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
RESPONSE TO ELECTION/RESTRICTION
Applicant’s election without traverse of:
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as the elected species in the reply filed on 8/11/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 63-65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
An action on the merits of claims 57-62 and 66-75 is contained herein. Applicant’s elected species was found free of the art and the search extended to cover a proper Markush grouping as that in claim 62.
Priority
This application is continuation of Serial No. 17/393,463, filed 8/4/2021 which is a continuation of 15/446,500, filed March 1, 2017, which was a divisional of Serial No. 14/559,294, filed December 3, 2014, which claimed the benefit under 35 U.S.C. §119(e) of Serial No. 61/912,074, filed December 5, 2013. Benefit for the provisional application is not accorded since subject matter disclosed within the instant application is not supported (e.g. method of treating/preventing alopecia using the claimed compounds). The claims in a U.S. application are entitled to the benefit of a foreign priority date or the filing date of a provisional application if the corresponding foreign application or provisional application supports the claims in the manner required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993); Kawaiv.Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989).
Claim Objections
Claims 69 and 74 are objected to because they should end with periods and not commas. Claims should only begin with a capital letter and end with a period. See MPEP 608.01(m). Correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 57-62 and 66-75 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 of US Patent 12,077,533. Although the conflicting claims are not identical, they are not patentably distinct from each other because there is significant overlap between the two applications.
The method of treating/preventing autoimmune alopecia using the genus structure of claim 57 in the instant application may fully encompass the method of treating alopecia using the subgenus of compounds (see claim 1) in ‘533. Both applications even recite the method of treating alopecia with the elected species (see claim 2 in patent and claim 66 in instant application). Note that there is no patentable distinction between autoimmune alopecia and alopecia as they are considered synonymous in the art as both being autoimmune disorders.
Specification
Applicant is reminded of the proper content of an Abstract of the Disclosure, see MPEP 608.01(b).
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., "The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics." Exemplification of a species could be illustrative of members of the class. For processes, the type reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
It is recommended that the structure of claim 62 be inserted into the abstract to accurately illustrate the claimed invention.
Claim Rejections – Improper Markush Grouping Rejection
Claims 57-61 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives.
A proper Markush group possesses species which share a “single structural similarity” and a common use which is derived from the substantial structural feature. See MPEP 803.02 and Ex Parte Hozumi, 3 USPQ2d 1059 (B.P.A.I. 1984). In the aforementioned claims, the instantly claimed Markush group in claim 24 may encompass a number of independent/distinct cores which do not have a common structure and are not recognized equivalents to those skilled in the art. Thus, these claims are properly rejected under the judicially approved “improper Markush grouping” doctrine, see Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. § 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011) and MPEP 706.03(y).
In re Harnish, 206 USPQ 300, 305, says, “ …we think it should be clear from our actions in Weber and Haas II that we there recognized the possibility of such a thing as an "improper Markush grouping." The court went on to reverse the rejection, (which had been made by the Board under Rule 196(b)) but not on the lack of a specific statutory basis but rather, “Clearly, they are all coumarin compounds which the board admitted to be "a single structural similarity." We hold, therefore, that the claimed compounds all belong to a subgenus, as defined by appellant, which is not repugnant to scientific classification (see claim 1 below for pictorial example):
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.
Under these circumstances we consider the claimed compounds to be part of a single invention so that there is unity of invention…” Thus, the rejection was overturned because of the specific facts in the case. The Markush group was held proper in that case, as was the case also in Ex parte Price 150 USPQ 467, Ex parte Beck and Taylor, 119 USPQ 100, and Ex parte Della Bella and Chiarino 7 USPQ2d 1669. Cases where the Markush group was held improper include Ex Parte Palmer, 7 USPQ 11, In re Winnek, 73 USPQ 225, In re Ruzicka, 66 USPQ 226, Ex parte Hentrich, 57 USPQ 419, Ex parte Barnard, 135 USPQ 109, Ex parte Reid, 105 USPQ 251, Ex parte Sun and Huggins, 85 USPQ 516, In re Thompson and Tanner, 69 USPQ 148, In re Swenson, 56 USPQ 180, and In re Kingston, 65 USPQ 371.
Indeed, as was stated in Ex parte Haas, 188 USPQ 374, “The rejection of a claim as containing an improper Markush grouping has a relatively long history in Office practice. The Court of Customs and Patent Appeals, at least as far back as 1942, has recognized that a rejection may be based upon the Examiner's holding that the claim has an improper Markush group. See In re Swenson, 30 CCPA 764, 132 F.2d 336, 56 USPQ 180, citing Ex parte Palmer, 398 OG 707, 1930 CD 3.”
It should be noted that in Harnish, there was a single heterocyclic core and that the claimed compounds all belong to a subgenus. That is exactly what is lacking in this case, as each groups represents a different heterocyclic core. The formula is shown below:
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A myriad of heterocycles (e.g. pyrrolo[2,3-d]pyrimidines, pyrrolo[2,3-b]pyrazines, etc.) may be encompassed by the above genus and clearly classifying each group as one subgeneric group would be repugnant to scientific classification.
The examiner recommends that the claims should be amended to include only species that share a single structural similarity and a common use (e.g. drawn to compounds of the formula shown in claim 62) to overcome the rejection.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 57-62 and 66-75 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 alopecia using the claimed compounds containing a proper Markush grouping, does not reasonably provide enablement for preventing alopecia using the full scope of compounds claimed. 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 and use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required:
(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.
Some experimentation is not fatal; the issue is whether the amount of experimentation is "undue"; see In re Vaeck, 20 USPQ2d 1438, 1444. Analysis is described below:
(A) Breadth of claims: The formula in claim 57 is drawn to a myriad of substituents that vary independently and lead to compounds of a wide variety of structures. These compounds encompass molecules that widely vary in the physical and chemical properties such as size, molecular weight, acidity, basicity, and properties that are known in the art to greatly influence pharmacokinetic and pharmacodynamic parameters, not to mention the ability to productively bind to claimed biological target molecules. The claims cover compounds easily in the millions given the number of possible rings, ring systems covered by the claims' scope along with varying choices for remaining variables; thus the claims are very broad.
(B) The nature of the invention:
(C),(F),(G) Direction/Examples/State of the Prior Art: Chemistry is unpredictable. See In Re Marzocchi and Horton 169 USPQ at 367 paragraph 3:
"Most non-chemists would probably be horrified if they were to learn how many attempted syntheses fail, and how inefficient research chemists are. The ratio of successful to unsuccessful chemical experiments in a normal research laboratory is far below unity, and synthetic research chemists, in the same way as most scientists, spend most of their time working out what went wrong, and why. Despite the many pitfalls lurking in organic synthesis, most organic chemistry textbooks and research articles do give the impression that organic reactions just proceed smoothly and that the total synthesis of complex natural products, for instance, is maybe a labor-intensive but otherwise undemanding task.
In fact, most syntheses of structurally complex natural products are the result of several years of hard work by a team of chemists, with almost every step requiring careful optimization. The final synthesis usually looks quite different from that originally planned, because of unexpected difficulties encountered in the initially chosen synthetic sequence. Only the seasoned practitioner who has experienced for himself the many failures and frustrations which the development (sometimes even the repetition) of a synthesis usually implies will be able to appraise such work ......Chemists tend not to publish negative results, because these are, as opposed to positive results, never definite (and far too copious)" Dorwald F. A. Side Reactions in Organic Synthesis, 2005, Wiley: VCH, Weinheim pg. IX of Preface.
Little guidance or direction is provided by Applicant in reference to making and subsequently preventing alopecia using the full scope of recited compounds in a patient. The presence of various bulky heterocyclic or carbocyclic rings attached to the compound’s core may be chemically incompatible with the method of use embraced in the instant claims. Specification offers no teachings or suggestion as to how to make and use these compounds. Also, note MPEP 2164.08(b) which states that claims that read on "... significant numbers of inoperative embodiments would render claims nonenabled when the specification does not clearly identify the operative embodiments and undue experimentation is involved in determining those that are operative.";
The specification gives some in vitro test results on JAK3 inhibitory effects of a limited number of preferable compounds, however it is too homogeneous to provide a clear evaluation of which moieties attached to the compound’s core out of the many claimed might affect potency to a large or small degree. The pharmaceutical art is unpredictable and target compounds need to be individually assessed for viability. Extremely broad generalizations as found in the instant claims are in contradiction with the basis of quantitative structure-activity-relationship (QSAR).
Furthermore, the art teaches that current methods using small molecule JAK inhibitors like those currently claimed have been explored for the treatment of alopecia and not in a prophylactic manner as recited in the claims (see Lensing et al. Front Immunol. 2022 Aug 30;13:955035, abstract). Specification nor the art in general does not suggest the claimed compounds may be used in the manner described in the claims as a prophylactic.
Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p).
(D) Skill of those in the art: The level of skill in the art is high.
(E) Level of predictability in the art: It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved," and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(H) The quantity of experimentation needed: Since there are very limited working examples as described above, the amount of experimentation is expected to be high and burdensome. Applicant fails to provide guidance and supporting information for how to make and/or use the thousands of other compounds which are encompassed by the claims, therefore undue experimentation would be expected.
Due to the level of unpredictability in the art, the very limited guidance provided, and the lack of working examples, the applicant has shown lack of enablement. MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)." That conclusion is clearly justified here.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Mark Shibuya can be reached at 571-272-0806. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624
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