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 .
Response to Amendment
The amendment filed October 21, 2025 has been entered. Claim 9 has been amended. Claims 1-8 are canceled. Claim 19 is new. Currently, claims 9-19 are pending for examination.
Response to Arguments
Applicant’s arguments with respect to claim(s) 9-19 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.
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 9-19 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.
Claim 9 has been amended to recite:
a housing comprising an opening;
….
a reflective surface on an interior portion of the housing and configured to direct irradiance and light delivery from the light source through the opening in the housing and to a targeted area within a gastrointestinal (GI) tract;
a first tissue anchor coupled to a first end of the housing, the first tissue anchor extending laterally from the opening of the housing and configured to couple to tissue of the GI tract;
a second tissue anchor coupled to a second end of the housing, the second tissue anchor extending laterally from the opening of the housing and configured to couple to tissue of the GI tract, each of the first and second tissue anchors comprising a resilient wire to engage the tissue of the GI tract and hold the opening of the housing in an elevated position over the targeted area, wherein the targeted area is disposed between the first tissue anchor and the second tissue anchor,
wherein the reflective surface directs irradiance and light from the light source through the opening and toward the targeted area located between the first and second tissue anchors.
Applicant’s election of Figure 4 in the October 29, 2024 response to the Restriction Requirement corresponds to paragraph [0046] of the specification which states:
[0046] FIG. 4 illustrates another example embodiment of a PBMT system, namely PBMT system 300. The PBMT system 300 is a localized PBMT device for local gastrointestinal ulcers treatment. As shown in FIG. 4, the LED or low energy laser is in a housing 330 that includes a reflective surface that will maximize irradiance and light delivery to the ulcerated area. The PBMT system 300 has two tissue anchors 310a-b that allow clipping and elevation of the PBMT system 300 above the targeted ulcer bed. The PBMT system 300 can be powered externally through a percutaneous or subcutaneous power source, or internally through a local power source. Hence, the power cord 320 is optional.
PNG
media_image1.png
278
398
media_image1.png
Greyscale
Figure 4 and para. [0046] makes no mention of “an opening” in the housing, does not indicate “an interior portion of the housing” such that a reflective surface can be “on an interior portion” and configured to direct irradiance and light delivery from a light source “through the opening in the housing and toward” a targeted area. No opening, light source or reflective surface is shown in Figure 4 in a clear manner to remedy the deficiencies of the originally filed specification. The disclosure does not support the first tissue anchor “extending laterally from the opening of the housing” or the second tissue anchor “extending laterally from the opening of the housing” as no opening is mentioned or identified.
Claim 19 recites “wherein the lateral extension of the first tissue anchor, the lateral extension of the second tissue anchor, and the opening of the housing are on the same plane relative to the housing”. As stated above for claim 9, the originally filed specification and drawings do not support the opening of the housing, let alone the claimed relationship to the first and second tissue anchors.
Claims 10-19 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 9.
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) 9, 11-12, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jafarzadeh (US 2023/0067979) in view of Singh et al. (US 2021/0196127).
Regarding claim 9, Jafarzadeh discloses a photobiomodulation therapy (PBMT) system comprising: a housing 102 comprising an opening 103 (fig. 1); a light source 107 coupled to the housing and comprising a low energy laser or light emitting diode (“LEDs” [0087]); a reflective surface (“reflective lining”) on an interior portion of the housing and configured to direct irradiance and light delivery from the light source through the opening in the housing and to a targeted area within a gastrointestinal (GI) tract ([0014]; [0085-0086]); wherein the reflective surface directs irradiance and light from the light source through the opening and toward a targeted area located between the ends of the housing (fig. 3-4; [0088-0092]).
Jafarzadeh does not expressly disclose a first tissue anchor coupled to a first end of the housing, the first tissue anchor extending laterally from the opening of the housing and configured to couple to tissue of the GI tract; and a second tissue anchor coupled to a second end of the housing, the second tissue anchor extending laterally from the opening of the housing and configured to couple to tissue of the GI tract, each of the first and second tissue anchors comprising a resilient wire to engage the tissue of the GI tract and hold the opening of the housing in an elevated position over the targeted area. Singh et al. teaches a similar ingestible device for moving through the GI tract where a first tissue anchor 101203a and a second tissue anchor 101203c are coupled to a first end of the housing and a second end of the housing, respectively, each tissue anchor extending laterally from an opening of the housing of the device and configured to couple to tissue of the GI tract to hold the opening of the housing in an elevated position over a targeted area that is located between the ends of the housing and the first and second tissue anchors (fig. 40-41), each of the first and second tissue anchors comprising a resilient wire to engage the tissue of the GI tract ([1170-1171]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jafarzadeh to incorporate the design and housing placement of the first and second tissue anchors of Singh et al., in order to provide an anchoring mechanism that will be effective in anchoring the device to the intestine for therapy delivery at the target site ([1170]), the results of such a modification being reasonably predictable and would not alter the overall operation of the device.
Regarding claim 11, the limitation “wherein the PBMT system is configured to be delivered to the targeted area within the GI tract through or over an endoscope” is directed to intended use and does not further limit the structure of the claim. The limitation does not impart additional structural limitations to the claimed invention. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).
Regarding claim 12, Jafarzadeh discloses a battery 105 coupled to the housing and configured to provide power to illuminate the light source ([0080-0082]).
Regarding claim 19, Jafarzadeh in view of Singh et al. disclose wherein the lateral extension of the first tissue anchor, the lateral extension of the second tissue anchor, and the opening of the housing are on the same plane relative to the housing (see Jafarzadeh fig. 3 and Singh et al. fig. 40-41).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jafarzadeh (US 2023/0067979) in view of Singh et al. (US 2021/0196127) and further in view of Rowland et al. (US 10,206,592).
Regarding claim 10, Jafarzadeh does not expressly disclose the first tissue anchor and the second tissue anchor are wire loops extending in opposite directions from the housing. Rowland et al. teaches a first tissue anchor 102 coupled to a first end of a housing 101 and a second tissue anchor 103 coupled to a second end of the housing (fig. 3) in order to “establish multiple points of contact… on the same or different planes relative to the implant body 101 to secure the implant body 101 in a desired location” (col. 4, lines 50-54), the anchors deployed via dissolving means on the implant body (col. 13, lines 5-7), the first and second tissue anchors being wire loops extending in opposite directions from the housing (fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jafarzadeh to change the shape of the anchor and use wire loops extending in opposite directions from the housing as the first tissue anchor and the second tissue anchor as taught by Rowland et al. since such a modification would have involved a mere change in the form or shape of a component and as it is a known anchor configuration within a tract and in order to “establish multiple points of contact… on the same or different planes relative to the implant body 101 to secure the implant body 101 in a desired location” (col. 4, lines 50-54). Furthermore, a change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jafarzadeh (US 2023/0067979) in view of Singh et al. (US 2021/0196127) and further in view of Gat et al. (US 2013/0053928).
Regarding claim 13, Jafarzadeh does not expressly disclose that when the light source is powered by the battery, the light source delivers an energy density in a range between 1 J/cm2 to 80 J/cm2. Gat et al. teaches a similar photobiomodulation therapy ingestible device where when a light source is powered by a battery (“LEDs 13 of detachable head 12 may then radiate the pathological lesions in the tissues of the GI tract walls for either predetermined period of time or until the batteries are depleted” [0059]), commonly known parameters of an energy density in the range of between 1 J/cm2 to 80 J/cm2 are known in the art (Table 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jafarzadeh and try applying these known energy density parameters as taught by Gat et al. with the PBMT system as a matter of routine optimization since it has been held that “where the general working conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jafarzadeh (US 2023/0067979) in view of Singh et al. (US 2021/0196127) and further in view of Sullivan (US 6,602,275).
Regarding claim 14, Jafarzadeh discloses wherein when the light source is powered by the battery ([0080-0082]), commonly known parameters of a light energy comprising a wavelength near infrared 660-980 nm are delivered ([0087])). Jafarzadeh does not expressly disclose this light energy of a wavelength near infrared 660-980 nm is alternating with blue (415 nm) and green (540 nm) lights. Sullivan teaches a photo therapy apparatus where emitted light from a light source includes emitting IR light, green light, and blue light alternated in a repeated pattern (col. 6, lines 41-48). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying Jafarzadeh by providing delivered light energy of infrared, alternated with blue and green lights as taught by Sullivan as it is a known technique in a photo therapy apparatus, ready for improvement to yield predictable results.
Regarding claim 15, Jafarzadeh in view of Sullivan discloses the light source delivering this aforementioned pattern of lights (see claim 14) comprises a pulsed delivery with a range between 2 Hz to 3000 Hz (col. 8, lines 27-29).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jafarzadeh (US 2023/0067979) in view of Singh et al. (US 2021/0196127) and further in view of Rudser et al. (US 2015/0048790).
Regarding claims 16-17, Jafarzadeh does not expressly disclose a power source that is external to the housing; and a power cord extending between the power source and the housing; wherein the power source is configured to be positioned subcutaneously. Rudser et al. teaches it is known in the art of implantable medical devices to supply power to the implanted device 102 via a cable connected from the housing of the implantable device to a subcutaneously positioned power source 124 that receives externally provided power ([0021]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the battery 105 of Jafarzadeh with an equivalent power source as taught by Rudser et al. in order to provide a rechargeable battery that may provide power to the implantable device for longer than a battery that Jafarzadeh states is important to operate the device ([0081-0082]).
Claim(s) 16, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jafarzadeh (US 2023/0067979) in view of Singh et al. (US 2021/0196127) and further in view of Sabin (US 2012/0059443).
Regarding claims 16, 18, Jafarzadeh does not expressly disclose a power source that is external to the housing; and a power cord extending between the power source and the housing; wherein the power source is configured to be positioned external to the body and the power cord is configured to extend percutaneously. Sabin teaches it is known in the art for a power source 3 of an implantable medical device 2 to be external to its housing, with a power cord 4 extending percutaneously from the implantable medical device housing to the external power source ([0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jafarzadeh to substitute the battery 105 with an external power source with a power cord extending percutaneously to the implantable medical device as taught by Sabin in order to provide a longer-lasting and more easily replaceable power source for the implantable device instead of an implanted battery that Jafarzadeh states is important to operate the device ([0081-0082]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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