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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 28, 2025 and amendment after final filed on October 28, 2025 has been entered. Claims 1-16, 18-32, 34 were canceled, claim 17 was amended and claims 17 and 33 are pending in the instant application.
The restriction requirement was deemed proper and made FINAL in a previous office action.
Claims 17 and 33 are examined on the merits of this office action.
Declaration under 37 C.F.R. 1.132
The Declaration under 37 CFR 1.132 filed October 28, 2025 is insufficient to overcome the rejection of Claims 17 and 33 under 35 U.S.C. 103 as being unpatentable over Van Scott (WO2013063615 A2) in view of Genscript (“Peptide Modifications”, 2010, pages 1-2) as applied to claim 17 above, and in further view of Minelli (Free Radical Biology & Medicine 49 (2010) 31–39) *All references cited previously.
Applicant argues that “the blood brain barrier is a main challenge for drug delivery for certain neurological diseases such as Parkinson's disease, as the BBB severely limits the ability of many drugs to reach the brain and have an effect in ameliorating a symptom of Parkinson's disease. In the process of development of compounds for treatment of Parkinson's disease, I had attempted to administer N-acetylcysteine. Our research, as detailed in Offen et al. (Journal of Neurochemistry, 2004, 89, 1241-1251) see in particular Fig. 1, indicated that N-acetylcysteine is not effective in crossing the blood-brain barrier. In this study (Offen et al., 2004) NAC-Amide, the uncharged form of NAC was prepared termed AD4/NACA, and showed that as opposed to NAC, crossed the BBB. I have developed the compounds described in the subject application, known as SD and SDA, as a drug which contains an N-acetylcysteine moiety, as well as a levodopa moiety. I have shown in in vivo models that the compounds can cross the blood- brain barrier, and have therapeutic effects to ameliorate Parkinson's disease system, unlike N-acetylcysteine. Both compounds have demonstrated efficacy in the rotenone-rat model, a complex 1 inhibitor, which destroys dopaminergic neurons and induces Parkinsonian symptoms. Like levodopa, both SD and SDA increased locomotor activity protecting against rotenone-induced motor impairment following intraperitoneal (i.p.) injection, which indicate BBB penetration and central nervous system activity (Wiesen and Atlas, 2022).
Applicants arguments have been fully considered but not found persuasive. While drug delivery to the brain can present challenges, the legal standard for obviousness requires only a reasonable expectation of success, not absolute predictability (see MPEP 2143.02). The combined prior art provides a rationale for L-DOPA based codrugs designed to improve delivery and reduce oxidative stress for treatment of Parkinson’s disease.
Applicants argument that NAC alone does not cross the BBB is not persuasive because the rejection does not rely on NAC alone as a therapeutic agent for Parkinson’s disease. Rather, the rejection relies on compounds containing L-DOPA linked to cysteine containing moieties, as taught by the combined references. The claimed compounds contain an L-DOPA moiety, which is well established therapeutic agent for Parkinson’s disease, and the presence of cysteine does not negate the expectation that L-DOPA would retain activity.
Applicant states that the inventor developed SD and SDA compounds containing both NAC and levodopa moieties and that SD and SDA cross the BBB and show efficacy in a rotenone rate model. To rebut a prima facie case of obviousness, unexpected results must be demonstrated relative to the closest prior art compounds. The declaration does not provide comparative data showing that the claimed compounds exhibit unexpected properties relative to structurally similar compounds taught in the cited prior art (Van Scotts N-Acyl-Cys DOPA compounds and Ac-Cys-LD-OMe of Minelli for example) which are taught for treating Parkinson’s disease (see MPEP 716.02 (c)). MPEP states “Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e)”. Because the declaration does not demonstrate that the claimed compounds exhibit unexpected properties relative to the closest prior art compounds, the submitted evidence is insufficient to overcome the prima facie case of obviousness.
Applicant argues that the drugs disclosed by Van Scott are intended for treatment of cancer not Parkinson’s disease and there would be not motivation to treat Parkinson’s disease. First, cancer is unrelated to Parkinson's disease, and there is no indication that an effect in cancer could indicate an effect in Parkinson's disease.
Applicant’s arguments have been fully considered but not found persuasive. Van Scott teaches treatment of a variety of diseases and disorders including Parkinson’s disease (see abstract, paragraph 0057). Accordingly, Applicant’s assertion that Van Scott is unrelated to Parkinson’s disease is not supported by the reference. Additionally, Van Scot discloses compounds structurally corresponding to those in formula I. For example, Van Scott teaches propanoyl-Cys-DOPA-NH2 (see claim 9), which meets formula 1 wherein n is 0 and R is a C2 alkyl group. Van Scott further teaches that the N-terminal acyl radical may be acetyl, propanoyl or benzoyl (see paragraph 00026). Therefore, Van Scott teaches both structurally similar N-acyl cysteine DOPA compounds and their use in treating Parkinson’s disease. The rejection further relies on Minelli and Genscript for additional teachings regarding levodopa based codrug strategies and further motivation to treat Parkinson’s disease.
As stated below, it would have been obvious before the effective filing date of the claimed invention to utilize Ac-Cys-L-Dopa-NH2 for treatment of Parkinson’s disease as taught by Van Scott in view of Genscript and Minelli. One of ordinary skill in the art would have been motivated to do so given that L-Dopa is a known effective treatment for Parkinson’s but has limitations given its oxidative effects. One of ordinary skill in the art would have been further motivated to use a codrug of Ac-Cys-L-Dopa for more sustained delivery reduced oxidation of L-Dopa allowing it to impart its therapeutic effects (which are known in the art) for treating Parkinson’s disease. There is a reasonable expectation of success given that co-drugs of L-Dopa (in particular with cysteine/sulfur containing compounds) are effective in sustained delivery of L-Dopa and L-Dopa is a well-known treatment for Parkinson’s disease.
Applicant argues “even taking into account Minelli, there is no indication that all modified levodopa moieties would be effective in crossing the blood-brain barrier. Nothing in Minelli would suggest to take anti-cancer drugs which are not intended to cross the blood brain barrier and repurpose them for treating Parkinson's disease. The third point mentioned above, stems from lack of predictability in the field of Parkinson's disease treatment and drug development. This is further illustrated from my experience in developing additional drugs for treatment of Parkinson's disease, including L-DOPA ethyl ester.
Applicant’s arguments have been fully considered but not found persuasive. First, the claims do not require blood brain barrier penetration only amelioration of a symptom of Parkinson’s disease. Accordingly, arguments regarding whether particular compounds would cross the blood brain barrier are not commensurate with the scope of the claims. Moreover, obviousness requires only a reasonable expectation of success, not absolute predictability that every modification will be successful.
Applicant argues “I am an inventor on US Patent 5,607,969, which addresses methods for treating Parkinson's disease with L-DOPA ethyl ester. Although this was an ester of L- DOPA, it was found that it was no more effective in treating of Parkinson's disease than treatment with L-DOPA, as seen in a study published after a clinical trial by Parkinson Study Group. (Parkinson Study Group. A Randomized Controlled Trial of Etilevodopa in Patients With Parkinson Disease Who Have Motor Fluctuations. Arch Neurol. 2006;63(2):210-216.) This article concludes, "Despite the theoretical pharmacokinetic advantage of etilevodopa, there was no improvement in TTON, response failures, or off time compared with levodopa." This further illustrates that lack of predictability within the field of Parkinson's disease treatment. Prior to the priority date of my application, no one has successfully shown that SD or SDA are effective in crossing the BBB or in treating a neurodegenerative disease or Parkinson's disease.
Applicant’s arguments have been fully considered but not found persuasive. Applicant further argues that L-DOPA ethyl ester was not more effective than levodopa in treating Parkinson’s disease and therefore the field is unpredictable. The cited clinical study merely shows that one particular levodopa derivative did not show improved efficacy over levodopa in that study. However, evidence that a particular derivative does not improve efficacy does not establish that structurally related levodopa derivatives would not have been reasonably expected to possess therapeutic activity. Moreover, the obviousness rejection does not require that the claimed compounds be superior to levodopa or other levodopa derivatives. Rather, the rejection is based on the structural teachings of Van Scott in combination with Minelli and Genscript suggesting modification of levodopa through conjugation with cysteine containing moieties. Accordingly, the cited study does not negate the reasonable expectation of success provided by the combined teachings of the prior art. Additionally, arguments regarding blood brain barrier penetration are not commensurate with the scope of the claims, which do not require demonstrating blood brain barrier transport.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Withdrawn Rejections
The rejection of claims 17, 33 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 specific neurodegenerative diseases such as Parkinson’s disease in patients that have Parkinson’s disease, does not reasonably provide enablement for prevention or curing of Parkinson’s disease (which is how Applicants defined “treatment”, paragraph 0050, pgpub) is withdrawn in view of amendment of the claims filed October 28, 2025.
Maintained/Revised Rejections
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 17 and 33 remain rejected under 35 U.S.C. 103 as being unpatentable over Van Scott (WO2013063615 A2, cited previously) in view of Genscript (“Peptide Modifications”, 2010, pages 1-2, cited previously) as applied to claim 17 above, and in further view of Minelli (Free Radical Biology & Medicine 49 (2010) 31–39, cited previously).
Van Scott discloses a composition comprising a propanoyl-Cys-DOPA-NH2 (see claim 9) which meets formula I wherein n is 0 and R is an ethyl group (C2 alkyl). Van Scott additionally teaches wherein the N-terminal acyl radical can be acetyl, propanoyl or benzoyl (see paragraph 0026, last four lines). Van Scott teaches treatment of a variety of diseases and disorders including Parkinson’s disease (see abstract, paragraph 0057).
Regarding the peptide of formula I, Van Scott does not specifically provide an example wherein R is acetyl with Cys-DOPA-NH2 (N-acetylcysteine Dopa).
Van Scott does teach “The N-acyldipeptide derivatives of the present invention have the alkaline radical such as an amino group modified by acylation, so that they are no longer amphoteric in nature, and are readily bioavailable for penetration and/or distribution to target tissues or sites for pharmacological actions by topical or systemic administration” (see paragraph 0044).
Genscript teaches that terminal amidation (C-terminus) or acetylation (N-terminus) will remove its charge and help it imitate its natural structure. In addition, this modification makes the resulting peptide more stable towards enzymatic degradation resulting from exopeptidases
It would have been obvious to select acetyl as the N-terminal acyl radical group thus resulting in the formula of Ac-Cys-DOPA-NH2 which results in a compound of formula I. One of ordinary skill in the art would have been motivated to do so given that Van Scott teaches acetyl as a preferred embodiment for the N-terminal moiety (in place of propanoyl) and N-terminal Acetylation is routine in the art for increasing stability of shorter peptides and mimicking the natural structure. There is a reasonable expectation of success given that N-terminal acetylation is routine in the art and Van Scott teaches N-terminal acetylation of the dipeptide and Van Scot teaches the preferred N-terminal acyl radicals can be acetyl, propanoyl or benzoyl. Furthermore, because the compounds disclosed by Van Scott are structurally similar to N-acyl cysteine DOPA derivatives, one of ordinary skill in the art would reasonably expect such structurally similar compounds to exhibit similar pharmacological effects.
Regarding treatment of Parkinson’s disease, the preferred condition to be treated is inclusive to multiple disorders involved with altered dopamine levels including Parkinson’s disease (see paragraph 0068 of Van Scott). Nevertheless, the combined references are silent to using Ac-Cys-L-Dopa for treating Parkinson’s disease.
Regarding treating Parkinson’s disease, Minelli teaches that “To date, L-Dopa is the most effective medication, although long-term treatment can enhance oxidative stress and accelerate the degenerative process of residual cells. Therefore the inhibition of oxidation of L-Dopa/dopamine and the inhibition of reactive oxygen species formation are important strategies for neuroprotective therapy” (see abstract). Minelli teaches “Recently, several dual acting drugs, in which L-Dopa/dopamine are covalently linked to antioxidant molecules, were shown to induce sustained delivery of both L-Dopa/dopamine in rat plasma and striatum, suggesting that these compounds might be proposed as useful agents against Parkinson's disease” (See abstract). Minelli teaches that “Codrugs, i.e. Ac-Cys-LD-OMe (1), Ac-LD-Cys-OMe (2) Ac-Met-LD-OMe (3), in which L-Dopa is linked to acetylcysteine and methionine induce sustained delivery of both L-Dopa and DA in rat plasma and striatum, indicating that these compounds, that have in brain a longer half-life than L-Dopa itself, might be proposed as useful agents against PD” (See introduction, right column).
It would have been obvious before the effective filing date of the claimed invention to utilize Ac-Cys-L-Dopa-NH2 for treatment of Parkinson’s disease as taught by Van Scott in view of Genscript and Minelli. One of ordinary skill in the art would have been motivated to do so given that L-Dopa is a known effective treatment for Parkinson’s but has limitations given its oxidative effects. One of ordinary skill in the art would have been further motivated to use a codrug of Ac-Cys-L-Dopa for more sustained delivery reduced oxidation of L-Dopa allowing it to impart its therapeutic effects (which are well known) for treating Parkinson’s disease. There is a reasonable expectation of success given that co-drugs of L-Dopa (in particular with cysteine/sulfur containing compounds) are effective in sustained delivery of L-Dopa and L-Dopa is a well-known treatment for Parkinson’s disease.
Regarding claim 17, the NacetylCys-L-Dopa-NH2 compound of Van Scott in view of Genscript and Minelli teach wherein R is a methyl, n is zero and the compound found in instant claim 33 (formula III).
Response to Applicant’s Arguments
Applicant argues that “Where there is a reason to modify or combine the prior art to achieve the claimed invention, the claims may be rejected as obvious only if there is also a reasonable expectation of success. As the examiner notes, Van Scott, even if combined with Genscript, disclose compounds, but does not disclose methods for treatment of Parkinson's disease. Van Scott relates to compounds which can be used in the treatment of cancer, but not in Parkinson's disease. As indicated in the declaration of Professor Daphne Atlas, attached herewith, there is no expectations of success for one of skill in the reading Van Scott and Genscript in combination with Minelli to achieve the claimed method for treatment. This is based on the fact that the indications of cancer and Parkinson's are not related. The success in treatment in one of the indications does not predict the success in treatment of the other. Prof. Atlas also mentions the importance of the challenge associated with treatment of Parkinson's disease: ensuring that the drug crosses the blood-brain barrier. This is not a concern for drugs in Van Scott, which are developed for the treatment of cancer, which are not required to cross the BBB. Even if a person of skill in the art at the time of the filing of the instant application were to take Minelli into account, there is no indication that all modified levodopa moieties would be effective in crossing the blood- brain barrier. Nothing in Minelli would suggest to take anti-cancer drugs which are not intended to cross the blood brain barrier and repurpose them for treating Parkinson's disease. Prof. Atlas illustrates that lack of predictability in the field of Parkinson's disease treatment. The mere disclosure of a drug for a different disease is not sufficient, Page Application Number 18/172,333 according to Prof. Atlas, to be able to predict or expect success in treating Parkinson's disease. As such, the combination of Van Scott, Genscript, in combination with Minelli do not provide a reasonable expectation of success, and it is requested that this rejection therefore be withdrawn.
Applicant’s arguments have been fully considered but not found persuasive. Applicants argue that Van Scott does not disclose treatment of Parkinson’s disease and instead relates to compounds used for treatment of Cancer. This argument is not found persuasive. The rejection does not rely on Van Scott for the therapeutic indication of Parkinson’s disease alone, but rather for the structural disclosure of N-Acyl-Cys-DOPA compounds encompassed by the claimed formula. In the present rejection, Minelli provides the teaching that L-DOPA based codrugs linked to antioxidant moieties such as cysteine are useful for treatment of Parkinson’s disease. The Examiner maintains that it would have been obvious before the effective filing date of the claimed invention to utilize Ac-Cys-L-Dopa-NH2 for treatment of Parkinson’s disease as taught by Van Scott in view of Genscript and Minelli. One of ordinary skill in the art would have been motivated to do so given that L-Dopa is a known effective treatment for Parkinson’s but has limitations given its oxidative effects. One of ordinary skill in the art would have been further motivated to use a codrug of Ac-Cys-L-Dopa for more sustained delivery reduced oxidation of L-Dopa allowing it to impart its therapeutic effects for treating Parkinson’s disease. There is a reasonable expectation of success given that co-drugs of L-Dopa (in particular with cysteine/sulfur containing compounds) are effective in sustained delivery of L-Dopa and L-Dopa is a well-known treatment for Parkinson’s disease.
Applicant argues that success in treating cancer would not predict success in treating Parkinson’s disease. This argument is not persuasive because the rejection dose not rely on the anti-cancer activity of Van Scott as evidence that that they would treating Parkinson’s disease. Instead, the motivation arises from Minelli, which teaches that L-DOPA linked to antioxidant molecules such as cysteine can reduce oxidative stress and may be useful for Parkinson’s disease therapy. Accordingly, a person of ordinary skill in the art would have recognized that compounds containing L-DOPA moiety linked to cysteine, as taught by Van Scott, would reasonably be expected to retain L-DOPA activity relevant to treatment of Parkinson’s disease.
Applicant argues that Parkinson’s disease drugs must cross the blood brain barrier whereas compounds disclosed in Van Scott are not designed to do so. Applicants arguments is not found persuasive. First, the claims do not require blood brain barrier penetration only amelioration of a symptom of Parkinson’s disease. Accordingly, arguments regarding whether particular compounds would cross the blood brain barrier are not commensurate with the scope of the claims. Moreover, obviousness requires only a reasonable expectation of success, not absolute predictability that every modification will be successful.
The cited prior art provides a rational for compounds containing L-DOPA linked to antioxidant moieties to improve delivery and stability of L-DOPA. Minelli teaches that L-DOPA co drugs linked to cysteine or related molecules can provide sustained delivery and reduced oxidative degradation. In view of this teaching, a person of ordinary skill in the art would have reasonably expected that a cysteine linked L DOPA compound, such as those disclosed in Van Scott, could provide therapeutic benefit in Parkinson’s disease. Absolute predictability with respect to blood brain barrier transport is not required to establish a reasonable expectation of success.
Applicant argues that Minelli does not indicate that modified levodopa moieties would be effective in crossing the blood brain barrier. This argument is not persuasive. Minelli teaches L-DOPA codrugs covalently linked to antioxidant molecules and proposes such compounds as useful for Parkinson’s disease. The reference further discusses sustained delivery and protection of L-DOPA from oxidative degradation. These teachings provide a reasonable rationale for modifying L-DOPA with cysteine containing moieties to improve therapeutic use. It is not required that every modified compound will cross blood brain barrier, only that a person of ordinary skill would have a reasonable expectation that such modification could provide therapeutic benefit.
Applicant argues that the field of Parkinson’s disease drug development is unpredictable. Applicant’s arguments have been considered but not found persuasive. While the art may involve some degree of unpredictability, unpredictability alone does not negate a reasonable expectation of success when the prior art provides a scientific rationale/reason supporting the claimed invention. Here, Minelli provides a clear rationale for using L-DOPA codrugs linked to antioxidant moieties such as cysteine to treat Parkinson’s disease, and Van Scott discloses compounds that include these structural features and general treatment of Parkinson’s disease. Accordingly, a person of ordinary skill in the art would have reasonably expected the claimed compounds to possess therapeutic use in treating Parkinson’s disease.
Applicant argues that the combination of Van Scott, Genscript and Minelli would not provide a reasonable expectation of success. For the same reasons stated above, this is not found persuasive. The cited references collectively teach L-DOPA cysteine codrug strategies for Parkinson’s disease (Minelli), compounds containing N-acyl-Cys-Dopa structures (Van Scott) for Parkinson’s disease, and routine peptide modification by N-terminal acetylation (Genscript). In view of these teachings, one of ordinary skill in the art would have been motivated to combine the references and would have had a reasonable expectation of success in arriving at the claimed method. There is a reasonable expectation of success given that co-drugs of L-Dopa (in particular with cysteine/sulfur containing compounds) are effective in sustained delivery of L-Dopa and L-Dopa is a well-known treatment for Parkinson’s disease (see MPEP2143.02, “Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
Conclusion
No claims are allowed.
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/ERINNE R DABKOWSKI/Examiner, Art Unit 1654