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 .
Applicant’s election without traverse of skeletal, decreases skeletal abnormalities, increases skull width, increases cross-sectional moment of inertia, or increases bone stiffness, immunotolerized, rAAV9, and iduronate-2-sulfatase in the reply filed on 5/6/26 is acknowledged.
It is noted that “decreases skeletal abnormalities, increases skull width, increases cross-sectional moment of inertia, or increases bone stiffness” is not an election of a single species, but rather is four separate species. Upon further consideration, claims 2-4 are rejoined because the claims are drafted as outcomes rather than method steps. Should the claims be amended to require specific method steps, a restriction may be imposed.
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/6/26.
Although claim 13 is withdrawn, it is noted that claim 13 recites “the mammal” of claim 1. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not recite “mammal”.
Drawings
The drawings filed on 5/6/26 are objected to because they are not fully legible. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Sequence Compliance
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 because there are sequences on page 40 of the specification, for example, that do not contain a SEQ ID NO.
A complete response to this office action must correct the defects cited above regarding compliance with the sequence rules and a response to the action on the merits which follows.
The aforementioned instance of failure to comply is not intended as an exhaustive list of all such potential failures to comply in the instant application. Applicants are encouraged to thoroughly review the application to ensure that the entire application is in full compliance with all sequence rules. This requirement will not be held in abeyance.
Claim Objections
Claims 9, 16, and 20 are objected to because of the following informalities: The claims do not end with a period. Appropriate correction is required.
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.
Claims 16, 25, and 26 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.
Claim 16 requires for the rAAV to encode one of the recited genes. However, the claim language is not definite because the claim does not specify which rAAV of the claim is required to encode one of the recited genes. Claim 1 recites a first and a second rAAV.
Claims 25 and 26 requires an amount of rAAV to be administered. The claim language is not definite because it is unclear whether the amount is referring to the first rAAV, the second rAAV, or the combination of rAAVs.
For purposes of the instant examination, the claims are interpreted to referring to one or both of the rAAVs.
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.
Claim 14 is 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.
Claim 14 requires for the human to be immunotolerized prior to administration of the rAAV.
The specification discloses that for example, an individual can be immunotolerized by injfection of IDUA or IDS protein. The minimal species of the specification are not representative of the entire claimed genus.
Without further description of what acutal step is required for immunotolerization, one would not be able to readily recognize which possible methods the patient can receive to be considered immunotolerized and meet the instant claim limitation.
Without further description of the steps and/or specific agents required for the outcome of immunotolerization, one would not be able to recognize what step and/or agent is required to induce or promote the required state of immunological tolerance in the subject prior to administration of the instantly recited compositions.
For example, Singh et al. (J Clin Invest, 2021, 131, 11, e148291, 1-11) teach that BCG has immunotolerizing effects in specific disease conditions including multiple sclerosis, type 1 diabetes, asthma, and atopic dermatitis; and that it remains largely unexplained why BCG can be immunotolerizing in some conditions but immunostimulatory in others (page 4).
This is evidence that agents that are immunotolerizing to a specific condition need to be determined and that broad recitation of “immunotolerized” does not readily define a specific genus of agents in a specific method.
The MPEP states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. See 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 species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. Additionally, in Carnegie Mellon University v. Hoffman-La Roche Inc., Nos. 07-1266, -1267 (Fed. Cir. Sept. 8, 2008), the Federal Circuit affirmed that a claim to a genus described in functional terms was not supported by the specification’s disclosure of species that were not representative of the entire genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The Guidelines for Examination of Patent Applications under the 35 USC § 112, first paragraph, “Written Description” Requirement”, published at Federal Register, Vol. 66, No. 4, pp. 1099-1111 outline the method of analysis of claims to determine whether adequate written description is present. The first step is to determine what the claim as a whole covers, i.e., discussion of the full scope of the claim. Second, the application should be fully reviewed to understand how applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim with the scope of the description. Third, determine whether the applicant was in possession of the claimed invention as a whole at the time of filing.
To achieve the desired function, it appears that the subject is required to have received IDUA or IDS protein.
Additionally, the claims recite a human having “lysosomal storage disorder”, which is recited in a manner of referring to a single specific disorder rather than “a lysosomal storage disorder”. As evidenced by Sheth et al. (The Lancet Regional Health- Southeast Asia, 2023, 9: 100108, 1-13), lysosomal storage disorders are a group of seventy different metabolic storage diseases due to accumulation of substrate mainly in the form of carbohydrate, lipids, proteins, and cellular debris. They occur due to variant in different genes that regulate lysosomal enzymes synthesis, transport, and secretion (Summary, page 1). The specification does not adequately describe which lysosomal storage disorder or the criteria required for the specific lysosomal storage disorder of the claims.
Thus, having analyzed the claims with regard to the Written Description guidelines, it is clear that the specification does not disclose a representative number of species for tolerization agents within the undefined genus that have the required function; or for the lysosomal storage disorder of the claims. Thus, one skilled in the art would be led to conclude that Applicant was not in possession of the claimed invention at the time the application was filed.
Claims 1-7, 9, 10, 14-20, 25, and 26 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 a method of treating Hunter Syndrome, MPSI, and MPSII, species of lysosomal storage disorders, via 5.6 x 1010 AAV9.hIDS vc via ICV injection, does not reasonably provide enablement for a method of preventing, inhibiting the progression of, reducing the severity of, or treating any cardiac, vascular, or skeletal dysfunction or defect in a human having lysosomal storage disorder via delivery of an rAAV comprising an open reading frame encoding any possible gene product. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in a determination of lack of enablement include, but are not limited to:
(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, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
The claims are directed to a method of preventing, inhibiting the progression of, reducing the severity of, or treating any cardiac, vascular, or skeletal dysfunction or defect in a human having lysosomal storage disorder via delivery by any means of an rAAV comprising an open reading frame encoding any possible gene product.
The claims recite a human having “lysosomal storage disorder”, which is recited in a manner of referring to a single specific disorder rather than “a lysosomal storage disorder”. As evidenced by Sheth et al. (The Lancet Regional Health- Southeast Asia, 2023, 9: 100108, 1-13), lysosomal storage disorders are a group of seventy different metabolic storage diseases due to accumulation of substrate mainly in the form of carbohydrate, lipids, proteins, and cellular debris. They occur due to variant in different genes that regulate lysosomal enzymes synthesis, transport, and secretion (Summary, page 1).
The specification does not draw an adequate nexus between delivery of a rAAV comprising an open reading frame of any possible gene product and optionally a second a rAAV comprising an open reading frame of any possible gene product and predictably preventing, inhibiting the progression of, reducing the severity of, or treating any cardiac, vascular, or skeletal dysfunction or defect in a human having any possible lysosomal storage disorder, a genus of at least seventy different diseases due to variance in different genes.
Additionally, the specification does not draw an adequate nexus between delivery of an rAAV comprising an open reading frame of any possible gene product or any of the gene products of instant claim 16 and the predictable outcome of preventing, inhibiting the progression of, reducing the severity of, or treating any cardiac, vascular, or skeletal “dysfunction or defect” in a human having even a single species of a lysosomal storage disorder.
With regards to prevention, the specification does not demonstrate absolute prevention of any possible cardiac, vascular, or skeletal dysfunction or defect in a human having any possible lysosomal storage disorder.
The specification demonstrates rAAV expression cassette comprising a CB7 promoter with CMV enhancer followed by HIDS or hSUMF1, rabbit beta-actin polyadenylation signal on the backbone of AAV2 ITR on both 3’ and 5’ ends. Co-expression constructs included an IRES between IDS and SUMF1.
The specification demonstrates AAV administration via intrathecal injection to mice of 5.6 x 1010 vg or intracerebroventricular injection. SUMF1 did not result in increased IDS activity.
The specification demonstrates intracerebroventricular injection of AAV9.hIDS vector at 5.6 x 1010 vg with CNS distribution through CSF. The specification demonstrates 5.6 x 1010 AAV9.hIDS vc via ICV injection with a resultant inhibition of latency to escape, a species of neurocognitive deficit in mice. The specification demonstrates treatment of Hunter Syndrome, MPSI, and MPSII, species of lysosomal storage disorder via 5.6 x 1010 AAV9.hIDS vc via ICV injection.
Delivery of a specific delivery construct via a specific mode of administration and treatment of specific species of lysosomal storage disorders is not enabling for a method of preventing, inhibiting the progression of, reducing the severity of, or treating any cardiac, vascular, or skeletal dysfunction or defect in a human having lysosomal storage disorder via delivery by any means of an rAAV comprising an open reading frame encoding any possible gene product and optionally a second rAAV comprising an open reading frame encoding any possible gene product.
The specification does not draw an adequate nexus between delivery of rAAVs comprising open reading frames for any possible gene product, even those that have the opposite effect of hIDS, and the predictable outcome of preventing, inhibiting the progression of, reducing the severity of, or treating any cardiac, vascular, or skeletal dysfunction or defect in a human having lysosomal storage disorder, wherein it is known that each of the at least seventy diseases have different gene considerations.
As outlined above, it is well known that there is a high level of unpredictability in the lysosomal storage disease art for therapeutic in vivo applications and design of specific targets for each disease state. The scope of the claims in view of the specification as filed together do not reconcile the unpredictability in the art to enable one of skill in the art to make and/or use the claimed invention, namely a broad method of preventing, inhibiting the progression of, reducing the severity of, or treating any cardiac, vascular, or skeletal dysfunction or defect in a human having lysosomal storage disorder encompassing in vivo effects.
MPEP 2164.01
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.
Also, MPEP 2164.01(a)
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Given the teachings of the specification as discussed above, one skilled in the art could not predict a priori whether introduction of any rAAV comprising an open reading frame of any possible gene in vivo by the broadly disclosed methodologies of the instantly claimed invention, would result in successful preventing, inhibiting the progression of, reducing the severity of, or treating any cardiac, vascular, or skeletal dysfunction or defect in a human having lysosomal storage disorder. To practice the claimed invention, one of skill in the art would have to de novo determine; the stability of the molecule in vivo, delivery of the molecule to the whole organism, specificity to the target tissue in vivo, dosage and toxicity in vivo, and entry of the molecule into the cell in vivo and the effective action therein. Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation (see MPEP 2164.01(a)).
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9, 10, 14-20, 25, and 26 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Hinderer et al. (WO 2019/010335 A1).
Hinderer et al. teach: A co-therapeutic regimen comprising AAV9-mediated (instant claim 15) intrathecal/intracisternal and/or systemic delivery (instant claim 7) of an expression cassette containing a hIDUA gene and two or more immunosuppressants is provided herein (instant claim 1). Also provided are methods useful for treating hIDUA deficiency (MPS1) and the symptoms associated with Hurler, Hurler-Scheie and Scheie syndromes, which are lysosomal storage disorders (abstract) (instant claim 1).
Hinderer et al. teach: In certain embodiments, a therapeutic regimen useful for treatment of an alpha-L- iduronidase deficiency in a human patient involves administering to the patient: (a) a recombinant AAV (rAAV) having an AAV9 capsid and a nucleic acid comprising a sequence encoding human a-L-iduronidase (hIDUA) under control of regulatory sequences which direct expression thereof in the patient, wherein the human hIDUA coding sequence has the nucleotide sequence of SEQ ID NO: 1 or a sequence at least about 80% identical to SEQ ID NO: 1 which encodes a functional hIDUA; (b) at least a first immunosuppressive agent selected from at least one of a glucocorticoid, a steroid, an antimetabolite, a T-cell inhibitor, a macrolide, or a cytostatic agent: and (c) at least a second immunosuppressive agent selected from at least one of a glucocorticoid, a steroid, an antimetabolite, a T-cell inhibitor, a macrolide, or a cytostatic agent, wherein administration of at least one immunosuppressive agent begins prior to or on the same day as delivery of the AAV vector (page 5)(instant claim 1).
It is noted that instant claims 2-4 recite outcomes rather than method steps and the outcomes would necessarily flow from the recited method and the method of the prior art that meets the instant claim limitations, absent evidence to the contrary.
Hinderer et al. teach: A replication deficient adeno-associated virus ("AAV") to deliver a human alpha-L- iduronidase (hIDUA) gene to the CNS of patients (human subjects) diagnosed with mucopolysaccharidosis type I (MPS1) is provided herein. The recombinant AAV ("rAAV") vector used for delivering the hIDUA gene (alpha-L-iduronidase)("rAAV.hlDUA") should have a tropism for the CNS (e.g., an rAAV bearing an AAV9 capsid), and the hIDUA transgene should be controlled by specific expression control elements, e.g., a hybrid of cytomegalovirus (CMV) enhancer and the chicken beta actin promoter (CB7). Pharmaceutical compositions suitable for intrathecal/intracisternal administration comprise a suspension of rAAV.hlDUA vectors in a formulation buffer comprising a physiologically compatible aqueous buffer, a surfactant and optional excipients (page 3) (instant claim 16).
Hinderer et al. teach: Combinations of gene therapy delivery of the rAAV. DUA to the CNS accompanied by systemic delivery of hIDUA are encompassed by the methods of the invention. Systemic delivery can be accomplished using ERT {e.g., using Aldurazyme.sup.®), or additional gene therapy using an rAAV.MDUA with tropism for the liver {e.g., an rAAV.MDUA bearing an AAV8 capsid) (page 9) (instant claims 1, 5, and 6).
Hinderer et al. recite coadministering the second vector intravenously (claim 16), wherein the first vector is administered via intrathecal injection (claim 15) (instant claim 9).
Hinderer et al. teach: In certain embodiments, the patient is administered an AAV.MDUA via liver-directed injections in order to tolerize the patient to MDUA, and the patient is subsequently administered AAV.MDUA via intrathecal/intraci sternal injections when the patient is an infant, child, and/or adult to express therapeutic concentrations of MDUA in the CNS (page 9)(instant claims 10, 17, and 20).
Hinderer et al. teach: The recombinant AAV ("rAAV") vector used for delivering the hIDUA gene ("rAAV.hlDUA") should have a tropism for the CNS (e.g., an rAAV bearing an AAV9 capsid), and the hIDUA transgene should be controlled by specific expression control elements, e.g., a hybrid of cytomegalovirus (CMV) enhancer and the chicken beta actin promoter (CB7) (page 3) (instant claims 18 and 19).
Hinderer et al. teach that the AAV8 or AAV9 capsid can be used (page 28) (instant claim 19).
Hinderer et al. teach various dosages anticipating the instant range including 1.2x1012 total genome copies (GC) (Page 7)(instant claims 25 and 26).
Hinderer et al. teach administration of immune co-therapy that can be delivered in combination with a sole gene therapy vector or a combination of gene therapy vectors. Immunosuppressive therapy can be given in addition to the vector-before, during, and/or subsequent to vector administration (instant claim 9), meeting the instant limitation of being immunotolerized before administration of the vector (page 51)(instant claim 14). Hinderer et al. teach that the subject is tolerized (page 11).
Therefore, the claims are anticipated by Hinderer et al.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 9, 10, 14-20, 25, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hinderer et al. (WO 2019/010335 A1) as applied above, and further in view of Littman et al. (WO 2015/025217 A2).
The instant rejection is specific for the elected species of iduronate-2-sulfatase from instant claim 16.
Given the extensive teachings of Hinderer et al., it would have been obvious to utilize the method and system of Hinderer et al. teach a wide array of lysosomal storage disorders, wherein selection of the ORF would be dependent upon the specific lysosomal storage disorder to be treated.
Hinderer et al. teach: Also provided are methods useful for treating hIDUA deficiency (MPS1) and the symptoms associated with Hurler, Hurler-Scheie and Scheie syndromes, which are lysosomal storage disorders (abstract) (instant claim 1).
In the scenario of Hurler syndrome or Hunter syndrome, it would have been obvious to utilize iduronate-2-sulfatase because Littman et al. teach that this is caused by a deficiency in iduronate-2-sulfatase [0005] and teaches administration of the enzyme for treatment of the condition [0200].
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 1-7, 9, 10, 14-20, 25, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. US 8,609,088 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US ‘088 B2 are directed to: 1. A method for treating or inhibiting one or more neurological signs or symptoms associated with a mucopolysaccharidosis in a mammal in need thereof, comprising: intranasally administering an effective amount of an enzyme composition comprising alpha-L-iduronidase, iduronate-2-sulfatase, N-acetyl-alpha-D-glucosaminidase, betagalactosidase, or beta-glucuronidase.
Therefore, the claims are directed to a species of the instant genus, wherein in would have been obvious to deliver the iduronate-2-sulfatase via a rAAV and to administer it in two separate rAAVs, as evidenced by Hinderer et al. (WO 2019/010335 A1). The claim sets recite overlapping delivery amounts and modes of administration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy R Hudson whose telephone number is (571)272-0755. The examiner can normally be reached M-F 8:00am-6:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636
Prosecution Insights