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
Claims 1-22 are pending in the application. Claims 1-5, 8 and 11-22 are rejected. Claims 1-5, 8 and 11-22 are objected to. Claims 6, 7, 9 and 10 are withdrawn.
Restriction/Election of Species
Applicant’s election without traverse of “Formula III” (e.g.,
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) in the reply filed on February 3, 2026 is acknowledged. The absence of any statement indicating whether the requirement to restrict is traversed or the failure to provide reasons for traverse will be treated as an election without traverse. See MPEP § 818.01.
Claims 1-5, 8 and 11-22 read on Applicant’s elected species. Claims 6, 7, 9 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 3, 2026.
Pursuant to MPEP § 803.02, the Markush claims that read on the elected species (e.g.,
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) were examined fully with respect to the elected species. As per MPEP § 803.02(III), the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species appears to be free of the prior art. Therefore, according to MPEP § 803.02(III): should the elected species be found allowable over the prior art, the examination of the Markush claim will be extended. The prior art search will be extended to cover non-elected species or group of species that fall within the scope of a proper Markush grouping which includes the elected species. Consequently, the prior art search was extended to include the full scope of the compound of Formula I as recited in claim 1 but did not result in any prior art being found.
Priority
This application claims benefit of Provisional Application No. 63/411,732, filed on September 30, 2022.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on April 9, 2024 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Drawings
The drawings are objected to because it is difficult to differentiate between the data points disclosed in FIG. 9 and FIG. 10. To further improve the clarity and reproducibility of the aforementioned figures, Applicant should submit replacement drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. 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. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in paragraphs [0588], [0610] and [0611]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 1-5, 8 and 11-22 are objected to because of the following informalities:
Claims 1-5, 21 and 22 should be amended to include the word -or- before “NH and p is from 0-2” in the definition for variable “X” for sake of clarity and consistency.
Claims 1-4, 21 and 22 should be amended to replace “Y1-Y2 are” with -Y1-Y2 is- for sake of clarity and consistency.
Claims 1, 2, 21 and 22 should be amended to replace the word “or” with the word -and- where indicated below for sake of clarity and proper Markush language.
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Claims 3-5 should be amended to replace the word “or” with the word -and- where indicated below for sake of clarity and proper Markush language.
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Claims 3-5 should be amended to include the word -and- before “COR3” as recited in the definition provided for variable “R4” for proper Markush language.
Claims 3-5, 8 and 11-22 should be amended to replace “A method” with -The method- for sake of clarity and consistency.
Claim 17 should be amended to replace “5 mg/d ay” with -5 mg/day- for sake of clarity.
Claim 21 should be amended to replace “Where” with -where- for sake of consistency.
Claims 21 and 22 should be amended to replace “Parkinsons disease” with -Parkinson’s disease- in the first line of each claim for sake of clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. § 112(a):
(a) IN GENERAL — The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. § 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 8, 11-14 and 16-20 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 a method of treating a neurodegenerative disease or a disease associated with synucleinopathies wherein the neurodegenerative disease is Gaucher’s disease, dementia with Lewy bodies and Alzheimer’s disease, does not reasonably provide enablement for treating a “neurodegenerative disease” in general which could reasonably be interpreted as any and all neurodegenerative diseases, e.g., multiple sclerosis. 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 this claim.
As a general rule, enablement must be commensurate in scope with the claim language. The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). See MPEP § 2164.08. That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is “undue.” In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
Breadth of the Claim – The breadth of claims 1 and 2 is drawn to a method of treating a neurodegenerative disease comprising administering to a subject a therapeutically effective amount of a compound of Formula (I) or a stereoisomer or pharmaceutically acceptable salt thereof. Accordingly, the claims are drawn to treating a broad scope of neurodegenerative diseases.
Nature of the Invention – The nature of the invention pertains to the following as disclosed in paragraph [0008] of the instant specification
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State of the Prior Art and Predictability in the Art – Even in view of the seemingly high level of skill in the art, there is no absolute predictability when determining the physiological effects of a compound of Formula (I) against any and all neurodegenerative diseases. It is well established that “the scope of enablement [] varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). For instance, with respect to a neurodegenerative disease such as multiple sclerosis (MS), ‘t Hart et al. (The Lancet Neurology, 2004, 3(10):588-597) teach that “[a]lthough many features of the MS immunopathogenesis have been elegantly modelled in inbred strains of rats and mice, successful therapeutic interventions in these models have shown limited predictive value for clinical success.” See e.g., page 596. Therefore, a skilled artisan would reasonably expect the efficacy of treatment methods to vary when considering the diverse causes and symptoms associated with any and all neurodegenerative diseases, such as multiple sclerosis.
Relative Skill of Those in the Art – The artisan making and using applicant’s pharmaceutical compound would be a synthetic chemist and/or a health practitioner, possessing a commensurate degree level and/or skill in the art, as well as several years of professional experience. The level of skill in the art is high; however, due to the unpredictability in the pharmaceutical art and the wide scope of neurodegenerative diseases, it is difficult to assess the potential pharmacological activity of a compound of Formula (I) against any and all neurodegenerative diseases.
Amount of Direction/Guidance Provided and Existence/Absence of Working Examples – The specification provides in vitro data regarding the instantly claimed compound of Formula (I) and soluble epoxide hydrolase inhibition and fatty acid amide hydrolase inhibition. See e.g., pages 126 and 127. The specification also provides in vitro and in vivo data evaluating the compounds of Formula (I) to treat diseases associated with synucleinopathies e.g., in Gaucher’s disease. See e.g., page 127. In addition, the specification discloses in vivo data regarding the instantly claimed compound of Formula (I) in mouse and zebrafish models. See e.g., pages 128 and 130. However, the disclosure does not provide support for treating any and all neurodegenerative diseases (i.e., the scope of instant claims 1 and 2). Therefore, there is no actual evidence of the effectiveness of the claimed compound of Formula (I) in treating the full scope of neurodegenerative diseases claimed.Quantity of Experimentation Necessary – The quantity of experimentation needed to use the invention based on the content of the disclosure is undue. One of skill in the art would need to determine which specific neurodegenerative disease not embraced by the instant disclosure would benefit from the pharmacological activities of a compound of Formula (I) by administering said compound to a patient. Using the full scope of the instant claim would be burdensome because it would require a person having ordinary skill to invest an indefinite amount of experimentation clearly beyond what can be considered as routine.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976). In view of the Wands factors and In re Fisher (CCPA 1970) discussed above, a person of skill in the art would have to engage in undue experimentation to test which neurodegenerative disease can be treated by a compound of Formula (I), with no assurance of success. To overcome this issue of lack of enablement,
it is suggested Applicant further limit the neurodegenerative disease/disease as recited in claims 1 and 2 by incorporating the limitations of claim 15 into both claims.
Claim Rejections - 35 USC § 112(b)
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 1-5, 8 and 11-22 are rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. § 112, the applicant), regards as the invention.
The term “associated” as recited in claims 1 and 2 is a relative term which renders the claim indefinite. The term “associated” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how one of ordinary skill could reasonably determine the objective boundaries of the scope of the claim based on the aforementioned terms. A claim that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). Dependent claims 3-5, 8 and 11-20 do not correct this issue of indefiniteness and are likewise rejected.
Claim 8 recites the expression “the compound of Formula 1 is one or more of the following compounds” and is rejected as indefinite. It is unclear how the compound of Formula I, as recited in parent claim 1, can be defined simultaneously by more than one chemical structure. It is suggested Applicant replace the aforementioned expression with the following: “the compound of Formula I is selected from the group consisting of:” to overcome this issue of indefiniteness.
Claims 11-14 recite “concentration (IC50)” and are rejected as indefinite. It is unclear whether or not Applicant intended to further limit the recited “concentration” to the “IC50” i.e., the half maximal inhibitory concentration. It is suggested Applicant amend the claims to avoid exemplary language e.g., replace “concentration (IC50)” with, for instance, “IC50.”
The term “related” as recited in claims 19, 21 and 22 is a relative term which renders the claim indefinite. The term “related” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how one of ordinary skill could reasonably determine the objective boundaries of the scope of the claim based on the aforementioned terms. A claim that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. The factual inquiries 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.
(1 of 3) Claims 1-5, 8 and 11-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,121,515 B2 (October 22, 2024) in view of Aarsland et al. (J Neurol Sci. 2010, 289(1-2):18-22). Claims 1-6 of the U.S. Patent 12,121,515 (‘515 patent) are drawn towards compositions comprising the instantly claimed formulas as recited in one of instant claims 1-5. With respect to the fact that the claims of the ’515 patent are drawn to compositions while the instant claims are drawn to methods of treating a neurodegenerative disease or a disease associated with synucleinopathies, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. “[T]he specification of an earlier patent may be used in the obviousness-type double patenting analysis.” See In re Basell, 547 F.3d 1378. Furthermore, the first compound as recited in claim 3 of the ‘515 patent corresponds to the first compound as recited in instant claim 8 (i.e., also Applicant’s elected species). Claims 7-12 of the ‘515 patent are drawn towards methods for treatment of pain, neurodegenerative disease, or inflammatory disease in a subject, the method comprising administering to the subject the instantly claimed compounds and, therefore, encompass the scope of instant claims 11-20. Claims 13-15 of the ‘515 patent are drawn towards methods for treatment of Parkinson’s disease in a subject and not, for instance, Parkinson’s disease with dementia as recited in instant claims 21 and 22. However, Aarsland et al. teach “[t]he point prevalence of dementia in PD is close to 30% and the incidence rate is increased 4–6 times as compared to controls. The cumulative prevalence is very high, at least 75% of PD patients who survive for more than 10 years will develop dementia.” See e.g., page 21. Therefore, a skilled artisan looking to treat the Parkinson’s disease patient population would be expected to encounter patients having Parkinson’s disease with dementia. At least in the interest of treating a larger prevalence of patients with Parkinson’s disease, a skilled artisan would be motivated to employ the instantly claimed methods.
(2 of 3) Claims 2 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,998,538 B2 (June 4, 2024). Claims 1-10 of U.S. Patent 11,998,538 (the ‘538 patent) are drawn towards pharmaceutical compositions comprising the instantly claimed formulas as recited in instant claims 2 and 4. With respect to the fact that the claims of the ’538 patent are drawn to compositions while the instant claims are drawn to methods of treating a neurodegenerative disease or a disease associated with synucleinopathies, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. “[T]he specification of an earlier patent may be used in the obviousness-type double patenting analysis.” See In re Basell, 547 F.3d 1378. In addition, claims 11-17 of the ‘538 patent teach methods for treatment of pain, neurodegenerative disease, or inflammatory disease in a subject, the method comprising administering to the subject the instantly claimed compounds and, therefore, encompass the scope of the instant claims. For instance, the first compound as recited in claim 15 of the ‘538 patent corresponds to Applicant’s instantly elected species and is encompassed by variable definitions of the instantly claimed compound of Formula (I), wherein X is O; R1 is alkyl; Y1-Y2 is C=CH; R4 is H; Y3 is H; and R6 is aryl.
(3 of 3) Claims 1-5, 8 and 11-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending U.S. Application No. 18/643,018 (‘018) in view of Aarsland et al. (J Neurol Sci. 2010, 289(1-2):18-22). Although the claims at issue are not identical, they are not patentably distinct from each other. Regarding instant claims 1-5, 8, 11-20, claims 1-16 of ‘018 are drawn towards the instantly claimed compound of Formula I. For instance, the first compound as recited in claim 6 of ‘018 corresponds to the first compound as recited in instant claim 8. In addition, the first compound as recited in claims 7 and 8 of ‘018 corresponds to the second compound as recited in instant claim 8. In addition, the first compound as recited in claims 9 and 10 of ‘018 corresponds to the sixth compound as recited in instant claim 8. In addition, the first compound as recited in claim 11 and 12 of ‘018 corresponds to the fourth compound as recited in instant claim 8. With respect to the fact that the claims of‘018 are drawn to compounds while the instant claims are drawn to methods of treating a neurodegenerative disease or a disease associated with synucleinopathies, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. “[T]he specification of an earlier patent may be used in the obviousness-type double patenting analysis.” See In re Basell, 547 F.3d 1378. Claims 17 and 18 teach methods for treatment of pain, neurodegenerative disease, or inflammatory disease in a subject, the method comprising administering to the subject the instantly claimed compounds and, therefore, encompass the scope of the instant claims. Claim 19 of the ‘018 is drawn towards a method for treatment of Parkinson’s disease in a subject and not, for instance, Parkinson’s disease with dementia as recited in instant claims 21 and 22. However, Aarsland et al. teach “[t]he point prevalence of dementia in PD is close to 30% and the incidence rate is increased 4–6 times as compared to controls. The cumulative prevalence is very high, at least 75% of PD patients who survive for more than 10 years will develop dementia.” See e.g., page 21. Therefore, a skilled artisan looking to treat the Parkinson’s disease patient population would be expected to encounter patients having Parkinson’s disease with dementia. At least in the interest of treating a larger prevalence of patients with Parkinson’s disease, a skilled artisan would be motivated to employ the instantly claimed method.
Double Patenting (Statutory)
Claims 1-5, 8 and 11-22 of this application are patentably indistinct from claims 1-5, 8 and 11-22 of Application No. 19/116,931. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-5, 8 and 11-22 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1-5, 8 and 11-22 of copending Application No. 19/116,931 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1-5, 8 and 11-22 are directed to the same invention as that of claim 1-5, 8 and 11-22 of commonly assigned copending Application No. 19/116,931. Under 35 U.S.C. 101, more than one patent may not be issued on the same invention.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). The applicant should amend or cancel claims such that the reference and the instant application no longer contain claims directed to the same invention.
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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