DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
8, 16, 21-26, 28-52 and 54-73
Pending:
1-7, 9-15, 17-20, 27 and 53
Withdrawn:
none
Examined:
1-7, 9-15, 17-20, 27 and 53
Independent:
1, 27 and 53
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x
102, 103
JE
Judicial Exception
x
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
x
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 10/5/2021 filing receipt, this application claims priority to no earlier than 1/22/2019. All claims have been interpreted as being accorded this priority date.
Objection to the drawings
The 9/30/2021 supplemental drawings are objected to for lack of quality and/or readability in some figures (e.g. 1A, 1B, etc.). Labels and pertinent features of figures must be legible. The drawings are of insufficient quality to permit examination. MPEP 608.02(b).I and generally 608 pertain. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled "Replacement Sheet" in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If filing electronically, then possibly higher resolution drawings should be filed as "Supplemental Content." If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Objection to the specification: title
The title should be amended to more specifically reflect the claims, particularly the independent claims and referencing steps/elements: setting the context of the invention, particular to all claims, and distinguishing the instant application from any related applications, for example a title including terms such as: cloud-based. The title should be "descriptive" and "as... specific as possible" (MPEP 606, 1st para. and 37 CFR 1.72; also MPEP 606.01 pertains).
Claim rejections - 112/b
The following is a quotation of 35 USC 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.
Claims 1-7, 9-15, 17-20, 27 and 53 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable.
The following issues cause the respective claims to be rejected under 112/b as indefinite:
Claim
Recitation
Comment (suggestions in bold)
1, 27
..., comprising:...
It is unclear what is the subject of this verb "comprising." Possibly: "..., said method comprising:..." Claim 27 is rejected similarly. Compare claim 53 not rejected here.
1, 27, 53
(b) ...
which set of genomic or phenotype data is generated from processing
In claim 1, it is unclear whether the recited step "...is generated..." (i) should be interpreted as product-by-process (PbP) or (ii) requires the step to be performed as part of the claimed "method."
(i) If PbP, then the recited "...data" is limited according to any structure clearly required by the recited PbP limitation of having been "generated." The recited process of having been "generated" is not itself claimed and is limiting only to the extent that the structure of the "models" is clearly required to be limited by that process or step. Regarding product-by-process limitations in method claims, MPEP 2113 pertains, as well as, for example, Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 9-28-2020, precedential).
(ii) If not PbP, then it should be clarified that the "generated" step is required as part of the recited "method." Generally, if the language of a claim, given its broadest reasonable interpretation, is such that PHOSITA would read it with more than one reasonable interpretation, then a rejection under 35 U.S.C. 112(b) is appropriate.
For compact examination, (i) is assumed. To achieve (i) without rendering the claim indefinite, the claim might be amended to, for example, "...previously was generated..."
Claims 27 and 53 are analyzed and rejected similarly. If (ii) applies to either of claims 27 or 53, then it should be clear that there is written description support for computer software to perform, i.e. for automation of, the "is generated" step.
27
A computer system..., comprising:
a cloud-based computer system comprising a network interface...
Claim 27 is to a 101 machine or manufacture, i.e. a "computer system" in this instance, interpreted by statute according to its claimed physical structure, but it is not clear what is the structure associated with the recited "cloud-based computer system comprising a network interface...," which elements read on data in the form of software without an inherent structural embodiment. Therefore, it is not clear whether the claim is limited according to this element. MPEP 2106.03, 5th-6th paras. pertain. Structure should be recited specifically corresponding to this element. This rejection might be overcome by, for example, reciting a data storage device, comprised by the claimed "computer system," and software stored therein and configured according to the recited "cloud-based computer system" and "network interface."
27
A computer system..., comprising:
a cloud-based computer system comprising a network interface that is in network communication with said first digital computer of said first user and said second digital computer of said second user;
Claim 27 claims a "computer system," interpreted as a claim to a 101 machine or manufacture (as opposed to a claim to a 101 process). As such, the claim is interpreted according to its claimed structure. It is not clear whether either, both or neither of the recited "first digital computer" of the first user and "second digital computer" of the second user is structurally comprised by the claimed "computer system."
27
...are individually collectively programmed...
The recited "individually collectively" is not interpretable.
53
machine-executable
code that... implements
Claim 53 is rejected as directly reciting a manufacture and a process in the same claim. A claim to a manufacture, e.g. here a "computer-readable medium," cannot directly recite a process step such as "implementes." MPEP 2173.05(p).II pertains. It may suffice to add "configured to" before the process step so as properly focus on claimed structure, e.g. "...code that is configured to implement, upon execution by one or more computer processors, a method..."
. Regarding any software-embodied steps, it should be clear whether such steps are in fact software-embodied, and it should be clear whether such software is comprised by the claimed machine or manufacture. MPEP 2173.05(p).II pertains regarding a claim directed to both product and process.
Claim rejections - 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 USC 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 35 USC 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 of this title, 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.
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 USC 102(b)(2)(C) for any potential 35 USC 102(a)(2) prior art against the later invention.
Claims 1-7, 9-15, 17-20, 27 and 53 are rejected under 35 USC 103 as unpatentable over Nelson (US PGPUB 2015/0227697 as cited on the 1/2/2025 IDS).
Nelson teaches each of the limitations as described below, however Nelson does not teach the limitations in a single embodiment in the same, consecutive sequence as recited. It would have been prima facie obvious to try the recited sequence as an example of combining prior art elements taught within the same reference according to known methods to yield predictable results.
Regarding claim 1, Nelson teaches the recited computer-implemented method for cloud-based genomic or phenotype data access among digital computers (Nelson: [12]; and entire document) including receiving a request (Nelson: [11]; and entire document) and permitting access (Nelson: [12]; and entire document).
Regarding claim 2, Nelson teaches the recited transferring (Nelson: [12]; and entire document).
Regarding claim 3, Nelson teaches the recited (i) permitting access or (ii) transferring (Nelson: [11-12]; and entire document).
Regarding claim 4, Nelson teaches the recited receiving (Nelson: [11-12]; and entire document).
Regarding claims 5-6, Nelson teaches the recited second set of data (Nelson: [11-12 and 15]; and entire document). Also, repetition of previously recited steps and/or elements such as processing second set of data would have been prima facie obvious (MPEP 2143 E., Example 9 pertains).
Regarding claim 7, Nelson teaches the recited user is the subject (Nelson: [41]; and entire document).
Regarding claims 9-10, Nelson teaches the recited item of value (Nelson: [69]; and entire document).
Regarding claim 11, Nelson teaches the recited company (Nelson: [67]; and entire document).
The art is applied to claim 12 as described above for claims 7 and 11.
Regarding claim 13, Nelson teaches the recited user account (Nelson: [51]; and entire document).
Regarding claims 14-15, Nelson teaches the recited health-related information (Nelson: [8]; and entire document).
Regarding claim 17, Nelson teaches the recited user management and granting access (Nelson: [12]; and entire document).
Regarding claim 18, Nelson teaches the recited graphical user interface (Nelson: [16]; and entire document).
Regarding claim 19, Nelson teaches the recited mobile or web application (Nelson: [51]; and entire document).
Regarding claim 20, Nelson teaches the recited private cloud (Nelson: [46, 69 and 85]; and entire document).
The are is applied to claims 27 and 53 similarly to the above claims. Nelson further discloses one or more computer processors operatively coupled to said cloud-based computer system, wherein said one or more computer processors are individual or collectively programmed and a non-transitory computer-readable medium comprising machine-executable code that, upon execution by one or more computer processors, (Nelson: [11 and 81]; and entire document).
Claim rejections - 101
35 USC 101 reads:
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.
For each rejection below, dependent claims are rejected similarly as not remedying the rejection, unless otherwise noted.
Judicial exceptions (JE) to 101 patentability
Claims 1-7, 9-15, 17-20, 27 and 53 are rejected under 35 USC 101 because the claimed inventions are not directed to patent eligible subject matter. After consideration of relevant factors with respect to each claim as a whole, each claim is directed to one or more JEs (i.e. an abstract idea, a natural phenomenon, a law of nature and/or a product of nature), as identified below. Any elements or combination of elements beyond the JE(s) (i.e. "additional elements") are conventional and do not constitute significantly more than the JE(s). Thus, no claim includes additional elements amounting to significantly more than the JE(s), as explained below.
In Alice, citing Mayo and Bilski, two Mayo/Alice questions determine eligibility under 101: First, is a claim directed to a JE? And second, if so, does the claim recite significantly more than the JE?
MPEP 2106 organizes JE analysis into Steps 1, 2A (1st & 2nd prongs) and 2B as follows below.
MPEP 2106 and the following USPTO website provide further explanation and case law citations: www.uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter? -- MPEP 2106.I and 2106.03
[Step 1: claims 1-7, 9-15, 17-20, 27 and 53: YES]
Step 2A, 1st prong: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea? -- abstract idea -- MPEP 2106.I and 2106.04
Preliminarily, in a 1st prong of Step 2A, elements of independent claim 1 are interpreted as directed to the abstract idea of controlling cloud-based genomic or phenotype data access including the JE elements of "permitting... to access... data...," each of which, including all recitation within each listed element, in at least some embodiments within a BRI, involves only manipulation of data. While manipulation of data is not per se directed to an abstract idea, in this instance the above-identified elements are directed to the abstract ideas identified below.
Claims 27 and 53 are analyzed similarly.
BRIs of the claims are analogous to an abstract idea in the form of at least a mental process, at least equivalent to a computer-implemented process, including obtaining and comparing intangible data (e.g. Cybersource, Synopsys and Electric Power Group). In a BRI, it is not clear that the claim embodiments are limited so as to require complexity precluding analogy to a mental process.
BRIs of the claims are analogous to an abstract idea in the form of at least a method of organizing human activity, such as the practice of a technologist, scientist, medical professional or a computer performing analogous functions (e.g. BASCOM, BSG, Meyer as cited in MPEP 2106).
The preceding case law examples are cited for the basic form of their identified abstract ideas, and analogy to these example abstract ideas need not be within the same technology field, 101 analysis generally being assumed to be neutral with respect to technology field.
As in Alice (at 306, as cited in the MPEP above) and Bilski (as cited in Alice, id), an abstract idea may comprise multiple abstract elements or steps (i.e. from Alice: "a series of steps" at 306) and need not be a single equation, relationship or principle.
It is not clear that the identified elements must represent other than an abstract idea according to any relevant analysis or case law.
[Step 2A, 1st prong, abstract idea: claims 1, 27 and 53: YES]
Step 2A, 2nd prong: If the claims recite a judicial exception under the 1st prong, then is the judicial exception integrated into a practical application? -- MPEP 2106.I and 2106.04(d)
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
In Step 2A, 1st prong above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In Step 2B below, any remaining steps and/or elements are therefore in addition to the identified JE(s). Any such additional steps and additional elements are further discussed in Step 2B.
Here in Step 2A, 2nd prong, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
At this point in examination it is not yet the case that any of the Step 2A, 2nd prong considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record.
For example, regarding the first consideration at MPEP 2106.04(d)(1), the record, including for example the specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement (e.g. specification: [2, 122]).
[Step 2A, 2nd prong: claims 1, 27 and 53: NO]
Step 2B: Do the claims recite a non-conventional arrangement of additional elements in addition to the identified JEs? -- MPEP 2106.I and 2106.05
Addressing the second Mayo/Alice question, all elements of claims 1, 27 and 53 are part of one or more identified JEs (as described above), except for elements identified here as conventional elements in addition to the above judicial exceptions:
The recited cloud-based computer system components and receiving and transferring are conventional elements of a computing environment and/or conventional data gathering/input/output elements, as exemplified in MPEP 2106.05(d).II and 2106.05(f-g), and as exemplified by Nelson (US PGPUB 2015/0227697 as cited on the 1/2/2025 IDS), and generally it is understood that the examples in the reference are well-known and routine.
Data gathering does not impose any meaningful limitation on the judicial exceptions or on how the judicial exceptions are performed. Data gathering is insufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)).
It is emphasized that, outside of an improvement argument, analysis of what is conventional generally pertains to the above-identified additional elements and not to elements identified as part of a JE.
[Step 2B: claims 1, 27 and 53: NO]
Summary and conclusion regarding claims 1, 27 and 53
Summing up the above analysis of claims 1, 27 and 53, each viewed as a whole and considering all elements individually and in combination, no claim recites limitations that transform the claim, finally interpreted as directed to the identified JE(s), into patent eligible subject matter, and it is not clear that any claim is sufficiently analogous to controlling case law identifying an example of an eligible claim.
Remaining claims
Claims 2-7, 9-15 and 17-20 add elements which also are part of the identified JEs for the same reasons described above regarding the independent claims and therefore do not provide the something significantly more necessary to satisfy 101. Or, the dependent claims further recite conventional elements of a computing environment and/or conventional data gathering/input/output elements, as exemplified in MPEP 2106.05(d).II and 2106.05(f-g), and as exemplified by Nelson (US PGPUB 2015/0227697 as cited on the 1/2/2025 IDS), and generally it is understood that the examples in the reference are well-known and routine.
None of the dependent claim elements provides the something significantly more than the identified JE(s) necessary to satisfy 101.
Nonstatutory double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine to prevent the improper timewise extension of the "right to exclude" granted by a patent and to prevent multiple suits against an accused infringer by different assignees of the same invention (MPEP 804.II.B, 1st para.). A nonstatutory double patenting rejection is appropriate where the conflicting claims (instant v. reference) are not identical, but an examined-application claim (instant claim) is not patentably distinct from a reference claim because the instant claim is either anticipated by, or would have been obvious over, the reference claim (MPEP 804.II.B, 2nd para.).
In cases of double patenting rejections versus reference claims of pending applications, as opposed to claims of an issued patent, the rejections are provisional because the reference claims have not been patented. Presently, no rejections are provisional.
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 application or patent of the reference claim either is shown to be commonly owned with the instant application or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must comply fully with 37 CFR 3.73(b).
Applicant may wish to consider electronically filing a terminal disclaimer (MPEP 1490.V pertains, along with https://www.uspto.gov/patents-application-process/applying-online/eterminal-disclaimer). Electronic filing may lead to faster approval of the disclaimer. Also, if filing electronically, Applicant is encouraged to notify the examiner by telephone so that examination may resume more quickly.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Double patenting rejections of instant claims 1-7, 9-15, 17-20, 27 and 53
Instant claims 1-7, 9-15, 17-20, 27 and 53 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference application 17/963,651 in view of Nelson (US PGPUB 2015/0227697 as cited on the 1/2/2025 IDS) and Mata-Fink (WO 2015/153102 as cited on the attached Form 892).
The reference application as well as the instant application recite claims which involve genomic or phenotype data, a request to provide access and providing access.
Although the reference claims are not identical to the instant claims, in a BRI they also are not patentably distinct from the instant claims: either (i) because the instant claims recite obviously equivalent or broader limitations in comparison to the reference claims or (ii) because the instant claims recite limitations which are obvious over the cited art. It is not clear that the instant claims recite limitations which are narrower than limitations in the reference claims.
It would have been obvious in view of the cited art to modify reference claims to arrive at the rejected instant claims. Either the instant limitations are interpreted as reading on a reference limitation, or the instant limitations would have been obvious in view of the cited art. That is, to the extent that any instant claims are narrower than reference claims, then any such narrowing would have been obvious over the cited art.
Citations to art
In the above citations to documents in the art, rejections refer to the portions of each document cited as example portions as well as to the entirety of each document, unless otherwise noted in the situation of lengthy, multi-subject documents. Other passages not specifically cited within a document may apply as well.
Conclusion
No claim is allowed.
A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
Inquiries
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The Electronic Business Center (EBC) at 866-217-9197 (toll-free) is available for additional questions, and assistance from a Customer Service Representative is available at 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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