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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/24/26 has been entered.
Response to Arguments
Regarding the claim objections, applicant’s amendments that make it clear that claims 16 and 17 are withdrawn have overcome this objection and it is hereby withdrawn.
Regarding the 102 rejection, applicant's amendments and related arguments filed have been fully considered but they are not persuasive. For clarity, the claim limitation argued by applicant is “wherein the expandable material is surrounded by a mesh configured to retain the expandable material within said mesh after the outer shell is dissolved or otherwise digested within the stomach”. The BRI of this claim language requires only that the mesh retain the expandable material for any amount of time after the outer shell is dissolved/digested within the stomach. For example, the mesh could retain the expandable material for only a brief/short amount of time and still read on the current claim language. The claim language does not require that the expandable material ALWAYS be retained within the mesh or any specific amount of time. That being said, applicant’s arguments that point to Par 0102 of Mintchev are not commensurate in scope with the BRI of the claims. Specifically, applicant points out that the mesh sacs (277) are eventually opened by controllably severing their attachment to the carrier. It is applicant’s position that because these sacs are designed to open in situ, it fails to read on the current claim language. Applicant disagrees. First and foremost, it is emphasized that the examiner has never interpreted mesh sacs (277) as the claimed mesh, but instead is interpreting the mesh sacs (276) as the claimed sacs. Therefore, applicant’s arguments that point to an element (277) not being used in the rejection are moot, as they are not germane to the current rejection. Second, even if applicant’s arguments pointed to the correct element (276) in their arguments, these arguments would not be persuasive. As made clear in Pars 0101-106, the expandable sacs (276) are made of an expandable mesh/gauze material, specifically a biodegradable material “so as to allow for biodegradation after several days or weeks”. Fig. 9B shows the sacs (276) before the outer shell (281) is dissolved and Fig. 9A shows the expandable mesh sacs (276) retaining the expandable material (222) after the outer shell has been dissolved/digested (Pars 0095 and 0104). In fact, Par 0095 makes it clear that “In its expanded state, the device 210 will remain in situ in the body until the expandable sacs 276 are decoupled (i.e., the device is disassembled), as discussed below. This allows the substance carrying particles to be released over a period of time until the complete disassembly of the device.”. Similarly, Pars 0097-103 make it clear that the opening, i.e. decoupling or disassembly, of the mesh expandable sacs (276) happens over a period of time based on the controlled disintegration or disruption of the sutures (274). So while the mesh sacs (276) eventually open to release the expandable material (222), it is abundantly clear that these sacs are configured to retain this material for a period time after shell (281) has dissolved or disintegrated, as explicitly shown in Fig. 9A. Stated differently, until the sutures are disintegrated or disrupted, the expandable material (222) remains contained within the mesh (276) after shell (281) has been dissolved. Therefore, the claim language is met. The examiner is substantially maintaining the previous 102 rejection with updated claim mapping to address the amendments.
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 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, 4, 7, 8 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2010/0145316 to Mintchev (provided on applicant’s IDS filed 1/31/2019).
[Claims 1 and 7] Mintchev discloses a capsule (210; Figures 9-12; Pars 0095 and 0107), comprising:
an outer shell configured to dissolve or otherwise be digested within a stomach after ingestion (shell 281, best seen in Fig. 9B, made of materials which dissolve under certain conditions such as the pH of the stomach; Par 0104);
an expandable material positioned within the outer shell (expandable material 222), the expandable material configured for expansion within the stomach after being in contact with liquid from the stomach after the outer shell has dissolved (expandable material 222 that expands in contact with bodily fluids; once shell 281 dissolves and exposure to bodily fluids occurs; Pars 0095, 0099 and 0101);
at least one element or sensor selected from the group consisting of an impedance element (“the internal cavity 272 may host a microelectronic feedback-providing mechanism registering the exact moment of disintegration, as will be discussed below” Par 0098; This is clearly referring to the feedback mechanism described in Pars 0107-108 which includes a microsensor 294, specifically an impedance sensor Par 0108) and a pressure sensor;
wherein the expandable material is surrounded by a mesh configured to retain the expandable material within said mesh and said mesh is configured to expand as the expandable material expands and after the outer shell is dissolved or otherwise digested within the stomach (permeable expandable sacs 276 made of medical gauze; “Once the device 210 is positioned in the body, bodily fluids allow the expandable particles 222 to swell or expand and the expandable sacs 276 to expand from a first dimension (as shown in FIG. 9B) to a second dimension (as shown in FIG. 9A).” and sacs 276 “initially folded (first dimension), containing the non-expanded expandable particles. It may be desirable that the material itself used to construct sacs 276 be expandable, so as to concurrently expand with the expandable particles 222.” Pars 0095 and 0101; Fig. 9B. Additionally, as can be seen in Figs. 9A, 9B and 10 and related Pars 0098-0105, the expandable material 222 is retained within the mesh/sac for a specific time until after shell 281 is dissolved the mesh/sac is opened, as shown in Fig. 11 and described in Par 0106. Specifically, Fig. 9B explicitly shows a configuration where the shell 281 is dissolved (compare to Fig. 9A where the shell is not dissolved), and the mesh sacs 276 are expanded and retain the expandable material 222 within the sacs. The mesh sacs continue to retain the expandable material until a later time when the sutures are eventually disintegrated/disrupted and the sacs are opened; See Pars 0095-106. This reads on the BRI of the current claim language.)
[Claims 4 and 8] Mintchev further discloses wherein the at least one element or sensor is/are coupled to the expandable material and the mesh (expandable sacks/mesh 276 which contain the expandable material 222 are shown in contact with carrier 212 where the microsensor 294 is located; best seen in Figs. 9A-B). Therefore, both the expandable material and the mesh are coupled to the sensor, via intermediary elements.
[Claim 10] Mintchev further discloses a substrate (carrier 212), wherein at least one of the at least one element or sensor is coupled to the substrate (the carrier 212 comprises an inner cavity 272 for housing a feedback mechanism, i.e. physiological sensor 294; Pars 0098 and 0107-108).
[Claim 11] As best seen in Fig. 9B, the mesh (sacs 276) at least partially surround the substrate (212).
[Claim 12] As best seen in Fig. 9A, the mesh (sacs 276) retain the substrate (212) via sutures (274), at least until the sutures disintegrate. Specifically, the mesh retains the substrate in a coupled positioned via the sutures. In other words, any two elements that are coupled together are considered retained by one another.
[Claim 13] Mintchev discloses the use of an impedance sensor (Par 0108) and an antimony electrode (Par 0070). By definition an impedance sensor requires two electrodes (one for excitation and one for detection). Based on this, the examiner contends that any electrode (including those taught by Mintchev) is inherently configured to deliver electrical stimulation.
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.
Claims 2, 5 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mintchev as applied to claim 1 above, and further in view of US 2005/0058701 to Gross et al.
[Claims 2, 5 and 18] Mintchev discloses “the microsensor 294 can be implemented using a variety of sensing technologies, including, but not limited to, electrochemical, chemical, physical, electrophysical, electronic, impedance, etc. for detecting various physiological parameters.” (Par 0108). However, the reference fails to explicitly teach that more than one of these sensors can be included into the capsule and fails to teach that the sensor is explicitly a pressure sensor. In the same field of endeavor, Gross discloses a similar capsule (Fig. 16) for drug delivery in the GI tract which includes multiple sensors, specifically a pressure sensor and/or a pH sensor (18, Par 0242). Therefore, it would have been obvious to one of ordinary skill in the art to modify the device taught by Mintchev to include multiple sensors (in addition to the impedance sensor already taught by Gross) including a pressure sensor and a pH sensor, as taught by Gross, as these are all known sensors commonly used to control the release of drugs in the GI tract (Par 0273 of Gross). Furthermore, Mintchev makes it clear that any number of sensors and related measurements are pertinent to various procedures/treatments. Therefore, the examiner takes the position that including multiple, different sensors would have been obvious to a POSITA in order to gather additional information and make a more informed/better decision as to when to release a therapeutic substance, as taught by both Mintchev and Gross.
Regarding claim 18, this claim merely recites the limitations of claims 1, 10 and 11 and requires both an impedance and pressure sensor (not just one). All of these limitations have been previously addressed in the 102 rejection of Mintchev. Furthermore, as discussed directly above, it would be obvious to include a pressure sensor as an additional/different sensor, as taught by Gross.
[Claim 19] This limitation has been previously addressed in the rejection of claims 1 and 7.
[Claim 20] As best seen in Fig. 9B, it is clear that the substrate (212) remains, i.e. is located, within the capsule, at least until the outer shell (281) dissolves.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Mintchev as applied to claim 1 above, and further in view of US 2005/0058701 to Gross et al. and further in view of US 2012/0172746 to Kassab.
The combination of Mintchev and Gross has already been discussed, specifically with regards to claim 5, this combination teaches a capsule having a pressure sensor and an impedance sensor, but fails to teach a specific configuration of the impedance sensor, as claimed. However, this arrangement of two detection electrodes (D) positioned between two excitation electrodes (E) is a commonly known and used configuration for taking impedance measurements in the gastrointestinal tract (Abstract, Pars 0016, 0072; Figs. 1A-E of Kassab). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to configure the impedance sensor taught by Mintchev in any known manner, including two detection electrodes positioned between two excitation electrodes, as taught by Kassab, in order to effectively take impedance measurements, specifically in the gastrointestinal tract, as taught by Kassab.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mintchev as applied to claim 1 above, and further in view of EP 0761105 Al to Chiba Machiko Cooking Studio Yugen Kaisha.
Mintchev is discussed above, but fails to disclose wherein the expandable material comprises a fungus. Chiba discloses an expandable material comprises a fungus (wood ear is a kind of edible mushroom, called black fungus; dried wood ears can expand in volume up to eight to ten times the original volume by absorbing water; page 2, lines 5-9, 20-21). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the capsule, as taught by Mintchev, with an expandable fungus, as taught by Chiba, for the advantage of providing an edible expansion material for enhanced safety (Chiba: wood ear can be swallowed in a dried form, giving the person who takes it the feeling of fullness quickly, while supplying necessary nutrients to the body in a balanced manner, without the possibility of any harmful side effects; page 2, lines 38-41).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mintchev as applied to claim 1 above, in view of US 2005/0058701 to Gross et al. in view of US 2012/0172746 to Kassab and further in view of EP 0761105 Al to Chiba Machiko Cooking Studio Yugen Kaisha.
The combination of Mintchev, Gross and Kassab has already been discussed above, in relation to claim 3. This combination teaches the claimed capsule of claim 9, but fails to disclose wherein the expandable material comprises a fungus. Chiba discloses an expandable material comprises a fungus (wood ear is a kind of edible mushroom, called black fungus; dried wood ears can expand in volume up to eight to ten times the original volume by absorbing water; page 2, lines 5-9, 20-21). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the capsule, as taught by Mintchev/Gross/Kassab, with an expandable fungus, as taught by Chiba, for the advantage of providing an edible expansion material for enhanced safety (Chiba: wood ear can be swallowed in a dried form, giving the person who takes it the feeling of fullness quickly, while supplying necessary nutrients to the body in a balanced manner, without the possibility of any harmful side effects; page 2, lines 38-41).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mintchev as applied to claim 1 above, and further in view of US 2007/0225634 to Ferren et al.
[Claim 14] Mintchev is discussed above, but fails to explicitly teach a movement element. However, in the same field of endeavor, Ferren discloses a drug delivery capsule (Fig. 6) designed to travel the gastrointestinal tract (Abstract, Par 0093) which includes a movement element (propeller 406; Par 0108). Therefore, it would have been obvious to modify the device taught by Mintchev to include a movement element, as taught by Ferren, in order to more precisely control movement of the device as it travels through the body lumen.
[Claim 15] Mintchev is discussed above, but fails to explicitly teach an attachment mechanism. However, in the same field of endeavor, Ferren discloses a drug delivery capsule (Fig. 5B) designed to travel the gastrointestinal tract (Abstract, Par 0093) which includes an attachment element (hook or claw-like structures 160; Par 0102). Therefore, it would have been obvious to modify the device taught by Mintchev to include an attachment mechanism, as taught by Ferren, in order to engage the lumen wall and maintain the device in a desired position with respect to the body lumen.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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