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
Claims 2-13 and 16-18 are currently pending.
Claim Objections
Claim 12 is objected to because of the following informalities:
“the eye surface” should instead read “an eye surface”
Appropriate correction is required.
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.
Claim 12 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 regards as the invention.
Claim 12 recites “the composition is administered to lubricate the eye surface”. It is unclear whether “is administered to lubricate” broadens the treatment of conditions listed in Claim 8 such that the claim scope now incorporates ‘methods of lubricating the eye surface’ in addition to specific treatment, or instead the claim is meant to recite a property of the composition, namely that it can lubricate the eye surface. If the latter is intended, it is suggested that applicant recite “the composition lubricates the eye surface” to clarify that the claim is specifying a capability of the composition being administered rather than altering the method of treatment.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, for failing to “contain a reference to a claim previously set forth”. Claims 2-7 depend on Claim 8 which is set forth after said rejected claims.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. As explained above in the rejection over 35 USC 112(b), it appears the language of Claim 12 (“the composition is administered to lubricate the eye surface”) broadens the scope of the methods of Claim 8 such that the claim scope incorporates ‘methods of lubricating the eye surface’ in addition to a specific treatment method.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
PROVISIONAL:
1. Claims 2-13 and 16-18 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 14, 16-20, 22-34 of copending Application No. 17350427 (hereinafter referred to as Novaliq).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to methods of treating dry eye disease (DED) (keratoconjunctivitis sicca) and/or Meibomian Gland Dysfunction (MGD) comprising administering 97% 1-perfluorohexyloctane and 3% or up to 25% 2-perfluorohexyloctane topically to the lower eyelid of a patient, the composition being no more viscous than 10 mPa*s. The compositions are not taught to require additional components.
Regarding the claims directed to compositions of matter, In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). See MPEP 804 (II) (B) (1). The compositions are taught to be used in methods of healing corneal damage/erosion (Specification: Pages 10 and 18-20). They are also useful for treating both aqueous deficient and evaporative DED, wherein the meibum (gland secretion) is of abnormal quality or quantity (Pages 8 and 10).
With respect to Claim 5, the same ingredients are taught. Therefore, a clear liquid solution is expected to result.
With respect to Claim 10, a person of skill in the art would find it obvious to administer the drops at least once daily to coincide with a daily routine for consistent administration, or twice daily, every morning and night, to coincide with other hygienic routines like brushing one’s teeth, or one or two additional times as needed to combat dry eyes.
With respect to Claim 12, applicant teaches lubrication is a property resulting from administration of the claimed compositions comprising semifluorinated alkanes (Instant Specification: Page 9). The same composition for eye administration is taught by Novaliq for the same purpose, resulting in the same lubricating effect.
Since both applications teach methods of using the same composition for the treatment of the same conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Novaliq. Claims 2-4, 8-9 and 11-12 are anticipated over method claims 26-30 of Novaliq.
This is a provisional nonstatutory double patenting rejection.
2. Claims 2-13 and 16-18 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-6, 9-14, and 19-21 of copending Application No. 19531476 (hereinafter referred to as Novaliq) in view of Driver (Survey of Ophthalmology. Vol 40- No. 5- MARCH-APRIL 1996. 343-367).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to methods of treating dry eye disease (DED) (keratoconjunctivitis sicca) and/or Meibomian Gland Dysfunction (MGD) and associated complications comprising administering 97% 1-perfluorohexyloctane and 3% or up to 25% 2-perfluorohexyloctane 1-4 times per day. The compositions are not taught to require additional components; Novaliq uses the language “consisting of” to preclude additional ingredients.
With respect to Claims 5 and 7, the same ingredients of the composition are taught. Therefore, a clear liquid solution with similar or the same viscosity is expected to result.
With respect to Claim 9, the eye to which the composition is administered is comprised of and constitutes ophthalmic tissue. Drops are administered to the surface which is tantamount to topical treatment of the tissues.
With respect to Claim 12, applicant teaches lubrication is a property resulting from administration of the claimed compositions comprising semifluorinated alkanes (Instant Specification: Page 9). The same composition for eye administration is taught by Novaliq for the same purpose, resulting in the same lubricating effect.
Novaliq does not claim particular symptoms of DED or forms of MGD.
However, Driver teaches MGD associated with abnormal secretions is extremely common (Page 343). Secretions are “usually abnormal in appearance, consistency and quantity” (Page 355). MGD can be associated with aqueous deficiency; result in corneal damage like corneal erosion, irritation, or irregular surface; or evaporative in nature (Pages 346-349 and 362). Therefore, one of skill in the art seeking to treat the common symptoms and effects of MGD and DED described in Driver would find it obvious to do so with the composition of the copending application because the copending claims treat the disorders like dry eye or insufficient abnormal secretion taught to be associated with or result in those conditions more specifically described in Driver.
Since both applications teach the same compositions in methods for the same use in treating MGD and DED, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Novaliq. Claims 2-4, 6, and 8-12 are anticipated over the same.
This is a provisional nonstatutory double patenting rejection.
NONPROVISIONAL:
1. Claims 2-13 and 16-18 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-12 of U.S. Patent No. 10682315 (hereinafter referred to as Novaliq) in view of Driver (Survey of Ophthalmology. Vol 40- No. 5- MARCH-APRIL 1996. 343-367).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to methods of treating dry eye disease (DED) (keratoconjunctivitis sicca) and/or Meibomian Gland Dysfunction (MGD) and associated complications and corneal damage comprising administering 97% 1-perfluorohexyloctane and 3% or up to 25% 2-perfluorohexyloctane 1-4 times per day. The compositions are not taught to require additional components; Novaliq uses the language “consisting essentially of” to preclude additional ingredients of instant Claim 6. The compositions are clear liquids which lubricate the eye surface.
With respect to Claim 7, the same ingredients of the composition are taught. Therefore, the same or similar viscosity is expected to result from compositions comprising similar amounts of the same chemicals.
Novaliq does not claim particular symptoms of DED or forms of MGD.
However, Driver teaches MGD associated with abnormal secretions is extremely common (Page 343). Secretions are “usually abnormal in appearance, consistency and quantity” (Page 355). MGD can be associated with aqueous deficiency; result in corneal damage like corneal erosion, irritation, or irregular surface; or evaporative in nature (Pages 346-349 and 362). Therefore, one of skill in the art seeking to treat the common symptoms and effects of MGD and DED described in Driver would find it obvious to do so with the composition of the copending application because the copending claims treat the disorders like dry eye or insufficient abnormal secretion taught to be associated with or result in those conditions more specifically described in Driver.
Since both claim sets teach the same active ingredients in compositions for treating the same conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Novaliq. Claims 2-6, 8-13 are anticipated over the same.
2. Claims 2-13 and 16-18 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-18 of U.S. Patent No. 11357738 (hereinafter referred to as Novaliq).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to compositions consisting of or comprising 97% 1-perfluorohexyloctane and 3% or up to 25% 2-perfluorohexyloctane which do not contain additional ingredients or ingredients selected from polymers, perfluorinated compounds, or dissolved APIs. The compositions have a viscosity of 10mPa*s. Both are directed to use for ophthalmic administration to an eye surface topically.
Regarding all the copending claims directed to compositions of matter, In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). See MPEP 804 (II) (B) (1). Novaliq teaches the compositions are useful for treating corneal damage and dry eye disease (keratoconjunctivitis sicca, comprising both aqueous deficient and evaporative variants) and/or Meibomian Gland Dysfunction (MGD), which entails abnormally low levels or quality of meibum oil secretions, and any symptoms thereof or associated therewith (Col. 4-6).
With respect to Claim 5, the same ingredients are taught. Therefore, a clear liquid solution is expected to result.
With respect to Claim 10, a person of skill in the art would find it obvious to administer the drops at least once daily to coincide with a daily routine for consistent administration, or twice daily, every morning and night, to coincide with other hygienic routines like brushing one’s teeth, or one or two additional times as needed to combat dry eyes.
With respect to Claim 12, applicant teaches lubrication is a property resulting from administration of the claimed compositions comprising semifluorinated alkanes (Instant Specification: Page 9). The same composition for eye administration is taught by Novaliq for the same purpose, resulting in the same lubricating effect.
Since both claim sets teach the same compositions for the same use in treating the same conditions and symptoms or variants associated therewith, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Novaliq.
3. Claims 2-13 and 16-18 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-20 of U.S. Patent No. 11896559 (hereinafter referred to as Novaliq) in view of Driver (Survey of Ophthalmology. Vol 40- No. 5- MARCH-APRIL 1996. 343-367).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to methods of treating dry eye disease (DED) (keratoconjunctivitis sicca) and/or Meibomian Gland Dysfunction (MGD) and associated complications and corneal damage comprising administering a composition comprising or consisting of (excluding other ingredients) 97% 1-perfluorohexyloctane and 3% or up to 25% 2-perfluorohexyloctane less than four times per day via drops topically to the surface of the eye.
With respect to Claims 5 and 7, the same ingredients of the composition are taught. Therefore, a clear liquid solution with the same or similar viscosity is expected to result from compositions comprising similar amounts of the same chemicals.
With respect to Claim 12, applicant teaches lubrication is a property resulting from administration of the claimed compositions comprising semifluorinated alkanes (Instant Specification: Page 9). The same composition for eye administration is taught by Novaliq for the same purpose, resulting in the same lubricating effect.
Novaliq does not claim particular symptoms of DED or forms of MGD.
However, Driver teaches MGD associated with abnormal secretions is extremely common (Page 343). Secretions are “usually abnormal in appearance, consistency and quantity” (Page 355). MGD can be associated with aqueous deficiency; result in corneal damage like corneal erosion, irritation, or irregular surface; or evaporative in nature (Pages 346-349 and 362). Therefore, one of skill in the art seeking to treat the common symptoms and effects of MGD and DED described in Driver would find it obvious to do so with the composition of the copending application because the copending claims treat the disorders like dry eye or insufficient abnormal secretion taught to be associated with or result in those conditions more specifically described in Driver.
Since both claim sets teach methods of treating the same conditions comprising administering the same ingredients in the same or similar amounts to the same ophthalmic surface regions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Novaliq. Claims 2-4, 6, and 8-13 are anticipated over the same.
4. Claims 2-13 and 16-18 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-13 of U.S. Patent No. 12128010 (hereinafter referred to as Novaliq).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to compositions comprising 97% 1-perfluorohexyloctane and 3% or up to 25% 2-perfluorohexyloctane which do not contain additional ingredients or ingredients selected from polymers, perfluorinated compounds, or dissolved APIs. The compositions have a viscosity of 10mPa*s. Both are directed to use for ophthalmic administration to an eye surface topically.
Regarding all the copending claims directed to compositions of matter, In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). See MPEP 804 (II) (B) (1). Novaliq teaches the compositions are useful for treating corneal damage and dry eye disease (keratoconjunctivitis sicca, comprising both aqueous deficient and evaporative variants) and/or Meibomian Gland Dysfunction (MGD), which entails abnormally low levels or quality of meibum oil secretions, and any symptoms thereof or associated therewith (Col. 4-6).
With respect to Claim 5, the same ingredients are taught. Therefore, a clear liquid solution is expected to result.
With respect to Claim 10, a person of skill in the art would find it obvious to administer the drops at least once daily to coincide with a daily routine for consistent administration, or twice daily, every morning and night, to coincide with other hygienic routines like brushing one’s teeth, or one or two additional times as needed to combat dry eyes.
With respect to Claim 12, applicant teaches lubrication is a property resulting from administration of the claimed compositions comprising semifluorinated alkanes (Instant Specification: Page 9). The same composition for eye administration is taught by Novaliq for the same purpose, resulting in the same lubricating effect.
Since both claim sets teach the same compositions for the same use in treating the same conditions and symptoms or variants associated therewith, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Novaliq.
5. Claims 2-5, 7-13, and 16-18 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-16 of U.S. Patent No. 12496326 (hereinafter referred to as Novaliq) in view of Driver (Survey of Ophthalmology. Vol 40- No. 5- MARCH-APRIL 1996. 343-367).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to treating dry eye disease (DED) (keratoconjunctivitis sicca) and/or corneal inflammation—tantamount to damage—comprising administering a composition comprising 97% 1-perfluorohexyloctane and 2 or 3% 2-perfluorohexyloctane twice per day in the copending claims which is within “up to four” times daily. Administration is taught to be topical to the eye, comprised of ophthalmic tissue. Treating inflammation, a symptom of DED, in a patient with DED is tantamount to treatment of DED.
Claim 4 recites “up to” which includes any value equal to or below 3%. Further, 2% 2-perfluorohexyoctane is close to 3%. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). One of skill in the art might find it obvious to vary the ingredient from 2% to 3% depending on a patient’s response and a scientist or practitioner’s desire to optimize the effective dose.
With respect to Claims 5 and 7, the same ingredients of the composition are taught to comprise 99% of the compositions. Therefore, a clear liquid solution with the same or similar viscosity is expected to result from compositions comprising similar amounts of the same chemicals.
With respect to Claim 12, applicant teaches lubrication is a property resulting from administration of the claimed compositions comprising semifluorinated alkanes (Instant Specification: Page 9). The same composition for eye administration is taught by Novaliq for the same purpose, resulting in the same lubricating effect. No evidence on the record suggests the small amount of ethanol or cyclosporine would inhibit the lubrication capabilities of the semifluorinated alkanes.
Novaliq does not claim particular symptoms of DED or causes like Meibomian Gland Dysfunction (MGD) and forms thereof.
Driver teaches “Meibomian gland dysfunction is frequently associated with keratoconjunctivitis sicca” (Page 346). MGD associated with abnormal secretions is extremely common (Page 343). Secretions are “usually abnormal in appearance, consistency and quantity” (Page 355). MGD can be associated with aqueous deficiency; result in corneal damage like corneal erosion, irritation, or irregular surface; or evaporative in nature (Pages 346-349 and 362). Therefore, one of skill in the art seeking to treat the common symptoms and effects of MGD and DED described in Driver would find it obvious to do so with the composition of the copending application because the copending claims treat the disorders like dry eye or insufficient abnormal secretion taught to be associated with or result in those conditions more specifically described in Driver.
Since both claim sets teach methods of treating corneal damage and DED or keratoconjunctivitis sicca, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Novaliq. Claims 2-4 and 8-13 are anticipated over the same.
6. Claims 2-13 and 16-18 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-21 of U.S. Patent No. 12569452 (hereinafter referred to as Novaliq) in view of Driver (Survey of Ophthalmology. Vol 40- No. 5- MARCH-APRIL 1996. 343-367).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to methods of treating dry eye disease (DED) (keratoconjunctivitis sicca) and/or Meibomian Gland Dysfunction (MGD) and corneal damage comprising administering a composition comprising or consisting of (excluding other ingredients) 97% 1-perfluorohexyloctane and 3% 2-perfluorohexyloctane twice per day in the copending claims which is within “up to four” times daily via drops topically to the surface of the cornea, an ophthalmic tissue. Enriching ophthalmic tissue in a patient with DED or MGD with the semifluorinated alkanes is tantamount to treatment.
With respect to Claims 5 and 7, the same ingredients of the composition are taught. Therefore, a clear liquid solution with the same or similar viscosity is expected to result from compositions comprising similar amounts of the same chemicals.
With respect to Claim 12, applicant teaches lubrication is a property resulting from administration of the claimed compositions comprising semifluorinated alkanes (Instant Specification: Page 9). The same composition for eye administration is taught by Novaliq for the same purpose, resulting in the same lubricating effect.
Regarding Claim 13, corneal fluorescin staining (NEI scale) indicates corneal damage in the patient to be treated.
Novaliq does not claim particular symptoms of DED or forms of MGD.
However, Driver teaches MGD associated with abnormal secretions is extremely common (Page 343). Secretions are “usually abnormal in appearance, consistency and quantity” (Page 355). MGD can be associated with aqueous deficiency; result in corneal damage like corneal erosion, irritation, or irregular surface; or evaporative in nature (Pages 346-349 and 362). Therefore, one of skill in the art seeking to treat the common symptoms and effects of MGD and DED described in Driver would find it obvious to do so with the composition of the copending application because the copending claims treat the disorders like dry eye or insufficient abnormal secretion taught to be associated with or result in those conditions more specifically described in Driver.
Since both claim sets teach methods of treating the same conditions comprising administering the same ingredients in the same or similar amounts to ophthalmic surfaces in a patient, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Novaliq. Claims 2-4, 6, and 8-13 are anticipated over the same.
Allowable Subject Matter
The closest prior art to the methods of using the composition of independent Claim 8 is found in Gunther (EP2708228; 12/09/2024 IDS).
Gunther teaches compositions of semifluorinated alkanes for administration to the eye of a subject (Abstract). The compound F6H8, as claimed, is taught to be formed in a composition with a different semifluorinated alkane (Para 18-19). Gunther teaches that semifluorinated alkanes may be linear or branched (Para 15). Gunther does not teach any examples of branched semifluorinated alkanes or administration for the treatment of the claimed conditions. One of skill in the art would not find it obvious to form a composition of branched semifluorinated alkanes as described in the instant Claims. Not only does Gunther fail to teach branching alkanes, but “branching” is a broad term that would require one of skill in the art to 1) select the second alkane with the same molecular formula as F6H8, 2) select the non-perfluorinated section of the semifluorinated alkane, and 3) select a branching pattern consistent with the single branched compound of the elected claims. It is noted that branching may occur at any carbon and result in alkyl or haloalkyl chains of various lengths and constitution at said carbon or carbons. Gunther provides no indication to select 2-perfluorohexyloctance or suggest that such compound can form a miscible solution with F6H8 for ophthalmic administration.
Further, the compound 2-perfluorohexyloctance, as claimed, was not known for ophthalmic or any therapeutic or industrial use before the effective filing date of the examined claims. Therefore, the claims are free of the prior art.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
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