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 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 1, 3-9 and 17-22 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.
The subject matter which was not described in the original disclosure is “wherein the at least one substance is not a chemotherapeutic drug”, in combination with the other steps and/or elements in the claims.
The original disclosure did not contain a negative limitation directly discounting only one drug/substance (i.e. a chemotherapeutic drug), but allowing every other drug/substance. Negative limitations or exclusionary provisos must have support in the original disclosure (MPEP 2173.05i). In addition, this is a different range of drugs/substances than what was originally presented (e.g. para. 42, etc.).
Claim Objections
Applicant is advised that should claim 17 be found allowable, claim 19 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 19 appears to have the same limitations as claim 17.
Claim Rejections - 35 USC § 102
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 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 10-12 and 14-15 are rejected under 35 U.S.C. 102a1 as being anticipated by Smith et al (2021/0379362). Smith discloses the claimed limitations as follows:
--applying an alternating electric field (e.g. abstract, para. 32, etc.) to at least a portion of an abdomen (e.g. figure 12, paras. 27, 61, etc.) for a period of time (e.g. para. 35, 72 hours, etc.)
--where the subject has not been diagnosed with an abdominal cancer (e.g. paras. 3, 23-26 of other intestinal diseases, etc.)
--where the application of the alternating electric field increase permeability of at least a portion of an intestinal epithelia of the subject. Since Smith’s electric field contains the same/similar pulse parameters as the current application, and are applied to the same/similar area of the body, Smith will necessarily result in increasing the permeability of at least a portion of an intestinal epithelia and treat or reduce the occurrence of malabsorption.
For claims: 11, inflammatory bowel disease (e.g. paras. 3, 23-26, etc. and since Smith’s electric field is the same as the applicant’s, it will necessarily treat any of the other conditions; 12, similarly to claim 11, Smiths electric field will treat these parasitic infections--in addition, claim 12 does not state the selected condition is a parasitic infection and therefore any other disease besides parasitic selected/met in claim 11, will meet claim 12; 14, as the field is applied for 72 hours, it necessarily is for a sufficient time to reduce claudin-2 (as set forth by the applicant in para. 38 of their disclosure); 15; 50khz to 10 Mhz for 24-72 hours (e.g. paras. 21, 35, etc.).
Claims 1, 4-5, 7, 9-12, and 17-22 are rejected under 35 U.S.C. 102a1 as being anticipated by Gross et al (2005/0058701). Gross discloses the claimed limitations as follows:
--applying an alternating electric field (e.g. paras. 13, 250, etc.) to at least a portion of an abdomen (e.g. abstract, paras. 64, 65, etc.) for a period of time (e.g. para. 250, etc.)
--where the subject has not been diagnosed with an abdominal cancer (e.g. for blood pressure, heart problems, etc. paras. 161, 351, etc.)
--where the application of the alternating electric field increase permeability of at least a portion of an intestinal epithelia of the subject (e.g. abstract, paras. 65, 70, 248, etc.) and will necessarily increase absorption of an ingested substance and/or treat or reduce the occurrence of a malabsorption condition as the intestinal epithelia will have an increase permeability and/or will be treated with the same drugs as set forth by the applicant/claims.
-- orally administering at least one substance after application of the alternating electric field to cross the intestinal wall into the blood stream (e.g. paras. 77, 336, etc.).
For claims: 4/20, Gross uses low molecular weight heparin (e.g. para. 351, etc.), which is from 4-8 kDa and therefore “about 5 kDa”—in the alternative, see the 103 rejection below); 5, as the pill is passed through the gut, and is needed to deliver the drug, the drug will be orally administered within 96 hours of when the period of time elapsed as the pill would be gone from the gut if it was any longer (e.g. para. 352, etc.); 7; as the stimulation is applied for up to 6 hours, this will give time for the epithelia to recover (e.g. para. 98, etc.); 11 and 12, as the method of Gross does increase the permeability of a portion of an intestinal epithelia, it will necessarily treat any of the conditions listed as the intestinal epithelia will have an increase permeability and/or will be treated with the same drugs as set forth by the applicant/claims; 17/19, orally administering at least one substance after application of the alternating electric field to cross the intestinal wall into the blood stream (e.g. paras. 77, 336, etc.); 9, 18, 21, 22 therapeutic drug such as an antibiotic or nsaid (e.g. paras. 201, 303, 316, etc.).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-7, 9, and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. Smith discloses the claimed invention (as discussed above in the 102 rejection) and applying additional therapy, such as drugs, for the disease that is being treated and after the alternating electric field is delivered (e.g. paras. 88, 113, 127, etc.) but does not specifically state it is an orally administered drug, such as an antibiotic/NSAID/nanoparticle, and has a molecular weight in a range from about 5 kDa to about 40 kDa. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Smith, with orally administering the drug, such as an antibiotic/NSAID/nanoparticle, and the drug having a molecular weight in a range from about 5 kDa to about 40 kDa, as is well known and common knowledge in the art (mpep 2144I, 2144.03) since it would provide the predictable results of; allowing the patient to easily take the drug at home and/or without any pain, where the drug is used to also treat the condition of the patient and prevent worsening of the condition, and where the drug is at a molecular weight that can easily be absorbed by the patient, such as into the bloodstream through the intestinal wall. For claim 5, as the system and method is applied for different amounts of time from 3, 6, 24, to 72 hours, the treatment and drug would therefore be administered within 96 hours of the alternating electrical therapy. For claim 7, as the system and method has breaks, or is delivered only partially during the day, the therapy is discontinued and allows for the intestinal epithelia to recover (e.g. paras. 74, 128, etc.).
Claims 3, 4, 6, 14, 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. Gross discloses the claimed system and delivering of electrical stimulation of an alternating electric field to increase permeability of at least a portion of an intestinal epithelia of the subject and applying additional therapy, such as drugs, for the disease that is being treated and after the alternating electric field is delivered but does not specifically state the stimulation is applied at a sufficient frequency and period to reduce claudin-2 expression in at least a portion of the tight junctions of the duodenum of the subject by at least about 10% (e.g. claims 3, 14), the drug has a molecular weight in a range from about 5 kDa to about 40 kDa (e.g. claims 4, 20), and the alternating electric field is applied at a frequency range of 50kHz to about 10MHz and for a period of time in a range of from about 24 hours to about 72 hours (e.g. claims 6 and 15). It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Gross, with applying the alternating electric field at a frequency range of 50kHz to about 10MHz and for a period of time in a range of from about 24 hours to about 72 hours, and necessarily, due to the alternating frequency pulse parameters, will result in the pulses applied at a sufficient frequency and period to reduce claudin-2 expression in at least a portion of the tight junctions of the duodenum of the subject by at least about 10% , and the drug having a molecular weight in a range from about 5 kDa to about 40 kDa, as is well known and common knowledge in the art (mpep 2144I, 2144.03) since it would provide the predictable results of providing known stimulation pulses over a known time period that provides successful and quick permeability of the cells, and where the drug is at a molecular weight that can easily be absorbed by the patient, such as into the bloodstream through the intestinal wall.
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al or Gross et al. Smith discloses the claimed invention and repeating the therapy, which would include the drugs, but does not disclose the time range of from about 24 hours to 1 month between repetitions. Gross also discloses the electrical stimulation and possibly drug should be delivered on a schedule (e.g. para. 352, etc.). It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Smith or Gross, with repeating the combined electrical and drug therapy after 24 hours up to 1 month, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of allowing the combined therapy to be repeated to ensure the patient’s condition improves and apply the therapy according to any drug timetable that requires a repeatable delivery of the drug to the patient to effectively treat the patient’s condition.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 8/11/26
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