DETAILED NOTICE
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 without traverse of group II, claims 10-20, drawn to a method for making a gel for treating hemorrhoids in the reply filed on April 24, 2026 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 § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Election was made without traverse in the reply filed on April 24, 2026.
Claims 1-9 have been cancelled. Pending claims 10-20 are being examined on the merits
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 10-15 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.
Claim 10 recites the limitation "crushing the… “plants”… in a grinder" in lines 11-13 . It is unclear of the method in use, as it seems the plants are crushed together. Applicant should/can clarify to say “crushing each one of the “plants” in a grinder” to then obtain the individual powders. As currently written the methods steps are unclear how individual powders are obtained.
Dependent claims 11-15 are rejected for failing to cure the indefiniteness and being dependent on the rejected claim 10.
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 10-20are rejected under 35 U.S.C 103 as being unpatentable over references Toda (US2018117000A1), Liu (CN109908312B), Jackson (US4659700A), Kshirsagar (V.124, 444-483 (2019) South African Journal of Botany) and Wang (CN104873725A).
Toda 000’ teaches a method relating to a new energy-metabolic activating agent for muscle cells. The invention is widely used in food, drinks and medicines and in quasi-drugs or the like (see abstract).
Toda teaches a method wherein a Black Ginger extract is combined with various ingredients to make an energy metabolic agent, this can be in the form of a spray dry or freeze dry agent, a tablet, creams or the like. (See Best mode for carrying out the invention paragraphs 0023,0032 and 0044. Toda references that such black-ginger extract is used for healing hemorrhoids and preventing hemorrhoidal diseases. The extracting-solvent used in the present invention can be ethyl alcohol and it is preferable to use room-temperature water, warm water, hot water or water with a slight amount of acid or ethanol. (see best mode paragraphs 0024, and 0028) Toda teaches that other antioxidants or compounding ingredients of the energy metabolic activating agent having a health maintenance function include: Chitosan, Dandelion (taraxacum mongolicum), Ginko Biloba extract, Panax Notoginseng, Ang-Khak (Chinese Red Rice) (monascus purpureus went). (see under Chemical formula 1, Paragraph 0041). Toda further teaches the agent can be used as lubricant agents or absorbents.
Liu 312’ teaches an invention related to the technical field of ointment, in particular to a hemorrhoid ointment and cream and a preparation method thereof. The present invention provides a method for preparing hemorrhoid cream which comprises glycerin as an ingredient to prepare the cream. The raw materials and preparation method for the hemorrhoid cream is as follows:
Phellodendron 6g; Calcined Gypsum 35g; Lithospermum 15g; Angelica 15g; Curcuma 5g; Frankincense 25g; Galla 5g; Calcined Keel 28g; Bletilla striata 15g; Borneol 5g; Pearl 25g; Calamine 35g, Potato 5g; Ammonium Glycyrrhizinate 10g; Mountain Hyoscyamine 3g; Gecko 4g; Sophora japonica 12g; Rhubarb 3g; Camellia 5g; Indigo Naturalis 8g; Saponins 7g; Figs 10g. It is noted that Camellia, is from the flower of Camellia, a plant of the genus Camellia of the Camellia family. (see example 4)
The preparation method includes, the comfrey, angelica, turmeric, sophora japonicus, camellia, and fig are respectively distilled and extracted, and the obtained extracts are mixed to obtain volatile oil. The mixed medicinal residue (a mixture of six medicinal residues) obtained by distillation is kept for later use, and the volatile oil is for later use. The Gecko was soaked in ethanol for 20 hours at a concentration of 98 wt%, The Indigo Naturalis is decocted, and the decoction liquid obtained from the decoction is concentrated to 80% by weight, and then ammonium glycyrrhizinate and anisodamine are added to the mixture, and the resulting mixture is ground into powder, and the powder is added for use. Add powdered calcined gypsum, calcined keel, calamine, pearl and gallnut to the molten petroleum jelly, then stir, stir until the temperature drops to 60℃, then add frankincense, borneol, added powder, potato powder and volatile oil, and finally Then add the extract. After stirring for 30 minutes, add the concentrate and clean slurry, continue stirring, and finally add glycerin and benzoic acid to obtain a paste that meets the requirements. The amount of glycerin needs to be determined according to the specific situation, so that the product can reach the hardness required by the paste. In this process, the total stirring time is 1 hour, and the stirring speed is 50 rpm (See Example 4.)
While this invention does not expressly teach a method of preparation for a gel, one of ordinary skill could be motivated to create a gel-cream application using the ingredients as listed as they have been shown in the art to be effective in gel applications and in cream and ointment applications.
Jackson 700’ teaches a method which relates to a chitosan carrier in wound care and to a process for its formation from a solution of chitosan in a glycerol-water-acid solution by neutralizing said chitosan solution.
Jackson teaches the chitosan starting material is preferably used in finely powdered form, 1% glacial acetic acid solution and glycerol was mixed in a ratio of 1 part of said acetic acid solution to 3 parts of glycerol to form a solvent. One gram (1 g) chitosan (in finely powdered form) was dissolved in 100 ml of the aforesaid solvent by stirring with a magnetic stirrer at room temperature for 1-2 hours to form a clear pale-yellow solution. The solution was neutralized by adding 5N NaOH until pH 7 was reached. Immediately a clear slightly tacky gel formed. The gel, which apparently results from the interaction of chitosan, glycerol and water, has a three-dimensional structure, and no free water or glycerol is apparent (See example 1- Chitosan Glycerol Acetic Acid Gel.)
Wang 725’ teaches a kind of Chinese medicine liniment for the treatment of inflammatory external hemorrhoid skin ulcer. The medicine comprises 22-27 parts of Gerbera. Gerbera is also known as Barberton daisy or gerbera jamesonii bolus. The invention adopts the ferbera to the sore muscles to stop bleeding and relieve pain, astringent anti-inflammatory, swelling, sore, have a better therapeutic effect on inflammatory external hemorrhoids. The coating agent is applied to the affected area and around the treatment. It can be made into a thick paste (see entire document.)
Kshirsagar shows that Swertia is a diverse genus of herbs belonging to the family Gentianacear with some Swertia species recognized for their anti-inflammatory effects and antioxidant effects, finding use in traditional medicine to treat gastric trouble and other ailments. Common names of Swertia include Swertia Perennis L in Western North America and Switzerland this can also be known as Swertia Perennis (Manshurica) (see number 9 in table 1).
Each of these references teach that that plants in the claimed invention can be used in a combination to make an application related to a hemorrhoid application. One of ordinary skill in the art would be motivated to take these references and combine these ingredients to make a hemorrhoid gel or a gel like cream because these plants have been shown to work together, all have anti-inflammatory or antioxidant effects, have been used in medicinal remedies before, and have been shown to be effects when used as a hemorrhoid application.
Even though none of the present inventions teach the parts by weight of the claimed inventions recited plants, MPEP §2114.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions, tells us:
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
A person having ordinary skill in the art would have been motivated to make the claimed gel for treating hemorrhoids, because the prior art discloses the use of the plant extracts for hemorrhoid treatments and the art recognized the topical administration for treatment of medicinal components in a chitosan, glycerine gel composition. There would have been a reasonable expectation of success of using the claimed ranges because the art has shown the optimization of the components for effective treatment conditions. Therefore, it would have been prima facie obvious to the person having ordinary skill in the art to manufacture a gel comprising the plant extracts as claimed, because the prior discloses the use of the components in anti-inflammatory hemorrhoid treatment protocols.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARNITIA T WALKER whose telephone number is (571)272-2550. The examiner can normally be reached Monday-Friday 8:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571) 272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Marnitia T Walker/
Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
Prosecution Insights