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 .
Withdrawn Objections/Rejections
The objections to claims 11, 12, and 13 are withdrawn in view of the claim amendments.
The rejections of claim 14 are withdrawn in view of the cancellation of the claim.
The rejections of claims 11-13 under 35 U.S.C. § 112(b) are withdrawn in view of the claim
amendments.
The previous rejections of claims 11-13 under 35 U.S.C. § 103 are withdrawn in view of the claim amendments.
Claim Status
Applicants' amendments and arguments filed on 02/26/2026 have been fully considered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the
complete set presently being applied to the instant application.
Claim 14 is cancelled.
Claims 1-10 are withdrawn.
Claims 15-17 are newly added.
Claims 11-13 and 15-17 are under current examination.
New Rejections Necessitated by Claim Amendments
Claim Rejections - 35 USC § 103
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 11-12 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Guasti (IT MI20100786 A1; published November 6th, 2011; of record) as evidenced by Oka et al. (“Relevance of anti-reactive oxygen species activity to anti-inflammatory activity of components of Eviprostat®, a phytotherapeutic agent for benign prostatic hyperplasia” Phytomedicine 2007, 14, 465-472), hereafter “Oka”, in view of Mota et al. (“Influence of a tryptophan-rich diet on prostatic growth and androgen receptor expression” The Journal of Urology 2018, Vol. 199, No. 4S, Supplement, e599-e600; of record), hereafter “Mota” and Graminex (“Graminex G63™ Flower Pollen Extract for Benign Prostatic Hyperplasia in Men”, August 2014, https://www.wholefoodsmagazine.com/ext/resources/2016/03/graminex-1.pdf; of record), as evidenced by Chambliss (“A Critical Review of Graminex Flower pollen extract for Symptomatic Relief of Lower Urinary Tract Symptoms (LUTS) in Men” 2003, Flower Pollen Extract and its Effect on the Prostate, https://www.graminex.com/wp-content/uploads/2017/11/A-critical-review-of-Graminex-flower-pollen-extract-for-symptomatic-relief-of-lower-urinary-tract-symptoms-in-men.pdf; of record).
Regarding instant claims 11 and 15-16, Guasti teaches treatment of lower urinary tract symptoms, particularly symptoms related to benign prostatic hyperplasia and prostatitis by administration to patients a composition comprising quercetin and lipoic acid (claim 5; paragraphs [0003] and [0020]-[0021]). Guasti teaches that lipoic acid is capable of displaying a powerful antioxidant action, being able to trap a large number of reactive oxygen species; after distribution in an organism, it is found in various body tissues at the intracellular, extracellular, and mitochondrial levels (paragraph [0015]). Guasti further teaches that quercetin has the ability to act as a scavenger of highly reactive radical species, and quercetin supplementation is useful and indicated for people suffering from pathologies associated with oxidative stress and inflammation (paragraph [0013]). The compositions of Guasti are effective in reducing inflammation in prostatic tissue (paragraph [0020]). As evidenced by Oka, inflammation is a common finding in benign prostatic hyperplasia (abstract); reactive oxygen species may be one of the pathogenic factors in inflammation and enlarged prostate, and antioxidants may be useful in the treatment of BPH (“Introduction”, paragraph 2).
Guasti does not teach that the composition comprises tryptophan (instant claim 11). Guasti does not teach that the composition comprises a Secale cereale pollen extract (instant claim 11) wherein said Secale cereale pollen extract comprises a water-soluble fraction and a liposoluble fraction in a water-soluble fraction: liposoluble fraction by weight ratio comprised in the range from 30: 1 to 10:1, wherein the water-soluble fraction is standardized in amino acids and the liposoluble fraction is standardized in phytosterols (instant claim 12).
Mota teaches that mice fed with a tryptophan-rich diet for 3 months present a significant reduction in prostatic weight and that modulating diet through tryptophan enrichment increases prostatic serotonin, decreases prostate size, and down regulates androgen receptor; a tryptophan rich diet could be used to prevent or treat benign prostatic hyperplasia (see entire document, particularly “Results” and “Conclusions”).
Graminex teaches that flower pollen extract under the trademark G63TM comprises substances shown to selectively act on prostate cells to help alleviate benign prostatic hyperplasia (BPH) symptoms and improve prostate health (pg. 4, “Chemical Composition of Flower Pollen Extract”). G63™ Flower Pollen Extract is a standardized product manufactured using a combination of the water soluble, G60™ Flower Pollen Extract, and the lipid soluble, GFX™ Flower Pollen Extract, portions of the pollen grain blended into a 20:1 ratio to create a standardized pharmaceutical grade powder; G60™ contains a standardized portion of amino acids and GFX™ contains a standardized portion of phytosterols (pg. 4, “Chemical Composition of Flower Pollen Extract”). As evidenced by Chambliss, Graminex Flower Pollen Extract is a standardized extract comprising rye pollen (Secale cereale) (see “Introduction”, paragraph 4). Further, as set forth in the instant specification, “Said product under the trade name Graminex® G63® comprises a standardised extract of rye (Secale cereale L.) pollen and, optionally, corn (Zea mays L.) pollen and Timothy (Phleum pratense L.) pollen (in short, pollen extract), in the form of a powder comprising a water-soluble fraction (soluble in water) and a liposoluble fraction (insoluble in water) in a weight ratio of about 20: 1 (hydro:lipo = about 20: 1 or 20±2: 1±0.1 ), wherein the water-soluble fraction is standardised in amino acids and the liposoluble fraction is standardised in phytosterols” (pg. 8, lines 5-10).
Graminex teaches that Flower Pollen Extract has an anti-inflammatory and anti-congestive action that helps prevent intraprostatic tissue edema from occurring in the prostate’s middle lobe as well as fibrosis (pg. 4, “Modes of Action: Anti-Inflammatory & Anti-Congestive”). Patients treated with G63™ experienced an improving trend in their symptoms of perineal pain, erection difficulty, ejaculation difficulty and pain during urination throughout the course of treatment, and a study conducted with prostatodynia patients using Flower Pollen Extract™ demonstrated a marked improvement of the associated symptoms that are also common to BPH (pg. 5, “Efficacy Studies”). Flower Pollen Extract is safe and effective for helping reduce the symptoms of BPH and may be used in combination with other dietary supplements and pharmaceuticals to help provide relief for men experiencing bothersome BPH symptoms (pg. 6, “Conclusions”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the composition in the treatment method of Guasti with tryptophan, as suggested by Mota, and Graminex® G63® Secale cereal pollen extract, as suggested by Graminex. One of ordinary skill in the art would have been motivated to do so to incorporate agents known to treat benign prostate hyperplasia by increasing prostatic serotonin and decreasing prostate size (Mota, “Conclusions”) and by acting as an anti-inflammatory and anti-congestive to improve symptoms of BPH (Graminex, “Modes of Action: Anti-Inflammatory & Anti-Congestive” and “Efficacy Studies”). There is a reasonable expectation of success as method of Guasti is taught to treat benign prostatic hyperplasia and reduce prostate inflammation, and Graminex suggests the combination of Secale cereal pollen extract with dietary supplements and pharmaceuticals for BPH treatment. Further, per MPEP 2144.06 I., “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)”.
Regarding the preamble recitation “for reducing reactive oxygen species in prostate cells”, the combination of the prior art of Guasti, Mota, and Graminex renders obvious the active method step of administering to a patient, particularly a patient with benign prostatic hyperplasia, a composition comprising a Secale cereale pollen extract, quercetin, lipoic acid, and tryptophan. Further, Guasti teaches that lipoic acid is distributed to tissues at the intracellular level and is capable of trapping reactive oxygen species (paragraph [0015]) and that quercetin acts as a scavenger of highly reactive radical species (paragraph [0013]). The method of the modified Guasti is effective to reduce inflammation in prostatic tissues (see Guasti paragraph [0020] and Graminex pg. 4, “Modes of Action: Anti-Inflammatory & Anti-Congestive”), with reactive oxygen species being a known pathogenic factor in BPH-associated inflammation (as evidenced by Oka). Thus, the method of the modified Guasti will result in the recited purpose of reduction of reactive oxygen species in prostate cells.
Claims 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Guasti, as evidenced by Oka, in view of Mota and Graminex, as evidenced by Chambliss, as applied to claims 11-12 and 15-16 above, and further in view of Guasti (IT MI20091375 A1, published January 31, 2011; of record), hereafter “Guasti 2” and Pharmel Inc. (“phl-Tryptophan (L-Tryptophan) Product Monograph”, December 9th, 2004, https://pdf.hres.ca/dpd_pm/00003369.PDF; of record).
The teachings of the modified Guasti are set forth above. Regarding instant claim 13, Guasti further teaches a daily dosed quantity of quercetin from 100 to 200 mg (paragraphs [0028] and [0030]). Graminex further teaches that clinical trials of G63™ have used a range of 500-1500 mg/day with 500 mg/day being the minimum scientifically supported dose and 1000 mg/day being the average scientifically supported dose (pg. 6, “G63™ Flower Pollen Extract Dosage”). Per MPEP 2144.05 I, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”. As described above, Mota suggests that a tryptophan rich diet could be used to prevent or treat benign prostatic hyperplasia.
The combination of Guasti, Mota, and Graminex does not teach administering a daily dose of from 300 to 600 mg of lipoic acid or from 150 to 300 mg of tryptophan.
Guasti 2 teaches lipoic acid for the treatment of pelvic pain (claim 1) with a daily dosed quantity of lipoic acid from 100 to 2,000 mg and more preferably from 350 to 900 mg (claims 4-5, paragraph [0032]). Guasti 2 teaches that lipoic acid is able to exert a powerful antioxidant action (paragraph [0020]) and can be used to treat inflammatory pathology of the prostate gland such as prostatitis (paragraphs [0005], [0008]-[0009], [0028]). A daily dosed amount is the total amount of active ingredient taken in a day (one or more times a day) in various dosage forms (paragraph [0033]).
Pharmel Inc. teaches that L-tryptophan increases serotonin synthesis in the central nervous system of humans, and that the minimum daily requirements are 0.25 g (250 mg) for males and 0.15 g (150 mg) for females (pg. 2, “Action and Clinical Pharmacology”). Pharmel Inc. further teaches that doses below 5 g/day may cause dry mouth and drowsiness, and in higher doses (9-12 g/day) nausea, anorexia, dizziness and headache have been reported (pg. 7, “Adverse Reactions”). Administration can be in divided doses, and the dose and frequency can be adjusted to the patient’s need and tolerance (pg. 7, “Dosage and Administration”).
It would have been prima facie to one of ordinary skill in the art before the effective filing date of the instant invention to adjust the daily administered dose of lipoic acid in the method of the modified Guasti within the range taught by Guasti 2, overlapping the range of instant claim 13. One of ordinary skill in the art would be motivated to routinely optimize the amount of lipoic acid to achieve a desired antioxidant effect that is effective to treat inflammatory pathology of the prostate gland, particularly as Guasti teaches compositions comprising lipoic acid that reduce inflammation in the prostatic tissue, and that inflammation is a recognized factor in the etiopathogenesis and progression of both BPH and prostatitis (paragraph [0020]).
It would further have been prima facie to one of ordinary skill in the art before the effective filing date of the instant invention to adjust the daily administered dose of tryptophan in the method of the modified Guasti to be equal to or greater than the minimum daily requirement of tryptophan suggested by Pharmel Inc. and lower than the amount of tryptophan that causes adverse effects, overlapping the range of instant claim 13. One of ordinary skill in the art would be motivated to routinely optimize the amount of tryptophan to achieve a desired serotonin synthesis effect while avoiding negative side effects, particularly as Mota teaches that a diet rich in tryptophan is capable of increasing prostatic serotonin and decreasing prostate size.
Further, per MPEP 2144.05 II. A, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” and per MPEP 2144.05 I, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding instant claim 17, as noted above, the combination of the prior art teaches effective daily dosage amounts of tryptophan, quercetin, lipoic acid and Secale cereale, and suggests that daily dosed amounts can be taken over multiple doses, adjusted for patient’s need and tolerance (Guasti 2, paragraph [0033]; pg. 7, “Dosage and Administration”). It would have been prima facie to one of ordinary skill in the art before the effective filing date of the instant invention to routinely optimize the amounts of components in an administered composition according to the needs and tolerance of the patient being treated. Per MPEP 2144.05 II. A, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.”
Response to Arguments
Applicant’s arguments filed 02/26/2026 have been fully considered.
Regarding the claim rejections under 35 U.S.C. § 103, Applicant argues that combining prior art elements must yield predictable results, and the claimed invention has achieved unexpected results which are not taught or suggested by the cited prior art references. Particularly, Applicant argues that, as demonstrated in Figure 3, a composition comprising a Secale cereale pollen extract, quercetin, lipoic acid, and tryptophan can synergistically reduce reactive oxygen species in prostate cells, whereas the individual components of the composition in isolation do not. None of the cited references teach, suggest, or contemplate that this combination would be capable of synergistically reducing reactive oxygen species in prostate cells.
These arguments are unpersuasive. The Examiner first notes that, per MPEP 716.02(d), "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." Here, the method of independent claim 1 is broad, comprising administering to any patient any amount of a composition comprising any amounts of a Secale cereale pollen extract, quercetin, lipoic acid, and tryptophan. The evidence relied upon in Figure 3 narrowly demonstrates the in vitro administration to PC3 cells of a mixture of 100 μg/ml tryptophan, 80 μM quercetin, 300 μM lipoic acid, and 1 μg/ml pollen, and serial dilutions thereof (see instant specification pg. 15, lines 11-20 and pg. 17, line 13-pg. 18, line 3). As demonstrated in Figure 3, only one dilution concentration (1:2), appears to show synergy in reducing reactive oxygen species, while other dilutions (1:4 and 1:8) appear to show higher amounts of ROS than the control group. Thus, the evidence of nonobviousness is not commensurate in scope with the instant claims.
The Examiner further notes that the claims do not recite a synergistic reduction in reactive oxygen species; although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). See also MPEP 2144 IV., “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)”.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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