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 .
Specification
The disclosure is objected to because of the following informalities: Use of a trade name without including a generic terminology description or proper trademark symbol.
Appropriate correction is required.
The use of the term Tetronic® 1107, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112 - Indefiniteness
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, 7, 8, and 11 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.
The term “vigorously” in claim 1 is a relative term which renders the claim indefinite. The term “vigorously” 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. The degree to which the container is shaken is rendered indefinite by use of the tern “vigorously” because the degree of agitation applied to the contrast agent solution would vary between different people. The dependent claims fall therewith.
The term “optimized” in claims 1 and 11 is a relative term which renders the claims indefinite. The term “optimized” is not defined by the claims, 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. Without knowing the aspect(s) of the formulation that is/are optimized, it is not possible to know the scope of the claimed composition. The contrast agent solution pH, osmolality, and tonicity and the concentrations of other ingredients are not defined by the term “optimized”. The dependent claims fall therewith.
The term “specific agents known to promote the contrast agent solution uptake by cells” in claims 7 and 8 is indefinite because currently known agents could, in the future, be discovered to promote the uptake of the contrast agent by cells. The term “specific agents known to promote the contrast agent solution by cells” is thus indefinite. The dependent claims fall therewith.
Claims 7 and 8 require addition of specific agents known to promote the contrast agent solution uptake by cells. However, claim 1 requires the addition of citrate and claim 8 recites citrate as an agent that promotes uptake of contrast agent by cells but citrate is already required to be present so it cannot be further added as required by claims 7 and 8. Claim 8 falls therewith.
Claim 8 contains the trademark/trade name Tetronic® 1107. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a surfactant block co-polymer and, accordingly, the identification/description is indefinite.
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.
Claim(s) 11- 13 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Moein (US 10588564 on PTO-892).
Moein discloses cervical staining for diagnosis of cancer (claim 21 and column 1, lines 35-37), a medical kit (claims 1 - 20) for diagnosis of cervical tissue exhibiting intraepithelial neoplasia (claim 21) which includes a pipette pre-filled with 10 – 100 mL saline solution (claim 9), a pipette filled with 10 – 100 mL fluorescein sodium solution (claim 11) and another pipette pre-filled with 10 – 100 mL saline solution (column 7, lines 5 and 6). Steps involved with the method of using the kit include rinsing of the cervix with normal saline solution (claim 21) to remove discharge (column 3, lines 36-37) before applying the fluorescein sodium solution to the cervix (claim 21 and column 3, lines 51 and 52) and rinsing the cervix again with normal saline solution following the exposure of the cervix to the fluorescein sodium solution (claim 21 and column 3, lines 55 and 56).
Because the general term “optimized” is not defined in claim 11 or the Specification as submitted, Moein is considered to have used an optimized contrast agent solution as the material was suitable for use in the method of Moein.
"If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). MPEP 2131.03
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.
Claim(s) 11 – 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moein (US 10588564 on PTO-892).
Moein is discussed above. Fluorescein Sodium solutions of at least 0.2% by weight and higher, up to 20% by weight (column 6, lines 60-64) can be used.
Moein does not explicitly teach the use of 10 ml of normal saline and contrast agent solutions.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the 10 ml volume of solutions from the range disclosed by Moein and the steps taught by Moein for staining the cervix into the method of applying contrast agent solution to a cancerous area of the cervix. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the range of solution volumes taught by the prior art are inclusive of the required volume solutions and the steps taught by the prior art include the required steps of the claimed method. One of ordinary skill in the art would select the volumes of solutions to use within the range disclosed by the prior art.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05.
Because the general term “optimized” is not defined in claim 11 or the Specification as submitted, Moein is considered to have used an optimized contrast agent solution as the material was suitable for use in the method of Moein.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moein (US 10588564 on PTO-892) as applied to claims 11 – 13 above, in further view of Marconi (Journal of Obstetrics & Gynecology and Reproductive Biology 2013 on PTO-892) or Viviano (International Journal of Women’s Health 2018 on PTO-892).
Moein is discussed above. Moein further discloses a medical kit for cervical diagnosis that contains cotton swabs (column 3, para. 6) and the exposure of an area of the cervix to a solution using a swab (claim 21).
Moein does not explicitly teach use of pipettes made of plastic for application of normal saline and the contrast agent solutions to the cervix nor does Moein explicitly teach the use of cotton swabs for application of the normal saline and contrast agent solutions to the cervix.
Marconi teaches the use of plastic pipettes for exposing vaginal tissue to a solution (p. 206, Materials and methods Section, second para., line 7).
Viviano teaches cotton swabs for vaginal sample collection (title).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate either the plastic pipette of Marconi or the cotton swab of Viviano into the method of Moein to expose the cervix to the normal saline and contrast agent solutions. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art teaches the use of plastic pipettes as a suitable applicator of solutions to vaginal tissue as well as the collection of samples from the vagina using a cotton swab which could obviously be adapted as a means of exposing the cervix to normal saline and fluorescein sodium solutions as has been demonstrated by the prior art of Moein disclosing a swab to expose the cervix to a different solution.
Claim(s) 1 – 6, 9, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moein (US 10588564 on PTO-892) as applied to claims 11 – 13 above, in further view of Reza (WO 2009/025763 on PTO-892) and Ellington (US 2020/0360675 on PTO-892).
Moein is discussed above.
Moein does not teach the use of fluorescein sodium strips for preparing the fluorescein sodium solution nor does Moein teach steps adjusting the pH, osmolality, and tonicity of the fluorescein sodium solution.
Reza discloses a fluorescein strip wet with sterile saline solution and touching the wet strip to the human inferior tarsal conjunctiva (inner surface of eyelid) to add fluorescein sodium solution to the tear film (example 2, para 147).
Ellington teaches citric acid and sodium citrate to adjust the pH (P.10/11, para.78, line 7 and p. 33, table 22) and NaCl, KCl, and sugars to adjust the tonicity and osmolality (p. 11, para. 83) of compositions topically exposed to the cervix.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the example of Reza where a single strip is wet with normal saline solution to prepare a relatively small volume of fluorescein sodium solution to the method of Moein where a larger volume of milliliters of fluorescein sodium solution would require dissolution of fluorescein sodium from multiple strips, and to incorporate the citric acid/citrate, NaCl, KCl, and sugars to adjust solution pH, osmolality and tonicity according to Ellington into the of method of Moein for preparing the contrast agent solution. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art shows the production of fluorescein sodium solution using a fluorescein strip and use of multiple strips to produce larger volumes of fluorescein sodium solution would have been obvious to one of ordinary skill in the art. Additionally, the prior art demonstrates adjusting solution pH, osmolality and tonicity using the recited solution modifiers claimed in the invention. One of ordinary skill in the art would adjust the pH, osmolality, and tonicity of compositions intended for topical application to the cervix as taught by Ellington.
Regarding claim 10, dissolution of sodium fluorescein in normal saline results in a transparent yellow solution as indicated by Example 1 of the Specification as submitted (p. 12, Example 1, para. 59, lines 2 and 3).
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moein (US 10588564 on PTO-892), Reza (WO 2009/025763 on PTO-892) and Ellington (US 2020/0360675 on PTO-892) as applied to claim 1-6, 9-13 above, and further in view of Awang (Molecules 2010 on PTO-892).
For this rejection, claims 7 and 8 are being interpreted as requiring an additional specific agent known to promote the contrast agent solution uptake by cells other than the citrate already required by claim 1.
Moein, Reza, and Ellington are discussed above.
Moein, Reza, and Ellington do not teach an acetate to promote the contrast agent solution uptake by cells.
Awang discloses the apoptotic effect of acetoxychavicol acetate on human cancer cells (title) relative to healthy cells (abstract) and the apoptotic associated permeation of fluorescence dyes into the apoptotic cancerous cells (p. 8055, para. 2, lines 3-4).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the acetoxychavicol acetate of Awang into the contrast agent solution of Moein. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art teaches that acetoxychavicol acetate has a preferential apoptotic effect on cancer cells. While promotion of uptake by cancer cells is not explicitly disclosed, application of a composition having the same ingredients, such as acetate, to the same tissue must necessarily result in the same effects including greater uptake of the contrast agent by cancer cells.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 11 - 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 10588564 (on PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 21 of US 10588564 encompasses the steps of claims 11 - 13.
US’564 is the same patent used in the prior art rejections above.
Claim 21 of US’564 discloses a method for diagnosis of cervical cancer comprising the steps of rinsing the cervix with saline solution before applying fluorescein sodium to the cervix followed by rinsing the cervix again with the saline solution after exposing the cervix to the fluorescein sodium.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the steps of the method taught by claim 21 of US’564 into the claimed invention method as recited in claims 11 – 13. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the steps taught by claim 21 of US’564 include the required steps of the claimed method and one of ordinary skill in the art would select the appropriate volumes of solutions to achieve the performance of the diagnostic method.
Because the general term “optimized” is not defined in claim 11, US’564 is considered to have used an optimized contrast agent solution as the material was suitable for use in the method of claim 21 of US’564.
Claims 11 - 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 10588564 (on PTO-892) in view of Marconi (Journal of Obstetrics & Gynecology and Reproductive Biology 2013 on PTO-892) or Viviano (International Journal of Women’s Health 2018 on PTO-892).
Claim 21 of US’564 is discussed above. Claim 21 of the US’564 additionally discloses the use of a swab to expose an area of the cervix to a solution.
Claim 21 of US’564 does not explicitly teach use of plastic pipettes for application of various solutions to the cervix, nor does Claim 21 of US’564 explicitly teach the use of cotton swabs for application of the normal saline and fluorescein sodium solutions to the cervix.
Marconi and Viviano are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate either the plastic pipette of Marconi or the cotton swab of Viviano into the method of claim 21 of US’564 as a means of exposing the cervix to the normal saline and contrast agent solutions. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art teaches the use of plastic pipettes as a suitable applicator of solutions to the vaginal tissue as well as the collection of samples from the vagina using a cotton swab which could obviously be adapted as a means of exposing the cervix to normal saline and fluorescein sodium solutions.
Claims 1 - 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 10588564 in view of Reza (WO 2009/025763 on PTO-892), Ellington (US 2020/0360675 on PTO-892), and Awang (Molecules 2010 on PTO-892).
For this rejection, claims 7 and 8 are being interpreted as requiring an additional specific agent known to promote the contrast agent solution uptake by cells other than the citrate already required by claim 1.
U.S. Patent No. 10588564,
U.S. Patent No. 10588564 does not teach the use of fluorescein sodium strips for preparing the fluorescein sodium solution, steps adjusting the pH, osmolality, and tonicity of the fluorescein sodium solution, or an acetate to promote the contrast agent solution uptake by cells.
Reza, Ellington, and Awang are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the example of Reza where a single strip is wet with normal saline solution to prepare a relatively small volume of fluorescein sodium solution to the method of U.S. Patent No. 10588564 where a larger volume of milliliters of fluorescein sodium solution would require dissolution of fluorescein sodium from multiple strips, and to incorporate the citric acid/citrate, NaCl, KCl, and sugars to adjust solution pH, osmolality and tonicity according to Ellington into the of method of U.S. Patent No. 10588564 for preparing the contrast agent solution. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art shows the production of fluorescein sodium solution using a fluorescein strip and use of multiple strips to produce larger volumes of fluorescein sodium solution would have been obvious to one of ordinary skill in the art. Additionally, the prior art demonstrates adjusting solution pH, osmolality and tonicity using the recited solution modifiers claimed in the invention. One of ordinary skill in the art would adjust the pH, osmolality, and tonicity of compositions intended for topical application to the cervix as taught by Ellington.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the acetoxychavicol acetate of Awang into the contrast agent solution of U.S. Patent No. 10588564. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art teaches that acetoxychavicol acetate has a preferential apoptotic effect on cancer cells. While promotion of uptake by cancer cells is not explicitly disclosed, application of a composition having the same ingredients, such as acetate, to the same tissue must necessarily result in the same effects including greater uptake of the contrast agent by cancer cells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES DAVID BURGESS whose telephone number is (571)270-5640. The examiner can normally be reached Monday - Friday 8:30AM - 5:00PM.
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/JAMES D BURGESS/Examiner, Art Unit 1618
/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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