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 .
Response to Amendment
Applicant’s amendment filed 04 December 2025 are acknowledged. It is understood that applicant amended claims 1-13 to refer to a process, instead of a system as previously presented. Claims 1-15 are under full consideration.
Response to Arguments
Applicant's arguments filed 04 December 2025 have been fully considered but they are not persuasive. The respective arguments are addressed below:
Applicant argued that the removable reactor closure system of the prior art has moving parts, such as the screw cap, and that “by definition” the screw cap of the prior art must be considered part of the removable closure system. Examiner respectfully disagrees. The instant specification defines the closure system as “wherein the closure system comprises an elastomeric septum and a rigid member with a small hole covering the septum… The closure system does not require moving parts”, and the claim language states, “the removable reactor closure system comprises no moving parts”. As pointed out in the Non-Final Office Action, the prior art discloses an elastomeric septum and a rigid seal covering the septum, both of which are not movable parts. There is no rational explanation necessitating that the screw cap of the prior art must be considered a part of the closure system.
Applicant argues that all standard Kaltez perfluoroeslastomer products have a Shore A hardness of 75, which is higher than the claimed “Shore A hardness less than 75”. Examiner respectfully disagrees and points Applicant to the cited prior art which shows a Shore A hardness of 69, as cited in the non-final office action.
Applicant argues that the compressible collar of the prior art is to be considered a rigid object. Examiner respectfully disagrees. Under the broadest reasonable interpretation, a rigid collar is one that substantially maintains its shape under expected operating loads. The applied prior art discloses a collar that is intentionally compressible, such that deformation under load is a functional characteristic of the collar. A structure configured to compress cannot reasonably be considered rigid. Applicant’s reliance on extrinsic literature regarding “rigid polyurethane foam” is unavailing, as the cited article is not part of the applied prior art and does not alter the ordinary meaning of “rigid” as used in the claims. Accepting applicant’s interpretation would improperly read the term “rigid” out of the claim. Accordingly, the rejection is maintained.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. In this case, in claim 3, the limitation stating “a fastening means” invokes 35 U.S.C. 112(f).
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.
Claims 1-6 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lebl et al. (US-6045755-A), hereinafter “Lebl”, in view of DuPontTM Kalrez, hereinafter “DuPont”.
Regarding Claim 1, Lebl discloses a process for performing batch reactions (“incubation of sealed reaction vessel arrays”; see Col. 4 Line 54; this is indicative of batchwise operation) in parallel (process in parallel many inexpensive reaction vessel arrays; see Col. 10 Lines 49-50) under pressurized atmosphere (generate higher internal pressures in the reaction vessels; see Col. 14 Lines 14-15) with a system comprising a plurality of pressurized parallel batch reactors (generate higher internal pressures in the reaction vessels; see Col. 14 Lines 14-15; and “parallel processing” see Col. 10 Line 22), which system comprises a plurality of reactors (reaction vessels; see Col. 14 Line 15) and at least one movable (needle is withdrawn; see Col. 25 Line 17) hollow needle connectable to a pressure source (aspiration through needle; see Col. 25 Lines 12-13), wherein a reactor comprises:
a reactor body having a volume of 0.5-50 ml (4 ml reaction vessels; see Col. 11 Line 9) and a reactor mouth with a diameter of between 2 and 30 mm (“capable of being punctured by a 14-gauge needle”; see Col. 24 Line 52, indicating that the mouth has to be at least 2mm and “15mm outside diameter”; see Col. 14 Line 64 and Fig. 2A indicating that the mouth has to be less than 15mm, as Fig. 2A shows the mouth as being more narrow than the outside diameter of the vessel);
a removable reactor closure system for covering said reactor mouth (rigid seal seals the septum assembly against the top of the reaction vessel; see Col. 25 Lines 33-34);
and wherein said hollow needle has an outer diameter of 2 millimeter or less (14-gauge needle; Col. 24 Line 52), and which hollow needle has an opening of the inner canal of the needle, which opening is located at the lateral side of the needle (lateral orifice; see Col. 25 Line 8) at a distance from the tip of the needle equal or larger than the diameter of the needle, to at most 5 cm from the tip of the needle (Outside diameter of needle is 0.05 inches… Pointed tip 353… is of approximately 0.19 inches overall; see Col. 29 Lines 52-62 and Fig. 13), wherein the removable reactor closure system for covering said reactor mouth comprises:
an elastomeric septum (septum is preferably made… or of an elastomer; see Col. 24 Lines 53-54) having a thickness of at least 200% of the diameter of the hollow needle (septum assembly… includes… puncturable septums 322 and 324, compressible collar 323; and Fig. 12A which shows the thickness of 322, 323, and 324 as being greater than 200% of the needle diameter)
and a rigid member covering the septum at the reactor mouth (rigid seal 321 seals the septum assembly against the top of the reaction vessel; see Col. 25 Lines 33-34) except for an opening in the rigid member leaving the septum exposed to the atmosphere (has a central aperture for permitting needle access; see Col. 25 Lines 37-38), which opening has a diameter of not more than 200% of the diameter of the hollow needle (aperture in septum is approximately from 1 to 4mm in diameter; see Col. 15 Lines 14-15 – it would naturally follow that the aperture in the rigid seal is of the same/similar size to the aperture of the septum),
wherein the removable reactor closure system comprises no moving parts (Lebl does not mention moving parts associated with the closure system)
Regarding the limitation claiming “wherein the elastomeric septum has a Shore A hardness of less than 75”, Lebl discloses the septum being made of an elastomer of Kalrez type. Lebl does not explicitly disclose the hardness of the septum, but DuPont makes Kalrez elastomers with Shore A hardness of 75 or less (see DuPont Page 1, Typical Physical Properties). KSR Rationale E (see MPEP 2141) states that it is obvious to choose “from a finite number of identified, predictable solutions, with a reasonable expectation of success”. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to select an elastomer with a Shore A hardness of less than 75 from the list of possible Kalrez elastomers produced by DuPont.
Regarding Claim 2, Lebl and DuPont together disclose the process according to claim 1. It is acknowledged that the Applicant directly addresses the removable closure system of Lebl in the specification of the instant application. It appears that Applicant considers the collar and screw cap of the prior art to be moving parts, but also defines moving parts as being “rigid parts that move or are moved from one position when open to a different position when closed before and after pressurising”. This definition is consistent with claim 2, but is not consistent with the collar or screw cap of Lebl as the Applicant declared in the instant specification. The collar of Lebl is described as being a “compressible collar” (see Col. 25 Line 62), which means it is not rigid and therefore is not a “rigid part”, as specified in claim 2. Further, the collar is described as being moved in order to more thoroughly seal the reaction vessel and to increase resistance to internal pressures (see Col. 26 Lines 1-3), but is not described as being required to move from an open position to a closed position to enable pressurization. Additionally, the removable closure system of Lebl is being defined by Examiner as including the septum and rigid member. The collar and screw cap are not considered to be a part of the removable closure system. Accordingly, the removable closure system does not include any moving parts, and therefore there are no rigid parts contained in the removable closure system that move or are moved from one position when open for pressurizing the reactor to a different position when closed after pressurizing the reactor.
Regarding Claim 3, Lebl and DuPont together disclose the process according to claim 1. Lebl further discloses the removable reactor closure system containing a fastening means for the rigid member (sealing means retained by clips; see Col. 19 Line 9 or “collar 302 seals septum 301 to reaction vessel 300”; see Col. 24 Lines 55-56)). The septum, rigid member, and fastening means disclosed by Lebl define the reactor closure system. All other parts disclosed by Lebl are not a part of the removable reactor closure system, even if they do assist in its function.
Regarding Claim 4, Lebl and DuPont together disclose the process according to claim 1. Leble further discloses the movable hollow needle having a diameter of less than 1.5mm (Outside diameter of needle is 0.05 inches; see Col. 29 Lines 53-54).
Regarding Claim 5, Lebl and DuPont together disclose the process according to claim 1. Lebl further discloses the needle being structurally analogous to a Gertie-Marx and Sprotte needle (see Fig. 13 and Fig. 11)
Regarding Claim 6, Lebl and DuPont together disclose the process according to claim 1. Lebl further discloses wherein the end of the needle opposite the point of the needle is connectable to a pressurized gas source and/or a device for sampling and/or analyzing gaseous or liquid samples. First, Lebl discloses that “Needles are attached to fluid passageways to permit drawing and expelling fluids” (see Col. 26 Lines 63-64) and “needles from individual fluid storage vessels” (see Col. 26 Line 36). This indicates that the needles are able to be connected to a fluid handling system, and that they are capable of handling fluids. Therefore, they are connectable to any fluid handling device, such as those listed in the claim limitation. Further, Lebl discloses dispensing a volume of air… distributed from container into a reaction vessel , through tube 806 (see Col. 34 Lines 5-8), which is described as being a needle (see Col. 33 Line 52). This indicates that the needle of Lebl is connected to a pressurized gas source.
Regarding Claim 9, Lebl and DuPont together disclose the process according to claim 1. DuPont further discloses Kalrez elastomers with Shore A hardness of less than 73 (see DuPont Page 1, Typical Physical Properties). KSR Rationale E (see MPEP 2141) states that it is obvious to choose “from a finite number of identified, predictable solutions, with a reasonable expectation of success”. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to select an elastomer with a Shore A hardness of less than 73 from the list of possible Kalrez elastomers produced by DuPont.
Regarding Claim 10, Lebl and DuPont together disclose the process according to claim 1. Lebl further discloses the opening of the rigid member having a diameter of not more than 150% of the diameter of the hollow needle (aperture in septum is approximately from 1 to 4mm in diameter; see Col. 15 Lines 14-15 – it would naturally follow that the aperture in the rigid seal is of the same/similar size to the aperture of the septum). MPEP 2144.05.I states that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists.
Regarding Claim 11, Lebl and DuPont together disclose the process according to claim 1. Lebl further discloses the system comprising at least 4 reactors (8 syringe-like reaction vessels; see Col. 26 Lines 43-44).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lebl et al. (US-6045755-A), hereinafter “Lebl”, in view of DuPontTM Kalrez, hereinafter “DuPont” and Tanner (WO-2008121819-A1).
Regarding Claim 7, Lebl and DuPont together disclose the process according to claim 1. Modified Lebl does not explicitly teach the claimed ratio of septum thickness to needle diameter. However, Tanner does disclose the elastomeric septum having a thickness of between 300 and 800% of the diameter of the hollow needle (“injection needle having a diameter of 0.025 inch”; see Pg. 4 Line 11 and “septum… with... an initial thickness of about 0.130 inch”; see Pg. 4 Lines 16-17).
Lebl and Tanner are both considered to be analogous to the claimed invention because they are in the same field of reaction vessels with septa pierceable by needles. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Lebl by incorporating the teachings of Tanner and including a septum with the specified thickness. Doing so would result in a septum sized appropriately for use with the specified port configuration (see Tanner Pg. 4 Lines 19-20).
Regarding Claim 8, Lebl and DuPont together disclose the process according to claim 1. Modified Lebl does not explicitly teach the claimed septum thickness. However, Tanner discloses the elastomeric septum having a thickness of between 2 mm and 10 mm (septum… with… an initial thickness of about 0.130 inch”; see Pg. 4 Lines 16-17). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Lebl by incorporating the teachings of Tanner and including a septum with the specified thickness. Doing so would result in a septum sized appropriately for use with the specified port configuration (see Tanner Pg. 4 Lines 19-20).
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lebl et al. (US-6045755-A), hereinafter “Lebl”, in view of DuPontTM Kalrez, hereinafter “DuPont” and Windhab (WO-9807026-A1).
Regarding Claim 12, Lebl and DuPont together disclose the process according to claim 1.
Modified Lebl does not explicitly teach reactor pressure and duration. However, Windhab discloses that the catalytic oxidation may be carried out batch-wise (see [0011]) at pressures of 10 to 200bar (see [0014]), which encompasses the claimed pressure of at least 20barg. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use a reactor capable of maintaining a pressure of 20barg to allow the data obtained to be subjected to a comprehensive set of parameters (see Windhab [0014]).
Although Windhab does not expressly state maintaining the pressure for at least 10 minutes, batch catalytic reactions are conducted for a period of time sufficient to allow the reaction to proceed. Selecting a reaction duration of at least 10 minutes represents a routine operational parameter that would have been determined through ordinary experimentation absent evidence of criticality. The claim recites that the reaction “can maintain” the pressure for at least 10 minutes, which merely requires capability. A reactor operated batch-wise at pressures within the disclosed 10-200 bar range would reasonably be expected to sustain such pressure for a typical reaction interval, including at least 10 minutes. Applicant has not provided evidence that maintaining pressure for at least 10 minutes yields unexpected results or requires structural features beyond those already disclosed. The instant specification describes maintaining pressure for at least 10 minutes as a preferred performance benchmark but does not provide comparative data or evidence demonstrating that a 10-minute duration yields unexpected results. Accordingly, the recited duration is considered a routine performance parameter absent a showing of criticality.
Regarding Claim 13, Lebl and DuPont together disclose the process according to claim 1. Lebl further discloses each reactor comprising a rigid reactor body (reaction vessels have threaded tops and are constructed from glass; see Col. 21 Lines 38-39).
Modified Lebl does not explicitly teach the reactor body capable of withstanding 150 barg. However, Windhab discloses a reactor capable of withstanding pressures up to and including 150 barg (the process can be carried out at different temperatures and pressures… preferably from 10 to 200 bar; see [0014]). MPEP 2144.05.I states that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists.
Lebl and Windhab are both considered to be analogous to the claimed invention because they are in the same field of miniature reactors arranged in parallel. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Lebl by incorporating the teachings of Windhab and making the reactor able to withstand pressures up to and including 150 barg. Doing so would allow the obtained data to be subjected to comprehensive parameters and data analysis (see Windhab [0014]).
Regarding Claim 14, Lebl and DuPont together disclose the process according to claim 1.
Modified Lebl does not explicitly disclose the pressure in the pressurized reactors being between 20 and 150 barg. However, Windhab does discloses the pressure being between 20 and 150 barg (the process can be carried out at different temperatures and pressures… preferably from 10 to 200 bar; see [0014]). MPEP 2144.05.I states that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. Doing so would allow the obtained data to be subjected to comprehensive parameters and data analysis (see Windhab [0014]).
Regarding Claim 15, Lebl, DuPont, and Windhab together disclose the process according to claim 14. Lebl further discloses after the pressurizing of the reactors the contents of the reactors are heated to induce chemical reaction inside the reactors (heat conduction to reaction vessels; see Col. 23 Lines 4-5), followed by sample-taking from the reactor content (samples were taken from each test tube; see Col. 41 Lines 54-55) using a hollow needle (solution was then removed with a 96 needle solvent-removal station; see Col. 40 Line 67 - Col. 41 Line 1) which has an outer diameter of 2 millimeter or less, and which hollow needle has an opening of the inner canal of the needle, which opening is located at the lateral side of the needle at a distance from the tip of the needle equal or larger than the diameter of the needle, to at most 5 cm from the tip of the needle (see the claim 1 rejection for the rejection of the structural limitations of the needle), and which needle enters the reactor via the septum (needle-based fluid handling elements can gain access to the interior of reaction vessel through puncturable septums; see Col. 25 Lines 51-53).
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 ALYSSA LEE KUYKENDALL whose telephone number is (571)270-3806. The examiner can normally be reached Monday- Friday 9:00am-5:00pm.
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, Claire Wang can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.L.K./Examiner, Art Unit 1774
/CLAIRE X WANG/Supervisory Patent Examiner, Art Unit 1774