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 .
Status of the application
Receipt of applicant’s remarks and claim amendments filed on 12/03/2025 are acknowledged.
However, applicants’ arguments for the previous 103 rejection are found not persuasive. Accordingly, the previous rejection is maintained and modified to address claim amendments. Please see the examiners response to applicants arguments below.
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.
Response to Arguments
Applicants’ argue that Yasuhiko discloses BDNF in a gelatin hydrogel but is silent regarding poloxamer 407 and provides no teaching concerning how BDNF concentration affects sustained release. Yasuhiko does not suggest using low BDNF concentrations, nor does it disclose any mechanism or principle that would lead the skilled artisan to expect that reducing BDNF concentration would maintain or enhance release duration.
First step in the formulations is finding suitable concentration ranges for the ingredients in the composition through a routine experimentation, which is standard in the art. In addition, established case law states that the differences in concentrations of components of a formulation will not support the patentability of subject matter encompassed by the prior art. Such formulations are results-effective variables which can be optimized. In in re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980), it was held that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Further, in In re Aller, 220 F. 2d454, 456, 105 USPQ 233,235 (CCPA 1955) the courts maintained that: "Where the general condition of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." As formulating optimal compositions for medicaments is routine in the art of pharmacology, the claims are considered to be prima facie obvious.
Applicants argue that a reference cited in the prosecution of a parallel European application, which reports detailed in vivo pharmacokinetic studies of poloxamer-based otic formulations. WO 2015/031393 demonstrates that formulations containing high concentrations of active agent (e.g., 2%, 6%, 12%) exhibit prolonged release exceeding five to ten days, whereas formulations containing lower concentrations (0.06%, 0.2%, 0.6%) release the active agent for substantially shorter durations, in some instances less than three to five days. Thus, WO '393 establishes a clear positive correlation between active concentration and sustained-release duration: higher concentrations release longer; lower concentrations release shorter. A skilled person seeking to achieve sustained release would therefore have been motivated to maintain or increase active concentration, and not to reduce concentration into the 0.005-0.5% range, which is far below the concentrations shown to be suboptimal.
This argument is irrelevant, because, in the cited WO’393 the active agent is different, which is organic compound for treating microbial infection, whereas in the instant case active agent is protein, which has totally different utility.
Applicants argue that none of the references identifies the concentration of BDNF in poloxamer 407 as a result-effective variable, nor do they disclose any predictable relationship between concentration and sustained release such that the presently claimed concentration range of 0.005% to 0.5% by weight could be obtained by routine optimization. The cited references contain no teaching that BDNF concentration in a poloxamer 407 matrix affects drug-release duration in any systematic or foreseeable manner.
The purpose of cited Hy or Dumortier or Engleder is to show the advantages of poloxamer 407 in the formulations. Also the property of BDNF is known, as evidenced from the teachings of Yasuhiko, and so, a skilled person in the art would determine suitable concentration range for BDNF, which is compatible to the concentration range of poloxamer 407 through a routine experimentation.
Applicants show how each cited reference differ from the instant invention, but the obviousness test under 35 U.S.C. 103 is whether the invention would have been obvious in view of the prior art taken as a whole. In re Metcalf et al. 157 U.S.P.Q. 423.
Applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, all the art rejections are under 35 USC 103, which relies on the combination of the references together.
Applicants further argue that, applicant has found that formulations containing 0.005% to 0.5% BDNF in poloxamer 407 unexpectedly achieve sustained release in vivo for extended periods-far exceeding what the prior art predicts. As demonstrated in Example A2 and Figure 4 of the present application, BDNF delivered at these low concentrations remains detectable in the inner ear across multiple days, with persistence observed out to approximately fourteen days following administration. This behavior is strikingly different from the trend reported in WO '393, where lower concentrations shortened release duration.
First, as explained above, WO’393 is irrelevant art in this context. Second, the shown data is a simple titration to see the property of the BDNF in poloxamer 407, and so expected. Finally, applicants failed to explain why the shown data is unexpected?
Claim objections
Claim 3 is objected to because of the following informalities: claim is not further limiting its independent claim and is substantially duplicate. Appropriate correction 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 3-10, 14-15, 18, 21-22, 24 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Yasuhiko (JP 2005220070 A) in view of Hy (Chinese Journal of Otorhinolaryngology Head and Neck Surgery, 01 Jun 2007, 42(6):443-446), Dumortier (Pharmaceutical Research, 2006, vol.23, No.12, 2709-2728) and Engleder (International Journal of Pharmaceutics, 2014, 471, 297-302).
For claim 1 and 3:
Yasuhiko teaches a sustained release preparation for inner ear administration containing BDNF and bioabsorbable polymer hydrogel [see claims, abstract and section “TECH-SOLUTION”]. Yasuhiko further teach that polyethylene glycol and its copolymer with propylene glycol is one of the bioabsorbable polymer [see section “BEST-MODE”].
In the above teachings BDNF and ‘polyethylene glycol and its copolymer with propylene glycol’ (aka poloxamer 407) reads applicants elected species.
Differences between Yasuhiko and instant claims are as follows:
(i) Yasuhiko exemplified their data with gelatin hydrogel, but silent on exemplifying their preparation or composition with applicants elected poloxamer 407.
(ii) Yasuhiko silent on the recited concentrations of growth factor.
With regard to (i) of above, advantages of poloxamer 407 are known for sustained release formulations in the art as evidenced from the following art:
Hy teaches effect of poloxamer 407 on the middle ear and inner ear after regional perfusion in guinea pigs and further states that poloxamer 407 can be biodegraded in vivo or discharged via eustachian tube, and causes no inflammation on the middle ear cavity. There are temperature changes on auditory function of inner ear after topical perfusion with poloxamer 407 in round window can cause, but no irreversible damage on function and morphology of cochlear and vestibular organs [see Title and Conclusions].
Dumortier teaches poloxamer 407 and its advantages in pharmaceutical formulations [see abstract].
Engleder teaches formulations of poloxamer 407 with triamcinolone acetonide and advantages of poloxamer 407 in the delivery of formulation to the inner ear [see abstract].
Therefore, a skilled person in the art would be motivated to replace gelatin hydrogel in the teachings of Yasuhiko with poloxamer 407 and reach applicants formulation with a reasonable expectation of success.
With regard to (ii) of above, generally, differences in concentrations of components of a formulation will not support the patentability of subject matter encompassed by the prior art. Such formulations are results-effective variables which can be optimized. In in re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980), it was held that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Further, in In re Aller, 220 F. 2d454, 456, 105 USPQ 233,235 (CCPA 1955) the courts maintained that: "Where the general condition of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." As formulating optimal compositions for medicaments is routine in the art of pharmacology, the claims are considered to be prima facie obvious.
In this case, advantages of poloxamer 407 is known in the art, as evidenced from the teachings of Hy or Dumortier or Engleder, and also property of BDNF is known, as evidenced from the teachings of Yasuhiko, and so, a skilled person in the art would determine suitable concentration range for BDNF, which is compatible to the concentration range of poloxamer 407 through a routine experimentation.
For claim 4-5:
Hy teaches that the right ears of 10 guinea pigs as experimental group were perfused with 20% poloxamer 407 in situ gel 100 microl in round window niche, with the left ears as control group with normal saline.
Hy further teaches effect of poloxamer 407 on the middle ear and inner ear after regional perfusion in guinea pigs and further states that poloxamer 407 can be biodegraded in vivo or discharged via eustachian tube, and causes no inflammation on the middle ear cavity. There are temperature changes on auditory function of inner ear after topical perfusion with poloxamer 407 in round window can cause, but no irreversible damage on function and morphology of cochlear and vestibular organs [see Title and Conclusions].
Based on the above teachings and also, since poloxamer 407 is identical to applicants elected species, and so, its properties are expected to be same in the resulted formulation from the combination of Hy or Dumortier or Engleder teachings with the teachings of Yasuhiko.
For claim 6:
It is a physical property of auris-acceptable gel and so, it is expected with poloxamer 407.
For claim 7:
Though it is common practice to use narrow gauge needle or cannula, but Yasuhiko teaches their formulation is administered using inner ear injection [see 6th paragraph in page 7].
For claim 8:
It is a physical property and so, it is expected in the formulation with poloxamer 407.
For claim 9:
In the teachings of Yasuhiko, it appears that the formulation is administered to inner ear at room temperature, since art specifically does not mentioned about temperature and so, it is interpreted as the formulation is at room temperature.
For claim 10:
Yasuhiko, further teaches that their formulation is at pH 7.4 [see Example 2].
For claims 14-15 and 18:
As explained above under For claims 1 and 3, generally, differences in concentrations of components of a formulation will not support the patentability of subject matter encompassed by the prior art. Such formulations are results-effective variables which can be optimized. In in re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980), it was held that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Further, in In re Aller, 220 F. 2d454, 456, 105 USPQ 233,235 (CCPA 1955) the courts maintained that: "Where the general condition of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." As formulating optimal compositions for medicaments is routine in the art of pharmacology, the claims are considered to be prima facie obvious.
In this case, advantages of poloxamer 407 is known in the art, as evidenced from the teachings of Hy or Dumortier or Engleder, and also property of BDNF is known, as evidenced from the teachings of Yasuhiko, and so a skilled person in the art would determine suitable concentration range for poloxamer 407 and BDNF through a routine experimentation.
For claim 21:
It is the property of formulation, and so, it is expected from the combination of above cited prior art.
For claims 22 and 24:
The cited limitations are also physical properties of BDNF in the gel.
For claims 26-28:
Yasuhiko teaches BDNF and its utility in treating inner ear diseases [see BACKGROUND-ART].
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components in the otic formulation and their use in treating inner ear diseases, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
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, 3-10, 14-15, 18, 21-22, 24 and 26-28 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, 3-10, 14-15, 18, 21-22, 24 and 26-28 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, 3-10, 14-15, 18-19, 21-22, 24 and 26-28 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, 3-10, 14-15, 18, 21-22, 24 and 26-28 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, 3-10, 14-15, 18, 21-22, 24 and 26-28 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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
Prosecution Insights