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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 18, 2025 has been entered.
Election/Restrictions
Claim 17 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The invention of claim 17 is different from the previously examined invention of claim 1. The invention of claim 1 does not require a method that is performed in real-time in-line during manufacturing; flowing the aqueous-based drug product into a filling conduit, wherein the filling conduit directs the aqueous-based drug product into a vial, and wherein the filling conduit is arranged to flow through a magnet and a probe of a nuclear magnetic resonance (NMR) spectrometer prior to direction to the vial. Furthermore, the method of claim 17 does not require the R2,m can be is measured without opening a vial containing the aqueous-based drug product and without adding any additives to the vial prior to measurement of the transverse relaxation rate of water. Had the claims been filed originally, the claims would have restricted.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 17 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant's arguments filed September 18, 2025 have been fully considered but they are not persuasive.
As to the 101 rejection, applicant arguments are essentially the same as those filed on 2/18/25 that have been addressed in the Final Office Action (5/22/25), hereby incorporated by reference. Since the arguments are essentially the same as those previously addressed in the prior Office Action, the examiner maintains the previously stated position.
Applicant has now amended the preamble of claim 1 recite the phrase “using water proton nuclear magnetic resonance (wNMR).
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
The preamble does not provide for any steps of the method.
The instant method is only defined by two steps: a measuring step and a determining step. There is no requirement in claim 1 for wNMR to be employed in either of such steps and there is no indication as to how nuclear magnetic resonance (a previously conventionally known analytical technique in the art that uses magnetic fields and radiofrequency pulses to detect hydrogen nuclei in water molecules) is employed in ether of the steps. NMR directly quantifies water content, porosity, pore-size distribution, and hydraulic conductivity in subsurface, porous materials, or biological samples.
Applicant’s opinion that “it is a sensitive measurement that surprisingly provides an enormous amount of information about whether the aqueous-based drug product” does not further limit the method. Furthermore the terms “non-invasively” and “non-destructively” recited in the preamble do not provide for nor are directed to actual steps recited in the body of the claim. There is no indication as to what the terms mean nor what the terms are intended to modify. The method is defined by the steps listed in the claim not by applicant’s opinion, subjective level of sensitivity, and amount of information (not specified) about the drug product. The steps recited in the claim are broad. It is not specified who, what, and how the measuring and determining steps are performed. There is nothing precluding one from performing the method by making mental observations. Furthermore, the determining step is merely an interpretation of data that can be made mentally. Once the measurement value is obtained, as clearly stated in the claim, the determination is made by comparing the measured value to some reference range (value). This can clearly be done mentally, using one’s brain. Furthermore, it is noted that no numerical values are provided for in the claim. The reference range value can be any range value that anyone chooses.
As to applicant remarks directed to the method providing for an improvement, it is noted that applicant recites numerous paragraphs from the specification. While the claims are read in light of specification, limitations recited in the specification will not be read into the claims. The arguments are not commensurate in scope with the claims. Claim 1 does not require the use of wNMR in measuring the nuclear spin relaxation rate constant, R1 and/or R2, of solvent, e.g., water, as a quality control and quality assurance parameter nor the determining step that only requires a comparison of an unspecified value of the traverse relaxation rate of water to a further unspecified reference value as asserted by applicant.
Applicant states: “In other words, following an assessment under Step 2A prong two, it is clear that claim 1 as a whole not only includes the use of a unique method of using wNMR, it integrates the alleged judicial exception into a practical application of the exception. Accordingly, applicant respectfully requests withdrawal of the rejection of claims 1, 3-5, 8, and 10-11 as being patent ineligible under 35 U.S.C. §101.”
The examiner disagrees. Although, as noted above claim 1 does not require NMR to be employed in either of the steps, applicant did not invent NMR nor measuring the transverse relaxation rate of a substance (as admitted by applicant in the paragraph 8 of the arguments). Using NMR to provide for a transverse relaxation rate value was previously known in the art. See for example, Sugarman et al., US 6307372. Once such relaxation rate value is obtained, the method only requires that such value be interpreted by comparing such value to a reference value to determine what the value subjectively means (is considered to subjectively indicate). Comparing and interpreting values (data) can be performed done mentally, which is an abstract idea.
Therefore, applicant’s remarks are not found persuasive and the 101 rejection is hereby maintained.
As to the 112 rejection directed to the terms “non-invasively” and “non-destructively”, it is noted that such are recited in the preamble of the claim, not in any specific step that defines the method. While paragraph 29 defines a “non-destructive” measurement, the claim does not recite “a non-destructive measurement” and the measuring step does not require a non-destructive measurement of any specific parameter to be performed on a vial containing any specific contents. If applicant intends for the method to require such, then the claim should clearly recite such. Unlike the term “non-destructive measurement” that is specifically defined in the specification, the term “non-invasively” is not specifically define in the specification (no statement that non-invasively is defined as…) and the recitation of such in the preamble is not directed to any specific step. However, it is presumed that applicant is asserting that the last “wherein” clause in the last paragraph of claim 1 is directed such. If so, it is suggested that the claim be amended to clearly indicate such. For example, “wherein the measuring of…is performed non-invasively, that is without opening….” or something similar to clearly indicate what is required to be done in the method that is considered non-invasive.
As to claims 10-11, the phrase “obtainment of” has been deleted. However, applicant refers to paragraph [0031] and (the Lee reference, US Publication 2007/0116602 cited on an IDS, but is not a part of the instant specification) and appears to rely upon such for asserting that the claims are clear. The examiner disagrees. The claims are interpreted in light of the specification for understanding. However, limitations recited in specification, but not claimed will not be read into the claims. "Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim.” MPEP 2111.01 Plain Meaning [R-01.2024] II. IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE SPECIFICATION. The method does not require anything (steps) to be performed to acquire the reference range value. The method does not recite any step that requires performing anything (measuring, testing, experiments, etc.) of anything using any specific parameters (including temperature and magnetic field strength) of anything to obtain the reference range value. The source of and how such range value was provided is not at issue. One can obtain, acquire, receive, determine, choose, etc. the reference range value from any source or by any means one chooses. The reference value could simply be written somewhere, told verbally, generated mentally, etc. none of such requires anything being to be done that requires measuring, using, performing, etc. anything at any temperature nor requiring anything to be at any specific temperature value. Therefore, it is unclear what is required for the measuring step to have a temperature value and what constitutes a temperature value of the reference range value because the claims do not clearly provide for such. Therefore, it is unclear how applicant can compare a temperature of the measuring step to a temperature of the reference range because the claims have not provided for what is required (no step) to be done such that the measuring step and temperature reference range value each have a temperature value.
Furthermore, as to the phrase “substantially similar” (in addition to the above remarks), it is noted that the claims nor specification define such phrase in manner such as “substantially similar” is defined as or means… There is no indication of what variations (degrees of freedom, differences) of temperature values other than being exactly the same are considered as being “substantially similar”. Different temperature values that may be considered as being “substantially similar” to one person may not be considered as such by another and vice versa. Therefore, the rejections are hereby maintained.
Response to Amendment
The amendment to the claims filed on September 18, 2025 does not comply with the requirements of 37 CFR 1.121(c) because the amendments to the claims are not consistent with that of the prior version of the claims filed on February 18, 2025. See for example claim 11. Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of “original,” “withdrawn” or “previously presented” will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of “withdrawn” or “previously presented.” Any claim added by amendment must be indicated with the status of “new” and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as “canceled” will constitute an instruction to cancel the claim.
(5) Reinstatement of previously canceled claim. A claim which was previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-5, 10-11, and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) in claim 1 determining if the aqueous-based drug product has undergone substantial oxidation2,m to a reference transverse relaxation rate of water R2,r, wherein the reference R2,r represents an acceptable range for substantially non-oxidized aqueous-based drug product. There is nothing in the claim element precludes the step from practically being performed in the mind, mentally. The step falls within the “Mental Processes” grouping of abstract ideas. Additionally, the MPEP states that collecting information, analyzing the information, and displaying results is an abstract idea when the analysis steps are recited at a high level of generality such that they could be performed in the human mind (MPEP 2106.04(a)(2) III A). Therefore, the claim is directed to an abstract idea.
This judicial exception is not integrated into a practical application because once the determining step is completed, nothing is done. Therefore there is no application much less a particular practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the measuring step, which is an insignificant extra solution activity (MPEP 2106.05(d)) and further is shown to be well understood, routine and conventional from the previous examiner’s art rejection. For example, see the prior rejections of the claims based upon Yu, US 2016/0047761 and Singh et al. (J. Pharm. Educ. Res., 3.1 (2012): 54). See also Response to Arguments above. Therefore, the claim is not patent eligible.
The dependent claims 3-5, 10-11, and 18 do not solve the issues of above.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed steps, the steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
It is noted that the “drug product” is relatively broad and not directed to any specific material, substance, chemical, etc.
It is noted that applicant has amended claim 1 to provide for what the results of comparing the measured value to the reference range (not specified as being and specific numerical value range) are concluded to mean. Which such account for what a value less than the range and within the range means, the claim does not account for what when the value is greater than the highest value of the range means.
It is noted that the “wherein” clauses of claim 1 do not provide for any further steps nor limit either of the measuring and determining steps. It is noted that the term “additive” does not encompass all substances and materials.
As to claim 4, it is noted that the list alternatives are not mutually exclusive. For example, there is nothing precluding an emulsion and suspension from being referenced as a solution and a solution from also being an emulsion or a suspension.
It is presumed that claim 5 is intended to refer to the measuring step of claim 1.
Claim Objections
Applicant is advised that should claim 10 be found allowable, claim 11 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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, 10-11, and 18 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.
Is unclear what is meant, required by the terms “non-invasively” and “non-destructively” recited in preamble of claim 1 because is unclear what is meant by the terms and what is required to be done and/or not to be done relative to any of the steps recited in the claim because the claim does not clearly provide for such. See also Response to Arguments above.
As to claims 10-11, it is unclear what temperatures are considered as a temperature of both measuring step and the reference value range because the measuring step does not require anything to be at any temperature (temperature of what) during the measuring of the relaxation rate numerical value and reference range numerical value. Neither value has a temperature. Furthermore, the method does not recite any step that requires anything to be done to acquire the reference range value via employing any temperature of anything. Therefore, it is unclear how applicant can compare a temperature of the measuring step to a temperature of the reference range value because the claims have not required, provided for any what is required (no step) to be done to what (using any temperature and magnetic field of anything) to obtain such reference range. See also Response to Arguments above.
It is further unclear what is meant by claims 10 and 11 because according to claim 1 R2,r is a reference value range (not numerically defined in the claims) that is already known (used as a comparison to the actual measured value) and is not required to be measured in claim 1. So it is unclear how any temperature/magnetic field strength is related to R2,r. Therefore, it is unclear what is required to be done, performed by the claims.
If applicant intends for the method to comprise a step that requires the reference range to be obtained by doing something (using a temperature of something and exposing, radiating something with a magnetic field) to something, then the claims should clearly recite such. Currently, how the reference value was obtained is not at issue and not provided for as a step(s) in the method. There is nothing precluding one from mentally choosing the reference value range.
The term “substantially similar” in claims 10-11 is a relative term which renders the claim indefinite. The term “substantially similar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no indication as what values different from the exact temperature and magnetic field strength value are considered as “substantially similar”. What may be considered as substantially similar to one person may not be considered as such to another and vice versa. See also Response to Arguments above.
As to claim 18, it is unclear where the steps of claim 18 are required to occur relative to the steps of claim 1 because the claim does not specify such. It is noted that Example 2, paragraph [0050] does not provide for a measuring step as provided for in claim 1. Therefore, the claim is not consistent with the specification.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. RAPOPORT; Uri et al.; YU; Yihua Bruce et al.; and Sugarman; Jeffrey H. et al. disclose measuring transverse relation rate.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798