DETAILED ACTION
Claims 1-18 are currently pending in the instant application.
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 .
Election/Restrictions
Applicant's election with traverse of species compound B-2
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in the reply filed on 12/10/2025 is acknowledged. Applicant has not provided a reason for the traversal.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
Applicant's elected species appears allowable over the prior art of record. Therefore, the search of the Markush-type claim has been extended to the non-elected species of
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. During the search, additional art has been identified as discussed below.
As prior art has been found which anticipates the above identified nonelected species, the Markush-type claims are rejected as follows and the subject matter of the claims drawn to nonelected species held withdrawn from consideration. Claims 1-18 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since art was found on the nonelected species, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
The remaining subject matter of claims 1-18 that are not drawn to the above elected invention stand withdrawn under 37 CFR 1.142(b) as being non-elected subject matter. The remaining compounds which are not within the elected invention are independent and distinct from the elected invention as they differ in structure and composition. Therefore the compounds, which are withdrawn, have been restricted as the withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference, which anticipates one group, would not render obvious the other. Thus all claims containing compounds falling outside the search strategy of the elected compound and structure shown above are heretofore directed to non-elected subject matter and are withdrawn from consideration under 35 U.S.C. § 121 and 37 C.FR. § 1.142(b). A complete reply to the non-final rejection must include cancellation of non-elected claims include cancellation of non-elected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b). If one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Priority
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Information Disclosure Statement
Applicant's Information Disclosure Statements filed on 02/10/2023 and 01/05/2026 have been considered. Please refer to Applicant's copies of the 1449 submitted herewith.
Claim Objections
Claims 9 and 16 are objected to because of the following informalities: They do not end in a period. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 11-18 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 treatment of a condition, disease or disorder that is associated with the MRGPRX4 receptor, does not reasonably provide enablement for prevention of a condition, disease or disorder that is associated with the MRGPRX4 receptor. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims. The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988).
In In re Wands. 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The nature of the invention
In the instant case, the nature of the invention is for prevention of a condition, disease or disorder that is associated with the MRGPRX4 receptor.
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening invitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can prevent a condition, disease or disorder that is associated with the MRGPRX4 receptor). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that that contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any preventive regimen on its fact.
The instant claimed invention is highly unpredictable as discussed below:
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427F.2d833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. The burden of enabling one skilled in the art to prevent a condition, disease or disorder that is associated with the MRGPRX4 receptor would be much greater than that of enabling the treatment of a condition, disease or disorder that is associated with the MRGPRX4 receptor. In the instant case, the specification does not provide guidance as to how one skilled in the art would accomplish the objective of preventing a condition, disease or disorder that is associated with the MRGPRX4 receptor. Nor is there any guidance provided as to a specific protocol to be utilized in order to show the efficacy of the presently claimed active ingredients for preventing a condition, disease or disorder that is associated with the MRGPRX4 receptor.
"To prevent" actually means to anticipate or counter in advance, to keep from happening etc. (as per Webster's II Dictionary) and there is no disclosure as to how one skilled in the art can reasonably establish the basis and the type of subject to which the instant compounds can be administered to order to have the "prevention" effect. There is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with a condition, disease or disorder that is associated with the MRGPRX4 receptor in general. Since applicants "preventive" assertion is contrary to what is known in medicine, proof must be provided that this revolutionary assertion has merits.
The amount of direction or guidance present and the presence or absence
of working examples
The specification does not provide examples of prevention of a condition, disease or disorder that is associated with the MRGPRX4 receptor. It discusses several assays use to determine potency of the compounds in activating the human wild-type MRGPRX4 (see Tables 1-4, p. 140-146).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure, specifically, the instant claims include prevention of a condition, disease or disorder that is associated with the MRGPRX4 receptor. However the specification only provides evidence that the compounds activate the MRGPRX4 receptor.
The quantity or experimentation needed and the level of skill in the art
It would require undue experimentation of one of ordinary skill in the art to ascertain the effectiveness of the compound in prevention of a condition, disease or disorder that is associated with the MRGPRX4 receptor. Factors such as "sufficient working examples", "the level of skill in the art" and "predictability", etc. have been demonstrated to be sufficiently lacking in the instant case for the compound with intended use claims. Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, it is apparent that undue experimentation is necessary because of variability in prediction of outcome that is not addressed by the present application disclosure, examples, teaching and guidance presented. Absent factual data to the contrary, the amount and level of experimentation needed is undue.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 11-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). Description of examples and preferences is properly set forth in the specification rather than in a single claim. A narrower range of preferred embodiment may also be set forth in another independent claim or in a dependent claim. If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim. See MPEP 2173.05(c),(d).
In the present instance, claim 4 recites the broad recitation “R1 represents -C1-10-alkyl, optionally substituted with -C≡CH; or…” and the claim also recites “preferably -C1-6-alkyl” and “more preferably -CH2CH3.” Further instances of the term “preferably” are found in R3, R7 and R8 of claim 4.
Claims 11-12, 14 and 17 also recites the term “preferably associated with the wildtype of the MRGPRX4 receptor”. Further claim 17 states “open wounds; preferably selected from the group consisting of” as well as “closed wounds; preferably selected from the group consisting of hematomas and crash injuries”. Claims 13, 15, and 16 depend from claim 12 and do not clarify the indefiniteness issue of claim 12.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4 and 14 are rejected 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. Claim 4 states that R8 represents aryl and claim 4 depends on claim 1. However claim 1 does not state that R8 may be aryl. Thus claim 4 is broader in scope than claim 1, the claim upon which it depends.
Further claim 14 states that (iv) R3 represents -C1-10-alkyl-O-C(=O)C1-10-alkyl, and claim 14 depends on claim 12. Claim 12 states that
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and does not recite that R3 represents -C1-10-alkyl-O-C(=O)C1-10-alkyl. Thus claim 14 contains subject matter not within scope than claim 12, from which claim 14 depends.
Applicant may cancel the claim 14, amend the claim to place it in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Casanovas et al (see WIPO Pub No. 2016/142486, pub. 09/15/2016). Casanovas et al teaches compound
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(see p. 20). This corresponds to a compound of Formula 1 wherein R1 is H, R3 is C1-10-alkyl-P(=O)(OH)2, R7 and R8 are H.
Regarding claims 10-11, according to MPEP 2111.02, Section II, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention' s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”).
In re Tuominen (213 USPQ 89) states the following:
The composition is the same no matter what its intended use is, and consequently, the appealed claims are not seen to distinguish over the art which also discloses a composition of the recited active ingredient. We will not construe the instant claims to be limited to compositions also containing other ingredients usually utilized in sunscreening compositions merely by the fact that the introductory clause of the claims recites a different contemplated utility for the claimed composition not taught by the art. Rather, as done by the Examiner, we interpret the claims to be drawn to a composition of the active ingredients, per se, and, as such, under the rationale of Pearson, they fail to distinguish over the references.
The compounds of Casanovas et al correspond to the same compound described in claims 10-11. As the preamble of claims 10-11 merely recite the intended use of the compound, the compounds of Casanovas et al would anticipate claims 10-11.
Claims 4 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shen et al (see Acta Pharmacologica Sinica, 2013, Vol. 34, p. 441-452). Shen et al teaches compound
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(see Scheme 1, p. 443) which corresponds to a compound of Formula 1 wherein R1 is C1-10 alkyl, R3 is C3-5-alkyl-C(=O)(OH), R7 is H, R8 is aryl.
The compounds of Shen et al correspond to the same compound described in claims 10-11. As the preamble of claims 10-11 merely recite the intended use of the compound, the compounds of Shen et al would anticipate claims 10-11.
Claims 1-3, 5-7, 10-13 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leyland-Jones et al (see WO 2000/0055624, pub. 09/21/2000). Leyland-Jones et al teaches compounds
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(see Drawings, Sheet 2 of 10). This corresponds to a compound of Formula I of claims 1 and 12 wherein R3 is -C1-10-alkyl-C(=O)(OH), R1 is C1-10-alkyl, R7 is C1-10-alkyl and R8 is H.
Regarding the intended use of claims 10-13 and 17-18, according to MPEP 2111.02, Section II, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention' s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”).
In re Tuominen (213 USPQ 89) states the following:
The composition is the same no matter what its intended use is, and consequently, the appealed claims are not seen to distinguish over the art which also discloses a composition of the recited active ingredient. We will not construe the instant claims to be limited to compositions also containing other ingredients usually utilized in sunscreening compositions merely by the fact that the introductory clause of the claims recites a different contemplated utility for the claimed composition not taught by the art. Rather, as done by the Examiner, we interpret the claims to be drawn to a composition of the active ingredients, per se, and, as such, under the rationale of Pearson, they fail to distinguish over the references.
The compounds of Leyland-Jones et al correspond to the same compound described in claims 10-13 and 17-18. As the preamble of claims 10-11 recite the intended use of the compounds while claims 12-13 and 17-18 recite the intended use of the compound, the compounds of Leyland-Jones et al would anticipate claims 10-13 and 17-18.
Claim(s) 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CA Reg No. 841313-38-0, entered into STN on 03/03/2005. CA Reg No. 841313-38-0 corresponds to
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which is a compound wherein R3 is C1-10-alkyl-O-C(=O) C1-10-alkyl, R1, R7 and R8 are H or C1-10-alkyl. Regarding the intended use of the compound, In re Tuominen (213 USPQ 89) states the following:
The composition is the same no matter what its intended use is, and consequently, the appealed claims are not seen to distinguish over the art which also discloses a composition of the recited active ingredient. We will not construe the instant claims to be limited to compositions also containing other ingredients usually utilized in sunscreening compositions merely by the fact that the introductory clause of the claims recites a different contemplated utility for the claimed composition not taught by the art. Rather, as done by the Examiner, we interpret the claims to be drawn to a composition of the active ingredients, per se, and, as such, under the rationale of Pearson, they fail to distinguish over the references.
Thus, the compound of CA Reg No. 841313-38-0 anticipates the compound of claim 14.
Allowable Subject Matter
Claim 8 is 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623