DETAILED ACTION
Applicants’ arguments, filed 19 December 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112(b) – 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.
Claims 19, 25, and 29-35 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 19 has been amended to recite the following limitation:
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It is unclear how the phrase “to remove a supernatant” further limits the claimed invention. This is because it is unclear whether the required supernatant would have been present prior to the centrifugation step.
For the purposes of examination under prior art, the examiner will examine the claim as if it requires first conducting the recited centrifugation step, followed by removal of the supernatant and retention of the pellet as a separate step that is conducted following the centrifugation step. This determination is made in view of the fact that the skilled artisan would have understood the term “supernatant” to have referred to the liquid present following centrifugation, whereby a pellet forms during centrifugation that is separate from the supernatant. The examiner will examine the claim with the understanding that desired product of the recited step to be in the pellet rather than in the supernatant.
Claim 25 has a similar limitation, is indefinite for a similar reason, and will be interpreted in a similar manner as in claim 19.
This is understood to be a new ground of rejection necessitated by amendment.
Withdrawal of Prior Art Rejection
Previously in the prosecution history, the examiner rejected the instant claims as being obvious over Shiuchi et al. (JP 2007238568 A1) in view of Sato et al. (Chemical and Pharmaceutical Bulletin, Vol. 38(8), 1990, pages 2228-2232) and Reynolds et al. (US 2018/0236075 A1). This rejection has been withdrawn for at least the following reasons.
Shiuchi Reference: As an initial matter, Shiuchi et al. (JP 2007238568 A1) is written in Japanese. The examiner has provided an English translation of Shiuchi et al. (JP 2007238568 A1). All page, line, and paragraph citations are to the translation unless otherwise noted. The examiner understands that the subject matter cited in the translation is present in the original Japanese application.
Shiuchi et al. (hereafter referred to as Shiuchi) is drawn to a method for producing a vesicle, as of Shiuchi, title and abstract. Shiuchi teaches the following method, as of page 1 of translation, relevant text reproduced below.
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The examiner’s best understanding of the above-reproduced text, the centrifugation method appears to entail the following:
a first centrifuging at 1500 to 3000 g, collecting and retaining the supernatant, and discarding the pellet; and
a second centrifugation step of centrifuging at 10,000 g or more, collecting and retaining the pellet (referred to as a precipitate by Shiuchi) and apparently discarding the supernatant.
The examiner notes that the maximum g-force of the first centrifugation step of Shiuchi is 3000 g, whereas the minimum g-force of the instantly claimed centrifugation step is 3500 g. This is only a 500 g difference, which appears to be a minor difference. Nevertheless, even if, purely en arguendo, the g-force of the first centrifugation step of Shiuchi were to overlap with the g-force of the claimed centrifugation step, this would not have supported rejecting the claims as obvious over Shiuchi. This is because in the claimed centrifugation step at a minimum of 3500 g, it is the pellet that is collected and the supernatant that is discard. In contrast, in the first centrifugation step of Shiuchi, it is supernatant that is collected and the pellet discarded. As such, despite the similarly in the g-force of the first step of Shiuchi and the claimed method, it is different material that is retained in the first step of Shiuchi as compared with the instantly claimed method. As such, the skilled artisan would not have been motivated to have modified the centrifugation method of Shiuchi to have achieved the claimed method.
Additionally, as Shiuchi isolates the desired product by obtaining a pellet from a 10,000+ g-force centrifugation. As such, there would have been no reasonable expectation that the desired product could have been successfully obtained after centrifuging only 5000 g, as required by the instant claims. This is because the skilled artisan would have understood that a higher g-force results in more material and/or material of a smaller physical size being able to have been pelleted. As such, even if there would have been a reasonable expectation that certain material would have successfully pelleted with centrifugation at 10,000 g, that does necessarily result in a reasonable expectation that said material would have successfully pelleted at only 3500-5000 g, as required by the instant claims.
Sato Reference: Sato et al. (hereafter referred to as Sato) is drawn to the interactions of liposomes with human erythrocytes, as of Sato, page 2228, title and abstract. Sato teaches interactions of liposomes with blood, as of Sato, page 2229, left column, bottom paragraph.
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As best understood by the examiner, this method entails the following centrifugation steps
a first centrifuging at 1000 g, collecting and retaining the supernatant, and discarding the pellet; and
a second centrifugation step of centrifuging at 22,000 g, collecting and retaining the supernatant, and apparently discarding the pellet.
In this case, the step of centrifuging at 22,000 g in Sato differs from the claimed centrifugation step. This is because in the step of centrifuging at 22,000 g in Sato, it is the supernatant that collected. In contrast, in the claimed method, it appears to be the pellet that is collected despite lower centrifugation g-force. The skilled artisan would not have been motivated to have modified Sato to have collected the pellet rather than the supernatant because this would appear to have changed the principle of operation of Sato. If the proposed modification or combination of the prior art would change the principle of operation of the prior art invention being modified, then the teachings of the references are not sufficient to render the claims prima facie obvious. See MPEP 2143.01(VI).
In view of this, this previously applied rejection has been withdrawn. The examiner clarifies that the rationale for withdrawing the previously applied rejection applies only to the examined method claims and not to the withdrawn claims.
Applicant’s Request for Rejoinder is Not Persuasive
In applicant’s response on 19 December 2025, applicant makes the following arguments on page 10, which are reproduced below.
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This is not persuasive. It is the examiner’s position that even if, purely en arguendo, claims 19, 25, and 29-35 were in condition for allowance, it would be the case that claims 11, 24, and 26-28 would not be in condition for rejoinder.
In support of this position, the examiner notes the restriction requirement mailed on 10 June 2025, which states the following on page 6.
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The above-reproduced text is drawn to the case in which applicant elects the product or apparatus claims and said product or apparatus claims are found allowable. In this situation, the withdrawn process claims are to be considered for rejoinder by the examiner.
However, the fact pattern described by the above-reproduced text differs from the fact pattern in the instant application. This is because in the instant application, applicant elected claims drawn to the method rather than to the product or apparatus. In this situation, the rejoinder provisions described in the above-reproduced paragraph are not applicable. See MPEP 821.04 for more information about rejoinder. There is no provision in the MPEP that withdrawn product claims are to be rejoined upon determination of the allowability of a process of making said product.
Response to Arguments
Applicant has provided arguments in applicant’s response on 19 December 2025. These arguments relate to the previously applied obviousness rejection over Shiuchi et al. (JP 2007238568 A1) in view of Sato et al. (Chemical and Pharmaceutical Bulletin, Vol. 38(8), 1990, pages 2228-2232) and Reynolds et al. (US 2018/0236075 A1). Applicant’s arguments are understood to be moot in view of the withdrawn of the rejection over this combination of references. As such, the examiner has not provided a substantive response to applicant’s arguments set forth on pages 6-9 of applicant’s response on 19 December 2025.
Note Regarding Email Communication
Applicant makes the following arguments on page 10 of applicant’s response on 19 December 2025.
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In response, the examiner notes that without a written authorization in place, the examiner will not response via email to internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122, and the examiner will not initiate communication via email. See MPEP 502.03(II). The examiner clarifies that the above-reproduced text is itself not an internet communication authorization. This is because internet authorization must be submitted on a separate paper to be entitled to acceptance in accordance with 37 CFR 1.4(c). The separate paper will facilitate processing and avoid confusion. Also, the internet communication authorization cannot be submitted itself through email. See also MPEP 502.03(II).
As such, the examiner will not communicate to applicant via email regarding subject matter related to the instant application.
If applicant wishes to engage in email communication with the examiner regarding issues related to the subject matter of the instant application, the examiner strongly suggests that applicant file the PTO/SB/439 in the file record of the instant application.
Conclusion
No claim is allowed.
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 ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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, Sahana S. Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612