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 Claims
Applicant’s election of trisodium citrate and heparin binding epidermal growth factor was previously acknowledged.
In the reply filed 1/29/26, Applicants cancelled claims 1-13, 15 and 16. Claims 14 and 19-20 were amended.
Claims 14 and 17-24 are pending and are under consideration.
Claim Rejections - Withdrawn
The rejection of claim 8 under 112(b) for lack of antecedence is withdrawn due to cancelation of the claim.
The rejection of claims 1-5, 7, 10-11, 14-16, 18 and 21 under 35 U.S.C. 102(a)(1) as being anticipated by Angi et al. (WO2018/118929) is withdrawn due to cancelation and amendment of the claims.
The rejection of claims 1-2, 7, 10-13 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Santa Maria et al. (WO2014/186075) as evidenced by GenBank (https://abss.uspto.gov/abss4examiners/ accessed 10/31/25) is withdrawn due to cancelation and amendment of the claims.
The rejection of claims 1-5, 7-16 and 18-23 under 35 U.S.C. 103 as being unpatentable over Santa Maria et al. (WO2014/186075) in view of CN105769753A
as evidenced by GenBank (https://abss.uspto.gov/abss4examiners/ accessed 10/31/25) is withdrawn due to cancelation and amendment of the claims.
The rejection of claims 14 and 17-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/246,418 in view of CN105769753 and Altma Kimya is withdrawn due to amendment of the claims.
Response to Arguments
Applicant’s arguments with respect to the rejections above have been considered but are moot because the rejections were withdrawn.
Claim Objections-NEW
Claim 17 is objected to because of the following informalities: “lease” should be corrected to “least”.
Claim 17 is objected to because of the following informalities: “one, or two or more…” should be amended to “at least one compound..”.
Claim 20 is objected to because of the following informalities: please remove the “cl” before “claim in line 2.
Claim 21 is objected to because of the following informalities: “wherein the drug is one, or two or more compounds..”, should be amended to “wherein the at least one drug is selected from the group consisting of …”.
Claims 22 and 23 are objected to because of the following informalities: “wherein the drug” should be amended to “wherein the at least one drug..”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112-NEW
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 is indefinite because it depends from canceled claim 16. For purposes of compact prosecution, claim 17 is interpreted to depend from claim 14.
This is a NEW rejection necessitated by amendment of the claims.
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.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Independent claim 14 recites a concentration in (w/v) while dependent claim 20 recites the concentration in (w/w). These units measure different things (weight per volume vs weight per weight of the composition) and are not directly comparable. As a result, the range recited in the dependent claim can fall outside the concentration range claimed in the independent claim. Therefore, it is unclear whether the dependent claim actually further limits the scope of independent claim 1. 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.
This is a NEW rejection necessitated by amendment of the claims.
Claim Rejections - 35 USC § 103-NEW
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 14 and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Gore et al. (USPN 9,579,385) in view of Gilbert et al. (USPN 10,525,033). This is a NEW rejection necessitated by amendment of the claims.
Gore et al. teach a composition comprising an active agent and polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (claim 1, 5, 8 and col. 1, lines 29-38, col. 3). Gore et al. teach the composition comprises a buffer, such as citrate buffer (col. 2, number 12; col 5, lines 20-22; Ex. 3; Table 9). Gore et al. does not teach the intended use of the pharmaceutical composition for otic administration. Please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation. In the instant case, the composition of Gore et al. comprises a drug, the copolymer and a buffer and is capable of the intended use.
Gore et al. does not teach the buffer is trisodium citrate at a concentration of 1-3.1% (w/v), however the teachings of Gilbert et al. cures this deficiency.
Gilbert et al. teach and claim pharmaceutical compositions comprising a drug and trisodium citrate at a concentration of 1.632% (w/v) (claims 9-11 and Study 2, col. 7).
With respect to claims 14 and 17, a person of ordinary skill in the art would have a motivation to try trisodium citrate in the buffered pharmaceutical composition of Gore et al. because trisodium citrate is a known pharmaceutically acceptable buffer and citrate based buffers are contemplated in Gore et al. It would be obvious to a person of ordinary skill in the art to select trisodium citrate for use in the composition as citrate salts are well known to be interchangeable buffering agents. There is a reasonable expectation of success given that Gilbert et al. demonstrates the suitability of trisodium citrate at the claimed range in a pharmaceutical composition. The MPEP 2144.05 (Obviousness of Ranges) states: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)
With respect to claim 18, Gore et al. teach the compositions comprise water (col. 7, line 29; Table 3, Table 5). Gilbert et al. teach the composition comprises water Col. 7, study 2). Water is a solvent.
With respect to claim 19, Gore et al. teach Table 10 comprising a buffer and 10% soluplus (col. 19). The concentration of ingredients in a formulation, such as polymers 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, the prior art teaches the copolymer at 1-10%. 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 concentration of the agent to arrive at a desired range of claim 19. Furthermore, MPEP 2144.05 states: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.". In the instant case, the concentration has not been shown to be critical.
With respect to claim 20, Gilbert et al. teach and claim pharmaceutical compositions comprising a drug and trisodium citrate at a concentration of 1.632% (w/v) (claims 9-11 and Study 2, col. 7). The MPEP 2144.05 (Obviousness of Ranges) states: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With respect to claim 21, Gore et al. teach the therapeutic agent is ketorolac, which is a small molecule (col. 2, number 5).
Claims 14 and 17-24 are rejected under 35 U.S.C. 103 as being unpatentable over Santa Maria et al. (WO2014/186075, previously cited) and CN105769753A (previously cited) in view of Gilbert et al. (USPN 10,525,033) as evidenced by GenBank (https://abss.uspto.gov/abss4examiners/ accessed 10/31/25, previously cited). This is a new rejection necessitated by amendment of the claims.
With respect to claims 14, 21, 22 and 24, Santa Maria et al. teach and claim compositions and methods for treating chronic tympanic membrane perforation by modulation of HB-EGF activity (Abstract, claim 1). Santa Maria teach and claim the agent that provides HB-EGF activity is human HB-EGF (claims 2-3), meeting the limitation of “at least one drug” in claim 14, “a protein” in claim 21, “drug that provided a biological activity of heparin-binding epidermal growth factor” in claim 22 and “a drug….” in claim 24. Santa Maria et al. teach and claim the composition is a sustained release gel comprising a cross-linked copolymer of chitosan and polylactide (claim 11, Fig. 2, [0086-0088]). In addition to the teachings above, Santa Maria teach the peptide compositions include an aqueous buffer system [0071 0078] , pH buffering agents [0072], can include other compounds that enhance the stability or enhance the properties of the peptide, such as citrate [0073].
With respect to the limitation “for otic administration", please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation. In the instant case, Santa Maria et al. teach and claim the pharmaceutical formulation is suitable for delivery to the ear canal (claims 4-5 and 10, [00107-00108]).
Santa Maria et al. do not teach the polymer is (polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft polymer (Soluplus). However, the teachings of CN105769753 cure this deficiency.
CN105769753 teaches a temperature sensitive gel matrix comprising Soluplus (Abstract). CN105769753 teaches the temperature sensitive gel matrix can be used as a drug carrier, is convenient, strong and drug release could be maintained over 7 days compared to 1 day with the poloxamer 407 polymer (Abstract). CN105769753 teaches that Soluplus not only has the characteristics of temperature sensitivity, but also can improve solubility of drugs to form a stable drug delivery system (2nd para of background technology).
With respect to claims 14 and 24 , it would have been obvious to a person of ordinary skill in the art to substitute the polymer Soluplus for polymer in the formulation of Santa Maria et al. because CN105769753 teaches the benefits and superior properties of Soluplus. A person of ordinary skill in the art would have a motivation to use Soluplus because CN105769753 teaches the polymer is strong, convenient, provides longer slow drug release and improves the solubility of drugs to form a stable drug delivery system. There is a reasonable expectation of success given that CN105769753 tests the benefits of soluplus for administration of agents to the ear.
Santa Maria et al. and CN105769753 do not teach a viscosity adjusting agent comprising trisodium citrate. However, the teachings of Gilbert et al. cure this deficiency.
Gilbert et al. teach and claim pharmaceutical compositions comprising a drug and trisodium citrate at a concentration of 1.632% (w/v) (claims 9-11 and Study 2, col. 7).
With respect to claim 14, 17 and 24, It would have been obvious to a person of ordinary skill in the art to use the trisodium citrate in the formulation of soluplus and HB-EGF as taught by Santa Maria et al. and CN105769753. It would have been obvious to a person of ordinary skill in the art to include trisodium citrate, as taught by Gilbert et al. into the composition of Santa Maria et al. and CN105769753 because Santa Maria et al. teach that citrate improves stability and the trisodium citrate is a pharmaceutically acceptable salt form of citrate. and Gilbert et al. teach trisodium citrate as a butter. Trisodium citrate is a known pharmaceutically acceptable buffer. It would be obvious to a person of ordinary skill in the art to select trisodium citrate for use in the composition as citrate salts are well known to be interchangeable buffering agents. There is a reasonable expectation of success given that Gilbert et al. demonstrates the suitability of trisodium citrate at the claimed range in a pharmaceutical composition. The MPEP 2144.05 (Obviousness of Ranges) states: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)
With respect to claim 18, Santa Maria et al. teach the formulation comprise water [0071-0072]. Santa Maria et al. teach with respect to delivery of HV-EGF, the vehicle refers to water [0066]. Water is a solvent.
With respect to claim 19, CN105769753 teaches the concentration of soluplus of 10, 15 and 20% (Example 5, p. 7). The MPEP 2144.05 (Obviousness of Ranges) states: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With respect to claim 20, Gilbert et al. teach and claim pharmaceutical compositions comprising a drug and trisodium citrate at a concentration of 1.632% (w/v) (claims 9-11 and Study 2, col. 7). The MPEP 2144.05 (Obviousness of Ranges) states: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With respect to claim 23, instant SEQ ID NO: 1 is human HB-EGF. Santa Maria et al. teach the preparation of human HB-EGF is preferred. As evidenced by Genbank, human HB-EGF is the sequence of instantly claimed SEQ ID NO: 1. Please note that MPEP 2131.01 states: that an extra reference or evidence can be used to show an inherent characteristic of the thing taught by the primary reference. In the instant case, the Genbank reference is relied upon only to establish that human HB-EGF is the same sequence as SEQ ID NO: 1.
Response to Arguments
Applicant's arguments filed 1/29/26 have been fully considered but they are not persuasive. Applicants argue that Santa Maria, CN’753A and Ataman Kimya et al. do not together disclose or suggest the from 1.0% (w/v) to 3.1% of an agent for adjusting complex viscosity. Applicants argue that considering Table 2 and 4 that indicated the salts that provide superior gel forming ability at 37C C were all added at concentrations from 1% to 3.1%. Applicants argue that Santa Maria and Altman Kimya does not suggest otic administration and do not teach or suggest the claimed concentration. Applicants argue that the compounds recited in amended claim 14 are all identified in Table 4 as among the compounds having the best gel forming ability at 37C.
These arguments were considered but are not persuasive for the reasons presented in the modified 103 above. Please note that Altma Kimya is no longer used as a reference in the rejections above (due to amendment of the claims). The Gilbert et al. reference clearly teaches trisodium citrate within the claimed concentration. The arguments that Table 2 and Table 4 show the criticality of the range of claim 14 is not persuasive. The data in Table 2 shows that concentrations outside the claimed range (e.g. sodium carbonate 0.9%) produces osmotic pressure values comparable to those obtained within the claimed range. Importantly, salts such as sodium chloride, ammonium acetate, calcium chloride in concentrations outside the claimed range also have comparable osmotic pressure values. This demonstrates that the results are not unique to the claimed salts or concentration range. The data of Table 2 and 4 demonstrate that substantially the same result is achieved both within and outside the claimed range with a wide range of salts. Importantly, the osmatic pressure values reflect predictable outcomes of adjusting salt concentrations in aqueous systems. A person of ordinary skill in the art would have reasonable expected that mOsm can be tuned by varying the amount and type of salt.
For the reasons presented above, the rejection is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 14 and 17-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/246,418 in view of CN105769753 and Gilbert et al. Please note this is a new rejection necessitated by amendment of the claims.
The copending Application claims a pharmaceutical composition for otic administration comprising one or more drugs and a water soluble polymer (claims 1-2). The copending Application claims a solvent and wherein the drug is a drug that provides the biological activity of a heparin binding epidermal growth factor (claims 12-13). SEQ ID NO: 1 of the copending Application is identical to the instantly claimed SEQ ID NO: 1.
The copending Application does not teach the same polymer or a viscosity enhancing agent. However, the teaching of CN105769753 and Gilbert et al. cure this deficiency.
The teachings of CN105769753 and Gilbert et al. are presented in detail above.
It would have been obvious to a person of ordinary skill in the art to substitute the polymer Soluplus for polymer in the formulation of the copending application because CN105769753 teaches the benefits and superior properties of Soluplus. A person of ordinary skill in the art would have a motivation to use Soluplus because CN105769753 teaches the polymer is strong, convenient, provides longer slow drug release and improves the solubility of drugs to form a stable drug delivery system. There is a reasonable expectation of success given that CN105769753 tests the benefits of soluplus for administration of agents to the ear.
With respect to claim 14, 17 and 24, It would have been obvious to a person of ordinary skill in the art to use the trisodium citrate in the formulation of soluplus and HB-EGF as taught by the copending application and CN105769753. It would have been obvious to a person of ordinary skill in the art to include trisodium citrate, as taught by Gilbert et al. because Gilbert et al. teach trisodium citrate as a butter and trisodium citrate is a known pharmaceutically acceptable buffer. It would be obvious to a person of ordinary skill in the art to select trisodium citrate for use in the composition as buffer salts are well known to be interchangeable buffering agents. There is a reasonable expectation of success given that Gilbert et al. demonstrates the suitability of trisodium citrate at the claimed range in a pharmaceutical composition.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 1/29/26 have been fully considered but they are not persuasive. Applicants argue that the claims are non-obvious over the copending claims for the reasons presented above (arguments to 103 rejection).
These arguments were not persuasive for the reasons presented above. The rejection is 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/Examiner, Art Unit 1654
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