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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “48” has been used to designate the first connector (¶46), second connector (¶48), integrity test connector (¶49), and second integrity test connector (¶49). Fig 16 uses reference numeral 19 for both a sampling bag and a vent bag.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 50.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
The drawings do not show “a clamp is disposed within the main conduit” of claim 1 in accordance with the interpretation consistent with Applicant’s arguments filed 27 Apr. 2026 page 6 where “within” means along the inner flow path.
The drawings do not show “wherein the redundant final-fill filter is arranged so product flows sequentially through the primary final fill filter and the redundant final fill filter before dispensing”. Figs 3, 9A, 9B, 11, 12, 14, 15, 16, 17, 18, and 19 show wherein the redundant final-fill filter is arranged so product flows sequentially through the redundant final fill filter and the primary final fill filter before dispensing, as shown with the flow arrows.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Applicant’s ¶49 recites “peristatic pump” which should recite “peristaltic pump”.
Applicant’s ¶45 recites “There can be fewer barrier filters as shown by the streamlined redundant filtration assembly in the FIG.s.” which should recite “There can be fewer barrier filters as shown by the streamlined redundant filtration assembly in the FIGs.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 1-15 are 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.
Claim 1 recites “wherein the redundant final-fill filter is arranged so product flows sequentially through the primary final fill filter and the redundant final fill filter before dispensing”. Figs 3, 9A, 9B, 11, 12, 14, 15, 16, 17, 18, and 19 show wherein the redundant final-fill filter is arranged so product flows sequentially through the redundant final fill filter and the primary final fill filter before dispensing, as shown with the flow arrows. The application as filed 3 May. 2023 does not teach the product flowing sequentially through the primary final fill tilter and the redundant final fill filter before dispensing.
Claims 2-15 depend upon claim 1.
Claim Rejections - 35 USC § 112(b)
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 1-15 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 recites “a clamp” multiple times, “two clamps”, and “the two clamps”. It is unclear if the clamps are the same or different. Examiner suggests that if the clamps are intended to be different clamps, that modifiers (such as “first”, “second”, etc) should be used.
Claim 1 recites “a pinch clamp” multiple times. It is unclear if the clamps are the same or different. Examiner suggests that if the clamps are intended to be different clamps, that modifiers (such as “first”, “second”, etc) should be used.
Claim 1 recites “at least one vent bag” and then further recites “two vent bags”. It is unclear if the two vent bags are the same or different than the at least one vent bag.
Claims 2-15 depend upon claim 1.
Claim 10 recites “the conduit” twice. It is unclear if the limitation refers to main conduit or the secondary conduit.
Response to Argument
The following is a response to Applicant’s arguments filed 27 Apr. 2026:
Applicant does not contest the objections to the drawings and specification. Therefore, the objections are maintained.
Applicant argues that a component of the main conduit that is located “within” the main conduit locates the component along the inner flow path of the main conduit.
Examiner agrees and the rejection is withdrawn.
As a consequence of the claim interpretation, the drawing are objected to for not showing the clamp located along the inner flow path of the main conduit. Applicant’s ¶48 recites “A pinch clamp 20 is disposed within the main conduit 44”. However, Figs 3, 9A, 9B, 11, 12, 14, 15, 16, 17, 18, and 19 show the clamps 20 disposed outside the inner flow path.
Applicant argues that MPEP 2173.05(e) expressly recognizes that the multiple recitations of clamps are definite.
Examiner disagrees. MPEP 2173.05(e) states “A claim is indefinite when it contains words or phrases whose meaning is unclear.” It is unclear if the clamps are the same or different clamps and the rejection is maintained. For instance, it is unclear if the two “a clamp” recitations can be referring to the same element. It is unclear if the “two clamps” can include the two “a clamp”s. It is unclear if the claimed assembly comprises two clamps or four clamps.
Examiner withdraws the 112b rejection of the term optional because the limitation is definite that the claimed feature can or cannot be included in the invention.
Applicant argues that a component of the main conduit that is jointed to the main conduit is not indefinite.
Examiner agrees and the rejection is withdrawn.
Applicant argues that the claim 1 reciting “at least one vent bag” and then further recites “two vent bags” is not indefinite in accordance with MPEP 2173.05(g). Applicant argues that “at least one vent bag” is one embodiment and then is further limited in the same claim to two vent bags.
Examiner disagrees. Similarly to the clamps argued above, it is unclear it the two vent bags are the same or different than the at least one vent bag. However, where Applicant argues above that establishing multiple antecedent bases of clamp is clear that all the clamps are different, Applicant here argues that the “two vent bags” are the vent bags from the “at least one vent bag”. The two contradictory arguments by Applicant provides evidence that claimed invention is not definite.
Further, even if the claim were amended to clarify that the two vent bags are the same as the at least one vent bag (such as by reciting “where the at least one vent bag is two vent bags), the claim would still be indefinite. It would be unclear why the number of vent bags would be established to include any number of vent bags while then being limited within the same claim to comprise two vent bags.
Claim 1 has been amended to recite “an air line” and then further “a second air line”, which clarifies that the two “an air line”s of the previously filed claims are two distinct features. Similar amendments to the clamp, pinch clamp, and vent bag would similarly clearly define the invention.
The 112b rejection to “an air line” being recited twice is withdrawn in light of the claim amendments.
Applicant argues that the claim recitation of “a conduit” is clear because the specification defines a pump conduit 72.
Examiner disagrees. The conduit of the claimed invention is unclear because it may or may not refer to main conduit or the secondary conduit. Where the feature amended to recite “pump conduit” instead of “conduit”.
Applicant argues that the recitation of “the conduit” in claim 10 “clearly refers back to the antecedent “conduit” of claim 8”.
Examiner disagrees. It is clear that claim 10 does not refer back to the conduit of claim 8 because claim 10 does not depend upon claim 8.
Applicant amended claim to further recite “wherein the redundant final-fill filter is arranged so product flows sequentially through the primary final fill filter and the redundant final fill filter before dispensing”.
The limitation is not supported by the originally filed disclosure. Figs 3, 9A, 9B, 11, 12, 14, 15, 16, 17, 18, and 19 show wherein the redundant final-fill filter is arranged so product flows sequentially through the redundant final fill filter and the primary final fill filter before dispensing, as shown with the flow arrows. The application as filed 3 May. 2023 does not teach the product flowing sequentially through the primary final fill tilter and the redundant final fill filter before dispensing.
Applicant does not provide further guidance as to how the claim limitation is supported in the originally filed disclosure.
Applicant argues that Applicant’s claim 1 does not include a barrier filter that is downstream of a redundant filter.
The feature is not claimed and is thus the argument is moot.
Applicant argues that the admitted prior art does not teach the limitation “wherein the redundant final-fill filter is arranged so product flows sequentially through the primary final fill filter and the redundant final fill filter before dispensing”.
Examiner agrees and the rejection is withdrawn. The prior art, similar to Applicant’s Figs 3, 9A, 9B, 11, 12, 14, 15, 16, 17, 18, and 19 show wherein the redundant final-fill filter is arranged so product flows sequentially through the redundant final fill filter and the primary final fill filter before dispensing, as shown with the flow arrows.
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 STEPHEN HOBSON whose telephone number is (571)272-9914. The examiner can normally be reached 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dieterle can be reached at 571-270-7872. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHEN HOBSON/Examiner, Art Unit 1776
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