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 10/14/2023 have been entered.
Claims 1, 7, 9, 16, 18 and 20 have thereby been amended.
Claims 1-20 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 § 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 1-20 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 1, 7, 9, 16 and 18 recite the limitation “structured as a hinge.” The phrasing of “structured as a hinge” makes it unclear what the required structures of the section(s) is/are, and what constitutes as a hinge-like structure given the broadest reasonable interpretation, rendering said claims indefinite.
For the purposes of examination, this limitation is being interpreted to encompass any structure that moves/bends/pivots in the same manner as structures about a hinge would move, as defined by The American Heritage Dictionary as “a joint or flexible part allowing a door, lid, or other attached item to swing or turn on a stationary frame.” According to this interpretation and definition of hinge, a folded paper or similar material would create a fold that is interpreted as a “structured as a hinge.”
Additionally, claims 1-6, 8, 10-15, 17, 19 and 20 should be included in the rejection because any claims that depend on a rejected claim inherit the problems of their parent claims.
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gross (US 20160015648).
Regarding claim 1, Gross discloses a self-sizing device for delivering a therapeutic formulation, the device comprising: a capsule (coating 22 of pill 20) sized and structured to be orally ingested (page 10, para. [0232], first sentence); and an expandable component disposed within the capsule (30), the expandable component including at least one non-compliant section (Fig. 7C: pieces 82 and 86, shown in attached configuration in Fig. 8) structured to resist deformation in an expanded configuration (Fig. 3B; page 14, para. [0281], sentences 1 and 2), the expandable component further including at least one compliant section that is readily deformed and structured as a hinge (Fig. 8: interfaces 92 and 90) to allow deformation in an expanded configuration (page 14, para. [0281], sentences 1 and 2), the expandable component structured to expand within a lumen and bend about the hinge to adapt to a circumference of an inner wall of the lumen (Fig. 3B; page 14, para. [0281], sentences 1 and 2) within a selected range.
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Gross Figs. 8 and 18 depicting claimed aspects of pistons for
drug delivery, and folding along interface/hinge elements
Regarding claim 2, Gross discloses the device of claim 1, as described above, wherein the selected range is about 50 mm to about 150 mm (page 2, para. [0011], last sentence: 6-30cm equals 60-300mm).
Regarding claim 3, Gross discloses the device of claim 1, as described above, wherein, while in the capsule, the expandable component is in a folded and/or rolled arrangement (Fig. 1A; Figs. 5A-C) 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 (Fig. 1C-F; page 10, para. [0234], first sentence) and to less than a maximum circumference in the presence of a constraining force (Fig. 1B; page 10, para. [0234], first sentence).
Regarding claim 4, Gross discloses the device of claim 1, as described above, wherein the hinge has a width or a circumference smaller than a respective width or circumference of the non-compliant section (Figs. 7C and 8: interfaces 92 and 90 have smaller length than length of sections 82 and 80).
Regarding claim 5, Gross discloses the device of claim 1, as described above, wherein the lumen is a lumen of the small intestine (Fig. 3B: 23).
Regarding claim 6, Gross discloses the device of claim 1, as described above, wherein the expandable component comprises at least two non-compliant sections (Fig. 7C: multiple pieces 82 and 86, shown in attached configuration in Fig. 8).
Regarding claim 7, Gross discloses the device of claim 1, as described above, wherein the expandable component comprises at least two compliant sections, each being readily deformed and structured as a hinge (Fig. 8: interfaces 92 and 90).
Regarding claim 8, Gross discloses the device of claim 1, as described above, further comprising the therapeutic formulation (page 14, para. 0282], last sentence) and a piston (96, pegs), wherein the self-sizing device is structured to, upon expansion of the expandable component, cause the piston to apply a force to the therapeutic formulation, the force designed to expel the therapeutic formulation from the device (Fig. 8: page 14, para. [0282], sentences 3-4).
Regarding claim 9, Gross discloses a system for delivering a formulation, the system comprising: a self-sizing device comprising an expandable component (30) that includes at least one non-compliant section structured to resist deformation in an expanded configuration (Fig. 7C: pieces 82 and 86, shown in attached configuration in Fig. 8; page 14, para. [0281], sentences 1 and 2), the expandable component further including at least one compliant section that is readily deformed and structured as a hinge to allow deformation in an expanded configuration (Fig. 8: interfaces 92 and 90; page 14, para. [0281], sentences 1 and 2), the expandable component structured to bend about the hinge upon expansion to adapt to an inner circumference of a lumen within a selected range (Fig. 3B; page 14, para. [0281], sentences 1 and 2); the formulation (page 14, para. 0282], last sentence); 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 (Fig. 8: page 14, para. [0282], sentences 3-4).
Regarding claim 10, Gross discloses the device of claim 9, as described above, further comprising a capsule (coating 22 of pill 20) in which the expandable component is disposed (Fig. 1A), wherein, while in the capsule, the expandable component is in a folded and/or rolled arrangement (page 12, para. [0258], sentences 1-2) and is structured to unfold and/or unroll when released from the capsule (Fig. 1C-F and Fig. 4; page 10, para. [0234], first sentence).
Regarding claim 11, Gross discloses the device 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 (Fig. 1C-F; page 10, para. [0234], first sentence) and expand to less than a maximum circumference in the presence of a constraining force (Fig. 1B; page 10, para. [0234], first sentence).
Regarding claim 12, Gross discloses the device of claim 9, as described above, wherein the self-sizing device is structured to be disposed in a gastrointestinal tract (), and the selected range is about 50 mm to about 150 mm (page 2, para. [0011], last sentence: 6-30cm equals 60-300mm).
Regarding claim 13, Gross discloses the device of claim 9, as described above, wherein the hinge has a width or a circumference smaller than a respective width or circumference of the non-compliant section (Figs. 7C and 8: interfaces 92 and 90 have smaller length than length of sections 82 and 80).
Regarding claim 14, Gross discloses the device of claim 9, as described above, wherein the lumen is a lumen of the small intestine (Fig. 3B: 23).
Regarding claim 15, Gross discloses the device of claim 9, as described above, wherein the expandable component comprises at least two non- compliant sections (Fig. 7C: multiple pieces 82 and 86, shown in attached configuration in Fig. 8).
Regarding claim 16, Gross discloses the device of claim 9, as described above, wherein the expandable component comprises at least two compliant section that is readily deformed and structured as a hinge (Fig. 8: interfaces 92 and 90).
Regarding claim 17, Gross discloses the device of claim 9, as described above, wherein the delivery mechanism comprises a piston (96, pegs), and the self- sizing device is structured such that upon expansion of the expandable component the piston applies the force to the formulation (Fig. 8: page 14, para. [0282]).
Regarding claim 18, Gross discloses a method for delivering a therapeutic formulation to a lumen of a body of a subject, comprising: providing a self-sizing device (30) comprising the therapeutic formulation (page 14, para. 0282], last sentence), the self-sizing device further comprising an expandable component that includes at least one non-compliant section structured to resist deformation in an expanded configuration (Fig. 7C: pieces 82 and 86, shown in attached configuration in Fig. 8; page 14, para. [0281], sentences 1 and 2), the expandable component further including at least one compliant section that is readily deformed and structured as a hinge to allow deformation in an expanded configuration (Fig. 8: interfaces 92 and 90; page 14, para. [0281], sentences 1 and 2), the expandable component structured to bend about the hinge upon expansion to adapt to an inner circumference of the lumen within a selected range (Fig. 3B; page 14, para. [0281], sentences 1 and 2); and providing instructions for disposing the self-sizing device within the body to deliver the therapeutic formulation into the lumen (page 5, para. [0095] and para. [0096]).
Regarding claim 19, Gross discloses the device of claim 18, as described above, wherein the instructions include instructions for swallowing the self-sizing device (page 5, para. [0095] and para. [0096]).
Regarding claim 20, Gross discloses the device of claim 18, as described above, wherein the instructions include instructions for manually inserting the self-sizing device into the lumen of the body (page 5, para. [0095] and para. [0096]; placement through ingestion).
Response to Arguments
Applicant's arguments filed 10/14/2025 have been fully considered but they are not persuasive.
Applicant argues that Gross fails to disclose the compliant and non-compliant portions of the self-sizing device, or a hinge, as claimed. Examiner refers to the Claim Interpretation and Claim Rejections - 35 USC § 112 sections above for the interpretation these limitations are examined under, given the broadest reasonable interpretation of the claim language as it is currently written.
Regarding Applicant’s arguments that Gross does not disclose a hinge, claimed as a component “structured as a hinge” in the amended claims, Examiner maintains that the device disclosed by Gross folds in a hinge-like manner about the referenced “interfaces,” as shown in Figure 18, as described in the rejections above. Furthermore, Gross discloses in sentence 2 of paragraph [0281], that without specific alignment of sections 82 and 86, the layers of the device will “tend to fold or flex sharply at the interface,” teaching that these interfaces on their own are, in fact, compliant for hinge-like folding, as claimed, in a way that the other portions of the segments are not.
Regarding Applicant’s arguments that Gross fails to disclose the claimed non-compliant sections, Examiner references the above response to the argument and the Claim Interpretation section above for the interpretation these limitations are examined and considered under. Therefore, examiner maintains that 82 and 86 resist deformation more than interfaces 90 and 92, in the expanded state, and they must be folded/rolled/twisted in a particular manner to deform prior to usage and later expansion (see paragraph [0268]). However, if Applicant further argues that these claimed features are not disclosed by Gross in their interpretation, Examiner points to the additional embodiment(s) disclosed by Gross, seen in Figures 12A-C and 13, and paragraphs [0303] – [307]. In this embodiment, Gross further discloses ribs 150 in Figures 12A-C and 13, and also ribs 350 in Figure 17, which are non-compliant portions for resisting twisting and collapsing deformations when the device is in the expanded state (para. [0298], sentence 3 and para. [306], sentence 3). Additionally, still, Gross discloses another portion of the device in this embodiment, being 162 in Figure 13 which is structured like a hinge amid the non-compliant ribs 150 surrounding it perpendicularly.
For these reasons, Examiner maintains that all claimed limitations are anticipated by Gross, and claims 1-20 stand rejected as recited in the rejections above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
/NATHAN R PRICE/Primary Examiner, Art Unit 3783