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 .
Non-Final Rejection
The Status of Claims:
Claims 1-13 are pending.
Claims 1-13 are rejected.
Claim 1 is objected.
DETAILED ACTION
1. Claims 1-13 are under consideration in this Office Action.
Priority
2. It is noted that this application has a priority of 63533901 08/21/2023.
Drawings
3. The drawings filed on 8/21/24 were accepted by the examiner.
IDS
4. The IDS filed on 12/16/2024 were reviewed by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1 , the term “ form” of the phrase “ the chemical structure selected form ” is recited. This term “ form” is mis-spelled in the claim. Appropriate correction is required.
In claim 1, there is no comma among the list of the PPh-2-3c, PPh-2-6C, PPh-4-3C, PPh-4-6C compounds; also, the term” and “ should be present before the last PPh-4-6C compound. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-13 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 pre-AIA the applicant regards as the invention.
In claim 1, the variable “ n” of the expression of “the chemical structure selected from:
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” is recited. This can be vague and indefinite because the variable “n” is undefined in the claim. The examiner recommends to put the the specific number for the the variable “n” for the chemical structure.
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
The following 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.
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 3-5 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim 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 specification is not enabled for the treatment of any condition in a subject in need thereof, comprising administering therapeutically effective amount of the compound selected from PPH-2-3C, PPh-2-6C, PPH-4-3C, and PPh-4-6C.
The specification falls short because data essential for treating numerous conditions by administering to a subject in need thereof a therapeutically-effective amount of a compound of claim 1.
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The Nature of the Invention
Claim 3 recites the following:
3. A method of treating a condition, the method comprising administering to a subject in need thereof a therapeutically-effective amount of a compound of claim 1 or an antibacterial composition of claim 2, and irradiating the compound.
The State of the Prior Art
The state of the prior art are in the followings:
According to the Wikipedia , it describes that an infection is the invasion of an organism's body tissues by disease-causing agents, their multiplication, and the reaction of host tissues to the infectious agents and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable disease, is an illness resulting from an infection.
Infections can be caused by a wide range of pathogens, most prominently bacteria and viruses. Hosts can fight infections using their immune system. Mammalian hosts react to infections with an innate response, often involving inflammation, followed by an adaptive response.
Specific medications used to treat infections include antibiotics, antivirals, antifungals, antiprotozoals, and antihelminthics. Infectious diseases resulted in 9.2 million deaths in 2013 (about 17% of all deaths). The branch of medicine that focuses on infections is referred to as infectious disease
Infections are caused by infectious agents (pathogens) including:
Bacteria (Mycobacterium tuberculosis, Staphylococcus aureus, Escherichia coli, Clostridium botulinum, and Salmonella spp.)
Viruses and related agents such as viroids (HIV, Rhinovirus, Lyssaviruses such as Rabies virus, Ebolavirus and Severe acute respiratory syndrome coronavirus 2)
Fungi, further subclassified into:
Ascomycota, including yeasts such as Candida, filamentous fungi such as Aspergillus, Pneumocystis species, and dermatophytes, a group of organisms causing infection of skin and other superficial structures in humans. Basidiomycota, including the human-pathogenic genus Cryptococcus.
Prions (although they don't secrete toxins)
Parasites, which are usually divided into:
Unicellular organisms (e.g. malaria, Toxoplasma, Babesia)
Macroparasites[8] (worms or helminths) including nematodes such as parasitic roundworms and pinworms, tapeworms (cestodes), and flukes (trematodes, such as schistosomiasis)
Arthropods such as ticks, mites, fleas, and lice, can also cause human disease, which conceptually are similar to infections, but invasion of a human or animal body by these macroparasites is usually termed infestation. (Diseases caused by helminths, which are also macroparasites, are sometimes termed infestations as well, but are sometimes called infections.
Ji et al (Langmuir 2011 Sep 6;27(17):10763-9) discloses antibacterial activity of conjugated polyelectrolytes with variable chain lengths in the following compound:
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.
However, there are no conclusive data which allow the approval for treating all kinds of conditions including infections by using the effective amount of the claimed compounds.
The amount of direction or guidance present
The direction present in the current specification is that the claimed compounds can be used to treat any condition in a subject. However, the specification does show that gram-positive bacteria Staphylococcus aureus and gram-negative bacterial strains Escherichia coli which can cause the microbial infection were tested by the claimed compounds as shown in Figs 2A-2D, 3A-3B and 4-6.
However, the specification is silent and fails to provide guidance as to whether all kinds of conditions including bacterial or fungal or viral or other types of infections require the claimed compounds in the patient, i.e. the specification fails to provide a correlation between all those conditions including infections and the use of the claimed compounds in the patient. Also, there is no direction and guidance for how all conditions including infections would be cured by using the claimed compounds.
The presence or absence of working examples
There is only one working example for all those conditions including infections-treatment by using the compounds for the evaluation against Staphylococcus aureus, and Escherichia coli. But the claimed compounds disclosed in the specification has no other pharmacological data regarding the treatment of all those conditions including infections using the claimed compounds except for that example. Therefore, the specification fails to provide sufficient working examples as to how many different kinds of conditions including infections can be treated by the claimed compounds in the subject, i.e. again, there is no direct correlation between all those conditions including infections and the claimed compounds.
The breadth of the claims
The breadth of the claim is that the claimed compounds can be used to treat all kinds of conditions including infections mentioned in the above, without regards as to the side-effect of the claimed compounds on the various kinds of conditions including infections.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine which kinds of those conditions including infections would be benefited by the affect of the claimed compounds.
The level of the skill in the art
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which conditions including infections would benefit from this activity.
Thus, the specification fails to provide sufficient support of the broad use of the claimed compounds for treating all kinds of conditions including infections. As a result, necessitating one of skill to perform an exhaustive search for which all the known conditions including infections can be treated by the claimed compounds in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001 (3/13/1997), states that “ a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which conditions including infections can be treated by the compounds encompassed in the current claims, with no assurance of success.
Claims 6-7 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim 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 specification is not enabled for the treatment of any infections in a patient in need thereof, comprising administering to a patient in need thereof a therapeutically effective amount of the of the compound selected from PPH-2-3c, PPh-2-6C, PPH-4-3C, and PPh-4-6C.
The specification falls short because data essential for treating numerous infections caused by a microbe administering to a subject in need thereof a therapeutically-effective amount of a compound of claim 1.
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The Nature of the Invention
Claims 6-7 recite the following:
6. The method of claim 3, wherein the condition is an infection.
7. The method of claim 6, wherein the infection is caused by a microbe.
The State of the Prior Art
The state of the prior art are in the followings:
According to the Wikipedia , it describes that an infection is the invasion of an organism's body tissues by disease-causing agents, their multiplication, and the reaction of host tissues to the infectious agents and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable disease, is an illness resulting from an infection.
Infections can be caused by a wide range of pathogens, most prominently bacteria and viruses. Hosts can fight infections using their immune system. Mammalian hosts react to infections with an innate response, often involving inflammation, followed by an adaptive response.
Specific medications used to treat infections include antibiotics, antivirals, antifungals, antiprotozoals, and antihelminthics. Infectious diseases resulted in 9.2 million deaths in 2013 (about 17% of all deaths). The branch of medicine that focuses on infections is referred to as infectious disease
Infections are caused by infectious agents (pathogens) including:
Bacteria (Mycobacterium tuberculosis, Staphylococcus aureus, Escherichia coli, Clostridium botulinum, and Salmonella spp.)
Viruses and related agents such as viroids (HIV, Rhinovirus, Lyssaviruses such as Rabies virus, Ebolavirus and Severe acute respiratory syndrome coronavirus 2)
Fungi, further subclassified into:
Ascomycota, including yeasts such as Candida, filamentous fungi such as Aspergillus, Pneumocystis species, and dermatophytes, a group of organisms causing infection of skin and other superficial structures in humans. Basidiomycota, including the human-pathogenic genus Cryptococcus.
Prions (although they don't secrete toxins)
Parasites, which are usually divided into:
Unicellular organisms (e.g. malaria, Toxoplasma, Babesia)
Macroparasites[8] (worms or helminths) including nematodes such as parasitic roundworms and pinworms, tapeworms (cestodes), and flukes (trematodes, such as schistosomiasis)
Arthropods such as ticks, mites, fleas, and lice, can also cause human disease, which conceptually are similar to infections, but invasion of a human or animal body by these macroparasites is usually termed infestation. (Diseases caused by helminths, which are also macroparasites, are sometimes termed infestations as well, but are sometimes called infections.
Ji et al (Langmuir 2011 Sep 6;27(17):10763-9) discloses antibacterial activity of conjugated polyelectrolytes with variable chain lengths in the following compound:
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However, there are no conclusive data which allow the approval for treating all kinds of infections by using the effective amount of the claimed compounds.
The amount of direction or guidance present
The direction present in the current specification is that the claimed compounds can be used to treat the microbial infection caused by gram-positive bacteria Staphylococcus aureus and gram-negative bacterial strains Escherichia coli as shown in Figs 2A-2D, 3A-3B and 4-6.
However, the specification is silent and fails to provide guidance as to whether all bacterial or fungal or viral or other types of infections require the claimed compounds in the patient, i.e. the specification fails to provide a correlation between all those infections and the use of the claimed compounds in the patient. Also, there is no direction and guidance for how all infections would be cured by using the claimed compounds.
The presence or absence of working examples
There is only one working example for all those infections-treatment by using the compounds for the evaluation against Staphylococcus aureus, and Escherichia coli.
But, the claimed compounds disclosed in the specification has no other pharmacological data regarding the treatment of all those infections using the claimed compounds except for that example. Therefore, the specification fails to provide sufficient working examples as to how many different infections can be treated by the claimed compounds in the subject, i.e. again, there is no direct correlation between all those infections and the claimed compounds.
The breadth of the claims
The breadth of the claim is that the claimed compounds can be used to treat all kinds of infections mentioned in the above, without regards as to the side-effect of the claimed compounds on the infections.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine which kinds of those infections would be benefited by the affect of the claimed compounds.
The level of the skill in the art
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which infections would benefit from this activity.
Thus, the specification fails to provide sufficient support of the broad use of the claimed compounds for all kinds of infections-treatment. As a result, necessitating one of skill to perform an exhaustive search for which all the known infections can be treated by the claimed compounds in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001 (3/13/1997), states that “ a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which infections can be treated by the compounds encompassed in the current claims, with no assurance of success.
Conclusion
Claims 1-13 are rejected.
Claim 1 is objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 8/21/2026
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