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 .
Claims 1-8 are pending and being examined on the merits.
Specification
The disclosure is objected to because throughout the document, COVID-19 is presented in various forms (e.g., COVID-19 on page 1, line 12; Covid-19 on page 2, line 5; and covid-19 on page 2, line 22) and should be corrected to “COVID-19” in each instance throughout the document.
On page 3, lines 8-9, SARS-CoV-2 is misspelled as “SARS-Co-2.”
On page 6, line 1, SARS-CoV-2 is misspelled as “SARS-CoV-3.”
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because “covid-19” should instead read “COVID-19” and “the formulation comprising” should instead read “wherein the formulation comprises.”
Claims 4-6 are objected to because the phrase “wherein the propolis proportion is from 0.25 wt.% to 2.00 wt.% and the xylitol proportion is from 0.25 wt.% to 3 wt.%” should instead read “wherein the formulation comprises 0.25 to 2.00 wt% of propolis and 0.25 to 3.00 wt% of xylitol.”
Claims 7 and 8 are objected to because the phrase “the formulation further comprising” should instead read “wherein the formulation further comprises.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 2, 3, 5, and 6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
In the instant case, Claims 2 and 3 recite the formulation bring for use as a toothpaste, rinse, or a spray. It is unclear what the steps are for using these specific formulations. The claims may be rephrased to overcome the 112(b) rejection, for example using the phrasing “The formulation of claim 1, wherein the formulation is formulated for oral administration in the form of a toothpaste or rinse” or similar phrasing.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. § 112(b) 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.
Claims 1, 3, 4, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (KR20160090495A, translation, 8 pages) in view of Berretta et al. (Biomed Pharmacotherapy, 2020, 17 pages) and Soler et al. (Cureus, July 2022, 8 pages).
The instant claims are as of record, drawn to a formulation for preventing and treating COVID-19 wherein the formulation comprises propolis and xylitol as active agents.
Yu teaches an anti-influenza virus agent (formulation) comprising propolis and xylitol as active ingredients (Yu, [0001], page 1; as required for instant Claim 1) with weight ratios of 1-90% for both propolis and xylitol (Yu, [0009], page 3; as required for instant Claims 4-6). The active ingredients are extracted in water (carrying agent; Yu, [0011], page 3; as required for instant Claim 7) and can be in the form of a rhinitis spray (nasal spray; Yu, [0015], page 4; as required for instant Claim 3).
Yu does not teach wherein the composition is for the treatment and prevention of COVID-19.
Berretta et al. teach that propolis is a risk-free product with biological activities that are useful for reducing the risk and impact of SARS-CoV-2 infection (Berretta et al., Conclusions, page 11; as required for instant Claim 1) and Solar et al. teach that xylitol has anti-viral effects against SARS-CoV-2, decrease the time to symptom resolution of COVID-19, prevent hospitalizations, and prevent persistent olfactory abnormalities (Solar et al., Abstract, page 1; as required for instant Claim 1).
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 provide the anti-viral composition of Yu for the treatment and prevention of COVID-19 because Berretta et al. and Soler et al. teach that propolis and xylitol are effective at preventing and treating various symptoms of COVID-19. Additionally, since the composition of Yu is already an anti-viral composition provided as a nasal spray, a skilled artisan would have a reasonable expectation of success using that composition to treat o prevent COVID-19.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (KR20160090495A, translation, 8 pages) in view of Berretta et al. (Biomed Pharmacotherapy, 2020, 17 pages) and Soler et al. (Cureus, July 2022, 8 pages) as applied to Claims 1, 3, 4, 6, and 7 above, and further in view of Ansari et al. (US 2018/0333349 A1).
The instant claims and teachings of Yu, Berretta et al., and Soler et al. are as of record.
Yu, Berretta et al., and Soler et al. do not teach wherein the composition comprises barbadensis leaf juice, hydroxyethyl cellulose, magnesium aluminum silicate, calcium carbonate, lemon flavor, sodium bicarbonate, and sodium lauryl sulfoacetate or wherein the composition is formulated as a toothpaste or rinse.
Ansari et al. teach oral care compositions comprising aloe vera (barbadensis leaf juice; Ansari et al., [0033], page 3), the thickener hydroxyethyl cellulose, magnesium aluminum silicate to thicken and improve texture (Ansari et al., [0068], page 7), calcium carbonate as an abrasive or colorant to act as an indicator of surface contact (Ansari et al., [0056], page 5,and [0086], page 9), lemon essential oil as a flavor to enhance taste (Ansari et al., [0052], page 5), sodium bicarbonate as a buffering agent to provide a suitable pH (Ansari et al., [0094], page 10), and sodium lauryl sulfoacetate as an anionic surfactant (Ansari et al., [0077], page 8; as required for instant Claim 8). The oral care compositions may be provided as a toothpaste or mouthwash (oral rinse; Ansari et al., [0020], page 2; as required for instant Claim 2).
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 provide the anti-viral composition of Yu, comprising propolis and xylitol which are effective against COVID-19 as taught by Berretta et al. and Solar et al., as an oral mouthwash or toothpaste composition with the ingredients of Ansari et al. A skilled artisan would know that ACE2 receptors are the gateway of SARS-CoV-2 (Soler et al., 2022) and that ACE2 receptors are found in the oral cavity (Okui et al., Healthcare, 2021, Introduction, page 1.) and would thus be motivated to provide the composition of Yu as an oral rinse or toothpaste in order to prevent or treat COVID-19 disease.
With respect to the USC 103 rejections above, please note that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
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, 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).
Relevant Prior Art Made of Record
The following prior art is considered relevant to the state of the art prior to the effective filing date of the instant application regarding compositions comprising propolis and xylitol.
Marcucci (WO 2022082277 A1) teaches an oral rinse composition for dental use comprising propolis and xylitol.
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/
Primary Examiner, Art Unit 1655