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 .
Non-Final Rejection
The Status of Claims:
Claims 1-17 are pending.
Claims 1-17 are rejected.
ACTION
1. Claims 1-17 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/IL2022/051283 12/01/2022, which has a priority of 63285101 12/02/2021.
Drawings
3. The drawings filed on 6/02/24 were accepted by the examiner .
IDS
4. The IDS filed on 7/8/25 were reviewed by the examiner.
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 1-17 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.
The issue concerning the meaning of phrase “ a triptolide prodrug” is to be discussed. Claim 1 does not contain a complete generic formula.
According to the MPEP §2163 I. A. “the issue of a lack of adequate written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.” The MPEP states in §2163 II 3 ii) “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.” Applicants have disclosed no species and have made no assertion that there is any correlation between the biological function of “a triptolide prodrug” and its structure. .
The Court of Appeals for the Federal Circuit held in University of California v. Eli Lilly and Co. 43 USPQ2d 1398 at 1406. "[a] written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." In re Smythe, 480 F.2d 1376, 1383, Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . .")." Applicants' functional definitions in the claimed formula simply lack the precision required by the Court of Appeals for the Federal Circuit.
As discussed above the terms “ a triptolide prodrug” is not art recognized in the art of chemistry in the absence of a definitive chemical structure of the “triptolide prodrug”. According to the MPEP §2163.02 Standard for Determining Compliance With the Written Description Requirement,
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed". In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter". Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
Thus, the chemist of ordinary skill in the art, who would use Applicants' compounds, would not know what “a triptolide prodrug can be. That chemist would not have understood the inventor to be in possession of the claimed triptolide prodrug at the time of filing.
This case was filed before Applicants had a clear idea of the structures of their desired compounds, how to make their compounds, and use the triptolide prodrug made from them. The specification provides broad areas of future research and speculation, inviting undue experimentation in learning how to use Applicants' invention. Applicants may well now be developing practical applications of the triptolide prodrug, but the question here is what application they possessed at the time of filing. Anything is possible but as the U.S. Patent and Trademark Office, Board of Patent Appeals and Interferences wrote in Bindra v. Kelly, 206 USPQ 570 “Probable utility does not establish practical utility. Practical utility can, in our view, be established only by actual testing therefore, or by establishing such facts as would be convincing that such utility could be "foretold with certainty.” Blicke v. Treves, supra, 112 USPQ at 475.”
Applicants are reminded of what the U.S. Court of Appeals Federal Circuit wrote in University of California v. Eli Lilly and Co. 43 USPQ2d 1398, "In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus." "A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). "It is only a definition of a useful result rather than a definition of what achieves that result." "The description requirement of the patent statute 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) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.")".
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 ,3 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Kachiguina et al( WO 2007/121369 A2).
Kachiguina et al discloses non-hormonal chemicals which suppress spermatogenesis and motility composition containing such as gossypol and triptolide may be used in combination with the device for the male contraception (see page 17, a paragraph#0104). This is inherently identical with the claims.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
6. Claims 1-9, 11-13, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Tong et al (CN 103372033) in view of Guthrie (US 10,568,855 B1).
.
Applicants claim the followings:
1. (Original) A composition comprising: (a) triptolide, a triptolide prodrug, a pharmaceutically acceptable salt of triptolide, a pharmaceutically acceptable salt of a triptolide prodrug, or any combination thereof; and (b) gossypol, a pharmaceutically acceptable salt of gossypol, or a combination thereof.
2. (Original) The composition of claim 1, wherein said triptolide, said triptolide prodrug, said pharmaceutically acceptable salt of triptolide, said pharmaceutically acceptable salt of said triptolide prodrug, said gossypol, said pharmaceutically acceptable salt of gossypol, or any combination thereof is extracted from a plant.
3. (Original) The composition of claim 1, wherein said triptolide, said triptolide prodrug, said pharmaceutically acceptable salt of triptolide, said pharmaceutically acceptable salt of said triptolide prodrug, said gossypol, said pharmaceutically acceptable salt of gossypol, or any combination thereof is synthetic or semi-synthetic.
4. (Currently Amended) The composition according to any one of claim[[s]] 1 to 3, further comprising at least one additional active ingredient.
5. (Currently Amended) The composition of claim 4, wherein said at least one additional active ingredient comprises an antibacterial agent, or an antiviral agent.
6. (Currently Amended) The composition according to any one of claim[[s]] 1to 5, wherein said composition is in an oral dosage form or an injectable dosage form.
7. (Original) A kit comprising: a first composition comprising: triptolide, a triptolide prodrug, a pharmaceutically acceptable salt of triptolide, a pharmaceutically acceptable salt of a triptolide prodrug or any combination thereof; and a second composition comprising gossypol, a pharmaceutically acceptable salt of gossypol, or a combination thereof.
8. (Currently Amended) A method for any one of limiting birth, inducing contraception, inducing abortion, andinducing sexual sterility[[,]] orinfertility in a subject in need thereof,the method comprising administering to said subject, a therapeutically effective amount of the composition of any one of claim[[s]] 1 to 6 or the kit of claim 7, thereby limiting birth, inducing contraception, inducing abortion, orinducing sexual sterility or infertility, in a-thesubject.
9. (Original) The method of claim 8, wherein said subject is a mammal, a reptile, or a bird.
11. (Currently Amended) The method of any one of claim[[s]] 8 to 10, wherein said first composition and said second composition are administered separately or sequentially.
12. (Currently Amended) The method of any one of claim[[s]] 8 to 10, wherein said first composition and said second composition are administered concomitantly.
13. (Currently Amended) The method of any one of claim[[s]] 8 to 12, wherein said administering comprises orally administering.
15. (Currently Amended) The method of any one of claim[[s]] 8 to 14, wherein said subject is a male.
17. (Currently Amended) The method of any one of claim[[s]] 8 to 16, wherein said subject is a mammal or a bird.
Determination of the scope and content of the prior art
Tong et al discloses an oral administration of gossypol that can block spermatogenesis and achieve an anti-fertility effect. It discloses gossypol as a chemical compound that can block the effect of spermatogenesis and therefore acts as a contraceptive agent in China (see page 12, a paragraph #0015). Furthermore, the crude extract Triptergium glycoside of the root of the Chinese herbal medicine Radix Triptergii Wilfordii (RTW) has shown spermatogenesis inhibition, sperm distortion and epididymal sperm immaturity. A few monomers were isolated from the crude extract such as triptolide, triprolactone and 16-hydroxy triptolide as in claims 1-3, 6, 13, 15, 17 (see page 15, a paragraph #0018 ).
The current invention, however, differs from the prior art in that the claimed additional active antibacterial or antiviral agent , a kit composition ; the first composition and the second composition being administered concomitantly and separately or sequentially are unspecified in the prior art.
Guthrie teaches that compositions and methods for contraception that also enhance the efficacy of microbicides ; such compositions serve the dual purpose of preventing pregnancy and lessening the risk of spreading sexually transmitted diseases . More specifically , the compositions and methods relate to syngergistic contraceptive microbicide and antiviral compositions comprising a combination of a contraceptive microbicide and an antiviral agent as in claims 4-5 in an acidic carrier that enhances the efficacy of both (see abstract).
Ascertainment of the difference between the prior art and the claims
The difference between the instant application and the applied Tong et al art is that the Tong et al does not expressly teach the claimed additional active antibacterial or antiviral agent , a kit composition ; the first composition and the second composition being administered concomitantly and separately or sequentially. The deficiencies of Tong et al are partially cured by Guthrie.
The difference between the instant application and the applied Guthrie art is that the Guthrie does not expressly teach the claimed composition containing triptolide, gossypol, its kit composition; the first composition and the second composition being administered concomitantly and separately or sequentially. The deficiencies of Guthrie are partially cured by Tong et al.
Resolving the level of ordinary skill in the pertinent art.
Regarding the claim 7 with respect to the lack of disclosing the kit composition, the prior art are silent about it. However, the kit composition containing chemicals in therapeutic use typically indicates that a pre-packaged collection of distinct chemical or pharmaceutical formulations (e.g., active ingredients and excipients) combined to produce a specific clinical effect. Furthermore, it is known from Tong et al that the chemical compounds gossypol and triptolide have antifertility properties.
So, if the skilled artisan in the art had desire to develop a kit composition containing well-known ingredients, such as triptolide, gossypol as shown in Tong et al along with an instruction for sheets for how to use them, it would have been obvious to be motivated to do so in order to to improve safety, ensure dosing accuracy, and promote patient compliance. This is because such a practice is within the purview of the skilled artisan in the art to do so.
In addition, USPTO personnel need not give patentable weight to printed matter absent a new and unobvious functional relationship between the printed matter and the substrate. See In re Lowry, 32 F.3d 1579, 1583-84, 32 USPQ2d 1031, 1035 (Fed. Cir. 1994).
Regarding the claims 11-12 with respect to the lack of disclosing the first composition and the second composition being administered concomitantly and separately or sequentially, the prior art are silent about them. However, the first composition and the second composition being administered concomitantly and separately or sequentially are dependent upon the patient’s physical or health conditions.
If a patient needs a strong and fast and effective infertility, it would have been obvious to be motivated to administer the first composition and the second composition concomitantly, but otherwise, the person can be administered by giving the first composition and the second composition separately or sequentially. Therefore, the prior art is still relevant to the claimed invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Tong et al expressly discloses the oral administration of gossypol that can block spermatogenesis and achieve an anti-fertility effect. Furthermore, it does teach the crude extract Triptergium glycoside of the root of the Chinese herbal medicine Radix Triptergii Wilfordii (RTW) has shown spermatogenesis inhibition, sperm distortion and epididymal sperm immaturity. Few monomers were isolated from the crude extract such as triptolide, triprolactone and 16-hydroxy triptolide (see page 15, (see page 15, a paragraph #0018 ). Whereas Guthrie does describe that syngergistic contraceptive microbicide and antiviral compositions comprising a combination of a contraceptive microbicide and an antiviral agent in an acidic carrier that enhances the efficacy of both (see abstract).
So, if the skilled artisan in the art had desired to improve a composition possessing infertility activity in animals as well as syngergistic contraceptive microbicide and antiviral activity, it would have been obvious to the skilled artisan in the art before the effective filing date of the claimed invention to be motivated to incorporate both chemical compounds triptolide or triptolide drug and gossypol in the preparation of the composition along with Guthrie’s antibacterial agent or antiviral agent into Tong et al composition for the method for enhancing infertility activity .This is because such combined prior art to be feasible and successful as guidance shown in the prior art .
Conclusion
Claims 1-17 are rejected.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 7/11/2026
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