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 .
Claim(s) 1-10 are currently pending.
Withdrawn Objections
Applicant’s arguments filed on April 22, 2026 have been fully considered.
In regards to the objection of the specification for the term “Cistanche tubulosa”, Applicant has elected to amend the specification and italicize the phrase “Cistanche tubulosa” and therefore, the objection of the specification has been withdrawn.
In regards to the claim objection for claim(s) 1, 3-6 and 10, Applicant has elected to amend claim(s) 1, 4-6 and 10 to italicize the phrase “Cistanche tubulosa” and for claim 3, applicant has amended the claim to provide the correct term, “echinacoside” and therefore, the objection of claim(s) 1, 3-6 and 10 has been withdrawn.
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.
Claim(s) 1-5 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (U.S. Pub. No. US 2016/0000847 A1) further in view of Lin et al (Saudi Journal of Ophthalmology (Year: 2014), vol. 28, issue. 3, pp 173-181), Seen et al (Acta Ophthalmologica (Year: 2018), vol. 96, issue. 4, pp e412-e420), Dogru et al (Invest Ophthalmology (Year: 2018), vol. 59, issue. 14, pp des163-des168), and Man-Ru et al (Cellular Physiology and Biochemistry (Year: 2018), vol. 51, issue. 1, pp 63-79).
Regarding claim(s) 1, 3, 4 and 10, Lee teaches a method of using [an] extract of Cistanche tubulosa (abstract), extract has a good protective effect for eye cells, and can be further developed to drugs or food for preventing eye disease or slowing [down] the progress of eye disease (abstract). The Lee reference teaches that the extract comprises echinacoside, acteoside, isoacteoside, tubuloside A, or a combination and that these components can decrease the damage of the oxidative stress to the eye cells, and thus make the prepared drugs or food have protecting effects to the eye cells (paragraph 0034). In addition, Lee teaches the drugs and food prepared from extract of Cistanche tubulosa may be in any forms, such as capsules, tablets, powder, or liquid (paragraph 0029).
The Lee reference does not explicitly teach relieving dry eye syndrome (as stated within claim(s) 1 and 10 of the present invention). The Lee reference does not explicitly teach wherein dry eye syndrome is associated with smoke, particulates, dry air, air conditioning, prolonged use of electronic devices, contact lens wear, aging, hormone changes, inflammation, autoimmune diseases, refractive surgery or medication (as stated within claim 2 of the present invention). The Lee reference does not explicitly teach that the C. tubulosa extract is administered once daily in an amount from 50 to 250 mg (as stated within claim 5 of the present invention). The Lee reference does not teach that the C. tubulosa extract is administered in combination with one or more additional dietary supplements selected from a group consisting of docosahexaenoic acid, eicosapentanoic acid, lactoferrin, linolenic acid, lutein, maqui berry extract, phosphatidylethanolamine, phosphatidylserine, phytosterols, sphingomyelin, turmeric extract, vitamin B6, vitamin C and vitamin E (as stated within claim 6 of the present invention). The Lee reference does not explicitly teach that the dry eye syndrome is relieved by increasing tear production, improving meibomian gland dysfunction and increasing tear film break-up time or tear film lipid layer thickness (as stated within claim(s) 7-9 of the present invention).
Dogru et al teaches oxidative stress damages the ocular surface and plays an important role in the mechanism of dry eye disease (abstract).
Lin et al teaches that Dry eye (DE) is a common ocular disease that results in eye discomfort, visual disturbance and substantially affects the quality of life (abstract).
Seen et al teaches environmental factors are also often implicated in dry eye including exposure to pollutants, ultraviolet (UV) radiation and ozone (abstract).
Man-Ru et al teaches that improvements in technology have resulted in people spending more time using modern digital devices, and consequently, people are exposed to blue light (BL) emissions over long periods (page 64). Overexposure to short wavelength BL (450-495 nm) results in the generation of reactive oxygen species (ROS), such as superoxide and hydroxyl radicals, which cause increases in oxygen consumption and induce mitochondrial DNA damage (page 64). Man-Ru et al teaches that the accumulation of ROS results in oxidative stress and the extensive accumulation of retinoid adducts, which damage the retina further (page 64). The Man-Ru et al reference teaches that administration of C. tubulosa extract is able to protect against the ocular damage caused by such overexposures (abstract and pages 76-77).
It would have been obvious to one of ordinary skill in the art to modify Lee's method that uses the Cistanche tubulosa extract to help prevent or slow down the progression of eye disease with the knowledge that oxidative stress is a key mechanism in developing dry eye disease as taught by Dogru et al, and that generally, dry eye is a common ocular (or eye) disease as taught by Lin et al. This combination of references can be made because Lee's method treats eyes that are impacted by oxidative stress. One would have been motivated to make such a combination to achieve treating a broad range of ocular diseases - such as dry eyes that has a root of being caused as a result of oxidative stress.
Regarding claim 2, it would have been obvious to one of ordinary skill in the art to modify Lee's method of using the Cistanche tubulosa extract to treat eye diseases caused as a result of oxidative stress such as dry eye that could have been triggered by pollutants, as taught by Seen et al.
The combination of references can be made because Lee's method of creating a protective effect for eye cells is similar to the present invention that discuss relieving dry eye symptoms using the Cistanche tubulosa extract, proving that the prior reference seeks to improve eye problems, just like the claimed invention.
One would have been motivated to make such a combination to treat eyes that experience symptoms such as discomfort or swelling as a result of exposure to household products or outside debris or toxins, because one of ordinary skill would determine that the exposure to these materials would result in oxidative stress that would lead to certain ocular diseases.
Regarding claim 5, the Lee reference does not specifically teach the administration of the Cistanche tubulosa extract in the dosages claimed by the applicant in claim 5 of the present invention. However, as discussed in MPEP section 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)."
Thus, an artisan of ordinary skill would have been motivated to modify the dosage of the administered extract through routine optimization in order to determine the optimal dosage for use in the method of treatment suggested by the combination of the references. It is considered obvious to administer an effective amount of the Cistanche tubulosa extract within a subject to obtain the intended result: reduction or complete amelioration of dry eye.
Regarding claims 7-9, tear production increase, improvement of meibomian gland dysfunction, and an increase of tear film break-up time or tear film lipid layer thickness, as stated in the present claims, would intrinsically occur as a result of a subject in need thereof being administered the Cistanche tubulosa extract as taught by the combination of the aforementioned references.
Claim(s) 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (U.S. Pub. No. US 2016/0000847 A1) in view of Lin et al (Saudi Journal of Ophthalmology (Year: 2014), Seen et al (Acta Ophthalmologica (Year: 2018), vol. 96, issue. 4, pp e412-e420), Dogru et al (Invest Ophthalmology (Year: 2018), vol. 59, issue. 14, pp des163-des168), vol. 28, issue. 3, pp 173-181) and Man-Ru et al (Cellular Physiology and Biochemistry (Year: 2018), vol. 51, issue. 1, pp 63-79), as applied to claims 1-5 and 7-10 above, and further in view of Lu (CN 106344733 A - English translation provided).
Regarding claim 6, the teachings of Lee, Lin, Seen, Dogru, and Man-Ru are discussed above; however, the references do not teach including the additional ingredients claimed by applicant in claim 6.
Lu teaches vitamin E [has] excellent oxidation resistance function, can effectively resist free radical, inhibiting lipid peroxide generation (page 4). The reference teaches that the vitamin E containing composition is also able to moisturize the eye (abstract).
It would have been obvious to one of ordinary skill in the art to modify Lee's method that uses the Cistanche tubulosa extract to help prevent or slow down the progression of eye disease with the knowledge that vitamin E can be administered with the extract due to vitamin E having oxidation resistance functions and eye moisturizing properties, as taught by Lu. Overall, oxidative stress is a key mechanism in developing dry eye disease as taught by Dogru et al, and that generally, dry eye is a common ocular (or eye) disease as taught by Lin et al.
This combination of references can be made because Lee's method combined with Lu's vitamin E dietary supplement can more profoundly treat eyes that are impacted by oxidative stress.
One would have been motivated to make such a combination using the aforementioned references to achieve treating a broad range of ocular diseases - such as dry eyes through a dietary supplement that includes the Cistanche tubulosa extract which would be administered to a subject in need thereof.
Response to Arguments
Applicant’s arguments filed April 22, 2026 have been fully considered, and the arguments regarding the rejection under 35 U.S.C. 103 are found to be non-persuasive.
Regarding applicant’s remarks for the 35 U.S.C. 103 rejection wherein the combination of the references used: Lee, Lin et al, Seen et al, Dogru et al, Manru et al and Lu are not obvious over the claims of the present invention because none of the references, alone or taken together, teach or suggest relieving dry eye syndrome by administering an effective amount of Cistanche tubulosa extract.
Beginning on page 5 of applicant’s arguments, Examiner has acknowledged the data provided within Example 2 of the present invention. Furthermore, Applicant states that “a prima facie case of obviousness has not been established. Oxidative stress can be caused by many factors and injuries. There is no evidence that diseases caused by oxidative stress could all be treated with the same therapeutic regimen… stated differently, a skilled person in the art, could not have deduced from Lee and Dogru that any antioxidant would exert a mitigating effect on dry eye disease with a reasonable expectation of success. Oxidative stress may occur following a variety of injuries, and Cistanche tubulosa extract cannot counteract all damage caused by oxidative stress.” Applicant moves on to further state that “the other secondary references do not cure the deficiencies. Seen relates to the treatment of desiccation stress-induced dry eye disease in mice using antioxidant plant extracts, but provides no technical suggestion that Cistanche tubulosa extract can relieve dry eye disease. Lin relates to therapeutic strategies for dry eye disease, but provides no technical suggestion that Cistanche tubulosa extract can inhibit dry eye disease. Man-Ru teaches using the extract of Cistanche tubulosa in protecting against blue light induced eye degenerative retinopathy.” Lastly, in applicants remarks on page 6, applicant also states that “Lu does not disclose or suggest the use of Cistanche tubulosa extract. Accordingly, Lu fails to cure the deficiencies of Lee, Lin, Dogru [and] Man-Ru… [and therefore, claims 1-10] are not obvious over the cited references”.
Focusing on claim(s) 1-5 and 7-10, and beginning with the Lee reference, the Lee reference teaches that the preparation of a Cistanche tubulosa extract that comprise echinacoside, acteoside, isoacteoside, tubuloside A, or a combination thereof… in which, the components can decrease the damage of oxidative stress to the eye cells and thus make the prepared drugs or food have protecting effects to the eye cells. With the Dogru et al reference, Dogru et al teaches that oxidative stress plays an important role in the mechanism of dry eye disease. Although in page 5 of applicant arguments applicant states that “despite the fact that Dogru is limited to conventional antioxidants such as green tea extract, ferulic acid, vitamins, and ferritin for reducing oxidative stress damages”, that doesn’t negate the fact that it is known in the art for an extract, like C. tubulosa to contain antioxidants in general that would be useful for reliving dry eye. In addition, it is also important to note that Dogru does not discuss ferritin but does discuss lactoferrin. Lin et al further reinforces what dry eye disease entails, in which, dry eye is a common ocular disease. Furthermore, Seen et al also explains that dry eye can happen as a result of pollutants, UV radiation and ozone. Lastly, Man-Ru et al further proves that, for example, overexposure to blue light is enough to induce oxidative stress which can essentially lead to dry eye. Thus, with the combination of the following references: Lee, Lin et al, Seen et al, Dogru et al and Man-Ru et al is sufficient enough that one skilled in the art would find the obvious to combine those references in order to deduce that oxidative stress can lead to dry eye, which is a type of ocular disease that could be treated with Lee’s Cistanche tubulosa extract, given that Lee is dedicated to treating ocular diseases – as stated within applicant arguments on page 5 and within the abstract of the Lee reference. In addition, one of ordinary skill in the art would also deduce too that oxidative stress is a common trigger to a number of diseases, however, in the context of dry eye, one would reasonably expect that devoid of dry eye, the use of the Cistanche tubulosa for the eyes would cover a diverse array of diseases related to the eye, such that the C. tubulosa extract could be an effective treatment for the eye on a broader scale. Moreover, regarding claim 5, the Lee reference does not specifically teach the administration of the Cistanche tubulosa extract in the dosages claimed by the applicant in claim 5 of the present invention. However, as discussed in MPEP section 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)." Thus, one would reasonably expect to optimize the dosages of the C. tubulosa extract that is to be administered to treat a subject that does have dry eye syndrome.
Moreover, claim 6 includes the aforementioned references used for claim(s) 1-5 and 7-10 with the exception that claim 6 includes the Lu reference. The Lu reference reinforces that vitamin E, an ingredient that can be administered with the C. tubulosa extract, possess oxidative resistance functions, in which, one would reasonably expect that since dry eye disease can occur as a result of oxidative damage, in order to reinforce the dry eye healing properties that C. tubulosa provides by itself, it would benefit a subject in need to include vitamin E with the C. tubulosa extract in order to exhibit the optimal effects of relieving dry eye syndrome. Needless to say, applicant’s arguments stating, essentially, that all of the aforementioned references combined for claim(s) 1-10 are not obvious has been proven to be incorrect based on the substantial evidence provided within the Non-Final rejection on December 22, 2025 and additional evidence within some of the references listed within the present final rejection in regards to oxidative stress being linked to dry eyes (an ocular disease), in which, one of ordinary skill in the art would find it obvious that the C. tubulosa extract has the capability of relieving this extremely common ocular disease that could be caused by a variety of known factors. Thus, the 103 rejection is maintained.
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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