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
Claims 24 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species B and C, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/25/2026.
Applicant’s arguments traversing the election requirement are unpersuasive. Applicant argues that trephine and carrier plate are merely ancillary components that may be included in a kit, and that therefore there is no search burden as these components would be present in other cellular transplant kits. These arguments are not aligning with Applicant’s disclosure and the current claims. As cited in Applicant’s Specification, and noted in the Restriction Requirement, the trephine and carrier plate are described not as generic components, but as specified inventions with specific parameters for the structure of the items (see Para. 0070 for the trephine, Para. 0073 for the carrier plate). Should the claims remain unrestricted, this causes the search burden for the Examiner, as the Examiner could be required to search the specific structures of the trephine and the carrier plate, structures that might not be found in the same kit with an implant device.
Further, Applicant is allowed one invention for one patent (see MPEP 802). Applicant provides in Claim 1 a claim solely for an implantation device. The surgical kits claimed Claims 23 and 28, depending on Claim 1, do not provide a second invention based on their dependency to Claim 1. However, the addition of the non-generic trephine and carrier plate transform into a kit of the combination of the three components, which transforms this into a distinct, second invention. Therefore, even if the trephine and the carrier plate were not species, they would still need to be restricted away based on how their inclusion transforms the kit claim.
Claim Rejections - 35 USC § 112
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.
Claim 30 is 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.
Regarding claim 30, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 1-6, 12-13, 17-19, 22, 28, 30, 32, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 20190254705 awarded to Humayun.
Regarding Claim 1, Humayun teaches a device for implantation of a cellular transplant into a target region of a subject (Para. 0003), comprising: a handpiece (handpiece 1710, Fig. 17); a shaft anchored with the handpiece and extending distally therefrom, the shaft comprising a proximal end, a distal end opposite the proximal end (unnumbered internal shaft attached to tines 1741 and 1742, Fig. 17, Para. 0118), a curved portion (Fig. 17), and forceps at the distal end thereof, the forceps comprising a pair of distal tips (forceps with tines 1742 and 1741) configured to releasably grasp the cellular transplant (Para. 0118, “This this embodiment, the tubular sheath 1720 is shaped like a “J”, thereby allowing the surgeon to place, with upper and lower tines 1742 and 1741, the substrate 1760 in a perpendicular orientation compared to the handpiece 1710”); and a tubular sheath movably coupled to and extending distally from the handpiece (tubular sheath 1720), the tubular sheath comprising a distal opening (Fig. 17), and a lumen configured to slidably receive the shaft and the forceps therein, wherein, in a non-deployed state, the distal tips of the forceps are positioned within the lumen of the tubular sheath, and, in a deployed state, the distal tips of the forceps are positioned at least partially outside the distal opening of the tubular sheath (Para. 0014, “In various embodiments, either the tubular sheath and/or the internal shaft may be configured to be longitudinally moveable comparatively to the tubular sheath and/or the internal shaft respectively to expose the internal shaft from the distal end. In some embodiments, the shaft movement control mechanism causes longitudinal movement of the internal shaft, wherein movement of the internal shaft in a proximal direction causes the distal-most portion of said internal shaft to retract within the distal most portion of the distal tubular sheath, and herein the retraction thereby causing said substrate interaction portion to release (e.g. forceps to close, scissors to cut, or orientation specific clasping mechanism to close), and wherein movement of the internal shaft in a distal direction causes the distal-most portion of the internal shaft to extend beyond the distal-most portion of the distal tubular sheath thereby causing the substrate interaction portion to actuate (e.g. forceps to open, scissors to open, or orientation specific clasping mechanism to open)”).
Regarding Claim 2, Humayun teaches the device of claim 1, wherein retraction of the tubular sheath relative to the handpiece transitions the device from the non-deployed state to the deployed state (Para. 0014, “In various embodiments, either the tubular sheath and/or the internal shaft may be configured to be longitudinally moveable comparatively to the tubular sheath and/or the internal shaft respectively to expose the internal shaft from the distal end. In some embodiments, the shaft movement control mechanism causes longitudinal movement of the internal shaft, wherein movement of the internal shaft in a proximal direction causes the distal-most portion of said internal shaft to retract within the distal most portion of the distal tubular sheath, and herein the retraction thereby causing said substrate interaction portion to release (e.g. forceps to close, scissors to cut, or orientation specific clasping mechanism to close), and wherein movement of the internal shaft in a distal direction causes the distal-most portion of the internal shaft to extend beyond the distal-most portion of the distal tubular sheath thereby causing the substrate interaction portion to actuate (e.g. forceps to open, scissors to open, or orientation specific clasping mechanism to open)”).
Regarding Claim 3, Humayun teaches the device of claim 2, wherein, in the non-deployed state, the forceps are configured to grasp the cellular transplant, and, in the deployed state, the forceps are configured to release the cellular transplant (Para. 0014, “In various embodiments, either the tubular sheath and/or the internal shaft may be configured to be longitudinally moveable comparatively to the tubular sheath and/or the internal shaft respectively to expose the internal shaft from the distal end. In some embodiments, the shaft movement control mechanism causes longitudinal movement of the internal shaft, wherein movement of the internal shaft in a proximal direction causes the distal-most portion of said internal shaft to retract within the distal most portion of the distal tubular sheath, and herein the retraction thereby causing said substrate interaction portion to release (e.g. forceps to close, scissors to cut, or orientation specific clasping mechanism to close), and wherein movement of the internal shaft in a distal direction causes the distal-most portion of the internal shaft to extend beyond the distal-most portion of the distal tubular sheath thereby causing the substrate interaction portion to actuate (e.g. forceps to open, scissors to open, or orientation specific clasping mechanism to open)”).
Regarding Claim 4, Humayun teaches the device of claim 2, wherein, in the non-deployed state, the forceps are compressed by the tubular sheath and grasp the cellular transplant (Fig. 11A, Para. 0014, “In various embodiments, either the tubular sheath and/or the internal shaft may be configured to be longitudinally moveable comparatively to the tubular sheath and/or the internal shaft respectively to expose the internal shaft from the distal end. In some embodiments, the shaft movement control mechanism causes longitudinal movement of the internal shaft, wherein movement of the internal shaft in a proximal direction causes the distal-most portion of said internal shaft to retract within the distal most portion of the distal tubular sheath, and herein the retraction thereby causing said substrate interaction portion to release (e.g. forceps to close, scissors to cut, or orientation specific clasping mechanism to close), and wherein movement of the internal shaft in a distal direction causes the distal-most portion of the internal shaft to extend beyond the distal-most portion of the distal tubular sheath thereby causing the substrate interaction portion to actuate (e.g. forceps to open, scissors to open, or orientation specific clasping mechanism to open)”).
Regarding Claim 5, Humayun teaches the device of claim 2, wherein the cellular transplant is configured to transition from a folded orientation to a generally flat orientation when the device transitions from the non-deployed state to the deployed state (Para. 0034, “In some embodiments, distal longitudinal movement of the movement control mechanism causes the outer edges of the substrate to move distally beyond the tubular sheath, thereby allowing the rolled support to unroll and return to its original configuration (e.g. flat or naturally biased to a curvature of the target implant tissue site. In several embodiments, the substrate is cell-seeded, and wherein the cell-seeded substrate rolls in conjunction with the substrate support, but to a degree that does not allow the cell-seeded surfaces to roll onto one another”).
Regarding Claim 6, Humayun teaches the device of claim 1, wherein the distal opening of the tubular sheath is beveled (Fig. 17).
Regarding Claim 12, Humayun teaches the device of claim 1, wherein the forceps are non-locking forceps further comprising a hinge opposite the distal tips (Para. 0018).
Regarding Claim 13, Humayun teaches the device of claim 1, wherein the curved portion of the shaft comprises at least one of the following: is configured to angle the forceps at an upward angle relative to the handpiece (Fig. 17), matches a profile of a posterior pole of an eye (Para. 0118).
Regarding Claim 17, Humayun teaches the device of claim 1, further comprising an actuator coupled with the tubular sheath and moveably coupled to the handpiece, whereby actuation of the actuator is configured to cause retraction of the tubular sheath relative to the handpiece to transition the device from the non- deployed state to the deployed state (Para. 0076, “In various embodiments, either the tubular sheath 120 and/or the internal 130 shaft may be configured to be longitudinally moveable comparatively to the tubular sheath 120 and/or the internal shaft 130 respectively to expose the distal end of the internal shaft 130 from the distal end of the tubular sheath 120. In some embodiments, the shaft movement control mechanism 115 causes longitudinal movement of the internal shaft 130”).
Regarding Claim 18, Humayun teaches the device of claim 17, wherein the actuator comprises a rotatable member in which rotation thereof causes retraction of the tubular sheath relative to the handpiece (Fig. 1, control mechanism 115, Para. 0080, similar to control mechanism 1715 in Fig. 17).
Regarding Claim 19, Humayun teaches the device of claim 1, wherein the shaft is rigid (Para. 0081, “In certain embodiments a stationary second inner tubular sheath 225, which extends well within the handpiece, surrounds a portion of the internal shaft to provided additional rigidity, but does not interact with the clamp heads 241 and 242”), and the tubular sheath is flexible to conform to a shape of the shaft as it slides over the shaft (Para. 0015, “In another embodiment, the tubular sheath movement control mechanism causes longitudinal movement of the tubular sheath, wherein movement of the tubular sheath in a distal direction causes the distal-most portion of said internal shaft to be sheathed within the distal most portion of the distal tubular sheath, and herein the retraction thereby causing said substrate interaction portion to release (e.g. forceps to close, scissors to cut, or orientation specific clasping mechanism to close), and wherein the movement of the tubular sheath in a proximal direction causes the distal-most portion of the internal shaft to be unsheathed beyond the distal-most portion of the distal tubular sheath thereby causing the substrate interaction portion to actuate (e.g. forceps to open, scissors to open, or orientation specific clasping mechanism to open)”).
Regarding Claim 22, Humayun teaches the device of claim 1, wherein the cellular transplant comprises at least one of a retinal pigment epithelium (RPE) cellular transplant a cellular transplant including retinal cells (Para. 0006).
Regarding Claim 28, Humayun teaches a method of implanting a cellular transplant into an eye of a subject, the method comprising: providing a device according to claim 1 (see rejection to Claim 1); using the forceps of the device to grasp the cellular transplant (Para. 0014); inserting a portion of the tubular sheath of the device into the eye of the subject and releasing the cellular transplant inside the eye of the subject (Para. 0021).
Regarding Claim 30, Humayun teaches the method of claim 28, wherein releasing the cellular transplant inside the eye comprises retracting the tubular sheath relative to the handpiece so as to unfold the cellular transplant and release the forceps from grasping the cellular transplant inside the eye of the subject (Para. 0014, “In various embodiments, either the tubular sheath and/or the internal shaft may be configured to be longitudinally moveable comparatively to the tubular sheath and/or the internal shaft respectively to expose the internal shaft from the distal end. In some embodiments, the shaft movement control mechanism causes longitudinal movement of the internal shaft, wherein movement of the internal shaft in a proximal direction causes the distal-most portion of said internal shaft to retract within the distal most portion of the distal tubular sheath, and herein the retraction thereby causing said substrate interaction portion to release (e.g. forceps to close, scissors to cut, or orientation specific clasping mechanism to close), and wherein movement of the internal shaft in a distal direction causes the distal-most portion of the internal shaft to extend beyond the distal-most portion of the distal tubular sheath thereby causing the substrate interaction portion to actuate (e.g. forceps to open, scissors to open, or orientation specific clasping mechanism to open)”); optionally, wherein the cellular transplant is released within a subretinal region of the eve of the subject (Para. 0021).
Regarding Claim 32, Humayun teaches the method of claim 28, wherein the cellular transplant comprises at least one of a retinal pigment epithelium (RPE) cellular transplant (Para. 0006).
Regarding Claim 34, Humayun teaches the method of claim 28, wherein the subject has a retinal condition comprising one or more of a retinal degenerative condition or a retinal injury (Para. 0007), retinitis pigmentosa (Para. 0007), retinal trauma (Para. 0007), or a combination thereof.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20190254705 awarded to Humayun.
Regarding Claim 23, Humayun teaches the device according to Claim 1. Humayun does not teach a kit including instructions for use of the device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Humayun, i.e. by including instructions in a kit with the device of Claim 1, as In Re John Ngai and David Lin, 367 F.3d 1336 (Fed. Cir. 2004) states “Here, the printed matter in no way depends on the kit, and the kit does not depend on the printed matter. All that the printed matter does is teach a new use for an existing product. As the Gulack court pointed out, " [w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability." Id. If we were to adopt Ngai's position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product”, see further MPEP 2111.05(B). Therefore, the inclusion of a set of instructions is an obvious addition.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Humayun as applied to Claim 6 above, and further in view of U.S. Patent Publication 20230064188 awarded to Davis et al.
Regarding Claim 7, Humayun teaches the device of claim 6. Humayun does not teach wherein the tubular sheath is beveled by an angle of about 15 to about 45 degrees, or about 25 to about 45 degrees, or about 35 to about 45 degrees, or about 45 degrees.
However, in the art of ophthalmic devices (Para. 0132), Davis teaches a beveled distal catheter end that is beveled at 30 degrees (Para. 0076, “about 30 degrees with respect to a longitudinal axis of the catheter 10).
It would have been obvious one of ordinary skill in the art before the effective filing date of the claimed invention to modify Humayun by Davis, i.e. by making the beveled end of Humayun beveled at 30 degrees as in Davis, as Humayun already teaches the usage of a beveled end and Davis shows this angle is known for ophthalmic devices/access to the eye.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Humayun as applied to Claim 1 above, and further in view of U.S. Patent Publication 20150032207 awarded to Humayun et al, hereinafter Ahuja for clarity.
Regarding Claim 11, Humayun teaches the device of Claim 1. Humayun does not teach wherein the device further comprises a seal positioned between the shaft and an inner wall of the tubular sheath, the seal preventing backflow of fluid into the lumen of the tubular sheath.
However, in the art of ophthalmic transplant devices (Para. 0013), Ahuja teaches a seal positioned between the shaft and an inner wall of the tubular sheath, the seal preventing backflow of fluid into the lumen of the tubular sheath (Para. 0214, “Upon removal of the pipette, the flaps return to their closed position, thereby retaining the deposited cells within the lumen. In some embodiments, the one way valve is formed such that a liquid tight seal is created to prevent backflow of cells, while in other embodiments, a fluid-tight seal is not formed”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Humayun by Ahuja, i.e. by using a backflow seal in the device of Humayun as in the device of Ahuja, for the predictable purpose of preventing improper cell migration in the device of Humayun as in Ahuja.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Humayun as applied to Claim 1 above, and further in view of U.S. Patent Publication 20110313506 awarded to Ray et al.
Regarding Claim 20, Humayun teaches the device of claim I, wherein the tubular sheath is at least one of translucent (Para. 0028). Humayun does not teach wherein the tubular sheath comprises a Teflon material.
However, in the art of transplant devices (Para. 0005), Ray teaches the usage of a tubular sheath made of a Teflon/PTFE material (Para. 0106, “The outer sheath 146 can be formed from materials suitable for use in the construction of standard introducer sheaths, including Pebax, HDPE, FEP, PTFE, or nylon.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Humayun by Ray, i.e. by using an outer sheath made of Teflon, since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended us (see MPEP 2144.07), and Davis shows that Teflon is a known material for sheaths.
Conclusion
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/JLM/
Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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