DETAILED ACTION
Examiner prosecuting this application has changed.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/28/2025 has been entered.
Claims Status
Claims 2-8, 12, 14, 16-17, 21-22, 24-31, 39-41 is/are cancelled. Claims 1, 9-11, 13, 15, 18-20, 23, 32-38 is/are currently pending. Claims 1, 9-11, 13, 15, 18-20, 23, 32-38 is/are under examination.
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.
Written Description:
Claims 1, 9-11, 13, 15, 18-20, 23, 32-38 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.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it”).
The pending claims recite terms which are not sufficiently described by structure and function. Claim 1 recites a “polynucleotide-handling protein” and a “leader”. Dependent claim 9 further limits a “polynucleotide-handling protein” to a helicase. Claim 32 further limits a “leader” to a polynucleotide or a charged polymer. A helicase is a single embodiment of a “polynucleotide-handling protein”, while a “polynucleotide” and a “charged polymer” are embodiments of a “leader”. However, a “polynucleotide-handling protein” is interpreted to encompass any protein that “handles” polynucleotides, including CRISPR nucleases; a “leader” encompasses any molecule which can “[facilitate] the threading of the conjugate through the transmembrane pore” (claim 1). Neither of these terms or the functional characteristics they require implicitly or explicitly describe the structural characteristics of the molecules encompassed, and, as all species encompassed by a “polynucleotide-handling protein” or a “leader” must have their respective functional characteristics, these functional characteristics do not distinguish or limit species of these genera.
The specification does not provide sufficient written description of “polynucleotide-handling proteins” or “leaders”. On pages 51-52, the “polynucleotide-handling protein” is described as a “motor protein”, and “[in] some embodiments of the claimed methods, the motor protein is a helicase, a polymerase, an exonuclease, a topoisomerase, or a variant thereof”. On page 50, “polynucleotide-handling proteins” are described as “also known as motor proteins or polynucleotide-handling enzymes”. Based on these descriptions in the disclosure, “motor proteins” are interpreted as embodiments of “polynucleotide-handling proteins”, but “motor protein” is not a limiting definition of “polynucleotide-handling protein”. Moreover, helicases, polymerases, exonucleases, and topoisomerases are merely embodiments of “polynucleotide-handling proteins”, and not limiting. As such, the specification does not further limit the definition of a “polynucleotide-handling protein” such that the genus of proteins is sufficiently described. The genus of “polynucleotide-handling proteins” is not described by structural characteristics or by distinguishing functional characteristics such that the full scope of the genus is described.
On page 26, a “leader” is described as “optionally a further polynucleotide”. On page 39, a “leader” is described as, “in some embodiments”, being a polynucleotide or a charged polymer. The specification thus renders clear that a “leader” is not limited to a polynucleotide or charged polymer. The disclosure leaves unclear what other types of molecules, comprising different structural characteristics, can or cannot be a “leader”. The specification additionally only provides a limited number of species as embodiments of “charged polymers”: PEG, polysaccharides, and “negatively-charged polymers” (page 39). These are not representative of the full scope of the genus of “charged polymers”, and as such, the recitation of these species (PEG) or sub-genera (negatively-charged polymers, polysaccharides) does not sufficiently describe the genus of “charged polymers”. As such, the genus of “leader” molecules is not sufficiently described by structural characteristics or by distinguishing functional characteristics such that the full scope of the genus is described.
While claim 9 does fulfill the written description requirement regarding the “polynucleotide-handling protein”, claim 9 does not rectify the lack of written description of the term “leader”, and so is rejected for failing to comply with the written description requirement.
Claim 10 recites “polypeptide sections” and “polynucleotide sections”, but does not describe what structural or functional characteristics characterize a “section”. The specification also does not define the structural or functional characteristics of a polynucleotide or polypeptide “section”. The broadest interpretation of a polynucleotide or polypeptide “section” encompasses embodiments in which a “section” consists of a single nucleotide or amino acid, respectively, and a polynucleotide or polypeptide longer than one nucleotide or amino acid, respectively, comprises any number of “sections” up to and including the number of nucleotides or amino acids in the polynucleotide or polypeptide, respectively. As the definition of a “section” is unclear, an artisan would not be able to determine what species encompassed by polynucleotide or polypeptide “sections” were described by the applicant and which were in the possession of the applicant.
Claim 11 recites the term “peptide units”; however, neither the claims nor the specification define what a “peptide unit” is. A “unit” does not imply any specific structure or function, and as such encompasses an enormous variety of species, including individual amino acids and protein domains. The only species of polypeptides provided are of SEQ ID NOs:20-24, which range in length from 10 amino acids to 21 amino acids. These polypeptides can be interpreted to have a length of 10 to 21 “peptide units”, if “peptide units” are “amino acid residues”, but also to have a length of 1-2 “peptide units”, if “peptide units” are amino acid sequences longer than one amino acid, up to 10-21 amino acids long. It is thus unclear how the polypeptides described in the disclosure correspond to the term “peptide units”—i.e., it is unclear how many “peptide units” each of the described polypeptides comprises. As a result, the term “peptide units” is not sufficiently described by structural or functional characteristics.
Claims 35 and 37 recite protein pores “derived from” pore proteins (Msp, α-hemolysin, CsgG, ClyA, Sp1, FraC). It is unclear what structural and functional characteristics a protein “derived from” another protein has, as neither the claims nor the specification define what a protein “derived from” another protein is. On pages 73-74 of the specification, the MspA protein is used in working examples; the working examples do not describe the use of a protein “derived from” MspA. The specification recites pores “derived from” known proteins, but does not describe the structures of these pores, leaving unclear how a pore “derived from” a protein differs from the protein in structure and/or function.
According to the MPEP § 2163, "The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or 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 function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire 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. See AbbVie Deutsch land GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.")."
The claims recite terms “polynucleotide-handling protein”, “leader”, “peptide units”, pores “derived from” proteins, “polynucleotide sections”, and “polypeptide sections” which create enormous genera of species, and which are not sufficiently described by structural or functional characteristics which would distinguish a representative number of species encompassed by each genus such that an artisan could determine that the applicant was in possession of the full scope of each genus.
Scope of Enablement:
Claims 1, 9-11, 13, 15, 18-20, 23, 32-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for distinguishing two polypeptides of different lengths where one polypeptide comprises the amino acid sequence of the other, distinguishing between post-translationally-modified and unmodified versions of the same polypeptide when the post-translational modifications affect the flow of electrical current through an in vitro transmembrane protein pore through which the polypeptides transit, and distinguishing between wildtype and mutant versions of the same polypeptide, does not reasonably provide enablement for determining the amino acid sequence of any polypeptide, or identifying polypeptides solely on the basis of measuring its characteristics as it transits a transmembrane pore absent some basis of comparison to measurements of a similar polypeptide transiting the same pore, or for performing the claimed method in vivo. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims:
With respect to claim breadth, the standard under 35 U.S.C. §112, first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. As such, the broadest reasonable interpretation of the claimed method is that it encompasses methods wherein one or more measurements taken while a polypeptide transits through a transmembrane protein pore are indicative of the sequence of the polypeptide, in the absence of any basis for comparison, i.e. merely on the basis of the measurements taken as the polypeptide transits the nanopore, without comparison to any reference standard polypeptide or some polypeptide of an unrelated sequence. Furthermore, the broadest reasonable interpretation of the claimed method is that polynucleotides having lengths of 8 nucleotides to 1200 nucleotides (“about” describes an error of +/-20%, page 15) and polypeptides having lengths of 2 to 51 “peptide units” can be used in the claimed method with a reasonable expectation of success. A skilled artisan would not know how to use the method with a reasonable expectation of success based solely on what is disclosed in the specification.
The amount of direction provided by the inventor and the level of predictability in the art:
The specification teaches that “amino acid identity” and protein “variant” imply modification of the amino acid sequence of a protein, compared to a reference amino acid sequence (pages 17-18).
The prior art taught that protein translocation through nanopores could be used to detect differences in size of similar proteins, detect variations in sequence of protein variants relative to wildtype where the proteins were of the same size, and distinguish between post-translationally-modified and unmodified forms of the same protein (Nivala, 2014, abstract, Fig. 4, of record; Restrepo-Perez, 2019, abstract, of record). The prior art did not teach how to characterize modification status, length, or identity of an unknown target protein given only measurements that could be taken while the protein transited a nanopore without any comparison to a reference protein.
The prior art also taught that nucleic acid-binding motor proteins could be used to control the transit of nucleic acids through transmembrane nanopores (Herron, WO2014013260, of record, pages 3, 32), and that oligonucleotides could be used to influence transit of polypeptides through transmembrane nanopores in an electrical field. Biswas (2015, of record) taught that conjugation of a T20 oligomer to the N termini of short peptides could facilitate translocation of the peptides through a solid state nanopore. Rodriguez-Larrea (2013, of record) taught that conjugation of an oligonucleotide to the C-terminus of the protein thioredoxin could provide transit of thioredoxin through a transmembrane nanopore in the presence of an electrical field, and that the electrical field was sufficient to unfold the protein such that it was able to be translocated through the nanopore.
However, at the time of filing, it was known in the art that it was not yet feasible to perform nanopore-mediated protein sequencing. One reason that this was so was the inability to distinguish each of the 20 naturally-occurring amino acids from one another based solely on data derived from the transit of polypeptides through transmembrane nanopores. Di Muccio (2019, of record) taught that the ability of a transmembrane nanopore device to provide different, distinguishable signals for each of the 20 naturally-occurring amino acids remained unsolved. Di Muccio taught that the signal for each amino acid must be unambiguously associated to a specific amino acid monomer, and there remained a need for development of nanopores capable of so distinguishing each of the 20 amino acids. Di Muccio further teaches that, using computational models at the time of filing, it was predicted that amino acids of similar volumes would present a significant challenge, as the signals produced by transit of similarly-sized amino acids through a transmembrane nanopore were predicted to be indistinguishably similar.
Moreover, the specification teaches polynucleotides of 27-60 nucleotides (SEQ ID NOs: 11-16). While the applicant has shown that polypeptides can be threaded through a nanopore when conjugated to polynucleotides of 27-60 nucleotides, the applicants have not shown that polynucleotides shorter than 27 nucleotides could be used in the same methods with a reasonable expectation of success.
The art at the time of filing described polynucleotide-peptide conjugates wherein the polynucleotides have a length of 20 nucleotides (Biswas, 9652; Ying 2012, page 8785, of record) or 30-92 nucleotides (Rodriguez-Larrea, page 289, Fig. 2a). It would not have been clear from the prior art that polynucleotides shorter than 20 nucleotides could be effectively used in methods of translocating a polynucleotide-polypeptide conjugate through a nanopore. Rodriguez-Larrea teaches that shorter polynucleotides (30-mer compared to 92-mer oligonucleotides) confer different voltage dependencies of polynucleotide-polypeptide conjugates; it would have been clear to an artisan that further shortening of the polynucleotide of the conjugate would alter the functional characteristics of the conjugate, and that shorter polynucleotides than those used in the art (shorter than 20 nucleotides) would need to be tested to determine their effects on the functional characteristics of the conjugates and on the effectiveness of the methods of translocating the conjugates through a nanopore.
The specification as filed does not provide guidance that overcomes this unpredictability within the art.
The existence of working examples:
What is enabled by the working examples is narrow in comparison to the breadth of the claims: The specification discloses that amino acids of SEQ ID NOs:20-22 produce different current traces; SEQ ID NOs:20-22 differ only in the identities of amino acid residues 5-6 (residues 5-6 of SEQ ID NOs:20-22 are “DD”, “RR”, and “YY”, respectively) (pages 72-74; Figs. 11-13). No direct comparison between the current traces of SEQ ID NOs:20-22 is provided. It is not clear from the drawings provided and a visual comparison of the provided drawings which parts of each current trace correspond to which amino acid residue of the corresponding sequence, and neither the drawings nor specification indicate such. Furthermore, despite the repeated amino acid residues on SEQ ID NOs:20-22 (GGSGXXSGSG, wherein “X” indicates the residues at which SEQ ID NOs:20-22 differ), the current traces provided do not appear to comprise repeated motifs indicative of repeated residues (G, S).
The specification provides an “Example 2” (pages 74-75), wherein a polynucleotide-polypeptide construct is transited through an transmembrane nanopore in vitro, and the current produced by this transit is recorded (Fig. 15). However, while the specification states that “characterisation of the peptide was possible”, the characteristics characterized by this working example are not clarified in the specification or the indicated figure in the drawings. The disclosure does not indicate how the current trace produced by the methods disclosed in “Example 2” could be indicative of length, post-translational modification, or amino acid sequence.
The specification provides an “Example 3” (pages 75-76), wherein two polynucleotide-polypeptide constructs are transited through a transmembrane nanopore in vitro, and the current produced by these transits are recorded, and wherein the polypeptides vary in length (10 residues and 21 residues, SEQ ID NOs:20, 24) (Fig. 16). This working example demonstrates that the relative lengths of two polypeptides could be determined, as “the current section for the 21-amino acid polypeptide is roughly twice as long as for the 10-amino acid polypeptide” (page 75).
The provided working examples do not teach that the post-translational modifications or length of any polypeptide can be determined without a step of comparing measurements obtained from transit of the polypeptide through a transmembrane nanopore to measurements obtained from transit of a reference polypeptide through the transmembrane nanopore. The working examples enable a reference polypeptide of a known length (when determination of length of a polypeptide is desired) or known post-translational modifications (when determination of post-translational modifications of a polypeptide is desired). Furthermore, the working examples do not provide evidence for the ability to determine the identity of a polypeptide. Example 1 provides evidence that polypeptides of different sequences produce different current traces during transit through a nanopore, but does not provide evidence or explanation which would allow an artisan to determine the precise sequence of an unknown polypeptide using the same methods, or to determine the specific sequence difference(s) between an unknown polypeptide and a reference polypeptide, wherein the sequence of the reference polypeptide was known. Moreover, given two known proteins of similar size and amino acid composition, but different sequences, the specification does not teach how to correctly identify each protein, or determine that the proteins are different, based solely on the measurements and steps recited in the claims. The disclosure thus does not provide evidence that the claimed methods produce one or more measurements considered on their own indicative of the identity, length, or post-translational modification of any polypeptide, as the measurements produced in the working examples do not indicate the identity, length, or post-translational modification of a polypeptide without any comparison to known values (a reference polypeptide of a known length, identical sequence, or without post-translational modifications). The specification also only teaches methods in in vitro systems, and does not provide evidence that the methods could be used in in vivo systems.
The quantity of experimentation needed to make or use the invention:
The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant specification is not enabling because one cannot follow the guidance presented therein, or within the art at the time of filing, and practice the claimed method without first making a substantial inventive contribution. Given the nature of the invention the breadth of the claims, the state of the art, the level of unpredictability in the art, and the failure of the specification to provide any working example or guidance required to perform polypeptide sequencing or identification of polypeptide identity (sequence), length, or post-translational modification in vivo and in the absence of comparison to a standard polypeptide of the same amino acid sequence or known length, using a polynucleotide-polypeptide conjugate wherein the polynucleotide is shorter than 20 nucleotides, a person having ordinary skill in the art would have to perform multiple further experiments in order to demonstrate the invention could be used with a reasonable expectation of success. The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of successfully treating any CNS disorder or neurodegenerative disease. Therefore, Claims 1, 9-11, 13, 15, 18-20, 23, 32-38 are rejected under 35 U.S.C. 112, first paragraph, for failing to meet the enablement requirement.
Response to Arguments
Applicant's arguments filed 07/28/2025 have been fully considered but they are not persuasive. Applicant argues that the rejection is improper because working examples are not required for claims to be enabled, as described in MPEP § 2164.02. MPEP § 2164.02(I) states that “if all other factors point toward enablement, then the absence of working examples will not by itself render the invention non-enabled”. In this case, “all other factors” do not point toward enablement. As described in the rejection above, the art provides evidence of significant uncertainty regarding the ability to use a nanopore to determine certain characteristics, such as polypeptide identity (on page 17 of the specification, “amino acid identity” is presented as sequence identity, i.e. amino acid sequence). The specification also does not define the bounds of the term “indicative”; as such, it is interpreted that a measurement indicative of the identity of the polypeptide indicates the identity of the polypeptide (i.e., the sequence of the polypeptide). However, Applicant has not shown that the measurements taken in the claimed method can be indicative of the identity of a polypeptide without comparison to a reference polypeptide of known, identical sequence. The claimed method does not require or reference a step of comparing the measurements taken of one polypeptide transiting through the nanopore to the measurements taken of a reference polypeptide of known characteristics transiting through the nanopore. Without this step, the measurements taken of a polypeptide are not indicative of the identity of the polypeptide, the length of the polypeptide, or whether the polypeptide is post-translationally modified. In order to overcome the uncertainty in the art, working examples would be required.
Applicant asserts that the rejection is improper because “the Office Action fails to meet the burden of establishing a reasonable basis to question enablement of the claimed method as is, i.e., without recitation of a ‘comparator’” (page 11 of arguments). The specification has not provided evidence that overcomes the uncertainty in the art. The art teaches that, as of the time of filing, it was not possible to determine polypeptide sequence (“identity”) merely using current measurements taken as the polypeptide passed through a nanopore. The only measurement described in the present specification is the current produced by the polypeptide passing through the nanopore. The specification only provides evidence that two polypeptides of different sequences can produce different current signatures, but does not provide evidence that the current signatures can be used to indicate the identity of either polypeptide, only that the current signatures are indicative that two sequences are different. No current traces indicative of each amino acid residue is taught, as would be required in order for the current produced by a polypeptide to be indicative of the identity of the polypeptide. Based solely on what is provided in the present specification and drawings, and what is taught by the art, an artisan would not be able to determine that the current produced by the transit of a polypeptide through a nanopore could indicate the identity of a polypeptide. The present disclosure also does not provide evidence that the length or post-translational modification of a polypeptide can be indicated by the current produced by the polypeptide transiting through a nanopore without comparison to a reference polypeptide of known length or known to not be post-translationally modified. The art at the time of filing does not teach that polypeptide length or post-translational modification can be indicated using only the current produced by the polypeptide. The specification only provides examples of methods wherein the current produced by the analyzed polypeptide is compared to a reference polypeptide of known length or known to be unmodified in order to determine length or post-translational modification, respectively.
The rejection of claims under 35 USC 112(a) for failing to meet the enablement requirement for the full scope of the claimed invention 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 1, 9-11, 13, 15, 18-20, 23, 32-33, 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 19314260 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the methods claimed by the copending application require all of the same limitations of the instant claimed methods. The copending claims recite a method comprising: conjugating a target polypeptide to a polynucleotide to form a polynucleotide-polypeptide conjugate; contacting the conjugate with a polynucleotide-handling protein capable of controlling the movement of the polynucleotide with respect to a nanopore; and taking one or more measurements characteristic of the polypeptide as the conjugate moves with respect to the nanopore (claim 1); wherein the one or more measurements are indicative of one or more characteristics of the polypeptide selected from: the length of the polypeptide, the identity of the polypeptide, and whether or not the polypeptide is modified (claim 25).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/AFRICA M MCLEOD/Examiner, Art Unit 1635
/RAM R SHUKLA/Supervisory Patent Examiner, Art Unit 1635