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 .
Claim Status
The amended claim set filed on 29 July 2025 is acknowledged. Claims 7 and 13 are currently pending. Of those, claims 7 and 13 are amended. Claim 13 is new, and claims 1-6 and 8-12 are cancelled. Claims 7 and 13 will be examined on the merits herein.
Response to Amendment
The Applicant’s arguments filed 29 July 2025 are acknowledged. For clarity, in this action said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 6 May 2025 will be referred to as “NFOA”.
Objection(s) and Rejection(s) Withdrawn
The objection to the drawings is withdrawn in view of the amendment to the brief description of the drawings in the specification.
The objection to claim 10 is moot because the claim has been cancelled.
The rejection(s) of claims 8-12 under 35 U.S.C. 112(a), 112(b), and/or 102(a)(1) is/are moot because claims 8-12 have been cancelled.
The rejections of claim 7 under 35 U.S.C. 112(a) and 102(a)(1) are withdrawn in view of the amendments to the claim.
New Rejection(s)
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 13 is newly rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 13 is drawn to a method for diagnosing cancer. The claim recites a step of “observing a near infrared fluorescence image in the subject”. The action of “observing a[n] … image” falls within the category of a mental process, one of the groups of abstract ideas set forth in MPEP 2106.04(a).
This judicial exception is not integrated into a practical application because the application or use of the judicial exception does not go beyond generally linking the use of the judicial exception (i.e., “observing a near infrared fluorescence image”) to a particular technological environment or field of use. In this case, the recited steps of “administering photosynthetic bacteria to a subject, [and] applying light irradiation to the subject, to which the photosynthetic bacteria is administered” are performed in order to gather data (i.e., prepare the image) for the step of “observing a near infrared fluorescence image” and are necessary precursors for all uses of the “observing” step. Thus, the remaining steps are extra-solution activity, and does not integrate the judicial exception into a practical application. See MPEP 2106.04(d)(2). Examples of data gathering that the courts have found to be insignificant extra-solution activity include, for example, performing clinical tests on individuals to obtain input for an equation (In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989)) and assessing or measuring data derived from an ultrasound scan to be used in a diagnosis (PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012)). See MPEP 2106.05(g). An example of limitations that the courts have described as merely indicating a field of use or technological environment in which to apply a judicial exception include, for example, language informing doctors to apply a law of nature (linkage disequilibrium) for purposes of detecting a genetic polymorphism, because this language merely informs the relevant audience that the law of nature can be used in this manner (Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1379, 118 USPQ2d 1541, 1549 (Fed. Cir. 2016)). See MPEP 2016.05(h). Furthermore, the judicial exception is not integrated into a practical application because the claim does not recite additional elements that apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional steps of “administering photosynthetic bacteria to a subject, [and] applying light irradiation to the subject, to which the photosynthetic bacteria is administered” are extra-solution activity of preparing for and gathering data for the step of “observing a near infrared fluorescence image” as discussed above. Additionally, the additional limitations only generally link the judicial exception to a particular field of use for the reasons described above. See MPEP 2106.05.
Therefore, claim 13 does not qualify as eligible subject matter (see MPEP 2106).
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.
Claims 7 and 13 are newly rejected under 35 U.S.C. 103 as being unpatentable over Kwon et al. (2014, Microbiol. Immunol.; cited in IDS; herein “Kwon”) in view of Kamal et al. (2009, Antonie van Leeuwenhoek; herein “Kamal”).
Regarding claims 7 and 13, Kwon teaches a method comprising administering Rhodobacter sphaeroides, a purple photosynthetic bacteria, to mice (pg. 173, left col., para 2-3 and pg. 174, left col., para. 2-3). Kwon also teaches that the method for visualizing cancerous tumors further comprises applying light using an ICG filter (i.e., applying 789 nm light; near infrared light) (pg. 174,left col., para. 4 and Fig. 1-2 descriptions).
Regarding claim 13, Kwon teaches observing images of the fluorescent signals emitted by the R. sphaeroides (which when excited using the ICG filter, emits NIR fluorescence) in the subject by overlaying the image of fluorescence intensity with images of the mice, thereby visualizing the tumors (pg. 174, left col., para. 4-5 and Figs. 1a and 2).
Kwon teaches that, in deep tissue, the intensity of the NIR fluorescence emitted by bacteriochlorophyll in R. sphaeroides was stronger than the GFP or RFP fluorescence emitted by other non-photosynthetic bacteria (Abstract). Kwon also teaches that bacteria are able to target tumors based on their metabolism and oxygen tolerance (pg. 177, right col., para. 3); thus, photosynthetic bacteria, like the purple photosynthetic bacteria R. sphaeroides can survive and proliferate in the anoxic tumor environment (pg. 177, right col., para. 3 and pg. 178, left col., 2-3). Kwon also teaches that bacteria can replicate in tumors unimpeded by macrophages and neutrophils that would normally target bacteria in healthy tissue (pg. 178, left col., para. 1).
However, Kwon does not teach Rhodopseudomonas, Blastochloris, Afifella, Pararhodospirillum, Rhodomicrobium, Rhodovulum, or Marichromatium bacteria as the photosynthetic bacteria.
Kamal teaches that photodynamic therapy is a promising cancer treatment, which uses a photosensitizer compound activated by light to produce reactive oxygen species to kill tumors (Abstract). Kamal teaches that bacteriochlorins, such as bacteriochlorophyll-a, obtained from photosynthetic bacteria including Rhodopseudomonas palustris may be used as photosensitizers in photodynamic therapy (Abstract and pg. 187, left col., para. 3). However, Kamal also teaches that the extracted bacteriochlorins are unstable (pg. 187, left col., para. 3).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to substitute the photosynthetic bacteria used in the method taught by Kwon, with Rhodopseudomonas palustris as taught by Kamal, thereby arriving at the claimed invention. The person of ordinary skill in the art would have been motivated to make the modification because Kamal teaches that bacteriochlorins are unstable when extracted from bacteria, and Kwon teaches that whole bacteria containing bacteriochlorophyll maintain their ability to absorb NIR light and are able to replicate in tumor environments. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because both photosynthetic bacteria taught by Kamal and Kwon contain bacteriochlorophyll, which is known to be a capable photosensitizer that absorbs light in the NIR range. Therefore, the combination leads to expected results because each element performs the same function as is does individually. The compositions of Kamal and Kwon are both made for the purpose of treating cancer. From MPEP 2144.06(I): "'It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art.' In re Kerkhoven, 626 F.2d 846,850,205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) .... "
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (Kwon) teaches a method that only differs from the claimed invention by the substitution of a single component (i.e., substitution of the photosynthetic bacteria used); the substituted element (i.e., Rhodopseudomonas palustris) was already known and already shown to contain bacteriochlorophyll-a, which may function as a photosensitizer for cancer treatment, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting one photosynthetic bacteria for another with a reasonable expectation of success (i.e., the substitution of the element would lead to predictable results). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645