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 .
Amendment Entered
In response to the amendment filed on 12/15/2025 , amended claims 1, 3, 15-18, 24, 25, and 27 are entered, and claim 4 is cancelled. Claims 1-3, 6-7, 9, 12, 15-18, 20, and 23-27 are pending in the instant application.
Response to Amendment
Applicant’s remarks and amendments with respect to the specification and claims have been fully considered and overcome each and every objection and rejection under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed 06/18/2025. The objections and rejections are withdrawn in view of amendments to the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-3, 6-7, 9, 12, 15-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0216443 A1 to Duan et al. (“Duan”) in view of US 2017/0157043 A1 to Zalit et al. (“Zalit”).
Regarding independent claim 1, Duan discloses a magnetically actuated capsule (see abstract, “…magnetically controlled digestive tract liquid collection system and a capsule…”) comprising two portions connected to each other (see Fig. 2 and [0023], “…the capsule 120 comprises an inner shell 121, an outer shell 122, a first magnetic cylinder 123, a second magnetic cylinder 124 and an absorption medium 125…inner shell 121 and the outer shell 122 are matched with each other and are latched by rotation to form an entire shell of the capsule 120”, outer shell 122 and inner shell 121 (i.e., two portions) latch together by rotation to form a connection defining the capsule 120) for allowing reconfiguration of the capsule between a closed configuration and an open configuration (see Fig. 10 and [0057], “..rotation between the magnetic cylinders 123 and 124 drives the inner shell 121 and the outer shell 122 to rotate relatively, causing the liquid inlets 1215 and 1225 thereon to be misaligned, and thereby making the liquid inlets 1215 and 1225 closed or opened depending on whether an external magnetic field is applied or not”, relative rotation of inner shell 121 to outer shell 122 exposes (i.e., opened configuration) or conceals (i.e., closed configuration) liquid inlets), the portions defining a chamber enclosed within the capsule when the capsule is in the closed configuration (see Figs. 3 and 10 and [0028], “…first magnetic cylinder 123 and the second magnetic cylinder 124 are separated by a certain distance L, which is the thickness of the adsorption medium 125 sandwiched in the middle…a certain distance is kept between the two magnetic cylinders (the distance is the thickness of the adsorption medium 125)…”, distance L separates magnetic cylinder 123 (attached to inner shell 121) and magnetic cylinder 124 (attached to outer shell 122) an defines a space within capsule 120 (i.e., a chamber) when capsule 120 is in a closed configuration (i.e., liquid inlets are covered)), and defining an aperture exposing the chamber to an exterior of the capsule when the capsule is in the open configuration (see Fig. 10 and [0040], “…the two liquid inlets reach an alignment by rotation of the outer and inner shells, making the capsule 120 opened for liquid collection”, alignment of liquid inlets 1215 and 1225 of the inner shell and outer shell results in an opening into capsule 120), each portion comprising at least one permanent magnet (see Fig. 2 and [0023], “…first magnetic cylinder 123 is fixed in the inner shell 121…second magnetic cylinder 124 is fixed in the outer shell 122…”, magnetic cylinders 123 and 124) having a magnetic moment disposed in a direction opposite to the magnetic moment of the at least one permanent magnet in the other portion (see Fig. 3 and [0028], “…the N pole of the first magnetic cylinder 123 is on the left side, and the S pole is on the right side; the N pole of the second magnetic cylinder 124 is on the right side, and the S pole is on the left side. N-S directions of the two magnetic cylinders in this case are opposite…”) such that:
(i) an inter-magnet attraction force is generated to bias the capsule to the closed configuration (see Fig. 3 and [0028], “…in the case of constant end of the two magnetic cylinders face spacing, a certain distance is kept between the two magnetic cylinders…the N-S directions of the two magnetic cylinders are opposite, and the two magnetic cylinders are attracted by magnetic force…” attractive force between magnetic cylinders 123 and 124 maintain space between the magnetic cylinders and maintain capsule 120 in a closed position), and
(ii) the capsule in the closed configuration has a net magnetic moment that aligns with an externally applied magnetic field to actuate reconfiguration of the capsule to the open configuration when said magnetic field is applied (see Figs. 5 and 10 and [0031], “When the external magnetic field continues to infinitely approach the first magnetic cylinder 123 and the second magnetic cylinder 124, the N pole of the second magnetic cylinder 124 is deflected to the opposite side, and the first magnetic cylinder 123 and the second magnetic cylinder 124 are in the same direction, which the rotation torque generated between the two is the largest…” reconfiguration of S and N poles of magnets 123 and 124 of capsule 120 (i.e., indicative of a net magnetic moment of capsule 120) in response to applying external magnetic field 110, aligns magnets 123 and 124 with external magnetic field 110, and induces rotation of cylinders 123/124, configuring capsule 120 into an open position).
However, Duan fails to disclose a magnetically actuated capsule comprising two portions pivotally connected to each other for allowing reconfiguration of the capsule between a closed configuration and an open configuration.
Zalit teaches a gastroretentive dosing system (see abstract) including two arm portions connected to each other with a hinge assembly (see Fig. 1 and [0007], “…gastroretentive dosage form 70 may include two arms 71 releasably connected to each other by a hinge assembly 73…”) the hinge assembly pivotably connecting the two arm portions for moving between the open and closed configuration respectively (see Figs. 1-2 and [0007], “…the two arms 71 are capable of pivoting about the hinge assembly 73 from a collapsed configuration, as shown in FIG. 1B into an expanded configuration, as shown in FIG. 1A…”).
Although Duan fails to explicitly disclose a pivotal mechanism connecting the two portions of capsule 120, Duan further discloses actuation of the two portions relative to each other (see Duan [0030]). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the actuation mechanism of Duan (to incorporate the hinge mechanism of Zalit) for the purpose of pivoting the device between an open and closed configuration, as evidenced by Zalit (see [0007]). Additionally, It would have been obvious to one having ordinary skill in the art at the time the invention was made to pivotally actuate the portions of Duan, since it has been held that the provision of adjustability, where needed, involves routine skill in the art. In re Stevens, 101 USPQ 284 (CCPA 1954).
Furthermore, one of ordinary skill in the art would have had predictable success combining Duan and Zalit since both teachings relate to the same narrow field of endeavor, i.e., utilizing ingestible capsule systems to obtain various biometric data.
Regarding claim 2, the Duan/Zalit combination discloses the device as claimed in claim 1 above. The Duan/Zalit combination further discloses wherein the capsule further comprises a seal for sealing the chamber when the capsule is in the closed configuration, the seal being disposed between the portions of the capsule in the closed configuration (see Duan Fig. 9 and [0006], “…the outer shell and the inner shell are matched with each other and are rotationally sealed...”, rotational seal exists between the outer shell 122 and the inner shell 121).
Regarding claim 3, the Duan/Zalit combination discloses the device as claimed in claim 1 above. The Duan/Zalit combination further discloses wherein the capsule in the closed configuration comprises a cylindrical midsection (see Duan Fig. 10 and [0024], “…matching of the outer shell and the inner shell means that the outer shell has the same shape as the inner shell, can cooperate with each other and can be tightly coupled…outer shell and the inner shell are both in a hollow cylindrical shape…”, cylindrical shape of the intersection between outer and inner shell (i.e., cylindrical midsection)), wherein the portions are pivotally connected at a pivot point on the cylindrical midsection of the capsule (see Duan Fig. 7 and [0035], “…rotation limiting pin 1218 cooperates with the rotation limiting slot 1228 for rotationally engaging the inner shell 121 with the outer shell 122”, pivotably rotates inner shell 121 relative to outer shell 122), and wherein in the closed configuration the magnetic moment of the at least one permanent magnet in each portion is disposed within the portion at an angle α0 relative to a line which intersects the pivot point and which about perpendicularly intersects the cylinder axis of the cylindrical midsection of the capsule (see Duan Fig. 4 and [0030], “… in the state of use after assembly, an angle always exists between the lines connecting the N and S poles of the two magnetic cylinders. The angle α may be any one, provided that the two magnetic cylinders can rotate…the angle meets 0°<α<90°…”, state of use after assembly (i.e., closed configuration) when the angle existing between line connecting magnets 123 and 124 (i.e., permanent magnets disposed in each portion) is 90°, magnetic moment is parallel to a line intersecting the midpoint of cylindrical capsule 120, relative to cylindrical axis of the capsule).
Regarding claim 6, the Duan/Zalit combination discloses the device as claimed in claim 1 above. The Duan/Zalit combination further discloses wherein the portions are pivotally connected by a hinge (see Zalit Figs. 1-2 and [0007], “…the two arms 71 are capable of pivoting about the hinge assembly 73 from a collapsed configuration, as shown in FIG. 1B into an expanded configuration, as shown in FIG. 1A…”).
Regarding claim 7, the Duan/Zalit combination discloses the device as claimed in claim 1 above. However, the Duan/Zalit combination fails to disclose wherein the capsule comprises a soft outer shell.
Zalit further a gastroretentive dosing system (see abstract) including two arm portions made of polymer material (see Zalit [0009], “…two arms 71 may be made of any combination of active pharmaceutical ingredients (APIs), diagnostic devices or materials and/or various excipients and polymers…”, a polymer is interpreted as a “soft” material). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Duan/Zalit combination (to make outer shell 122 from a polymer material) for the purpose of enabling effective swallowing of the device, as evidence by Zalit (see [0004]). Additionally, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07.
Regarding claim 9, the Duan/Zalit combination discloses the device as claimed in claim 1 above. The Duan/Zalit combination further discloses wherein the capsule is configured to be swallowed and passed through the intestinal tract of a subject (see Duan [0022], “…the capsule 120 is microstructured and enters human digestive tract through the mouth…”, capsule 120 entering through the mouth and passing through to the digestive tract of a human (i.e., a subject) is interpreted as being swallowed).
Regarding claim 12, the Duan/Zalit combination discloses the device as claimed in claim 9/1 above. The Duan/Zalit combination further discloses wherein said capsule is adapted for collecting a sample from the intestinal tract or delivering one or more agents to the intestinal tract (see Duan [0041], “…the digestive liquid in the digestive tract can be collected for sampling…”, collect sample of digestive tract liquid (i.e., intestinal tract sample)).
Regarding claim 15, the Duan/Zalit combination discloses the device as claimed in claim 1 above. The Duan/Zalit combination further discloses a system comprising the capsule of claim 1 (capsule of the Duan/Zalit combination) and an external magnet (see Duan Fig. 5 and [0022], “…a magnetically controlled digestive tract liquid collection system 100 comprises an external magnet 110 and a capsule 120…”, magnet 110) for generating the magnetic field , wherein application of the magnetic field remotely actuates alignment of the capsule with the magnetic field to activate reconfiguration of the capsule from the closed configuration to the open configuration (see Duan Figs. 5 and 10 and [0031], “When the external magnetic field continues to infinitely approach the first magnetic cylinder 123 and the second magnetic cylinder 124, the N pole of the second magnetic cylinder 124 is deflected to the opposite side, and the first magnetic cylinder 123 and the second magnetic cylinder 124 are in the same direction, which the rotation torque generated between the two is the largest…” reconfiguration of S and N poles of magnets 123 and 124 of capsule 120 (i.e., indicative of a net magnetic moment of capsule 120) in response to applying magnetic field of magnet 110, aligns magnets 123 and 124 with external magnetic field of magnet 110, and induces rotation of cylinders 123/124, configuring capsule 120 into an open position).
Regarding claim 16, the Duan/Zalit combination discloses the device as claimed in claim 1 above. The Duan/Zalit combination further discloses a method of collecting a sample from the intestinal tract of a subject (see Duan [0041], “…the digestive liquid in the digestive tract can be collected for sampling…”, collecting sample from intestinal tract), the method comprising:
(a) providing the capsule of claim 1 in the closed configuration (of the Duran/Zalit combination) for ingestion by the subject (see Duan [0022], “…the capsule 120 is microstructured and enters human digestive tract through the mouth…”, capsule 120 entering through the mouth and passing through to the digestive tract of a human (i.e., a subject) is interpreted as being swallowed);
(b) applying the magnetic field to the subject to actuate reconfiguration of the capsule to the open configuration, thereby exposing the chamber of the capsule to the exterior of the capsule for collection of the sample in the chamber (see Duan Fig. 10 and [0032], “…when the external magnetic field approaches, both of the first magnetic cylinder 123 and the second magnetic cylinder 124 rotate…”, expose chamber (of Duan/Zalit combination) from closed position to open position with application of an external magnetic field);
(c) removing the magnetic field to actuate reconfiguration of the capsule to the closed configuration, thereby enclosing the sample in the chamber (see Duan Fig. 10 and [0040], “…When there is no external magnetic field, the two liquid inlets are covered mutually, making the capsule 120 closed”, no external magnetic field (i.e., removal of external magnetic field) reconfigures capsule (of the Duan/Zalit combination) to closed position); and
(d) allowing the capsule to transit through the intestinal tract (see Duan [0022], “…the capsule 120 is microstructured and enters human digestive tract through the mouth…”, transit through digestive tract) for recovery by stool passage (see Duan [0054], “…confirm that the capsule 120 has reached the colon”, microstructured capsule 120, passing through digestive tract and reaching the colon, is interpreted as recoverable by stool passage, as presence of capsule 120 in the colon indicates presence of fecal matter).
Furthermore, it has been held that when the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).
Regarding claim 17, the Duan/Zalit combination discloses the method as claimed in claim 16/1 above. The Duan/Zalit combination further discloses the step of (e) analyzing the sample contained in the recovered capsule so as to diagnose a disease or condition in the subject (see Duan [0004], “…the capsule for diagnosis and treatment of digestive tract conditions…”, diagnostic capsule for diagnosis and treatment of digestive conditions).
Although the Duan/Zalit combination is silent regarding analyzing the sample contained in the recovered capsule so as to diagnose a disease or condition in the subject, Zalit further teaches analyzing data collected by a recovered device (see Zalit [0063], “…transferring said data to an interface platform for analysis and/or health data management”). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Duan/Zalit combination to analyze a sample contained in the recovered sample for the purpose of diagnosing and treating digestive tract conditions, as evidence by Duan (see [0004]).
Regarding claim 23, the Duan/Zalit combination discloses the method as claimed in claim 16/1 above.
Although the Duan/Zalit combination is silent regarding wherein step (a) comprises providing more than one capsule to the subject to ingest in intervals, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the duan/Zalit combination to provide more than one capsule for a subject to ingest in intervals, for the purpose of accounting for gastric retention, as evidence by Zalit (see [0019]). Furthermore, the mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art. See In re Harza, 124 USPQ 378 (CCPA 1960) (see MPEP § 2144.04).
Regarding claim 18, the Duan/Zalit combination discloses the device as claimed in claim 1 above. The Duan/Zalit combination further discloses a method for delivering an agent to a subject, the method comprising:
(a) providing the capsule of claim 1 in the closed configuration (of the Duran/Zalit combination), the chamber of the capsule containing the agent (of the Duran/Zalit combination) for ingestion by the subject (see Duan [0022], “…the capsule 120 is microstructured and enters human digestive tract through the mouth…”, capsule 120 entering through the mouth and passing through to the digestive tract of a human (i.e., a subject) is interpreted as being swallowed);
(b) administering the capsule to the subject by ingestion;
(c) allowing the capsule to transit through the subject's intestinal tract; and
(d) applying the magnetic field to the subject to actuate reconfiguration of the capsule to the open configuration to dispense the agent contained in the chamber into the intestinal tract of the subject .
However, the Duan/Zalit combination fails to disclose “…delivering an agent to a subject… providing the capsule of claim 1 in the closed configuration, the chamber of the capsule containing the agent… applying an external magnetic field to the subject to actuate reconfiguration of the capsule to the open configuration to dispense the agent contained in the chamber into the intestinal tract of the subject”.
Zalit further teaches a gastroretentive device, containing a compartment, delivering an agent to the gastrointestinal tract (see Zalit [0041], “…delivering said stored gastroretentive dosage form on the compartment of the assembly unit upon operation of the actuation mechanism…”). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Duan/Zalit combination to deliver an agent to a subject (by dispensing the agent contained in the chamber of the capsule) for the purpose of controlled release of biologic agents and diagnostic formulations into the digestive tract, as evidenced by Zalit (see [0007]). Furthermore, it has been held that when the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).
Regarding claim 20, the Duan/Zalit combination discloses the device as claimed in claim 18/1 above. The Duan/Zalit combination further discloses wherein the agent is a biological agent or a non-biological agent (see Zalit [0007], “…controlled release of biologically active agents or diagnostic formulations…”).
Claims 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of Zalit, and further in view of US 2013/0303847 A1 to Sitti et al. (“Sitti”).
Regarding claim 24, the Duan/Zalit combination discloses the device as claimed in claim 1 above. The Duan/Zalit combination further discloses contacting the two portions to each other so as to allow the portions to magnetically connect to each other to form the capsule.
However, the Duan/Zalit fails to discloses a method of manufacturing the magnetically actuated capsule of claim 1 (of the Duan/Zalit combination).
Sitti teaches a method of manufacturing the magnetically actuated capsule of claim 1 (of the Duan/Zalit combination) method comprising:
(a) for each portion, providing a mold for forming the portion (see [0094], “…parts are manufactured by molding 3D printed parts by a soft polyurethane elastomer…”, mold for forming each portion), the mold comprising a chamber ridge for forming the chamber (see Figs. 1F-1G and [0084], “Upper head 122 and lower head 111 are assembled in an orientation having drug chamber 118 of upper head 122 opposing recess 111B of lower head 111 with gap 116…”, recess 111B (i.e., ridge) opposes upper head 122, forming chamber 118),
(b) mounting at least one permanent magnet to the mold, (see [0094], “…After the flexible molds are cured, internal magnets 112A, 112B are placed in the cavities of the mold… all parts are assembled together using the same polyurethane (e.g. ST-1060) as a bonding layer. Thus, except for electronics and magnets 112A, 112B, the whole body is made of polyurethane elastomer.”, internal (i.e., at least one permanent magnet) magnets mounted into mold on separate pieces), the at least one permanent magnet being positioned in the mold such that the two portions are biased to magnetically connect to each other to form the capsule (see [0084], “…Once assembled, drug chamber 118 is in opposing orientation to recess 111B of lower head 111 such that when base 118 B contacts recess 111B, resilient drug chamber 118 compresses or contracts as side linkages 126 blend or flex (discussed further below) as permanent magnets 112A, 112B are drawn toward each other due to a mutual magnetic attraction and/or an external force…”, positioning of magnets 112A and 112B allows assembly of drug chamber 118 to draw magnetic portions together)
(c) pouring a polymer in a liquid state into the mold and allowing the polymer to solidify, thereby forming the portion comprising the at least one permanent magnet (see [0094], “…polyurethane is poured onto the mold with magnets 112A, 112B. After the polyurethane is cured in room temperature… all parts are peeled separately”, polyurethane poured over magnet portion (i.e., liquid state polymer), allowed to cure (i.e., solidify), resulting in separable parts peeled separately (i.e., forming portion comprising at least one permanent magnet));
The Duan/Zalit combination discloses the device as claimed in claim 1 above, but fails to methods of manufacturing the device as claimed. Sitti teaches a method of manufacturing a capsule having two shell portions, using molding techniques involving polymers, and embedding magnets into capsule portions during manufacturing, such that alignment of both portions upon completion of manufacturing, both portions are drawn together.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to apply the method of manufacturing taught by Sitti, to the capsule disclosed by the Duan/Zalit combination, since it has been held that if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966.
Regarding claim 25, the Duan/Zalit/Sitti combination discloses the device and method as claimed in claim 24/1. The Duan/Zalit/Sitti combination further discloses wherein the mold further comprises a magnet holder for mounting the at least one permanent magnet, and wherein in step (b) the at least one permanent magnet is mounted on the magnet holder. (see [0094], “…After the flexible molds are cured, internal magnets 112A, 112B are placed in the cavities of the mold… all parts are assembled together using the same polyurethane (e.g. ST-1060) as a bonding layer. Thus, except for electronics and magnets 112A, 112B, the whole body is made of polyurethane elastomer.”, internal (i.e., at least one permanent magnet) magnets mounted into mold on separate pieces, in cavities (i.e., a magnet holder)).
Regarding claim 26, the Duan/Zalit/Sitti combination discloses the device and method as claimed in claim 24/1. The Duan/Zalit/Sitti combination further discloses wherein the method further comprises pivotally joining the portions to each other with a hinge at a pivot point (see Sitti Fig. 1E and [0155], “…the flexure hinge 130B becomes a pivot of the rotating…”, portions joined at hinge 130B (i.e., pivot point) to rotatably pivot).
Regarding claim 27, the Duan/Zalit/Sitti combination discloses the device and method as claimed in claim 26/24/1. The Duan/Zalit/Sitti combination further discloses wherein pivotally joining the portions to each other comprises pouring into a hinge mold a composite in a liquid state, the composite being a reinforced form of the polymer used to create the portions of the capsule and being flexible in the solid state (see Sitti [0094], “… master parts are made using a rapid prototyping machine…and the side linkage parts 126 are manufactured using a micro-wire electrical discharge machine…due to their complex geometry…flexible molds are made by casting the master parts by silicone rubber…”, silicone rubber (i.e., composite form of reinforced polymer) is used to cast (i.e., pouring in a liquid state) flexible molds around rapid prototype master parts), placing the capsule in the hinge mold containing the composite such that a longitudinal strip of the capsule surface spanning both portions contacts the composite, and allowing the composite to solidify, (see Siti [0094], “…the polyurethane is cured in room temperature…all parts are assembled together using the same polyurethane…as a bonding layer. Thus, except for electronics and magnets 112A, 112B, the whole body is made of polyurethane elastomer…”, assembly of components together, contacting composite of cast mold, bonded together using elastomeric polyurethane), thereby pivotally connecting the portions of the capsule to each other with a flexible composite hinge at the pivot point (see Siti [0083], “…Hinge ends 130A, 130C of side linkages 126 are fixedly attached to upper head 122 and lower head 111, respectively…”, attachment (i.e., bonding) of side links to capsule body to form flexible hinge at pivot point (of the Duan/Zalit/Sitti combination)).
Response to Arguments
Applicant's arguments filed 12/15/2025 with respect to the rejection of claims 1-3, 6, 7, 9, 12, 15-18, 20, and 23-27 under 35 U.S.C. § 103 have been fully considered but they are not persuasive.
Applicant argues that Examiner has not established the obviousness of claim 1 because Duan and Zalit, taken individually or in combination, fail to teach or suggest a magnetically actuated capsule comprising two portions pivotally connected to each other, as recited in claim 1. In particular, applicant argues that there is no teaching suggestion, or motivation to combine Duan and Zalit absent hindsight bias (see pg. 11-12 of remarks) because modifying the actuation mechanism of Duan with the actuation mechanism of Zalit would require reconfiguration of the magnetic capsule of Duan (see pg. 10 of remarks), further reciting technical advantages of the claimed invention (see pg. 12 of remarks).
However, a reference does not teach away from a claimed invention merely by expression a preference or an alternative feature. See In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004), "the prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed....". See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023), "a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed".
In response to applicant's argument that modifying the actuation mechanism of Duan (with the actuation mechanism of Zalit), the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the teachings of Duan and Zalit, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In the instant case, Examiner relies on Zalit for the teaching, suggestion, or motivation to combine the teachings of Duan and Zalit, so as to enable pivoting between an open and closed configuration, as discussed above (see Zalit [0007], “…connected to each other by a hinge assembly 73, wherein the two arms 71 are capable of pivoting about the hinge assembly…”).
Regarding Applicant’s citations of portions of the specification describing technical advantages of the claimed invention, MPEP § 2145 (II) states that the fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious, see Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985.
Applicant further argues that Duan and Zalit, taken individually or in combination, fail to teach or suggest the position of the magnets as claimed in amended claim 3 (see pg. 12 of remarks).
Examiner respectfully disagrees that the prior art of record does not teach the magnet position as claimed in amended claim 3. Examiner relies on Duan to teach an angle α0, relative to a line that intersects a pivot point, as described above (see Duan Fig. 4 and [0030], “…angle α may be any one, provided that the two magnetic cylinders can rotate… at least one of the magnetic cylinders rotates relative to the other one…”). Furthermore, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant further argues that Duan, Zalit, and Sitti, taken individually or in combination fail to teach or suggest the features recited in amended claim 27 above. In particular, applicant argues that Sitti fails to disclose hinge molding in which two halves of the magnetic capsule are bound together in addition to creating a hinge (see pg. 13 of remarks).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA P NOVAK whose telephone number is (703)756-1947. The examiner can normally be reached M-F: 8-5.
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/ALYSSA PAIGE NOVAK/Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791