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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 5/20/2024 wherein specification and claims 5 and 7 were amended.
Note(s): Claims 1-9 are pending.
Priority and Priority Document
This application is a 371 of PCT/CN2022/079674 filed 3/08/2022 which claims benefit to CHINA CN202210159121.5 filed 2/22/2022.
Note(s): The earliest effective filing date 3/8/2022 because the pending invention is fully disclosed therein.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 USC 119 (a) – (d). The certified copy was filed in the pending application on 5/20/2024.
While a certified copy of the prior document was submitted, an English language translation is not of record. Should Applicant desire to obtain the benefit of foreign priority under 35 USC 119 (a) – (d) prior to declaration of an interference, a certified English language translation of the foreign application should be submitted. 37 CFR 41.154(b) and 41.202(e). Failure to provide the certified translation may result in no benefit being accorded for the non-English document.
Claim Interpretation
Independent claim 1 is directed to a polyethylene glycol modified zwitterionic fluorescent probe
having the structure,
PNG
media_image1.png
293
442
media_image1.png
Greyscale
, wherein the variables are defined in independent claim 1.
Claim 5 is directed to a lyophilized formulation as set forth therein.
Claim 7 is directed to the use of a fluorescent probe.
Information Disclosure Statement
The information disclosure statement filed 5/20/2024 was considered.
Specification
The disclosure is objected to because of the following informalities: the structures on pages, 3, 5, 6, 20, and 21 are difficult to read. In addition, on page 19, the text under the arrow is written over with other text. As a result, it is unclear what is written..
Appropriate correction is required.
Written Description Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection. The pending application does not sufficiently describe the invention as it relates to lyophilization protecting agents other than glucose, sucrose, maltose, trehalose, galactose, fructose, mannitol, glutamic acid, alanine, glycine, creating, arginine, polyethylene glycol, glucan, polyvinyl alcohol, and polyvinylpyrrolidone. Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms as set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
112 Second Paragraph Rejections
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 1-9 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.
Claims 1-9: Independent claim 1 is ambiguous because the structure is difficult to read. Applicant is respectfully requested to submit a readable structure.
In addition, the term “small” in claim 1 (line 5) is a relative term which renders the claim indefinite. The term “small” 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 (lines 8-11 and 15) recites the broad recitation non-natural alkaline amino acid and values of x, y, and z, respectively, and the claim also recites preferred embodiments of non-natural alkaline amino acid and values of x, y, and z, respectively which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Also, the claim is ambiguous because there are multiple periods in the claim (see lines 11 and 16. According to MPEP 608.01(m) which discloses the form of claims, each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in in the claims except for abbreviations. Applicant is respectfully requested to make the appropriate correction(s) as it is unclear is the claim should could all of the text therein.
Still, claim 1 (line 16) is ambiguous because the values of d and e range from 1 to infinity. Specifically, the claim is ambiguous because ring structures wherein the (CH2)d and (CH2)e groups may be infinity (see line 4 of the claim). Such structures are unclear as one cannot determine the actual size or chemical name of a ring structure or repeating CH2 group that repeats to infinite.
Furthermore, claim 1 recites the limitations "the chemical structural formula" (line 2). There is insufficient antecedent basis for this limitation in the claim.
Since claims 2-9 depend upon independent claim 1 for clarity, those claims are also vague and indefinite.
Claim 2: The claim is ambiguous because there is only one ligand in the structure. As a result, it is unclear how one or more RGD polypeptide targeting agents are present (see claim 2, lines 2-3). In the structure appearing in independent claim 1, there are not multiple ligands present.
Claim 2: The claim is ambiguous because it is unclear what derivatives of glutamic urea Applicant is referencing. In particular, there is no indication of what portion of the parent structure must be present in the derivative.
Claims 3 and 4: The claims are ambiguous because it is difficult to read the structures.
Claims 3 and 4: The claim recites the limitations "the chemical structural formula" (lines 2-3). There is insufficient antecedent basis for this limitation in the claim.
Claims 7-9: The claims are ambiguous because they are directed to a use and not do not recite steps for obtaining a desired result. Thus, it is unclear what is being claimed and how to obtain the desired result.
101 Rejection
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 7-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because according to MPEP 2173.05(q), Section I, it is proper to reject claims that are not directed to a process, machine, manufacture, or composition of matter, but are directed to a non-statutory category.
Comments/Notes
For clarity of independent claim 1, line 12, it is respectfully requested that Applicant replace ‘vacant’ with ‘absent’.
For clarity of claim 5, it is respectfully suggested that the claim be written as follows: “A lyophilized formulation comprising the polyethylene glycol modified zwitterionic fluorescent probe according to claim 1 and a lyophilization protein agent”.
It should be noted that no prior art is cited against the pending claims. In addition, it should be noted that the full scope of the claims could not be determined as some claims were non-statutory as they were not directed to a process, machine, manufacture, or composition (see claims 7-9).
For claims 1-6, the claims were found to be free of the prior art of record because of the structures present therein which are neither rendered obvious or anticipated by the prior art of record..
Conclusion
Claims 1-9 are rejected.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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, Michael G. Hartley can be reached at (571)272-0616. 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.
/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
August 7, 2026
Prosecution Insights