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 .
Applicant’s response (amendments and arguments) are acknowledged.
Claims 12,15-18,20-23,25-26 and 29-31 are pending and examined on the merits, following the amendments.
Claimed Subject Matter Class: In the previous filing, the previous claims (product and methods of use) have been cancelled without prejudice and replaced with new/amended claims 12-18,20-23,25-26 and 28-33 directed to a method of making, a new subject matter class not by original presentation for which the examiner indicated willingness to examiner on the merits.
Jumbo IDS’s: The examiner notes the filing of a very large volume of references, for which it cannot be known – with the limited examination time examiners have per application - which, if any of these references, may have express teachings and/or suggestions specific to the new subject matter class claimed, though not claimed by original presentation, but picked up here by the examiner mid-prosecution. Applicant, as the expert here, is welcome to opine on whether any one or more references within the jumbo IDS’s filed, may contain information material to the new subject matter class now claimed. Absent such, the examiner is not granted the time to mine such a volume of references in search of any potential needles within any of these haystacks.
Election/Restrictions – Withdrawn, Amendment to Subject Matter Class, Group II
Claim Rejections - 35 USC § 112(a)(i)/(pre-AIA ) – Written Description, Maintained, Modified
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 12,15-18,20-23,25-26 and 29-31remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In this case, in e.g. claim 12, there is a lack of possession as to what element(s)/step(s) beyond merely the claimed oxygen and pH ranges respectively allows simply (i) ‘culturing’ bone marrow mesenchymal cells (MSCs) “to secrete a conglomerate mixture comprising the exosome and the one more growth factors”. Namely, the claims lack support as to whether these are the only molecules left ‘secreted’ from the bone marrow? The specification doe not sufficiently guide PHOSITA what further elements/steps are required/needed in order to (ii) separate the exosome and one or more growth factors from the MSC’s? Until such is expressly claimed, with support as to that in possession, a reasonable search of the new subject matter class now claimed cannot be reasonably carried out, especially mid-prosecution against the all the jumbo IDS references filed in totality – absent further guidance from applicant as the expert here.
In the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of that claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111; clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry,whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Therefore, the full breadth of the claims are not presently deemed to have been in Applicant’s ‘possession’ and found to meet the written description provision of 35 U.S.C. §112.
Response to Amendments and Arguments
Applicant’s amendments and arguments have been fully considered but not yet found persuasive. Applicant argues on page 7 of the response “that the secretome is collected from the condition media”; however, a secretome is not presently claimed and it is unclear if such is intended to be claimed? Further, as now claimed in claim 12, part (ii) collection step: 1) exosomes are not listed as “comprised” (aka required) therein after collection (yet claim 22 recites their intended presence); 2) while every listed growth factor is listed as ‘comprised’ therein (aka required), absent evidence to the contrary that such was intended as a Markush group (e.g. comprising one or more growth factors selected from the group consisting of . . . see also claims 29 and 30 and whether such equally applies there, as “further comprising one or more growth factors selected from the group consisting of . . . “?). As such, the intended claim scope (possession), in part, remains in question as to the required elements that will necessarily result from the ‘culturing’ of ‘any’ bone marrow MSC, since a specific MSC has not been identified. As such, a reasonable search of the intended claim scope of the invention is not presently possible. The rejection is maintained, in part, pending further amendment and/or arguments.
Claim Rejections - 35 USC § 112(b) – Indefiniteness, Metes & Bounds,
Maintained-In-Part (Elements), Modified
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.
Claims 12,15-18,20-23,25-26 and 29-31 remain, in-part, 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.
Claims 12-18,20-23,25-26 and 28-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements and/or steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted elements and/or steps are: in e.g. claim 12, what element(s)/step(s) beyond merely the claimed oxygen and pH ranges respectively allows simply (i) ‘culturing’ bone marrow mesenchymal cells (MSCs) “to secrete a conglomerate mixture comprising the exosome and the one more growth factors”. Namely, the claims are unclear as to whether these are the only molecules left ‘secreted’ from the bone marrow? If not, then what further elements/steps are needed in order to (ii) separate the exosome and one or more growth factors from the MSC’s? Until such is expressly claimed, a reasonable search of the new subject matter class now claimed cannot be reasonably carried out, especially mid-prosecution against the all the jumbo IDS references filed in totality – absent further guidance from applicant as the expert here.
Response to Amendments and Arguments
Applicant’s amendments and arguments have been fully considered but not yet found persuasive. Applicant argues on page 7 of the response (and relevant equally to the metes and bounds of the invention here) “that the secretome is collected from the condition media”; however, a secretome is not presently claimed and it is unclear if such is intended to be claimed? Further, as now claimed in claim 12, part (ii) collection step: 1) exosomes are not listed as “comprised” (aka required) therein after collection (yet claim 22 recites their intended presence); 2) while every listed growth factor is listed as ‘comprised’ therein (aka required), absent evidence to the contrary that such was intended as a Markush group (e.g. comprising one or more growth factors selected from the group consisting of . . . see also claims 29 and 30 and whether such equally applies there, as “further comprising one or more growth factors selected from the group consisting of . . . “?). As such, the intended claim scope elements (metes and bounds), in part, remains in question as to the required elements that will necessarily result from the ‘culturing’ of ‘any’ bone marrow MSC, since a specific MSC has not been identified. As such, a reasonable search of the intended claim scope of the invention is not presently possible. The rejection is maintained, in part, pending further amendment and/or arguments.
Claim Rejections - 35 USC § 112(b) – Indefiniteness, Antecedent Basis
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.
Claims 22 (depending to claim 12) 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.
Claim 22 recites the limitation "one or more exosomes" in line 1. There is insufficient antecedent basis for this limitation in the claim, because as now claimed in claim 12 (to which claim 22 depends), part (ii) collection step: 1) exosomes are not listed as “comprised” (aka required) therein after collection (yet claim 22 recites their intended presence). Further amendment and/or arguments are required.
Claim Rejections - 35 USC § 112(d) – Failure to Further Limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 23 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 23 is not further limiting, lacking an active step or new element and merely drawn to a potentially inherent end result. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Prior Art Made of Record But Not Relied On
Naughton et al. (U.S. 8257947) teach mesenchymal stem cell (MSC) culturing, wherein the methods therein speak to oxygen and pH concentrations employed in/around the ranges now claimed (col. 14-15; col. 21).
Oxygen (Here 0.1%-2%)
(68) Incubation of the inoculated culture is performed under hypoxic conditions, which is discovered to produce an ECM and surrounding media with unique properties as compared to ECM generated under normal culture conditions. As used herein, hypoxic conditions are characterized by a lower oxygen concentration as compared to the oxygen concentration of ambient air (approximately 15%-20% oxygen). In one aspect, hypoxic conditions are characterized by an oxygen concentration less than about 10%. In another aspect hypoxic conditions are characterized by an oxygen concentration of about 1% to 10%, 1% to 9%, 1% to 8%, 1% to 7%, 1% to 6%, 1% to 5%, 1% to 4%, 1% to 3%, or 1% to 2%. In a certain aspect, the system maintains about 1-3% oxygen within the culture vessel. Hypoxic conditions can be created and maintained by using a culture apparatus that allows one to control ambient gas concentrations, for example, an anaerobic chamber.
pH (Here 6.4-6.8)
Naughton also teach methods employing physiologic pH (e.g. 6.8): and to physiological pH (i.e., pH 6.8 to 7.5).
Generally, concentrations are deemed routinely optimizable parameters absent a showing of criticality in attaining something other than expected, see:
MPEP 2144.05 I. 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)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654
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