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 .
DETAILED ACTION
Application Status
Claim(s) 1-8 are pending in this application.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) Application No. CN202410228306.6, filed on 02/29/2024.
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.
The term “ultra-low-temperature environment” in claim(s) 1 is a relative term which renders the claim indefinite. The term “ultra-low-temperature environment” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The collagen solution that is placed in an ice cube mold is rendered indefinite because it does not allow one skilled in the art to properly obtain frozen collagen solution without at a minimum having some knowledge on the range of temperature that would correspond to the “ultra-low-temperature” that would provide the freezing of the collagen solution.
Therefore claim(s) 1 is rejected for indefiniteness. Claim(s) 2-8 inherit the deficiency of claim(s) 1 and are rejected for being indefinite.
The term “low-temperature” in claim(s) 1, 5, 7-8 are a relative term which renders the claim indefinite. The term “low-temperature” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Without having the term “low-temperature” defined in the specification or given a range of temperatures, the term makes the claim(s) indefinite. The term is also interchanged with temperatures that seem to be associated with the previously rejected indefinite term “ultra-low temperature” having it covering an area where it should not be regarded at all.
Therefore, claim(s) 1, 5, 7-8 are rejected for being indefinite. Claim(s) 2-4 and 6 inherit the deficiency of claim(s) 1 and therefore are rejected as being indefinite.
The term “increased solid content” in claim(s) 1 and 3 is a relative term which renders the claim indefinite. The term “increased solid content” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “increased solid content” is a descriptive term providing no way to ascertain its meaning. It is subjective to the inventor and provides no standard in the claim(s) or the specification for one of ordinary skill in the art to practice the invention without the knowing what content is to be added or reached in total content of “increased solid content”.
Therefore, claim(s) 1 and 3 are rejected for being indefinite. Claim(s) 2, 4-8 inherit the deficiency of claim(s) 1 and 3 and therefore are rejected for being indefinite.
The term “quickly lyophilizing” and “quick lyophilization” in claim(s) 1 and 6, respectively, are relative terms which renders the claim indefinite. The terms “quickly lyophilizing” and “quick lyophilization” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The lack of a time or time frame that is not established for lyophilizing the crushed solid collagen and removing the crushed solid collagen, makes the claim(s) 1 and 6 indefinite. Does the inventor employ a time constraint on each of the two steps for lyophilizing the crushed solid collagen and then to remove the crushed solid collagen after reaching room temperature? To state after reaching room temperature, the term “quickly lyophilizing” makes the statement indefinite, there is no way to ascertain if the time is for leaving the collagen out to warm at a pace not subjected to interference by the inventor or if the inventor applies a method to allow the collagen to reach room temperature faster.
Claim(s) 1 and 6 are rejected for being indefinite. Claim(s) 2-8 inherit the deficiency from claim(s) 1 and are also rejected for being indefinite.
Regarding claim(s) 4, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 recites the limitation "freezing limitation" in the first line. There is insufficient antecedent basis for this limitation in the claim. Claim(s) 2 of which claim(s) 8 is dependent from never states this limitation.
Therefore, claim(s) 8 is rejected for lack of antecedent basis.
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.
Claim(s) 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2006138718 A2, (Examiner cited) published 12/28/2006, hereafter regarded as Lelkes, et al., and further in view of BR 112016013322 B1, (Examiner cited) and published 07/21/2020, hereafter regarded as Larsen.
In the instant case, applicants’ claim(s) are directed to a method of preparing a lyophilized collagen powder with the steps; weighing an amount of collagen solution, filling ice trays and freezing in ultra-low temperature (Step 1.1). Then crush the solid collagen in a low-temperature crusher to ensure solid state stays (Step 1.2), lyophilize (freeze drying) crushed solid for an intermediate lyophilized collagen powder (Step 1.3), weighing a second collagen solution and mixing the intermediate collagen into the second collagen solution (Step 1.4). Taking mixed second collagen solution with mixed intermediate and again filling ice trays and repeating steps 1.1-1.3 (Step 1.5). With a final step of sterilizing the lyophilized collagen powder by means of terminal sterilization (Step 1.6) directed at claim(s) 1 . The terminal sterilization step is gamma irradiation, directed at claim(s) 2, repeating claim(s) 1.4 and 1.5 if required, directed at claim(s) 3. Preparing the lyophilized collagen powder according to claim 1, wherein in step (1) the freezing temperature of -80℃ to -20℃, and the freezing time is 10-20 hrs., directed at claim(s) 4; preparing a lyophilized collagen powder according to claim 1, wherein in step (2), further, the temperature during low-temperature crushing is -30℃ to -5℃, directed at claim(s) 5; preparing a lyophilized collagen powder according to claim 1, wherein in step (3), during the quick lyophilization, the pre-freezing temperature is -20℃ to -80℃, the pre-freezing time is 4 to 12 hrs, and the lyophilizing time is 48 to 96 hrs, directed at claim(s) 6; and finally preparing a lyophilized collagen powder according to claim 1, wherein in step (4), the weight ratio of the solid contents in the collagen solutions in Step (1) and Step (4) is 1:1.5-1:2, and the low-temperature stirring temperature is 2℃-10℃, directed at claim(s) 7.
Regarding claim(s) 1, step 1-5, and claim(s) 3-6 Lelkes, et al. teaches that for natural collagen (Embodiments in which the additional substance comprises cells include cells that can be cultured in vitro, derived from a natural source, genetically engineered, or produced by any other means. [00112]) these can be made by freezing a dispersion/solution of collagen and then freeze-drying it; [0003]. The method includes the step of suspending, mixing, or otherwise placing pieces of a naturally occurring extracellular matrix material in a liquid. The naturally occurring extracellular matrix material and the liquid are formed into a mass; [0012]. Lelkes, et al. teaches that the method comprising: providing an unfractionated extracellular matrix extract from a mammalian tissue; freezing the unfractionated aqueous extracellular matrix extract at a temperature of at most -60°C and freeze drying to provide a lyophilized unfractionated extracellular matrix extract; then combining the lyophilized unfractionated extracellular matrix extract with an aqueous or non-aqueous solvent to form a solution, a hydrogel or a suspension; [0027].
Regarding claim(s) 1, step 1-2, and step 5, and claim(s) 3-4, Lelkes, et al. also teaches that the method includes: placing the unfractionated extracellular matrix extract in a mold; freezing the unfractionated extra cellular matrix extract at 0°C or below at a controlled freezing rate; freeze-drying the unfractionated extra cellular matrix extract by subjecting the unfractionated extracellular matrix extract to a temperature of at most -60°C for a time sufficient to remove at least 90% of a liquid from the unfractionated extracellular matrix extract and thereby obtaining a lyophilized unfractionated extracellular matrix extract; [00166] and that in certain embodiments of the method, freeze-drying is conducted at a temperature of between about -130°C to about -80°C; [00167].
Regarding claim(s) 1, step 3, and claim(s) 6, Lelkes, et al. also teaches lyophilize for 2 days (48 hours); ([00207] Example 8). Lelkes, et al. continues to teach that that terms "freeze dry" and "lyophilization" when referred to the process described herein are used interchangeably; [00164].
Regarding claim(s) 1, step 1 and step 4, and claim(s) 7-8, Lelkes, et al. teaches that in one embodiment of the invention the ratio is between about 0.1: 1 and 1: 1, [000107], and also teaches that if needed, defrost if required (from -80.sup.0C), and homogenize, all in 4°C. (keep the ratio as 1:2 w/v). [000200].
Lelkes, et al. does not teach claim(s) 1, step 6, wherein the final product is sterilized through terminal sterilization, and also does not teach claim(s) 2, wherein the terminal sterilization is irradiation sterilization after the collagen powder is filled.
However, regarding claim(s) 1 and 2 and 8, Larsen teaches first that hemostatic protein-based materials, such as collagen and gelatin, are commercially available in the form of a solid sponge and loose or unpackaged powder for use in surgical procedures; [0002]. Larsen teaches the radiation sterilization includes X-rays, gamma and beta rays; [000191] and when sensitive bioactive agents are present in the dry product, sterilization is usually performed as terminal sterilization with about 25 kGy or less of beta or gamma irradiation; [0005].
Finally, Larsen teaches that the dry composition of the present description is preferably sterile. Any suitable sterilization technique known in the art can be used. Sterilization preferably takes place after the packaging step, that is, when the dry composition is contained in an outer packaging. Thus, in a preferred embodiment, sterilization is terminal sterilization; [000190].
Therefore, the claimed invention as a whole would have been prima facie obvious before the effective date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains, to combine the terminal sterilization method with the method describing the major steps of preparing the lyophilized collagen powder. Therefore, there would be a reasonable expectation of success to arrive at the invention as the primary reference of Lelkes, et al. teaches the major steps involved in the method of preparing lyophilized collagen powder and Larsen provides the steps to terminal sterilization for the lyophilized collagen powder using gamma irradiation. Please see MPEP 2141-2144.
Claim(s) 1-8 are rejected for obviousness.
Conclusion
Claim(s) 1-8 are rejected in this application
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH RICCI MATTHEWS whose telephone number is (571)270-7306. The examiner can normally be reached Mon - Fri (8:00a - 5:00p).
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, Manjunath N Rao can be reached at (571) 272-0939. 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.
/JOSEPH RICCI MATTHEWS/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Prosecution Insights