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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 7, the instant claim constitutes an indefinite “use” claim inasmuch as it lacks any recitation toward the specific steps necessary to accomplish any particularly stated goal. Firstly, it is unclear if the intended use of the “vibrating ingestible capsule FOR promoting absorption of an ingested medicament into the blood stream” is in fact the goal of the method or if such limitations are merely directed toward capabilities of the vibrating ingestible capsule. Likewise, it is unclear if the functional language directed toward the “control mechanism” of the capsule is positively recited (or merely functionally recited) and therefore whether or not the method, as claimed, actually concerns itself with controlling the timing or activation delay of the capsule in order to coordinate its operation with the absorption period of the medicament. As such, the ordinary artisan would not be apprised as to what they could or could not do with a “vibrating ingestible capsule” without infringing upon the patent.
For the sake of prosecution, the functional limitations recited in Claim 7 will be understood to comprise positively recited method steps which are executed when paired with ingestion of the capsule and medicament to accomplish the stated purpose of promoting absorption as claimed.
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
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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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
12/15/2025