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
Applicant's submission filed on 11/17/2025 has been entered. Accordingly, claims 32, 35, and 37-44 remain pending, claims 32and 35 have been amended, claims 34, 36, and 45-55 are previously withdrawn, and claims 1-31 and 33 have been previously canceled.
Response to Arguments
Specification Objections
In light of the amendments to the specification filed 11/17,2025, the previous objection has been rendered moot and has been withdrawn.
Rejections under 35 USC 112
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive.
Regarding the 112(a) rejection of claim 38, applicant cites [0010] and [0069] for support. While applicant has support for “further comprising coupling the light source to the annular device with a linkage” (light source as being part of the control unit as shown in FIG. 5A), applicant does not have support for, in their elected embodiment, the alternate arrangement of the light source and annular device. However, neither of these portions of the specification, provide support for applicant’s elected embodiment for the the alternative latter portion of the limitation claim 38, e.g., that “further comprising coupling the light source to the annular device…directly within a region of the annular device”, which corresponds to the non-elected embodiment shown in FIG. 5B, which applicant has elected against, without traverse in their response filed 05/27/2025. Applicant is advised to cancel the portion of claim 38 reciting the non-elected embodiment to avoid having the entirety of claim 38 being withdrawn for reciting non-elected subject matter in a subsequent office action.
Applicant remarks in pages 11-12 of the response that amendments presented to claims 32 and 35 have addressed the previous issues under 112(b). Regarding claim 32, the amendments do not remedy the outstanding issues which have been compounded by the amendments made to claim 32. Therefore, the rejection has been updated to incorporate the present amendments and to provide further clarity.
It is noted that applicant’s amendment to claim 35 resolves the previous rejection of the claim, however, the newly filed amendments have introduced new issues regarding clarity and a new rejection under 112(b) has been issued below for claim 35.
Therefore, the claims remain rejected and the rejections have been made final.
Rejections under 35 USC 103
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive.
Applicant argues in the x paragraph through the y paragraph of page 7
“None of the cited references, alone or in combination, describe an annular device having two different chambers for applying different forces to achieve different results. The treatment chamber of the annular device transmits a force to deform the anterior surface for treating glaucoma. The fixation chamber of the annular device transmits negative pressure for fixation of the device to the anterior surface.
Two chambers positioned on the anterior surface
Claim 32 recites ‘positioning a treatment chamber and a fixation chamber of an annular device on the anterior surface of the eye so as to encircle the cornea’. Thus, there are two chambers that are each positioned ‘on the anterior surface’ so as to encircle the cornea …”.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “an annular device having two different chambers for applying different forces to achieve different results”, “[t]he treatment chamber of the annular device transmits a force to deform the anterior surface for treating glaucoma.”, “[t]he fixation chamber of the annular device transmits negative pressure for fixation of the device to the anterior surface”, “[t]wo chambers positioned on the anterior surface”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Nonetheless, applicant’s arguments with respect to claim(s) 32 have been considered but are moot because the new grounds of rejection have been presented. Consequently, the arguments do not apply to new references or the new combination of the references being used in the current rejection.
Information Disclosure Statement
The information disclosure statements filed 01/25/2025 and 10/09/2023, each which respectively cite “pending U.S. and International Applications that have one or more common inventors and/or are commonly owned” (see the attached corresponding documents, each having an “X” marked through each improperly formatted page in each of above referenced documents) and each fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because applicant has provided the list of these documents in an improper formation which does not follow the format of the PTO/SB/08 form. Applicant cites these documents in the format of a signed letter which is improper and does not provide fields for examiner signature/initials and date considered. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Additionally, applicant has cited multiple PCT documents, which, if applicant wishes to be considered and made of record, applicant should provide copies of each of these documents in their next reply when correcting these deficient IDS documents. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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.
Claim 38 is 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 38 recites “further comprising coupling the light source to the annular device with a linkage or directly within a region of the annular device” in lines 1-2, while support could be found for the light source being a LED within the control unit that is transmitted to a region of the annular device via fiber optic or light pipe (see [0069], FIG. 5A); in a nonelected embodiment, the LED is embedded into a region of the device powered via an electrical connection from the control unit (see [0069, FIG. 5B, (nonelected species C2).
However, this does not provide support for what is claimed, and no basis has been pointed to for these limitations in applicant' s remarks. The absence of support for the recited limitations as rejected raises doubt to regarding at the time the application was filed, if the applicant had possession of the claimed invention. These claims and claims dependent thereon are deemed to failing to comply with the written description requirement. This is a WRITTEN DESCRIPTION rejection.
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 32, 35, 37-43, and 44 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.
Claim 32 has been amended to recite “transmitting a force to at least a portion of a limbus of the eye through the treatment chamber of the annular device, the force causes a deformation of the anterior surface of the eye and underlying tissues within the eye in an inwardly direction, an outwardly direction, or a combination of the inwardly and outwardly directions and improves outflow of aqueous from the eye to reduce intraocular pressure”, in lines 6-10, which renders the claim indefinite because it is unclear if the deformation of the anterior surface of the eye includes all types of tissues underlying the eye, for example, including (but not limited to): stem cells for the corneal epithelium, stromal keratocytes, corneal endothelium, etc., as known in the anatomical and cellular arts – or only those tissues directly underlying the limbus. It is unclear if the underlying tissues (plural) within the eye that are deformed by the force transmitted to the limbus, is also inclusive of the limbus, e.g., it is unclear if the limbus is also deformed or only tissues underlying the limbus are deformed. It is additionally unclear what aqueous substance the outflow is improved thereupon by the deformation of the anterior surface of the eye.
All dependent claims are also rejected by the nature of their dependency.
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.
Claim(s) 32, 35, 37-38, 42-43, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Romano et al. (US20200229972, hereafter “Romano”), in view of Langham (US4282882), further in view of Belkin et al. (US20130218145, hereafter “Belkin”).
Regarding claim 32, Romano discloses a method of treating a cornea of an eye comprising a cornea and an anterior surface surrounding the cornea (see FIG. 7, [0097]), the method comprising:
positioning a treatment chamber (internal space 37 in in FIGS. 3, 5-6) and a fixation chamber (35, 36 in FIGS. 3, 5-6) of an annular device on the anterior surface of the eye so as to encircle the cornea (step 100 in FIG. 7, also see annular device encircling the cornea in FIGS. 3, 5-6);
transmitting a force to at least a portion of the eye through the treatment chamber of the annular device ([0036], [0113], FIGS. 3, 4A, since it is known that the aspiration force F is a function of the Vacuum P and the Surface S on which this vacuum is applied, so that: F=P×S, therefore, the aspiration force transmitted to the eye of 3 Newtons, requires vacuum is of: P=F/S, P=3/301.10−6, namely P=9966 Pa=0.099 bar=74 mmHg,); and
fixing the annular device to the anterior surface of the eye by transmitting* a negative pressure through the fixation chamber drawing the fixation chamber against the anterior surface of the eye ([0036], [0113], FIGS. 3, 4A, the pressure of the device is 74 mmHg is generated through the fixation chamber 35, 36, being less than the known atmospheric pressure at sea level being a value of 760 mmHg, the pressure exerted via suction/drawing the anterior surface of the eye to the annular device in order to secure/fix the annular device to the anterior surface of the eye is negative pressure as it is understood by one of ordinary skill in the physics arts as it is less than atmospheric pressure); while the force disclosed by Romano is disclosed as being a negative pressure, as the pressure used in the suction for the fixation of the annular device is less than atmospheric pressure, and therefore may provide an outwardly deforming or distending force, and therefore causes a deformation*, ** of the anterior surface of the eye in an outwardly direction (see as cited above), Romano does not explicitly disclose that the disclosed force as being sufficient to cause a deformation*, ** of the anterior surface of the eye and underlying tissues of the eye*** in an outwardly direction.
However, in the same field of endeavor, Langham teaches the force causes to cause a deformation*, ** of the anterior surface of the eye and underlying tissues of the eye*** in an outwardly direction (column 1, lines 34-36, column 2, line 5-52, the suction cup results in the flange exerting a positive pressure on the perilimbal area, thereby occluding the underlying drainage vessels and provide an ocular suction cup suitable for applying a distorting force on the eye).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify method disclosed by Romano with the force causing a deformation*, ** of the anterior surface of the eye and underlying tissues of the eye in an outwardly direction as taught by in order to transmit the negative pressure to the anterior surface of the eye via the fixation chamber so as to hold the treatment chamber is held in place while measurements such as intraocular pressure, pulse, and any other desired measurements are being completed (column 5, lines 28-37 and column 6, lines 1-3 of Langham).
While Romano, in view of Langham, contemplates design of their device not to cause discomfort to patients with glaucoma and also to provide a diagnosis of glaucoma (column 1, lines 17-19 of Langham), Romano does not explicitly disclose that the treatment of the cornea is explicitly for treating glaucoma, nor the transmitting force being to at least a portion of the limbus of the eye through the treatment chamber of the annular device the force causes to cause a deformation*, ** of the anterior surface of the eye and underlying tissues of the eye*** and improves outflow of aqueous from the eye to reduce intraocular pressure.
However, in the same field of endeavor, Belkin teaches a method for treating glaucoma (title, abstract, for treating glaucoma);
transmitting a force to at least a portion of the limbus of the eye ([0012] via the limbus) through the treatment chamber of the annular device ([0008] gonioscopic contact lens which includes a mirror is applied to the eye, as known in the surgical anatomical arts, application of a gonioscopic contact lens to the eye is via application of force to the surface of the eye), the force causes to cause a deformation*, ** ([0008] as known in the surgical anatomical arts, the application of a gonioscopic contact lens to the eye is via applying force to the surface of the eye, causes temporary deformation to the eye surface) of the anterior surface of the eye and underlying tissues of the eye*** ([0008], [0012], FIG. 1 the trabecular meshwork under the limbal area) and improves outflow of aqueous from the eye to reduce intraocular pressure ([0012] to enhance the flow of aqueous humor through the trabecular meshwork, and to cause a significant decrease in intraocular pressure).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify method disclosed by Romano with the method being a method for treating glaucoma, the transmitting force being to at least a portion of the limbus of the eye through the treatment chamber of the annular device the force causes to cause a deformation of the anterior surface of the eye and underlying tissues of the eye and improves outflow of aqueous from the eye to reduce intraocular pressure as taught by Belkin in order to alter some of the trabecular meshwork in order to improve the flow of aqueous humor through the trabecular meshwork without damaging the trabecular meshwork ([0006]-[0007] of Belkin).
*For the purposes of examination, the term has been interpreted as defined by the applicant in [0044], [0062] of the specification to mean when a negative pressure (i.e., less than atmospheric pressure) is generated by the vacuum source and is transmitted through the treatment chamber, the negative pressure provides a force transmitted by the treatment chamber which can be an outwardly deforming or distending force.
**For the purposes of examination, the limitation has been interpreted in the alternative, requiring the force causes a deformation of the anterior surface of the eye and underlying tissues of the eye in an inwardly direction; or requiring the force causes a deformation of the anterior surface of the eye and underlying tissues of the eye in an outwardly direction; requiring the force causes a deformation of the anterior surface of the eye and underlying tissues of the eye in or a combination of the inwardly and outwardly directions.
***For the purposes of examination, the phrase “underlying tissues of the eye” has been interpreted to mean any and all and in any part, combination or alone, any tissue located under the anterior surface of the eye as known in the anatomical arts.
Regarding claim 35, Romano substantially discloses all the limitations of the claimed invention, specifically, Romano discloses wherein fixing the annular device to the anterior surface of the eye by transmitting the negative pressure through the fixation chamber further comprises generating the negative pressure with a vacuum source in fluid communication with the fixation chamber ([0049], [0064], [0082]-[0084], [0131]-[0141], FIG. 3, the aspiration pump with a vacuum sensor and has a coupling interface and an infusion line/irrigation channel that together are used to generate the vacuum [source] and provides an automatic infusion of liquid via the irrigation channel which defines an opening between the window and the side wall of the device, where at the opening, the vacuum is created by the activation of the liquid aspiration device/pump[vacuum source] and the liquid irrigation device ); and wherein generating the negative pressure with the vacuum source occurs during transmitting the force via the treatment chamber ([0082]-[0084], [0131]-[0141], [0143]-[0151], FIGS. 3, 5-6, as the irrigation channel of the fixation chamber has a slightly smaller diameter than the diameter of the aspiration channel of the fixation chamber, it is then possible to keep a slight vacuum during the filling of the interior space 37 of the treatment chamber with liquid, and thus to ensure the sealing of the coupling interface during this step, therefore the liquid seal helps during the transmission of force due to the pressure exerted by the vacuum).
Regarding claim 37, Romano substantially discloses all the limitations of the claimed invention, specifically, Romano discloses further comprising illuminating a region of the eye through the treatment chamber with a light source ([0064], [0077]-[0081], [0096]-[0103], [0130], having the treatment chamber filled with liquid simplifies the trajectory of laser beams/illumination from a laser light source to a region of the eye through the treatment chamber).
Regarding claim 38, Romano substantially discloses all the limitations of the claimed invention, specifically, Romano discloses further comprising coupling the light source to the annular device with* a linkage or directly within a region of the annular device.
*For the purposes of examination, the limitation has been interpreted in the alternative, requiring coupling the light source to the annular device with a linkage; or requiring coupling the light source to the annular device directly within a region of the annular device.
Regarding claim 42, Romano substantially discloses all the limitations of the claimed invention, specifically, Romano discloses wherein transmitting the force comprises generating* the negative pressure within the treatment chamber ([0036], [0082]-[0084], [0113], [0131]-[0141], [0145]-[0151], FIGS. 3, FIGS. 3, 4A, 5-6, the pressure of the device is 74 mmHg is generated through the fixation chamber 35, 36, being less than the known atmospheric pressure at sea level being a value of 760 mmHg, the pressure exerted via suction/drawing the anterior surface of the eye to the annular device in order to secure/fix the annular device to the anterior surface of the eye is negative pressure as it is understood by one of ordinary skill in the physics arts as it is less than atmospheric pressure; the negative pressure generated through the fixation chamber is generated within the treatment chamber/ring 3 as the irrigation channel of the fixation chamber has a slightly smaller diameter than the diameter of the aspiration channel of the fixation chamber, it is then possible to keep a slight vacuum during the filling of the interior space 37 of the treatment chamber with liquid, and thus to ensure the sealing of the coupling interface during this step, therefore the liquid seal helps during the transmission of force due to the pressure exerted by the vacuum).
*For the purposes of examination, the limitation has been interpreted in the alternative, requiring transmitting the force comprises generating the negative pressure within the treatment chamber; or requiring transmitting the force comprises generating a positive pressure within the treatment chamber.
Regarding claim 43, Romano substantially discloses all the limitations of the claimed invention, specifically, Romano discloses wherein the treatment chamber has no lower surface so as to transmit the force via a fluid interface ([0103], [0123], [0149], FIG. 3, the treatment chamber/ring 3 is open only at its proximal end 311 intended to come into contact with the patient's eye 2, the enclosed interior space 37 of the treatment chamber/ring 3 is defined between the cornea 2, the side wall 31 and the window 32 is filled with liquid in 1 to 2 seconds [fluid interface] and simultaneously the air is aspired, creating a sufficient vacuum for the suction in 2 to 3 seconds [force transmitted via the fluid interface]).
Regarding claim 44, Romano substantially discloses all the limitations of the claimed invention, specifically, Romano discloses wherein the fluid interface* is a liquid interface ([0149]-[0152], FIG. 3, liquid is infused into the interior space of treatment chamber/ring 3 between the window 32 and the anterior surface of the patient’s eye 2).
*For the purposes of examination, the limitation has been interpreted in the alternative, requiring the fluid interface is a gas interface; or requiring the fluid interface is a liquid interface.
Claim(s) 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Romano, in view of Langham and of Belkin, as applied to claims 32 and 37 above, further in view of Jones et al. (US20060271025, hereafter “Jones”).
Regarding claim 39, Romano, in view of Belkin, substantially discloses all the limitations of the claimed invention, specifically, Belkin discloses using laser beam is capable of penetrating the 1 mm thick limbal area and reaches the trabecular tissue to be treated with an adequate intensity to enhance the flow of aqueous humor through the trabecular meshwork ([0012], [0015], [0018], [0037], using a wavelength in the visible or near infrared range, between 514 and 810 nm, and a 532 Nd:YAG laser), but does not explicitly disclose wherein the light source is configured for photobiomodulation of the region of the eye.
However, in the same field of endeavor, Jones teaches wherein the light source is configured for photobiomodulation of the region of the eye ([0044], [0047] the light source is configured for low-level laser therapy, which is known by one of ordinary skill in the art of therapeutic ophthalmology to be an alternate/previously used term in the art for the present term of photobiomodulation).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify method disclosed by Romano with the light source being configured for photobiomodulation of the region of the eye as taught by Jones in order to rejuvenate tissues of the eye, such as an elasticity of the lens of the eye ([0044 in Jones).
Regarding claim 40, Romano, in view of Jones substantially discloses all the limitations of the claimed invention, specifically, Jones discloses wherein the light source is* a red light source ([0045] the wavelength of the laser is 670 nm [red light]).
*For the purposes of examination, the limitation has been interpreted in the alternative, requiring the light source is a red light source; or requiring the light source is a green light source; or requiring the light source is a blue light source.
Regarding claim 41, Romano, in view of Jones substantially discloses all the limitations of the claimed invention, specifically, Jones discloses further comprising measuring intraocular pressure with a tonometer while transmitting the force ([0062], [0066] using a tonometer to check intraocular pressure, before and during a procedure).
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 AMY SHAFQAT whose telephone number is (571)272-4054. The examiner can normally be reached Monday-Friday 9:30AM-5:30PM MST.
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, Keith Raymond can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.S./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798