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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 23, 2025 has been entered.
Response to Amendment
The amendment filed October 23, 2025 has been entered. Claim 1 has been amended. Claims 3-4, 6-8, 11-14, 16-20, 23-24, 27-28, 30-36, 38, 40-44, 49-50 are canceled. Claims 57-58 are new. Claims 10, 15, 21-22, 25-26, 29, 37, 39, 45-48, 51-53 are withdrawn. Currently, claims 1-2, 5, 9, 54-58 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 11-14, filed October 23, 2025, with respect to the rejection(s) of claim(s) 1-2, 5, 9, 54-58 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made using an alternative interpretation of the existing prior art, or in the alternative, in view of Mankin (US 2016/0114185).
Claim Objections
Claim 54 is objected to because of the following informalities: claim 54 recites, “wherein said set of conditions comprises plurality of illumination episodes at the wavelength in the range of 420-460 nm, 640-680 nm, or 830-870 nm” and should instead state, “wherein said set of conditions comprises a plurality of illumination episodes at the wavelength in the range of 420-460 nm, 640-680 nm, or 830-870 nm”. Appropriate correction is required.
Claim Interpretation
Claim 1 recites, “…subjecting the plurality of bacterial species to at least one protocol, wherein said protocol comprises a predefined set of conditions, and, wherein said set of conditions comprises at least two episodes of illumination at a wavelength in the range of 420-460 nm, 640-680 nm, or 830-870 nm, and, wherein manipulating the growth of the plurality of bacterial species of gut microbiota comprises enhancing the growth of at least one of the plurality of bacterial species” (lines 5-10). This emphasized limitation is regarded as reciting purpose or intended use that does not result in a manipulative difference between the claimed invention and the prior art and therefore does not serve to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963). When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 54 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 54 recites, “wherein said set of conditions comprises plurality of illumination episodes at the wavelength in the range of 420-460 nm, 640-680 nm, or 830-870 nm”. However, claim 1 recites, “wherein said set of conditions comprises at least two episodes of illumination at a wavelength in the range of 420-460 nm, 640-680 nm, or 830-870 nm”. The emphasized limitations of claim 1 and claim 54 are regarded as equivalent: claim 1 sets forth the requirement of a plurality of illumination episodes by requiring the set of conditions comprises “at least two episodes of illumination” and claim 54 fails to further limit this limitation when reciting, “wherein said set of conditions comprises plurality of illumination episodes”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
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) 1-2, 5, 9, 54, 57-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scharf et al. (US 2016/0151639) in view of Gat et al. (US 2013/0053928) or in the alternative, further in view of Mankin (US 2016/0114185).
Regarding claim 1, Scharf et al. teaches a method for manipulating the growth of a plurality of bacterial species of gut microbiota comprising subjecting the plurality of bacterial species to at least one protocol (“The light source can be constructed and arranged to produce light to at least one of reduce or eliminate a bacteria selected from the group consisting of: Escherichia coli; Klebsiella; Pseudomonas and other gram negative intestinal bacteria” [0042]), wherein said protocol comprises a predefined set of conditions, and wherein said set of conditions comprises at least two episodes (“The pulsed light can comprise a first pulse of light at a first wavelength and a second pulse of light at a second wavelength” [0042]; “The energy delivery elements 555 of the present inventive concepts can be constructed and arranged to deliver light (e.g. in a continuous or pulsed, intermittent manner) to provide phototherapy” [0205]; “light… can be delivered continuously or in a pulsed manner” [0224]; “In some embodiments, the light or other energy delivered by device 500a can be pulsed (e.g. turned on and off)” [0251]; a pulsed manner is regarded as a plurality of episodes) of illumination at a wavelength in the range of 420-460 nm, 640-680 nm, or 830-870 nm (“The light source can be constructed and arranged to deliver light at a wavelength between approximately 300 nanometers and 900 nanometers, such as between approximately 400 nanometers and 750 nanometers or between approximately 400 nanometers and 430 nanometers.” [0042]; “In some embodiments, the wavelength comprises approximately 470 nm and the microorganism to be treated comprises staphylococcus.” [0049]).
Scharf et al. does not expressly disclose administering a swallowable vehicle configured to move through the GI tract of a human subject, wherein said vehicle comprises at least one light emitting unit, and a software operated controller configured to control the vehicle. Gat et al. teaches in the technology of delivering light within the body to treat bacteria within the GI tract ([0013], [0033]), using a swallowable vehicle configured to move through the GI tract of a human subject wherein said vehicle comprises at least one light emitting unit 1 (fig. 1a-2) and a software operated controller (“microcontroller” [0040]) is known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Scharf et al. to utilize a swallowable vehicle with at least one light emitting unit and a software operated controller as taught by Gat et al. to apply the disclosed method of manipulating the growth of the plurality of bacterial species of gut microbiota in order to provide an in vivo device that “may be designed to access and treat difficult to reach areas, where standard tethered endoscopes cannot reach or cannot easily reach. The in vivo device may quicken the delivery of energy to the desired regions and thereby result in a short, easy and painless administration and treatment.” [0032]), such a modification being reasonably predictable and would not alter the overall operation of the method.
Scharf et al. does not expressly disclose wherein manipulating the growth of the plurality of bacterial species of gut microbiota comprises enhancing the growth of at least one of the plurality of bacterial species. As stated above, “enhancing the growth of at least one of the plurality of bacterial species is regarded as reciting purpose or intended use that does not result in a manipulative difference between the claimed invention and the prior art and therefore does not serve to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963). Additionally, Scharf et al. discloses all of the set of conditions (“at least two episodes of illumination at a wavelength in the range of 420-460 nm, 640-680 nm, or 830-870 nm”) required by the method claim when the device is used in ‘normal and usual operation’ and is therefore regarded as necessarily and inherently performing the same function of enhancing the growth of at least one of the plurality of bacterial species. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).
Alternatively, while Scharf et al. does not expressly disclose wherein manipulating the growth of the plurality of bacterial species of gut microbiota comprises enhancing the growth of at least one of the plurality of bacterial species, this limitation does not require being a direct result of subjecting the plurality of bacterial species to the at least one protocol. Mankin teaches delivering daily probiotics supplements of “good bacteria” (“Lactobacillus”) while treating a patient with at least one light emitting unit (“UV treatment”), thus enhancing the growth of at least one of a plurality of bacterial species ([0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Scharf et al. to additionally provide daily probiotics supplements of good bacteria during the at least one protocol, as taught by Mankin in order to enhance the growth of at least one of the plurality of bacterial species, thereby promoting the recurrent growth of helpful bacterial ([0056]), such a modification being reasonably predictable and would not alter the overall operation of the device.
Regarding claim 2, Scharf et al. discloses wherein manipulating the growth of the plurality of bacterial species of gut microbiota: b) is done in-situ and comprises subjecting at least a portion of GI tract of a subject to the at least one protocol comprising the at least two episodes of illumination (“The pulsed light can comprise a first pulse of light at a first wavelength and a second pulse of light at a second wavelength” [0042]; “The energy delivery elements 555 of the present inventive concepts can be constructed and arranged to deliver light (e.g. in a continuous or pulsed, intermittent manner) to provide phototherapy” [0205]; “light… can be delivered continuously or in a pulsed manner” [0224]; “In some embodiments, the light or other energy delivered by device 500a can be pulsed (e.g. turned on and off)” [0251]; a pulsed manner is regarded as a plurality of episodes; “multiple wavelengths are provided by light source 150 to enhance the bactericidal effects of device 100, such as to effect multiple forms of bacteria, such as to reduce or eliminate one or more of: Escherichia coli; Klebsiella; Pseudomonas and other gram negative intestinal bacteria” [0150]).
Regarding claim 5, Scharf et al. discloses wherein the at least one protocol (“The pulsed light can comprise a first pulse of light at a first wavelength and a second pulse of light at a second wavelength” [0042]; “The energy delivery elements 555 of the present inventive concepts can be constructed and arranged to deliver light (e.g. in a continuous or pulsed, intermittent manner) to provide phototherapy” [0205]; “light… can be delivered continuously or in a pulsed manner” [0224]; “In some embodiments, the light or other energy delivered by device 500a can be pulsed (e.g. turned on and off)” [0251]; a pulsed manner is regarded as a plurality of episodes) is designed to create a specific profile of the plurality of bacterial species of gut microbiota (“multiple wavelengths are provided by light source 150 to enhance the bactericidal effects of device 100, such as to effect multiple forms of bacteria, such as to reduce or eliminate one or more of: Escherichia coli; Klebsiella; Pseudomonas and other gram negative intestinal bacteria” [0150]). Furthermore it is asserted that given the prior art applies the same protocol parameters as currently claimed, without further specifics recited differentiating the currently claimed protocol from the prior art protocol, it would be obvious if not inherent to one of ordinary skill in the art that a specific profile of the plurality of bacterial species of gut microbiota would be created.
Regarding claim 9, Scharf et al. discloses wherein the at least one protocol further comprises at least one of the parameters selected from the group consisting of illumination doses (“the light or other energy delivered by device 500a can be pulsed (e.g. turned on and off), or simply turned off after a sufficient clinical improvement is achieved and/or pre-determined dose is delivered” [0251]), wavelengths (“The light source can be constructed and arranged to deliver light at a wavelength between approximately 300 nanometers and 900 nanometers, such as between approximately 400 nanometers and 750 nanometers or between approximately 400 nanometers and 430 nanometers” [0042]), duration of each illumination ([0323]), number of illumination episodes ([0323]), frequency of illumination episodes ([0323]), exposure to oxygen, humidity, exposure to acoustic wave, pH, exposure to radio frequency, temperature, presence of medication, presence of bacterial species, and presence of bioactive substance.
Regarding claim 54, Scharf et al. discloses wherein said set of conditions comprises plurality of illumination episodes (“The pulsed light can comprise a first pulse of light at a first wavelength and a second pulse of light at a second wavelength” [0042]; “The energy delivery elements 555 of the present inventive concepts can be constructed and arranged to deliver light (e.g. in a continuous or pulsed, intermittent manner) to provide phototherapy” [0205]; “light… can be delivered continuously or in a pulsed manner” [0224]; “In some embodiments, the light or other energy delivered by device 500a can be pulsed (e.g. turned on and off)” [0251]; a pulsed manner is regarded as a plurality of episodes) at the wavelength in the range of 420-460 nm, 640-680 nm, or 830-870 nm (“The light source can be constructed and arranged to deliver light at a wavelength between approximately 300 nanometers and 900 nanometers, such as between approximately 400 nanometers and 750 nanometers or between approximately 400 nanometers and 430 nanometers.” [0042]; “In some embodiments, the wavelength comprises approximately 470 nm and the microorganism to be treated comprises staphylococcus.” [0049]).
Regarding claims 57-58, Scharf et al. discloses further comprising eliminating at least one of the plurality of the bacterial species and inhibiting the growth of at least one of the plurality of the bacterial species (“multiple wavelengths are provided by light source 150 to enhance the bactericidal effects of device 100, such as to effect multiple forms of bacteria, such as to reduce or eliminate one or more of: Escherichia coli; Klebsiella; Pseudomonas and other gram negative intestinal bacteria” [0150]).
Claim(s) 55-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scharf et al. (US 2016/0151639) in view of Gat et al. (US 2013/0053928), or in the alternative, further in view of Mankin (US 2016/0114185), and further in view of Ben-Yehuda et al. (US 2014/0005758).
Regarding claims 55-56, Scharf et al. does not expressly disclose the human subject is afflicted with a condition associated with alterations in gut microbiota; the condition is selected from the group consisting if Inflammatory Bowel Diseases; Crohn Disease; Type II Diabetes; HIV; malignancy of GI tract; Ulcerative Colitis; Proctitis; Over-weight; Irritable Bowel syndrome; Alzheimer; depression; Celiac; Specific food allergies; Clostridium Difficile infection; Diarrhea; Chronic constipation; Dysbiosis. Ben-Yehuda et al. teaches a similar treatment method with an ingestible capsule device suitable for phototherapy of the GI tract where the subject is afflicted with irritable bowel syndrome, such as ulcerative colitis and Crohn’s disease, Proctitis, and Diabetes Type II ([0019]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Scharf et al. to further apply the disclosed treatment to a human subject afflicted with a condition associated with alterations in gut microbiota such as irritable bowel syndrome, such as ulcerative colitis and Crohn’s disease, Proctitis, Diabetes Type II as taught by Ben-Yehuda et al. as it appears such a treatment may be beneficial to a subject afflicted with such conditions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERICA S LEE/Primary Examiner, Art Unit 3796