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 .
Status of the Claims
Applicant’s submission filed 29 June 2026 has been entered. Claims 1-10 and 12-27 are pending. Claims 1, 3, 6, 12, 14, 18, 20-21, and 26-27 have been amended, while claim 11 has been cancelled without prejudice or disclaimer. Therefore, prosecution on the merits continues for claims 1-10 and 12-27. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Objection to claim 3
Applicant’s amendments to instant claim 3 correct the minor informality, thus obviating the objection of record.
Therefore, the objection is withdrawn.
RE: Rejection of claims 12 and 14 under 35 USC 112(b)
Applicant’s amendments to instant claims 12 and 14 clarify the scope of reach respective claim, thus obviating the rejections of record.
Therefore, the rejections are withdrawn.
RE: Rejection of claims 1-3, 6-10, 20-22, and 24-26 under 35 USC 103 over Daniel et al in view of Asari et al
Applicant’s amendments to independent claim 1 requiring the fetal tissue product to not be dehydrated – which was previously recited in now cancelled claim 11 – obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-10, 12-13, 15, 17-18, and 20-26 under 35 USC 103 over Daniel et al in view of Asari et al, and further in view of Tseng et al
Applicant’s amendments to independent claim 1 requiring the fetal tissue product to not be dehydrated – which was previously recited in now cancelled claim 11 – obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-10, 12-13, 15-18, and 20-26 under 35 USC 103 over Daniel et al in view of Asari et al and Tseng et al, and further in view of Liu et al
Applicant’s amendments to independent claim 1 requiring the fetal tissue product to not be dehydrated – which was previously recited in now cancelled claim 11 – obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-10, 12-13, 15, and 17-26 under 35 USC 103 over Daniel et al in view of Asari et al and Tseng et al, and further in view of Tello
Applicant’s amendments to independent claim 1 requiring the fetal tissue product to not be dehydrated – which was previously recited in now cancelled claim 11 – obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1, 3, 7, 11, 14, 17-18, 20-22, and 24-27 under 35 USC 103 over Liu et al in view of Asari et al
The cancellation of claim 11 renders the rejection of that claim moot. For the remaining claims, Applicant's arguments filed 29 June 2023 have been fully considered but they are not persuasive.
Applicant has traversed the rejection, asserting in Pages 8-9 of the Remarks filed 29 June 2026 that Liu et al fail to teach a fetal tissue product that is not dehydrated. In response, the Examiner respectfully submits that, although Liu et al disclose that the bandage contact lens is made from a biomaterial that has been decellularized and dehydrated, Liu et al disclose that the final amniotic membrane-coated bandage contact lens product is rehydrated via immersion in normal saline. See, for example, Paragraphs [0078], [0081], [0117] of Liu et al. Accordingly, the final fetal tissue product is not dehydrated. It is also of note that Liu et al teach separate embodiments wherein a homogenized placental tissue product is suspended in solution and utilized as eye drops, wherein the homogenized placental tissue has not been dehydrated at any point. See, for example, Paragraphs [0089]-[0091], [0131]-[0143] of Liu et al.
Therefore, the rejection is maintained and amended to encompass the claims as written.
New/Maintained Grounds of Rejection
Claim Interpretation
Under the broadest reasonable interpretation of each claim, the “optional” limitations recited in instant claims 3, 7, 24, and 27 are not required.
Applicant defines “low molecular weight hyaluronic acid” as hyaluronic acid (HA) that has a weight average molecular weight that is less than about 20 kDa. See Paragraph [0053] of the instant disclosure filed 08 October 2025.
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.
Claims 1, 3, 7, 14, 17-18, 20-22, and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (US 2008/0181967 A1, of record on IDS filed 09 October 2025) in view of Asari et al (US 2015/0018305 A1, of record on IDS filed 09 October 2025).
Regarding claims 1, 7, 14, and 17-18: Liu et al disclose compositions manufactured from amniotic membrane, umbilical cord membrane, or both (Abstract).
As such, Liu et al disclose in an embodiment of the invention that the amniotic membrane product is coated on a bandage contact lens, and administered to subjects in need thereof for the treatment of ocular conditions (Paragraphs [0016]-[0017], [0021], [0097], [0117]). Liu et al further disclose that the amniotic membrane product comprises hyaluronic acid (Paragraphs [0080], [0083], [0096]).
Liu et al further disclose that the bandage contact lens is rehydrated and stored in 0.9% normal saline solution (Paragraphs [0012], [0023], [0078], [0081], [0117]-[0118], [0125], [0137]).
Liu et al do not disclose that the amniotic membrane product comprises less than about 30 micrograms of hyaluronic acid per 32 cm2, as required by instant claim 1.
Asari et al, however, disclose tissue repairing pharmaceuticals comprising hyaluronic acid fragments for the repair of the cornea (Abstract; Paragraphs [0007], [0014]-[0017], [0035], [0086]-[0088], [0124]-[0125], [0249]). Asari et al further disclose that the tissue repairing pharmaceutical comprises 0.01 μg to 1000 μg/cm2 hyaluronic acid fragments (Paragraph [0093]).
Therefore, it would have been prima facie obvious to have modified the coated amniotic membrane product of Liu et al such that the amount of hyaluronic acid comprised within the coating is 0.01 μg/cm2, as detailed in Asari et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to ensure that a therapeutic amount of hyaluronic acid is comprised within the coating for the treatment of corneal wounds, and would have had a reasonable expectation of success since the disclosures of both Liu et al and Asari et al are concerned with the treatment of corneal wounds via pharmaceutical patches and/or membranes comprising hyaluronic acid. See MPEP § 2143(I)(G).
Consequently, Liu et al as modified by Asari et al render obvious an amniotic membrane (claim 7) product comprising about 0.01 μg/cm2 hyaluronic acid that is coated on a bandage contact lens (claims 17-18), wherein the final amniotic membrane-coated bandage contact lens product is suspended in 0.9% normal saline solution (claim 14). As the final amniotic membrane-coated bandage contact lens product is not dehydrated, this therefore renders obvious the fetal tissue product of instant claim 1. See MPEP § 2144.05.
Regarding claim 3: Following the discussion of claim 1, Asari et al further disclose that the hyaluronic acid fragments have a molecular weight of 400 to 10,000 Daltons (Paragraph [0003]). As this is less than about 20 kDa, this therefore renders obvious the fetal tissue product of the instant claim for the same reasons as discussed in the rejection of instant claim 1. See Claim Interpretation section.
Regarding claim 20: Following the discussion of claim 18, Liu et al further disclose administering the amniotic membrane coated bandage lens to the eye of a subject suffering from an eye disorder (Paragraphs [0016], [0020]-[0021], [0112]-[0122]). This therefore reads on the method of the instant claim.
Regarding claim 21: Following the discussion of claim 20, Liu et al further disclose that the eye disorder is on the surface of the eye (Paragraph [0113]). This therefore reads on the method of the instant claim.
Regarding claim 22: Following the discussion of claim 20, Liu et al further disclose that the eye disorder is a corneal defect (Paragraph [0113]). This therefore reads on the method of the instant claim.
Regarding claim 24: Following the discussion of claim 20, Liu et al further disclose that the eye disorder is a burn (Paragraph [0120]). This therefore reads on the method of the instant claim.
Regarding claim 25: Following the discussion of claim 20, Liu et al further disclose that the eye disorder is a wound from eye surgery (Paragraph [0113]). This therefore reads on the method of the instant claim.
Regarding claim 26: As aforementioned in the discussion of claim 1, Liu et al disclose compositions manufactured from amniotic membrane, umbilical cord membrane, or both (Abstract).
As such, Liu et al disclose in an embodiment of the invention that the amniotic membrane product is homogenized, suspended in solution, and utilized as eye drops (Paragraphs [0089]-[0091], [0131]-[0143]). Liu et al further disclose that the amniotic membrane product comprises hyaluronic acid (Paragraphs [0080], [0096]).
Liu et al further disclose that the amniotic membrane product is isolated from a subject and then sterilized via radiation (Paragraphs [0094], [0129], [0131]-[0138]).
Liu et al do not disclose that the amniotic membrane product comprises less than about 30 micrograms of hyaluronic acid per 32 cm2, as required by instant claim 1.
Asari et al, however, disclose tissue repairing pharmaceuticals comprising hyaluronic acid fragments for the repair of the cornea, wherein the pharmaceutical can be in liquid form (Abstract; Paragraphs [0007], [0014]-[0017], [0035], [0086]-[0088], [0124]-[0125], [0249]). Asari et al further disclose that the tissue repairing pharmaceutical comprises 0.01 μg to 1000 μg/cm2 hyaluronic acid fragments (Paragraph [0093]).
Therefore, it would have been prima facie obvious to have modified the suspended amniotic membrane product of Liu et al such that the amount of hyaluronic acid comprised within suspension is 0.01 μg/cm2, as detailed in Asari et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to ensure that a therapeutic amount of hyaluronic acid is comprised within the suspension for the treatment of corneal wounds, and would have had a reasonable expectation of success since the disclosures of both Liu et al and Asari et al are concerned with the treatment of corneal wounds via pharmaceuticals comprising hyaluronic acid. See MPEP § 2143(I)(G).
Consequently, Liu et al as modified by Asari et al render obvious a method of making an amniotic membrane product comprising about 0.01 μg/cm2 hyaluronic acid, wherein an amniotic membrane is sterilized via radiation and then suspended in an eyedrop formulation. As the amniotic membrane has not been dehydrated throughout the eyedrop fabrication process, this therefore renders obvious the method of the instant claim. See MPEP § 2144.05.
Regarding claim 27: Following the discussion of claim 1, Liu et al further disclose that the amniotic membrane product and bandage contact lens are comprised within a kit (Paragraphs [0123]-[0127]). This therefore reads on the kit of the instant claim.
Claims 1, 3-5, 7, 12-18, and 20-27 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (US 2008/0181967 A1, of record on IDS filed 09 October 2025) in view of Asari et al (US 2015/0018305 A1, of record on IDS filed 09 October 2025), and further in view of Tseng et al (US 2015/0335771 A1, of record on IDS filed 09 October 2025).
The discussion of Liu et al as modified by Asari et al regarding claims 1, 18, and 20 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Liu et al as modified by Asari et al render obvious claims 1, 3, 7, 14, 17-18, 20-22, and 24-27. Tseng et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2), with a publication date of 26 November 2015 – which is greater than one year prior to the effective filing date of the instant invention.
Regarding claims 4-5: As aforementioned in the discussion of claim 1 above, Liu et al as modified by Asari et al render obvious an amniotic membrane product comprising about 0.01 μg/cm2 hyaluronic acid that is coated on a bandage contact lens.
Liu et al further disclose that the amniotic membrane product is isolated from a subject and then sterilized via radiation (Paragraphs [0094], [0129], [0131]-[0138]).
Liu et al further disclose treating conditions of the eye via the administration of the final amniotic membrane-coated bandage contact lens to a subject in need thereof (Paragraphs [0016]-[0017], [0117]-[0119]).
The combination of Liu et al and Asari et al fail to teach that the hyaluronic acid is complexed to a heavy chain of Iα1 (HC1) and pentraxin 3 (PTX3), as required by instant claims 4-5.
Tseng et al, however, disclose methods of sterilizing amniotic tissues and methods of using the sterilized amniotic tissues (Abstract).
As such, Tseng et al disclose amniotic tissues comprising protein-glycan complexes, such as hyaluronic acid complexed to a heavy chain of IαI and PTX3, wherein about 20% of the hyaluronic acid within the tissue is complexed (Paragraphs [0156], [0159], [0170], [0186], [0194], [0199], [0203], [0226]-[0230]; Tables 10-11).
Therefore, it would have been prima facie obvious to have modified the amniotic membrane-coated bandage contact lens of Liu et al as modified by Asari et al such that about 20% of the hyaluronic acid comprised within the amniotic tissue is covalently bonded to HC1 complexed with PTX3, as detailed in Tseng et al. One of ordinary skill before the effective filing date of the invention would have been motivated to include these hyaluronic acid complexes, as they promote the repair of wounded tissues within soft tissues and nerves (Tseng et al: Paragraphs [0168]-[0171], [0187], [0199]), and would have had a reasonable expectation of success since the disclosures of Liu et al and Tseng et al are both concerned with the development of fetal tissues comprising hyaluronic acid for the treatment of ocular soft tissue wounds. See MPEP § 2143(I)(G).
Consequently, Liu et al as modified by Asari et al and Tseng et al render obvious an amniotic membrane coating comprising hyaluronic acid, wherein about 20% of the hyaluronic acid is covalently bonded to HC1 complexed with PTX3. This therefore renders obvious the fetal tissue product of instant claims 4-5.
Regarding claims 12-13 and 15: Following the discussion of claim 1 above, Liu et al further disclose that the amniotic membrane product is isolated from a subject and then sterilized via radiation (Paragraphs [0094], [0129], [0131]-[0138]).
The combination of Liu et al and Asari et al fail to teach that the amniotic tissue is terminally sterilized at a temperature at or below 0°C, as required by instant claim 13.
Tseng et al, however, disclose methods of sterilizing amniotic tissues and methods of using the sterilized amniotic tissues (Abstract).
As such, Tseng et al disclose amniotic tissues comprising hyaluronic acid that is terminally sterilized via exposure to γ-irradiation at a temperature of about 0°C, wherein the sterilized amniotic tissue is stable at room temperature for at least 1 year (Paragraphs [0003]-[0005], [0027]-[0028], [0039], [0041], [0064]). Tseng et al further disclose that sterilizing the amniotic tissue at 0°C kills all cells found in the amniotic tissue product (Paragraph [0121]).
Therefore, it would have been prima facie obvious to have modified the amniotic membrane-coated bandage contact lens of Liu et al as modified by Asari et al such that it is terminally sterilized via exposure to γ-irradiation at a temperature of about 0°C, as detailed in Tseng et al. One of ordinary skill before the effective filing date of the invention would have been motivated to terminally sterilize the amniotic tissue this way, as it maintains the structural integrity of the tissue while protecting the active ingredient – or hyaluronic acid – comprised within the tissue (Tseng et al: Paragraph [0065]), and would have had a reasonable expectation of success since the disclosures of Liu et al and Tseng et al are both concerned with the sterilization of amniotic tissues using radiation. See MPEP § 2143(I)(G).
Consequently, Liu et al as modified by Asari et al and Tseng et al render obvious an amniotic membrane coating that is terminally sterilized via exposure to γ-irradiation at 0°C (claim 13), wherein sterilizing the tissue at 0° C kills all cells found in the amniotic tissue product (claim 12) and allows the sterilized amniotic tissue to be stable at room temperature – or 20°C to 25°C – for at least on year (claim 15). This therefore renders obvious the fetal tissue product of the instant claims.
Regarding claim 16: Following the discussion of claim 1 above, Liu et al further disclose that the amniotic membrane product is isolated from a subject and then sterilized via radiation (Paragraphs [0094], [0129], [0131]-[0138]).
Liu et al further disclose that the bandage contact lens is comprised of lotrafilcon A (Paragraph [0117]).
The combination of Liu et al and Asari et al fail to teach that the amniotic tissue coating is adhered to the bandage contact lens comprised of lotrafilcon A with a force greater than 0.0001 pounds per square inch (psi), as required by instant claim 16.
Tseng et al, however, disclose methods of sterilizing amniotic tissues and methods of using the sterilized amniotic tissues (Abstract).
As such, Tseng et al disclose the treatment of corneal ulcers in a subject in need thereof via the administration of a contact lens that is coated with an amniotic tissue product comprising hyaluronic acid to the subject’s eye, such that the amniotic tissue product is in contact with the surface of the subject’s eye (Paragraphs [0168], [0191]).
Tseng et al further disclose that amniotic tissue is terminally sterilized via exposure to γ-irradiation at a temperature of 0°C (Paragraphs [0003]-[0005], [0027]-[0028], [0039], [0041], [0064]).
Therefore, it would have been prima facie obvious to have modified the amniotic membrane-coated bandage contact lens of Liu et al as modified by Asari et al such that it is terminally sterilized via exposure to γ-irradiation at a temperature of about 0°C, as detailed in Tseng et al. One of ordinary skill before the effective filing date of the invention would have been motivated to terminally sterilize the amniotic tissue this way, as it maintains the structural integrity of the tissue while protecting the active ingredient – or hyaluronic acid – comprised within the tissue (Tseng et al: Paragraph [0065]), and would have had a reasonable expectation of success since the disclosures of Liu et al and Tseng et al are both concerned with the sterilization of amniotic tissues using radiation. See MPEP § 2143(I)(G).
Consequently, Liu et al as modified by Asari et al and Tseng et al render obvious an amniotic tissue coating that is terminally sterilized with gamma radiation and adhered to a bandage contact lens comprising lotrafilcon A. As the amniotic tissue coating has a hyaluronic acid content that is less than about 1 μg/cm2 and is terminally sterilized with gamma radiation at 0°C, the amniotic tissue coating will be adhered to the lotrafilcon A lens with a force greater than 0.0001 psi. See MPEP § 2112.01 and Paragraphs [0004], [0073], [0093] of the instant disclosure. This therefore renders obvious the fetal tissue product of the instant claim.
Regarding claim 23: As aforementioned in the discussion of claim 1 above, Liu et al as modified by Asari et al render obvious an amniotic membrane product comprising about 0.01 μg/cm2 hyaluronic acid that is coated on a bandage contact lens.
Liu et al further disclose that the amniotic membrane product is isolated from a subject and then sterilized via radiation (Paragraphs [0094], [0129], [0131]-[0138]).
Liu et al further disclose administering the amniotic membrane-coated bandage lens to the eye of a subject suffering from an eye disorder (Paragraphs [0016], [0020]-[0021], [0112]-[0122]).
The combination of Liu et al and Asari et al fail to teach that the amniotic tissue coating is utilized in the treatment of Stevens-Johnson syndrome, glaucoma, macular hole, retinal detachment, macular degeneration, or oculoplastic diseases, as required by instant claim 23.
Tseng et al, however, disclose methods of sterilizing amniotic tissues and methods of using the sterilized amniotic tissues (Abstract).
As such, Tseng et al disclose the treatment of glaucoma in a subject in need thereof via the administration of an amniotic tissue product comprising hyaluronic acid to the end of a glaucoma drainage device within the subject’s eye (Paragraphs [0187]-[0189]).
Therefore, it would have been prima facie obvious to have modified the method of Liu et al and Asari et al such that the amniotic tissue coating is utilized in the treatment of glaucoma, as detailed in Tseng et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to utilize the amniotic tissue coating as a patch to cover the glaucoma drainage device tube, as it prevents the erosion of the tube and lowers the potential for intraocular infection (Tseng et al: Paragraph [0188]), and would have had a reasonable expectation of success given that the disclosures of Liu et al and Tseng et al are both concerned with the treatment of ocular disorders via the administration of fetal tissue products. See MPEP § 2143(I)(G).
Consequently, Liu et al as modified by Asari et al and Tseng et al render obvious a method of treating glaucoma, wherein an amniotic tissue product coats the end of a glaucoma drainage device tube. This therefore renders obvious the method of the instant claim.
Claims 1-3, 6-10, 14, 17-22, and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (US 2008/0181967 A1, of record on IDS filed 09 October 2025) in view of Asari et al (US 2015/0018305 A1, of record on IDS filed 09 October 2025) and Tseng et al (US 2015/0335771 A1, of record on IDS filed 09 October 2025), and further in view of Tello (US 2022/0218522 A1, of record).
The discussion of Liu et al as modified by Asari et al regarding claims 1 and 18 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Liu et al as modified by Asari et al render obvious claims 1, 3, 7, 14, 17-18, 20-22, and 24-27. Tello is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claim 2: As aforementioned in the discussion of claim 1 above, Liu et al as modified by Asari et al render obvious an amniotic membrane product comprising about 0.01 μg/cm2 hyaluronic acid that is coated on a bandage contact lens and inserted into the eye of a subject in need thereof for the treatment of ocular conditions.
The combination of Liu et al and Asari et al fail to teach that the amniotic tissue coating is a sheet, as required by instant claim 2.
Tello, however, discloses a biodegradable multi-purpose lens-shaped patch useful for the treatment of ocular conditions, wherein the patch is formed from collagen (Abstract; Paragraphs [0005], [0011], [0023], [0027], [0035], [0041], [0075]). Tello further discloses that the patch supports amniotic membrane (Abstract; Paragraphs [0002], [0008]-[0011], [0022], [0031], [0042], [0061]-[0062], [0075], [0077]).
Tello further discloses that the multi-purpose lens-shaped patch is formed in batches, wherein sheets of the collagen with amniotic membrane is hot pressed and then thermoformed into lens shapes (Paragraphs [0072], [0090]).
Therefore, it would have been prima facie obvious to have modified the amniotic membrane-coated bandage contact lens of Liu et al as modified by Asari et al such that it is first formed into a sheet, as detailed in Tello. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to mass produce the bandage contact lenses, and would have had a reasonable expectation of success given that the disclosures of Liu et al and Tello are concerned with the amniotic membrane-coated contact lenses for the treatment of ocular conditions. See MPEP § 2143(I)(G).
Consequently, Liu et al as modified by Asari et al and Tello render obvious an amniotic membrane-coated contact that is first formed into a sheet. This therefore renders obvious the fetal tissue product of the instant claim.
Regarding claims 6 and 8-10: Following the discussion of claim 2, Tello further discloses that lens-shaped patch is punched out of the sheet to have a diameter of 14 mm (claim 8) and thickness of about 0.05 mm, or 50 micrometers (claims 9-10) (Paragraphs [0033], [0087], [0090]). Accordingly, the lens-shaped patch having a diameter of 14 mm – and an area of 1.54 cm2 – will have an approximate total hyaluronic acid content of 0.0154 μg. This therefore renders obvious the fetal tissue product of the instant claims for the same reasons as discussed in the rejection of instant claim 2. See MPEP § 2131.03 and 2144.05.
Regarding claim 19: As aforementioned in the discussion of claim 18 above, Liu et al as modified by Asari et al render obvious an amniotic membrane product comprising about 0.01 μg/cm2 hyaluronic acid that is coated on a bandage contact lens and inserted into the eye of a subject in need thereof for the treatment of ocular conditions.
The combination of Liu et al and Asari et al fail to teach that the bandage contact lens is a collagen shield, as required by instant claim 19.
Tello, however, discloses a biodegradable multi-purpose lens-shaped patch useful for the treatment of ocular conditions, wherein the patch is formed from collagen (Abstract; Paragraphs [0005], [0011], [0023], [0027], [0035], [0041], [0075]). Tello further discloses that the patch supports amniotic membrane (Abstract; Paragraphs [0002], [0008]-[0011], [0022], [0031], [0042], [0061]-[0062], [0075], [0077]).
Therefore, it would have been prima facie obvious to have substituted the bandage contact lens of Liu et al with the collagen lens of Tello, as doing so would have been a simple substitution of one protective lens for another. See MPEP § 2143(I)(B). One of ordinary skill in the art before the effective filing date of the invention would have recognized that the two lenses are functionally comparable, as both are coated with amniotic membrane and utilized in the treatment of ocular conditions, and thereby would have been able to substitute the two lenses with predictable results.
Consequently, Liu et al as modified by Asari et al and Tello render obvious an amniotic tissue coating that is adhered to a collagen shield lens. This therefore renders obvious the ophthalmic device of the instant claim.
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 ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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