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 election with traverse of Group I in the reply filed on October 29th, 2025 is acknowledged. Applicant has argued that it would not be burdensome to examine Groups II-IV together. Applicant’s arguments have been fully considered, however, the arguments are not persuasive of error over group I and groups II-IV. the restriction between Group I (Claims 1-7) and Groups II-IV (Claims 8-20) is deemed proper, for reasons of record. Upon further consideration and to expedite prosecution, the claims of Groups III and IV have been placed in group II and have been examine therewith.
Claims 1-20 are pending of which claims 1-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Pending claims 8-20 have been examined on the merits.
The Examiner assigned to this case has changed. Please note the Examiner' s contact information at the close of this Office action.
Information Disclosure Statement
The information disclosure statements are is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The IDS contains references in a foreign language which have been considered to the
extent presented in the English language; as presented and accompanied by reference document
which is an English language equivalent or translation, to the extent cited in the instant
Application' s disclosure, or as cited by the Examiner in a PTO-892. Additional references which
have been considered have been initialed (fully considered) or also annotated in the IDS (to
indicate the extent considered). References which have not been considered have been lined
through. An initialed copy of the IDS has been placed in the instant Application file.
In the instant case, several of the included non-patent literature files received have at least partial illegibility:
Kinoshita and Aoyama (Int. J. Mol. Sci. 2021, 22 (8), 4245),
Gao (CN104667255A),
Mody et al. (Experientia 1976, 32 (7), 829-830),
Ammonium-Acrylodimethyl Taurate (<www.truthinaging.com/ingredients/ammonium-acryloyldimethyltaurate>),
a completely illegible 1-page document possibly from the Wayback Machine (judging by webpage layout), possibly:“Preparation of Suppositories” (<web.archive.org/web/ 20081211055237/http://pharmlabs.unc.edu/labs/suppository/bases.htm>),
Shrewsbury et al. (Compounding Facilities and Equipment. Applied Pharmaceuticals in Contemporary Compounding, 2nd edition 2008, pp. 29-33),
Baraks et al. (Cancer Res. 2022 82 (7), 1159-1166), and
Sarma (Int. J. Biol. Macromol. 2022 219, 395-413).
Compromised legibility may result from the conversion of color to black-and white and the resolution of which the documents are imported or scanned into the application file; however, clear original electronic copies of the non-patent literature document and priority documents are required.
Specification
The disclosure is objected to because of the following informalities:
The term “Coronavirus Disease 2019" should not be capitalized (paragraph [0012]);
The phrase "the keratin help move" should be grammatically corrected to recite the phrase --the keratin helps move-- (paragraph [0074]).
The applicant is advised to check the specification for informalities. Please note the above are considered necessary grammatical corrections; however, is not exhaustive of all possible informalities, as examination is not made for the purpose of securing grammatical perfection. (See MPEP 601.01(g)). Appropriate correction is required.
The use of the term "Sarravis® Core" (multiple instances in the Specification, see esp. para. [0062]), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 18 objected to because of the following informalities: The term "Coronavirus Disease 2019" should not be capitalized. Appropriate correction is required.
Note Regarding Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked (see MPEP § 2181).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “about” in claims 8, 19, and 20 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The quantities rendered indefinite are: % wt of an herbal preparation of a carnivorous plant (Claim 8); % wt of magnesium (Claims 8 and 19), glutathione (Claim 8), or both (Claim 8); and % wt of a drug product (Claim 8); % wt of an herbal preparation of a pitcher plant (Claim 19); %wt of valacyclovir (Claim 19); % wt of a protease inhibitor, a DNA/RNA polymerase inhibitor, or a combination thereof (Claim 20).
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
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.
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.
I. Claims 8, 9, 11-14, 16, 18-20; are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology 2016, 122 (5), e163); Palamara et al. (Antiviral Res. 1995, 27 (3), 237-253); Bede et al. (Inflamm. Res. 2008 57, 279-286); and Poole and James (Clin. Ther. 2018, 40 (8), 1282-1298).
The claims are as of record. The claims, in part are as follows: Claim 8 recites: A composition comprising: a. about 0.1%-99% wt of an herbal preparation of a carnivorous plant; b. about 0.01%-95% wt of magnesium, glutathione, or both; and c. about 0.01%-95% wt of a drug product. Claim 9, recites: wherein the carnivorous plant is Sarracenia flava, Sarracenia purpurea, or mixed hybrids thereof. Claims 11-12, recite: wherein the drug product comprises an antiviral drug, an anti-inflammatory drug, a cancer-modulating drug, an immune-modulating drug, a polymerase inhibitor, a protease inhibitor, or a combination thereof; including thereamong the drugs/antiviral drugs “acyclovir, valacyclovir, …or a combination thereof”.
Patel et al. recites the carnivorous plant Sarracenia purpurea inhibiting the replication of the herpes simplex virus type-1 (HSV-1) (see Patel at abstract; as required of claims 8-9; broadly, a composition component providing decreased viral expression, a therapeutically-effective amount, and HSV viral disease, respectively as required of instant claims 13,15,16, and 18-20). Patel teaches, in part, administering the composition, including topically applying, a therapeutically effective amount to treat HSV-1 infected cells and herpes virus-afflicted patients (see Patel at Objectives, Methods, and Results; as required of instant claims 14-16 and 18).
The claims are distinguished over the reference in that Patel does not teach providing an amount of glutathione, magnesium, or a drug product.
Palamara et al. recites the addition of exogenous glutathione, inhibiting HSV-1 replication in infected VERO cells (under subheading 3.2).
Furthermore, Bede et al. recites a significantly higher glutathione blood concentration in patients given oral magnesium supplementation over a 12-week period (Results, Reduced and oxidized glutathione in the blood).
Poole and James recite examples of known anti-HSV (antiviral) drugs such as acyclovir (broadly, a DNA polymerase inhibitor as required of instant claim 20) and valacyclovir (under heading: Acyclovir, Valacyclovir, Penciclovir, and Famciclovir: Indicated for Treatment of HSV-1, HSV-2 and VZV).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined in an herbal HSV-1 inhibiting/treating preparation of Patel (a carnivorous plant) with magnesium and/or glutathione, and a drug product (for example, acyclovir or valacyclovir), as each was known in the art as taught by the respective further teachings of Palamara and Bede. One would have been motivated to have provided glutathione and combined with magnesium because glutathione as taught by Palamara was known in the art to be useful for the same purpose of inhibiting HSV-1 replication and as taught by Bede that magnesium provides increased levels of glutathione. One would have been motivated to have provided the HSV treating compositions with drugs including one or more of the drugs taught by Poole and James (e.g. acyclovir, valacyclovir), such drugs being known for the same HSV-treating purpose. One would have had a reasonable expectation of success in providing such combination, because success merely requires providing/contacting the known component materials, and especially in the absence of objective evidence to the contrary or criticality of some unrecited features of the instantly claimed invention.
Patel et al., Palamara et al., Bede et al., and Poole and James are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the common applicability of amounts of carnivorous plant, glutathione, magnesium, and drug products for treating HSV-1, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof, including the therapeutic amounts and the broad wt% ranges as recited in claims 8 and 19) in which to provide the composition), 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 Patel et al., Palamara et al., Bede et al., and Poole and James, the invention as a whole, drawn to a composition as described in Claim 8, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
II. Claims 8-14, 16, and 18-20; are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology 2016, 122 (5), e163); Palamara et al. (Antiviral Res. 1995, 27 (3), 237-253); Bede et al. (Inflamm. Res. 2008 57, 279-286); and Poole and James (Clin. Ther. 2018, 40 (8), 1282-1298); as applied to claims 8, 9, 11-14, 16, and 18-20 above, and in further view of Arens and Travis (J. Clin. Microbiol. 2000, 38 (5), 1758-1762) (to address Claim 10).
The claims and teachings of the cited references are as record above.
The claims are further distinguished in that Claim 10 recites the composition further comprising zinc, chromium, selenium, B-vitamins, keratin, cannabidiol, tetrahydrocannabinol, or a combination thereof.
As shown supra, producing or administering an anti-HSV composition as claimed (satisfying the limitations of claims 8+) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. Further, as taught by the cited reference of Arens and Travis, it would have been obvious to have provided zinc therein, because zinc salts were known in the art and have been shown to inactivate HSV-1 (see A&T at Abstract). Therefore, further adding zinc to the composition would have been obvious as zinc was known in the art and useful for the same HSV-1 treating purpose, or, in the alternative, would have at least been obvious to try to one of ordinary skill in the art before the effective filing date of the claimed invention.
III. Claims 8, 9, 11-16, and 18-20; are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology 2016, 122 (5), e163); Palamara et al. (Antiviral Res. 1995, 27 (3), 237-253); Bede et al. (Inflamm. Res. 2008 57, 279-286); and Poole and James (Clin. Ther. 2018, 40 (8), 1282-1298); as applied to claims 8, 9, 11-14, 16, and 18-20 above, and in further view of Hammond et al. (J. Hepatol. 2001, 34 (6), 946-954) (to address Claim 15).
The claims and teachings of the cited references are as record above.
The claims are further distinguished in that Claim 15 recites A method of enhancing gene silencing in a subject in need thereof, the method comprising administering to the subject a therapeutic amount of the composition. Claim 8 recites a composition comprising glutathione and/or magnesium (with other materials).
Hammond et al. recites that “GSH pretreatment of fibroblasts reduces the upregulation of heme oxygenase mRNA” (under subheading 5.3), where GSH is the chemically reduced form of glutathione. Therefore, GSH is known in the art to decrease the transcription of a heme oxygenase gene in fibroblasts. Therefore, whereas the HSV-1 treating composition of the combined teachings of the prior art, comprising the same component materials (e.g. carnivorous plant/Sarcenia:GSH/Mg: drug/(val)acyclovir) is broadly interpreted as intrinsically providing the gene silencing, in the alternative it would have been obvious before the effective filing date of the claimed invention that a administering a composition comprising glutathione as further taught and evidenced by Hammond would be enhancing of the silencing of at least a certain gene (e.g. for heme oxygenase in fibroblast tissue).
IV. Claims 8, 9, 11-14, and 16-20; are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology 2016, 122 (5), e163); Palamara et al. (Antiviral Res. 1995, 27 (3), 237-253); Bede et al. (Inflamm. Res. 2008, 57, 279-286); and Poole and James (Clin. Ther. 2018, 40 (8), 1282-1298); as applied to claims 8, 9, 11-14, 16, and 18-20 above, and in further view of Watzinger et al. (Molecular Aspects of Medicine 2006, 27 (2-3), 254-298) (to address Claim 17).
The claims and teachings of the cited references are as record above.
The claims are further distinguished in that Claim 17 recites “The method of claim 16, further comprising: a. prior to administering the composition, testing the subject for a virus using polymerase chain reaction (PCR) or mRNA testing, and b. after administering the composition, retesting the subject for the virus using PCR or mRNA testing, wherein if the virus is still present in the subject, a result of the testing will come back positive and/or will indicate presence of mRNA for that particular virus”.
However, according to Watzinger et al., “RQ-PCR has become the most important technique for the detection and monitoring of virus infections” (Introduction, paragraph 3), where RQ-PCR refers to real-time quantitative PCR. Therefore, using a PCR to test a subject for a virus before and after administering a composition, including the composition of the combined references as argued of record above, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Please note, since the Office does not have the facilities for examining and comparing
Applicants’ composition and methods with the composition and methods of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed invention and the inventions 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 allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655