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
This office action is in reply to the applicant’s response to a restriction response, filed on 22 January 2026, for the application filed on 15 June 2023. Claims 18, 20-26, and 30-40 are canceled. Claims 19 and 27-29 are amended. Claims 41-66 are new. Currently, claims 1-17, 19, 27-29, and 41-66 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement filed 10 October 2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. The non-patent literature document cited number 1, Japanese patent office ISR in IPA No. PCT/JP2023/022253 (August 8, 2023), 4 pages, has no English copy or abstract provided despite an English language translation being indicated in the form.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 22 January 2026 is acknowledged.
Applicant’s election without traverse of compound 57, illustrated below, in the reply filed on 22 January 2026 is acknowledged:
PNG
media_image1.png
134
231
media_image1.png
Greyscale
The elected species was searched and found to be free of the prior art.
Applicant’s election without traverse of thrombosis as a single species of disease/disorder/condition in the reply filed on 22 January 2026 is acknowledged.
Claims 3-9, 19, 27-29, 42-49 and 51-66 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 January 2026.
The search was expanded to the full scope of the claims. The closest match are structures described by Rosenblum et al. (Synthesis of dihydrooxadiazinones and study of geometrical isomerism in α-ketol carbethoxyhydrazones, JACS Legacy, 1963, 85, 3874-3878), Ellermann et al. (Dihydrooxadiazinones for the treatment of hyperproliferative diseases, WO 2020/157188 A1, 2020), and Metrick. (Human PLD structures enable drug design and characterization of isoenzyme selectivity, Nat. Chem. Biol. 2020, 16, 391-399, entered in IDS on 10 October 2023) as described by III-f, formula (I), and compound 5, respectively:
PNG
media_image2.png
152
278
media_image2.png
Greyscale
PNG
media_image3.png
254
263
media_image3.png
Greyscale
PNG
media_image4.png
160
301
media_image4.png
Greyscale
Here in formula (I), R1 can be a cyano group, R2 can be a halogen atom (Br), R3 is selected from substituents that do not include hydrogen, and R4 is a hydrogen atom or C1-C3 alkyl group. While compound 5 does not contain the correct substructures, the relative correct connections can be observed.
Claims 1, 2, 10-17, 41, and 50 encompass the elected species and will be examined.
Claim 41 is allowable. The restriction requirement between Groups I and III, as set forth in the Office action mailed on 23 October 2025, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 23 October 2025 is partially withdrawn. Claims 3-9, 19, 27-29, 42-49 and 51-66 are no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or non-statutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Rejections - 35 USC § 112
Claims 29, 62 and 66 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
A review of the rejected claim language indicates that these claims are drawn toward “a method for treating or preventing a disease from the group consisting” in this case, thrombosis, by species election, “comprising administering a therapeutically effective amount of a compound as defined in claim 1, or a pharmaceutically acceptable salt thereof to the mammal” in the case of claim 29. Similar language is utilized in claims 62 and 66. A description of the term “a method of treating or preventing a disease or disorder…” may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B (1), the court states “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention”. Hence, an adequate written description of the components requires more than a mere statement that it is part of the invention. The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984). In Applicant’s originally filed specification, background art, expounds upon thrombus formation including three important factors specified to be changes in blood components, changes in properties of vascular wall, and changes in blood flow. The specification also identifies that arterial blood flow is laminar and therefore platelet aggregation primarily occurs near the vascular wall and one means of triggering this aggregation is arteriosclerotic plaque rupture, which is further compounded by platelet activation signaling, i.e. von Willebrand factor and collagen interaction. The applicant also notes in the instant specification that there are many factors that activate platelets and induce platelet aggregation, but all aggregation is terminally characterized by the cross-linking of platelets. As such, drugs whose mechanism of action interferes with the signaling pathway of platelet activation carry a bleeding risk. The applicant also describes PLD1 and PLD2, enzymes that contribute to various signaling pathways with regulatory and functional properties such as cell proliferation, cell death and inflammation, having phenotypic anti-thrombotic effects in in vitro murine cell knock-out experiments. Additionally, the specification notes that activation of PLD1 and PLD2 are thought to contribute to a number of pathologies with over-expression and increase activities being observed in a number of cancers. However, the applicant only demonstrates applications in two instances: biochemical inhibition of the full-length human PLD1 and PLD2 proteins derived from encoded HEK-293 derived expi293f cells. Applicant does not demonstrate that the product is capable of the claimed method of “treating or preventing the disease of thrombosis” to the breadth and scope of which broadest reasonable interpretation requires. The limited biochemical data leads one to conclude that the applicant was not in possession of a method of treating or preventing thrombosis. Estevez et al. (New concepts and mechanisms of platelet activation signaling, Physiology 2017, 32, 162-177) teaches that thrombosis, and therefore platelet aggregation, is the product of numerous factors, has different etiologies such as injury or trauma, medical conditions, lifestyle influences, and genetic predispositions. These idiopathic factors undermine the concept that biochemical results are prophetic to the final therapeutic application of the invention in a mammal. Whether the specification shows that the inventor was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structures, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. “In contrast, for inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predicable which are known to one of ordinary skill in the art, more evidence is required to show possession”. One of skill in the art would not recognize from the disclosure that the applicant was in possession of “a method of treating or preventing a disease…” as claimed.
Additionally, it is also known that there are significant challenges translating biochemical, in vitro, and in vivo studies to a clinical setting, and that not all biochemical, in vitro and in vivo studies can be directly translated to the clinical setting. Indeed, J. M. McKim (Building a tiered approach to in vitro predictive toxicity screening: a focus on assays with in vivo resistance, Combo. Chem. & High Throughput Scr. 2010, 13, 188-206) emphasizes a truism of the pharmaceutical industry that persists to this day, is the failure of over 90% of promising new drug candidates due to unanticipated adverse effects or a lack of efficacy in humans, contrary to anticipated results based on prior biochemical, cell, or animal models (Introduction). As the specification discloses working examples only performed biochemically, one of skill in the art would not recognize that the Applicant was in possession of “a method of preventing or treating thrombosis” in an in vivo, much less a clinical, setting.
Claims 29, 62 and 66 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 treating thrombosis by inhibiting purified full-length human PLD1 and PLD2 proteins, does not reasonably provide enablement for treating thrombosis in a mammal, comprised of administering “a compound”. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
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) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.01 (a).
Upon consideration of the factors discussed below, the examiner concludes that one skilled in the art could not practice the invention without being burdened with undue experimentation based on the information provided by the applicant. A discussion of these factors as they relate to the pending claims is as follows:
(A) Breadth of claims & (B) nature of invention –
The applicant’s claims are broad. For example, claim 29 is directed to “ a method of treating or preventing a disease, selected to be thrombosis…, comprising the step of administering a therapeutically effective amount a compound to a mammal” As the genus of mammal is very broad, including not only animals that are commonly used for laboratory testing such as mice, rats, dogs of various breeds, pot-bellied pigs and monkeys, but can very obviously include humans along with any number of other uncommon possibilities such as bears, whales, elephants, etc. While the Applicant discloses the potential application of the product in the inhibition of purified PLD1 and PL2 enzymes, they are not unto themselves demonstrative single agent means of treating thrombosis. For example, Estevez et al. (New concepts and mechanisms of platelet activation signaling, Physiology 2017, 32, 162-177) teaches that platelet activation requires intracellular signal transduction initiated by platelet receptors for adhesion proteins and soluble agonists that, at the time of publication, was described as an increasingly complex and sophisticated picture of platelet signaling and amplification network. Estevez divides platelet activation signaling into four phases including 1) divergent early receptor signaling induced by not only classic soluble platelet agonists but also adhesion receptor ligands and inflammatory stimuli, 2) convergence of early signaling pathways on common intermediates and signal amplification networks, 3) inside-out signaling leading to activation of the main platelet adhesion receptor, the integrin αIIbβ3, which mediates stable platelet adhesion and aggregation, and 4) integrin outside-in signaling, which greatly amplifies platelet activation and thrombus size. (pg. 1). Indeed, the Applicant themselves note that thrombosis is influenced by several factors including physiological and signaling factors. As the specification discloses working examples only performed in biochemical assays, one of ordinary skill in the art would not recognize that the evidence provided by the Applicant in the instant specification is “a method of preventing or treating thrombosis” and can be used to prevent and treat the possible breadth of what is a diverse disease that appears to arise from multiple factors and pathways.
(C) The state of the prior art –
The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification. See MPEP § 2164.05(a). As taught by Estevez, thrombosis and therefore platelet aggregation is the product of numerous factors, has different etiologies such as injury or trauma, medical conditions, lifestyle influences, and genetic predispositions. Therefore, it is reasonable to conclude that the current state of the art is highly unpredictable, indicating that more details, working examples, and guidance would be required to practice the invention as disclosed for treating and/or preventing thrombosis as claimed.
(D) The level of one of ordinary skill in the art - MPEP 2141.03 states (in part), “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art' to which the claimed subject matter pertains would, of necessity, have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) disagreeing with the examiner' s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering).
These hurdles render application of “a method for preventing or treating thrombosis comprising the step of administering a therapeutically effective amount of a compound” to a very high level of unpredictability. The lack of significant guidance from the present specification makes practicing the claimed invention unpredictable. Where the predictability in the art is low, the Applicant is required to provide greater disclosure and guidance to comply with the enablement requirement. MPEP § 2164.03.
(E) Existence of working examples & (F) amount of direction or guidance by the inventor –
As previously established by Estevez, thrombosis and therefore platelet aggregation is a complex and sophisticated process. Conversely, the specification does not demonstrate, also as previously established, a means to prevent or treat thrombosis generally in possible etiologies in all mammals, instead only providing results of biochemical inhibition of PLD1 and PLD2 enzymes. Therefore, the applicant has not provided sufficient guidance to enable one of skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims.
(G) Quantity of experimentation needed to make or use the invention –
Taken together, the prior art demonstrates that the disease of thrombosis, arises from multiple factors and etiologies. This covers a breadth and scope of material that is far from adequately addressed in the instant specification. While the specification demonstrates inhibition on the specific enzymes, it does not demonstrate how “a compound” would be able to matriculate into a preclinical candidate, much less a new investigational drug with a reasonable chance of success to reach the status as a demonstrative drug containing therapeutically efficacious properties. Even if the compound was not being considered from human treatment, there are, as established by McKim, numerous hurdles that must be overcome for use in the broad category of mammals including the most basic of demonstrating efficacy in vitro and in vivo, which is not a guaranteed, linear progression. This constitutes undue experimentation. Therefore, the lack of working examples commensurate in scope to the claimed invention and the unpredictability in successful application as described by claims 29, 62 and 66, and as described in the specification, as filed, does not provide enablement for the claimed method of use.
In conclusion, the claimed invention does not provide enablement for the application in the method of use in preventing or treating thrombosis. Thus, for the reasons outlined above, the specification is not considered to be enabling for one skilled in the art to make and use the claimed invention as the amount of experimentation is undue, due to the broad scope of the claim, the lack of guidance and working examples provided in the specification. Therefore, the specification is not representative of the instant claims and the specification is not fully enabled for the instant claims. In view of the above, one of ordinary skill in the art would be forced into undue experimentation to practice the claimed invention.
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 (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 non-obviousness.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Metrick. (Human PLD structures enable drug design and characterization of isoenzyme selectivity, Nat. Chem. Biol. 2020, 16, 391-399, entered in IDS on 10 October 2023) in view of Ellermann et al. (Dihydrooxadiazinones for the treatment of hyperproliferative diseases, WO 2020/157188 A1, 2020) and Waterson et al. (Isoforms selective PLD inhibition by novel, chiral 2,8-diazaspiro[4.5]decan-1-one derivatives, Bioorg. Med. Chem. Lett. 2018, 28, 3670-3673).
Metrick discloses compound 5, a spiro carbamate that reads on formula (Ia) where R1a is phenyl substituted by one halogen, (R2a)m is a halogen where m is one, R3a is C-1 alkyl, R4a is hydrogen, R6a is hydrogen, Aa is nitrogen, A2a is CH2, R7a is hydrogen, R8a is hydrogen, Cya is aryl, and R9a is hydrogen, as illustrated below.
PNG
media_image4.png
160
301
media_image4.png
Greyscale
This spiro-carbamate scaffold, with a novel 6-membered A-ring, differs from other known PLD1/PLD2 inhibitors, such as those taught by Waterson, i.e. compounds ML299, a dual PLD1/PLD2 inhibitor, and ML395, a PLD2 selective inhibitor, as illustrated below:
PNG
media_image5.png
271
668
media_image5.png
Greyscale
Waterson notes that this series, while potent inhibitors, characteristically exhibits high plasma protein binding, high hepatic clearance in rat, and short in vivo half-lives, inviting new structural motifs to overcome these deficiencies. Metrick characterizes both 5- and 6-member cores by single crystal x-ray diffraction, highlighting a different trajectory of the B-ring as expected of an sp3 attachment compared to the sp2 nitrogen and potentially a loss of interaction with residues W381 or W364 as the structure transitions from 5- to 6-member rings, as illustrated in the crystal structures below:
PNG
media_image6.png
377
597
media_image6.png
Greyscale
Metrick, however, does not disclose a dihydrooxadiazinone core.
This deficiency is rectified by Ellermann, who teaches the use of dihydrooxadiazinone containing compounds represented by formula (I) as inhibitors against cancer target PDE3, as illustrated below:
PNG
media_image3.png
254
263
media_image3.png
Greyscale
As such, it would have been prima facie obvious, to a person of ordinary skill in the art, at the time of filing, to consider the use of a dihydrooxadiazinone core, demonstrated to be a moiety viable in pharmaceutical therapies applied to a cancer related target by Ellermann, to recapture the sp2 character of the dihydrooxadiazinone-aryl bond and the associated B ring orientation which, as observed in crystal structure d with compound ML299, could potentially interact with either residue W364 or W381 in a π- π interaction as demonstrated by Metrick.
Claims 19, 59 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Metrick, Ellermann and Waterson as applied to claims 1-9 above, and further in view of Allen et al. (Ansel’s pharmaceutical dosage forms and drug delivery systems 10th ed., Wolters Kluwer Health, copyright 2014).
Metrick discloses compound 5, a spiro carbamate structure that reads on formula (Ia) except for the absence of a dihydrooxadiazinone core. Waterson discloses structures ML299 and ML395, known potent PLD1/2 and PLD2 inhibitors, which is characterized along with compound 5 by Metrick, in which a change in conformer of ring B can be observed due to a change of sp2 to sp3 bonding. Ellermann teaches dihydrooxadiazinone core structures with a similar substitution pattern that is demonstratively applicable to treating cancer related scenarios, giving a two-fold impetus of utilizing a dihydrooxadiaizone core for the proven therapeutic component and as a means to recover a lost substrate-residue interaction by reintroducing a sp2 bond.
Metrick, Ellermann and Waterson do not, however, teach a pharmaceutical composition or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier.
Allen rectifies this deficiency by extensively covering many topics within the field of drug formulation, including, but not limited to, typical properties of many excipients, incompatibilities, safety, related substances, among others. As such, it would have been prima facie obvious, to a person of ordinary skill in the art, to explore well known and documented excipients and other factors associated with drug formulation to develop a pharmaceutical composition using well established literature that is exemplified by Allen.
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Metrick, Ellermann, and Waterson as applied to claims 1-9 above, and further in view of Beelen and Strum (G1T38 superior dosage regimes, US 2020/0405721 A1, 2020).
Metrick discloses compound 5, a spiro carbamate structure that reads on formula (Ia) except for the absence of a dihydrooxadiazinone core. Waterson discloses structures ML299 and ML395, known potent PLD1/2 and PLD2 inhibitors, which is characterized along with compound 5 by Metrick, in which a change in conformer of ring B can be observed due to a change of sp2 to sp3 bonding. Ellermann teaches dihydrooxadiazinone core structures with a similar substitution pattern that is demonstratively applicable to treating cancer related scenarios, giving a two-fold impetus of utilizing a dihydrooxadiaizone core for the proven therapeutic component and as a means to recover a lost substrate-residue interaction by reintroducing a sp2 bond.
Metrick, Ellermann and Waterson do not, however, teach administering a therapeutically effective amount of a compound as defined in claim 1 for inhibiting PLD1 or PLD1/2 in a mammal.
Beelen and Strum address this by teaching that pharmaceutical compositions can be formulated for oral administration and can contain any amount of active compound that achieves the desired result, e.g. between 0.1% and 99% w./w. of the compounds and usually at least about 5 wt. % though some embodiments contain at least about 10%, 15%, 25%, 25 wt. % to about 50 wt. % or from about 5 wt. % to about 75 wt. % of the active compound (para. 135). While Beelen and Strum do not explicitly teach inhibiting PLD1 or PLD1/2, the compounds as derived from formula (Ia) are proposed to have such properties in the instant application and would therefore inherently do so, meeting the limitation of claims 27-28.
As such, it would have been prima facie obvious, to a person of ordinary skill in the art, to consider utilizing a therapeutically effective amount of a compound as defined in claim 1 for inhibiting PLD1 in a mammal.
Allowable Subject Matter
Claims 10-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 41-49, 50-58, 60-61 and 64-65 are allowed.
Reasons For Allowance
The following is an examiner’s statement of reasons for allowance: the following is a statement of reason for the indication of allowable subject matter: structure as defined by compound 57 and other analogous structures in claims 41-49 were not taught in the prior art in a 100% embodiment. The closest match are disparate structures as disclosed by Rosenblum et al. (Synthesis of dihydrooxadiazinones and study of geometrical isomerism in α-ketol carbethoxyhydrazones, JACS Legacy, 1963, 85, 3874-3878), Ellermann et al. (Dihydrooxadiazinones for the treatment of hyperproliferative diseases, WO 2020/157188 A1, 2020), and Metrick. (Human PLD structures enable drug design and characterization of isoenzyme selectivity, Nat. Chem. Biol. 2020, 16, 391-399, entered in IDS on 10 October 2023) without encompassing all aspects. No examples of connected structures were found in the prior art search.
As the claimed compounds are, as described by the instant specification, as enabled in inhibiting PLD1 and PLD2, claims 60-61, dependent on claims 41-49, are allowed. Claims 50-58 are substantially similar structures to those in claims 40-49, but further limit the claims through claiming the free base. Claims 64-65, similarly to claims 60-61 enabled in inhibiting PLD1 and PLD2, dependent on claims 50-58, are allowed.
Therefore, the prior art neither anticipates nor reasonably makes obvious the claimed invention and therefore, the claimed invention is deemed novel and unobvious over the prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Summary
Claims 29, 62 and 66 are rejected under 35 U.S.C. 112(a). Claims 1-9, 19, 27-29, 59 and 63 are rejected under 35 U.S.C. 103. Claims 10-17 are objected as being allowable but dependent upon a rejected base claim. Claims 41-49, 50-58, 60-61 and 64-65 are allowable.
Conclusion
Claims 1-9, 19, 27-29, 59, 62-63 and 66 are rejected. Claims 10-17 are objected to. Claims 41-49, 50-58, 60-61 and 64-65 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allen Chao whose telephone number is (571)272-7001. The examiner can normally be reached Monday - Friday 0700-1300.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALLEN CHAO/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622