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 .
Claims 1-15 have been cancelled. Claims 16-43 have been newly added.
Claim Rejections - 35 USC § 112
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.
Claims 16-18 and 20-43 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 16 and 30 recite an “agent that provides heparin binding epidermal growth factor (HB-EGF) activity.” The claims are not limited to the HB-EGF polypeptide but include any agent with the stated activity. Other than soluble, human HB-EGF, the specification does not describe or disclose the other agents embraced by the claims that would have the required activity, particularly with respect to improving healing of a chronic tympanic membrane perforation (claim 16) or to promote closing of a chronic tympanic membrane perforation (claim 30). The specification discloses soluble, human HB-EGF as having the properties recited in the claims; however, the structural variability of the claimed “agents” is large. No reasonable structure-function correlation has been established that is commensurate in scopewith the claims. The specification does not describe representative examples to support the fullscope of the claims. The genus of agents is not adequately described.
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.
Claims 28 and 41 are 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.
Claims 28 and 41 require at least one additional active agent. However, the claims do not make clear what activity this additional agent must have. The metes and bounds of the claims cannot be determined.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16, 20, 25, 28, 30, 31, 37-38, and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schacht et al. (U.S. Patent No. 6,132,759, of record).
Schacht discloses a pharmaceutical composition of a gelatin-dextranox polymer (GDP) and HB-EGF. This composition can be used for tympanic membrane reconstruction. The GDP provides sustained release. Additional active agents can be included. See at least abstract; column 5, line 50, column 6, lines 53-57; column 10, lines 3-7; and claims, especially claim 11.
Tympanic membrane reconstruction would have been understood by one of skill in the art to include treating a site of chronic tympanic membrane perforation. The method of Schacht et al. would improve healing and promote closing of a chronic tympanic membrane perforation.
Claims 16, 20, 25-26, 28-31, 37-39, and 42-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Sulner et al. (U.S. Patent Application Publication 2007/0038298, of record).
Sulner discloses a method of improving healing of a chronic tympanic membrane perforation in an individual by contacting the tympanic membrane with a collagen biofabric for a time sufficient to heal the tympanic membrane. The perforation may be acute or chronic. The collagen biofabric can be combined with a hydrogel. The collagen biofabric can contain one or more bioactive compounds such as antibiotics and cytokines. The collagen biofabric may be coated or impregnated with heparin binding epidermal growth factor (HEGF, referred to in the instant specification and claims as HB-EGF). Sustained release of biologically active compounds is disclosed. A preference for using proteins from the same species as the recipient of the proteins is disclosed. Humans as subjects are specifically disclosed. Kits are disclosed. See at least abstract and paragraphs [0007, 0014, 0016, 0020, 0036, 0040, 0041, 0048, 0049, and 0248]. The method of Sulner et al. would include improving healing and promoting closing of a chronic tympanic membrane perforation.
Claim Rejections - 35 USC § 103
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.
Claims 16-20, 25-26, 28-31, 37-39, and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Sulner et al. (U.S. Patent Application Publication 2007/0038298, of record) in view of Raab et al. (1997, of record) and Santos et al. (U.S. Patent Application Publication 2009/0192079, of record).
Sulner et al. is applied as above.
Santos et al. discloses that HB-EGF can be used to enhance healing of tympanic membrane perforations. See at least abstract, claims, and paragraphs [0020 and 0042]. Santos et al. does not specifically disclose the soluble mature form of HB-EGF.
Raab et al. discloses the sequence for human HB-EGF and the structure of the biologically active soluble form. See at least abstract, Figures 2A-B, and section 4.5.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Sulner to use soluble human HB-EGF as taught by Raab et al. Santos et al. makes clear that HB-EGF can be used to enhance healing of tympanic membrane perforations. One would have been motivated to do so to develop effective methods of improving healing of a chronic tympanic membrane perforation in humans. The collagen biofabric and hydrogel disclosed by Sulner meets the formulation limitations for sustained release of HB-EGF.
Claims 16-26, 28-35, 37-39, and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Sulner et al. (U.S. Patent Application Publication 2007/0038298, of record) in view of Raab et al. (1997, of record), Santos et al. (U.S. Patent Application Publication 2009/0192079, of record), and Ma et al. (2002, of record).
Sulner et al., Raab et al., and Santos et al. are applied as above. The references do not specify particular time periods of treatment as recited in instant claims 21-24 and 32-35.
Ma et al. discloses topical treatment with growth factors to treat tympanic membrane perforations. Ma et al. discloses treating perforated tympanic membranes with a growth factor for a week or every other day for a period of 8-14 days. Large perforations were treated for a maximum of 30 days. See at least abstract and page 594, right column.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Sulner to use the soluble human HB-EGF of Raab et al. and to include treatment for a period of at least 5 days, at least 7 days, at least 10 days, or at least two weeks as taught by Ma et al. in order to develop effective methods of improving healing of a chronic tympanic membrane perforation. Sulner et al. discloses sustained release of biologically active compounds from the collagen biofabric and hydrogel. Santos makes clear that HB-EGF can be used to enhance healing of tympanic membrane perforations.
Claims 30-31, 36, 38-40, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Sulner et al. (U.S. Patent Application Publication 2007/0038298, of record) in view of Raab et al. (1997, of record), Santos et al. (U.S. Patent Application Publication 2009/0192079, of record), and Ny et al. (U.S. Patent No. 7,067,492, of record).
Sulner et al., Raab et al., and Santos et al. are applied as above. The references do not specify daily administration as recited in instant claim 36 and spraying the formulations as recited in instant claim 40.
Ny et al. discloses a method of promoting healing of a tympanic membrane perforation by applying plasminogen directly onto the tympanic membrane perforation. The carrier can be an aqueous solution, gel, lotion, balm, or paste. The composition can be administered by spraying. Additional active ingredients can also be administered. Administration can be performed daily. See at least abstract, claims, and column 11, line 55, through column 12, column 55.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Sulner et al. to include soluble human HB-EGF as taught by Raab et al. in the composition of Ny et al. for treatment of tympanic membrane perforation as taught by Ny et al. Santos makes clear that HB-EGF can be used to enhance healing of tympanic membrane perforations. One would have been motivated to do so in order to develop effective methods of improving healing of a chronic tympanic membrane perforation.
Claims 16-20, 25-27, 30-31, 37-39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Sulner et al. (U.S. Patent Application Publication 2007/0038298, of record) in view of Raab et al. (1997, of record), Santos et al. (U.S. Patent Application Publication 2009/0192079, of record), and Sawchuk et al. (U.S. Patent Application Publication 2004/0101560, of record).
Sulner et al., Raab et al., and Santos et al. are applied as above. The references do not specify formulations as recited in instant claims 27 and 41.
Sawchuk et al. discloses compositions for applying compositions against the tympanic membrane. Application of liquid compositions that gel (i.e. harden) into a gel against the tympanic membrane, thereby maintaining the drug in the formulation in close proximity to the tympanic membrane are disclosed.
It would have been obvious at the time of the effective filing date to include soluble human HB-EGF as taught by Raab et al. in the composition of Sawchuk et al. for treatment of tympanic membrane perforation as taught by Sulner et al. and Sawchuk et al. Santos makes clear that HB-EGF can be used to enhance healing of tympanic membrane perforations. One would have been motivated to do so in order to develop effective methods of improving healing of a chronic tympanic membrane perforation.
Claims 16-35, 37-39, and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Horn-Ranney et al. (U.S. Patent Application Publication 2015/0112244, of record) in view of Kim et al. (WO 2014/169045, of record), Santos et al. (U.S. Patent Application Publication 2009/0192079, of record), Raab et al. (1997, of record), and Besner et al. (U.S. Patent No. 6,191,109, of record).
The instant claims are not entitled to benefit of the filing date of provisional application 61/823,749, filed 5/15/2013. The effective filing date for these claims is 9 April 2014. Provisional application 61/823,749 does not disclose administering an “agent that provides heparin binding epidermal growth factor (HB-EGF) activity.” See instant claims 16 and 30. The provisional application discloses using only HB-EGF for chronic tympanic membrane treatment. See at least page 3, lines 19-27 of the claims in the provisional application. The provisional application does not disclose the time periods in instant claims 21-24 or 32-35. The provisional application does not disclose administering a “soluble form of HG-EGF” as in instant claim 17.
Horn-Ranney et al. discloses hydrogel scaffolds loaded with time-released drugs such as growth factors for repairing chronic tympanic membrane perforations. The time-released drugs can be growth factors including epidermal growth factors. More than one therapeutic agent can be present. The hydrogel is initially a liquid polymer that only gels upon exposure to specific conditions such as certain wavelengths of light, change of pH, or change of temperature. See at least paragraphs [0011 and 0013]. Using the polymer chitosan is disclosed. The document also discloses combining the polymer chitosan with other polymers including poly(lactic acids) (i.e. polylactide) and fibrin (i.e. polymerized fibrinogen). See paragraph [0048]. The liquid pre-polymer is administered to the site of the perforation prior to gelling. See paragraph [0011]. Only tens of microliters are needed to cover the perforation. A gel patch adhered to the perforation site and was present 3 weeks after implantation. See at least abstract; claims; examples; and paragraphs [0002, 0015, 0043, 0052, 0057, 0114, and 0147-0148]. Horn-Ranney et al. was filed 28 December 2014 as a continuation of PCT/US2013/048383 filed 28 June 2013 and claims priority to provisional application 61/665,639 filed 28 June 2012. The reference is entitled to the priority date of the provisional application for the disclosure relied upon above. Horn-Ranney et al. is valid prior art against the instant claims.
Kim et al. discloses incorporating one or more bioactive agents by crosslinking copolymer hydrogels in situ. The site can be a tympanic membrane perforation. The bioactive agent may range from 0.001 mg to 500 mg or 0.005-500 µM. Kim et al. discloses that in certain embodiments the bioactive agent is not heparin-binding endothelial growth factor HB-EGF. This is a disclosure that the bioactive could be HB-EGF. The sustained delivery can be for 2 days or longer, or 7 days or longer, and 15 days or longer. See at least abstract; claims, particularly claim 14; Figures 21-22; page 4, lines 20-30; page 13; pages 29-30, bridging paragraph; page 34; page 49, lines 23-25; page 53, lines 1-6. Kim et al. (WO 2014/169045) was filed 9 April 2014 and claims priority to provisional application 61/810,101 filed 9 April 2013. Kim et al. is entitled to benefit of this provisional application for the information relied upon in this ground of rejection. (See at least pages 7, 23-24, 38, 40, 44, and 62 of the provisional application.) Note that the WO 2014/169045 document does not identify any embodiments where HB-EGF is specifically excluded and the provisional document does not have this exclusion. Kim et al. is valid prior art against the instant claims.
Santos et al. (U.S. Patent Application Publication 2009/0192079, of record) discloses that HB-EGF can be used to enhance healing of tympanic membrane perforations. See at least abstract, claims, and paragraphs [0020 and 0042].
Raab et al. (1997) discloses the sequence for human HB-EGF and the structure of the biologically active soluble or mature form of HB-EGF. See at least abstract, Figures 2A-B, and sections 3.1-3.3 and 4.5.
Besner et al. discloses pharmaceutical formulations of soluble, mature human HB-EGF at a concentration of about 0.5-10 mg/ml soluble human HB-EGF, for example. Additional ingredients and bioactive compounds, including slow-release polymers, can be present. See at least column 2, lines 7-34; column 3, lines 36-40; and column 4, lines 6-18.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Horn-Ranney et al. to use soluble human HB-EGF as taught by Raab et al. Santos makes clear that HB-EGF can be used to enhance healing of tympanic membrane perforations. Besner et al. makes clear that soluble, mature human HB-EGF in a concentration of 0.5-10 mg/ml is suitable for pharmaceutical uses. The sustained release hydrogel copolymers of Kim et al. could have been used according to Horn-Ranney et al. where they release HB-EGF in the amounts and time period recited in the claims. Kim et al. suggests using growth factors in copolymer hydrogels to treat tympanic membrane perforations. The time period for release correspond to the instant claims. The combination of prior art demonstrates that those of ordinary skill in the art had a reasonable expectation of success that HB-EGF could be used to enhance healing of tympanic membrane perforations. In addition, the prior art provides ample guidance for how to administer HB-EGF to achieve that effect. The combined teachings of the prior art would have suggested the claimed methods to one of ordinary skill in the art at the time of the effective filing date.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 16-22, 25-28, 30-33, 37-39, and 41-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,235,027. Although the claims at issue are not identical, they are not patentably distinct from each other.
Issued claim 1 is directed to a method to promote closing of a chronic tympanic membrane perforation that has not healed after at least 2 months in an individual human, the method comprising: contacting a site of the chronic tympanic membrane perforation with a liquid formulation comprising an effective dose of a human heparin binding epidermal growth factor (HB-EGF) protein, wherein the liquid formulation is mixed with a viscogenic agent or cross-linking agent before or concurrently with said contacting the site of the chronic tympanic membrane perforation with the liquid formulation, wherein the liquid formulation transforms into a more viscous state or a gel that remains localized against the tympanic membrane and provides for sustained release of the HB-EGF for a period of time that is 7 days or longer, to promote closing of the chronic tympanic membrane perforation. As defined by the specification, “HB-EGF” includes the soluble mature form of HB-EGF. In addition, issued claim 6 depends upon claim 1 and specifically recites a soluble mature form of HB-EGF. This method meets the limitations of the instant claims. Issued claim 3 indicates that the liquid formulation can include an additional active agent. See instant claims 28 and 42.
Issued claim 8 is directed to a method to promote closing of a chronic tympanic membrane perforation that has not healed after at least 2 months in an ear of an individual human, the method comprising: contacting a site of the chronic tympanic membrane perforation with a liquid formulation comprising at least 1 mg/ml and up to 500 mg/ml of a soluble mature form of human heparin binding epidermal growth factor (HB-EGF) protein, wherein the liquid formulation is mixed with a viscogenic agent or cross-linking agent before or concurrently with said contacting the site of the chronic tympanic membrane perforation with the liquid formulation, wherein the liquid formulation transforms into a more viscous state or a gel that remains localized against the tympanic membrane and provides sustained release of the HB-EGF for a period of time 7 days or longer, to promote closing of the chronic tympanic membrane perforation. This method meets the limitations of instant claims.
Issued claim 11 is directed to a method to promote closing of a chronic tympanic membrane perforation that has not healed after at least 2 months in an ear of an individual human, the method comprising: contacting a site of the chronic tympanic membrane perforation with a liquid formulation comprising at least 1 mg/ml and up to 500 mg/ml of a soluble mature form of human heparin binding epidermal growth factor (HB-EGF) protein, wherein the liquid formulation is mixed with a viscogenic agent or cross-linking agent before or concurrently with said contacting the site of the chronic tympanic membrane perforation with the liquid formulation, wherein the liquid formulation transforms into a more viscous state or a gel that remains localized against the tympanic membrane and provides sustained release of the HB-EGF for a period of time that is 3 days or longer, to promote closing of the chronic tympanic membrane perforation. This method meets the limitations of instant claims.
Issued claim 14 is directed to a method to promote closure of a chronic tympanic membrane perforation in a human subject, the method comprising: mixing a liquid formulation comprising chitosan, polylactic acid, fibrinogen, and an effective dose of human heparin binding epidermal growth factor (HB-EGF) protein with a cross-linking agent immediately before administering the formulation to the site of said perforation, wherein the mixture forms a sustained release cross-linked copolymer hydrogel against the tympanic membrane and wherein the chronic tympanic membrane perforation in the human subject completely closes. As defined by the specification, “HB-EGF” includes the soluble mature form of HB-EGF. This method meets the limitations of instant claims.
The instant claims are not patentably distinct from the issued claims.
Claims 16-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,963,998. Although the claims at issue are not identical, they are not patentably distinct from each other.
Issued claim 1 is directed to a method to promote closing of a chronic tympanic membrane perforation in an individual, wherein the method comprises contacting a site of chronic tympanic membrane perforation that has not healed after 2 months or longer in an ear of the individual with a formulation comprising an effective dose of human heparin binding epidermal growth factor (HB-EGF) protein. See at least instant claims 16 and 30. Issued claim 2 recites that the individual is a human and the HB-EGF is human HB-EGF. See at least instant claims 18, 19, and 31. Issued claim 3 recites the method of claim 2, wherein the human HB-EGF is a soluble mature form of the human HB-EGF. See instant claim 17. Issued claim 4 requires contact for at least 7 days. See at least instant claims 21-22 and 32-33. Issued claim 5 requires contact for at least 2 weeks. See at least instant claims 23-24 and 34-35. Issued claim 6 recites that the formulation is administered at least daily. See at least instant claim 36. Issued claim 7 requires that the formulation provides for sustained release of the HB-EGF. See at least instant claims 20 and 37. Issued claim 8 requires that the formulation is provided as an aqueous solution, a gel, a lotion, a balm or paste. See at least instant claims 25 and 38. Issued claim 9 depends upon claim 8 and recites the formulation is administered as a liquid that then solidifies to stay adjacent to the tympanic membrane. See at least instant claims 26-27, 39, and 41. Issued claim 10 recites that the formulation is administered by a spray. See at least instant claim 40. Issued claim 14 recited that the formulation comprises an additional active agent selected from the group consisting of an antimicrobial agent, a cytokine, and a growth factor. See at least instant claims 28-29 and 42-43.
The instant claims are not patentably distinct from the issued claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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