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 .
The Amendments filed on 10/17/2025 has been received and entered.
Claim(s) 1, 3-8, and 10 are currently pending and under examination.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated below are hereby withdrawn.
Information Disclosure Statement (IDS)
The information disclosure statement (IDS) submitted on 10/17/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
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 1, 3-8, and 10 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.
In Claims 1, 3, 5, and 10, the term “traditional Chinese medicine bag” indefinite because it is not clear what is considered “Chinese” and “traditional” and what is a medicine bag. It is not clear what “Chinese” entails. Is it a trademark origin? What is considered traditional? How far back is the tradition going? What type of shape, size, material of the bag for it to be a “medicine bag”?
In Claims 4, 5, and 10, the term “mass” is indefinite because mass does not change with the material. Mass is an inherent part of the ingredient. Do you mean weight? Please amend as proper.
In Claims 5 and 10, the “(1500-2500): (3:4)” ratio are in parentheses. Why are they in parentheses? Is it part of the claim or not?
In Claims 1 and 10, the term “natural” renders the claims vague and indefinite because one does not know what origin or process would make something "natural" as opposed to not being "natural". For example, all of the listed herbal ingredients in the composition used in claim 1 are some sort of extract meaning that some sort of extraction process was performed to make each extract (including the listed oils) and thus it is unclear how those processes would be "natural" versus not being "natural". Therefore, the term “natural"” makes the claims unclear.
Furthermore, Claim 10 is 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 because it is unclear what Applicant intended with regard to the step of “smashing” the crocodile fat (e.g. crushing, grinding, pressing, etc.). All other terms dependent directly or indirectly from the rejected claim(s) are, therefore, also rejected for the reasons as set forth above. Appropriate amendment is required.
Claim Rejections - 35 USC § 103
Claim(s) 1 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Santativogchai, et al., “Comparison of Physicochemical Properties and Fatty Acid Composition of Crocodile Oil (Crocodylus siamensis) Extracted by Using Various Extraction Methods” International Journal of Food Properties, 23(1), 1465–1474. (September 8, 2020) in view of Chieh, W. (WO2021066740A1) and Naoko, et al., (WO2018216047A1). This is not a new rejection.
The instant claim(s) is/are of record, drawn to the following: an extraction method of natural crocodile oil (claims 1-8) and the crocodile oil obtained by said extraction method (claim 9, now cancelled).
Santativogchai, et al., generally teaches several methods of extracting crocodile oil from crocodile adipose tissue including dry rendering, wet rendering, wet cold pressing (i.e. mechanical pressing and filtering with solvent) and dry cold pressing (i.e. mechanical pressing and filtering without solvent). For example, Santativogchai, et al., teaches a dry cold-pressing extraction method crocodile fat to extract crocodile oil (see Introduction, pages 1465-66). Santativogchai, et al., teaches crocodile fat samples are cleaned and ground into tiny pieces; mechanically cold-pressed with filter cloth(s)) (i.e. filter mesh, as required in claim 6 of the instant application) to obtain a crude crocodile oil solution; the solution is left to settle until separation is observed and the clear oil fraction is collected, evaporated and stored. (see Materials and Methods, Oil Extractions, page 1466-67), as broadly required in claim(s) 1-9 (see claim 1 of the instant application requiring “… (1) washing crocodile fat, smashing, adding the smashed crocodile fat into a traditional Chinese medicine bag, and then standing, and (2) taking out the fat and then pulping to obtain a muddy material, filtering the muddy material, and then collecting filtrate to obtain crocodile oil.”).
Santativogchai, et al. is silent regarding adding the smashed crocodile fat into a traditional Chinese medicine bag comprising calendula, cherry blossom, frankincense, patchouli, Centella asiatica, and Allium macrostemon (claim(s) 1-9), standing for 30-50 hours, filter mesh diameter is 150-300 mesh, ambient temperature 15-25 degree C.
Chieh, W., however generally teaches a method of preparing a crocodile oil with reduced unpleasant odor. Chieh, W., does not teach the use of a traditional Chinese medicine bag; however, Chieh, W., does teach the step of infusion of the crude crocodile oil with plant essence(s) (see Abstract; Detailed Embodiments), as required in claim(s) 1-9. For example, Chieh, W., teaches combining the crude crocodile extract with plant essence and emulsifier, mixing for 6 hours, and then filtering out oil dregs to obtain the milky liquid. (Specification, page 6).
Naoko, et al., generally teaches a sheet material for infusion (e.g. an “infusion bag” that can be used with liquid foods such as soup stock and/or medicine such as herbal medicines) (see Naoko, et al., Specification, paragraph(s) [0001]-[0002]). Naoko, et al., teaches the infusion sheet material can be used broadly for “beverage materials, food materials, medicines and quasi-drugs” and includes examples such as “mackerel flakes” “dried sardines” (Specification, paragraph(s) [0028]-[0029]).
It would have been obvious to one of ordinary skill in the art of extraction and/or infusion of extracts to infuse crocodile oil with plant essence(s) to reduce the foul odor of the oil (e.g. cherry blossom, frankincense, and patchouli) and to use a Chinese medicine bag for extraction/infusion (e.g. a gauze bag), as required in claim(s) 1-9 (see Specification, paragraph [0074]). As taught by Chieh, W., crocodile oil extraction/infusion with plant essence(s) to improve foul odor was well-known in the art. Similarly, as taught by Naoko, et al., the use of an infusion bag during extraction for infusion was well-known in the art (see Abstract). Thus, it would be prima facie obvious for one skilled in the art to combine the teachings of the above references and use a Chinese medicine bag with crocodile oil extraction/infusion to remove foul odor, which is taught by the prior art to form a crocodile oil infused with plant essence(s) which is useful for the same purpose.
The references also do not specifically teach performing the process in the time span and temperature range claimed by applicant. The process in the time span and temperature range is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal process in the time span and temperature range to use in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use mesh size for the bag because the ground crocodile fat would have to be separated from the oil. One would have been motivated to make a bag with a specific mesh size to separate oil from the fat. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Claim(s) 1, 3-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Santativogchai, et al., “Comparison of Physicochemical Properties and Fatty Acid Composition of Crocodile Oil (Crocodylus siamensis) Extracted by Using Various Extraction Methods” International Journal of Food Properties, 23(1), 1465–1474. (September 8, 2020) in view of Chieh, W., (WO2021066740A1) and Naoko, et al., (WO2018216047A1), as applied to claims 1, and 5-8 above, and in further view of Ning, et al. “Botanical Drugs in Traditional Chinese Medicine with Wound Healing Properties” Front Pharmacol. 2022 May 12;13:885484. and prior art admitted by Applicant in the Specification (pages 6-9 [0041-0074]).
The instant claim(s) are of record above.
Santativogchai, et al., Chieh, W., and Naoko, et al., is/are silent regarding the combination of calendula, cherry blossom, frankincense, patchouli, Centella asiatica, and Allium macrostemon (claim(s) 3 and 4).
Ning, et al., however, teaches botanical drugs in traditional Chinese medicine used in the treatment of wounds (see Abstract). Ning, et al. generally teaches topical application of multiherbal preparations for wound healing activities (See Table 2). Ning, et al., teaches multiple botanical drug compositions can be used together in a particular ratio can reduce toxicity and give a better therapeutic effect (see page 18), as required in claim(s) 3 and 4. Ning, et al., teaches the herbs calendula and Centellae asiatica (i.e. discussed as Centellae herba) inhibit inflammation and are known for their wound healing activity (See page 2), as required in claim(s) 3 and 4.
It would have been obvious to one of ordinary skill in the art to combine calendula, cherry blossom, frankincense, patchouli, Centella asiatica and Allium macrostemon due to their well-known anti-inflammatory and skin protective/enhancing properties. As taught by the references above, it is well known in the art the individual anti-inflammatory and skin and/or wound healing effects of calendula (i.e. anti-inflammatory effects and ability to treat skin infections; Specification, [0044]-[0054]); cherry blossom (i.e. rich natural vitamins, strengthening mucous membranes; Specification, [0054]-[0057]); frankincense (i.e. reducing swelling and improving skin related redness heat, pain and ulceration; Specification, [0061]-[0065]); patchouli (i.e. for heat relief and for its fragrant aroma; Specification, [0066]-[0069]); Centella asiatica (i.e. anti-inflammatory benefits and use as an ointment for treating scars and protecting the skin; Specification, [0058]-[0060]); and Allium macrostemon (i.e. skin lightening, scar repair and anti-aging effects (Specification, [0070]-[0073]), according to long understood principles of Chinese traditional medicine as Applicant states in the specification (Specification page(s) 6-9, paragraphs [0041]-[0074]). Thus, it would be prima facie obvious for one skilled in the art to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a composition for infusion which is useful for the same purpose. The idea for combining them flows logically from there having been used individually in the prior art. Moreover, based on the disclosure by these reference that these substances are used as a fragrance and/or used medicinally for their anti-inflammatory and/or skin protecting/enhancing effects, a person of ordinary skill in the art would have a reasonable expectation of success in combining the substances and using them as an infusion step in an extraction method.
Thus, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Santativogchai, P., et al., Chieh, W., Naoko, et al., and Ning, et al., to arrive at the instantly claimed invention(s) with a reasonable expectation of success. If not expressly taught by the references, based on the overall beneficial teaching provided by the references with respect to the ingredients of the composition(s) and/or method(s) of making and/or using disclosed therein, the adjustments of particular conventional working conditions (E.g. regarding the standing time of the smashed crocodile fat in the traditional Chinese medicine bag being 30-50 hours (claim 2); the mass ratio of the traditional Chinese medicine bag components and the ratio of the crocodile oil to the components of the traditional Chinese medicine bag (claim(s) 4-5); and filter pore diameter (claim 7), and the temperature range (claim 8)) in which to perform such method is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
The references do not specifically teach adding the ingredients in the amounts claimed by applicant for inflammation. The amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Please note, since the Office does not have the facilities for examining and comparing Applicants' method(s) with the method(s) of the prior art (including compositions within recited processes), 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).
Response to Arguments
Applicant argues that “smashing” and “mincing” are the same through translation.
In response to Applicant’s argument, “smashing” is crushing with a blunt force, while “mincing” is using a sharp object to chop. These two processes would result in different textures and physical properties that would result in different tissue damages for extraction.
Applicant argues that the references do not teach “mincing”.
In response to Applicant’s argument, Santativogchai, et al., teaches crocodile fat samples are cleaned and ground into tiny pieces. Mechanical grounding of fat is done with knife blades through a grounder. The process is essentially mincing because the blades cutting through the fat would result in mincing action.
Applicant argues that there is no motivation to combine the references.
In response to Applicant’s argument, crocodile fat is known to have an odor. It would have been obvious to one of ordinary skill in the art of extraction and/or infusion of extracts to infuse crocodile oil with plant essence(s) to reduce the foul odor of the oil (e.g. cherry blossom, frankincense, and patchouli) and to use a Chinese medicine bag for extraction/infusion (e.g. a gauze bag), as required in claim(s) 1-9 (see Specification, paragraph [0074]). As taught by Chieh, W., crocodile oil extraction/infusion with plant essence(s) to improve foul odor was well-known in the art. Similarly, as taught by Naoko, et al., the use of an infusion bag during extraction for infusion was well-known in the art (see Abstract). Thus, it would be prima facie obvious for one skilled in the art to combine the teachings of the above references and use a Chinese medicine bag with crocodile oil extraction/infusion to remove foul odor, which is taught by the prior art to form a crocodile oil infused with plant essence(s) which is useful for the same purpose.
Thus, there is a reason to combine the references.
Applicant argues that the plant ratios are not taught and there is superior result.
In response to Applicant’s argument, the ratios are in equal parts. The references do not specifically teach adding the ingredients in the amounts claimed by applicant for inflammation. The amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached Monday-Friday 9-5:30 PM.
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 U 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.
Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
