DETAILED ACTION
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 response, dated 24 April 2026, to the restriction requirement dated 25 February 2026 is acknowledged. Due to amendment of the claims to be dependent from elected Group II, Claims 9-14, the restriction requirement is withdrawn.
Claims 1-14 are pending in the instant application. Claims 15-20 are cancelled by applicant’s amendment. Claims 1-14 are being examined on the merits.
Specification
The disclosure is objected to because it is standard convention in biological sciences to list genus and either sp. (indicating a single unspecified or unknown species in a genus) or spp. (indicating several or all species in the same genus). In the instant case, the broadest reasonable interpretation is that all species in the same genus are being referenced. “Saururaceae Houttuynia” should therefore be presented as --Houttuynia spp.--; “Rosaceae Crataegus” as --Crataegus spp.--; “Compositae Chamaemelum” as --Chamaemelum spp.--; and “Vitaceae Vitis” as --Vitis spp.--.
Appropriate correction is required.
Claim Objections
Claims 1-8 are objected to because a series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim. A claim which depends from a dependent claim should not be separated by any claim which does not also depend from said dependent claim. It should be kept in mind that a dependent claim may refer to any preceding independent claim. In general, applicant's sequence will not be changed. See MPEP § 608.01(n). In the instant case, it is recommended that Claims 1-8 be cancelled and simultaneously reinstated (effectively renumbered) as new Claims 21-28.
Claims 1-14 objected to because of the listing of the family and genus of the different plants in Claims 1, 2, 5, 7, 9, and 10. It is standard convention in biological sciences to list genus and either sp. (indicating a single unspecified or unknown species in a genus) or spp. (indicating several or all species in the same genus). In the instant case, the broadest reasonable interpretation is that all species in the same genus are being referenced. “Saururaceae Houttuynia” should therefore be presented as --Houttuynia spp.--; “Rosaceae Crataegus” as --Crataegus spp.--; “Compositae Chamaemelum” as --Chamaemelum spp.--; and “Vitaceae Vitis” as --Vitis spp.--.
All other claims depend directly or indirectly from the objected claims and are, therefore, also objected to for the reasons set forth above.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
The specification, while being enabling for ameliorating dysuria, does not reasonably provide enablement for prevention of dysuria. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice 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(a) (AIA ), or 35 U.S.C. 112, first paragraph (pre-AIA ), have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary (see MPEP 2164.01(a)).
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method for preventing or ameliorating dysuria comprising supplying an effective amount of a composition containing extracts of plants as active ingredients to a subject in need thereof. Thus, the claims taken together with the specification imply that supplying the claimed plant extracts of Houttuynia spp., Crataegus spp., Chamaemelum spp., and Vitis spp. to any subject not experiencing dysuria would prevent them from ever experiencing dysuria.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Dysuria, or painful urination, is experienced by men and women of any age and those who are pregnant, have diabetes, or have a bladder disease are at a higher risk of dysuria. Dysuria can be caused by various different factors, including bladder infection, vaginal infection, urinary tract infection, endometriosis, diverticulosis, diverticulitis, inflammation of the bladder or urethra, sexual intercourse, douches, soaps, scented toilet paper, contraceptive sponges, spermicides, prostate disease, and cancer. Drinking more water and practicing proper hygiene can help prevent dysuria (Cleveland Clinic, 2020, 4 pages; see entire document).
Since the causes for dysuria are widely varied, means for prevention thereof remained highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high, with respect to risk factors and treatments for dysuria in general. However, prevention thereof remained unresolved as evidenced by Cleveland Clinic (2020, entire document) and beyond the purview of one of skill. Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided data showing that the claimed extract composition inhibits phosphodiesterase 5, which leads to smooth muscle relaxation (Specification, [0002] and Figure 1). However, the specification does not provide data showing that the composition prevents dysuria from occurring in a subject.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Cleveland Clinic and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to determine how to use the claimed composition for the prevention of dysuria.
It is the Examiner’s position that one skilled in the art could not practice the invention commensurate in the scope of the claims without undue experimentation.
Claim Rejections - 35 USC § 102/103
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 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.
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 nonobviousness.
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.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yagi et al. (US 2011/0117136 A1) as evidenced by Nitzan et al. (Diabetes Metab Syndr Obes, 2015, 129-136) and Wikipedia (Crataegus laevigata, 2026, 4 pages).
MPEP § 2112 provides guidance as to the Examiner' s burden of proof for a rejection of claims under 35 U.S.C. 102 or 103 based upon the express, implicit, and inherent disclosures of a prior art reference. The case law clearly states that something which is old does not become patentable upon the discovery of a new property.
The instant claims are as of record, drawn to drawn to a method for ameliorating dysuria comprising supplying an effective amount of a composition containing extracts of plants as active ingredients to a subject in need thereof wherein the plants are Houttuynia spp., Crataegus spp., Chamaemelum spp., and Vitis spp.
Yagi et al. teach a composition for dehydroepiandrosterone (DHEA) promotion comprising extracts of a least one plant selected from Crataegus spp. (including C. oxyacantha and C. cuneata), Houttuynia spp. (including H. cordata), Vitis spp. (including V. vinifera), and Chamamelum nobile (also referred to as Anthemis nobilis) (Yagi et al., [0012]-[0015]; as required for instant Claims 1, 9, and 10). It is noted that C. oxyacantha is a rejected scientific name known to refer to C. laevigata, and thus the two are considered synonymous with one another (see e.g., Wikipedia, Taxonomy, page 2). The extracts are obtained from dried products of C. nobile anthodium, H.cordata above ground (aerial) part, C. oxycantha fruit, and V. vinifera leaf mixed in equal parts which are then immersed in purified water (aqueous solvent) at approximately 80°C (hot water) for five hours and then dried to obtain a powder (dried products; Yagi et al., [0034]; as required for instant Claims 1-6, 11, and 12). The powder extract is mixed with dextrin(polysaccharide), starch (polysaccharide), calcium stearate, silicon dioxide, caramel pigment, titanium dioxide, and lecithin (fats and oils; Yagi et al., [0034]; as required for instant Claims 8 and 13) and administered (supplied) in an effective dose to patients in need of DHEA promotion, such as those with diabetes (Yagi et al., [0034], Claims 24 and 25; as required for instant Claim 9).
Although Yagi et al. teach each of the active steps in the claimed method, they are
silent regarding the intended use of the method recited in the preamble i.e. ameliorating dysuria. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the compositions of the prior art are identical and capable of both treating diabetes and dysuria. The single-step method of administration and/or supplying are the same, and thus the properties of preventing dysuria are inherent, especially in the absence of evidence to the contrary. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the composition of the prior art and administration thereof is either identical or sufficiently similar to the claimed method that whatever differences exist, they are not patentably significant.
The cited reference discloses a composition comprising the same ingredients prepared in the same manner as the instantly claimed composition, and thus appears to be the same as the claimed composition since it is formulated and/or obtained from the same component materials and is administered/administrable to a subject in need. Additionally, Nitzan et al. disclose that urinary tract infections are more common, more severe, and have worse outcomes in patients with diabetes, the symptoms of which include dysuria (Nitzan et al., Abstract, page 129; Diagnosis, page 131). The patient population of Yagi et al., which encompasses those with diabetes, would also inherently comprise those with dysuria. Consequently, the claimed process (and compositions provided therein) appears to be anticipated by the reference. In the alternative, even if the process (and compositions therein (with respect to an intended therapeutic effect against dysuria) is not identical to the referenced process, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of in the claimed process, particularly in view of the similar characteristics which they have been shown to share (e.g. the similar component materials/formulations and the same broad administration). Thus, the claimed process (and administered-composition effects intrinsic thereto) would have at least been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within the processes thereof), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yagi et al. (US 2011/0117136 A1) as evidenced by Nitzan et al. (Diabetes Metab Syndr Obes, 2015, 129-136).
The claims and teachings of Yagi et al. as evidenced by Nitzan et al. are as of record.
Yagi et al. as evidenced by Nitzan et al. do not teach wherein a content of the extracts of the plants in the composition is 30-80 wt% in terms of dry weight. Yagi et al. do, however, teach that the extract composition is provided at a dose of 50 to 2000 mg daily (Yagi, [0023]) and that the compositions or constitutions of the pharmaceutical agents comprising the extract composition are not limited (Yagi, [0026]). The composition can be in the form of a solid, liquid, or gel with various additives such as diluents added (Yagi, [0022]).
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to modify the amount of the extract in the composition in order to arrive at the instantly claimed invention. A skilled artisan could maintain the required daily dose of the extract composition while modifying the amount of the extracts in the overall composition, dependent on its dosage form, with a reasonable expectation of success. Based upon these beneficial teachings, adjustments of particular conventional working conditions (e.g., determining one or more suitable dry weight of extract composition (instant Claim 14) ), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within the processes thereof), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are currently allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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