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 .
DETAILED ACTION
Election/Restrictions
Applicant's election without traverse of Group I and in the reply filed on is acknowledged.
Status of the Application
Claims 12, 15-22, 32, 62, 66, 79, 81, 83, 84, 87, 88, 90, 38, 99, 101, 111, 121 and 122 are pending. Claims 12, 15-22, 32, 62, 66, 79, 81, 83, 84, 87, 88, 90, 111, 121 and 122 are currently under examination. Claims 98, 99, 101 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
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 21 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 pre-AIA the applicant regards as the invention.
Claim 21 recites "a minimal GJB2 promoter” and is indefinite because the metes and bounds of the promoter are not defined. The specification describes the term as referring to a promoter that includes less than the fully naturally occurring promoter sequence which is still capable of directing transcription of a coding sequence. It is unclear what the amount of the promoter is required, is it 90, 80 or eve 50% of the naturally occurring promoter that will be functional? Thus the claim is indefinite.
Claim Rejections - 35 USC § 112
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.
Written Description
Claims 12, 15-22, 32, 62, 66, 79, 81, 83, 84, 87, 88, 90, 111, 121 and 122 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966; Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial Structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed structure, and v. Correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art.
Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species by “…disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between functional and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Thus when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The claims are drawn to an expression construct comprising a genus of coding sequences for a Connexin 26 polypeptide or a functional fragment thereof linked to a promoter having a least 85-100% identity to SEQ ID No. 96 or 99 and any second promoter such as a minimal GJB2 promoter having a least 85-100% identity to SEQ ID No. 86 that is capable of directing transcription of the coding sequence in a vast number of inner ear support cells.
When determining whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. In the instant case, the specification describes a rAAV expression construct expressing a supporting cell protein (a hGJB2 gene) operably linked to a supporting cell promoter in combination with a minimal GJB2 promoter that was capable of expressing Connexin 26 in neonate cochlear explants (Example 5). The specification does not describe the promoter as having either of SEQ ID No. 96 or 99 or 85-100% identity to these sequences, does not describe any functional fragments of Connexin 26 and does not describe any second promoter or a second promoter comprising a minimal GJB2 having 85-100% sequence identity to SEQ ID No. 86. The specification describes a minimal GJB2 promoter as a promoter that includes less than the full naturally occurring promoter but still capable of directing transcription of a coding sequence (0128). This example does not encompass the vast number of different expression vectors comprising a first promoter have 85-100% sequence identity to SEQ ID No. 96 or 99 and a second promoter comprising any promoter or a promoter having a minimal GJB2 promoter or 85-100% identity to it with the function of expression of Connexin 26 or functional variants thereof in a vast number of inner ear support cells.
It is then determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics (i.e. other than nucleotide sequence), specific features and functional attributes that would distinguish different members of the claimed genera. In the instant case, the only other identifying characteristics are expression of Connexin 26 using a rAAV expression construct expressing a supporting cell protein (a hGJB2 gene) operably linked to a supporting cell supporter in combination with a minimal GJB2 promoter in neonate cochlear explants. Such functional limitations cannot be identifying characteristics for the vast number of expression constructs claimed. The disclosure has not described any sequence at least 85%-100% identical to SEQ ID No. 96, 99 or any second promoter or any second promoter 85%-100% identical to a minimal GJB2 with the function of expression Connexin 26 or any functional fragment thereof. A review of the specification shows that it provides no description or guidance that would allow one of skill to distinguish the functional species of the recited structural genus from the non-functional members without empirical determination.
With respect to the functional variants of Connexin 26 polypeptide, the prior art of Adadey et al. ("Connexin genes variants associated with non-syndromic hearing impairment: a systematic review of the global burden." Life 10.11 (2020): 258) teach there have been 337 variants of the Connexin 26 gene GJB2 found (see page 4 2.1 and page 2 para. 4). Adadey et al. do not teach each one of these variants are functional fragments of Connexin 26 that are associated with hearing loss.
Since the disclosure and the prior art fail to describe the common attributes and characteristics concisely identifying members of the proposed genus, and because the claimed genus is highly variant a vast number of sequences of promoters and functional fragments of a Connexin 26 protein with the function of expression in any type of inner ear support cell, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus claimed.
"A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus" (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) (emphasis added).
Further, “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
Thus the specification and claims lack written description because it is clear that Applicant did not have possession of every variation of the expression construct. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521,222 USPQ 369,372-372 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the entire scope of the claimed invention.
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. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970);and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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/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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 12, 15-22, 32, 62, 66, 79, 81, 83, 84, 87, 88, 90, 111, 121 and 122 are provisionally rejected under the judicially created doctrine of double patenting over claims 139, 144, 249, 263 of co-pending Application No. 18/560,064. This is a provisional double patenting rejection since the conflicting claims have not yet been patented. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter. The instant claims are drawn to an expression construct comprising a coding sequence of Connexin 26 polypeptide and a promoter having 85-100% identity to a nucleic acid sequence of SEQ ID No. 96 or 99.
The claims of Patent ‘064 are drawn to an expression construct linked to a polynucleotide encoding a polypeptide linked to an inner ear supporting cell selective promoter comprising 85-100% identity to a nucleic acid sequence of SEQ ID No. 96 or 99 and thus the instant claims are encompassed in the claims of Patent ‘064 and therefore are not patentably distinct.
Claims 249 and 263 of Patent ‘064 are drawn to methods of using the claims expression construct for treatment and it would have been obvious to use the expression construct of the instant claims in the methods of Patent ‘064. The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application. Thus, the co-pending product could be used in the method of the instant claims.
This is a provisional obviousness-type double patenting rejection.
Claims 12, 15-22, 32, 62, 66, 79, 81, 83, 84, 87, 88, 90, 111, 121 and 122 are provisionally rejected under the judicially created doctrine of double patenting over claims 8-10, 12, 13, 17, 87, 91, 92, 106, 109, 113, 114, 117, 118, 120, 131, 133, 142, 157 and 167 of co-pending Application No. 18/314,671. This is a provisional double patenting rejection since the conflicting claims have not yet been patented. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter. The instant claims are drawn to an expression construct comprising a coding sequence of Connexin 26 polypeptide and a promoter having 85-100% identity to a nucleic acid sequence of SEQ ID No. 96 or 99.
The claims of Patent ‘671 are drawn to an expression construct linked to a polynucleotide encoding a Connexin 26 polypeptide linked to an inner ear supporting cell selective promoter comprising 85-100% identity to a nucleic acid sequence of SEQ ID No. 96 or 99 and thus the instant claims are encompassed in the claims of Patent ‘671 and therefore are not patentably distinct.
Claims 129, 131, 133 and 142 of Patent ‘671 are drawn to methods of using the claims expression construct for treatment and it would have been obvious to use the expression construct of the instant claims in the methods of Patent ‘671. The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application. Thus, the co-pending product could be used in the method of the instant claims.
This is a provisional obviousness-type double patenting rejection.
Closest Prior Art
SEQ ID Nos. 96 and 99 and sequence having 85-100% sequence identity to said sequences are free of the prior art. A Blast search did not reveal alignments of sequences having 85-100% sequence identity. The prior art of Bartolome et al. (US 2021/0095313). teach an rAAV expression construct comprising a coding sequence for Connexin 26 polypeptide (0148) linked to a nucleic acid sequence of GLB2 (0011) for expression of the polypeptide in the inner ear to improve hearing (0011). Bartolome et al. do not teach SEQ ID Nos. 96 or 99 and sequence having 85-100% sequence identity to said sequences.
Bartolome et al. teach the nucleic acid sequence is SEQ ID No. 10 which is identical to instantly claimed SEQ ID No. 117, SEQ ID No. 7 which is identical to instantly claimed SEQ ID No. 118, SEQ ID No. 11 which is identical to instantly claimed SEQ ID No. 123, SEQ ID No. 12 which is identical to instantly claimed SEQ ID No. 124,
SEQ ID No. 13 which is identical to instantly claimed SEQ ID No. 125, SEQ ID No. 18 which is identical to instantly claimed SEQ ID No. 126 and SEQ ID No. 18 which is identical to instantly claimed SEQ ID No. 126. Bartolome et al. do not teach the construct comprises an additional promotor comprising these sequences or SEQ ID Nos. 96 or 99 or make obvious use of a second promoter in the expression construct.
Li et al (10,662477) teach SEQ ID No. 234 which is identical to SEQ ID No. 120 (see result 1 of us-18-314-661-120.match85perct.rni search result).
SEQ ID Nos. 119, 121, 122 and 127 are free of the prior art search and the prior art does not make it obvious to use these sequences as a second promoter in the construct.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Chong at (571)272-3111. The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm.
If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public. For more information about the PAIR system, see http://pair-direct.uspto.gov.
For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199.
/KIMBERLY CHONG/
Primary Examiner Art Unit 1636