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 .
Applicants' arguments, filed June 17, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 – New Matter
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1 and 11 – 13 were 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This new matter rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed May 5, 2026 and those set forth herein.
New language has been added to claim 1 which adds additional new matter to the claims. The disclosure as filed requires the centrifugation at 150,000 ×g step to be carried out from 120 minutes and claim 1 sets forth no time limitations for this step and therefore encompasses any length of time. Steps of removing the precipitate and filtering the obtained supernatant through a 0.22 µm filter are taught as required steps between the centrifugation at 15,400 ×g for 30 min and the low-temperature ultracentrifugation at 150,000 ×g steps in the disclosure as originally filed but no such steps are required by the amended claim.
Applicants traverse this rejection on the grounds that the disclosure of the integral ultracentrifugation preceded by steps that take place at 4°C would lead one of ordinary skill in the art, who readily understands ultracentrifugation to begin at 100,000 ×g, means that centrifugation is not new matter. From reading the description, a person of ordinary skill in the art would appreciate centrifugation is always carried out at a low temperature of 4°C regardless of the exact centrifugation speed that escalates from 300 ×g to 150,000 ×g. The continual and uninterrupted process as a whole includes different centrifugation speeds yet a constant temperature of 4°C. No other temperatures are disclosed so it stands to reason that low-temperature means 4°C. Low temperature ultracentrifugation is used in the application as filed and emphasizes centrifugation conducted at 4°C at 150,000 ×g and does not specify a temperature different from the preceding centrifugation operations. One of ordinary skill in the art would recognize that using two different temperatures in immediately sequential operations unnecessarily complicates and draws out the procedure, because one would need to wait for the centrifuge and sample to equilibrate to a new temperature.
These arguments are unpersuasive. As discussed above, the steps disclosed in the specification as originally filed do not have 4 sequential centrifugation steps but rather requires removal the precipitate and filtering the obtained supernatant through a 0.22 µm filter are taught as required steps between the centrifugation at 15,400 ×g for 30 min and the low-temperature ultracentrifugation at 150,000 ×g steps. Therefore there is no disclosure of continual and uninterrupted centrifugation steps as argued by Applicants. The arguments regarding support for the claim language rely on numerous assumptions about what would be read into the method as disclosed. Arguments without factual support are mere allegations and are not found persuasive. The fact that specific temperatures other than 4°C are not disclosed does not mean that “low temperature” must mean 4°C. If all centrifugation steps were carried out, with interruption for precipitate removal and filtering of the supernatant, at 4°C then why would a different description of that step be used if 4°C is the only possible low temperature? This could also suggest to one of ordinary skill that low temperature does not absolutely mean 4°C and could still be considered a low temperature. Such as temperature could fall within the scope of “low temperature” but the range of “low temperature” could be broader than any specific temperature. While in haec verba support is not required and implicit or inherent support can be sufficient, that one of multiple possible interpretations arising from the disclosure as filed is now recited in the claims is not sufficient to fully support claim language from the disclosure as filed such that the claims do not contain new matter. The amended claim and arguments of record do not result in claims that are fully supported by the disclosure as filed and therefore the claims still contain new matter.
Claim Rejections - 35 USC § 112 – Indefiniteness
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.
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.
Claim 10 now recites “conducting low temperature ultracentrifugation at 150,000 ×g for 120 min”. The term “low temperature” is 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. Does this mean a temperature lower than the cells were being grown at? Lower than room temperature? Or some other range of temperatures? The discussion from “What is ultracentrifugation?” (from daiscientific.com, accessed November 5, 2025) states that “[u]ltracentrifugation typically operates a controlled, low temperatures to prevent degradation of sensitive biological samples” (next to last para on p 2). No actual temperatures are provided and what is low enough to prevent sufficient degradation may not be the same from one person of skill in the art to another and can also depend on the particular sample and intended use of the sample. “The Role of Refrigerated Centrifuges in Cryogenic and Ultra-Low Temperature Centrifugation” from drawellanalytical.com (accessed November 5, 2025) discusses cryogenic and ultra-low temperatures (p 3, section 1) but these are not the terms used in the claims so no guidance as what is considered “low temperature” is given. While one of ordinary skill in the art may be aware of the use of “low temperature ultracentrifugation method”, the exact metes and bounds of such a method cannot be determined, rendering the scope of the claimed method unclear as it is not clear at what temperatures the ultracentrifugation must be carried out at.
Given the language of wholesale replacement of the language of step (b) set forth in claim 10 compared to that of claim 1, from which claim 10 depends, it would be improper to interpret that ultracentrifugation step as necessarily occurring at 4°C which would be required for the phrase “conducting low temperature ultracentrifugation at 150,000 ×g for 120 min” to be definite.
Please clarify.
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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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