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
This action is in response to the papers filed March 5, 2026.
Amendments
Applicant's response and amendments, filed March 5, 2026, is acknowledged. Applicant has cancelled Claims 2-5, 7-9, 11-26, and 28, and amended Claim 1.
The amendment to the claims filed on March 5, 2026 does not comply with the requirements of 37 CFR 1.121(c). Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
The correct status of Claims 33-40 is (Withdrawn).
Claims 1, 6, 10, 27, and 29-41 are pending.
Election/Restrictions
Applicant has elected without traverse the following species, wherein:
i) the alternative in vivo retinal imaging assay/step is retinal imaging performed using ultrahigh-resolution optical coherence tomography (OCT), as recited in Claim 34;
ii) alternative microarchitecture to be imaged, measured, or evaluated, is reestablishment of proper apposition between RPE cells and photoreceptor (PR) outer segments (cytoarchitecture of RPE-PR interface); as recited in Claim 41;
iii) the alternative additional assay/step is further evaluation for Muller glial trunks/projections penetrating ONL layer with astrogliosis, as recited in Claim 37; and
iv) the alternative AAV capsid is AAV2, as recited in Claim 27.
Claims 1, 6, 10, 27, and 29-41 are pending.
Claims 33-40 are pending but withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 1, 6, 10, 27, 29-32, and 41 are under consideration.
Priority
This application is a 371 of PCT/US2021/020171 filed on February 28, 2021. Applicant’s claim for the benefit of a prior-filed application provisional application 62/983,052 filed on February 28, 2020 and 62/983,046 filed on February 28, 2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
The Examiner also acknowledges Applicant’s co-pending application 17/904,899, which is a 371 of PCT/US2021/020169 filed on February 28, 2021, which also claims benefit of prior-filed application provisional application 62/983,052 filed on February 28, 2020 and 62/983,046 filed on February 28, 2020.
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.
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.
1. The prior rejection of Claims 1, 3, 5-6, 10, 27, and 29-32 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of Applicant’s amendment to the independent claim reciting the dose is administered in a volume between 50µl and 500µl, which the Examiner finds persuasive.
The claim is directed to administering via subretinal, intravitreal, or suprachoroidal injection a dose of about 5x10^8, 1x10^9, 5x10^9, 1x10^10, 5x10^11, 5x10^12, 1x10^13, or 1x10^14 rAAV-BEST1 vector genomes per eye of the subject in a volume in a volume between 50µl and 500µl.
2. The prior rejections of Claims 1, 3, 5-6, 17, 27, 29, and 31-32 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn in light of Applicant’s amendment to the independent claim reciting the rAAV vector encodes a promoter operably linked to the nucleic acid sequence encoding BEST1.
3. Claims 1, 6, 10, 27, 29-32, 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.
The term “elongated” in amended Claim 1 is a relative term which renders the claim indefinite. The term “elongated” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While it is clear that the subject is to be suffering from a bestrophinopathy caused by a biallelic BEST1 mutation, the phenotypic change in the rod outer segment which does/does not fulfill “elongated” is considered to be an arbitrary and subjective determination, rendering the claim indefinite.
The instant claims as a whole do not apprise one of ordinary skill in the art of its scope and, therefore, does not serve the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent.
Dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claim(s).
4. Claims 1, 6, 10, 27, 29-32, and 41 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.
Claim 1 has been amended to recite wherein the subject suffers from a bestrophinopathy caused by a biallelic BEST1 mutation with elongated rod outer segments.
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function ... does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is’).
In analyzing 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. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. The disclosure of a single species is rarely, if ever, sufficient to describe a broad genus, particularly when the specification fails to describe the features of that genus, even in passing. (see In re Shokal 113USPQ283(CCPA1957); Purdue Pharma L.P. vs Faulding Inc. 56 USPQ2nd 1481 (CAFC 2000).
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997).
National Library of Medicine (NC_000011.10, human BEST1 gene; last visited March 17, 2026) evidences that the human BEST1 gene is about 15,700 nucleotides in length (chromosome 11, coordinates 61965515-61949821).
Thus, the instant claims encompass an infinite genus of structurally undisclosed biallelic BEST1 mutations [structures] that result in elongated rod outer segments [function].
GenBank KR709593 (human BEST1 mRNA, complete protein, 2015) is considered relevant prior art for teach a human BEST1 cDNA that is about 1626 nucleotides in length.
Even if one narrows the genus of biallelic mutations to the BEST1 mRNA (and cDNA resulting therefrom), one is still left with an infinite genus (4x10^1600 = infinite) structurally undisclosed biallelic BEST1 mutations [structures] that are to result in elongated rod outer segments [function].
(www.calculator.net/exponent-calculator; last visited March 18, 2026).
Those of ordinary skill in the art would immediately recognize that Applicant simply does not possess infinity, as such violates natural law of physics.
The specification fails to disclose a structure/function nexus between the infinite genus of undisclosed biallelic BEST1 mutations [structures] that necessarily and predictably result in elongated rod outer segments [function].
The claims fail to recite, and the specification fails to disclose, a first bestrophinopathy caused by a first biallelic BEST1 mutation that does not produce elongated rod outer segments, as opposed to a second bestrophinopathy caused by a second biallelic BEST1 mutation that necessarily and predictably produces elongated rod outer segments.
While the specification discloses, for example, a cBest-Het genotype that yields elongated rod outer segments (pg 7, Figure 7a-d, legend; pg 34, lines 8-9), neither the specification nor figures disclose the actual BEST1 mutation(s), nor biallelic conditions thereof, that yielded the elongated rod outer segment phenotype. Rather, the specification and figures is/are obfuscatory.
At best, the specification discloses only five biallelic BEST1 mutation conditions, to wit:
i) c.73C>T/p.R25*;
ii) -c.482G>A/p.Gl61D;
iii) c.1388delC/P463fs;
iv) cBESTl-C73T/R25* -; and
v) G482A/Gl61D (e.g. pg 33, lines 18-19).
The five biallelic BEST1 mutation conditions species do not adequately represent the infinite genus of undisclosed biallelic BEST1 mutations [structures] that necessarily and predictably result in elongated rod outer segments [function] encompassed by the claims.
In Amgen, Inc., v. Sanofi (872 F.3d 1367 (2017)
At 1375, [T]he use of post-priority-date evidence to show that a patent does not disclose a representative number of species of a claimed genus is proper.
At 1377, [W]e questioned the propriety of the "newly characterized antigen" test and concluded that instead of "analogizing the antibody-antigen relationship to a `key in a lock,'" it was more apt to analogize it to a lock and "a ring with a million keys on it." Id. at 1352.
An adequate written description must contain enough information about the actual makeup of the claimed products — "a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials," which may be present in "functional" terminology "when the art has established a correlation between structure and function." Ariad, 598 F.3d at 1350. But both in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies. See, e.g., J.A. 1241 (549:5-
16) (Appellants' expert Dr. Eck testifying that knowing "that an antibody binds to a particular amino acid on PCSK9 ... does not tell you anything at all about the structure of the antibody"); J.A. 1314 (836:9-11) (Appellees' expert Dr. Petsko being informed of Dr. Eck's testimony and responding that "[m]y opinion is that [he's] right"); Centocor, 636 F.3d at 1352 (analogizing the antibody-antigen relationship as searching for a key "on a ring with a million keys on it") (internal citations and quotation marks omitted).
In the instant case, knowing that the initial bestrophinopathy is to be caused by a biallelic mutation [structure] that results in elongated rod outer segments [function] tells you nothing about the infinite genus of structurally undisclosed biallelic BEST1 mutations [structures] present anywhere in the about 15,700 nucleotides of the BEST1 gene and/or about 1626 nucleotides of the BEST1 mRNA/cDNA that necessarily and predictably results in elongated rod outer segments [function] encompassed by the claims.
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function ... does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is’).
In Amgen, Inc., v. Sanofi (U.S. Supreme Court, No. 21-757 (2023))
“Amgen seeks to monopolize an entire class of things defined by their function”.
“The record reflects that this class of antibodies does not include just the 26 that Amgen has described by their amino acid sequence, but a “vast” number of additional antibodies that it has not.”
“It freely admits that it seeks to claim for itself an entire universe of antibodies.”
In the instant case, the record reflects that the claimed class of the BEST1 biallelic mutations encompasses an infinite genus of structurally undisclosed biallelic BEST1 mutations [structures] present anywhere in the about 15,700 nucleotides of the BEST1 gene and/or about 1626 nucleotides of the BEST1 mRNA/cDNA that are to result in elongated rod outer segments [function] encompassed by the claims.
“They leave a scientist forced to engage in painstaking experimentation to see what works. 159 U.S., at 475.
This is not enablement. More nearly, it is “a hunting license”. Brenner v. Manson, 383 U.S. 519, 536 (1966).
“Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation”.
While the “roadmap” would produce functional combinations, it would not enable others to make and use the functional combinations; it would instead leave them to “random trial-and-error discovery”.
“Amgen offers persons skilled in the art little more than advice to engage in “trial and error”.
“The more a party claims for itself the more it must enable.”
“Section 112 of the Patent Act reflects Congress’s judg-ment that if an inventor claims a lot, but enables only a lit-tle, the public does not receive its benefit of the bargain. For more than 150 years, this Court has enforced the stat-utory enablement requirement according to its terms. If the Court had not done so in Incandescent Lamp, it might have been writing decisions like Holland Furniture in the dark. Today’s case may involve a new technology, but the legal principle is the same.
Those of ordinary skill in the art would immediately recognize that Applicant simply does not possess infinity, as such violates natural law of physics.
Applicant is essentially requiring the ordinary artisans to discover for themselves that which Applicant fails to disclose.
Thus, for the reasons outlined above, it is concluded that the claims do not meet the requirements for written description under 35 U.S.C. 112, first paragraph.
MPEP 2163 - 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the “specification shall contain a written description of the invention ....” This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc)
Dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claim(s).
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.
5. Claim(s) 1, 6, 10, 27, 29-32, and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guziewicz et al (BEST1 gene therapy corrects a diffuse retina-wide microdetachment modulated by light exposure, Proc. Nat’l. Acad. Sci. 115(12): e2839-e2848, available online March 5, 2018; Applicant’s own work; of record in IDS).
With respect to Claim 1, Guziewicz et al is considered relevant prior art for having taught a method of treating a subject suffering from two mutant BEST1 alleles, to wit, canine subjects comprising homozygous or biallelic BEST1 mutations (e.g. pg e2847, col. 2, Methods, canine model) comprising the step of administering to an eye of the subject a dose of at least 1x10^8 to 9x10^9 vector genomes an rAAV vector encoding BEST1 (e.g. human BEST1, pg e2842, col. 2) operably linked to a human VMD2 (syn. BEST1) promoter (Supplementary Methods; pg e2842, col. 2).
Guziewicz et al taught wherein the rAAV was administered in a volume of 50µl to 180µl (Supplemental Methods).
Guziewicz et al taught wherein the subject is suffering from two mutant BEST1 alleles, to wit, canine subjects comprising homozygous or biallelic BEST1 mutations (e.g. pg e2847, col. 2, Methods, canine model).
Guziewicz et al taught wherein the method comprised administering the rAAV-BEST1 gene therapy to human patients (e.g. pg e2847, col. 1, Methods, Human Subjects), including patients with ARB (e.g. Figure 5, legend).
Guziewicz et al taught wherein the human patients suffered from abnormalities in the photoreceptor outer segments, the distance of which appeared to be greater than normal (e.g. pg e2845, col.s 1-2, “greater than normal”), which the Examiner interprets to reasonably fulfill instant amended limitation of a bestrophinopathy caused by a biallelic BEST1 mutation with elongated rod outer segments.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
With respect to Claim 6, Guziewicz et al taught wherein the rAAV is administered to the subject’s retina (e.g. pg e2842, col. 2, heading, subretinal).
With respect to Claim 10, Guziewicz et al taught wherein the rAAV encoding a human BEST1 protein (e.g. human BEST1, pg e2842, col. 2) operably linked to a human VMD2 (syn. BEST1) promoter (Supplementary Methods; pg e2842, col. 2).
With respect to Claims 27 and 29-30, Guziewicz et al taught wherein the rAAV is an AAV2 comprising an AAV2 capsid (syn. AAV2/2; pg e2842, col. 2; Supplemental Methods).
With respect to Claim 32, Guziewicz et al taught wherein the rAAV was administered one of the subject’s eyes (e.g. pg e2842, col. 2, “the fellow eye was not injected”).
With respect to Claim 31, Guziewicz et al taught wherein the rAAV was administered both of the subject’s eyes (e.g. Figure 3, legend, “both eyes were injected”).
With respect to Claim 41, Guziewicz et al taught wherein the gene therapy method further comprises the step of measuring a re-establishment of proper apposition between RPE cells and photoreceptor (PR) outer segments (cytoarchitecture of RPE-PR interface) (e.g. Figures 1 and 3D).
Thus, Guziewicz et al anticipate the claims.
6. Claim(s) 1, 6, 10, 27, and 29-32 are rejected under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Maclaren et al (U.S. 2019/0307900; filed April 5, 2019; priority to April 5, 2018).
With respect to Claim 1, Maclaren et al is considered relevant prior art for having disclosed an rAAV expression vector whose genome comprises a VMD2 promoter operably linked to a BEST1 cDNA (e.g. Figure 1), and a method of using said rAAV vector to treat a bestrophinopathy in a human subject, wherein the subject has a mutation in one or both BEST1 alleles, e.g. a dominant mutation causing BVMD, retinitis pigmentosa, or a recessive mutation causing ARB (e.g. [0026, 67]).
Maclaren et al disclosed administering about 5x10^10, 1x10^11, 5x10^11, or 1x10^12 vector genomes in a volume of 100 µl to the eye of the human subject (e.g. Figures 30-31), wherein the rAAV may be administered via subretinal, suprachoroidal, or intravitreal route (e.g. [0027]).
With respect to Claim 6, Maclaren et al disclosed the rAAV may be administered via subretinal, suprachoroidal, or intravitreal route (e.g. [0027]).
With respect to Claims 10 and 30, Maclaren et al disclosed an rAAV expression vector whose genome comprises a VMD2 promoter operably linked to a BEST1 cDNA (e.g. Figure 1; [0005], “human VMD2 promoter”, “human BEST1 protein”).
With respect to Claims 27 and 29, Maclaren et al disclosed the rAAV vector comprises an AAV2, AAV3, AAV4, AAV5, AAV6, AAV7, AAVS, AAV9, AAV10, or AAV11 capsid serotype (e.g. [0017]).
With respect to Claims 31-32, Maclaren et al disclosed bilateral injection of the rAAV to the eyes of a subject (e.g. Figure 29) or to one eye of the subject (e.g. Figure 15).
Thus, Maclaren et al anticipate the claims.
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.
7. Claims 1, 6, 10, 27, 29-32, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 17, 27, 29, 31-32, and 34 of copending Application No. 17/904,899 (reference application) (claim set filed March 5, 2026). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant Claim 1 recites a method of a bestrophinopathy in a subject comprising two mutant BEST1 alleles.
‘899 recites a method of a bestrophinopathy in a subject comprising at least one mutant BEST1 allele.
As a first matter, it is axiomatic and natural law of biology that if the subject comprises two mutant BEST1 alleles (‘903), they necessarily comprise at least one mutant BEST1 allele (‘899).
As a second matter, the term "comprising" is open-ended and allows for additional, unrecited elements in the claims. MPEP 2111.03 specifically sets forth that the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). ‘899 Claim 1 fails to specifically exclude the presence of a second mutant BEST1 allele.
As a third matter, it would have been obvious to one of ordinary skill in the art to choose from a finite number of identified, predictable options because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipate success, it is likely that product not of innovation but of ordinary skill and common sense.”
One of ordinary skill in the art immediately recognizes that mammals, including humans, are diploid, and thus their genomes only comprise two BEST1 alleles, be they mutant or non-mutant. Thus, it is axiomatic that a subject suffering from a bestrophinopathy will necessarily comprise at least one mutant BEST1 allele or two BEST1 alleles, whereby the ordinary artisan could have pursued the known potential options, two wit, one mutant BEST1 allele or two mutant BEST1 alleles, with a reasonable expectation of success, whereby the number of possible mutant BEST1 genotypes from which to choose, 1 or 2 mutant BEST1 alleles, is neither astronomical nor insurmountable.
Thus, instantly claimed method(s) is/are considered to anticipate and/or be obvious variants of the co-pending ‘899 claimed method(s).
Conclusion
8. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN K. HILL whose telephone number is (571)272-8036. The examiner can normally be reached 12pm-8pm EST.
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KEVIN K. HILL
Examiner
Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638
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