DETAILED ACTION
This Action is in response to the amendment filed on 04/29/2025.
Upon entry of the amendment claims 1, 3-21, 59-71, 74, 77-117, and 130-132 are pending.
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 .
Status of the Claims
Claims 1, 3-21, 59-71, 74, 77-117, 130-132 are pending.
Claims 13-19, 21, 59, 62, 65-71, 78, 80, 83-103, 105, 109-114, 116-117, and 130-132 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species as previously indicated, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/06/2024.
Claims 1, 3-12, 20, 60, 61, 63, 64, 74, 77, 79, 81-82, 104, 106-108, 115 are under consideration.
Maintained Rejection: 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.
Claim 74 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 2017/0035796 (hereafter “Wooddell”, of record).
As indicated in the previous Office Action, Wooddell teaches an siNA molecule with a sense strand that comprising SEQ ID NO: 435 and an antisense strand that comprises SEQ ID NO: 513. Specifically, Wooddell teaches RNAi duplex AD04003 (Table 2) comprises the 21 nucleotide antisense strand AM5054-AS asUfsusGfaGfaGfaAfgUfcCfaCfcAfcusu, identified as Wooddell’s SEQ ID NO: 407 (see Table 1A), and 22 nucleotide sense strand identified as Wooddell’s SEQ ID NO: 636 AM05046-SS (NAG25)sasaguggugGfAfCfuucucucaaus(invAb) (See Table 1B). It is noted that instant SEQ ID NO: 435 (SS) is identical to the nucleotide sequence of Wooddell’s SEQ ID NO: 636 (SS), and instant SEQ ID NO: 513 (AS) is identical to the nucleotide sequence of Wooddell’s SEQ ID NO: 407 (AS).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues that the Office Action alleges that Wooddell’s SEQ ID NO: 636 AM05046-SS and instant SEQ ID NO: 435 (SS) are identical and “This is simply not correct.” Asserting that Wooddell’s SEQ ID NO: 636 and present SEQ ID NO: 435 have plainly different modification patterns.
This is not persuasive. First it is respectfully pointed out that Office Action stated, It is noted that instant SEQ ID NO: 435 (SS) is identical to the nucleotide sequence of Wooddell’s SEQ ID NO: 636 (SS), and instant SEQ ID NO: 513 (AS) is identical to the nucleotide sequence of Wooddell’s SEQ ID NO: 407 (AS).” Emphasis added for clarity. It is also noted that claim 74 was drawn to an siNA molecule comprising a sense strand (SS) comprising a first nucleotide sequence that comprises a nucleotide of any one of SEQ ID Nos: 103-158, 205-260, 307-362 and 415-444 and an antisense strand (AS) comprising a second nucleotide sequence that comprises a nucleotide of any one of SEQ ID Nos: 159-204, 261-306, 363-409, 445-533, and 536-539. The elected species is SS SEQ ID NO: 435 and AS SEQ ID NO: 513. Claim 74 does not include any explicit requirement that the SS or AS strand has any chemical modifications. Furthermore, SEQ ID NO: 435 in the sequence listing also does not indicate that the nucleotide sequence includes any modifications:
SEQUENCE LISTING INFORMATION FOR SEQ ID NO: 435:
<210> 435
<211> 19
<212> RNA
<213> Artificial Sequence
<220>
<223> Description of Artificial Sequence: Synthetic
oligonucleotide
<400> 435
gugguggacu ucucucaau 19
Since claim 74 and the sequence listing submission for SEQ ID NO: 435 do not require that the nucleotide sequence of SEQ ID NO: 435 comprises any chemical modifications, Applicants’ arguments are not persuasive. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
New Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 recites, “comprising a first nucleotide sequence that is at least about 90
Appropriate correction or clarification is required.
In the interest of compact prosecution the claim will be interpretate as if it indicated “90%”.
New 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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, 3-12, 60, 61, 63, 64, 81, 104, 106-108, 115 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2017/0035796 (hereafter “Wooddell”, of record).
Wooddell, as applied to the instant claims, teaches an siNA molecule with a sense strand comprising SEQ ID NO: 636 (instant SEQ ID NO: 40 which is the same nucleotide sequence as SEQ ID NO: 435) and an antisense strand comprising SEQ ID NO: 407 (instant SEQ ID NO: 88 which is the same nucleotide sequence as instant SEQ ID NO: 513). That is, Wooddell teaches RNAi duplex AD04003 (Table 2) comprises the 21 nucleotide antisense strand AM5054-AS, identified as Wooddell’s SEQ ID NO: 407 wherein the unmodified sequence is Wooddell’s SEQ ID NO: 97 (see Table 1A), and a 22 nucleotide sense strand identified as Wooddell’s SEQ ID NO: 636 AM05046-SS wherein the unmodified sequence is Wooddell’s SEQ ID NO: 202 (See Table 1B), as described in the rejection above.
Wooddell does not teach the specific pattern of chemical modifications to the siNA required by the instant claims.
However, Wooddell does teach siNA with various patterns of chemical modifications, including siNA having chemical modification pattern as required by the instant claim. For instance, Wooddell teaches siNA duplex AD00003 comprising SS AM00005-SS and AS AM00006-AS (e.g., see TABLE 2) wherein AM00005-SS comprises 15 nucleotides that are modified with either 2’-O-methyl or 2’-fluoro nucleotides, at least 11 nucleotides are modified with 2’O-methyl modifications and at least 4 nucleotides are 2’-fluoro modified including at positions 8, 10, 12, 14, 17, 19 (see Table 1B), and wherein AM00006-AS comprises 15 nucleotides that are modified with either 2’-O-methyl or 2’-fluoro nucleotides, at least 11 nucleotides are modified with 2’O-methyl modifications and 3 to 6 nucleotides are 2’-fluoro modified including at positions, 8, 10, 12, 14 (see Table 1A).
Regarding claim 3, Wooddell teaches an siNA with a first strand (sense strand) that comprises 16 or more modified nucleotides independently selected from 2’-O-methyl modified nucleotide and 2’-fluoro modified nucleotide (see above, all modified nucleotides).
Regarding claim 4, Wooddell teaches an siNA that comprises at least 70%, 75%, 80%, 85%, 90%, 95% or 100% of the nucleotides in the first nucleotide sequence (sense strand) are modified nucleotides independently selected from a 2' -0-methyl nucleotide and a 2'-fluoro nucleotide (see above, all modified nucleotides).
Regarding claim 5, Wooddell teaches at least 2 modified nucleotides of the first strand (sense strand) are 2’-fluoro nucleotides (see above, 2’-fluoro at position 9-11).
Regarding claim 6, Wooddell teaches an siRNA wherein the second strand (antisense strand) comprising at least 16 modified nucleotides independently selected from a 2' -0-methyl nucleotide and a 2'-fluoro nucleotide (see above, all modified nucleotides).
Regarding claim 7, Wooddell teaches an siNA wherein 100% of the nucleotides in the second nucleotide sequence are modified nucleotides independently selected from a 2'-O-methyl nucleotide and a 2'-fluoro nucleotide (see above, 100% modified).
Regarding claim 8, Wooddell teaches an siNA wherein at least 2, 3, 4, 5, or 6 modified nucleotides of the second nucleotide sequence are 2'- fluoro nucleotides (see above).
Regarding claim 9, Wooddell teaches an siNA comprising 1 or more phosphorothioate internucleoside linkage in the sense strand and/or antisense strand (see above, where s=phosphorothioate linkages).
Regarding claim 10, Wooddell teaches an siNA comprising a galactosamine (see above where NAG is N-acetylgalactosamine (NAG) as indicated in [0058]).
Regarding claim 11, Wooddell teaches an siNA wherein at least 1, nucleotide at position 3, 5, 7, 8, 9, 10, 11, 12, or 17 from the 5' end of the first nucleotide sequence is a 2'-fluoro nucleotide (see above where position 9, 10 and 11 are 2’-fluoro (GfAfCf)).
Regarding claim 12, Wooddell teaches an siNA wherein at least 1 nucleotide at position 2, 5, 6, 8, 10, 14, 16, 17, and/or 18 from the 5' end of the second nucleotide sequence is a 2'-fluoro nucleotide (see above where at least position 8, 10, 14, 16, 18 of the antisense strand are 2’-fluoro nucleotides (Gf, Af, Cf, Cf, Af)).
Regarding claim 60, Wooddell teaches an siNAwherein the sense strand comprises at least 1 phosphorothioate linkage (see above where s=phosphorothioate linkage).
Regarding claim 61, Wooddell teaches an siNA with a phosphorothioate internucleoside linkage between the nucleotides at positions 1 and 2 from the 5' end of the first nucleotide sequence; (ii) a phosphorothioate internucleoside linkage between the nucleotides at positions 2 and 3 from the 5' end of the first nucleotide sequence. Specifically, see AM04660-SS gsgsuggsCfuUfCfUfcucaAfUfuuua(NAG13) (Table1B, where s=phosphorothioate)
Regarding claim 62, Wooddell teaches an siNA wherein the antisense strand further comprises TT sequence adjacent to the second nucleotide sequence. For example, see AM000006-AS dTAfcCfaAfuUfuAfuGfcCfuAfcAfgdTsdT (where dTsdT is two Ts connected by a phosphorothioate linker (s)).
Regarding claim 63, Wooddell teaches an siNA wherein the antisense strand further comprises at least 1 phosphorothioate internucleoside linkage (see above).
Regarding claim 64, Wooddell teaches an siNA, wherein the antisense strand comprises a phosphorothioate internucleoside linkage between nucleotides at positions 1 and 2 from the 5’ end of the second nucleotide sequence (see above).
Regarding claim 81, Wooddell teaches an siNA which further comprises a galactosamine. For instance, see the siNA comprising AM05046-SS (NAG25)sasaguggugGfAfCfuucuc-ucaaus(invAb) (See Table 1B), wherein (NAG25) comprises a galactosamine.
Regarding claim 104, Wooddell teaches that the siNAs target a gene from Hepatitis B Virus (HBV). For example, see abstract.
Regarding claims 106-108, Wooddell teaches the siNA molecules comprising a 21 nucleotide antisense strand AM5054-AS asUfsusGfaGfaGfaAfgUfcCfaCfcAfcusu, identified as Wooddell’s SEQ ID NO: 407 (see Table 1A), which is identical to SEQ ID NO: 513, and a 22 nucleotide sense strand identified as Wooddell’s SEQ ID NO: 636 AM05046-SS (NAG25)sasaguggugGfAfCfuucucucaaus(invAb) (See Table 1B), identical to instant SEQ ID NO: 435. Alignment of the two strands (Wooddell’s 21 nucleotide AS SEQ ID NO: 407 and 22 nucleotide SS SEQ ID NO: 636) indicates that at least one end of the dsNA complex would be a blunt end and one end would have an overhang nucleotide. Furthermore, the dsNA of Wooddell having AM05046-SS and AM5054-AS is identical to ds-siNA-0138 which has the elected species SEQ ID NO: 435 and SEQ ID NO: 513.
Regarding claim 115, Wooddell teaches that the siNA can be formulated with a pharmaceutically acceptable excipient to make a pharmaceutical composition (e.g., see [0017], [0122], claims 18-19, etc.).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the day the claimed invention was filed to modify the chemical modification pattern required by the instant claims with a reasonable expectation of success. Since Wooddell teaches that the chemical modifications including their specific location in siNA molecules was known, it would have been a matter of applying a chemical modification known in siNAs to the specific duplex siNA comprising Wooddell’s SS- SEQ ID NO: 202 and AS-SEQ ID NO: 97.
The combination of prior art satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 USPQ2d 1385 (2007):
“Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.”
In this case, it would have been a matter of (A) Combining the prior art elements (the specific double stranded nucleotides sequences and the specific pattern of modifications) according to known methods to yield predictable results; (B) Simple substitution of one known element for another (substituting the known chemical modification to the specific double stranded nucleotide sequences) to obtain predictable results; or (E) “Obvious to try” the combination of the specific chemical modifications with the specific double stranded siNA nucleotides sequences, with a reasonable expectation of success.
Claims 20 and 82 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2017/0035796 (hereafter “Wooddell”, of record).
Wooddell, as applied to the instant claims, is described in the rejection above.
With respect to claim 20, Wooddell does not teach a siNA molecule represented by Formula (IX) wherein the siRNA has the specific modifications of the elected species that requires 2’-fluoro nucleotides at positions 3, 7, 8, 9, 12 and 17 of the sense strand and 2, 7, and 14 of the antisense strand and 2’-O-methyl nucleotides at positions 1, 2, 4-6, 10, 11, 13-16, 18, and 19 of the sense strand and 1, 3-6, 8-13, and 15-21 of the antisense strand, as indicated above. However, Wooddell does teach the use of 2’-fluoro modified nucleotides and 2’O-methyl modified nucleotides at various positions throughout the sense and antisense strands. Since Wooddell teaches siNAs with 2’-fluoro nucleotides and 2’-O-methyl nucleotides at various positions throughout both strands of the siNA, it would have been further prima facie obvious to one of ordinary skill in the art to prior to the date the claimed invention was filed to include chemical modifications at the required positions of the 2’-fluoro and 2’-O-methyl nucleotides in the siNA and to arrive at the claimed pattern of modifications, with a reasonable expectation of success. The motivation to try different positions would be to identify the location of modifications which result in an more effective siNA molecule. That is, KSR’s rationales (A), (B), and/or (E), as indicatd above apply here. It is note that there does not appear to be anything in the disclosure indicating that the specific pattern of modifications claimed conferred any unexpected properties/characteristics to the claimed siNA compared to the siNAs with different modification patterns, such as those explicitly taught by Wooddell.
With respect to claim 82, although Wooddell teaches that the siNA can comprise a galactosamine (as indicated in the 102 rejection above), and further explicitly indicates that the galactosamine can be N-acetylgalactosamine (GalNAc or NAG) including multiple (multimeric) galactosamines (see [0107]), and specifically teaches a siNA with a trimer n-acetylgalactosamine identified as [NAG25], Wooddell does not teach the use of the GalNAc of Formula (VII).
It is noted that Wooddell teaches,
“The affinities of numerous galactose derivatives for the asialoglycoprotein receptor have been studied… or are readily determined using methods well known and commonly used in the art. Other terms common in the art for galactose trimer having three terminal galactose derivatives include tri-antennary galactose, tri-valent galactose. Other terms common in the art for galactose trimer include galactose cluster. It is known that tri-antennary galactose derivative clusters are bound to the ASGPr with greater affinity than bi-antennary or mono-antennary galactose derivative structures…” (References to citations removed).
Therefore, it also would have been further prima facie obvious to one of ordinary skill in the art prior to the day the claimed invention was filed to further modify the modified siNA duplex taught by Wooddell as indicated above and use a different known tri-valent GalNAc, including a GalNAc of Formula (VII) with a reasonable expectation of success. KSR’s rationales (A), (B), and/or (E), as indicatd above apply here. Official notice is taken that the GalNAc of Formula (VII) was previously known in the art.
Therefore, the instant claims are unpatentable under 35 USC 103.
Claims 77 and 79 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2017/0035796 (hereafter “Wooddell”, of record), in view of WO2010141726 (hereafter “Basu”)
Wooddell, as applied to the instant claims is described in the rejection above.
With respect to claim 77, 79, although Wooddell generally teaches that locked nucleotides are one of the types of modified nucleotides that can be used the siNA (see [0045]), Wooddell does not provide any specific examples of siNA comprising locked nucleotides, and does not teach a locked nucleotide of Formula (IV).
Basu teaches locked nucleic acids (LNAs) can be used to stabilize dsRNAs and improve dsRNA performance (see page 77, second to last paragraph). Basu also explicitly teaches that LNA is incorporated into the 5’ terminus of the sense strand (see page 82, second to last paragraph). Although Basu does not provide the specific structure of the LNA, Basu provides several references indicating “LNA’s are well known to a skilled artisan” citing several references (see page 82, second to last paragraph); furthermore, official notice is also taken that the LNA of formula (IV) was known.
Therefore, it also would have been further prima facie obvious to one of ordinary skill in the art prior to the day the claimed invention was filed further modify the siNA duplex taught by Wooddell and use LNA, including a LNA of Formula (IV), at the 5’ terminal end of the sense strand of Wooddell’s siNA, with a reasonable expectation of success. The motivation would be to stabilize the siNA and improve its performance. As such, KSR’s rationales (A), (B), and/or (E), as indicated above apply here.
Therefore, the instant claims are unpatentable under 35 USC 103.
Response to Arguments
With respect to the pending rejection of claims under 35 USC 103, Applicant's arguments have been fully considered but they are not persuasive. Applicant argues that although a person of skill in the art could have arrived at the claimed pattern, this does not show that a skilled person would have been motivated to combine the elements precisely as claimed. Applicant also argues that claims 77, 79 and 82 depend on claim amended claim 1.
It is first noted that the rejection of amended claim 1 is addressed in the 103 rejection above and now applies to claims 77, 79 and 82 as well. Furthermore, it is noted that MPEP 2141 III states:
Prior art is not limited just to the references being applied, but includes the understanding of one of ordinary skill in the art. The prior art reference (or references when combined) need not teach or suggest all the claim limitations. However, Office personnel must explain why the difference(s) between the prior art and the claimed invention would have been obvious to one of ordinary skill in the art. The "mere existence of differences between the prior art and an invention does not establish the invention’s nonobviousness." Dann v. Johnston, 425 U.S. 219, 230, 189 USPQ 257, 261 (1976). The gap between the prior art and the claimed invention may not be "so great as to render the [claim] nonobvious to one reasonably skilled in the art." Id. In determining obviousness, neither the particular motivation to make the claimed invention nor the problem the inventor is solving controls. The proper analysis is whether the claimed invention would have been obvious as of the relevant time to one of ordinary skill in the art after consideration of all the facts…
Office personnel should also consider whether one or more of the other rationales set forth below supports a conclusion of obviousness. The Court in KSR identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham…
The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
MPEP 2141 III also provides examples of rationales that may support a conclusion of obvious, including rationales (A)-(G) indicated above. The rejection of claims under 103 address the rationales that support the conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness. The rejections include a clear articulation of the reason(s), including approved rationales, why the claimed invention would have been obvious.
Therefore, Applicant’s arguments are not persuasive with respect to the pending rejections under 35 USC 103.
Maintained Double Patenting Rejection
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, 3-12, 19-21, 60, 61, 63, 64, 74, 77, 79, 81-82, 84, 86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,549,110. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader in scope than the claims of the ‘110 patent. Since broader genus claims are anticipated by the narrower species they encompass, the instant claims are anticipated by the claims of the ‘110 patent.
Response to Arguments
With respect to the non-statutory double patenting rejection, Applicant's arguments have been fully considered but they are not persuasive. Applicant argues that the rejection does not provide the required substantive analysis. It is noted that MPEP 804 states:
Nonstatutory double patenting includes rejections based on anticipation, a one-way determination of "obviousness," or a two-way determination of "obviousness." It is important to note that the "obviousness" analysis for "obviousness-type" double-patenting is "similar to, but not necessarily the same as, that undertaken under 35 U.S.C. 103." In re Braat, 937 F.2d 589, 592-93, 19 USPQ2d 1289, 1292 (Fed. Cir. 1991) (citing In re Longi, 759 F.2d 887, 892 n.4, 225 USPQ 645, 648 n.4 (Fed. Cir. 1985))…
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)…
MPEP 804 II. B. 2. Anticipation analysis states:
A nonstatutory double patenting rejection is appropriate where a claim in an application under examination claims subject matter that is different, but not patentably distinct, from the subject matter claimed in a prior patent or a copending application. The claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by 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, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993). This type of nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim. In such a situation, a later patent to a genus would, necessarily, extend the right to exclude granted by an earlier patent directed to a species or sub-genus. In this type of nonstatutory double patenting situation, an obviousness analysis is not required for the nonstatutory double patenting rejection. The nonstatutory double patenting rejection in this case should explain the fact that the species or sub-genus claimed in the conflicting patent or application anticipates the claimed genus in the application being examined and, therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus.
Such is that case here, where the instant claims are broader in scope than the claims of the ‘110 patent, as indicated in the rejection. Since broader genus claims are anticipated by the narrower species they encompass, the instant claims are anticipated by the claims of the ‘110 patent. In this type of nonstatutory double patenting situation, an obviousness analysis is not required for the nonstatutory double patenting rejection, as indicated in MPEP 804.
Therefore, the rejection is appropriate and Applicants’ arguments are not persuasive.
Conclusion
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 J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL, Ph.D./Primary Examiner, Art Unit 1637
Prosecution Insights