DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 10 November 2025. The Examiner acknowledges the amendments to claim 1, the cancellation of claims 25 and 32-33, as well as the addition of new claims 59-62. Claims 1, 6-20, and 59-62 are pending.
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 .
Claim Objections
Claim(s) 59 is/are objected to because of the following informalities:
Claim 59 should read “a chromatographic strip disposed within the cavity and configured for interacting with [[the]] fluid” [lines 6-7, as the Examiner notes that the fluid recited in line 4 is not positively recited].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 59 and 61-62 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rabinovitz (WO-2016193981-A1, previously presented), hereinafter Rabinovitz ‘981.
Regarding claim 59, Rabinovitz ‘981 teaches
A swallowable in-vivo device, comprising:
a shell defining a longitudinal axis and a cavity of the in-vivo device, the shell forming an outermost surface of the in-vivo device and including at least one radially oriented aperture formed in a circumferential wall portion of the shell and configured for allowing ingress of fluid into the cavity [a capsule or other unit where all the components are substantially contained within a housing, case or shell, and where the device does not require wires or cables in order to receive power or transmit information, for example (Rabinovitz p. 17:7-9); Fig. 8 schematically illustrates an in-vivo device ("capsule") according to an example embodiment… Plug 890 may be made of biodegradable material that degrades at an intended (predetermined) site/location in the GI tract (Rabinovitz ‘981 p. 22:1-2,15-1); the gate arrangement comprises a closure which is biodegradable and/or dissolvable, subject to the above predetermined conditions, to expose said inlet. In this case, the closure can be a thin film layer which may be adhered to the shell (Rabinovitz ‘981 p. 11:20-24), wherein as depicted in Fig. 8, capsule 800 extends along a longitudinal length and plug 890 is radially positioned to define a closure for an aperture formed in a circumferential wall of capsule 800 to prevent ingress of fluid into the cavity of capsule 800 until the plug 890 dissolves];
a chromatographic strip disposed within the cavity and configured for interacting with the fluid, the at least one aperture being radially aligned with at least a portion of the chromatographic strip along the longitudinal axis [Capsule 800 may include a LFS 810 and a printed circuit board ("PCB") 830. LFS 810 may include a sample pad 812, a conjugate pad 814, an absorbent pad 816 and a cellulose membrane 822 including a test line 818 and a control line 820 (Rabinovitz ‘981 p. 22:2-5, Fig. 8); a lateral flow (LF) arrangement configured for absorbing said fluid, said LF arrangement comprising a test zone configured for coming into contact, in-vivo, with a predetermined substance present in said fluid or a compound comprising said substance, thereby causing a change in at least one property of said test zone (Rabinovitz ‘981 p. 7:16-20); It is, therefore, an object of the present invention to provide a swallowable in- vivo device with on-board chromatographic strip that can provide rapid and sensitive in- vivo detection of low levels of various ligands, antigens or antibodies in body fluids (Rabinovitz ‘981p. 2:30-32)]; and
at least one breach mechanism covering the at least one aperture for preventing ingress of the fluid into the cavity via the at least one aperture, the at least one breach mechanism configured to become breached upon exposure to the fluid [the gate arrangement comprises a closure which is biodegradable and/or dissolvable, subject to the above predetermined conditions, to expose said inlet. In this case, the closure can be a thin film layer which may be adhered to the shell (Rabinovitz ‘981 p. 11:20-24); Plug 890 may be made of biodegradable material that degrades at an intended (predetermined) site/location in the GI tract (Rabinovitz p. 22:15-17, Fig. 8)].
Regarding claim 61, Rabinovitz ‘981 teaches
The swallowable in-vivo device according to claim 59, wherein the at least one breach mechanism includes a film layer directly adhered to the outermost surface of the in- vivo device [Rabinovitz ‘981 p. 11:20-24].
Regarding claim 62, Rabinovitz ‘981 teaches
The swallowable in-vivo device according to claim 61, wherein the film layer surrounds the at least one aperture [Rabinovitz ‘981 p. 11:20-24, p. 22:15-17, Fig. 8].
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.
Claim(s) 1, 6-7, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rabinovitz (WO-2016193981-A1, previously presented), hereinafter Rabinovitz ‘981, in view of Rabinovitz (US-20140206956-A1, previously presented), hereinafter Rabinovitz ‘956.
Regarding claim 1, Rabinovitz ‘981 teaches
A swallowable in-vivo device, comprising:
a shell defining a longitudinal axis and a cavity of the in-vivo device, the shell forming an outermost surface of the in-vivo device and including at least one radially oriented aperture formed in a circumferential wall portion of the shell and configured for allowing ingress of fluid into the cavity [a capsule or other unit where all the components are substantially contained within a housing, case or shell, and where the device does not require wires or cables in order to receive power or transmit information, for example (Rabinovitz p. 17:7-9); Fig. 8 schematically illustrates an in-vivo device ("capsule") according to an example embodiment… Plug 890 may be made of biodegradable material that degrades at an intended (predetermined) site/location in the GI tract (Rabinovitz ‘981 p. 22:1-2,15-1); the gate arrangement comprises a closure which is biodegradable and/or dissolvable, subject to the above predetermined conditions, to expose said inlet. In this case, the closure can be a thin film layer which may be adhered to the shell (Rabinovitz ‘981 p. 11:20-24), wherein as depicted in Fig. 8, capsule 800 extends along a longitudinal length and plug 890 is radially positioned to define a closure for an aperture formed in a circumferential wall of capsule 800 to prevent ingress of fluid into the cavity of capsule 800 until the plug 890 dissolves];
an immunoassay system disposed within the cavity and configured for interacting with fluid, the immunoassay system including a lateral flow strip extending between a fluid intake end and a distal end, the lateral flow strip including a test pad and the at least one aperture is radially aligned with the fluid-intake end of the lateral flow strip along the longitudinal axis [Capsule 800 may include a LFS 810 and a printed circuit board ("PCB") 830. LFS 810 may include a sample pad 812, a conjugate pad 814, an absorbent pad 816 and a cellulose membrane 822 including a test line 818 and a control line 820 (Rabinovitz ‘981 p. 22:2-5, Fig. 8); a lateral flow (LF) arrangement configured for absorbing said fluid, said LF arrangement comprising a test zone configured for coming into contact, in-vivo, with a predetermined substance present in said fluid or a compound comprising said substance, thereby causing a change in at least one property of said test zone (Rabinovitz ‘981 p. 7:16-20)]; and
at least one breach mechanism covering the at least one aperture for preventing ingress of fluid into the cavity via the at least one aperture, the at least one breach mechanism including a film layer adhered directly to an exterior of the shell surrounding the at least one aperture and configured to become breached upon exposure to gastrointestinal (GI) fluid of a person [the gate arrangement comprises a closure which is biodegradable and/or dissolvable, subject to the above predetermined conditions, to expose said inlet. In this case, the closure can be a thin film layer which may be adhered to the shell (Rabinovitz ‘981 p. 11:20-24); Plug 890 may be made of biodegradable material that degrades at an intended (predetermined) site/location in the GI tract (Rabinovitz p. 22:15-17, Fig. 8)].
However, Rabinovitz ‘981 fails to explicitly disclose wherein the immunoassay system includes a backing card juxtaposed with the test pad, wherein the backing card is made of a material allowing at least partial passage of light therethrough.
Rabinovitz ‘956 discloses a swallowable in-vivo device, wherein the device comprises an immunoassay system disposed within a cavity of a shell of the device and configured for interacting with fluid [chromatography strip 3 can come into contact with environmental fluids (e.g., body lumen fluids), and a fluid sample may be drawn into strip 3 (Rabinovitz ‘956 ¶0087)], the immunoassay system including a lateral flow strip extending between a fluid intake end and a distal end [Wick pad 14 of chromatography strip 3 (shown in FIG. 1) extends into chamber 9 and pulls fluid off reaction membrane 13 to allow the capillary flow along strip 3 to keep flowing in the proper direction and at the proper rate. Consequently, liquids drawn from exterior body lumens into tube 2 may easily move along chromatography strip 3 under capillary action (Rabinovitz ‘956 ¶0087, Fig. 1), wherein the Examiner notes that additional reference to Rabinovitz Figure 1 is to refer to portions of the chromatography strip 3 as used by Rabinovitz and not particularly any prior art strip as referred to by Rabinovitz ‘956 Figure 1 (see Rabinovitz ‘956 ¶¶0010-0011, which defines the lateral flow immunoassay chromatography strip as referred to in the invention of Rabinovitz)], the lateral flow strip including a test pad [reaction membrane 13 (Rabinovitz ‘956 Figs. 1, 4C)] and a backing card juxtaposed with the test pad [inert backing material 15 (Rabinovitz ‘956 Figure 1, Figure 4C)], wherein the backing card is made of a material allowing at least partial passage of light therethrough [As shown in FIG. 4C, the photodiodes 20 and 20' may be positioned very close to tube 2, just opposite to the detection zones. This may be done in order that each photodiode would sense only one respective zone on the chromatography strip. A single LED 19 may lights the strip from the side of tube 2, which is opposite the side of tube 2 where photodiodes 20 and 20' are positioned. Sensor 6 may be, but need not necessarily be, capable of acquiring an image of the chromatography strip or a portion thereof (Rabinovitz ‘956 ¶¶0102-0103, Figs. 4C), wherein the inert backing material 15 (backing card) allowing at least a portion of the light emitted from the LED 19 to reach the photodiodes 20,20’ (as depicted in Figure 4C) is considered to define a material allowing at least partial passage of light therethrough].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Rabinovitz ‘981 to employ wherein the immunoassay system includes a backing card juxtaposed with the test pad, wherein the backing card is made of a material allowing at least partial passage of light therethrough, as this modification would amount to mere simple substitution of one known element for another [the immunoassay system as assembled by Rabinovitz ‘981 for the immunoassay system as assembled by Rabinovitz ‘956] with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 6, Rabinovitz ‘981 in view of Rabinovitz ‘956 teaches
The swallowable in-vivo device according to claim 1, wherein the film layer is configured to erode over a period of exposure time to the GI fluid [Rabinovitz ‘981 p. 11:20-24, p. 22:15-17].
Regarding claim 7, Rabinovitz ‘981 in view of Rabinovitz ‘956 teaches
The swallowable in-vivo device according to claim 1, wherein the film layer is configured to prevent ingress of fluid into the at least one aperture before the film layer is breached [Rabinovitz ‘981 p. 11:20-24, p. 22:15-17].
Regarding claim 18, Rabinovitz ‘981 in view of Rabinovitz ‘956 teaches
The swallowable in-vivo device according to claim 1, wherein the film layer functions as an indicator that the in-vivo device has reached a desired location along the GI tract [Rabinovitz p. 22:15-17].
Regarding claim 19, Rabinovitz ‘981 in view of Rabinovitz ‘956 teaches
The swallowable in-vivo device according to claim 18, wherein the in-vivo device comprises a sensor behind the film layer [Capsule 800 may also have an optical section 870. Imager 850 and optical section 870 may have a field of view ("FOV") 880 such that imager 850, an example sensor, can take images of (sense) both test line 818 and control line 820 in order to enable, for example the on-board processor or controller, to determine, based on the visual state of the two lines (818, 820), whether the fluids tested by capsule 800 include a sought for fluid particles or substance(s) (Rabinovitz ‘981 p. 22:8-13, Fig. 8)], and the film layer is configured to be breached at the desired location along the GI tract [Rabinovitz p. 22:15-17], wherein, when the film layer is breached, the fluid triggers the sensor, thereby indicating that the in-vivo device has reached a desired location [wherein fluids being tested by capsule 800 at the desired location of the GI tract is considered to be indicative of the device reaching the desired location].
Claim(s) 8-16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rabinovitz ‘981 in view of Rabinovitz ‘956, as applied to claim 1 above, in further view of view of Iddan (US-8394034-B2, previously presented).
Regarding claim 8, Rabinovitz ‘981 in view of Rabinovitz ‘956 teaches
The swallowable in-vivo device according to claim 1.
However, Rabinovitz ‘981 is not specific regarding the composition of the film layer, such that Rabinovitz ‘981 in view of Rabinovitz ‘956 as presently modified fails to explicitly disclose wherein the film layer comprises a combination of at least the following materials: a cut-off active material having a threshold response to a specific substance of the GI fluid or to a specific parameter of the GI fluid; a plasticizer configured, together with the cut-off active material, for forming the film layer; and an auxiliary active material.
Rabinovitz ‘956 does disclose a breach mechanism that comprises a cut-off active material having a threshold response to a specific substance of the GI fluid or to a specific parameter of the GI fluid [plug 7 is made of a polymethacrylate polymer, such as Eudragit.RTM., which dissolves at rising pH values, for example, when in vivo diagnostic device 100 reaches the pylorus. The different grades of commercially available Eudragit.RTM. can be combined with each other, making it possible to adjust the dissolution pH, and thus to achieve the required GI targeting for conducting the test. An example of material that would result in opening of plug 7 in a time-dependent manner is Parylene.RTM. C, which is a coated hydrogel polymer, such as ethyl cellulose acetate (Rabinovitz ‘956 ¶0088-0089)].
Iddan discloses a swallowable in-vivo device [see Iddan Abstract; see also previously applied § 102 rejection under Iddan in Non-Final Rejection dated 16 September 2024], wherein Iddan discloses a breach mechanism including a film layer configured for reacting with GI fluid and configured to be breached after a predetermined amount of exposure time to gastrointestinal (GI) fluid of a person [As device 10 travels through the body lumen, and comes in contact with, for example, body lumen fluids, one or more of gates 16 may begin to dissolve. In one embodiment, gate 16A, having the least volume, may dissolve first, thus gate 16A may "open" first and may allow fluid into inlet 14A first. Similarly, gate 16B may dissolve after gate 16A, and may therefore "open" after gate 16A; fluid may then flow into inlet 14B. Gate 16C may dissolve after gate 16B, and thus may "open" to allow fluid into inlet 14C. Other properties of the gates 16 and/or gate materials may determine the rate, speed, sequence and/or timing of the gates 16 opening… gates 16D, 16E and 16F may be made of, for example, a pH sensitive material. Gate 16D may be sensitive to a pH of 4-6, for example, whereas gate 16E may be sensitive to a pH of 6-7, for example, and gate 16F may be sensitive to a pH of 7-8. Other suitable values or ranges may be used. According to some embodiments, the different gates 16 may dissolve with different kinetics at different pH levels (Iddan Col 7:11-21,28-34)] to allow fluid to interact with an immunoassay system covered by the film layer [sampling chambers and/or wells my include reagents or indicators that may be configured to react with a sample or with components of a sample to give indication of, for example, substances or a concentration of substances within the sample. Such reagents or indicators may include, for example, proteins or other biologically active molecules, color indicators, ions or larger charged molecules, or the like. A reaction occurring in a sampling chamber or well may cause changes in the well, such as an optical or electrical change; an indication of the change, or data representing properties of the change, may be transmitted externally from the body, for example, by imaging the wells, and may be detected by an external operator. An imager within the in-vivo device may partially or completely include a sampling chamber or well, and may image the chamber, and such images may be transmitted from the device to an external receiver/recorder (Iddan Col 11:27-43)], wherein the film layer comprises a combination of at least the following materials: a cut-off active material having a threshold response to a specific substance of the GI fluid or to a specific parameter of the GI fluid; a plasticizer configured, together with the cut-off active material, for forming the film layer; and an auxiliary active material [Additionally or alternatively, different materials, having different properties which may affect their dissolving rates, may be used in the different gates 16. According to some embodiments, a combination of materials may be used to achieve differential dissolving of gates 16. Some dissolvable materials according to embodiments of the invention may include biocompatible degradable materials, for example, polymers such as polyethylene glycol, natural materials such as polysaccharose, wax, lipophilic material of plant origin, hydrocarbons and any other suitable material or combination of materials. In some embodiments, additives, for example, hydrogel polymers, may be used to impart, e.g., mechanical strength, and/or to determine dissolving kinetics, for example, based on the extent of the hydrogel polymer cross linking, its concentration, its thickness, or the like. According to some embodiments, additives, such as, for example, those used in pharmaceutical preparations, may be included in the dissolvable material(s) (Iddan Col 6:60-7:10)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the film layer of the swallowable in-vivo device of Rabinovitz ‘981 in view of Rabinovitz ‘956 to comprise a combination of at least the following materials: a cut-off active material having a threshold response to a specific substance of the GI fluid or to a specific parameter of the GI fluid; a plasticizer configured, together with the cut-off active material, for forming the film layer; and an auxiliary active material, so as to impart mechanical strength to the film layer and to allow for particular dissolving kinetics [Iddan Col 6:60-7:10].
Regarding claim 9, Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan teaches
The swallowable in-vivo device according to claim 8, wherein the cut-off active material is an enteric material configured for reacting with the GI fluid [see § 103 modification of claim 8 above; Rabinovitz ‘956 ¶¶0088-0089].
Regarding claim 10, Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan teaches
The swallowable in-vivo device according to claim 8, wherein the cut-off active material remains inactive until a pH level of the GI fluid is one of under or over a threshold pH level [see § 103 modification of claim 8 above; Rabinovitz ‘956 ¶¶0088-0089].
Regarding claim 11, Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan teaches
The swallowable in-vivo device according to claim 1.
While Rabinovitz ‘956 teaches “different grades of commercially available Eudragit.RTM. can be combined with each other, making it possible to adjust the dissolution pH, and thus to achieve the required GI targeting for conducting the test” [¶0088], Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan does not explicitly teach wherein the film layer contains between 40-98% of enteric material. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP 2144.05 II. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the film to dissolve in the desired location of the GI.
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the ranges recited in claim 11 are somehow ‘critical’ or lead to unexpected results.
Regarding claim 12, Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan teaches
The swallowable in-vivo device according to claim 8, wherein the plasticizer is selected from the group consisting of triethyl citrate glycols, diesters and triesters of acids, diesters and triesters of alcohols, natural oils, and Polyethylene Glycols [see § 103 modification of claim 8 above; Iddan Col 6:60-7:10].
Regarding claim 13, Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan teaches
The swallowable in-vivo device according to claim 12, wherein the plasticizer is propylene glycol or polyethylene glycol (PEG). The swallowable in-vivo device according to claim 9, wherein the amount of plasticizer in the film layer is the complement of the enteric material to 100% [see § 103 modification of claim 8 above; Iddan Col 6:60-7:10].
Regarding claim 14, Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan teaches
The swallowable in-vivo device according to claim 9.
However, the modified Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan fails to explicitly disclose wherein the amount of plasticizer in the film layer is the complement of the enteric material to 100%. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP 2144.05 II. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amounts of the disclosed materials for the film to dissolve in the desired location of the GI.
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the ranges recited in claim 14 are somehow ‘critical’ or lead to unexpected results.
Regarding claim 15, Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan teaches
The swallowable in-vivo device according to claim 8.
However, the modified Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan fails to explicitly disclose wherein the amount of plasticizer in the film layer ranges from 60-2%. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP 2144.05 II. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of plasticizer for the film to dissolve in the desired location of the GI.
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the ranges recited in claim 15 are somehow ‘critical’ or lead to unexpected results.
Regarding claim 16, Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan teaches
The swallowable in-vivo device according to claim 8, wherein the auxiliary active material is configured for providing the film layer with additional resilience [see § 103 modification of claim 8 above; Iddan Col 6:60-7:10].
Regarding claim 20, Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan teaches
The swallowable in-vivo device according to claim 16.
However, the modified Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan fails to explicitly disclose wherein the amount of auxiliary active material is provided as being between 2-40% of the combined weight of the cut-off material and the plasticizer. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP 2144.05 II. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amounts of the disclosed materials for the film to dissolve in the desired location of the GI.
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the ranges recited in claim 20 are somehow ‘critical’ or lead to unexpected results.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan, as applied to claim 8 above, and in further view of Hadley (US-20170245742-A1, previously presented).
Regarding claim 17, Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan teaches
The swallowable in-vivo device according to claim 8.
However, the modified Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan fails to explicitly disclose wherein the auxiliary active material is a hydro-swelling enteric polymer configured for retaining fluid within the film layer before the film layer is breached.
Hadley discloses a swallowable in-vivo device, wherein Hadley teaches wherein the auxiliary active material is a hydro-swelling enteric polymer configured for retaining fluid within the film layer before the film layer is breached [The coating may not necessarily be related to pH or enzyme. For example, the coating material may just slow the dissolution of the gel capsule to cause a timed coating so that the coating is expected to dissolve within a period of time. The timed coating may have double layer structures with inner coating being ionic and outer layer being any of the above enteric coatings. Water diffuses through the enteric coating into the ionic coating, which absorbs the water and once a sufficient amount of water has been absorbed by the inner layer the outer coating cracks which allow the whole coating matrix to come off (Hadley ¶0040); wherein the coating has a double layer structure with inner coating being ionic and outer layer being an enteric coating, wherein water diffuses through the enteric coating into the ionic coating, which absorbs the water and once a sufficient amount of water has been absorbed by the inner layer the outer coating cracks which allow the whole coating matrix to come off (Hadley claim 26)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the film layer of Rabinovitz ‘981 in view of Rabinovitz ‘956 and Iddan, such that it withstands a corrosive environment until the desired location is reached [Hadley ¶0040].
Claim(s) 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rabinovitz ‘981, as applied to claim 59 above, in view of Rabinovitz (US-20140206956-A1, previously presented), hereinafter Rabinovitz ‘956.
Regarding claim 60, Rabinovitz ‘981 teaches
The swallowable in-vivo device according to claim 59, the chromatographic strip including a lateral flow strip extending between a fluid intake end and a distal end, the lateral flow strip including a test pad and the at least one aperture is radially aligned with the fluid-intake end of the lateral flow strip along the longitudinal axis [Rabinovitz ‘981 p. 22:2-5, Fig. 8].
However, Rabinovitz ‘981 fails to explicitly disclose wherein the immunoassay system includes a backing card juxtaposed with the test pad, wherein the backing card is made of a material allowing at least partial passage of light therethrough.
Rabinovitz ‘956 discloses a swallowable in-vivo device, wherein the device comprises an immunoassay system disposed within a cavity of a shell of the device and configured for interacting with fluid [Rabinovitz ‘956 ¶0087], the immunoassay system including a lateral flow strip extending between a fluid intake end and a distal end [Rabinovitz ‘956 ¶0087, Fig. 1, wherein the Examiner notes that additional reference to Rabinovitz Figure 1 is to refer to portions of the chromatography strip 3 as used by Rabinovitz and not particularly any prior art strip as referred to by Rabinovitz ‘956 Figure 1 (see Rabinovitz ‘956 ¶¶0010-0011, which defines the lateral flow immunoassay chromatography strip as referred to in the invention of Rabinovitz)], the lateral flow strip including a test pad [reaction membrane 13 (Rabinovitz ‘956 Figs. 1, 4C)] and a backing card juxtaposed with the test pad [inert backing material 15 (Rabinovitz ‘956 Figure 1, Figure 4C)], wherein the backing card is made of a material allowing at least partial passage of light therethrough [Rabinovitz ‘956 ¶¶0102-0103, Figs. 4C, wherein the inert backing material 15 (backing card) allowing at least a portion of the light emitted from the LED 19 to reach the photodiodes 20,20’ (as depicted in Figure 4C) is considered to define a material allowing at least partial passage of light therethrough].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Rabinovitz ‘981 to employ wherein the immunoassay system includes a backing card juxtaposed with the test pad, wherein the backing card is made of a material allowing at least partial passage of light therethrough, as this modification would amount to mere simple substitution of one known element for another [the immunoassay system as assembled by Rabinovitz ‘981 for the immunoassay system as assembled by Rabinovitz ‘956] with similar expected results [MPEP § 2143(I)(B)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 6-8, filed 10 November 2025, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rabinovitz ‘981 in view of Rabinovitz ‘956.
The Applicant asserts that Rabinovitz ‘956 does not disclose “a shell defining a longitudinal axis and a cavity of the in-vivo device, the shell forming an outermost surface of the in-vivo device and including at least one radially oriented aperture formed in a circumferential wall portion of the shell and configured for allowing ingress of fluid into the cavity” [emphasis applied by Applicant], wherein the Applicant notes that the transparent tube 2 of Rabinovitz ‘956 [which was applied to read to read on the claimed shell] as being an internal component of the device 100 of Rabinovitz ‘956, such that the in-vivo device of Rabinovitz ‘956 comprises a different structural arrangement from what is claimed. However, the Applicant’s arguments with respect to claim(s) 1 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. Rabinovitz ‘981, which was not previously applied to teach the argued subject matter, is now applied to teach the argued subject matter regarding “a shell defining a longitudinal axis and a cavity of the in-vivo device, the shell forming an outermost surface of the in-vivo device and including at least one radially oriented aperture formed in a circumferential wall portion of the shell and configured for allowing ingress of fluid into the cavity” [a capsule or other unit where all the components are substantially contained within a housing, case or shell, and where the device does not require wires or cables in order to receive power or transmit information, for example (Rabinovitz p. 17:7-9); Fig. 8 schematically illustrates an in-vivo device ("capsule") according to an example embodiment… Plug 890 may be made of biodegradable material that degrades at an intended (predetermined) site/location in the GI tract (Rabinovitz ‘981 p. 22:1-2,15-1); the gate arrangement comprises a closure which is biodegradable and/or dissolvable, subject to the above predetermined conditions, to expose said inlet. In this case, the closure can be a thin film layer which may be adhered to the shell (Rabinovitz ‘981 p. 11:20-24), wherein as depicted in Fig. 8, capsule 800 extends along a longitudinal length and plug 890 is radially positioned to define a closure for an aperture formed in a circumferential wall of capsule 800 to prevent ingress of fluid into the cavity of capsule 800 until the plug 890 dissolves].
The Applicant further asserts that Rabinovitz ‘956 fails to describe or suggest “at least one breach mechanism covering the at least one aperture [of the shell forming an outermost surface of the in-vivo device] for preventing ingress of fluid into the cavity via the at least one aperture, the at least one breach mechanism including a film layer adhered directly to an exterior of the shell surrounding the at least one aperture and configured to become breached upon exposure to gastrointestinal (GI) fluid of a person”, wherein the Applicant notes that the sealing element 7 of Rabinovitz ‘956 does not cover a radially oriented aperture formed in a circumferential wall portion of an outermost surface of the device. However, the Applicant’s arguments with respect to claim(s) 1 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. Rabinovitz ‘981, which was not previously applied to teach the argued subject matter [specifically in light of the amendment to recite wherein the shell forms an outermost surface of the in-vivo device], is now applied to teach the argued subject matter regarding “at least one breach mechanism covering the at least one aperture [of the shell forming an outermost surface of the in-vivo device] for preventing ingress of fluid into the cavity via the at least one aperture, the at least one breach mechanism including a film layer adhered directly to an exterior of the shell surrounding the at least one aperture and configured to become breached upon exposure to gastrointestinal (GI) fluid of a person” [the gate arrangement comprises a closure which is biodegradable and/or dissolvable, subject to the above predetermined conditions, to expose said inlet. In this case, the closure can be a thin film layer which may be adhered to the shell (Rabinovitz ‘981 p. 11:20-24); Plug 890 may be made of biodegradable material that degrades at an intended (predetermined) site/location in the GI tract (Rabinovitz p. 22:15-17, Fig. 8)].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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