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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/01/2026 has been entered.
Status of the application
Receipt of applicant’s remarks and claim amendments filed on 07/01/2026 are acknowledged.
In light of claim amendments and applicants arguments, previous Claim Objections and 103 rejection are withdrawn.
With regard to nonstatutory double patenting rejections, since applicants offer no direct arguments against the rejections of record nor has a Terminal Disclaimer been filed over the pending rejections. As such, the rejections are maintained.
Nonstatutory Double Patenting Rejection
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(i) Claims 1, 6, 9-10, 21-22, 24, 26-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 10,751,281 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The claims of present application are drawn to an otic formulation comprising a therapeutically effective amount of a growth factor and an auris-acceptable vehicle, wherein the otic formulation is formulated to provide sustained release of the growth factor into the inner ear to promote formation or repair of synapses, wherein growth factor is BDNF and auris-acceptable vehicle is poloxamer 407.
The claims of US patent are drawn to a method of treating or alleviating hearing loss, the method comprising intratympanically administering an otic composition to a subject in need thereof, wherein the otic composition comprises an otic hair cell growth factor and an auris acceptable gel, wherein the otic hair cell growth factor is multiparticulate and non-microencapsulated, and wherein the otic hair cell growth factor is not a glial cell-line derived neurotrophic factor (GDNF), wherein otic hair cell growth factor is BDNF and auris acceptable gel is thermoreversible gel comprises a copolymer of polyoxyethylene and polyoxypropylene (aka poloxamer 407).
So, the otic formulation is common in both cases. The difference is that the claims of present application do not recite the method limitations in the claims.
However, this difference is obvious and so, not patentable, because the product is not distinct from its process of using, and so these are not separable. Moreover, the specification of present application disclosed the benefits of formulation in treating hearing loss by administering the claimed formulation [see 0003].
MPEP 804 says:
The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." 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); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Accordingly, the claims are obvious over the claims of US patent.
(ii) Claims 1, 6, 9-10, 21-22, 24, 26-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 11,123,285 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent. Independent claims of both the patent and instant application are claiming common subject matter of pharmaceutical composition comprising growth factor and auris-acceptable vehicle, wherein growth factor is BDNF and auris-acceptable vehicle is poloxamer 407. In addition, dependent claims are identical or overlap the scope in narrow range.
Therefore, the claims of present application are anticipated by US patent claims.
(iii) Claims 1, 6, 9-10, 21-22, 24, 26-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 11,969,501 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent. Independent claims of both the patent and instant application are claiming common subject matter of pharmaceutical composition comprising growth factor and auris-acceptable vehicle, wherein growth factor is BDNF and auris-acceptable vehicle is poloxamer 407. In addition, dependent claims are identical or overlap the scope in narrow range.
Therefore, the claims of present application are anticipated by US patent claims.
(iv) Claims 1, 6, 9-10, 21-22, 24, 26-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US copending application number 17/794,935.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The claims of present application are drawn to an otic formulation comprising a therapeutically effective amount of a growth factor and an auris-acceptable vehicle, wherein the otic formulation is formulated to provide sustained release of the growth factor into the inner ear to promote formation or repair of synapses, wherein growth factor is BDNF and auris-acceptable vehicle is poloxamer 407.
Claims of copending application are drawn to a method of treating an otic disease or condition associated with a synapses-affecting event in a subject in need thereof, the method comprising administering an otic formulation comprising a therapeutically effective amount of a growth factor and an auris-acceptable vehicle within 14 days after onset of the synapses-damaging event, wherein the otic formulation is formulated to provide sustained release of the growth factor into the inner ear to promote formation of synapses or repair damaged synapses.
So, the otic formulation is common in both cases. The difference is that the claims of present application do not recite the method limitations in the claims.
However, this difference is obvious and so, not patentable, because the product is not distinct from its process of using, and so these are not separable. Moreover, the specification of present application disclosed the benefits of formulation in treating hearing loss by administering the claimed formulation [see 0003].
MPEP 804 says:
The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." 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); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Accordingly, the claims are obvious over the claims of US patent.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not been patented yet.
(v) Claims 1, 6, 9-10, 21-22, 24, 26-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US copending application number 18/603,065.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent. Independent claims of both the patent and instant application are claiming common subject matter of pharmaceutical composition comprising growth factor and auris-acceptable vehicle, wherein growth factor is BDNF and auris-acceptable vehicle is poloxamer 407. In addition, the subject matter in the dependent claims overlap the scope.
It appears that instant claims are broader in scope, whereas claim of copending application are limited to the recited auris-acceptable vehicle, concentrations etc.
The differences, however, does not constitute a patentable distinct, because the subject matter, such as components in the formulation, concentrations and properties overlap with each other. Accordingly, claims of present application simply fall with the scope of copending US patent application.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not been patented yet.
Conclusion
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/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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