial and rotational (e.g., a track and cam arrangement)” – Page 66 Paragraph 1).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device disclosed by Hashim wherein the actuator mechanism is configured to convert the stored energy to the kinetic energy by rotating at least one of the first body part or the second body part with respect to one another as taught by Shimizu so that despite the high pressure produced by the actuator, the drug device is able to rotate along a defined path to deliver a substance (Shimizu, Page 66 Paragraph 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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