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 .
Priority
The instant application is a Continuation of earlier application 16/955,336 filed 18 June 2020, now U.S. Patent 11,779,543, which is a National Stage entry of International application PCT/IB2018/060528 filed 21 December 2018.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 pertaining to British national application GB1721832.2 filed 22 December 2017.
Election/Restrictions
Applicant's election with traverse of the composition of Claims 1-5 and 9-21 in the reply filed on 18 August 2025 is acknowledged. The traversal is on the ground(s) that there would be no undue search burden examining each of the independent and distinct inventions claimed. This is not found persuasive because no evidence to support this assertion has been provided.
The requirement is still deemed proper and is therefore made FINAL.
Upon further consideration, the Examiner has WITHDRAWN the election of species requirement made in the Office Action mailed 17 March 2025.
Status of the Claims
Claims 1-5, 9-21, 24, and 25 are pending.
Claims 24 and 25 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-5 and 9-21 are presented for examination and rejected as set forth below.
Claim Rejections - 35 USC § 112(b)
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 2-4, 14, and 19 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “wherein the solid lipid comprises or consists of cholesterol,” and Claim 4 indicates the “liquid core comprises or consists of a lipid selected from the group comprising…” Given the conflict in breadth between claims which “comprise” certain elements, which permit the inclusion of other non-recited elements, and those which “consist of” recited elements, which forbid the inclusion of non-named components, the claims are considered indefinite because there is a question or doubt as to whether the broader or narrower embodiment of the composition component recited is to control defining the metes and bounds of the composition component claimed. Claims 2 and 4 further add to this ambiguity in claim scope by incorporating various trademarks as claim limitations (See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product; A trademark or trade name is used to identify a source of goods, and not the goods themselves.).
Alternative expressions are permitted if they present no uncertainty or ambiguity with respect to the question of scope or clarity of the claims. A “Markush” claim recites a list of alternatively useable species. In re Harnisch, 631 F.2d 716, 719-20, 206 USPQ 300, 303-04 (CCPA 1980); Ex parte Markush, 1925 Dec. Comm’r Pat. 126, 127 (1924). A Markush claim is commonly formatted as: "selected from the group consisting of A, B, and C;" however, the phrase “Markush claim" means any claim that recites a list of alternatively useable species regardless of format. Ex parte Markush sanctions claiming a genus expressed as a group consisting of certain specified materials; However, a Markush group may be so expansive that persons skilled in the art cannot determine the metes and bounds of the claimed invention.
Instant Claims 2, 3, 4, 14, and 19 present just such a case where the objective metes and bounds of the invention claimed cannot be determined, as the listing of alternative solid lipid, liquid lipid, corticosteroids, and particle size ranges, respectively, is open-ended, (the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004)), rather than closed as is required to properly present a Markush-style claim.
Claim 19 is further indefinite as lacking a unit of measurement or other frame of reference to determine whether a particle addresses the “comprises between about 1:4 and about 1:30 of solid outer shell relative to liquid core.”
For purposes of compact prosecution, the broader aspects of each of the aforementioned limitations will apply for the examiner’s consideration of art relevant to the instant application. See Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification.").
Claim Interpretation
Applicants’ claims are directed to nanostructured lipid carriers combining a solid lipid, which in dependent claims 2 and 3 is narrowed ultimately to cholesterol, with a liquid lipid which in dependent claims 4 and 5 is narrowed to medium chain triglyceride (MCT) and an active agent in the core. Dependent Claim 5 narrow the identity of the MCT, to a particular caprylic and/or caprylic acid triglyceride. Claims 9-17 further narrow the identity of the active agent. The examiner notes that applicants’ claims which incorporate dexamethasone, by applicants own admission address the functional limitations of Claims 9-11. See Specification, pg. 1. Claim 18 specifies the NLC is nanoparticle size. Claim 19 defines a ratio of solid to liquid lipid in the core. The composition of Claim 20 requires a plurality of the cores of Claim 1, with Claim 21 specifying that the compositions is in a form suitable for ophthalmic administration.
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 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 1-5 and 9-21 are rejected under 35 U.S.C. 103 as being unpatentable over Viladot Petit (WO2011/116963)(of record in parent).
Viladot Petit describes nanostructured lipid carriers (NLC) having pharmaceutical active agents contained therein. (Abs.). Viladot Petit describes the NLC as possessing a liquid lipid encased in a solid lipid matrix. (Pg.2). Viladot Petit indicates that lipophilic agents are dissolved in the lipid solution. (Pg. 5). The liquid lipids to be included in such NLC include each of the paraffin, isopropyl myristate, and capric and caprylic triglycerides of Claims 5-8. (Pg. 8). Cholesterol, tripalmitin, tristerin, glyceryl stearate, glyceryl palmitostearate, and cetyl palmitate of the instant claims is recited as a suitable solid lipid for use in formulating the NCL described therein. (Pg. 8). The ratio of solid to liquid lipid in the NLC includes a 4:1 ratio by percentage of the NLC, addressing the limitations of Claim 19. (Pg. 9). Active agents are described as representing anywhere from 0.001-30% by weight of the composition, a range overlapping and therefore rendering obvious the 0.001-0.1% concentration recited by Claim 16. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Dexamethasone, which applicants’ specification indicates addresses not only the explicit limitation of Claims 12-14 but also the functional limitations of Claims 9-11, is recited as a particular anti-inflammatory and/or analgesic agent to be incorporated in such NLC, either alone or in combination with additional agents, addressing the limitations of Claim 17. (Pg. 23). Antihistamines of Claim 15 represent an alternative active agent which can be included in such NLC. (pg.33). Ophthalmic routes of delivery are included as alternative routes of administration for the NLC compositions described, addressing limitations of Claims 1, 20, and 21. (Pg.35).
On the basis of the disclosure of Viladot Petit describing each of the limitations of Claims 1-5 and 9-21 as useful embodiments of the NLC compositions described therein, it would have been prima facie obvious for a person having ordinary skill in the art at the time of the instant application to have formulated NLC combining a shell of solid lipid such as cholesterol with a liquid core containing each of capric/caprylic triglycerides containing between 0.001-30% of a therapeutic agent such as dexamethasone or a combination of dexamethasone with an additional anti-inflammatory agent, or in the alternative an antihistamine, in a ratio of solid to liquid lipid of 1:4, to provide an ophthalmically acceptable therapeutic composition. This is because, as set forth above, such a selection of solid lipid, liquid lipid, relative amount of each, amount and identity of active agent are each taught by Viladot Petit as useful for formulating therapeutic compositions for ophthalmic delivery. it must be remembered that “[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 at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5 and 9-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,779,543. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘543 patent fall within the scope of and therefore anticipate those of the present claims.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614