DETAILED ACTION
Applicant’s amendment and response received on 4/13/26 has been entered. Claims 6-14 have been canceled. Claims 1-5 are currently pending and under examination in this application. The present application is being examined under the pre-AIA first to invent provisions. An action on the merits follows.
Those sections of Title 35, US code, not included in this action can be found in a previous office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/22/26 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statement has been considered by the examiner, and an initialed and signed copy of the 1449 is attached to this action.
Claim Rejections - 35 USC § 112
The rejection of claims 6-14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention, is withdrawn in view of the cancellation of these claims.
The rejection of claims 1-14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for scope of enablement is withdrawn over canceled claims 6-14 and maintained in modified form over amended claims 1-5. Applicant’s amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the modified grounds of rejection set forth below.
Based on the claims as currently amended, the following scope of enablement has been identified: the specification, while being enabling for a process of producing a B cell that produces an antibody that binds to a desired antigen, wherein the process comprises isolating a B cell from a transgenic murine animal that has been immunized to generate an immune response against the antigen, wherein the genome of said animal comprises: (1) a transgene comprising a single human immunoglobulin light chain V gene segment fused to a single human immunoglobulin light chain J gene segment, which transgene encodes a rearranged immunoglobulin light chain variable region, wherein the transgene lacks a regulatory element that contributes to somatic hypermutation of the light chain variable region; and wherein:(i) the transgene comprises a nucleic acid sequence encoding an immunoglobulin light chain constant region, or (ii) the variable region of the transgene is operably linked to an endogenous immunoglobulin light chain constant region gene segment; and (2) an immunoglobulin locus of a heavy chain, wherein the locus is capable of forming a diversity of heavy chain variable regions, does not reasonably provide enablement for said process where the antibody producing B cell is isolated from a transgenic avian animal wherein the transgene lacks a regulatory element that contributes to somatic hypermutation of the light chain variable region in the transgenic avian. 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 or use the invention commensurate in scope with these claims.
The claims were previously limited to B cells isolated from a transgenic murine animal. Independent claim 1 has been amended to recite: a process for producing a B cell that produces an antibody that binds to a desired antigen, wherein the process comprises isolating a B cell from a transgenic murine or avian animal that has been immunized to generate an immune response against the antigen, wherein the genome of said animal comprises: (1) a transgene comprising a single human immunoglobulin light chain V gene segment fused to a single human immunoglobulin light chain J gene segment, which transgene encodes a rearranged immunoglobulin light chain variable region, wherein the transgene lacks a regulatory element that contributes to somatic hypermutation of the light chain variable region; and wherein:(i) the transgene comprises a nucleic acid sequence encoding an immunoglobulin light chain constant region, or (ii) the variable region of the transgene is operably linked to an endogenous immunoglobulin light chain constant region gene segment; and (2) an immunoglobulin locus of a heavy chain, wherein the locus is capable of forming a diversity of heavy chain variable regions.
It is noted that applicant’s amendments and arguments have overcome previously raised issues related to genomic modification in murine animals other than mice. However, the rejection of record is maintained in modified form over generating transgenic avian animals whose genome comprises the claimed transgene, particularly at the endogenous avian light chain locus, where the transgene is expressed and the avian produces antibodies comprising a light chain comprising the transgene encoded human light chain variable region and a diversity of endogenous heavy chains. The claims as amended further raise the issue of the lack of enabling disclosure regarding regulatory elements that contributes to somatic hypermutation of the light chain variable region in an avian.
In regards to the enablement for making transgenic avians and particularly avians with site-specific insertions of a transgene into a particular locus, the applicant argues that it was recognized in the prior art that transgenic avians were possible including germ line transmission of transgenes, citing Scott and Lois. The applicant also argues that ES cells that can colonize the germ line of animals other than mice were reported by a number of groups, citing abstracts by Li et al., Buehr et al., and Ueda et al. In response, none of references cited- Scott and Lois, Li et al., Buehr et al., or Ueda et al.- were provided with the instant response or cited in an IDS. As such, the teachings of these references could not be evaluated. It is also noted that several of the references- Li et al., and Buehr et al.- were cited by the applicant as having been published December 26, 2008, which is months after the effective filing date of 6/27/2008. As such, neither of these two references appear to teach the state of the prior art at the time of filing. For these reasons, applicant’s arguments based on these references have not been found persuasive.
In regards to the generation of B cells expressing antibody specific antibodies comprising a light chain comprising the human rearranged light chain variable region encoded by the transgene and an endogenous heavy chain in transgenic immunized avians as currently claimed, the applicant argues that Flajnik et al., cited in the rejection of record, recognized fundamental structural and functional similarities of the claimed transgenic and avian animals. According to applicant, Flajnik et al. states that birds, humans, and mice all have immunoglobulin loci comprising V, D, and J gene segments, even if they differ in the number of individual segments and relative utilization of VDJ rearrangement and somatic mutation. The applicant states that the rejection of record does not identify why the skilled artisan would not reasonable conclude that the human and avian sequences would pair. In response, the rejection of record stated that the specification only provides specific guidance for generating transgenic mice, and further provides specific guidance for transgenes comprising a single human V gene segment fused to a single J gene segment and encoding a single rearranged human light chain variable region and wherein the rearranged V-J genes are operably linked either to a constant region present in the transgene, or are site-specifically inserted into the mouse genome into the kappa light chain locus such that the V-J sequence present in the transgene is operably linked to the endogenous kappa light chain constant region gene. The specification clearly teaches that the purpose of the transgenic non-human animals, specifically mice, is the generation of human/humanized antibodies. The specification discloses that other non-human mammals may be generated, including avines, but provides no specific guidance for preparing a transgenic avine. The word avine only appears once in the specification in paragraph 17. The working examples are limited to the generation and use of transgenic mice whose genome comprises a transgene encoding a single rearranged human kappa V gene segment where the transgene comprises a human IGVK1-39 gene sequence fused to a human JK gene segment and operably linked to a murine constant region gene, where the transgene lacks the MoEki enhancer and/or contains a truncated mouse 3’ kappa enhancer, where the transgene has been inserted into a mouse ES cell which is then implanted into a surrogate female mouse. Regarding regulatory elements that contribute to somatic hypermutation, the specification only discloses the mouse MoEki enhancer and a mouse 3’ kappa enhancer, and further only teaches and demonstrates that lack of the mouse intronic enhance (MoEki enhancer) and/or the present of a truncated mouse 3’ kappa enhancer can affect somatic hypermutation. The specification does not teach that these same regulatory elements are present in the avine light chain immunoglobulin locus, or that any such sequences present in avines have the same function in regards to somatic hypermutation as they have in mice. Thus, the specification, while broadly teaching the generation of non-human animals, including an avine, provides no specific guidance for generating a targeted insertion into the genome of an avine, and further does not disclose regulatory elements that contribute to somatic hypermutation in avians (avines).
In addition, the rejection of record pointed out that at the time of filing it was well known that not all animal species share the same or equivalent immunoglobulin loci structure or functions. Flajnik et al., for example, teaches that there are substantial differences in antibody loci structure, the classes and structure of antibody generated, and the mechanism of producing antibody diversity between placental mammals, avians, amphibians, and various fish (Flajnik et al. (2002) Nat. Rev., Vol. 2, 688-698). While applicant is correct that Flajnik does teach that many animals including chickens (avians), mice, and humans have V, (D),and J gene segments, Flajnik further teaches that in contrast to humans and mice which utilize gene rearrangement of light chain locus comprising multiple V gene segments and multiple J gene segments followed by somatic hypermutation to diversify the light chain loci, the avian light chain locus comprises only a single functional V gene segments and a single function J gene segment and utilizes a completely different mechanism for generating antibody diversity which involves gene conversion between multiple V pseudogenes and the single functional V gene segment (see Flajnik, Box 1, Table I). Flajnik et al. teaches:
[s]o, in contrast to the human and mouse models, in which B cells are generated throughout life in the bone marrow, chicken B cells (and most probably B cells in all GALT species) seed secondary lymphoid tissues early in life, after which time the primary lymphoid tissue degenerates (FIG. 2 and TABLE 1).There is only a single functional V gene that rearranges at chicken heavy- and light-chain loci (chickens have only one light chain of the λ type) in developing B cells, which is modified by gene conversion by upstream V pseudogenes (Flajnik et al., page 690)
Flajnik et al. also states: “[t]he V(D)J-recombination events that occur in chicken B cells do not create diversity as in mouse and human B cells but, instead, provide the substrate for subsequent gene-conversion events that create the antibody repertoire” (Flajnik et l., page 690). Thus, contrary to applicant’s argument, Flajnik et al. identifies substantial differences between the immunoglobulin loci in mice and humans, versus avians such as chickens, and the methods in which antibody diversity is generated in these animals. Furthermore, in regards to regulatory elements associated with somatic hypermutation, Flajnik et al. teaches that the mechanism and components required for gene conversion and/or hypermutation were still being elucidated (Flajnik et al., page 694). Blagodatski et al. states in 2009, several months after the effective filing date, that they were searching for the elusive cis-acting hypermutation control sequence in the chicken IgL locus (Blagodatski et al. (2009) PloS Genet., Vol. 5(1): e100332 doi:10.1371/journal.pgen.1000332, pages 1-11). Thus, at the time of filing, not only were the substantial mechanistic differences between antibody production in avians versus mice and humans well known, but the regulatory elements required and associated with somatic hypermutation in chickens were yet to be identified.
Therefore, it is maintained that due to the art recognized substantial differences in Ig loci and diversity generation between humans and mice, and avians, the lack of specific guidance in the specification for inserting transgenes into the genomes of animals other than mice, the lack of guidance in the specification and in the art at the time of filing regarding regulatory elements associated with somatic hypermutation in chickens, the limitation of the working examples to the generation of knock-in transgenic mice using mouse ES cells, and the breadth of the claims, it would have required undue experimentation to make and use the scope of the methods of producing an antigen specific antibody expressing B cell as claimed where the transgenic animal is a transgenic avian.
Claim Rejections - 35 USC § 102
The rejection of claims 6-14 under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent Application Publication 2006/0015957 (2006), hereafter referred to as Lonberg '957, is withdrawn in view of the cancellation of these claims.
Claim Rejections - 35 USC § 103
The rejection of claims 6-14 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication 2006/0015957 (2006), hereafter referred to as Lonberg '957, in view of WO 02/066,630 (2002), hereafter referred to as Murphy et al., is withdrawn in view of the cancellation of these claims.
Double Patenting
The rejection of claims 1-7 and 9-14 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,944,695, hereafter referred to as the ‘695 patent claims, is withdrawn over canceled claims 6-7 and 9-14, and maintained over amended claims 1-5. Applicant’s amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
The applicant argues that claims 1-5 are entitled to the benefit of the safe harbor provision of 35 U.S.C. 120 relative to each of the cited claims. According to applicant, there was an original restriction requirement made in application 12/589,181 which recited eight different inventions. The applicant argues that the parent application to this application, 15/870,647 was filed as divisional of the 12/589,181 application with claims directed to Group VII of the restriction requirement made I the 12/589,181 application. The applicant states that this application is a divisional application of the 15/870,647 application and is also dawn to the subject matter of Group VII and therefore is protected by the safe harbor provision of 35 U.S.C. 120 from a non-statutory double patenting rejection over the claims of the 9,944,596 patent since the 14/266,540 application is also a divisional application of the 12/589,181 application and contains claims drawn to a different group identified in the 12/589,181 restriction.
In response, it is first noted that the safe harbor provision is not provided by 35 U.S.C. 120 as repeatedly argued by the applicant. Instead, it is 35 U.S.C. 121 which provides the “safe harbor” protection against non-statutory double patenting under specific circumstances. See 35 U.S.C. 121, and MPEP 804.01. Second, it is noted that the instant application, while identified as divisional of parent application 15/870,647, is not a true divisional application since the restriction requirement made in the 15/870,647 application was directed to different claims and different inventions than that claimed in the instant application, which are also different from the claims and inventions set forth and restricted in the 12/589,181 application. The subject matter of the instant claims was neither claimed in the 15/870,647 application, nor restricted in the restriction requirement made in the 15/870,647 application. In other words, the instant claims do not correspond to either Group I or Group II identified in the restriction requirement made in the 15/870,647 application. Further, contrary to applicant’s arguments, none of the claims in the 15/870,647 application correspond to Group VII or any other group identified in the restriction requirement made in the 12/589,181 application. For the record, the claims of the 12/589,181 application did not include claims to the B cell products recited in the claims of the 15/870,647 application, nor did the claims of the 12/589,181 application include claims to the methods of producing a antibody comprising either culture of an isolated B cell, or isolation of nucleic acids from an isolated B cell as recited in the 15/870,657 claims. Group VII of the restriction requirement made in the 12/589,181 application listed Group VII as claim 41 drawn to a process for producing a cell, the process comprising isolating a cell from the transgenic animal of claim 1 where the isolated cell comprises a heavy or light chain encoding sequence together with a means for rendering the heavy or light chain encoding sequence resistant to DNA rearrangements and/or somatic hypermutation. The transgenic animal of claim 1 of the 12/589,181 application was not immunized, and the invention of Group VII does not recite the same method step as recited in the instant methods which recite a step of isolating a B cell that produces an antibody that binding to an antigen from an immunized transgenic murine or avian animal. As such, the claims of the instant application do not correspond to any of the groups listed in the restriction requirement made in the 15/870,657 application or the 12/589,181 application. Therefore, the instant claims do not in fact qualify for the safe harbor provisions of 35 U.S.C. 121. In particular, note the following guidance in MPEP 804.01 regarding where the prohibition against a nonstatutory double patenting rejection does not apply:
The following are situations where the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply:
(A) The applicant voluntarily files two or more applications without a restriction requirement by the examiner. In order to obtain the benefit of 35 U.S.C. 121, claims must be formally entered, restricted in, and removed from an earlier application before they are filed in a divisional application . Geneva Pharms. Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1379, 68 USPQ2d 1865, 1870 (Fed. Cir. 2003) (For claims that were not in the original application and are first formally entered in a later divisional application, 35 U.S.C. 121 "does not suggest that the original application merely needs to provide some support for claims that are first entered formally in the later divisional application." Id.); In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968).
(emphasis added by examiner)
(B) The claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made. For example, the divisional application filed includes additional claims not consonant in scope with the original claims subject to restriction in the parent. Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569, 19 USPQ2d 1241 (Fed. Cir. 1991); Gerber Garment Technology, Inc. v. Lectra Systems, Inc., 916 F.2d 683, 16 USPQ2d 1436 (Fed. Cir. 1990). In order for consonance to exist, the line of demarcation between the independent and distinct inventions identified by the examiner in the requirement for restriction must be maintained. 916 F.2d at 688, 16 USPQ2d 1440 (emphasis added by examiner)
Therefore, for the reason set forth above, the rejection of record over claims 1-5 stands.
The rejection of claims 1-7, and 9-14 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9,951,124, hereafter referred to as the ‘124 patent claims, is withdrawn over canceled claims 6-7 and 9-14, and maintained over amended claims 1-5. Applicant’s amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
The applicant argues that claims 1-5 are entitled to the benefit of the safe harbor provision of 35 U.S.C. 120 relative to each of the cited claims. According to applicant, there was an original restriction requirement made in application 12/589,181 which recited eight different inventions. The applicant argues that the parent application to this application, 15/870,647 was filed as divisional of the 12/589,181 application with claims directed to Group VII of the restriction requirement made I the 12/589,181 application. The applicant states that this application is a divisional application of the 15/870,647 application and is also drawn to the subject matter of Group VII and therefore is protected by the safe harbor provision of 35 U.S.C. 120 from a non-statutory double patenting rejection over the claims of the 9,951,124 patent since the 13/750,753 application is a continuation application of the 12/589,181 application and contains claims drawn to a different group identified in the 12/589,181 restriction.
In response, it is first noted that the safe harbor provision is not provided by 35 U.S.C. 120 as repeatedly argued by the applicant. Instead, it is 35 U.S.C. 121 which provides the “safe harbor” protection against non-statutory double patenting under specific circumstances. See 35 U.S.C. 121, and MPEP 804.01. Second, it is noted that the instant application, while identified as divisional of parent application 15/870,647, is not a true divisional application since the restriction requirement made in the 15/870,647 application was directed to different claims and different inventions than that claimed in the instant application, which are also different from the claims and inventions set forth and restricted in the 12/589,181 application. The subject matter of the instant claims was neither claimed in the 15/870,647 application, nor restricted in the restriction requirement made in the 15/870,647 application. In other words, the instant claims do not correspond to either Group I or Group II identified in the restriction requirement made in the 15/870,647 application. Further, contrary to applicant’s arguments, none of the claims in the 15/870,647 application correspond to Group VII or any other group identified in the restriction requirement made in the 12/589,181 application. For the record, the claims of the 12/589,181 application did not include claims to the B cell products recited in the claims of the 15/870,647 application, nor did the claims of the 12/589,181 application include claims to the methods of producing a antibody comprising either culture of an isolated B cell, or isolation of nucleic acids from an isolated B cell as recited in the 15/870,657 claims. Group VII of the restriction requirement made in the 12/589,181 application listed Group VII as claim 41 drawn to a process for producing a cell, the process comprising isolating a cell from the transgenic animal of claim 1 where the isolated cell comprises a heavy or light chain encoding sequence together with a means for rendering the heavy or light chain encoding sequence resistant to DNA rearrangements and/or somatic hypermutation. The transgenic animal of claim 1 of the 12/589,181 application was not immunized, and the invention of Group VII does not recite the same method step as recited in the instant methods which recite a step of isolating a B cell that produces an antibody that binding to an antigen from an immunized transgenic murine or avian animal. As such, the claims of the instant application do not correspond to any of the groups listed in the restriction requirement made in the 15/870,657 application or the 12/589,181 application. Therefore, the instant claims do not in fact qualify for the safe harbor provisions of 35 U.S.C. 121. In particular, note the following guidance in MPEP 804.01 regarding where the prohibition against a nonstatutory double patenting rejection does not apply:
The following are situations where the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply:
(A) The applicant voluntarily files two or more applications without a restriction requirement by the examiner. In order to obtain the benefit of 35 U.S.C. 121, claims must be formally entered, restricted in, and removed from an earlier application before they are filed in a divisional application . Geneva Pharms. Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1379, 68 USPQ2d 1865, 1870 (Fed. Cir. 2003) (For claims that were not in the original application and are first formally entered in a later divisional application, 35 U.S.C. 121 "does not suggest that the original application merely needs to provide some support for claims that are first entered formally in the later divisional application." Id.); In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968).
(emphasis added by examiner)
(B) The claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made. For example, the divisional application filed includes additional claims not consonant in scope with the original claims subject to restriction in the parent. Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569, 19 USPQ2d 1241 (Fed. Cir. 1991); Gerber Garment Technology, Inc. v. Lectra Systems, Inc., 916 F.2d 683, 16 USPQ2d 1436 (Fed. Cir. 1990). In order for consonance to exist, the line of demarcation between the independent and distinct inventions identified by the examiner in the requirement for restriction must be maintained. 916 F.2d at 688, 16 USPQ2d 1440 (emphasis added by examiner)
Therefore, for the reason set forth above, the rejection of record over claims 1-5 stands.
The rejection of claims 1-7 and 9-14 on the ground of nonstatutory double patenting as being unpatentable over 1) claims 1-14 of U.S. Patent No. 10,966,411, hereafter referred to as the ‘411 patent, OR 2) claims 1-7 of U.S. Patent No. 11,559,049, hereafter referred to as the ‘049 patent, OR 3) claims 1-5 of U.S. Patent No. 9,765,133, hereafter referred to as the ‘133 patent, OR 4) claims 1-6 of U.S. Patent No. 11,925,174, hereafter referred to as the ‘174 patent, in view of U.S. Patent Application Publication 2006/0015957 (2006), hereafter referred to as Lonberg '957, is withdrawn over canceled claims 6-7 and 9-14, and maintained over amended claims 1-5. Applicant’s amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
The applicant argues that claims 1-5 are entitled to the benefit of the safe harbor provision of 35 U.S.C. 120 relative to each of the cited claims. According to applicant, there was an original restriction requirement made in application 12/589,181 which recited eight different inventions. The applicant argues that the parent application to this application, 15/870,647 was filed as divisional of the 12/589,181 application with claims directed to Group VII of the restriction requirement made I the 12/589,181 application. The applicant states that this application is a divisional application of the 15/870,647 application and is also drawn to the subject matter of Group VII and therefore is protected by the safe harbor provision of 35 U.S.C. 120 from a non-statutory double patenting rejection over the claims of the ‘411, ‘049, ‘133, and ‘174 patents contains claims drawn to a different group identified in the 12/589,181 restriction.
In response, it is first noted that the safe harbor provision is not provided by 35 U.S.C. 120 as repeatedly argued by the applicant. Instead, it is 35 U.S.C. 121 which provides the “safe harbor” protection against non-statutory double patenting under specific circumstances. See 35 U.S.C. 121, and MPEP 804.01. Second, it is noted that the instant application, while identified as divisional of parent application 15/870,647, is not a true divisional application since the restriction requirement made in the 15/870,647 application was directed to different claims and different inventions than that claimed in the instant application, which are also different from the claims and inventions set forth and restricted in the 12/589,181 application. The subject matter of the instant claims was neither claimed in the 15/870,647 application, nor restricted in the restriction requirement made in the 15/870,647 application. In other words, the instant claims do not correspond to either Group I or Group II identified in the restriction requirement made in the 15/870,647 application. Further, contrary to applicant’s arguments, none of the claims in the 15/870,647 application correspond to Group VII or any other group identified in the restriction requirement made in the 12/589,181 application. For the record, the claims of the 12/589,181 application did not include claims to the B cell products recited in the claims of the 15/870,647 application, nor did the claims of the 12/589,181 application include claims to the methods of producing a antibody comprising either culture of an isolated B cell, or isolation of nucleic acids from an isolated B cell as recited in the 15/870,657 claims. Group VII of the restriction requirement made in the 12/589,181 application listed Group VII as claim 41 drawn to a process for producing a cell, the process comprising isolating a cell from the transgenic animal of claim 1 where the isolated cell comprises a heavy or light chain encoding sequence together with a means for rendering the heavy or light chain encoding sequence resistant to DNA rearrangements and/or somatic hypermutation. The transgenic animal of claim 1 of the 12/589,181 application was not immunized, and the invention of Group VII does not recite the same method step as recited in the instant methods which recite a step of isolating a B cell that produces an antibody that binding to an antigen from an immunized transgenic murine or avian animal. As such, the claims of the instant application do not correspond to any of the groups listed in the restriction requirement made in the 15/870,657 application or the 12/589,181 application. Therefore, the instant claims do not in fact qualify for the safe harbor provisions of 35 U.S.C. 121. In particular, note the following guidance in MPEP 804.01 regarding where the prohibition against a nonstatutory double patenting rejection does not apply:
The following are situations where the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply:
(A) The applicant voluntarily files two or more applications without a restriction requirement by the examiner. In order to obtain the benefit of 35 U.S.C. 121, claims must be formally entered, restricted in, and removed from an earlier application before they are filed in a divisional application . Geneva Pharms. Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1379, 68 USPQ2d 1865, 1870 (Fed. Cir. 2003) (For claims that were not in the original application and are first formally entered in a later divisional application, 35 U.S.C. 121 "does not suggest that the original application merely needs to provide some support for claims that are first entered formally in the later divisional application." Id.); In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968).
(emphasis added by examiner)
(B) The claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made. For example, the divisional application filed includes additional claims not consonant in scope with the original claims subject to restriction in the parent. Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569, 19 USPQ2d 1241 (Fed. Cir. 1991); Gerber Garment Technology, Inc. v. Lectra Systems, Inc., 916 F.2d 683, 16 USPQ2d 1436 (Fed. Cir. 1990). In order for consonance to exist, the line of demarcation between the independent and distinct inventions identified by the examiner in the requirement for restriction must be maintained. 916 F.2d at 688, 16 USPQ2d 1440 (emphasis added by examiner)
Therefore, for the reason set forth above, the rejection of record over claims 1-5 stands.
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 from the examiner should be directed to Anne Marie S. Wehbé, Ph.D., whose telephone number is (571) 272-0737. If the examiner is not available, the examiner’s supervisor, Maria Leavitt, can be reached at (571) 272-1085. For all official communications, the technology center fax number is (571) 273-8300. Please note that all official communications and responses sent by fax must be directed to the technology center fax number. For informal, non-official communications only, the examiner’s direct fax number is (571) 273-0737. For any inquiry of a general nature, please call (571) 272-0547.
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Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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