DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission of RCE on 10/7/25 and the amendment of claims has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I, claimed in claims 1-10 and 20 in the reply filed on 6/10/24 was previously acknowledged. Election was made without traverse of SEQ ID NO: 8. SEQ ID NO: 8 (GFWSRLINRLLEI) is 13 amino acids in length and is residue 1704 to 1716.
Claims 2, 11-14 and 21-23 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
In the reply filed 1/14/25, Applicants amended claims 1, 3-4, 6-10, 20 and added NEW claim 24. Claim 5 was canceled.
In the reply filed 10/7/25, Applicants amended claims 1-4, 6-11, 14, 20-21, 23-24.
Claims 1-4, 6-14 and 20-24 are pending.
Claims 1, 3-4, 6-10, 20 and 24 read on the elected Group I and elected species and are under consideration.
Claim Rejections-Withdrawn
The rejection of claims 3-4, 6-7 and 10 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of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn due to Applicants arguments.
MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 112-Maintained
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.
The rejection of claims 1, 3-4, 6-9, 20 and 24 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 is maintained. This rejection has been modified necessitated by amendment of the claims. Please not that claim 9 is no longer rejection because it was amended to an independent claim.
Claim 1 is indefinite because the claim language is unclear. Claim 1 was amended to a peptide inhibitor of LRRK2/PP1 interaction which consists of a fragment of 7 to 50 consecutive amino acid having at least 70% sequence identity with a polypeptide of SEQ ID NO: 1, wherein the peptide has a sequence of amino acids having at least 70% sequence identity with amino acid residues at position 1709-1715 of said SEQ ID NO: 1, optionally fused to a carrier peptide. The claim uses both open and closed language in the same claim. The limitation “consists of” is closed language, which limits the claimed peptide to exactly and only the recited components (i.e. the precise amino acid sequence provided) (see MPEP 2111.03). However, the term “having” and “has” is interpreted as open language, meaning the peptide must include but is not limited to the specified sequence. Thus, the peptide could include additional amino acids outside of the recited sequence. The conflicting use of both open and closed language in the same claim renders the scope of the claim ambiguous because it creates internal inconsistency in the claim and one of ordinary skill in the art would be unable to determine with reasonable certainty the boundaries of the claimed invention.
For purposes of examination, the Examiner is interpreting claim 1 to be drawn to a peptide fragment of SEQ ID NO: 1 that is between 7 and 50 amino acids in length, wherein the peptide fragment comprises at least 70% sequence identity with the 7 amino acids at residues of 1709 to 1715 of SEQ ID NO: 1.
Claims 3-4, 6-9, 20 and 24 are rejected for depending from claim 1.
Response to Arguments
Applicant's did not provide arguments to the rejections above. Accordingly, the rejection is maintained.
Claim Rejections - 35 USC § 102-Maintained
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The rejection of claims 1, 3-4, 6-8, 10 and 24 under 35 U.S.C. 102(a)(2) as being anticipated by Sulzer et al. (WO2019/070813) is maintained.
Sulzer et al. teach a peptide that is 15 amino acids in length and is at least 70% sequence identity to residues 1709 to 1715 of SEQ ID NO: 1 (the sequence is 100% identical to residues 1709-1715 of SEQ ID NO: 1).
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With respect to the new limitation “inhibitor or LRRK2/PP1”, the peptide from Sulzer et al. would inherently have all of the activities and properties of the claims. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzqerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433- 34 (CCPA 1977)).” In other words, the references teaches a peptide that meets the structural limitations of the claim. The same peptide would inherently have the same properties. Moreover, MPEP 2112.01 states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Importantly, MPEP 2112 states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer” and “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference
With respect to claim 3, the peptide of Sulzer et al. is 72% identical to residues 1701-1718 of SEQ ID NO: 1.
With respect to claim 4, the peptide of Sulzer et al. is 100% identical to residues 1703-1715.
With respect to claim 6, the peptide of Sulzer et al.is 72% identical to residues 1701-1718.
With respect to claim 7, the peptide of Sulzer et al. is 100% identical to residues 1703-1715.
With respect to claim 8, the peptide of Sulzer et al. contains W1705, S1706, R1707, I1709, R1711, L1712, L1713, and E1714.
With respect to claim 10, the peptide of Sulzer et al. meets the limitation of at least 60% sequence identity to SEQ ID NO: 2-9.
With respect to new claim 24, Sulzer at al. teach a peptide that meets the limitations of claim 1. Please note, regarding the limitation “obtained by recombinant techniques or chemical synthesis” MPEP 2113 states "The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” Therefore, determination of patentability is based on the product itself (the peptide) and does not depend on the method of production (recombinant techniques or chemical synthesis).
Response to Arguments
Applicant's arguments filed 10/7/25, have been fully considered but they are not persuasive. Applicants argue that Sulzer nowhere discloses a peptide inhibitor of LRRK2/PP1 interaction as required by the amended claims. Applicants argue that the peptides in Sulzer are epitopes used as biomarkers no inhibitors. Applicants argue that the peptides of Sulzer come from proteins that are not LRRK2 or PP! as required in the present claims. Applicants argue that Sulzer nowhere mentions or suggest the two required targets, LRRK2 and PP1. Applicants argue that the claims require the peptide comprises a sequence of amino acids having at least 70% sequence identity to 1709-1715 of SEQ ID NO: 1, which is not taught by Sulzer. Applicants argue that therefore Sulzer cannot anticipate the claimed invention.
This argument was considered but is not persuasive. Sulzer teaches a peptide that meets the structural limitations of the claims. It is 7-50 amino acids in length, at least 70% identical to residues 1709-1715 of SEQ ID NO: 1. The Examiner agrees that it does not teach the peptide is an inhibitor or LRRK2/PP1, however that function would be inherent to the peptide. As indicated above the references teaches a peptide that meets the structural limitations of the claim. The same peptide would inherently have the same properties. Moreover, MPEP 2112.01 states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Importantly, MPEP 2112 states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer” and “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.
For the reasons presented above, the rejection is maintained.
Claim Rejections - 35 USC § 101-Maintained
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The rejection of claims 1, 3-4, 6-8, 10 and 24 under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter is maintained. Based upon an analysis with respect to the claim as a whole, claims 1, 3-4,6-8, 10 and 24 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below and is based on the analysis presented in the USPTO’s 2019 Revised Patent subject matter Eligibility Guidance (referred to as 2019 PEG) published January 2019 and the “PEG update” in October 2019.
Claim Interpretation
Claim 1 claims a peptide inhibitor of LRRK2/PP1 interaction which consists of a fragment of 7 to 50 consecutive amino acid of polypeptide of SEQ ID NO: 1, wherein the peptide has a sequence of amino acids having at least 70% sequence identity with amino acid residues at position 1709-1715 of said SEQ ID NO: 1, optionally fused to a carrier peptide.
Subject Matter Eligibility Test for Products and Processes
Step 1: Is the claim to a process, machine, manufacture, or composition of matter (see, e.g., 79 FR 74621)?
Yes, the instant claims are directed to a statutory patent-eligible subject matter category, namely a composition of matter.
Step 2A (1): Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (see, e.g., 79 FR 74621)?
Yes, the claims are directed to a natural phenomenon, SEQ ID NO: 1 is a naturally occurring protein. The instant specification discloses that SEQ ID NO: 1 is human LRRK2. Accordingly, the pending claims are directed to a fragment of a naturally occurring product.
Absent evidence to the contrary, a fragment of a naturally occurring protein does not impart a different structure that would distinguish it from the natural product.
Step 2A (2): Does the Claim recite additional Elements that integrate the judicial Exception into a Practical Application?
No, the claim does not recite additional elements that integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception (see, e.g., 79 FR 74621)?
No, the claims do not recite additional elements that amount to significantly more than the judicial exception. As indicated above, the claimed SEQ ID NO:1 is naturally occurring and the claims do not recite additional elements that amount to significantly more. The new limitation “inhibitor of LRRL2/PP1” does not add significantly more since the peptide is a fragment of a naturally occurring protein and the only two peptides of the claims that were shown to inhibit the interaction are fused to a carrier peptide. There is no teaching in the specification that the claimed fragments have the claimed function. The limitation “optionally fused to a carrier peptide” does not add significantly more since the limitation is optional and not a required component of the claim. With respect to new claim 24, obtained by recombinant techniques or chemical synthesis does not add more, since the peptide still has the amino acid sequence of a naturally occurring protein.
Factors for determining if the claim directed to a product of nature, as a whole, recites something significantly more than the judicial exception, are provided in the Guidance (74623; see esp. 79 FR 74623 at §I.A.3.b). see also, 79 FR.
In sum, when the relevant considerations are analyzed, they weigh against a significant difference. Accordingly, claims 1, 3-4, 6-8, 10 and 24 do not qualify as eligible subject matter.
Response to Arguments
Applicant's arguments filed 10/7/25 have been fully considered but they are not persuasive. Applicants argue that the peptide inhibitor of KRRK2/PP1 interaction does not have any enzymatic activity. This very difference distinguishes the present claimed invention as patent eligible subject matter since the fragment actually eliminate an adverse property of the full length natural protein. Applicants argue that the fragments as claimed block or inhibit the interaction between the LRRK2 and PP1 proteins by specifically targeting their interaction site. Applicants argue that they identified a specific binding/inhibitory region and demonstrated new functional properties of isolated peptides made from this region. Applicants argue that the office does not identify any naturally occurring 7-50mer that has the claimed functions. The Applicants argue that claimed invention is directed to a human made functionally defined inhibitor not to a natural protein. Applicants also argue that peptides are integrated into concrete therapeutic and biological applications demonstrated in the specification: altering LRRK2 phosphorylation/localization and neuronal phenotypes, induces apoptosis in cancer cells etc. Applicants argue that markedly different characteristics include length, sequence variation and chimeric constructs. Applicants argue that markedly different functional characteristics include able to inhibit LRRK2/PP1 interaction, internalized within cells and induce apoptosis. Applicants argue that the naturally occurring protein does not inhibit LRRK2/PP1 interaction. Applicants argue that designing short specific PP1 blocking peptides with the mandated motif is not a routine generic step. Applicants argue the structure is distinct and in some embodiments fused to a carrier peptide and there is no evidence they occur in nature. Applicants argue that even not fused to a carrier the record establishes both structural differences and functional differences.
These arguments were considered but are not found persuasive because the peptides are fragments of a naturally occurring protein. Greater than 70% sequence identity can be 100% sequence identity to the naturally occurring protein. The mere truncation of a naturally occurring protein does not render the product patent-eligible unless the claimed product exhibits markedly different characteristic. The Examiner understands that the embodiment of the fragments fused to a carrier peptide would overcome the 101 rejection. However, the limitation is optional and not a required limitation of the claim. Importantly, the functional characteristics argued are tested in only the fragments fused to a carrier peptide (e.g. peptide 13 and 14). The instant specification does not show markedly different characteristics for the peptide fragments not fused to a carrier peptide and only in the specific 15 and 18 amino acid fragments (peptide 13 and 14). There is no evidence that the unfused peptides exhibit the asserted activity. It is reasonable that the observed activity is attributed to fusion or to the two specific tested sequence only. The record does not support that the claimed peptide fragment possess markedly different characteristics from naturally occurring LRRK2. For the reasons presented above, the rejection is maintained.
NEW REJECTION
Claim Rejections - 35 USC § 112-NEW
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, 3-4, 6-10, 20 and 24 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. This is a NEW rejection necessitated by amendment of the claims.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or 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 function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire 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.
Scope of the claimed genus
Claim 1 claims a peptide inhibitor of LRRK2/PP1 interaction which consists of a fragment of 7 to 50 consecutive amino acid of polypeptide of SEQ ID NO: 1, wherein the peptide has a sequence of amino acids having at least 70% sequence identity with amino acid residues at position 1709-1715 of said SEQ ID NO: 1, optionally fused to a carrier peptide.
The USPTO provides claim terms with broadest reasonable interpretation in light of the specification.
Assessment of whether species are support in the original specification
Two embodiment of the invention of the invention were reduced to practice at the time of filing. The instant application discloses peptides 13 and 14 (SEQ ID NO: 14 and 15 respectively), which are peptide fused to a carrier peptide VKKKKIKAEIKI.
In addition, the complete structure of the following species was disclosed: SEQ ID NOs: 2-28.
There was no disclosure of other peptide sequences that were reduced to practice and had the function of inhibitor of LRRK2/PP1.
In summary, for these reasons, the skilled artisan would reasonably conclude that the inventor(s), at the time the application was filed, had possession of peptides 13 and 14 at the time the invention was filed.
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire 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.
In the instant case, the disclosure of two peptides is not representative of the genus. The disclosure of the sequences are not representative of the entire genus encompassed by peptides 7-50 amino acids in length that have at least 70% sequence identity to residues 1709-1715 of SEQ ID NO: 1 and have the claimed function.
With the aid of a computer, one of ordinary skill in the art could identify all of the peptides with at least 70% to residues 1709-1715 of SEQ ID NO: 1 and is between 7 to 50 amino acids in length. However, there is no teaching regarding which amino acids can vary and still result in a peptide with the claimed function. Although a variation of 30% amino acids does not seem to be a great number, if one considers that there are 20 natural amino acids and a great number of non-natural amino acids and the substitutions/deletions can occur at any position of the peptide, the number of peptides that meet the structural requirement of the claim is enormous.
Therefore, disclosure of peptide 13 and 14 is not representative of the genus.
Identifying characteristics and structure/function correlation
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied 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 function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. To meet this requirement in the instant case, the specification must describe the structural, physical and/or chemical properties of the peptide that meet the structural limitations of the claim. The data do not suggest the physical basis for the claimed activity and therefore do not describe which substitutions, deletions or additions could be made while preserving function.
Importantly, the art teaches peptides that meet the structural limitations of the claims that do not have the claimed function. Dong et al. (PLOS ONE 15(8), Aug. 13,2020) teaches peptide 13 and 14 (identical to instantly claimed peptide 13 ad 14) have the function of inhibition of LRRK2/PP1 interaction. The peptides of Dong et al. are also fused to VKKKKIKAEIKI carrier peptide. Dong et al. also teach 4 peptides Mut3DPT-LRRK2-5, 2-6, 2-7 and 2-8 (Fig. 4) did not inhibit the interaction between LRRK2 and PP1. Therefore, the art teaches peptides that meet the structural limitations of the claims do not necessarily have the claimed function.
This is an issue of written description. The specification does not make clear which proteins are in the genus and which are not because it does not describe the physical basis for the claimed activity. In other words, the specification does not describe which proteins to make.
In conclusion, for the reasons presented above, the skilled artisan would reasonably conclude that the inventors, at the time the application was filed had full possession of peptides 13 and 14 (SEQ ID NO: 14 and 15).
Claim Rejections - 35 USC § 103-NEW
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 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 1, 3-4, 6-10, 20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Sulzer et al. (WO2019/070813) in view of Garcia et al. (USPN 9,644,001 5/9/2017).
The teachings of Sulzer et al. are presented in detail above. The reference does not teach the peptide is fused to a carrier peptide. However, the teachings of Garcia et al. cure this deficiency.
Garcia et al. teach the cell penetrating peptide VKKKKIKNEIKI , which is identical to instantly claimed SEQ ID NO: 29 (claim 20).
With respect to claims 9 and 20, It would have been obvious to a person of ordinary skill in the art to fuse a cell penetrating peptide, such as VKKKKIKNEIKI to an epitope because Sulzer et al. teach administering the epitope peptides to reduce activation of leukocytes. A person of ordinary skill in the art would have a clear motivation to fuse the peptide to a cell penetrating peptide in order to improve delivery to a cell. There is a reasonable expectation of success given that fusion of peptides to cell penetrating peptides is routine in the art.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-4, 6-10, 20 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 19/525,862 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The copending Application claims a peptide inhibitor of LRRK2/PP1 interaction with the peptide of at least 7 amino acids ranging in position 1701-1715 of SEQ ID NO: 5. The peptides of the copending application meet the limitations of the instant claims.
This is a NEW rejection as the copending application was filed after mailing of the Final rejection.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA L MARTINEZ/Examiner, Art Unit 1654
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