DETAILED ACTION
This action is in reply to papers filed 7/2/2026.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20200114164A1, Published 4/16/2020.
Election/Restrictions
Applicant's election without traverse of Group I, claims 1-7, 9-18, 20-21 and 29-43, in the reply filed on 7/2/2026 is acknowledged.
Acknowledgement is also made of the species election, without traverse, of (1) the location of the first region being inside the subject overlapping the second region (claim 9) (2) the artificial material comprising a material capable of transmission of biophotons (claim 12), (3) initiating a change comprising cell death of the biological material of the first region (claim 18), and (4) selectively treating comprising chemically inducing cell death by radiation (claim 39).
Claims 11 and 13-16 are withdrawn because claim 12 was elected. Claims 19-21 and 29-32 are withdrawn because claim 18 was elected. Claim 38 is withdrawn because claim 39 was elected. Applicant’s cancellation of claim 22 renders the species restriction with respect to claim 22 moot.
Examiner notes the following errors in the original requirement to elect a species. With respect to ‘effect of initiating a change’ claim 29 and claim 34 were erroneously excluded, while claim 39 was erroneously included. Additionally, with respect to ‘selectively treating’, claim 37 was erroneously included and claim 39 was erroneously excluded. The examined claims reflect Applicant’s election of ‘initiating a change comprises causing cell death of the biological material of the first region’ and ‘selectively treating comprises cell death by radiation’ which read on claims 18 and 39, respectively.
.
Claim 33 is withdrawn because it depends on non-elected claim 32.
Thus, claims 1-7, 9-18, 20-21 and 29-74 are pending with claims 1-7, 9, 10, 12, 17-18,35-37 and 39-43 are examined herein.
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 1-7, 9, 10, 12, 17-18, 35-37 and 39-43 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The test of enablement is whether one skilled in the art could make and use the claimed
invention from the disclosures in the patent coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is required is not based on a single factor but is rather a
conclusion reached by weighing many factors (See Ex parte Forman, 230 USPQ 546 (Bd. Pat.
App. & Inter, 1986) and In re Wands, 8USPQ2d 1400 (Fed. Cir. 1988); these factors include the
following:
The claimed invention is drawn to a method of treating a subject comprising: providing a first region of biological material coupled to the subject; initiating a change in a cellular environment of the cells in the first region; and due to a change in biological or chemical activity of the cells in the first region, inducing a biological change in a second region inside the subject. The breadth of the claims embraces treatment of any disease or disorder. Additionally, the breadth of the claims embraces any biological or chemical change in the cellular environment of a first region whereby this first change induces a second biological change such that the subject to be treated for any disease or disorder is treated. The specification fails to provide a working example of treatment of any disease by the claimed method. This is problematic.
This is because the extremely broad scope of the claims and lack of guidance in the specification exacerbates a highly unpredictable art~ treatment with biophotonics. In fact, Anvari (Front. Photon., 22 June 2021; Ref. AX in IDS filed 1/26/24) notes that that despite remarkable achievements and tremendous contributions to life sciences and medicine, there are significant challenges in biophotonics. Inherently, Anvari teaches depth of optical penetration in biological materials remains limited to a few cm. Furthermore, increased optical penetration depth is accompanied by decreased spatial resolution (Pg. 1, para. 4). These are known challenges that are not addressed in the specification. While the results presented in the art do not necessarily preclude Applicant's hypothesis, they certainly fail to support it. Applicants do not provide the details of the diseases or disorders that can be treated by the claimed method nor provide a correlation between the ability to initiate a change in the cellular environment of cells in a first region and treatment of any disease or disorder nor reduce to practice the induction of a biological change in a second region by way of a chemical or biological change in a first region and the treatment of any disease or disorder. Accordingly, the lack of any disclosed direct experimental test of Applicant's hypothesis, shows that one of skill in the art before the effective filing date of the claimed invention would have had no basis to reasonably predict or conclude that any of the broadly embraced diseases or disorders could be treated by the initiation of the broadly recited biological or chemical changes. Though not controlling, the lack of working examples, is, nevertheless, a factor to be considered in a case involving both physiological activity and an undeveloped art. When a patent applicant chooses to forego exemplification and bases utility on broad terminology and general allegations, he runs the risk that unless one with ordinary skill in the art would accept the allegations as obviously valid and correct, the PTO may, properly, ask for evidence to substantiate them. Ex parte Sudilovsky, 21 USPQ2d 1702, 1705 (BPAI 1991); In re Novak, 134 USPA 335 (CCPA 1962); In re Fouche, 169 USPQ 429 (CCPA 1971).
In essence, the specification merely presents an idea of, and leaves it entirely up to the
practitioner to determine whether the method would produce a therapeutically relevant effect,
and if so, how to carry out the claimed method. It has been established by legal decision that a
patent is not a hunting license. It is not a reward for the search, but compensation for its
successful conclusion. Tossing out the germ of an idea does not constitute an enabling
disclosure. While every aspect of a generic claim need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable the skilled artisan to understand and carry out the invention. It is true that a specification need not disclose what is well known in the art. However, that general, oft-repeated statement is merely a rule of supplementation, not a substitute for a basic enabling disclosure. It means that the omission of minor details does not cause a specification to fail to meet the enablement requirement under 35 USC 112, first paragraph. When there is no disclosure of the specific meet the enablement requirement. See Genentech Inc. v. Novo Nordisk A/S, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997). starting materials or conditions under which the process can be carried out, there is a failure to meet the enablement requirement. See Genentech Inc. v. Novo Nordisk A/S, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997).
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Prior Art Rejection 1
Claim(s) 1-4, 18, 35-37 and 39-41 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Oldham et al. (PgPub US20170157418A1, Published 6/8/2017, Filed 2/16/2017; Reference AK in IDS filed 1/26/24).
Regarding claim 1, Oldham et al. discloses a method of treating a subject (Abstract) comprising: providing a first region of biological material coupled to the subject; initiating a change in a cellular environment of the cells in the first region; and due to a change in biological or chemical activity of the cells in the first region, inducing a biological change in a second region inside the subject (Pg. 10, para. 90- “cancer cells can be removed from a diseased site in the patient [first region], and then treated ex-vivo with psoralen and ultraviolet light to induce cell kill [initiate a change in cellular environment] (as in claim 18). The “killed” cancer cells are then as part of an initial treatment or a booster treatment injected into the disease region [second region] of the patient [biological material coupled to subject]. The body in response to these “killed” cells would trigger the patient's immune system [induce a biological change in a second region inside the subject].”).
Regarding claim 2, Oldham discloses defining for the first region a region inside the subject proximate the second region (Pg. 10, para. 90- “cancer cells can be removed from a diseased site in the patient [first region], and then treated ex-vivo .. are ….. injected into the disease region [second region] of the patient”).
Regarding claim 3, Oldham discloses wherein the region inside the subject is formed of the subject's own tissue (Pg. 10,para. 90-“cancer cells can be removed from a diseased site in the patient …”).
Regarding claim 4, Oldham discloses the region inside the subject is biological material
implanted inside the subject (Pg.10, para. 90-“The “killed” cancer cells are then as part of an initial treatment or a booster treatment injected into the disease region of the patient.”).
Regarding claim 35, Oldham discloses wherein the change in the viability of the cells in the first region produces a similar change in the second region of the subject (Pg. 10, para. 90-“cancer cells can be removed from a diseased site in the patient, and then treated ex-vivo with psoralen and ultraviolet light to induce cell kill. The “killed” cancer cells are then as part of an initial treatment or a booster treatment injected into the disease region of the patient. The body in response to these “killed” cells would trigger the patient's immune system (to kill cells in the second region.”).
Regarding claim 36, Oldham discloses wherein providing comprises: surgically defining the first region from a diseased organ in the subject; applying a treatment to the first region to promote cell death; and thereby inducing cell death as the biological change in the second region of the subject (Pg.10, para. 90- “cancer cells can be removed from a diseased site in the patient, and then treated ex-vivo with psoralen and ultraviolet light to induce cell kill. The “killed” cancer cells are then as part of an initial treatment or a booster treatment injected into the disease region of the patient. The body in response to these “killed” cells would trigger the patient's immune system (to kill cells in the second region.”).
Regarding claim 37, Oldham discloses wherein applying a treatment comprises: selectively treating the surgically defined first region to induce cell death (Pg. 10 ,para. 90-; “cancer cells can be removed from a diseased site in the patient, and then treated ex-vivo with psoralen and ultraviolet light to induce cell kill. The “killed” cancer cells are then as part of an initial treatment or a booster treatment injected into the disease region of the patient. The body in response to these “killed” cells would trigger the patient's immune system (to kill cells in the second region.”).
Regarding claim 39, Oldham discloses the selectively treating comprises inducing cell death in the surgically defined first region by radiation (Pg.10, para. 90- “cancer cells can be removed from a diseased site in the patient [first region], and then treated ex-vivo with x-ray activatable psoralen (as in claim 41) (Pg. 1, para. 7) and ultraviolet light (as in claim 40) to induce cell kill. The “killed” cancer cells are then as part of an initial treatment or a booster treatment injected into the disease region of the patient. The body in response to these “killed” cells would trigger the patient's immune system (to kill cells in the second region.).
Accordingly, Oldham anticipates the claimed invention.
Prior Art Rejection 2
Claim(s) 1 and 5-7 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Barrows et al. (PgPub US20040068284A1, Published 4/8/4004, Filed 1/29/2002; Reference AE in IDS filed 1/26/24).
Regarding claim 1, Barrows discloses a method of treating (Pg. 2,para. 27- “hair follicle neogenesis method comprising the steps of”) a subject comprising: providing a first region of biological material coupled to the subject (Pg. 2,para. 28-32 “providing follicle progenitor cells from biopsied hair follicles; Pg. 2, para.32- e) injecting an aliquot of cell clusters (formed from culturing hair follicle cells) into the bleb (interface of dermis (second region) and epidermis (first region) of skin of subject)”; initiating a change in a cellular environment of the cells in the first region (Pg. 1-2,para. 13- “clump of cells mounted on the end of a wire has been injected into the bleb through the cut opening (found on the epidermis)”; and due to a change in biological or chemical activity of the cells in the first region, inducing a biological change in a second region inside the subject (Abstract; growth of new hair in the dermis).
Regarding claim 5, Barrows discloses defining for the first region a region
inside the subject remote from the second region (Pg. 2, para. 31- creating a bleb at the interface between the dermis [second region] and epidermis[first region] of the skin at a site where one or more new hair follicles are desire).
Regarding claim 6, Barrows discloses the region inside the subject is formed of the
subject's own tissue (Pg.1-2, para. 13- the bleb has been punctured with a sharp instrument e.g. a scalpel, (5) and a clump of cells (6) mounted on the end of a wire (7) has been injected into the bleb through the cut opening; Pg. 2-3, para. 33- cells are obtained from the biopsied hair follicles of a live human subject and the patient supplying the biopsy of hair follicles is the same person who receives the injections of cells).
Regarding claim 7, Barrows discloses the region inside the subject is biological material
implanted inside the subject (Pg.2-3, para. 33- cells are obtained from the biopsied hair follicles of a live human subject and the patient supplying the biopsy of hair follicles is the same person who receives the injections of cells).
Accordingly, Barrows anticipates the claimed invention.
Prior Art Rejection 3
Claim(s) 1 and 10 and 12 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Beyer et al. (WO2017189506A1, Published 11/2/2017, Filed 4/25/2017; Reference AO in IDS filed 1/26/24).
Regarding claim 1, Beyer discloses a method of treating a subject (Pg. 23, lines 25-33) comprising: providing a first region of biological material coupled to the subject; initiating a change in a cellular environment of the cells in the first region (Pg. 14, lines 19-32- the insertion device is a microdevice or an array of insertion devices. The insertion devices (first region) in various embodiments can include channels or microchannels for injection (in patient~ coupled to subject) of an activatable agent (biological material); Pg. 25, lines 25-28- an activatable agent may be .. a biological molecule such as a protein, a nucleic acid or lipid; Pg. 25, lines 6-10- when activated, the activatable pharmaceutical agent may affect cellular changes that include, but are not limited to, apoptosis); and due to a change in biological or chemical activity of the cells in the first region, inducing a biological change in a second region inside the subject (Pg. 95, lines 16-24- the insertion device(s) 3 are part of an intravenous ultraviolet implant inserted into blood supply vessel close to a diseased organ; Pg. 24, lines 24-26- when activated, the activatable pharmaceutical agent may affect cellular changes that include, but are not limited to, apoptosis).
Regarding claim 10, Beyer discloses providing comprises segregating the biological material of the first region from the second region by an artificial material (Pg. 14, lines 19-32-; - the insertion devices in various embodiments can include channels or for injection of an activatable agent (biological material); Pg. 15, lines 22-28- In various embodiments, the insertion device(s) 3 are encapsulated in silica or a polymer (i.e. artificial material) for biocompatibility).
Regarding claim 12, Beyer discloses the artificial material comprises a material capable of transmission of biophotons therethrough (Pg. 15, lines 22-28- In various embodiments, the insertion device(s) 3 are encapsulated in silica or a polymer for biocompatibility. The silica or polymer in these embodiments is capable of transmitting the infrared, visible, or ultraviolet light into the medium 4 surrounding the insertion device(s) 3.).
Accordingly, Beyers anticipates the claimed invention.
Claim Rejections - 35 USC § 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 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.
Prior Art Rejection 4
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Oldham et al. (PgPub US20170157418A1, Published 6/8/2017, Filed 2/16/2017; Reference AK in IDS filed 1/26/24) as applied to claims 1-4, 18, 35-37 and 39-41 above, and further in view of Andersson, M. (PgPub US20130041206A1, Published 4/4/2017; Reference AI in IDS filed 1/26/24).
The teachings of Oldham et al. are relied upon as detailed above. However Oldham fails to teach defining for the first region a region inside the subject overlapping the second region (as in claim 9).
Before the effective filing date of the claimed invention, Andersson taught an implant 10 (first region) comprising a barrier member implanted in a recipient having a bone 3, skin 5 and other tissues disposed between the skin and the bone (second region) (Abstract; Pg. 2, para. 41). Andersson notes that the separation of the epidermis from the dermis by the barrier member prevents the epidermis from growing between the dermis and the implant, thereby allowing the dermis to attach to the implant (Pg. 2,para. 38).
When taken with Oldham’s teaching of injecting an implant between an epidermis and a dermis, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Oldham et al. such that the implant of Oldham comprises the barrier member of Andersson in order to reduce the risk of post-implant infection between the dermis of the skin and the implant.
Thus, the combination would have been prima facie obvious.
Prior Art Rejection 5
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Oldham et al. (PgPub US20170157418A1, Published 6/8/2017, Filed 2/16/2017; Reference AK in IDS filed 1/26/24) as applied to claims 1-4, 18, 35-37 and 39-41 above, and further in view of Hu, H (PgPub US20070203655A1, Published 8/30/2007; Reference AF in IDS filed 1/26/24).
The teachings of Oldham et al. are relied upon as detailed above. However Oldham fails to teach the first region and the second region are quantum entangled regions (as in claim 17).
Before the effective filing date of the claimed invention, Hu taught an apparatus which is disposed adjacent to a responsive target such as a person's brain, and plays music on the audio system with a desired output power and for a desired length of time whereby the photons generated by the magnetic coil first quantum-entangle with quantum entities inside the substance (first region), then travel to the biological system and subsequently entangle with the quantum entities inside the biological system (second region) producing non-local effect of the substance on the biological system through quantum entanglement (Abstract; Pg. 3,para. 45).
Hu shares that a benefit of the present invention is that the beneficial effect of a substance such as a medication can be, in one broad embodiment, delivered to a biological system such as a patient from a remote location of arbitrary distance (Pg. 2, para. 24). When taken with the objective of Oldham et al., wherein Oldham is drawn to a method of treating a diseased site in a human, inclusion of the teachings of Hu would have been prima facie obvious. This is because Hu notes an advantage of his system to be ability to remotely deliver medication to a desired site in the human subject.
Thus, for this reason, the combination would have been prima facie obvious.
Prior Art Rejection 7
Claim(s) 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Oldham et al. (PgPub US20170157418A1, Published 6/8/2017, Filed 2/16/2017; Reference AK in IDS filed 1/26/24).as applied to claims 1-4, 18, 35-37 and 39-41 above, and further in view of Pu et al. (PgPub US20080319513A1, Published 12/25/2098; Reference AD in IDS filed 1/26/24).
The teachings of Oldham et al. are relied upon as detailed above. However Oldham fails to teach the biological change in the second region comprises a change in neuron activity (as in claim 42) and wherein the change in neuron activity is stimulation and/or control of neural communication (as in claim 43).
Before the effective filing date of the claimed invention, and with regards to claim 42 and claim 43, Pu et al. taught wherein the biological change in the second region comprises a change in neuron activity and the wherein change in neuron activity is stimulation (Pg. 4 ,para. 43- The controller 313 controls the neural stimulation therapy delivery system 314 to deliver neural stimulation to a neural target [second region] through neural stimulation electrode(s) 318 or using transducers such as transducers that deliver neural stimulation using ultrasound, thermal, light and magnetic energy).
When taken with the objective of Oldham et al., wherein Oldham is drawn to a method of treating a diseased site in a human, inclusion of the teachings of Pu would have been prima facie obvious. This is because Pu teaches a neural stimulation therapy delivery module that is adapted to generate a neural stimulation signal for use in stimulating the autonomic neural target of the patient for the chronic neural stimulation therapy.
Thus, the combination would have been prima facie obvious.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-7, 9, 10, 12, 17-18,35-37 and 39-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/433911 (reference application) in view of Hottinger et al (Neuro Oncol. 2016 Oct; 18(10): 1338–1349; Ref. AY in IDS filed 1/26/24). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Instant claims are drawn to method of treating a subject comprising: providing a first region of biological material coupled to the subject; initiating a change in a cellular environment of the cells in the first region; and due to a change in biological or chemical activity of the cells in the first region, inducing a biological change in a second region inside the subject.
Claim 1 of the ‘911 application is drawn to a method of treating a subject by triggering cell to cell communication comprising: providing a first region of biological material coupled to the subject; initiating a change in a cellular environment of the first region; and due to a change in biological or chemical activity in the first region through cell to cell communication between the first and second region via biophotons, and with assistance of an induced electrical field, wherein the induced electric field is a region of intensified electric field generated by interaction of least one (i) energy emitter, (ii) energy augmentation structure, or (iii) energy collector.
It is clear that all the elements of the application claims are to be found in Claim 1 of the ‘911 application. The difference between instant application claims and claim 1 of the ‘911 application lies in the fact that the ‘911 application limits the means of inducing a biological change (assistance of an electric field). However, such would have been prima facie obvious in view of Hottinger et al. (attached) who teach tumor treating fields (TTFields) are alternating, low-intensity, intermediate frequency electric fields that aim to disrupt cell division and inhibit tumor growth (Pg. 1338). Hottinger teaches an experimental model of rats with intracranially inoculated GBM cells treated with TTFields at a frequency of 200kHz over 6 days showed smaller tumors compared with untreated rats (Pg. 1339, Col. 1, para. 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TITILAYO MOLOYE whose telephone number is (571)270-1094. The examiner can normally be reached on Working Hours: 6 a.m-3:30 p.m. M-F. Off first Friday of biweek.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras Jr. can be reached on (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632
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