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 .
Election/Restrictions
Applicant’s election without traverse of Species Set A, Species XXVIII in the reply filed on 05/04/2026 is acknowledged.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature(s) canceled from the claim(s).
the trigger –plug 4508-- of Species Set A, Species XXVIII, with the rupturable element
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 24 is objected to because of the following informalities.
Claim 24 should read --The ingestible device of claim 17 wherein the at least one outlet comprises a nozzle configured to create a high-pressure jet of the dispensable substance able to penetrate an intestinal wall.--
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to Claim 17, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims “a trigger configured to actuate the device after the device is ingested”, “a rupturable element between the storage reservoir and the at least one outlet”, and “when the trigger is actuated, the force generator exerts pressure on the dispensable substance, rupturing the rupture element”. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain how the force generator is capable of rupturing the rupture element when the trigger is actuated.
Applicant elected Species Set A, Species XXVIII, which is shown in instant application Figure 45. Based on the claim language and Applicant’s remarks in the 05/04/2026 Remarks, it appears Applicant is integrating the structure of instant application Figure 46 into the species shown in Figure 45. However, these two figures are not compatible with each other. Instant application Paragraph 0436 describes plug 4508 as acting as the claimed trigger, by dissolving, allowing the pressure within reservoir 4505 to reduce, creating a pressure imbalance between reservoir 4505 and chamber 4503, forcing piston 4504 to the left –as viewed in Figure 45, which then forces a dispensable substance out via conduit 4509.
If the rupturable element –burst disc 4608 in Figure 46A—was integrated into the embodiment shown in Figure 45, the pressure imbalance described above by plug 4508 dissolving would not be able to occur, preventing plug 4508 from acting as a trigger, as claimed. As such, the original disclosure does not provide sufficient written description for the claimed ingestible device.
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.
Claims 17-25 are 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.
As to Claim 17, the limitation “a dispensable substance”, in Line 4, is indefinite. It is not clear if the dispensable substance in Line 4 is the same dispensable substance in Line 1, or if the two substances are different. For the purpose of examination, the two substances will be interpreted as the same substance.
The limitation “when the trigger is actuated, the force generator exerts pressure on the dispensable substance, rupturing the rupture element, with the dispensable substance flowing out of the housing as a jet of liquid from the at least one outlet”, in Lines 11-13, is indefinite. As described in the 112(a) rejection above, the claim does not have sufficient written support, since the claimed rupture element prevents the claimed trigger from acting as a trigger in the elected Species. As such, it is not clear how the claimed ingestible device is capable of rupturing the rupture element, and dispensing the substance simply by actuating the trigger 4508 in instant application Figure 45.
Additionally, it is not clear if the trigger being actuated in Line 11, is the same as the device being actuated in Line 6, since one of ordinary skill in the art would conclude actuating the trigger would also actuate the device. For the purpose of examination, the trigger actuation will be interpreted as the device actuation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17-19, 21-22 & 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gross (U.S. PGPub 2004/0253304).
As to Claim 17, Gross teaches an ingestible device (Figures 29A/29B) for delivery of a dispensable substance (106), comprising:
a housing (102);
a storage reservoir (the reservoir within 102, to the right of 122, as viewed in Figure 29A) in the housing (102) for storing (as shown in Figure 29A) a dispensable substance (106);
a force generator (118) configured to exert pressure on (Paragraph 0439) the dispensable substance (106) when the device is actuated (Paragraph 0439);
a trigger (the portion of 104 around driving mechanism, as viewed in Figure 29A) configured to actuate (Paragraph 0440) the device (Figures 29A/29B) after the device (Figures 29A/29B) is ingested (one of ordinary skill in the art would conclude the device was ingested, since the device is located in small intestine 120);
the storage reservoir (the reservoir within 102, to the right of 122, as viewed in Figure 29A) connecting with (as shown in Figure 29A) at least one outlet (the outlet within 102 through which the needle portion of 220 extends, as shown in Figure 29B, shown as 110 in other figures);
a rupturable element (the portion of 104 around outlet 110, as viewed in Figure 29A; Paragraphs 0464/0465) between (as shown in Figures 29A/29B) the storage reservoir (the reservoir within 102, to the right of 122, as viewed in Figure 29A) and the at least one outlet (the outlet within 102 through which the needle portion of 220 extends, as shown in Figure 29B, shown as 110 in other figures);
wherein when the trigger (the portion of 104 around driving mechanism, as viewed in Figure 29A) is actuated (Paragraph 0440), the force generator (118) exerts pressure on (Paragraph 0440) the dispensable substance (106), rupturing (Paragraphs 0464/0465) the rupture element (the portion of 104 around outlet 110, as viewed in Figure 29A; Paragraphs 0464/0465), with the dispensable substance (106) flowing out of the housing (102) as a jet of liquid from (Paragraph 0465) the at least one outlet (the outlet within 102 through which the needle portion of 220 extends, as shown in Figure 29B, shown as 110 in other figures).
As to Claim 18, Gross teaches all the limitations of Claim 17, and continues to teach the force generator (118) comprises a compressed gas (118, where the gas generated is compressed by 122 prior to decompressing as 122 moves to the right, as viewed in Figure 29A).
As to Claim 19, Gross teaches all the limitations of Claim 17, and continues to teach the force generator (118) comprises a gas generator (Paragraph 0439).
As to Claim 21, Gross teaches all the limitations of Claim 17, and continues to teach the trigger (the portion of 104 around driving mechanism, as viewed in Figure 29A) comprises a dissolvable material (Paragraph 0429).
As to Claim 22, Gross teaches all the limitations of Claim 17, and continues to teach the trigger (the portion of 104 around driving mechanism, as viewed in Figure 29A) comprises an enteric coating (Paragraph 0429; an enteric coating is being interpreted as a coating capable of dissolving within the intestines).
As to Claim 24, Gross teaches all the limitations of Claim 17, and continues to teach the at least one outlet (the outlet within 102 through which the needle portion of 220 extends, as shown in Figure 29B, shown as 110 in other figures) comprises a nozzle (as shown in Figure 29B) configured to create a high-pressure jet of dispensable substance (106)able to penetrate the intestinal wall (Paragraph 0465).
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.
Claims 20 & 25 are rejected under 35 U.S.C. 103 as being unpatentable over Gross.
As to Claim 20, Gross teaches all the limitations of Claim 17, but does not teach the force generator comprises at least one spring.
Gross continues to describe a piston as an alternative (Paragraph 0071) to a membrane, and teaches the use of a spring (200) to help actuate (Paragraph 0457) the piston (202)
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use a piston/spring combination instead of a membrane, as taught by Gross, since the two structures are alternatives to each other. Additionally, the use of a piston/spring combination is well-known, and yields predictable results, i.e., provides a reliable rigid structure capable of controlling pressure when actuated biased in a particular direction.
As to Claim 25, Gross teaches all the limitations of Claim 17, but does not teach a piston in the housing between the force generator and the storage reservoir, the piston slidable towards the at least one outlet when the device is actuated.
Gross continues to describe a piston as an alternative (Paragraph 0071) to a membrane, and teaches a piston (202) in the housing (102) between (as shown in Figure 27A) the force generator (200) and the storage reservoir (the reservoir within 102, to the right of 202, as viewed in Figure 27A), the piston (202) slidable towards (Paragraph 0459) the at least one outlet (110) when the device (100) is actuated (Paragraph 0458).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use a piston/spring combination instead of a membrane, as taught by Gross, since the two structures are alternatives to each other. Additionally, the use of a piston/spring combination is well-known, and yields predictable results, i.e., provides a reliable rigid structure capable of controlling pressure when actuated biased in a particular direction.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Aran (2017/0246438) and Balaban (5,456,679) describe similar devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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