DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 30, 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 35-53 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-8, 11, 12, 14, 20, 33, 34, 44-46, and 48 of U.S. Patent No. 11,179,341 in view of Imran (US 2011/0160699). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses a self-righting article, comprising: a payload portion configured to comprise an active pharmaceutical ingredient for release internally of a subject that ingests the self-righting article (Col. 99, lines 55-57 disclose an ingestible self-righting article), wherein the self-righting article is a monostatic body due to a center of mass of the self- righting article and/or the shape of the self-righting article, such that the self-righting article has a single stable resting position (Col. 99, lines 57-63 disclose a torque value consistent with a monostatic body as claimed), wherein, upon obtaining the single stable resting position, the self-righting article is oriented in a direction such that the active pharmaceutical ingredient is released directly into a tissue of the subject (Col. 99, lines 55-56 disclose a payload portion carrying an agent for release at the target site). The patent fails to disclose that a tissue-engaging surface of the self-righting article is configured to contact a surface of a tissue of the subject and that the pharmaceutical is released through the tissue-engaging surface directly into the tissue of the subject.
Imran teaches (e.g., Figure 2) a swallowable drug delivery device comprising a tissue engaging surface (comprising aperture 26, Figure 2) which is configured to contact a surface of a tissue of the subject (e.g., intestinal wall as depicted in Figure 8b) to release an active pharmaceutical ingredient through the tissue engaging surface directly into the tissue of the subject (paragraphs [0122], [0128], and [0132] disclose the tissue penetrating member 40 passing into the tissue of the intestinal wall).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the patent device to align the weighed section of the capsule to comprise the tissue engagement feature of Imran, since Imran teaches that, for swallowable capsules, it is desired to align a drug delivery portion of the device with the target tissue that it is intended to interface with. In this manner, the patent and Imran teach a weighted capsule with a single stable resting surface, and that it would be obvious to place the delivery portion of the device at the location of the device which engages the tissue so as to deliver a drug to such tissue during a procedure.
Regarding claims 36 and 37, the subject matter is known from claim 2 of the patent which teaches, as set forth above for claim 35, a monostatic body having a single stable resting position as claimed (e.g., a gomboc shape).
Regarding claim 38, the subject matter is known from claim 4 of the patent.
Regarding claim 39, the subject matter is known from claim 5 of the patent.
Regarding claim 40, the subject matter is known from claim 6 of the patent.
Regarding claim 41, the subject matter is known from claim 7 of the patent.
Regarding claim 42, the subject matter is known from claim 8 of the patent.
Regarding claim 43, the subject matter is known from claim 11 of the patent.
Regarding claim 44, the subject matter is known from claim 12 of the patent.
Regarding claim 45, the subject matter is known from claim 14 of the patent.
Regarding claim 46, the subject matter is known from claim 20 of the patent.
Regarding claim 47, the subject matter is known from claim 33 of the patent.
Regarding claim 48, the subject matter is known from claim 34 of the patent.
Regarding claims 49 and 50, the subject matter is known from claim 44 of the patent.
Regarding claim 51, the subject matter is known from claim 45 of the patent.
Regarding claim 52, the subject matter is known from claim 46 of the patent.
Regarding claim 53, the subject matter is known from claim 48 of the patent.
Regarding claims 54 and 55, the subject matter is known from claim 28 of the patent which discloses the tissue interface component with the active pharmaceutical agent which would be released into the target tissue, internally of a subject, that ingests the capsule as modified by Imran.
Claims 35 and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 42 of co-pending Application No. 19/235,367 in view of Imran.
Regarding claim 35, the co-pending application discloses a self-righting article, comprising: a payload portion configured to comprise an active pharmaceutical ingredient for release internally of a subject that ingests the self-righting article (lines 2-3 of claim 23), wherein the self-righting article is a monostatic body due to a center of mass of the self-righting article (the self-righting article of claim 23 is considered to achieve such an effect based upon the location of its center of mass) and/or the shape of the self-righting article, such that the self-righting article has a single stable resting position, wherein, upon obtaining the single stable resting position, the self-righting article is oriented in a direction such that the active pharmaceutical ingredient is released directly into a tissue of the subject (lines 1-6 of claim 23 disclose the same self-righting article with a payload portion capable of release of a therapeutic with a single resting orientation; and claim 42 discloses directly releasing the payload portion into the target tissue). This is a provisional nonstatutory double patenting rejection. The co-pending application fails to teach the tissue-engaging surface of the self-righting article is configured to contact a surface of a tissue of the subject to release the drug directly into the tissue.
Imran teaches (e.g., Figure 2) a swallowable drug delivery device comprising a tissue engaging surface (comprising aperture 26, Figure 2) which is configured to contact a surface of a tissue of the subject (e.g., intestinal wall as depicted in Figure 8b) to release an active pharmaceutical ingredient through the tissue engaging surface directly into the tissue of the subject (paragraphs [0122], [0128], and [0132] disclose the tissue penetrating member 40 passing into the tissue of the intestinal wall).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the co-pending application device to align the weighed section of the capsule to comprise the tissue engagement feature of Imran, since Imran teaches that, for swallowable capsules, it is desired to align a drug delivery portion of the device with the target tissue that it is intended to interface with. In this manner, the patent and Imran teach a weighted capsule with a single stable resting surface, and that it would be obvious to place the delivery portion of the device at the location of the device which engages the tissue so as to deliver a drug to such tissue during a procedure.
Regarding claim 36, the co-pending application discloses a self-righting article configured for administration to a subject, wherein the self-righting article is configured for delivery of an active pharmaceutical ingredient to the subject (lines 1-3 of claim 23), and wherein the self-righting article is a monostatic body due to a center of mass of the self-righting article and/or the shape of the self-righting article, such that the self-righting article has a single stable resting position (the self-righting article of claim 23 is considered to achieve such an effect based upon the location of its center of mass), wherein, upon obtaining the single stable resting position, the self-righting article is oriented in a direction such that the active pharmaceutical ingredient is released directly into a tissue of the subject (lines 1-6 of claim 23 disclose the same self-righting article with a payload portion capable of release of a therapeutic with a single resting orientation; and claim 42 discloses directly releasing the payload portion into the target tissue). This is a provisional nonstatutory double patenting rejection. The co-pending application fails to teach the tissue-engaging surface of the self-righting article is configured to contact a surface of a tissue of the subject to release the drug directly into the tissue.
Imran teaches (e.g., Figure 2) a swallowable drug delivery device comprising a tissue engaging surface (comprising aperture 26, Figure 2) which is configured to contact a surface of a tissue of the subject (e.g., intestinal wall as depicted in Figure 8b) to release an active pharmaceutical ingredient through the tissue engaging surface directly into the tissue of the subject (paragraphs [0122], [0128], and [0132] disclose the tissue penetrating member 40 passing into the tissue of the intestinal wall).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the co-pending application device to align the weighed section of the capsule to comprise the tissue engagement feature of Imran, since Imran teaches that, for swallowable capsules, it is desired to align a drug delivery portion of the device with the target tissue that it is intended to interface with. In this manner, the patent and Imran teach a weighted capsule with a single stable resting surface, and that it would be obvious to place the delivery portion of the device at the location of the device which engages the tissue so as to deliver a drug to such tissue during a procedure.
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.
Claim(s) 35, 36, and 47-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullick et al. (US 2003/0167000) in view of Kawano et al. (US 2009/0005639), and further in view of Imran (US 2011/0160699).
Regarding claims 35 and 36, Mullick et al. (henceforth Mullick) discloses a self-righting article, comprising: a payload portion (e.g., paragraph [0077] discloses the injection of dyes for imaging or treatment ports for delivering local currents; and paragraph [0080] discloses the use of needles with epinephrine as being infused through the tool 300) configured to comprise an active pharmaceutical ingredient for release internally of a subject that ingests the article, wherein the self-righting article is has a single stable resting position (e.g., paragraph [0019] discloses that the capsule may be weighted so as to maintain a particular orientation within the stomach; paragraph [0080] also discloses the operation of the device as controlled with the weight positioning), wherein, upon obtaining the single stable resting position, the self-righting article is oriented in a direction such that the active pharmaceutical ingredient is released directly into a tissue of the subject (the claim still only requires that the device be capable of release of a pharmaceutical agent at the site and not from the actual interaction of the resting surface of the device with the tissue site; see e.g., Figure 10 depicting a treatment tool 300 for injection at the site as per paragraph [0080]). Mullick fails to explicitly disclose that the capsule is embodied as a monostatic body as claimed and fails to explicitly disclose the cited embodiment as weighted in the claimed manner, or that a tissue engaging surface of the self-righting article is configured to contact a surface of a tissue of the subject such that the active pharmaceutical is released through the tissue engaging surface directly into the tissue of the subject.
Kawano et al. (henceforth Kawano) teaches a medical capsule apparatus (3, Figure 2) which is weighted in such a way so as to stabilize the posture of the capsule after delivery around a single stable resting position (paragraph [0077] discloses the capsule is weighed so as to balance around a single point on the base which is considered monostatic as claimed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the capsule of Mullick to comprise the center of gravity placement taught by Kawano so as to maintain the capsule in a desired orientation during a procedure as taught by Kawano.
As above, Mullick/Kawano fail to explicitly disclose aligning the tissue-engagement portion of the device with the target tissue so as to deliver a therapeutic directly to the desired tissue.
Imran teaches (e.g., Figure 2) a swallowable drug delivery device comprising a tissue engaging surface (comprising aperture 26, Figure 2) which is configured to contact a surface of a tissue of the subject (e.g., intestinal wall as depicted in Figure 8b) to release an active pharmaceutical ingredient through the tissue engaging surface directly into the tissue of the subject (paragraphs [0122], [0128], and [0132] disclose the tissue penetrating member 40 passing into the tissue of the intestinal wall).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Mullick/Kawano to align the weighed section of the capsule to comprise the tissue engagement feature of Imran, since Imran teaches that, for swallowable capsules, it is desired to align a drug delivery portion of the device with the target tissue that it is intended to interface with. In this manner, the patent and Imran teach a weighted capsule with a single stable resting surface, and that it would be obvious to place the delivery portion of the device at the location of the device which engages the tissue so as to deliver a drug to such tissue during a procedure.
Regarding claim 47, Imran further teaches wherein the self-righting article comprises a self-actuating component (spring 80 and release element 70; paragraph [0136]) comprising a spring (80) and a support material (70) adapted to maintain the spring in at least a partially compressed state and structured for at least partial degradation when exposed to a biological fluid (paragraph [0136] discloses that the release element degrades to release the spring; see also paragraphs [0140] and [0141]). It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the degradable release mechanism of Imran with the device of Mullick/Kawano so as to provide a means of releasing the drug only after sufficient time to degrade the release element, thereby controlling the timing of delivery at the desired site, as taught by Imran.
Regarding claim 48, Mullick/Kawano/Imran fail to explicitly disclose the ambient compressive strain placed on the spring, however, there is no evidence of record that establishes that changing the level of preload (it is understood that the spring of Rudel is preloaded to apply a compressive force on the medicament in the chamber) would result in a difference in function of the combined device. Furthermore, one of ordinary skill in the art, being faced with modifying the combined device would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed spring preload value. Lastly, Applicant has not disclosed that the claimed spring preload solves any stated problem, indicating a variety of return load values and a disclosure that other reversibly compressive material other than springs could function in the desired manner (e.g., paragraph [0218]) and therefore there appears to be no criticality placed on the value as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the combined device of Mullick/Kawano/Imran/Rudel to have the spring under at least 5% compressive strain under ambient conditions as an obvious matter of design choice within the skill of the art.
Regarding claim 49, Mullick/Kawano/Imran/Rudel further teach wherein the self-righting article comprises a tissue interfacing component (Imran teaches the penetrating member 40 extending from the tissue-interfacing component of the device as depicted in Figure 2).
Regarding claim 50, as set forth above for claim 47, the modified device of Mullick/Kawano/Imran comprises a spring (spring 80 Imran; Figure 2).
Regarding claim 51, Mullick further discloses a biopsy component (e.g., Abstract discloses biopsy forceps as part of the device).
Regarding claim 52, the device of Mullick/Kawano/Imran comprises the active pharmaceutical agent in the form of the dissolvable drug matrix biased to be released during a procedure as set forth above for claim 47.
Regarding claim 53, Mullick/Kawano/Imran fail to explicitly disclose the amount of pharmaceutical agent relative to the needle weight, however, there is no evidence of record that establishes that changing the level of drug as a function of needle weight would result in a difference in function of the combined device but only the delivery of more or less therapeutic. Furthermore, one of ordinary skill in the art, being faced with modifying the combined device would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed weight. Lastly, Applicant has not disclosed that the drug weight as a percentage of needle weight solves any stated problem, indicating a variety of values and a disclosure that other values might result in physiologically relevant treatments (e.g., paragraph [0249]) and therefore there appears to be no criticality placed on the value as claimed such that it produces an unexpected result (e.g., more or less drug weight being delivered will inherently change the effect of the drug at the target site). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the combined device of Mullick/Kawano/Imran to have the active pharmaceutical weight be at least 10 wt% of the total needle weight depending on the amount of therapeutic desired to be delivered at the site. It is therefore an obvious matter of design choice within the skill of the art.
Regarding claims 54 and 55, Mullick/Kawano/Imran teach the invention substantially as set forth above for claims 35 and 36, and further teach wherein the payload portion comprises an outlet end (see outlet 26 of Imran which would be located at the single-stable resting surface in the modified device), in the single stable resting position, the outlet engages with the tissue of the subject and configured to comprise the active pharmaceutical ingredient for release internally of the subject that ingests the self-righting article (Figure 8b of Imran teaches direct tissue interface of penetrating member 40 into the target tissue; in the combined device, this would be located at the single-stable resting surface of the modified device).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullick in view of Kawano in view of Imran, and further in view of Shi et al. (US 2012/0305574).
Regarding claim 37, Mullick/Kawano/Imran teach the claimed invention substantially as set forth above for claim 35, but do not explicitly disclose a gomboc-type shape.
Shi et al. (henceforth Shi) teaches a self-righting object which is embodied as a gomboc-type shape (e.g., paragraph [0010]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the capsule of Mullick/Kawano/Imran to comprise a gomboc-type shape as it represents a well-known analogous self-righting shape which would achieve the same end properties of the capsule of Mullick/Kawano by maintaining the capsule in a desired orientation throughout use.
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullick in view of Kawano in view of Imran, and further in view of Cho et al. (US 2004/0106849).
Regarding claim 46, Mullick/Kawano/Imran teach the claimed invention substantially as set forth above for claim 35, but do not explicitly disclose the largest cross-sectional dimension of less than or equal to 2cm.
Cho et al. (henceforth Cho) teaches an ingestible capsule comprising a largest cross-sectional dimension of less than or equal to 2 cm (paragraph [0019] discloses a length of 3 cm or less and a diameter of 0.7-1 cm).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the capsule of Mullick/Kawano/Imran to comprise the claimed dimensions as Cho teaches that such a capsule size is sufficient for creating an ingestible pill device for use in a procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783