DETAILED ACTION
Election Acknowledged
Applicant’s election of Group III encompassing claims 8-12 in the reply filed on 7/1/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-7 are withdrawn as being directed to nonelected subject matter and claims 8-12 are presented for examination on the merits.
The following rejections are made.
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 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.
Claims 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwon et al. (CN 101437529; translation provided) in view of Cheng et al. (Evidence-Based Complementary and Alternative Medicine, 2011, 1-10), Kim et al. (Internation J Molecular Sciences, 2021, 22, 1-10) and Delisle-Houde et al. (J Plant Pathology, 2021, 103, 461-471).
Kwon describes a composition/method of treating viral infections, such as coronavirus infections, by administering an oral composition, the oral composition comprising an extract of Houttuynia cordata (see pages 1 and 3). The extract is administered in a dose of between 5-20 mg/kg per day and the method may be such that the extract is provided in proper time intervals several times per day, e.g. 2-3 times per day (see page 3) (see instant claims 8, 9 and 12). Regarding the volume of Houttuynia cordata extract administered as recited by instant claim 1 (i.e. 10-25 mL), this is not considered inventive as the general framework and dosage of the composition is provided by the art and so determining a volume of composition to be administered to inhibit a viral infection would have been a routine matter of optimization. See MPEP 2144.05(II)(A).
Kwon fails to teach applying to the subject a topical solution containing a therapeutically effective amount of Phyllanthus urinaria extract or one of its physiologically acceptable forms.
Cheng is directed to the use of Phyllanthus urinaria extract in inhibiting herpes simplex virus type 2 infections through inactivation of viral particles. Extracts of Phyllanthus urinaria contain various therapeutic compounds such as excoecarianin and geraniin (see pages 1-2). The composition for delivering the extract may be in the form of a topical cream (see page 8) which would be applied topically. Although Cheng does not describe a ‘solution’ as claimed, Kwon (see above) teaches that emulsions (e.g. a cream) and solutions are interchangeable formulations. Regardless, the exact form of the topically applied composition (e.g. cream, solution, etc.) is not seen as providing any significant difference in therapeutic outcome. Upon application of the extract composition, it would necessarily be applied to ‘some’ of the body as required by instant claim 10.
Regarding instant claim 11, 15 oC is considered room temperature and so it would be expected that the normal carrying forward of applying the Phyllanthus urinaria extract would meet the claimed limitation.
Cheng and Kwon fail to teach a method of applying Phyllanthus urinaria extract to treat a coronavirus infection. Cheng and Kown fail to teach the method as providing treatment for bacterial infections.
Kim is directed to the use of geraniin in the treatment of coronavirus infections. It is taught that geraniin demonstrates a high affinity to spike protein and ACE2 receptors and such affinity would be critical in preventing the entry of the virus into target cells and limit infection (see page 1). Thus, it would have been obvious to use Cheng’s Phyllanthus urinaria extract in methods of treating coronavirus infections as the Phyllanthus urinaria extracts are known to contain active compound, e.g. geraniin, that are active against coronavirus. Moreover, it would have been obvious to modify Kwon’s method of treating coronavirus to further include applying the topical Phyllanthus urinaria extract if Cheng with a reasonable expectation for success in yielding a dual action method for treating coronavirus. Combining prior art elements according to known methods to yield predictable results is indicia of obviousness. See MPEP 21433(I)(A). See also MPEP 2144.06(I).
Delisle-Houde teaches that geraniin exhibits antibacterial activity. It is taught that geraniin exhibits activity against a variety of bacterial species such as E. coli, S. aureus, H. pylori and so on (see page 461). Upon arriving at an obvious method of administering Phyllanthus urinaria extract and Houttuynia cordata extract in the treatment of coronavirus, the result would necessarily encompass a method capable of also treating bacterial infections as the method provides geraniin which is known to possess antibacterial activity. Thus, one of ordinary skill in the art would identify a patient population suffering from both coronavirus and bacterial infection as a target for the method of administering the combination therapy as said therapy is known to be useful in treating both coronavirus infection and bacterial infection. See MPEP 2143(I)(C).
Therefore, the invention as a whole is 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 absence of evidence to the contrary.
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.
Claim 9 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor.
Claim 9, dependent from claim 8, recites “wherein the second step is repeated at regular intervals.” However, claim 8 from which claim 9 does not recite a “second step”. While claim 8 does provide two steps of administration, it is not clear which of the two is considered the “second step” as neither are defined as occurring first and second. Claim 9 is unclear and clarification is requested.
However, for purposes of examination, the Examiner will assume that the administration of the Houttuynia cordata extract is the intended second step.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 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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/KYLE A PURDY/Primary Examiner, Art Unit 1611