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 without traverse of the compound of Example 34 in Table 4-1 in the reply filed on November 21, 2025 is acknowledged.
The elected species has the following structural formula
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290
331
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.
This compound was not found in the prior art. The search was expanded to embrace a genus of compounds wherein in Formula I, X represents S and Y represents CR1 (thienyl group without any additional ring fusions); R3 represent -(CH2)0-3-Phenyl, optionally substituted along with the full scope of the remaining variables.
Claims 12-16 and subject matter not directed to the genus searched have been withdrawn from consideration as being drawn to non-elected subject matter.
Applicants are advised of MPEP 803.02 Restriction - Markush Claims [R - 2], fourth and fifth paragraph, where is stated:
“As an example, in the case of an application with a Markush - type claim drawn to the compound C - R, wherein R is a radical selected from the group consisting of A, B, C, D, and E, the examiner may require a provisional election of a single species, CA, CB, CC, CD, or CE. The Markush - type claim would then be examined fully with respect to the elected species and any species considered to be clearly unpatentable over the elected species. If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush - type claim and claims to the elected species shall be rejected, and claims to the non - elected species would be held withdrawn from further consideration. As in the prevailing practice, a second action on the rejected claims would be made final.” (emphasis added).
On the other hand, should no prior art be found that anticipates or renders obvious the elected species, the search of the Markush-type claim will be extended. If prior art is found that anticipates or renders obvious the Markush-type claim with respect to a non-elected species, the Markush-type claim shall be rejected and claims to the nonelected species held withdrawn from further consideration. The prior art search, however, will not be extended unnecessarily to cover all nonelected species. Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection, as by amending the Markush-type claim to exclude the species anticipated or rendered obvious by the prior art, the amended Markush-type claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during the reexamination that anticipates or renders obvious the amended Markush-type claim, the claim will be rejected and the action made final. Amendments submitted after the final rejection further restricting the scope of the claim may be denied entry.
Improper Markush Rejection
Claims 1-11, 17-19 and 25-29 are rejected under a judicially created doctrine as being drawn to an improper Markush group, that is, the claims lack unity of invention. The variables X, Y, R2 and R3 are defined in such a way that they keep changing the core of the compound that determines the classification. By changing these values, several patentably distinct and independent compounds are claimed. In order to have unity of invention the compounds must have “a community of chemical or physical characteristics” which justify their inclusion in a common group, and that such inclusion is not repugnant to principles of scientific classification” In re JONES (CCPA) 74 USPQ 149 (see footnote 2). The structural formula (I) does not have a significant structural feature that is shared by all of its alternatives which is inventive. The structure has only a fragment as common. This feature is not inventive. Compounds embraced by formula (I) are so diverse in nature that a prior art anticipating a claim with respect to one member under 35 USC 102 would not render obvious the same claim under 35 USC 103. This is evidentiary of patentably distinct and independent inventions.
Limiting the claims to the group searched would overcome this rejection.
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 1-11, 17-19 and 25-29 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.
i) In formula (I) the group “P” is present and is defined as a variable. However, in chemistry, P is already reserved to mean phosphorous. Applicants need to replace this with another symbol because this creates confusion as one skilled in the art would automatically assume that the compound is a phosphorous containing compound. Appropriate correction is required.
ii) The group “heteroaryl” is indefinite because it is not known how many atoms are present, how many and what kind of heteroatoms are involved, what size ring is intended and how many rings are present. The 4-membered heteroaryl group is not known.
iii) The group “heterocycloalkyl” is indefinite because it is not known whether a “-hetero-cycloalkyl” is intended or a saturated “heterocycle” or a “heterocycle-alkyl-“ group is intended. Applicants need to say which atoms are present and what kind of a ring (monocyclic, bicyclic, spiro, fused, bridged, saturated, etc.) is intended.
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 25-29 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention.
The how to use portion of the statute has not been addressed. This means that Applicants must teach the skilled practitioner, in this case a physician, how to treat or prevent a disease which is somehow associated with prostaglandin E2 overexpression and/or prostaglandin E2 receptor overexpression in a given subject. The physician clearly must know what diseases and what symptoms are to be treated or prevented. In this case, Applicants have not provided what is being treated or prevented, who the subject is who needs treatment or prevention, how one can identify said subject (i.e. how one can identify a subject who needs prevention), given no specific dose, given no specific dosing regimen, given no specific route of administration, and do not specify what diseases or symptom they intend to treat.
Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
As the Supreme Court said in Brenner v. Manson, 148 USPQ at 696: “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” As U.S. Court of Customs and Patent Appeals stated In re Diedrich 138 USPQ at 130, quoting with approval from the decision of the board: “We do not believe that it was the intention of the statutes to require the Patent Office, the courts, or the public to play the sort of guessing game that might be involved if an applicant could satisfy the requirements of the statutes by indicating the usefulness of a claimed compound in terms of possible use so general as to be meaningless and then, after his research or that of his competitors has definitely ascertained an actual use for the compound, adducing evidence intended to show that a particular specific use would have been obvious to men skilled in the particular art to which this use relates.”
Claim 26 is drawn to the treatment or prevention of cancer, a neurodegenerative disease or an inflammatory disease.
The specification does not provide enablement for the treatment or prevention of cancer generally. No compound has ever been found that can treat, much less prevent, cancers generally even though massive efforts have been directed towards this end. Since this assertion is contrary to what is known in oncology, proof must be provided that this revolutionary assertion has merits. Nearly all anticancer drugs are effective against treating only a limited group of related cancers. Therefore, a compound effective against cancer generally would be a revolutionary exception. Applicant is asserting that he succeeded where others have failed. Where extensive efforts have all failed, it is reasonable for the Patent and Trademark Office to require proof that the claimed invention actually works for this specific utility. It is well established that a utility rejection is proper when scope of enablement is not reasonably correlated to the scope of the claims. (In re Vaeck 20 USPQ2d 1439, 1444, In re Ferens 163 USPQ 609).
For example, Vaeck refers to “the relatively incomplete understanding of the biology of cyanobacteria.” To say that the understanding of chemo - prevention is “incomplete” would be an understatement.
It has been recited in claim 26, a method of treating or preventing a neurodegenerative disease. There is no such an agent, which can treat or prevent neurodegenerative diseases generally. That is because neurodegenerative disorders are extremely varied in origin and nature of effect. The origin and the nature of many neurodegenerative diseases, such as, Huntington’s disease, Pick’s disease, Frontotemporal dementia, Cerebro-Oculo-Facio-Skeletal (COFS) syndrome (cranofacial and skeletal abnormalities), Motor neuron disease (muscle weakness), Corticobasal ganglionic degeneration, Creutzfeldt-Jacob disease (fatal disease), Dementia with Lewy bodies, and Progressive supranuclear palsy Dementia are different one from the other. Many neurodegenerative disorders are untreatable to this day.
The symptoms and nature of these diseases are also different one from the other. It can be shown that many of these neurodegenerative diseases have different origin and nature of effect. Some neurodegenerative diseases are hereditary (Charcot-Marie-Tooth disease). Many neurodegenerative diseases vary in how they affect the body and its functions. Diseases such as Cerebral palsy and Parkinson’s disease affect the movement of the patient. Diseases such as Alzheimer’s disease affect the memory of the patient.
Inflammation is a process that can take place in virtually any part of the body. There is a vast range of forms that it can take, causes for the problem, and biochemical pathways that mediate the inflammatory reaction. There is no common mechanism by which all, or even most, inflammations arise. Mediators include bradykinin, serotonin, C3a, C5a, histamine, leukotrienes, cytokines, and many, many others. Accordingly, treatments for inflammation are normally tailored to the particular type of inflammation present, as there is no, and there can be no “magic bullet” against inflammation generally.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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February 20, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624