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 .
Election/Restrictions
Applicant’s election without traverse of plasminogen in the reply filed on 5/20/2025 is acknowledged.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 9 and 10 provide for the limitation “at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99%” is objected to because of the following informalities: writing “at least 75%” accomplishes the same task as the above limitation and does not change the claim scope, because “at least 75%” implies all percents from 75% to 100%. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 9 and 10 are 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. Both claims 9 and 10 provide for a functional limitation in a claim drawn to a sequence with less than 100% homology to a claimed sequence. Unless the Applicant has shown a reasonable number of exemplars that explicitly provide for this function, the instant specification does not reasonably convey that the Applicant was in possession of these embodiments at the time of filing.
For example, claim 9 provides for a polypeptide with 95% homology to SEQ ID No 2, as long as the polypeptide has “plasminogen activity.” 95% homology on a 791 amino acid polypeptide means that up to 40 amino acids can be mutated, deleted or added; however, the Applicant has not shown a representative number of sequences that fulfill this limitation, and also have plasminogen activity. Similarly, claim 10 requires proteolytic or lysine binding activity, which is not demonstrated in the specification for all of the possible embodiments.
Even without the functional limitations provided in claims 9 and 10, homology less than 95% does not appear to be reasonably described in the instant specification to show that the Applicant was in possession of a reasonable number of embodiments.
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.
Claim 14 is 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.
Claim 14 is indefinite because it provides for the parenthetical limitation “(e.g. steroid hormones).” This limitation is indefinite because it is unclear if “hormonal medication” can only be limited to “steroid hormones” or if this is an example that is not supposed to further limit the non-parenthetical limitation. Either provide “steroid hormones” as its own limitation, or remove the parenthetical limitation.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
Claims 1, 4, and 6-15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ny, et al (US Pat. 8,318,661). Ny teaches the administration of plasminogen as a means of treatment or prophylaxis for a number of pathologies. See column 1, lines 14-25; column 14, lines 16-22. Ny notes that bacterial pneumonia can be treated by this method, but also suggests that viral forms of pneumonia can be treatable, too. See column 4, line 27; column 11, line 63. Ny further suggests that the method could be extended to treatments for coronavirus. See column 12, line 8.
With respect to claim 1, based upon Ny’s disclosure, as a whole, it is clear that the invention is not specifically drawn to treatment for pneumonia (treatments for pneumonia are not claimed, and there do not appear to be any examples of using plasminogen to treat pneumonia). However, it appears clear that Ny either is explicitly providing for an anticipating method or has reasonable theoretical underpinning as to why plasminogen could be used to effectively treat pneumonia, in a predictable manner. Since it appears as though Ny is explicitly teaching a treatment for pneumonia, Ny must have anticipated the instant claim. If it can be shown that Ny never reduced the method to practice, Ny very clearly provided motivations to treat pneumonia with plasminogen, and provided a theoretical underpinning to show that there should be a reasonable expectation of success.
With respect to claim 4, Ny teaches the claimed forms of pneumonia. See column 11, lines 1, 2, and 19-21.
With respect to claim 6, Ny teaches coronavirus.
With respect to claim 7, although Ny is silent to the claimed pathologies related to a SARS-CoV-2 based pneumonia, Ny explicitly teaches coronavirus, which would necessarily include SARS-CoV-2. Since Ny anticipates the administration of plasminogen, all of the effects the administration of plasminogen had on the subject is entirely inherent to the method of providing plasminogen to an individual with coronavirus-based pneumonia. There is no evidence to suggest that the claimed SARS-CoV-2 pneumonia provides for any unexpected differences than those disclosed in Ny, and as such, there is a reasonable expectation that the method of Ny would work on any form of coronavirus-based pneumonias.
With respect to claim 8, the instant claim teaches providing the same plasminogen as that disclosed in Ny, and as such, the effect must have been the same.
With respect to claims 9-11, Ny teaches a naturally occurring form of plasminogen, as there does not appear to be any evidence that the plasminogen is anything other human plasminogen. See column 26, Example 5. Following a BLAST search for SEQ ID No 2, it was revealed that this is the sequence for human plasminogen; after comparing this to SEQ ID No 16, it appears as though SEQ ID No 16 is a subsequence found in SEQ ID No 2, starting at amino acid 562. Since Ny teaches human plasminogen, Ny must necessarily teach 100% homology to the claimed SEQ ID No 2 and 16. Although Ny does not present any sequences, there is no evidence to suggest that Ny provides for any other form of plasminogen that does not anticipate the claimed plasminogen.
With respect to claim 12, Ny teaches human plasminogen; although it appears as though Ny teaches a “natural” form, it is unclear. However, unless evidence can be provided, natural and synthetic forms of this polypeptide are considered identical.
With respect to claims 13 and 14, Ny teaches that the method can further include antibiotics. See column 4, line 35.
With respect to claim 15, Ny teaches the same routes of administration. See column 4, lines 46-49.
Claim Rejections - 35 USC § 103
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ny, et al (US Pat. 8,318,661) and Schultz, et al (Critical Care Medicine, 34, 871-877, 2006). Ny only appears to teach pneumonia with bacterial, viral, or fungal origins; Ny does not explicitly state that pneumonia from a non-infective cause can be treated. Schultz provides a review for the use of therapeutics that treat pulmonary coagulopathy, which co-presents with pneumonia (both infective and non-infective). Schultz shows that activation of the plasminogen pathway aids in the treatment of pulmonary coagulopathy, and notes that plasminogen provides for fibrinolytic activity. See Schultz, entire. When taking the teachings of Schultz, and applying it to the methods of treating, discussed in Ny, it would be obvious to the ordinary artisan that the treatment provided in Ny would likely work in all forms of pneumonia, since both infective and non-infective pneumonia are characterized by a deposition of fibrin. Since the treatment provided in Ny was aimed to treat the symptoms of the inflammation, and not the infection, per se, it would be reasonable to suggest that the ordinary artisan would find it obvious that the method of Ny could apply to all forms of pneumonia, since they are all characterized by fibrin deposition.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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, Adam Weidner can be reached at 571-272-3045. 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.
/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
Prosecution Insights