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 Amendments filed 04/27/2026 have been entered.
Claims 1, 7, 9, 16, and 18-20 have thereby been amended.
Claims 4 and 13 have been cancelled.
Claims 1-3, 5-12 and 14-20 are being examined in this office action.
Claim Interpretation
Claims 1, 4, 6, 7, 9, 13, 15, 16 and 18 recite the limitations of “compliant” and/or “non-compliant” sections. As these claimed limitations do not specify any structural or material qualities related to this compliance (being for example, definitive qualities such as joints or degrees of elasticity, rigidity, stiffness, etc.), the claimed “compliant” and “non-compliant” limitations are interpreted to mean that the portion either does or does not bend/fold in the claimed hinge-like manner, when folded/moved as such.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-7, 9-12 and 14-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gross (US 20200054568) in view of De Laat (US 10939865).
Regarding claim 1, Gross discloses a self-sizing device for delivering a therapeutic formulation, the device comprising: a capsule sized and structured to be orally ingested (Fig. 1A: capsule 28 with coating 22; para. [0216]); and an expandable component disposed within the capsule (Figs. 1A-B: component 24 and 672 of Figs. 8A-B, the device being fully expandable, para. [0085]; para. [0216]; specifically component embodiment 624 in Figs. 8A-B), the expandable component including at least one compliant section that is readily deformed to allow deformation and operation as a hinge in an expanded configuration (Figs. 6C-E: dotted lines depicting the hinging compliant portions), wherein the expandable component is structured to expand within a lumen and bend about the compliant section to adapt to a circumference of an inner wall of the lumen within a selected range (para. [0242], sentences 2-3; Fig. 1B). However, although Gross discloses folding, or hinging, of the expanding device, Gross fails to explicitly disclose a structure which includes separate compliant and non-compliant sections, wherein each have separate circumferences.
De Laat teaches an analogous self-sizing device for delivering a therapeutic formation, structured wherein the expandable component (Figs. 2 and 5: 100) including at least one non-compliant section structured to resist deformation in an expanded configuration (Fig. 2: sections 101 and 102; col. 5, lines 57-67; or Fig. 5: sections 101, 102, 103 and 104; col. 7, lines 10-16) and at least one compliant section that is readily deformed to allow deformation and operation as a hinge in an expanded configuration (Fig. 2: sections 110 and 111 and 102; col. 5, lines 57-67; or Fig. 5: sections 111, 112, 113 and 114; col. 7, lines 10-16), wherein the compliant section has a circumference smaller than a corresponding circumference of the non-compliant section (Fig. 2: 101 and 102 have center larger circumferences than the center circumferences of 110 and 111 where they fold like a hinge). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Gross by incorporating the distinct rigid and flexible sections as taught by De Laat, in order to ensure that large portions of the expanded device resist deformation by the intestinal walls around it while still maintaining the flexible portions allowing for the folding as taught by Gross.
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Regarding claim 2, Gross in view of De Laat teaches the device of claim 1, as described above, wherein the selected range is about 50 mm to about 150 mm (Gross: para. [0235], last sentence, between 60 and 150mm).
Regarding claim 3, Gross in view of De Laat teaches the device of claim 1, as described above, wherein, while in the capsule, the expandable component is in a folded and/or rolled arrangement (Gross: Fig. 1A; Fig. 5B; Figs. 6A-F) and is structured to unfold and/or unroll when released from the capsule to expand to a maximum circumference in the absence of a constraining force and to less than a maximum circumference in the presence of a constraining force (Gross: Fig. 1B; para. [0217], sentence 3).
Regarding claim 5, Gross in view of De Laat teaches the device of claim 1, as described above, wherein the lumen is a lumen of the small intestine (Gross: Figs. 1A-B).
Regarding claim 6, Gross in view of De Laat teaches the device of claim 1, as described above, wherein the expandable component comprises at least two non-compliant sections (De Laat: Fig. 2: sections 101 and 102; Fig. 5: sections 101, 102, 103 and 104).
Regarding claim 7, Gross in view of De Laat teaches the device of claim 1, as described above, wherein the expandable component comprises at least two compliant sections (De Laat: Fig. 2: sections 110 and 111 and 102; Fig. 5: sections 111, 112, 113 and 114), each being readily deformed to allow deformation and operation as a hinge in an expanded configuration (De Laat: Figs. 2 and 5, hinged folding; Gross: Fig. 3B and Figs. 6B-F, hinged folding).
Regarding claim 9, Gross discloses a system for delivering a formulation, the system comprising: a self-sizing device comprising an expandable component (Figs. 1A-B: component 24 and 672 of Figs. 8A-B, the device being fully expandable, para. [0085]; para. [0216]; specifically component embodiment 624 in Figs. 8A-B), that includes at least one compliant section that is readily deformed to allow deformation and operation as a hinge in an expanded configuration (Figs. 6C-E: dotted lines depicting the hinging compliant portions), wherein the expandable component is structured to bend about the compliant section upon expansion to adapt to an inner circumference of a lumen within a selected range (para. [0242], sentences 2-3; Fig. 1B); the formulation (Figs. 8A-B: medication 52 in chamber 670; para. [0247]); and a delivery mechanism, wherein the self-sizing device is structured to, upon expansion of the expandable component, cause the delivery mechanism to apply a force to the formulation, the force designed to expel the formulation from the self-sizing device (Figs. 8A-B; paras. [0247] and [0259]). However, although Gross discloses folding, or hinging, of the expanding device, Gross fails to explicitly disclose a structure which includes separate compliant and non-compliant sections, wherein each have separate circumferences.
De Laat teaches an analogous self-sizing device for delivering a therapeutic formation, that includes at least one non-compliant section structured to resist deformation in an expanded configuration (Fig. 2: sections 101 and 102; col. 5, lines 57-67; or Fig. 5: sections 101, 102, 103 and 104; col. 7, lines 10-16) and at least one compliant section that is readily deformed to allow deformation and operation as a hinge in an expanded configuration (Fig. 2: sections 110 and 111 and 102; col. 5, lines 57-67; or Fig. 5: sections 111, 112, 113 and 114; col. 7, lines 10-16), wherein the compliant section has a circumference smaller than a corresponding circumference of the non-compliant section (Fig. 2: 101 and 102 have center larger circumferences than the center circumferences of 110 and 111 where they fold like a hinge). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Gross by incorporating the distinct rigid and flexible sections as taught by De Laat, in order to ensure that large portions of the expanded device resist deformation by the intestinal walls around it while still maintaining the flexible portions allowing for the folding as taught by Gross.
Regarding claim 10, Gross in view of De Laat teaches the system of claim 9, as described above, further comprising a capsule in which the expandable component is disposed (Gross: Fig. 1A: capsule 28 with coating 22; para. [0216]), wherein, while in the capsule, the expandable component is in a folded and/or rolled arrangement (Gross: Fig. 1A; Fig. 5B; Figs. 6A-F) and is structured to unfold and/or unroll when released from the capsule (Gross: Fig. 1B; para. [0217], sentence 3).
Regarding claim 11, Gross in view of De Laat teaches the system of claim 10, as described above, wherein the expandable component is further structured to, after being released from the capsule, expand to a maximum circumference in the absence of a constraining force and expand to less than a maximum circumference in the presence of a constraining force (Gross: Fig. 1B; para. [0217], sentence 3).
Regarding claim 12, Gross in view of De Laat teaches the system of claim 9, as described above, wherein the self-sizing device is structured to be disposed in a gastrointestinal tract (Gross: Figs. 1A-B), and the selected range is about 50 mm to about 150 mm (Gross: para. [0235], last sentence, between 60 and 150mm).
Regarding claim 14, Gross in view of De Laat teaches the system of claim 9, as described above, wherein the lumen is a lumen of the small intestine (Gross: Figs. 1A-B).
Regarding claim 15, Gross in view of De Laat teaches the system of claim 9, as described above, wherein the expandable component comprises at least two non-compliant sections (De Laat: Fig. 2: sections 101 and 102; Fig. 5: sections 101, 102, 103 and 104).
Regarding claim 16, Gross in view of De Laat teaches the system of claim 9, as described above, wherein the expandable component comprises at least two compliant sections (De Laat: Fig. 2: sections 110 and 111 and 102; Fig. 5: sections 111, 112, 113 and 114), each being readily deformed to allow deformation and operation as a hinge in an expanded configuration (De Laat: Figs. 2 and 5, hinged folding; Gross: Fig. 3B and Figs. 6B-F, hinged folding).
Regarding claim 18, Gross discloses a method for delivering a therapeutic formulation to a lumen of a body of a subject, comprising: disposing within the body a self-sizing device (Fig. 1B, device 24) comprising the therapeutic formulation (Figs. 8A-B: medication 52 in chamber 670; para. [0247]), the self-sizing device further comprising an expandable component (Figs. 1A-B: component 24 and 672 of Figs. 8A-B, the device being fully expandable, para. [0085]; para. [0216]; specifically component embodiment 624 in Figs. 8A-B) that includes at least one compliant section that is readily deformed to allow deformation and operation as a hinge in an expanded configuration (Figs. 6C-E: dotted lines depicting the hinging compliant portions), wherein the expandable component is structured to bend about the compliant section upon expansion to adapt to an inner circumference of the lumen within a selected range (para. [0242], sentences 2-3; Fig. 1B); the formulation (Figs. 8A-B: medication 52 in chamber 670; para. [0247]). However, although Gross discloses folding, or hinging, of the expanding device, Gross fails to explicitly disclose a structure which includes separate compliant and non-compliant sections, wherein each have separate circumferences.
De Laat teaches an analogous self-sizing device for delivering a therapeutic formation, that includes at least one non-compliant section structured to resist deformation in an expanded configuration (Fig. 2: sections 101 and 102; col. 5, lines 57-67; or Fig. 5: sections 101, 102, 103 and 104; col. 7, lines 10-16) and at least one compliant section that is readily deformed to allow deformation and operation as a hinge in an expanded configuration (Fig. 2: sections 110 and 111 and 102; col. 5, lines 57-67; or Fig. 5: sections 111, 112, 113 and 114; col. 7, lines 10-16), wherein the compliant section has a circumference smaller than a corresponding circumference of the non-compliant section (Fig. 2: 101 and 102 have center larger circumferences than the center circumferences of 110 and 111 where they fold like a hinge). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the Gross method by incorporating the distinct rigid and flexible sections as taught by De Laat, in order to ensure that large portions of the expanded device resist deformation by the intestinal walls around it while still maintaining the flexible portions allowing for the folding as taught by Gross.
Regarding claim 19, Gross in view of De Laat teaches the method of claim 18, as described above, wherein the disposing comprises swallowing of the self-sizing device by the subject (Gross: claim 113).
Regarding claim 20, Gross in view of De Laat teaches the method of claim 18, as described above, wherein the disposing comprises manually inserting the self-sizing device into the lumen of the body (Gross: para. [0202] and claim 113, placement via ingestion; De Laat: col. 6, line 62 – col. 7, line 9, insertion into lumen).
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gross (US 20200054568) in view of De Laat (US 10939865) in further view of Imran (US 9757514).
Regarding claim 8, Gross in view of De Laat teaches the device of claim 1, as described above, further comprising the therapeutic formulation (Gross: Figs. 8A-B: medication 52 in chamber 670; para. [0247]), wherein the self-sizing device is structured to, upon expansion of the expandable component, apply a force to the therapeutic formulation, the force designed to expel the therapeutic formulation from the device (Gross: Figs. 8A-B; paras. [0247] and [0259]). However, Gross fails to disclose a piston forcing out the medication, and De Laat fails to remedy this.
Imran teaches an analogous intestinal therapeutic delivery device with an expanding portion that also comprises a piston (Fis. 12A-B: 252+253), wherein the device is structured to cause the piston to apply a force to the therapeutic formulation (Figs. 12A-B: therapeutic formulation 101 of 100/40), the force designed to expel the therapeutic formulation from the device (col. 31, lines 48-59). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug delivery mechanism via inflation force of the Gross-De Laat device (described in Gross: Figs. 8A-B, paras. [0247] and [0259]), by incorporating the pistons for drug delivery taught by Imran. Upon incorporation of the pressure activated piston of Imran (Figs. 12A-B: element 250 including the piston 252+253 and medication dose in 100), the pressure chambers of Gross (Figs. 8A-B: expanding chamber 672 applying force to 670) would apply the force to the piston to expel the drug, rather than on a chamber of the drug alone (as depicted in Gross Fig. 8B), which does not ensure accurately expelling the full and complete drug dose (as can be deduced from Gross Fig. 8B), in order to ensure that the full and accurate drug does is delivered.
Regarding claim 17, Gross in view of De Laat teaches the system of claim 9, as described above, wherein the self-sizing device is structured such that upon expansion of the expandable component applies the force to the formulation (Gross: Figs. 8A-B; paras. [0247] and [0259]). However, Gross fails to disclose a piston forcing out the medication, and De Laat fails to remedy this.
Imran teaches an analogous intestinal therapeutic delivery device with an expanding portion that also comprises a piston (Fis. 12A-B: 252+253), wherein the device is structured to cause the piston to apply a force to the therapeutic formulation (Figs. 12A-B: therapeutic formulation 101 of 100/40), the force designed to expel the therapeutic formulation from the device (col. 31, lines 48-59). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug delivery mechanism via inflation force of the Gross-De Laat device (described in Gross: Figs. 8A-B, paras. [0247] and [0259]), by incorporating the pistons for drug delivery taught by Imran. Upon incorporation of the pressure activated piston of Imran (Figs. 12A-B: element 250 including the piston 252+253 and medication dose in 100), the pressure chambers of Gross (Figs. 8A-B: expanding chamber 672 applying force to 670) would apply the force to the piston to expel the drug, rather than on a chamber of the drug alone (as depicted in Gross Fig. 8B), which does not ensure accurately expelling the full and complete drug dose (as can be deduced from Gross Fig. 8B), in order to ensure that the full and accurate drug does is delivered.
Response to Arguments
Applicant's arguments filed 04/27/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
For these reasons, claims 1-3, 5-12 and 14-20 stand rejected in view of Gross, De Laat and Imran.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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