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 .
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
When there are drawings, there shall be a “brief description of the several views of the drawings” (See 37 C.F.R. 1.74.).
The section heading “brief description of the several views of the drawings” as set forth in 37 C.F.R. 1.74 is missing. Please correct.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “step (b)” is written instead of “the step (b)”. The phrase “step (b)” is previously set forth.
Claims 3-6, 8-10, 12, 14-15, 19-21, 23 and 24 are objected for the same reasons. Please set forth the language “the step …” in all instances.
Claim 11 is objected to because of the following informalities: the abbreviation “ABV(R)” in line 6 is written without setting forth the unabbreviated text in the first instance like with claim 1.
Appropriate correction is required.
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 1-26 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.
The phrase “1/k V1” in claim 1, line 7 is vague and indefinite as it is unclear whether “V1” is in the numerator or denominator. Please amend the claim to make it clear.
The phrase “(k-1)/k V1” in claim 1, line 10 is vague and indefinite as it is unclear whether “V1” is in the numerator or denominator. Please amend the claim to make it clear.
Claim 1 recites the limitation "ABV(P)" in line 15. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating "the ABV(P)".
Claim 1 recites the limitation "ABV(R)" in line 19. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating "the ABV(R)".
Claim 1 recites the limitation “ABV(P metabolised)” in line 21. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “the ABV(P metabolised)”.
Claim 1 recites the limitation “retenate” in line 23. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “the retenate”.
Claim 1 recites the limitation “diafiltered” in line 23. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “the diafiltered”.
Claim 1 recites the limitation “metabolised permeate” in line 24. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “the metabolised permeate”.
The phrase “the volume of culture” in claim 8, line 8 is vague and indefinite as it is unclear what culture this is refereeing to as “culture is not previously set forth”.
Claim 8 recites the limitation “of permeate” in line 9. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “of the permeate”.
Claim 8 recites the limitation “of permeate” in line 9. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “of the permeate”.
Claim 11 recites the limitation “the volume V1” in line 3. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “a volume V1”.
The phrase “1/k V1” in claim 11, line 6 is vague and indefinite as it is unclear whether “V1” is in the numerator or denominator. Please amend the claim to make it clear.
The phrase “(k-1)/k V1” in claim 11, line 8 is vague and indefinite as it is unclear whether “V1” is in the numerator or denominator. Please amend the claim to make it clear.
Claim 12 is objected to as it is unclear what limitations further limit independent claim 11. Claim 12 had been a “use” claim and has not been converted to a “method” claim. In doing so Applicant appears to have pasted a very large of text from somewhere. For example, claim 11 already has steps “a)” and “b)” but claim 12 has added additional steps “a)” and “b)” with much of the same language already set forth in claim 11. Applicant is advised to consider deleting claim 12 or amend it to remove the duplicate language and make the language properly further limit the language in claim 11.
The phrase “1/k V1” in claim 12, line 7 is vague and indefinite as it is unclear whether “V1” is in the numerator or denominator. Please amend the claim to make it clear.
The phrase “(k-1)/k V1” in claim 12, line 10 is vague and indefinite as it is unclear whether “V1” is in the numerator or denominator. Please amend the claim to make it clear.
Claim 12 recites the limitation "ABV(P)" in line 15. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating "the ABV(P)".
Claim 12 recites the limitation “retentate” in line 23. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “the retentate”.
Claim 12 recites the limitation “diafiltered retentate” in line 23. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “the diafiltered retentate”.
Claim 12 recites the limitation “metabolised permeate” in line 24. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to consider stating “the metabolised permeate”.
Claim 14 is objected to as it is unclear what limitations further limit independent claim 1. Claim 14 has been amended. In doing so Applicant has added additional steps “a)”, “b)”, “c)” and “d)” with much of the same language already set forth in claim 1. Applicant is advised to consider deleting claim 12 or amend it to remove the duplicate language and make the language properly further limit the language in claim 1.
The phrase “1/k V1” in claim 14, line 7 is vague and indefinite as it is unclear whether “V1” is in the numerator or denominator. Please amend the claim to make it clear.
The phrase “(k-1)/k V1” in claim 14, line 10 is vague and indefinite as it is unclear whether “V1” is in the numerator or denominator. Please amend the claim to make it clear.
The phrase “1/k V1” in claim 15, line 5 is vague and indefinite as it is unclear whether “V1” is in the numerator or denominator. Please amend the claim to make it clear.
The phrase “(k-1)/k V1” in claim 15, line 6 is vague and indefinite as it is unclear whether “V1” is in the numerator or denominator. Please amend the claim to make it clear.
Claim 23 is objected to as it is unclear what limitations further limit independent claim 11. Claim 23 is newly presented. In doing so Applicant has added additional steps “a)”, “b)”, “c)” and “d)” with much of the same language already set forth in claim 11. Applicant is advised to consider deleting claim 12 or amend it to remove the duplicate language and make the language properly further limit the language in claim 11.
The phrase “1/k V1” in claim 23, line 7 is vague and indefinite as it is unclear whether “V1” is in the numerator or denominator. Please amend the claim to make it clear.
The phrase “(k-1)/k V1” in claim 23, line 10 is vague and indefinite as it is unclear whether “V1” is in the numerator or denominator. Please amend the claim to make it clear.
Clarification and/or correction required
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T O'HERN whose telephone number is (571)272-6385. The examiner can normally be reached M-Th 5:00 am - 3:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENT T O'HERN/ Primary Examiner, Art Unit 1793 April 16, 2026
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