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 .
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.
Claim(s) 7 and 15-24 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-17 of U.S. Patent No. 10,537,720. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 7, the ‘720 reference patent claims (see Clm. 16) a vibrating ingestible capsule configured to promote absorption of an ingested medicament into the blood stream, the capsule comprising:
a housing;
a vibrating agitation mechanism adapted such that, in a vibration mode of operation, said housing exerts vibrations on an environment surrounding said vibrating gastrointestinal capsule;
a power supply disposed within said housing and adapted to power said vibrating agitation mechanism; and
a control mechanism adapted to activate said vibrating agitation mechanism to operative in said vibration mode of operation, said control mechanism adapted to control a timing or activation delay of said vibration mode of operation such that said vibration mode of operation at least partially transpires within at least one of an estimated absorption time period and an actual absorption time period of said ingested medicament within said gastrointestinal tract of said subject.
While the ‘720 reference patent is silent as to this controlled timing or activation being a “first occurrence”, the lack of any claim limitations toward using the vibrational energy BEFORE the absorption time period (estimated or actual) clearly obviates practice of the invention wherein the claimed occurrence is the FIRST occurrence.
Regarding Claim 15, the ‘720 reference patent claims (see Clm. 1) a method of using a vibrating ingestible capsule in coordination with an ingestible medicament, the method comprising:
(a) providing the vibrating ingestible capsule, the capsule including:
a housing;
a vibrating agitation mechanism adapted such that, in a vibration mode of operation, said housing exerts vibrations on an environment surrounding the vibrating ingestible capsule;
a power supply disposed within said housing and adapted to power said vibrating agitation mechanism; and a control mechanism adapted to activate said vibrating agitation mechanism to operate in said vibration mode of operation;
(b) ingesting the ingestible medicament;
(c) ingesting the vibrating ingestible capsule; and
(d) controlling at least one of a time of said ingesting of the vibrating ingestible capsule and a timing or activation delay of said vibration mode of operation, such that a the vibration mode of operation at least partially transpires within at least one of an estimated absorption time period and an actual absorption time period of the ingestible medicament within the gastrointestinal tract of the subject.
While the ‘720 reference patent is silent as to this controlled timing or activation being a “first occurrence”, the lack of any claim limitations toward using the vibrational energy BEFORE the absorption time period (estimated or actual) clearly obviates practice of the invention wherein the claimed occurrence is the FIRST occurrence.
Clm. 16 maps to Clm. 2
Clm. 17 maps to Clm. 4
Clm. 18 maps to Clm. 5
Clm. 19 maps to Clm. 6
Clm. 20 maps to Clm. 7
Clm. 21 maps to Clm. 8
Clm. 22-23 is maps to Clm. 13
Clm. 24 maps to Clm. 14
Claim(s) 7 and 15-24 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-16 of U.S. Patent No. 10,543,348. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 7 and 15, the ‘348 reference patent Claims (see Clm. 1):
A method of using a vibrating ingestible capsule in coordination with an ingestible medicament, the method comprising:
(a) providing the vibrating ingestible capsule, the capsule including:
a housing;
a vibrating agitation mechanism adapted such that, in a vibration mode of operation, said housing exerts vibrations on an environment surrounding the vibrating ingestible capsule;
a power supply disposed within said housing and adapted to power said vibrating agitation mechanism; and a control mechanism adapted to activate said vibrating agitation mechanism to operate in said vibration mode of operation;
(b) ingesting the ingestible medicament;
(c) ingesting the vibrating ingestible capsule; and
(d) controlling at least one of a time of said ingesting of the vibrating ingestible capsule and a timing or activation delay of said vibration mode of operation, such that a first occurrence of said vibration mode of operation at least partially transpires within at least one of an estimated absorption time period and an actual absorption time period of the ingestible medicament within the gastrointestinal tract of the subject.
While the ‘348 reference patent is silent as to this controlled timing or activation being a “first occurrence”, the lack of any claim limitations toward using the vibrational energy BEFORE the absorption time period (estimated or actual) clearly obviates practice of the invention wherein the claimed occurrence is the FIRST occurrence.
Clm. 16 maps to Clm. 2
Clm. 17 maps to Clm. 4
Clm. 18 maps to Clm. 5
Clm. 19 maps to Clm. 6
Clm. 20 maps to Clm. 7
Clm. 21 maps to Clm. 8
Clm. 22-23 map to Clm. 12
Clm. 24 maps to Clm. 13
Claim(s) 7 and 15-18, 20-24 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-21 of U.S. Patent No. 10,814,113. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 7, the ‘113 reference patent claims (see Clm. 2):
a vibrating ingestible capsule comprising:a housing; a
vibrating agitation mechanism adapted such that, in a vibration mode of operation, said housing exerts vibrations on an environment surrounding said vibrating gastrointestinal capsule;
a power supply disposed within said housing and adapted to power said vibrating agitation mechanism; and a control mechanism adapted to activate said vibrating agitation mechanism to operative in said vibration mode of operation, said control mechanism adapted to control a timing or activation delay of said vibration mode of operation such that said vibration mode of operation at least partially transpires within at least one of an estimated absorption time period and an actual absorption time period of said ingested medicament within said gastrointestinal tract of said subject.
While the ‘113 reference patent is silent as to this controlled timing or activation being a “first occurrence”, the lack of any claim limitations toward using the vibrational energy BEFORE the absorption time period (estimated or actual) clearly obviates practice of the invention wherein the claimed occurrence is the FIRST occurrence.
Regarding Claim 15, the ‘113 reference patent claims (Clm. 8) a method of using a vibrating ingestible capsule in coordination with an ingestible medicament, the method comprising:
(a) providing the vibrating ingestible capsule, the capsule including:
a housing;
a vibrating agitation mechanism adapted such that, in a vibration mode of operation, said housing exerts vibrations on an environment surrounding the vibrating ingestible capsule;
a power supply disposed within said housing and adapted to power said vibrating agitation mechanism; and a control mechanism adapted to activate said vibrating agitation mechanism to operate in said vibration mode of operation;
(b) ingesting the ingestible medicament;
(c) ingesting the vibrating ingestible capsule; and
(d) controlling at least one of a time of said ingesting of the vibrating ingestible capsule and a timing or activation delay of said vibration mode of operation, such that said vibration mode of operation at least partially transpires within at least one of an estimated absorption time period and an actual absorption time period of the ingestible medicament within the gastrointestinal tract of the subject.
While the ‘113 reference patent is silent as to this controlled timing or activation being a “first occurrence”, the lack of any claim limitations toward using the vibrational energy BEFORE the absorption time period (estimated or actual) clearly obviates practice of the invention wherein the claimed occurrence is the FIRST occurrence.
Clm. 16 maps to Clm. 8
Clm. 17 maps to Clm. 8
Regarding Claims 18 and 21, while the ‘113 reference patent fails to explicitly disclose the exact timing (in hours), Examiner submits that the “absorption time” is clearly established by the claims to be a result effective variable and as such determining the optimal or workable range for any specific and particular medicament based on its understood absorption pattern with a specific patient is obvious.
Regarding Claim 20, to the extent that the device of the ‘113 has a “medicament tablet” provided in association with an integrated “medication compartment” ingestion is understood to be simultaneous in the practice of the method of Claim 8.
Regarding Claim 22-24, Examiner submits that these limitations constitute mere recognition of physiological responses to the vibrational energy applied in practice of the method of Claim 8 without requiring any modification to the claimed device.
Claim(s) 7 and 15-18, 20-24 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-19 of U.S. Patent No. 12,115,330. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 7 and 15, the ‘330 reference patent claims (Clm. 14) a method of using a vibrating ingestible capsule in coordination with an ingestible medicament, the method comprising:
(a) providing the vibrating ingestible capsule, the capsule including:
a housing;
a vibrating agitation mechanism adapted such that, in a vibration mode of operation, said housing exerts vibrations on an environment surrounding the vibrating ingestible capsule;
a power supply disposed within said housing and adapted to power said vibrating agitation mechanism; and a control mechanism adapted to activate said vibrating agitation mechanism to operate in said vibration mode of operation;
(b) ingesting the ingestible medicament;
(c) ingesting the vibrating ingestible capsule; and
(d) controlling at least one of a time of said ingesting of the vibrating ingestible capsule and a timing or activation delay of said vibration mode of operation, such that a said vibration mode of operation at least partially transpires within at least one of an estimated absorption time period and an actual absorption time period of the ingestible medicament within the gastrointestinal tract of the subject.
While the ‘330 reference patent is silent as to this controlled timing or activation being a “first occurrence”, the lack of any claim limitations toward using the vibrational energy BEFORE the absorption time period (estimated or actual) clearly obviates practice of the invention wherein the claimed occurrence is the FIRST occurrence.
Clm. 16-17 map to Clm. 14.
Regarding Claims 18 and 21, while the ‘113 reference patent fails to explicitly disclose the exact timing (in hours), Examiner submits that the “absorption time” is clearly established by the claims to be a result effective variable and as such determining the optimal or workable range for any specific and particular medicament based on its understood absorption pattern with a specific patient is obvious.
Regarding Claim 20, to the extent that the vibrating capsule is “associated” with the hollow medicament delivery compartment ingestion of the medicament and capsule is held to be simultaneous.
Regarding Claim 22-24, Examiner submits that these limitations constitute mere recognition of physiological responses to the vibrational energy applied in practice of the method of Claim 8 without requiring any modification to the claimed device.
Claim(s) 7 and 15-18, 20-24 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-24 of U.S. Patent No. 11,020,018. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 7 and 15, the ‘018 reference patent claims a vibrating ingestible capsule for promoting absorption of an ingested medicament into the blood stream, the vibrating ingestible capsule comprising:
a housing; a vibrating agitation mechanism adapted such that, in a vibration mode of operation, said housing exerts vibrations on an environment surrounding said vibrating gastrointestinal capsule;
a power supply disposed within said housing and adapted to power said vibrating agitation mechanism; and a control mechanism adapted to activate said vibrating agitation mechanism to operative in said vibration mode of operation, said control mechanism adapted to control a timing or activation delay of said vibration mode of operation such that said vibration mode of operation at least partially transpires within at least one of an estimated absorption time period and an actual absorption time period of said ingested medicament within said gastrointestinal tract of said subject.
While the ‘018 reference patent is silent as to this controlled timing or activation being a “first occurrence”, the lack of any claim limitations toward using the vibrational energy BEFORE the absorption time period (estimated or actual) clearly obviates practice of the invention wherein the claimed occurrence is the FIRST occurrence.
While Claim 16 does not particularly recite the “method” it is sufficient in the recitation of functional language and intended use to obviate providing the vibrating ingestible capsule, (b) ingesting the ingestible medicament; (c) ingesting the vibrating ingestible capsule; and (d) controlling at least one of a time of said ingesting of the vibrating ingestible capsule and a timing or activation delay of said vibration mode of operation as functionally described.
Clm. 16-17 map to Clm. 16.
Regarding Claims 18 and 21, while the ‘018 reference patent fails to explicitly disclose the exact timing (in hours), Examiner submits that the “absorption time” is clearly established by the claims to be a result effective variable and as such determining the optimal or workable range for any specific and particular medicament based on its understood absorption pattern with a specific patient is obvious.
Regarding Claim 20, to the extent that the vibrating capsule is paired with the medicament reservoir ingestion of the medicament and capsule is held to be simultaneous.
Regarding Claim 22-24, Examiner submits that these limitations constitute mere recognition of physiological responses to the vibrational energy applied in practice of the method of Claim 8 without requiring any modification to the claimed device.
Allowable Subject Matter
Claim(s) 15-24 is/are allowable over the prior art presuming satisfaction of the above noted Double Patenting issues.
Here, the closest analogous prior art pertains to U.S. Publication No. 2016/0136104 (“Nichel”), wherein Nichel differs from then claimed subject matter as Nichel does not explicitly concern itself with controlling the timing or activation of the vibrational mechanism to coincide within a period of time representing either an actual absorption time or estimated absorption time, the vibrational energy being used to promote absorption of an ingested medicament into the blood stream.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 06/15/2026
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