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
Election/Restrictions
Applicant's election without traverse of the species of a hairpin polyamide from claim 153 and a PRC2 binder from claim 156 in the reply filed on 09/30/2025 is acknowledged.
Status of the Application
Claims 152-155 and 157-168 are pending and are currently under examination.
Information Disclosure Statement
The submission of the Information Disclosure Statement on 12/15/2022 is in compliance with 37 CFR 1.97. The information disclosure statement has been considered by the examiner and signed copies have been placed in the file.
Claim Rejections – Improper Markush
Claims 153 and 155 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and a common use that flows from the substantial structural feature for the following reasons: The claims are directed to a large multitude of different polyamide structures and protein binding amino acid sequences. Although the polyamide are DNA binding moieties, they do not share any significant structural similarity. Likewise, although the protein binding moieties are made of amino acids, they do not share any significant sequence similarity.
When the Markush grouping is for alternatives of chemical compounds, they shall be regarded as being of a similar nature where the following criteria are fulfilled:
(A) All alternatives have a common property or activity; and
(B) (1) A common structure is present, i.e., a significant structural element is shared by all of the alternatives; or
(B) (2) In cases where the common structure cannot be the unifying criteria, all alternatives belong to a recognized class of chemical compounds in the art to which the invention pertains.
In paragraph (B)(1), above, the words “significant structural element is shared by all of the alternatives” refer to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity. The structural element may be a single component or a combination of individual components linked together.
In paragraph (B)(2), above, the words “recognized class of chemical compounds” mean that there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved.
In order for the members of the Markush group to belong to “recognized class of chemical compounds” there must be an expectation that the members of the class will behave in the same way in the context of the claimed invention. In other words, each member of the class could be substituted one for the other with the expectation that the same intended result would be achieved. In the instant case, activity of any specific DNA binding moiety is dependent upon the specific type and structure and any protein binding moiety is depended on the specific amino acid sequence. There is no expectation that any one of the DNA binding moieties or protein biding moieties as claimed can be substituted for any of the other with the expectation of the same activity.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. 134 and 37 CFR 41.31(a)(1).
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 152-154 and 160-168 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ansari et al. (WO 2017172914 of record IDS 12/15/2022), Melander et al. (US 2006270727 of record IDS 12/15/2022), Will et al. (US 20170166953), JP 2016108249 (hereinafter JP249 of record IDS 12/15/2022), Teive et al. ("Spinocerebellar ataxia type 10–a review." Parkinsonism & related disorders 17.9 (2011): 655-661) and Ishige et al. ("Pentanucleotide repeat-primed PCR for genetic diagnosis of spinocerebellar ataxia type 31." Journal of human genetics 57.12 (2012): 807-808).
Regarding claim 152, Ansari et al. teach methods of modulating expression of a gene comprising a repeat sequence GAA using an agent comprising a first terminus comprising DNA-binding polyamide that binds to the repeat sequence and is linked to an oligomeric backbone that is linked to a second terminus comprising a protein-binding moiety (0004-0006). Ansari et al. teach the methods of modulation is a decrease in transcription (0135).
Regarding claim 154, Ansari et al. teach the repeat sequence comprises at least 30 to 200 repeats (see 0012).
Regarding claim 161, Ansari et al. teach the linker has about 10 to 50 atoms (0052-0053).
Ansari et al. do not teach targeting a TGGAA repeat sequence, the DNA-binding moiety is a hairpin polyamide, the linker has a length measured in angstroms, the gene is BEAN and methods of treating a disease mediated a TGGAA repeat sequence in BEAN such as spinocerebellar ataxia type 31 (SCA13).
Regarding claims 153, Melander et al. teach polyamide DNA binding moieties that bind DNA repeat sequences that cause disease to modulate transcription of a gene (see 0004-0008, 0013). Melander et al. teach the target gene can be a neurological gene such as SCA8, SCA10 and SCA12 which are associated with spinocerebellar ataxia (0016). Melander et al. teach the polyamide is a hairpin polyamide (0065).
Regarding claim 160, Will et al. teach using linkers that are measured in angstroms of less than about 50 angstroms that join two moieties together (0059).
Regarding claims 162-168, JP249 teach spinocerebellar ataxia type 31 (SCA31) is caused by a repeat sequence UGGAA (0007). JP249 teach UGGAA expressed with a binding protein TDP-43 or FUS/TLS caused inhibitory effects which are based on the fact that these RNA-binding proteins function as RNA chaperones to inhibit abnormal aggregation of UGGAA and it has been found that by inhibiting structural abnormalities of RNA, which are thought to be the cause of the onset of SCA31, toxicities can be greatly reduced, thereby exhibiting therapeutic effects (0009). JP249 teach spinocerebellar degeneration is one of intractable neurological diseases for which there is currently no cure, and it is said that there are about 30000 sufferers in Japan. When affected, ataxia symptoms appear due to impairment of the function of the cerebellum and the brain related thereto, and the disease often progresses in several years and becomes unable to walk (0002).
Teive et al. teach autosomal dominant cerebellar ataxias, currently collectively known as spinocerebellar ataxias (SCAs), represent a heterogeneous group of neurodegenerative disorders primarily affecting the cerebellum and both its afferent and efferent connections, particularly brainstem, and spinal cord (introduction page 655). Teive et al. teach SCA10 is caused by an expansion composed of ATTCT pentanucleotide repeats, localized in intron 9 of the ATXN10 gene on chromosome 22q13.1 and teach classical clinical findings of SCAs are progressive gait and limb cerebellar ataxia, associated with nystagmus, dysarthria, and ophthalmoparesis (introduction page 655). SCA10 and SCA31, a new SCA subtype recently described in Japan, are the only human diseases known to be caused by pentanucleotide repeat mutations, ATTCT repeat expansion in SCA10 and TGGAA repeat insertion in SCA31 (see page 656 para, 2).
Ishige et al. teach SCA31 is associated with the NEDDA (BEAN) gene on chromosome 16q22 (page 807).
It would have been obvious to one of ordinary skill in the art to use the method of Ansari et al. to target a TGGAA repeat sequence to modulate expression of the BEAN gene in methods of treating a disease mediated by TGGAA such as SCA31. It would have been obvious to try given there is a need because there is no cure for spinocerebellar ataxias as taught by JP249, Ansari et al. teach an efficient method for targeting pentanucleotide repeat sequences of spinocerebellar ataxias and Teive et al. teach only two spinocerebellar ataxias, SCA10 and SCA31, are the only human diseases known to be caused by pentanucleotide repeat mutations. Further it would have been obvious to use an oligonucleotide linker to connect the first and second terminus wherein the linker is measure in angstroms or chain atoms which are known in the art to measure linker length. Teive et al. teach SCAs cause degeneration of the cerebellum and decreased movements of limbs and one would have expected treatment would improve these symptoms. Furthermore, given there was a finite number of diseases known to be caused by pentanucleotide repeat mutations, one of skill in the art would have had good reason to pursue this method of modulating transcription to decrease BEAN transcription.
With respect to claim 168 having the limitation of a percent decrease in expression of BEAN in the range of 20-99%, it would have been obvious after making the claimed agent to test the agent for activity to ensure the modulation of transcription of the BEAN gene occurs. See MPEP §2144.05: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." Moreover, it would have been obvious to test for an optimal amount of inhibition of transcription of BEAN for methods of treating spinocerebellar ataxia type 31. “[C]onducting clinical trials to test for an optimal dose for a drug ‘is generally a routine process[‘].” Eli Lilly and Co. v. Teva Pharmaceuticals USA, Inc., 619 F.3d 1329, 1342 (Fed. Cir. 2010). “In Mayo, the application of the natural law was merely routine optimization of drug dosage to maximize therapeutic effect.” Ariosa Dignostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1293 (Fed. Cir. 2015) (Dyk, J., concurring).
Lastly, there is an expectation of an advantage for using the method of Ansari et al. to make the claimed agent for modulating expression of a gene comprising a repeat sequence TGGAA wherein said agent comprises a first terminus comprising DNA-binding polyamide that binds to the repeat sequence and is linked to an oligomeric backbone that is linked to a second terminus comprising a protein-binding moiety and thus a motivation to combine the prior art references (see MPEP 2144). Conclusive proof of efficacy is not required to show a reasonable expectation of success and obviousness does not require absolute predictability, but at least some degree of predictability is required (MPEP 2143.02).
Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 152-155 and 157-168 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification,
while being enabling for providing guidance on identifying DNA-binding moieties, identifying pentanucleotide repeat sequences and describing types of oligomeric backbones,
does not reasonably provide enablement for making the claimed agent having a first terminus, a second terminus and an oligomeric backbone that is capable of modulating transcription of any gene. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
In the analysis of determining whether the instant specification provides an enabling disclosure, the Examiner did not find any direction provided by Applicant that would enable the claimed invention. A person of skill while reading the instant specification would not be capable of making and using the claimed invention based on the lack of direction provided by Applicant because Applicant has not described any agent as claimed that modulates transcription of any gene.
The following factors have been considered in the analysis of enablement: (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims and nature of the invention:
The claims are drawn to methods for modulating transcription of any gene comprising a pentanucleotide repeat sequence TGGAA comprising and agent comprising a first terminus comprising a DNA binding moiety, a second terminus comprising any protein-binding moiety and a oligomeric backbone linker linking the first and second terminus. The nature of the invention relies broadly on modulating any transcription of gene comprising a repeat sequence of TGGAA using any DNA binding moiety polyamide and any type of protein binding moiety and further treating any disease mediated by transcription of a BEAN gene comprising TGGAA.
Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.
The state of the prior art:
The prior art describes methods of modulating expression of a gene comprising a repeat sequence GAA using an agent comprising a first terminus comprising DNA-binding polyamide that binds to the repeat sequence in frataxin FXN gene and is linked to an oligomeric backbone that is linked to a second terminus comprising a protein-binding moiety (0004-0006) (see Ansari et al. cited above). The prior art describes spinocerebellar ataxia type 31 (SCA31) is caused by a repeat sequence UGGAA (0007). JP249 teach UGGAA expressed with a binding protein TDP-43 or FUS/TLS caused inhibitory effects and SCA31 is associated with the NEDDA (BEAN) gene on chromosome 16q22 as cited by Teive et al. and Ishige et al. above.
A review of the prior art does not provide a correlation between administration of the agent taught by Ansari et al. and the claimed agent having a first terminus DNA binding moiety, a second terminus and an oligomeric backbone along with any protein binding moiety and modulation of any transcript of a gene comprising TGGAA repeat sequence wherein the agent modulates (upregulation or downregulation) expression of any gene and treatment of any disease mediated by transcription of a BEAN gene.
The level of one of ordinary skill:
While the level of one of ordinary skill practicing said invention would be high, the level of predictability is considered variable as evident in the prior art discussed above and is not considered to provide sufficient enablement to practice the claimed invention.
Because the state of the prior art does not provide evidence of the degree of predictability that methods for modulating any gene comprising a repeat sequence TGGAA and protein binding moiety using the claimed agent or provide evidence for treatment of any disease, one of ordinary skill in the art would look for guidance or direction in the instant specification.
The level of predictability in the art:
“The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.” (MPEP 2164.03). In this instance, one of skill cannot predict the outcome of modulation of any gene comprising TGGAA using the agent and any protein binding moiety and methods of treatment of any disease.
The amount of direction provided by the inventor:
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004).
The existence of working examples:
The instant disclosure does not describe any embodiments of the claimed method. The disclosure describes many different types of a first terminus, a second terminus and an oligomeric linker but does not describe using any combination of components in an agent to modulate expression of any gene or treat any disease such as SCA13.
The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant invention suggests modulation of any gene comprising a TGGAA repeat sequence and treatment of any disease mediated by expression of a BEAN gene comprising this repeat sequence without an enabling disclosure or guidance in the prior art.
While the MPEP 2164.02 states the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970), the lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The prior art is undeveloped for the role a TGGAA repeat sequence has in any gene or the role expression of a BEAN gene comprising this repeat sequence has in mediating any disease. The specification does not provide sufficient guidance for these methods and without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
Written Description
Claims 152-155 and 157-168 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966; Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial Structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed structure, and v. Correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art.
Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species by “…disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between functional and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Thus when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The claims are drawn to a genus of genes composing a pentanucleotide repeat sequence TGGAA, a genus of agents comprising a DNA binding moiety, a second terminus comprising any protein-binding moiety or excludes the moieties in claims 157-158 and oligomeric backbone linker sequences linking the first and second terminus with the function of modulating transcription of any gene and treating any disease mediated by expression of a BEAN gene comprising the repeat sequence.
The specification does not describe any agent broadly comprising the claimed components with the function as discussed above. The prior art describes a DNA-binding polyamide that binds to the repeat sequence GAA and is linked to an oligomeric backbone that is linked to a second terminus comprising a protein-binding moiety (0004-0006) wherein the methods of modulation is a decrease in transcription (0135) (see Ansari et al. cited above). The prior art describes spinocerebellar ataxia type 31 (SCA31) is caused by a repeat sequence UGGAA (0007). JP249 teach UGGAA expressed with a binding protein TDP-43 or FUS/TLS caused inhibitory effects and SCA31 is associated with the NEDDA (BEAN) gene on chromosome 16q22 as cited by Teive et al. and Ishige et al. above.
Neither the specification, claims or prior art indicate what distinguishing characteristics of the agent having a DNA binding polyamide binding GAA and a protein-biding moiety TDP-43 or FUS/TLs that are concisely shared by the members of the broad genus of agents claimed. A review of the specification shows that it provides no description or guidance that would allow one of skill to distinguish the functional species of the recited structural genus from the non-functional members without empirical determination. Thus it is clear from the prior art that the specification does not describe a representative number of species to describe the entire genus.
Since the disclosure and the prior art fail to describe the common attributes and characteristics concisely identifying members of the proposed genus, and because the claimed genus is highly variant comprising a vast number of DNA binding agents, genes comprising TGGAA, protein binding moieties, oligonucleotide linker sequences and sizes and types of diseases, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus claimed.
"A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus" (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) (emphasis added).
Further, “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
Thus the specification and claims lack written description because it is clear that Applicant did not have possession of every DNA binding agent, genes comprising TGGAA, protein binding moieties, oligonucleotide linker sequences and sizes and diseases. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521,222 USPQ 369,372-372 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.").
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 163 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 163 recites “The method of claim 162, wherein the DNA-binding moiety is capable of selectively binding to a TGGAA pentanucleotide repeat sequence of BEAN.”
Claim 162 recites “The method of claim 152, wherein the gene is BEAN.”
Claim 152 recites “A method for modulating transcription of a gene comprising a pentanucleotide repeat sequence TGGAA… wherein:(a) the first terminus comprises a DNA-binding moiety capable of noncovalently binding to the pentanucleotide repeat sequence TGGAA”.
Claim 163 fails to further limit claim 162 because claim 162 essentially recites the gene is BEAN that comprises TGGAA and is bound by a DNA-binding moiety. Claims 152 and 162 recite “noncovalently binding” and claim 163 recites “selectively binding” which does appear to be a significant limitation that would further limit the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Chong at (571)272-3111. The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm.
If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public. For more information about the PAIR system, see http://pair-direct.uspto.gov.
For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199.
/KIMBERLY CHONG/
Primary Examiner Art Unit 1636