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 listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered:
U.S. Provisional Application No. 62/971,507 (paragraph [0044])
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “if the differential HSP value is greater than 10” (claim 1, lines 4-5) must be shown or the feature(s) canceled from the claim(s). 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 abstract of the disclosure is objected to because:
In line 3, “includes” should be changed to “wherein the method includes”
In lines 4-5, “the differential Hansen Solubility Parameter (HSP) value” should be changed to “a differential Hansen Solubility Parameter (HSP) value”
In line 5, “ingredient” should be changed to “an ingredient”
In line 6, “a medical device” should be changed to “the medical device”
In line 6, “the concentration” should be changed to “a concentration”
In line 7, “the maximum solubility” should be changed to “a maximum solubility”
In line 8, “the pH” should be changed to “a pH”
In line 9, “the potential” should be changed to “a potential”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
A Cross-Reference to Related Applications section is missing in which it is stated that the application is a 371 of PCT/US2021/016289, filed 02/03/2021, and has priority to US 62/979,100, filed 02/20/2020.
Appropriate correction is required.
Claim Objections
Claims 1-2, 8, 12, and 18 are objected to because of the following informalities:
In regards to claim 1, line 3, “fluid composition” should be changed to “a fluid composition”.
In regards to claim 1, line 3, “component” should be changed to “a component”.
In regards to claim 2, line 3, “fluid composition” should be changed to “a fluid composition”.
In regards to claim 2, line 3, “component” should be changed to “a component”.
In regards to claim 2, line 4, “the maximum solubility” should be changed to “a maximum solubility”.
In regards to claim 2, line 4, “the pH” should be changed to “a pH”.
In regards to claim 2, line 7, “the concentration” should be changed to “a concentration”.
In regards to claim 8, line 3, “fluid composition” should be changed to “a fluid composition”.
In regards to claim 8, line 3, “component” should be changed to “a component”.
In regards to claim 8, line 4, “the maximum solubility” should be changed to “a maximum solubility”.
In regards to claim 8, line 4, “the pH” should be changed to “a pH”.
In regards to claim 8, line 7, “the concentration” should be changed to “a concentration”.
In regards to claim 12, lines 2-3, “the relative concentration” should be changed to “a relative concentration”.
In regards to claim 18, lines 2-3, “the relative concentration” should be changed to “a relative concentration”.
Appropriate correction is required.
Applicant is advised that should claim 10 be found allowable, claim 16 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).
Applicant is advised that should claim 11 be found allowable, claim 17 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).
Applicant is advised that should claim 12 be found allowable, claim 18 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 2-5 and 8-20 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.
In regards to claim 2, lines 8-9 recite: “the maximum concentration for solubility”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 2, line 4 previously recites “the maximum solubility”. It is unclear whether the two terms are the same or different. Claims 3-5 are rejected by virtue of being dependent upon claim 2. Claim 3, line 2, claim 4, line 2, and claim 5, line 2 recite the unclear term “the maximum concentration for solubility”.
In regards to claim 8, lines 8-9 recite: “the maximum concentration for solubility”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 8, line 4 previously recites “the maximum solubility”. It is unclear whether the two terms are the same or different. Claims 9-20 are rejected by virtue of being dependent upon claim 8. Claim 9, line 2 recites the unclear term “the maximum concentration for solubility”.
In regards to claim 13, line 2 recites “a potential for interaction”. Claim 13 depends upon claim 12, which depends upon claim 11, which depends upon claim 10. Claim 10, line 2 recites “a potential for interaction”. It is unclear whether the two terms are the same or different. Claims 14-15 are rejected by virtue of being dependent upon claim 13.
In regards to claim 14, line 2 recites “the potential for interaction”. Claim 14 depends upon claim 13. Claim 13, line 2 recites “a potential for interaction”. Claim 13 depends upon claim 12, which depends upon claim 11, which depends upon claim 10. Claim 10, line 2 recites “a potential for interaction”. It is unclear which potential for interaction is being referred to in claim 14, whether of claim 13 or of claim 10.
In regards to claim 15, line 2 recites “the potential for interaction”. Claim 15 depends upon claim 13. Claim 13, line 2 recites “a potential for interaction”. Claim 13 depends upon claim 12, which depends upon claim 11, which depends upon claim 10. Claim 10, line 2 recites “a potential for interaction”. It is unclear which potential for interaction is being referred to in claim 15, whether of claim 13 or of claim 10.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13-15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regards to claim 13, lines 1-2 recite: further comprising determining whether the ingredient may have a potential for interaction with the component of the medical device. Claim 13 depends upon claim 12, which depends upon claim 11, which depends upon claim 10. Claim 10, lines 1-2 already recite: further comprising determining whether the ingredient may have a potential for interaction with the component of the medical device. Thus, claim 13 is of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Claims 14-15 are rejected by virtue of being dependent upon claim 13.
In regards to claim 14, lines 1-2 recite: wherein the medical device is manufactured or selected if it is determined that the potential for interaction is low. Claim 14 depends upon claim 13, which depends upon claim 12, which depends upon claim 11. Claim 11, lines 1-2 already recite: wherein the medical device is manufactured or selected if it is determined that the potential for interaction is low. Thus, claim 14 is of improper dependent form for failing to further limit the subject matter of the claim upon which it depends.
In regards to claim 15, lines 1-3 recite: wherein the medical device is manufactured or selected if it is determined that the potential for interaction is low when factoring in the relative concentration of the ingredient and the HSP value. Claim 15 depends upon claim 13, which depends upon claim 12. Claim 12, lines 1-3 already recite: wherein the medical device is manufactured or selected if it is determined that the potential for interaction is low when factoring in the relative concentration of the ingredient and the HSP value. Thus, claim 15 is of improper dependent form for failing to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites: determining a differential Hansen Solubility Parameter (HSP) value for an ingredient of fluid composition and component of a medical device; manufacturing or selecting the medical device for use with the fluid composition if the differential HSP value is greater than 10.
The limitation of “determining a differential Hansen Solubility Parameter (HSP) value for an ingredient of fluid composition and component of a medical device” is a mental process that can be performed in the human mind. The term “determining” encompasses a user mentally calculating by subtraction the difference between a Hansen Solubility Parameter (HSP) value for an ingredient of fluid composition and a Hansen Solubility Parameter (HSP) value for component of a medical device.
Similarly, the limitation of “manufacturing or selecting the medical device for use with the fluid composition if the differential HSP value is greater than 10” is a mental process that can be performed in the human mind. The term “manufacturing” encompasses “inventing” (https://www.merriam-webster.com/dictionary/manufacture) which encompasses “producing (something, such as a useful device or process) for the first time through the use of the imagination or of ingenious thinking and experiment” (https://www.merriam-webster.com/dictionary/invent). Thus, the user can mentally imagine or think of choosing the medical device if the differential HSP value is greater than 10. And the term “selecting” encompasses the user mentally choosing the medical device if the differential HSP value is greater than 10.
This judicial exception is not integrated into a practical application because the claim does not recite additional elements integrating the abstract idea into a practical application. The claim only recites an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception, thus the claim does not include an inventive concept. The claim only recites an abstract idea. Claim 1 is not patent eligible.
Claims 6-7 are rejected by virtue of being dependent upon claim 1.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites: determining a differential Hansen Solubility Parameter (HSP) value for an ingredient of fluid composition and component of a medical device; determining the maximum solubility of the ingredient at the pH of the fluid composition; manufacturing or selecting the medical device for use with the fluid composition if the differential HSP value is between 7 and 10 and if the concentration of the ingredient in the fluid composition is less than the maximum concentration for solubility at the pH of the fluid composition.
The limitation of “determining a differential Hansen Solubility Parameter (HSP) value for an ingredient of fluid composition and component of a medical device” is a mental process that can be performed in the human mind. The term “determining” encompasses a user mentally calculating by subtraction the difference between a Hansen Solubility Parameter (HSP) value for an ingredient of fluid composition and a Hansen Solubility Parameter (HSP) value for component of a medical device.
Similarly, the limitation of “determining the maximum solubility of the ingredient at the pH of the fluid composition” is a mental process that can be performed in the human mind. The term “determining” encompasses a user mentally calculating the maximum solubility of the ingredient at the pH of the fluid composition.
Similarly, the limitation of “manufacturing or selecting the medical device for use with the fluid composition if the differential HSP value is between 7 and 10 and if the concentration of the ingredient in the fluid composition is less than the maximum concentration for solubility at the pH of the fluid composition” is a mental process that can be performed in the human mind. The term “manufacturing” encompasses “inventing” (https://www.merriam-webster.com/dictionary/manufacture) which encompasses “producing (something, such as a useful device or process) for the first time through the use of the imagination or of ingenious thinking and experiment” (https://www.merriam-webster.com/dictionary/invent). Thus, the user can mentally imagine or think of choosing the medical device if the differential HSP value is between 7 and 10 and if the concentration of the ingredient in the fluid composition is less than the maximum concentration for solubility at the pH of the fluid composition. And the term “selecting” encompasses the user mentally choosing the medical device if the differential HSP value is between 7 and 10 and if the concentration of the ingredient in the fluid composition is less than the maximum concentration for solubility at the pH of the fluid composition.
This judicial exception is not integrated into a practical application because the claim does not recite additional elements integrating the abstract idea into a practical application. The claim only recites an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception, thus the claim does not include an inventive concept. The claim only recites an abstract idea. Claim 2 is not patent eligible.
Claims 3-5 are rejected by virtue of being dependent upon claim 2.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites: determining a differential Hansen Solubility Parameter (HSP) value for an ingredient of fluid composition and component of a medical device; determining the maximum solubility of the ingredient at the pH of the fluid composition; manufacturing or selecting the medical device for use with the fluid composition if the differential HSP value is lower than 7 and if the concentration of the ingredient in the fluid composition is less than 50% of the maximum concentration for solubility at the pH of the fluid composition.
The limitation of “determining a differential Hansen Solubility Parameter (HSP) value for an ingredient of fluid composition and component of a medical device” is a mental process that can be performed in the human mind. The term “determining” encompasses a user mentally calculating by subtraction the difference between a Hansen Solubility Parameter (HSP) value for an ingredient of fluid composition and a Hansen Solubility Parameter (HSP) value for component of a medical device.
Similarly, the limitation of “determining the maximum solubility of the ingredient at the pH of the fluid composition” is a mental process that can be performed in the human mind. The term “determining” encompasses a user mentally calculating the maximum solubility of the ingredient at the pH of the fluid composition.
Similarly, the limitation of “manufacturing or selecting the medical device for use with the fluid composition if the differential HSP value is lower than 7 and if the concentration of the ingredient in the fluid composition is less than 50% of the maximum concentration for solubility at the pH of the fluid composition” is a mental process that can be performed in the human mind. The term “manufacturing” encompasses “inventing” (https://www.merriam-webster.com/dictionary/manufacture) which encompasses “producing (something, such as a useful device or process) for the first time through the use of the imagination or of ingenious thinking and experiment” (https://www.merriam-webster.com/dictionary/invent). Thus, the user can mentally imagine or think of choosing the medical device if the differential HSP value is lower than 7 and if the concentration of the ingredient in the fluid composition is less than 50% of the maximum concentration for solubility at the pH of the fluid composition. And the term “selecting” encompasses the user mentally choosing the medical device if the differential HSP value is lower than 7 and if the concentration of the ingredient in the fluid composition is less than 50% of the maximum concentration for solubility at the pH of the fluid composition.
This judicial exception is not integrated into a practical application because the claim does not recite additional elements integrating the abstract idea into a practical application. The claim only recites an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception, thus the claim does not include an inventive concept. The claim only recites an abstract idea. Claim 8 is not patent eligible.
Claims 9-20 are rejected by virtue of being dependent upon claim 8.
Allowable Subject Matter
Claims 1 and 6-7 are allowed over the prior art of record. Note: claims 1 and 6-7 are also rejected under 35 USC 101.
In regards to independent claim 1, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a method, as claimed, specifically including manufacturing or selecting the medical device for use with the fluid composition if the differential HSP value is greater than 10.
Hetzler et al (US 6,595,961) teaches a method comprising: determining a differential Hansen Solubility Parameter (HSP) value for an ingredient of fluid composition and component of a medical device (column 2, lines 59-60: The distance between the HSP coordinate of polymer A to HSP coordinates of another material (liquid or Polymer B))(column 2, line 56: components of medical devices).
However, Hetzler et al does not teach manufacturing or selecting the medical device for use with the fluid composition if the differential HSP value is greater than 10.
Thus, independent claim 1 is allowed over the prior art of record. Dependent claims 6-7 are allowed over the prior art of record by virtue of being dependent upon independent claim 1. Note: claims 1 and 6-7 are also rejected under 35 USC 101.
Claims 2-5 and 8-20 would be allowable over the prior art of record if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. Note: claims 2-5 and 8-20 are also rejected under 35 USC 101, and claims 13-15 are also rejected under 35 USC 112(d).
In regards to independent claim 2, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a method, as claimed, specifically including determining the maximum solubility of the ingredient at the pH of the fluid composition; manufacturing or selecting the medical device for use with the fluid composition if the differential HSP value is between 7 and 10 and if the concentration of the ingredient in the fluid composition is less than the maximum concentration for solubility at the pH of the fluid composition.
Hetzler et al teaches a method comprising: determining a differential Hansen Solubility Parameter (HSP) value for an ingredient of fluid composition and component of a medical device (column 2, lines 59-60: The distance between the HSP coordinate of polymer A to HSP coordinates of another material (liquid or Polymer B))(column 2, line 56: components of medical devices).
However, Hetzler et al does not teach determining the maximum solubility of the ingredient at the pH of the fluid composition; manufacturing or selecting the medical device for use with the fluid composition if the differential HSP value is between 7 and 10 and if the concentration of the ingredient in the fluid composition is less than the maximum concentration for solubility at the pH of the fluid composition.
Thus, independent claim 2 would be allowable over the prior art of record if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action. Dependent claims 3-5 would be allowable over the prior art of record if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action, by virtue of being dependent upon independent claim 2. Note: claims 2-5 are also rejected under 35 USC 101.
In regards to independent claim 8, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a method, as claimed, specifically including determining the maximum solubility of the ingredient at the pH of the fluid composition; manufacturing or selecting the medical device for use with the fluid composition if the differential HSP value is lower than 7 and if the concentration of the ingredient in the fluid composition is less than 50% of the maximum concentration for solubility at the pH of the fluid composition.
Hetzler et al teaches a method comprising: determining a differential Hansen Solubility Parameter (HSP) value for an ingredient of fluid composition and component of a medical device (column 2, lines 59-60: The distance between the HSP coordinate of polymer A to HSP coordinates of another material (liquid or Polymer B))(column 2, line 56: components of medical devices).
However, Hetzler et al does not teach determining the maximum solubility of the ingredient at the pH of the fluid composition; manufacturing or selecting the medical device for use with the fluid composition if the differential HSP value is lower than 7 and if the concentration of the ingredient in the fluid composition is less than 50% of the maximum concentration for solubility at the pH of the fluid composition.
Thus, independent claim 8 would be allowable over the prior art of record if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action. Dependent claims 9-20 would be allowable over the prior art of record if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action, by virtue of being dependent upon independent claim 8. Note: claims 8-20 are also rejected under 35 USC 101, and claims 13-15 are also rejected under 35 USC 112(d).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
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, Kevin C Sirmons can be reached at (571) 272-4965. 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.
/SHEFALI D PATEL/Primary Examiner, Art Unit 3783