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 preliminary amendment of 29 May 2024, in which claims 4-8, 10, 12-23 have been amended, is acknowledged.
Claims 1-23 are pending.
Claims 1-23 are examined here.
Priority
This application is a National entry 371 of International Application PCT/EP2022/083986, filed on 1 December 2022, which claims priority from European Patent Application 21211990.3, filed on 2 December 2021.
A certified copy of the priority document, in English, has been submitted on 22 November 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 May 2024 is acknowledged and considered.
Claim objection
Claims 1-3 are objected to because they recite “or any specific value within said range”. This recitation is unnecessary, and it does not add clarity to the claims.
Claim 2 is objected to because it should read “(iii) 1.0% to 4.0% w/w of a co-solvent which is Polyethylene glycol 400”. That is because claim 2 depends on claim 1, and claim 1 recites that component (iii) is a co-solvent.
Claims 6, 7 are objected to because a semi-colon between the different buffer systems listed, for example, ”boric acid and disodium hydrogen phosphate heptahydrate; disodium […]” will help with the clarity of the claim.
Claim 8 is objected to because it should recite “further comprising” (instead of “further comprises”).
Claim 9 is objected to because the text “[…] acid or its salts” should read --[…] acid or a salt thereof.--“
Claim 14 is objected to because it should read “(iii) 2.8% w/w of a co-solvent which is Polyethylene glycol 400; (iv) a buffer system which is […]”. That is because claim 14 depends on claim 1, and claim 1 recites that component (iii) is a co-solvent; (iii) is a buffer system.
Claims 15-22 are objected to for the same reason as claim 14 above.
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 1 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.
Claim 1 recites “wherein the osmolality of the ophthalmic formulations is 240 to 400 mOsm/kg, preferably 240 to 380 mOsm/kg”. Regarding claim 1, the phrase "preferably" 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).
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 1 recites the broad recitation “240 to 400 mOsm/kg”, and the claim also recites “240 to 380 mOsm/kg”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Appropriate correction is required.
Claims 1-4, 6-7, 10, 12, 13 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.
In claim 1, the phrase a surfactant component “selected from the following mixtures: a, b, or c” is vague and indefinite because the term “or c” would mean that the claim is open ended in the closed Markush expression “selected from the following (interpreted as selected from the group consisting of)”. The claim should recite “a surfactant component selected from a, b and c”. Alternatively, claim 1 could recite “a surfactant component which is a, b or c”.
The same analysis applies to recitations ”selected from the following mixtures”/”selected from” in claims 2-4, 6-7, 10, 12, 13.
Appropriate correction is required.
Claims 14-22 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 14 is drawn to the ophthalmic formulation of claim 1 consisting essentially of (i)-(v), further comprising […]. The claim is unclear because it contains two transitional phrases, namely “consisting essentially of” and “comprising”, in the same claim. The transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. MPEP 2111.03.III. Claim 14 depends on claim 1 and recites that the formulation consists essentially of 5 elements, and comprises (an unlimited number of) additional elements. One of the 5 elements that the formulation “consists essentially of” is (v) water, the other being (iv) a buffer system to adjust the pH in the range of 4.5 to 7.5. Yet, the claim states that the formulation “further comprises”, which is inclusive or open-ended and does not exclude additional, unrecited elements (MPEP 2111.03.I.), other three ingredients (and any additional ones), including HCl and NaOH to adjust the pH to 6.5 to 6.9. It is unclear how the buffer (iv) used to adjust the pH in the range of 4.5 to 7.5 materially affects the basic and novel characteristics of the formulation (due to the recitation “consisting essentially of”), while other elements used to adjust the pH to 6.5 to 6.9 do not materially affect the basic and novel characteristics of the formulation.
Further, it is unclear what the pH of the formulation actually is- is it 4.5 to 7.5, since element (iv) is used to adjust the pH in that range, or is it rather 6.5-6.9?
The same analysis applies to claims 15-22.
Appropriate clarification is required.
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.
Claim interpretation: If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”). See MPEP 2111.02.
In claim 23, the body of the claim fully and intrinsically sets forth all the limitations of the claimed invention, namely an ophthalmic formulation comprising [(2S)-1-(4-{[(3-chloro-4- methoxyphenyl)methyl]amino} -5- {[(pyrimidin-2- yl)methyl]carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6- (nitrooxy)hexanoate; the preamble only states the intended use of the composition. Thus, the preamble is not given any patentable weight.
"[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir. 2002).
Claims 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over Almirante et al. (WO 2020/030489, published 13 February 2020, cited in IDS), in view of Horn (US2014/0378401, cited in PTO-892).
Almirante (WO 2020/030489) teaches (page 40, Example 1) the following compound:
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,
which is the very compound in the instant claims, or a pharmaceutical salt thereof, as a nitric oxide releasing PDE5 inhibitor, and compositions thereof (page 1, line 2), useful for the treatment of ocular conditions associated with elevated intraocular pressure such as ocular hypertension, glaucoma or retinopathies (abstract).
Almirante teaches (page 27, lines 17-20) ophthalmic pharmaceutical compositions comprising a compound of the invention and a pharmaceutically acceptable excipient and/or vehicle.
The concentration of the compounds of the invention in the compositions is from 0.003% to 3% w/w (page 30, lines 1-3), which encompasses the range in the instant claims.
Almirante also teaches (example 5, page 47)
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, which is the citrate salt of the compound in the instant claims,
and an ophthalmic formulation comprising (Example 23, page 67, lines 9-12) said citrate salt 2.2% w/v, in a vehicle containing
5% Cremophor EL (alternative name macrogolglycerol ricinoleate), which is a surfactant component in the instant claims,
0.02% w/v benzalkonium chloride, which is an antimicrobial preservative of instant claims 10, 11, 14-22,
phosphate buffer pH 6, which is a buffer system as (iv) in the instant claims, and water.
Almirante does not teach the ophthalmic formulation of the instant claims.
Horn (US2014/0378401) teaches [0225] a delivery vehicle for mild to highly lipophilic drugs comprising combination of a nonionic surfactant, a viscosity enhancer or combination thereof, and a hypotonic solution, that 1) is independent of pH and largely independent of the individual drug's lipophilicity; 2) is more easily solubilized for topical delivery; 3) achieves enhanced intraocular bioavailability.
Horns teaches drug lipophilicity in ophthalmic formulations. Horn teaches [0220] that, for any given ophthalmic drug, an optimal polarity exists to maximize requisite penetration into the lipophilic cornea surface epithelium and, to a lesser extent, inner layer endothelium.
Horn teaches ophthalmic formulations comprising an ophthalmic drug;
[0106] a nonionic surfactant particularly polyoxyl 40 stearate, which is macrogol stearate 40 of the instant claims, or polyoxyl 35 castor oil, which is macrogolglycerol ricinoleate of the instant claims, at a concentration at about 12% or less, and preferably between about 3% and 10%; and more preferably between about 5% and 6%; and where similarly a polysorbate up to 10% may be added or substituted to create the same cumulative concentration; polysorbates may include Polysorbate 80, which is polyoxyethylenesorbitan monooleate of the instant claims;
[0105] a polyol or a tonicity enhancer;
[0107] a viscosity enhancer.
Thus, Horns teaches the very non-ionic surfactants in the instant claims, and particularly exemplifies [0141]-[0200] polyoxyl 40 stearate, which is macrogol stearate 40 of the instant claims, in ophthalmic formulations of highly lipophilic drugs.
Horn exemplifies [0141]-[0200] a number of ophthalmic formulations comprising
[0142] an ophthalmic drug at a concentration from about 0.25% to about 2.0% w/v, where the concentration of active agent overlaps with the range in the instant claims;
[0143] polyoxyl 40 stearate, which is macrogol stearate 40 of the instant claims, at a concentration from about 1% to about 15% w/v, which encompasses the range in the instant claims;
[0145] phosphate buffer;
water, [0146] and where the formulation has a pH from about 5.0 to about 8.0, which overlaps with the range in the instant claims.
Some of the formulations exemplified by Horns further include EDTA at 0.01% to 0.02% [0179], benzalkonium chloride [0180], and buffers such as borate [0163], [0199].
Horn teaches [0226] that the optimal pH of the ophthalmic formulations is 4.5 to 7.8, which encompasses the range in the instant claims, for optimal comfort and stability.
Horn teaches [0227] that, for highly lipophilic drugs, borate buffers may be preferred, as in instant claims 6, 7. Horn teaches [0253] buffers and pH adjustors include, citrate buffers, phosphate buffers and borate buffers, as in the instant claims. pH adjusting agents include sodium hydroxide and hydrochloric acid, as in instant claims 14-17.
Horn teaches [0230] that, for purposes of comfort, topical ophthalmic drugs typically require about 275 to 320 mOsm/kg tonicity, which is within the range in instant claim 1.
Horn teaches [0230], [249] tonicity enhancers, including polyols, such as mannitol, glycerin, as in instant claims 4, 12.
Horn teaches [0245] the compositions of the invention may include inactive ingredients commonly used in formulating topical compositions and that improve stability of the formulation such as alcohols and/or surface active agents, including, for example, polyethylene glycols, as in instant claims 4, 5; in a total amount of 0.05% to 5% by mass of the composition, which overlaps with the range of (iii) in instant claim 1.
Horn teaches [0247] that the compositions of the invention include chelating agents that further improve stability, including ethylenediaminetetraacetic acid (EDTA) or its salt, as in instant claims 8, 9, 22, present at a concentration of between 0.005% and 0.2% weight/vol., which overlaps with the range in instant claim 9, and includes the concentration in instant claims 14-22.
Horn teaches [0248] that the compositions of the invention include preservatives, particularly effective being benzalkonium chloride (BAK), as in instant claims 11, 14-22.
Horn teaches [0251] that the compositions of the invention include a corneal permeation enhancing agent such as BAK at 0.01% to 0.02% weight by volume, where the concentration of BAK is as in instant claims 14-22, or EDTA, or citric acid, as in instant claims 14-18, 20.
Horn does not teach ophthalmic formulations of [(2S)-1-(4-{[(3-chloro-4- methoxyphenyl)methyl]amino} -5- {[(pyrimidin-2- yl)methyl]carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6- (nitrooxy)hexanoate, as in the instant claims.
Horn does not teach ophthalmic formulations comprising a mixture of non-ionic surfactants which is a mixture of polyoxyl 40 stearate (alternative name macrogol stearate 40) and polyoxyl 35 castor oil (alternative name macrogolglycerol ricinoleate), or a mixture of polyoxyl 40 stearate (macrogol stearate 40) and Polysorbate 80 (alternative name polyoxyethylenesorbitan monooleate), as in the instant claims.
It would have been obvious for one of ordinary skill in the art to prepare an ophthalmic aqueous formulation of [(2S)-1-(4-{[(3-chloro-4- methoxyphenyl)methyl]amino} -5- {[(pyrimidin-2- yl)methyl]carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6- (nitrooxy)hexanoate, by combining the teachings of Almirante and Horn. The person of ordinary skill would have prepared an aqueous ophthalmic formulation containing lipophilic drug [(2S)-1-(4-{[(3-chloro-4- methoxyphenyl)methyl]amino} -5- {[(pyrimidin-2- yl)methyl]carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6- (nitrooxy)hexanoate, using the non-ionic surfactants, buffers, cosolvents/tonicity agents, chelating agents and preservatives disclosed by Horn, having the pH and osmolality disclosed by Horn, because Horn teaches a delivery vehicle for mild to highly lipophilic drugs comprising such combination of a nonionic surfactant, a viscosity enhancer, buffers which achieves enhanced intraocular bioavailability.
The person of ordinary skill in the art would have prepared an ophthalmic formulation containing a mixture of two non-ionic surfactants selected from polyoxyl 40 stearate (alternative name macrogol stearate 40), polyoxyl 35 castor oil (alternative name macrogolglycerol ricinoleate), and Polysorbate 80 (alternative name polyoxyethylenesorbitan monooleate), because Almirante teaches ophthalmic formulations comprising a salt of the instant compound and Cremophor EL (alternative name macrogolglycerol ricinoleate), and Horns teaches polyoxyl 40 stearate (alternative name macrogol stearate 40), polyoxyl 35 castor oil (alternative name macrogolglycerol ricinoleate), and Polysorbate 80 as preferred non-ionic surfactants in ophthalmic formulations of lipophilic drugs. Thus, the person of ordinary skill in the art would have combined the non-ionic surfactant polyoxyl 35 castor oil (alternative name macrogolglycerol ricinoleate) taught by Almirante and Horns, with polyoxyl 40 stearate (alternative name macrogol stearate 40), or with Polysorbate 80 (alternative name polyoxyethylenesorbitan monooleate) taught by Horns, in an ophthalmic formulation of lipophilic drug [(2S)-1-(4-{[(3-chloro-4- methoxyphenyl)methyl]amino} -5- {[(pyrimidin-2- yl)methyl]carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6- (nitrooxy)hexanoate, and would have added the polyol, buffer, water, in the concentrations disclosed by Horns, and would have adjusted the pH and the osmolality of the formulation, as taught by Horns, with the expectation of obtaining an ophthalmic formulation with intraocular bioavailability.
It is well within the skill of the art to determine the effective amount within a range through routine experimentation. It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955.)
It would have been obvious for one of ordinary skill in the art to specifically use boric acid, or phosphate as buffers, disodium edetate as complexing agent, BAK as preservative, glycerin or mannitol or PEG as co-solvents, in the ophthalmic formulation, because Horns teaches these ingredients in combination with non-ionic solvents such as polyoxyl 40 stearate (alternative name macrogol stearate 40), in ophthalmic formulations of lipophilic drugs.
As such, claims 1-23 are rejected as prima facie obvious.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-7, 10 of U.S. Patent 11,980,618 (cited in PTO-892) in view of Horn (US2014/0378401, cited in PTO-892).
Claims 1-7, 10 of U.S. Patent 11,980,618 are drawn to a compound which is, for example, [(2S)-1-(4-{[(3-chloro-4- methoxyphenyl)methyl]amino} -5- {[(pyrimidin-2- yl)methyl]carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6- (nitrooxy)hexanoate or salt thereof (claim 7), or an ophthalmic pharmaceutical composition comprising said compound.
Horn is as above.
It would have been obvious for one of ordinary skill in the art to prepare an ophthalmic aqueous formulation of [(2S)-1-(4-{[(3-chloro-4- methoxyphenyl)methyl]amino} -5- {[(pyrimidin-2- yl)methyl]carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6- (nitrooxy)hexanoate. The person of ordinary skill would have prepared an aqueous ophthalmic formulation containing lipophilic drug [(2S)-1-(4-{[(3-chloro-4- methoxyphenyl)methyl]amino} -5- {[(pyrimidin-2- yl)methyl]carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6- (nitrooxy)hexanoate, using the non-ionic surfactants, buffers, cosolvents/tonicity agents, chelating agents and preservatives disclosed by Horn, having the pH and osmolality disclosed by Horn, because Horn teaches a delivery vehicle for mild to highly lipophilic drugs comprising such combination of a nonionic surfactant, a viscosity enhancer, buffers which achieves enhanced intraocular bioavailability.
The person of ordinary skill in the art would have prepared an ophthalmic formulation containing a mixture of two non-ionic surfactants selected from polyoxyl 40 stearate (alternative name macrogol stearate 40), polyoxyl 35 castor oil (alternative name macrogolglycerol ricinoleate), and Polysorbate 80 (alternative name polyoxyethylenesorbitan monooleate), because Horns teaches polyoxyl 40 stearate (alternative name macrogol stearate 40), polyoxyl 35 castor oil (alternative name macrogolglycerol ricinoleate), and Polysorbate 80 as preferred non-ionic surfactants in ophthalmic formulations of lipophilic drugs. Thus, the person of ordinary skill in the art would have combined non-ionic surfactants polyoxyl 35 castor oil (alternative name macrogolglycerol ricinoleate), polyoxyl 40 stearate (alternative name macrogol stearate 40), and/or Polysorbate 80 (alternative name polyoxyethylenesorbitan monooleate) taught by Horns, in an ophthalmic formulation of lipophilic drug [(2S)-1-(4-{[(3-chloro-4- methoxyphenyl)methyl]amino} -5- {[(pyrimidin-2- yl)methyl]carbamoyl}pyrimidin-2-yl)pyrrolidin-2-yl]methyl 6- (nitrooxy)hexanoate, and would have added the polyol, buffer, water, in the concentrations disclosed by Horns, and would have adjusted the pH and the osmolality of the formulation, as taught by Horns, with the expectation of obtaining an ophthalmic formulation with intraocular bioavailability.
For similar reasons, instant claims 1-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-3, 6-9 of co-pending U.S. Patent Application 18/841,347 (cited in PTO-892) in view of Horn (US 2014/0378401, cited in PTO-892); and instant claims 1-13, 23 are rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1, 2, 12 of co-pending U.S. Patent Application 17/760,012 (notice of allowance mailed, cited in PTO-892) in view of Horn (US2014/0378401, cited in PTO-892).
Conclusion
Claims 1-23 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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