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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 6/22/2026 is acknowledged. The requirement is deemed proper and is therefore made FINAL.
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 3 and its dependent claims 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 3 recites “a densely coagulated material (pelleted material).” It is unclear if the language in the parenthesis is intended to be part of the claimed invention. Appropriate correction and/or clarification is required.
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.
Claim(s) 3-6, 11-13, 16, 18, and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sengun et al. (Pub. No.: US 2013/0084310 A1; hereinafter “Sengun”).
Sengun teaches the following regarding claim 3: a method for producing a scaffold graft material for tissue repair and/or tissue support or reinforcement in a subject (paras. 0008-0009), comprising the steps of: (i) providing a whole blood sample in combination with an anti-coagulant agent and a coagulation activator or surface which initiates coagulation (paras. 0079-0081); (ii) subjecting the blood sample to a separation force while the blood sample is coagulating to separate the whole blood into a densely coagulated material (pelleted material) and supernatant (paras. 0082-0086, 0140, 0164); (iii) separating the densely coagulated material from the supernatant to provide the scaffold graft material for tissue repair and/or tissue support or reinforcement in the subject (paras. 0086-0089).
Sengun teaches the limitations of the claimed invention, as described above. However, it does not explicitly recite that the anti-coagulant agent is sufficient to prevent coagulation of the blood sample within about 5 minutes. Sengun teaches that the appropriate anti-coagulant agent amount is added to the blood sample in order to ensure the premature coagulation is prevented (paras. 0026-0028, 0079). The optimization of parameters 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 one of ordinary skill to determine the optimal amounts of the anti-coagulant agent needed to achieve the desired results and prevent premature coagulation for the desired amount of time. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amount of anti-coagulant agent need to prevent coagulation for about 5 minutes, would have been obvious at the time of applicant's invention in view of the teachings of Sengun. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Sengun teaches the following regarding claim 4: the method according to claim 3, wherein the blood sample is subjected to a one-step centrifugation in the range of about 2250 x g to 3750 x g (para. 0082).
Sengun teaches the following regarding claim 5: the method according to claim 4, wherein the centrifugation period is between 50 and 60 mins (para. 0083).
Sengun teaches the following regarding claim 6: the method according to claim 3, further comprising (iv) harvesting the densely coagulated material (paras. 0086-0089).
Sengun teaches the following regarding claim 11: the method according to claim 3, wherein the blood is autologous to the subject (para. 0022).
Sengun teaches the following regarding claim 12: the method according to claim 3, wherein the scaffold material comprises a substantially homogenous mixture of plasma, platelets, red blood cells and white blood cells (paras. 0074-0086, 0164).
Sengun teaches the following regarding claim 13: the method according to claim 12, wherein (i) the densely coagulated material comprises at least about 95% of the platelets in the whole blood; and/or (ii) the densely coagulated material comprises about 30% or less of the water content of plasma; and/or (iii) the densely coagulated material comprises less than 10% red and white blood cells (paras. 0087-0088, 0092).
Sengun teaches the following regarding claim 16: the method according to claim 3, wherein the coagulation activator is selected from a calcium salt, iron (ferrous) salt, aluminium salt, sodium salt or zinc salt (para. 0028) and the anti-coagulant agent is selected from heparin, ethylenediaminetetraacetic acid (EDTA), citrate, oxalate, and thrombin inhibitor (para. 0027).
Regarding claims 18 and 21-24, Sengun does not explicitly recite the claimed ratios of the of the whole blood and the agents, and the claimed values of the dimensions and the physical properties of the graft. Sengun teaches that the appropriate amount of agents are used for the appropriate volume of collected blood (paras. 0026-0028). Sengun further teaches that the dimensions and the physical properties of the scaffold graft material can be controlled and modified to have the desired values (paras. 0094-0098, 0106-0108). The optimization of parameters 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 one of ordinary skill to determine the optimal ratios and the optimum values of the properties of the scaffold graft material needed to achieve the desired results and to appropriately treat the target implant site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the ratios of the blood and the agents and the optimum values of the properties of the scaffold graft material, would have been obvious at the time of applicant's invention in view of the teachings of Sengun. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Sengun teaches the following regarding claim 21: the method according to claim 3, wherein the scaffold graft material is a flexibly solid non-gel homogenous material comprising about 95-100% platelets, less than 10% red and white blood cells and at least about 30% water content of plasma (paras. 0068-0073, 0086-0088).
Claim(s) 10, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sengun in view of Turzi (WO 2011/110948 A2).
Regarding claim 10, Sengun teaches the limitations of the claimed invention, as described above. It further teaches that its scaffold graft materials can be used at a variety of target treatment sites (paras. 0119-0121). However, it does not explicitly recite the tissue support, repair, or reinforcement of a vaginal wall. Turzi teaches that it is well known in the art that tissue repair materials are applied to a variety of target sites, such a vaginal wall (pgs. 39-40), as would be needed to appropriately treat a particular patient. It would have been obvious to one having ordinary skill in the art to apply the scaffold graft material of Sengun to a vaginal wall as taught by Turzi, as would be needed to appropriately treat a particular patient. Such a modification would be made with a reasonable expectation of success.
Regarding claims 17 and 19, Sengun teaches the limitations of the claimed invention, as described above. However, it does not explicitly recite the coagulation activator being calcium gluconate and the anti-coagulant being sodium citrate. Turzi teaches that calcium gluconate is a well-known coagulation activator and sodium citrate is a well-known anti-coagulant (pgs. 8-9, 11-12), and would be applied to provide the resultant scaffold with the desired mechanical properties. It would have been obvious to one having ordinary skill in the art to use the coagulation activator and the anti-coagulant taught by Turzi, as would be needed to provide the resultant scaffold with the desired mechanical properties. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case one type of agent for another, is generally considered to be within the level of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANN HU/Primary Examiner, Art Unit 3774
Prosecution Insights