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 .
DETAILED ACTION
Applicant's election with traverse of claims 1-8, 12-13, 15, 19, 23, 28-31, and newly added claim 56 in the reply filed on 03/02/2026 is acknowledged. The traversal is on the ground(s) that applicant believes that the multiple groups can be searched and examined together. This is not found persuasive because as provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The search system and the focus of the invention are completely different, requiring an undue burden on the patent examiner. While searches may seem to be overlapping, however extensive since the patent examiner searches the databases mostly literally. Rarely do applicants present claims to an inventions where the distinctness of the invention are readily clear such as a chemical compound and a gene sequence. It is the responsibility of the examiner to enforce 35 USC 101, which allows the applicant to obtain a patent for a single invention. In the opinion of the examiner the applicants present three distinct inventions.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-8, 12-13, 15, 19, 23, 28-31, and 56 are currently under examination and the subject of the present Office Action. Claims 47 and 54 are withdrawn from consideration; claims 9-11, 14, 16-18, 20-22, 24-27, 32-46, 48-53 and 55 are cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 02/26/2024 has been considered here.
Claim Objections
Claim 8 is objected to because of the following informalities: The claim reads “The device of claim 1wherein” which should read “The device of claim 1 wherein”. Appropriate correction is required.
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.
Claims 13, 19, and 29 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 13 recites the limitation "the first hardened layer" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of search and examination, the claim is understood to read “the first layer”.
Claim 19 recites the limitation “fourth layer" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of search and examination, the claim is understood to be dependent from claim 15, instead of claim 1.
Claim 29 recites the limitation "at least one outer layer" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of search and examination, the claim is understood to read “at least one layer”. It is also noted that with this interpretation, claims 28 and 29 are identical and one of these claims should be cancelled as to not have duplicate claims or amended to remedy the issue of indefiniteness.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, 6-8, 12-13, 15, and 28-29 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US PGPUB 20160158146 A1 (Robinson, 2016; as submitted on IDS of 02/26/2024).
In regards to claims 1 and 7-8, Robinson teaches an ocular implant prepared by introducing a silicone fluid in a mold and curing it (i.e., a first layer), a pellet comprising a therapeutic agent (i.e., a second layer), and covering the pellet with additional silicone fluid and curing it (i.e., a third layer) (see claim 53). The silicone fluid is taught as a polymeric material (see paragraph 0107). It is also noted that there is no direction given in the claims as to the order of the layers and as such the labels above of first layer, second layer, and third layer are interchangeable.
In regards to claim 2 and 4, it is taught that the second layer of silicone fluid has a different therapeutic agent than what is in the pellet (see claim 58).
In regards to claim 6, Robinson teaches an example wherein the silicone coating is 0.20 mm around a 3 mm pellet, or similar designs wherein the pellet is thicker than the silicone coatings, which are understood as the first and third layer (see paragraphs 0256-0258).
In regards to claims 12 and 28-29, example 1 teaches that the pellet comprises hydroxypropyl methylcellulose (HPMC) (i.e., a biodegradable polymer) (see paragraph 0209). This is a different polymer than the silicone fluid discussed above.
In regards to claim 13, it can be seen in Figures 2A and 2B that one of the layer circumferentially extends beyond the second layer, which would be capable of making contact with the sclera of the eye.
In regards to claim 15, the device is taught to comprise a polyester mesh (i.e., a fourth layer) (see claim 60).
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 4, 6-8, 12-13, 15, 19, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20160158146 A1 (Robinson, 2016; as submitted on IDS of 02/26/2024).
The teachings of Robinson have been described supra in regards to claims 1-2, 4, 6-8, 12-13, 15, and 28-29. Further in regards to claim 19, Robinson teaches implant has a polymer top coat that is impermeable to the therapeutic agent such as polymethyl methacrylate, which is distinct from the other layers (see Robinson, paragraph 0117).
Robinson does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Robinson with a reasonable expectation of success to obtain the ocular implant of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the ocular implant of the instant claims with predictable results.
Claims 1, 3-6, 8, 12-13, 23, 28-30, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021240180 A1 (Qi, 2021; priority date 05/2020).
In regards to claims 1, 3-4, 8, 23, 28-30, Qi teaches a method of coating ocular devices, wherein the ocular device is a contact lens (see Qi, abstract; page 5, lines 21-32). It is taught that the contact lens (i.e., the first layer) is layered with nanoelectrospray comprising a therapeutic agent, such as nepafenac, and polylactic-polyglycolic acid (PLGA) (see Qi, page 7, lines 15-25; page 18, lines 10-14), which is taught as a biodegradable polymer in the instant specification as filed (see page 3, first full paragraph of the instant specification as filed). The implant is taught to have multiple layers (see Qi, paragraph bridging pages 21-22). It is also taught that the polymer (i.e., PLGA) allows for the controlled release of an active ingredient to the eye (see Qi, page 21, lines 11-19), which one with ordinary skill in the art would understand that the polymer is a rate-controlling agent as instantly claimed. It is also noted that there is no direction given in the claims as to the order of the layers and as such the labels above of first layer, second layer, and third layer are interchangeable.
In regards to claims 5-6, the thickness of the ocular device (i.e., the contact lens) is shown to be greater than the thickness of the coatings (see Qi, Figure 3). The thickness of the layers on the device is taught to be from 1µm to 10µm (see Qi, page 21, lines 21-26).
In regards to claim 12, the ocular device (i.e., the first layer) is taught to comprise different polymers such as polymethylmethacrylate among others, which are different than PLGA (see Qi, page 23, final paragraph).
In regards to claim 13, it is taught that the coating is along the edge of the contact lens, which can be seen in Figure 30 clearly showing that the circumference of the coating (i.e., second and third layers) does not extend beyond the contact lens (see Qi, figure 30; page 4, lines 8-26).
Qi does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Qi with a reasonable expectation of success to obtain the ocular implant of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the ocular implant of the instant claims with predictable results.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2021240180 A1 (Qi, 2021; priority date 05/2020) as applied to claims 1, 3-6, 8, 12-13, 23, 28-30, and 56 above, and further in view of US PGPUB 20240132823 A1 (Ma et al., 2024; filing date of 2020).
The teachings of Qi have been described supra.
The teachings of Qi are silent on the use of poly(glycerol sebacate).
Ma teaches a photoreceptor scaffold comprising poly(glycerol sebacate) (PGS)(see Ma, paragraphs 0028, 0045-0047).
In regards to claim 31, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Qi with Ma as Qi teaches that the carrier species in the composition is a biocompatible polymer that is known to be used in cell cultures, implants, regenerative, therapeutic, and pharmaceutical compositions (see Qi, paragraph bridging pages 14-15). Ma teaches that PGS is a known polymer used in cell culture (see Ma, paragraphs 0010, 0028, 0045-0047) and teaches that PLGA and PGS are equivalents (see Ma, paragraph 0028). One with ordinary skill in the art would be motivated to simply substitute the PGLA of Qi with the PGS of Ma to obtain predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to simply substitute one known element for another to obtain predictable results.
Conclusion
No claims allowed.
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/Isis A Ghali/Primary Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611