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 Group I and miR-Let-7a-5p and SEQ ID No. 40 in the reply filed on 12/04/2025 is acknowledged.
Status of the Application
Claims 1-73 are pending. Claims 1, 2, 10-23, 26, 27 and 35-73 are currently under examination. Claims 3-9, 24, 25 and 28-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The submission of the Information Disclosure Statement on 09/13/2022 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.
Compliance with Sequence Rules
The drawings are objected to because Figure 1 recites sequences that do not have the required sequence identifiers. Figure 1 contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2).
If these sequences are listed in the current Sequence Listing, then the Figure can be amended to include the appropriate SEQ ID NO. Corrected drawing sheets in compliance with 37 CFR 1.121(d). Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Applicant can also submit a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
A complete response to this office action must correct the defects cited above regarding compliance with the sequence rules and a response to the action on the merits which follows.
The aforementioned instance of failure to comply is not intended as an exhaustive list of all such potential failures to comply in the instant application. Applicants are encouraged to thoroughly review the application to ensure that the entire application is in full compliance with all sequence rules. This requirement will not be held in abeyance.
Claim Rejections – Improper Markush
Claims 1, 10, 11, 23, 57, 58, 59, 61 and 62 is 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/or a common use that flows from the substantial structural feature for the following reasons: The claims are directed to a large multitude of sequences, therapeutic agents and therapies, reperfusion methods, disease and results.
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.
Regarding antagonists: the antagonist of a miRNA is dependent upon the specific sequence of nucleotides. There is no expectation that any one of the nucleotide sequences as claimed can be substituted for any of the other with a completely different sequence with the expectation of the same activity.
Regarding therapeutic agents and therapies: each agent or therapy has a different function and structure and there is no expectation that any one of the agents or therapies as claimed can be substituted for any of the other with the expectation of the same activity.
Regarding reperfusion methods of claim 59, each method has different outcomes and there is no expectation that any of the methods would have the same outcome after treatment with the claimed antagonist.
Regarding the different conditions of claims 61 and 62, each condition has a different function in the subject and there is not expectation that substituting one for the other would have the same outcome after treatment of the subject with the claimed antagonist.
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 § 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 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(s) 1, 10-23, 26, 27, 35-37, 42, 43, 46, 47, 50, 52, 54-67 and 70-73 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018017483 (Publication date 01/25/2018).
Under AIA 35 U.S.C. 102(a)(1), there is no requirement that the prior art relied upon be by others. Thus, any prior art which falls under AIA 35 U.S.C. 102(a)(1) need not be by another to constitute potentially available prior art. However, disclosures of the subject matter made one year or less before the effective filing date of the claimed invention by the inventor or a joint inventor or another who obtained the subject matter directly or indirectly from the inventor or a joint inventor may fall within an exception under AIA 35 U.S.C. 102(b)(1) to AIA 35 U.S.C. 102(a)(1). See MPEP 2152.02(f).
Claim interpretation:
The claims are drawn to preventing, inhibiting, reducing, or treating cardiac ischemic reperfusion injury comprising administering a therapeutic composition to a subject before, during and/or after a cardiac ischemic event wherein the composition is one or more of a miR-Let-7a-5p antagonist. The instant specification defines a cardiac ischemic event as one or more of myocardial infarction, coronary artery bypass grafting (CABG), cardiac bypass surgery, cardiac transplantation, and angioplasty. In some embodiments, the cardiac ischemic event comprises a vascular interventional procedure employing a stent, laser catheter, atherectomy catheter, angioscopy device, beta or gamma radiation catheter, rotational atherectomy device, coated stent, radioactive balloon, heatable wire, heatable balloon, biodegradable stent strut, a biodegradable sleeve, or any combination thereof (see 0022).
The claim recites one method step of administering one or more of a miR-Let-7a-5p antagonist to a subject and therefore administration of one or more of a miR-Let-7a-5p antagonist to a subject would have the inherent feature of preventing, inhibiting, reducing, or treating cardiac ischemic reperfusion injury in a subject. Therefore any prior art that teach a method step of administering one or more of a miR-Let-7a-5p antagonist to a subject before, during and/or after a cardiac ischemic event would inherently teach preventing, inhibiting, reducing, or treating cardiac ischemic reperfusion injury in a subject, induce endogenous cardiomyocyte regeneration and increase creatine levels.
Regarding claims 1, 10, 11, 60-67 and 70-73, WO 2018017483 teach a plurality of antagonists of miR-Let-7a-5p having at least 80-100% sequence identity to SEQ ID No. 40 or one or two mismatches (0011-0012) for treating cardiac ischemic events such as myocardial infarction (0020).
Regarding claims 12-20, WO 2018017483 teach the anti- miR-Let-7a-5p can comprise chemical modifications such as modified internucleoside linkages, nucleotides and sugar moieties (0013 and 0016).
Regarding claim 21-23, 26, 27 and 35, WO 2018017483 teach the cloning or expression cassette comprises a viral vector such as an AAV or lentiviral vector that comprises SEQ ID No. 86 and a pharmaceutical composition (0017) and further teach the plurality of antagonists are encoded by the same or different expression cassettes (0023).
Regarding claims 54-59, WO 2018017483 teach at least one additional therapeutic as recited in the claims (0019).
Regarding claims 42, 43, 46 and 47, WO 2018017483 teach administration such as subcutaneous or systemic or intravenous administration (0155) and at a dose of 1 pg/kg to 10 mg/kg (0156). Because WO 2018017483 teach subcutaneous administration, the results would be an inherent feature of the method of administration.
Regarding claims 36 and 37, WO 2018017483 teach the expression vector or antagonist can be administered prior to or during the occurrence of the disease (0162).
Regarding claims 50-52, WO 2018017483 teach the antagonist can be administered once or multiple times such as every week (0163).
Thus WO 2018017483 anticipates the instant claims.
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 2, 38-41, 44-46, 49, 64 and 68-69 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018017483 and Aguirre et al. ("In vivo activation of a conserved microRNA program induces mammalian heart regeneration." Cell stem cell 15.5 (2014): 589-604).
WO 2018017483 is relied upon as above.
Regarding claims 2, 44, 45, 48, 49, 64, 68 and 69, Aquirre et al. teach administration of an anti-Let-7a by intracardiac injection in a myocardial infarction mouse model in vivo results in improved ejection fraction and fraction shortening compare to control animals and improved ventricular wall thickness and significant reduction in fibrotic scarring and infarct size (see page 597). Aquirre et al. teach the administration also caused increased numbers of cardiomyocytes. Aquirre et al. concludes the study demonstrates that failure to naturally downregulate Let-7a/c and subsequent upregulation of their target genes FNTb and SMARCA5 as a response to heart injury acts as a major roadblock preventing adult mammalian heart regeneration. More interestingly, barriers to mammalian heart regeneration could be experimentally overcome by anti-miR administration (see page 597), therefore teaching treatment of cardiac ischemic damage.
It would have been obvious to one skilled in the art to use an miR-Let-7a-5p antagonist in treatments to improve ventricular wall thickness, reduce fibrotic scarring and infarct size and increase the number of cardiomyocytes given Aquirre et al. observed these treatments in vivo using an anti-Let-7a. It would have been further obvious to demine the optimal concentration of the therapeutic composition to use given WO 2018017483 teach a dose of 1 pg/kg to 10 mg/kg which encompasses the claim limitations.
Regarding claims 38-41, WO 2018017483 teach the expression vector or antagonist can be administered prior to or during the occurrence of the disease and teach the antagonist can be administered once or multiple times such as every week, it would have been obvious to teach treating ischemic cardiac tissue in the methods of Aquirre to improve and treat the regenerative potential of the cardiac cells.
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(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16, 38-40, 47, 49, 52, 53, 57, 60 and 63-66 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 16, 47, 49, 52 and 60 are indefinite because the word "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 38-40 and 53 lack antecedent basis because they recite prior to, concurrent or after “reperfusion of ischemic cardiac tissue” and depend from claim 1 which does not have a step of “reperfusion of ischemic cardiac tissue”. Claim 2 has this step and in the interest of compact prosecution, the claims will be interpreted as depending from claim 2. If Applicant presents a claim interpretation that is different than posited by the Examiner, that will not prevent the next Office Action from going Final if new claim rejections are necessary due to the new claim interpretation.
Claim 57 recites the trademark/tradename Idebenone, PTC124, Translarna, and VECTTOR. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe one or more “therapeutic therapies or agents” and, accordingly, the identification/description is indefinite. The trademark serial numbers are: (1) 77437048 for PTC124 (2) 90020103 for Translarna. It is unclear if the term VECTTOR is a trademark/tradename. However, since the term VECTTOR is in all capital letters, it is assumed that Applicants intended to include a trademark/tradename.
Claims 63, 64 and 66 are indefinite because claim 63 recites wherein the cardiac ischemic reperfusion injury comprise cardiac ischemic damage or cardiac reperfusion injury. The claims depend from claim 1 which recites treating the cardiac ischemic reperfusion injury of a subject having a cardiac ischemic event. It is unclear because cardiac ischemic reperfusion injury would encompass a cardiac ischemic damage and encompass a cardiac reperfusion injury. The claims are interpreted such that treatment of a cardiac ischemic reperfusion injury would treat treating a cardiac ischemic damage.
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 57, 61 and 69 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 57, 61 and 69 is 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 treating cardiac ischemic reperfusion injury comprising administering a therapeutic composition to a subject before, during and/or after a cardiac ischemic event wherein the composition is one or more of a miR-Let-7a-5p antagonist which results in increased survival, improved ejection fraction and fraction shortening compare to control animals and improved ventricular wall thickness and significant reduction in fibrotic scarring and infarct size increased number of cardiomyocytes,
does not reasonably provide enablement for
administration of one additional agent or therapy such as the many listed therapeutics in claim 57 genome editing thru CRISPR/Cas9 to any target or any gene delivery therapy targeted to any exon to treat the dystrophin gene or,
treating wherein the subject has any congenital disorder or any genetic disorder unrelated to a cardiac disease or,
administration results such as (1) –(10) of claim 69 such as increased survival as compared to a control subject, (5) a decrease in end diastolic volume and/or end systolic volume as compared to a control subject, (6) an increase in ejection fraction as compared to a control subject, (7) an increase in the number of cardiomyocytes and/or mRNAs encoding proteins that are involved in differentiated cardiomyocyte muscle structure and function as compared to a control subject, (8) an increase in the mRNA levels and/or protein levels of one or more of the proteins of claim 68, and (10) an increase in one of more of cardiomyocyte formation, cardiomyocyte cell cycle activation, mitotic index of cardiomyocytes, myofilament density, borderzone wall thickness, or any combination thereof, as compared to a control subject.
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.
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 the nature of the invention:
The breadth of the claims are drawn to methods of administering a therapeutic composition to a subject before, during and/or after a cardiac ischemic event wherein the composition is one or more of a miR-Let-7a-5p antagonist which results improvement of vast number of conditions in a subject and administration of a vast number of therapeutic agents or therapies.
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 of WO 2018017483 and Aquirre et al, teach treating cardiac ischemic reperfusion injury comprising administering a therapeutic composition to a subject wherein the composition is one or more of a miR-Let-7a-5p antagonist which results in improved ejection fraction and fraction shortening compare to control animals and improved ventricular wall thickness and significant reduction in fibrotic scarring and infarct size increased number of cardiomyocytes.
The prior art of WO 2018017483 teach administration of agents and therapies such as Idebenone, Eplerenone, VECTTOR, AVI-4658, Ataluren/PTC124/Translarna, BMN044/PRO044, CAT-1004, MicroDystrophin AAV Gene Therapy (SGT-001), Galectin-1 Therapy (SB-002), LTBB4 (SB-001), rAAV2.5-CMVminidystrophin, Glutamine, NFKB inhibitors, Sarcoglycan, delta (35kDa dystrophinassociated glycoprotein), Insulin like growth factor-I (IGF-1), and combinations thereof. The prior art does not teach administration of any gene delivery therapy, exon skipping therapeutics or the vast number of agents and therapies broadly claimed.
A review of the prior art does not provide a correlation between administration of the miR-Let-7a-5p antagonist and improvement in the vast number of conditions as claimed.
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 improving the vast number of conditions in a subject after administration of miR-Let-7a-5p antagonist in a subject can occur, 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).
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 working embodiment in the instant application describes increased survival, an indication of the drugs impact on increased diastolic function, increased creatine levels and decreased scar size as measured by a decrease in fibrotic tissue after administration of a miR-Let-7a-5p antagonist. The working embodiments do not describe methods wherein the results are as stated in claim 68. The working embodiments do not illustrate administration of the vast number of agents and therapies of claim 57.
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 administration of a miR-Let-7a-5p antagonist to a subject to treatment of the vast number of conditions 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 miR-Let-7a-5p antagonist plays in all the conditions stated in claim 68 and undeveloped for the vast number of additional agents and therapies of claim 57 that could be used in the methods. The specification does not provide sufficient guidance 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See 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);and, 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 10-23, 26, 27 and 35-73 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,124,793. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter.
The claims of Patent ‘793 are drawn to a cloning or expression vector comprising SEQ ID No. 86, which is identical to instantly claimed expression vector comprising SEQ ID No. 86 used in the instant methods. It would have been obvious to use the expression vector of Patent ‘793 in the instant methods. The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application.
Claims 1, 2, 10-23, 26, 27 and 35-73 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,421,232. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter.
The claims of Patent ‘232 are drawn to a cloning or expression vector comprising a mir-Let-7a-5p having SEQ ID No. 40, which is identical to instantly claimed antagonist of a mir-Let-7a-5p used in the instant methods. It would have been obvious to use the antagonist of Patent ‘232 in the instant methods. The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application.
Claims 1, 2, 10-23, 26, 27 and 35-73 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,566,243. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter.
The claims of Patent ‘243 are drawn to a composition comprising a mir-Let-7a-5p having SEQ ID No. 40 wherein the anti-miR comprises modifications, which is identical to instantly claimed antagonist of a mir-Let-7a-5p with modifications used in the instant methods. It would have been obvious to use the antagonist of Patent ‘243 in the instant methods. The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application.
MPEP 804 “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 determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
“The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) ("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.")”.
Conclusion
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/KIMBERLY CHONG/
Primary Examiner Art Unit 1636