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 .
Election/Restrictions
Applicant’s election without traverse of sudden sensorineural hearing loss (the synapses-affecting event) and BDNF (growth factor) in the reply filed was previously acknowledged.
In the reply filed 5/26/26, Applicants amended claims 1, 15, 21-23 and canceled claim 16. In a supplemental amendment filed 6/8/26, Applicants amended claim 14.
Claims 1-3, 6-8, 11-15 and 20-23 are pending and are under consideration.
Claim Rejections-Withdrawn
The rejection of claims 1-3, 6-8, 11-16 and 20-23 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn due to amendment of the claims.
The rejection of claims 1, 6-8, 11-16 and 20-23 under 35 U.S.C. 103 as being unpatentable over Lichter et al. (US 2016/0243028) in view of Suzuki et al. (“Round window delivery of neurotrophin 3 regenerates cochlear synapses after acoustic overexposure” Sci Rep. 2016 Apr 25;6:24907) is withdrawn due to amendment of the claims.
The rejection of claims 1-3, 6-8, 11-16 and 20-23 under 35 U.S.C. 103 as being unpatentable over Lichter et al. (US 2016/0243028) and Suzuki et al. (“Round window delivery of neurotrophins 3 regenerates cochlear synapses after acoustic overexposure” Sci Rep. 2016 Apr 25;6:24907) in view of R&D systems (July 4, 2015 < https://www.rndsystems.com/products/recombinant-human-bdnf-protein-cf_11166-bd>) is withdrawn due to amendment of the claims.
Claim Rejections - 35 USC § 112, first paragraph-NEW
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Amended claims 1, 15 and 21-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. These claims are drawn to a method of treating ribbon synapse degeneration in a subject in need thereof after onset of a ribbon synapse degeneration causing event.
Lack of Ipsis Verbis Support
The specification is void of any literal support for the “ribbon synapse degeneration” or “ribbon synapse degeneration causing event”.
Lack of Implicit or Inherent Support
“While there is not in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure.” See MPEP 2163. Thus support can be furnished implicitly or inherently for a specifically claimed limitation. However, the specification lacks any implicit or inherent support for the claimed “ribbon synapse degeneration” or “ribbon synapse degeneration causing event”. The specification does not define “ribbon synapse degeneration causing event”. The instant specification discloses increased number of ribbon synapses following BDNF treatment, however that does not equate to “ribbon synapse degeneration”.
Claim Rejections - 35 USC § 112-Maintained
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of claims 1-3, 6-8, 11-15 and 20-23 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for therapeutic treatment of acoustic trauma, sudden sensorineural hearing loss and regeneration of ribbon synapses in the ear, does not reasonably provide enablement for preventing all ribbon synapse degeneration (including acoustic trauma and sudden sensorineural hearing loss). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. This rejection has been modified necessitated by amendment of the claims.
As stated in MPEP 2164.01(a), “there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
The factors to be considered when determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, were described in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) as:
1. the nature of the invention;
2. the breadth of the claims;
3. the state of the prior art;
4. the relative skill of those in the art;
5. the predictability or unpredictability of the art;
6. the amount of direction or guidance presented [by the inventor];
7. the presence or absence of working examples; and
8. the quantity of experimentation necessary [to make and/or use the invention.
(1) The Nature of the Invention and (2) The Breadth of the claims
Amended claim 1 is drawn to a method of treating ribbon synapse degeneration in a subject in need thereof after onset of a ribbon synapse degenerating causing event, comprising administering BDNP and poloxamer 407 between 1 day and 14 days after onset of the ribbon synapse degeneration causing event into the inner ear.
The instant specification does not define “ribbon synapse degeneration” of “ribbon synapse degermation-causing event”. The instant specification defines “treatment” [PGPUB0080]:
The terms “treat,” “treating” or “treatment,” as used herein, include alleviating, abating or ameliorating a disease or condition or the associated symptoms, preventing additional symptoms, ameliorating or preventing the underlying metabolic causes of symptoms, inhibiting the disease or condition, e.g., arresting the development of the disease or condition, relieving the disease or condition, causing regression of the disease or condition, relieving a condition caused by the disease or condition, or controlling or stopping the symptoms of the disease or condition either prophylactically and/or therapeutically.
The claims will be given its broadest reasonable interpretation. The applicable rule for interpreting the claims is that “each claim must be separately analyzed and given its broadest reasonable interpretation in light of and consistent with the written description.” See MPEP 2163(II)(1), citing In re Morris, 127 F.3d 1048, 1053-1054; 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). In view of this rule, the broadest reasonable interpretation includes both treatment and prevention of the disease or condition or associated symptoms.
(3) The state of the prior art and (5) The predictability or unpredictability of the art
The instant specification is enabled for therapeutic treatment of acoustic trauma, sudden sensorineural hearing loss and regeneration of ribbon synapses in the ear. For example, Lichter et al. (presented in the 103 rejection below) teach therapeutic treatment of sensorineural hearing loss with BDNF and poloxamer 407.
Wan et al. teach treatment of ribbon synapse regeneration with BDNF. Therefore, the prior art is enabling for treatment of acoustic trauma, sensorineural hearing loss and regeneration of ribbon synapses in the ear.
There was not art found that teaches or suggest BDNF administered intratympanically for prevention of ribbon synapse degeneration.
It is noted that pharmaceutical and biological art is generally unpredictable, requiring each embodiment to be individually assessed for physiological activity. are different diseases with distinct etiologies and pathologies. Given this fact, historically the development of new drugs has been difficult and time-consuming. Adding to the unpredictability is that many treatment options may show promise in animal models, but may fail to show therapeutic improvement in clinical trials. There is no absolute predictability, even in view of the high level of skill in the art. Thus, for treating and preventing otic disease or condition related to a synapses damaging event, the possibilities are vast. It would be highly unpredictable given the art and the breadth of the claims.
(4) The relative skill of those in the art
MPEP 2141.03 states (in part)” A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high.
(6) The amount of direction or guidance presented (by the inventor) and (7) The presence or absence of working examples
The applicant provided sufficient guidance or direction regarding the potential therapeutic treatment of acoustic trauma. Example L discloses acoustic trauma in rats, wherein human recombinant BDNF was administered intratympanically 1 day, 3 days, 7 days or 14 days after onset of the acoustic trauma. Fig. 20 discloses BDNF in poloxamer 407 between 1-14 days yielded a rapid recovery of auditory threshold shifts and a significant reduction in hearing loss.
In contrast, the applicant provides little in way of direction or guidance regarding preventing ribbon synapse degeneration. There was no disclosure of treatment or prevention of other otic diseases or condition related to ribbon synapses damaging event other than treatment of acoustic trauma.
(8) The quantity of experimentation necessary (to make and/or use the invention)
Owing to the factors listed above, especially in points 6 and 7, the amount of experimentation needed will be extensive in view of the lack of guidance by the inventor.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
In conclusion, the instant application is enabled for therapeutic treatment of acoustic trauma, sudden sensorineural hearing loss and regeneration of ribbon synapses.
Response to Arguments
Applicant's response filed 5/26/26 stated that the claims have been amended in response to the rejection above.
The amendment was reviewed and the claims remain rejected for the reasons presented above.
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.
The rejection of claims 21-23 are 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 is maintained. Claims 21-23 depended from claim 1. Claim 1 was amended to administering the composition between 1 day and 14 days. Claims 21-23 claim the formulation is administered within 7 days (claim 21), within 3 days (claim 22) and within 1 day after onset of the synapse-damaging event. The time period recited in claims 21-23 are broader than the time frame of claim 1 because they encompass administration earlier than 1 day. 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.
Response to Arguments
Applicant's response filed 5/26/26 stated that the claims have been amended in response to the rejection above.
The amendment was reviewed and the claims remain rejected for the reasons presented above.
Claim Rejections - 35 USC § 103-NEW
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1, 6-8, 11-15 and 20-23 under 35 U.S.C. 103 as being unpatentable over Lichter et al. (US 2016/0243028) and Wan et al. (Hear Res. 2015 April 30;329:1-10) in view of Suzuki et al. (“Round window delivery of neurotrophin 3 regenerates cochlear synapses after acoustic overexposure” Sci Rep. 2016 Apr 25;6:24907). This is a NEW rejection necessitated by amendment of the claims.
With respect to claims 1 and 15, Lichter et al. teach and claim a method of treating or preventing hearing loss comprising intratympanically administering an otic composition to a subject in need thereof, wherein the otic composition comprises an otic hair growth factor and an auris acceptable gel (claim 1), wherein the otic hair growth factor is BDNF, CNTF… and IGF (Claim 28-29). Lichter et al. teach the condition is sudden sensorineural hearing loss (elected species) [0032, 0056, 0064, 0167-0172, 0312, 0318, 0499). Lichter et al. teach sustained release of the otic formulation [0010, 0068,0311].
With respect to “poloxamer 407” (claim 1) and the limitation of claim 6, Lichter et al. teach about 16-21% by weight of a polyoxethylene-polyoxypropylene copolymer [0015]. Lichter et al. teach examples of the gel comprising 17% poloxamer 407 ([0915-0918, 0925, 0930, 0956], Table 6).
With respect to the limitation “.0005% to 0.5% by weight of BNNF”, Lichter et al. teach a therapeutically effective amount [0015, 0020,0044, 0116]. Lichter et al. the 0.2-6% of the active agent [0015,0033, 0039, 0057]. The amount of the active agent in a composition is a result-effective variable and the determination of the optimum or workable ranges of said variable maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Lichter et al. teach 0.2-6% of the active agent. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the amount of the active agent, to arrive at the range of claims 9-10.
Lichter et al. does teach treatment of ribbon synapse degeneration. However, the teachings of Wan et al. cure this deficiency.
Wan et al. teach cochlear ribbon synapses are required for rapid and precise neural transmission of acoustic signals from inner hair cells to the spiral ganglion neurons (Abstract). Wan et al. teach that degeneration of ribbon synapses is a common pathology in sensorineural hearing loss (Highlights, last section). Wan et al. also teach that NT-3 and BNDF promote regeneration of the ribbon synapses after noise exposure (Fig. 1 legend).
It would have been obvious to a person of ordinary skill in the art to treat ribbon synapse degeneration is a subject with sensorineural hearing loss because Wan et al. teach that ribbon synapse degeneration is a common pathology in sensorineural hearing loss. A person of ordinary skill in the art would have a motivation to treat sensorineural hearing loss and subsequent ribbon synapse degeneration with BDNF because Wan et al. teach that BDNF promotes regeneration of ribbon synapses and Lichter et al. teach treatment of sensorineural hearing loss with BDNF. There is a reasonable expectation of success given Wan et al. describes evidence connecting BFNF to ribbon synapse regeneration.
Lichter et al. and Wan et al. do not teach administration between 1 day and 14 days after onset of the ribbon synapse degeneration causing event. However, the teachings of Suzuki et al. cure this deficiency.
Suzuki et al. teach delivery of NT-3 to noise exposed mice to the round window 24 hours after noise exposure (Abstract). Suzuki et al. teach that delivery of NT-3 can regenerate pre and post synaptic elements at the hair cell/cochlear nerve interface (Abstract).
It would have been obvious to a person of ordinary skill in the art to administer the sustained release otic formulation comprising BDNF for treatment of sudden sensorineural hearing loss as taught by Lichter et al. within 1 day after the onset of injury because Suzuki et al. teach that administration 24 hours of a growth factor after injury resulted in regeneration of pre and post synaptic elements. There is a reasonable expectation of success given that both Lichter et al., Wan et al. and Suzuki et al. address treatment of auditory damage by growth factor therapy. Furthermore, the timing of the administration of the active agent is a result-effective variable and the determination of the optimum or workable time of delivery maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Suzuki et al. teach administration of a growth factor 24 hours after auditory injury. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the delivery time, to arrive at the greatest therapeutic effect.
With respect to claim 7, Lichter et al. teach and claim the osmolarity of the formulation is 100 to about 500 mOsm/L ([0666] and claim 24).
With respect to claim 8, Lichter et al. teach and claim a pH of 7 to 8 ([0650] and claim 27).
With respect to claim 11, Lichter et al. claim the formulation provides sustained release of the growth factor over a period of at least 5 day (claim 39) or 7 days (claim 40). Lichter et al. also teach the compositions have very low ototoxicity and provide sustained release of the formulation for a period of at least one week, two weeks or a month [0311].
With respect to claim 12, Lichter et al. teach the active ingredients are dissolved in a suitable vehicle [0637,0773, 0774].
With respect to claims 13-14, Lichter et al. intratympanic administration to the round window membrane [0085, 0144, 0149, 0151].
With respect to the limitation “repairs ribbon synapses” (claim 20), administration of the sustained release gel comprising BDNF of Lichter et al. would inherently have all of the activities and properties of the composition of claim 1. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzqerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433- 34 (CCPA 1977)).” In other words, Lichter et al. and Suzuki et al. teach administering the same composition BDNF to the same patient population (a subject with an otic disease of condition associated with a synapse-affecting event) in the same manner (sustained release into the inner ear) therefore the same results would inherently occur. Moreover, MPEP 2112.01 states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Importantly, Wan et al. teach BDNF promotes regeneration of the ribbon synapses after noise exposure (Fig. 1 legend).
With respect to claims 21-23, Suzuki et al. teach administration of NT-3 to the round window membrane 24 hours after the noise exposure, meeting the limitations of “within 7 days…”, “within 3 days…”.
Claims 1-3, 6-8, 11-16 and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Lichter et al. (US 2016/0243028), Wan et al. (Hear Res. 2015 April 30;329:1-10) and Suzuki et al. (“Round window delivery of neurotrophins 3 regenerates cochlear synapses after acoustic overexposure” Sci Rep. 2016 Apr 25;6:24907) in view of R&D systems (July 4, 2015 < https://www.rndsystems.com/products/recombinant-human-bdnf-protein-cf_11166-bd>)
The teachings of Lichter et al., Wan et al. and Suzuki et al. are presented above in detail.
Lichter et al. and Wan et al. do not teach the BDNF is recombinant human BDNF. However, the teachings of R&D cure this deficiency.
R&D systems teaches recombinant human BDNF protein for sale. R&D system teaches quality control testing to verify active protein with lot specific assays by in house scientists.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to use recombinant human BDNF in the formulation of Lichter et al. A person of ordinary skill in the art would have a motivation because R&D teaches the recombinant human BDNF is quality control tested to be very active with lot specific assays. There is a reasonable expectation of success given that recombinant human BDNF is routinely used in the art and is commercially available.
Response to Arguments
Applicant's arguments filed 5/26/26 were considered but are not persuasive. Applications argue that the combination of references to no disclose or suggest the features of claim 1. Applicants argue the Lichter does not disclose ribbon synapse degeneration or repair within the specific time period required. Applicants argue that Lichter is primarily focused on formulation technology and general delivery paradigms. Applicants argue that Suzuki does not teach BDNF in a sustained release thermoreversible poloxamer 407 formulation nor does Suzuki teach the claimed therapeutic window. Importantly, Suzuki utilizes NT-3 rather than BDNF. Applicants argue that PHOSITA would not have reasonable expected that substitution of BDNF for NT-3 would produce equivalent biological outcomes. Applicants argue that R&D systems does not disclose intratympanic delivery of rBDNF and ribbon synapse degeneration treatment. Applicants argue that the reference merely discloses rBDNF protein existed commercially. Applicants argue that the timing limitation is not a result driven variable. Applicants argue that the timing window is not an optimization of a known parameter, rather Applicants discovered that delayed administration of sustained release BDNF after onset of cochlear trauma remains therapeutically effective for synaptic recovery. Applicants also argue impermissible hindsight and that the cited art lacks any teaching or reasonable expectation that the claimed combination would successfully treat ribbon synapse degeneration within the claimed therapeutic window.
These arguments were considered but are not persuasive. In response to applicant's arguments against the references individually, 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). The Examiner agrees that Lichter does not specifically disclose ribbon synapse degeneration. However, the Wan reference does disclose ribbon synapse degeneration in sensorineural hearing loss and how NT-3 and BDNF promotes regeneration of ribbon synapses after noise exposure. The Suzuki reference teaches that administration 24 hours of a growth factor after injury resulted in regeneration of pre and post synaptic elements. Therefore, Suzuki makes obvious administration of a growth factor 24 hours after the onset of acoustic trauma. The arguments regarding R&D are not persuasive as the reference was used only to make obvious recombinant BDNF. The combination of Lichter, Wan and Suzuki make obvious the claimed method. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The 103 rejection above clearly discloses each element of the claim and person of ordinary skill in the art would be motivated to administer the BDNF between 1 to 14 days as taught in the prior art.
Double Patenting-Modified
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.
The rejection of claims 1-3, 6-8, 11-15 and 20-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2-10, 14-15,18, 21-22, 24 and 26-28 of copending Application No. 16/873,803 (reference application) in view of Suzuki et al. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims an otic formulation comprising a therapeutically effective amount of a growth factor and auris-acceptable vehicle comprising poloxamer 407, wherein the formulation is formulated for sustained release of the growth factor into the inner ear wherein the growth factor is BDNF (claims 1 and 3), administration through the tympanic membrane (claim 7), wherein the formulation has an osmolarity of 100-1000 mOsm/L (claim 8), pH of 7-8 (claim 10), comprises 15-17% by wt of poloxamer 407 (claims 14-15), comprises 0.0001-1% by weight of the growth factor (claims 18-19), formulated to provide sustained release for at least 3 days (claim 21), is dissolved in the formulation (claim 24), wherein the treatment repairs synapses associated with treatment of an otic disease or condition (claim 26), is hearing loss (claim 27), and wherein the otic formulation repairs ribbon synapses (claim 28). MPEP 804 states” The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. In the instant case, the instant specification teaches the formulation is used to treatment of sensorineural hearing loss [PGPUB0105].
The copending application does not teach administration between 1 and 14 days. However, the teaching of Suzuki et al. et al. cure this deficiency.
It would have been obvious to a person of ordinary skill in the art to administer the sustained release otic formulation comprising BDNF for treatment of sudden sensorineural hearing loss within 1 day after the onset of injury because Suzuki et al. teach that administration 24 hours of a growth factor after injury resulted in regeneration of pre and post synaptic elements. There is a reasonable expectation of success given Suzuki et al. address treatment of auditory damage by growth factor therapy. Furthermore, the timing of the administration of the active agent is a result-effective variable and the determination of the optimum or workable time of delivery maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Suzuki et al. teach administration of a growth factor 24 hours after auditory injury. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the delivery time, to arrive at the greatest therapeutic effect.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 6-8, 11-16 and 20-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,751,281 in view of Suzuki et al. and Wan et al. Although the claims at issue are not identical, they are not patentably distinct from each other. The USPN claims treating or alleviating hearing loss comprising intratympanically administering an otic composition comprising a hair cell growth factor and an auris acceptable gel, wherein the otic hair cell growth factor is not GDNF (claim 1), wherein the formulation is injected through the tympanic membrane or near the round window membrane (claim 3), has an osmolarity from 100-500 mOsm/L, has pH of 7-8 (claim 6), wherein the growth factor is BDNF, CNTS…PDGF (claim 7-8), wherein the gel comprises a copolymer of polyoxethylene and polyoxypropylene (Claim 15), wherein the sustained release occurs over a period of 5 days or 7 days (claims 17-18). MPEP 804 states” The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. In the instant case, the instant specification teaches the formulation is used to treatment of sensorineural hearing loss.
The USPN does not teach administration between 1 day and 14 days after the onset of the damage or treating ribbon synapse degeneration. However, the teaching of Wan et al. and Suzuki et al. cure this deficiency.
It would have been obvious to a person of ordinary skill in the art to administer the sustained release otic formulation comprising BDNF for treatment of sudden sensorineural hearing loss within 1 day after the onset of injury because Suzuki et al. teach that administration 24 hours of a growth factor after injury resulted in regeneration of pre and post synaptic elements. There is a reasonable expectation of success given Suzuki et al. address treatment of auditory damage by growth factor therapy. Furthermore, the timing of the administration of the active agent is a result-effective variable and the determination of the optimum or workable time of delivery maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Suzuki et al. teach administration of a growth factor 24 hours after auditory injury. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the delivery time, to arrive at the greatest therapeutic effect.
Wan et al. teach cochlear ribbon synapses are required for rapid and precise neural transmission of acoustic signals from inner hair cells to the spiral ganglion neurons (Abstract). Wan et al. teach that degeneration of ribbon synapses is a common pathology in sensorineural hearing loss (Highlights, last section). Wan et al. also teach that NT-3 and BNDF promote regeneration of the ribbon synapses after noise exposure (Fig. 1 legend).
It would have been obvious to a person of ordinary skill in the art to treat ribbon synapse degeneration is a subject with sensorineural hearing loss because Wan et al. teach that ribbon synapse degeneration is a common pathology in sensorineural hearing loss. A person of ordinary skill in the art would have a motivation to treat sensorineural hearing loss and subsequent ribbon synapse degeneration with BDNF because Wan et al. teach that BDNF promotes regeneration of ribbon synapses and the USPN teach treatment of sensorineural hearing loss with BDNF. There is a reasonable expectation of success given Wan et al. describes evidence connecting BFNF to ribbon synapse regeneration.
Claims 1-3, 6-8, 11-15 and 20-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 9-10,15-22, 24-27, 30 and 36 of copending application 18/267,739 in view of Suzuki et al. and Wan et al.
The copending Application claims a method of treating hearing loss or hearing impairment in a human subject, comprising intratympanically administering an otic formulation to the human subject, wherein the otic composition comprises from about 0.005 mg to about 1.90 mg of brain-derived neurotrophic factor (BDNF) and an auris-acceptable vehicle, wherein the otic formulation is formulated to provide sustained release of BDNF into the inner ear (claims 1-2, 9-10), wherein the auris acceptable vehicle is an auris acceptable gel (claim 15), comprises a copolymer of polyoxethylene and polyoxypropylene (claim 17), wherein the copolymer is poloxamer 407 (14-18%) (claims 18-21), has an osmolarity from 100-1000 mOsm/L (claim 24). The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. In the instant case, the instant specification teaches the formulation is used to treatment of sensorineural hearing loss [PGPUB0101,0109].
The copending application does not teach administration within 14 days after the onset of the damage or treatment of ribbon synapse degeneration. However, the teaching of Wan et al. and Suzuki et al. cure this deficiency.
It would have been obvious to a person of ordinary skill in the art to administer the sustained release otic formulation comprising BDNF for treatment of sudden sensorineural hearing loss within 1 day after the onset of injury because Suzuki et al. teach that administration 24 hours of a growth factor after injury resulted in regeneration of pre and post synaptic elements. There is a reasonable expectation of success given Suzuki et al. address treatment of auditory damage by growth factor therapy. Furthermore, the timing of the administration of the active agent is a result-effective variable and the determination of the optimum or workable time of delivery maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Suzuki et al. teach administration of a growth factor 24 hours after auditory injury. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the delivery time, to arrive at the greatest therapeutic effect.
Wan et al. teach cochlear ribbon synapses are required for rapid and precise neural transmission of acoustic signals from inner hair cells to the spiral ganglion neurons (Abstract). Wan et al. teach that degeneration of ribbon synapses is a common pathology in sensorineural hearing loss (Highlights, last section). Wan et al. also teach that NT-3 and BNDF promote regeneration of the ribbon synapses after noise exposure (Fig. 1 legend).
It would have been obvious to a person of ordinary skill in the art to treat ribbon synapse degeneration is a subject with sensorineural hearing loss because Wan et al. teach that ribbon synapse degeneration is a common pathology in sensorineural hearing loss. A person of ordinary skill in the art would have a motivation to treat sensorineural hearing loss and subsequent ribbon synapse degeneration with BDNF because Wan et al. teach that BDNF promotes regeneration of ribbon synapses and the USPN teach treatment of sensorineural hearing loss with BDNF. There is a reasonable expectation of success given Wan et al. describes evidence connecting BFNF to ribbon synapse regeneration.
Claims 1-3, 6-8, 11-16 and 20-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,123,285 in view of Suzuki et al. and Wan et al.
The USPN claims a pharmaceutical composition comprising: between about 0.1 mg/ml to about 20 mg/ml of one and no more than one growth factor selected from brain-derived neurotrophic factor (BDNF) or neurotrophin-3, or pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is a thermoreversible gel formulated for intratympanic administration, wherein the pharmaceutical composition comprises from 14% to 17% by weight of Poloxamer 407, and wherein the growth factor is not a glial cell-line derived neurotrophic factor (GDNF) (claims 1, 13-17), wherein the pH is 7-8 (claim 3), an osmolarity of 250-320 mOsm/L (claim 4), comprises 15-16% poloxamer 407 (claim 5), released over a period of 5-7 days (claims 7-8), wherein the growth factor is BDNF (claim 12). The MPEP 804 states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. In the instant case, the instant specification teaches the formulation is used to treatment of sensorineural hearing loss.
The USPN does not teach administration within 14 days after the onset of the synapses damage or treatment of ribbon synapse degeneration. However, the teaching of Suzuki et al. cure this deficiency.
It would have been obvious to a person of ordinary skill in the art to administer the sustained release otic formulation comprising BDNF for treatment of sudden sensorineural hearing loss within 1 day after the onset of injury because Suzuki et al. teach that administration 24 hours of a growth factor after injury resulted in regeneration of pre and post synaptic elements. There is a reasonable expectation of success given Suzuki et al. address treatment of auditory damage by growth factor therapy. Furthermore, the timing of the administration of the active agent is a result-effective variable and the determination of the optimum or workable time of delivery maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Suzuki et al. teach administration of a growth factor 24 hours after auditory injury. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the delivery time, to arrive at the greatest therapeutic effect.
Wan et al. teach cochlear ribbon synapses are required for rapid and precise neural transmission of acoustic signals from inner hair cells to the spiral ganglion neurons (Abstract). Wan et al. teach that degeneration of ribbon synapses is a common pathology in sensorineural hearing loss (Highlights, last section). Wan et al. also teach that NT-3 and BNDF promote regeneration of the ribbon synapses after noise exposure (Fig. 1 legend).
It would have been obvious to a person of ordinary skill in the art to treat ribbon synapse degeneration is a subject with sensorineural hearing loss because Wan et al. teach that ribbon synapse degeneration is a common pathology in sensorineural hearing loss. A person of ordinary skill in the art would have a motivation to treat sensorineural hearing loss and subsequent ribbon synapse degeneration with BDNF because Wan et al. teach that BDNF promotes regeneration of ribbon synapses and the USPN teach treatment of sensorineural hearing loss with BDNF. There is a reasonable expectation of success given Wan et al. describes evidence connecting BFNF to ribbon synapse regeneration.
Claims 1-3, 6-8, 11-15 and 20-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,969,501 in view of Suzuki et al. and Wan et al.
The USPN claims a pharmaceutical composition comprising: one and no more than one growth factor selected from brain-derived neurotrophic factor (BDNF) or neurotrophin-3, or pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is a thermoreversible gel formulated for intratympanic administration, wherein the pharmaceutical composition comprises from 14% to 17% by weight of Poloxamer 407, and wherein the pharmaceutical composition provides sustained release of therapeutically effective amount of the growth factor into the ear following a single administration (claims 1, 14-20), with a pH of 7-8 (claim 3), has an osmolarity of 250-320 mOsm/L (claim 5), comprises 14-16% poloxamer (claim 8), formulated to provide sustained release for at least 3 days, 5 days, 7 days, 14 days (claims 9-12). MPEP 804 states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. In the instant case, the instant specification teaches the formulation is used to treatment of sensorineural hearing loss.
The USPN does not teach administration within 14 days after the onset of the synapses damage or treatment of ribbon synapse degeneration. However, the teaching of Suzuki et al. cure this deficiency.
It would have been obvious to a person of ordinary skill in the art to administer the sustained release otic formulation comprising BDNF for treatment of sudden sensorineural hearing loss within 1 day after the onset of injury because Suzuki et al. teach that administration 24 hours of a growth factor after injury resulted in regeneration of pre and post synaptic elements. There is a reasonable expectation of success given Suzuki et al. address treatment of auditory damage by growth factor therapy. Furthermore, the timing of the administration of the active agent is a result-effective variable and the determination of the optimum or workable time of delivery maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Suzuki et al. teach administration of a growth factor 24 hours after auditory injury. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the delivery time, to arrive at the greatest therapeutic effect.
Wan et al. teach cochlear ribbon synapses are required for rapid and precise neural transmission of acoustic signals from inner hair cells to the spiral ganglion neurons (Abstract). Wan et al. teach that degeneration of ribbon synapses is a common pathology in sensorineural hearing loss (Highlights, last section). Wan et al. also teach that NT-3 and BNDF promote regeneration of the ribbon synapses after noise exposure (Fig. 1 legend).
It would have been obvious to a person of ordinary skill in the art to treat ribbon synapse degeneration is a subject with sensorineural hearing loss because Wan et al. teach that ribbon synapse degeneration is a common pathology in sensorineural hearing loss. A person of ordinary skill in the art would have a motivation to treat sensorineural hearing loss and subsequent ribbon synapse degeneration with BDNF because Wan et al. teach that BDNF promotes regeneration of ribbon synapses and the USPN teach treatment of sensorineural hearing loss with BDNF. There is a reasonable expectation of success given Wan et al. describes evidence connecting BFNF to ribbon synapse regeneration.
Claims 1-3, 6-8, 11-15 and 20-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-40 of copending Application No. 18/603,065 (reference application) in view of Suzuki et al. and Wan et al. Although the claims at issue are not identical, they are not patentably distinct from each other. The copending Application claims thermoreversible intratympanic composition comprising: a neurotrophic factor or pharmaceutically acceptable salt thereof, and from about 14% to about 25% by weight of Poloxamer 407, wherein the growth factor is BDNF or neurotrophin-3, and wherein the pharmaceutical composition provides sustained release of therapeutically effective amount of the growth factor into the ear following a single administration (claims 21 and 37-40), wherein the pharmaceutical composition has a pH of from 7.0 to 8.0 (claim 23), wherein the pharmaceutical composition has an osmolarity of from 250 mOsm/L to 320 mOsm/L (claim 25), wherein the pharmaceutical composition comprises from 14% to 20% by weight of the poloxamer (claim 27), wherein the pharmaceutical composition is formulated to provide sustained release of the growth factor into an inner ear for a period of at least 3, 5, 7 or 14 days following a single administration (claims 29-32), wherein the growth factor is NT-3 or BDNF (claim 33-34). The MPEP 804 states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. In the instant case, the instant specification teaches the formulation is used to treatment of sensorineural hearing loss [PGPUB0031].
The copending application does not teach administration within 14 days after the onset of the synapses damage or treatment of ribbon synapse degeneration. However, the teaching of Suzuki et al. and Wan et al. cure this deficiency.
It would have been obvious to a person of ordinary skill in the art to administer the sustained release otic formulation comprising BDNF for treatment of sudden sensorineural hearing loss within 1 day after the onset of injury because Suzuki et al. teach that administration 24 hours of a growth factor after injury resulted in regeneration of pre and post synaptic elements. There is a reasonable expectation of success given Suzuki et al. address treatment of auditory damage by growth factor therapy. Furthermore, the timing of the administration of the active agent is a result-effective variable and the determination of the optimum or workable time of delivery maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Suzuki et al. teach administration of a growth factor 24 hours after auditory injury. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the delivery time, to arrive at the greatest therapeutic effect.
Wan et al. teach cochlear ribbon synapses are required for rapid and precise neural transmission of acoustic signals from inner hair cells to the spiral ganglion neurons (Abstract). Wan et al. teach that degeneration of ribbon synapses is a common pathology in sensorineural hearing loss (Highlights, last section). Wan et al. also teach that NT-3 and BNDF promote regeneration of the ribbon synapses after noise exposure (Fig. 1 legend).
It would have been obvious to a person of ordinary skill in the art to treat ribbon synapse degeneration is a subject with sensorineural hearing loss because Wan et al. teach that ribbon synapse degeneration is a common pathology in sensorineural hearing loss. A person of ordinary skill in the art would have a motivation to treat sensorineural hearing loss and subsequent ribbon synapse degeneration with BDNF because Wan et al. teach that BDNF promotes regeneration of ribbon synapses and the USPN teach treatment of sensorineural hearing loss with BDNF. There is a reasonable expectation of success given Wan et al. describes evidence connecting BFNF to ribbon synapse regeneration.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 5/26/26 have been fully considered but they are not persuasive. Applicants argue that the amended claims recite a distinct pathological condition and a distinct treatment paradigm directed to post injury cochlear synaptic repair and regeneration. Applications argue that the amended claims are not unpatentable over the copending applications. Applicants argue that the Examiner improperly relies on the specification disclosure to expand the scope of the claims.
These arguments were considered but are not persuasive. The amended claims are obvious over the respective claims, Suzuki et al. and Wan et al. Suzuki et al. makes obvious the treatment paradigm and Wan et al. makes obvious the treatment condition. The Examiner does not agree that the specification was improperly used to expand the scope of the claims. The MPEP 804 states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. In the instant case, the references specification was considered to ascertain the scope of the claim. For the reasons presented above, the rejections are maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/TARA L MARTINEZ/Primary Examiner, Art Unit 1654
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