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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/17/2023, 07/18/2024 and 01/21/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-19 in the reply filed on 06/24/2026 is acknowledged. The traversal is on the ground(s) that Groups II and III are related to Group I as combination-subcombination, because claims 20 and 23 both recite “a probe according to Claim 1”. Applicant submits that the subject matter of Groups II and III can be searched and examined together with Group I without undue burden. This is not found persuasive because the present application is filed under 35 U.S.C. § 371 and no showing of a search burden is required. Further, distinctness (i.e., how the inventions are related) is not a threshold in a PCT application. Moreover, as previously disclosed, the instant application lacks unity of invention as it fails to provide a special technical feature for the reasons disclosed in the restriction requirement dated 05/15/2026.
Claims 20-23 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/24/2026.
The requirement is still deemed proper and is therefore made FINAL.
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 2-3 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 2 recites the limitation “the cross-sectional profile of the port channel” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “the diameter or maximum cross-sectional dimension” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-11, 13-16 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hu et al. (hereinafter Hu) US 2019/0264161 cited in the IDS filed 11/17/2023.
Regarding claim 1, Hu discloses a sensing probe (pH sensor 100) for operatively engaging with a port that comprises a channel (plastic or polymeric tube 116) that communicates between the interior and the exterior of a bioreactor, the probe comprising: an elongate body comprising a first body portion (plunger sleeve 114, plunger 134) that is locatable within the port channel; a second body portion (plunger flange 118) comprising means for enabling the probe to be secured to the port (slide lock Fig. 3C:120) [0024 and 0027-0029]; and a sensing means (pH sensing bulb 142) located on the first body portion [0025-0030], wherein the probe is configured to operatively engage with the port such that the first body portion is at least partially located within the port channel and the sensing means is exposed to the interior of the bioreactor [0030-0031].
Regarding claim 4, Hu discloses wherein the first body portion is substantially cylindrical in shape as shown in at least Fig. 1B.
Regarding claim 5, Hu discloses wherein the first body portion protrudes into the interior of the bioreactor when operatively engaged with the port [0030-0031].
Regarding claim 6, as to the second body portion being located outside the port channel on the exterior of the bioreactor when the probe is operatively engaged with the port, the device disclosed by Hu is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Hu is capable of providing the operating conditions as listed in the intended use section of the claim in view of at least paragraphs [0030-0031].
In other words, absent evidence to the contrary, the device disclosed by Hu would be able to perform the same functions.
It is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 7, Hu discloses wherein the second body portion (plunger flange 118) has a larger cross-sectional profile than the first body portion (plunger 134) as shown in at least Fig. 3B.
Regarding claim 8, Hu discloses wherein the first and second body portions are elongate and arranged coaxially as shown in at least Figs. 3A and 4B.
Regarding claim 9, Hu discloses wherein the probe body further comprises a shoulder located at the interface between the first and second body portions as shown in Fig. 3B reproduced below.
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Regarding claim 10, as to wherein the shoulder is configured to abut the port when the probe is operatively engaged with the port, the device disclosed by Hu is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Hu is capable of providing the operating conditions as listed in the intended use section of the claim in view of at least paragraphs [0030-0031].
In other words, absent evidence to the contrary, the device disclosed by Hu would be able to perform the same functions.
It is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 11, Hu discloses wherein the means for enabling the probe to be secured to the port comprises means for securing the probe to the port or means for engaging one or more additional components that secure the probe to the port [0024 and 0027-0029].
Regarding claim 13, as to wherein the probe is configured to operatively engage with the port such that the sensing means is at least partly located in the interior of the bioreactor when the sensing probe is operatively engaged with the port, the device disclosed by Hu is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Hu is capable of providing the operating conditions as listed in the intended use section of the claim in view of at least paragraphs [0024 and 0030-0031].
In other words, absent evidence to the contrary, the device disclosed by Hu would be able to perform the same functions.
It is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 14, Hu discloses wherein the probe is configured to form a watertight seal with the port when the probe is operatively engaged with the port [0023].
Regarding claim 15, Hu discloses wherein the first body portion comprises a sealing member (hose barb 112) that is configured to contact the interior surface of the port channel when the probe is operatively engaged with the port [0023].
Regarding claim 16, Hu discloses that the probe is a pH probe, a temperature probe [0033]
Regarding claim 19, Hu discloses the probe body is formed of a single component as shown in at least Figs. 1B, 3A, 3B and 5A.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hu US 2019/0264161 as applied to claims 1, 4-11, 13-16 and 19 above.
Regarding claim 2, Hu does not expressly disclose wherein the first body portion has a cross-sectional profile that is the same as or marginally smaller than the cross-sectional profile of the port channel.
However, since providing a cross-sectional profile that is the same as or marginally smaller than the cross-sectional profile of the port channel would only require a mere change in the size (or dimension) of a component which is generally recognized as being within the level of ordinary skill in the art, a mere change in size or dimension of the device, i.e. cross section, would have been prima facie obvious to one of ordinary skill in the art. Furthermore, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP §2144.04 (IV)(A).
Regarding claim 3, Hu does not expressly disclose wherein the diameter or maximum cross-sectional dimension of the first body port is about 1% to about 10%, smaller than the diameter or maximum cross-sectional dimension of the port channel.
However, since providing a diameter or maximum cross-sectional dimension of the first body port is about 1% to about 10%, smaller than the diameter or maximum cross-sectional dimension of the port channel would only require a mere change in the size (or dimension) of a component which is generally recognized as being within the level of ordinary skill in the art, a mere change in size or dimension of the device, i.e. diameter or cross section, would have been prima facie obvious to one of ordinary skill in the art. Furthermore, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP §2144.04 (IV)(A).
Regarding claim 12, Hu discloses wherein the means for engaging one or more additional components comprise one or more depressions or projections as shown in Fig.3 reproduced above as shown in Fig. 2. Also see [0024 and 0027-0029]. However, Hu does not disclose that the one or more depressions are located on the second body portion.
Absent unexpected results, it would have been an obvious matter of design choice to provide the one or more depressions are located on the second body portion, since it appears that the invention would perform equally well with the securing means of Hu.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hu US 2019/0264161 as applied to claims 1-16 and 19 above, and further in view of Jones et al. (hereinafter Jones) WO 2019/116043 cited in the IDS filed 11/17/2023.
Regarding claim 17, Hu does not expressly disclose that the probe is a single-use probe.
Jones discloses a single-use probe as discussed on at least page 9, line 26-page 10 line 4. Also see page 13, lines 16-22.
Absent unexpected results, it would have been prima facie obvious to one of ordinary skill to modify Hu with a single-use probe as taught by Jones because the use of single use probes permits the use of less robust materials in the manufacture of the probes, primarily because the probes do not have to be resistant to repeated sterilization procedures.
Regarding claim 18, Hu does not expressly disclose wherein the probe body is formed of material that is sterilizable by gamma irradiation, electron-beam irradiation, heat sterilization, steam sterilization or ethylene oxide (ETO).
Jones discloses a probe body formed of material that is sterilizable by gamma irradiation sterilization discussed on page 10, lines 20-27.
Absent unexpected results, it would have been prima facie obvious to one of ordinary skill to modify Hu with a probe body formed of material that is sterilizable as taught by Jones, particularly by gamma irradiation sterilization, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP §2144.07.
Alternatively, it would have been prima facie obvious to one of ordinary skill to modify Jones with a probe body formed of material that is sterilizable as taught by Jones because gamma irradiation sterilization is well known in the art to prevent contamination.
Claims 17 and 18 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Hu US 2019/0264161 as applied to claims 1-16 and 19 above, and further in view of Selman et al. (hereinafter Selman) US 2011/0260738 cited in the IDS filed 11/17/2023.
Regarding claim 17, Hu does not expressly disclose that the probe is a single-use probe.
Selman discloses a single-use probe [0021 and 0043].
Absent unexpected results, it would have been prima facie obvious to one of ordinary skill to modify Hu with a single-use probe as taught by Selman because the use of single use probes permits the use of less robust materials in the manufacture of the probes, primarily because the probes do not have to be resistant to repeated sterilization procedures.
Regarding claim 18, Hu does not expressly disclose wherein the probe body is formed of material that is sterilizable by gamma irradiation, electron-beam irradiation, heat sterilization, steam sterilization or ethylene oxide (ETO).
Selman discloses a probe body formed of material that is sterilizable by gamma irradiation sterilization [0016, 0019 and 0041].
Absent unexpected results, it would have been prima facie obvious to one of ordinary skill to modify Hu with a probe body formed of material that is sterilizable as taught by Selman, particularly by gamma irradiation sterilization, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP §2144.07.
Alternatively, it would have been prima facie obvious to one of ordinary skill to modify Hu with a probe body formed of material that is sterilizable as taught by Selman because gamma irradiation sterilization is well known in the art to prevent contamination.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 EST.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
