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 .
Priority
The present application claims benefit to the application, 63/504,856, with the effective filing date of 30 May 2023.
Claim Status
This Office Action is in response to Applicant’s Application filed, 29 May 2024.
Claims 1-20 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed 17 June 2025 and the references cited therein have been considered, unless indicated otherwise.
Claim Interpretation
1. For purposes of clarity, the Examines notes that claims 1-16 recite a composition for management of HPV, which is interpreted to be a composition, because “for management of HPV” is the intended use of the composition. Additionally, claims 15 and 19 recite a capsule, tablet, liquid, or loose powder for oral ingestion, which is interpreted as a capsule, tablet, liquid, or loose powder, because “for oral ingestion” is the intended use of the composition. Accordingly, the Examiner respectfully suggests that the Applicant amend the claims to remove the intended use from claims 1-16 and 19.
37 CFR 1.105
2. In the course of examining or treating a matter in a pending or abandoned application, in a patent, or in a reexamination proceeding, including a reexamination proceeding ordered as a result of a supplemental examination proceeding, the examiner or other Office employee may require the submission, from individuals identified under § 1.56(c), or any assignee, of such information as may be reasonably necessary to properly examine or treat the matter, for example:
(i) Commercial databases: The existence of any particularly relevant commercial database known to any of the inventors that could be searched for a particular aspect of the invention.
(ii) Search: Whether a search of the prior art was made, and if so, what was searched.
(iii) Related information: A copy of any non-patent literature, published application, or patent (U.S. or foreign), by any of the inventors, that relates to the claimed invention.
(iv) Information used to draft application: A copy of any non-patent literature, published application, or patent (U.S. or foreign) that was used to draft the application.
(v) Information used in invention process: A copy of any non-patent literature, published application, or patent (U.S. or foreign) that was used in the invention process, such as by designing around or providing a solution to accomplish an invention result.
(vi) Improvements: Where the claimed invention is an improvement, identification of what is being improved.
(vii) In Use: Identification of any use of the claimed invention known to any of the inventors at the time the application was filed notwithstanding the date of the use.
(viii) Technical information known to applicant. Technical information known to applicant concerning the related art, the disclosure, the claimed subject matter, other factual information pertinent to patentability, or concerning the accuracy of the examiner’s stated interpretation of such items.
Requirements for factual information known to applicant may be presented in any appropriate manner, for example:
(i) A requirement for factual information;
(ii) Interrogatories in the form of specific questions seeking applicant’s factual knowledge; or
(iii) Stipulations as to facts with which the applicant may agree or disagree.
The Examiner requires Applicant to submit information relating to the formulation of Papillex® on sale in 2022 to properly examine the claimed invention. See MPEP 1.105.
Claim Rejections - 35 USC § 102
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.
4. Claim(s) 1-8 and 10-20* are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hill-Strathy (“Oral HPV and Oropharyngeal Cancer,” Wellex, 15 Mar 2022, < wellex.co/oral-hpv-and-oropharyngeal-cancer/?srsltid=AfmBOops79lQDSVDokm1ByaOJXPtxO-Z2Cl5AOsqzHqVkVfYdDVbD6gG>, accessed 22 May 2026) as evidenced by Reddit (“Can I take Papillex after AHCC?” Reddit, 2022, <www.reddit.com/r/HPV/comments/vqwqro/can_i_take_papillex_after_ahcc/>, accessed 26 May 2026), Wellex FAQ (“Your Questions, Answered.” Wellex, 2026, <wellex.co/faq/?srsltid=AfmBOopXR8Olx_wZRU7uXgd9LVQ5mf9c_0RMqh8gV9N5KYJS8HJp57Nd>, accessed 26 May 2026), Wellex (“Papillex®,” Wellex, 2026, <wellex.co/product/papillex/?srsltid=AfmBOoqw-9YNhTLqDNIImwr76Chqo1GB0n4B_qeSaCB21l0PQa1FLbpa>, accessed 22 May 2026), Seeking Health (“The Different Types of Folate: Which One is Right for You?” Seeking Health, 26 Mar 2021, <seekinghealth.com/blogs/education/types-of-folate?srsltid=AfmBOooa4nI-tv_St_7dru0yxig45lZEmovmJH1z4Fuiqu9XYp-RIASu> accessed 22 May 2026), Wikipedia 1 (“3,3’-diindolylmethane,” Wikipedia, 2026, <en.wikipedia.org/wiki/3,3%27-Diindolylmethane>, accessed 22 May 2026), Wikipedia 2 (“Lycopene,” Wikipedia, 2026, <en.wikipedia.org/wiki/Lycopene>, accessed 22 May 2026), and Manufacturing Chemist (“Hypromellose is changing the role of capsules,” Manufacturing Chemist, 14 Jul 2017, <manufacturingchemist.com/hypromellose-is-changing-the-role-of-capsules-131609>, accessed 22 May 2026).
*The Examiner notes that the Office Action requires a response to 37 CFR 1.105.
Hill-Strathy teaches treating HPV via Papillex® (page 4, paragraph 1). Hill-Strathy specifies that Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1), which was on sale as of 26 May 2022 as evidenced by Reddit (page 1, User: ColorMeChaotic_; page 1, User: [deleted]).
While Hill-Strathy is silent to the ingredients in Papillex®, the formulation has not changed as evidenced by Wellex FAQ (page 1, “Have any of the formulas changed?”). Thus, the formulation taught by Wellex is the same formulation taught by Hill-Strathy.
Wellex sells Papillex® and details the ingredients (Supplement Facts, page 1). Wellex teaches that Papillex® contains 5-methyltetrahydrofolic acid (activated folate), zinc sulfate (a zinc compound), EGCG (a polyphenol catechin, as defined by claim 5), broccoli sprout powder, vitamin A (mixed carotenoids), lycopene (a carotenoid, as defined by claim 11), Astragalus, and reishi mushroom extract (Supplement Facts, page 1).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Products of identical chemical composition cannot have mutually exclusive properties. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Thus, the Papillex® of Hill-Strathy possesses the same properties as the Papillex® sold by Wellex.
Regarding claim 1, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains 5-methyltetrahydrofolic acid (activated folate), zinc sulfate (a zinc compound), EGCG (a polyphenol catechin, as defined by claim 5), broccoli sprout powder, vitamin A (mixed carotenoids), and lycopene (which is a carotenoid, as defined by claim 11) (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex® which is a composition comprising activated folate, a zinc compound, a polyphenol catechin, broccoli sprout powder, and one or more carotenoids.
Regarding claim 2, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains zinc sulfate (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising zinc sulfate.
Regarding claim 3, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains reishi mushroom extract (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising reishi mushroom extract.
Regarding claim 4, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains 5-methyltetrahydrofolic acid (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising 5-methyltetrahydrofolic acid.
Regarding claim 5, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains EGCG (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising EGCG.
Regarding claim 6, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains EGCG derived from green tea extract (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising EGCG derived from green tea extract.
Regarding claim 7, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains 5-methyltetrahydrofolic acid (Supplement Facts, page 1), which is a form of L-methylfolate as evidenced by Seeking Health (page 9, L-methylfolate, bullet point 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising L-methylfolate.
Regarding claim 8, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains broccoli sprout powder (Supplement Facts, page 1), which contains 3,3-diindolylmethane as evidenced by Wikipedia 1 (page 1, paragraph 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising diindolylmethane.
Regarding claim 10, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains broccoli sprout powder (Supplement Facts, page 1), which contains 3,3-diindolylmethane as evidenced by Wikipedia 1 (page 1, paragraph 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising diindolylmethane.
Regarding claim 11, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains lycopene (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising lycopene.
Regarding claim 12, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains lycopene (Supplement Facts, page 1), which is found in tomatoes and other red fruits as evidenced by Wikipedia 2 (page 1, paragraph 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising lycopene, which is derived from a fruit.
Regarding claim 13, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains vitamin A (mixed carotenoids) and lycopene (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising vitamin A.
Regarding claim 14, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains vitamin C, vitamin E, vitamin B12, lycopene, selenium, and Astragalus root (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising vitamin C, vitamin E, vitamin B12, lycopene, selenium, and Astragalus root.
Regarding claim 15, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that the serving size of Papillex® is 2 capsules (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition formulated as capsules.
Regarding claim 16, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® is made out of a hypomellose capsule (Supplement Facts, page 1), which is an enteric capsule as evidenced by Manufacturing Chemist (page 2, paragraphs 2-3). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition formulated as an enteric capsule.
Regarding claim 17, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains 5-methyltetrahydrofolic acid (activated folate), zinc sulfate, EGCG (green tea extract), broccoli sprout powder, vitamin A (mixed carotenoids), lycopene (a carotenoid, as defined by claim 11), and reishi mushroom extract (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising 5-methyltetrahydrofolic acid (activated folate), zinc sulfate, EGCG (green tea extract), broccoli sprout powder, one or more carotenoids, and reishi mushroom extract.
Regarding claim 18, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains Astragalus root (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition comprising Astragalus root.
Regarding claim 19, Hill-Strathy teaches Papillex® was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that the serving size of Papillex® is 2 capsules (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition formulated as capsules.
Regarding claim 20, Hill-Strathy teaches treating HPV via Papillex®, which was formulated to help correct nutrient deficiencies associated with persistent HPV and to provide immune-supporting nutrients and herbs and that the ingredients in Papillex® can help support the immune system response to oral HPV (page 4, paragraph 1). Wellex teaches that Papillex® contains 5-methyltetrahydrofolic acid (activated folate), zinc sulfate (a zinc compound), EGCG (a polyphenol catechin, as defined by claim 5), broccoli sprout powder, vitamin A (mixed carotenoids), and lycopene (which is a carotenoid, as defined by claim 11) (Supplement Facts, page 1). Because the Papillex® of Hill-Strathy is the same Papillex® of Wellex, Hill-Strathy teaches Papillex®, which is a composition for treating HPV infection.
Claim Rejections - 35 USC § 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 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.
5. Claim(s) 1-20* are rejected under 35 U.S.C. 103 as being unpatentable over Hill-Strathy (“Oral HPV and Oropharyngeal Cancer,” Wellex, 15 Mar 2022, < wellex.co/oral-hpv-and-oropharyngeal-cancer/?srsltid=AfmBOops79lQDSVDokm1ByaOJXPtxO-Z2Cl5AOsqzHqVkVfYdDVbD6gG>, accessed 22 May 2026) as evidenced by Reddit (“Can I take Papillex after AHCC?” Reddit, 2022, <www.reddit.com/r/HPV/comments/vqwqro/can_i_take_papillex_after_ahcc/>, accessed 26 May 2026), Wellex FAQ (“Your Questions, Answered.” Wellex, 2026, <wellex.co/faq/?srsltid=AfmBOopXR8Olx_wZRU7uXgd9LVQ5mf9c_0RMqh8gV9N5KYJS8HJp57Nd>, accessed 26 May 2026), Wellex (“Papillex®,” Wellex, 2026, <wellex.co/product/papillex/?srsltid=AfmBOoqw-9YNhTLqDNIImwr76Chqo1GB0n4B_qeSaCB21l0PQa1FLbpa>, accessed 22 May 2026), Seeking Health (“The Different Types of Folate: Which One is Right for You?” Seeking Health, 26 Mar 2021, <seekinghealth.com/blogs/education/types-of-folate?srsltid=AfmBOooa4nI-tv_St_7dru0yxig45lZEmovmJH1z4Fuiqu9XYp-RIASu> accessed 22 May 2026), Wikipedia 1 (“3,3’-diindolylmethane,” Wikipedia, 2026, <en.wikipedia.org/wiki/3,3%27-Diindolylmethane>, accessed 22 May 2026), Wikipedia 2 (“Lycopene,” Wikipedia, 2026, <en.wikipedia.org/wiki/Lycopene>, accessed 22 May 2026), and Manufacturing Chemist (“Hypromellose is changing the role of capsules,” Manufacturing Chemist, 14 Jul 2017, <manufacturingchemist.com/hypromellose-is-changing-the-role-of-capsules-131609>, accessed 22 May 2026) in view of Levy (“What is EGCG? Benefits, Dosage, Safety, & Top Foods/Drinks,” Dr. Axe, 19 June 2020, <draxe.com/nutrition/egcg/>, accessed 22 May 2026).
*The Examiner notes that the Office Action requires a response to 37 CFR 1.105.
Hill-Strathy (“Oral HPV and Oropharyngeal Cancer,” Wellex, 15 Mar 2022, < wellex.co/oral-hpv-and-oropharyngeal-cancer/?srsltid=AfmBOops79lQDSVDokm1ByaOJXPtxO-Z2Cl5AOsqzHqVkVfYdDVbD6gG>, accessed 22 May 2026) as evidenced by Reddit (“Can I take Papillex after AHCC?” Reddit, 2022, <www.reddit.com/r/HPV/comments/vqwqro/can_i_take_papillex_after_ahcc/>, accessed 26 May 2026), Wellex FAQ (“Your Questions, Answered.” Wellex, 2026, <wellex.co/faq/?srsltid=AfmBOopXR8Olx_wZRU7uXgd9LVQ5mf9c_0RMqh8gV9N5KYJS8HJp57Nd>, accessed 26 May 2026), Wellex (“Papillex®,” Wellex, 2026, <wellex.co/product/papillex/?srsltid=AfmBOoqw-9YNhTLqDNIImwr76Chqo1GB0n4B_qeSaCB21l0PQa1FLbpa>, accessed 22 May 2026), Seeking Health (“The Different Types of Folate: Which One is Right for You?” Seeking Health, 26 Mar 2021, <seekinghealth.com/blogs/education/types-of-folate?srsltid=AfmBOooa4nI-tv_St_7dru0yxig45lZEmovmJH1z4Fuiqu9XYp-RIASu> accessed 22 May 2026), Wikipedia 1 (“3,3’-diindolylmethane,” Wikipedia, 2026, <en.wikipedia.org/wiki/3,3%27-Diindolylmethane>, accessed 22 May 2026), Wikipedia 2 (“Lycopene,” Wikipedia, 2026, <en.wikipedia.org/wiki/Lycopene>, accessed 22 May 2026), and Manufacturing Chemist (“Hypromellose is changing the role of capsules,” Manufacturing Chemist, 14 Jul 2017, <manufacturingchemist.com/hypromellose-is-changing-the-role-of-capsules-131609>, accessed 22 May 2026) are applied as discussed above in the 35 U.S.C. 102 rejection above.
The Examines notes the relevant teachings with respect to claims 1-8 and 10-20 are set forth above and are incorporated herein by reference.
Additional relevant teachings are set forth below.
Hill-Strathy teaches treating HPV via Papillex® (page 4, paragraph 1), which was on sale as of 26 May 2022 as evidenced by Reddit (page 1, User: ColorMeChaotic_; page 1, User: [deleted]). The formulation taught by Wellex is the same formulation taught by Hill-Strathy as evidenced by Wellex FAQ (page 1, “Have any of the formulas changed?”). Wellex sells Papillex® and details the ingredients (Supplement Facts, page 1). Wellex teaches that Papillex® contains 5-methyltetrahydrofolic acid (activated folate), zinc sulfate (a zinc compound), EGCG (a polyphenol catechin, as defined by claim 5), broccoli sprout powder, vitamin A (mixed carotenoids), lycopene (a carotenoid, as defined by claim 11), Astragalus, and reishi mushroom extract (Supplement Facts, page 1).
Regarding claim 9, Hill-Strathy fails to teach that the catechin is in the form of a nut or berry that contains EGCG not from green tea leaf or green tea leaf extract.
Levy teaches foods and drinks that contain EGCG (epigallocatechin gallate), which are black tea, white tea, oolong tea, kiwis, cherries, pears, peaches, apples, avocados, and nuts (pistachios, pecans, and hazelnuts) (page 2, paragraph 4; page 3, paragraph 1). Levy teaches that the concentration of EGCG in green tea depends upon the type of green tea and preparation thereof (page 3, paragraphs 4-5; page 4, paragraphs 1-3). Levy also teaches the benefits of consuming EGCG (page 4, paragraph 9; page 5, 1-12). Levy teaches that people sensitive to caffeine or oxalates found in tea (persons with kidney disease) should minimize tea consumption and avoid supplements that contain caffeine or tea (page 6, paragraphs 2 and 8).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to modify the composition of Hill-Strathy with a nut or berry as taught by Levy to arrive at a composition wherein the catechin is in the form of a nut or berry that contains EGCG.
One or ordinary skill in the art would have been motivated to make such a selection with a reasonable expectation of success, because:
-Hill-Strathy teaches treating HPV via Papillex®.
-While Hill-Strathy is silent to the ingredients in Papillex®, Wellex sells Papillex® and details the ingredients. Wellex teaches that Papillex® contains 5-methyltetrahydrofolic acid (activated folate), zinc sulfate (a zinc compound), EGCG (from green tea extract), broccoli sprout powder, vitamin A (mixed carotenoids), lycopene (a carotenoid, as defined by claim 11), Astragalus, and reishi mushroom extract,
-Levy teaches foods and drinks that contain EGCG (epigallocatechin gallate), which are black tea, white tea, oolong tea, kiwis, cherries, pears, peaches, apples, avocados, and nuts (pistachios, pecans, and hazelnuts),
-Levy teaches that the concentration of EGCG in green tea depends upon the type of green tea and preparation thereof, and
-Levy teaches that people sensitive to caffeine or oxalates found in tea (persons with kidney disease) should minimize tea consumption and avoid supplements that contain caffeine or tea.
As such, an artisan having ordinary skill in the art would have been motivated to substitute one known element for another to predictably arrive at a composition having a catechin in the form of a nut or berry that contain EGCG not from green tea leaf or green tea leaf extract.
Conclusion
No claim is allowed.
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/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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