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
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 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.
Election/Restrictions
Applicant's election with traverse of Invention I, claims 1 and 3-7, in the reply filed on Dec. 8, 2025 is acknowledged. Claims 8, 12 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
The traversal is on the grounds that that search burden is not that great to search for all groups (Remarks pg. 1 para. 2). This is not found persuasive because as evidenced by the rejection below, the special technical feature was known in the art. Thus the groups do not contain a special technical feature which contributes over the prior art. In addition, while the groups may overlap in search, an overlapping search is not a coextensive search. As such a reference that anticipates one group may not anticipate or even make obvious the invention of another group.
The requirement for the restriction of Inventions I-IV is still deemed proper and is therefore made FINAL.
Claims 1 and 3-7 are presented for examination on the merits.
Status of the Claims
Claims 1, 3-8, 12 and 13 are currently pending.
Claims 8, 12 and 13 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 2 and 9-11 are cancelled.
Claims 1 and 3-7 have been considered 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 1 and 3-7 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 1 provides a method for producing an injectable preparation for a periodontal tissue, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a method without any active, positive steps delimiting how this method is actually practiced. The claims contain a series of wherein clauses containing product by process type-like limitations which describe the method of production of the autologous condition serum and the culture supernatant. Similarly, claims 3-7 further describe the method of production of the culture supernatant. It is unclear whether these limitations are to be interpreted as active steps that must be practiced in the method of preparing the injectable preparation or whether these limitations are only describing the sources of the two components of the composition being prepared and that the preparation of the injectable preparation merely requires the combining of a autologous condition serum and a culture supernatant. For the sake of compact prosecution the claim will be interpreted to mean a method for an injectable preparation for a periodontal tissue comprising autologous condition serum and a culture supernatant comprising a step of combining the autologous condition serum and a culture supernatant.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under USC 112 for the reasons set forth above.
Appropriated correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3-7 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Harlan et al. (US 2010/0297094 A1).
With respect to claim 1, Harlan teaches preparing a composition containing autologous serum and conditioned media (culture supernatant) (0088). Harlan teaches the CM (conditioned medium) can be injected and teaches the composition for periodontal disease and diabetic periodontitis (0183 and 0188). With respect to claim 1, Harlan teaches the method where the CM is obtained from mesenchymal stem cells that are from fat tissue (0079 and 0081).
Harlan is silent with respect to method by which the autologous serum is obtained and does not teach that the autologous serum is obtained by incubating blood collected from a patient using the preparation for a periodontal tissue with bringing the blood into contact with glass in a range of 30°C to 45°C for 1 hour or longer; and separating serum from the incubated blood as recited in claim 1. However, these limitations are interpreted as product by process type limitations. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. Furthermore, it is noted that the method for producing the autologous conditioned serum for the producing an injectable preparation for a periodontal tissue, is immaterial or inconsequential to the operation of the method. In other words, the autologous conditioned serum of Harlan is the same autologous conditioned serum as the claimed invention regardless of method of production absent a showing of secondary considerations.
With respect to claim 3, Harlan teaches culturing the cells in a first medium containing serum for expansion (first culturing step), then culturing the cells in a second medium without serum if desired (second culturing step in a different medium from the first medium), and then obtaining the conditioned medium after culturing (0088 and 0090). Even though Harlan teaches the method of obtaining the culture supernatant, these limitations are interpreted as product by process type limitations. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. In this case, the method for producing the autologous conditioned serum for the producing an injectable preparation for a periodontal tissue, is immaterial or inconsequential to the operation of the method. In other words, the autologous conditioned serum of Harlan is the same autologous conditioned serum as the claimed invention regardless of method of production absent a showing of secondary considerations.
Harlan does not teach the method where the second culturing step is performed in a non-CO2 atmosphere as recited in claim 4. Likewise, Harlan does not teach the method where the second medium contains calcium ions and a buffering agent as recited in claim 5. Similarly, Harlan does not teach the method where the buffering agent is a Good’s buffer as recited in claim 6 or where it is HEPES as recited in claim 7. Although, Harlan does not teach the method by which the conditioned medium is obtained as in claims 4-7, these limitations are interpreted as product by process type limitations. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. In this case, the method for producing the autologous conditioned serum for the producing an injectable preparation for a periodontal tissue, is immaterial or inconsequential to the operation of the method. In other words, the autologous conditioned serum of Harlan is the same autologous conditioned serum as the claimed invention regardless of method of production absent a showing of secondary considerations.
Therefore, the reference anticipates the claimed subject matter.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632